Fluoxetine
Fluoxetine Hydrochloride · Capsule · Oral
Uses
Fluoxetine is indicated for the treatment of: Acute and maintenance treatment of Major Depressive Disorder [see Clinical Studies (14.1) ] . Acute and maintenance treatment of obsessions and compulsions in patients with Obsessive Compulsive Disorder (OCD) [see Clinical Studies (14.2) ] . Acute and maintenance treatment of binge-eating and vomiting behaviors in patients with moderate to severe Bulimia Nervosa [see Clinical Studies (14.3) ] . Acute treatment of Panic Disorder, with or without agoraphobia [see Clinical Studies (14.4) ] . Fluoxetine and Olanzapine in Combination is indicated for the treatment of: Acute treatment of depressive episodes associated with Bipolar I Disorder. Treatment resistant depression (Major Depressive Disorder in patients, who do not respond to 2 separate trials of different antidepressants of adequate dose and duration in the current episode). Fluoxetine monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder or the treatment of treatment resistant depression. When using fluoxetine and olanzapine in combination, also refer to the Clinical Studies section of the package insert for Symbyax ® . Fluoxetine capsules are a selective serotonin reuptake inhibitor indicated for: Acute and maintenance treatment of Major Depressive Disorder (MDD) ( 1 ) Acute and maintenance treatment of Obsessive Compulsive Disorder (OCD) ( 1 ) Acute and maintenance treatment of Bulimia Nervosa ( 1 ) Acute treatment of Panic Disorder, with or without agoraphobia ( 1 ) Fluoxetine capsules and olanzapine in combination for treatment of: Acute Depressive Episodes Associated with Bipolar I Disorder ( 1 ) Treatment Resistant Depression ( 1 )
Dosage and administration
Indication Adult Pediatric MDD ( 2.1 ) 20 mg/day in am (initial dose) 10 to 20 mg/day (initial dose) OCD ( 2.2 ) 20 mg/day in am (initial dose) 10 mg/day (initial dose) Bulimia Nervosa ( 2.3 ) 60 mg/day in am Panic Disorder ( 2.4 ) 10 mg/day (initial dose) Depressive Episodes Associated with Bipolar I Disorder ( 2.5 ) Oral in combination with olanzapine: 5 mg of oral olanzapine and 20 mg of fluoxetine once daily (initial dose) Oral in combination with olanzapine: 2.5 mg of oral olanzapine and 20 mg of fluoxetine once daily (initial dose) Treatment Resistant Depression ( 2.6 ) Oral in combination with olanzapine: 5 mg of oral olanzapine and 20 mg of fluoxetine once daily (initial dose) A lower or less frequent dosage should be used in patients with hepatic impairment, the elderly, and for patients with concurrent disease or on multiple concomitant medications ( 2.7 ) Fluoxetine capsules and olanzapine in combination: Dosage adjustments should be made with the individual components according to efficacy and tolerability ( 2.5 , 2.6 ) Fluoxetine monotherapy is not indicated for the treatment of Depressive Episodes associated with Bipolar I Disorder or treatment resistant depression ( 2.5 , 2.6 ) Safety of the coadministration of doses above 18 mg olanzapine with 75 mg fluoxetine has not been evaluated in adults ( 2.5 , 2.6 ) Safety of the coadministration of doses above 12 mg olanzapine with 50 mg fluoxetine has not been evaluated in children and adolescents ages 10 to 17 ( 2.5 ) 2.1 Major Depressive Disorder Initial Treatment Adult — Initiate fluoxetine 20 mg/day orally in the morning. Consider a dose increase after several weeks if insufficient clinical improvement is observed. Administer doses above 20 mg/day once daily in the morning or twice daily (i.e., morning and noon). The maximum fluoxetine dose should not exceed 80 mg/day. In controlled trials used to support the efficacy of fluoxetine, patients were administered morning doses ranging from 20 mg/day to 80 mg/day. Studies comparing fluoxetine 20 mg/day, 40 mg/day, and 60 mg/day to placebo indicate that 20 mg/day is sufficient to obtain a satisfactory response in Major Depressive Disorder in most cases [see Clinical Studies (14.1) ]. Pediatric (children and adolescents) — Initiate Fluoxetine 10 mg/day or 20 mg/day. After 1 week at 10 mg/day, increase the dose to 20 mg/day. However, due to higher plasma levels in lower weight children, the starting and target dose in this group may be 10 mg/day. Consider a dose increase to 20 mg/day after several weeks if insufficient clinical improvement is observed. In the short-term (8 to 9 week) controlled clinical trials of fluoxetine supporting its effectiveness in the treatment of Major Depressive Disorder, patients were administered fluoxetine doses of 10 to 20 mg/day [see Clinical Studies (14.1) ]. All patients — As with other drugs effective in the treatment of Major Depressive Disorder, the full effect may be delayed until 4 weeks of treatment or longer. Periodically reassess to determine the need for maintenance treatment. Switching Patients to a Tricyclic Antidepressant (TCA) — Dosage of a TCA may need to be reduced, and plasma TCA concentrations may need to be monitored temporarily when fluoxetine is coadministered or has been recently discontinued [see Warnings and Precautions (5.2) and Drug Interactions (7.7) ]. 2.2 Obsessive Compulsive Disorder Initial Treatment Adult — Initiate fluoxetine 20 mg/day, orally in the morning. Consider a dose increase after several weeks if insufficient clinical improvement is observed. The full therapeutic effect may be delayed until 5 weeks of treatment or longer. Administer doses above 20 mg/day once daily in the morning or twice daily (i.e., morning and noon). A dose range of 20 mg/day to 60 mg/day is recommended; however, doses of up to 80 mg/day have been well tolerated in open studies of OCD. The maximum fluoxetine dose should not exceed 80 mg/day. In the controlled clinical trials of fluoxetine supporting its effectiveness in the treatment of OCD, patients were administered fixed daily doses of 20 mg, 40 mg, or 60 mg of fluoxetine or placebo [see Clinical Studies (14.2) ]. In one of these studies, no dose-response relationship for effectiveness was demonstrated. Pediatric (children and adolescents) — In adolescents and higher weight children, initiate treatment with a dose of 10 mg/day. After 2 weeks, increase the dose to 20mg/day. Consider additional dose increases after several more weeks if insufficient clinical improvement is observed. A dose range of 20 mg/day to 60 mg/day is recommended. In lower weight children, initiate treatment with a dose of 10 mg/day. Consider additional dose increases after several more weeks if insufficient clinical improvement is observed. A dose range of 20 mg/day to 30 mg/day is recommended. Experience with daily doses greater than 20 mg is very minimal, and there is no experience with doses greater than 60 mg. In the controlled clinical trial of fluoxetine supporting its effectiveness in the treatment of OCD, patients were administered fluoxetine doses in the range of 10 mg/day to 60 mg/day [see Clinical Studies (14.2) ]. Periodically reassess to determine the need for treatment. 2.3 Bulimia Nervosa Initial Treatment — Administer fluoxetine 60 mg/day in the morning. For some patients it may be advisable to titrate up to this target dose over several days. Fluoxetine doses above 60 mg/day have not been systematically studied in patients with bulimia. In the controlled clinical trials of fluoxetine supporting its effectiveness in the treatment of Bulimia Nervosa, patients were administered fixed daily fluoxetine doses of 20 or 60 mg, or placebo [see Clinical Studies (14.3) ] . Only the 60 mg dose was statistically significantly superior to placebo in reducing the frequency of binge-eating and vomiting. Periodically reassess to determine the need for maintenance treatment.
Dosage forms and strengths
Fluoxetine capsules, USP 10 mg** are white to off white powder filled in size “4” hard gelatin capsules with opaque light blue colored cap and opaque light orange colored body imprinted “SG” on cap and “113” on body with black ink. Fluoxetine capsules, USP 20 mg** are white to off white powder filled in size “2” hard gelatin capsules with opaque light blue colored cap and opaque light green colored body imprinted “SG” on cap and “114” on body with black ink. Fluoxetine capsules, USP 40 mg** are white to off white powder filled in size “0” hard gelatin capsules with opaque light blue colored cap and opaque white colored body imprinted “SG” on cap and “115” on body with black ink. **Fluoxetine base equivalent. Capsules: 10 mg, 20 mg, and 40 mg ( 3 )
Contraindications
When using fluoxetine capsules and olanzapine in combination, also refer to the Contraindications section of the package insert for Symbyax. Serotonin Syndrome and MAOIs: Do not use MAOIs intended to treat psychiatric disorders with fluoxetine or within 5 weeks of stopping treatment with fluoxetine. Do not use fluoxetine within 14 days of stopping an MAOI intended to treat psychiatric disorders. In addition, do not start fluoxetine in a patient who is being treated with linezolid or intravenous methylene blue ( 4.1 ) Pimozide: Do not use. Risk of QT prolongation and drug interaction ( 4.2 , 5.11 , 7.7 , 7.8 ) Thioridazine: Do not use. Risk of QT interval prolongation and elevated thioridazine plasma levels. Do not use thioridazine within 5 weeks of discontinuing fluoxetine. Do not use thioridazine within 5 weeks of discontinuing fluoxetine ( 4.2 , 5.11 , 7.7 , 7.8 ) When using fluoxetine and olanzapine in combination, also refer to the Contraindications section of the package insert for Symbyax ( 4 ) 4.1 Monoamine Oxidase Inhibitors (MAOIs) The use of MAOIs intended to treat psychiatric disorders with fluoxetine or within 5 weeks of stopping treatment with fluoxetine is contraindicated because of an increased risk of serotonin syndrome. The use of fluoxetine within 14 days of stopping an MAOI intended to treat psychiatric disorders is also contraindicated [see Dosage and Administration (2.9) and Warnings and Precautions (5.2) ]. Starting fluoxetine in a patient who is being treated with MAOIs such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome [see Dosage and Administration (2.10) and Warnings and Precautions (5.2) ]. 4.2 Other Contraindications The use of fluoxetine is contraindicated with the following: Pimozide [see Warnings and Precautions (5.11) and Drug Interactions (7.7 , 7.8) ] Thioridazine [see Warnings and Precautions (5.11) and Drug Interactions (7.7 , 7.8) ] Pimozide and thioridazine prolong the QT interval. Fluoxetine can increase the levels of pimozide and thioridazine through inhibition of CYP2D6. Fluoxetine can also prolong the QT interval.
Warnings and precautions
When using fluoxetine and olanzapine in combination, also refer to the Warnings and Precautions section of the package insert for Symbyax. Suicidal Thoughts and Behaviors in Children, Adolescents, and Young Adults: Monitor for clinical worsening and suicidal thinking and behavior ( 5.1 ) Serotonin Syndrome: Serotonin syndrome has been reported with SSRIs and SNRIs, including fluoxetine, both when taken alone, but especially when co-administered with other serotonergic agents. If such symptoms occur, discontinue fluoxetine and serotonergic agents and initiate supportive treatment. If concomitant use of fluoxetine with other serotonergic drugs is clinically warranted, patients should be made aware of a potential increased risk for serotonin syndrome, particularly during treatment initiation and dose increases ( 5.2 ) Allergic Reactions and Rash: Discontinue upon appearance of rash or allergic phenomena ( 5.3 ) Activation of Mania/Hypomania: Screen for Bipolar Disorder and monitor for mania/hypomania ( 5.4 ) Seizures: Use cautiously in patients with a history of seizures or with conditions that potentially lower the seizure threshold ( 5.5 ) Altered Appetite and Weight: Significant weight loss has occurred ( 5.6 ) Incresed Risk of Bleeding: May increase the risk of bleeding. Use with NSAIDs, aspirin, warfarin, or other drugs that affect coagulation may potentiate the risk of gastrointestinal or other bleeding ( 5.7 ) Angle-Closure Glaucoma: Angle-closure glaucoma has occurred in patients with untreated anatomically narrow angles treated with antidepressants ( 5.8 ) Hyponatremia: Has been reported with fluoxetine in association with syndrome of inappropriate antidiuretic hormone (SIADH). Consider discontinuing if symptomatic hyponatremia occurs ( 5.9 ) Anxiety and Insomnia: May occur ( 5.10 ) QT Prolongation: QT prolongation and ventricular arrhythmia including Torsades de Pointes have been reported with fluoxetine use. Use with caution in conditions that predispose to arrhythmias or increased fluoxetine exposure. Use cautiously in patients with risk factors for QT prolongation ( 4.2 , 5.11 ) Potential for Cognitive and Motor Impairment: Has potential to impair judgment, thinking, and motor skills. Use caution when operating machinery ( 5.13 ) Long Half-Life: Changes in dose will not be fully reflected in plasma for several weeks ( 5.14 ) Fluoxetine and Olanzapine in Combination: When using fluoxetine and olanzapine in combination, also refer to the Warnings and Precautions section of the package insert for Symbyax ( 5.16 ) Sexual Dysfunction: Fluoxetine may cause symptoms of sexual dysfunction ( 5.17 ) 5.1 Suicidal Thoughts and Behaviors in Children, Adolescents, and Young Adults Patients with Major Depressive Disorder (MDD), both adult and pediatric, may experience worsening of their depression and/or the emergence of suicidal ideation and behavior (suicidality) or unusual changes in behavior, whether or not they are taking antidepressant medications, and this risk may persist until significant remission occurs. Suicide is a known risk of depression and certain other psychiatric disorders, and these disorders themselves are the strongest predictors of suicide. There has been a long-standing concern, however, that antidepressants may have a role in inducing worsening of depression and the emergence of suicidality in certain patients during the early phases of treatment. Pooled analyses of short-term placebo-controlled trials of antidepressant drugs (SSRIs and others) showed that these drugs increase the risk of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults (ages 18 to 24) with Major Depressive Disorder (MDD) and other psychiatric disorders. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction with antidepressants compared to placebo in adults aged 65 and older. The pooled analyses of placebo-controlled trials in children and adolescents with MDD, Obsessive Compulsive Disorder (OCD), or other psychiatric disorders included a total of 24 short-term trials of 9 antidepressant drugs in over 4,400 patients. The pooled analyses of placebo-controlled trials in adults with MDD or other psychiatric disorders included a total of 295 short-term trials (median duration of 2 months) of 11 antidepressant drugs in over 77,000 patients. There was considerable variation in risk of suicidality among drugs, but a tendency toward an increase in the younger patients for almost all drugs studied. There were differences in absolute risk of suicidality across the different indications, with the highest incidence in MDD. The risk differences (drug versus placebo), however, were relatively stable within age strata and across indications. These risk differences (drug-placebo difference in the number of cases of suicidality per 1,000 patients treated) are provided in Table 2. Table 2: Suicidality per 1,000 Patients Treated Age Range Drug-Placebo Difference in Number of Cases of Suicidality per 1,000 Patients Treated Increases Compared to Placebo <18 14 additional cases 18-24 5 additional cases Decreases Compared to Placebo 25-64 1 fewer case ≥65 6 fewer cases No suicides occurred in any of the pediatric trials. There were suicides in the adult trials, but the number was not sufficient to reach any conclusion about drug effect on suicide. It is unknown whether the suicidality risk extends to longer-term use, i.e., beyond several months. However, there is substantial evidence from placebo-controlled maintenance trials in adults with depression that the use of antidepressants can delay the recurrence of depression.
Side effects
The following adverse reactions are discussed in more detail in other sections of the labeling: Suicidal Thoughts and Behaviors in Children, Adolescents, and Young Adults [see Boxed Warning and Warnings and Precautions (5.1) ] Serotonin Syndrome [see Warnings and Precautions (5.2) ] Allergic Reactions and Rash [see Warnings and Precautions (5.3) ] Screening Patients for Bipolar Disorder and Monitoring for Mania/Hypomania [see Warnings and Precautions (5.4) ] Seizures [see Warnings and Precautions (5.5) ] Altered Appetite and Weight [see Warnings and Precautions (5.6) ] Increased Risk of Bleeding [see Warnings and Precautions (5.7) ] Angle-Closure Glaucoma [see Warnings and Precautions (5.8) ] Hyponatremia [see Warnings and Precautions (5.9) ] Anxiety and Insomnia [see Warnings and Precautions (5.10) ] QT Prolongation [see Warnings and Precautions (5.11) ] Potential for Cognitive and Motor Impairment [see Warnings and Precautions (5.13) ] Discontinuation Adverse Reactions [see Warnings and Precautions (5.15) ] Sexual Dysfunction [see Warnings and Precautions (5.17) ] When using fluoxetine and olanzapine in combination, also refer to the Adverse Reactions section of the package insert for Symbyax. Most common adverse reactions (≥5% and at least twice that for placebo) associated with: Major Depressive Disorder, Obsessive Compulsive Disorder, Bulimia, and Panic Disorder: abnormal dreams, abnormal ejaculation, anorexia, anxiety, asthenia, diarrhea, dry mouth, dyspepsia, flu syndrome, impotence, insomnia, libido decreased, nausea, nervousness, pharyngitis, rash, sinusitis, somnolence, sweating, tremor, vasodilatation, and yawn ( 6.1 ) Fluoxetine and olanzapine in combination – Also refer to the Adverse Reactions section of the package insert for Symbyax ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact ScieGen Pharmaceuticals Inc at 1-855-724-3436 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect or predict the rates observed in practice. Multiple doses of fluoxetine have been administered to 10,782 patients with various diagnoses in US clinical trials. In addition, there have been 425 patients administered fluoxetine in panic clinical trials. The stated frequencies represent the proportion of individuals who experienced, at least once, a treatment-emergent adverse reaction of the type listed. A reaction was considered treatment-emergent if it occurred for the first time or worsened while receiving therapy following baseline evaluation. Incidence in Major Depressive Disorder, OCD, bulimia, and Panic Disorder placebo-controlled clinical trials (excluding data from extensions of trials) — Table 3 enumerates the most common treatment-emergent adverse reactions associated with the use of fluoxetine (incidence of at least 5% for fluoxetine and at least twice that for placebo within at least 1 of the indications) for the treatment of Major Depressive Disorder, OCD, and bulimia in US controlled clinical trials and Panic Disorder in US plus non-US controlled trials. Table 5 enumerates treatment-emergent adverse reactions that occurred in 2% or more patients treated with fluoxetine and with incidence greater than placebo who participated in US Major Depressive Disorder, OCD, and bulimia controlled clinical trials and US plus non-US Panic Disorder controlled clinical trials. Table 4 provides combined data for the pool of studies that are provided separately by indication in Table 3. Table 3: Most Common Treatment-Emergent Adverse Reactions: Incidence in Major Depressive Disorder, OCD, Bulimia, and Panic Disorder Placebo-Controlled Clinical Trials 1,2 Percentage of Patients Reporting Event Major Depressive Disorder OCD Bulimia Panic Disorder 1 Incidence less than 1%. 2 Includes US data for Major Depressive Disorder, OCD, Bulimia, and Panic Disorder clinical trials, plus non-US data for Panic Disorder clinical trials. 3 Denominator used was for males only (N=690 fluoxetine Major Depressive Disorder; N=410 placebo Major Depressive Disorder; N=116 fluoxetine OCD; N=43 placebo OCD; N=14 fluoxetine bulimia; N=1 placebo bulimia; N=162 fluoxetine panic; N=121 placebo panic). Body System/Adverse Reaction Fluoxetine (N=1,728) Placebo (N=975) Fluoxetine (N=266) Placebo (N=89) Fluoxetine (N=450) Placebo (N=267) Fluoxetine (N=425) Placebo (N=342) Body as a Whole Asthenia 9 5 15 11 21 9 7 7 Flu syndrome 3 4 10 7 8 3 5 5 Cardiovascular System Vasodilatation 3 2 5 -- 2 1 1 -- Digestive System Nausea 21 9 26 13 29 11 12 7 Diarrhea 12 8 18 13 8 6 9 4 Anorexia 11 2 17 10 8 4 4 1 Dry mouth 10 7 12 3 9 6 4 4 Dyspepsia 7 5 10 4 10 6 6 2 Nervous System Insomnia 16 9 28 22 33 13 10 7 Anxiety 12 7 14 7 15 9 6 2 Nervousness 14 9 14 15 11 5 8 6 Somnolence 13 6 17 7 13 5 5 2 Tremor 10 3 9 1 13 1 3 1 Libido decreased 3 -- 11 2 5 1 1 2 Abnormal dreams 1 1 5 2 5 3 1 1 Respiratory System Pharyngitis 3 3 11 9 10 5 3 3 Sinusitis 1 4 5 2 6 4 2 3 Yawn -- -- 7 -- 11 -- 1 -- Skin and Appendages Sweating 8 3 7 -- 8 3 2 2 Rash 4 3 6 3 4 4 2 2 Urogenital System Impotence 3 2 -- -- -- 7 -- 1 -- Abnormal ejaculation 3 -- -- 7 -- 7 -- 2 1 Table 4: Treatment-Emergent Adverse Reactions: Incidence in Major Depressive Disorder, OCD, Bulimia, and Panic Disorder Placebo-Controlled Clinical Trials 1, 2 Percentage of Patients Reporting Event Major Depressive Disorder, OCD, Bulimia, and Panic Disorder Combined 1 Incidence less than 1%. 2 Includes US data for Major Depressive Disorder, OCD, Bulimia, and Panic Disorder clinical trials, plus non-US data for Panic Disorder clinical trials.
Drug interactions
As with all drugs, the potential for interaction by a variety of mechanisms (e.g., pharmacodynamic, pharmacokinetic drug inhibition or enhancement, etc.) is a possibility. Monoamine Oxidase Inhibitors (MAOIs): ( 2.9 , 2.10 , 4.1 , 5.2 ) Drugs Metabolized by CYP2D6: Fluoxetine is a potent inhibitor of CYP2D6 enzyme pathway ( 7.7 ) Tricyclic Antidepressants (TCAs): Monitor TCA levels during coadministration with fluoxetine or when fluoxetine has been recently discontinued ( 5.2 , 7.7 ) CNS Acting Drugs: Caution should be used when taken in combination with other centrally acting drugs ( 7.2 ) Benzodiazepines: Diazepam – increased t½, alprazolam - further psychomotor performance decrement due to increased levels ( 7.7 ) Antipsychotics: Potential for elevation of haloperidol and clozapine levels ( 7.7 ) Anticonvulsants: Potential for elevated phenytoin and carbamazepine levels and clinical anticonvulsant toxicity ( 7.7 ) Serotonergic Drugs: ( 2.9 , 2.10 , 4.1 , 5.2 ) Drugs that Interfere with Hemostasis (e.g. NSAIDs, Aspirin, Warfarin): May potentiate the risk of bleeding ( 7.4 ) Drugs Tightly Bound to Plasma Proteins: May cause a shift in plasma concentrations ( 7.6 , 7.7 ) Olanzapine: When used in combination with fluoxetine, also refer to the Drug Interactions section of the package insert for Symbyax ( 7.7 ) Drugs that Prolong the QT Interval: Do not use fluoxetine with thioridazine or pimozide. Use with caution in combination with other drugs that prolong the QT interval ( 4.2 , 5.11 , 7.7 , 7.8 ) 7.1 Monoamine Oxidase Inhibitors (MAOI) [See Dosage and Administration (2.9 , 2.10) , Contraindications (4.1) , and Warnings and Precautions (5.2) ]. 7.2 CNS Acting Drugs Caution is advised if the concomitant administration of fluoxetine and such drugs is required. In evaluating individual cases, consideration should be given to using lower initial doses of the concomitantly administered drugs, using conservative titration schedules, and monitoring of clinical status [see Clinical Pharmacology (12.3) ] . 7.3 Other Serotonergic Drugs The concomitant use of serotonergic drugs (including other SSRIs, SNRIs, triptans, tricyclic antidepressants, opioids, lithium, buspirone, amphetamines, tryptophan, and St. John's Wort) with fluoxetine increases the risk of serotonin syndrome. Monitor patients for signs and symptoms of serotonin syndrome, particularly during treatment initiation and dosage increases. If serotonin syndrome occurs, consider discontinuation of fluoxetine and/or concomitant serotonergic drugs [see Warnings and Precautions (5.2) ]. 7.4 Drugs that Interfere with Hemostasis (e.g., NSAIDS, Aspirin, Warfarin) Serotonin release by platelets plays an important role in hemostasis. Epidemiological studies of the case-control and cohort design that have demonstrated an association between use of psychotropic drugs that interfere with serotonin reuptake and the occurrence of upper gastrointestinal bleeding have also shown that concurrent use of an NSAID or aspirin may potentiate this risk of bleeding. Altered anticoagulant effects, including increased bleeding, have been reported when SNRIs or SSRIs are coadministered with warfarin. Patients receiving warfarin therapy should be carefully monitored when fluoxetine is initiated or discontinued [see Warnings and Precautions (5.7) ] . 7.5 Electroconvulsive Therapy (ECT) There are no clinical studies establishing the benefit of the combined use of ECT and fluoxetine. There have been rare reports of prolonged seizures in patients on fluoxetine receiving ECT treatment. 7.6 Potential for Other Drugs to affect Fluoxetine Drugs Tightly Bound to Plasma Proteins — Because fluoxetine is tightly bound to plasma proteins, adverse effects may result from displacement of protein-bound fluoxetine by other tightly-bound drugs [see Clinical Pharmacology (12.3) ] . 7.7 Potential for Fluoxetine to affect Other Drugs Pimozide — Concomitant use in patients taking pimozide is contraindicated. Pimozide can prolong the QT interval. Fluoxetine can increase the level of pimozide through inhibition of CYP2D6. Fluoxetine can also prolong the QT interval. Clinical studies of pimozide with other antidepressants demonstrate an increase in drug interaction or QT prolongation. While a specific study with pimozide and fluoxetine has not been conducted, the potential for drug interactions or QT prolongation warrants restricting the concurrent use of pimozide and fluoxetine Thioridazine — Thioridazine should not be administered with fluoxetine or within a minimum of 5 weeks after fluoxetine has been discontinued, because of the risk of QT Prolongation [see Contraindications (4.2) , Warnings and Precautions (5.11) , and Drug Interactions (7.8)]. In a study of 19 healthy male subjects, which included 6 slow and 13 rapid hydroxylators of debrisoquin, a single 25 mg oral dose of thioridazine produced a 2.4-fold higher Cmax and a 4.5-fold higher AUC for thioridazine in the slow hydroxylators compared with the rapid hydroxylators. The rate of debrisoquin hydroxylation is felt to depend on the level of CYP2D6 isozyme activity. Thus, this study suggests that drugs which inhibit CYP2D6, such as certain SSRIs, including fluoxetine, will produce elevated plasma levels of thioridazine. Thioridazine administration produces a dose-related prolongation of the QT interval, which is associated with serious ventricular arrhythmias, such as Torsades de Pointes-type arrhythmias, and sudden death. This risk is expected to increase with fluoxetine-induced inhibition of thioridazine metabolism. Drugs Metabolized by CYP2D6 — Fluoxetine inhibits the activity of CYP2D6, and may make individuals with normal CYP2D6 metabolic activity resemble a poor metabolizer.
Use in specific populations
When using fluoxetine and olanzapine in combination, also refer to the Use in Specific Populations section of the package insert for Symbyax. Pregnancy: SSRI use, particularly later in pregnancy, may increase risk for persistent pulmonary hypertension and symptoms of poor adaptation (respiratory distress, temperature instability, feeding difficulty, hypotonia, tremor, irritability) in the neonate ( 8.1 ) Pediatric Use: Safety and effectiveness of fluoxetine in patients <8 years of age with Major Depressive Disorder and <7 years of age with OCD have not been established. Safety and effectiveness of fluoxetine and olanzapine in combination in patients <10 years of age for depressive episodes associated with Bipolar I Disorder have not been established ( 8.4 ) Hepatic Impairment: Lower or less frequent dosing may be appropriate in patients with cirrhosis ( 8.6 ) 8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Antidepressants at 1-844-405-6185 or visiting online at https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/antidepressants/. Risk Summary Based on data from published observational studies, exposure to SSRIs, particularly in the month before delivery, has been associated with a less than 2-fold increase in the risk of postpartum hemorrhage [see Warnings and Precautions (5.7) and Clinical Considerations] . Available data from published epidemiologic studies and postmarketing reports over several decades have not established an increased risk of major birth defects or miscarriage. Some studies have reported an increased incidence of cardiovascular malformations; however, these studies results do not establish a causal relationship (see Data) . There are risks associated with untreated depression in pregnancy and risks of persistent pulmonary hypertension of the newborn (PPHN) (see Data) and poor neonatal adaptation with exposure to selective serotonin reuptake inhibitors (SSRIs), including fluoxetine, during pregnancy (see Clinical Considerations) . In rats and rabbits treated with fluoxetine during the period of organogenesis, there was no evidence of developmental effects at doses up to 1.6 and 3.9 times, respectively, the maximum recommended human dose (MRHD) of 60 mg/day given to adolescents on a mg/m 2 basis. However, in other reproductive studies in rats, an increase in stillborn pups, a decrease in pup weight, and an increase in pup deaths early after birth occurred at doses that are 1.5 times (during gestation) and 0.97 time (during gestation and lactation) the MRHD given to adolescents on a mg/m 2 basis. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the US general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Clinical Considerations Disease-associated maternal and/or embryo/fetal risk Women who discontinue antidepressants during pregnancy are more likely to experience a relapse of major depression than women who continue antidepressants. This finding is from a prospective, longitudinal study that followed 201 pregnant women with a history of major depressive disorder who were euthymic and taking antidepressants at the beginning of pregnancy. Consider the risk of untreated depression when discontinuing or changing treatment with antidepressant medication during pregnancy and postpartum. Maternal Adverse Reactions Use of fluoxetine in the month before delivery may be associated with an increased risk of postpartum hemorrhage [see Warnings and Precautions (5.7) ] . Fetal/Neonatal adverse reactions Neonates exposed to fluoxetine and other SSRI or SNRIs late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding. Such complications can arise immediately upon delivery. Reported clinical findings have included respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypotonia, hypertonia, hyperreflexia, tremors, jitteriness, irritability, and constant crying. These findings are consistent with either a direct toxic effect of SSRIs and SNRIs or possibly a drug discontinuation syndrome. It should be noted that, in some cases, the clinical picture is consistent with serotonin syndrome [see Warnings and Precautions (5.2)] . Data Human Data — It has been shown that SSRIs (including fluoxetine) can cross the placenta. Published epidemiological studies of pregnant women exposed to fluoxetine have not established an increased risk of major birth defects, miscarriage, and other adverse developmental outcomes. Several publications reported an increased incidence of cardiovascular malformations in children with in utero exposure to fluoxetine. However, these studies results do not establish a causal relationship. Methodologic limitations of these observational studies include possible exposure and outcome misclassification, lack of adequate controls, adjustment for confounders and confirmatory studies. However, these studies cannot definitely establish or exclude any drug-associated risk during pregnancy. Exposure to SSRIs, particularly later in pregnancy, may have an increased risk for PPHN. PPHN occurs in 1-2 per 1000 live births in the general population and is associated with substantial neonatal morbidity and mortality.
Pregnancy
8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Antidepressants at 1-844-405-6185 or visiting online at https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/antidepressants/. Risk Summary Based on data from published observational studies, exposure to SSRIs, particularly in the month before delivery, has been associated with a less than 2-fold increase in the risk of postpartum hemorrhage [see Warnings and Precautions (5.7) and Clinical Considerations] . Available data from published epidemiologic studies and postmarketing reports over several decades have not established an increased risk of major birth defects or miscarriage. Some studies have reported an increased incidence of cardiovascular malformations; however, these studies results do not establish a causal relationship (see Data) . There are risks associated with untreated depression in pregnancy and risks of persistent pulmonary hypertension of the newborn (PPHN) (see Data) and poor neonatal adaptation with exposure to selective serotonin reuptake inhibitors (SSRIs), including fluoxetine, during pregnancy (see Clinical Considerations) . In rats and rabbits treated with fluoxetine during the period of organogenesis, there was no evidence of developmental effects at doses up to 1.6 and 3.9 times, respectively, the maximum recommended human dose (MRHD) of 60 mg/day given to adolescents on a mg/m 2 basis. However, in other reproductive studies in rats, an increase in stillborn pups, a decrease in pup weight, and an increase in pup deaths early after birth occurred at doses that are 1.5 times (during gestation) and 0.97 time (during gestation and lactation) the MRHD given to adolescents on a mg/m 2 basis. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the US general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Clinical Considerations Disease-associated maternal and/or embryo/fetal risk Women who discontinue antidepressants during pregnancy are more likely to experience a relapse of major depression than women who continue antidepressants. This finding is from a prospective, longitudinal study that followed 201 pregnant women with a history of major depressive disorder who were euthymic and taking antidepressants at the beginning of pregnancy. Consider the risk of untreated depression when discontinuing or changing treatment with antidepressant medication during pregnancy and postpartum. Maternal Adverse Reactions Use of fluoxetine in the month before delivery may be associated with an increased risk of postpartum hemorrhage [see Warnings and Precautions (5.7) ] . Fetal/Neonatal adverse reactions Neonates exposed to fluoxetine and other SSRI or SNRIs late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding. Such complications can arise immediately upon delivery. Reported clinical findings have included respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypotonia, hypertonia, hyperreflexia, tremors, jitteriness, irritability, and constant crying. These findings are consistent with either a direct toxic effect of SSRIs and SNRIs or possibly a drug discontinuation syndrome. It should be noted that, in some cases, the clinical picture is consistent with serotonin syndrome [see Warnings and Precautions (5.2)] . Data Human Data — It has been shown that SSRIs (including fluoxetine) can cross the placenta. Published epidemiological studies of pregnant women exposed to fluoxetine have not established an increased risk of major birth defects, miscarriage, and other adverse developmental outcomes. Several publications reported an increased incidence of cardiovascular malformations in children with in utero exposure to fluoxetine. However, these studies results do not establish a causal relationship. Methodologic limitations of these observational studies include possible exposure and outcome misclassification, lack of adequate controls, adjustment for confounders and confirmatory studies. However, these studies cannot definitely establish or exclude any drug-associated risk during pregnancy. Exposure to SSRIs, particularly later in pregnancy, may have an increased risk for PPHN. PPHN occurs in 1-2 per 1000 live births in the general population and is associated with substantial neonatal morbidity and mortality. Animal Data — In embryofetal development studies in rats and rabbits, there was no evidence of malformations or developmental variations following administration of fluoxetine at doses up to 12.5 and 15 mg/kg/day, respectively (1.6 and 3.9 times, respectively, the MRHD of 60 mg given to adolescents on a mg/m 2 basis) throughout organogenesis. However, in rat reproduction studies, an increase in stillborn pups, a decrease in pup weight, and an increase in pup deaths during the first 7 days postpartum occurred following maternal exposure to 12 mg/kg/day (1.5 times the MRHD given to adolescents on a mg/m 2 basis) during gestation or 7.5 mg/kg/day (0.97 time the MRHD given to adolescents on a mg/m 2 basis) during gestation and lactation. There was no evidence of developmental neurotoxicity in the surviving offspring of rats treated with 12 mg/kg/day during gestation. The no-effect dose for rat pup mortality was 5 mg/kg/day (0.65 time the MRHD given to adolescents on a mg/m 2 basis).
Pediatric use
8.4 Pediatric Use Use of fluoxetine in children - The efficacy of fluoxetine for the treatment of Major Depressive Disorder was demonstrated in two 8- to 9-week placebo-controlled clinical trials with 315 pediatric outpatients ages 8 to ≤ 18 [see Clinical Studies (14.1) ]. The efficacy of fluoxetine for the treatment of OCD was demonstrated in one 13-week placebo-controlled clinical trial with 103 pediatric outpatients ages 7 to < 18 [see Clinical Studies (14.2) ]. The safety and effectiveness in pediatric patients < 8 years of age in Major Depressive Disorder and < 7 years of age in OCD have not been established. Fluoxetine pharmacokinetics were evaluated in 21 pediatric patients (ages 6 to ≤18) with Major Depressive Disorder or OCD [see Clinical Pharmacology (12.3) ]. The acute adverse reaction profiles observed in the 3 studies (N=418 randomized; 228 fluoxetine-treated, 190 placebo-treated) were generally similar to that observed in adult studies with fluoxetine. The longer-term adverse reaction profile observed in the 19-week Major Depressive Disorder study (N=219 randomized; 109 fluoxetine-treated, 110 placebo-treated) was also similar to that observed in adult trials with fluoxetine [see Adverse Reactions (6.1) ]. Manic reaction, including mania and hypomania, was reported in 6 (1 mania, 5 hypomania) out of 228 (2.6%) fluoxetine-treated patients and in 0 out of 190 (0%) placebo-treated patients. Mania/hypomania led to the discontinuation of 4 (1.8%) fluoxetine-treated patients from the acute phases of the 3 studies combined. Consequently, regular monitoring for the occurrence of mania/hypomania is recommended. As with other SSRIs, decreased weight gain has been observed in association with the use of fluoxetine in children and adolescent patients. After 19 weeks of treatment in a clinical trial, pediatric subjects treated with fluoxetine gained an average of 1.1 cm less in height and 1.1 kg less in weight than subjects treated with placebo. In addition, fluoxetine treatment was associated with a decrease in alkaline phosphatase levels. The safety of fluoxetine treatment for pediatric patients has not been systematically assessed for chronic treatment longer than several months in duration. In particular, there are no studies that directly evaluate the longer-term effects of fluoxetine on the growth, development and maturation of children and adolescent patients. Therefore, height and weight should be monitored periodically in pediatric patients receiving fluoxetine [see Warnings and Precautions (5.6) ]. Fluoxetine is approved for use in pediatric patients with MDD and OCD [see Box Warning and Warnings and Precautions (5.1) ] . Anyone considering the use of fluoxetine in a child or adolescent must balance the potential risks with the clinical need. Animal Data - Significant toxicity on muscle tissue, neurobehavior, reproductive organs, and bone development has been observed following exposure of juvenile rats to fluoxetine from weaning through maturity. Oral administration of fluoxetine to rats from weaning postnatal day 21 through adulthood day 90 at 3 mg/kg/day, 10 mg/kg/day, or 30 mg/kg/day was associated with testicular degeneration and necrosis, epididymal vacuolation and hypospermia (at 30 mg/kg/day corresponding to plasma exposures [AUC] approximately 5 to 10 times the average AUC in pediatric patients at the MRHD of 20 mg/day), increased serum levels of creatine kinase (at AUC as low as 1 to 2 times the average AUC in pediatric patients at the MRHD of 20 mg/day), skeletal muscle degeneration and necrosis, decreased femur length/growth and body weight gain (at AUC 5 to10 times the average AUC in pediatric patients at the MRHD of 20 mg/day). The high dose of 30 mg/kg/day exceeded a maximum tolerated dose. When animals were evaluated after a drug-free period (up to 11 weeks after cessation of dosing), fluoxetine was associated with neurobehavioral abnormalities (decreased reactivity at AUC as low as approximately 0.1 to 0.2 times the average AUC in pediatric patients at the MRHD and learning deficit at the high dose), and reproductive functional impairment (decreased mating at all doses and impaired fertility at the high dose). In addition, the testicular and epididymal microscopic lesions and decreased sperm concentrations found in high dose group were also observed, indicating that the drug effects on reproductive organs are irreversible. The reversibility of fluoxetine-induced muscle damage was not assessed. These fluoxetine toxicities in juvenile rats have not been observed in adult animals. Plasma exposures (AUC) to fluoxetine in juvenile rats receiving 3 mg/kg/day, 10 mg/kg/day, or 30 mg/kg/day doses in this study are approximately 0.1 to 0.2, 1 to 2, and 5 to 10 times, respectively, the average exposure in pediatric patients receiving the MRHD of 20 mg/day. Rat exposures to the major metabolite, norfluoxetine, are approximately 0.3 to 0.8, 1 to 8, and 3 to 20 times, respectively, the pediatric exposure at the MRHD. A specific effect on bone development was reported in juvenile mice administered fluoxetine by the intraperitoneal route to 4 week old mice for 4 weeks at doses 0.5 and 2 times the oral MRHD of 20 mg/day on mg/m 2 basis. There was a decrease in bone mineralization and density at both doses, but the overall growth (body weight gain or femur length) was not affected. Use of fluoxetine in combination with olanzapine in children and adolescents: Safety and efficacy of fluoxetine and olanzapine in combination in patients 10 to 17 years of age have been established for the acute treatment of depressive episodes associated with Bipolar I Disorder. Safety and effectiveness of fluoxetine and olanzapine in combination in patients less than 10 years of age have not been established.
Geriatric use
8.5 Geriatric Use US fluoxetine clinical trials included 687 patients ≥65 years of age and 93 patients ≥75 years of age. The efficacy in geriatric patients has been established [see Clinical Studies (14.1) ] . For pharmacokinetic information in geriatric patients, [see Clinical Pharmacology (12.4) ] . No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. SNRIs and SSRIs, including fluoxetine, have been associated with cases of clinically significant hyponatremia in elderly patients, who may be at greater risk for this adverse reaction [see Warnings and Precautions (5.9) ] . Clinical studies of olanzapine and fluoxetine in combination did not include sufficient numbers of patients ≥65 years of age to determine whether they respond differently from younger patients.
Overdosage
The following have been reported with fluoxetine overdosage:
• Seizures, which may be delayed, and altered mental status including coma.
• Cardiovascular toxicity, which may be delayed, including QRS and QTc interval prolongation, wide complex tachyarrhythmias, torsade de pointes, and cardiac arrest. Hypertension most commonly seen, but rarely can see hypotension alone or with co-ingestants including alcohol.
• Serotonin syndrome (patients with a multiple drug overdosage with other pro-serotonergic drugs may have a higher risk). Gastrointestinal decontamination with activated charcoal should be considered in patients who present early after a fluoxetine overdose. Consider contacting a Poison Center (1-800-221-2222) or a medical toxicologist for additional overdosage management recommendations.
Description
Fluoxetine capsules, USP are a selective serotonin reuptake inhibitor for oral administration. It is designated (±)-N-methyl-3-phenyl-3- [(α,α,α-trifluoro-p-tolyl)oxy]propylamine hydrochloride and has the empirical formula of C 17 H 18 F 3 NO
• HCl. Its molecular weight is 345.79. The structural formula is: Fluoxetine hydrochloride, USP is a white to off-white crystalline powder with a solubility of 14 mg/mL in water. Each capsule contains fluoxetine hydrochloride equivalent to 10 mg (32.3 μmol), 20 mg (64.7 μmol), or 40 mg (129.3 μmol) of fluoxetine. The capsules also contain the following inactive ingredients: pregelatinized starch (maize [corn]), colloidal silicon dioxide, gelatin, sodium lauryl sulphate, FD&C Blue #1 and titanium dioxide. In addition 20 mg capsules also contains D&C Yellow #10 and 10 mg capsules also contains FD&C Yellow #6. The capsules are printed with edible ink containing black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution. Chemical Structure
Mechanism of action
12.1 Mechanism of Action Although the exact mechanism of fluoxetine is unknown, it is presumed to be linked to its inhibition of CNS neuronal uptake of serotonin.
How supplied
16.1 How Supplied Fluoxetine Capsules, USP 10 mg** are white to off white powder filled in size “4” hard gelatin capsules with opaque light blue colored cap and opaque light orange colored body imprinted “SG” on cap and “113” on body with black ink. Bottles of 30 NDC 50228-113-30 Bottles of 100 NDC 50228-113-01 Bottles of 500 NDC 50228-113-05 Bottles of 1000 NDC 50228-113-10 Fluoxetine Capsules USP, 20 mg** are white to off white powder filled in size “2” hard gelatin capsules with opaque light blue colored cap and opaque light green colored body imprinted “SG” on cap and “114” on body with black ink. Bottles of 30 NDC 50228-114-30 Bottles of 100 NDC 50228-114-01 Bottles of 500 NDC 50228-114-05 Bottles of 1000 NDC 50228-114-10 Fluoxetine Capsules USP, 40 mg** are white to off white powder filled in size “0” hard gelatin capsules with opaque light blue colored cap and opaque white colored body imprinted “SG” on cap and “115” on body with black ink. Bottles of 30 NDC 50228-115-30 Bottles of 100 NDC 50228-115-01 Bottles of 500 NDC 50228-115-05 Bottles of 1,000 NDC 50228-115-10 **Fluoxetine base equivalent. 16.2 Storage and Handling Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. 16.1 How Supplied Fluoxetine Capsules, USP 10 mg** are white to off white powder filled in size “4” hard gelatin capsules with opaque light blue colored cap and opaque light orange colored body imprinted “SG” on cap and “113” on body with black ink. Bottles of 30 NDC 50228-113-30 Bottles of 100 NDC 50228-113-01 Bottles of 500 NDC 50228-113-05 Bottles of 1000 NDC 50228-113-10 Fluoxetine Capsules USP, 20 mg** are white to off white powder filled in size “2” hard gelatin capsules with opaque light blue colored cap and opaque light green colored body imprinted “SG” on cap and “114” on body with black ink. Bottles of 30 NDC 50228-114-30 Bottles of 100 NDC 50228-114-01 Bottles of 500 NDC 50228-114-05 Bottles of 1000 NDC 50228-114-10 Fluoxetine Capsules USP, 40 mg** are white to off white powder filled in size “0” hard gelatin capsules with opaque light blue colored cap and opaque white colored body imprinted “SG” on cap and “115” on body with black ink. Bottles of 30 NDC 50228-115-30 Bottles of 100 NDC 50228-115-01 Bottles of 500 NDC 50228-115-05 Bottles of 1,000 NDC 50228-115-10 **Fluoxetine base equivalent.
Storage
16.2 Storage and Handling Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
Patient information
Advise the patient to read the FDA-approved patient labeling (Medication Guide). Patients should be advised of the following issues and asked to alert their prescriber if these occur while taking fluoxetine as monotherapy or in combination with olanzapine. When using fluoxetine and olanzapine in combination, also refer to the Patient Counseling Information section of the package insert for Symbyax. General Information Healthcare providers should instruct their patients to read the Medication Guide before starting therapy with fluoxetine and to reread it each time the prescription is renewed. Healthcare providers should inform patients, their families, and their caregivers about the benefits and risks associated with treatment with fluoxetine and should counsel them in its appropriate use. Healthcare providers should instruct patients, their families, and their caregivers to read the Medication Guide and should assist them in understanding its contents. Patients should be given the opportunity to discuss the contents of the Medication Guide and to obtain answers to any questions they may have. Patients should be advised of the following issues and asked to alert their healthcare provider if these occur while taking fluoxetine. When using fluoxetine and olanzapine in combination, also refer to the Medication Guide for Symbyax. Suicidal Thoughts and Behaviors in Children, Adolescents, and Young Adults Patients, their families, and their caregivers should be encouraged to be alert to the emergence of anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, mania, other unusual changes in behavior, worsening of depression, and suicidal ideation, especially early during antidepressant treatment and when the dose is adjusted up or down. Families and caregivers of patients should be advised to look for the emergence of such symptoms on a day-to-day basis, since changes may be abrupt. Such symptoms should be reported to the patient’s prescriber or health professional, especially if they are severe, abrupt in onset, or were not part of the patient’s presenting symptoms. Symptoms such as these may be associated with an increased risk for suicidal thinking and behavior and indicate a need for very close monitoring and possibly changes in the medication [see Box Warning and Warnings and Precautions (5.1) ]. Serotonin Syndrome Patients should be cautioned about the risk of serotonin syndrome with the concomitant use of fluoxetine and other serotonergic agents including triptans, tricyclic antidepressants, opioids, lithium, tryptophan, buspirone, amphetamines, and St. John’s Wort [see Contraindications (4.1) , Warnings and Precautions (5.2) , and Drug Interactions (7.3) ] . Patients should be advised of the signs and symptoms associated with serotonin syndrome that may include mental status changes (e.g., agitation, hallucinations, delirium, and coma), autonomic instability (e.g., tachycardia, labile blood pressure, dizziness, diaphoresis, flushing, hyperthermia), neuromuscular changes (e.g., tremor, rigidity, myoclonus, hyperreflexia, incoordination), seizures, and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea). Patients should be cautioned to seek medical care immediately if they experience these symptoms. Allergic Reactions and Rash Patients should be advised to notify their healthcare provider if they develop a rash or hives [see Warnings and Precautions (5.3) ]. Patients should also be advised of the signs and symptoms associated with a severe allergic reaction, including swelling of the face, eyes, or mouth, or have trouble breathing. Patients should be cautioned to seek medical care immediately if they experience these symptoms. Increased Risk of Bleeding Patients should be cautioned about the concomitant use of fluoxetine and NSAIDs, aspirin, warfarin, or other drugs that affect coagulation since combined use of psychotropic drugs that interfere with serotonin reuptake and these agents have been associated with an increased risk of bleeding [see Warnings and Precautions (5.7) and Drug Interactions (7.4) ]. Patients should be advised to call their healthcare provider if they experience any increased or unusual bruising or bleeding while taking fluoxetine. Angle-Closure Glaucoma Patients should be advised that taking fluoxetine can cause mild pupillary dilation, which in susceptible individuals, can lead to an episode of angle-closure glaucoma. Pre-existing glaucoma is almost always open-angle glaucoma because angle-closure glaucoma, when diagnosed, can be treated definitively with iridectomy. Open-angle glaucoma is not a risk factor for angle-closure glaucoma. Patients may wish to be examined to determine whether they are susceptible to angle closure, and have a prophylactic procedure (e.g., iridectomy), if they are susceptible [see Warnings and Precautions (5.8) ]. Hyponatremia Patients should be advised that hyponatremia has been reported as a result of treatment with SNRIs and SSRIs, including fluoxetine. Signs and symptoms of hyponatremia include headache, difficulty concentrating, memory impairment, confusion, weakness, and unsteadiness, which may lead to falls. More severe and/or acute cases have been associated with hallucination, syncope, seizure, coma, respiratory arrest, and death [see Warnings and Precautions (5.9) ]. QT Prolongation Patients should be advised that QT interval prolongation and ventricular arrhythmia including Torsades de Pointes have been reported in patients treated with fluoxetine. Signs and symptoms of ventricular arrhythmia include fast, slow, or irregular heart rate, dyspnea, syncope, or dizziness, which may indicate serious cardiac arrhythmia [see Warnings and Precautions (5.11) ] . Potential for Cognitive and Motor Impairment Fluoxetine may impair judgment, thinking, or motor skills.
Label text from the FDA structured product label by ScieGen Pharmaceuticals, Inc. (revised Aug 20, 2026). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Fluoxetine Hydrochloride in 201 products
Fluoxetine NDC products (201)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 50090-7232 | Fluoxetine Hydrochloride 40 mg/1 Capsule | A-S Medication Solutions | ANDA |
| 50090-6065 | Fluoxetine Hydrochloride 10 mg/1 Capsule | A-S Medication Solutions | ANDA |
| 50090-6081 | Fluoxetine Hydrochloride 20 mg/1 Capsule | A-S Medication Solutions | ANDA |
| 50090-6193 | Fluoxetine Hydrochloride 10 mg/1 Capsule | A-S Medication Solutions | ANDA |
| 50090-6574 | Fluoxetine Hydrochloride 20 mg/1 Capsule | A-S Medication Solutions | ANDA |
| 50090-6702 | Fluoxetine Hydrochloride 10 mg/1 Capsule | A-S Medication Solutions | ANDA |
| 50090-6863 | Fluoxetine Hydrochloride 40 mg/1 Capsule | A-S Medication Solutions | ANDA |
| 50090-6986 | Fluoxetine Hydrochloride 20 mg/1 Capsule | A-S Medication Solutions | ANDA |
| 50090-7225 | Fluoxetine Hydrochloride 20 mg/1 Capsule | A-S Medication Solutions | ANDA |
| 50090-7226 | Fluoxetine Hydrochloride 20 mg/1 Capsule | A-S Medication Solutions | ANDA |
| 50090-7899 | Fluoxetine Hydrochloride 40 mg/1 Capsule | A-S Medication Solutions | ANDA |
| 50090-7914 | Fluoxetine Hydrochloride 40 mg/1 Capsule | A-S Medication Solutions | ANDA |
| 50090-7915 | Fluoxetine Hydrochloride 40 mg/1 Capsule | A-S Medication Solutions | ANDA |
| 50090-7951 | Fluoxetine Hydrochloride 20 mg/1 Capsule | A-S Medication Solutions | ANDA |
| 50090-7952 | Fluoxetine Hydrochloride 20 mg/1 Capsule | A-S Medication Solutions | ANDA |
| 50090-6064 | Fluoxetine Hydrochloride 40 mg/1 Capsule | A-S Medication Solutions | ANDA |
| 50090-5678 | Fluoxetine Hydrochloride 40 mg/1 Capsule | A-S Medication Solutions | ANDA |
| 50090-2589 | Fluoxetine Hydrochloride 40 mg/1 Capsule | A-S Medication Solutions | ANDA |
| 50090-0745 | Fluoxetine Hydrochloride 20 mg/1 Capsule | A-S Medication Solutions | ANDA |
| 80425-0313 | Fluoxetine Hydrochloride 20 mg/1 Capsule | Advanced Rx Pharmacy of Tennessee, LLC | ANDA |
| 62332-023 | Fluoxetine Hydrochloride 20 mg/1 Capsule | Alembic Pharmaceuticals Inc. | ANDA |
| 62332-022 | Fluoxetine Hydrochloride 10 mg/1 Capsule | Alembic Pharmaceuticals Inc. | ANDA |
| 62332-024 | Fluoxetine Hydrochloride 40 mg/1 Capsule | Alembic Pharmaceuticals Inc. | ANDA |
| 62332-243 | Fluoxetine Hydrochloride 20 mg/1 Tablet, Film Coated | Alembic Pharmaceuticals Inc. | ANDA |
| 62332-242 | Fluoxetine Hydrochloride 10 mg/1 Tablet, Film Coated | Alembic Pharmaceuticals Inc. | ANDA |
| 46708-271 | Fluoxetine Hydrochloride 10 mg/1 Capsule | Alembic Pharmaceuticals Limited | ANDA |
| 46708-272 | Fluoxetine Hydrochloride 20 mg/1 Capsule | Alembic Pharmaceuticals Limited | ANDA |
| 46708-273 | Fluoxetine Hydrochloride 40 mg/1 Capsule | Alembic Pharmaceuticals Limited | ANDA |
| 68002-105 | Fluoxetine Hydrochloride 40 mg/1 Capsule | American Health Packaging | ANDA |
| 60687-845 | Fluoxetine Hydrochloride 20 mg/5mL Solution | American Health Packaging | ANDA |
| 60687-659 | Fluoxetine Hydrochloride 40 mg/1 Capsule | American Health Packaging | ANDA |
| 71610-699 | Fluoxetine Hydrochloride 20 mg/1 Capsule | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 71610-683 | Fluoxetine Hydrochloride 10 mg/1 Capsule | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 53401-024 | Fluoxetine Hydrochloride 20 mg/1 Capsule | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 59651-309 | Fluoxetine Hydrochloride 20 mg/1 Tablet, Film Coated | Aurobindo Pharma Limited | ANDA |
| 59651-324 | Fluoxetine Hydrochloride 60 mg/1 Tablet, Film Coated | Aurobindo Pharma Limited | ANDA |
| 59651-898 | Fluoxetine Hydrochloride 10 mg/1 Capsule | Aurobindo Pharma Limited | ANDA |
| 59651-308 | Fluoxetine Hydrochloride 10 mg/1 Tablet, Film Coated | Aurobindo Pharma Limited | ANDA |
| 84386-106 | Fluoxetine Hydrochloride 60 mg/1 Tablet, Film Coated | Aurobindo Pharma Limited | ANDA |
| 59651-900 | Fluoxetine Hydrochloride 40 mg/1 Capsule | Aurobindo Pharma Limited | ANDA |
| 84386-105 | Fluoxetine Hydrochloride 20 mg/1 Tablet, Film Coated | Aurobindo Pharma Limited | ANDA |
| 84386-104 | Fluoxetine Hydrochloride 10 mg/1 Tablet, Film Coated | Aurobindo Pharma Limited | ANDA |
| 65862-306 | Fluoxetine Hydrochloride 20 mg/5mL Solution | Aurobindo Pharma Limited | ANDA |
| 65862-194 | Fluoxetine Hydrochloride 40 mg/1 Capsule | Aurobindo Pharma Limited | ANDA |
| 65862-193 | Fluoxetine Hydrochloride 20 mg/1 Capsule | Aurobindo Pharma Limited | ANDA |
| 65862-192 | Fluoxetine Hydrochloride 10 mg/1 Capsule | Aurobindo Pharma Limited | ANDA |
| 59651-899 | Fluoxetine Hydrochloride 20 mg/1 Capsule | Aurobindo Pharma Limited | ANDA |
| 68001-672 | Fluoxetine Hydrochloride 40 mg/1 Capsule | BluePoint Laboratories | ANDA |
| 68001-671 | Fluoxetine Hydrochloride 20 mg/1 Capsule | BluePoint Laboratories | ANDA |
| 68001-399 | Fluoxetine Hydrochloride 10 mg/1 Capsule | BluePoint Laboratories | ANDA |
| 68001-670 | Fluoxetine Hydrochloride 10 mg/1 Capsule | BluePoint Laboratories | ANDA |
| 68001-400 | Fluoxetine Hydrochloride 20 mg/1 Capsule | BluePoint Laboratories | ANDA |
| 68001-401 | Fluoxetine Hydrochloride 40 mg/1 Capsule | BluePoint Laboratories | ANDA |
| 83209-192 | Fluoxetine Hydrochloride 10 mg/1 Capsule | Boswell Pharmacy Services LLC d/b/a BPS Wholesale | ANDA |
| 83209-721 | Fluoxetine Hydrochloride 20 mg/1 Capsule | Boswell Pharmacy Services LLC d/b/a BPS Wholesale | ANDA |
| 71335-1048 | Fluoxetine Hydrochloride 10 mg/1 Capsule | Bryant Ranch Prepack | ANDA |
| 71335-1548 | Fluoxetine Hydrochloride 10 mg/1 Capsule | Bryant Ranch Prepack | ANDA |
| 71335-1482 | Fluoxetine Hydrochloride 40 mg/1 Capsule | Bryant Ranch Prepack | ANDA |
| 71335-1145 | Fluoxetine Hydrochloride 40 mg/1 Capsule | Bryant Ranch Prepack | ANDA |
| 71335-2597 | Fluoxetine Hydrochloride 60 mg/1 Tablet, Film Coated | Bryant Ranch Prepack | ANDA |
| 71335-0827 | Fluoxetine Hydrochloride 40 mg/1 Capsule | Bryant Ranch Prepack | ANDA |
| 71335-1033 | Fluoxetine Hydrochloride 10 mg/1 Capsule | Bryant Ranch Prepack | ANDA |
| 71335-0924 | Fluoxetine Hydrochloride 20 mg/1 Capsule | Bryant Ranch Prepack | ANDA |
| 71335-0923 | Fluoxetine Hydrochloride 20 mg/1 Capsule | Bryant Ranch Prepack | ANDA |
| 63629-5930 | Fluoxetine Hydrochloride 10 mg/1 Tablet, Film Coated | Bryant Ranch Prepack | ANDA |
| 63629-2201 | Fluoxetine Hydrochloride 60 mg/1 Tablet, Film Coated | Bryant Ranch Prepack | ANDA |
| 63629-1610 | Fluoxetine Hydrochloride 20 mg/1 Capsule | Bryant Ranch Prepack | ANDA |
| 63629-1609 | Fluoxetine Hydrochloride 10 mg/1 Capsule | Bryant Ranch Prepack | ANDA |
| 71335-2020 | Fluoxetine Hydrochloride 20 mg/1 Capsule | Bryant Ranch Prepack | ANDA |
| 71335-2778 | Fluoxetine Hydrochloride 10 mg/1 Tablet, Film Coated | Bryant Ranch Prepack | ANDA |
| 72162-2221 | Fluoxetine Hydrochloride 40 mg/1 Capsule | Bryant Ranch Prepack | ANDA |
| 72162-1506 | Fluoxetine Hydrochloride 60 mg/1 Tablet, Film Coated | Bryant Ranch Prepack | ANDA |
| 71335-2784 | Fluoxetine Hydrochloride 10 mg/1 Tablet, Film Coated | Bryant Ranch Prepack | ANDA |
| 71335-2785 | Fluoxetine Hydrochloride 20 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 71209-040 | Fluoxetine Hydrochloride 10 mg/1 Capsule | Cadila Pharmaceuticals Limited | ANDA |
| 71209-041 | Fluoxetine Hydrochloride 20 mg/1 Capsule | Cadila Pharmaceuticals Limited | ANDA |
| 71209-042 | Fluoxetine Hydrochloride 40 mg/1 Capsule | Cadila Pharmaceuticals Limited | ANDA |
| 17224-174 | Fluoxetine Hydrochloride 20 mg/1 Capsule | Calvin Scott & Co., Inc. | ANDA |
| 17224-171 | Fluoxetine Hydrochloride 10 mg/1 Capsule | Calvin Scott & Co., Inc. | ANDA |
| 55154-2638 | Fluoxetine Hydrochloride 20 mg/1 Capsule | Cardinal Health 107, LLC | ANDA |
| 68999-730 | Fluoxetine Hydrochloride 20 mg/5mL Liquid | Chartwell Governmental & Specialty RX, LLC | ANDA |
| 62135-730 | Fluoxetine Hydrochloride 20 mg/5mL Liquid | Chartwell RX, LLC | ANDA |
| 67046-0552 | Fluoxetine Hydrochloride 40 mg/1 Capsule | Coupler LLC | ANDA |
| 67046-1670 | Fluoxetine Hydrochloride 20 mg/1 Capsule | Coupler LLC | ANDA |
| 67046-2083 | Fluoxetine Hydrochloride 10 mg/1 Capsule | Coupler LLC | ANDA |
| 67046-1580 | Fluoxetine Hydrochloride 40 mg/1 Capsule | CouplerLLC | ANDA |
| 72189-067 | Fluoxetine Hydrochloride 40 mg/1 Capsule | DIRECT RX | ANDA |
| 43598-566 | Fluoxetine Hydrochloride 20 mg/1 Tablet, Film Coated | Dr.Reddy's Laboratories Inc. | ANDA |
| 55111-150 | Fluoxetine Hydrochloride 10 mg/1 Tablet, Film Coated | Dr.Reddy's Laboratories Limited | ANDA |
| 23155-028 | Fluoxetine Hydrochloride 10 mg/1 Capsule | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | ANDA |
| 23155-029 | Fluoxetine Hydrochloride 20 mg/1 Capsule | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | ANDA |
| 23155-030 | Fluoxetine Hydrochloride 40 mg/1 Capsule | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | ANDA |
| 54838-523 | Fluoxetine Hydrochloride 20 mg/5mL Liquid | Lannett Company, Inc. | ANDA |
| 68645-131 | Fluoxetine Hydrochloride 10 mg/1 Capsule | Legacy Pharmaceutical Packaging, LLC | ANDA |
| 68645-130 | Fluoxetine Hydrochloride 20 mg/1 Capsule | Legacy Pharmaceutical Packaging, LLC | ANDA |
| 0904-7346 | Fluoxetine Hydrochloride 20 mg/1 Capsule | Major Pharmaceuticals | ANDA |
| 0904-7345 | Fluoxetine Hydrochloride 10 mg/1 Capsule | Major Pharmaceuticals | ANDA |
| 25000-147 | Fluoxetine Hydrochloride 10 mg/1 Capsule | MARKSANS PHARMA LIMITED | ANDA |
| 25000-149 | Fluoxetine Hydrochloride 40 mg/1 Capsule | MARKSANS PHARMA LIMITED | ANDA |
| 25000-148 | Fluoxetine Hydrochloride 20 mg/1 Capsule | MARKSANS PHARMA LIMITED | ANDA |
| 45865-174 | Fluoxetine Hydrochloride 20 mg/1 Capsule | Medsource Pharmaceuticals | ANDA |
| 72241-009 | Fluoxetine Hydrochloride 40 mg/1 Capsule | Modavar Pharmaceuticals LLC | ANDA |
| 72241-008 | Fluoxetine Hydrochloride 20 mg/1 Capsule | Modavar Pharmaceuticals LLC | ANDA |
| 72241-007 | Fluoxetine Hydrochloride 10 mg/1 Capsule | Modavar Pharmaceuticals LLC | ANDA |
| 0615-7625 | Fluoxetine Hydrochloride 20 mg/1 Capsule | NCS HealthCare of KY, LLC dba Vangard Labs | ANDA |
| 0615-8612 | Fluoxetine Hydrochloride 40 mg/1 Capsule | NCS HealthCare of KY, LLC dba Vangard Labs | ANDA |
| 0615-8093 | Fluoxetine Hydrochloride 10 mg/1 Capsule | NCS HealthCare of KY, LLC dba Vangard Labs | ANDA |
| 0615-8183 | Fluoxetine Hydrochloride 40 mg/1 Capsule | NCS HealthCare of KY, LLC dba Vangard Labs | ANDA |
| 16714-721 | Fluoxetine Hydrochloride 20 mg/1 Capsule | NorthStar Rx LLC | ANDA |
| 16714-112 | Fluoxetine Hydrochloride 10 mg/1 Tablet, Film Coated | NorthStar Rx LLC | ANDA |
| 72603-490 | Fluoxetine Hydrochloride 40 mg/1 Capsule | NorthStar Rx LLC | ANDA |
| 72603-489 | Fluoxetine Hydrochloride 20 mg/1 Capsule | NorthStar Rx LLC | ANDA |
| 16714-113 | Fluoxetine Hydrochloride 20 mg/1 Tablet, Film Coated | NorthStar Rx LLC | ANDA |
| 16714-720 | Fluoxetine Hydrochloride 10 mg/1 Capsule | NorthStar Rx LLC | ANDA |
| 16714-722 | Fluoxetine Hydrochloride 40 mg/1 Capsule | NorthStar Rx LLC | ANDA |
| 72603-488 | Fluoxetine Hydrochloride 10 mg/1 Capsule | NorthStar Rx LLC | ANDA |
| 51655-274 | Fluoxetine Hydrochloride 20 mg/1 Capsule | Northwind Health Company, LLC | ANDA |
| 51655-081 | Fluoxetine Hydrochloride 40 mg/1 Capsule | Northwind Health Company, LLC | ANDA |
| 51655-100 | Fluoxetine Hydrochloride 20 mg/1 Capsule | Northwind Health Company, LLC | ANDA |
| 51655-314 | Fluoxetine Hydrochloride 10 mg/1 Capsule | Northwind Health Company, LLC | ANDA |
| 51655-750 | Fluoxetine Hydrochloride 10 mg/1 Capsule | Northwind Health Company, LLC | ANDA |
| 51655-981 | Fluoxetine Hydrochloride 40 mg/1 Capsule | Northwind Health Company, LLC | ANDA |
| 82868-105 | Fluoxetine Hydrochloride 10 mg/1 Capsule | Northwind Health Company, LLC | ANDA |
| 82868-098 | Fluoxetine Hydrochloride 20 mg/1 Capsule | Northwind Health Company, LLC | ANDA |
| 68071-3284 | Fluoxetine Hydrochloride 20 mg/1 Capsule | NuCare Pharmaceuticals, Inc. | ANDA |
| 68071-2275 | Fluoxetine Hydrochloride 10 mg/1 Capsule | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-2375 | Fluoxetine Hydrochloride 40 mg/1 Capsule | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-4033 | Fluoxetine Hydrochloride 20 mg/1 Capsule | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-4606 | Fluoxetine Hydrochloride 10 mg/1 Capsule | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-5240 | Fluoxetine Hydrochloride 20 mg/1 Capsule | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-5276 | Fluoxetine Hydrochloride 20 mg/1 Capsule | NuCare Pharmaceuticals,Inc. | ANDA |
| 0121-0721 | Fluoxetine Hydrochloride 20 mg/5mL Solution | PAI Holdings, LLC dba PAI Pharma | ANDA |
| 0121-4721 | Fluoxetine Hydrochloride 20 mg/5mL Solution | PAI Holdings, LLC dba PAI Pharma | ANDA |
| 49884-468 | Fluoxetine Hydrochloride 60 mg/1 Tablet, Film Coated | Par Health USA, LLC | ANDA |
| 43063-712 | Fluoxetine Hydrochloride 20 mg/1 Capsule | PD-Rx Pharmaceuticals, Inc. | ANDA |
| 43063-839 | Fluoxetine Hydrochloride 40 mg/1 Capsule | PD-Rx Pharmaceuticals, Inc. | ANDA |
| 43063-993 | Fluoxetine Hydrochloride 40 mg/1 Capsule | PD-Rx Pharmaceuticals, Inc. | ANDA |
| 43063-570 | Fluoxetine Hydrochloride 10 mg/1 Capsule | PD-Rx Pharmaceuticals, Inc. | ANDA |
| 72789-545 | Fluoxetine Hydrochloride 20 mg/1 Capsule | PD-Rx Pharmaceuticals, Inc. | ANDA |
| 72789-554 | Fluoxetine Hydrochloride 40 mg/1 Capsule | PD-Rx Pharmaceuticals, Inc. | ANDA |
| 72789-557 | Fluoxetine Hydrochloride 10 mg/1 Capsule | PD-Rx Pharmaceuticals, Inc. | ANDA |
| 68788-8618 | Fluoxetine Hydrochloride 40 mg/1 Capsule | Preferred Pharmaceuticals Inc. | ANDA |
| 68788-7909 | Fluoxetine Hydrochloride 20 mg/1 Capsule | Preferred Pharmaceuticals, Inc. | ANDA |
| 68788-7741 | Fluoxetine Hydrochloride 40 mg/1 Capsule | Preferred Pharmaceuticals, Inc. | ANDA |
| 68788-7817 | Fluoxetine Hydrochloride 10 mg/1 Capsule | Preferred Pharmaceuticals, Inc. | ANDA |
| 71205-975 | Fluoxetine Hydrochloride 20 mg/1 Capsule | Proficient Rx LP | ANDA |
| 63187-069 | Fluoxetine Hydrochloride 20 mg/1 Capsule | Proficient Rx LP | ANDA |
| 63187-081 | Fluoxetine Hydrochloride 10 mg/1 Capsule | Proficient Rx LP | ANDA |
| 63187-233 | Fluoxetine Hydrochloride 10 mg/1 Capsule | Proficient Rx LP | ANDA |
| 63187-361 | Fluoxetine Hydrochloride 40 mg/1 Capsule | Proficient Rx LP | ANDA |
| 71205-979 | Fluoxetine Hydrochloride 40 mg/1 Capsule | Proficient Rx LP | ANDA |
| 71205-974 | Fluoxetine Hydrochloride 10 mg/1 Capsule | Proficient Rx LP | ANDA |
| 71205-393 | Fluoxetine Hydrochloride 40 mg/1 Capsule | Proficient Rx LP | ANDA |
| 71205-188 | Fluoxetine Hydrochloride 40 mg/1 Capsule | Proficient Rx LP | ANDA |
| 71205-178 | Fluoxetine Hydrochloride 20 mg/1 Capsule | Proficient Rx LP | ANDA |
| 71205-125 | Fluoxetine Hydrochloride 20 mg/1 Capsule | Proficient Rx LP | ANDA |
| 42708-182 | Fluoxetine Hydrochloride 20 mg/1 Capsule | QPharma Inc | ANDA |
| 42708-200 | Fluoxetine Hydrochloride 20 mg/1 Capsule | QPharma Inc | ANDA |
| 42708-025 | Fluoxetine Hydrochloride 20 mg/1 Capsule | QPharma Inc | ANDA |
| 82009-102 | Fluoxetine Hydrochloride 40 mg/1 Capsule | QUALLENT PHARMACEUTICALS HEALTH LLC | ANDA |
| 82009-101 | Fluoxetine Hydrochloride 20 mg/1 Capsule | QUALLENT PHARMACEUTICALS HEALTH LLC | ANDA |
| 82009-100 | Fluoxetine Hydrochloride 10 mg/1 Capsule | QUALLENT PHARMACEUTICALS HEALTH LLC | ANDA |
| 77771-114 | Fluoxetine Hydrochloride 20 mg/1 Capsule | RADHA PHARMACEUTICALS, INC. | ANDA |
| 77771-113 | Fluoxetine Hydrochloride 10 mg/1 Capsule | RADHA PHARMACEUTICALS, INC. | ANDA |
| 77771-115 | Fluoxetine Hydrochloride 40 mg/1 Capsule | RADHA PHARMACEUTICALS, INC. | ANDA |
| 67296-1898 | Fluoxetine Hydrochloride 20 mg/1 Capsule | Redpharm Drug | ANDA |
| 70518-1174 | Fluoxetine Hydrochloride 10 mg/1 Capsule | REMEDYREPACK INC. | ANDA |
| 70518-4420 | Fluoxetine Hydrochloride 20 mg/1 Capsule | REMEDYREPACK INC. | ANDA |
| 70518-0417 | Fluoxetine Hydrochloride 20 mg/1 Capsule | REMEDYREPACK INC. | ANDA |
| 70518-1619 | Fluoxetine Hydrochloride 20 mg/1 Capsule | REMEDYREPACK INC. | ANDA |
| 70518-3483 | Fluoxetine Hydrochloride 10 mg/1 Capsule | REMEDYREPACK INC. | ANDA |
| 70518-3554 | Fluoxetine Hydrochloride 40 mg/1 Capsule | REMEDYREPACK INC. | ANDA |
| 70518-4611 | Fluoxetine Hydrochloride 10 mg/1 Capsule | REMEDYREPACK INC. | ANDA |
| 70518-4576 | Fluoxetine Hydrochloride 20 mg/1 Capsule | REMEDYREPACK INC. | ANDA |
| 70518-4543 | Fluoxetine Hydrochloride 20 mg/1 Capsule | REMEDYREPACK INC. | ANDA |
| 70518-4429 | Fluoxetine Hydrochloride 10 mg/1 Tablet, Film Coated | REMEDYREPACK INC. | ANDA |
| 70518-4428 | Fluoxetine Hydrochloride 20 mg/1 Tablet, Film Coated | REMEDYREPACK INC. | ANDA |
| 70518-3752 | Fluoxetine Hydrochloride 10 mg/1 Capsule | REMEDYREPACK INC. | ANDA |
| 71656-089 | Fluoxetine Hydrochloride 20 mg/5mL Solution | Saptalis Pharmaceuticals, LLC. | ANDA |
| 50228-420 | Fluoxetine Hydrochloride 10 mg/1 Tablet, Film Coated | ScieGen Pharmaceuticals, Inc | ANDA |
| 50228-421 | Fluoxetine Hydrochloride 20 mg/1 Tablet, Film Coated | ScieGen Pharmaceuticals, Inc | ANDA |
| 50228-113 | Fluoxetine Hydrochloride 10 mg/1 Capsule | ScieGen Pharmaceuticals, Inc. | ANDA |
| 50228-114 | Fluoxetine Hydrochloride 20 mg/1 Capsule | ScieGen Pharmaceuticals, Inc. | ANDA |
| 50228-115 | Fluoxetine Hydrochloride 40 mg/1 Capsule | ScieGen Pharmaceuticals, Inc. | ANDA |
| 50228-422 | Fluoxetine Hydrochloride 60 mg/1 Tablet | ScieGen Pharmaceuticals, Inc. | ANDA |
| 50228-638 | Fluoxetine Hydrochloride 60 mg/1 Tablet | ScieGen Pharmaceuticals, Inc. | ANDA |
| 60760-311 | Fluoxetine Hydrochloride 20 mg/1 Capsule | St. Mary's Medical Park Pharmacy | ANDA |
| 64380-903 | Fluoxetine Hydrochloride 20 mg/1 Tablet | Strides Pharma Science Limited | ANDA |
| 64380-902 | Fluoxetine Hydrochloride 10 mg/1 Tablet | Strides Pharma Science Limited | ANDA |
| 0093-7198 | Fluoxetine Hydrochloride 40 mg/1 Capsule | Teva Pharmaceuticals USA, Inc. | ANDA |
| 50111-647 | Fluoxetine Hydrochloride 10 mg/1 Capsule | Teva Pharmaceuticals USA, Inc. | ANDA |
| 50111-648 | Fluoxetine Hydrochloride 20 mg/1 Capsule | Teva Pharmaceuticals USA, Inc. | ANDA |
| 49483-702 | Fluoxetine Hydrochloride 20 mg/1 Capsule | TIME CAP LABORATORIES, INC. | ANDA |
| 49483-703 | Fluoxetine Hydrochloride 40 mg/1 Capsule | TIME CAP LABORATORIES, INC. | ANDA |
| 49483-701 | Fluoxetine Hydrochloride 10 mg/1 Capsule | TIME CAP LABORATORIES, INC. | ANDA |
| 13668-473 | Fluoxetine Hydrochloride 20 mg/1 Tablet | Torrent Pharmaceuticals Limited | ANDA |
| 13668-443 | Fluoxetine Hydrochloride 10 mg/1 Tablet | Torrent Pharmaceuticals Limited | ANDA |
| 87441-031 | Fluoxetine Hydrochloride 20 mg/1 Capsule | Unit Dose Solutions, Inc. | ANDA |
| 42543-727 | Fluoxetine Hydrochloride 40 mg/1 Capsule | Vensun Pharmaceuticals, Inc. | ANDA |
| 42543-726 | Fluoxetine Hydrochloride 20 mg/1 Capsule | Vensun Pharmaceuticals, Inc. | ANDA |
| 42543-725 | Fluoxetine Hydrochloride 10 mg/1 Capsule | Vensun Pharmaceuticals, Inc. | ANDA |
Fluoxetine recalls
- D-0455-2025 Jun 11, 2025 · Class II · Completed
CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit. - D-0456-2025 Jun 11, 2025 · Class II · Completed
CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit. - D-0970-2015 May 6, 2015 · Class II · Terminated
Chemical Contamination: Product recalled due to an elevated level of a residual solvent impurity in the API that exceeds the Threshold of Toxicological Concern (TTC) calculation for the impurity. - D-0971-2015 May 6, 2015 · Class II · Terminated
Chemical Contamination: Product recalled due to an elevated level of a residual solvent impurity in the API that exceeds the Threshold of Toxicological Concern (TTC) calculation for the impurity. - D-1279-2014 May 7, 2014 · Class II · Terminated
Chemical Contamination: The recalling firm received notice that their supplier is recalling capsules due to complaints of capsules having an unusual odor. - D-1280-2014 May 7, 2014 · Class II · Terminated
Chemical Contamination: Recall due to a customer complaint trend regarding capsule odor. - D-1281-2014 May 7, 2014 · Class II · Terminated
Chemical Contamination: Recall due to a customer complaint trend regarding capsule odor.
Frequently asked questions
What is Fluoxetine used for?
Fluoxetine is indicated for the treatment of: Acute and maintenance treatment of Major Depressive Disorder [see Clinical Studies (14.1) ] . Acute and maintenance treatment of obsessions and compulsions in patients with Obsessive Compulsive Disorder (OCD) [see Clinical Studies (14.2) ] . Acute and maintenance treatment of binge-eating and vomiting behaviors in patients with moderate to severe…
What are the side effects of Fluoxetine?
The following adverse reactions are discussed in more detail in other sections of the labeling: Suicidal Thoughts and Behaviors in Children, Adolescents, and Young Adults [see Boxed Warning and Warnings and Precautions (5.1) ] Serotonin Syndrome [see Warnings and Precautions (5.2) ] Allergic Reactions and Rash [see Warnings and Precautions (5.3) ] Screening Patients for Bipolar Disorder and… See the full label for the complete list.
Who makes Fluoxetine?
Fluoxetine is listed by 53 labelers in the FDA NDC directory, including A-S Medication Solutions, Advanced Rx Pharmacy of Tennessee, LLC, Alembic Pharmaceuticals Inc., Alembic Pharmaceuticals Limited.
Has Fluoxetine been recalled?
The FDA enforcement database lists 7 recalls for Fluoxetine, most recently D-0455-2025 (class ii): CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit.