citalopram
Tablet, Film Coated · Oral
Uses
Citalopram Capsules are indicated for the treatment of Major Depressive Disorder (MDD) in adults [see Clinical Studies ( 14 )] . Citalopram Capsules is a selective serotonin reuptake inhibitor (SSRI) indicated for treatment of Major Depressive Disorder (MDD) in adults. ( 1 )
Dosage and administration
Do not initiate treatment with Citalopram Capsules. Use another citalopram product for initial dosage titration or dosages other than 30 mg once daily. ( 2.1 ) Administer once daily with or without food. ( 2.1 ) Recommended dosage of Citalopram Capsules is 30 mg once daily. ( 2.1 ) Citalopram dosages above 40 mg once daily are not recommended due to the risk of QT prolongation. ( 2.1 ) When discontinuing Citalopram Capsules, reduce dose gradually. Gradual dosage reduction will require use of another citalopram product. ( 2.4 , 5.6 ) 2.1 Recommended Dosage Do not initiate treatment with Citalopram Capsules because the only available dose strength is 30 mg. Use another citalopram product for initial dosage, titration, and dosages other than 30 mg once daily. Refer to Prescribing Information of the other citalopram products for the recommended dosage for those products. Administer Citalopram Capsules orally, once daily, with or without food. Citalopram should be administered at an initial dose of 20 mg once daily, with an increase to a maximum dose of 40 mg once daily at an interval of no less than one week. Citalopram dosages above 40 mg once daily are not recommended due to the risk of QT prolongation [see Warnings and Precautions ( 5.2 )] . 2.2 Screen for Bipolar Disorder Prior to Starting Citalopram Capsules Prior to initiating treatment with Citalopram Capsules or another antidepressant, screen patients for a personal or family history of bipolar disorder, mania, or hypomania [see Warnings and Precautions ( 5.5 )] . 2.3 Switching Patients to or from a Monoamine Oxidase Inhibitor Antidepresssant At least 14 days must elapse between discontinuation of an monoamine oxidase inhibitor (MAOI) and initiation of therapy with Citalopram Capsules. Conversely, at least 14 days must elapse after stopping Citalopram Capsules before starting an MAOI antidepressant [see Contraindications ( 4 ), Warnings and Precautions ( 5.3 )] . 2.4 Discontinuing Treatment with Citalopram Capsules Adverse reactions may occur upon discontinuation of Citalopram Capsules [see Warnings and Precautions ( 5.6 )] . Gradually reduce the dosage rather than stopping Citalopram Capsules abruptly whenever possible. Given that 30 mg is only available dosage strength of Citalopram Capsules, gradual dosage reduction will require the use of another citalopram product.
Dosage forms and strengths
30 mg: Hard shell gelatin capsules, with “ALM” printed axially on the blue opaque cap in black ink and “691” printed axially on the white opaque body in black ink. Citalopram Capsules dosage strength is based on the active moiety, citalopram. Capsules: 30 mg ( 3 )
Contraindications
Citalopram Capsules is contraindicated in patients: taking, or within 14 days of stopping, MAOIs (including MAOIs such as linezolid or intravenous methylene blue) because of an increased risk of serotonin syndrome [see Warnings and Precautions ( 5.3 ), Drug Interactions ( 7 )] . taking pimozide because of risk of QT prolongation [see Drug Interactions ( 7 )] . with known hypersensitivity to citalopram or any of the inactive ingredients in Citalopram Capsules. Reactions have included angioedema and anaphylaxis [see Adverse Reactions ( 6.2 )] . Concomitant use of monoamine oxidase inhibitors (MAOIs) or use within 14 days of discontinuing an MAOI. ( 4 ) Concomitant use of pimozide. ( 4 ) Known hypersensitivity to citalopram or any of the inactive ingredients of Citalopram Capsules. ( 4 )
Warnings and precautions
Prolongation and Torsade de Pointes: Dose-dependent QTc prolongation, Torsade de pointes, ventricular tachycardia, and sudden death have occurred. Avoid use of Citalopram Capsules in patients with congenital long QT syndrome, bradycardia, hypokalemia or hypomagnesemia, recent acute myocardial infarction, or uncompensated heart failure and patients taking other drugs that prolong the QTc interval. Monitor electrolytes in patients at high risk for hypokalemia or hypomagnesemia. Discontinue Citalopram Capsules in patients with persistent QTc measurements > 500 ms. ( 5.2 , 7 ) Serotonin Syndrome: Increased risk when co-administered with other serotonergic agents, but also when taken alone. If it occurs, discontinue Citalopram Capsules and serotonergic agents and initiate supportive treatment ( 4 , 5.3 , 7 ) Increased Risk of Bleeding: Concomitant use of aspirin, nonsteroidal anti-inflammatory drugs, other antiplatelet drugs, warfarin, and other anticoagulants may increase this risk. ( 5.4 ) Activation of Mania or Hypomania: Screen patients for bipolar disorder. ( 5.5 ) Discontinuation Syndrome: When discontinuing Citalopram Capsules, reduce dosage gradually and monitor for discontinuation symptoms. Gradual reduction will require use of another citalopram product. ( 5.6 ) Seizures: Use with caution in patients with seizure disorder. ( 5.7 ) Angle Closure Glaucoma: Avoid use of Citalopram Capsules in patients with untreated anatomically narrow angles treated. ( 5.8 ) Hyponatremia: Can occur in association with syndrome of inappropriate antidiuretic hormone secretion. ( 5.9 ) Sexual Dysfunction: Citalopram Capsules may cause symptoms of sexual dysfunction. ( 5.10 ) 5.1 Suicidal Thoughts and Behaviors in Adolescent and Young Adults In pooled analyses of placebo-controlled trials of antidepressant drugs (SSRIs and other antidepressant classes) that included approximately 77,000 adult patients and over 4,500 pediatric patients, the incidence of suicidal thoughts and behaviors in antidepressant-treated patients age 24 years and younger was greater than in placebo-treated patients. There was considerable variation in risk of suicidal thoughts and behaviors among drugs, but there was an increased risk identified in young patients for most drugs studied. There were differences in absolute risk of suicidal thoughts and behaviors across the different indications, with the highest incidence in patients with MDD. These drug-placebo differences in the number of cases of suicidal thoughts and behaviors per 1,000 patients treated are provided in Table 1. Table 1: Risk Differences of the Number of Patients with Suicidal Thoughts or Behavior in the Pooled Placebo-Controlled Trials of Antidepressants in Pediatric* and Adult Patients *Citalopram Capsules is not approved for use in pediatric patients. Age Range Drug-Placebo Difference in Number of Patients* with Suicidal Thoughts or Behaviors per 1,000 Patients Treated Increases Compared to Placebo <18 years old 14 additional cases 18 to 24 years old 5 additional cases Decreases Compared to Placebo 25 to 64 years old 1 fewer case ≥65 years old 6 fewer cases It is unknown whether the risk of suicidal thoughts and behaviors in children, adolescents, and young adults extends to longer-term use, i.e., beyond four months. However, there is substantial evidence from placebo-controlled maintenance trials in adults with MDD that antidepressants delay the recurrence of depression and that depression itself is a risk factor for suicidal thoughts and behaviors. Monitor all antidepressant-treated patients for any indication for clinical worsening and emergence of suicidal thoughts and behaviors, especially during the initial few months of drug therapy, and at times of dosage changes. Counsel family members or caregivers of patients to monitor for changes in behavior and to alert the healthcare provider. Consider changing the therapeutic regimen, including possibly discontinuing Citalopram Capsules, in patients whose depression is persistently worse, or who are experiencing emergent suicidal thoughts or behaviors. 5.2 QT-Prolongation and Torsade de Pointes Citalopram causes dose-dependent QTc prolongation, an ECG abnormality that has been associated with Torsade de Pointes (TdP), ventricular tachycardia, and sudden death, all of which have been observed in postmarketing reports for citalopram [see Adverse Reactions 6.2)]. Because of the risk of QTc prolongation at higher citalopram doses, it is recommended that citalopram should not be given at doses above 40 mg/day [see Clinical Pharmacology ( 12.2 )] . Avoid use of Citalopram Capsules in CYP2C19 poor metabolizers, patients receiving concomitant cimetidine or another CYP2C19 inhibitor, patients with hepatic impairment, and patients who are greater than 60 years of age, because Citalopram Capsules are only available in a 30 mg dose strength and dosage adjustments are not possible [see Drug Interactions ( 7 ), Use in Specific Populations ( 8.5 , 8.6 ), Clinical Pharmacology ( 12.3 )] . Citalopram should be avoided in patients with congenital long QT syndrome, bradycardia, hypokalemia or hypomagnesemia, recent acute myocardial infarction, or uncompensated heart failure unless the benefits outweigh the risks for a particular patient. Citalopram should also not be used in patients who are taking other drugs that prolong the QTc interval [see Drug Interactions (7)]. Such drugs include Class 1A (e.g., quinidine, procainamide) or Class III (e.g., amiodarone, sotalol) antiarrhythmic medications, antipsychotic medications (e.g., chlorpromazine, thioridazine), antibiotics (e.g., gatifloxacin, moxifloxacin), or any other class of medications known to prolong the QTc interval (e.g., pentamidine, levomethadyl acetate, methadone). Electrolyte and/or ECG monitoring is recommended in certain circumstances.
Side effects
The following adverse reactions are discussed in greater detail in other sections of the labeling: Hypersensitivity reactions [see Contraindications ( 4 )] Suicidal Thoughts and Behaviors in Adolescent and Young Adults [see Warnings and Precautions ( 5.1 )] QT-Prolongation and Torsade de Pointes [see Warnings and Precautions ( 5.2 )] Serotonin Syndrome [see Warnings and Precautions ( 5.3 )] Increased Risk of Bleeding [see Warnings and Precautions ( 5.4 )] Activation of Mania or Hypomania [see Warnings and Precautions ( 5.5 )] Discontinuation Syndrome [see Warnings and Precautions ( 5.6 )] Seizures [see Warnings and Precautions ( 5.7 )] Angle Closure Glaucoma [see Warnings and Precautions ( 5.8 )] Hyponatremia [see Warnings and Precautions ( 5.9 )] Sexual Dysfunction [see Warnings and Precautions ( 5.10 )] Most commonly observed adverse reactions (incidence at least twice the incidence of placebo) are: fever, arthalgia, myalgia, anorexia, agitation, yawning, sinusitis, ejaculation disorder (primarily ejaculatory delay), decreased libido, and impotence ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Almatica Pharma LLC at 1-877-447-7979, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. The safety of Citalopram Capsules for the treatment for major depressive disorder (MDD) in adults is based upon adequate and well-controlled studies of another citalopram product. The results of these adequate and well-controlled studies of citalopram are presented below. The safety for citalopram included exposures in patients and/or healthy subjects from 3 different groups of studies: 429 healthy subjects in clinical pharmacology/ pharmacokinetic studies; 4,422 exposures from patients in controlled and uncontrolled clinical trials, corresponding to approximately 1,370 patient-exposure years. There were, in addition, over 19,000 exposures from mostly open-label, European postmarketing studies. The conditions and duration of treatment with citalopram varied greatly and included (in overlapping categories) open-label and double-blind studies, inpatient and outpatient studies, fixed-dose and dose-titration studies, and short-term and long-term exposure. Adverse Reactions Associated with Discontinuation of Treatment Among 1,063 patients with MDD who received citalopram at doses ranging from 10 mg to 80 mg once daily in placebo-controlled trials of up to 6 weeks in duration, 16% discontinued treatment due to an adverse reaction, as compared to 8% of 446 patients receiving placebo. The adverse reactions associated with discontinuation (i.e., associated with discontinuation in at least 1% of citalopram-treated patients at a rate at least twice that of placebo) are shown in Table 2. Table 2: Adverse Reactions Associated with Discontinuation of Treatment in Short-Term, Placebo-Controlled, Depression Trials * A patient can report more than one reason for discontinuation and be counted more than once in this table. Body System/Adverse Reaction Citalopram* (N=1,063) % Placebo (N=446) % General Asthenia 1 <1 Gastrointestinal Disorders Nausea 4 0 Dry Mouth 1 <1 Vomiting 1 0 Central and Peripheral Nervous System Disorders Dizziness 2 <1 Psychiatric Disorders Insomnia 3 1 Somnolence 2 1 Agitation 1 <1 Table 3 enumerates adverse reactions that occurred among 1,063 patients with MDD who received citalopram at doses ranging from 10 mg to 80 mg once daily in placebo-controlled trials of up to 6 weeks in duration. The most common adverse reaction that occurred in citalopram-treated patients with an incidence of 5% or greater and at least twice the incidence in placebo patients was ejaculation disorder (primarily ejaculatory delay) in male patients, see Table 3. Table 3: Adverse Reactions (≥2% and Greater than Placebo) Among Citalopram-treated Patients* * Except for the following adverse reactions which had an incidence on placebo. Citalopram: headache, asthenia, dizziness, constipation, palpitation, vision abnormal, sleep disorder, nervousness, pharyngitis, micturition disorder, back pain. 1 Denominator used was for females only (N=638 citalopram; N=252 placebo). 2 Primarily ejaculatory delay. 3 Denominator used was for males only (N=425 citalopram; N=194 placebo). Body System/Adverse Reaction Citalopram (N=1,063) % Placebo (N=446) % Gastrointestinal Disorders Nausea 21 14 Diarrhea 8 5 Dyspepsia 5 4 Vomiting 4 3 Abdominal Pain 3 2 Autonomic Nervous System Disorders Dry Mouth 20 14 Sweating Increased 11 9 Psychiatric Disorders Somnolence 18 10 Insomnia 15 14 Anxiety 4 3 Anorexia 4 2 Agitation 3 1 Dysmenorrhea 1 3 2 Libido Decreased 2 <1 Yawning 2 <1 Central & Peripheral Nervous System Disorders Tremor 8 6 Urogenital Ejaculation Disorder 2,3 6 1 Impotence 3 3 <1 Respiratory System Disorders Upper Respiratory Tract Infection 5 4 Rhinitis 5 3 Sinusitis 3 <1 General Fatigue 5 3 Fever 2 <1 Musculoskeletal System Disorders Arthralgia 2 1 Myalgia 2 1 Dose Dependency of Adverse Reactions The potential relationship between the dose of citalopram administered and the incidence of adverse reactions was examined in a fixed-dose study in depressed patients receiving placebo or citalopram 10 mg, 20 mg, 40 mg, and 60 mg (1.5 times the maximum recommended dosage of citalopram). A positive dose response (p<0.05) for the following adverse reactions: fatigue, impotence, insomnia, sweating increased, somnolence, and yawning. Male and Female Sexual Dysfunction with SSRIs Although changes in sexual desire, sexual performance, and sexual satisfaction often occur as manifestations of a psychiatric disorder, they may also be a consequence of SSRI treatment.
Drug interactions
Table 5 presents clinically important drug interactions with Citalopram Capsules. CYP2C19 inhibitors and CYP2C19 poor metabolizers: Avoid concomitant use. There is an increased risk of QT prolongation with concomitant use. ( 7 ) Table 5: Clinically Important Drug Interactions with Citalopram Capsules Monoamine Oxidase Inhibitors (MAOIs) Clinical Impact: Concomitant use of SSRIs, including Citalopram Capsules, and MAOIs increases the risk of serotonin syndrome. Intervention: Citalopram Capsules is contraindicated in patients taking MAOIs, including MAOIs such as linezolid or intravenous methylene blue [see Dosage and Administration ( 2.3 ), Contraindications ( 4 ), Warnings and Precautions ( 5.3 )] . Pimozide Clinical Impact: Concomitant use of citalopram with pimozide increases plasma concentrations of pimozide, a drug with a narrow therapeutic index, and may increase the risk of QT prolongation and/or ventricular arrhythmias compared to use of citalopram alone [see Clinical Pharmacology ( 12.3 )]. Intervention: Citalopram Capsules is contraindicated in patients taking pimozide [see Contraindications ( 4 ), Warnings and Precautions ( 5.2 )] . Drugs that Prolong the QTc Interval Clinical Impact: Concomitant use of citalopram with drugs that prolong QT can cause additional QT prolongation compared to the use of citalopram alone [see Clinical Pharmacology ( 12.3 )]. Intervention: Avoid concomitant use of Citalopram Capsules with drugs that prolong the QT interval (Citalopram Capsules is contraindicated in patients taking pimozide) [see Contraindications ( 4 ), Warnings and Precautions ( 5.2 )] . CYP2C19 Inhibitors Clinical Impact: Concomitant use of citalopram with CYP2C19 inhibitors increases the risk of QT prolongation and/or ventricular arrhythmias compared to the use of citalopram alone [see Clinical Pharmacology ( 12.3 )]. Intervention: Avoid concomitant use of Citalopram Capsules with CYP2C19 inhibitors [see Warnings and Precautions ( 5.2 )]. Other Serotonergic Drugs Clinical Impact: Concomitant use of Citalopram Capsules with other serotonergic drugs (including other SSRIs, SNRIs, triptans, tricyclic antidepressants, opioids, lithium, buspirone, amphetamines, tryptophan, and St. John's Wort) increases the risk of serotonin syndrome. Intervention: Monitor patients for signs and symptoms of serotonin syndrome, particularly during Citalopram Capsules initiation and changes in citalopram dosage. If serotonin syndrome occurs, consider discontinuation of Citalopram Capsules and/or concomitant serotonergic drugs [see Dosage and Administration ( 2.1 , 2.4 ), Warnings and Precautions ( 5.3 )] . Drugs That Interfere With Hemostasis (antiplatelet agents and anticoagulants) Clinical Impact: Concomitant use of citalopram and an antiplatelet or anticoagulant may potentiate the risk of bleeding. Intervention: Inform patients of the increased risk of bleeding associated with the concomitant use of Citalopram Capsules and antiplatelet agents and anticoagulants. For patients taking warfarin, carefully monitor the international normalized ratio [see Warnings and Precautions ( 5.4 )].
Use in specific populations
Pregnancy: SSRI use, particularly late in pregnancy, may increase the risk for persistent pulmonary hypertension and symptoms of poor adaptation (respiratory distress, temperature instability, feeding difficulties, hypotonia, tremor, irritability) in the neonate. ( 8.1 ) Elderly patients: Not recommended. ( 8.5 ) Hepatic Impairment: Not recommended. ( 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/research/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 ( 5.4 ) and Clinical Considerations] . Available data from published epidemiologic studies and postmarketing reports with citalopram use in pregnancy have not established an increased risk of major birth defects or miscarriage. Published studies demonstrated that citalopram levels in both cord blood and amniotic fluid are similar to those observed in maternal serum. There are risks of persistent pulmonary hypertension of the newborn (PPHN) (see Data) and/or poor neonatal adaptation with exposure to selective serotonin reuptake inhibitors (SSRIs), including Citalopram Capsules, during pregnancy. There also are risks associated with untreated depression in pregnancy (see Clinical Considerations) . In animal reproduction studies, citalopram caused adverse embryo/fetal effects at doses that caused maternal toxicity (see Data) . 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 U.S. general population, the estimated background risk of major birth defects and miscarriage in the 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 of 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 Citalopram Capsules in the month before delivery may be associated with an increased risk of postpartum hemorrhage [see Warnings and Precautions ( 5.4 )] . Fetal/Neonatal Adverse Reactions Neonates exposed to citalopram and other SSRIs late in 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, tremor, jitteriness, irritability, and constant crying. These findings are consistent with either a direct toxic effect of SSRIs 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 ( 5.3 )] . Data Human Data Exposure during late pregnancy to SSRIs may have an increased risk for persistent pulmonary hypertension of the newborn (PPHN). PPHN occurs in 1- 2 per 1,000 live births in the general population and is associated with substantial neonatal morbidity and mortality. Animal Data Citalopram was administered orally to pregnant rats during the period of organogenesis at doses of 32, 56, and 112 mg/kg/day, which are approximately 8, 14, and 27 times the Maximum Recommended Human Dose (MRHD) of 40 mg, based on mg/m 2 body surface area. Citalopram caused maternal toxicity of CNS clinical signs and decreased weight gain at 112 mg/kg/day, which is 27 times the MRHD. At this maternally toxic dose, citalopram decreased embryo/fetal growth and survival and increased fetal abnormalities (including cardiovascular and skeletal defects). The no observed adverse effect level (NOAEL) for maternal and embryofetal toxicity is 56 mg/kg/day, which is approximately 14 times the MRHD. Citalopram was administered orally to pregnant rabbits during the period of organogenesis at doses up to 16 mg/kg/day, which is approximately 8 times the MRHD of 40 mg, based on mg/m 2 body surface area. No maternal or embryofetal toxicity was observed. The NOAEL for maternal and embryofetal toxicity is 16 mg/kg/day, which is approximately 8 times the MRHD. Citalopram was administered orally to pregnant rats during late gestation and lactation periods at doses of 4.8, 12.8, and 32 mg/kg/day, which are approximately 1, 3, and 8 times the MRHD of 40 mg, based on mg/m 2 body surface area. Citalopram increased offspring mortality during the first 4 days of birth and decreased offspring growth at 32 mg/kg/day, which is approximately 8 times the MRHD. The NOAEL for developmental toxicity is 12.8 mg/kg/day, which is approximately 3 times the MRHD. In a separate study, similar effects on offspring mortality and growth were seen when dams were treated throughout gestation and early lactation at doses ≥ 24 mg/kg/day, which is approximately 6 times the MRHD. A NOAEL was not determined in that study.
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/research/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 ( 5.4 ) and Clinical Considerations] . Available data from published epidemiologic studies and postmarketing reports with citalopram use in pregnancy have not established an increased risk of major birth defects or miscarriage. Published studies demonstrated that citalopram levels in both cord blood and amniotic fluid are similar to those observed in maternal serum. There are risks of persistent pulmonary hypertension of the newborn (PPHN) (see Data) and/or poor neonatal adaptation with exposure to selective serotonin reuptake inhibitors (SSRIs), including Citalopram Capsules, during pregnancy. There also are risks associated with untreated depression in pregnancy (see Clinical Considerations) . In animal reproduction studies, citalopram caused adverse embryo/fetal effects at doses that caused maternal toxicity (see Data) . 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 U.S. general population, the estimated background risk of major birth defects and miscarriage in the 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 of 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 Citalopram Capsules in the month before delivery may be associated with an increased risk of postpartum hemorrhage [see Warnings and Precautions ( 5.4 )] . Fetal/Neonatal Adverse Reactions Neonates exposed to citalopram and other SSRIs late in 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, tremor, jitteriness, irritability, and constant crying. These findings are consistent with either a direct toxic effect of SSRIs 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 ( 5.3 )] . Data Human Data Exposure during late pregnancy to SSRIs may have an increased risk for persistent pulmonary hypertension of the newborn (PPHN). PPHN occurs in 1- 2 per 1,000 live births in the general population and is associated with substantial neonatal morbidity and mortality. Animal Data Citalopram was administered orally to pregnant rats during the period of organogenesis at doses of 32, 56, and 112 mg/kg/day, which are approximately 8, 14, and 27 times the Maximum Recommended Human Dose (MRHD) of 40 mg, based on mg/m 2 body surface area. Citalopram caused maternal toxicity of CNS clinical signs and decreased weight gain at 112 mg/kg/day, which is 27 times the MRHD. At this maternally toxic dose, citalopram decreased embryo/fetal growth and survival and increased fetal abnormalities (including cardiovascular and skeletal defects). The no observed adverse effect level (NOAEL) for maternal and embryofetal toxicity is 56 mg/kg/day, which is approximately 14 times the MRHD. Citalopram was administered orally to pregnant rabbits during the period of organogenesis at doses up to 16 mg/kg/day, which is approximately 8 times the MRHD of 40 mg, based on mg/m 2 body surface area. No maternal or embryofetal toxicity was observed. The NOAEL for maternal and embryofetal toxicity is 16 mg/kg/day, which is approximately 8 times the MRHD. Citalopram was administered orally to pregnant rats during late gestation and lactation periods at doses of 4.8, 12.8, and 32 mg/kg/day, which are approximately 1, 3, and 8 times the MRHD of 40 mg, based on mg/m 2 body surface area. Citalopram increased offspring mortality during the first 4 days of birth and decreased offspring growth at 32 mg/kg/day, which is approximately 8 times the MRHD. The NOAEL for developmental toxicity is 12.8 mg/kg/day, which is approximately 3 times the MRHD. In a separate study, similar effects on offspring mortality and growth were seen when dams were treated throughout gestation and early lactation at doses ≥ 24 mg/kg/day, which is approximately 6 times the MRHD. A NOAEL was not determined in that study.
Pediatric use
8.4 Pediatric Use The safety and effectiveness of citalopram have not been established in pediatric patients. Two placebo-controlled trials in 407 pediatric patients with MDD have been conducted with other another formulation of citalopram, and the data were not sufficient to support use in pediatric patients. Antidepressants increase the risk of suicidal thoughts and behaviors in pediatric patients [see Boxed Warning , Warnings and Precautions ( 5.1 )] . Decreased appetite and weight loss have been observed in association with the use of SSRIs in pediatric patients.
Geriatric use
8.5 Geriatric Use Citalopram Capsules is not recommended for use in the elderly because dosage adjustments are not possible with the available strengths of Citalopram Capsules. In two pharmacokinetic studies, citalopram AUC was increased by 23% and 30%, respectively, in subjects ≥ 60 years of age as compared to younger subjects, and its half-life was increased by 30% and 50%, respectively. Of 4,422 patients in clinical studies of citalopram, 1357 were 60 and over, 1034 were 65 and over, and 457 were 75 and over. SSRIs, including citalopram, 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 )] .
Overdosage
The following have been reported with citalopram tablet 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, and torsade de pointes. 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 proserotonergic drugs may have a higher risk). Prolonged cardiac monitoring is recommended in Citalopram Capsules overdosage ingestions due to the arrhythmia risk. Gastrointestinal decontamination with activated charcoal should be considered in patients who present early after a Citalopram Capsules overdose. Consider contacting a Poison Center (1‐800‐221‐2222) or a medical toxicologist for additional overdosage management recommendations.
Description
Citalopram Capsules contain citalopram, a selective serotonin reuptake inhibitor (SSRI). Citalopram hydrobromide is a racemic bicyclic phthalane derivative designated (±)-1-(3-dimethylaminopropyl)-1-(4-fluorophenyl)-1,3-dihydroisobenzofuran-5carbonitrile, hydrobromide with the following structural formula: The molecular formula is C 20 H 22 BrFN 2 O and its molecular weight is 405.35. Citalopram hydrobromide is a white to almost white crystalline powder. Citalopram hydrobromide is freely soluble in chloroform and sparingly soluble in ethanol and water. Citalopram Capsules is for oral administration and contains 30 mg of citalopram, equivalent to 37.5 mg of citalopram hydrobromide. The strengths reflect citalopram base equivalent content. Citalopram Capsules also contain the inactive ingredients copovidone, croscarmellose sodium, gelatin, magnesium stearate, microcrystalline cellulose, talc and titanium dioxide. The capsule shells contain the colorants FD&C Blue #1 and FD&C Red #3.
Mechanism of action
12.1 Mechanism of Action The mechanism of action of citalopram as an antidepressant is unclear, but is presumed to be related to potentiation of serotonergic activity in the central nervous system (CNS) resulting from its inhibition of CNS neuronal reuptake of serotonin (5-HT).
How supplied
Citalopram Capsules are supplied as: 30 mg capsules: Hard shell gelatin capsules, with “ALM” printed axially on the blue opaque cap in black ink and “691” printed axially on the white opaque body in black ink: NDC 52427-691-30 Bottle of 30 capsules Storage and Handling Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
Patient information
Advise the patient to read the FDA-approved patient labeling ( Medication Guide ). Suicidal Thoughts and Behaviors Advise patients, and caregivers to look for the emergence of suicidality, especially during treatment and when the dose is adjusted up or down, and instruct them to report such symptoms to their healthcare provider [see Boxed Warning and Warnings and Precautions ( 5.1 )] . QTc Prolongation and Torsade de Pointes Advise patients to consult their healthcare provider immediately if they feel faint, lose consciousness, or have heart palpitations. Instruct patients to inform their healthcare provider that they are taking Citalopram Capsules before taking any new medications [see Warnings and Precautions ( 5.2 )] . Serotonin Syndrome Caution patients about the risk of serotonin syndrome, particularly with the concomitant use of Citalopram Capsules with other serotonergic drugs including triptans, tricyclic antidepressants, opioids, lithium, amphetamines, tryptophan, buspirone, St. John’s Wort, and with drugs that impair metabolism of serotonin (in particular, MAOIs, both those intended to treat psychiatric disorders and also others, such as linezolid). Instruct patients to contact their health care provider or report to the emergency room if they experience signs or symptoms of serotonin syndrome [see Warnings and Precautions ( 5.3 ), Drug Interactions ( 7 )] . Increased Risk of Bleeding Inform patients about the concomitant use of Citalopram Capsules with aspirin, NSAIDs, other antiplatelet drugs, warfarin, or other anticoagulants because the combined use has been associated with an increased risk of bleeding. Advise patients to inform their health care provider if they are taking or are planning to take any prescription or over-the-counter medications that increase the risk of bleeding [see Warnings and Precautions ( 5.4 )] . Activation of Mania or Hypomania Advise patients and their caregivers to observe for signs of activation of mania/hypomania and instruct them to report such symptoms to the healthcare provider [see Warnings and Precautions ( 5.5 )] . Discontinuation Syndrome Advise patients not to abruptly discontinue Citalopram Capsules and to discuss any tapering regimen with their healthcare provider. Inform patients that adverse reactions can occur when Citalopram Capsules is discontinued [see Warnings and Precautions ( 5.6 )] . Sexual Dysfunction Advise patients that use of Citalopram Capsules may cause symptoms of sexual dysfunction in both male and female patients. Inform patients that they should discuss any changes in sexual function and potential management strategies with their healthcare provider [see Warnings and Precautions ( 5.10 )] . Pregnancy Advise pregnant women to notify their healthcare providers if they become pregnant or intend to become pregnant during treatment with Citalopram Capsules. Advise patients that Citalopram Capsules use late in pregnancy may lead to an increased risk for neonatal complications requiring prolonged hospitalization, respiratory support, tube feeding, and/or persistent pulmonary hypertension of the newborn (PPHN) [see Use in Specific Populations ( 8.1 )] . Advise women that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to citalopram during pregnancy [see Use in Specific Populations ( 8.1 )] . Lactation Advise breastfeeding women to monitor infants for excess sedation, restlessness, agitation, poor feeding and poor weight gain and to seek medical care if they notice these signs [see Use in Specific Populations ( 8.2 )] .
Label text from the FDA structured product label by Almatica Pharma LLC (revised Oct 7, 2025). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Citalopram Hydrobromide in 85 products
- Citalopram in 8 products
citalopram NDC products (93)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 50090-3136 | Citalopram Hydrobromide 40 mg/1 Tablet, Film Coated | A-S Medication Solutions | ANDA |
| 50090-5170 | Citalopram Hydrobromide 10 mg/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-5172 | Citalopram Hydrobromide 20 mg/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-5175 | Citalopram Hydrobromide 40 mg/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-6433 | Citalopram Hydrobromide 20 mg/1 Tablet, Film Coated | A-S Medication Solutions | ANDA |
| 50090-7039 | Citalopram Hydrobromide 40 mg/1 Tablet, Film Coated | A-S Medication Solutions | ANDA |
| 50090-7419 | Citalopram Hydrobromide 10 mg/1 Tablet, Film Coated | A-S Medication Solutions | ANDA |
| 80425-0557 | Citalopram Hydrobromide 10 mg/1 Tablet, Film Coated | Advanced Rx of Tennessee, LLC | ANDA |
| 80425-0093 | Citalopram Hydrobromide 20 mg/1 Tablet | Advanced Rx of Tennessee, LLC | ANDA |
| 65162-054 | Citalopram Hydrobromide 40 mg/1 Tablet | Amneal Pharmaceuticals LLC | ANDA |
| 65162-053 | Citalopram Hydrobromide 20 mg/1 Tablet | Amneal Pharmaceuticals LLC | ANDA |
| 65162-052 | Citalopram Hydrobromide 10 mg/1 Tablet | Amneal Pharmaceuticals LLC | ANDA |
| 71610-422 | Citalopram Hydrobromide 40 mg/1 Tablet, Film Coated | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 71610-413 | Citalopram Hydrobromide 40 mg/1 Tablet, Film Coated | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 71610-412 | Citalopram Hydrobromide 40 mg/1 Tablet | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 87063-221 | Citalopram Hydrobromide 40 mg/1 Tablet, Film Coated | ASCLEMED USA INC. | ANDA |
| 87063-219 | Citalopram Hydrobromide 10 mg/1 Tablet, Film Coated | ASCLEMED USA INC. | ANDA |
| 87063-220 | Citalopram Hydrobromide 20 mg/1 Tablet, Film Coated | ASCLEMED USA INC. | ANDA |
| 65862-005 | Citalopram Hydrobromide 10 mg/1 Tablet, Film Coated | Aurobindo Pharma Limited | ANDA |
| 65862-006 | Citalopram Hydrobromide 20 mg/1 Tablet, Film Coated | Aurobindo Pharma Limited | ANDA |
| 65862-007 | Citalopram Hydrobromide 40 mg/1 Tablet, Film Coated | Aurobindo Pharma Limited | ANDA |
| 59651-964 | Citalopram Hydrobromide 30 mg/1 Capsule | Aurobindo Pharma Limited | ANDA |
| 72162-2567 | Citalopram Hydrobromide 20 mg/1 Tablet, Film Coated | Bryant Ranch Prepack | ANDA |
| 72162-2517 | Citalopram Hydrobromide 20 mg/1 Tablet, Film Coated | Bryant Ranch Prepack | ANDA |
| 71335-0377 | Citalopram Hydrobromide 10 mg/1 Tablet, Film Coated | Bryant Ranch Prepack | ANDA |
| 71335-2232 | Citalopram Hydrobromide 40 mg/1 Tablet, Film Coated | Bryant Ranch Prepack | ANDA |
| 55154-3349 | Citalopram Hydrobromide 10 mg/1 Tablet, Film Coated | Cardinal Health 107, LLC | ANDA |
| 55154-3329 | Citalopram Hydrobromide 20 mg/1 Tablet, Film Coated | Cardinal Health 107, LLC | ANDA |
| 68999-540 | Citalopram Hydrobromide 10 mg/5mL Solution | Chartwell Governmental & Specialty RX, LLC. | ANDA |
| 62135-540 | Citalopram Hydrobromide 10 mg/5mL Solution | Chartwell RX, LLC | ANDA |
| 69097-824 | Citalopram Hydrobromide 40 mg/1 Tablet | Cipla USA Inc. | ANDA |
| 69097-822 | Citalopram Hydrobromide 10 mg/1 Tablet | Cipla USA Inc. | ANDA |
| 69097-823 | Citalopram Hydrobromide 20 mg/1 Tablet | Cipla USA Inc. | ANDA |
| 67046-0795 | Citalopram Hydrobromide 20 mg/1 Tablet, Film Coated | Coupler LLC | ANDA |
| 67046-0793 | Citalopram Hydrobromide 10 mg/1 Tablet, Film Coated | Coupler LLC | ANDA |
| 67046-0113 | Citalopram Hydrobromide 40 mg/1 Tablet, Film Coated | Coupler LLC | ANDA |
| 42806-019 | Citalopram Hydrobromide 10 mg/1 Tablet, Film Coated | Epic Pharma, LLC | ANDA |
| 42806-021 | Citalopram Hydrobromide 40 mg/1 Tablet, Film Coated | Epic Pharma, LLC | ANDA |
| 42806-020 | Citalopram Hydrobromide 20 mg/1 Tablet, Film Coated | Epic Pharma, LLC | ANDA |
| 60429-175 | Citalopram Hydrobromide 40 mg/1 Tablet, Film Coated | Golden State Medical Supply, Inc. | ANDA |
| 0054-0062 | Citalopram Hydrobromide 10 mg/5mL Solution | Hikma Pharmaceuticals USA Inc. | ANDA |
| 0904-6085 | Citalopram Hydrobromide 20 mg/1 Tablet, Film Coated | Major Pharmaceuticals | ANDA |
| 0904-6084 | Citalopram Hydrobromide 10 mg/1 Tablet, Film Coated | Major Pharmaceuticals | ANDA |
| 0378-6231 | Citalopram Hydrobromide 10 mg/1 Tablet, Film Coated | Mylan Pharmaceuticals Inc. | ANDA |
| 0378-6233 | Citalopram Hydrobromide 40 mg/1 Tablet, Film Coated | Mylan Pharmaceuticals Inc. | ANDA |
| 0378-6232 | Citalopram Hydrobromide 20 mg/1 Tablet, Film Coated | Mylan Pharmaceuticals Inc. | ANDA |
| 0615-8022 | Citalopram Hydrobromide 10 mg/1 Tablet, Film Coated | NCS HealthCare of KY, LLC dba Vangard Labs | ANDA |
| 0615-8023 | Citalopram Hydrobromide 20 mg/1 Tablet, Film Coated | NCS HealthCare of KY, LLC dba Vangard Labs | ANDA |
| 0615-8141 | Citalopram Hydrobromide 40 mg/1 Tablet, Film Coated | NCS HealthCare of KY, LLC dba Vangard Labs | ANDA |
| 51655-938 | Citalopram Hydrobromide 10 mg/1 Tablet | Northwind Health Company, LLC | ANDA |
| 51655-605 | Citalopram Hydrobromide 10 mg/1 Tablet, Film Coated | Northwind Health Company, LLC | ANDA |
| 51655-664 | Citalopram Hydrobromide 20 mg/1 Tablet, Film Coated | Northwind Health Company, LLC | ANDA |
| 51655-680 | Citalopram Hydrobromide 20 mg/1 Tablet, Film Coated | Northwind Health Company, LLC | ANDA |
| 51655-667 | Citalopram Hydrobromide 40 mg/1 Tablet, Film Coated | Northwind Health Company, LLC | ANDA |
| 51655-137 | Citalopram Hydrobromide 20 mg/1 Tablet | Northwind Health Company, LLC | ANDA |
| 51655-209 | Citalopram Hydrobromide 40 mg/1 Tablet | Northwind Health Company, LLC | ANDA |
| 68071-3357 | Citalopram Hydrobromide 40 mg/1 Tablet, Film Coated | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-3558 | Citalopram Hydrobromide 40 mg/1 Tablet, Film Coated | NuCare Pharmaceuticals,Inc. | ANDA |
| 43063-683 | Citalopram Hydrobromide 20 mg/1 Tablet, Film Coated | PD-Rx Pharmaceuticals, Inc. | ANDA |
| 72789-071 | Citalopram Hydrobromide 40 mg/1 Tablet, Film Coated | PD-Rx Pharmaceuticals, Inc. | ANDA |
| 43063-670 | Citalopram Hydrobromide 40 mg/1 Tablet, Film Coated | PD-Rx Pharmaceuticals, Inc. | ANDA |
| 43063-481 | Citalopram Hydrobromide 10 mg/1 Tablet, Film Coated | PD-Rx Pharmaceuticals, Inc. | ANDA |
| 43063-063 | Citalopram Hydrobromide 20 mg/1 Tablet | PD-Rx Pharmaceuticals, Inc. | ANDA |
| 63187-679 | Citalopram Hydrobromide 20 mg/1 Tablet, Film Coated | Proficient Rx LP | ANDA |
| 63187-140 | Citalopram Hydrobromide 40 mg/1 Tablet, Film Coated | Proficient Rx LP | ANDA |
| 42708-091 | Citalopram Hydrobromide 20 mg/1 Tablet, Film Coated | QPharma, Inc. | ANDA |
| 42708-019 | Citalopram Hydrobromide 20 mg/1 Tablet, Film Coated | QPharma, Inc. | ANDA |
| 82009-106 | Citalopram Hydrobromide 10 mg/1 Tablet, Film Coated | QUALLENT PHARMACEUTICALS HEALTH LLC | ANDA |
| 82009-107 | Citalopram Hydrobromide 20 mg/1 Tablet, Film Coated | QUALLENT PHARMACEUTICALS HEALTH LLC | ANDA |
| 82009-108 | Citalopram Hydrobromide 40 mg/1 Tablet, Film Coated | QUALLENT PHARMACEUTICALS HEALTH LLC | ANDA |
| 70518-4335 | Citalopram Hydrobromide 20 mg/1 Tablet, Film Coated | REMEDYREPACK INC. | ANDA |
| 70518-4476 | Citalopram Hydrobromide 10 mg/1 Tablet, Film Coated | REMEDYREPACK INC. | ANDA |
| 70518-4416 | Citalopram Hydrobromide 10 mg/1 Tablet, Film Coated | REMEDYREPACK INC. | ANDA |
| 70518-4334 | Citalopram Hydrobromide 40 mg/1 Tablet, Film Coated | REMEDYREPACK INC. | ANDA |
| 70518-4114 | Citalopram Hydrobromide 20 mg/1 Tablet, Film Coated | REMEDYREPACK INC. | ANDA |
| 70518-2617 | Citalopram Hydrobromide 20 mg/1 Tablet | REMEDYREPACK INC. | ANDA |
| 70518-2601 | Citalopram Hydrobromide 40 mg/1 Tablet, Film Coated | REMEDYREPACK INC. | ANDA |
| 70518-2553 | Citalopram Hydrobromide 10 mg/1 Tablet, Film Coated | REMEDYREPACK INC. | ANDA |
| 70518-2228 | Citalopram Hydrobromide 40 mg/1 Tablet | REMEDYREPACK INC. | ANDA |
| 60760-495 | Citalopram Hydrobromide 20 mg/1 Tablet, Film Coated | St. Mary's Medical Park Pharmacy | ANDA |
| 60760-009 | Citalopram Hydrobromide 10 mg/1 Tablet, Film Coated | St. Mary's Medical Park Pharmacy | ANDA |
| 13668-009 | Citalopram Hydrobromide 10 mg/1 Tablet, Film Coated | Torrent Pharmaceuticals Limited | ANDA |
| 13668-011 | Citalopram Hydrobromide 40 mg/1 Tablet, Film Coated | Torrent Pharmaceuticals Limited | ANDA |
| 13668-010 | Citalopram Hydrobromide 20 mg/1 Tablet, Film Coated | Torrent Pharmaceuticals Limited | ANDA |
| 52427-691 | Citalopram Hydrobromide 30 mg/1 Capsule | Almatica Pharma LLC | NDA |
| 37662-0338 | Citalopram 30 [hp_C]/1 Pellet | Hahnemann Laboratories, INC. | UNAPPROVED HOMEOPATHIC |
| 37662-0337 | Citalopram 12 [hp_C]/1 Pellet | Hahnemann Laboratories, INC. | UNAPPROVED HOMEOPATHIC |
| 37662-0336 | Citalopram 6 [hp_C]/1 Pellet | Hahnemann Laboratories, INC. | UNAPPROVED HOMEOPATHIC |
| 37662-0343 | Citalopram 1 [hp_Q]/1 Pellet | Hahnemann Laboratories, INC. | UNAPPROVED HOMEOPATHIC |
| 37662-0342 | Citalopram 1 [hp_M]/1 Pellet | Hahnemann Laboratories, INC. | UNAPPROVED HOMEOPATHIC |
| 37662-0341 | Citalopram 500 [hp_C]/1 Pellet | Hahnemann Laboratories, INC. | UNAPPROVED HOMEOPATHIC |
| 37662-0340 | Citalopram 200 [hp_C]/1 Pellet | Hahnemann Laboratories, INC. | UNAPPROVED HOMEOPATHIC |
| 37662-0339 | Citalopram 100 [hp_C]/1 Pellet | Hahnemann Laboratories, INC. | UNAPPROVED HOMEOPATHIC |
citalopram recalls
- D-0173-2024 Jan 3, 2024 · Class II · Terminated
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Frequently asked questions
What is citalopram used for?
Citalopram Capsules are indicated for the treatment of Major Depressive Disorder (MDD) in adults [see Clinical Studies ( 14 )] . Citalopram Capsules is a selective serotonin reuptake inhibitor (SSRI) indicated for treatment of Major Depressive Disorder (MDD) in adults. ( 1 )
What are the side effects of citalopram?
The following adverse reactions are discussed in greater detail in other sections of the labeling: Hypersensitivity reactions [see Contraindications ( 4 )] Suicidal Thoughts and Behaviors in Adolescent and Young Adults [see Warnings and Precautions ( 5.1 )] QT-Prolongation and Torsade de Pointes [see Warnings and Precautions ( 5.2 )] Serotonin Syndrome [see Warnings and Precautions ( 5.3 )]… See the full label for the complete list.
Who makes citalopram?
citalopram is listed by 29 labelers in the FDA NDC directory, including A-S Medication Solutions, Advanced Rx of Tennessee, LLC, Amneal Pharmaceuticals LLC, Aphena Pharma Solutions - Tennessee, LLC.
Has citalopram been recalled?
The FDA enforcement database lists 1 recall for citalopram, most recently D-0173-2024 (class ii): CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.