Sertraline hydrochloride
Tablet, Film Coated · Oral
Uses
Sertraline hydrochloride capsules are indicated for the treatment of the following [see Clinical Studies ( 14 )] : Major depressive disorder (MDD) in adults Obsessive-compulsive disorder (OCD) in adults and pediatric patients 6 years and older Sertraline hydrochloride capsules are a selective serotonin reuptake inhibitor (SSRI) indicated for the treatment of ( 1 ): Major depressive disorder (MDD) in adults Obsessive-compulsive disorder (OCD) in adults and pediatric patients 6 years and older
Dosage and administration
Do not initiate treatment with sertraline hydrochloride capsules. Use another sertraline hydrochloride product for initial dosage, titration, and dosages below 150 mg once daily ( 2.1 ) Recommended dosage is 150 mg or 200 mg once daily ( 2.1 ) Maximum recommended dosage is 200 mg once daily ( 2.1 ) Swallow capsules whole. Do not open, crush, or chew ( 2.2 ) When discontinuing sertraline hydrochloride capsules, reduce dose gradually whenever possible. Gradual dosage reduction will require use of another sertraline hydrochloride product ( 2.5 , 5.5 ) 2.1 Dosage in Patients with MDD and OCD Do not initiate treatment with sertraline hydrochloride capsules because the only available dose strengths are 150 mg and 200 mg. Use another sertraline hydrochloride product for initial dosage, titration, and dosages below 150 mg once daily. Refer to Prescribing Information of the other sertraline hydrochloride products for the recommended dosage for those products. Sertraline hydrochloride capsules can be initiated in patients receiving 100 mg or 125 mg of sertraline hydrochloride for at least one week. The recommended dosage of sertraline hydrochloride capsules is 150 mg or 200 mg once daily. The maximum recommended dosage is 200 mg once daily. 2.2 Administration Instructions Administer sertraline hydrochloride capsules orally. Swallow capsules whole; do not open, crush, or chew. 2.3 Screen for Bipolar Disorder Prior to Starting Sertraline Hydrochloride Capsules Prior to initiating treatment with sertraline hydrochloride capsules or another antidepressant, screen patients for a personal or family history of bipolar disorder, mania, or hypomania [see Warnings and Precautions ( 5.4 )] . 2.4 Switching Patients to or from a Monoamine Oxidase Inhibitor Antidepressant At least 14 days must elapse between discontinuation of a monoamine oxidase inhibitor (MAOI) antidepressant and initiation of sertraline hydrochloride capsules. In addition, at least 14 days must elapse after stopping sertraline hydrochloride capsules before starting an MAOI antidepressant [see Contraindications ( 4 ), Warnings and Precautions ( 5.2 )] . 2.5 Discontinuation of Treatment with Sertraline Hydrochloride Capsules Adverse reactions may occur upon discontinuation of sertraline hydrochloride capsules [see Warnings and Precautions ( 5.5 )] . Gradually reduce the dosage rather than stopping sertraline hydrochloride capsules abruptly whenever possible. Given that dosage strengths lower than 150 mg of sertraline hydrochloride capsules are not available, gradual dosage reduction will require the use of another sertraline hydrochloride product.
Dosage forms and strengths
150 mg capsules: Hard shell capsules, with "ALM" printed axially on the opaque yellow cap and "664" printed axially on the opaque white body. 200 mg capsules: Hard shell capsules, with "ALM" printed axially on the opaque yellowish green cap and "672" printed axially on the opaque white body. Dosage strengths are based on the active moiety, sertraline. The 150 mg capsules contain 168 mg of sertraline hydrochloride, USP. The 200 mg capsules contain 224 mg of sertraline hydrochloride, USP. Capsules: 150 mg and 200 mg ( 3 )
Contraindications
Sertraline hydrochloride capsules are contraindicated in patients: Taking, or within 14 days of stopping, MAOIs, (including the MAOIs linezolid and intravenous methylene blue) because of an increased risk of serotonin syndrome [see Warnings and Precautions ( 5.2 ), Drug Interactions ( 7.1 )] . Taking pimozide [see Drug Interactions ( 7.1 )] . With known hypersensitivity to sertraline or the excipients in sertraline hydrochloride capsules (e.g., anaphylaxis, angioedema) [see Adverse Reactions ( 6.1 , 6.2 )] . Concomitant use of monoamine oxidase inhibitors (MAOIs), or use within 14 days of stopping MAOIs ( 4 , 7.1 ) Concomitant use of pimozide ( 4 , 7.1 ) Known hypersensitivity to sertraline or excipients ( 4 )
Warnings and precautions
Serotonin Syndrome: Increased risk when co-administered with other serotonergic agents, but also when taken alone. If it occurs, discontinue sertraline hydrochloride capsules and serotonergic agents and initiate supportive treatment ( 4 , 5.2 , 7.1 ) Increased Risk of Bleeding: Concomitant use of aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), other antiplatelet drugs, warfarin, and other anticoagulants may increase this risk ( 5.3 ) Activation of Mania or Hypomania: Screen patients for bipolar disorder ( 5.4 ) Discontinuation Syndrome: When discontinuing sertraline hydrochloride capsules, reduce dosage gradually whenever possible, and monitor for discontinuation symptoms. Gradual reduction will require use of another sertraline hydrochloride product ( 5.5 ) Seizures: Use with caution in patients with seizure disorders ( 5.6 ) Angle Closure Glaucoma: Avoid use of antidepressants, including sertraline hydrochloride capsules, in patients with untreated anatomically narrow angles ( 5.7 ) QTc Prolongation: Sertraline hydrochloride capsules should be used with caution in patients with risk factors for QTc prolongation ( 5.10 ) Allergic Reactions to FD&C Yellow No. 5 (Tartrazine): Contains FD&C Yellow No. 5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible persons ( 5.11 ) Sexual Dysfunction: Sertraline hydrochloride capsules may cause symptoms of sexual dysfunction ( 5.12 ) 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. The 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 of Suicidal Thoughts or Behavior in the Pooled Placebo-Controlled Trials of Antidepressants in Pediatric and Adult Patients Age Range Drug-Placebo Difference in Number of Patients of Suicidal Thoughts or Behaviors per 1,000 Patients Treated Increases Compared to Placebo <18 years old 14 additional patients 18 to 24 years old 5 additional patients Decreases Compared to Placebo 25 to 64 years old 1 fewer patient ≥65 years old 6 fewer patients 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 sertraline hydrochloride capsules, in patients whose depression is persistently worse, or who are experiencing emergent suicidal thoughts or behaviors. 5.2 Serotonin Syndrome SSRIs, including sertraline hydrochloride capsules, can precipitate serotonin syndrome, a potentially life-threatening condition. The risk is increased with concomitant use of other serotonergic drugs (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, meperidine, methadone, tryptophan, buspirone, amphetamines, and St. John’s Wort) and with drugs that impair metabolism of serotonin, i.e., MAOIs [see Contraindications ( 4 ), Drug Interactions ( 7.1 )] . Serotonin syndrome can also occur when these drugs are used alone. Serotonin syndrome signs and symptoms 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 symptoms (e.g., tremor, rigidity, myoclonus, hyperreflexia, incoordination), seizures, and gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea). The concomitant use of sertraline hydrochloride capsules with MAOIs is contraindicated. In addition, do not initiate sertraline hydrochloride capsules in a patient being treated with MAOIs such as linezolid or intravenous methylene blue. No reports involved the administration of methylene blue by other routes (such as oral ingestion or local tissue injection). If it is necessary to initiate treatment with an MAOI such as linezolid or intravenous methylene blue in a patient taking sertraline hydrochloride capsules, discontinue sertraline hydrochloride capsules before initiating treatment with the MAOI [see Contraindications ( 4 ), Drug Interactions ( 7.1 )] . Monitor all patients taking sertraline hydrochloride capsules for the emergence of serotonin syndrome. Discontinue treatment with sertraline hydrochloride capsules and any concomitant serotonergic agents immediately if the above symptoms occur, and initiate supportive symptomatic treatment. If concomitant use of sertraline hydrochloride capsules with other serotonergic drugs is clinically warranted, inform patients of the increased risk for serotonin syndrome and monitor for symptoms.
Side effects
The following adverse reactions are described in more detail in other sections of the prescribing information: Hypersensitivity reactions to sertraline or excipients of sertraline hydrochloride capsules [see Contraindications ( 4 )] Suicidal Thoughts and Behaviors in Adolescent and Young Adults [see Warnings and Precautions ( 5.1 )] Serotonin Syndrome [see Contraindications ( 4 ), Warnings and Precautions ( 5.2 ), Drug Interactions ( 7.1 )] Increased Risk of Bleeding [see Warnings and Precautions ( 5.3 )] Activation of Mania or Hypomania [see Warnings and Precautions ( 5.4 )] Discontinuation Syndrome [see Warnings and Precautions ( 5.5 )] Seizures [see Warnings and Precautions ( 5.6 )] Angle-Closure Glaucoma [see Warnings and Precautions ( 5.7 )] Hyponatremia [see Warnings and Precautions ( 5.8 )] QTc Prolongation [see Warnings and Precautions ( 5.10 )] Allergic reactions to FD&C Yellow No. 5 (Tartrazine) [see Warnings and Precautions ( 5.11 )] Sexual Dysfunction [see Warnings and Precautions ( 5.12 )] Most common adverse reactions (≥5% and twice placebo) in pooled placebo-controlled clinical trials with sertraline hydrochloride were nausea, diarrhea/loose stool, tremor, dyspepsia, decreased appetite, hyperhidrosis, ejaculation failure, and decreased libido ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Alvogen, Inc. at 1-866-770-3024 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 the rates observed in practice. The safety of sertraline hydrochloride capsules for the treatment of MDD and OCD is based on adequate and well-controlled studies of another sertraline hydrochloride product. Below is a display of adverse reactions of sertraline hydrochloride (referred to as “sertraline” in this section) from those adequate and well-controlled studies in MDD, OCD, and other conditions. The data described below reflect exposure in randomized, double-blind, placebo-controlled trials of sertraline in 3066 adults. These 3066 patients exposed to sertraline for 8 to 12 weeks represent 568 patient-years of exposure. The mean age was 40 years; 57% were females and 43% were males. The most common adverse reactions (≥5% and twice placebo) in all pooled placebo-controlled clinical trials of all sertraline-treated patients (MDD, OCD, and other conditions) were nausea, diarrhea/loose stool, tremor, dyspepsia, decreased appetite, hyperhidrosis, ejaculation failure, and decreased libido (see Table 2). The following are the most common adverse reactions in trials of sertraline (≥5% and twice placebo) by indication that were not mentioned previously. MDD: somnolence OCD: insomnia, agitation Table 2: Common Adverse Reactions (Greater than 2% of Adults with MDD, OCD, and Other Conditions Treated with Sertraline Hydrochloride and Greater than or Equal to Twice the Incidence of Placebo) in Pooled Placebo-Controlled Trials* (1) Denominator used was for male patients only (n=1316 sertraline; n=973 placebo). * Adverse reactions that occurred greater than 2% in sertraline hydrochloride-treated patients and at least 2% greater in sertraline hydrochloride-treated patients than placebo-treated patients. Sertraline Hydrochloride (N=3066) % Placebo (N=2293) % Cardiac disorders Palpitations 4 2 Eye disorders Visual impairment 4 2 Gastrointestinal Disorders Nausea 26 12 Diarrhea/Loose Stools 20 10 Dry mouth 14 9 Dyspepsia 8 4 Constipation 6 4 Vomiting 4 1 General disorders and administration site conditions Fatigue 12 8 Metabolism and nutrition disorders Decreased appetite 7 2 Nervous system disorders Dizziness 12 8 Somnolence 11 6 Tremor 9 2 Psychiatric Disorders Insomnia 20 13 Agitation 8 5 Libido Decreased 6 2 Reproductive system and breast disorders Ejaculation failure (1) 8 1 Erectile dysfunction (1) 4 1 Ejaculation disorder (1) 3 0 Male sexual dysfunction (1) 2 0 Skin and subcutaneous tissue disorders Hyperhidrosis 7 3 Adverse Reactions Leading to Discontinuation in Placebo-Controlled Clinical Trials In all placebo-controlled studies, 368 (12%) of the 3066 patients who received sertraline discontinued treatment due to an adverse reaction, compared with 93 (4%) of the 2293 placebo-treated patients. In placebo-controlled studies, the following were the common adverse reactions leading to discontinuation in sertraline-treated patients: All sertraline -treated patients (MDD, OCD, and Other Conditions): nausea (3%), diarrhea (2%), agitation (2%), and insomnia (2%). MDD (>2% and twice placebo): decreased appetite, dizziness, fatigue, headache, somnolence, tremor, and vomiting. OCD: somnolence. Male and Female Sexual Dysfunction 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. However, reliable estimates of the incidence and severity of untoward experiences involving sexual desire, performance and satisfaction are difficult to obtain, in part because patients and healthcare providers may be reluctant to discuss them. Accordingly, estimates of the incidence of untoward sexual experience and performance cited in labeling may underestimate their actual incidence. Table 3 below displays the incidence of sexual adverse reactions reported by at least 2% of sertraline -treated patients and twice placebo from pooled placebo-controlled trials of MDD, OCD, and other conditions. For men and all indications, the most common adverse reactions (>2% and twice placebo) included: ejaculation failure, decreased libido, erectile dysfunction, ejaculation disorder, and male sexual dysfunction. For women, the most common adverse reaction (≥2% and twice placebo) was decreased libido.
Drug interactions
Protein-bound drugs: Monitor for adverse reactions and reduce dosage of sertraline hydrochloride capsules or other protein-bound drugs (e.g., warfarin) as warranted ( 7.1 , 12.3 ) CYP2D6 substrates: Reduce dosage of drugs metabolized by CYP2D6 ( 7.1 , 12.3 ) 7.1 Clinically Significant Drug Interactions Table 4 includes clinically significant drug interactions with sertraline hydrochloride capsules [see Clinical Pharmacology ( 12.3 )] . Table 4. Clinically-Significant Drug Interactions with Sertraline Hydrochloride Capsules Monoamine Oxidase Inhibitors (MAOIs) Clinical Impact: The concomitant use of SSRIs, including sertraline hydrochloride capsules, and MAOIs increases the risk of serotonin syndrome. Intervention: Sertraline hydrochloride capsules are contraindicated in patients taking MAOIs, including MAOIs such as linezolid or intravenous methylene blue [see Dosage and Administration ( 2.4 ), Contraindications ( 4 ), Warnings and Precautions ( 5.2 )] . Pimozide Clinical Impact: Increased plasma concentrations of pimozide, a drug with a narrow therapeutic index, may increase the risk of QTc prolongation and ventricular arrhythmias. Intervention: Concomitant use of pimozide and sertraline hydrochloride capsules is contraindicated [see Contraindications ( 4 )] . Other Serotonergic Drugs Clinical Impact: Concomitant use of sertraline hydrochloride 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 treatment initiation and dosage increases. If serotonin syndrome occurs, consider discontinuation of sertraline hydrochloride capsules and/or concomitant serotonergic drugs [see Warnings and Precautions ( 5.2 )] . Drugs that Interfere with Hemostasis (antiplatelet agents and anticoagulants) Clinical Impact: The concurrent use of an antiplatelet agent or anticoagulant with sertraline hydrochloride capsules may potentiate the risk of bleeding. Intervention: Inform patients of the increased risk of bleeding associated with the concomitant use of sertraline hydrochloride capsules and antiplatelet agents and anticoagulants. For patients taking warfarin, carefully monitor the international normalized ratio [see Warnings and Precautions ( 5.3 )] . Drugs Highly Bound to Plasma Protein Clinical Impact: Sertraline is highly bound to plasma protein. The concomitant use of sertraline hydrochloride capsules with another drug that is highly bound to plasma protein may increase free concentrations of sertraline or other tightly-bound drugs in plasma [see Clinical Pharmacology ( 12.3 )] . Intervention: Monitor for adverse reactions and reduce dosage of sertraline hydrochloride capsules or other protein-bound drugs as warranted. Drugs Metabolized by CYP2D6 Clinical Impact: Sertraline hydrochloride capsules are a CYP2D6 inhibitor [see Clinical Pharmacology ( 12.3 )] . The concomitant use of sertraline hydrochloride capsules with a CYP2D6 substrate may increase the exposure of the CYP2D6 substrate. Intervention: Decrease the dosage of a CYP2D6 substrate if needed with concomitant sertraline hydrochloride capsules use. Conversely, an increase in dosage of a CYP2D6 substrate may be needed if sertraline hydrochloride capsules are discontinued. Phenytoin Clinical Impact: Phenytoin is a narrow therapeutic index drug. Sertraline hydrochloride capsules may increase phenytoin concentrations. Intervention: Monitor phenytoin levels when initiating or titrating sertraline hydrochloride capsules. Reduce phenytoin dosage if needed. Drugs that Prolong the QTc Interval Clinical Impact: The risk of QTc prolongation and/or ventricular arrhythmias (e.g., TdP) is increased with concomitant use of sertraline hydrochloride capsules with other drugs which prolong the QTc interval [see Warnings and Precautions ( 5.10 ), Clinical Pharmacology ( 12.2 )] . Intervention: Pimozide is contraindicated for use with sertraline hydrochloride capsules. Avoid the concomitant use of drugs known to prolong the QTc interval. 7.2 Drugs Having No Clinically Important Interactions with Sertraline Hydrochloride Based on pharmacokinetic studies with another sertraline hydrochloride formulation, no dosage adjustment of sertraline hydrochloride capsules is necessary when used in combination with cimetidine. Additionally, no dosage adjustment is required for diazepam, lithium, atenolol, tolbutamide, digoxin, and drugs metabolized by CYP3A4, when sertraline hydrochloride capsules is administered concomitantly [see Clinical Pharmacology ( 12.3 )] . 7.3 False-Positive Screening Tests for Benzodiazepines False-positive urine immunoassay screening tests for benzodiazepines have been reported in patients taking another sertraline hydrochloride product. This finding is due to lack of specificity of the screening tests. False-positive test results may be expected for several days following discontinuation of sertraline hydrochloride capsules. Confirmatory tests, such as gas chromatography/mass spectrometry, will distinguish sertraline from benzodiazepines.
Use in specific populations
Pregnancy: Third trimester use may increase risk for persistent pulmonary hypertension and symptoms of poor adaptation (respiratory distress, temperature instability, feeding difficulty, hypotonia, irritability) in the neonate ( 8.1 ) Pediatric use: Safety and effectiveness in pediatric patients other than those with OCD (6 to 17 years) have not been established ( 8.4 ) 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 should encourage patients to enroll by calling the National Pregnancy Registry for Antidepressants at 1-866-961-2388 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 ( 5.3 ) and Clinical Considerations] . Overall, available published epidemiologic studies of pregnant women exposed to sertraline in the first trimester suggest no difference in major birth defect risk compared to the background rate for major birth defects in comparator populations. Some studies have reported increases for specific major birth defects; however, these study results are inconclusive (see Data) . There are clinical considerations regarding neonates exposed to SSRIs, including sertraline hydrochloride capsules, during the third trimester of pregnancy (see Clinical Considerations) . Although no malformations were observed in animal reproduction studies, delayed fetal ossification was observed when sertraline was administered during the period of organogenesis at doses less than the maximum recommended human dose (MRHD) in rats and doses approximately 4 times the MRHD in rabbits on a mg/m 2 basis in adults. When sertraline was administered to female rats during the last third of gestation, there was an increase in the number of stillborn pups and pup deaths during the first four days after birth at the MRHD (see Data) . The background risk of major birth defects and miscarriage for the indicated population are unknown. In the U.S. 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. Advise a pregnant woman of possible risks to the fetus when prescribing sertraline hydrochloride capsules. Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk A prospective longitudinal study followed 201 pregnant women with a history of major depression who were euthymic taking antidepressants at the beginning of pregnancy. The women who discontinued antidepressants during pregnancy were more likely to experience a relapse of major depression than women who continued antidepressants. Consider the risks of untreated depression when discontinuing or changing treatment with antidepressant medication during pregnancy and postpartum. Maternal Adverse Reactions Use of sertraline hydrochloride capsules in the month before delivery may be associated with an increased risk of postpartum hemorrhage [see Warnings and Precautions ( 5.3 )] . Fetal/Neonatal Adverse Reactions Exposure to SSRIs, including sertraline hydrochloride capsules, in late pregnancy may lead to an increased risk for neonatal complications requiring prolonged hospitalization, respiratory support, and tube feeding, and/or persistent pulmonary hypertension of the newborn (PPHN). When treating a pregnant woman with sertraline hydrochloride capsules during the third trimester, carefully consider both the potential risks and benefits of treatment. Monitor neonates who were exposed to sertraline in the third trimester of pregnancy for PPHN and drug discontinuation syndrome (see Data) . Data Human Data Third Trimester Exposure Neonates exposed to sertraline and other SSRIs late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding. These findings are based on post-marketing reports. 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 features are consistent with either a direct toxic effect of SSRIs or, possibly, a drug discontinuation syndrome. In some cases, the clinical picture was consistent with serotonin syndrome [see Warnings and Precautions ( 5.2 )] . Exposure during late pregnancy to SSRIs may have an increased risk for persistent pulmonary hypertension of the newborn (PPHN). PPHN occurs in 1 to 2 per 1,000 live births in the general population and is associated with substantial neonatal morbidity and mortality. In a retrospective case-control study of 377 women whose infants were born with PPHN and 836 women whose infants were born healthy, the risk for developing PPHN was approximately six-fold higher for infants exposed to SSRIs after the 20 th week of gestation compared to infants who had not been exposed to antidepressants during pregnancy. A study of 831,324 infants born in Sweden in 1997 to 2005 found a PPHN risk ratio of 2.4 (95% CI 1.2 to 4.3) associated with patient-reported maternal use of SSRIs “in early pregnancy” and a PPHN risk ratio of 3.6 (95% CI 1.2 to 8.3) associated with a combination of patient-reported maternal use of SSRIs “in early pregnancy” and an antenatal SSRI prescription “in later pregnancy”.
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 should encourage patients to enroll by calling the National Pregnancy Registry for Antidepressants at 1-866-961-2388 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 ( 5.3 ) and Clinical Considerations] . Overall, available published epidemiologic studies of pregnant women exposed to sertraline in the first trimester suggest no difference in major birth defect risk compared to the background rate for major birth defects in comparator populations. Some studies have reported increases for specific major birth defects; however, these study results are inconclusive (see Data) . There are clinical considerations regarding neonates exposed to SSRIs, including sertraline hydrochloride capsules, during the third trimester of pregnancy (see Clinical Considerations) . Although no malformations were observed in animal reproduction studies, delayed fetal ossification was observed when sertraline was administered during the period of organogenesis at doses less than the maximum recommended human dose (MRHD) in rats and doses approximately 4 times the MRHD in rabbits on a mg/m 2 basis in adults. When sertraline was administered to female rats during the last third of gestation, there was an increase in the number of stillborn pups and pup deaths during the first four days after birth at the MRHD (see Data) . The background risk of major birth defects and miscarriage for the indicated population are unknown. In the U.S. 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. Advise a pregnant woman of possible risks to the fetus when prescribing sertraline hydrochloride capsules. Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk A prospective longitudinal study followed 201 pregnant women with a history of major depression who were euthymic taking antidepressants at the beginning of pregnancy. The women who discontinued antidepressants during pregnancy were more likely to experience a relapse of major depression than women who continued antidepressants. Consider the risks of untreated depression when discontinuing or changing treatment with antidepressant medication during pregnancy and postpartum. Maternal Adverse Reactions Use of sertraline hydrochloride capsules in the month before delivery may be associated with an increased risk of postpartum hemorrhage [see Warnings and Precautions ( 5.3 )] . Fetal/Neonatal Adverse Reactions Exposure to SSRIs, including sertraline hydrochloride capsules, in late pregnancy may lead to an increased risk for neonatal complications requiring prolonged hospitalization, respiratory support, and tube feeding, and/or persistent pulmonary hypertension of the newborn (PPHN). When treating a pregnant woman with sertraline hydrochloride capsules during the third trimester, carefully consider both the potential risks and benefits of treatment. Monitor neonates who were exposed to sertraline in the third trimester of pregnancy for PPHN and drug discontinuation syndrome (see Data) . Data Human Data Third Trimester Exposure Neonates exposed to sertraline and other SSRIs late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding. These findings are based on post-marketing reports. 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 features are consistent with either a direct toxic effect of SSRIs or, possibly, a drug discontinuation syndrome. In some cases, the clinical picture was consistent with serotonin syndrome [see Warnings and Precautions ( 5.2 )] . Exposure during late pregnancy to SSRIs may have an increased risk for persistent pulmonary hypertension of the newborn (PPHN). PPHN occurs in 1 to 2 per 1,000 live births in the general population and is associated with substantial neonatal morbidity and mortality. In a retrospective case-control study of 377 women whose infants were born with PPHN and 836 women whose infants were born healthy, the risk for developing PPHN was approximately six-fold higher for infants exposed to SSRIs after the 20 th week of gestation compared to infants who had not been exposed to antidepressants during pregnancy. A study of 831,324 infants born in Sweden in 1997 to 2005 found a PPHN risk ratio of 2.4 (95% CI 1.2 to 4.3) associated with patient-reported maternal use of SSRIs “in early pregnancy” and a PPHN risk ratio of 3.6 (95% CI 1.2 to 8.3) associated with a combination of patient-reported maternal use of SSRIs “in early pregnancy” and an antenatal SSRI prescription “in later pregnancy”. First Trimester Exposure The weight of evidence from epidemiologic studies of pregnant women exposed to sertraline in the first trimester suggest no difference in major birth defect risk compared to the background rate for major birth defects in pregnant women who were not exposed to sertraline. A meta-analysis of studies suggest no increase in the risk of total malformations (summary odds ratio=1.01, 95% CI=0.88 to 1.17) or cardiac malformations (summary odds ratio=0.93, 95% CI=0.70 to 1.23) among offspring of women with first trimester exposure to sertraline.
Pediatric use
8.4 Pediatric Use The safety and effectiveness of sertraline hydrochloride capsules have been established in the treatment of OCD in pediatric patients aged 6 to 17 [see Adverse Reactions ( 6.1 ), Clinical Pharmacology ( 12.3 ), Clinical Studies ( 14.2 )] . Safety and effectiveness in pediatric patients with OCD below the age of 6 have not been established. Safety and effectiveness have not been established in pediatric patients for indications other than OCD. Two placebo-controlled trials were conducted with another sertraline hydrochloride product in pediatric patients with MDD, but the data were not sufficient to support an indication for use in pediatric patients. Monitoring Pediatric Patients Treated with Sertraline Hydrochloride Capsules Monitor all patients being treated with antidepressants for clinical worsening, suicidal thoughts, and unusual changes in behavior, especially during the initial few months of treatment, or at times of dose increases or decreases [see Boxed Warning , Warnings and Precautions ( 5.1 )] . Decreased appetite and weight loss have been observed with the use of SSRIs. Monitor weight and growth in pediatric patients treated with SSRIs including sertraline hydrochloride capsules. Weight Loss in Studies in Pediatric Patients with MDD In a pooled analysis of two 10-week, double-blind, placebo-controlled, flexible dose (50 to 200 mg) outpatient trials for MDD (n=373) with another sertraline hydrochloride product, there was a difference in weight change between sertraline hydrochloride and placebo of roughly 1 kg, for both pediatric patients ages 6 to 11 and pediatric patients ages 12 to 17, in both age groups representing a slight weight loss for the sertraline hydrochloride group compared to a slight gain for the placebo group. For pediatric patients (ages 6 to 11), about 7% of the sertraline hydrochloride-treated patients had a weight loss greater than 7% of body weight compared to 0% of the placebo-treated patients; for pediatric patients (ages 12 to 17), about 2% of sertraline hydrochloride-treated patients had a weight loss > 7% of body weight compared to about 1% of placebo-treated patients. A subset of patients who completed the randomized controlled trials in patients with MDD (sertraline n=99, placebo n=122) were continued into a 24-week, flexible-dose, open-label, extension study. Those subjects who completed 34 weeks of sertraline hydrochloride treatment (10 weeks in a placebo-controlled trial + 24 weeks open-label, n=68) had weight gain that was similar to that expected using data from age-adjusted peers. However, there are no studies that directly evaluate the long-term effects of sertraline hydrochloride on the growth, development, and maturation in pediatric patients. Juvenile Animal Toxicity Data A study conducted in juvenile rats at clinically relevant doses showed delay in sexual maturation, but there was no effect on fertility in either males or females. In this study in which juvenile rats were treated with oral doses of sertraline at 0, 10, 40 or 80 mg/kg/day from postnatal day 21 to 56, a delay in sexual maturation was observed in males treated with 80 mg/kg/day and females treated with doses ≥10 mg/kg/day. There was no effect on male and female reproductive endpoints or neurobehavioral development up to the highest dose tested (80 mg/kg/day), except a decrease in auditory startle response in females at 40 and 80 mg/kg/day at the end of treatment but not at the end of the drug-free period. The highest dose of 80 mg/kg/day produced plasma levels (AUC) of sertraline 5 times those seen in pediatric patients (6 to 17 years of age) receiving the maximum recommended dose of sertraline (200 mg/day).
Geriatric use
8.5 Geriatric Use Of the total number of patients with MDD, OCD, and other conditions in clinical studies with another sertraline product, 797 (17%) were ≥ 65 years old, while 197 (4%) were ≥ 75 years old. 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. In general, dose selection for an elderly patient should be conservative, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. In 354 geriatric subjects treated with another sertraline hydrochloride product in MDD placebo-controlled trials, the overall profile of adverse reactions was generally similar to that shown in Table 2 [see Adverse Reactions ( 6.1 )] , except for tinnitus, arthralgia with an incidence of at least 2% and at a rate greater than placebo in geriatric patients. SSRIs, including sertraline hydrochloride, 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 ( 5.8 )] .
Overdosage
The following have been reported with sertraline hydrochloride 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. 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). Gastrointestinal decontamination with activated charcoal should be considered in patients who present early after a sertraline overdose. Consider contacting a Poison Center (1-800-221-2222) or a medical toxicologist for additional overdosage management recommendations.
Description
Sertraline hydrochloride capsules contain sertraline hydrochloride, a selective serotonin reuptake inhibitor (SSRI). Sertraline hydrochloride has a molecular weight of 342.7 and has the following chemical name: (1S,4S)-4-(3,4-dichlorophenyl)-N-methyl-tetralin-1-amine hydrochloride. The empirical formula C 17 H 17 Cl 2 N
• HCl is represented by the following structural formula: Sertraline hydrochloride is a white to almost white crystalline powder that is slightly soluble in water, acetone and isopropyl alcohol. Sertraline hydrochloride capsules are for oral administration and contain 168 mg and 224 mg sertraline hydrochloride, USP equivalent to 150 mg and 200 mg sertraline, and the following inactive ingredients: croscarmellose sodium, gelatin, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, silicon dioxide and titanium dioxide. The 150 mg capsules contain FD&C Yellow No. 5 as a color additive. The 200 mg capsules contain FD&C Blue No. 1 and FD&C Yellow No. 5 as color additives. Chemical Structure
Mechanism of action
12.1 Mechanism of Action Sertraline potentiates serotonergic activity in the central nervous system through inhibition of neuronal reuptake of serotonin (5-HT).
How supplied
Sertraline hydrochloride capsules are supplied as: 150 mg Capsules: Hard shell capsules, with "ALM" printed axially on the opaque yellow cap and "664" printed axially on the opaque white body. NDC 47781-951-30 Bottles of 30 200 mg Capsules: Hard shell capsules, with "ALM" printed axially on the opaque yellowish green cap and "672" printed axially on the opaque white body. NDC 47781-962-30 Bottles of 30 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 early during treatment and when the dosage is adjusted up or down, and instruct them to report such symptoms to the healthcare provider [see Boxed Warning , Warnings and Precautions ( 5.1 )] . Serotonin Syndrome Caution patients about the risk of serotonin syndrome, particularly with the concomitant use of sertraline hydrochloride capsules with other serotonergic drugs including triptans, tricyclic antidepressants, opioids, lithium, tryptophan, buspirone, amphetamines, 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 ( 5.2 ), Drug Interactions ( 7.1 )] . Increased Risk of Bleeding Inform patients about the concomitant use of sertraline hydrochloride 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 providers if they are taking or planning to take any prescription or over-the-counter medications that increase the risk of bleeding [see Warnings and Precautions ( 5.3 )] . 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 ( 5.4 )] . Discontinuation Syndrome Advise patients not to abruptly discontinue sertraline hydrochloride capsules and to discuss any tapering regimen with their healthcare provider. Inform patients that adverse reactions can occur when sertraline hydrochloride capsules are discontinued [see Warnings and Precautions ( 5.5 )] . Sexual Dysfunction Advise patients that use of sertraline hydrochloride 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 ( 5.12 )] . Allergic Reactions and Reactions to FD&C Yellow No. 5 (Tartrazine) Advise patients to notify their healthcare provider if they develop an allergic reaction such as rash, hives, swelling, or difficulty breathing [see Adverse Reactions ( 6.2 )] . Advise patients that sertraline hydrochloride capsules contain FD&C Yellow No. 5 (tartrazine), which may cause allergic-type reactions (including bronchial asthma) in certain susceptible persons or in patients who also have an aspirin hypersensitivity [see Warnings and Precautions ( 5.11 )] . Pregnancy Advise women to notify their healthcare provider if they are pregnant or are planning to become pregnant during treatment with sertraline hydrochloride capsules. Advise women that there is a pregnancy exposure registry that monitors pregnancy outcomes of women exposed to sertraline hydrochloride capsules during pregnancy. Inform women that sertraline hydrochloride capsules may cause withdrawal symptoms in the newborn or persistent pulmonary hypertension of the newborn (PPHN) [see Use in Specific Populations ( 8.1 )] .
Label text from the FDA structured product label by Alvogen, Inc. (revised Aug 6, 2025). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Sertraline Hydrochloride in 181 products
Sertraline hydrochloride NDC products (181)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 50090-7691 | Sertraline Hydrochloride 50 mg/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-2080 | Sertraline Hydrochloride 100 mg/1 Tablet, Film Coated | A-S Medication Solutions | ANDA |
| 50090-2071 | Sertraline Hydrochloride 50 mg/1 Tablet, Film Coated | A-S Medication Solutions | ANDA |
| 50090-3203 | Sertraline Hydrochloride 100 mg/1 Tablet, Film Coated | A-S Medication Solutions | ANDA |
| 50090-6379 | Sertraline Hydrochloride 50 mg/1 Tablet, Film Coated | A-S Medication Solutions | ANDA |
| 50090-6613 | Sertraline Hydrochloride 25 mg/1 Tablet, Film Coated | A-S Medication Solutions | ANDA |
| 50090-6614 | Sertraline Hydrochloride 25 mg/1 Tablet, Film Coated | A-S Medication Solutions | ANDA |
| 50090-6861 | Sertraline Hydrochloride 50 mg/1 Tablet, Film Coated | A-S Medication Solutions | ANDA |
| 50090-6917 | Sertraline Hydrochloride 100 mg/1 Tablet, Film Coated | A-S Medication Solutions | ANDA |
| 50090-7395 | Sertraline Hydrochloride 25 mg/1 Tablet, Film Coated | A-S Medication Solutions | ANDA |
| 50090-7396 | Sertraline Hydrochloride 25 mg/1 Tablet, Film Coated | A-S Medication Solutions | ANDA |
| 50090-7661 | Sertraline Hydrochloride 50 mg/1 Tablet, Film Coated | A-S Medication Solutions | ANDA |
| 50090-7662 | Sertraline Hydrochloride 50 mg/1 Tablet, Film Coated | A-S Medication Solutions | ANDA |
| 50090-7692 | Sertraline Hydrochloride 50 mg/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-7693 | Sertraline Hydrochloride 100 mg/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-7694 | Sertraline Hydrochloride 100 mg/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-7698 | Sertraline Hydrochloride 25 mg/1 Tablet, Film Coated | A-S Medication Solutions | ANDA |
| 50090-7699 | Sertraline Hydrochloride 25 mg/1 Tablet, Film Coated | A-S Medication Solutions | ANDA |
| 50090-7700 | Sertraline Hydrochloride 100 mg/1 Tablet, Film Coated | A-S Medication Solutions | ANDA |
| 50090-7701 | Sertraline Hydrochloride 100 mg/1 Tablet, Film Coated | A-S Medication Solutions | ANDA |
| 50090-7830 | Sertraline Hydrochloride 50 mg/1 Tablet, Film Coated | A-S Medication Solutions | ANDA |
| 16729-217 | Sertraline Hydrochloride 100 mg/1 Tablet, Film Coated | Accord Healthcare, Inc. | ANDA |
| 16729-216 | Sertraline Hydrochloride 50 mg/1 Tablet, Film Coated | Accord Healthcare, Inc. | ANDA |
| 16729-215 | Sertraline Hydrochloride 25 mg/1 Tablet, Film Coated | Accord Healthcare, Inc. | ANDA |
| 80425-0310 | Sertraline Hydrochloride 100 mg/1 Tablet, Film Coated | Advanced Rx Pharmacy of Tennessee, LLC | ANDA |
| 80425-0200 | Sertraline Hydrochloride 50 mg/1 Tablet, Film Coated | Advanced Rx Pharmacy of Tennessee, LLC | ANDA |
| 60687-231 | Sertraline Hydrochloride 25 mg/1 Tablet | American Health Packaging | ANDA |
| 60687-253 | Sertraline Hydrochloride 100 mg/1 Tablet | American Health Packaging | ANDA |
| 60687-242 | Sertraline Hydrochloride 50 mg/1 Tablet | American Health Packaging | ANDA |
| 70954-899 | Sertraline Hydrochloride 150 mg/1 Capsule | ANI Pharmaceuticals, Inc. | ANDA |
| 70954-900 | Sertraline Hydrochloride 200 mg/1 Capsule | ANI Pharmaceuticals, Inc. | ANDA |
| 71610-435 | Sertraline Hydrochloride 100 mg/1 Tablet, Film Coated | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 71610-651 | Sertraline Hydrochloride 100 mg/1 Tablet, Film Coated | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 71610-886 | Sertraline Hydrochloride 100 mg/1 Tablet | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 43353-447 | Sertraline Hydrochloride 100 mg/1 Tablet, Film Coated | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 43602-980 | Sertraline Hydrochloride 50 mg/1 Tablet | Ascent Pharmaceuticals, Inc. | ANDA |
| 43602-981 | Sertraline Hydrochloride 100 mg/1 Tablet | Ascent Pharmaceuticals, Inc. | ANDA |
| 43602-979 | Sertraline Hydrochloride 25 mg/1 Tablet | Ascent Pharmaceuticals, Inc. | ANDA |
| 76420-779 | Sertraline Hydrochloride 25 mg/1 Tablet, Film Coated | Asclemed USA, Inc. | ANDA |
| 76420-781 | Sertraline Hydrochloride 50 mg/1 Tablet, Film Coated | Asclemed USA, Inc. | ANDA |
| 76420-786 | Sertraline Hydrochloride 100 mg/1 Tablet, Film Coated | Asclemed USA, Inc. | ANDA |
| 84386-097 | Sertraline Hydrochloride 25 mg/1 Tablet, Film Coated | Aurobindo Pharma Limited | ANDA |
| 65862-224 | Sertraline Hydrochloride 20 mg/mL Solution, Concentrate | Aurobindo Pharma Limited | ANDA |
| 65862-013 | Sertraline Hydrochloride 100 mg/1 Tablet, Film Coated | Aurobindo Pharma Limited | ANDA |
| 65862-012 | Sertraline Hydrochloride 50 mg/1 Tablet, Film Coated | Aurobindo Pharma Limited | ANDA |
| 65862-011 | Sertraline Hydrochloride 25 mg/1 Tablet, Film Coated | Aurobindo Pharma Limited | ANDA |
| 84386-099 | Sertraline Hydrochloride 100 mg/1 Tablet, Film Coated | Aurobindo Pharma Limited | ANDA |
| 84386-098 | Sertraline Hydrochloride 50 mg/1 Tablet, Film Coated | Aurobindo Pharma Limited | ANDA |
| 50268-825 | Sertraline Hydrochloride 100 mg/1 Tablet, Film Coated | AvPAK | ANDA |
| 50268-824 | Sertraline Hydrochloride 50 mg/1 Tablet, Film Coated | AvPAK | ANDA |
| 50268-823 | Sertraline Hydrochloride 25 mg/1 Tablet, Film Coated | AvPAK | ANDA |
| 71335-0808 | Sertraline Hydrochloride 25 mg/1 Tablet, Film Coated | Bryant Ranch Prepack | ANDA |
| 72162-2370 | Sertraline Hydrochloride 50 mg/1 Tablet, Film Coated | Bryant Ranch Prepack | ANDA |
| 72162-2407 | Sertraline Hydrochloride 100 mg/1 Tablet, Film Coated | Bryant Ranch Prepack | ANDA |
| 71335-1078 | Sertraline Hydrochloride 25 mg/1 Tablet, Film Coated | Bryant Ranch Prepack | ANDA |
| 71335-0896 | Sertraline Hydrochloride 100 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 71335-9714 | Sertraline Hydrochloride 50 mg/1 Tablet, Film Coated | Bryant Ranch Prepack | ANDA |
| 71335-3110 | Sertraline Hydrochloride 100 mg/1 Tablet, Film Coated | Bryant Ranch Prepack | ANDA |
| 71335-2300 | Sertraline Hydrochloride 50 mg/1 Tablet, Film Coated | Bryant Ranch Prepack | ANDA |
| 71335-2587 | Sertraline Hydrochloride 25 mg/1 Tablet, Film Coated | Bryant Ranch Prepack | ANDA |
| 71335-0510 | Sertraline Hydrochloride 100 mg/1 Tablet, Film Coated | Bryant Ranch Prepack | ANDA |
| 71335-2955 | Sertraline Hydrochloride 50 mg/1 Tablet, Film Coated | Bryant Ranch Prepack | ANDA |
| 63629-8774 | Sertraline Hydrochloride 20 mg/mL Solution | Bryant Ranch Prepack | ANDA |
| 71335-0415 | Sertraline Hydrochloride 50 mg/1 Tablet, Film Coated | Bryant Ranch Prepack | ANDA |
| 71335-0403 | Sertraline Hydrochloride 50 mg/1 Tablet, Film Coated | Bryant Ranch Prepack | ANDA |
| 71335-0328 | Sertraline Hydrochloride 25 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 71335-0210 | Sertraline Hydrochloride 100 mg/1 Tablet, Film Coated | Bryant Ranch Prepack | ANDA |
| 31722-147 | Sertraline Hydrochloride 100 mg/1 Tablet | Camber Pharmaceuticals, Inc. | ANDA |
| 31722-146 | Sertraline Hydrochloride 50 mg/1 Tablet | Camber Pharmaceuticals, Inc. | ANDA |
| 31722-145 | Sertraline Hydrochloride 25 mg/1 Tablet | Camber Pharmaceuticals, Inc. | ANDA |
| 55154-4692 | Sertraline Hydrochloride 100 mg/1 Tablet | Cardinal Health 107, LLC | ANDA |
| 55154-4687 | Sertraline Hydrochloride 50 mg/1 Tablet | Cardinal Health 107, LLC | ANDA |
| 55154-3570 | Sertraline Hydrochloride 100 mg/1 Tablet, Film Coated | Cardinal Health 107, LLC | ANDA |
| 55154-3569 | Sertraline Hydrochloride 50 mg/1 Tablet, Film Coated | Cardinal Health 107, LLC | ANDA |
| 69097-834 | Sertraline Hydrochloride 50 mg/1 Tablet | Cipla USA Inc. | ANDA |
| 69097-833 | Sertraline Hydrochloride 25 mg/1 Tablet | Cipla USA Inc. | ANDA |
| 69097-451 | Sertraline Hydrochloride 200 mg/1 Capsule | Cipla USA Inc. | ANDA |
| 69097-438 | Sertraline Hydrochloride 150 mg/1 Capsule | Cipla USA Inc. | ANDA |
| 69097-835 | Sertraline Hydrochloride 100 mg/1 Tablet | Cipla USA Inc. | ANDA |
| 67046-0554 | Sertraline Hydrochloride 100 mg/1 Tablet, Film Coated | Coupler LLC | ANDA |
| 67046-0555 | Sertraline Hydrochloride 50 mg/1 Tablet, Film Coated | Coupler LLC | ANDA |
| 67046-1181 | Sertraline Hydrochloride 25 mg/1 Tablet | Coupler LLC | ANDA |
| 67046-1483 | Sertraline Hydrochloride 50 mg/1 Tablet, Film Coated | Coupler LLC | ANDA |
| 67046-1665 | Sertraline Hydrochloride 25 mg/1 Tablet, Film Coated | Coupler LLC | ANDA |
| 67046-1682 | Sertraline Hydrochloride 100 mg/1 Tablet, Film Coated | Coupler LLC | ANDA |
| 72189-122 | Sertraline Hydrochloride 100 mg/1 Tablet, Film Coated | DIRECT RX | ANDA |
| 75907-310 | Sertraline Hydrochloride 150 mg/1 Capsule | Dr. Reddy's Laboratories Inc. | ANDA |
| 75907-311 | Sertraline Hydrochloride 200 mg/1 Capsule | Dr. Reddy's Laboratories Inc. | ANDA |
| 70010-203 | Sertraline Hydrochloride 25 mg/1 Tablet, Film Coated | Granules Pharmaceuticals Inc. | ANDA |
| 70010-204 | Sertraline Hydrochloride 50 mg/1 Tablet, Film Coated | Granules Pharmaceuticals Inc. | ANDA |
| 70010-205 | Sertraline Hydrochloride 100 mg/1 Tablet, Film Coated | Granules Pharmaceuticals Inc. | ANDA |
| 68645-521 | Sertraline Hydrochloride 25 mg/1 Tablet | Legacy Pharmaceutical Packaging, LLC | ANDA |
| 68645-522 | Sertraline Hydrochloride 50 mg/1 Tablet | Legacy Pharmaceutical Packaging, LLC | ANDA |
| 68645-523 | Sertraline Hydrochloride 100 mg/1 Tablet | Legacy Pharmaceutical Packaging, LLC | ANDA |
| 68180-352 | Sertraline Hydrochloride 50 mg/1 Tablet, Film Coated | Lupin Pharmaceuticals, Inc. | ANDA |
| 68180-353 | Sertraline Hydrochloride 100 mg/1 Tablet, Film Coated | Lupin Pharmaceuticals, Inc. | ANDA |
| 68180-978 | Sertraline Hydrochloride 25 mg/1 Tablet, Film Coated | Lupin Pharmaceuticals, Inc. | ANDA |
| 68180-986 | Sertraline Hydrochloride 50 mg/1 Tablet, Film Coated | Lupin Pharmaceuticals, Inc. | ANDA |
| 68180-992 | Sertraline Hydrochloride 100 mg/1 Tablet, Film Coated | Lupin Pharmaceuticals, Inc. | ANDA |
| 68180-351 | Sertraline Hydrochloride 25 mg/1 Tablet, Film Coated | Lupin Pharmaceuticals, Inc. | ANDA |
| 0904-6926 | Sertraline Hydrochloride 100 mg/1 Tablet, Film Coated | Major Pharmaceuticals | ANDA |
| 0904-6925 | Sertraline Hydrochloride 50 mg/1 Tablet, Film Coated | Major Pharmaceuticals | ANDA |
| 0904-6924 | Sertraline Hydrochloride 25 mg/1 Tablet, Film Coated | Major Pharmaceuticals | ANDA |
| 0615-8604 | Sertraline Hydrochloride 100 mg/1 Tablet, Film Coated | NCS HealthCare of KY, LLC dba Vangard Labs | ANDA |
| 0615-8603 | Sertraline Hydrochloride 50 mg/1 Tablet, Film Coated | NCS HealthCare of KY, LLC dba Vangard Labs | ANDA |
| 0615-8596 | Sertraline Hydrochloride 25 mg/1 Tablet, Film Coated | NCS HealthCare of KY, LLC dba Vangard Labs | ANDA |
| 16714-613 | Sertraline Hydrochloride 100 mg/1 Tablet, Film Coated | NorthStar Rx LLC | ANDA |
| 16714-612 | Sertraline Hydrochloride 50 mg/1 Tablet, Film Coated | NorthStar Rx LLC | ANDA |
| 16714-611 | Sertraline Hydrochloride 25 mg/1 Tablet, Film Coated | NorthStar Rx LLC | ANDA |
| 16714-601 | Sertraline Hydrochloride 20 mg/mL Solution | NorthStar Rx LLC | ANDA |
| 51655-265 | Sertraline Hydrochloride 50 mg/1 Tablet, Film Coated | Northwind Health Company, LLC | ANDA |
| 82868-100 | Sertraline Hydrochloride 50 mg/1 Tablet, Film Coated | Northwind Health Company, LLC | ANDA |
| 51655-173 | Sertraline Hydrochloride 100 mg/1 Tablet, Film Coated | Northwind Health Company, LLC | ANDA |
| 51655-345 | Sertraline Hydrochloride 25 mg/1 Tablet | Northwind Health Company, LLC | ANDA |
| 68071-3951 | Sertraline Hydrochloride 25 mg/1 Tablet | NuCare Pharmaceuticals, Inc. | ANDA |
| 68071-4993 | Sertraline Hydrochloride 50 mg/1 Tablet, Film Coated | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-4494 | Sertraline Hydrochloride 50 mg/1 Tablet, Film Coated | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-4973 | Sertraline Hydrochloride 100 mg/1 Tablet, Film Coated | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-4658 | Sertraline Hydrochloride 100 mg/1 Tablet | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-4462 | Sertraline Hydrochloride 25 mg/1 Tablet, Film Coated | NuCare Pharmaceuticals,Inc. | ANDA |
| 43063-754 | Sertraline Hydrochloride 100 mg/1 Tablet | PD-Rx Pharmaceuticals, Inc. | ANDA |
| 72789-013 | Sertraline Hydrochloride 50 mg/1 Tablet, Film Coated | PD-Rx Pharmaceuticals, Inc. | ANDA |
| 43063-033 | Sertraline Hydrochloride 50 mg/1 Tablet | PD-Rx Pharmaceuticals, Inc. | ANDA |
| 43063-855 | Sertraline Hydrochloride 50 mg/1 Tablet, Film Coated | PD-Rx Pharmaceuticals, Inc. | ANDA |
| 72789-346 | Sertraline Hydrochloride 25 mg/1 Tablet, Film Coated | PD-Rx Pharmaceuticals, Inc. | ANDA |
| 72789-273 | Sertraline Hydrochloride 100 mg/1 Tablet, Film Coated | PD-Rx Pharmaceuticals, Inc. | ANDA |
| 72789-092 | Sertraline Hydrochloride 100 mg/1 Tablet, Film Coated | PD-Rx Pharmaceuticals, Inc. | ANDA |
| 72789-088 | Sertraline Hydrochloride 100 mg/1 Tablet, Film Coated | PD-Rx Pharmaceuticals, Inc. | ANDA |
| 68788-6429 | Sertraline Hydrochloride 50 mg/1 Tablet, Film Coated | Preferred Pharmaceuticals Inc. | ANDA |
| 68788-6437 | Sertraline Hydrochloride 25 mg/1 Tablet, Film Coated | Preferred Pharmaceuticals Inc. | ANDA |
| 68788-4151 | Sertraline Hydrochloride 50 mg/1 Tablet, Film Coated | Preferred Pharmaceuticals Inc. | ANDA |
| 68788-4045 | Sertraline Hydrochloride 25 mg/1 Tablet, Film Coated | Preferred Pharmaceuticals Inc. | ANDA |
| 68788-8210 | Sertraline Hydrochloride 100 mg/1 Tablet, Film Coated | Preferred Pharmaceuticals Inc. | ANDA |
| 68788-6835 | Sertraline Hydrochloride 100 mg/1 Tablet, Film Coated | Preferred Pharmaceuticals Inc. | ANDA |
| 68788-8689 | Sertraline Hydrochloride 25 mg/1 Tablet, Film Coated | Preferred Pharmaceuticals Inc. | ANDA |
| 68788-8732 | Sertraline Hydrochloride 50 mg/1 Tablet, Film Coated | Preferred Pharmaceuticals Inc. | ANDA |
| 63187-859 | Sertraline Hydrochloride 25 mg/1 Tablet | Proficient Rx LP | ANDA |
| 63187-795 | Sertraline Hydrochloride 100 mg/1 Tablet | Proficient Rx LP | ANDA |
| 63187-767 | Sertraline Hydrochloride 50 mg/1 Tablet | Proficient Rx LP | ANDA |
| 71205-047 | Sertraline Hydrochloride 100 mg/1 Tablet, Film Coated | Proficient Rx LP | ANDA |
| 71205-455 | Sertraline Hydrochloride 100 mg/1 Tablet, Film Coated | Proficient Rx LP | ANDA |
| 71205-343 | Sertraline Hydrochloride 25 mg/1 Tablet, Film Coated | Proficient Rx LP | ANDA |
| 71205-205 | Sertraline Hydrochloride 50 mg/1 Tablet, Film Coated | Proficient Rx LP | ANDA |
| 71205-028 | Sertraline Hydrochloride 50 mg/1 Tablet, Film Coated | Proficient Rx LP | ANDA |
| 82804-311 | Sertraline Hydrochloride 100 mg/1 Tablet, Film Coated | Proficient Rx LP | ANDA |
| 42708-124 | Sertraline Hydrochloride 50 mg/1 Tablet, Film Coated | QPharma Inc | ANDA |
| 42708-092 | Sertraline Hydrochloride 50 mg/1 Tablet, Film Coated | QPharma, Inc. | ANDA |
| 55700-362 | Sertraline Hydrochloride 100 mg/1 Tablet, Film Coated | Quality Care Products LLC | ANDA |
| 82009-049 | Sertraline Hydrochloride 50 mg/1 Tablet, Film Coated | Quallent Pharmaceuticals Health LLC | ANDA |
| 82009-050 | Sertraline Hydrochloride 100 mg/1 Tablet, Film Coated | Quallent Pharmaceuticals Health LLC | ANDA |
| 70518-2448 | Sertraline Hydrochloride 100 mg/1 Tablet, Film Coated | REMEDYREPACK INC. | ANDA |
| 70518-1748 | Sertraline Hydrochloride 25 mg/1 Tablet, Film Coated | REMEDYREPACK INC. | ANDA |
| 70518-2812 | Sertraline Hydrochloride 50 mg/1 Tablet, Film Coated | REMEDYREPACK INC. | ANDA |
| 70518-4157 | Sertraline Hydrochloride 50 mg/1 Tablet, Film Coated | REMEDYREPACK INC. | ANDA |
| 70518-4171 | Sertraline Hydrochloride 25 mg/1 Tablet, Film Coated | REMEDYREPACK INC. | ANDA |
| 70518-4307 | Sertraline Hydrochloride 25 mg/1 Tablet | REMEDYREPACK INC. | ANDA |
| 70518-4518 | Sertraline Hydrochloride 50 mg/1 Tablet, Film Coated | REMEDYREPACK INC. | ANDA |
| 70518-4590 | Sertraline Hydrochloride 100 mg/1 Tablet, Film Coated | REMEDYREPACK INC. | ANDA |
| 70518-4606 | Sertraline Hydrochloride 25 mg/1 Tablet, Film Coated | REMEDYREPACK INC. | ANDA |
| 70518-4707 | Sertraline Hydrochloride 100 mg/1 Tablet, Film Coated | REMEDYREPACK INC. | ANDA |
| 64980-409 | Sertraline Hydrochloride 20 mg/mL Solution, Concentrate | Rising Pharma Holdings, Inc. | ANDA |
| 50228-467 | Sertraline Hydrochloride 25 mg/1 Tablet, Film Coated | ScieGen Pharmaceuticals Inc | ANDA |
| 50228-468 | Sertraline Hydrochloride 50 mg/1 Tablet, Film Coated | ScieGen Pharmaceuticals Inc | ANDA |
| 50228-469 | Sertraline Hydrochloride 100 mg/1 Tablet, Film Coated | ScieGen Pharmaceuticals Inc | ANDA |
| 60760-738 | Sertraline Hydrochloride 100 mg/1 Tablet, Film Coated | St. Mary's Medical Park Pharmacy | ANDA |
| 60760-091 | Sertraline Hydrochloride 100 mg/1 Tablet, Film Coated | St. Mary's Medical Park Pharmacy | ANDA |
| 60760-612 | Sertraline Hydrochloride 50 mg/1 Tablet, Film Coated | St. Mary's Medical Park Pharmacy | ANDA |
| 60760-988 | Sertraline Hydrochloride 50 mg/1 Tablet, Film Coated | ST. MARY'S MEDICAL PARK PHARMACY | ANDA |
| 87441-075 | Sertraline Hydrochloride 25 mg/1 Tablet, Film Coated | Unit Dose Solutions, Inc. | ANDA |
| 87441-076 | Sertraline Hydrochloride 100 mg/1 Tablet, Film Coated | Unit Dose Solutions, Inc. | ANDA |
| 87441-077 | Sertraline Hydrochloride 50 mg/1 Tablet, Film Coated | Unit Dose Solutions, Inc. | ANDA |
| 72865-207 | Sertraline Hydrochloride 100 mg/1 Tablet | XLCare Pharmaceuticals, Inc. | ANDA |
| 72865-206 | Sertraline Hydrochloride 50 mg/1 Tablet | XLCare Pharmaceuticals, Inc. | ANDA |
| 72865-205 | Sertraline Hydrochloride 25 mg/1 Tablet | XLCare Pharmaceuticals, Inc. | ANDA |
| 70771-1913 | Sertraline Hydrochloride 150 mg/1 Capsule | Zydus Lifesciences Limited | ANDA |
| 70771-1914 | Sertraline Hydrochloride 200 mg/1 Capsule | Zydus Lifesciences Limited | ANDA |
| 70710-1948 | Sertraline Hydrochloride 150 mg/1 Capsule | Zydus Pharmaceuticals (USA) Inc. | ANDA |
| 70710-1949 | Sertraline Hydrochloride 200 mg/1 Capsule | Zydus Pharmaceuticals (USA) Inc. | ANDA |
| 47781-962 | Sertraline Hydrochloride 200 mg/1 Capsule | Alvogen, Inc. | NDA AUTHORIZED GENERIC |
| 47781-951 | Sertraline Hydrochloride 150 mg/1 Capsule | Alvogen, Inc. | NDA AUTHORIZED GENERIC |
| 59762-0067 | Sertraline Hydrochloride 20 mg/mL Solution, Concentrate | Mylan Pharmaceuticals Inc. | NDA AUTHORIZED GENERIC |
Sertraline hydrochloride recalls
- D-0227-2026 Dec 17, 2025 · Class II · Ongoing
Defective container - seal not adhering to bottles - D-0205-2024 Jan 3, 2024 · Class II · Ongoing
CGMP Deviations: Inadequate line clearance which may result in a potential comingling of product.
Frequently asked questions
What is Sertraline hydrochloride used for?
Sertraline hydrochloride capsules are indicated for the treatment of the following [see Clinical Studies ( 14 )] : Major depressive disorder (MDD) in adults Obsessive-compulsive disorder (OCD) in adults and pediatric patients 6 years and older Sertraline hydrochloride capsules are a selective serotonin reuptake inhibitor (SSRI) indicated for the treatment of ( 1 ): Major depressive disorder (MDD)…
What are the side effects of Sertraline hydrochloride?
The following adverse reactions are described in more detail in other sections of the prescribing information: Hypersensitivity reactions to sertraline or excipients of sertraline hydrochloride capsules [see Contraindications ( 4 )] Suicidal Thoughts and Behaviors in Adolescent and Young Adults [see Warnings and Precautions ( 5.1 )] Serotonin Syndrome [see Contraindications ( 4 ), Warnings and… See the full label for the complete list.
Who makes Sertraline hydrochloride?
Sertraline hydrochloride is listed by 44 labelers in the FDA NDC directory, including A-S Medication Solutions, Accord Healthcare, Inc., Advanced Rx Pharmacy of Tennessee, LLC, American Health Packaging.
Has Sertraline hydrochloride been recalled?
The FDA enforcement database lists 2 recalls for Sertraline hydrochloride, most recently D-0227-2026 (class ii): Defective container - seal not adhering to bottles