Sertraline Hydrochloride

Serious warning

The strongest warning the FDA requires. It is printed in a box at the top of the label.

Quoted from the official label, section “Boxed Warning”.

Do not take it if

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

• 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 are 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 .

Quoted from the official label, section “Dosage & Administration”.

Other warnings

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

Other medicines

Quoted from the official label, section “Drug Interactions”.

If you take too much

In an emergency, call your local emergency number or a poison control centre.

Quoted from the official label, section “Overdosage”.

Misuse and dependence

Quoted from the official label, section “Drug Abuse and Dependence”.

Use in children

• 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 mg 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 mg/kg/day 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).

Quoted from the official label, section “Pediatric Use”.

Use in older people

• 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 )] .

Quoted from the official label, section “Geriatric Use”.

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 )] 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 capsules were nausea, diarrhea/loose stool, tremor, dyspepsia, decreased appetite, hyperhidrosis, ejaculation failure, and decreased libido ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Zydus Pharmaceuticals (USA) Inc. at 1-877-993-8779 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 3,066
• adults.
• These 3,066 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* Sertraline Hydrochloride (N=3,066) % Placebo (N=2,293) % 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 (1) Denominator used was for male patients only (n=1,316 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.
• Adverse Reactions Leading to Discontinuation in Placebo-Controlled Clinical Trials In all placebo-controlled studies, 368 (12%) of the 3,066 patients who received sertraline discontinued treatment due to an adverse reaction, compared with 93 (4%) of the 2,293 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.
• Table 3:
• Most Common Sexual Adverse Reactions (≥2% and twice placebo) in Men or Women from Sertraline Hydrochloride Pooled Controlled Trials in
• Adults with MDD, OCD, and Other Conditions Sertraline Hydrochloride % Placebo % Men only (N=1,316) (N=973) Ejaculation failure 8 1 Libido decreased 7 2 Erectile dysfunction 4 1 Ejaculation disorder 3 0 Male sexual dysfunction 2 0 Women only (N=1,750) (N=1,320) Libido decreased 4 2 Adverse Reactions in Pediatric Patients In 281 pediatric patients treated with sertraline in placebo-controlled studies, the overall profile of adverse reactions was generally similar to that seen in adult studies.
• Adverse reactions that do not appear in Table 2 (most common adverse reactions in
• adults) yet were reported in at least 2% of pediatric patients and at a rate of at least twice the placebo rate include fever, hyperkinesia, urinary incontinence, aggression, epistaxis, purpura, arthralgia, decreased weight, muscle twitching, and anxiety.
• Other Adverse Reactions Observed During the Premarketing Evaluation of Sertraline Other infrequent adverse reactions, not described elsewhere in the prescribing information, occurring at an incidence of <2% in patients treated with sertraline were:
• Cardiac disorders – tachycardia Ear and labyrinth disorders – tinnitus Endocrine disorders - hypothyroidism Eye disorders - mydriasis, blurred vision Gastrointestinal disorders - hematochezia, melena, rectal hemorrhage General disorders and administration site conditions - edema, gait disturbance, irritability, pyrexia Hepatobiliary disorders - elevated liver enzymes Immune system disorders - anaphylaxis Metabolism and nutrition disorders - diabetes mellitus, hypercholesterolemia, hypoglycemia, increased appetite Musculoskeletal and connective tissue disorders – arthralgia, muscle spasms, tightness, or twitching Nervous system disorders - ataxia, coma, convulsion, decreased alertness, hypoesthesia, lethargy, psychomotor hyperactivity, syncope Psychiatric disorders - aggression, bruxism, confusional state, euphoric mood, hallucination Renal and urinary disorders – hematuria Reproductive system and breast disorders - galactorrhea, priapism, vaginal hemorrhage Respiratory, thoracic and mediastinal disorders - bronchospasm, epistaxis, yawning Skin and subcutaneous tissue disorders - alopecia; cold sweat; dermatitis; dermatitis bullous; pruritus; purpura; erythematous, follicular, or maculopapular rash; urticaria Vascular disorders - hemorrhage, hypertension, vasodilation
• 6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of another sertraline product.
• Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
• Bleeding or clotting disorders - increased coagulation times (altered platelet function) Cardiac disorders - AV block, bradycardia, atrial arrhythmias, QTc-interval prolongation, ventricular tachycardia (including Torsade de Pointes) [see Clinical Pharmacology ( 12.2 )] Endocrine disorders - gynecomastia, hyperprolactinemia, menstrual irregularities, SIADH Eye disorders - blindness, optic neuritis, cataract Hepatobiliary disorders - severe liver events (including hepatitis, jaundice, liver failure with some fatal outcomes), pancreatitis Hemic and lymphatic disorders - agranulocytosis, aplastic anemia and pancytopenia, leukopenia, thrombocytopenia, lupus-like syndrome, serum sickness Immune system disorders - angioedema Metabolism and nutrition disorders - hyponatremia, hyperglycemia Musculoskeletal and connective tissue disorders - rhabdomyolysis, trismus Nervous system disorders - serotonin syndrome, extrapyramidal symptoms (including akathisia and dystonia), oculogyric crisis Psychiatric disorders - psychosis, enuresis, paroniria Renal and urinary disorders - acute renal failure Respiratory, thoracic and mediastinal disorders - pulmonary hypertension, anosmia, hyposmia Skin and subcutaneous tissue disorders - photosensitivity skin reaction and other severe cutaneous reactions, which potentially can be fatal, such as Stevens-Johnson Syndrome (SJS) and toxic epidermal necrolysis (TEN) Vascular disorders - cerebrovascular spasm (including reversible cerebral vasoconstriction syndrome and Call-Fleming syndrome), vasculitis

Quoted from the official label, section “Adverse Reactions”.

What to discuss with your doctor

• 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 and 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 )] .
• 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 )] .
• Manufactured by: Zydus Pharmaceuticals Ltd., Ahmedabad-382213, India Rev.: 03/25

Quoted from the official label, section “Patient Counseling Information”.

Strengths and forms

• FORMS AND STRENGTHS 150 mg capsules:
• White to off white granular powder filled in size "2" empty hard gelatin capsules having a cream colored opaque cap imprinted with "1948" in blank ink and a cream colored opaque body. 200 mg capsules:
• White to off white granular powder filled in size "1" empty hard gelatin capsules having a light green colored opaque cap imprinted with "1949" in blank ink and a light green colored opaque body.
• Dosage strengths are based on the active moiety, sertraline.
• The 150 mg capsules contain 168 mg of sertraline hydrochloride.
• The 200 mg capsules contain 224 mg of sertraline hydrochloride.
• Capsules: 150 mg and 200 mg ( 3 )

Quoted from the official label, section “Dosage Forms & Strengths”.

What it looks like and how it is packed

• Sertraline hydrochloride capsules are supplied as:
• 150 mg Capsules:
• White to off white granular powder filled in size "2" empty hard gelatin capsules having a cream colored opaque cap imprinted with "1948" in blank ink and a cream colored opaque body.
• NDC 70771-1913-3 Bottles of 30 with child-resistant closure. 200 mg Capsules:
• White to off white granular powder filled in size "1" empty hard gelatin capsules having a light green colored opaque cap imprinted with "1949" in blank ink and a light green colored opaque body.
• NDC 70771-1914-3 Bottles of 30 with child-resistant closure.
• Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Quoted from the official label, section “How Supplied”.

What is in it

• Sertraline hydrochloride capsules contain sertraline hydrochloride, a selective serotonin reuptake inhibitor (SSRI). Sertraline hydrochloride, USP has a molecular weight of 342.690 g/mol and has the following chemical name:
• (1S,4S)-4-(3,4-Dichlorophenyl)-N-methyl-1,2,3,4-tetrahydro-1-naphthalen amine hydrochloride. The molecular formula C 17 H 17 Cl 2 N
• HCl is represented by the following structural formula:
• Sertraline hydrochloride, USP is a white or off 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, colloidal silicon dioxide, gelatin, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose and titanium dioxide. The 150 mg capsules contain D&C Yellow 10 and FD&C red 40 as color additives. The 200 mg capsules contain D&C Yellow 10 and FD&C blue 1 as a color additive. Each capsule is imprinted with black ink which contains black iron oxide, potassium hydroxide, propylene glycol and shellac. Image

Quoted from the official label, section “Description”.

Ingredients people check for

Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.

Details

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

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Other strengths and forms

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Same active substance

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