Last reviewed 2026-04-20 · How we verify

SERTRALINE

At a glance

Approved indications

• Major Depressive Disorder
• Obsessive-Compulsive Disorder
• Panic Disorder

Boxed warnings

• BOXED WARNING Suicidality and Antidepressant Drugs Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of Sertraline hydrochloride or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Sertraline hydrochloride tablets are not approved for the treatment of major depressive disorder in pediatric patients. (See WARNINGS:Clinical Worsening and Suicide Risk , PRECAUTIONS:Information for Patients , and PRECAUTIONS:Pediatric Use ).

Common side effects

• Nausea
• Diarrhea/Loose stool
• Tremor
• Dyspepsia
• Decreased appetite
• Hyperhidrosis
• Ejaculation failure
• Decreased libido
• Erectile dysfunction
• Ejaculation disorder
• Male sexual dysfunction
• Fever

Drug interactions

• warfarin, digitoxin
• cimetidine
• diazepam
• lithium
• pimozide

Key clinical trials

• TDM-Guided Treatment With SSRIs in Hospitalized Adults and Children (PHASE4)
• Moving on After Breast Cancer Trial for Depressed Breast Cancer Survivors in Pakistan (NA)
• ACE-D Aim 3 Clinical Cognitive Trial to Enhance Translation in Depression (PHASE2)
• Pattern Separation in Major Depressive Disorder (PHASE1)
• Pharmacokinetics and Safety of Commonly Used Drugs in Lactating Women and Breastfed Infants
• Predicting SSRI Efficacy in Veterans With PTSD (PHASE4)
• Sertraline and the Risk of Serious Adverse Events
• Sequenced Treatment Alternatives to Relieve Adolescent Depression (STAR-AD) (PHASE1, PHASE2)

Primary sources

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