Sertraline: Side Effects, Uses & Monitoring
Major Depressive Disorder – Sertraline hydrochloride is indicated for the treatment of major depressive disorder in adults.
- Data source
- FDA labeling via NIH DailyMed (label 80adf27d…)
- Label version
- current
- Last reviewed
- 2026
Reported adverse reactions
Reactions listed in current FDA labeling, with the highest frequency reported across summarized placebo-controlled trials.
| Adverse reaction (as reported in labeling) | Reported frequency* |
|---|---|
| Headache | 25% |
| Nausea | 25% |
| Insomnia | 21% |
| Diarrhea/loose stools | 20% |
| Ejaculation failure (1) | 14% |
| Mouth dry | 14% |
| Somnolence | 13% |
| Dizziness | 12% |
| Fatigue | 12% |
| Tremor | 8% |
| Dyspepsia | 8% |
| Sweating increased | 7% |
| Anorexia | 6% |
| Constipation | 6% |
| Libido decreased | 6% |
| Decreased libido** | 6% |
| Agitation | 5% |
| Nervousness | 5% |
| Vomiting | 4% |
| Anxiety | 4% |
*Highest percentage reported for the active moiety across placebo-controlled trial tables in current FDA labeling. Values reflect trial reporting, not your individual risk.
Labeled uses (from FDA prescribing information)
Major Depressive Disorder – Sertraline hydrochloride is indicated for the treatment of major depressive disorder in adults. The efficacy of Sertraline hydrochloride in the treatment of a major depressive episode was established in six to eight week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III category of major depressive disorder (see Clinical Trials under CLINICAL PHARMACOLOGY ). A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation. The antidepressant action of sertraline hydrochloride in hospitalized depressed patients has not been adequately studied. The efficacy of sertraline hydrochloride in maintaining an antidepressant response for up to 44 weeks following 8…
Tests providers may use to monitor Sertraline therapy
Conditions associated with Sertraline in labeling
Frequently Asked Questions
What is Sertraline used for?
FDA labeling lists the approved uses shown above under "Labeled uses." This summary is informational; only a qualified prescriber can determine whether a medication is appropriate for you.
What are the most commonly reported side effects of Sertraline?
The table above shows adverse reactions and the highest frequencies reported in placebo-controlled trials summarized in current FDA labeling for Sertraline. Individual risk varies.
Does Sertraline require lab monitoring?
Labeling and standard practice associate Sertraline with periodic laboratory monitoring; the tests above are commonly ordered by clinicians to monitor patients on therapy. Your provider decides what is appropriate.
Where does this information come from?
All clinical facts on this page were extracted from the current FDA-registered product labeling for this ingredient, published by manufacturers through NIH DailyMed. See the source link below.
Medical disclaimer: Educational content extracted from public FDA labeling. Not medical advice. Always consult a qualified healthcare professional before starting, stopping, or changing any medication.