What the label lists and what reports show
Sertraline side effects
Sertraline's FDA label: “Most common adverse reactions (≥5% and twice placebo) in pooled placebo-controlled MDD, OCD, PD, PTSD, SAD and PMDD clinical trials were nausea, diarrhea/loose stool, tremor, dyspepsia, decreased appetite, hyperhidrosis, ejaculation failure, and decreased …” FAERS holds 218,311 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is nausea (13,859 reports).
- Generic listed
- Boxed warning
Check it at the source: the sertraline FDA label on DailyMed (effective August 8, 2023, Viatris Specialty LLC); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of ZOLOFT?ZOLOFT may cause serious side effects, including: • See “What is the most important information I should know about ZOLOFT?” The most common side effects in adults who take ZOLOFT include: • nausea, loss of appetite, diarrhea, or indigestion • increased sweating • tremor or shaking • agitation • change in sleep habits including increased sleepiness or insomnia • sexual problems including decreased libido and ejaculation failure • feeling tired or fatigued • anxiety The most common side effects in children and adolescents who take ZOLOFT include abnormal increase in muscle movement or agitation, nose bleeds, urinary incontinence, aggressive reaction, possible slowed growth rate, and weight change. Your child’s height and weight should be monitored during treatment with ZOLOFT. Tell your healthcare provider if you have any side effect that bothers you or that does not go away. […]
Source: FDA drug label, Viatris Specialty LLC, effective August 8, 2023 (SPL set fda754f6-d0f3-4dce-a17a-927d64f912f7), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions (≥5% and twice placebo) in pooled placebo-controlled MDD, OCD, PD, PTSD, SAD and PMDD clinical trials were nausea, diarrhea/loose stool, tremor, dyspepsia, decreased appetite, hyperhidrosis, ejaculation failure, and decreased libido.
Table 3: Common Adverse Reactions in Pooled Placebo-Controlled Trials in Adults with MDD, OCD, PD, PTSD, SAD, and PMDD Adverse reactions that occurred greater than 2% in ZOLOFT-treated patients and at least 2% greater…
| Reaction | ZOLOFT (N=3066) | Placebo (N=2293) |
|---|---|---|
| Palpitations | 4% | 2% |
| Visual impairment | 4% | 2% |
| Nausea | 26% | 12% |
| Diarrhea/Loose stools | 20% | 10% |
| Dry mouth | 14% | 9% |
| Dyspepsia | 8% | 4% |
| Constipation | 6% | 4% |
| Vomiting | 4% | 1% |
| Fatigue | 12% | 8% |
| Decreased appetite | 7% | 2% |
| Dizziness | 12% | 8% |
| Somnolence | 11% | 6% |
| Tremor | 9% | 2% |
| Insomnia | 20% | 13% |
| Agitation | 8% | 5% |
| Libido decreased | 6% | 2% |
| Ejaculation failure Denominator used was for male patients only (n=1316 ZOLOFT; n=973… | 8% | 1% |
| Erectile dysfunction | 4% | 1% |
| Ejaculation disorder | 3% | 0% |
| Male sexual dysfunctiom | 2% | 0% |
| Hyperhidrosis | 7% | 3% |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following adverse reactions are described in more detail in other sections of the prescribing information: • Hypersensitivity reactions to sertraline [See Contraindications (4) ] • Disulfiram-alcohol reaction when ZOLOFT oral solution is taken with disulfiram [See Contraindications (4) ] • QTc prolongation and ventricular arrhythmias when taken with pimozide [See Contraindications (4), Clinical Pharmacology (12.2) ] • Suicidal thoughts and behaviors [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/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) ] • Sexual Dysfunction [See Warnings and Precautions (5.11) ] Most common adverse reactions (≥5% and twice placebo) in pooled placebo-controlled MDD, OCD, PD, PTSD, SAD and PMDD clinical trials were nausea, diarrhea/loose stool, tremor, dyspepsia, decreased appetite, hyperhidrosis, ejaculation failure, and decreased libido.
Source: FDA drug label, Viatris Specialty LLC, effective August 8, 2023 (SPL set fda754f6-d0f3-4dce-a17a-927d64f912f7), via openFDA; the full label on DailyMed
What do FAERS reports show?
218,311 reports list sertraline among the medicines taken, each a report of something that happened, not proof the medicine caused it; 18,962 are coded as a death and 68,336 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 18 reactions below, 11 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Sertraline: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions