Sertraline side effects: what 116,614 FDA adverse event reports show
Drug class
Not stated in label
Who reports
116,614 reports · 79% serious · 11,842 with death outcome · 65% female
Used for
Sertraline hydrochloride tablets are indicated for the treatment of the following [ See Clinical Studies ( 14 ) ]: • Major depressive disorder (MDD) • Obsessive-compulsive disorder (OCD) • Panic disorder (PD) • Posttraumatic stress disorder (PTSD) • So.
What it is
Sertraline is a member of the class of tetralins that is tetralin which is substituted at positions 1 and 4 by a methylamino and a 3,4-dichlorophenyl group, respectively (the S,S diastereoisomer).
Boxed warning
SUICIDAL THOUGHTS AND BEHAVIORS Antidepressants increased the risk of suicidal thoughts and behavior in pediatric and young adult patients in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors [ See Warnings and Precautions ( 5.1 ) ].
Causality screen of the 40 strongest signals
What the badges mean
- Labeled — boxed warning The term (or its clinical synonym) appears in the FDA boxed warning: causality is regulator-recognised and considered serious.
- Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
- Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
- Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only (and, for the 300 most-reported drugs, adjusted for age band), and flags pairs whose reports are unusually skewed by sex or come mostly from consumers. Each row also shows the PRR against the other drugs of the same FDA class, which removes most confounding by the condition being treated, and a calibrated p-value: on validation, known non-causes average an ROR of about 2, so significance is judged against that empirical null (✓ = p < 0.05 after calibration). 1,150 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Multiple acyl-coenzyme a dehydrogenase deficiency | 290 | 473.7 379.8–590.8ROR 474.9 · calibrated p 2e-13 ✓ | 128.2 EB05 116.3 · IC025 +6.5 3/3 methods agree | Not in label — unassessed | serious n=290 · 100% clinician | not reported in cached trials |
| Total lung capacity increased | 75 | 67.9 52.0–88.5ROR 67.9 · calibrated p 3e-6 ✓ | 48.7 EB05 40.1 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious n=75 · ♀ 100% (drug 65%) · 100% clinician | not reported in cached trials |
| Agitation neonatal | 160 | 36.1 30.5–42.8ROR 36.2 · calibrated p 1e-4 ✓ | 30.1 EB05 26.4 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious n=159 · ♀ 0% (drug 65%) | not reported in cached trials |
| Asthma-chronic obstructive pulmonary disease overlap syndrome | 76 | 30.6 24.0–39.0ROR 30.6 · calibrated p 3e-4 ✓ | 26.1 EB05 21.5 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious n=75 · ♀ 100% (drug 65%) · 100% clinician | not reported in cached trials |
| Respiratory disorder neonatal | 206 | 26.6 23.0–30.8ROR 26.7 · calibrated p 5e-4 ✓ | 23.2 EB05 20.7 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=206 · ♀ 39% (drug 65%) | not reported in cached trials |
| Amaurosis fugax | 129 | 24.5 20.4–29.5ROR 24.6 · calibrated p 8e-4 ✓ | 21.6 EB05 18.7 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious n=129 · 100% clinician | not reported in cached trials |
| Anorgasmia | 320 | 23.9 21.2–26.8ROR 23.9 · calibrated p 9e-4 ✓ | 21.1 EB05 19.2 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=301 · 72% consumer | not reported in cached trials |
| Disturbance in sexual arousal | 99 | 21.6 17.5–26.6ROR 21.6 · calibrated p 0.002 ✓ | 19.3 EB05 16.3 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious n=95 · 100% consumer | not reported in cached trials |
| Intrusive thoughts | 120 | 21.3 17.6–25.7ROR 21.3 · calibrated p 0.002 ✓ | 19.1 EB05 16.4 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious n=120 | not reported in cached trials |
| Oromandibular dystonia | 72 | 19.8 15.6–25.3ROR 19.9 · calibrated p 0.002 ✓ | 17.9 EB05 14.6 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=67 · ♀ 0% (drug 65%) · 100% clinician | not reported in cached trials |
| Serotonin syndrome | 1,863 | 19.3 18.4–20.3ROR 19.6 · calibrated p 0.002 ✓ | 17.5 EB05 16.8 · IC025 +4.0 3/3 methods agree | Labeled — boxed warning exact term | age-adj. PRR 15.3 · serious PRR 12.8 | NCT00605865: 1/2,157 (0.0%) on Sertraline (serious AE) |
| Genital hypoaesthesia | 95 | 18.7 15.1–23.1ROR 18.7 · calibrated p 0.003 ✓ | 16.9 EB05 14.2 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=93 · ♀ 0% (drug 65%) · 100% consumer | not reported in cached trials |
| Hypomania | 324 | 17.2 15.4–19.3ROR 17.3 · calibrated p 0.004 ✓ | 15.8 EB05 14.4 · IC025 +3.8 3/3 methods agree | Labeled — boxed warning exact term | serious n=306 | not reported in cached trials |
| Depersonalisation/derealisation disorder | 139 | 16.9 14.2–20.1ROR 16.9 · calibrated p 0.004 ✓ | 15.5 EB05 13.4 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=135 | not reported in cached trials |
| Emotional poverty | 148 | 16.5 13.9–19.5ROR 16.5 · calibrated p 0.005 ✓ | 15.1 EB05 13.2 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=143 · 100% consumer | not reported in cached trials |
| Bruxism | 451 | 16.3 14.8–18.0ROR 16.4 · calibrated p 0.005 ✓ | 15.0 EB05 13.9 · IC025 +3.7 3/3 methods agree | Labeled adverse reaction exact term | serious n=391 | not reported in cached trials |
| Intentional self-injury | 1,596 | 15.4 14.6–16.2ROR 15.6 · calibrated p 0.006 ✓ | 14.2 EB05 13.6 · IC025 +3.7 3/3 methods agree | Reporting / coding artifact | serious PRR 10.5 | NCT00605865: 1/2,157 (0.0%) on Sertraline |
| Butterfly rash | 77 | 14.9 11.8–18.8ROR 14.9 · calibrated p 0.008 ✓ | 13.7 EB05 11.3 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=77 · ♀ 100% (drug 65%) | not reported in cached trials |
| Colitis microscopic | 314 | 12.8 11.4–14.4ROR 12.9 · calibrated p 0.013 ✓ | 12.0 EB05 10.9 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=314 | not reported in cached trials |
| Derealisation | 137 | 12.2 10.3–14.6ROR 12.3 · calibrated p 0.016 ✓ | 11.4 EB05 9.9 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=132 | not reported in cached trials |
| Obsessive thoughts | 107 | 11.2 9.2–13.7ROR 11.2 · calibrated p 0.022 ✓ | 10.5 EB05 8.9 · IC025 +3.0 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=103 | not reported in cached trials |
| Yawning | 152 | 10.8 9.1–12.7ROR 10.8 · calibrated p 0.026 ✓ | 10.1 EB05 8.8 · IC025 +3.0 3/3 methods agree | Labeled adverse reaction exact term | serious n=123 | not reported in cached trials |
| Psychiatric decompensation | 110 | 10.7 8.8–13.0ROR 10.7 · calibrated p 0.027 ✓ | 10.0 EB05 8.5 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious n=110 · ♀ 0% (drug 65%) · 100% clinician | not reported in cached trials |
| Depression suicidal | 195 | 10.7 9.2–12.3ROR 10.7 · calibrated p 0.026 ✓ | 10.0 EB05 8.9 · IC025 +3.1 3/3 methods agree | Labeled (related wording) related wording | serious n=195 | not reported in cached trials |
| Antipsychotic drug level increased | 158 | 10.6 9.1–12.5ROR 10.6 · calibrated p 0.027 ✓ | 10.0 EB05 8.7 · IC025 +3.0 3/3 methods agree | Lab value / disease marker | serious n=158 · ♀ 33% (drug 65%) · 100% clinician | not reported in cached trials |
| Small for dates baby | 279 | 10.6 9.4–12.0ROR 10.6 · calibrated p 0.027 ✓ | 10.0 EB05 9.0 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=279 | not reported in cached trials |
| Self-injurious ideation | 230 | 10.4 9.1–11.9ROR 10.4 · calibrated p 0.029 ✓ | 9.8 EB05 8.8 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=229 · ♀ 86% (drug 65%) | not reported in cached trials |
| Depressive symptom | 189 | 10.2 8.8–11.8ROR 10.2 · calibrated p 0.031 ✓ | 9.6 EB05 8.5 · IC025 +3.0 3/3 methods agree | Labeled (related wording) related wording | serious n=183 | not reported in cached trials |
| Hyperreflexia | 188 | 10.2 8.8–11.8ROR 10.2 · calibrated p 0.031 ✓ | 9.6 EB05 8.4 · IC025 +3.0 3/3 methods agree | Labeled adverse reaction exact term | serious n=187 | not reported in cached trials |
| Hallucinations, mixed | 217 | 9.7 8.5–11.1ROR 9.7 · calibrated p 0.036 ✓ | 9.2 EB05 8.2 · IC025 +3.0 3/3 methods agree | Labeled (related wording) related wording | serious n=205 | not reported in cached trials |
| Psychomotor retardation | 142 | 9.6 8.1–11.4ROR 9.6 · calibrated p 0.038 ✓ | 9.0 EB05 7.8 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious n=141 · 100% clinician | not reported in cached trials |
| Psychomotor skills impaired | 133 | 9.5 8.0–11.4ROR 9.5 · calibrated p 0.039 ✓ | 8.9 EB05 7.7 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious n=132 · ♀ 39% (drug 65%) · 100% clinician | not reported in cached trials |
| Flat affect | 113 | 9.3 7.7–11.3ROR 9.4 · calibrated p 0.042 ✓ | 8.7 EB05 7.4 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious n=103 | not reported in cached trials |
| Reversible cerebral vasoconstriction syndrome | 97 | 9.3 7.6–11.4ROR 9.3 · calibrated p 0.043 ✓ | 8.7 EB05 7.3 · IC025 +2.8 3/3 methods agree | Labeled adverse reaction exact term | serious n=97 · ♀ 100% (drug 65%) · 100% clinician | not reported in cached trials |
| Hyperparathyroidism secondary | 123 | 9.1 7.6–10.9ROR 9.1 · calibrated p 0.045 ✓ | 8.6 EB05 7.3 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious n=123 | not reported in cached trials |
| Electric shock sensation | 128 | 8.9 7.5–10.7ROR 8.9 · calibrated p 0.048 ✓ | 8.4 EB05 7.2 · IC025 +2.8 3/3 methods agree | Labeled adverse reaction exact term | serious n=113 · 100% consumer | not reported in cached trials |
| Psychotic symptom | 97 | 8.9 7.3–11.0ROR 8.9 · calibrated p 0.049 ✓ | 8.3 EB05 7.0 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious n=97 · 100% clinician | not reported in cached trials |
| Sexual dysfunction | 551 | 8.9 8.1–9.6ROR 8.9 · calibrated p 0.048 ✓ | 8.4 EB05 7.9 · IC025 +2.9 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 8.6 · ♀ 40% (drug 65%) | NCT00605865: 1/2,157 (0.0%) on Sertraline |
| Tearfulness | 202 | 8.8 7.6–10.1ROR 8.8 · calibrated p 0.051 | 8.3 EB05 7.4 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious n=192 | not reported in cached trials |
| Loss of libido | 417 | 8.7 7.9–9.6ROR 8.7 · calibrated p 0.051 | 8.3 EB05 7.6 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 7.3 · ♀ 37% (drug 65%) · 70% consumer | not reported in cached trials |
Clinical concept groups
MedDRA splits one clinical problem across several terms (e.g. "neutropenia", "neutrophil count decreased", "agranulocytosis"), which dilutes term-level signals. These rows count reports with any term in a concept group (an exact union, not a sum), compared with all other drugs. Groups are hand-built and listed in the methods.
| Concept | Reports | PRR 95% CI | Reading |
|---|---|---|---|
| Suicidality | 8,391 | 6.36.2–6.5 | signal |
| Extrapyramidal | 2,609 | 4.54.4–4.7 | signal |
| Hyponatraemia | 1,742 | 4.03.8–4.1 | signal |
| Depression | 5,003 | 3.23.1–3.3 | signal |
| Rhabdomyolysis / myopathy | 1,196 | 2.72.5–2.8 | signal |
| Arrhythmia / qt | 2,171 | 2.01.9–2.1 | raised |
| Seizure | 2,125 | 2.01.9–2.0 | raised |
| Fall / fracture | 4,011 | 1.91.8–2.0 | raised |
| Gi bleeding | 1,772 | 1.71.7–1.8 | raised |
| Kidney injury | 3,526 | 1.41.3–1.4 | raised |
| Dependence / withdrawal | 2,007 | 1.21.2–1.3 | raised |
| Serious infection | 5,231 | 1.21.2–1.3 | raised |
| Interstitial lung disease | 635 | 1.21.1–1.3 | raised |
| Pancreatitis | 531 | 1.21.1–1.3 | raised |
| Severe cutaneous reaction | 484 | 1.21.1–1.3 | raised |
| Liver injury | 1,956 | 1.21.1–1.2 | raised |
Trial evidence (ClinicalTrials.gov)
✓ Trial adverse-event data found on ClinicalTrials.gov
Largest completed trials with posted results that list Sertraline as a study intervention. The right-hand column of the signal table shows whether each FAERS term was also recorded in these trials, with a real denominator (3 of 40 signal terms matched).
- NCT00605865 — Drug Use Investigation of Jzoloft. (N=2272, phase n/a; 85 AE terms posted; arms: Sertraline)
Caveats: trial populations, doses and follow-up differ from the reporting population; AE terms are sponsor-coded and matched here by wording; absence from a trial list means the term was not reported above the sponsor's frequency threshold, not that it cannot occur.
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Drug ineffective (drug did not work) | 7,043 | 1.0 0.9–1.0ROR 1.0 · calibrated p 0.280 | 1.0 EB05 0.9 · IC025 -0.1 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | age-adj. PRR 1.0 · serious PRR 1.2 | not reported in cached trials |
| Nausea | 6,761 | 1.5 1.5–1.6ROR 1.6 · calibrated p 0.693 | 1.5 EB05 1.5 · IC025 +0.6 | Labeled adverse reaction exact term | age-adj. PRR 1.4 · serious PRR 1.6 | NCT00605865: 87/2,157 (4.0%) on Sertraline |
| Fatigue (tiredness) | 6,126 | 1.4 1.4–1.5ROR 1.4 · calibrated p 0.605 | 1.4 EB05 1.4 · IC025 +0.5 | Labeled adverse reaction exact term | age-adj. PRR 1.2 · serious PRR 1.4 | not reported in cached trials |
| Diarrhoea (diarrhea) | 5,437 | 1.5 1.5–1.6ROR 1.5 · calibrated p 0.674 | 1.5 EB05 1.5 · IC025 +0.6 | Labeled adverse reaction exact term | age-adj. PRR 1.3 · serious PRR 1.4 | NCT00605865: 27/2,157 (1.3%) on Sertraline |
| Headache | 5,094 | 1.5 1.4–1.5ROR 1.5 · calibrated p 0.634 | 1.5 EB05 1.4 · IC025 +0.5 | Labeled adverse reaction exact term | age-adj. PRR 1.3 · serious PRR 1.7 | NCT00605865: 8/2,157 (0.4%) on Sertraline |
| Off label use (used outside approved label) | 4,828 | 1.0 1.0–1.0ROR 1.0 · calibrated p 0.307 | 1.0 EB05 1.0 · IC025 -0.0 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | age-adj. PRR 0.9 · serious PRR 1.1 | not reported in cached trials |
| Anxiety | 4,750 | 3.0 2.9–3.1ROR 3.1 · calibrated p 0.590 | 3.0 EB05 2.9 · IC025 +1.5 3/3 methods agree | Likely indication confounding term in indications; also in warnings | age-adj. PRR 2.9 · serious PRR 2.7 | NCT00605865: 4/2,157 (0.2%) on Sertraline |
| Dizziness | 4,745 | 1.7 1.7–1.8ROR 1.8 · calibrated p 0.800 | 1.7 EB05 1.7 · IC025 +0.7 | Labeled adverse reaction exact term | age-adj. PRR 1.5 · serious PRR 1.8 | NCT00605865: 8/2,157 (0.4%) on Sertraline |
| Drug interaction | 4,372 | 5.1 4.9–5.2ROR 5.2 · calibrated p 0.211 | 5.0 EB05 4.8 · IC025 +2.3 3/3 methods agree | Reporting / coding artifact | age-adj. PRR 4.3 · serious PRR 3.9 | not reported in cached trials |
| Vomiting | 4,349 | 1.7 1.6–1.7ROR 1.7 · calibrated p 0.769 | 1.7 EB05 1.6 · IC025 +0.7 | Labeled adverse reaction exact term | age-adj. PRR 1.5 · serious PRR 1.6 | NCT00605865: 2/2,157 (0.1%) on Sertraline |
| Depression | 3,942 | 3.1 3.0–3.2ROR 3.2 · calibrated p 0.561 | 3.1 EB05 3.0 · IC025 +1.6 3/3 methods agree | Labeled — boxed warning synonym match | age-adj. PRR 2.8 · serious PRR 2.7 | not reported in cached trials |
| Fall | 3,804 | 2.1 2.0–2.1ROR 2.1 · calibrated p 1.000 | 2.1 EB05 2.0 · IC025 +1.0 3/3 methods agree | Labeled adverse reaction exact term | age-adj. PRR 1.9 · serious PRR 1.6 | NCT00605865: 1/2,157 (0.0%) on Sertraline (serious AE) |
| Dyspnoea (shortness of breath) | 3,784 | 1.2 1.2–1.2ROR 1.2 · calibrated p 0.448 | 1.2 EB05 1.2 · IC025 +0.2 | Not in label — unassessed | age-adj. PRR 1.1 · serious PRR 1.0 | NCT00605865: 3/2,157 (0.1%) on Sertraline |
| Toxicity to various agents | 3,528 | 3.8 3.7–4.0ROR 3.9 · calibrated p 0.391 | 3.8 EB05 3.7 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | age-adj. PRR 3.3 · serious PRR 2.8 · 93% clinician | not reported in cached trials |
| Pain | 3,352 | 1.0 0.9–1.0ROR 1.0 · calibrated p 0.293 | 1.0 EB05 1.0 · IC025 -0.1 PRR-only: not supported by EBGM or IC | Labeled adverse reaction exact term | age-adj. PRR 1.0 · serious PRR 0.9 | NCT00605865: 2/2,157 (0.1%) on Sertraline |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Multiple acyl-coenzyme a dehydrogenase deficiency — n=290, PRR 473.7
- Total lung capacity increased — n=75, PRR 67.9
- Agitation neonatal — n=160, PRR 36.1
- Asthma-chronic obstructive pulmonary disease overlap syndrome — n=76, PRR 30.6
- Respiratory disorder neonatal — n=206, PRR 26.6
- Amaurosis fugax — n=129, PRR 24.5
- Anorgasmia — n=320, PRR 23.9
- Disturbance in sexual arousal — n=99, PRR 21.6
- Intrusive thoughts — n=120, PRR 21.3
- Oromandibular dystonia — n=72, PRR 19.8
✓ A hand-written Bradford Hill causality assessment exists for this drug: Sertraline (SSRIs) ↔ Upper gastrointestinal bleeding.
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Sertraline?
In FDA FAERS, the most frequently co-reported reaction terms for Sertraline are nausea, fatigue, diarrhoea, headache, anxiety, dizziness. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Sertraline have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: SUICIDAL THOUGHTS AND BEHAVIORS Antidepressants increased the risk of suicidal thoughts and behavior in pediatric and young adult patients in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors [ See Warnings and Precautions ( 5.1 ) ].
Do FAERS signals prove that Sertraline causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID 03e1f274-fa9a-4461-b7c9-31ba6428c107, effective 20260330; matched on
openfda.generic_name.exact:"SERTRALINE") - PubChem CID 68617 description (ChEBI)
- Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 1,190 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath - ClinicalTrials.gov API v2 (query
SERTRALINE, results-bearing studies sorted by enrollment)
Page generated 2026-10-14. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.