Fluoxetine side effects: what 66,282 FDA adverse event reports show
Drug class
Not stated in label
Who reports
66,282 reports · 80% serious · 9,086 with death outcome · 69% female
Used for
Fluoxetine capsules are indicated for the treatment of: • Acute and maintenance treatment of Major Depressive Disorder [ see Clinical Studies (14.1)]. • Acute and maintenance treatment of obsessions and compulsions in patients with Obsessive Compulsive Disorder (OCD) [ see Clinical Studies (14.2 )].
What it is
Fluoxetine capsules, USP are a selective serotonin reuptake inhibitor for oral administration. It is designated (±)-N-methyl-3-phenyl-3-[(α,α,α-trifluoro-p-tolyl) oxy] propylamine hydrochloride and has the empirical formula of C 17 H 18 F 3 NO•HCl.
Boxed warning
SUICIDAL THOUGHTS AND BEHAVIORS • Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term studies. These studies did not show an increase in the r.
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.
- Outcome field, not a reaction Death is a report outcome, not a reaction term. It is dominated by the underlying illness; see the seriousness profile and the boxed warning instead.
- 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). 1,163 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 |
|---|---|---|---|---|---|---|
| Heart sounds | 45 | 274.6 183.9–409.9ROR 274.7 · calibrated p 1e-10 ✓ | 137.9 EB05 107.3 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious n=45 · ♀ 100% (drug 69%) | not reported in cached trials |
| Antidepressant drug level increased | 72 | 80.0 61.8–103.7ROR 80.1 · calibrated p 9e-7 ✓ | 62.8 EB05 51.6 · IC025 +5.1 3/3 methods agree | Lab value / disease marker | serious n=72 · ♀ 48% (drug 69%) · 100% clinician | not reported in cached trials |
| Prolonged expiration | 44 | 63.1 45.6–87.2ROR 63.1 · calibrated p 5e-6 ✓ | 51.5 EB05 40.0 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious n=45 · ♀ 100% (drug 69%) | not reported in cached trials |
| Antipsychotic drug level below therapeutic | 106 | 56.9 46.2–69.9ROR 57.0 · calibrated p 7e-6 ✓ | 47.8 EB05 40.7 · IC025 +5.0 3/3 methods agree | Lab value / disease marker | serious n=103 · ♀ 0% (drug 69%) · 100% clinician | not reported in cached trials |
| Drug-genetic interaction | 43 | 47.6 34.5–65.6ROR 47.6 · calibrated p 3e-5 ✓ | 40.7 EB05 31.5 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious n=41 · ♀ 0% (drug 69%) · 100% clinician | not reported in cached trials |
| Epidural lipomatosis | 43 | 44.5 32.3–61.2ROR 44.5 · calibrated p 4e-5 ✓ | 38.4 EB05 29.7 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious n=43 · ♀ 0% (drug 69%) · 100% clinician | not reported in cached trials |
| Serotonin syndrome | 1,720 | 31.2 29.7–32.8ROR 32.0 · calibrated p 2e-4 ✓ | 28.4 EB05 27.3 · IC025 +4.7 3/3 methods agree | Labeled — boxed warning exact term | age-adj. PRR 23.1 · serious PRR 20.6 | not reported in cached trials |
| Disinhibition | 135 | 28.9 24.2–34.4ROR 28.9 · calibrated p 4e-4 ✓ | 26.4 EB05 22.9 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious n=134 · ♀ 0% (drug 69%) | not reported in cached trials |
| Bezoar | 107 | 26.6 21.8–32.3ROR 26.6 · calibrated p 6e-4 ✓ | 24.4 EB05 20.8 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious n=107 · ♀ 100% (drug 69%) · 100% clinician | not reported in cached trials |
| Amaurosis fugax | 80 | 25.5 20.3–32.0ROR 25.5 · calibrated p 7e-4 ✓ | 23.5 EB05 19.5 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious n=80 · 100% clinician | not reported in cached trials |
| Reversible cerebral vasoconstriction syndrome | 134 | 23.1 19.4–27.6ROR 23.2 · calibrated p 0.001 ✓ | 21.5 EB05 18.6 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious n=134 · ♀ 100% (drug 69%) · 100% clinician | not reported in cached trials |
| Intrusive thoughts | 57 | 16.8 12.9–21.9ROR 16.8 · calibrated p 0.005 ✓ | 15.9 EB05 12.6 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=56 · 100% consumer | not reported in cached trials |
| Agitation neonatal | 48 | 16.7 12.5–22.4ROR 16.7 · calibrated p 0.005 ✓ | 15.8 EB05 12.3 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=48 · 100% clinician | not reported in cached trials |
| Oculogyric crisis | 100 | 15.7 12.9–19.2ROR 15.8 · calibrated p 0.006 ✓ | 15.0 EB05 12.6 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=97 | not reported in cached trials |
| Antipsychotic drug level increased | 132 | 15.5 13.0–18.5ROR 15.5 · calibrated p 0.006 ✓ | 14.8 EB05 12.8 · IC025 +3.5 3/3 methods agree | Lab value / disease marker | serious n=130 · ♀ 45% (drug 69%) · 100% clinician | not reported in cached trials |
| Binge eating | 50 | 15.4 11.6–20.5ROR 15.4 · calibrated p 0.007 ✓ | 14.6 EB05 11.4 · IC025 +3.2 3/3 methods agree | Likely indication confounding term in indications | serious n=49 · ♀ 100% (drug 69%) | not reported in cached trials |
| Clonus | 127 | 15.3 12.8–18.3ROR 15.3 · calibrated p 0.007 ✓ | 14.6 EB05 12.6 · IC025 +3.5 3/3 methods agree | Labeled adverse reaction exact term | serious n=124 · 100% clinician | not reported in cached trials |
| Hyperreflexia | 158 | 14.9 12.7–17.5ROR 14.9 · calibrated p 0.007 ✓ | 14.2 EB05 12.5 · IC025 +3.5 3/3 methods agree | Labeled adverse reaction exact term | serious n=155 · 100% clinician | not reported in cached trials |
| Suspected suicide | 204 | 14.1 12.3–16.2ROR 14.1 · calibrated p 0.009 ✓ | 13.5 EB05 12.0 · IC025 +3.5 3/3 methods agree | Labeled (related wording) related wording | serious n=204 · 100% clinician | not reported in cached trials |
| Anorgasmia | 113 | 13.7 11.3–16.5ROR 13.7 · calibrated p 0.011 ✓ | 13.1 EB05 11.1 · IC025 +3.3 3/3 methods agree | Labeled adverse reaction exact term | serious n=105 · 76% consumer | not reported in cached trials |
| Vasoplegia syndrome | 65 | 13.2 10.3–17.0ROR 13.2 · calibrated p 0.013 ✓ | 12.6 EB05 10.1 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=65 · 100% clinician | not reported in cached trials |
| Accidental death | 72 | 12.8 10.1–16.1ROR 12.8 · calibrated p 0.015 ✓ | 12.1 EB05 9.9 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=72 · 100% clinician | not reported in cached trials |
| Depersonalisation/derealisation disorder | 62 | 12.6 9.8–16.3ROR 12.6 · calibrated p 0.015 ✓ | 12.0 EB05 9.6 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=59 · ♀ 0% (drug 69%) · 100% consumer | not reported in cached trials |
| Electrocardiogram qrs complex prolonged | 196 | 12.6 10.9–14.5ROR 12.6 · calibrated p 0.014 ✓ | 12.1 EB05 10.7 · IC025 +3.3 3/3 methods agree | Lab value / disease marker | serious n=196 · 100% clinician | not reported in cached trials |
| Suicidal behaviour | 159 | 12.5 10.6–14.6ROR 12.5 · calibrated p 0.015 ✓ | 11.9 EB05 10.4 · IC025 +3.3 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=159 | not reported in cached trials |
| Obsessive-compulsive disorder | 300 | 12.2 10.9–13.7ROR 12.2 · calibrated p 0.016 ✓ | 11.7 EB05 10.6 · IC025 +3.3 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=280 · ♀ 31% (drug 69%) | not reported in cached trials |
| Torsade de pointes | 286 | 11.9 10.6–13.4ROR 12.0 · calibrated p 0.017 ✓ | 11.5 EB05 10.4 · IC025 +3.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 8.3 · 90% clinician | not reported in cached trials |
| Completed suicide (death by suicide) | 3,007 | 11.7 11.3–12.1ROR 12.2 · calibrated p 0.016 ✓ | 11.3 EB05 11.0 · IC025 +3.4 3/3 methods agree | Outcome field, not a reaction | age-adj. PRR 8.6 · serious PRR 8.1 · 96% clinician | not reported in cached trials |
| Intentional self-injury | 710 | 11.5 10.7–12.4ROR 11.6 · calibrated p 0.019 ✓ | 11.1 EB05 10.4 · IC025 +3.3 3/3 methods agree | Reporting / coding artifact | serious PRR 8.1 | not reported in cached trials |
| Alcohol interaction | 68 | 11.4 8.9–14.5ROR 11.4 · calibrated p 0.022 ✓ | 10.8 EB05 8.7 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious n=65 · ♀ 100% (drug 69%) | not reported in cached trials |
| Bradypnoea | 93 | 11.3 9.2–13.9ROR 11.3 · calibrated p 0.022 ✓ | 10.8 EB05 9.0 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious n=93 · 100% clinician | not reported in cached trials |
| Coma scale abnormal | 95 | 10.8 8.8–13.3ROR 10.8 · calibrated p 0.026 ✓ | 10.3 EB05 8.6 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious n=94 · 100% clinician | not reported in cached trials |
| Intentional overdose | 2,106 | 10.8 10.3–11.2ROR 11.1 · calibrated p 0.022 ✓ | 10.4 EB05 10.1 · IC025 +3.3 3/3 methods agree | Reporting / coding artifact | age-adj. PRR 7.3 · serious PRR 7.8 · 92% clinician | not reported in cached trials |
| Self-injurious ideation | 138 | 10.8 9.1–12.8ROR 10.8 · calibrated p 0.026 ✓ | 10.3 EB05 8.9 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=134 · ♀ 100% (drug 69%) | not reported in cached trials |
| Hypersexuality | 60 | 10.7 8.2–13.8ROR 10.7 · calibrated p 0.028 ✓ | 10.0 EB05 8.0 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious n=45 · 100% clinician | not reported in cached trials |
| Homicide | 59 | 10.7 8.2–13.8ROR 10.7 · calibrated p 0.028 ✓ | 10.0 EB05 8.0 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious n=58 · ♀ 0% (drug 69%) · 100% clinician | not reported in cached trials |
| Inhibitory drug interaction | 51 | 10.4 7.9–13.8ROR 10.5 · calibrated p 0.031 ✓ | 9.8 EB05 7.6 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious n=49 · ♀ 100% (drug 69%) | not reported in cached trials |
| Akathisia (inner restlessness) | 414 | 9.9 8.9–10.9ROR 9.9 · calibrated p 0.033 ✓ | 9.5 EB05 8.8 · IC025 +3.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 9.3 · ♀ 45% (drug 69%) | not reported in cached trials |
| Rebound acid hypersecretion | 93 | 9.9 8.0–12.1ROR 9.9 · calibrated p 0.035 ✓ | 9.4 EB05 7.8 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious n=93 | not reported in cached trials |
| Poisoning | 381 | 9.8 8.9–10.9ROR 9.9 · calibrated p 0.034 ✓ | 9.5 EB05 8.7 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 7.0 · 100% clinician | 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 | 6,664 | 8.88.6–9.0 | signal |
| Extrapyramidal | 1,606 | 4.94.6–5.1 | signal |
| Depression | 3,076 | 3.53.4–3.6 | signal |
| Hyponatraemia | 829 | 3.33.1–3.5 | signal |
| Arrhythmia / qt | 1,791 | 2.92.8–3.1 | signal |
| Seizure | 1,610 | 2.62.5–2.7 | signal |
| Rhabdomyolysis / myopathy | 641 | 2.52.3–2.7 | signal |
| Fall / fracture | 2,162 | 1.81.7–1.9 | raised |
| Kidney injury | 2,508 | 1.71.7–1.8 | raised |
| Pancreatitis | 377 | 1.51.3–1.6 | raised |
| Gi bleeding | 806 | 1.41.3–1.5 | raised |
| Dependence / withdrawal | 1,242 | 1.31.3–1.4 | raised |
| Hypoglycaemia | 396 | 1.31.2–1.4 | raised |
| Interstitial lung disease | 368 | 1.21.1–1.3 | raised |
| Venous thromboembolism | 819 | 1.21.1–1.3 | raised |
| Tendon disorder | 144 | 1.21.0–1.4 | raised |
Trial evidence (ClinicalTrials.gov)
✓ Trial adverse-event data found on ClinicalTrials.gov
Largest completed trials with posted results that list Fluoxetine 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 (0 of 40 signal terms matched).
- NCT03466346 — SMART-DAPPER: Leveraging the Depression And Primary-care Partnership for Effectiveness-implementation Research (N=2162, NA; 57 AE terms posted; arms: Stage 1: Interpersonal Psychotherapy (IP; Stage 1: Fluoxetine; Stage 2: IPT After Fluoxetine; Stage 2: Fluoxetine After IPT)
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) | 3,770 | 0.9 0.9–0.9ROR 0.9 · calibrated p 0.243 | 0.9 EB05 0.9 · IC025 -0.2 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | age-adj. PRR 0.9 · serious PRR 1.2 | not reported in cached trials |
| Drug interaction | 3,474 | 7.1 6.8–7.3ROR 7.4 · calibrated p 0.084 | 6.9 EB05 6.7 · IC025 +2.7 3/3 methods agree | Reporting / coding artifact | age-adj. PRR 6.1 · serious PRR 5.4 | not reported in cached trials |
| Toxicity to various agents | 3,455 | 6.6 6.4–6.9ROR 6.9 · calibrated p 0.101 | 6.5 EB05 6.3 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | age-adj. PRR 5.5 · serious PRR 4.8 · 94% clinician | not reported in cached trials |
| Nausea | 3,356 | 1.3 1.3–1.4ROR 1.4 · calibrated p 0.552 | 1.3 EB05 1.3 · IC025 +0.4 | Labeled adverse reaction exact term | age-adj. PRR 1.1 · serious PRR 1.4 | not reported in cached trials |
| Fatigue (tiredness) | 3,271 | 1.3 1.3–1.4ROR 1.4 · calibrated p 0.542 | 1.3 EB05 1.3 · IC025 +0.4 | Labeled (related wording) related wording | age-adj. PRR 1.1 · serious PRR 1.3 | NCT03466346: 1/1,082 (0.1%) on Fluoxetine (serious AE) |
| Completed suicide (death by suicide) | 3,007 | 11.7 11.3–12.1ROR 12.2 · calibrated p 0.016 ✓ | 11.3 EB05 11.0 · IC025 +3.4 3/3 methods agree | Outcome field, not a reaction | age-adj. PRR 8.6 · serious PRR 8.1 · 96% clinician | not reported in cached trials |
| Headache | 2,853 | 1.4 1.4–1.5ROR 1.5 · calibrated p 0.618 | 1.4 EB05 1.4 · IC025 +0.5 | Labeled adverse reaction exact term | age-adj. PRR 1.2 · serious PRR 1.6 | NCT03466346: 1/160 (0.6%) on Fluoxetine |
| Off label use (used outside approved label) | 2,593 | 0.9 0.9–1.0ROR 0.9 · calibrated p 0.270 | 0.9 EB05 0.9 · IC025 -0.1 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | age-adj. PRR 0.9 · serious PRR 1.0 | not reported in cached trials |
| Anxiety | 2,524 | 2.8 2.7–2.9ROR 2.9 · calibrated p 0.664 | 2.8 EB05 2.7 · IC025 +1.4 3/3 methods agree | Labeled adverse reaction exact term | age-adj. PRR 2.5 · serious PRR 2.6 | not reported in cached trials |
| Dizziness | 2,453 | 1.6 1.5–1.6ROR 1.6 · calibrated p 0.695 | 1.6 EB05 1.5 · IC025 +0.6 | Labeled adverse reaction exact term | age-adj. PRR 1.3 · serious PRR 1.5 | NCT03466346: 1/160 (0.6%) on Fluoxetine |
| Diarrhoea (diarrhea) | 2,449 | 1.2 1.2–1.3ROR 1.2 · calibrated p 0.449 | 1.2 EB05 1.2 · IC025 +0.2 | Labeled adverse reaction exact term | age-adj. PRR 1.0 · serious PRR 1.1 | not reported in cached trials |
| Vomiting | 2,355 | 1.6 1.5–1.7ROR 1.6 · calibrated p 0.715 | 1.6 EB05 1.5 · IC025 +0.6 | Likely indication confounding term in indications; also in warnings | age-adj. PRR 1.3 · serious PRR 1.4 | not reported in cached trials |
| Depression | 2,351 | 3.3 3.1–3.4ROR 3.4 · calibrated p 0.520 | 3.3 EB05 3.1 · IC025 +1.6 3/3 methods agree | Labeled — boxed warning synonym match | age-adj. PRR 2.8 · serious PRR 2.8 | not reported in cached trials |
| Dyspnoea (shortness of breath) | 2,220 | 1.2 1.2–1.3ROR 1.3 · calibrated p 0.475 | 1.2 EB05 1.2 · IC025 +0.2 | Labeled adverse reaction exact term | age-adj. PRR 1.1 · serious PRR 1.1 | not reported in cached trials |
| Intentional overdose | 2,106 | 10.8 10.3–11.2ROR 11.1 · calibrated p 0.022 ✓ | 10.4 EB05 10.1 · IC025 +3.3 3/3 methods agree | Reporting / coding artifact | age-adj. PRR 7.3 · serious PRR 7.8 · 92% clinician | not reported in cached trials |
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.
- Heart sounds — n=45, PRR 274.6
- Prolonged expiration — n=44, PRR 63.1
- Drug-genetic interaction — n=43, PRR 47.6
- Epidural lipomatosis — n=43, PRR 44.5
- Disinhibition — n=135, PRR 28.9
- Bezoar — n=107, PRR 26.6
- Amaurosis fugax — n=80, PRR 25.5
- Reversible cerebral vasoconstriction syndrome — n=134, PRR 23.1
- Intrusive thoughts — n=57, PRR 16.8
- Agitation neonatal — n=48, PRR 16.7
✓ A hand-written Bradford Hill causality assessment exists for this drug: Fluoxetine ↔ Serotonin syndrome.
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 Fluoxetine?
In FDA FAERS, the most frequently co-reported reaction terms for Fluoxetine are toxicity to various agents, nausea, fatigue, 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 Fluoxetine 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 children, adolescents, and young adults in short-term studies. These studies did not show an increase in the r.
Do FAERS signals prove that Fluoxetine 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 05b0781b-50e2-4311-bde0-430b96e2ef8e, effective 20240712; matched on
openfda.generic_name.exact:"FLUOXETINE") - 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, 1,203 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
FLUOXETINE, 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.