Fluvoxamine side effects: what 2,389 FDA adverse event reports show
Drug class
Selective serotonin reuptake inhibitor (ssri)
Label matched
Fluvoxamine Maleate (Fluvoxamine Maleate)
Who reports
2,389 reports · 78% serious · 256 with death outcome · 57% female
Used for
Fluvoxamine maleate extended-release capsules is a selective serotonin reuptake inhibitor (SSRI) indicated for the treatment of obsessive compulsive disorder (OCD) ( 1 ). Efficacy was demonstrated in: One 12-week study fluvoxamine maleate extended-release capsules in adults ( 14.1 ).
What it is
Fluvoxamine maleate extended-release capsules, for oral administration, contain fluvoxamine maleate, USP a selective serotonin (5-HT) reuptake inhibitor (SSRI) belonging to the chemical series, the 2-aminoethyl oxime ethers of aralkylketones.
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.
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.
- 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 flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 102 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 |
|---|---|---|---|---|---|---|
| Serotonin syndrome | 81 | 37.3 30.1–46.3ROR 38.6 · χ² 2,817 / p <1e-300 | 36.9 EB05 30.6 · IC025 +4.6 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 26.9 · 91% clinician | no trial data cached |
| Neuroleptic malignant syndrome | 33 | 24.4 17.4–34.3ROR 24.7 · χ² 716 / p 4e-158 | 24.1 EB05 17.9 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 17.5 · 95% clinician | no trial data cached |
| Drug toxicity | 30 | 19.1 13.4–27.3ROR 19.3 · χ² 496 / p 4e-110 | 18.8 EB05 13.7 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 14.6 · 95% clinician | no trial data cached |
| Blood lactate dehydrogenase increased | 30 | 16.5 11.6–23.6ROR 16.7 · χ² 422 / p 4e-94 | 16.3 EB05 11.8 · IC025 +3.1 3/3 methods agree | Lab value / disease marker | serious PRR 12.5 | no trial data cached |
| Blood creatine phosphokinase increased | 55 | 16.5 12.7–21.5ROR 16.9 · χ² 787 / p 2e-173 | 16.4 EB05 13.0 · IC025 +3.4 3/3 methods agree | Lab value / disease marker | serious PRR 13.3 | no trial data cached |
| Muscle rigidity | 21 | 15.4 10.1–23.7ROR 15.6 · χ² 269 / p 9e-61 | 14.9 EB05 9.9 · IC025 +2.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 10.9 | no trial data cached |
| Akathisia (inner restlessness) | 23 | 14.8 9.9–22.3ROR 14.9 · χ² 282 / p 1e-63 | 14.3 EB05 9.7 · IC025 +2.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 14.8 | no trial data cached |
| Inappropriate antidiuretic hormone secretion | 17 | 14.7 9.1–23.6ROR 14.8 · χ² 203 / p 2e-46 | 13.9 EB05 8.6 · IC025 +2.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 10.9 | no trial data cached |
| Drug level increased | 26 | 13.8 9.4–20.2ROR 13.9 · χ² 296 / p 1e-66 | 13.3 EB05 9.2 · IC025 +2.8 3/3 methods agree | Reporting / coding artifact | serious PRR 11.2 · 91% clinician | no trial data cached |
| Bipolar disorder | 17 | 13.6 8.5–21.9ROR 13.7 · χ² 187 / p 9e-43 | 12.8 EB05 7.8 · IC025 +2.5 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 11.5 | no trial data cached |
| Myoclonus | 18 | 13.3 8.4–21.0ROR 13.4 · χ² 192 / p 6e-44 | 12.4 EB05 7.8 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 9.2 | no trial data cached |
| Sopor | 20 | 13.2 8.5–20.4ROR 13.3 · χ² 212 / p 2e-48 | 12.4 EB05 8.0 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 9.7 · 100% clinician | no trial data cached |
| Intentional self-injury | 29 | 12.6 8.8–18.1ROR 12.8 · χ² 299 / p 3e-67 | 12.1 EB05 8.6 · IC025 +2.8 3/3 methods agree | Reporting / coding artifact | serious PRR 8.7 · ♀ 79% (drug 57%) | no trial data cached |
| Drug interaction | 220 | 12.2 10.7–13.8ROR 13.3 · χ² 2,262 / p <1e-300 | 12.1 EB05 10.8 · IC025 +3.3 3/3 methods agree | Reporting / coding artifact | serious PRR 9.6 · 92% clinician | no trial data cached |
| Mydriasis | 17 | 11.7 7.3–18.7ROR 11.7 · χ² 155 / p 7e-36 | 10.5 EB05 6.5 · IC025 +2.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 10.4 | no trial data cached |
| Suicide attempt | 80 | 11.6 9.3–14.4ROR 11.9 · χ² 763 / p 3e-168 | 11.4 EB05 9.4 · IC025 +3.1 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 8.5 | no trial data cached |
| Schizophrenia | 16 | 11.6 7.1–18.8ROR 11.6 · χ² 144 / p 2e-33 | 10.3 EB05 6.2 · IC025 +2.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.8 | no trial data cached |
| Salivary hypersecretion | 13 | 11.4 6.6–19.7ROR 11.5 · χ² 113 / p 9e-27 | 9.9 EB05 5.6 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 10.5 | no trial data cached |
| Grand mal convulsion | 11 | 10.3 5.7–18.6ROR 10.4 · χ² 83 / p 3e-20 | 8.4 EB05 4.6 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 7.7 | no trial data cached |
| Electrocardiogram qt prolonged | 42 | 10.3 7.6–13.8ROR 10.4 · χ² 342 / p 1e-76 | 9.8 EB05 7.4 · IC025 +2.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.7 · 90% clinician | no trial data cached |
| Altered state of consciousness | 25 | 10.2 6.9–15.1ROR 10.3 · χ² 198 / p 3e-45 | 9.4 EB05 6.4 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 7.6 | no trial data cached |
| Body temperature decreased | 11 | 9.7 5.4–17.6ROR 9.8 · χ² 78 / p 6e-19 | 7.8 EB05 4.4 · IC025 +1.8 3/3 methods agree | Lab value / disease marker | serious PRR 8.0 | no trial data cached |
| Suicidal ideation (thoughts of suicide) | 100 | 9.6 7.9–11.6ROR 10.0 · χ² 763 / p 3e-168 | 9.4 EB05 7.9 · IC025 +2.9 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 7.3 | no trial data cached |
| Blood potassium increased | 17 | 9.2 5.7–14.8ROR 9.3 · χ² 116 / p 2e-27 | 8.0 EB05 5.1 · IC025 +2.1 3/3 methods agree | Lab value / disease marker | serious PRR 8.3 | no trial data cached |
| Restlessness | 35 | 8.4 6.0–11.7ROR 8.5 · χ² 221 / p 3e-50 | 7.8 EB05 5.8 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.6 | no trial data cached |
| Paranoia | 16 | 8.1 5.0–13.2ROR 8.2 · χ² 93 / p 3e-22 | 6.9 EB05 4.4 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 7.0 | no trial data cached |
| Completed suicide (death by suicide) | 69 | 7.2 5.7–9.1ROR 7.4 · χ² 364 / p 2e-81 | 6.9 EB05 5.6 · IC025 +2.4 3/3 methods agree | Outcome field, not a reaction | serious PRR 5.3 · 92% clinician | no trial data cached |
| Mania | 13 | 6.9 4.0–12.0ROR 7.0 · χ² 60 / p 4e-15 | 5.7 EB05 3.5 · IC025 +1.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.8 | no trial data cached |
| Anorexia | 10 | 6.7 3.6–12.5ROR 6.7 · χ² 43 / p 3e-11 | 5.3 EB05 3.1 · IC025 +1.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.8 | no trial data cached |
| Apathy | 11 | 6.6 3.7–12.0ROR 6.7 · χ² 47 / p 3e-12 | 5.4 EB05 3.2 · IC025 +1.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.8 | no trial data cached |
| Pulmonary congestion | 10 | 6.6 3.6–12.3ROR 6.7 · χ² 42 / p 4e-11 | 5.3 EB05 3.0 · IC025 +1.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.7 | no trial data cached |
| Intentional overdose | 48 | 6.6 5.0–8.8ROR 6.7 · χ² 224 / p 7e-51 | 6.3 EB05 4.9 · IC025 +2.2 3/3 methods agree | Reporting / coding artifact | serious PRR 4.9 | no trial data cached |
| Alanine aminotransferase increased | 46 | 6.6 4.9–8.8ROR 6.7 · χ² 212 / p 2e-48 | 6.2 EB05 4.8 · IC025 +2.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.2 · 94% clinician | no trial data cached |
| Orthostatic hypotension (dizziness on standing) | 13 | 6.5 3.8–11.3ROR 6.6 · χ² 56 / p 4e-14 | 5.4 EB05 3.4 · IC025 +1.5 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 5.1 | no trial data cached |
| Delirium | 25 | 6.3 4.3–9.4ROR 6.4 · χ² 107 / p 2e-25 | 5.7 EB05 4.1 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.8 | no trial data cached |
| Rhabdomyolysis (muscle breakdown) | 30 | 6.3 4.4–9.0ROR 6.4 · χ² 130 / p 3e-30 | 5.8 EB05 4.3 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.5 · 91% clinician | no trial data cached |
| Aggression | 36 | 6.3 4.6–8.7ROR 6.4 · χ² 156 / p 5e-36 | 5.9 EB05 4.4 · IC025 +2.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.5 · ♀ 31% (drug 57%) | no trial data cached |
| Agitation | 52 | 6.2 4.7–8.1ROR 6.3 · χ² 222 / p 1e-50 | 5.9 EB05 4.7 · IC025 +2.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.4 · ♀ 37% (drug 57%) | no trial data cached |
| Sinus tachycardia | 10 | 6.2 3.3–11.5ROR 6.2 · χ² 39 / p 3e-10 | 5.0 EB05 2.9 · IC025 +1.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.7 | no trial data cached |
| Blood sodium decreased | 13 | 6.1 3.5–10.4ROR 6.1 · χ² 50 / p 7e-13 | 5.1 EB05 3.2 · IC025 +1.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.3 | no trial data cached |
Trial evidence (ClinicalTrials.gov)
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 interaction | 220 | 12.2 10.7–13.8ROR 13.3 · χ² 2,262 / p <1e-300 | 12.1 EB05 10.8 · IC025 +3.3 3/3 methods agree | Reporting / coding artifact | serious PRR 9.6 · 92% clinician | no trial data cached |
| Somnolence (drowsiness) | 115 | 5.0 4.2–6.0ROR 5.2 · χ² 370 / p 1e-82 | 4.9 EB05 4.2 · IC025 +2.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.8 | no trial data cached |
| Suicidal ideation (thoughts of suicide) | 100 | 9.6 7.9–11.6ROR 10.0 · χ² 763 / p 3e-168 | 9.4 EB05 7.9 · IC025 +2.9 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 7.3 | no trial data cached |
| Tremor (shaking) | 82 | 4.3 3.5–5.4ROR 4.4 · χ² 208 / p 2e-47 | 4.2 EB05 3.5 · IC025 +1.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.1 | no trial data cached |
| Serotonin syndrome | 81 | 37.3 30.1–46.3ROR 38.6 · χ² 2,817 / p <1e-300 | 36.9 EB05 30.6 · IC025 +4.6 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 26.9 · 91% clinician | no trial data cached |
| Suicide attempt | 80 | 11.6 9.3–14.4ROR 11.9 · χ² 763 / p 3e-168 | 11.4 EB05 9.4 · IC025 +3.1 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 8.5 | no trial data cached |
| Toxicity to various agents | 71 | 3.7 3.0–4.7ROR 3.8 · χ² 139 / p 2e-32 | 3.6 EB05 3.0 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 2.6 · 91% clinician | no trial data cached |
| Completed suicide (death by suicide) | 69 | 7.2 5.7–9.1ROR 7.4 · χ² 364 / p 2e-81 | 6.9 EB05 5.6 · IC025 +2.4 3/3 methods agree | Outcome field, not a reaction | serious PRR 5.3 · 92% clinician | no trial data cached |
| Overdose | 59 | 2.4 1.9–3.1ROR 2.4 · χ² 47 / p 4e-12 | 2.4 EB05 1.9 · IC025 +0.8 | Reporting / coding artifact | serious PRR 2.1 · 90% clinician | no trial data cached |
| Hyperhidrosis (excessive sweating) | 57 | 3.9 3.0–5.0ROR 4.0 · χ² 120 / p 4e-28 | 3.8 EB05 3.0 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 4.2 | no trial data cached |
| Blood creatine phosphokinase increased | 55 | 16.5 12.7–21.5ROR 16.9 · χ² 787 / p 2e-173 | 16.4 EB05 13.0 · IC025 +3.4 3/3 methods agree | Lab value / disease marker | serious PRR 13.3 | no trial data cached |
| Agitation | 52 | 6.2 4.7–8.1ROR 6.3 · χ² 222 / p 1e-50 | 5.9 EB05 4.7 · IC025 +2.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.4 · ♀ 37% (drug 57%) | no trial data cached |
| Intentional overdose | 48 | 6.6 5.0–8.8ROR 6.7 · χ² 224 / p 7e-51 | 6.3 EB05 4.9 · IC025 +2.2 3/3 methods agree | Reporting / coding artifact | serious PRR 4.9 | no trial data cached |
| Alanine aminotransferase increased | 46 | 6.6 4.9–8.8ROR 6.7 · χ² 212 / p 2e-48 | 6.2 EB05 4.8 · IC025 +2.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.2 · 94% clinician | no trial data cached |
| Electrocardiogram qt prolonged | 42 | 10.3 7.6–13.8ROR 10.4 · χ² 342 / p 1e-76 | 9.8 EB05 7.4 · IC025 +2.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.7 · 90% clinician | no trial data cached |
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.
- Neuroleptic malignant syndrome — n=33, PRR 24.4
- Drug toxicity — n=30, PRR 19.1
- Sopor — n=20, PRR 13.2
- Altered state of consciousness — n=25, PRR 10.2
✓ A hand-written Bradford Hill causality assessment exists for this drug: Fluvoxamine ↔ 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 Fluvoxamine?
In FDA FAERS, the most frequently co-reported reaction terms for Fluvoxamine are somnolence, suicidal ideation, tremor, serotonin syndrome, suicide attempt, toxicity to various agents. 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 Fluvoxamine have an FDA boxed warning?
Yes. The current FDA label carries a 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.
Do FAERS signals prove that Fluvoxamine 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 0a6836ab-bd0e-410b-82af-07720e386532, effective 20251104; matched on
openfda.generic_name.exact:"FLUVOXAMINE MALEATE") - 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, 142 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
Page generated 2026-10-08. 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.