Amisulpride side effects: what 5,989 FDA adverse event reports show

Amisulpride · Barhemsys · 360 reaction terms · 21,633 drug–reaction co-reports · data 2026-09-14

Drug class

Dopamine-2 Receptor Antagonist

FDA label (Established Pharmacologic Class)

Brand names

Barhemsys

openFDA label

Who reports

5,989 reports · 98% serious · 762 with death outcome · 41% female

openFDA FAERS counts, all years, deduplication not applied

Used for

BARHEMSYS ® is indicated in adults for: prevention of postoperative nausea and vomiting (PONV), either alone or in combination with an antiemetic of a different class. treatment of PONV in patients who have received antiemetic prophylaxis with an agent of a different class or have not received prophylaxis.

FDA label, Indications and Usage

What it is

The active ingredient of BARHEMSYS is amisulpride, a dopamine-2 (D 2 ) receptor antagonist.

FDA label, Description section

Boxed warning

None in the current label

How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation. Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)? That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.

Causality screen of the 40 strongest signals

Labeled adverse reaction 3Labeled (related wording) 1Reporting / coding artifact 2Lab value / disease marker 5Not in label — unassessed 29

What the badges mean

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.
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. 320 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Schizophrenia	339	100.4 90.4–111.5ROR 106.4 · χ² 32,338 / p <1e-300	97.1 EB05 88.7 · IC025 +6.2 3/3 methods agree	Not in label — unassessed	serious PRR 59.1	no trial data cached
Akathisia (inner restlessness)	306	80.3 71.9–89.7ROR 84.6 · χ² 23,354 / p <1e-300	78.1 EB05 71.0 · IC025 +5.9 3/3 methods agree	Not in label — unassessed	serious PRR 65.1	no trial data cached
Neuroleptic malignant syndrome	225	67.5 59.3–76.8ROR 70.1 · χ² 14,405 / p <1e-300	65.9 EB05 59.0 · IC025 +5.6 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 39.1	no trial data cached
Myocarditis	208	65.5 57.2–75.0ROR 67.8 · χ² 12,910 / p <1e-300	63.9 EB05 57.0 · IC025 +5.6 3/3 methods agree	Not in label — unassessed	serious PRR 37.8	no trial data cached
Euphoric mood	186	64.4 55.8–74.2ROR 66.4 · χ² 11,332 / p <1e-300	62.8 EB05 55.6 · IC025 +5.5 3/3 methods agree	Not in label — unassessed	serious n=186 · ♀ 10% (drug 41%)	no trial data cached
Neutrophil count increased	162	56.1 48.1–65.3ROR 57.6 · χ² 8,570 / p <1e-300	54.8 EB05 48.1 · IC025 +5.3 3/3 methods agree	Lab value / disease marker	serious PRR 35.2 · ♀ 21% (drug 41%) · 91% clinician	no trial data cached
Salivary hypersecretion	149	53.0 45.2–62.2ROR 54.3 · χ² 7,439 / p <1e-300	51.9 EB05 45.3 · IC025 +5.2 3/3 methods agree	Not in label — unassessed	serious PRR 39.7	no trial data cached
Extrapyramidal disorder	299	42.2 37.8–47.2ROR 44.4 · χ² 11,864 / p <1e-300	41.6 EB05 37.8 · IC025 +5.1 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 26.8 · 94% clinician	no trial data cached
Hallucination, auditory	182	40.5 35.1–46.8ROR 41.7 · χ² 6,895 / p <1e-300	39.9 EB05 35.3 · IC025 +4.9 3/3 methods agree	Not in label — unassessed	serious PRR 27.0	no trial data cached
Delusion	162	37.0 31.8–43.1ROR 38.0 · χ² 5,583 / p <1e-300	36.5 EB05 32.0 · IC025 +4.8 3/3 methods agree	Not in label — unassessed	serious PRR 25.9	no trial data cached
Increased appetite	178	33.5 28.9–38.7ROR 34.5 · χ² 5,525 / p <1e-300	33.0 EB05 29.2 · IC025 +4.7 3/3 methods agree	Not in label — unassessed	serious PRR 50.3 · ♀ 5% (drug 41%)	no trial data cached
Parkinsonism	91	33.0 26.9–40.5ROR 33.5 · χ² 2,764 / p <1e-300	32.5 EB05 27.2 · IC025 +4.5 3/3 methods agree	Not in label — unassessed	serious PRR 22.0	no trial data cached
Leukaemia	87	32.6 26.4–40.2ROR 33.1 · χ² 2,609 / p <1e-300	32.1 EB05 26.8 · IC025 +4.4 3/3 methods agree	Not in label — unassessed	serious PRR 19.1 · ♀ 0% (drug 41%)	no trial data cached
Psychotic disorder	233	27.8 24.5–31.6ROR 28.9 · χ² 5,961 / p <1e-300	27.6 EB05 24.7 · IC025 +4.5 3/3 methods agree	Not in label — unassessed	serious PRR 17.5	no trial data cached
Electrocardiogram qt prolonged	276	27.1 24.1–30.4ROR 28.3 · χ² 6,856 / p <1e-300	26.8 EB05 24.3 · IC025 +4.5 3/3 methods agree	Labeled (related wording) related wording	serious PRR 16.0 · 94% clinician	no trial data cached
Obesity	119	26.3 22.0–31.4ROR 26.8 · χ² 2,852 / p <1e-300	26.0 EB05 22.3 · IC025 +4.3 3/3 methods agree	Not in label — unassessed	serious PRR 17.8 · ♀ 9% (drug 41%)	no trial data cached
Mental impairment	177	25.7 22.2–29.7ROR 26.5 · χ² 4,154 / p <1e-300	25.5 EB05 22.5 · IC025 +4.3 3/3 methods agree	Not in label — unassessed	serious PRR 18.9 · 94% clinician	no trial data cached
Sedation	174	23.5 20.3–27.2ROR 24.2 · χ² 3,709 / p <1e-300	23.3 EB05 20.5 · IC025 +4.2 3/3 methods agree	Not in label — unassessed	serious PRR 18.1	no trial data cached
White blood cell count increased	245	22.4 19.8–25.3ROR 23.3 · χ² 4,968 / p <1e-300	22.2 EB05 20.0 · IC025 +4.2 3/3 methods agree	Lab value / disease marker	serious PRR 15.6 · ♀ 20% (drug 41%)	no trial data cached
Leukopenia (low white blood cells)	315	22.2 20.0–24.8ROR 23.4 · χ² 6,343 / p <1e-300	22.1 EB05 20.1 · IC025 +4.2 3/3 methods agree	Not in label — unassessed	serious PRR 13.4 · 91% clinician	no trial data cached
Respiratory depression	74	21.3 16.9–26.7ROR 21.5 · χ² 1,400 / p <1e-300	21.0 EB05 17.3 · IC025 +3.8 3/3 methods agree	Not in label — unassessed	serious PRR 12.8	no trial data cached
Sopor	75	19.7 15.8–24.7ROR 20.0 · χ² 1,310 / p 4e-287	19.6 EB05 16.1 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	serious PRR 11.5 · ♀ 76% (drug 41%) · 95% clinician	no trial data cached
Prescribed overdose	108	19.6 16.3–23.7ROR 20.0 · χ² 1,883 / p <1e-300	19.5 EB05 16.6 · IC025 +3.9 3/3 methods agree	Not in label — unassessed	serious PRR 19.6 · ♀ 13% (drug 41%)	no trial data cached
Dystonia	108	19.5 16.2–23.6ROR 19.9 · χ² 1,871 / p <1e-300	19.4 EB05 16.5 · IC025 +3.8 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 12.4 · 93% clinician	no trial data cached
Drug level increased	82	17.4 14.0–21.6ROR 17.6 · χ² 1,247 / p 2e-273	17.3 EB05 14.3 · IC025 +3.6 3/3 methods agree	Reporting / coding artifact	serious PRR 11.3 · 95% clinician	no trial data cached
Muscle rigidity	59	17.4 13.5–22.4ROR 17.5 · χ² 890 / p 9e-196	17.2 EB05 13.8 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious PRR 11.2	no trial data cached
Sinus tachycardia	69	17.1 13.5–21.7ROR 17.3 · χ² 1,027 / p 1e-225	17.0 EB05 13.8 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious PRR 9.9	no trial data cached
Cardiomyopathy	72	17.1 13.6–21.5ROR 17.3 · χ² 1,072 / p 2e-235	17.0 EB05 13.9 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious PRR 10.1	no trial data cached
Suicide attempt	281	16.3 14.5–18.2ROR 17.0 · χ² 4,003 / p <1e-300	16.2 EB05 14.6 · IC025 +3.8 3/3 methods agree	Not in label — unassessed	serious PRR 9.5 · ♀ 20% (drug 41%) · 92% clinician	no trial data cached
Paranoia	80	16.2 13.1–20.2ROR 16.4 · χ² 1,125 / p 7e-247	16.1 EB05 13.3 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious PRR 11.9	no trial data cached
Intentional self-injury	93	16.2 13.2–19.8ROR 16.4 · χ² 1,307 / p 2e-286	16.1 EB05 13.5 · IC025 +3.6 3/3 methods agree	Reporting / coding artifact	serious PRR 9.6	no trial data cached
Hallucination, visual	95	15.9 13.0–19.4ROR 16.2 · χ² 1,309 / p 7e-287	15.8 EB05 13.3 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious PRR 10.6	no trial data cached
Blood creatine phosphokinase increased	129	15.5 13.1–18.4ROR 15.8 · χ² 1,731 / p <1e-300	15.4 EB05 13.3 · IC025 +3.6 3/3 methods agree	Lab value / disease marker	serious PRR 10.0 · ♀ 19% (drug 41%) · 91% clinician	no trial data cached
Hepatic cytolysis	52	15.0 11.4–19.6ROR 15.1 · χ² 661 / p 5e-146	14.7 EB05 11.6 · IC025 +3.3 3/3 methods agree	Not in label — unassessed	serious PRR 8.8 · ♀ 17% (drug 41%)	no trial data cached
Neutrophil count decreased	172	14.9 12.9–17.3ROR 15.3 · χ² 2,215 / p <1e-300	14.8 EB05 13.0 · IC025 +3.6 3/3 methods agree	Lab value / disease marker	serious PRR 10.1 · 91% clinician	no trial data cached
Leukocytosis	76	14.8 11.8–18.5ROR 15.0 · χ² 959 / p 8e-211	14.6 EB05 12.0 · IC025 +3.4 3/3 methods agree	Not in label — unassessed	serious PRR 8.7 · ♀ 19% (drug 41%)	no trial data cached
Inappropriate antidiuretic hormone secretion	40	13.8 10.1–18.8ROR 13.9 · χ² 461 / p 2e-102	13.5 EB05 10.2 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious PRR 8.2 · ♀ 83% (drug 41%) · 97% clinician	no trial data cached
Aspiration	42	13.6 10.1–18.4ROR 13.7 · χ² 477 / p 5e-106	13.3 EB05 10.1 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious PRR 8.2	no trial data cached
Thinking abnormal	68	12.8 10.1–16.2ROR 12.9 · χ² 723 / p 2e-159	12.5 EB05 10.2 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious PRR 11.7	no trial data cached
Platelet count increased	46	12.4 9.3–16.5ROR 12.5 · χ² 468 / p 5e-104	12.0 EB05 9.2 · IC025 +3.0 3/3 methods agree	Lab value / disease marker	serious PRR 9.5	no trial data cached

Trial evidence (ClinicalTrials.gov)

Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).

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)	863	2.3 2.2–2.4ROR 2.5 · χ² 672 / p 2e-148	2.3 EB05 2.2 · IC025 +1.1 3/3 methods agree	Reporting / coding artifact	serious PRR 3.8 · 91% clinician	no trial data cached
Drug interaction	464	10.3 9.4–11.2ROR 11.0 · χ² 3,889 / p <1e-300	10.2 EB05 9.4 · IC025 +3.2 3/3 methods agree	Reporting / coding artifact	serious PRR 6.7	no trial data cached
Weight increased (weight gain)	443	7.0 6.4–7.6ROR 7.5 · χ² 2,281 / p <1e-300	6.9 EB05 6.4 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	serious PRR 7.5	no trial data cached
Toxicity to various agents	400	8.4 7.6–9.2ROR 8.9 · χ² 2,600 / p <1e-300	8.3 EB05 7.6 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious PRR 5.0	no trial data cached
Neutropenia (low neutrophils (infection-fighting cells))	394	10.2 9.3–11.2ROR 10.9 · χ² 3,275 / p <1e-300	10.1 EB05 9.3 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious PRR 6.2	no trial data cached
Schizophrenia	339	100.4 90.4–111.5ROR 106.4 · χ² 32,338 / p <1e-300	97.1 EB05 88.7 · IC025 +6.2 3/3 methods agree	Not in label — unassessed	serious PRR 59.1	no trial data cached
Leukopenia (low white blood cells)	315	22.2 20.0–24.8ROR 23.4 · χ² 6,343 / p <1e-300	22.1 EB05 20.1 · IC025 +4.2 3/3 methods agree	Not in label — unassessed	serious PRR 13.4 · 91% clinician	no trial data cached
Akathisia (inner restlessness)	306	80.3 71.9–89.7ROR 84.6 · χ² 23,354 / p <1e-300	78.1 EB05 71.0 · IC025 +5.9 3/3 methods agree	Not in label — unassessed	serious PRR 65.1	no trial data cached
Extrapyramidal disorder	299	42.2 37.8–47.2ROR 44.4 · χ² 11,864 / p <1e-300	41.6 EB05 37.8 · IC025 +5.1 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 26.8 · 94% clinician	no trial data cached
Suicide attempt	281	16.3 14.5–18.2ROR 17.0 · χ² 4,003 / p <1e-300	16.2 EB05 14.6 · IC025 +3.8 3/3 methods agree	Not in label — unassessed	serious PRR 9.5 · ♀ 20% (drug 41%) · 92% clinician	no trial data cached
Electrocardiogram qt prolonged	276	27.1 24.1–30.4ROR 28.3 · χ² 6,856 / p <1e-300	26.8 EB05 24.3 · IC025 +4.5 3/3 methods agree	Labeled (related wording) related wording	serious PRR 16.0 · 94% clinician	no trial data cached
Somnolence (drowsiness)	275	4.8 4.3–5.4ROR 5.0 · χ² 829 / p 1e-182	4.8 EB05 4.3 · IC025 +2.1 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 4.7	no trial data cached
Drug abuse	260	10.9 9.7–12.3ROR 11.4 · χ² 2,333 / p <1e-300	10.8 EB05 9.8 · IC025 +3.2 3/3 methods agree	Reporting / coding artifact	serious PRR 6.5	no trial data cached
Confusional state (confusion)	245	5.3 4.7–6.0ROR 5.5 · χ² 857 / p 1e-188	5.2 EB05 4.7 · IC025 +2.2 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 4.0	no trial data cached
White blood cell count increased	245	22.4 19.8–25.3ROR 23.3 · χ² 4,968 / p <1e-300	22.2 EB05 20.0 · IC025 +4.2 3/3 methods agree	Lab value / disease marker	serious PRR 15.6 · ♀ 20% (drug 41%)	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.

Schizophrenia — n=339, PRR 100.4
Akathisia — n=306, PRR 80.3
Myocarditis — n=208, PRR 65.5
Euphoric mood — n=186, PRR 64.4
Salivary hypersecretion — n=149, PRR 53.0
Hallucination, auditory — n=182, PRR 40.5
Delusion — n=162, PRR 37.0
Increased appetite — n=178, PRR 33.5
Parkinsonism — n=91, PRR 33.0
Leukaemia — n=87, PRR 32.6

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 Amisulpride?

In FDA FAERS, the most frequently co-reported reaction terms for Amisulpride are weight increased, toxicity to various agents, neutropenia, schizophrenia, leukopenia, akathisia. 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 Amisulpride have an FDA boxed warning?

No. The FDA label retrieved for Amisulpride has no boxed warning; see the label's Warnings and Precautions for the recognised risks.

Do FAERS signals prove that Amisulpride 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 ab23bc6e-b6a8-165f-e053-2a95a90ab144, effective 20260617; matched on openfda.generic_name.exact:"AMISULPRIDE")
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, field patient.drug.openfda.generic_name.exact, 360 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.