Amisulpride: adverse event reports filed with FDA

3,503

reports as suspect product

0% of all reports · about 156 a year

295

reports, 12 months to June 2026

346 in the 12 months before

98.4%

marked serious by the reporter

91.9% across the class

11.7%

record death among outcomes, as reported

411 reports · not verified by FDA

Reports by month, five years

Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

By year received

2026 covers reports received through June 2026 only.

Reactions recorded in the reports

share of Amisulpride reports recording the termmedian drug in dopamine-2 receptor antagonist

1. Drug ineffectivethe medicine did not work as expected20.3%711
2. Weight increasedweight gain10%350
3. Toxicity to various agentspoisoning or toxic effect of one or more substances9.6%335
4. Drug interactionan interaction between medicines8.9%311
5. Akathisiainner restlessness and an urge to move7.5%261
6. Suicide attempta suicide attempt7.1%250
7. Extrapyramidal disordermovement problems such as stiffness or tremor6.9%243
8. Schizophreniaschizophrenia6.7%234
9. Leukopenialow white blood cells6.5%227
10. Neutropenialow neutrophils, a type of white blood cell6.3%222
11. Electrocardiogram QT prolongeda QT prolongation on the ECG6.2%218
12. Therapeutic product effect incomplete6.1%214
13. Drug abusemisuse of a medicine6.1%212
14. Neuroleptic malignant syndromea rare severe reaction with fever and rigidity5.8%203
15. Off label useused for a purpose or in a way not on the label5.7%200
16. Euphoric mood5.2%181
17. Product use in unapproved indicationused for a purpose not on the label5.2%181
18. Antipsychotic drug level below therapeutic5.1%179
19. Increased appetite5%174
20. Somnolencedrowsiness4.9%173
21. Disinhibition4.9%172
22. Obsessive-compulsive disorder4.6%162
23. Overdosea dose above the recommended amount4.6%160
24. Hyperprolactinaemia4.3%150
25. Therapeutic product effect variable4.2%148
26. Hypertensionhigh blood pressure4%140
27. Suicidal ideationthoughts of suicide4%140
28. Condition aggravatedthe condition being treated got worse3.9%136
29. Confusional stateconfusion3.8%133
30. Psychotic disordera loss of contact with reality3.6%127

Top 30 of 880 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 6 drugs in the dopamine-2 receptor antagonist class; it describes the reports, not the patients. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Outcomes recorded

Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 40,014 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."

Patients and reporters

Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 1.1% of reports give the United States as the country of the event or reporter.

Reason for use recorded

The indication field is filled in by the reporter and is often blank; shares are of all 3,503 reports.

Drugs most often listed in the same reports

Other products listed in reports where Amisulpride is a suspect product, whatever their own role. Co-listing means the two were recorded together; it says nothing about either product's part in the event. Only the 2,500 most-reported names are counted here.

In context

Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Other drugs in the dopamine-2 receptor antagonist class

Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." A brand and its generic are separate rows because reporters name them separately.

Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A report counts here when it lists Amisulpride as a suspect or interacting product; reports listing it only as a concomitant medication (2,651) are excluded. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.