AMISULPRIDE

N/A

Manufactured by Acacia Pharma Ltd

16,736 FDA adverse event reports analyzed

Last updated: 2026-04-15

About AMISULPRIDE

AMISULPRIDE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Acacia Pharma Ltd. The most commonly reported adverse reactions for AMISULPRIDE include DRUG INEFFECTIVE, DRUG INTERACTION, WEIGHT INCREASED, TOXICITY TO VARIOUS AGENTS, NEUTROPENIA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for AMISULPRIDE.

Top Adverse Reactions

DRUG INEFFECTIVE825 reports
DRUG INTERACTION442 reports
WEIGHT INCREASED426 reports
TOXICITY TO VARIOUS AGENTS382 reports
NEUTROPENIA379 reports
SCHIZOPHRENIA320 reports
LEUKOPENIA311 reports
OFF LABEL USE305 reports
AKATHISIA299 reports
EXTRAPYRAMIDAL DISORDER278 reports
SUICIDE ATTEMPT277 reports
ELECTROCARDIOGRAM QT PROLONGED262 reports
SOMNOLENCE260 reports
DRUG ABUSE249 reports
WHITE BLOOD CELL COUNT INCREASED238 reports
CONFUSIONAL STATE236 reports
WHITE BLOOD CELL COUNT DECREASED230 reports
MALAISE220 reports
OVERDOSE220 reports
PSYCHOTIC DISORDER220 reports
TACHYCARDIA217 reports
CONDITION AGGRAVATED213 reports
PRODUCT USE IN UNAPPROVED INDICATION211 reports
THERAPEUTIC PRODUCT EFFECT INCOMPLETE207 reports
NEUROLEPTIC MALIGNANT SYNDROME200 reports
MYOCARDITIS194 reports
FATIGUE192 reports
ANTIPSYCHOTIC DRUG LEVEL BELOW THERAPEUTIC188 reports
CONSTIPATION186 reports
EUPHORIC MOOD185 reports
HYPERTENSION182 reports
SUICIDAL IDEATION182 reports
HALLUCINATION, AUDITORY180 reports
OBSESSIVE COMPULSIVE DISORDER179 reports
INCREASED APPETITE176 reports
AGITATION172 reports
DISINHIBITION171 reports
SEDATION171 reports
FALL170 reports
VOMITING169 reports
AGGRESSION168 reports
DEATH166 reports
INSOMNIA164 reports
MENTAL IMPAIRMENT162 reports
TREATMENT NONCOMPLIANCE162 reports
NEUTROPHIL COUNT INCREASED161 reports
HYPOTENSION160 reports
DIZZINESS159 reports
HYPERPROLACTINAEMIA155 reports
LOSS OF CONSCIOUSNESS155 reports
NEUTROPHIL COUNT DECREASED155 reports
DELUSION150 reports
THERAPEUTIC PRODUCT EFFECT VARIABLE147 reports
TREMOR140 reports
ANXIETY139 reports
SALIVARY HYPERSECRETION139 reports
BLOOD CREATINE PHOSPHOKINASE INCREASED130 reports
ANTIPSYCHOTIC DRUG LEVEL INCREASED128 reports
PYREXIA126 reports
DYSPNOEA123 reports
OBESITY119 reports
NAUSEA116 reports
HAEMOGLOBIN DECREASED115 reports
DEPRESSION106 reports
PRESCRIBED OVERDOSE106 reports
DYSTONIA105 reports
HEADACHE102 reports
HALLUCINATION101 reports
BLOOD PROLACTIN INCREASED100 reports
PNEUMONIA99 reports
RHABDOMYOLYSIS99 reports
PLATELET COUNT DECREASED96 reports
INTENTIONAL OVERDOSE95 reports
CHEST PAIN94 reports
C REACTIVE PROTEIN INCREASED93 reports
DIARRHOEA93 reports
DYSLIPIDAEMIA92 reports
TYPE 2 DIABETES MELLITUS92 reports
HALLUCINATION, VISUAL91 reports
MENTAL DISORDER91 reports
WEIGHT DECREASED91 reports
INTENTIONAL SELF INJURY90 reports
IRRITABILITY88 reports
SEIZURE88 reports
DEPRESSED MOOD87 reports
ABDOMINAL PAIN86 reports
LEUKAEMIA86 reports
PARKINSONISM83 reports
HYPERHIDROSIS82 reports
DRUG LEVEL INCREASED81 reports
THROMBOCYTOPENIA79 reports
ASTHENIA78 reports
COMA78 reports
ABNORMAL BEHAVIOUR77 reports
LOWER RESPIRATORY TRACT INFECTION75 reports
SOPOR75 reports
HYPONATRAEMIA74 reports
PARANOIA74 reports
HOSPITALISATION73 reports
INTENTIONAL PRODUCT MISUSE73 reports

Report Outcomes

Out of 5,762 classified reports for AMISULPRIDE:

Serious 98.0%Non-Serious 2.0%

The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.

Demographics Breakdown

Reports by Sex

Male3,083 (58.6%)
Female2,167 (41.2%)
Unknown10 (0.2%)

Reports by Age

Age 30148 reports
Age 34133 reports
Age 45123 reports
Age 38121 reports
Age 36120 reports
Age 40119 reports
Age 51119 reports
Age 44109 reports
Age 52108 reports
Age 3997 reports
Age 4797 reports
Age 5395 reports
Age 3593 reports
Age 4991 reports
Age 2589 reports
Age 4289 reports
Age 4388 reports
Age 3185 reports
Age 2482 reports
Age 3282 reports

Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.

Frequently Asked Questions

How many FDA adverse event reports are associated with AMISULPRIDE?

This profile reflects 16,736 FDA FAERS reports that mention AMISULPRIDE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for AMISULPRIDE?

Frequently reported terms in FAERS include DRUG INEFFECTIVE, DRUG INTERACTION, WEIGHT INCREASED, TOXICITY TO VARIOUS AGENTS, NEUTROPENIA, SCHIZOPHRENIA. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures AMISULPRIDE?

Labeling and FAERS entries often list Acacia Pharma Ltd in connection with AMISULPRIDE. Always verify the specific product and NDC with your pharmacist.

Important Disclaimer: This content is generated by AI analysis of FDA adverse event reports and is provided for informational purposes only. It is not medical advice. Adverse event reports submitted to the FDA do not prove that a medication caused the reported side effect. Always consult your healthcare provider before starting, stopping, or changing any medication. If you experience a serious side effect, contact your doctor or call 911 immediately.