ZIPRASIDONE

N/A

Manufactured by ROERIG

36,171 FDA adverse event reports analyzed

Last updated: 2026-04-14

About ZIPRASIDONE

ZIPRASIDONE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by ROERIG. The most commonly reported adverse reactions for ZIPRASIDONE include DRUG INEFFECTIVE, WEIGHT INCREASED, DIABETES MELLITUS, ANXIETY, TYPE 2 DIABETES MELLITUS. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for ZIPRASIDONE.

Top Adverse Reactions

DRUG INEFFECTIVE1,349 reports
WEIGHT INCREASED1,176 reports
DIABETES MELLITUS1,004 reports
ANXIETY875 reports
TYPE 2 DIABETES MELLITUS859 reports
INSOMNIA801 reports
DEPRESSION782 reports
SOMNOLENCE744 reports
FATIGUE719 reports
TARDIVE DYSKINESIA700 reports
TREMOR686 reports
NAUSEA674 reports
DIZZINESS587 reports
FEELING ABNORMAL587 reports
SUICIDAL IDEATION567 reports
HEADACHE555 reports
OBESITY510 reports
DYSKINESIA484 reports
DYSPNOEA483 reports
OFF LABEL USE482 reports
SUICIDE ATTEMPT480 reports
DYSTONIA445 reports
VOMITING442 reports
HYPERTENSION425 reports
MALAISE424 reports
AGITATION423 reports
PAIN417 reports
WEIGHT DECREASED412 reports
BLOOD CHOLESTEROL INCREASED409 reports
DRUG INTERACTION395 reports
COMPLETED SUICIDE388 reports
SEDATION383 reports
NEUROLEPTIC MALIGNANT SYNDROME371 reports
PSYCHOTIC DISORDER368 reports
DIARRHOEA366 reports
CONDITION AGGRAVATED361 reports
AKATHISIA357 reports
FALL356 reports
EXTRAPYRAMIDAL DISORDER347 reports
AGGRESSION343 reports
RASH340 reports
HALLUCINATION327 reports
DRUG HYPERSENSITIVITY320 reports
ASTHENIA316 reports
CONFUSIONAL STATE312 reports
OVERDOSE312 reports
PANCREATITIS310 reports
TOXICITY TO VARIOUS AGENTS293 reports
BLOOD GLUCOSE INCREASED290 reports
VISION BLURRED288 reports
BLOOD TRIGLYCERIDES INCREASED278 reports
MANIA275 reports
CHEST PAIN273 reports
LOSS OF CONSCIOUSNESS272 reports
CONVULSION268 reports
HYPERGLYCAEMIA265 reports
IRRITABILITY262 reports
ELECTROCARDIOGRAM QT PROLONGED257 reports
DEATH247 reports
HALLUCINATION, AUDITORY243 reports
HYPERHIDROSIS240 reports
GAIT DISTURBANCE239 reports
PARANOIA237 reports
ABNORMAL BEHAVIOUR234 reports
DYSPHAGIA234 reports
MUSCLE SPASMS231 reports
MENTAL DISORDER230 reports
CONSTIPATION227 reports
RESTLESSNESS224 reports
SCHIZOPHRENIA223 reports
BIPOLAR DISORDER222 reports
DIABETES MELLITUS INADEQUATE CONTROL214 reports
HYPERLIPIDAEMIA214 reports
PAIN IN EXTREMITY209 reports
MEMORY IMPAIRMENT207 reports
HYPOAESTHESIA202 reports
PRODUCT USE IN UNAPPROVED INDICATION202 reports
BACK PAIN200 reports
ARTHRALGIA194 reports
PYREXIA190 reports
DIABETIC KETOACIDOSIS188 reports
HYPOTENSION187 reports
MUSCULOSKELETAL STIFFNESS187 reports
SPEECH DISORDER184 reports
ABDOMINAL PAIN181 reports
DECREASED APPETITE180 reports
PRURITUS180 reports
NERVOUSNESS175 reports
PNEUMONIA175 reports
PARAESTHESIA174 reports
PALPITATIONS173 reports
TACHYCARDIA173 reports
GYNAECOMASTIA172 reports
HYPERSENSITIVITY172 reports
ABDOMINAL PAIN UPPER171 reports
INCREASED APPETITE170 reports
SYNCOPE170 reports
RENAL FAILURE169 reports
DISTURBANCE IN ATTENTION167 reports
ACUTE KIDNEY INJURY166 reports

Report Outcomes

Out of 17,326 classified reports for ZIPRASIDONE:

Serious 68.9%Non-Serious 31.1%

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

Female9,454 (61.1%)
Male5,832 (37.7%)
Unknown197 (1.3%)

Reports by Age

Age 45249 reports
Age 40236 reports
Age 35223 reports
Age 32219 reports
Age 42219 reports
Age 48218 reports
Age 44215 reports
Age 30208 reports
Age 55203 reports
Age 49200 reports
Age 38198 reports
Age 46190 reports
Age 50185 reports
Age 52184 reports
Age 47176 reports
Age 43175 reports
Age 39174 reports
Age 54172 reports
Age 23168 reports
Age 51167 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 ZIPRASIDONE?

This profile reflects 36,171 FDA FAERS reports that mention ZIPRASIDONE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for ZIPRASIDONE?

Frequently reported terms in FAERS include DRUG INEFFECTIVE, WEIGHT INCREASED, DIABETES MELLITUS, ANXIETY, TYPE 2 DIABETES MELLITUS, INSOMNIA. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures ZIPRASIDONE?

Labeling and FAERS entries often list ROERIG in connection with ZIPRASIDONE. 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.