ZIPRASIDONE HYDROCHLORIDE

N/A

Manufactured by ROERIG

35,561 FDA adverse event reports analyzed

Last updated: 2026-04-14

About ZIPRASIDONE HYDROCHLORIDE

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

Top Adverse Reactions

DRUG INEFFECTIVE1,339 reports
WEIGHT INCREASED1,135 reports
DIABETES MELLITUS1,040 reports
TYPE 2 DIABETES MELLITUS833 reports
ANXIETY784 reports
INSOMNIA734 reports
DEPRESSION711 reports
DYSKINESIA685 reports
DYSTONIA680 reports
SOMNOLENCE672 reports
SUICIDE ATTEMPT666 reports
NAUSEA649 reports
TARDIVE DYSKINESIA637 reports
TREMOR636 reports
FATIGUE629 reports
SEDATION606 reports
FEELING ABNORMAL579 reports
DIZZINESS556 reports
HEADACHE536 reports
OBESITY493 reports
BLOOD GLUCOSE INCREASED492 reports
SUICIDAL IDEATION491 reports
CONDITION AGGRAVATED470 reports
DYSPNOEA455 reports
SEXUAL DYSFUNCTION422 reports
VOMITING407 reports
BLOOD CHOLESTEROL INCREASED403 reports
HYPERTENSION397 reports
WEIGHT DECREASED392 reports
MALAISE388 reports
PAIN388 reports
AGITATION376 reports
AKATHISIA371 reports
OFF LABEL USE368 reports
BLOOD PROLACTIN ABNORMAL367 reports
METABOLIC DISORDER354 reports
DIARRHOEA333 reports
ANOSOGNOSIA322 reports
DRUG HYPERSENSITIVITY322 reports
RASH315 reports
PERSONALITY CHANGE313 reports
DISTURBANCE IN SOCIAL BEHAVIOUR312 reports
HALLUCINATION309 reports
PANCREATITIS308 reports
FALL301 reports
PSYCHOTIC DISORDER294 reports
SCHIZOPHRENIA291 reports
ASTHENIA281 reports
EXTRAPYRAMIDAL DISORDER281 reports
CONVULSION268 reports
AGGRESSION264 reports
BLOOD TRIGLYCERIDES INCREASED264 reports
LOSS OF CONSCIOUSNESS264 reports
CONFUSIONAL STATE261 reports
MANIA258 reports
DRUG INTERACTION257 reports
CHEST PAIN254 reports
HYPERGLYCAEMIA254 reports
VISION BLURRED254 reports
NEUROLEPTIC MALIGNANT SYNDROME249 reports
OVERDOSE239 reports
GAIT DISTURBANCE221 reports
DYSPHAGIA220 reports
MENTAL DISORDER220 reports
BIPOLAR DISORDER216 reports
MUSCLE SPASMS214 reports
ADVERSE DRUG REACTION213 reports
PARANOIA212 reports
DIABETES MELLITUS INADEQUATE CONTROL211 reports
ABNORMAL BEHAVIOUR210 reports
HYPERLIPIDAEMIA210 reports
IRRITABILITY209 reports
HYPERHIDROSIS208 reports
MEMORY IMPAIRMENT201 reports
PAIN IN EXTREMITY201 reports
CONSTIPATION199 reports
HYPOAESTHESIA199 reports
RESTLESSNESS196 reports
BACK PAIN195 reports
ELECTROCARDIOGRAM QT PROLONGED195 reports
DEATH194 reports
HALLUCINATION, AUDITORY194 reports
INCREASED APPETITE192 reports
DIABETIC KETOACIDOSIS180 reports
ARTHRALGIA179 reports
MUSCULOSKELETAL STIFFNESS178 reports
PRURITUS173 reports
ABDOMINAL PAIN172 reports
PYREXIA169 reports
PARAESTHESIA168 reports
OBSESSIVE COMPULSIVE DISORDER167 reports
HYPERSENSITIVITY164 reports
PALPITATIONS164 reports
DIABETIC NEUROPATHY162 reports
PRODUCT USE IN UNAPPROVED INDICATION161 reports
THINKING ABNORMAL159 reports
TOXICITY TO VARIOUS AGENTS158 reports
ABDOMINAL PAIN UPPER157 reports
NEUROPATHY PERIPHERAL156 reports
WITHDRAWAL SYNDROME155 reports

Report Outcomes

Out of 15,314 classified reports for ZIPRASIDONE HYDROCHLORIDE:

Serious 67.2%Non-Serious 32.8%

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

Female8,620 (62.5%)
Male4,991 (36.2%)
Unknown170 (1.2%)

Reports by Age

Age 23270 reports
Age 32229 reports
Age 45214 reports
Age 40192 reports
Age 42182 reports
Age 44176 reports
Age 35173 reports
Age 48170 reports
Age 38168 reports
Age 50162 reports
Age 49159 reports
Age 46157 reports
Age 55157 reports
Age 43156 reports
Age 52153 reports
Age 25150 reports
Age 30150 reports
Age 47149 reports
Age 39143 reports
Age 54137 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 HYDROCHLORIDE?

This profile reflects 35,561 FDA FAERS reports that mention ZIPRASIDONE HYDROCHLORIDE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for ZIPRASIDONE HYDROCHLORIDE?

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

Who manufactures ZIPRASIDONE HYDROCHLORIDE?

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