ZIPRASIDONE MESYLATE

N/A

Manufactured by ROERIG

30,183 FDA adverse event reports analyzed

Last updated: 2026-04-14

About ZIPRASIDONE MESYLATE

ZIPRASIDONE MESYLATE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by ROERIG. The most commonly reported adverse reactions for ZIPRASIDONE MESYLATE include WEIGHT INCREASED, DIABETES MELLITUS, DRUG INEFFECTIVE, 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 MESYLATE.

Top Adverse Reactions

WEIGHT INCREASED961 reports
DIABETES MELLITUS960 reports
DRUG INEFFECTIVE952 reports
TYPE 2 DIABETES MELLITUS827 reports
ANXIETY732 reports
INSOMNIA683 reports
DEPRESSION654 reports
SOMNOLENCE641 reports
TARDIVE DYSKINESIA627 reports
TREMOR606 reports
NAUSEA604 reports
FATIGUE596 reports
FEELING ABNORMAL559 reports
DIZZINESS516 reports
HEADACHE497 reports
DYSPNOEA426 reports
SUICIDAL IDEATION426 reports
OBESITY409 reports
DYSKINESIA404 reports
BLOOD CHOLESTEROL INCREASED397 reports
DYSTONIA396 reports
VOMITING389 reports
WEIGHT DECREASED381 reports
MALAISE376 reports
SUICIDE ATTEMPT360 reports
PAIN359 reports
AGITATION353 reports
HYPERTENSION351 reports
OFF LABEL USE323 reports
DIARRHOEA314 reports
SEDATION309 reports
DRUG HYPERSENSITIVITY308 reports
PANCREATITIS301 reports
RASH297 reports
HALLUCINATION280 reports
FALL277 reports
PSYCHOTIC DISORDER277 reports
CONDITION AGGRAVATED270 reports
BLOOD GLUCOSE INCREASED268 reports
ASTHENIA265 reports
CONVULSION264 reports
BLOOD TRIGLYCERIDES INCREASED260 reports
LOSS OF CONSCIOUSNESS255 reports
EXTRAPYRAMIDAL DISORDER254 reports
CHEST PAIN251 reports
HYPERGLYCAEMIA251 reports
VISION BLURRED250 reports
CONFUSIONAL STATE248 reports
MANIA247 reports
AGGRESSION242 reports
AKATHISIA231 reports
DRUG INTERACTION230 reports
NEUROLEPTIC MALIGNANT SYNDROME225 reports
OVERDOSE212 reports
DYSPHAGIA211 reports
BIPOLAR DISORDER210 reports
DIABETES MELLITUS INADEQUATE CONTROL209 reports
GAIT DISTURBANCE208 reports
HYPERLIPIDAEMIA208 reports
MUSCLE SPASMS204 reports
MENTAL DISORDER199 reports
ABNORMAL BEHAVIOUR197 reports
PARANOIA193 reports
HYPERHIDROSIS192 reports
HYPOAESTHESIA189 reports
RESTLESSNESS189 reports
PAIN IN EXTREMITY188 reports
SCHIZOPHRENIA184 reports
MEMORY IMPAIRMENT183 reports
IRRITABILITY182 reports
CONSTIPATION179 reports
HALLUCINATION, AUDITORY179 reports
BACK PAIN176 reports
DIABETIC KETOACIDOSIS176 reports
DEATH175 reports
ELECTROCARDIOGRAM QT PROLONGED173 reports
ARTHRALGIA170 reports
MUSCULOSKELETAL STIFFNESS168 reports
PARAESTHESIA163 reports
PRURITUS163 reports
DIABETIC NEUROPATHY162 reports
ABDOMINAL PAIN158 reports
HYPERSENSITIVITY158 reports
PYREXIA158 reports
PALPITATIONS156 reports
NEUROPATHY PERIPHERAL155 reports
NERVOUSNESS153 reports
ABDOMINAL PAIN UPPER151 reports
ANGER146 reports
SYNCOPE146 reports
ADVERSE DRUG REACTION145 reports
GYNAECOMASTIA145 reports
PANIC ATTACK145 reports
DRUG WITHDRAWAL SYNDROME144 reports
THINKING ABNORMAL144 reports
AMNESIA143 reports
WITHDRAWAL SYNDROME141 reports
DECREASED APPETITE139 reports
DISTURBANCE IN ATTENTION138 reports
HEART RATE INCREASED137 reports

Report Outcomes

Out of 14,125 classified reports for ZIPRASIDONE MESYLATE:

Serious 65.8%Non-Serious 34.2%

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

Female7,928 (62.6%)
Male4,562 (36.0%)
Unknown170 (1.3%)

Reports by Age

Age 45207 reports
Age 42174 reports
Age 32166 reports
Age 40165 reports
Age 44164 reports
Age 35161 reports
Age 48160 reports
Age 38158 reports
Age 50158 reports
Age 49152 reports
Age 46149 reports
Age 52147 reports
Age 55145 reports
Age 43143 reports
Age 30140 reports
Age 47138 reports
Age 39133 reports
Age 53129 reports
Age 54128 reports
Age 23123 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 MESYLATE?

This profile reflects 30,183 FDA FAERS reports that mention ZIPRASIDONE MESYLATE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for ZIPRASIDONE MESYLATE?

Frequently reported terms in FAERS include WEIGHT INCREASED, DIABETES MELLITUS, DRUG INEFFECTIVE, 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 MESYLATE?

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