VALPROATE SODIUM

N/A

Manufactured by Fresenius Kabi USA, LLC

37,274 FDA adverse event reports analyzed

Last updated: 2026-04-14

About VALPROATE SODIUM

VALPROATE SODIUM is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Fresenius Kabi USA, LLC. The most commonly reported adverse reactions for VALPROATE SODIUM include DRUG INEFFECTIVE, DRUG INTERACTION, OFF LABEL USE, FOETAL EXPOSURE DURING PREGNANCY, SOMNOLENCE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for VALPROATE SODIUM.

Top Adverse Reactions

DRUG INEFFECTIVE1,404 reports
DRUG INTERACTION1,185 reports
OFF LABEL USE1,081 reports
FOETAL EXPOSURE DURING PREGNANCY1,043 reports
SOMNOLENCE951 reports
EPILEPSY815 reports
TOXICITY TO VARIOUS AGENTS757 reports
SEIZURE754 reports
PYREXIA740 reports
CONVULSION612 reports
VOMITING598 reports
NEUTROPENIA522 reports
DIARRHOEA520 reports
WEIGHT INCREASED504 reports
CONDITION AGGRAVATED499 reports
NAUSEA498 reports
FATIGUE489 reports
ANXIETY473 reports
OVERDOSE467 reports
CONFUSIONAL STATE454 reports
SUICIDE ATTEMPT452 reports
THROMBOCYTOPENIA446 reports
TREMOR438 reports
PLATELET COUNT DECREASED435 reports
MALAISE432 reports
FALL426 reports
PRODUCT USE IN UNAPPROVED INDICATION426 reports
AGGRESSION410 reports
PNEUMONIA394 reports
RASH391 reports
HYPOTENSION389 reports
DRUG ABUSE381 reports
DYSMORPHISM381 reports
DYSPNOEA368 reports
DIZZINESS366 reports
TACHYCARDIA364 reports
LOSS OF CONSCIOUSNESS363 reports
COMA362 reports
FOETAL ANTICONVULSANT SYNDROME362 reports
DISTURBANCE IN ATTENTION361 reports
HEADACHE358 reports
AGITATION354 reports
COGNITIVE DISORDER346 reports
LEUKOPENIA336 reports
GAIT DISTURBANCE333 reports
WHITE BLOOD CELL COUNT DECREASED327 reports
DEPRESSION322 reports
INSOMNIA319 reports
STATUS EPILEPTICUS316 reports
PSYCHOTIC DISORDER313 reports
HEPATIC FUNCTION ABNORMAL311 reports
INTENTIONAL OVERDOSE307 reports
ASTHENIA295 reports
CONSTIPATION290 reports
DEVELOPMENTAL DELAY286 reports
WEIGHT DECREASED279 reports
DECREASED APPETITE274 reports
HYPERAMMONAEMIA274 reports
MEMORY IMPAIRMENT272 reports
HYPERTENSION270 reports
HYPONATRAEMIA268 reports
DEPRESSED LEVEL OF CONSCIOUSNESS266 reports
SUICIDAL IDEATION261 reports
ABDOMINAL PAIN258 reports
SOPOR257 reports
AUTISM SPECTRUM DISORDER250 reports
BEHAVIOUR DISORDER250 reports
IRRITABILITY245 reports
MATERNAL EXPOSURE DURING PREGNANCY241 reports
LEARNING DISORDER240 reports
EXTRAPYRAMIDAL DISORDER239 reports
DEATH238 reports
ABNORMAL BEHAVIOUR234 reports
DRUG EXPOSURE DURING PREGNANCY231 reports
SEDATION225 reports
PAIN220 reports
NEUROLEPTIC MALIGNANT SYNDROME217 reports
SPEECH DISORDER216 reports
SPEECH DISORDER DEVELOPMENTAL213 reports
DISORIENTATION210 reports
WHITE BLOOD CELL COUNT INCREASED210 reports
THERAPEUTIC PRODUCT EFFECT INCOMPLETE209 reports
BLOOD CREATINE PHOSPHOKINASE INCREASED207 reports
PNEUMONIA ASPIRATION207 reports
ANAEMIA204 reports
GRANULOCYTOPENIA204 reports
DRUG INEFFECTIVE FOR UNAPPROVED INDICATION203 reports
MANIA203 reports
ALANINE AMINOTRANSFERASE INCREASED201 reports
MENTAL DISORDER201 reports
ALTERED STATE OF CONSCIOUSNESS199 reports
SEPSIS199 reports
HYPOTONIA198 reports
BALANCE DISORDER197 reports
AKATHISIA195 reports
PSYCHOMOTOR SKILLS IMPAIRED195 reports
ENCEPHALOPATHY193 reports
HAEMOGLOBIN DECREASED192 reports
LANGUAGE DISORDER192 reports
GENERALISED TONIC CLONIC SEIZURE191 reports

Report Outcomes

Out of 19,782 classified reports for VALPROATE SODIUM:

Serious 94.1%Non-Serious 5.9%

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

Male9,286 (52.6%)
Female8,297 (47.0%)
Unknown76 (0.4%)

Reports by Age

Age 50263 reports
Age 54260 reports
Age 40247 reports
Age 35236 reports
Age 30230 reports
Age 60228 reports
Age 29227 reports
Age 53225 reports
Age 41220 reports
Age 55217 reports
Age 38214 reports
Age 52213 reports
Age 45212 reports
Age 47212 reports
Age 16206 reports
Age 4204 reports
Age 56204 reports
Age 42199 reports
Age 22196 reports
Age 36196 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 VALPROATE SODIUM?

This profile reflects 37,274 FDA FAERS reports that mention VALPROATE SODIUM. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for VALPROATE SODIUM?

Frequently reported terms in FAERS include DRUG INEFFECTIVE, DRUG INTERACTION, OFF LABEL USE, FOETAL EXPOSURE DURING PREGNANCY, SOMNOLENCE, EPILEPSY. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures VALPROATE SODIUM?

Labeling and FAERS entries often list Fresenius Kabi USA, LLC in connection with VALPROATE SODIUM. 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.