valproate Side Effects
Also known as: Depakote, Depakene
Analysis of 19,772 adverse event reports submitted to the FDA from 2001 to 2025.
Total Reports
19,772
Death-Related
1,782
9.0% of reports
Hospitalizations
8,459
42.8% of reports
Top Indication
Product Used For Unknown Indication
Most Reported Adverse Reactions
Who Reports Side Effects
Gender Distribution
Age Distribution
Reporting Trend by Year
Reactions in Death Reports
Top reactions reported in 1,782 reports where death was an outcome. These are voluntarily reported and do not establish causation.
| Reaction | Reports |
|---|---|
| DEATH | 237 |
| SEPSIS | 104 |
| PNEUMONIA | 101 |
| CARDIAC ARREST | 97 |
| PYREXIA | 88 |
| TOXICITY TO VARIOUS AGENTS | 87 |
| DRUG INTERACTION | 82 |
| FOETAL EXPOSURE DURING PREGNANCY | 82 |
| OFF LABEL USE | 80 |
| MALAISE | 73 |
| VOMITING | 71 |
| STATUS EPILEPTICUS | 67 |
| CONVULSION | 66 |
| DIARRHOEA | 66 |
| DRUG INEFFECTIVE | 64 |
| COMPLETED SUICIDE | 62 |
| OVERDOSE | 53 |
| NAUSEA | 51 |
| CARDIO-RESPIRATORY ARREST | 50 |
| SUDDEN DEATH | 50 |
Reactions in Hospitalization Reports
Top reactions in 8,459 reports where hospitalization was an outcome.
| Reaction | Reports |
|---|---|
| DRUG INEFFECTIVE | 650 |
| DRUG INTERACTION | 595 |
| PYREXIA | 542 |
| SOMNOLENCE | 489 |
| OFF LABEL USE | 472 |
| TOXICITY TO VARIOUS AGENTS | 394 |
| VOMITING | 345 |
| SUICIDE ATTEMPT | 308 |
| PNEUMONIA | 304 |
| EPILEPSY | 297 |
| SEIZURE | 278 |
| CONFUSIONAL STATE | 277 |
| OVERDOSE | 272 |
| DIARRHOEA | 266 |
| FALL | 258 |
| MALAISE | 258 |
| CONVULSION | 257 |
| WEIGHT INCREASED | 256 |
| THROMBOCYTOPENIA | 245 |
| HYPOTENSION | 241 |
Nearby — Related Medications
What the FAERS Data Reveals About valproate Side Effects
The FDA Adverse Event Reporting System (FAERS) contains 19,772 voluntary reports linked to valproate and its brand equivalents (Depakote, Depakene), spanning 2001 through 2025. Of those, 1,782 (9.0%) listed death as an outcome and 8,459 (42.8%) involved hospitalization. The most common indication reported alongside adverse events was Product Used For Unknown Indication.
Demographic breakdowns help contextualize who is being exposed to the drug. Of reports with known sex, 47% were female and 53% male; age distribution skews toward 18-44, with 4,890 reports in that bracket. The single most reported reaction is drug ineffective with 1,403 submissions, followed by drug interaction and off label use.
FAERS is a signal-detection tool, not a scorecard. Reports are voluntary, and a single case may list multiple suspect drugs, so numbers above should not be read as incidence rates or per-patient risk. Widely prescribed drugs naturally accumulate more reports than niche therapies even when individual risk is low. These aggregates are useful for spotting patterns that merit further pharmacovigilance, not for choosing between medications. This page is for educational reference only and is not medical advice — speak with a licensed clinician about any side-effect concerns.
Read our methodology — how this data is sourced, computed, and verified.