Drug side effects
valproate Side Effects
The reactions most often reported to the FDA for valproate (also sold as Depakote, Depakene), with demographics, serious outcomes, and reporting trends.
Data updated 2026-05-15
- 19,772
- FAERS reports
Data from the FDA Adverse Event Reporting System (FAERS), 2001 to 2025. A FAERS report records a temporal association, not proof of cause. See our methodology for how figures are compiled and de-duplicated.
The most commonly reported side effects of valproate come from 19,772 reports to the FDA, broken down here by frequency, patient demographics, and serious outcomes.
This page analyzes 19,772 reports to the FDA Adverse Event Reporting System (FAERS) for valproate (Depakote): the reactions reported most often, who reported them, serious outcomes such as hospitalization, and year-over-year trends. A FAERS report does not prove the drug caused the effect, and report volume tracks how widely a drug is used, not how likely an effect is for any one person. Educational information, not medical advice.
Total Reports
19,772
Reports Mentioning Death
1,782
9.0% of reports — not proof the medicine caused the death
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 |
| MALAISE | 73 |
| VOMITING | 71 |
| STATUS EPILEPTICUS | 67 |
| CONVULSION | 66 |
| DIARRHOEA | 66 |
| 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 INTERACTION | 595 |
| PYREXIA | 542 |
| SOMNOLENCE | 489 |
| 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 interaction with 1,185 submissions, followed by foetal exposure during pregnancy and somnolence.
How to read these numbers
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.
Drugs With a Similar FAERS Report Volume
Other medications with a total FDA adverse-event report count closest to valproate's 19,772.
Read our methodology - how this data is sourced, computed, and verified.