Valproate Safety Profile & Adverse Events

Safety Profile Overview

Anticonvulsant and mood stabilizer for epilepsy, bipolar disorder, and migraine. Boxed warnings for hepatotoxicity, pancreatitis, and teratogenicity.

Generic Name

valproic acid

Brand Names

Depakote, Depakene

Therapeutic Class

Anticonvulsant / Mood Stabilizer

Manufacturer

AbbVie

What Pharma Signal Tracks for Valproate

Adverse Events (FAERS) — All FDA Adverse Event Reporting System reports mentioning Valproate, including serious outcomes, hospitalizations, and deaths.
FDA Recalls — Class I, II, and III recalls, market withdrawals, and safety alerts related to Valproate products.
Label Changes — Boxed warning additions, new contraindications, dosing modifications, and safety-related labeling supplements.
Risk Score — Composite risk score (0–100) combining adverse event rates, recall history, and label severity with explainable breakdown.
Pharmacovigilance Signals — Proportional Reporting Ratio (PRR) and Reporting Odds Ratio (ROR) analysis detecting disproportionate adverse reactions.
Trend Analysis — Monthly time series with anomaly detection for emerging safety signals.

Data Disclaimer: Pharma Signal aggregates data from the FDA Adverse Event Reporting System (FAERS) and other public regulatory sources. FAERS reports do not establish causation. Report counts may reflect prescription volume rather than relative safety. Always consult healthcare professionals for medical decisions.

Get Valproate Safety Data via API

One API call returns adverse events, risk scores, recalls, and pharmacovigilance signals for Valproate.

curl "https://api.pharma-signal.com/drug/safety/valproate" \
  -H "X-API-Key: your_key"

# Returns risk score, adverse event counts,
# serious/death rates, recalls, and signals

Try the API API Reference

Related Safety Intelligence

Pharma Signal provides comparative analysis across therapeutic classes. Compare Valproate against other Anticonvulsant / Mood Stabilizer drugs, or explore the full manufacturer portfolio for AbbVie.

Head-to-head comparison — Compare up to 5 drugs side by side on all safety metrics.
Therapeutic class benchmarking — See how Valproate ranks within Anticonvulsant / Mood Stabilizer on serious event rates.
Company portfolio risk — View all drugs from AbbVie with aggregate risk exposure.
AI analyst briefs — Get a natural-language safety assessment combining all data sources.