Safety Profile Overview
Retinoid for severe cystic acne. iPLEDGE REMS program for teratogenicity prevention. Also monitored for depression, IBD, and hepatotoxicity.
Generic Name
isotretinoin
Brand Names
Accutane, Absorica, Claravis
Therapeutic Class
Retinoid
Manufacturer
Various
What Pharma Signal Tracks for Accutane
- Adverse Events (FAERS) — All FDA Adverse Event Reporting System reports mentioning Accutane, including serious outcomes, hospitalizations, and deaths.
- FDA Recalls — Class I, II, and III recalls, market withdrawals, and safety alerts related to Accutane 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 Accutane Safety Data via API
One API call returns adverse events, risk scores, recalls, and pharmacovigilance signals for Accutane.
curl "https://api.pharma-signal.com/drug/safety/accutane" \ -H "X-API-Key: your_key" # Returns risk score, adverse event counts, # serious/death rates, recalls, and signals
Related Safety Intelligence
Pharma Signal provides comparative analysis across therapeutic classes. Compare Accutane against other Retinoid drugs, or explore the full manufacturer portfolio for Various.
- Head-to-head comparison — Compare up to 5 drugs side by side on all safety metrics.
- Therapeutic class benchmarking — See how Accutane ranks within Retinoid on serious event rates.
- Company portfolio risk — View all drugs from Various with aggregate risk exposure.
- AI analyst briefs — Get a natural-language safety assessment combining all data sources.