Safety Profile Overview
Oral PDE4 inhibitor for psoriasis and psoriatic arthritis. Monitored for depression, weight loss, and gastrointestinal effects.
Generic Name
apremilast
Brand Names
Otezla
Therapeutic Class
PDE4 Inhibitor
Manufacturer
Amgen
What Pharma Signal Tracks for Otezla
- Adverse Events (FAERS) — All FDA Adverse Event Reporting System reports mentioning Otezla, including serious outcomes, hospitalizations, and deaths.
- FDA Recalls — Class I, II, and III recalls, market withdrawals, and safety alerts related to Otezla 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 Otezla Safety Data via API
One API call returns adverse events, risk scores, recalls, and pharmacovigilance signals for Otezla.
curl "https://api.pharma-signal.com/drug/safety/otezla" \ -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 Otezla against other PDE4 Inhibitor drugs, or explore the full manufacturer portfolio for Amgen.
- Head-to-head comparison — Compare up to 5 drugs side by side on all safety metrics.
- Therapeutic class benchmarking — See how Otezla ranks within PDE4 Inhibitor on serious event rates.
- Company portfolio risk — View all drugs from Amgen with aggregate risk exposure.
- AI analyst briefs — Get a natural-language safety assessment combining all data sources.