Safety Profile Overview
Long-acting NSAID often preferred for potentially lower cardiovascular risk versus other NSAIDs. GI bleeding and renal effects remain concerns.
Generic Name
naproxen sodium
Brand Names
Aleve, Naprosyn
Therapeutic Class
NSAID
Manufacturer
Bayer
What Pharma Signal Tracks for Naproxen
- Adverse Events (FAERS) — All FDA Adverse Event Reporting System reports mentioning Naproxen, including serious outcomes, hospitalizations, and deaths.
- FDA Recalls — Class I, II, and III recalls, market withdrawals, and safety alerts related to Naproxen 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 Naproxen Safety Data via API
One API call returns adverse events, risk scores, recalls, and pharmacovigilance signals for Naproxen.
curl "https://api.pharma-signal.com/drug/safety/naproxen" \ -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 Naproxen against other NSAID drugs, or explore the full manufacturer portfolio for Bayer.
- Head-to-head comparison — Compare up to 5 drugs side by side on all safety metrics.
- Therapeutic class benchmarking — See how Naproxen ranks within NSAID on serious event rates.
- Company portfolio risk — View all drugs from Bayer with aggregate risk exposure.
- AI analyst briefs — Get a natural-language safety assessment combining all data sources.