Hydroxychloroquine Safety Profile & Adverse Events

Safety Profile Overview

Antimalarial used as a DMARD for lupus and RA. Retinal toxicity requires ophthalmologic monitoring. Received global attention during COVID-19.

Generic Name

hydroxychloroquine

Brand Names

Plaquenil

Therapeutic Class

Antimalarial / DMARD

Manufacturer

Sanofi

What Pharma Signal Tracks for Hydroxychloroquine

Adverse Events (FAERS) — All FDA Adverse Event Reporting System reports mentioning Hydroxychloroquine, including serious outcomes, hospitalizations, and deaths.
FDA Recalls — Class I, II, and III recalls, market withdrawals, and safety alerts related to Hydroxychloroquine 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 Hydroxychloroquine Safety Data via API

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

curl "https://api.pharma-signal.com/drug/safety/hydroxychloroquine" \
  -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 Hydroxychloroquine against other Antimalarial / DMARD drugs, or explore the full manufacturer portfolio for Sanofi.

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