Simvastatin Safety Profile & Adverse Events

Safety Profile Overview

Second most prescribed statin. 80mg dose restricted by FDA due to myopathy risk. Significant CYP3A4 drug interactions.

Generic Name

simvastatin

Brand Names

Zocor

Therapeutic Class

HMG-CoA Reductase Inhibitor

Manufacturer

Merck

What Pharma Signal Tracks for Simvastatin

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

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

curl "https://api.pharma-signal.com/drug/safety/simvastatin" \
  -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 Simvastatin against other HMG-CoA Reductase Inhibitor drugs, or explore the full manufacturer portfolio for Merck.

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