Sildenafil Safety Profile & Adverse Events

Safety Profile Overview

PDE5 inhibitor for erectile dysfunction (Viagra) and pulmonary arterial hypertension (Revatio). Contraindicated with nitrates due to severe hypotension.

Generic Name

sildenafil

Brand Names

Viagra, Revatio

Therapeutic Class

PDE5 Inhibitor

Manufacturer

Pfizer

What Pharma Signal Tracks for Sildenafil

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

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

curl "https://api.pharma-signal.com/drug/safety/sildenafil" \
  -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 Sildenafil against other PDE5 Inhibitor drugs, or explore the full manufacturer portfolio for Pfizer.

Head-to-head comparison — Compare up to 5 drugs side by side on all safety metrics.
Therapeutic class benchmarking — See how Sildenafil ranks within PDE5 Inhibitor on serious event rates.
Company portfolio risk — View all drugs from Pfizer with aggregate risk exposure.
AI analyst briefs — Get a natural-language safety assessment combining all data sources.