Safety Profile Overview
Long-acting PDE5 inhibitor for ED, BPH, and pulmonary hypertension. 36-hour duration of action distinguishes it from sildenafil.
Generic Name
tadalafil
Brand Names
Cialis, Adcirca
Therapeutic Class
PDE5 Inhibitor
Manufacturer
Eli Lilly
What Pharma Signal Tracks for Tadalafil
- Adverse Events (FAERS) — All FDA Adverse Event Reporting System reports mentioning Tadalafil, including serious outcomes, hospitalizations, and deaths.
- FDA Recalls — Class I, II, and III recalls, market withdrawals, and safety alerts related to Tadalafil 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 Tadalafil Safety Data via API
One API call returns adverse events, risk scores, recalls, and pharmacovigilance signals for Tadalafil.
curl "https://api.pharma-signal.com/drug/safety/tadalafil" \ -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 Tadalafil against other PDE5 Inhibitor drugs, or explore the full manufacturer portfolio for Eli Lilly.
- Head-to-head comparison — Compare up to 5 drugs side by side on all safety metrics.
- Therapeutic class benchmarking — See how Tadalafil ranks within PDE5 Inhibitor on serious event rates.
- Company portfolio risk — View all drugs from Eli Lilly with aggregate risk exposure.
- AI analyst briefs — Get a natural-language safety assessment combining all data sources.