Testosterone Safety Profile & Adverse Events

Safety Profile Overview

Androgen replacement for hypogonadism. FDA required cardiovascular risk labeling update in 2015. Monitored for polycythemia and liver toxicity.

Generic Name

testosterone

Brand Names

AndroGel, Testopel, Depo-Testosterone

Therapeutic Class

Androgen

Manufacturer

AbbVie

What Pharma Signal Tracks for Testosterone

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

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

curl "https://api.pharma-signal.com/drug/safety/testosterone" \
  -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 Testosterone against other Androgen drugs, or explore the full manufacturer portfolio for AbbVie.

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