Opdivo Safety Profile & Adverse Events

Safety Profile Overview

PD-1 checkpoint inhibitor used across numerous cancer indications. Key safety signals include immune-mediated pneumonitis, colitis, and hepatitis.

Generic Name

nivolumab

Brand Names

Opdivo

Therapeutic Class

PD-1 Inhibitor

Manufacturer

Bristol-Myers Squibb

What Pharma Signal Tracks for Opdivo

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

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

curl "https://api.pharma-signal.com/drug/safety/opdivo" \
  -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 Opdivo against other PD-1 Inhibitor drugs, or explore the full manufacturer portfolio for Bristol-Myers Squibb.

Head-to-head comparison — Compare up to 5 drugs side by side on all safety metrics.
Therapeutic class benchmarking — See how Opdivo ranks within PD-1 Inhibitor on serious event rates.
Company portfolio risk — View all drugs from Bristol-Myers Squibb with aggregate risk exposure.
AI analyst briefs — Get a natural-language safety assessment combining all data sources.