Suboxone Safety Profile & Adverse Events

Safety Profile Overview

Combination opioid partial agonist for opioid use disorder treatment. Critical role in the opioid crisis response. FDA dental erosion warning added in 2022.

Generic Name

buprenorphine/naloxone

Brand Names

Suboxone

Therapeutic Class

Opioid Partial Agonist

Manufacturer

Indivior

What Pharma Signal Tracks for Suboxone

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

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

curl "https://api.pharma-signal.com/drug/safety/suboxone" \
  -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 Suboxone against other Opioid Partial Agonist drugs, or explore the full manufacturer portfolio for Indivior.

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