Mounjaro Safety Profile & Adverse Events

Safety Profile Overview

Dual GIP/GLP-1 receptor agonist for type 2 diabetes. The first in its class, with FDA monitoring for pancreatitis, thyroid tumors, and gastrointestinal adverse events.

Generic Name

tirzepatide

Brand Names

Mounjaro

Therapeutic Class

GLP-1/GIP Receptor Agonist

Manufacturer

Eli Lilly

What Pharma Signal Tracks for Mounjaro

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

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

curl "https://api.pharma-signal.com/drug/safety/mounjaro" \
  -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 Mounjaro against other GLP-1/GIP Receptor Agonist 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 Mounjaro ranks within GLP-1/GIP Receptor Agonist 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.