Singulair Safety Profile & Adverse Events

Safety Profile Overview

Leukotriene receptor antagonist for asthma and allergic rhinitis. 2020 boxed warning added for neuropsychiatric events including suicidal thoughts and behavior.

Generic Name

montelukast

Brand Names

Singulair

Therapeutic Class

Leukotriene Receptor Antagonist

Manufacturer

Merck

What Pharma Signal Tracks for Singulair

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

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

curl "https://api.pharma-signal.com/drug/safety/singulair" \
  -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 Singulair against other Leukotriene Receptor Antagonist drugs, or explore the full manufacturer portfolio for Merck.

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