Safety Profile Overview
Long-acting muscarinic antagonist for COPD and asthma maintenance. Well-established safety profile over decades of clinical use.
Generic Name
tiotropium
Brand Names
Spiriva, Spiriva Respimat
Therapeutic Class
LAMA
Manufacturer
Boehringer Ingelheim
What Pharma Signal Tracks for Spiriva
- Adverse Events (FAERS) — All FDA Adverse Event Reporting System reports mentioning Spiriva, including serious outcomes, hospitalizations, and deaths.
- FDA Recalls — Class I, II, and III recalls, market withdrawals, and safety alerts related to Spiriva 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 Spiriva Safety Data via API
One API call returns adverse events, risk scores, recalls, and pharmacovigilance signals for Spiriva.
curl "https://api.pharma-signal.com/drug/safety/spiriva" \ -H "X-API-Key: your_key" # Returns risk score, adverse event counts, # serious/death rates, recalls, and signals
Related Safety Intelligence
Pharma Signal provides comparative analysis across therapeutic classes. Compare Spiriva against other LAMA drugs, or explore the full manufacturer portfolio for Boehringer Ingelheim.
- Head-to-head comparison — Compare up to 5 drugs side by side on all safety metrics.
- Therapeutic class benchmarking — See how Spiriva ranks within LAMA on serious event rates.
- Company portfolio risk — View all drugs from Boehringer Ingelheim with aggregate risk exposure.
- AI analyst briefs — Get a natural-language safety assessment combining all data sources.