Safety Profile Overview
Anticonvulsant widely used off-label for neuropathic pain. Increasing FDA concern about respiratory depression, especially with opioid co-administration.
Generic Name
gabapentin
Brand Names
Neurontin, Gralise
Therapeutic Class
Gabapentinoid
Manufacturer
Pfizer
What Pharma Signal Tracks for Gabapentin
- Adverse Events (FAERS) — All FDA Adverse Event Reporting System reports mentioning Gabapentin, including serious outcomes, hospitalizations, and deaths.
- FDA Recalls — Class I, II, and III recalls, market withdrawals, and safety alerts related to Gabapentin 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 Gabapentin Safety Data via API
One API call returns adverse events, risk scores, recalls, and pharmacovigilance signals for Gabapentin.
curl "https://api.pharma-signal.com/drug/safety/gabapentin" \ -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 Gabapentin against other Gabapentinoid drugs, or explore the full manufacturer portfolio for Pfizer.
- Head-to-head comparison — Compare up to 5 drugs side by side on all safety metrics.
- Therapeutic class benchmarking — See how Gabapentin ranks within Gabapentinoid on serious event rates.
- Company portfolio risk — View all drugs from Pfizer with aggregate risk exposure.
- AI analyst briefs — Get a natural-language safety assessment combining all data sources.