Tramadol Safety Profile & Adverse Events

Safety Profile Overview

Atypical opioid with dual mechanism for moderate pain. Rescheduled to Schedule IV in 2014. Seizure risk and serotonin syndrome are unique concerns.

Generic Name

tramadol

Brand Names

Ultram, ConZip

Therapeutic Class

Opioid Analgesic

Manufacturer

Various

What Pharma Signal Tracks for Tramadol

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

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

curl "https://api.pharma-signal.com/drug/safety/tramadol" \
  -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 Tramadol against other Opioid Analgesic drugs, or explore the full manufacturer portfolio for Various.

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