Safety Profile Overview
Oral disease-modifying therapy for relapsing MS. Common GI side effects and flushing. Rare cases of PML reported.
Generic Name
dimethyl fumarate
Brand Names
Tecfidera
Therapeutic Class
Nrf2 Activator
Manufacturer
Biogen
What Pharma Signal Tracks for Tecfidera
- Adverse Events (FAERS) — All FDA Adverse Event Reporting System reports mentioning Tecfidera, including serious outcomes, hospitalizations, and deaths.
- FDA Recalls — Class I, II, and III recalls, market withdrawals, and safety alerts related to Tecfidera 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 Tecfidera Safety Data via API
One API call returns adverse events, risk scores, recalls, and pharmacovigilance signals for Tecfidera.
curl "https://api.pharma-signal.com/drug/safety/tecfidera" \ -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 Tecfidera against other Nrf2 Activator drugs, or explore the full manufacturer portfolio for Biogen.
- Head-to-head comparison — Compare up to 5 drugs side by side on all safety metrics.
- Therapeutic class benchmarking — See how Tecfidera ranks within Nrf2 Activator on serious event rates.
- Company portfolio risk — View all drugs from Biogen with aggregate risk exposure.
- AI analyst briefs — Get a natural-language safety assessment combining all data sources.