A pharmacovigilance analysis of the FDA FAERS database reveals the real-world safety profiles of four gepant CGRP antagonists used for migraine, identifying both known and potentially new safety signals.
4 gepants comparedFirst comprehensive FAERS analysis comparing all marketed CGRP receptor antagonists
What the researchers found
FAERS database analysis identified distinct safety profiles for each of the four marketed gepants, with both expected and potentially novel adverse event signals detected.
Why it matters
Gepants are relatively new drugs prescribed to millions. Real-world safety data from the FDA's reporting system can detect rare side effects that clinical trials miss, protecting patients.
How the study worked
Retrospective disproportionality analysis of the FDA FAERS database examining adverse event reports for rimegepant, ubrogepant, atogepant, and zavegepant.
What this study cannot tell us
FAERS data is voluntary reporting — underreporting is common; cannot determine causation; reporting biases (newer drugs may be over-reported); no denominator (total prescriptions) for incidence calculation.
How to read the evidence
Pharmacovigilance database analysis — useful for safety signal detection but cannot establish causation or determine true incidence rates.
When this study was published
Published in 2026, providing the most current real-world safety data as gepant prescribing increases rapidly.
The bigger picture
As CGRP antagonists become mainstream migraine treatment, comprehensive safety surveillance ensures that the benefits of these drugs continue to outweigh risks across diverse real-world patient populations.
Questions still open
- Do the safety signals identified require changes to prescribing guidelines for any specific gepant?
- Are there meaningful safety differences between gepants that should guide drug selection?
Common questions
What are gepants?
How reliable is FDA adverse event data?
Read the original research
Safety analysis of gepants for migraine treatment: A pharmacovigilance study using the FDA Adverse Event Reporting System (FAERS) database.
Headache
Citation
Chen, Hui; Li, Yan. (2026). Safety analysis of gepants for migraine treatment: A pharmacovigilance study using the FDA Adverse Event Reporting System (FAERS) database.. Headache. https://doi.org/10.1111/head.70049