OBJECTIVES: Signal detection is a promising technique used for prompt detection of novel reactions. It is a modern method of detecting new reaction of a drug. Ubrogepant and Rimegepant are calcitonin gene-related peptide (CGRP) receptor antagonists were approved by US Food and Drug Administration (USFDA) in December 2019 and February 2020 respectively for acute treatment of Migraine. This study was to identify the signal strength for Ubrogepant and Rimegepant associated ADRs using data mining technique in USFDA adverse event reporting system (AERS) database.

METHODS: Data was obtained from the public release of data in USFDA adverse event reporting system (AERS) database. Case/non-case method was adopted for the analysis of novel adverse events of Ubrogepant and Rimegepant. The data-mining algorithm used for the analysis were Reporting Odds Ratio (ROR) and Proportional Reporting Ratio (PRR). A value of ROR-1.96SE> 1, PRR≥2 was considered as positive signal.

RESULTS: A total 349 reactions were associated with Ubrogepant which comprised of 25 adverse events. ROR, PRR showed positive signal for chest pain (PRR:2.539 ROR:2.572), Dysstasia (PRR:3.538 ROR:3.549), paraesthesia oral (PRR:7.494 ROR:7.523), neck pain (PRR: 3.042 ROR:3.056) and euphoric mood (PRR:6.096 ROR: 6.113). A total 525 reactions were associated with Rimegepant which comprised of 45 adverse events. ROR, PRR showed positive signal for pharyngeal swelling (PRR:4.69 ROR:4.695) and taste disorder (PRR:5.663 ROR: 5.676).

CONCLUSIONS: The present study suggests that Ubrogepant and Rimegepant may result in these adverse events. Further pharmacoepidemiologic studies are necessary to confirm this conclusion and to improve the accuracy of the prevalence and the risk factors for ADRs.