Arterial hypertension: A safety risk of calcitonin gene-related peptide ligand and receptor blocker class
Abstract
OBJECTIVE: To identify and analyze adverse event reports of arterial hypertension (hereinafter referred as hypertension) associated with calcitonin gene-related peptide (CGRP) ligand (L) and receptor (R) blockers.
BACKGROUND: CGRP is a potent peripheral and cerebral vasodilator and plays a key role in the pathogenesis of migraine. The US Food and Drug Administration (FDA) previously identified postmarketing case reports of hypertension associated with erenumab resulting in an amendment of the US Prescribing Information. However, at that time, no hypertension safety signal was apparent for other CGRP-L/R blockers.
METHODS: In this retrospective pharmacovigilance case series, we reviewed case reports from the FDA Adverse Event Reporting System database and the medical literature through October 15, 2025, for hypertension associated with the use of any of the eight CGRP-L/R blockers approved and marketed in the United States, except for erenumab. A case of hypertension was defined as (1) the initiation of a pharmacological intervention or emergency department visit or hospitalization for emergent de novo or worsening of preexisting hypertension, OR (2) blood pressure (BP) measurement ≥140 mmHg systolic or ≥90 mmHg diastolic with or without baseline BP measurement reported.
RESULTS: We identified a total of 106 cases of hypertension in FDA Adverse Event Reporting System and the medical literature with a probable or possible causal association with CGRP-L/R blocker use: 78 (74%)…
How strong is the evidence?
Evidence Hub reads this as a case series, done in people. Its evidence level is 5 of 5 (Very low · case / narrative / animal / in vitro / in silico). Case reports, narrative reviews, and animal, cell or computer-model studies give the weakest evidence for human health.
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