Psychiatric Adverse Events Associated With Dihydropyridine Calcium Channel Blockers: A Pharmacovigilance Study Based...

Dihydropyridine calcium channel blockers (DHPCCBs) are widely employed in managing cardiovascular diseases. Although some studies suggest a potential link to psychiatric adverse events (PAEs), a systematic investigation is lacking.

Adverse event reports for seven DHPCCBs marketed in the United States were collected from the FDA Adverse Event Reporting System (FAERS). PAEs were extracted from these reports and then performed using disproportionality analysis.

A total of 9164 PAEs associated with 7 DHPCCBs were identified, revealing 18 positive signal associations. For amlodipine, 18 positive signals were detected, with "completed suicide," "suicide attempt," and "mental status changes" being the most frequent. In contrast, nifedipine showed only 2 positive signals, which overlapped with amlodipine. No positive signals were found for the remaining five DHPCCBs. PAEs typically occur within the first 30 days of treatment. After adjusting for sex and age, 13 positive signals remained, 11 of which were related to suicidal behaviors.

The disproportionality analysis identified signal associations between DHPCCBs and PAEs. These findings should be interpreted as hypothesis-generating signals requiring further validation through controlled studies. Clinicians may consider monitoring psychiatric symptoms in high-risk patients, particularly given the conflicting evidence from previous studies.