Are there gender differences in adverse drug reactions to levodopa? A real-world safety comparison in the global pharmacovigilance database.

J. Montastruc

Published 2025 in The´rapie (Paris)

ABSTRACT

BACKGROUND Gender differences were reported in Parkinson's disease as well as in drug effects in general. OBJECTIVE The study was performed to investigate putative gender differences in levodopa-related adverse drug reactions (ADRs). METHODS Using Vigibase®, the global pharmacovigilance database, all ADRs reports with levodopa between 01/01/2000 and 31/12/2024 in adults were included. The main levodopa (motor and non-motor) ADRs were compared between women and men. Results are presented as reporting odds ratios (ROR) with their 95% confidence interval. RESULTS Among 2887 ADRs with levodopa, the reporting risk in women was significantly higher for dyskinesia (ROR=1.31 [1.00-1.71]), dystonia (1.41 [1.03-1.93]), nausea-vomiting (2.08 [1.45-2.99]), and significantly lower for hypersexuality (0.10 [0.02-0.42]), dopamine dysregulation syndrome (0.32 [0.14-0.73]) pathological gambling (0.33 [0.14-0.76]) and all ADRs in general (0.48 [0.45-0.52]), with no difference for other ADRs. CONCLUSION This study shows gender-related differences for not only motor (dyskinesia, dystonia) but also non-motor levodopa ADRs.

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