Psychiatric and Behavioral Adverse Event Reporting Patterns Among Dopamine Agonists in Parkinson’s Disease Using the Food and Drug Administration Adverse Event Reporting System.

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Psychiatric and Behavioral Adverse Event Reporting Patterns Among Dopamine Agonists in Parkinson’s Disease Using the Food and Drug Administration Adverse Event Reporting System.

Psychiatric and Behavioral Adverse Event Reporting Patterns Among Dopamine Agonists in Parkinson’s Disease Using the Food and Drug Administration Adverse Event Reporting System.

アブストラクト	BACKGROUND: Dopamine agonists used in Parkinson's disease are associated with neuropsychiatric and behavioral adverse events (AEs), including hallucinations and impulse control disorders. This study aimed to compare AE reporting patterns among pramipexole, ropinirole, and rotigotine in the Food and Drug Administration Adverse Event Reporting System (FAERS) and to identify drug-specific pharmacovigilance signals. METHODS: This retrospective study analyzed FAERS data using disproportionality analysis. Reporting odds ratios (RORs) and adjusted RORs (aRORs) were calculated with pramipexole as the reference drug; ropinirole and rotigotine were each compared with pramipexole. A Bonferroni-corrected significance threshold of P < 0.025 was used for the two pairwise comparisons. RESULTS: We analyzed 5,959 cases (pramipexole N = 1,654; ropinirole N = 1,450; rotigotine N = 2,855). Compared with pramipexole, ropinirole was associated with significantly higher reporting of gastrointestinal disorders and lower reporting of impulse control disorders. Rotigotine was associated with lower reporting of neuropsychiatric disorders (excluding impulse control disorders), impulse control disorders, and general and systemic disorders, but higher reporting of dermatological and application-site disorders, infectious disorders, and serious outcome-related events. CONCLUSIONS: Dopamine agonists showed distinct AE reporting profiles in FAERS, particularly for neuropsychiatric, impulse-control, and other regimen-related events. These findings are pharmacovigilance signals rather than causal associations, but they may help inform psychiatric risk assessment and individualized dopamine agonist selection. Confirmation in prospective clinical or pharmacoepidemiological studies is warranted.
ジャーナル名	Psychopharmacology bulletin
Pubmed追加日	2026/11/4
投稿者	Ogura, Toru; Shiraishi, Chihiro
組織名	Ogura, PhD, Clinical Research Center, Saga University Hospital, Saga, Japan.;Shiraishi, PhD, Department of Pharmaceutical Sciences for Health Crisis;Management, Faculty of Pharmaceutical Sciences, Fukuoka University, Fukuoka,;Japan.
Pubmed リンク	https://www.ncbi.nlm.nih.gov/pubmed/42979628/