OBJECTIVES: This study estimates annual adverse event rates per treatment and category for all US FDA-approved AD treatments as of May 31, 2023.

METHODS: Safety information about AEs, types, and rates were collected from FDA website product labels and/or clinical trial data. Descriptive analyses were used to classify product AEs by treatment and category. AE rates for Alzheimer's disease were estimated by dividing the number of events by the sample size over a specific period. AEs reported in trials at ≥5% were considered.

RESULTS: 6 FDA-approved NMEs between 2001 and 2023 included cholinesterase inhibitors (3, 42.8%), NMDA antagonists (1, 14.2%), immunotherapies (2, 28.5%), and combination medication (1,14.2%). The most common AEs were nausea (Galantamine 9%, Rivastigmine 55%), accident (Donepezil 7%), dizziness (Memantine 4%), infusion-related reaction (Lecanemab 19%), and ARIA-E (Aducanumab 33%). The lowest frequencies were decreasing appetite, diarrhea, dizziness, headache (Galantamine 3%), anxiety, malaise, somnolence (Rivastigmine 6%), ecchymosis, insomnia, and nausea (Donepezil 3%), confusion, constipation, headache (Memantine 3%), diarrhea (Lecanemab 7%), confusion/delirium (Aducanumab 7%).

CONCLUSIONS: From 2001 to 2023, none of the six approved NMEs were discontinued due to AEs, with infusion-related reactions being the most common. Most AEs were managed with other treatments.