Alzheimer's: FDA Approvals, Recalls, 510(k) Clearances and Side Effect Reports

• 3new drug approvals (since 1 Jan 2023)
• 9,591side effect reports (reports received since 1 Jan 2023)

Each number has its full source under its own list below.

• 29Aug2025

  Leqembi Iqlik (lecanemab-irmb)

  Approved for: LEQEMBI is indicated for the treatment of Alzheimer’s disease. Treatment with LEQEMBI should be initiated in patients with mild cognitive impairment or mild dementia stage of dise…

  BLA761375
• 2Jul2024

  Kisunla (donanemab-azbt)

  Approved for: KISUNLA TM is indicated for the treatment of Alzheimer's disease. Treatment with KISUNLA should be initiated in patients with mild cognitive impairment or mild dementia stage of d…

  BLA761248
• 6Jan2023

  Leqembi (lecanemab)

  Approved for: LEQEMBI is indicated for the treatment of Alzheimer’s disease. Treatment with LEQEMBI should be initiated in patients with mild cognitive impairment or mild dementia stage of dise…

  BLA761269

Source: openFDA, Novel drug approvals (new molecular entities and new biologics), since 1 Jan 2023. Retrieved 12 Nov 2026.

1. 1Amyloid related imaging abnormality-oedema/effusion664 reports
2. 2Fall624 reports
3. 3Amyloid related imaging abnormality-microhaemorrhages and haemosiderin deposits611 reports
4. 4Headache564 reports
5. 5Infusion related reaction430 reports
6. 6Confusional state395 reports
7. 7Dizziness362 reports
8. 8Fatigue353 reports
9. 9Hallucination328 reports
10. 10Nausea320 reports

Anyone can send a report. A report does not prove that the medicine caused the reaction, and the counts do not show how often it happens.

Source: openFDA, FDA Adverse Event Reporting System (FAERS), reports by reaction, reports received since 1 Jan 2023. Retrieved 12 Nov 2026.

• Clinical trials: Alzheimer's disease
• Alzheimer's disease death rate

• Brain and nerves
• Diagnostics and lab testing
• Geriatric