• FDA APPROVAL DATE: 06/07/2021
  • CLINICALLY IMPORTANT, POTENTIALLY HAZARDOUS INTERACTIONS WITH:
    None known
  • PREGNANCY: No adequate data to evaluate use in pregnant women.

Aducanumab can cause amyloid-related imaging abnormalities–edema, which can be
observed on MRI as brain edema or sulcal effusions, and amyloid-related imaging abnormalities–hemosiderin deposition, which includes microhemorrhage and superficial siderosis.

Approved under accelerated approval based on reduction in amyloid beta plaques observed in patients treated with aducanumab. Continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trial(s).

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Page last updated 08/11/2024

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Incidence

<1% 1‑5% 5‑10% 10‑15% 15‑20% 20‑30% >30%

Seriousness

Hospitalization possible
Life threatening
Fatal

Warnings in other populations

BreastfeedingBreast feeding

GeriatricGeriatric

PediatricPediatric