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Important: This site presents data from the FDA Adverse Event Reporting System (FAERS). A report does not mean the drug caused the event. Full disclaimer.

DONANEMAB-AZBT: 1,018 Adverse Event Reports & Safety Profile

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1,018
Total FAERS Reports
18 (1.8%)
Deaths Reported
117
Hospitalizations
1,018
As Primary/Secondary Suspect
26
Life-Threatening
2
Disabilities
Prescription
Status

FDA Application: 761248 ·

First Report: 20050213 · Latest Report: 20250926

What Are the Most Common DONANEMAB-AZBT Side Effects?

#1 Most Reported
Amyloid related imaging abnormality-oedema/effusion
185 reports (18.2%)
#2 Most Reported
Amyloid related imaging abnormality-microhaemorrhages and haemosiderin deposits
139 reports (13.7%)
#3 Most Reported
Headache
111 reports (10.9%)

All DONANEMAB-AZBT Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Amyloid related imaging abnormality-oedema/effusion 185 18.2% 2 20
Amyloid related imaging abnormality-microhaemorrhages and haemosiderin deposits 139 13.7% 1 12
Headache 111 10.9% 1 16
Infusion related reaction 97 9.5% 1 11
Amyloid related imaging abnormalities 80 7.9% 4 13
Flushing 68 6.7% 0 7
Cerebral haemorrhage 54 5.3% 4 14
Dizziness 48 4.7% 1 9
Nausea 44 4.3% 0 4
Cerebral microhaemorrhage 41 4.0% 0 1
Confusional state 40 3.9% 1 9
Dyspnoea 39 3.8% 0 8
Chills 38 3.7% 0 4
Erythema 34 3.3% 0 4
Blood pressure increased 33 3.2% 0 6
Cerebrovascular accident 31 3.1% 1 7
Back pain 28 2.8% 0 1
Brain oedema 27 2.7% 1 8
Fall 27 2.7% 2 6
Off label use 26 2.6% 2 4

Who Reports DONANEMAB-AZBT Side Effects? Age & Gender Data

Gender: 58.6% female, 41.4% male. Average age: 74.6 years. Most reports from: US. View detailed demographics →

Is DONANEMAB-AZBT Getting Safer? Reports by Year

YearReportsDeathsHosp.
2005 1 0 1
2024 65 0 10
2025 395 9 66

View full timeline →

What Is DONANEMAB-AZBT Used For?

IndicationReports
Product used for unknown indication 603
Dementia alzheimer's type 347
Cognitive disorder 96
Dementia 25

DONANEMAB-AZBT vs Alternatives: Which Is Safer?

DONANEMAB-AZBT vs DONEPEZIL DONANEMAB-AZBT vs DONEPEZIL\DONEPEZIL DONANEMAB-AZBT vs DONEPEZIL\MEMANTINE DONANEMAB-AZBT vs DONEPEZIL\OMEPRAZOLE\OMEPRAZOLE DONANEMAB-AZBT vs DONOR HUMAN STOOL DONANEMAB-AZBT vs DOPAMINE DONANEMAB-AZBT vs DOPAMINE\DOPAMINE DONANEMAB-AZBT vs DORAVIRINE DONANEMAB-AZBT vs DORAVIRINE\LAMIVUDINE\TENOFOVIR DISOPROXIL DONANEMAB-AZBT vs DORIPENEM

Official FDA Label for DONANEMAB-AZBT

Official prescribing information from the FDA-approved drug label.