Drug
Donanemab-azbt
Important: Reactions below are the flagged terms from this drug’s
FAERS report history (min. 3 co-reports per term) — PRR/ROR indicate
disproportionality in spontaneous reporting, not causation.
Data from FDA FAERS via openFDA. Last recalculated: 2026-09-14.
| Reaction | Co-reports (a) | PRR | ROR | Signal | |
|---|---|---|---|---|---|
| 1 | Brain Oedema | 63 | 41.5 | 42.5 | signal |
| 2 | Infusion Related Reaction | 321 | 40.4 | 46.1 | signal |
| 3 | Cerebral Haemorrhage | 121 | 28.1 | 29.4 | signal |
| 4 | Flushing | 170 | 13.8 | 14.7 | signal |
| 5 | Ischaemic Stroke | 20 | 9.3 | 9.3 | signal |
| 6 | Cerebral Infarction | 26 | 8.8 | 8.9 | signal |
| 7 | Subdural Haematoma | 15 | 8.6 | 8.7 | signal |
| 8 | Brain Fog | 12 | 6.8 | 6.8 | signal |
| 9 | Anaphylactic Shock | 21 | 6.8 | 6.8 | signal |
| 10 | Anaphylactic Reaction | 44 | 6.6 | 6.7 | signal |
| 11 | Dizziness Postural | 7 | 6.0 | 6.0 | signal |
| 12 | Chills | 83 | 5.9 | 6.0 | signal |
| 13 | Subarachnoid Haemorrhage | 7 | 5.7 | 5.7 | signal |
| 14 | Head Discomfort | 11 | 5.2 | 5.2 | signal |
| 15 | Feeling Hot | 38 | 5.1 | 5.2 | signal |
| 16 | Chest Discomfort | 58 | 4.7 | 4.8 | signal |
| 17 | Aphasia | 16 | 4.4 | 4.4 | signal |
| 18 | Blood Pressure Decreased | 35 | 4.4 | 4.4 | signal |
| 19 | Cold Sweat | 9 | 4.2 | 4.2 | signal |
| 20 | Cognitive Disorder | 23 | 4.1 | 4.1 | signal |
| 21 | Pallor | 13 | 3.9 | 4.0 | signal |
| 22 | Feeling Cold | 13 | 3.9 | 3.9 | signal |
| 23 | Blood Pressure Systolic Increased | 9 | 3.8 | 3.8 | signal |
| 24 | Throat Tightness | 12 | 3.7 | 3.7 | signal |
| 25 | Head Injury | 14 | 3.7 | 3.7 | signal |
| 26 | Cerebrovascular Accident | 58 | 2.8 | 2.9 | signal |
| 27 | Muscle Rigidity | 4 | 2.8 | 2.8 | no signal |
| 28 | Posterior Reversible Encephalopathy Syndrome | 3 | 2.6 | 2.6 | no signal |