What the label lists and what reports show
Donanemab side effects
Donanemab's FDA label: “Most common adverse reactions (at least 10% and higher incidence compared to placebo): ARIA-E, ARIA-H microhemorrhage, ARIA-H superficial siderosis, and headache.” FAERS holds 2,535 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is amyloid related imaging abnormality-oedema/effusion (421 reports).
- No generic listed
- Boxed warning
Check it at the source: the donanemab FDA label on DailyMed (effective December 30, 2025); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of KISUNLA?KISUNLA can cause serious side effects, including: See “What is the most important information I should know about KISUNLA?” Serious allergic reactions. Swelling of the face, lips, mouth, or eyelids, difficulty breathing, and hives have happened during a KISUNLA infusion. Tell your healthcare provider if you have any symptoms of a serious allergic reaction during or after KISUNLA infusion. Infusion-related reactions. Infusion-related reactions, which can be serious, have happened. If you have an infusion-related reaction, your infusion may be slowed down or stopped. […]
Source: FDA drug label, Eli Lilly and Company, effective December 30, 2025 (SPL set 190352d4-ef62-4679-b4fa-e846e2766afa), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions (at least 10% and higher incidence compared to placebo): ARIA-E, ARIA-H microhemorrhage, ARIA-H superficial siderosis, and headache.
Table 7: Adverse Reactions Reported in at Least 5% of Patients Treated With KISUNLA and at Least 2% Higher Than Placebo in Study 1
| Adverse Reaction | KISUNLA a N = 853 % | Placebo N = 874 % |
|---|---|---|
| ARIA-H microhemorrhage b | 25 | 11 |
| ARIA-E | 24 | 2 |
| ARIA-H superficial siderosis b | 15 | 3 |
| Headache | 13 | 10 |
| Infusion-related reaction | 9 | 0.5 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following clinically significant adverse reactions are described elsewhere in the labeling: Amyloid Related Imaging Abnormalities [see Warnings and Precautions ( 5.1 )] Hypersensitivity Reactions [see Warnings and Precautions ( 5.2 )] Infusion-Related Reactions [see Warnings and Precautions ( 5.3 )] Most common adverse reactions (at least 10% and higher incidence compared to placebo): ARIA-E, ARIA-H microhemorrhage, ARIA-H superficial siderosis, and headache. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Dosing Regimen and Safety A lower incidence of ARIA occurred with the dosing regimen administered in Study 2 (350 mg/700 mg/1,050 mg/1,400 mg; Dosing Regimen 2) as compared to the regimen administered in Study 1 (700 mg/700 mg/700 mg/1,400 mg; Dosing Regimen 1); therefore, Dosing Regimen 2 is recommended for administration of KISUNLA [see Dosage and Administration ( 2.2 ), Warnings and Precautions ( 5.1 ), Clinical Pharmacology ( 12.2 ), Clinical Studies ( 14 )]. …
Source: FDA drug label, Eli Lilly and Company, effective December 30, 2025 (SPL set 190352d4-ef62-4679-b4fa-e846e2766afa), via openFDA; the full label on DailyMed
What do FAERS reports show?
2,535 reports list donanemab among the medicines taken, each a report of something that happened, not proof the medicine caused it; 54 are coded as a death and 302 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Reports rose sharply in 2025 (1,447, against a median of 0 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens. Of the 24 reactions below, 8 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Donanemab: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions