Prescription medicine
Donanemab Brand names: Kisunla
Donanemab (Kisunla) is a prescription medicine. No generic is listed in FDA's NDC Directory.
- No generic listed
- Boxed warning
Check it at the source: the donanemab FDA label on DailyMed (effective December 30, 2025); every donanemab label on DailyMed.
Highlights of the record
FDA label of December 30, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
AMYLOID RELATED IMAGING ABNORMALITIES.
Monoclonal antibodies directed against aggregated forms of beta amyloid, including KISUNLA, can cause amyloid related imaging abnormalities (ARIA), characterized as ARIA with edema (ARIA-E) and ARIA with hemosiderin deposition (ARIA-H). Incidence and timing of ARIA vary among treatments. ARIA usually occurs early in treatment and is usually asymptomatic, although serious and life-threatening events can occur. ARIA can be fatal. Serious intracerebral hemorrhages >1 cm, some of which have been fatal, have been observed in patients treated with this class of medications. Because ARIA-E can cause focal neurologic deficits that can mimic an ischemic stroke, treating clinicians should consider whether such symptoms could be due to ARIA-E before giving thrombolytic therapy in a patient being treated with KISUNLA [see Warnings and Precautions ( 5.1 ), Adverse Reactions ( 6.1 )]. ApoE ε4 Homozygotes Patients who are apolipoprotein E ε4 (ApoE ε4) homozygotes (approximately 15% of Alzheimer's disease patients) treated with this class of medications, including KISUNLA, have a higher incidence of ARIA, including symptomatic, serious, and severe radiographic ARIA, compared to heterozygotes and noncarriers [see Warnings and Precautions ( 5.1 )]. […]
Used for
From the label: indications and usageKISUNLA TM is indicated for the treatment of Alzheimer's disease.
Forms and strengths
- 17.5 mg/ml
Injection (solution).
On the market
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 2,535 through July 30, 2026
What is donanemab used for?
From the label: indications and usageKISUNLA 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 disease, the population in which treatment was initiated in the clinical trials. KISUNLA is an amyloid beta-directed antibody 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 disease, the population in which treatment was initiated in the clinical trials.
Conditions named in the indications of donanemab's FDA labels, with every medicine labeled for each:
Source: FDA drug label (Kisunla), 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 patient leaflet for donanemab say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about KISUNLA?KISUNLA can cause serious side effects, including: Amyloid Related Imaging Abnormalities or ARIA. ARIA is a common side effect that does not usually cause any symptoms, but serious symptoms can occur. ARIA can be fatal. It is most commonly seen as temporary swelling in areas of the brain that usually resolves over time. Some people may also have small spots of bleeding in or on the surface of the brain, and infrequently, larger areas of bleeding in the brain can occur. Most people who develop ARIA do not get symptoms; however, some people may have symptoms such as: headache confusion dizziness vision changes nausea seizures difficulty walking Some people have a genetic risk factor (homozygous apolipoprotein E ε4 gene carriers) that may cause an increased risk for ARIA. Talk to your healthcare provider about testing to see if you have this risk factor. You may be at a higher risk of developing bleeding in the brain if you take medicines to reduce blood clots from forming (antithrombotic medicines) while receiving KISUNLA. Your healthcare provider will do magnetic resonance imaging (MRI) scans before and during your treatment with KISUNLA to check you for ARIA. You should carry information that you are receiving KISUNLA which can cause ARIA, and that ARIA symptoms can look like stroke symptoms. Call your healthcare provider or go to the nearest hospital emergency room right away if you have any of the symptoms listed above. There are registries that collect information on treatments for Alzheimer's disease. Your healthcare provider can help you become enrolled in these registries. For more information, go to www.kisunla.com or call 1-800-LillyRx (1-800-545-5979).
Source: FDA drug label (Kisunla), Eli Lilly and Company, effective December 30, 2025 (SPL set 190352d4-ef62-4679-b4fa-e846e2766afa), via openFDA; the full label on DailyMed
Is there a generic for donanemab (Kisunla)?
No generic donanemab is approved (Drugs@FDA, October 8, 2026).
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the donanemab label say about other medicines?
The donanemab label names 2 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Acetaminophen | warnings and precautions | The infusion rate may be reduced, or the infusion may be discontinued, and appropriate therapy initiated as clinically indicated. Consider pre-treatment with antihistamines, acetaminophen, or corticosteroids prior to subsequent dosing. |
| Aspirin | warnings and precautions | The majority of exposures to antithrombotic medications were to aspirin. |
Source: FDA drug label (Kisunla), 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 for donanemab?
The FDA Adverse Event Reporting System holds 2,535 reports that list donanemab among the medicines taken, through July 30, 2026, 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.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as donanemab?
1 other medicine is given the same way (intravenous) and in the same FDA class as donanemab or labeled mainly for the same use (alzheimer's disease), the same class first. Alzheimer's disease lists all 7 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (intravenous) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Lecanemab | Alzheimer's disease | none listed | n/a | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Donanemab side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other