Prescription medicine
Lecanemab Brand names: Leqembi
Lecanemab (Leqembi) is a prescription medicine. No generic is listed in FDA's NDC Directory.
- No generic listed
- Boxed warning
Check it at the source: the lecanemab FDA label on DailyMed (effective July 21, 2026); every lecanemab label on DailyMed.
Highlights of the record
FDA label of July 21, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
AMYLOID RELATED IMAGING ABNORMALITIES.
Monoclonal antibodies directed against aggregated forms of beta amyloid, including LEQEMBI, 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 to a patient being treated with LEQEMBI [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 LEQEMBI, have a higher incidence of ARIA, including symptomatic, serious, and severe radiographic ARIA, compared to heterozygotes and noncarriers. Testing for ApoE ε4 status should be performed prior to initiation of treatment to inform the risk of developing ARIA. […]
Used for
From the label: indications and usageLEQEMBI is indicated for the treatment of Alzheimer’s disease.
Forms and strengths
- 100 mg/ml
- 200 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
- 3,591 through July 30, 2026
What is lecanemab used for?
From the label: indications and usageLEQEMBI is indicated for the treatment of Alzheimer’s disease. Treatment with LEQEMBI should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials. LEQEMBI is an amyloid beta-directed antibody indicated for the treatment of Alzheimer’s disease. Treatment with LEQEMBI should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials.
Conditions named in the indications of lecanemab's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Amyloid Beta-directed Antibody.
Source: FDA drug label (LEQEMBI), Eisai Inc., effective July 21, 2026 (SPL set 9d1ff786-e577-410a-a273-c4d7d0e4e975), via openFDA; the full label on DailyMed
What does the patient leaflet for lecanemab 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 LEQEMBI?LEQEMBI can cause serious side effects including: Amyloid Related Imaging Abnormalities or “ARIA”. ARIA is a 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 ○ vision changes ○ seizures ○ confusion ○ nausea ○ difficulty speaking ○ dizziness ○ difficulty walking ○ muscle weakness Some people have a genetic risk factor (homozygous apolipoprotein E 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 LEQEMBI. Your healthcare provider will do magnetic resonance imaging (MRI) scans before and during your treatment with LEQEMBI to check you for ARIA. You should carry information that you are receiving LEQEMBI 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, call Eisai at 888-274-2378.
From the patient leaflet: How should I store LEQEMBI IQLIK ?Store LEQEMBI IQLIK autoinjectors in a refrigerator between 36°F to 46°F (2°C to 8°C). Do not freeze. Keep LEQEMBI IQLIK autoinjectors in the original carton until ready to use, to protect from light. LEQEMBI IQLIK may be stored at room temperature up to 77°F (25°C) for up to 14 days in the original carton. Do not place it back in the refrigerator if it has been brought to room temperature. Do not shake LEQEMBI IQLIK. Throw away (dispose of) LEQEMBI IQLIK that is out of date, or if it is not stored the right way. Keep LEQEMBI IQLIK and all medicines out of the reach of children.
Source: FDA drug label (LEQEMBI), Eisai Inc., effective July 21, 2026 (SPL set 9d1ff786-e577-410a-a273-c4d7d0e4e975), via openFDA; the full label on DailyMed
Is there a generic for lecanemab (Leqembi)?
No generic lecanemab 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 lecanemab label say about other medicines?
The lecanemab 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 | Consider prophylactic treatment with antihistamines, acetaminophen, nonsteroidal anti-inflammatory drugs, or corticosteroids prior to future infusions. |
| Aspirin | warnings and precautions | The majority of exposures to antithrombotic medications were to aspirin. |
Source: FDA drug label (LEQEMBI), Eisai Inc., effective July 21, 2026 (SPL set 9d1ff786-e577-410a-a273-c4d7d0e4e975), via openFDA; the full label on DailyMed
What do FAERS reports show for lecanemab?
The FDA Adverse Event Reporting System holds 3,591 reports that list lecanemab among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 154 are coded as a death and 898 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 2024 (1,410, 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 lecanemab?
1 other medicine is given the same way (intravenous) and in the same FDA class as lecanemab 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 |
|---|---|---|---|---|
| Donanemab | 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?
- Lecanemab side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other