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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.

LECANEMAB-IRMB: 2,469 Adverse Event Reports & Safety Profile

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2,469
Total FAERS Reports
82 (3.3%)
Deaths Reported
474
Hospitalizations
2,469
As Primary/Secondary Suspect
18
Life-Threatening
20
Disabilities
Eisai Inc.
Manufacturer
Prescription
Status

Drug Class: Amyloid Beta-directed Antibody Interactions [MoA] · Manufacturer: Eisai Inc. · FDA Application: 761269 ·

First Report: 20140101 · Latest Report: 20250915

What Are the Most Common LECANEMAB-IRMB Side Effects?

#1 Most Reported
Headache
399 reports (16.2%)
#2 Most Reported
Amyloid related imaging abnormality-oedema/effusion
307 reports (12.4%)
#3 Most Reported
Amyloid related imaging abnormality-microhaemorrhages and haemosiderin deposits
298 reports (12.1%)

All LECANEMAB-IRMB Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Headache 399 16.2% 1 27
Amyloid related imaging abnormality-oedema/effusion 307 12.4% 4 80
Amyloid related imaging abnormality-microhaemorrhages and haemosiderin deposits 298 12.1% 3 53
Infusion related reaction 219 8.9% 2 85
Chills 205 8.3% 1 13
Fatigue 178 7.2% 0 10
Pyrexia 135 5.5% 0 21
Confusional state 132 5.4% 1 21
Dizziness 126 5.1% 1 17
Nausea 119 4.8% 2 9
Tremor 74 3.0% 0 7
Amyloid related imaging abnormalities 72 2.9% 0 9
Fall 69 2.8% 5 33
Vomiting 69 2.8% 1 12
Cerebral haemorrhage 63 2.6% 9 27
Asthenia 62 2.5% 1 11
Influenza like illness 61 2.5% 0 0
Pain 50 2.0% 0 2
Diarrhoea 49 2.0% 0 8
Somnolence 44 1.8% 0 2

Who Reports LECANEMAB-IRMB Side Effects? Age & Gender Data

Gender: 58.6% female, 41.4% male. Average age: 74.1 years. Most reports from: US. View detailed demographics →

Is LECANEMAB-IRMB Getting Safer? Reports by Year

YearReportsDeathsHosp.
2014 1 0 0
2023 400 3 22
2024 1,081 40 242
2025 519 30 158

View full timeline →

What Is LECANEMAB-IRMB Used For?

IndicationReports
Dementia alzheimer's type 1,473
Product used for unknown indication 720
Cognitive disorder 282
Dementia 30

LECANEMAB-IRMB vs Alternatives: Which Is Safer?

LECANEMAB-IRMB vs LECITHIN\POLOXAMER 407 LECANEMAB-IRMB vs LEDIPASVIR LECANEMAB-IRMB vs LEDIPASVIR\SOFOSBUVIR LECANEMAB-IRMB vs LEFLUNOMIDE LECANEMAB-IRMB vs LEMBOREXANT LECANEMAB-IRMB vs LENACAPAVIR LECANEMAB-IRMB vs LENALIDOMIDE LECANEMAB-IRMB vs LENIOLISIB LECANEMAB-IRMB vs LENOGRASTIM LECANEMAB-IRMB vs LENVATINIB

Other Drugs in Same Class: Amyloid Beta-directed Antibody Interactions [MoA]

LECANEMAB (171) View all → Class side effects → Compare in class →

Official FDA Label for LECANEMAB-IRMB

Official prescribing information from the FDA-approved drug label.