ArticleAlzheimer's research & therapy2025
Post-marketing safety concerns with lecanemab: a pharmacovigilance study based on the FDA Adverse Event Reporting System database.
Article in Alzheimer's research & therapy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers, 2 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
19 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Regulatory, clinical, and post-marketing challenges of lecanemab for Alzheimer's disease: insights from real-world data.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2026Pooled it
- Comparative efficacy and safety of symptomatic therapy and disease-modifying therapy for Alzheimer's disease: a systematic review and network meta-analysis.Frontiers in neuroscience · 2025Pooled it
- Post-marketing safety profile of bictegravir/emtricitabine/tenofovir alafenamide: a FAERS pharmacovigilance study with EudraVigilance validation and mechanistic investigation of pancreatitis.Virology journal · 2026Article
- Muscle toxicity reports in FAERS: a disproportionality analysis with focus on rhabdomyolysis and cross-database assessment.Frontiers in pharmacology · 2026Article
- Real‑world safety evaluation of tranexamic acid: Signal detection from FAERS and VigiAccess databases.PloS one · 2026Article
- Post-marketing safety of lecanemab: a real-world study based on FAERS database, multicenter cohort and network pharmacology.Frontiers in psychiatry · 2026Article
- Post-marketing safety profile of lumacaftor/ivacaftor in cystic fibrosis treatment: a pharmacovigilance analysis based on FAERS.Frontiers in medicine · 2026Article
- Post-market safety profile and suicide risk signals of vortioxetine: a real-world pharmacovigilance study.Frontiers in pharmacology · 2026Article
- Amyloid-targeting treatment in Alzheimer's disease and concomitant antiplatelets: a clinical gray zone?Frontiers in neurology · 2026Article
- The Biomarker Profile of Alzheimer's Disease for Disease-Modifying Treatment Eligibility: Questions and Debates.International journal of molecular sciences · 2025Review
- Doxycycline: An essential tool for Alzheimer's disease.Biomedicine & pharmacotherapy = Biomedecine & pharmacotherapie · 2025Review
- Characteristics of Adverse Events and Clinical Risks of Omaveloxolone Based on FAERS Data.Cerebellum (London, England) · 2025Article
- Response to Xing et al.: post-marketing safety concerns with Lecanemab: a pharmacovigilance study based on the FDA adverse event reporting system database.Alzheimer's research & therapy · 2025Article
- Post-marketing safety profile of ganirelix in women: a 20-year pharmacovigilance analysis of global adverse drug event databases (2004-2024).BMC pharmacology & toxicology · 2025Article
- Long-term surveillance of the anti-amyloid monoclonal antibody lecanemab: rights and duties of pharmacovigilance.Alzheimer's research & therapy · 2025Article
- Post-marketing safety concerns with pirfenidone and nintedanib: an analysis of individual case safety reports from the FDA adverse event reporting system database and the Japanese adverse drug event report databases.Frontiers in pharmacology · 2025Article
- Comparison of safety of lecanemab and aducanumab: a real-world disproportionality analysis using the FDA adverse event reporting system.Frontiers in pharmacology · 2025Article
- Oncology drug repurposing as a blueprint for Alzheimer's therapy.Alzheimer's & dementia (New York, N. Y.)Article
- Analysis signals of disproportionate reporting associated with donanemab: A retrospective pharmacovigilance study using the FAERS database.Science progressArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe safety data of lecanemab in the post-marketing period has yet to be fully investigated in the current literature. We aimed to identify and characterise the safety profile of lecanemab in the post-marketing period.
methodsWe searched and reviewed the reports submitted to the FDA's Adverse Event Reporting System (FAERS). We used a case/non-case approach to estimate the reporting odds ratio (ROR) and information component (IC) with 95% confidence intervals (CI) for lecanemab-related adverse events (AEs) reported at least four counts. We compared the difference between serious and non-serious reports using non-parametric tests.
resultsThe FAERS recorded 1,986 lecanemab-related AEs affecting 868 patients. Two hundred and three patients experienced serious AEs, including 22 deaths. The most frequently reported AEs were headache (n = 193), chills (n = 100), fatigue (n = 93), and amyloid-related imaging abnormality-oedema/effusion (ARIA-E) (n = 91). Safety signals were detected, such as headache (ROR: 10.4, 95%CI: 8.97, 12.07; IC: 3.25, 95%CI: 2.97, 3.40), ARIA-E (ROR: 18,299.69, 95%CI: 14,001.27, 23,917.73; IC: 13.37, 95%CI: 6.15, 6.87), and infusion-related reaction (ROR: 35.25, 95CI 27.58, 45.07; IC: 5.09, 95CI 4.15, 4.87). We also identified several new AEs, such as migraine and pancreatic carcinoma. Patients with serious AEs were more likely to be on polypharmacy for Alzheimer's disease and use aspirin, acid-suppressing medications, statins, antidepressants, or benzodiazepines compared to those with non-serious AEs.
conclusionsLecanemab may have a significant potential for AEs. Our results provide evidence for healthcare professionals and patients to weigh the risks and benefits of lecanemab treatment. Further prospective studies are needed to explore rare and unexpected AEs.
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