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Disproportionality analysis of adverse event signals associated with seven Alzheimer's drugs: insights from the FAERS database
Liu K, Yang X, Kong L.. Frontiers in pharmacology, 2026-09-24
Topic: Amyloid, tau and blood-test diagnosis
Objective To compare adverse event reporting patterns for seven Alzheimer's disease (AD) drugs (aducanumab, donanemab, lecanemab, donepezil, galantamine, rivastigmine, and memantine) using the FDA Adverse Event Reporting System (FAERS), and to explore potential reporting signals. Methods FAERS reports from the first quarter of 2004 to the second quarter of 2026 were retrospectively analyzed. Adverse events were coded using MedDRA version 28.1 preferred terms (PTs) and system organ classes (SOCs). Disproportionality signals were detected using the reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian confidence propagation neural network (BCPNN), and multi-item gamma-Poisson shrinker (MGPS). PT-level signals were additionally controlled using Benjamini-Hochberg false discovery rate correction. Drug-level comparisons, sex- and age-stratified analyses, time-to-onset (TTO) analysis, and Weibull distribution fitting were performed. Results A total of 39,301 valid reports involving the seven AD drugs were included. Reports were more frequent among women (52.3%, n = 20,537) and patients aged ≥65 years. Anti-Aβ monoclonal antibodies showed concentrated reporting signals in nervous system disorders, with amyloid related imaging abnormalities (ARIA) related events as the core PT-level signal. Donanemab and lecanemab were also associated with prominent infusion-related reaction signals. Conventional symptomatic drugs demonstrated broader multi-system reporting patterns: donepezil and galantamine were mainly associated with cholinergic cardiovascular and fall-related signals; rivastigmine with administration-site reactions and fall-related events; and memantine with confusional state, agitation, dizziness, and somnolence. Several PT-level signals were not listed in the reviewed prescribing information and were annotated as potential reporting signals. Sex- and age-stratified analyses showed broadly consistent PT-level spectra. TTO analyses revealed heterogeneous onset patterns among different drug and adverse events. Conclusion This study utilized FAERS data to compare adverse event reporting signals for seven anti-AD drugs. Distinct reporting profiles were observed across drugs, and several potential ADE signals, including potential unlabeled reporting signals, were identified. These findings may support pharmacovigilance surveillance and hypothesis generation, but should be interpreted as reporting associations rather than evidence of causality.
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APA 7th
Liu, K., Yang, X., & Kong, L. (2026). Disproportionality analysis of adverse event signals associated with seven Alzheimer's drugs: insights from the FAERS database. Frontiers in pharmacology. https://doi.org/10.3389/fphar.2026.1955230
Vancouver
Liu K, Yang X, Kong L. Disproportionality analysis of adverse event signals associated with seven Alzheimer's drugs: insights from the FAERS database. Frontiers in pharmacology. 2026. doi:10.3389/fphar.2026.1955230. PMID: 42851720.
BibTeX
@article{liu2026-42851720,
author = {Liu, K. and Yang, X. and Kong, L.},
title = {{Disproportionality analysis of adverse event signals associated with seven Alzheimer's drugs: insights from the FAERS database}},
journal = {Frontiers in pharmacology},
year = {2026},
doi = {10.3389/fphar.2026.1955230},
pmid = {42851720},
url = {https://doi.org/10.3389/fphar.2026.1955230}
}
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Key findings
- Results A total of 39,301 valid reports involving the seven AD drugs were included.
- Donanemab and lecanemab were also associated with prominent infusion-related reaction signals.
- Conventional symptomatic drugs demonstrated broader multi-system reporting patterns: donepezil and galantamine were mainly associated with cholinergic cardiovascular and fall-related signals; rivastigmine with administration-site reactions and fall-related events; and memantine with confusional state, agitation, dizziness, and somnolence.
- TTO analyses revealed heterogeneous onset patterns among different drug and adverse events.
- These findings may support pharmacovigilance surveillance and hypothesis generation, but should be interpreted as reporting associations rather than evidence of causality.
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Study details
- Participants20,537
- Effect size52.3%
- Evidence strengthLow
How this study scored 59/100
Published in a peer-reviewed journal. Scored zero for study design and randomised / blinded because the record does not state it. We have no data on journal's citation record, times cited, citations per year, impact for its field and year, cited by studies here, still being cited, senior author's track record, institution's track record and multi-centre collaboration, so those were left out: it earned 34 of the 58 points we could judge it on, which is 59 out of 100.
| Component | Points | Why |
|---|---|---|
| Journal tier | 7 / 10 | Tier 3 — peer-reviewed journal (Frontiers in pharmacology) |
| Journal's citation record | — / 4 | No journal record from OpenAlex — left out of this score |
| Study design | 0 / 12 | No study design recorded — scores zero, not guessed (not stated in the record — scored 0) |
| Strength of evidence | 1 / 5 | Rated “low” in our summary |
| Peer-review validation | 10 / 10 | Peer-reviewed. Published as an article in a named peer-reviewed journal. |
| How recent | 5 / 5 | 2026 — within 1 year(s) of the newest study here |
| Sample size | 4 / 4 | 20,537 participants |
| Effect reported | 2 / 3 | Effect reported as a number, without an interval or test |
| Studied in people | 3 / 3 | Studied in people (participant count stated) |
| Randomised / blinded | 0 / 2 | No randomisation or blinding stated — scores zero (not stated in the record — scored 0) |
| Times cited | — / 7 | No citation count (not found in OpenAlex) — left out of this score |
| Citations per year | — / 5 | No citation count or no year — left out of this score |
| Impact for its field and year | — / 6 | No field-weighted citation impact (OpenAlex has none yet) — left out of this score |
| Cited by studies here | — / 6 | Not yet checked against this library's citation graph — left out of this score |
| Still being cited | — / 4 | No yearly citation counts — left out of this score |
| Senior author's track record | — / 4 | Senior author's record not available — left out of this score |
| Institution's track record | — / 3 | No institution listed in OpenAlex — left out of this score |
| Multi-centre collaboration | — / 3 | Institutions not listed — left out of this score |
| Indexed in PubMed | 2 / 2 | Indexed in PubMed (PMID 42851720) |
| Free to read | 0 / 2 | Behind a paywall — scores zero |
| Points | 34 / 58 | Scored on 11 of 20 parts. We have no data for the rest, so they are left out: 34 of the 58 points we could judge it on is 59 out of 100. |
| Total | 59 / 100 | — |
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