ArticleInternational journal of clinical pharmacy2026
Post-marketing safety profile of cladribine in multiple sclerosis: a disproportionality analysis based on the FDA adverse event reporting system.
Article in International journal of clinical pharmacy, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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
3 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Efficacy and safety of IL-23p19 antagonists versus placebo in inflammatory bowel disease: a systematic review and meta‑analysis of randomized controlled trials.International journal of clinical pharmacy · 2025Pooled it
- Real-world safety profile of mitomycin: signal detection and time-to-onset analysis from FDA adverse event reporting system and VigiAccess databases.International journal of clinical pharmacy · 2025Article
- Real-world safety assessment of ublituximab: a pharmacovigilance analysis based on the FDA adverse event reporting system.International journal of clinical pharmacy · 2025Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors.
Funding
Abstract
introductionCladribine has been widely recognized as a therapeutic option for relapsing-remitting multiple sclerosis (MS), but there is still a dearth of real-world data regarding its safety profile.
aimThis study aimed to assess adverse events (AEs) linked to cladribine in MS patients, utilizing data from the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS).
methodAE reports identifying cladribine as the primary suspect drug were extracted from the U.S. FAERS, covering the period from the first quarter of 2019 to the third quarter of 2024. Four disproportionality methods-reporting odds ratio (ROR), proportional reporting ratio, Bayesian confidence propagation neural network, and empirical Bayes geometric mean-were employed to evaluate the association between cladribine and AEs. Furthermore, the Weibull distribution model was applied to analyze time-to-onset patterns, and subgroup analyses were conducted based on sex and age.
resultsAfter screening 4,833 cladribine-related reports, 113 preferred terms (PTs) were identified as positive across all four disproportionality methods. Known AEs such as pneumonia (n = 190, ROR 2.85), lymphopenia (n = 111, ROR 4.19), and drug-induced liver injury (n = 22, ROR 5.94). Unexpected events, including rheumatoid arthritis (ROR 5.64), hypothyroidism (ROR 5.04), eye hemorrhage (ROR 6.88), uveitis (ROR 4.86), retinal detachmen (ROR 4.37), brain edema (ROR 6.12), acute myocardial infarction (ROR 3.70), and completed suicide (ROR 7.46), were also reported. Stratified analysis revealed that females were at a higher risk of nausea, alopecia, and migraine, while males were more susceptible to gait disturbance and sepsis. Older adults (≥ 65 years) faced increased risks of leukopenia and urinary tract infections (UTIs). The median onset of AEs was 152 days, with the highest proportion (28.18%) reported in the first month. Weibull analysis indicated an early peak (shape parameter 0.72).
conclusionThis study not only corroborates previously established risks associated with cladribine but also uncovers new potential safety signals, highlighting the importance of vigilance for early acute toxicity.
Indexed as
Identifiers
What Socratic holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.