ArticleFrontiers in pharmacology2023
A real-world pharmacovigilance study of mepolizumab in the FDA adverse event reporting system (FAERS) database.
Article in Frontiers in pharmacology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 42 papers.
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
42 citing papers in PubMed, 54 citations in OpenAlex.
- QT Prolongation, Ventricular Arrhythmia, and Cardiac Arrest Signals During Ceftriaxone Co-therapy with Individual Proton Pump Inhibitors: A Multidatabase Study.Cardiovascular toxicology · 2026Observational
- Tiopronin safety in cystinuria: first real-world pharmacovigilance analysis using the FDA Adverse Event Reporting System (FAERS): an EAU YAU and Endourology sections review.Pediatric nephrology (Berlin, Germany) · 2026Article
- Systematic analysis of adverse reaction signals induced by leflunomide, upadacitinib, and baricitinib in the treatment of rheumatoid arthritis: a FAERS database analysis.Frontiers in medicine · 2026Article
- Thromboembolic adverse events associated with TPO-RA in ITP treatment: a pharmacovigilance analysis of the FDA Adverse Event Reporting System.Frontiers in immunology · 2026Article
- A Real-World Disproportionality Analysis of FDA Adverse Event Reporting System Events for Tazemetostat.Therapeutic innovation & regulatory science · 2026Article
- Anthracycline Cardiotoxicity: A Real-World Study Based on FDA Adverse Event Reporting System Database.Cardiovascular therapeutics · 2026Article
- Adverse event reporting signals for SGLT-2 inhibitor-metformin combination therapy: a disproportionality analysis of the FAERS database.Frontiers in endocrinology · 2026Article
- 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
- Analysis of Adverse Drug Reactions of Clofazimine Reported in the FDA Adverse Event Reporting System from 2004 to 2025 Q1.Infectious diseases and therapy · 2025Article
- Eosinophil CD48 interactions with Candida albicans Als6 is protective in vitro and in mouse systemic candidiasis.Nature communications · 2025Article
- FDA-Approved Biologics for CRSwNP: A Five-Year Analysis of the FDA Adverse Event Reporting System.Laryngoscope investigative otolaryngology · 2025Article
- Immune checkpoint inhibitor-associated myocarditis and pericarditis: a pharmacovigilance study based on the FAERS database.BMC cancer · 2025Article
- Recombinant BCG Expressing IL-12 as A Novel Immunomodulatory Strategy for Allergic Asthma: Opportunities and Challenges.Clinical reviews in allergy & immunology · 2025Review
- Postmarketing safety evaluation of pemetrexed using FAERS and JADER databases.Scientific reports · 2025Article
- A real-world pharmacovigilance study of omalizumab using disproportionality analysis in the FDA adverse drug events reporting system database.Scientific reports · 2025Article
- Case Report: Omalizumab-associated hair loss: a case of eyebrow alopecia areata, literature review and FAERS database analysis.Frontiers in medicine · 2025Article
- Safety Profile of Statins for Post-Marketing Adverse Cardiovascular Events: A Real-World Pharmacovigilance Analysis.Endocrine, metabolic & immune disorders drug targets · 2025Article
- A post-marketing disproportionality analysis of the safety of ribociclib based on the FDA Adverse Event Reporting System.Therapeutic advances in drug safety · 2025Article
- Signal mining and analysis of ripretinib adverse events: a real-world pharmacovigilance analysis based on the FAERS database.Frontiers in pharmacology · 2025Article
- Safety assessment of ripretinib: a real-world adverse event analysis from the food and drug administration adverse event reporting system.Frontiers in oncology · 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
9 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Mepolizumab is primarily used in the treatment of asthma, eosinophilic granulomatosis with polyangiitis, eosinophilia syndrome, and chronic rhinitis with nasal polyps. The information about its adverse drug reactions is mainly derived from clinical trials, and there is a shortage of real-world studies with extensive sample sizes. In this study, the U.S. FDA's Adverse Event Reporting System (FAERS) database was analyzed to evaluate the side effects of mepolizumab. A total of 18,040 reports of mepolizumab-associated adverse events were identified from the FDA Adverse Event Reporting System database. Multiple disproportionality analysis algorithms were used to determine the significance of these AEs. The study identified 198 instances of mepolizumab-induced AEs, including some important AEs not mentioned in the product labeling. The time to onset of adverse reactions was also analyzed, with a median time of 109 days. Most AEs occurred within the first month of mepolizumab use, but some may still occur after 1 year of treatment. Gender-specific analysis showed different high-risk AEs for females (digestive and neurological side effects) and males (serious adverse effects leading to hospitalization and death). The findings mentioned provide valuable insights on optimizing the use of mepolizumab, enhancing its effectiveness, and minimizing potential side effects. This information will greatly contribute to the practical implementation of the drug in clinical settings.
Indexed as
Identifiers
What OpenQuestion 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 OpenQuestion graph.