ArticleOrphanet journal of rare diseases2026
Real-world safety assessment of burosumab: a pharmacovigilance study utilizing the FDA adverse event reporting system.
Article in Orphanet journal of rare diseases, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
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
1 citing paper in PubMed.
- Real-world safety profile of givinostat: an early post-marketing pharmacovigilance study based on the FAERS database.Frontiers in pharmacology · 2026Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
2 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveThis study aims to evaluate the adverse events (AEs) associated with burosumab in real-world clinical practice using data from the United States Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS), and to provide evidence for optimizing its clinical safety management.
methodsData for this study were retrieved from the FAERS database via OpenVigil 2.1, covering the period from the first quarter of 2018 to the third quarter of 2024. Disproportionality analyses were performed to quantify adverse event signals associated with burosumab, employing four established methods: Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Multi-Item Gamma Poisson Shrinker (MGPS), and Bayesian Confidence Propagation Neural Network (BCPNN).
resultsA total of 5054 adverse events (AEs) associated with burosumab were identified. Commonly reported AEs included injection site reactions, musculoskeletal pain, restless leg syndrome, skeletal deformities, and corrective orthopedic surgeries necessitated by severe bone deformities. Additionally, several concerning AEs were observed, such as hyperparathyroidism, tertiary hyperparathyroidism, nephrocalcinosis, and dental and periodontal complications.
conclusionThis study provides an initial evaluation of burosumab’s safety in real-world practice, identifying noteworthy adverse event signals that broaden current understanding and support more informed prescribing decisions for patients with XLH.
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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.