ArticleBMC pharmacology & toxicology2025
Drug-induced sinusoidal obstruction syndrome: a real-world pharmacovigilance study based on the FDA Adverse Event Reporting System (FEARS).
Article in BMC pharmacology & toxicology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
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.
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Who cites it
2 citing papers in PubMed.
- A real-world study of adverse event profiles associated with the four key components of antibody-drug conjugates based on the FAERS database.Frontiers in pharmacology · 2026Article
- Current landscape and clinical progress of targeted alpha radioimmunotherapy.American journal of nuclear medicine and molecular imaging · 2025Review
Corrections and comments
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Authors and funding
5 authors.
Funding
Abstract
backgroundHepatic Sinusoidal Obstruction Syndrome (SOS) represents a rare but serious adverse drug reaction. This study aimed to identify the medications most frequently associated with SOS risk through the analysis of the United States Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) database.
methodsWe queried the FAERS database using OpenVigil 2.1 to search for all reported cases of SOS from 2004Q1 to 2022Q3. The 50 most frequently reported medications were ranked based on reported odds ratio (ROR) and proportional reporting ratio (PRR) values. We also compared these drugs with those reported in the LiverTox
resultsA total of 1,976 SOS reports were indentified within the selected study period. Oxaliplatin was the most frequently reported medication associated with SOS, whereas the drug exhibited the strongest association with SOS death was busulfan. Disproportionality analysis revealed that the top five medications with the greatest association with SOS were tioguanine, inotuzumab ozogamicin, gemtuzumab ozogamicin, busulfan, and dactinomycin. Approximately half of the top 50 drugs (28 based on ROR and 27 based on PRR) were not outlined in LiverTox
conclusionsOur study offers a potential list of drugs commonly associated with SOS and identified several novel drugs associated with SOS that had not been previously described in LiverTox CLINICAL TRIAL NUMBER: Not applicable.
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