ArticleFrontiers in pharmacology2021
Potential Adverse Events Reported With the Janus Kinase Inhibitors Approved for the Treatment of Rheumatoid Arthritis Using Spontaneous Reports and Online Patient Reviews.
Article in Frontiers in pharmacology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers.
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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
18 citing papers in PubMed, 26 citations in OpenAlex.
- Characteristics of adverse event reporting of Xeljanz/Xeljanz XR, Olumiant, and Rinvoq to the US Food and Drug Administration.Journal of managed care & specialty pharmacy · 2022Trial
- Janus Kinase Inhibitors and Body Weight: Current Evidence and Potential.Life (Basel, Switzerland) · 2026Review
- Necrotizing scleritis resistant to biologics successfully managed with the JAK inhibitor upadacitinib: a case report.Journal of ophthalmic inflammation and infection · 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
- Comparing drug combinations for graft-versus-host disease prophylaxis using the U.S. Food and Drug Administration Adverse Event Reporting System.Clinical transplantation and research · 2025Article
- Safety of Advanced Combination Treatment With Selective JAK1 Inhibitors and Biological Therapies in Inflammatory Bowel Diseases: A Real World Experience.Alimentary pharmacology & therapeutics · 2025Article
- Weight gain secondary to the use of oral Janus kinase inhibitors: A systematic review and meta-analysis.JAAD international · 2025Review
- Cancer Risk in IBD Patients Treated with JAK Inhibitors: Reassuring Evidence from Trials and Real-World Data.Cancers · 2025Review
- Fracture-Related Safety Reporting of JAK Inhibitors: An Analysis from the WHO Global VigiBase.Drug safety · 2025Article
- First-in-human study of CPL'116 - a dual JAK/ROCK inhibitor - in healthy subjects.Frontiers in pharmacology · 2025Article
- Adverse events of ursodeoxycholic acid: a real-world pharmacovigilance study using FAERS (2004-2023).Frontiers in medicine · 2025Article
- Efficacy and safety of tofacitinib on COVID-19 patients: A systematic review and meta-analysis.Heliyon · 2024Article
- The Value of Social Media Analysis for Adverse Events Detection and Pharmacovigilance: Scoping Review.JMIR public health and surveillance · 2024Article
- Drug-induced interstitial lung disease: a real-world pharmacovigilance study of the FDA Adverse Event Reporting System from 2004 to 2021.Therapeutic advances in drug safety · 2024Article
- Comparative analysis of semaglutide induced adverse reactions: Insights from FAERS database and social media reviews with a focus on oral vs subcutaneous administration.Frontiers in pharmacology · 2024Article
- Systematic Literature Review of Real-World Evidence on Baricitinib for the Treatment of Rheumatoid Arthritis.Rheumatology and therapy · 2023Review
- Cardiovascular risk of Janus kinase inhibitors compared with biologic disease-modifying antirheumatic drugs in patients with rheumatoid arthritis without underlying cardiovascular diseases: a nationwide cohort study.Frontiers in pharmacology · 2023Article
- Safety of triazole antifungals: a pharmacovigilance study from 2004 to 2021 based on FAERS.Therapeutic advances in drug safety · 2022Article
Corrections and comments
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Authors and funding
4 authors at 4 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
The aim of this study was to analyze the potential adverse events (AEs) caused by Janus kinase (JAK) inhibitors, including tofacitinib, baricitinib, and upadacitinib, used to treat rheumatoid arthritis using spontaneous AE reports from the FDA (FAERS) and interpreting them in correlation with those from Korea (KAERS) and an online patient review (WebMD). Potential AEs were identified based on a disproportionality analysis using the proportional reporting ratio (PRR), reporting odds ratio (ROR), and the information component (IC). A total of 23,720 reports were analyzed from FAERS database, of which 91.5% were reports on tofacitinib. Potentially important medical AEs related to infections were reported frequently, as well as thromboembolism-related AEs. The AEs, such as malignancy, interstitial lung diseases, myocardial infarction, and gastrointestinal disorder, also reported. In an online patient review report, the ineffectiveness of the drug and gastrointestinal AEs were frequently reported. Infection with baricitinib and symptoms related to pain or edema due to upadacitinib were the main discomfort experienced by patients. In conclusion, the results of this study highlight the possible safety issues associated with JAK inhibitors. Routine clinical observations and further research using various real-world databases are needed.
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