ArticleFrontiers in pharmacology2023
Methotrexate-related adverse events and impact of concomitant treatment with folic acid and tumor necrosis factor-alpha inhibitors: An assessment using the FDA adverse event reporting system.
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 19 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
19 citing papers in PubMed.
- Potential impact of nicorandil on the pharmacodynamics of anti-angiogenic agents.Scientific reports · 2026Article
- Exploring the Reliability of Detecting Drug-Drug Interactions that Increase the Risk of Gestational Diabetes in Adverse Event Reporting Systems.Drug safety · 2026Article
- Atraumatic Splenic Rupture: A Case Report.Cureus · 2026Article
- Comprehensive pharmacovigilance assessment of pairwise drug-drug interactions and acute pancreatitis in the FDA adverse event reporting system: focus on incretin-based drugs.Frontiers in drug safety and regulation · 2026Article
- Trastuzumab-TKI combination in HER2-Positive tumors: a FAERS-Based safety profile and multimodal analysis of Tanespimycin's role in enhancing targeting of the HSP90AA1-PI3K-Akt-mTOR axis.Frontiers in pharmacology · 2026Article
- Drug-drug interactions between sex hormones and analgesics linked to thromboembolic events: an FDA adverse event reporting system analysis.Frontiers in pharmacology · 2026Article
- Modulation of SIRT-1, NF-κB/TNF-α/IL-6, and ERK/Caspase-3 by Lutein Mitigates Methotrexate-Induced Hepatotoxicity.Pharmaceuticals (Basel, Switzerland) · 2025Article
- Niosome-loaded silibinin and methotrexate for synergistic breast cancer combination chemotherapy: in silico and in vitro study.Cancer cell international · 2025Article
- Real-world pharmacovigilance assessment of hepatotoxicity risk with HER2-Targeted drugs using FAERS database analysis.Scientific reports · 2025Article
- Cardiotoxicity Assessment of EGFR Tyrosine Kinase Inhibitors Using Human iPS Cell-Derived Cardiomyocytes and FDA Adverse Events Reporting System.Clinical and translational science · 2025Article
- Methotrexate-related drug reactions on kidneys and liver in rheumatoid arthritis: an analysis of spontaneous reports in EudraVigilance.Arthritis research & therapy · 2025Article
- Nitazoxanide alleviates CFA-induced rheumatoid arthritis in Wistar rats by modulating the STAT-3 and NF-κB pathways.Rheumatology and immunology research · 2025Article
- Methotrexate-Induced Leukocytoclastic Vasculitis: A Case Report and Literature Review.Clinical, cosmetic and investigational dermatology · 2025Article
- Effects of Dietary Yeast β-1,3/1,6-D-Glucan on Immunomodulation in RAW 264.7 Cells and Methotrexate-Treated Rat Models.International journal of molecular sciences · 2024Article
- Successful Management of Cervical and Tubal Stump Double Pregnancy after Assisted Reproductive Technologies Using Multiple High Doses of Methotrexate: A Case Report.Iranian journal of medical sciences · 2024Article
- Drug-drug interaction assessment based on a large-scale spontaneous reporting system for hepato- and renal-toxicity, and thrombocytopenia with concomitant low-dose methotrexate and analgesics use.BMC pharmacology & toxicology · 2024Article
- Safety of Tocilizumab on Rheumatoid Arthritis in Patients with Interstitial Lung Disease.Open access rheumatology : research and reviews · 2024Article
- Progressive multifocal leukoencephalopathy reports in rheumatoid arthritis concerning different treatment patterns-an exploratory assessment using the food and drug administration adverse event reporting system.Frontiers in drug safety and regulation · 2024Article
- Co-Delivery of Aceclofenac and Methotrexate Nanoparticles Presents an Effective Treatment for Rheumatoid Arthritis.International journal of nanomedicine · 2024Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Methotrexate (MTX) is an essential anti-rheumatic drug used to treat rheumatoid arthritis (RA). Prevention or management of adverse reactions, including interstitial lung disease (ILD), hepatotoxicity, myelosuppression, and infection, remains fundamental for safe MTX therapy. Using the Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) (JAPIC AERS), we performed disproportionality analyses of adverse events related to MTX use and the impact of concomitant medications. Upon analyzing all reported cases in FAERS between 1997 and 2019, the crude reporting odds ratios (cRORs; 95% confidence intervals) for ILD, hepatotoxicity, myelosuppression, and tuberculosis (TB) in relation to MTX use were 4.00 (3.83-4.17), 1.99 (1.96-2.02), 3.66 (3.58-3.74), and 7.97 (7.65-8.3), respectively. Combining MTX with folic acid (FA) or tumor necrosis factor-alpha inhibitors (TNFis) tended to reduce cRORs for these adverse events (except for TB). Multiple logistic regression analysis in patients with RA was conducted to calculate adjusted reporting odds ratios (aRORs) for age, sex, and MTX treatment patterns (MTX alone and combined with FA and TNFi). Higher age (except for hepatotoxicity) and male sex were significantly associated with adverse events. Combining FA or TNFi with MTX reduced aRORs for MTX-related hepatotoxicity and myelosuppression; in contrast, the effect of FA was not obvious in ILD or TB. Although studies assessing spontaneous reporting systems have limitations such as reporting bias, data from our logistic regression analysis demonstrated that adding FA to MTX-based therapy could help reduce the dose-dependent adverse events of MTX, thereby providing clinical evidence that supports the beneficial effect of FA. This study also demonstrated the usefulness of FAERS in comparing adverse events based on treatment patterns.
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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.