ArticleIn vivo (Athens, Greece)
Disproportionality Analysis of Hepatotoxic and Gastrointestinal Adverse Events Associated With Nintedanib Using the Japanese Adverse Drug Event Report (JADER) Database.
Article in In vivo (Athens, Greece). The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
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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.
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Who cites it
2 citing papers in PubMed.
- Real-World Experience with Nintedanib in a Progressive Pulmonary Fibrosis Cohort.Medicina (Kaunas, Lithuania) · 2026Observational
- Advances in Targeted and Systemic Therapy for Salivary Gland Carcinomas: Current Options and Future Directions.Current oncology (Toronto, Ont.) · 2025Review
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Authors and funding
7 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
BACKGROUND/
aimNintedanib may cause adverse events such as elevated liver enzyme levels, diarrhea, and decreased appetite. These adverse events should be managed appropriately as they affect the quality of life of patients. This study has aimed to analyze patient characteristics and time-to-onset of adverse events caused by nintedanib using the Japanese Adverse Drug Event Report (JADER) database. PATIENTS AND
methodsData from April 2004 to June 2023 were extracted from the JADER database and the patient characteristics of nintedanib administration were evaluated using reported odds ratio (ROR) and 95% confidence interval (95%CI). The data were analyzed for time-to-onset and patient characteristics such as age, sex, body mass index (BMI), and the presence or absence of prednisolone.
resultsThe JADER database included 1,419 adverse event reports in which nintedanib was suspected. The number (%) and ROR of adverse events known to occur with the use of nintedanib were 72 (5.07%) cases of decreased appetite [ROR=7.09 (95%CI=5.59-8.99)], and 79 (5.57%) cases of diarrhea [ROR=6.52 (5.19-8.18)]. The median days until onset were 19.5 (IQR=6.25-50.5) days for hepatotoxicity, 119.5 (IQR=24.5-258.5) days for diarrhea, and 131.5 (IQR=20.5-334.5) days for decreased appetite.
conclusionNintedanib is more likely to cause elevated liver enzyme levels, diarrhea, and decreased appetite than other drugs. These events occurred within approximately 3-4 months. The concomitant use of prednisolone may also be associated with gastrointestinal hemorrhage.
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