ArticlePharmaceuticals (Basel, Switzerland)2022
Liver Injury with Nintedanib: A Pharmacovigilance-Pharmacokinetic Appraisal.
Article in Pharmaceuticals (Basel, Switzerland), 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers, 1 of them a synthesis that pooled it.
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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
13 citing papers in PubMed, 1 synthesis or guideline pooled it, 17 citations in OpenAlex.
- Real-world safety and effectiveness of pirfenidone and nintedanib in the treatment of idiopathic pulmonary fibrosis: a systematic review and meta-analysis.European journal of clinical pharmacology · 2024Pooled it
- Improving the bioavailability of nintedanib by formulating inhalable ufasomes as a targeted therapy for non-small cell lung cancer.International journal of pharmaceutics: X · 2026Article
- Clinical profiles and risk predictors of drug-induced liver injury from pirfenidone and nintedanib used to treat idiopathic pulmonary fibrosis: a real-world analysis of a tertiary Chinese hospital cohort combined with FAERS data mining.Translational gastroenterology and hepatology · 2026Article
- Survival impact and safety comparison of pirfenidone and nintedanib for idiopathic pulmonary fibrosis: A meta-analysis.Sarcoidosis, vasculitis, and diffuse lung diseases : official journal of WASOG · 2025Article
- Unveiling the therapeutic mechanisms of Saorilao-4 decoction in pulmonary fibrosis through metabolomics and transcriptomics.Frontiers in nutrition · 2025Article
- Post-marketing safety concerns with pirfenidone and nintedanib: an analysis of individual case safety reports from the FDA adverse event reporting system database and the Japanese adverse drug event report databases.Frontiers in pharmacology · 2025Article
- Article
- Real-world evidence of brigatinib as second-line treatment after crizotinib for ALK+ non-small cell lung cancer using South Korean claims data (K-AREAL).Cancer medicine · 2024Article
- Pirfenidone-induced liver injury, a case report of a rare idiosyncratic reaction.Therapeutic advances in drug safety · 2024Article
- Adverse events related to neuromuscular blocking agents: a disproportionality analysis of the FDA adverse event reporting system.Frontiers in pharmacology · 2024Article
- Cardiovascular Adverse Events Associated with Monoclonal Antibody Products in Patients with COVID-19.Pharmaceuticals (Basel, Switzerland) · 2022Article
- Safety profile of tyrosine kinase inhibitors used in non-small-cell lung cancer: An analysis from the Italian pharmacovigilance database.Frontiers in oncology · 2022Article
- Disproportionality Analysis of Hepatotoxic and Gastrointestinal Adverse Events Associated With Nintedanib Using the Japanese Adverse Drug Event Report (JADER) Database.In vivo (Athens, Greece)Article
Corrections and comments
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Authors and funding
6 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Drug-induced liver injury (DILI) with nintedanib has emerged as an adverse event of special interest in premarketing clinical trials. We characterized DILI with nintedanib in the real world and explored the underlying pharmacological basis. First, we assessed serious hepatic events reported to the Food and Drug Administration's Adverse Event Reporting System by combining the disproportionality approach [reporting odds ratio (ROR) with 95% confidence interval (CI)] with individual case assessment. Demographic and clinical features were inspected (seriousness, onset, discontinuation,
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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.