ArticleBritish journal of clinical pharmacology2016
Risk of acute and serious liver injury associated to nimesulide and other NSAIDs: data from drug-induced liver injury case-control study in Italy.
Article in British journal of clinical pharmacology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 27 papers, 1 of them a synthesis that pooled it.
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Who cites it
27 citing papers in PubMed, 1 synthesis or guideline pooled it, 87 citations in OpenAlex.
- Pooled it
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- Naproxen as a cause of acute cholestatic hepatitis: a case report.Journal of medical case reports · 2026Article
- Safety-I Versus Safety-II: A Mixed-Methods Study Revealing the Imbalance of Approaches in Primary Care Medication Safety.Journal of patient safety · 2025Article
- Ketoprofen Lysine Salt Versus Corticosteroids in Early Outpatient Management of Mild and Moderate COVID-19: A Retrospective Study.Pharmacy (Basel, Switzerland) · 2025Article
- Piperine as an Herbal Alternative for the Prevention of Drug-Induced Liver Damage Caused by Paracetamol.Pharmaceuticals (Basel, Switzerland) · 2024Article
- Alzheimer's Disease: Cellular and Pharmacological Aspects.Geriatrics (Basel, Switzerland) · 2024Review
- Nimesulide, a COX-2 inhibitor, sensitizes pancreatic cancer cells to TRAIL-induced apoptosis by promoting DR5 clustering †.Cancer biology & therapy · 2023Article
- Phase 1 study of the safety, pharmacokinetics, and preliminary efficacy of CA102N as monotherapy and in combination with trifluridine-tipiracil in patients with locally advanced or metastatic solid tumors.Investigational new drugs · 2023Article
- Home as the new frontier for the treatment of COVID-19: the case for anti-inflammatory agents.The Lancet. Infectious diseases · 2023Review
- Binaprofen induces zebrafish liver injury via the mitochondrial pathway.Molecular medicine reports · 2022Article
- New Insights Into the Pharmacological Management of Postoperative Pain: A Narrative Review.Cureus · 2022Review
- A Home-Treatment Algorithm Based on Anti-inflammatory Drugs to Prevent Hospitalization of Patients With Early COVID-19: A Matched-Cohort Study (COVER 2).Frontiers in medicine · 2022Article
- Ketogal Safety Profile in Human Primary Colonic Epithelial Cells and in Mice.Pharmaceuticals (Basel, Switzerland) · 2021Article
- Nimesulide poisoning in white-rumped vulture Gyps bengalensis in Gujarat, India.Environmental science and pollution research international · 2021Article
- A simple, home-therapy algorithm to prevent hospitalisation for COVID-19 patients: A retrospective observational matched-cohort study.EClinicalMedicine · 2021Article
- Serious liver injury induced by Nimesulide: an international collaborative study.Archives of toxicology · 2021Article
- Association of Direct Oral Anticoagulants (DOACs) and Warfarin With Haemorrhagic Risk by Applying Correspondence Analysis to Data From the Italian Pharmacovigilance Database - A Case Study.Frontiers in pharmacology · 2021Article
- Can Nimesulide Nanoparticles Be a Therapeutic Strategy for the Inhibition of the KRAS/PTEN Signaling Pathway in Pancreatic Cancer?Frontiers in oncology · 2021Review
- S-allyl-L-cysteine protects hepatocytes from indomethacin-induced apoptosis by attenuating endoplasmic reticulum stress.FEBS open bio · 2020Article
Corrections and comments
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Authors and funding
15 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
aimDrug-induced liver injury is one of the most serious adverse drug reactions and the most frequent reason for restriction of indications or withdrawal of drugs. Some nonsteroidal anti-inflammatory drugs (NSAIDs) were withdrawn from the market because of serious hepatotoxicity. We estimated the risk of acute and serious liver injury associated with the use of nimesulide and other NSAIDs, with a prevalence of use greater than or equal to 5%.
methodsThis is a multicentre case-control study carried out in nine Italian hospitals from October 2010 to January 2014. Cases were adults, with a diagnosis of acute liver injury. Controls presented acute clinical disorders not related to chronic conditions, not involving the liver. Adjusted odds ratio (ORs) with 95% confidence interval (CI) were calculated initially with a bivariate and then multivariate analysis.
resultsWe included 179 cases matched to 1770 controls. Adjusted OR for acute serious liver injury associated with all NSAIDs was 1.69, 95% CI 1.21-2.37. Thirty cases were exposed to nimesulide (adjusted OR 2.10, 95% CI 1.28-3.47); the risk increased according to the length of exposure (OR > 30 days: 12.55, 95% CI 1.73-90.88) and to higher doses (OR 10.69, 95% CI 4.02-28.44). Risk of hepatotoxicity was increased also for ibuprofen, used both at recommended dosages (OR 1.92, 95% CI 1.13-3.26) and at higher doses (OR 3.73, 95% CI 1.11-12.46) and for ketoprofen ≥ 150 mg (OR 4.65, 95% CI 1.33-10.00).
conclusionAmong all NSAIDs, nimesulide is associated with the higher risk, ibuprofen and high doses of ketoprofen are also associated with a modestly increased risk of hepatotoxicity.
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