ArticleScientific reports2022
A real-world pharmacovigilance study of FDA adverse event reporting system (FAERS) events for niraparib.
Article in Scientific reports, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 46 papers.
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Who cites it
46 citing papers in PubMed, 85 citations in OpenAlex.
- Comparative Pharmacovigilance Analysis of Safety Signals Among Advanced Prostate Cancer Therapies Using FAERS (FDA Adverse Event Reporting System).Current oncology (Toronto, Ont.) · 2026Article
- Evaluating the Evolving Real-World Adverse Events of GLP-1RAs Using FDA Adverse Event Reporting System (FAERS).Obesity (Silver Spring, Md.) · 2026Article
- Heterogeneity in adverse events associated with lumateperone: a study on potential subgroup-specific differences.The international journal of neuropsychopharmacology · 2026Article
- Article
- Niraparib induces hyperglycemia in ovarian cancer patients: a preliminary pilot study.Pharmacological reports : PR · 2026Article
- Adverse events associated with tirzepatide: a focus on subgroup-specific differences.BMC pharmacology & toxicology · 2026Article
- Potential heterogeneity of epcoritamab associated adverse events in demographics and dosing regimens.Frontiers in medicine · 2026Article
- Kidney adverse events associated with calcineurin inhibitors: a real-world study based on the FAERS database and network pharmacology.Frontiers in medicine · 2026Article
- Psychiatric adverse events linked to glucagon-like peptide 1 analogues: a disproportionality analysis in American, Canadian and Australian adverse event databases.International journal of clinical pharmacy · 2025Article
- Analysis of Adverse Drug Reactions of Clofazimine Reported in the FDA Adverse Event Reporting System from 2004 to 2025 Q1.Infectious diseases and therapy · 2025Article
- Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) caused by niraparib: a novel antineoplastic agent.Allergy, asthma, and clinical immunology : official journal of the Canadian Society of Allergy and Clinical Immunology · 2025Article
- Post-marketing safety signals of imatinib: pharmacovigilance insights from the FDA Adverse Event Reporting System (FAERS) and implications for clinical practice.European journal of clinical pharmacology · 2025Article
- Real world pharmacovigilance comparison of viloxazine and dextroamphetamine adverse reaction profiles.Scientific reports · 2025Article
- Exploration of adverse event profiles for cefotaxime: a disproportionality analysis using the FDA adverse event reporting system.BMC pharmacology & toxicology · 2025Article
- Retrospective analysis of pembrolizumab-related adverse reactions and death outcomes based on the FAERS database.BMC cancer · 2025Article
- Niraparib Maintenance Therapy in Patients with Platinum-Sensitive Recurrent Ovarian Cancer: Real-World Experience at Hospitals in Spain.Targeted oncology · 2025Observational
- Cardiac adverse events associated with statins in myocardial infarction patients: a pharmacovigilance analysis of the FDA Adverse Event Reporting System.International journal of clinical pharmacy · 2025Article
- Post-Marketing Pharmacovigilance of Canakinumab from the FDA Adverse Event Reporting System (FAERS).Pharmaceuticals (Basel, Switzerland) · 2025Article
- Adverse drug events associated with sodium zirconium cyclosilicate: A real-world pharmacovigilance study based on the FAERS database.PloS one · 2025Article
- Post marketing safety assessment of the novel postpartum depression drug, Zuranolone: evidence from real-world pharmacovigilance analysis based on the FDA adverse event reporting system.Frontiers in psychiatry · 2025Article
Corrections and comments
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Authors and funding
5 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Niraparib was approved for the treatment of platinum-sensitive recurrent epithelial ovarian cancer, fallopian tube and primary peritoneal cancer. The authors retrospectively investigated niraparib-related adverse events (AEs) through data mining of the US Food and Drug Administration Adverse Event Reporting System (FAERS). Four algorithms were employed to quantify the signals of niraparib associated AEs, using data from the FAERS between 2017 and 2021. MYSQL 8.0, Navicat Premium 15, Microsoft EXCEL 2019 and the GraphPad Prism 8 were used to conduct statistical analysis. There are 7,238,157 reports collected from the FAERS database, of which 11,701 reports listed niraparib as the 'primary suspected (PS)' drug. A total of 97 significant disproportionality PTs conforming to the four algorithms were simultaneously retained. Unexpected significant AEs such as neuropathy peripheral, photosensitivity reaction, gastrooesophageal reflux disease might also occur. The median onset time of niraparib-associated AEs was 18 days (interquartile range [IQR] 4-66 days), and most of the cases occurred within the first months after niraparib initiation. The study found niraparib-associated AEs and might provide important support for clinical monitoring and risk identification of niraparib.
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