ArticlePharmaceuticals (Basel, Switzerland)2022
A Sex- and Gender-Based Analysis of Adverse Drug Reactions: A Scoping Review of Pharmacovigilance Databases.
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 49 papers, 2 of them syntheses that pooled it.
What it found
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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.
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
49 citing papers in PubMed, 2 syntheses or guidelines pooled it, 66 citations in OpenAlex.
- A systematic review and meta-analysis of interventions to delabel low-risk penicillin allergies with consideration for sex and gender.British journal of clinical pharmacology · 2025Pooled it
- Aesthetic lip filler augmentation is not free of adverse reactions: lack of evidence-based practice from a systematic review.Frontiers in oral health · 2024Pooled it
- Lot-to-lot consistency, immunogenicity, and safety of a 23-valent pneumococcal polysaccharide vaccine (PPV23) in healthy adults aged 40-65 years: A randomized, double-blind, controlled, phase IV clinical trial.Human vaccines & immunotherapeutics · 2025Trial
- A Framework for Standardising Toxicity Management Guidelines in Oncology Clinical Trials.Pharmaceutical medicine · 2026Article
- Prescription Patterns in Psoriatic Arthritis: Insights from a Sex-Based Perspective.Rheumatology and therapy · 2026Article
- An Updated 16-Year Pharmacovigilance Analysis of Neuropsychiatric Safety Profiles of Ciprofloxacin, Levofloxacin, and Moxifloxacin Using FAERS Data.Pharmaceuticals (Basel, Switzerland) · 2026Article
- Evidence and Tradition in Dialogue: Biological Sex Variability in Phytomedicine Research as a Foundation for Safety, Efficacy, and Robust Evidence Standards.Medicines (Basel, Switzerland) · 2026Review
- Disproportionality Analysis of Tirzepatide vs. Semaglutide and Liraglutide: System Organ Class-Level Post-Marketing Reporting Patterns in EudraVigilance.International journal of molecular sciences · 2026Article
- Impact of Reporter Type on Signal Detection of Cancer Therapy-Induced Alopecia: A Hypothesis-Generating Study Using the FDA Adverse Event Reporting System.Pharmaceuticals (Basel, Switzerland) · 2026Article
- Topic and Sentiment Trends in Semaglutide Discussions on X: Subpopulation-Based Longitudinal Analysis.Online journal of public health informatics · 2026Article
- Do sex and gender matter in the pharmacological treatment of depression?Naunyn-Schmiedeberg's archives of pharmacology · 2026Review
- A Two-Year Pharmacovigilance Analysis of Adverse Drug Reactions Reported from a University Allergy Setting.Journal of clinical medicine · 2026Article
- Statins and reporting signals for amnesia: a pharmacovigilance analysis based on adverse event reporting database.Frontiers in pharmacology · 2026Article
- Post-marketing safety of tarlatamab in small cell lung cancer based on FAERS and WHO-VigiAccess with SHAP-based interpretable machine learning analysis of immune-related adverse events.Frontiers in pharmacology · 2026Article
- Sex-specific pharmacovigilance signals and time-to-onset patterns of drug-related myoclonus and epileptic seizures: a real-world pharmacovigilance analysis.Frontiers in pharmacology · 2026Article
- Disproportionality analysis of methylphenidate-associated adverse events in pediatric patients using the FDA Adverse Event Reporting System: overall signals and stratification by gender and dosage form.Frontiers in psychiatry · 2026Article
- A real-world pharmacovigilance study of adverse events associated with esketamine: disproportionality analysis and detection of potential drug-drug interaction signals.European journal of clinical pharmacology · 2025Article
- Sex-related differences in treatment outcomes of chronic hepatitis C with direct-acting antivirals.World journal of hepatology · 2025Article
- Sex-Specific Safety Signals of Trelegy Ellipta: A FAERS Pharmacovigilance Analysis.Medical sciences (Basel, Switzerland) · 2025Article
- Evidence of Sex-Related Pharmacodynamic Differences in Photosensitive Epilepsy Treated with Valproate: Findings from a Retrospective, Observational, Single-Center, Within-Patient, Cohort Study.Drugs - real world outcomes · 2025Article
Corrections and comments
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Authors and funding
6 authors at 4 institutions in 1 country.
Funding
Abstract
Drug-related adverse events or adverse drug reactions (ADRs) are currently partially or substantially under-reported. ADR reporting systems need to expand their focus to include sex- and gender-related factors in order to understand, prevent, or reduce the occurrence of ADRs in all people, particularly women. This scoping review describes adverse drug reactions reported to international pharmacovigilance databases. It identifies the drug classes most commonly associated with ADRs and synthesizes the evidence on ADRs utilizing a sex- and gender-based analysis plus (SGBA+) to assess the differential outcomes reported in the individual studies. We developed a systematic search strategy and applied it to six electronic databases, ultimately including 35 papers. Overall, the evidence shows that women are involved in more ADR reports than men across different countries, although in some cases, men experience more serious ADRs. Most studies were conducted in higher-income countries; the terms adverse drug reactions and adverse drug events are used interchangeably, and there is a lack of standardization between systems. Additional research is needed to identify the relationships between sex- and gender-related factors in the occurrence and reporting of ADRs to adequately detect and prevent ADRs, as well as to tailor and prepare effective reporting for the lifecycle management of drugs.
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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.