ArticleEClinicalMedicine2019
Reported adverse drug reactions in women and men: Aggregated evidence from globally collected individual case reports during half a century.
Article in EClinicalMedicine, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 155 papers, 3 of them syntheses that pooled it.
What it found
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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
155 citing papers in PubMed, 3 syntheses or guidelines pooled it, 297 citations in OpenAlex.
- Sex differences in pharmacological treatment of heart failure: a meta-analysis of randomized trials.European heart journal · 2026Pooled it
- Impact of female underrepresentation in trials investigating long-term pharmacologic therapy after acute coronary syndrome: a meta-analysis and meta-regression.European heart journal. Acute cardiovascular care · 2026Pooled it
- Sex Differences in Adverse Effects of Antiseizure Medications in Adults with Epilepsy: A Systematic Review.CNS drugs · 2024Pooled it
- Effects of food and ethnicity on the pharmacokinetics of venadaparib, a next-generation PARP inhibitor, in healthy Korean, Caucasian, and Chinese male subjects.Investigational new drugs · 2024Trial
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- Redesigning cardiovascular medicine around sex differences.Nature medicine · 2026Review
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- Reporting patterns of adverse drug withdrawal events using individual case safety reports in the FAERS and Eudravigilance databases.Exploratory research in clinical and social pharmacy · 2026Article
- Integration and Outcomes of Entrustable Professional Activities Performed by PharmD Trainees at Hospital Practice Sites.Pharmacy (Basel, Switzerland) · 2026Article
- Heterogeneity of Treatment Effects Across Nine Glucose-Lowering Drug Classes in Type 2 Diabetes: Extension of the LEGEND-T2DM Network Study.Diabetes, obesity & metabolism · 2026Observational
- Adverse Events Associated with Clascoterone: A Real-World Pharmacovigilance Study of the Food and Drug Administration Adverse Event Reporting System.Therapeutic innovation & regulatory science · 2026Article
- Article
- Female underrepresentation and adverse events reporting biases in lung cancer clinical trials: a systematic review and meta-analysis.Journal of the National Cancer Center · 2026Article
- VigiBase: Resource Profile Update with a Summary of Global Patterns and Trends in Adverse Event Reports for Medicines and Vaccines.Drug safety · 2026Review
- Patterns of Spontaneous Adverse Drug Reaction Reporting in Germany From 2012 to 2021.Pharmacology research & perspectives · 2026Article
- Incretin-Based Drugs for Obesity: Common and Drug-Specific Reporting Patterns of Adverse Drug Reactions-A Comparative Disproportionality Analysis Using EudraVigilance Reports Integrating SmPC Data.Pharmaceuticals (Basel, Switzerland) · 2026Article
- MVA-BN monkeypox vaccine safety in a clinical trial in the Democratic Republic of the Congo.NPJ vaccines · 2026Article
- An Updated 16-Year Pharmacovigilance Analysis of Neuropsychiatric Safety Profiles of Ciprofloxacin, Levofloxacin, and Moxifloxacin Using FAERS Data.Pharmaceuticals (Basel, Switzerland) · 2026Article
- Physicians' gender and specialty in relation to adverse drug reaction reporting in Sweden.European journal of clinical pharmacology · 2026Observational
- Sex-based differences in the NRF2 oxidative stress response: Implications for precision therapeutics.Redox biology · 2026Review
95 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors at 3 institutions in 4 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundAdverse drug reactions (ADRs) are an important cause of morbidity and mortality. Reports on differences in reporting patterns between women and men exist nationally. The goal of the present study was to assess the global evidence on spontaneous post-marketing ADR reporting differences between reports for women and men.
methodsWe analysed data collected within VigiBase, the WHO global database of individual case safety reports, between 1967-2 January 2018. VigiBase contains more than 18 million reports from the 131 member countries of the WHO Programme for International Drug Monitoring.
findingsOf the reports with information on sex, 9,056,566 (60.1%) concerned female and 6,012,804 (39.9%) male children and adults. More female ADR reports were submitted in all regions of the world and by all types of reporters. A higher proportion of female reports was seen in all age groups from the age group 12-17 years and older. The largest difference was observed in the age group of 18-44 years and could not be explained by hormonal contraceptive use. The proportion of serious and fatal reports was higher for male reports.
interpretationGlobal post marketing surveillance data on spontaneous reports indicate that women, from puberty and onwards and especially in their reproductive years, report more ADRs than men. However, there is a higher proportion of serious and fatal ADRs among male reports. Our results suggest important underlying sex-related differences in ADRs. These findings highlight the importance of considering sex throughout the entire life-cycle of drug development and surveillance and understanding the underlying reasons for reporting ADRs.
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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.