Identification and comparison of sex-specific serious adverse drug reactions in spontaneous reports and systematically collected reports (ADRED).

AIM: Adverse drug reactions (ADRs) are known to show sex-specific differences in occurrence and phenotype. The aim of this study was to analyse sex-specific differences in ADR-drug combinations which required hospitalisation based on two different datasets.

METHODS: We performed a complementary analysis of i) spontaneously reported (n=12,564, female=51.7%) and ii) systematically collected ADR reports from a prospective multi-centre observational study (ADRED, n=2,355, female=48.2%) from Germany in the ADR database EudraVigilance (EV). Both datasets were analysed separately concerning the suspected drugs, ADRs and ADR-drug combinations more frequently reported for females or males by calculating reporting odds ratios (ROR) with 95% confidence intervals (CI). ADR-drug combinations more frequently reported for either females or males in EV reports were related to prescription data. Finally, the results from both datasets were discussed with regard to their con-/disconcordance.

RESULTS: In both datasets, some antineoplastic agents and nervous system drugs were found to be reported more often for females than males (RORs ranging from 1.5 [1.1-2.1] (quetiapine EV) to 41.3 [13.1-130.0] (trastuzumab EV)). ADRs of the respiratory system, and haemorrhages were described predominantly for males in both datasets. In EV the ADR-drug combination self-injurious behaviour - quetiapine was more often reported for females without and with consideration of drug prescriptions (ROR: 3.8 [1.3-11.0]). Quetiapine and psychiatric disorders (superordinate level) was exclusively reported for females in ADRED reports.

CONCLUSION: Our results can contribute to raise awareness and further knowledge regarding sex-specific ADRs. The findings require further in-depth investigation.

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PMID: 37897066