Isotretinoin-related adverse sexual and reproductive outcomes: a real-world pharmacovigilance study of the FDA Adverse Event Reporting System (FAERS)
Cansu Altınöz Güney; Huriye Aybüke Koç
Cutaneous and Ocular Toxicology2025
Summary (paraphrased)
Using FAERS data from 2004-2024 via the public dashboard and OpenVigil 2.1, the authors pulled isotretinoin-related adverse events and ran disproportionality analyses (PRR, ROR with 95% CIs, Evans' criteria) across four MedDRA system organ classes. From 53,017 isotretinoin reports, 1,300 reproductive/sexual events (92 preferred terms) qualified, with analysis on 1,151 reports naming isotretinoin as primary suspect; 59.7% of reports were female. Significant signals included erectile dysfunction (195 reports, PRR ~4.5), decreased libido (76 reports), and loss of libido (64 reports), plus 31 more: genital hypoaesthesia, genital anaesthesia, anorgasmia, decreased orgasmic sensation, sexual dysfunction, vulvovaginal dryness, dyspareunia, infertility, abnormal spermatozoa, testicular pain, and others. The authors stress FAERS limits (underreporting, reporting bias, no causal inference) and urge routine inquiry and patient education about sexual and reproductive effects during isotretinoin therapy.
Why it’s in the corpus
The largest real-world signal-detection study of isotretinoin's sexual/reproductive harms (20 years of FAERS); gives the corpus hard numbers — e.g. significant genital-anaesthesia and decreased-orgasmic-sensation signals — that mirror PSSD/PFS symptom profiles and directly inform PRSD.
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