A retrospective safety review has raised concerns about eye disorders and abnormal hair growth in babies linked to minoxidil, a widely used over-the-counter treatment for hair loss. 

Originally developed as an oral antihypertensive, minoxidil (eg. Regaine) was later reformulated for topical use after its hair growth effects were observed, driving widespread consumer use with limited regulatory oversight, the study claimed. 

Using adverse drug reaction reports from the World Health Organization’s global safety database, VigiBase, reserchers analysed post-market data collected up to March 2025. They identified 1,669 global reports of eye disorders associated with minoxidil use in the general population, including 25 cases from India. Reported ocular symptoms included eyelid oedema, blurred vision and central serous chorioretinopathy (CSCR). Of nine serious eye-related reports, the authors noted that four remained after de-duplication, comprising three cases of CSCR and one retinal artery occlusion. 

Among 2,664 global reports of infantile hypertrichosis, the authors also identified 45 cases involving babies aged 0 to 23 months linked to maternal exposure during pregnancy or breastfeeding, accidental contact, or unknown causes. 

These findings raise concerns about early-life exposure, particularly given the drug’s ready availability and lack of strict dispensing controls, and authors said stronger caregiver education, clearer usage guidance and tighter regulation are needed to reduce preventable risks to both infants and eye health.

The study was published in Archives of Dermatological Research.