Daily tadalafil may increase glaucoma risk

Clinical takeaway: For men taking daily tadalafil for lower urinary tract symptoms due to benign prostatic hyperplasia, clinicians should consider glaucoma risk when discussing long-term therapy. Patients with pre-existing glaucoma, ocular hypertension, high myopia, or a family history of glaucoma may warrant baseline ophthalmic evaluation and periodic follow-up.

Tadalafil is commonly prescribed as a daily treatment for lower urinary tract symptoms associated with benign prostatic hyperplasia. While phosphodiesterase type 5 (PDE5) inhibitors have previously been linked to several ocular adverse events, evidence regarding glaucoma risk has remained uncertain.

A large multinational observational study found that men prescribed tadalafil for lower urinary tract symptoms had a 22% higher relative risk of developing glaucoma over five years than similar men who were not treated with a PDE5 inhibitor. The study also found increased risks of ocular hypertension (32%), primary open-angle glaucoma (33%), and initiation of glaucoma treatment (33%).

Researchers analyzed electronic health record data from 73,854 men aged 40 years or older with lower urinary tract symptoms. Researchers compared 36,927 men taking tadalafil with 36,927 similar men who were not prescribed a PDE5 inhibitor, matching the groups for age, medical conditions, and other factors that could influence glaucoma risk. The 5-year cumulative incidence of glaucoma was 3.93% among tadalafil users versus 3.16% among nonusers. The association remained consistent across multiple sensitivity analyses designed to reduce the likelihood of detection bias.

The study did not find significant associations with normal-tension glaucoma or angle-closure glaucoma.

“These findings do not contraindicate tadalafil use but highlight the importance of baseline ophthalmic assessment and regular follow-up, particularly in patients with pre-existing glaucoma, ocular hypertension, a family history of glaucoma, high myopia or those requiring long-term therapy,” the study authors concluded.

Source: Hsia Y, et al. (2026 Aug 4) Br J Ophthalmol. Risk of glaucoma among patients using tadalafil for lower urinary tract symptoms: a multinational cohort study