Drug Landscape ›
5-alpha reductase inhibitor ›
Regulatory · United States
Marketing authorisation
FDA
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
Window: 20 April 2025 – 20 April 2026
Total reports: 10
Most-reported reactions
Bladder Cancer — 1 report (10%) Dysuria — 1 report (10%) Erectile Dysfunction — 1 report (10%) Haemoglobin Decreased — 1 report (10%) Libido Decreased — 1 report (10%) Metastasis — 1 report (10%) Mobility Decreased — 1 report (10%) Myocardial Infarction — 1 report (10%) Pelvic Pain — 1 report (10%) Prostate Cancer — 1 report (10%)
Source database →
5-alpha reductase inhibitor in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is 5-alpha reductase inhibitor approved in United States?
Yes. FDA has authorised it.
Who is the marketing authorisation holder for 5-alpha reductase inhibitor in United States?
Ain Shams University is the originator. The local marketing authorisation holder may differ — check the official source linked above.