Drug Landscape ›
Tadalafil 5 mg ›
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
Animal Attack — 1 report (10%) Atrial Fibrillation — 1 report (10%) Back Pain — 1 report (10%) Bacteraemia — 1 report (10%) Coagulopathy — 1 report (10%) Cold Sweat — 1 report (10%) Confusional State — 1 report (10%) Dizziness — 1 report (10%) Dyskinesia — 1 report (10%) Fall — 1 report (10%)
Source database →
Tadalafil 5 mg 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 Tadalafil 5 mg approved in United States?
Yes. FDA has authorised it.
Who is the marketing authorisation holder for Tadalafil 5 mg in United States?
Eli Lilly and Company is the originator. The local marketing authorisation holder may differ — check the official source linked above.