🇺🇸 Dapoxetine hydrochloride in United States

30 US adverse-event reports

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: 22 April 2025 – 22 April 2026
• Total reports: 30

Most-reported reactions

1. Anti-Neutrophil Cytoplasmic Antibody Positive Vasculitis — 3 reports (10%)
2. Antineutrophil Cytoplasmic Antibody — 3 reports (10%)
3. Asthma — 3 reports (10%)
4. Cough — 3 reports (10%)
5. Erectile Dysfunction — 3 reports (10%)
6. Fev1/Fvc Ratio Decreased — 3 reports (10%)
7. Forced Expiratory Volume Decreased — 3 reports (10%)
8. Full Blood Count Abnormal — 3 reports (10%)
9. Hypersensitivity — 3 reports (10%)
10. Obstructive Airways Disorder — 3 reports (10%)

Source database →

Frequently asked questions

Is Dapoxetine hydrochloride approved in United States?

Dapoxetine hydrochloride does not currently have US marketing authorisation in our dataset.

Who is the marketing authorisation holder for Dapoxetine hydrochloride in United States?

Janssen Research & Development, LLC is the originator. The local marketing authorisation holder may differ — check the official source linked above.