🇺🇸 Fluoxetine (prozac) in United States

25 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: 25

Most-reported reactions

1. Dizziness — 4 reports (16%)
2. Asthenia — 3 reports (12%)
3. Escherichia Urinary Tract Infection — 3 reports (12%)
4. Haemoglobin Decreased — 3 reports (12%)
5. Drug Ineffective — 2 reports (8%)
6. Fall — 2 reports (8%)
7. Gastrointestinal Haemorrhage — 2 reports (8%)
8. Haemorrhage — 2 reports (8%)
9. Malaise — 2 reports (8%)
10. Nausea — 2 reports (8%)

Source database →

Frequently asked questions

Is Fluoxetine (prozac) approved in United States?

Fluoxetine (prozac) does not currently have US marketing authorisation in our dataset.

Who is the marketing authorisation holder for Fluoxetine (prozac) in United States?

Neuropharm is the originator. The local marketing authorisation holder may differ — check the official source linked above.