🇺🇸 Rozerem (Ramelteon) in United States

22 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: 23 April 2025 – 23 April 2026
• Total reports: 22

Most-reported reactions

1. Nausea — 3 reports (13.64%)
2. Renal Failure Acute — 3 reports (13.64%)
3. Altered State Of Consciousness — 2 reports (9.09%)
4. Asthenia — 2 reports (9.09%)
5. Back Pain — 2 reports (9.09%)
6. Condition Aggravated — 2 reports (9.09%)
7. Diarrhoea — 2 reports (9.09%)
8. Dizziness — 2 reports (9.09%)
9. Fall — 2 reports (9.09%)
10. Hypertension — 2 reports (9.09%)

Source database →

Frequently asked questions

Is Rozerem (Ramelteon) approved in United States?

Rozerem (Ramelteon) does not currently have US marketing authorisation in our dataset.

Who is the marketing authorisation holder for Rozerem (Ramelteon) in United States?

Southern California Institute for Research and Education is the originator. The local marketing authorisation holder may differ — check the official source linked above.