🇺🇸 Opium tincture in United States

581 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: 581

Most-reported reactions

1. Diarrhoea — 132 reports (22.72%)
2. Nausea — 79 reports (13.6%)
3. Vomiting — 66 reports (11.36%)
4. Dehydration — 50 reports (8.61%)
5. Drug Ineffective — 50 reports (8.61%)
6. Fatigue — 49 reports (8.43%)
7. Abdominal Pain — 44 reports (7.57%)
8. Weight Decreased — 43 reports (7.4%)
9. Decreased Appetite — 38 reports (6.54%)
10. Off Label Use — 30 reports (5.16%)

Source database →

Frequently asked questions

Is Opium tincture approved in United States?

Opium tincture does not currently have US marketing authorisation in our dataset.

Who is the marketing authorisation holder for Opium tincture in United States?

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