🇺🇸 Botanicals in United States

14 US adverse-event reports

Marketing authorisation

FDA

• Status: approved

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: 28 March 2025 – 28 March 2026
• Total reports: 14

Most-reported reactions

1. Vomiting — 3 reports (21.43%)
2. Drug Ineffective — 2 reports (14.29%)
3. Headache — 2 reports (14.29%)
4. Abdominal Distension — 1 report (7.14%)
5. Abdominal Pain — 1 report (7.14%)
6. Agitation — 1 report (7.14%)
7. Alanine Aminotransferase Increased — 1 report (7.14%)
8. Anion Gap Increased — 1 report (7.14%)
9. Anxiety — 1 report (7.14%)
10. Aphasia — 1 report (7.14%)

Source database →

Frequently asked questions

Is Botanicals approved in United States?

Yes. FDA has authorised it.

Who is the marketing authorisation holder for Botanicals in United States?

National Center for Complementary and Integrative Health (NCCIH) is the originator. The local marketing authorisation holder may differ — check the official source linked above.