🇺🇸 Rowachol in United States

21 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.

Most-reported reactions

  1. Off Label Use — 4 reports (19.05%)
  2. Dyspnoea — 3 reports (14.29%)
  3. Ascites — 2 reports (9.52%)
  4. Burning Sensation — 2 reports (9.52%)
  5. Dizziness — 2 reports (9.52%)
  6. Hypotension — 2 reports (9.52%)
  7. Pyrexia — 2 reports (9.52%)
  8. Vomiting — 2 reports (9.52%)
  9. Abdominal Pain Lower — 1 report (4.76%)
  10. Abdominal Pain Upper — 1 report (4.76%)

Source database →

Rowachol in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Other Other approved in United States

Frequently asked questions

Is Rowachol approved in United States?

Yes. FDA has authorised it.

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

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