🇺🇸 GUANIDINE HYDROCHLORIDE in United States

FDA authorised GUANIDINE HYDROCHLORIDE on 2 October 1939 · 10 US adverse-event reports

Marketing authorisations

FDA — authorised 2 October 1939

  • Application: NDA001546
  • Marketing authorisation holder: MERCK SHARP DOHME
  • Local brand name: GUANIDINE HYDROCHLORIDE
  • Indication: TABLET — ORAL
  • Status: approved

Read official source →

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. Abdominal Discomfort — 1 report (10%)
  2. Amyloid Arthropathy — 1 report (10%)
  3. Arthropathy — 1 report (10%)
  4. Drug Abuse — 1 report (10%)
  5. Intentional Product Misuse — 1 report (10%)
  6. Knee Arthroplasty — 1 report (10%)
  7. Lower Respiratory Tract Infection — 1 report (10%)
  8. Obesity — 1 report (10%)
  9. Off Label Use — 1 report (10%)
  10. Overdose — 1 report (10%)

Source database →

GUANIDINE HYDROCHLORIDE in other countries

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

Frequently asked questions

Is GUANIDINE HYDROCHLORIDE approved in United States?

Yes. FDA authorised it on 2 October 1939; FDA has authorised it.

Who is the marketing authorisation holder for GUANIDINE HYDROCHLORIDE in United States?

MERCK SHARP DOHME holds the US marketing authorisation.