🇺🇸 RANITIDINE BISMUTH CITRATE in United States

FDA authorised RANITIDINE BISMUTH CITRATE on 23 March 1998 · 52 US adverse-event reports

Marketing authorisations

FDA — authorised 23 March 1998

  • Application: NDA020559
  • Marketing authorisation holder: GLAXOSMITHKLINE
  • Local brand name: TRITEC
  • Indication: TABLET — ORAL
  • Status: approved

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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. Arthralgia — 6 reports (11.54%)
  2. Dizziness — 6 reports (11.54%)
  3. Abdominal Discomfort — 5 reports (9.62%)
  4. Abdominal Pain Upper — 5 reports (9.62%)
  5. Alopecia — 5 reports (9.62%)
  6. Anti-Cyclic Citrullinated Peptide Antibody Positive — 5 reports (9.62%)
  7. Arthropathy — 5 reports (9.62%)
  8. Asthenia — 5 reports (9.62%)
  9. Blepharospasm — 5 reports (9.62%)
  10. Blister — 5 reports (9.62%)

Source database →

RANITIDINE BISMUTH CITRATE 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 RANITIDINE BISMUTH CITRATE approved in United States?

Yes. FDA authorised it on 23 March 1998; FDA has authorised it.

Who is the marketing authorisation holder for RANITIDINE BISMUTH CITRATE in United States?

GLAXOSMITHKLINE holds the US marketing authorisation.