🇺🇸 Butyrate in United States

FDA authorised Butyrate on 14 January 2004 · 5,649 US adverse-event reports

Marketing authorisations

FDA — authorised 14 January 2004

  • Application: ANDA076364
  • Marketing authorisation holder: TARO PHARM INDS
  • Status: approved

FDA — authorised 3 August 2005

  • Application: ANDA076654
  • Marketing authorisation holder: TARO PHARM INDS
  • Status: approved

FDA — authorised 18 May 2007

  • Application: NDA022076
  • Marketing authorisation holder: BAUSCH
  • Status: supplemented

FDA — authorised 21 November 2017

  • Application: ANDA209556
  • Marketing authorisation holder: THE J MOLNER
  • Status: approved

FDA — authorised 17 August 2018

  • Application: ANDA210209
  • Marketing authorisation holder: LUPIN LTD
  • Status: approved

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 — 673 reports (11.91%)
  2. Rash — 654 reports (11.58%)
  3. Drug Ineffective — 615 reports (10.89%)
  4. Fatigue — 604 reports (10.69%)
  5. Systemic Lupus Erythematosus — 567 reports (10.04%)
  6. Pain — 556 reports (9.84%)
  7. Abdominal Discomfort — 497 reports (8.8%)
  8. Condition Aggravated — 496 reports (8.78%)
  9. Infusion Related Reaction — 496 reports (8.78%)
  10. Pyrexia — 491 reports (8.69%)

Source database →

Other Other approved in United States

Frequently asked questions

Is Butyrate approved in United States?

Yes. FDA authorised it on 14 January 2004; FDA authorised it on 3 August 2005; FDA authorised it on 18 May 2007.

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

TARO PHARM INDS holds the US marketing authorisation.