🇺🇸 Hydralazine Isosorbide Dinitrate in United States

FDA authorised Hydralazine Isosorbide Dinitrate on 23 June 2005 · 39 US adverse-event reports

Marketing authorisations

FDA — authorised 23 June 2005

  • Application: NDA020727
  • Marketing authorisation holder: AZURITY
  • Local brand name: BIDIL
  • 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. Hypotension — 8 reports (20.51%)
  2. Fall — 6 reports (15.38%)
  3. Product Prescribing Error — 5 reports (12.82%)
  4. Cerebrovascular Accident — 4 reports (10.26%)
  5. Confusional State — 4 reports (10.26%)
  6. Mental Disorder — 4 reports (10.26%)
  7. Mental Status Changes — 3 reports (7.69%)
  8. Infarction — 2 reports (5.13%)
  9. Unresponsive To Stimuli — 2 reports (5.13%)
  10. Altered State Of Consciousness — 1 report (2.56%)

Source database →

Hydralazine Isosorbide Dinitrate 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 Hydralazine Isosorbide Dinitrate approved in United States?

Yes. FDA authorised it on 23 June 2005; FDA has authorised it.

Who is the marketing authorisation holder for Hydralazine Isosorbide Dinitrate in United States?

AZURITY holds the US marketing authorisation.