🇺🇸 Valturna in United States

FDA authorised Valturna on 16 September 2009 · 319 US adverse-event reports

Marketing authorisations

FDA — authorised 16 September 2009

  • Application: NDA022217
  • Marketing authorisation holder: NOVARTIS
  • Local brand name: VALTURNA
  • 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. Cerebrovascular Accident — 48 reports (15.05%)
  2. Blood Pressure Increased — 45 reports (14.11%)
  3. Dizziness — 40 reports (12.54%)
  4. Hypertension — 40 reports (12.54%)
  5. Renal Failure — 37 reports (11.6%)
  6. Chronic Kidney Disease — 25 reports (7.84%)
  7. Oedema Peripheral — 23 reports (7.21%)
  8. Headache — 21 reports (6.58%)
  9. Diarrhoea — 20 reports (6.27%)
  10. Drug Ineffective — 20 reports (6.27%)

Source database →

Other Other approved in United States

Frequently asked questions

Is Valturna approved in United States?

Yes. FDA authorised it on 16 September 2009; FDA has authorised it.

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

NOVARTIS holds the US marketing authorisation.