🇺🇸 "Drug:Carvedilol" and "Drug:Ivabradine" in United States

FDA authorised "Drug:Carvedilol" and "Drug:Ivabradine" on 28 August 1981 · 2,094,861 US adverse-event reports

Marketing authorisations

FDA — authorised 28 August 1981

  • Application: ANDA086173
  • Marketing authorisation holder: FOSUN PHARMA
  • Status: supplemented

FDA — authorised 17 September 2010

  • Application: ANDA079025
  • Marketing authorisation holder: CHARTWELL RX
  • Status: approved

FDA — authorised 21 December 2011

  • Application: ANDA090653
  • Marketing authorisation holder: HOSPIRA INC
  • Status: approved

FDA — authorised 26 June 2012

  • Application: ANDA090979
  • Marketing authorisation holder: PADAGIS ISRAEL
  • Status: approved

FDA — authorised 12 September 2017

  • Application: ANDA206120
  • Marketing authorisation holder: XIROMED
  • Status: supplemented

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. Drug Ineffective — 321,339 reports (15.34%)
  2. Off Label Use — 246,100 reports (11.75%)
  3. Nausea — 240,768 reports (11.49%)
  4. Fatigue — 234,104 reports (11.18%)
  5. Diarrhoea — 193,152 reports (9.22%)
  6. Dyspnoea — 191,155 reports (9.12%)
  7. Headache — 183,020 reports (8.74%)
  8. Pain — 177,597 reports (8.48%)
  9. Dizziness — 156,433 reports (7.47%)
  10. Death — 151,193 reports (7.22%)

Source database →

"Drug:Carvedilol" and "Drug:Ivabradine" 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 "Drug:Carvedilol" and "Drug:Ivabradine" approved in United States?

Yes. FDA authorised it on 28 August 1981; FDA authorised it on 17 September 2010; FDA authorised it on 21 December 2011.

Who is the marketing authorisation holder for "Drug:Carvedilol" and "Drug:Ivabradine" in United States?

FOSUN PHARMA holds the US marketing authorisation.