🇺🇸 IBUPROFEN LYSINE in United States

FDA authorised IBUPROFEN LYSINE on 13 April 2006 · 117 US adverse-event reports

Marketing authorisations

FDA — authorised 13 April 2006

  • Application: NDA021903
  • Marketing authorisation holder: RECORDATI RARE
  • Status: supplemented

FDA — authorised 30 March 2016

  • Application: ANDA202402
  • Marketing authorisation holder: XGEN PHARMS
  • 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. Dizziness — 18 reports (15.38%)
  2. Headache — 15 reports (12.82%)
  3. Nausea — 13 reports (11.11%)
  4. Somnolence — 13 reports (11.11%)
  5. Diarrhoea — 12 reports (10.26%)
  6. Insomnia — 12 reports (10.26%)
  7. Pancreatitis Acute — 10 reports (8.55%)
  8. Anxiety — 8 reports (6.84%)
  9. Disturbance In Attention — 8 reports (6.84%)
  10. Gait Disturbance — 8 reports (6.84%)

Source database →

IBUPROFEN LYSINE 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 IBUPROFEN LYSINE approved in United States?

Yes. FDA authorised it on 13 April 2006; FDA authorised it on 30 March 2016; FDA has authorised it.

Who is the marketing authorisation holder for IBUPROFEN LYSINE in United States?

RECORDATI RARE holds the US marketing authorisation.