🇺🇸 Intuniv in United States

FDA authorised Intuniv on 2 September 2009 · 1,832 US adverse-event reports

Marketing authorisations

FDA — authorised 2 September 2009

  • Application: NDA022037
  • Marketing authorisation holder: TAKEDA PHARMS USA
  • 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 — 278 reports (15.17%)
  2. Somnolence — 249 reports (13.59%)
  3. Off Label Use — 237 reports (12.94%)
  4. Aggression — 176 reports (9.61%)
  5. Suicidal Ideation — 169 reports (9.22%)
  6. No Adverse Event — 155 reports (8.46%)
  7. Fatigue — 147 reports (8.02%)
  8. Electrocardiogram Qt Prolonged — 146 reports (7.97%)
  9. Dizziness — 138 reports (7.53%)
  10. Syncope — 137 reports (7.48%)

Source database →

Other Other approved in United States

Frequently asked questions

Is Intuniv approved in United States?

Yes. FDA authorised it on 2 September 2009; FDA has authorised it.

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

TAKEDA PHARMS USA holds the US marketing authorisation.