🇺🇸 Nucynta ER in United States

FDA authorised Nucynta ER on 25 August 2011 · 1,367 US adverse-event reports

Marketing authorisations

FDA — authorised 25 August 2011

  • Application: NDA200533
  • Marketing authorisation holder: COLLEGIUM PHARM INC
  • 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 — 313 reports (22.9%)
  2. Medication Error — 231 reports (16.9%)
  3. Pain — 172 reports (12.58%)
  4. Drug Dose Omission — 127 reports (9.29%)
  5. Nausea — 108 reports (7.9%)
  6. Headache — 92 reports (6.73%)
  7. Dependence — 90 reports (6.58%)
  8. Somnolence — 81 reports (5.93%)
  9. Overdose — 79 reports (5.78%)
  10. Drug Withdrawal Syndrome — 74 reports (5.41%)

Source database →

Nucynta ER 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 Nucynta ER approved in United States?

Yes. FDA authorised it on 25 August 2011; FDA has authorised it.

Who is the marketing authorisation holder for Nucynta ER in United States?

COLLEGIUM PHARM INC holds the US marketing authorisation.