🇺🇸 Detrol LA in United States

FDA authorised Detrol LA on 22 December 2000 · 4,386 US adverse-event reports

Marketing authorisation

FDA — authorised 22 December 2000

  • Application: NDA021228
  • Marketing authorisation holder: UPJOHN
  • Status: supplemented

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 — 1,177 reports (26.84%)
  2. Dry Mouth — 453 reports (10.33%)
  3. Fall — 397 reports (9.05%)
  4. Dizziness — 369 reports (8.41%)
  5. Fatigue — 355 reports (8.09%)
  6. Diarrhoea — 344 reports (7.84%)
  7. Constipation — 323 reports (7.36%)
  8. Nausea — 323 reports (7.36%)
  9. Pain — 323 reports (7.36%)
  10. Headache — 322 reports (7.34%)

Source database →

Other Urology approved in United States

Frequently asked questions

Is Detrol LA approved in United States?

Yes. FDA authorised it on 22 December 2000.

Who is the marketing authorisation holder for Detrol LA in United States?

UPJOHN holds the US marketing authorisation.