🇺🇸 Tolterodine Tartrate ER in United States

FDA authorised Tolterodine Tartrate ER on 22 December 2000 · 31 US adverse-event reports

Marketing authorisation

FDA — authorised 22 December 2000

  • Application: NDA021228
  • Marketing authorisation holder: UPJOHN
  • Local brand name: DETROL LA
  • Indication: CAPSULE, EXTENDED RELEASE — ORAL
  • Status: approved

Read official source →

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. Flushing — 5 reports (16.13%)
  2. Headache — 4 reports (12.9%)
  3. Muscle Spasms — 4 reports (12.9%)
  4. Urinary Incontinence — 4 reports (12.9%)
  5. Drug Ineffective — 3 reports (9.68%)
  6. Product Substitution Issue — 3 reports (9.68%)
  7. Abdominal Discomfort — 2 reports (6.45%)
  8. Alopecia — 2 reports (6.45%)
  9. Back Pain — 2 reports (6.45%)
  10. Death — 2 reports (6.45%)

Source database →

Other Urology approved in United States

Frequently asked questions

Is Tolterodine Tartrate ER approved in United States?

Yes. FDA authorised it on 22 December 2000.

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

UPJOHN holds the US marketing authorisation.