🇺🇸 TIOTROPIUM in United States

FDA authorised TIOTROPIUM on 20 June 2023 · 22,137 US adverse-event reports

Marketing authorisations

FDA — authorised 20 June 2023

  • Application: ANDA211287
  • Marketing authorisation holder: LUPIN
  • Status: approved

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. Dyspnoea — 4,379 reports (19.78%)
  2. Asthma — 3,737 reports (16.88%)
  3. Wheezing — 2,688 reports (12.14%)
  4. Therapeutic Product Effect Incomplete — 1,867 reports (8.43%)
  5. Cough — 1,857 reports (8.39%)
  6. Loss Of Personal Independence In Daily Activities — 1,656 reports (7.48%)
  7. Pneumonia — 1,608 reports (7.26%)
  8. Chronic Obstructive Pulmonary Disease — 1,607 reports (7.26%)
  9. Sleep Disorder Due To A General Medical Condition — 1,407 reports (6.36%)
  10. Obstructive Airways Disorder — 1,331 reports (6.01%)

Source database →

TIOTROPIUM 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 TIOTROPIUM approved in United States?

Yes. FDA authorised it on 20 June 2023; FDA has authorised it.

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

LUPIN holds the US marketing authorisation.