🇺🇸 Indacaterol maleate and glycopyrronium bromide in United States

20 US adverse-event reports

Marketing authorisation

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 Interaction — 4 reports (20%)
  2. Somnolence — 3 reports (15%)
  3. Hallucination — 2 reports (10%)
  4. Hypoglycaemia — 2 reports (10%)
  5. Hypotension — 2 reports (10%)
  6. Parkinsonism — 2 reports (10%)
  7. Tachycardia — 2 reports (10%)
  8. Acute Kidney Injury — 1 report (5%)
  9. Aspartate Aminotransferase Increased — 1 report (5%)
  10. Basophil Count Increased — 1 report (5%)

Source database →

Indacaterol maleate and glycopyrronium bromide 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 Indacaterol maleate and glycopyrronium bromide approved in United States?

Yes. FDA has authorised it.

Who is the marketing authorisation holder for Indacaterol maleate and glycopyrronium bromide in United States?

Orion Corporation, Orion Pharma is the originator. The local marketing authorisation holder may differ — check the official source linked above.