Drug Landscape ›
UMECLIDINIUM BROMIDE ›
Regulatory · United States
Marketing authorisation
FDA
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.
Window: 20 April 2025 – 20 April 2026
Total reports: 9,712
Most-reported reactions
Asthma — 1,857 reports (19.12%) Dyspnoea — 1,539 reports (15.85%) Wheezing — 1,197 reports (12.32%) Therapeutic Product Effect Incomplete — 1,057 reports (10.88%) Obstructive Airways Disorder — 783 reports (8.06%) Loss Of Personal Independence In Daily Activities — 782 reports (8.05%) Cough — 770 reports (7.93%) Condition Aggravated — 604 reports (6.22%) Chronic Obstructive Pulmonary Disease — 595 reports (6.13%) Drug Ineffective — 528 reports (5.44%)
Source database →
UMECLIDINIUM 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 UMECLIDINIUM BROMIDE approved in United States?
Yes. FDA has authorised it.
Who is the marketing authorisation holder for UMECLIDINIUM BROMIDE in United States?
Marketing authorisation holder not available in our data.