UMECLIDINIUM

N/A

Manufactured by GlaxoSmithKline LLC

18,218 FDA adverse event reports analyzed

Last updated: 2026-04-14

About UMECLIDINIUM

UMECLIDINIUM is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by GlaxoSmithKline LLC. The most commonly reported adverse reactions for UMECLIDINIUM include DYSPNOEA, DRUG INEFFECTIVE, COUGH, ASTHMA, WRONG TECHNIQUE IN DEVICE USAGE PROCESS. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for UMECLIDINIUM.

Top Adverse Reactions

DYSPNOEA1,352 reports
DRUG INEFFECTIVE752 reports
COUGH701 reports
ASTHMA604 reports
WRONG TECHNIQUE IN DEVICE USAGE PROCESS520 reports
PNEUMONIA509 reports
CHRONIC OBSTRUCTIVE PULMONARY DISEASE403 reports
FATIGUE364 reports
WHEEZING325 reports
DEATH321 reports
PRODUCT DOSE OMISSION ISSUE319 reports
MALAISE315 reports
HEADACHE311 reports
OFF LABEL USE311 reports
NAUSEA284 reports
PRODUCT COMPLAINT265 reports
PAIN260 reports
DIARRHOEA259 reports
DIZZINESS256 reports
CONDITION AGGRAVATED248 reports
PRODUCT USE IN UNAPPROVED INDICATION239 reports
DRUG DOSE OMISSION234 reports
FALL226 reports
PRODUCTIVE COUGH205 reports
LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES203 reports
ASTHENIA200 reports
THERAPEUTIC PRODUCT EFFECT INCOMPLETE180 reports
VOMITING177 reports
ARTHRALGIA172 reports
HOSPITALISATION172 reports
DEVICE USE ERROR170 reports
NASOPHARYNGITIS170 reports
CHEST DISCOMFORT167 reports
PRODUCT DOSE OMISSION167 reports
DYSPHONIA165 reports
BRONCHITIS153 reports
PRURITUS152 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION149 reports
RASH143 reports
PAIN IN EXTREMITY140 reports
BACK PAIN139 reports
ANXIETY138 reports
DYSPNOEA EXERTIONAL133 reports
COVID 19132 reports
HYPERTENSION132 reports
CHEST PAIN131 reports
WRONG TECHNIQUE IN PRODUCT USAGE PROCESS130 reports
WEIGHT DECREASED128 reports
CONSTIPATION126 reports
PRODUCT QUALITY ISSUE126 reports
PERIPHERAL SWELLING125 reports
DECREASED APPETITE121 reports
INFLUENZA121 reports
PYREXIA121 reports
INSOMNIA118 reports
SINUSITIS111 reports
OROPHARYNGEAL PAIN110 reports
FEELING ABNORMAL109 reports
OXYGEN SATURATION DECREASED109 reports
URINARY TRACT INFECTION107 reports
WEIGHT INCREASED106 reports
ABDOMINAL PAIN101 reports
DRUG HYPERSENSITIVITY99 reports
LUNG DISORDER99 reports
MYOCARDIAL INFARCTION99 reports
PRODUCT USE ISSUE99 reports
RHINORRHOEA99 reports
SLEEP DISORDER DUE TO A GENERAL MEDICAL CONDITION97 reports
DRUG DISPENSING ERROR94 reports
HYPERSENSITIVITY93 reports
ILLNESS92 reports
SPUTUM DISCOLOURED92 reports
VISION BLURRED91 reports
MUSCLE SPASMS89 reports
UNDERDOSE89 reports
GAIT DISTURBANCE88 reports
HEART RATE INCREASED88 reports
BLOOD PRESSURE INCREASED86 reports
MYALGIA86 reports
ACUTE KIDNEY INJURY85 reports
ATRIAL FIBRILLATION85 reports
NASAL CONGESTION85 reports
OBSTRUCTIVE AIRWAYS DISORDER85 reports
HYPOTENSION84 reports
PALPITATIONS84 reports
DRY MOUTH83 reports
ABDOMINAL PAIN UPPER82 reports
PRODUCT DISPENSING ERROR82 reports
INFECTION81 reports
THROAT IRRITATION81 reports
TREMOR81 reports
DEPRESSION80 reports
CONFUSIONAL STATE79 reports
EXTRA DOSE ADMINISTERED79 reports
GASTROOESOPHAGEAL REFLUX DISEASE79 reports
INTENTIONAL PRODUCT MISUSE79 reports
FULL BLOOD COUNT ABNORMAL78 reports
LOWER RESPIRATORY TRACT INFECTION78 reports
URTICARIA76 reports
DYSPEPSIA75 reports

Report Outcomes

Out of 8,523 classified reports for UMECLIDINIUM:

Serious 52.5%Non-Serious 47.5%

The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.

Demographics Breakdown

Reports by Sex

Female4,766 (62.4%)
Male2,864 (37.5%)
Unknown6 (0.1%)

Reports by Age

Age 66160 reports
Age 70159 reports
Age 74154 reports
Age 68143 reports
Age 69142 reports
Age 73136 reports
Age 77135 reports
Age 65127 reports
Age 67127 reports
Age 72124 reports
Age 71121 reports
Age 78120 reports
Age 63118 reports
Age 80118 reports
Age 60115 reports
Age 64115 reports
Age 75114 reports
Age 76109 reports
Age 61106 reports
Age 7998 reports

Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.

Frequently Asked Questions

How many FDA adverse event reports are associated with UMECLIDINIUM?

This profile reflects 18,218 FDA FAERS reports that mention UMECLIDINIUM. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for UMECLIDINIUM?

Frequently reported terms in FAERS include DYSPNOEA, DRUG INEFFECTIVE, COUGH, ASTHMA, WRONG TECHNIQUE IN DEVICE USAGE PROCESS, PNEUMONIA. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures UMECLIDINIUM?

Labeling and FAERS entries often list GlaxoSmithKline LLC in connection with UMECLIDINIUM. Always verify the specific product and NDC with your pharmacist.

Important Disclaimer: This content is generated by AI analysis of FDA adverse event reports and is provided for informational purposes only. It is not medical advice. Adverse event reports submitted to the FDA do not prove that a medication caused the reported side effect. Always consult your healthcare provider before starting, stopping, or changing any medication. If you experience a serious side effect, contact your doctor or call 911 immediately.