UMECLIDINIUM BROMIDE AND VILANTEROL TRIFENATATE

N/A

Manufactured by GlaxoSmithKline LLC

30,147 FDA adverse event reports analyzed

Last updated: 2026-04-14

About UMECLIDINIUM BROMIDE AND VILANTEROL TRIFENATATE

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

Top Adverse Reactions

DYSPNOEA2,306 reports
DRUG INEFFECTIVE1,589 reports
WRONG TECHNIQUE IN DEVICE USAGE PROCESS1,571 reports
PRODUCT COMPLAINT1,130 reports
COUGH1,073 reports
PRODUCT DOSE OMISSION ISSUE835 reports
PNEUMONIA651 reports
CHRONIC OBSTRUCTIVE PULMONARY DISEASE607 reports
CONDITION AGGRAVATED498 reports
DRUG DISPENSING ERROR496 reports
DRUG DOSE OMISSION472 reports
OFF LABEL USE459 reports
DEATH456 reports
FATIGUE435 reports
DEVICE USE ERROR428 reports
PRODUCT USE IN UNAPPROVED INDICATION428 reports
HEADACHE421 reports
PRODUCT DOSE OMISSION416 reports
MALAISE411 reports
DIZZINESS403 reports
PRODUCT QUALITY ISSUE389 reports
NAUSEA386 reports
DIARRHOEA363 reports
WHEEZING346 reports
PRODUCTIVE COUGH341 reports
PAIN IN EXTREMITY331 reports
DYSPHONIA311 reports
FALL280 reports
PAIN267 reports
OROPHARYNGEAL PAIN264 reports
OVERDOSE253 reports
CHEST PAIN247 reports
ASTHMA240 reports
ASTHENIA236 reports
UNDERDOSE233 reports
ANXIETY231 reports
RASH227 reports
TREMOR224 reports
VISION BLURRED220 reports
WRONG TECHNIQUE IN PRODUCT USAGE PROCESS218 reports
CHEST DISCOMFORT217 reports
NASOPHARYNGITIS216 reports
PRODUCT PACKAGING CONFUSION215 reports
VOMITING206 reports
ARTHRALGIA205 reports
HOSPITALISATION205 reports
PRODUCT LABEL CONFUSION205 reports
CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR201 reports
LABELLED DRUG DRUG INTERACTION MEDICATION ERROR198 reports
INSOMNIA196 reports
LUNG NEOPLASM MALIGNANT194 reports
CONSTIPATION193 reports
INTENTIONAL PRODUCT MISUSE188 reports
MUSCLE SPASMS188 reports
BRONCHITIS187 reports
HYPERTENSION185 reports
EXTRA DOSE ADMINISTERED184 reports
FEELING ABNORMAL180 reports
LUNG DISORDER179 reports
PERIPHERAL SWELLING172 reports
DYSPNOEA EXERTIONAL171 reports
THROAT IRRITATION171 reports
PRURITUS170 reports
PRODUCT USE ISSUE169 reports
HEART RATE INCREASED168 reports
OXYGEN SATURATION DECREASED166 reports
URINARY RETENTION166 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION165 reports
THERAPEUTIC PRODUCT EFFECT INCOMPLETE162 reports
WEIGHT DECREASED160 reports
DRY MOUTH158 reports
BACK PAIN153 reports
VISUAL IMPAIRMENT153 reports
BLOOD PRESSURE INCREASED151 reports
PRODUCT DISPENSING ERROR147 reports
COVID 19144 reports
URINARY TRACT INFECTION144 reports
ILL DEFINED DISORDER140 reports
PYREXIA140 reports
WEIGHT INCREASED139 reports
MYOCARDIAL INFARCTION137 reports
PALPITATIONS137 reports
SINUSITIS135 reports
RHINORRHOEA134 reports
DYSGEUSIA133 reports
OEDEMA PERIPHERAL127 reports
DECREASED APPETITE124 reports
HAEMOPTYSIS124 reports
ABDOMINAL DISCOMFORT123 reports
LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES116 reports
DYSURIA115 reports
INFLUENZA115 reports
EXPIRED PRODUCT ADMINISTERED113 reports
HYPERSENSITIVITY113 reports
CANDIDA INFECTION112 reports
GAIT DISTURBANCE112 reports
GASTROOESOPHAGEAL REFLUX DISEASE111 reports
MYALGIA109 reports
HYPOXIA108 reports
THROMBOSIS106 reports

Report Outcomes

Out of 16,209 classified reports for UMECLIDINIUM BROMIDE AND VILANTEROL TRIFENATATE:

Serious 35.0%Non-Serious 65.0%

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

Female8,404 (57.6%)
Male6,188 (42.4%)
Unknown7 (0.0%)

Reports by Age

Age 71259 reports
Age 76249 reports
Age 75247 reports
Age 73244 reports
Age 65243 reports
Age 72239 reports
Age 74238 reports
Age 68229 reports
Age 77225 reports
Age 70218 reports
Age 78212 reports
Age 80211 reports
Age 69210 reports
Age 79202 reports
Age 66193 reports
Age 67189 reports
Age 63172 reports
Age 81163 reports
Age 64160 reports
Age 61156 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 BROMIDE AND VILANTEROL TRIFENATATE?

This profile reflects 30,147 FDA FAERS reports that mention UMECLIDINIUM BROMIDE AND VILANTEROL TRIFENATATE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for UMECLIDINIUM BROMIDE AND VILANTEROL TRIFENATATE?

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

Who manufactures UMECLIDINIUM BROMIDE AND VILANTEROL TRIFENATATE?

Labeling and FAERS entries often list GlaxoSmithKline LLC in connection with UMECLIDINIUM BROMIDE AND VILANTEROL TRIFENATATE. 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.