ACLIDINIUM BROMIDE

N/A

Manufactured by Covis Pharma US, Inc

27,417 FDA adverse event reports analyzed

Last updated: 2026-04-15

About ACLIDINIUM BROMIDE

ACLIDINIUM BROMIDE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Covis Pharma US, Inc. The most commonly reported adverse reactions for ACLIDINIUM BROMIDE include DYSPNOEA, DEVICE MALFUNCTION, DRUG DOSE OMISSION, ASTHMA, CHRONIC OBSTRUCTIVE PULMONARY DISEASE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for ACLIDINIUM BROMIDE.

Top Adverse Reactions

DYSPNOEA1,869 reports
DEVICE MALFUNCTION1,281 reports
DRUG DOSE OMISSION1,017 reports
ASTHMA814 reports
CHRONIC OBSTRUCTIVE PULMONARY DISEASE764 reports
INTENTIONAL PRODUCT MISUSE741 reports
OFF LABEL USE710 reports
PNEUMONIA692 reports
COUGH655 reports
WHEEZING645 reports
PRODUCT QUALITY ISSUE592 reports
DEVICE ISSUE475 reports
OBSTRUCTIVE AIRWAYS DISORDER442 reports
DRUG INEFFECTIVE401 reports
MALAISE389 reports
PRODUCTIVE COUGH362 reports
GASTROOESOPHAGEAL REFLUX DISEASE340 reports
THERAPEUTIC PRODUCT EFFECT INCOMPLETE337 reports
BRONCHIECTASIS336 reports
INTENTIONAL DEVICE MISUSE336 reports
CONDITION AGGRAVATED334 reports
PRODUCT DOSE OMISSION ISSUE317 reports
FATIGUE305 reports
LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES301 reports
DEVICE FAILURE296 reports
HYPERTENSION291 reports
FALL278 reports
WEIGHT DECREASED276 reports
BRONCHITIS245 reports
HEADACHE244 reports
DYSPNOEA EXERTIONAL239 reports
LOWER RESPIRATORY TRACT INFECTION229 reports
PRODUCT USE IN UNAPPROVED INDICATION228 reports
FULL BLOOD COUNT ABNORMAL220 reports
PYREXIA218 reports
CHEST DISCOMFORT216 reports
NASAL POLYPS213 reports
PRODUCT DOSE OMISSION210 reports
GAIT DISTURBANCE208 reports
WEIGHT INCREASED207 reports
HEART RATE INCREASED206 reports
NAUSEA204 reports
SINUSITIS202 reports
DIZZINESS199 reports
MEMORY IMPAIRMENT199 reports
DIARRHOEA194 reports
PAIN192 reports
PRODUCT USE ISSUE192 reports
CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR186 reports
VOMITING186 reports
OEDEMA PERIPHERAL179 reports
BLOOD PRESSURE INCREASED177 reports
INCORRECT DOSE ADMINISTERED173 reports
LUNG DISORDER173 reports
VISUAL IMPAIRMENT173 reports
LUNG NEOPLASM MALIGNANT172 reports
INFLUENZA170 reports
PAIN IN EXTREMITY169 reports
SLEEP DISORDER DUE TO A GENERAL MEDICAL CONDITION163 reports
DYSPHONIA162 reports
NASOPHARYNGITIS162 reports
DEATH161 reports
ARTHRALGIA160 reports
ASTHENIA159 reports
BREATH SOUNDS ABNORMAL158 reports
JOINT INJURY158 reports
PERIPHERAL SWELLING157 reports
CORONARY ARTERY DISEASE156 reports
CHILLS155 reports
BACK PAIN153 reports
BODY HEIGHT DECREASED150 reports
FEELING ABNORMAL149 reports
ANXIETY145 reports
OROPHARYNGEAL PAIN143 reports
CATARACT141 reports
DECREASED APPETITE141 reports
SPUTUM DISCOLOURED141 reports
SINUS DISORDER138 reports
MYOCARDIAL INFARCTION137 reports
CHEST PAIN136 reports
MUSCULAR WEAKNESS136 reports
RASH135 reports
HYPOACUSIS133 reports
DEPRESSION132 reports
ASTHMA CHRONIC OBSTRUCTIVE PULMONARY DISEASE OVERLAP SYNDROME127 reports
DRUG HYPERSENSITIVITY127 reports
CARDIAC FAILURE124 reports
CELLULITIS124 reports
RHINITIS ALLERGIC124 reports
CARDIAC MURMUR123 reports
PRURITUS123 reports
SARCOIDOSIS123 reports
HAEMOGLOBIN DECREASED121 reports
MUSCLE SPASMS121 reports
TOTAL LUNG CAPACITY INCREASED121 reports
DRUG DEPENDENCE119 reports
TRANSIENT ISCHAEMIC ATTACK119 reports
BODY TEMPERATURE INCREASED115 reports
BLOOD IRON DECREASED113 reports
URINARY TRACT INFECTION113 reports

Report Outcomes

Out of 6,311 classified reports for ACLIDINIUM BROMIDE:

Serious 55.2%Non-Serious 44.8%

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

Female3,819 (63.9%)
Male2,158 (36.1%)
Unknown4 (0.1%)

Reports by Age

Age 65188 reports
Age 80134 reports
Age 72117 reports
Age 52100 reports
Age 6798 reports
Age 7896 reports
Age 7692 reports
Age 6990 reports
Age 6389 reports
Age 7488 reports
Age 6684 reports
Age 5682 reports
Age 7380 reports
Age 5979 reports
Age 6477 reports
Age 7576 reports
Age 6875 reports
Age 7074 reports
Age 7774 reports
Age 6271 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 ACLIDINIUM BROMIDE?

This profile reflects 27,417 FDA FAERS reports that mention ACLIDINIUM BROMIDE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for ACLIDINIUM BROMIDE?

Frequently reported terms in FAERS include DYSPNOEA, DEVICE MALFUNCTION, DRUG DOSE OMISSION, ASTHMA, CHRONIC OBSTRUCTIVE PULMONARY DISEASE, INTENTIONAL PRODUCT MISUSE. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures ACLIDINIUM BROMIDE?

Labeling and FAERS entries often list Covis Pharma US, Inc in connection with ACLIDINIUM BROMIDE. 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.