BUDESONIDE, GLYCOPYRROLATE, AND FORMOTEROL FUMARATE

N/A

Manufactured by AstraZeneca Pharmaceuticals LP

23,211 FDA adverse event reports analyzed

Last updated: 2026-04-14

About BUDESONIDE, GLYCOPYRROLATE, AND FORMOTEROL FUMARATE

BUDESONIDE, GLYCOPYRROLATE, AND FORMOTEROL FUMARATE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by AstraZeneca Pharmaceuticals LP. The most commonly reported adverse reactions for BUDESONIDE, GLYCOPYRROLATE, AND FORMOTEROL FUMARATE include DYSPNOEA, DEVICE DELIVERY SYSTEM ISSUE, PRODUCT DOSE OMISSION ISSUE, WRONG TECHNIQUE IN DEVICE USAGE PROCESS, DEATH. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for BUDESONIDE, GLYCOPYRROLATE, AND FORMOTEROL FUMARATE.

Top Adverse Reactions

DYSPNOEA1,670 reports
DEVICE DELIVERY SYSTEM ISSUE1,350 reports
PRODUCT DOSE OMISSION ISSUE1,097 reports
WRONG TECHNIQUE IN DEVICE USAGE PROCESS1,087 reports
DEATH1,079 reports
DEVICE USE ISSUE1,019 reports
INCORRECT DOSE ADMINISTERED BY DEVICE732 reports
DEVICE MALFUNCTION667 reports
COUGH657 reports
WRONG TECHNIQUE IN PRODUCT USAGE PROCESS573 reports
DRUG INEFFECTIVE541 reports
CHRONIC OBSTRUCTIVE PULMONARY DISEASE523 reports
DRUG DOSE OMISSION BY DEVICE494 reports
ASTHMA466 reports
INCORRECT DOSE ADMINISTERED421 reports
PRODUCT USE ISSUE411 reports
PNEUMONIA361 reports
FATIGUE314 reports
VISUAL IMPAIRMENT287 reports
DYSPHONIA282 reports
HEADACHE279 reports
OFF LABEL USE270 reports
ILLNESS230 reports
DEVICE DEFECTIVE225 reports
FEELING ABNORMAL201 reports
DIZZINESS198 reports
MALAISE195 reports
DEVICE ISSUE194 reports
COVID 19188 reports
DIARRHOEA185 reports
CONDITION AGGRAVATED181 reports
WHEEZING181 reports
NAUSEA174 reports
OXYGEN SATURATION DECREASED168 reports
PAIN166 reports
PRODUCTIVE COUGH155 reports
ASTHENIA153 reports
CHEST DISCOMFORT151 reports
ARTHRALGIA147 reports
MEMORY IMPAIRMENT146 reports
NASOPHARYNGITIS146 reports
LUNG DISORDER138 reports
FALL137 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION132 reports
ANXIETY130 reports
OROPHARYNGEAL PAIN130 reports
DYSPNOEA EXERTIONAL120 reports
INTENTIONAL DEVICE MISUSE119 reports
CANDIDA INFECTION114 reports
OVERDOSE114 reports
BACK PAIN113 reports
MUSCLE SPASMS113 reports
PRODUCT USE IN UNAPPROVED INDICATION111 reports
CHEST PAIN108 reports
WEIGHT DECREASED108 reports
INJECTION SITE PAIN107 reports
PRURITUS106 reports
THROAT IRRITATION105 reports
BRONCHITIS101 reports
RASH100 reports
INSOMNIA99 reports
SINUSITIS99 reports
HYPERSENSITIVITY98 reports
GAIT DISTURBANCE97 reports
NO ADVERSE EVENT97 reports
PAIN IN EXTREMITY97 reports
TREMOR96 reports
VISION BLURRED95 reports
HYPOACUSIS93 reports
EMPHYSEMA92 reports
VOMITING89 reports
HEART RATE INCREASED87 reports
PYREXIA86 reports
DRUG DELIVERY SYSTEM ISSUE85 reports
PERIPHERAL SWELLING82 reports
CATARACT81 reports
INTENTIONAL PRODUCT MISUSE80 reports
HYPERTENSION78 reports
WEIGHT INCREASED76 reports
DECREASED APPETITE75 reports
EYE DISORDER74 reports
BLOOD PRESSURE INCREASED73 reports
APHONIA71 reports
INFLUENZA69 reports
CARDIAC DISORDER66 reports
URINARY TRACT INFECTION66 reports
DEPRESSION65 reports
NASAL CONGESTION64 reports
ARTHRITIS63 reports
CEREBROVASCULAR ACCIDENT61 reports
MYOCARDIAL INFARCTION61 reports
CONSTIPATION60 reports
EXTRA DOSE ADMINISTERED60 reports
DRY MOUTH59 reports
LUNG NEOPLASM MALIGNANT59 reports
PALPITATIONS59 reports
HYPOTENSION58 reports
ABDOMINAL PAIN UPPER57 reports
ATRIAL FIBRILLATION57 reports
NERVOUSNESS57 reports

Report Outcomes

Out of 8,384 classified reports for BUDESONIDE, GLYCOPYRROLATE, AND FORMOTEROL FUMARATE:

Serious 44.0%Non-Serious 56.0%

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

Female3,917 (57.9%)
Male2,850 (42.1%)

Reports by Age

Age 6896 reports
Age 7295 reports
Age 6682 reports
Age 7180 reports
Age 7079 reports
Age 7479 reports
Age 7579 reports
Age 6774 reports
Age 7374 reports
Age 6368 reports
Age 8066 reports
Age 6964 reports
Age 6062 reports
Age 6462 reports
Age 7762 reports
Age 7860 reports
Age 7659 reports
Age 6157 reports
Age 6256 reports
Age 6555 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 BUDESONIDE, GLYCOPYRROLATE, AND FORMOTEROL FUMARATE?

This profile reflects 23,211 FDA FAERS reports that mention BUDESONIDE, GLYCOPYRROLATE, AND FORMOTEROL FUMARATE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for BUDESONIDE, GLYCOPYRROLATE, AND FORMOTEROL FUMARATE?

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

Who manufactures BUDESONIDE, GLYCOPYRROLATE, AND FORMOTEROL FUMARATE?

Labeling and FAERS entries often list AstraZeneca Pharmaceuticals LP in connection with BUDESONIDE, GLYCOPYRROLATE, AND FORMOTEROL FUMARATE. 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.