Budesonide, Glycopyrrolate, / Formoterol Fumarate

Common brands: Breztri, Albuterol, Ventolin Hfa, Proair Digihaler, Proair Respiclick

Top reporter: Astrazeneca Pharmaceuticals Lp

Corticosteroid [EPC]beta2-Adrenergic Agonist [EPC]Nonsteroidal Anti-inflammatory Drug [EPC]Interleukin-4 Receptor alpha Antagonist [EPC]Loop Diuretic [EPC]
9,320
Total Reports
9,062
Serious Reports
1,226
Death Reports
30
Reported Reactions
Death Report Ratio: High (13.15%)

Patient Demographics

Male
3,116
Female
4,346

Reported Adverse Reactions (30)

Side effects reported in FDA adverse event reports for Budesonide, Glycopyrrolate, / Formoterol Fumarate.

# Reaction Reports % of Total
1 DYSPNOEA 1,826
10.4%
2 DEVICE DELIVERY SYSTEM ISSUE 1,458
8.3%
3 PRODUCT DOSE OMISSION ISSUE 1,283
7.3%
4 WRONG TECHNIQUE IN DEVICE USAGE PROCESS 1,126
6.4%
5 DEATH 1,102
6.3%
6 DEVICE USE ISSUE 1,063
6.0%
7 INCORRECT DOSE ADMINISTERED BY DEVICE 763
4.3%
8 COUGH 733
4.2%
9 DEVICE MALFUNCTION 733
4.2%
10 WRONG TECHNIQUE IN PRODUCT USAGE PROCESS 635
3.6%
11 DRUG INEFFECTIVE 593
3.4%
12 CHRONIC OBSTRUCTIVE PULMONARY DISEASE 576
3.3%
13 ASTHMA 510
2.9%
14 DRUG DOSE OMISSION BY DEVICE 508
2.9%
15 INCORRECT DOSE ADMINISTERED 459
2.6%
16 PRODUCT USE ISSUE 456
2.6%
17 PNEUMONIA 392
2.2%
18 FATIGUE 341
1.9%
19 HEADACHE 317
1.8%
20 VISUAL IMPAIRMENT 317
1.8%
21 DYSPHONIA 313
1.8%
22 OFF LABEL USE 296
1.7%
23 DEVICE DEFECTIVE 250
1.4%
24 ILLNESS 248
1.4%
25 DEVICE ISSUE 238
1.4%
26 MALAISE 229
1.3%
27 DIZZINESS 218
1.2%
28 DIARRHOEA 217
1.2%
29 FEELING ABNORMAL 216
1.2%
30 WHEEZING 213
1.2%

Important Disclaimer

FDA adverse event reports are submitted voluntarily and do not prove causation. A reported reaction does not mean the drug caused it. Drugs with more users naturally have more reports. Always consult your doctor or pharmacist before making medication decisions.