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Important: This site presents data from the FDA Adverse Event Reporting System (FAERS). A report does not mean the drug caused the event. Full disclaimer.

ALBUTEROL\BUDESONIDE: 711 Adverse Event Reports & Safety Profile

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711
Total FAERS Reports
30 (4.2%)
Deaths Reported
28
Hospitalizations
711
As Primary/Secondary Suspect
5
Life-Threatening
4
Disabilities

Active Ingredient: ALBUTEROL SULFATE\BUDESONIDE ·

First Report: 20190101 · Latest Report: 20250915

What Are the Most Common ALBUTEROL\BUDESONIDE Side Effects?

#1 Most Reported
Device delivery system issue
244 reports (34.3%)
#2 Most Reported
Wrong technique in device usage process
110 reports (15.5%)
#3 Most Reported
Product dose omission issue
109 reports (15.3%)

All ALBUTEROL\BUDESONIDE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Device delivery system issue 244 34.3% 0 1
Wrong technique in device usage process 110 15.5% 0 4
Product dose omission issue 109 15.3% 0 3
Device use issue 83 11.7% 0 1
Wrong technique in product usage process 82 11.5% 0 2
Device malfunction 71 10.0% 0 0
Incorrect dose administered by device 69 9.7% 0 1
Asthma 67 9.4% 0 6
Incorrect dose administered 64 9.0% 0 3
Dyspnoea 63 8.9% 1 5
Drug ineffective 62 8.7% 0 3
Drug dose omission by device 61 8.6% 0 1
Device defective 47 6.6% 0 0
Product use issue 43 6.1% 0 1
Cough 38 5.3% 0 1
Death 29 4.1% 29 0
Off label use 26 3.7% 0 1
Device issue 24 3.4% 0 0
Overdose 23 3.2% 0 0
Illness 22 3.1% 0 1

Who Reports ALBUTEROL\BUDESONIDE Side Effects? Age & Gender Data

Gender: 68.6% female, 31.4% male. Average age: 57.1 years. Most reports from: US. View detailed demographics →

Is ALBUTEROL\BUDESONIDE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2019 1 0 0
2020 1 0 0
2023 8 0 0
2024 61 7 0
2025 92 4 3

View full timeline →

What Is ALBUTEROL\BUDESONIDE Used For?

IndicationReports
Asthma 90
Product used for unknown indication 25
Chronic obstructive pulmonary disease 12
Dyspnoea 7
Wheezing 6

ALBUTEROL\BUDESONIDE vs Alternatives: Which Is Safer?

ALBUTEROL\BUDESONIDE vs ALBUTEROL\IPRATROPIUM ALBUTEROL\BUDESONIDE vs ALCAFTADINE ALBUTEROL\BUDESONIDE vs ALCOHOL ALBUTEROL\BUDESONIDE vs ALCOHOL\CHLORHEXIDINE ALBUTEROL\BUDESONIDE vs ALDACTONE ALBUTEROL\BUDESONIDE vs ALDESLEUKIN ALBUTEROL\BUDESONIDE vs ALECTINIB ALBUTEROL\BUDESONIDE vs ALEMTUZUMAB ALBUTEROL\BUDESONIDE vs ALENDRONATE ALBUTEROL\BUDESONIDE vs ALENDRONATE\CHOLECALCIFEROL

Official FDA Label for ALBUTEROL\BUDESONIDE

Official prescribing information from the FDA-approved drug label.