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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.

BUDESONIDE\FORMOTEROL: 36,416 Adverse Event Reports & Safety Profile

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36,416
Total FAERS Reports
3,117 (8.6%)
Deaths Reported
9,869
Hospitalizations
36,416
As Primary/Secondary Suspect
941
Life-Threatening
535
Disabilities

Active Ingredient: BUDESONIDE\FORMOTEROL FUMARATE DIHYDRATE ·

First Report: 00010101 · Latest Report: 20250912

What Are the Most Common BUDESONIDE\FORMOTEROL Side Effects?

#1 Most Reported
Dyspnoea
11,158 reports (30.6%)
#2 Most Reported
Asthma
10,045 reports (27.6%)
#3 Most Reported
Wheezing
5,632 reports (15.5%)

All BUDESONIDE\FORMOTEROL Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Dyspnoea 11,158 30.6% 177 4,190
Asthma 10,045 27.6% 140 4,482
Wheezing 5,632 15.5% 60 2,802
Cough 4,466 12.3% 15 1,581
Therapeutic product effect incomplete 4,392 12.1% 38 2,175
Drug ineffective 3,469 9.5% 35 1,174
Intentional product misuse 3,399 9.3% 37 532
Loss of personal independence in daily activities 3,397 9.3% 35 1,792
Off label use 3,269 9.0% 63 727
Device malfunction 2,771 7.6% 9 399
Sleep disorder due to a general medical condition 2,742 7.5% 38 1,414
Death 2,390 6.6% 2,389 135
Chronic obstructive pulmonary disease 2,279 6.3% 82 1,148
Pneumonia 2,258 6.2% 99 1,520
Obstructive airways disorder 2,210 6.1% 41 1,240
Drug dose omission 1,920 5.3% 19 401
Chest discomfort 1,904 5.2% 4 801
Malaise 1,833 5.0% 40 656
Full blood count abnormal 1,786 4.9% 53 986
Productive cough 1,778 4.9% 61 800

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

Gender: 63.6% female, 36.4% male. Average age: 63.5 years. Most reports from: US. View detailed demographics →

Is BUDESONIDE\FORMOTEROL Getting Safer? Reports by Year

YearReportsDeathsHosp.
2000 7 0 2
2001 18 1 5
2002 24 1 8
2003 16 0 7
2004 21 0 7
2005 25 1 14
2006 55 0 22
2007 61 3 22
2008 79 2 29
2009 87 6 35
2010 193 5 82
2011 180 14 79
2012 259 8 95
2013 529 10 135
2014 1,035 34 267
2015 1,192 75 353
2016 1,272 83 355
2017 1,330 62 426
2018 1,259 53 333
2019 975 64 251
2020 1,092 138 292
2021 1,010 223 143
2022 935 221 147
2023 756 249 147
2024 530 76 98
2025 373 24 50

View full timeline →

What Is BUDESONIDE\FORMOTEROL Used For?

IndicationReports
Asthma 9,986
Product used for unknown indication 9,035
Chronic obstructive pulmonary disease 6,539
Emphysema 965
Dyspnoea 876
Bronchitis 461
Cough 255
Lung disorder 240
Bronchitis chronic 237
Wheezing 138

BUDESONIDE\FORMOTEROL vs Alternatives: Which Is Safer?

BUDESONIDE\FORMOTEROL vs BUDESONIDE\FORMOTEROL\GLYCOPYRROLATE BUDESONIDE\FORMOTEROL vs BUDESONIDE\FORMOTEROL\GLYCOPYRRONIUM BUDESONIDE\FORMOTEROL vs BUMETANIDE BUDESONIDE\FORMOTEROL vs BUPIVACAINE BUDESONIDE\FORMOTEROL vs BUPIVACAINE\BUPIVACAINE ANHYDROUS BUDESONIDE\FORMOTEROL vs BUPIVACAINE\EPINEPHRINE BUDESONIDE\FORMOTEROL vs BUPIVACAINE\MELOXICAM BUDESONIDE\FORMOTEROL vs BUPRENORPHINE BUDESONIDE\FORMOTEROL vs BUPRENORPHINE\NALOXONE BUDESONIDE\FORMOTEROL vs BUPROPION

Official FDA Label for BUDESONIDE\FORMOTEROL

Official prescribing information from the FDA-approved drug label.