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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.

FORMOTEROL\GLYCOPYRROLATE: 1,492 Adverse Event Reports & Safety Profile

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1,492
Total FAERS Reports
247 (16.6%)
Deaths Reported
143
Hospitalizations
1,492
As Primary/Secondary Suspect
13
Life-Threatening
12
Disabilities

Active Ingredient: FORMOTEROL FUMARATE\GLYCOPYRROLATE ·

First Report: 1982 · Latest Report: 20250703

What Are the Most Common FORMOTEROL\GLYCOPYRROLATE Side Effects?

#1 Most Reported
Dyspnoea
302 reports (20.2%)
#2 Most Reported
Death
231 reports (15.5%)
#3 Most Reported
Device malfunction
145 reports (9.7%)

All FORMOTEROL\GLYCOPYRROLATE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Dyspnoea 302 20.2% 4 37
Death 231 15.5% 230 1
Device malfunction 145 9.7% 0 14
Device issue 139 9.3% 0 15
Wrong technique in device usage process 139 9.3% 0 15
Off label use 134 9.0% 1 15
Cough 129 8.7% 0 14
Chronic obstructive pulmonary disease 125 8.4% 6 43
Intentional product misuse 115 7.7% 0 20
Intentional device misuse 103 6.9% 0 7
Wrong technique in product usage process 101 6.8% 0 9
Drug ineffective 97 6.5% 1 12
Product dose omission issue 93 6.2% 0 10
Device delivery system issue 78 5.2% 1 6
Device use issue 77 5.2% 0 8
Product use issue 76 5.1% 2 10
Product dose omission 69 4.6% 0 6
Product use in unapproved indication 65 4.4% 0 5
Incorrect dose administered by device 57 3.8% 0 4
Feeling abnormal 49 3.3% 0 5

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

Gender: 58.1% female, 41.9% male. Average age: 70.9 years. Most reports from: US. View detailed demographics →

Is FORMOTEROL\GLYCOPYRROLATE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2006 1 0 1
2008 2 0 2
2009 1 0 0
2010 2 0 2
2014 4 0 1
2015 10 0 4
2016 23 2 6
2017 149 6 28
2018 94 1 13
2019 65 2 9
2020 57 2 5
2021 54 21 4
2022 49 12 6
2023 37 22 2
2024 42 30 3
2025 19 12 0

View full timeline →

What Is FORMOTEROL\GLYCOPYRROLATE Used For?

IndicationReports
Chronic obstructive pulmonary disease 688
Emphysema 62
Asthma 59
Dyspnoea 43
Product used for unknown indication 39
Bronchitis chronic 11
Bronchitis 10
Cough 10
Lung disorder 10
Bronchiectasis 9

FORMOTEROL\GLYCOPYRROLATE vs Alternatives: Which Is Safer?

FORMOTEROL\GLYCOPYRROLATE vs FORMOTEROL\MOMETASONE FORMOTEROL\GLYCOPYRROLATE vs FORMOTEROL\MOMETASONE FUROATE FORMOTEROL\GLYCOPYRROLATE vs FORTEO FORMOTEROL\GLYCOPYRROLATE vs FOSAMAX FORMOTEROL\GLYCOPYRROLATE vs FOSAMAX PLUS D FORMOTEROL\GLYCOPYRROLATE vs FOSAMPRENAVIR FORMOTEROL\GLYCOPYRROLATE vs FOSAPREPITANT FORMOTEROL\GLYCOPYRROLATE vs FOSAPREPITANT DIMEGLUMINE FORMOTEROL\GLYCOPYRROLATE vs FOSCARBIDOPA\FOSLEVODOPA FORMOTEROL\GLYCOPYRROLATE vs FOSCARNET

Official FDA Label for FORMOTEROL\GLYCOPYRROLATE

Official prescribing information from the FDA-approved drug label.