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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.

GLYCOPYRROLATE\INDACATEROL: 1,711 Adverse Event Reports & Safety Profile

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1,711
Total FAERS Reports
452 (26.4%)
Deaths Reported
625
Hospitalizations
1,711
As Primary/Secondary Suspect
70
Life-Threatening
20
Disabilities

Active Ingredient: GLYCOPYRROLATE\INDACATEROL MALEATE ·

First Report: 1995 · Latest Report: 20230316

What Are the Most Common GLYCOPYRROLATE\INDACATEROL Side Effects?

#1 Most Reported
Dyspnoea
396 reports (23.1%)
#2 Most Reported
Cough
209 reports (12.2%)
#3 Most Reported
Death
200 reports (11.7%)

All GLYCOPYRROLATE\INDACATEROL Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Dyspnoea 396 23.1% 54 232
Cough 209 12.2% 14 74
Death 200 11.7% 198 30
Product use in unapproved indication 170 9.9% 37 72
Malaise 166 9.7% 23 81
Chronic obstructive pulmonary disease 156 9.1% 30 93
Wheezing 137 8.0% 3 92
Asthma 125 7.3% 5 92
Fatigue 122 7.1% 8 44
Drug ineffective 106 6.2% 10 44
Pneumonia 106 6.2% 39 78
Lung disorder 80 4.7% 19 46
Weight decreased 71 4.2% 14 31
Emphysema 69 4.0% 27 32
Lung neoplasm malignant 64 3.7% 28 14
Loss of personal independence in daily activities 63 3.7% 0 57
Productive cough 58 3.4% 4 30
Weight increased 58 3.4% 2 30
Asthenia 56 3.3% 10 25
Cardiac disorder 54 3.2% 17 33

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

Gender: 46.7% female, 53.3% male. Average age: 69.9 years. Most reports from: BR. View detailed demographics →

Is GLYCOPYRROLATE\INDACATEROL Getting Safer? Reports by Year

YearReportsDeathsHosp.
2002 1 1 0
2006 2 0 0
2011 1 0 1
2012 1 0 1
2013 3 1 1
2014 7 1 3
2015 30 4 17
2016 77 18 30
2017 255 77 116
2018 151 56 59
2019 85 38 28
2020 10 4 5
2021 1 0 0
2022 1 0 1
2023 1 0 1

View full timeline →

What Is GLYCOPYRROLATE\INDACATEROL Used For?

IndicationReports
Chronic obstructive pulmonary disease 745
Product used for unknown indication 559
Emphysema 182
Asthma 96
Dyspnoea 55
Lung disorder 35
Bronchitis 20
Bronchitis chronic 15
Pneumonia 14
Pulmonary fibrosis 13

GLYCOPYRROLATE\INDACATEROL vs Alternatives: Which Is Safer?

GLYCOPYRROLATE\INDACATEROL vs GLYCOPYRROLATE\INDACATEROL\MOMETASONE FUROATE GLYCOPYRROLATE\INDACATEROL vs GLYCOPYRRONIUM GLYCOPYRROLATE\INDACATEROL vs GLYCOPYRRONIUM\INDACATEROL GLYCOPYRROLATE\INDACATEROL vs GOLD GLYCOPYRROLATE\INDACATEROL vs GOLD THIOMALATE GLYCOPYRROLATE\INDACATEROL vs GOLIMUMAB GLYCOPYRROLATE\INDACATEROL vs GOLODIRSEN GLYCOPYRROLATE\INDACATEROL vs GONADORELIN GLYCOPYRROLATE\INDACATEROL vs GONADOTROPHIN, CHORIONIC GLYCOPYRROLATE\INDACATEROL vs GOSERELIN

Official FDA Label for GLYCOPYRROLATE\INDACATEROL

Official prescribing information from the FDA-approved drug label.