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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.

INDACATEROL: 1,765 Adverse Event Reports & Safety Profile

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1,765
Total FAERS Reports
349 (19.8%)
Deaths Reported
723
Hospitalizations
1,765
As Primary/Secondary Suspect
64
Life-Threatening
24
Disabilities
Jul 1, 2011
FDA Approved
Discontinued
Status

FDA Application: 022383 ·

Patent Expires: Oct 11, 2028 · First Report: 2008 · Latest Report: 20240723

What Are the Most Common INDACATEROL Side Effects?

#1 Most Reported
Dyspnoea
489 reports (27.7%)
#2 Most Reported
Asthma
232 reports (13.1%)
#3 Most Reported
Cough
223 reports (12.6%)

All INDACATEROL Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Dyspnoea 489 27.7% 44 265
Asthma 232 13.1% 5 141
Cough 223 12.6% 10 67
Pneumonia 201 11.4% 36 103
Malaise 163 9.2% 16 91
Wheezing 161 9.1% 3 136
Death 144 8.2% 144 10
Chronic obstructive pulmonary disease 137 7.8% 23 93
Drug ineffective 125 7.1% 4 25
Condition aggravated 121 6.9% 8 48
Fall 120 6.8% 4 93
Weight decreased 120 6.8% 10 38
Blood pressure increased 111 6.3% 1 88
General physical health deterioration 103 5.8% 11 90
Therapeutic product effect incomplete 102 5.8% 0 99
Product use issue 100 5.7% 18 38
Fatigue 97 5.5% 7 50
Hypertension 97 5.5% 5 24
Bronchospasm 95 5.4% 1 77
Pain 93 5.3% 2 74

Who Reports INDACATEROL Side Effects? Age & Gender Data

Gender: 49.9% female, 50.1% male. Average age: 68.7 years. Most reports from: COUNTRY NOT SPECIFIED. View detailed demographics →

Is INDACATEROL Getting Safer? Reports by Year

YearReportsDeathsHosp.
2008 1 0 0
2009 2 0 0
2010 2 1 0
2011 17 0 9
2012 24 6 9
2013 83 20 45
2014 158 33 77
2015 134 27 72
2016 109 26 41
2017 83 17 42
2018 46 14 19
2019 35 7 13
2020 41 6 8
2021 16 4 9
2022 19 1 12
2023 10 0 3
2024 19 0 18

View full timeline →

What Is INDACATEROL Used For?

IndicationReports
Chronic obstructive pulmonary disease 676
Product used for unknown indication 607
Emphysema 153
Asthma 132
Lung disorder 67
Dyspnoea 53
Off label use 26
Respiratory disorder 15
Bronchitis chronic 12
Bronchitis 10

INDACATEROL vs Alternatives: Which Is Safer?

INDACATEROL vs INDAPAMIDE INDACATEROL vs INDAPAMIDE\PERINDOPRIL INDACATEROL vs INDAPAMIDE\PERINDOPRIL ARGININE INDACATEROL vs INDAPAMIDE\PERINDOPRIL ERBUMINE INDACATEROL vs INDINAVIR INDACATEROL vs INDOMETHACIN INDACATEROL vs INDOMETHACIN\INDOMETHACIN INDACATEROL vs INEBILIZUMAB-CDON INDACATEROL vs INEXIUM INDACATEROL vs INFLIXIMAB

Official FDA Label for INDACATEROL

Official prescribing information from the FDA-approved drug label.