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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.

ACLIDINIUM\FORMOTEROL: 474 Adverse Event Reports & Safety Profile

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474
Total FAERS Reports
10 (2.1%)
Deaths Reported
292
Hospitalizations
474
As Primary/Secondary Suspect
12
Life-Threatening
87
Disabilities

Active Ingredient: ACLIDINIUM BROMIDE\FORMOTEROL FUMARATE ·

First Report: 20141001 · Latest Report: 20250723

What Are the Most Common ACLIDINIUM\FORMOTEROL Side Effects?

#1 Most Reported
Chronic obstructive pulmonary disease
252 reports (53.2%)
#2 Most Reported
Wheezing
232 reports (48.9%)
#3 Most Reported
Bronchiectasis
225 reports (47.5%)

All ACLIDINIUM\FORMOTEROL Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Chronic obstructive pulmonary disease 252 53.2% 3 204
Wheezing 232 49.0% 1 174
Bronchiectasis 225 47.5% 1 186
Gastrooesophageal reflux disease 200 42.2% 1 156
Dyspnoea 155 32.7% 1 118
Asthma 148 31.2% 1 127
Obstructive airways disorder 138 29.1% 1 110
Therapeutic product effect incomplete 136 28.7% 1 119
Breath sounds abnormal 118 24.9% 1 112
Oedema peripheral 110 23.2% 1 75
Asthma-chronic obstructive pulmonary disease overlap syndrome 109 23.0% 0 74
Cardiac murmur 109 23.0% 0 74
Nasal polyps 109 23.0% 0 74
Rhinitis allergic 109 23.0% 0 74
Sarcoidosis 109 23.0% 0 74
Total lung capacity increased 109 23.0% 0 74
Benign prostatic hyperplasia 106 22.4% 1 102
Congenital hiatus hernia 106 22.4% 1 102
Transient ischaemic attack 106 22.4% 1 102
Full blood count abnormal 102 21.5% 1 100

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

Gender: 35.5% female, 64.5% male. Average age: 69.4 years. Most reports from: CA. View detailed demographics →

Is ACLIDINIUM\FORMOTEROL Getting Safer? Reports by Year

YearReportsDeathsHosp.
2014 2 0 2
2015 2 0 0
2016 5 1 1
2017 3 0 2
2018 7 0 4
2019 10 2 3
2020 14 0 4
2021 13 0 3
2022 6 0 0
2023 10 0 6
2024 9 1 3
2025 2 0 1

View full timeline →

What Is ACLIDINIUM\FORMOTEROL Used For?

IndicationReports
Product used for unknown indication 272
Chronic obstructive pulmonary disease 112
Asthma 36
Emphysema 5

ACLIDINIUM\FORMOTEROL vs Alternatives: Which Is Safer?

ACLIDINIUM\FORMOTEROL vs ACORAMIDIS ACLIDINIUM\FORMOTEROL vs ACTEMRA ACLIDINIUM\FORMOTEROL vs ACTIQ ACLIDINIUM\FORMOTEROL vs ACTIVATED CHARCOAL ACLIDINIUM\FORMOTEROL vs ACTONEL ACLIDINIUM\FORMOTEROL vs ACYCLOVIR ACLIDINIUM\FORMOTEROL vs AD26.COV2.S ACLIDINIUM\FORMOTEROL vs ADAGRASIB ACLIDINIUM\FORMOTEROL vs ADALIMUMAB ACLIDINIUM\FORMOTEROL vs ADALIMUMAB-AACF

Official FDA Label for ACLIDINIUM\FORMOTEROL

Official prescribing information from the FDA-approved drug label.