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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.

OLODATEROL\TIOTROPIUM: 4,430 Adverse Event Reports & Safety Profile

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4,430
Total FAERS Reports
342 (7.7%)
Deaths Reported
1,312
Hospitalizations
4,430
As Primary/Secondary Suspect
82
Life-Threatening
54
Disabilities

Active Ingredient: OLODATEROL HYDROCHLORIDE\TIOTROPIUM BROMIDE MONOHYDRATE ·

First Report: 19920101 · Latest Report: 20250918

What Are the Most Common OLODATEROL\TIOTROPIUM Side Effects?

#1 Most Reported
Dyspnoea
1,149 reports (25.9%)
#2 Most Reported
Wheezing
575 reports (13.0%)
#3 Most Reported
Asthma
526 reports (11.9%)

All OLODATEROL\TIOTROPIUM Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Dyspnoea 1,149 25.9% 28 489
Wheezing 575 13.0% 6 408
Asthma 526 11.9% 7 402
Cough 485 11.0% 4 217
Drug ineffective 403 9.1% 7 172
Chronic obstructive pulmonary disease 373 8.4% 32 245
Therapeutic product effect incomplete 319 7.2% 0 238
Loss of personal independence in daily activities 307 6.9% 6 225
Pneumonia 280 6.3% 24 245
Off label use 265 6.0% 15 91
Sleep disorder due to a general medical condition 259 5.9% 6 197
Bronchiectasis 199 4.5% 0 155
Death 186 4.2% 186 18
Chest discomfort 175 4.0% 0 117
Asthma-chronic obstructive pulmonary disease overlap syndrome 171 3.9% 0 129
Obstructive airways disorder 167 3.8% 0 118
Product quality issue 167 3.8% 0 15
Lung neoplasm malignant 153 3.5% 12 74
Gastrooesophageal reflux disease 146 3.3% 0 88
Oedema peripheral 137 3.1% 1 87

Who Reports OLODATEROL\TIOTROPIUM Side Effects? Age & Gender Data

Gender: 56.7% female, 43.3% male. Average age: 70.3 years. Most reports from: US. View detailed demographics →

Is OLODATEROL\TIOTROPIUM Getting Safer? Reports by Year

YearReportsDeathsHosp.
2004 2 0 1
2007 1 0 0
2008 1 0 1
2009 1 0 1
2010 4 2 1
2011 3 0 1
2012 5 0 2
2013 3 0 2
2014 7 1 1
2015 212 8 41
2016 414 50 139
2017 323 18 75
2018 286 21 66
2019 194 14 42
2020 249 29 71
2021 213 16 38
2022 184 19 36
2023 171 20 46
2024 101 8 24
2025 59 2 10

View full timeline →

What Is OLODATEROL\TIOTROPIUM Used For?

IndicationReports
Product used for unknown indication 2,048
Chronic obstructive pulmonary disease 1,881
Asthma 165
Emphysema 141
Dyspnoea 52
Bronchitis chronic 19
Lung disorder 19
Bronchiectasis 18
Bronchitis 10
Lung neoplasm malignant 9

OLODATEROL\TIOTROPIUM vs Alternatives: Which Is Safer?

OLODATEROL\TIOTROPIUM vs OLOPATADINE OLODATEROL\TIOTROPIUM vs OLUTASIDENIB OLODATEROL\TIOTROPIUM vs OMACETAXINE MEPESUCCINATE OLODATEROL\TIOTROPIUM vs OMADACYCLINE OLODATEROL\TIOTROPIUM vs OMALIZUMAB OLODATEROL\TIOTROPIUM vs OMAVELOXOLONE OLODATEROL\TIOTROPIUM vs OMBITASVIR OLODATEROL\TIOTROPIUM vs OMBITASVIR\PARITAPREVIR\RITONAVIR OLODATEROL\TIOTROPIUM vs OMEGA-3-ACID ETHYL ESTERS OLODATEROL\TIOTROPIUM vs OMEGA-3-CARBOXYLIC ACIDS

Official FDA Label for OLODATEROL\TIOTROPIUM

Official prescribing information from the FDA-approved drug label.