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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.

SPIRIVA: 3,472 Adverse Event Reports & Safety Profile

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3,472
Total FAERS Reports
114 (3.3%)
Deaths Reported
495
Hospitalizations
3,472
As Primary/Secondary Suspect
36
Life-Threatening
20
Disabilities

First Report: 2000 · Latest Report: 20140625

What Are the Most Common SPIRIVA Side Effects?

#1 Most Reported
Incorrect route of drug administration
1,554 reports (44.8%)
#2 Most Reported
Product quality issue
621 reports (17.9%)
#3 Most Reported
Dyspnoea
485 reports (14.0%)

All SPIRIVA Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Incorrect route of drug administration 1,554 44.8% 0 44
Product quality issue 621 17.9% 0 70
Dyspnoea 485 14.0% 5 101
Off label use 292 8.4% 2 21
Drug ineffective 240 6.9% 1 19
Pneumonia 134 3.9% 18 104
Cough 124 3.6% 0 11
Chronic obstructive pulmonary disease 122 3.5% 19 81
Dry mouth 72 2.1% 0 9
Dysphonia 62 1.8% 0 13
Lung neoplasm malignant 48 1.4% 6 19
Cataract 47 1.4% 0 12
Fall 46 1.3% 3 29
Bronchitis 38 1.1% 2 17
Myocardial infarction 37 1.1% 5 21
Death 36 1.0% 36 5
Oropharyngeal pain 36 1.0% 1 8
Fatigue 34 1.0% 0 5
Vision blurred 34 1.0% 0 5
Asthenia 33 1.0% 1 10

Who Reports SPIRIVA Side Effects? Age & Gender Data

Average age: 69.0 years. Most reports from: US. View detailed demographics →

Is SPIRIVA Getting Safer? Reports by Year

YearReportsDeathsHosp.
2000 1 0 0
2002 1 0 1
2003 3 1 0
2004 18 0 8
2005 4 0 0
2006 11 0 3
2007 16 0 6
2008 15 0 7
2009 35 0 9
2010 53 2 22
2011 81 3 31
2012 146 6 50
2013 739 27 173
2014 1,984 38 120

View full timeline →

What Is SPIRIVA Used For?

IndicationReports
Chronic obstructive pulmonary disease 2,255
Product used for unknown indication 518
Emphysema 201
Asthma 199
Bronchitis chronic 65
Dyspnoea 55
Cough 15
Lung neoplasm malignant 15
Pneumonia 10
Pulmonary fibrosis 9

SPIRIVA vs Alternatives: Which Is Safer?

SPIRIVA vs SPIRONOLACTONE SPIRIVA vs SPRYCEL SPIRIVA vs STALEVO SPIRIVA vs STANNOUS FLUORIDE SPIRIVA vs STANOZOLOL SPIRIVA vs STAVUDINE SPIRIVA vs STELARA SPIRIVA vs STIRIPENTOL SPIRIVA vs STIVARGA SPIRIVA vs STRATTERA

Official FDA Label for SPIRIVA

Official prescribing information from the FDA-approved drug label.