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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.

SYMBICORT: 381 Adverse Event Reports & Safety Profile

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381
Total FAERS Reports
24 (6.3%)
Deaths Reported
77
Hospitalizations
381
As Primary/Secondary Suspect
5
Life-Threatening
11
Disabilities

First Report: 1993 · Latest Report: 20140620

What Are the Most Common SYMBICORT Side Effects?

#1 Most Reported
Dyspnoea
92 reports (24.1%)
#2 Most Reported
Off label use
70 reports (18.4%)
#3 Most Reported
Intentional product misuse
69 reports (18.1%)

All SYMBICORT Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Dyspnoea 92 24.2% 4 28
Off label use 70 18.4% 2 21
Intentional product misuse 69 18.1% 1 16
Drug dose omission 60 15.8% 0 17
Asthma 38 10.0% 0 8
Cough 38 10.0% 0 6
Circumstance or information capable of leading to medication error 35 9.2% 1 6
Malaise 32 8.4% 1 11
Pneumonia 31 8.1% 0 17
Device misuse 27 7.1% 1 5
Drug ineffective 24 6.3% 1 5
Intentional drug misuse 22 5.8% 0 6
Dysphonia 19 5.0% 0 5
Bronchitis 17 4.5% 1 2
Death 17 4.5% 17 3
Hearing impaired 16 4.2% 0 0
Wheezing 16 4.2% 0 4
Chronic obstructive pulmonary disease 15 3.9% 1 6
Adverse event 14 3.7% 0 4
Memory impairment 14 3.7% 1 3

Who Reports SYMBICORT Side Effects? Age & Gender Data

Average age: 65.3 years. Most reports from: US. View detailed demographics →

Is SYMBICORT Getting Safer? Reports by Year

YearReportsDeathsHosp.
2001 2 0 1
2002 1 0 0
2004 1 0 0
2007 4 0 1
2008 11 0 4
2009 5 0 2
2010 8 0 3
2011 10 0 3
2012 20 1 7
2013 74 9 23
2014 123 6 20

View full timeline →

What Is SYMBICORT Used For?

IndicationReports
Chronic obstructive pulmonary disease 136
Asthma 131
Emphysema 17
Dyspnoea 12
Product used for unknown indication 10

SYMBICORT vs Alternatives: Which Is Safer?

SYMBICORT vs SYNAGIS SYMBICORT vs SYNTHROID SYMBICORT vs TACROLIMUS SYMBICORT vs TACROLIMUS\TACROLIMUS ANHYDROUS SYMBICORT vs TADALAFIL SYMBICORT vs TAFAMIDIS SYMBICORT vs TAFAMIDIS MEGLUMINE SYMBICORT vs TAFASITAMAB SYMBICORT vs TAFASITAMAB-CXIX SYMBICORT vs TAFINLAR

Official FDA Label for SYMBICORT

Official prescribing information from the FDA-approved drug label.