SYMBICORT PMDI: 86 Adverse Event Reports & Safety Profile
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86
Total FAERS Reports
5 (5.8%)
Deaths Reported
22
Hospitalizations
86
As Primary/Secondary Suspect
1
Life-Threatening
1
Disabilities
First Report: 1992 · Latest Report: 20140608
What Are the Most Common SYMBICORT PMDI Side Effects?
#1 Most Reported
Drug dose omission
37 reports (43.0%)
#2 Most Reported
Dyspnoea
31 reports (36.0%)
#3 Most Reported
Off label use
23 reports (26.7%)
All SYMBICORT PMDI Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Drug dose omission | 37 | 43.0% | 0 | 13 |
| Dyspnoea | 31 | 36.1% | 1 | 9 |
| Off label use | 23 | 26.7% | 0 | 5 |
| Intentional product misuse | 18 | 20.9% | 0 | 5 |
| Intentional drug misuse | 16 | 18.6% | 1 | 5 |
| Chronic obstructive pulmonary disease | 13 | 15.1% | 2 | 6 |
| Gastrooesophageal reflux disease | 11 | 12.8% | 0 | 5 |
| Malaise | 11 | 12.8% | 2 | 4 |
| Feeling abnormal | 10 | 11.6% | 0 | 5 |
| Pneumonia | 10 | 11.6% | 2 | 5 |
| Condition aggravated | 8 | 9.3% | 0 | 4 |
| Cough | 8 | 9.3% | 1 | 0 |
| Circumstance or information capable of leading to medication error | 7 | 8.1% | 0 | 1 |
| Drug ineffective | 7 | 8.1% | 0 | 2 |
| Insomnia | 7 | 8.1% | 0 | 2 |
| Asthma | 6 | 7.0% | 0 | 2 |
| Cataract | 6 | 7.0% | 0 | 1 |
| Chest pain | 6 | 7.0% | 0 | 1 |
| Fall | 6 | 7.0% | 0 | 3 |
| Hypertension | 6 | 7.0% | 0 | 2 |
Who Reports SYMBICORT PMDI Side Effects? Age & Gender Data
Average age: 62.3 years. Most reports from: US. View detailed demographics →
Is SYMBICORT PMDI Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2002 | 2 | 0 | 1 |
| 2005 | 1 | 0 | 0 |
| 2008 | 1 | 0 | 0 |
| 2009 | 1 | 0 | 1 |
| 2010 | 5 | 0 | 1 |
| 2011 | 6 | 0 | 1 |
| 2012 | 9 | 0 | 5 |
| 2013 | 9 | 0 | 1 |
| 2014 | 20 | 3 | 6 |
What Is SYMBICORT PMDI Used For?
| Indication | Reports |
|---|---|
| Asthma | 28 |
| Chronic obstructive pulmonary disease | 27 |
| Emphysema | 6 |
Official FDA Label for SYMBICORT PMDI
Official prescribing information from the FDA-approved drug label.