DULERA: 526 Adverse Event Reports & Safety Profile
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526
Total FAERS Reports
2 (0.4%)
Deaths Reported
22
Hospitalizations
526
As Primary/Secondary Suspect
6
Life-Threatening
2
Disabilities
First Report: 2009 · Latest Report: 20140617
What Are the Most Common DULERA Side Effects?
#1 Most Reported
Product quality issue
287 reports (54.6%)
#2 Most Reported
Drug dose omission
227 reports (43.2%)
#3 Most Reported
No adverse event
187 reports (35.6%)
All DULERA Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Product quality issue | 287 | 54.6% | 0 | 7 |
| Drug dose omission | 227 | 43.2% | 0 | 6 |
| No adverse event | 187 | 35.6% | 0 | 0 |
| Dyspnoea | 66 | 12.6% | 0 | 7 |
| Underdose | 53 | 10.1% | 0 | 1 |
| Incorrect dose administered | 42 | 8.0% | 0 | 1 |
| Drug ineffective | 35 | 6.7% | 0 | 3 |
| Cough | 29 | 5.5% | 0 | 2 |
| Asthma | 28 | 5.3% | 1 | 7 |
| Product container issue | 24 | 4.6% | 0 | 1 |
| Dysphonia | 19 | 3.6% | 0 | 1 |
| Off label use | 18 | 3.4% | 0 | 1 |
| Inappropriate schedule of drug administration | 17 | 3.2% | 0 | 0 |
| Headache | 16 | 3.0% | 0 | 2 |
| Wheezing | 16 | 3.0% | 0 | 1 |
| Wrong technique in drug usage process | 15 | 2.9% | 0 | 0 |
| Candida infection | 12 | 2.3% | 0 | 0 |
| Malaise | 12 | 2.3% | 0 | 2 |
| Drug administered to patient of inappropriate age | 11 | 2.1% | 0 | 1 |
| Chest pain | 10 | 1.9% | 0 | 2 |
Who Reports DULERA Side Effects? Age & Gender Data
Average age: 55.1 years. Most reports from: US. View detailed demographics →
Is DULERA Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2009 | 1 | 0 | 1 |
| 2010 | 1 | 0 | 0 |
| 2011 | 3 | 0 | 1 |
| 2012 | 8 | 0 | 3 |
| 2013 | 54 | 0 | 7 |
| 2014 | 176 | 1 | 2 |
What Is DULERA Used For?
| Indication | Reports |
|---|---|
| Asthma | 190 |
| Chronic obstructive pulmonary disease | 42 |
| Emphysema | 9 |
| Bronchitis | 7 |
| Dyspnoea | 5 |
DULERA vs Alternatives: Which Is Safer?
DULERA vs DULOXETINE
DULERA vs DUPILUMAB
DULERA vs DURAGESIC
DULERA vs DUROGESIC
DULERA vs DUROTEP MT
DULERA vs DURVALUMAB
DULERA vs DUTASTERIDE
DULERA vs DUTASTERIDE\TAMSULOSIN
DULERA vs DUVELISIB
DULERA vs DYDROGESTERONE
Official FDA Label for DULERA
Official prescribing information from the FDA-approved drug label.