SINGULAIR: 262 Adverse Event Reports & Safety Profile
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262
Total FAERS Reports
29 (11.1%)
Deaths Reported
60
Hospitalizations
262
As Primary/Secondary Suspect
9
Life-Threatening
12
Disabilities
First Report: 199810 · Latest Report: 20140524
What Are the Most Common SINGULAIR Side Effects?
#1 Most Reported
Drug ineffective
25 reports (9.5%)
#2 Most Reported
Exposure during pregnancy
16 reports (6.1%)
#3 Most Reported
Asthma
14 reports (5.3%)
All SINGULAIR Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Drug ineffective | 25 | 9.5% | 1 | 2 |
| Exposure during pregnancy | 16 | 6.1% | 0 | 2 |
| Asthma | 14 | 5.3% | 2 | 6 |
| Aggression | 13 | 5.0% | 0 | 2 |
| Depression | 13 | 5.0% | 2 | 2 |
| Drug hypersensitivity | 13 | 5.0% | 0 | 2 |
| Dyspnoea | 13 | 5.0% | 2 | 6 |
| Overdose | 13 | 5.0% | 5 | 4 |
| Crying | 11 | 4.2% | 0 | 1 |
| Foetal exposure during pregnancy | 11 | 4.2% | 0 | 0 |
| Anxiety | 10 | 3.8% | 0 | 2 |
| Cough | 10 | 3.8% | 0 | 2 |
| Insomnia | 10 | 3.8% | 0 | 5 |
| Abnormal behaviour | 9 | 3.4% | 0 | 1 |
| Rash | 9 | 3.4% | 0 | 3 |
| Completed suicide | 8 | 3.1% | 8 | 1 |
| Lobar pneumonia | 8 | 3.1% | 8 | 0 |
| Nightmare | 8 | 3.1% | 0 | 2 |
| No adverse event | 8 | 3.1% | 0 | 0 |
| Pneumonia | 8 | 3.1% | 2 | 6 |
Who Reports SINGULAIR Side Effects? Age & Gender Data
Average age: 38.3 years. Most reports from: US. View detailed demographics →
Is SINGULAIR Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2000 | 1 | 0 | 0 |
| 2004 | 1 | 1 | 0 |
| 2005 | 2 | 0 | 0 |
| 2006 | 1 | 1 | 1 |
| 2007 | 1 | 1 | 0 |
| 2008 | 5 | 0 | 1 |
| 2009 | 6 | 2 | 3 |
| 2010 | 3 | 1 | 1 |
| 2011 | 6 | 0 | 3 |
| 2012 | 18 | 1 | 8 |
| 2013 | 46 | 5 | 15 |
| 2014 | 41 | 3 | 6 |
What Is SINGULAIR Used For?
| Indication | Reports |
|---|---|
| Asthma | 84 |
| Product used for unknown indication | 25 |
| Hypersensitivity | 19 |
| Multiple allergies | 5 |
| Seasonal allergy | 5 |
SINGULAIR vs Alternatives: Which Is Safer?
SINGULAIR vs SINTILIMAB
SINGULAIR vs SIPONIMOD
SINGULAIR vs SIPULEUCEL-T
SINGULAIR vs SIROLIMUS
SINGULAIR vs SIRUKUMAB
SINGULAIR vs SITAGLIPTIN
SINGULAIR vs SOAP
SINGULAIR vs SODIUM
SINGULAIR vs SODIUM BICARBONATE
SINGULAIR vs SODIUM BICARBONATE\SODIUM
Official FDA Label for SINGULAIR
Official prescribing information from the FDA-approved drug label.