SAGE: 10 Adverse Event Reports & Safety Profile
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10
Total FAERS Reports
0
Deaths Reported
8
Hospitalizations
10
As Primary/Secondary Suspect
Hahnemann Laboratories, INC.
Manufacturer
Drug Class: Allergens [CS] · Route: ORAL · Manufacturer: Hahnemann Laboratories, INC. · HUMAN OTC DRUG · FDA Label: Available
First Report: 20011127 · Latest Report: 201705
What Are the Most Common SAGE Side Effects?
#1 Most Reported
Swelling face
5 reports (50.0%)
#2 Most Reported
Stevens-johnson syndrome
5 reports (50.0%)
#3 Most Reported
Restlessness
5 reports (50.0%)
All SAGE Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Alanine aminotransferase increased | 5 | 50.0% | 0 | 5 |
| Aspartate aminotransferase increased | 5 | 50.0% | 0 | 5 |
| Dysphagia | 5 | 50.0% | 0 | 5 |
| Epilepsy | 5 | 50.0% | 0 | 5 |
| Erythema | 5 | 50.0% | 0 | 5 |
| Fatigue | 5 | 50.0% | 0 | 5 |
| Gamma-glutamyltransferase increased | 5 | 50.0% | 0 | 5 |
| Liver function test abnormal | 5 | 50.0% | 0 | 5 |
| Mucosal erosion | 5 | 50.0% | 0 | 5 |
| Nasopharyngitis | 5 | 50.0% | 0 | 5 |
| Nausea | 5 | 50.0% | 0 | 5 |
| Pruritus | 5 | 50.0% | 0 | 5 |
| Pyrexia | 5 | 50.0% | 0 | 5 |
| Rash macular | 5 | 50.0% | 0 | 5 |
| Restlessness | 5 | 50.0% | 0 | 5 |
| Stevens-johnson syndrome | 5 | 50.0% | 0 | 5 |
| Swelling face | 5 | 50.0% | 0 | 5 |
Who Reports SAGE Side Effects? Age & Gender Data
Gender: 30.0% female, 70.0% male. Average age: 47.3 years. Most reports from: DE. View detailed demographics →
Is SAGE Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2001 | 5 | 0 | 5 |
| 2013 | 1 | 0 | 0 |
| 2014 | 1 | 0 | 1 |
| 2017 | 2 | 0 | 1 |
What Is SAGE Used For?
| Indication | Reports |
|---|---|
| Nasopharyngitis | 5 |
Other Drugs in Same Class: Allergens [CS]
Official FDA Label for SAGE
Official prescribing information from the FDA-approved drug label.