AMMONIUM\DIPHENHYDRAMINE\MENTHOL\SODIUM: 39 Adverse Event Reports & Safety Profile
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39
Total FAERS Reports
23 (59.0%)
Deaths Reported
35
Hospitalizations
39
As Primary/Secondary Suspect
5
Life-Threatening
8
Disabilities
Active Ingredient: AMMONIUM CHLORIDE\DIPHENHYDRAMINE HYDROCHLORIDE\MENTHOL\SODIUM CITRATE ·
First Report: 20080101 · Latest Report: 20240322
What Are the Most Common AMMONIUM\DIPHENHYDRAMINE\MENTHOL\SODIUM Side Effects?
#1 Most Reported
Off label use
28 reports (71.8%)
#2 Most Reported
Intentional product use issue
27 reports (69.2%)
#3 Most Reported
Infusion related reaction
27 reports (69.2%)
All AMMONIUM\DIPHENHYDRAMINE\MENTHOL\SODIUM Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Off label use | 28 | 71.8% | 20 | 25 |
| General physical health deterioration | 27 | 69.2% | 22 | 27 |
| Infusion related reaction | 27 | 69.2% | 22 | 27 |
| Intentional product use issue | 27 | 69.2% | 20 | 24 |
| Abdominal discomfort | 26 | 66.7% | 21 | 26 |
| Alopecia | 26 | 66.7% | 22 | 26 |
| Arthralgia | 26 | 66.7% | 21 | 26 |
| Decreased appetite | 26 | 66.7% | 22 | 26 |
| Fatigue | 26 | 66.7% | 21 | 26 |
| Hypertension | 26 | 66.7% | 21 | 26 |
| Mobility decreased | 26 | 66.7% | 22 | 26 |
| C-reactive protein increased | 25 | 64.1% | 21 | 25 |
| Condition aggravated | 25 | 64.1% | 20 | 25 |
| Drug ineffective | 25 | 64.1% | 21 | 25 |
| Drug intolerance | 25 | 64.1% | 21 | 25 |
| Headache | 25 | 64.1% | 21 | 25 |
| Hepatic enzyme increased | 24 | 61.5% | 22 | 24 |
| Blood cholesterol increased | 23 | 59.0% | 22 | 23 |
| Fibromyalgia | 23 | 59.0% | 22 | 23 |
| Helicobacter infection | 23 | 59.0% | 22 | 23 |
Who Reports AMMONIUM\DIPHENHYDRAMINE\MENTHOL\SODIUM Side Effects? Age & Gender Data
Gender: 97.5% female, 2.5% male. Average age: 36.3 years. Most reports from: CA. View detailed demographics →
Is AMMONIUM\DIPHENHYDRAMINE\MENTHOL\SODIUM Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2008 | 1 | 0 | 1 |
| 2024 | 1 | 0 | 1 |
What Is AMMONIUM\DIPHENHYDRAMINE\MENTHOL\SODIUM Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 33 |
Official FDA Label for AMMONIUM\DIPHENHYDRAMINE\MENTHOL\SODIUM
Official prescribing information from the FDA-approved drug label.