FENBENDAZOLE: 23 Adverse Event Reports & Safety Profile
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23
Total FAERS Reports
0
Deaths Reported
12
Hospitalizations
23
As Primary/Secondary Suspect
1
Disabilities
B & L Healthcare Products INC
Manufacturer
Route: ORAL · Manufacturer: B & L Healthcare Products INC · HUMAN OTC DRUG · FDA Label: Available
First Report: 20210612 · Latest Report: 20241211
What Are the Most Common FENBENDAZOLE Side Effects?
#1 Most Reported
Off label use
9 reports (39.1%)
#2 Most Reported
Diarrhoea
6 reports (26.1%)
#3 Most Reported
Torsade de pointes
5 reports (21.7%)
All FENBENDAZOLE Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Off label use | 9 | 39.1% | 0 | 5 |
| Diarrhoea | 6 | 26.1% | 0 | 0 |
| Abdominal pain upper | 5 | 21.7% | 0 | 0 |
| Electrocardiogram qt prolonged | 5 | 21.7% | 0 | 5 |
| Tachyarrhythmia | 5 | 21.7% | 0 | 5 |
| Torsade de pointes | 5 | 21.7% | 0 | 5 |
Who Reports FENBENDAZOLE Side Effects? Age & Gender Data
Gender: 61.5% female, 38.5% male. Average age: 59.3 years. Most reports from: US. View detailed demographics →
Is FENBENDAZOLE Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2021 | 2 | 0 | 0 |
| 2024 | 2 | 0 | 1 |
Official FDA Label for FENBENDAZOLE
Official prescribing information from the FDA-approved drug label.
FDA Approved Uses (Indications)
Dewormer
Dosage & Administration
2 capsules per day
Warnings
These statements have not been evaluated by the Food and DrugAdministration. This product is not intended to diagnose, treat, cure, or prevent any diseases.
Active Ingredient
Febendazole
Inactive Ingredients
Ivermectin