BUTENAFINE: 768 Adverse Event Reports & Safety Profile
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Active Ingredient: BUTENAFINE HYDROCHLORIDE · Drug Class: Benzylamine Antifungal [EPC] · Route: TOPICAL · Manufacturer: Kroger Company · FDA Application: 020524 · HUMAN OTC DRUG · FDA Label: Available
First Report: 20081124 · Latest Report: 20250805
What Are the Most Common BUTENAFINE Side Effects?
All BUTENAFINE Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Drug ineffective | 235 | 30.6% | 0 | 3 |
| Product use issue | 120 | 15.6% | 0 | 0 |
| Product use in unapproved indication | 98 | 12.8% | 0 | 0 |
| Off label use | 97 | 12.6% | 0 | 0 |
| Pruritus | 35 | 4.6% | 0 | 0 |
| Burning sensation | 29 | 3.8% | 0 | 0 |
| Drug effective for unapproved indication | 29 | 3.8% | 0 | 0 |
| Rash | 28 | 3.7% | 0 | 0 |
| Therapeutic response unexpected | 27 | 3.5% | 0 | 0 |
| Product administered at inappropriate site | 26 | 3.4% | 0 | 0 |
| Erythema | 25 | 3.3% | 0 | 0 |
| Product prescribing issue | 23 | 3.0% | 0 | 0 |
| Drug ineffective for unapproved indication | 22 | 2.9% | 0 | 0 |
| Condition aggravated | 21 | 2.7% | 0 | 1 |
| Expired product administered | 21 | 2.7% | 0 | 0 |
| Circumstance or information capable of leading to medication error | 20 | 2.6% | 0 | 0 |
| Wrong technique in product usage process | 18 | 2.3% | 0 | 0 |
| Accidental exposure to product | 17 | 2.2% | 0 | 0 |
| Drug administered at inappropriate site | 16 | 2.1% | 0 | 0 |
| Application site pain | 15 | 2.0% | 0 | 0 |
Who Reports BUTENAFINE Side Effects? Age & Gender Data
Gender: 46.9% female, 53.1% male. Average age: 59.8 years. Most reports from: US. View detailed demographics →
Is BUTENAFINE Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2008 | 1 | 0 | 0 |
| 2011 | 2 | 0 | 0 |
| 2014 | 15 | 0 | 0 |
| 2015 | 35 | 0 | 0 |
| 2016 | 46 | 0 | 0 |
| 2017 | 49 | 0 | 0 |
| 2018 | 49 | 0 | 1 |
| 2019 | 27 | 0 | 0 |
| 2020 | 22 | 0 | 0 |
| 2021 | 12 | 0 | 0 |
| 2022 | 11 | 0 | 0 |
| 2023 | 6 | 0 | 0 |
| 2024 | 6 | 0 | 0 |
| 2025 | 4 | 0 | 0 |
What Is BUTENAFINE Used For?
| Indication | Reports |
|---|---|
| Therapeutic skin care topical | 215 |
| Tinea pedis | 65 |
| Fungal infection | 44 |
| Onychomycosis | 43 |
| Tinea cruris | 42 |
| Product used for unknown indication | 41 |
| Pruritus | 35 |
| Rash | 31 |
| Tinea infection | 24 |
| Prophylaxis | 20 |
BUTENAFINE vs Alternatives: Which Is Safer?
Official FDA Label for BUTENAFINE
Official prescribing information from the FDA-approved drug label.
FDA Approved Uses (Indications)
Uses cures most ringworm cures most jock itch cures most athlete's foot between the toes. Effectiveness on the bottom or sides of foot is unknown. relieves itching, burning, cracking, and scaling which accompany these conditions
Dosage & Administration
Directions adults and children 12 years and older: use the tip of the cap to break the seal and open the tube wash the affected skin with soap and water and dry completely before applying for athlete's foot between the toes: apply to affected skin between and around the toes twice a day for 1 week (morning and night), or once a day for 4 weeks, or as directed by a doctor. Wear well-fitting, ventilated shoes. Change shoes and socks at least once daily. Apply between and around the toes 1 week twice a day or 4 weeks once a day for jock itch and ringworm: apply once a day to affected skin for 2 weeks or as directed by a doctor. wash hands after each use children under 12 years: ask a doctor Figure
Warnings
Warnings For external use only Do not use on nails or scalp in or near the mouth or the eyes for vaginal yeast infections When using this product do not get into the eyes. If eye contact occurs, rinse thoroughly with water. Stop use and ask a doctor if too much irritation occurs or irritation gets worse Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Active Ingredient
Active ingredient Butenafine hydrochloride 1%
Inactive Ingredients
Inactive ingredients Tea Tree Oil, benzyl alcohol, cetyl alcohol, glycerin, glyceryl monostearate SE, polyoxyethylene (23) cetyl ether, propylene glycol dicaprylate, purified water, sodium benzoate, stearic acid, trolamine, white petrolatum