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Important: This site presents data from the FDA Adverse Event Reporting System (FAERS). A report does not mean the drug caused the event. Full disclaimer.

BUTENAFINE: 768 Adverse Event Reports & Safety Profile

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768
Total FAERS Reports
0
Deaths Reported
4
Hospitalizations
768
As Primary/Secondary Suspect
Dec 7, 2001
FDA Approved
Kroger Company
Manufacturer
Discontinued
Status
Yes
Generic Available

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?

#1 Most Reported
Drug ineffective
235 reports (30.6%)
#2 Most Reported
Product use issue
120 reports (15.6%)
#3 Most Reported
Product use in unapproved indication
98 reports (12.8%)

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

YearReportsDeathsHosp.
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

View full timeline →

What Is BUTENAFINE Used For?

IndicationReports
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?

BUTENAFINE vs BUTORPHANOL BUTENAFINE vs BUTRANS BUTENAFINE vs BUTYLSCOPOLAMINE BUTENAFINE vs BYETTA BUTENAFINE vs BYETTA PEN DISPOSABLE BUTENAFINE vs CABAZITAXEL BUTENAFINE vs CABERGOLINE BUTENAFINE vs CABOTEGRAVIR BUTENAFINE vs CABOTEGRAVIR\RILPIVIRINE BUTENAFINE vs CABOZANTINIB

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