TOLNAFTATE: 237 Adverse Event Reports & Safety Profile
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Route: TOPICAL · Manufacturer: Natureplex, LLC · HUMAN OTC DRUG · FDA Label: Available
First Report: 19700101 · Latest Report: 20250901
What Are the Most Common TOLNAFTATE Side Effects?
All TOLNAFTATE Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Drug ineffective | 37 | 15.6% | 0 | 0 |
| Pain | 22 | 9.3% | 4 | 2 |
| Recalled product administered | 20 | 8.4% | 1 | 5 |
| Mesothelioma | 16 | 6.8% | 4 | 1 |
| Anxiety | 13 | 5.5% | 4 | 2 |
| Exposure to chemical pollution | 12 | 5.1% | 2 | 0 |
| Off label use | 12 | 5.1% | 0 | 0 |
| Burning sensation | 11 | 4.6% | 0 | 0 |
| Pruritus | 11 | 4.6% | 0 | 0 |
| Drug administered at inappropriate site | 10 | 4.2% | 0 | 0 |
| Erythema | 10 | 4.2% | 0 | 0 |
| Mesothelioma malignant | 10 | 4.2% | 4 | 1 |
| Emotional distress | 9 | 3.8% | 2 | 2 |
| Expired product administered | 9 | 3.8% | 0 | 0 |
| Product quality issue | 9 | 3.8% | 0 | 0 |
| Condition aggravated | 8 | 3.4% | 0 | 0 |
| Product use issue | 8 | 3.4% | 1 | 0 |
| Rash | 8 | 3.4% | 0 | 0 |
| Urticaria | 8 | 3.4% | 0 | 2 |
| Accidental exposure to product | 7 | 3.0% | 0 | 2 |
Who Reports TOLNAFTATE Side Effects? Age & Gender Data
Gender: 42.3% female, 57.7% male. Average age: 58.4 years. Most reports from: US. View detailed demographics →
Is TOLNAFTATE Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2011 | 1 | 0 | 0 |
| 2013 | 1 | 0 | 0 |
| 2014 | 11 | 0 | 0 |
| 2015 | 8 | 0 | 0 |
| 2016 | 10 | 0 | 0 |
| 2017 | 3 | 0 | 0 |
| 2018 | 5 | 0 | 0 |
| 2019 | 8 | 0 | 0 |
| 2020 | 10 | 2 | 4 |
| 2021 | 30 | 1 | 2 |
| 2022 | 14 | 1 | 2 |
| 2023 | 12 | 1 | 0 |
| 2024 | 5 | 2 | 0 |
| 2025 | 6 | 0 | 0 |
What Is TOLNAFTATE Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 49 |
| Tinea pedis | 40 |
| Onychomycosis | 18 |
| Tinea cruris | 18 |
| Fungal infection | 12 |
| Therapeutic skin care topical | 10 |
| Pruritus | 8 |
| Skin odour abnormal | 6 |
TOLNAFTATE vs Alternatives: Which Is Safer?
Official FDA Label for TOLNAFTATE
Official prescribing information from the FDA-approved drug label.
Drug Description
Antifungal Lotion provides effective relief of itching, scaling, burning, irritation and discomfort associated with athlete's foot, jock itch and ringworm. The active ingredient, Tolnaftate, combines with a soothing base of natural botanical extracts to yield a truly unique formula. You can count on Home Health to deliver the natural heath products your family deserves.
No Mineral
Oil, No petroleum, No Artificial Colors, No Artificial Fragrance.
Carefully
Manufactured for HomeHealth, Co. Ronkonxoma, NY 11779 U.S.A. 800-445-7137 www.HomeHealthUS.com 2009 Home Health B11812 03B
FDA Approved Uses (Indications)
1. Clean the affected area and dry thoroughly. Apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor. Gently file the nail to make it thinner and remove debris, being cautious not to harm the nail bed. For best results, file nails every 2-3 days. 2. Supervise children in the use of this product. For athlete's foot: Pay special attention to spaces between the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily. To prevent athlete's foot, apply once or twice daily (morning and/or night). For toe fungus, apply to skin around the nail and cuticle. Visible improvement may be seen in as little as 7 days. Continue regular use to help prevent fungus regrowth.
Dosage & Administration
Directions Read all package directions and warnings before use. Use only as directed. Clean the affected area with soap and warm water and dry thoroughly. Apply a thin layer of FUNGICURE Liquid over the affected area twice daily (morning and night), or as directed by a doctor. To prevent athlete's foot, wash the feet and dry thoroughly. Apply a thin layer of the product to the feet once or twice daily (morning and/or night). This product is not effective on scalp or nails. For ringworm and athlete's foot, use daily for 4 weeks. If condition persists longer, consult a doctor. For athlete's foot, pay special attention to spaces between toes; wear well fitting, ventillated shoes, and change shoes and socks at least once daily. Intended for use for use by normally healthy adults only. Persons under 18 years of age or those with highly sensitive or allergic skin should use only as directed by a doctor. Supervise children in the use of this product.
Contraindications
CONTRAINDICATIONS: Tolnaftate topically applied is not likely to affect drugs taken or injected, but many drugs can interact with each other.
Known Adverse Reactions
ADVERSE REACTIONS: For athlete’s foot and ringworm - if irritation occurs or there is no improvement within 4 weeks. For prevention of athlete’s foot – if irritation occurs, discontinue use and consult a doctor.
Warnings
Warnings For external use only. Flammable: Contents under pressure. Avoid spraying in eyes. Do not use or store near heat or open flame. Do not puncture or incinerate container. Do not store at temperature above 120ºF. Keep out of the reach of children. Use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal. When using this product avoid contact with the eyes or mouth use only as directed Stop use and ask a doctor if irritation occurs no improvement within 4 weeks for athlete's foot and ringworm Stop use and ask a doctor if irritation occurs no improvement within 4 weeks for athlete's foot and ringworm Do not use on children under 2 years of age unless directed by a doctor. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Precautions
PRECAUTIONS: Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Avoid contact with eyes, lips and mucous membranes.
Active Ingredient
Active ingredient (in each gram)
Purpose Tolnaftate
1%--------------------------------------------------------------------------------- Antifungal
Inactive Ingredients
Inactive Ingredients Achillea Millefolium (Yarrow) Extract, Allantoin, Anthemis Nobilis (Chamomile) Extract, Bentonite, Citric Acid, Echinacea Purpurea Extract, Equisetum Arvense (Horsetail) Extract, Glycereth-7 Cocoate, Glycerin, Glycyrrhiza Glabra (Licorice Root) Extract, Hamamelis Virginiana (Witch Hazel) Extract, Hibiscus Syriacus (Althaea) Extract, Kaolin, Laminaria Digitata (Sea Kelp) Extract, Magnesium Aluminum Silicate, Melaleuca Alternifolia (Tea Tree) Oil, Melissa Officinalis (Balm Mint) Extract, Menthol, Methyl Paraben, Mixed Tocopherols (Vitamin E), Origanum Vulgare (Oregano) Oil, Panthenol, Propyl Paraben, Purified Water, Rosmarinus Officinalis (Rosemary) Extract, Salvia Officinalis (Sage) Extract, Stearic Acid, Thymus Vulgaris (Thyme) Extract, Tussilago Farfara (Coltsfoot) Extract, Zinc Oxide.