TAVABOROLE: 713 Adverse Event Reports & Safety Profile
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Drug Class: Boron Compounds [CS] · Route: TOPICAL · Manufacturer: Viona Pharmaceuticals Inc · FDA Application: 204427 · HUMAN PRESCRIPTION DRUG · FDA Label: Available
First Report: 2014 · Latest Report: 20240501
What Are the Most Common TAVABOROLE Side Effects?
All TAVABOROLE Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Drug ineffective | 129 | 18.1% | 0 | 0 |
| Application site erythema | 71 | 10.0% | 0 | 0 |
| Application site exfoliation | 56 | 7.9% | 0 | 0 |
| Application site pain | 54 | 7.6% | 0 | 0 |
| Application site irritation | 40 | 5.6% | 0 | 0 |
| Nail discolouration | 38 | 5.3% | 0 | 0 |
| Drug administered at inappropriate site | 37 | 5.2% | 0 | 2 |
| Erythema | 36 | 5.1% | 0 | 0 |
| Pruritus | 36 | 5.1% | 0 | 0 |
| Skin exfoliation | 30 | 4.2% | 0 | 0 |
| Hypersensitivity | 27 | 3.8% | 0 | 0 |
| Ingrowing nail | 25 | 3.5% | 0 | 0 |
| Accidental exposure to product | 21 | 3.0% | 0 | 1 |
| Nail disorder | 19 | 2.7% | 0 | 0 |
| Onychomadesis | 19 | 2.7% | 0 | 0 |
| Application site vesicles | 18 | 2.5% | 0 | 0 |
| Blister | 18 | 2.5% | 0 | 0 |
| Off label use | 18 | 2.5% | 0 | 0 |
| Onychomycosis | 18 | 2.5% | 0 | 0 |
| Rash | 18 | 2.5% | 0 | 0 |
Who Reports TAVABOROLE Side Effects? Age & Gender Data
Gender: 71.9% female, 28.1% male. Average age: 63.5 years. Most reports from: US. View detailed demographics →
Is TAVABOROLE Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2014 | 4 | 0 | 0 |
| 2015 | 155 | 0 | 2 |
| 2016 | 104 | 1 | 3 |
| 2017 | 22 | 1 | 0 |
| 2018 | 14 | 1 | 0 |
| 2019 | 1 | 0 | 0 |
| 2020 | 2 | 0 | 0 |
| 2021 | 1 | 0 | 0 |
| 2022 | 4 | 0 | 0 |
| 2023 | 4 | 0 | 0 |
| 2024 | 2 | 0 | 0 |
What Is TAVABOROLE Used For?
| Indication | Reports |
|---|---|
| Onychomycosis | 308 |
| Fungal infection | 51 |
| Product used for unknown indication | 10 |
| Dermatophytosis of nail | 6 |
| Fungal skin infection | 5 |
| Nail disorder | 5 |
TAVABOROLE vs Alternatives: Which Is Safer?
Official FDA Label for TAVABOROLE
Official prescribing information from the FDA-approved drug label.
Drug Description
Tavaborole topical solution, 5% contains tavaborole, 5% (w/w) in a clear, colorless alcohol-based solution for topical use. The active ingredient, tavaborole, is an oxaborole antifungal with the chemical name of 5-fluoro-1,3-dihydro-1-hydroxy-2,1-benzoxaborole. The chemical formula is C 7 H 6 BFO 2 , the molecular weight is 151.93 and the structural formula is: Tavaborole is a white to off-white powder. It is slightly soluble in water and freely soluble in ethanol and propylene glycol. Each mL of tavaborole topical solution contains 43.5 mg of tavaborole. Inactive ingredients include ethyl alcohol (76.4% v/v), edetate calcium disodium, propylene glycol, and purified water. image description
FDA Approved Uses (Indications)
1 INDICATIONS & USAGE Tavaborole topical solution, 5% is an oxaborole antifungal indicated for the treatment of onychomycosis of the toenails due to Trichophyton rubrum or Trichophyton mentagrophytes. Tavaborole topical solution is an oxaborole antifungal indicated for the topical treatment of onychomycosis of the toenails due to Trichophyton rubrum or Trichophyton mentagrophytes . ( 1 ) ( 1 )
Dosage & Administration
2 DOSAGE & ADMINISTRATION Apply tavaborole topical solution to affected toenails once daily for 48 weeks. Tavaborole topical solution should be applied to the entire toenail surface and under the tip of each toenail being treated. Tavaborole topical solution is for topical use only and not for oral, ophthalmic, or intravaginal use. Apply tavaborole topical solution to affected toenails once daily for 48 weeks. ( 2 ) Tavaborole topical solution should be applied to the entire toenail surface and under the tip of each toenail being treated. ( 2 ) For topical use only. ( 2 ) Not for oral, ophthalmic, or intravaginal use. ( 2 ) ( 2 )
Contraindications
None. None. ( 4 )
Known Adverse Reactions
REACTIONS Common adverse reactions occurring in ≥1% in subjects treated with tavaborole topical solution included application site exfoliation, ingrown toenail, application site erythema, and application site dermatitis. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Encube Ethicals Private Limited at 1-833-285-4151 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In two clinical trials, 791 subjects were treated with Tavaborole topical solution. The most commonly reported adverse reactions are listed below (Table 1).
Table
1 : Adverse Reactions Occurring in ≥1% of Tavaborole topical solution, 5%-Treated Subjects and at a Greater Frequency than Observed with Vehicle Preferred Term Tavaborole topical solution N= 791 n(%) Vehicle N= 395 n(%) Application site exfoliation 21 (2.7%) 1 (0.3%) Ingrown toenail 20 (2.5%) 1 (0.3%) Application site erythema 13 (1.6%) 0 (0%) Application site dermatitis 10 (1.3%) 0 (0%)