SERTACONAZOLE: 53 Adverse Event Reports & Safety Profile
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Active Ingredient: SERTACONAZOLE NITRATE · Drug Class: Azole Antifungal [EPC] · Route: TOPICAL · Manufacturer: Coral Way Pharma, LLC · FDA Application: 021385 · HUMAN PRESCRIPTION DRUG · FDA Label: Available
First Report: 20061129 · Latest Report: 20220718
What Are the Most Common SERTACONAZOLE Side Effects?
All SERTACONAZOLE Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Urethral valves | 14 | 26.4% | 14 | 0 |
Who Reports SERTACONAZOLE Side Effects? Age & Gender Data
Gender: 51.8% female, 48.2% male. Average age: 47.7 years. Most reports from: FR. View detailed demographics →
Is SERTACONAZOLE Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2006 | 1 | 0 | 0 |
| 2007 | 1 | 0 | 1 |
| 2010 | 1 | 0 | 0 |
| 2011 | 1 | 0 | 0 |
| 2012 | 2 | 0 | 1 |
| 2014 | 3 | 0 | 1 |
| 2015 | 5 | 0 | 4 |
| 2016 | 1 | 0 | 0 |
| 2019 | 1 | 0 | 0 |
| 2020 | 4 | 4 | 0 |
| 2021 | 18 | 13 | 5 |
| 2022 | 1 | 0 | 0 |
What Is SERTACONAZOLE Used For?
| Indication | Reports |
|---|---|
| Vulvovaginal mycotic infection | 17 |
| Product used for unknown indication | 14 |
Other Drugs in Same Class: Azole Antifungal [EPC]
Official FDA Label for SERTACONAZOLE
Official prescribing information from the FDA-approved drug label.
Drug Description
ERTACZO (sertaconazole nitrate) cream, 2%, is for topical application. It contains the azole antifungal, sertaconazole nitrate. Sertaconazole nitrate contains one asymmetric carbon atom and exists as a racemic mixture of equal amounts of R and S enantiomers. Sertaconazole nitrate is designated chemically as (±)-1-[2,4-dichloro-β-[(7-chlorobenzo-[ b ]thien-3-yl)methoxy]phenethyl]imidazole nitrate. It has a molecular weight of 500.8. The molecular formula is C 20 H 15 Cl 3 N 2 OS
- HNO 3 , and the structural formula is as follows: Sertaconazole nitrate is a white or almost white powder. It is practically insoluble in water, soluble in methanol, and sparingly soluble in alcohol and in methylene chloride. Each gram of ERTACZO cream, 2%, contains 17.5 mg of sertaconazole (as sertaconazole nitrate, 20 mg) in a white cream base of ethylene glycol, glyceryl isostearate, glycolized saturated glycerides, light mineral oil, methylparaben, polyethylene glycol palmitostearate, polyoxyethylened saturated glycerides, purified water, and sorbic acid. Sertaconzole nitrate chemical structure
FDA Approved Uses (Indications)
AND USAGE ERTACZO ® cream, 2%, is indicated for the topical treatment of interdigital tinea pedis in immunocompetent adult and pediatric patients 12 years of age and older caused by Trichophyton rubrum , Trichophyton mentagrophytes, and Epidermophyton floccosum . ERTACZO cream, 2% is an azole antifungal indicated for the topical treatment of interdigital tinea pedis in immunocompetent adult and pediatric patients 12 years of age and older caused by Trichophyton rubrum, Trichophyton mentagrophytes , and Epidermophyton floccosum . ( 1 )
Dosage & Administration
AND ADMINISTRATION Apply ERTACZO cream, 2% twice daily for 4 weeks. Apply a sufficient amount of ERTACZO cream, 2% to cover both the affected areas between the toes and the immediately surrounding healthy skin. Use ERTACZO cream, 2% for the full treatment time recommended by the physician, even though symptoms may have improved. Dry the affected area(s) thoroughly before application, if using ERTACZO cream, 2% after bathing. Wash hands after use. Avoid the use of occlusive dressings or wrappings. For topical use. Not for ophthalmic, oral, or intravaginal use. Apply ERTACZO cream, 2% to the affected and immediate surrounding area(s) twice daily for 4 weeks. ( 2 ) Not for ophthalmic, oral, or intravaginal use. ( 2 )
Contraindications
None. None. ( 4 )
Known Adverse Reactions
REACTIONS Most common adverse reactions observed in clinical trials (incidence >2%) were contact dermatitis, dry skin, burning skin, application site skin tenderness. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Coral Way Pharma, LLC at 1-210-641-5334 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 clinical trials, cutaneous adverse events occurred in 7 of 297 (2%) subjects (2 of them severe) receiving ERTACZO cream, 2%, and in 7 of 291 (2%) subjects (2 of them severe) receiving vehicle. These reported cutaneous adverse events included contact dermatitis, dry skin, burning skin, and application site skin tenderness. In a dermal sensitization trial, 8 of 202 evaluable subjects tested with ERTACZO cream, 2%, and 4 of 202 evaluable subjects tested with vehicle exhibited a erythematous reaction in the challenge phase. There was no evidence of cumulative irritation or contact sensitization in a repeated insult patch test involving 202 healthy volunteers.
6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of ERTACZO cream, 2%. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Cutaneous adverse events: erythema, pruritus, vesiculation, desquamation, and hyperpigmentation.
Warnings
AND PRECAUTIONS