Econazole

Ecoza topical foam is an azole antifungal [ see Clinical Pharmacology (12.4) ] .

• Ecoza (econazole nitrate) topical foam, 1%, is indicated for the treatment of interdigital tinea pedis caused by Trichophyton rubrum, Trichophyton mentagrophytes, and Epidermophyton floccosum in patients 12 years of age and older. Ecoza is an azole antifungal indicated for the treatment of interdigital tinea pedis caused by Trichophyton rubrum, Trichophyton mentagrophytes , and Epidermophyton floccosum in patients 12 years of age and older.ICD-10: B35.3

• None. None.contraindicated

Ecoza topical foam, 1% is for topical use only. Ecoza topical foam, 1% is not for oral, ophthalmic, or intravaginal use. Ecoza topical foam, 1% should be applied to cover affected areas once daily for 4 weeks. For topical use only; not for oral, ophthalmic, or intravaginal use. ( 2 ) Apply once daily for 4 weeks. ( 2 )

Contents are flammable. Instruct the patient to avoid heat, flame, and/or smoking during and immediately following application. ( 5.1 ) 5.1 Flammability Ecoza topical foam is flammable. Avoid heat, flame, and smoking during and immediately following application. Contents under pressure. Do not puncture and/or incinerate the containers. Do not expose containers to heat and/or store at temperatures above 120°F (49°C) even when empty. Do not store in direct sunlight.

During clinical trials with Ecoza topical foam, the most common adverse reactions were application site reactions which occurred in less than 1% of subjects in both the Ecoza and vehicle arms. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Resilia Pharmaceuticals at 1-888-998-0770 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 double-blind, vehicle-controlled clinical trials, 495 subjects were exposed to Ecoza topical foam or vehicle (246 subjects were exposed to Ecoza topical foam, 1% and 249 were exposed to vehicle). Subjects with interdigital tinea pedis applied foam or vehicle once daily for approximately 28 days. During clinical trials with Ecoza topical foam, the most common adverse reactions were application site reactions which occurred in less than 1% of subjects in both the Ecoza and vehicle arms.

8.1 Pregnancy Pregnancy Category C There are no adequate and well-controlled trials with Ecoza topical foam in pregnant women. Ecoza topical foam should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Econazole nitrate has not been shown to be teratogenic when administered orally to mice, rabbits or rats. Fetotoxic or embryotoxic effects were observed in Segment I oral studies with rats receiving 10 to 40 times the human dermal dose. Similar effects were observed in Segment II or Segment III studies with mice, rabbits and/or rats receiving oral doses 80 or 40 times the human dermal dose. 8.3 Nursing Mothers It is not known whether econazole nitrate is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when econazole nitrate is administered to a nursing woman. Following oral administration of econazole nitrate to lactating rats, econazole and/or metabolites were excreted in milk and were found in nursing pups. 8.4 Pediatric Use Of the 173 subjects treated with Ecoza topical foam, 1% in the clinical trials, 2 subjects were 12 to 17 years old. In a pediatric maximal use trial, Ecoza topical foam, 1% was applied once daily to eighteen subjects aged 12 to 17 years with interdigital tinea pedis for 28 days [ see Clinical Pharmacology (12.3) ].

Metabolism

The systemic absorption of Ecoza topical foam, 1% following topical application was studied in one clinical trial in adults and one clinical study in pediatric subjects. In the adult trial, 19 subjects (male and female) with tinea pedis applied Ecoza topical foam, 1% once daily for 29 days.

• Nov 26, 2002ANDAANDA076005Sun Pharma Canada
• Jun 23, 2004ANDAANDA076479Padagis Israel
• Oct 24, 2013NDANDA205175Resilia Pharms
• Apr 18, 2018ANDAANDA210364Aurobindo Pharma Usa

1. 1Fatigue596.5%
2. 2Drug Ineffective586.4%
3. 3Dyspnoea475.2%
4. 4Pain465.1%
5. 5Nausea444.9%
6. 6Rash444.9%
7. 7Diarrhoea424.7%
8. 8Dizziness414.5%
9. 9Asthenia384.2%
10. 10Headache384.2%
11. 11Renal Failure384.2%
12. 12Anxiety353.9%
13. 13Drug Interaction343.8%
14. 14Fall343.8%
15. 15Pruritus343.8%

Recent PubMed references pinned to Econazole as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

• Correlation between MIC of econazole nitrate and clinical response in otomycosis.
  Frontiers in cellular and infection microbiology · 2026 · Sun Y, Liu D
  PMID 42256225DOI 10.3389/fcimb.2026.1820764
• Evaluation of the efficacy of combination therapy in the treatment of fungal otitis externa.
  Scientific reports · 2025 · Li Y, Bai G, Jin Y, et al.
  PMID 41152297DOI 10.1038/s41598-025-21405-8
• [Preliminary efficacy of triamcinolone and econazole cream in the treatment of keratosis obturans of external ear canal].
  Zhonghua er bi yan hou tou jing wai ke za zhi = Chinese journal of otorhinolaryngology head and neck surgery · 2024 · Zheng C, Tang Y, Gao X, et al.
  PMID 39734289DOI 10.3760/cma.j.cn115330-20240505-00260
• Nociceptive transient receptor potential ankyrin 1 (TRPA1) in sensory neurons are targets of the antifungal drug econazole.
  BMC pharmacology & toxicology · 2024 · Kasuya K, Takahashi K, Hashimoto M, et al.
  PMID 39169383DOI 10.1186/s40360-024-00779-x
• Structural mechanism of TRPV5 inhibition by econazole.
  Structure (London, England : 1993) · 2024 · De Jesús-Pérez JJ, Gabrielle M, Raheem S, et al.
  PMID 38141613DOI 10.1016/j.str.2023.11.012
• The effect of charges on the corneal penetration of solid lipid nanoparticles loaded Econazole after topical administration in rabbits.
  European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences · 2023 · Liang Z, Zhang Z, Lu P, et al.
  PMID 37315870DOI 10.1016/j.ejps.2023.106494
• Diversity of Parengyodontium spp. strains isolated from the cultural heritage environment: Phylogenetic diversity, phenotypical diversity, and occurrence.
  Mycologia · 2022 · Leplat J, François A, Bousta F, et al.
  PMID 35904483DOI 10.1080/00275514.2022.2094046
• Corrigendum to: Oleic Acid Vesicles as a New Approach for Transdermal Delivery of Econazole Nitrate: Development, Characterization, and In-vivo Evaluation in Wistar Rats.
  Recent advances in anti-infective drug discovery · 2021 · Verma S, Utreja P
  PMID 34961436DOI 10.2174/277243441602211018160649

The 9 most recently updated of 9 ClinicalTrials.gov registrations naming Econazole as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Efficacy of Self Vs. Physician Application of Triamcinolone-Econazole in Otomycosis
  Completed · Phase 4 · Interventional · 200 enrolled · Zhongshan Hospital Xiamen University
  NCT06431542updated 2024-11-01
• Therapeutic Equivalence and Safety of Two Econazole Nitrate Cream, 1% Products in Tinea Pedis
  Completed · Phase 3 · Interventional · 876 enrolled · Mylan Inc.
  NCT03129321updated 2022-03-07
• A Trial of the Safety and Efficacy of EcoNail™ in the Treatment of Fungus Infections of the Great Toenail
  Completed · Phase 2 · Interventional · 40 enrolled · Abeona Therapeutics, Inc
  NCT00385502updated 2020-09-03
• Tolerability and Pharmacokinetic Study of Econazole Nitrate and Benzydamine HCl Intravaginal Cream
  Completed · Phase 1 · Interventional · 48 enrolled · Aziende Chimiche Riunite Angelini Francesco S.p.A
  NCT02713893updated 2018-01-17
• Tolerability and Pharmacokinetic Study of Econazole Nitrate Plus Benzydamine HCl Vaginal Pessary
  Completed · Phase 1 · Interventional · 49 enrolled · Aziende Chimiche Riunite Angelini Francesco S.p.A
  NCT02720783updated 2017-02-07
• A Study of Econazole Foam 1% in Athlete's Foot
  Completed · Phase 2 · Interventional · 135 enrolled · AmDerma
  NCT00768599updated 2013-01-09
• Safety and Efficacy of Econazole Nitrate Foam 1% in Subjects With Tinea Pedis
  Completed · Phase 3 · Interventional · 264 enrolled · AmDerma
  NCT01353976updated 2013-01-09
• Comparative PK Study of Econazole Nitrate Foam and Econazole Nitrate Cream in Subjects With Interdigital Tinea Pedis Aged 12 Years to Less Than 18 Years
  Completed · Phase 2 · Interventional · 42 enrolled · AmDerma
  NCT01696799updated 2012-10-01
• Safety and Efficacy of Econazole Nitrate Foam 1% and Foam Vehicle in Subjects With Tinea Pedis
  Completed · Phase 3 · Interventional · 336 enrolled · AmDerma
  NCT01358240updated 2012-09-28

Frequently asked questions

How does Econazole work?

Ecoza topical foam is an azole antifungal [ see Clinical Pharmacology (12.4) ] .

What is Econazole used for?

According to FDA labeling, Econazole carries indications including: Ecoza (econazole nitrate) topical foam, 1%, is indicated for the treatment of interdigital tinea pedis caused by Trichophyton rubrum, Trichophyton mentagrophytes, and Epidermophyton floccosum in patients 12 years of age and older. Ecoza is an azole antifungal indicated for the treatment of interdigital tinea pedis caused by Trichophyton rubrum, Trichophyton mentagrophytes , and Epidermophyton floccosum in patients 12 years of age and older.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Econazole?

Econazole is classified as Imidazole and triazole derivatives, Imidazole derivatives, Azole Antifungal, 14-alpha Demethylase Inhibitors, Decreased Cell Wall Integrity.

What are the brand names for Econazole?

Econazole is marketed under brand names including Ecoza.

What are the contraindications for Econazole?

Econazole labeling lists contraindications including: None. None.. Always consult the full prescribing information and a clinician.