Butoconazole Brand Name– Gynazole-1

What is Butoconazole

Butoconazole is an imidazole antifungal agent. It is fungicidal in vitro against Candida spp. and is clincally effective in treating vulvovaginal candidiasis.

Butoconazole is available as a vaginal preparation. Butoconazole was FDA-approved in 1985 for the treatment of vulvovaginal candidiasis.

In December 1995, multiple-dose butoconazole formulations were approved for over-the-counter (OTC) use.

A single dose vaginal product (Gynazole-1®) was FDA-approved in July 2000 as a prescription-only product.


  1. Candida albicans
  2. Candida glabrata
  3. Candida sp.
  4. Candida tropicalis
  5. Epidermophyton floccosum
  6. Microsporum canis
  7. Microsporum gypseum
  8. Trichophyton mentagrophytes
  9. Trichophyton rubrum
  10. Trichophyton sp.
  11. Trichophyton tonsurans
  12. vulvovaginal candidiasis

Side Effects

  1. abdominal pain
  2. pelvic pain
  3. pruritus
  4. vaginal irritation
  5. vaginal pain

Of the 314 patients treated with butoconazole intravaginally for 1 day in controlled clinical trials, 18 patients (5.7%) experienced an adverse event; however, these events were considered treatment-related in only 3 patients (1%).

Butoconazole-associated adverse events consist primarily of localized vaginal irritation including burning, pruritus, swelling, and vaginal pain or soreness. Systemic events include pelvic pain, abdominal pain, and abdominal cramping

Monitoring Parameters

  • laboratory monitoring not necessary


  • abdominal pain
  • azole antifungals hypersensitivity
  • breast-feeding
  • children
  • contraceptive devices
  • diabetes mellitus
  • fever
  • human immunodeficiency virus (HIV) infection
  • immunosuppression
  • infants
  • menstruation
  • neonates
  • ocular exposure
  • onychomycosis
  • ophthalmic administration
  • pregnancy
  • vaginal discharge


There are no drug interactions associated with Butoconazole products.


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