"Investigators from the Women's Health Initiative (WHI) Hormone Trials are reaffirming conclusions that hormone therapy is not recommended for the prevention of chronic disease, but may remain a reasonable option for the short-term management "...
Gynazole Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Gynazole 1 (butoconazole nitrate) vaginal cream is used to treat vaginal candida (yeast) infections. It is an antifungal medication. Common side effects include increased vaginal/urethral burning/itching/pain, or mild abdominal cramps.
The recommended dose of Gynazole 1 is one applicatorful of cream (approximately 5 grams of the cream) intravaginally. This amount of cream contains approximately 100 mg of butoconazole nitrate. Other drugs may affect Gynazole 1 vaginal. Tell your doctor all medications and supplements you use. During pregnancy, Gynazole 1 should be used only when prescribed. Pregnant women should use extra care when using the vaginal applicator. Follow your doctor's instructions closely on how to insert the medication using the applicator. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.
Our Gynazole 1 (butoconazole nitrate) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Gynazole in Detail - Patient Information: Side Effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Other less serious side effects are more likely to occur, such as:
- pelvic pain or cramps;
- soreness and swelling; or
- increased urination.
This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Gynazole (Butoconazole) »
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Gynazole Overview - Patient Information: Side Effects
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
A different type of infection (bacterial vaginosis) or a more serious condition (Pelvic Inflammatory Disease-PID) may require different treatment. Tell your doctor immediately if you have any of the following symptoms: flu-like symptoms (including fever/chills), foul-smelling discharge from the vagina, stomach/abdominal pain.
A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Gynazole (Butoconazole)»
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Gynazole FDA Prescribing Information: Side Effects
Of the 314 patients treated with GYNAZOLE (butoconazole) •1® for 1 day in controlled clinical trials, 18 patients (5.7%) reported complaints such as vulvar/vaginal burning, itching, soreness and swelling, pelvic or abdominal pain or cramping, or a combination of two or more of these symptoms. In 3 patients (1%) these complaints were considered treatment-related. Five of the 18 patients reporting adverse events discontinued the study because of them.
Read the entire FDA prescribing information for Gynazole (Butoconazole) »
Additional Gynazole Information
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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