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Femstat Prefill Side Effects

Generic Name: butoconazole topical

Note: This page contains information about the side effects of butoconazole topical. Some of the dosage forms included on this document may not apply to the brand name Femstat Prefill.

For the Consumer

Applies to butoconazole topical: intravaginal cream

Side effects include:

Vulvar/vaginal burning, itching, soreness and swelling, pelvic or abdominal pain or cramping.

For Healthcare Professionals

Applies to butoconazole topical: vaginal cream

General

Discontinuation of butoconazole due to adverse effects occurs in less than 2% of patients.

Local

Local side effects have been reported the most frequently. These have involved the genitourinary and occur in less than 5% of patients. Reported effects include burning, itching, pain, and irritation.[Ref]

Nervous system

Nervous system side effects have included headache.[Ref]

Hematologic

Thrombocytopenia developed one week after beginning butoconazole. It resolved slowly over the next few weeks after drug discontinuation.[Ref]

Hematologic side effects have included thrombocytopenia.[Ref]

Gastrointestinal

Gastrointestinal side effects have included pelvic and abdominal pain or cramping.[Ref]

References

1. Ruf H, Vitse M "A comparison of butoconazole nitrate cream with econazole nitrate cream for the treatment of vulvovaginal candidiasis." J Int Med Res 18 (1990): 389-99

2. "Butoconazole or vulvovaginal candidiasis." Med Lett Drugs Ther 28 (1986): 68

3. "Product Information. Femstat (butoconazole)." Syntex Laboratories Inc, Palo Alto, CA.

4. Brown D Jr, Henzl MR, LePage ME, Tsao LL, Izu AE, Walker KA, Adamson GD, Droegmuller W "Butoconazole vaginal cream in the treatment of vulvovaginal candidiasis. Comparison with miconazole nitrate and placebo." J Reprod Med 31 (1986): 1045-8

5. Maloley PA, Nelson E, Montgomery HA, Campbell JR "Severe reversible thrombocytopenia resulting from butoconazole cream." DICP 24 (1990): 143-4

Not all side effects for Femstat Prefill may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

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