Butoconazole adverse reactions: Difference between revisions
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Ahmed Zaghw (talk | contribs) Created page with "__NOTOC__ {{Butoconazole}} {{CMG}}; {{AE}} {{AZ}} <ref name="dailymed.nlm.nih.gov">{{Cite web | last = | first = | title = GYNAZOLE 1 (BUTOCONAZOLE NITRATE) CREAM [THER-RX..." |
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{{CMG}}; {{AE}} {{AZ}} | {{CMG}}; {{AE}} {{AZ}} | ||
<ref name="dailymed.nlm.nih.gov">{{Cite web | last = | first = | title = GYNAZOLE 1 (BUTOCONAZOLE NITRATE) CREAM [THER-RX CORPORATION] | url =http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=5eebfdbb-4800-4f59-9eaa-93e1c02b7b5f | publisher = | date = | accessdate = }}</ref> | ==Adverse Reactions== | ||
Of the 314 patients treated with GYNAZOLE • 1® Butoconazole Nitrate Vaginal Cream USP, 2% 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.<ref name="dailymed.nlm.nih.gov">{{Cite web | last = | first = | title = GYNAZOLE 1 (BUTOCONAZOLE NITRATE) CREAM [THER-RX CORPORATION] | url =http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=5eebfdbb-4800-4f59-9eaa-93e1c02b7b5f | publisher = | date = | accessdate = }}</ref> | |||
==References== | ==References== | ||
Latest revision as of 04:21, 10 January 2014
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Ahmed Zaghw, M.D. [2]
Adverse Reactions
Of the 314 patients treated with GYNAZOLE • 1® Butoconazole Nitrate Vaginal Cream USP, 2% 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.[1]
References
Adapted from the FDA Package Insert.