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Podofilox Gel Side Effects

Please note - some side effects for Podofilox Gel may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).



Podofilox Gel Side Effects - for the Professional

Podofilox Gel

In clinical trials with Podofilox Gel 0.5%, the following local adverse reactions were reported during the treatment of anogenital warts. The severity of local adverse reactions were predominantly mild or moderate and did not increase during the treatment period. Severe reactions were most frequent within the first 2 weeks of treatment.

Adverse Reaction Mild Moderate Severe
Inflammation 32.2% 30.4% 9.3%
Burning 37.1% 25.9% 11.5%
Erosion 27.0% 20.8% 8.9%
Pain 23.7% 20.4% 11.5%
Itching 32.2% 16.0% 7.8%
Bleeding 19.2% 3.0% 0.7%

Other local adverse reactions reported included stinging (7%), and erythema (5%); less commonly reported local adverse events included desquamation, scabbing, discoloration, tenderness, dryness, crusting, fissures, soreness, ulceration, swelling/edema, tingling, rash, and blisters.

The most common systemic adverse event reported during the clinical studies was headache (7%).

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