openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Warnings sections page 1 of 1 · 1 matching rows.
warnings
WARNINGS Correct diagnosis of the lesions to be treated is essential. See the “ Diagnosis ” subsection of the INDICATIONS AND USAGE statement. Podofilox 0.5% Solution is intended for cutaneous use only. Avoid contact with the eye. If eye contact occurs, patients should immediately flush the eye with copious quantities of water and seek medical advice.
ADVERSE REACTIONS In clinical trials, the following local adverse reactions were reported at some point during treatment. Adverse Experience Males Females Burning 64% 78% Pain 50% 72% Inflammation 71% 63% Erosion 67% 67% Itching 50% 65% Reports of burning and pain were more frequent and of greater severity in women than in men. Adverse effects reported in less than 5% of the patients included pain with intercourse, insomnia, tingling, bleeding, tenderness, chafing, malodor, dizziness, scarring, vesicle formation, crusting edema, dryness/peeling, foreskin irretraction, hematuria, vomiting and ulceration.