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Podofilox Side Effects

Please note - some side effects for Podofilox may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Podofilox - for the Consumer

Podofilox Gel

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Podofilox Gel:

Headache; mild burning, inflammation, stinging, pain, or redness.

Seek medical attention right away if any of these SEVERE side effects occur when using Podofilox Gel:

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bleeding, swelling, or severe or prolonged pain, burning, or itching at the application site.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Podofilox Solution

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Podofilox Solution:

Headache; mild burning, inflammation, stinging, pain, or redness.

Seek medical attention right away if any of these SEVERE side effects occur when using Podofilox Solution:

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bleeding, swelling, or severe or prolonged pain, burning, or itching at the application site; blood in the urine.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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Podofilox Side Effects - for the Professional

Podofilox

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.

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Side Effects by Body System - for Healthcare Professionals

Gastrointestinal

Gastrointestinal side effects have included vomiting.

Local

Local side effects have included burning, pain, inflammation, erosion, itching, and bleeding. Reports of burning and pain were greater and more severe in women than in men. Tenderness, chafing, malodor, scarring, vesicle formation, crusting edema, dryness, peeling, and ulceration have also been reported.

Genitourinary

Genitourinary side effects have included pain with intercourse, foreskin irretraction, and hematuria.

Nervous system

Nervous system side effects have included headache, insomnia, and dizziness.

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