Ingenol Side Effects

Please note - some side effects for Ingenol 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 Ingenol - for the Consumer

Ingenol

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 Ingenol:

Headache; mild pain, itching, irritation, redness, flaking or scaling, crusting, or swelling at the application site; nose and throat irritation.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blisters, pus, sores, or ulcers at the application site; severe redness, flaking or scaling, crusting, or swelling 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.

Side Effects by Body System - for Healthcare Professionals

Applies to: topical gel

Local

Local skin reactions were assessed within the selected treatment area and graded on a scale of 0 to 4. A grade of 0 represented no reaction present in the treated area and a grade of 4 indicated a marked and severe skin reaction that extended beyond the treated area. Local skin reactions generally occurred within 1 day of therapy initiation and peaked in intensity up to 1 week after therapy completion. Local skin reactions generally resolved within 2 weeks for areas treated on the face and scalp and within 4 weeks for areas treated on the trunk and extremities.

Local side effects have included application site pain (up to 15%), application site pruritus (8%), application site irritation (4%), application site infection (3%), and local skin reactions. Local skin reactions have included erythema (any Grade: up to 94%; Grade 4: up to 24%), flaking/scaling (any Grade: up to 90%; Grade 4: up to 9%), crusting (any Grade: up to 80%; Grade 4: up to 6%), swelling (any Grade: up to 79%; Grade 4: up to 5%), vesiculation/pustulation (any Grade: up to 56%; Grade 4: up to 5%), and erosion/ulceration (any Grade: up to 32%; Grade 4: up to 1%).

Ocular

Ocular side effects have included periorbital edema (3%), eye pain, eyelid edema, eyelid ptosis, and conjunctivitis.

Nervous system

Nervous system side effects have included headache (2%).

Respiratory

Respiratory side effects have included nasopharyngitis (2%).

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