Note: This document contains side effect information about ingenol topical. Some dosage forms listed on this page may not apply to the brand name Picato.

Summary

Common side effects of Picato include: dermal ulcer, localized vesiculation, skin erosion, swelling of skin, and erythema of skin. Continue reading for a comprehensive list of adverse effects.

Applies to ingenol topical: external gel.

Serious side effects of Picato

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of a severe skin reaction (Stevens-Johnson syndrome) like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in the mouth, throat, nose, or eyes.
• Signs of skin infection like oozing, heat, swelling, redness, or pain.
• Skin ulcers.
• Skin breakdown where this drug is used.
• Dizziness or passing out.

Other side effects of Picato

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Headache.
• Nose and throat irritation.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

For Healthcare Professionals

Applies to ingenol topical: topical gel.

General

The most commonly reported side effects were local skin responses including erythema, flaking/scaling, crusting, swelling, vesiculation/postulation, and erosion.^[Ref]

Hypersensitivity

Frequency not reported: Hypersensitivity reactions^[Ref]

Local

Very common (10% or more): Application site erythema (up to 94%), application site exfoliation (up to 90%), application site scab (up to 80%), application site swelling (up to 79%), application site erosion/ulceration (up to 32%), application site vesicles (up to 20%), application site pain (including application site burning) (up to 15%)

Common (1% to 10%): Application site pruritus, application site irritation

Uncommon (0.1% to 1%): Application site discharge, application site paresthesia, application site ulcer, application site warmth^[Ref]

Dermatologic

Very common (10% or more): Flaking/scaling (85%), crusting (80%), vesiculation/postulation (56%)

Postmarketing reports: Allergic contact dermatitis, application site pigmentation changes, application site scarring, chemical conjunctivitis^[Ref]

Immunologic

Very common (10% or more): Application site pustules (up to 43%)

Common (1% to 10%): Application site infection

Postmarketing reports: Herpes zoster^[Ref]

Nervous system

Common (1% to 10%): Headache^[Ref]

Ocular

Common (1% to 10%): Eye lid edema, periorbital edema

Uncommon (0.1% to 1%): Eyelid pain

Frequency not reported: Chemical conjunctivitis, corneal burn, eyelid ptosis^[Ref]

Other

Very common (10% or more): Swelling (79%)^[Ref]