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Picato Side Effects

Generic Name: ingenol topical

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

In Summary

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

For the Consumer

Applies to ingenol topical: topical application gel/jelly

Along with its needed effects, ingenol topical (the active ingredient contained in Picato) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking ingenol topical:

More Common

  • Blistering, peeling, or loosening of the skin
  • pain and itching at the application site
  • redness of the skin (severe)
  • skin ulcers
  • swelling of the skin

Less Common

  • Burning, dry, or itching eyes
  • discharge or excessive tearing
  • eye pain
  • infection at the application site
  • redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid
  • swelling around the eyes

Some side effects of ingenol topical may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More Common

  • Flaking or scaling of the skin
  • redness of the skin (mild)

Less Common

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[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]

References

1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

2. "Product Information. Picato (ingenol topical)." Leo Pharma Inc, Parsippany, NY.

3. Cerner Multum, Inc. "Australian Product Information." O 0

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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