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Ingenol topical Side Effects

In Summary

Commonly reported side effects of ingenol topical 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

In addition to its needed effects, some unwanted effects may be caused by ingenol topical. In the event that any of these side effects do occur, they may require medical attention.

Major Side Effects

You should check with your doctor immediately if any of these side effects occur when 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

Minor Side Effects

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

More common:
  • Flaking or scaling of the skin
  • redness of the skin (mild)
Less common:
  • Headache

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

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

Not all side effects for ingenol topical may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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