Medication Guide App

Ingenol topical Side Effects

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.

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.

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

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

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.[Ref]

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%).[Ref]

Ocular

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

Nervous system

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

Respiratory

Respiratory side effects have included nasopharyngitis (2%).[Ref]

References

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

2. Siller G, Gebauer K, Welburn P, Katsamas J, Ogbourne SM "PEP005 (ingenol mebutate) gel, a novel agent for the treatment of actinic keratosis: results of a randomized, double-blind, vehicle-controlled, multicentre, phase IIa study." Australas J Dermatol 50 (2009): 16-22

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.

Hide
(web3)