Picato Side Effects
Generic Name: ingenol topical
Note: This page contains side effects data for the generic drug ingenol topical. It is possible that some of the dosage forms included below may not apply to the brand name Picato.
It is possible that some side effects of Picato may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.
For the Consumer
Applies to ingenol topical: topical application gel/jelly
As well as its needed effects, ingenol topical (the active ingredient contained in Picato) may cause unwanted side effects that require medical attention.
If any of the following side effects occur while taking ingenol topical, check with your doctor immediately: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
- 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 ingenol topical side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:More common
- Flaking or scaling of the skin
- redness of the skin (mild)
For Healthcare Professionals
Applies to ingenol topical: topical gel
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 side effects have included periorbital edema (3%), eye pain, eyelid edema, eyelid ptosis, and conjunctivitis.[Ref]
Nervous system side effects have included headache (2%).[Ref]
Respiratory side effects have included nasopharyngitis (2%).[Ref]
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
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