Protopic Adverse Reactions



LEO Pharma


Getz Bros
Full Prescribing Info
Adverse Reactions
The use of Protopic may cause local symptoms eg, skin burning (burning sensation, stinging, soreness) or pruritus. Localized symptoms are most common during the first few days of Protopic application and typically improve as the lesions of atopic dermatitis heal. The local symptoms are usually mild or moderate in severity and are of limited duration. With Protopic 0.1%, 90% of the skin burning events had a median duration of 15 min. Ninety percent of the pruritus events had a mean duration of 20 min.
Adverse reactions with suspected relationship to treatment are listed below by body system. Frequencies are defined as: Very common (>1/10) and common (<1/100, <1/10).
Skin and Appendages: Very common: Burning skin, pruritus, skin erythema. Common: Tingling skin, folliculitis, acne, herpes simplex [herpes, cold sores, eczema herpeticum (Kaposi's varicelliform eruption)].
Nervous System: Common: Hyperesthisia (increased skin sensitivity, especially to hot and cold).
Body as a Whole: Common: Alcohol intolerance (facial flushing or skin irritation after consumption of an alcoholic beverage).
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