Panretin Side Effects

Please note - some side effects for Panretin may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Panretin - for the Consumer

Panretin

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Panretin:

Burning; flaking; itching; pain; peeling; rash; redness; scaling; skin inflammation; skin irritation; stinging; tingling.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blistering; cracking; crusting; draining; excessive pain; oozing; scabbing of the skin; swelling.

Panretin Side Effects - for the Professional

Panretin

The safety of Panretin® gel has been assessed in clinical studies of 385 patients with AIDS-related KS. Adverse events associated with the use of Panretin® gel in patients with AIDS-related KS occurred almost exclusively at the site of application. The dermal toxicity begins as erythema; with continued application of Panretin® gel, erythema may increase and edema may develop. Dermal toxicity may become treatment-limiting, with intense erythema, edema, and vesiculation. Usually, however, adverse events are mild to moderate in severity; they led to withdrawal from the study in only 7% of the patients. Severe local (application site) skin adverse events occurred in about 10% of patients in the U.S. study (versus 0% in the vehicle control). Table 2 lists the adverse events that occurred at the application site with an incidence of at least 5% during the double-blind phase in the Panretin® gel-treated group and in the vehicle control group in either of the two controlled studies. Adverse events were reported at other sites but generally were similar in the two groups.

Side Effects by Body System

Dermatologic

Dermal toxicity associated with topical alitretinoin has been the primary adverse event reported and has occurred primarily at the site of application. Dermatologic toxicity begins as erythema which may worsen and result in edema with continued use. This toxicity may be treatment-limiting with intense erythema, edema, and vesiculation.

Other reported dermal side effects include rash, pain, pruritus, exfoliative dermatitis, skin disorder (defined as excoriation, cracking, scab, crusting, drainage, eschar, fissure, or oozing) and paresthesia.

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