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.
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:
Seek medical attention right away if any of these SEVERE side effects occur 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.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
TopPanretin 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.
| Adverse Event Term | Study 1 | Study 2 | ||
|---|---|---|---|---|
| Includes Investigator terms: 1 Erythema, scaling, irritation, redness, rash, dermatitis 2 Burning, pain 3 Itching, pruritus 4 Flaking, peeling, desquamation, exfoliation 5 Excoriation, cracking, scab, crusting, drainage, eschar, fissure or oozing 6 Stinging, tingling 7 Edema, swelling, inflammation |
||||
| Panretin® Gel N=134 Pts. % |
Vehicle Gel N=134 Pts. % |
Panretin® Gel N=36 Pts. % |
Vehicle Gel N=46 Pts. % |
|
| Rash1 | 77 | 11 | 25 | 4 |
| Pain2 | 34 | 7 | 0 | 4 |
| Pruritus3 | 11 | 4 | 8 | 4 |
| Exfoliative dermatitis4 | 9 | 2 | 3 | 0 |
| Skin disorder5 | 8 | 1 | 0 | 0 |
| Paresthesia6 | 3 | 0 | 22 | 7 |
| Edema7 | 8 | 3 | 3 | 0 |
Side Effects by Body System - for Healthcare Professionals
General
Side effects associated with the use of alitretinoin topical in patients with AIDS-related Kaposi's sarcoma occurred almost exclusively at the application site. Dermal toxicity began as erythema, which could worsen and result in edema with continued use. This toxicity was treatment-limiting, with intense erythema, edema, and vesiculation. Side effects were typically mild to moderate in severity and led to study withdrawal in 7% of patients. During one study, severe local (application site) skin reactions were reported in about 10% of patients.
Local
Local side effects have included application site rash (term includes erythema, scaling, irritation, redness, dermatitis), pain (term includes burning, pain), pruritus (term includes itching, pruritus), exfoliative dermatitis (term includes flaking, peeling, desquamation, exfoliation), skin disorder (term includes excoriation, cracking, scab, crusting, drainage, eschar, fissure, or oozing), paresthesia (term includes stinging, tingling), and edema (term includes edema, swelling, inflammation).
TopMore Panretin resources
- Panretin Prescribing Information (FDA)
- Panretin Concise Consumer Information (Cerner Multum)
- Panretin Monograph (AHFS DI)
- Panretin Topical Advanced Consumer (Micromedex) - Includes Dosage Information
- Panretin MedFacts Consumer Leaflet (Wolters Kluwer)
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