Panretin
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Panretin
Panretin Side Effects Center
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Panretin in Detail - Patient Information: Side Effects
Serious side effects are not likely to occur. Stop using alitretinoin topical and seek emergency medical attention if you experience an allergic reaction (shortness of breath; closing of your throat; swelling of your lips, face, or tongue; or hives).
If you experience any of the following less serious side effects at the application site(s), continue to use alitretinoin topical and notify your doctor
- redness;
- itching;
- irritation;
- warmth;
- burning, stinging, or pain;
- rash;
- peeling;
- swelling or inflammation;
- numbness or tingling;
- cracking, crusting, or scabbing; or
- drainage.
Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Panretin (Alitretinoin) »
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Panretin Overview - Patient Information: Side Effects
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor immediately if any of these unlikely but serious side effects occur: blistering/crusting/oozing/peeling of the skin, severe burning/stinging of the skin, swelling of the skin.
A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Panretin (Alitretinoin)»
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Panretin FDA Prescribing Information: Side Effects
(Adverse Reactions)
SIDE EFFECTS
The safety of Panretin® (alitretinoin) gel has been assessed in clinical studies of 385 patients with AIDS-related KS. Adverse events associated with the use of Panretin® (alitretinoin) 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® (alitretinoin) 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® (alitretinoin) 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.
TABLE 2: Adverse Events with an Incidence of at Least 5%
at the Application Site in Either Controlled Study in Patients Receiving Panretin® (alitretinoin)
Gel or Vehicle Control
| Adverse Event Term | Study 1 | Study 2 | ||
| Panretin® (alitretinoin) Gel N=134 Pts .% |
Vehicle Gel N=134 Pts. % |
Panretin® (alitretinoin) 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 |
| Includes Investigator terms: 1Erythema, scaling, irritation, redness, rash, dermatitis 2Burning, pain 3Itching, pruritis 4Flaking, peeling, desquamation, exfoliation 5Excoriation, cracking, scab, crusting, drainage, eschar, fissure or oozing 6Stinging, tingling 7Edema, swelling, inflammation |
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Read the entire FDA prescribing information for Panretin (Alitretinoin) »
Additional Panretin Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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