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Targretin Gel 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.
Targretin Gel in Detail - Patient Information: Side Effects
Serious side effects are not likely to occur. Stop using bexarotene 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).
You may experience some redness, itching, warmth, swelling, burning, scaling, or other irritation while you are using bexarotene topical. If these side effects are excessive, talk to your doctor. Your doctor may prescribe less frequent applications of bexarotene topical.
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 Targretin Gel (Bexarotene Gel) »
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Targretin Gel FDA Prescribing Information: Side Effects
The safety of Targretin® gel has been assessed in clinical studies of 117 patients with CTCL who received Targretin® gel for up to 172 weeks. In the multicenter open-label study, 50 patients with CTCL received Targretin® gel for up to 98 weeks. The mean duration of therapy for these 50 patients was 199 days. The most common adverse events reported with an incidence at the application site of at least 10% in patients with CTCL were rash, pruritus, skin disorder, and pain.
Adverse events leading to dose reduction or study drug discontinuation in at least two patients were rash, contact dermatitis, and pruritus.
Of the 49 patients (98%) who experienced any adverse event, most experienced events categorized as mild (9 patients, 18%) or moderate (27 patients, 54%). There were 12 patients (24%) who experienced at least one moderately severe adverse event. The most common moderately severe events were rash (7 patients, 14%) and pruritus (3 patients, 6%). Only one patient (2%) experienced a severe adverse event (rash).
In the patients with CTCL receiving Targretin® gel, adverse events reported regardless of relationship to study drug at an incidence of 5% are presented in Table 1.
A similar safety profile for Targretin® gel was demonstrated in the Phase I-II program. For the 67 patients enrolled in the Phase I-II program, the mean duration of treatment was 436 days (range 12-1203 days). As in the multicenter study, the most common adverse events regardless of relationship to study drug in the Phase I-II program were rash (78%), pain (40%), and pruritus (40%).
Table 1: Incidence of All Adverse Events* and Application
Site Adverse Events with Incidence ≥ 5% for All Application Frequencies of
Targretin® Gel in the Multicenter CTCL Study
|COSTART 5 Body System/Preferred Term||All Adverse Events
N = 50
|Application Site Adverse Events
N = 50
|Skin and Appendages|
|Contact Dermatitis1||7 (14)||4 (8)|
|Exfoliative Dermatitis||3 (6)||0|
|Pruritus2||18 (36)||9 (18)|
|Rash3||36 (72)||28 (56)|
|Maculopapular Rash||3 (6)||0|
|Skin Disorder (NOS)4||13 (26)||9 (18)|
|Body as a Whole|
|Pain||15 (30)||9 (18)|
|Peripheral Edema||3 (6)||0|
|Hemic and Lymphatic|
|WBC Abnormal||3 (6)||0|
|Metabolic and Nutritional|
|Paresthesia||3 (6)||3 (6)|
|Cough Increased||3 (6)||0|
|* Regardless of association with treatment
Includes Investigator terms such as:
1 Contact dermatitis, irritant contact dermatitis, irritant dermatitis
2 Pruritus, itching, itching of lesion
3 Erythema, scaling, irritation, redness, rash, dermatitis
4 Skin inflammation, excoriation, sticky or tacky sensation of skin; NOS = Not Otherwise Specified
Read the entire FDA prescribing information for Targretin Gel (Bexarotene Gel) »
Additional Targretin Gel 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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