Home FDA labels e90bb84a-0b45-4163-92da-d8ed239a0b1d Bexarotene openFDA label record# This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.
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Brand name Bexarotene
Generic name BEXAROTENE
Manufacturer Amneal Pharmaceuticals NY LLC
Product type HUMAN PRESCRIPTION DRUG
SPL set ID 2c21f361-e3d1-45a5-a6e7-df8164e3f90d
SPL ID e90bb84a-0b45-4163-92da-d8ed239a0b1d
Version 7
Effective date 2023-12-29
Source export date 2026-09-28
Source partition 11
Source file https://download.open.fda.gov/drug/label/drug-label-0011-of-0014.json.zip
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adverse reactions ADVERSE REACTIONS The safety of bexarotene gel has been assessed in clinical studies of 117 patients with CTCL who received bexarotene gel for up to 172 weeks. In the multicenter open-label study, 50 patients with CTCL received bexarotene 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 bexarotene 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 bexarotene 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 to 1,203 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 Bexarotene Gel in the Multicenter CTCL Study All Adverse Events Application Site Adverse Events COSTART 5 Body System/Preferred Term N = 50 n (%) N = 50 n (%) Skin and Appendages Contact Dermatitis 1 7 (14) 4 (8) Exfoliative Dermatitis 3 (6) 0 Pruritus 2 18 (36) 9 (18) Rash 3 36 (72) 28 (56) Maculopapular Rash 3 (6) 0 Skin Disorder (NOS) 4 13 (26) 9 (18) Sweating 3 (6) 0 Body as a Whole Asthenia 3 (6) 0 Headache 7 (14) 0 Infection 9 (18) 0 Pain 15 (30) 9 (18) Cardiovascular Edema 5 (10) 0 Peripheral Edema 3 (6) 0 Hemic and Lymphatic Leukopenia 3 (6) 0 Lymphadenopathy 3 (6) 0 WBC Abnormal 3 (6) 0 Metabolic and Nutritional Hyperlipemia 5 (10) 0 Nervous Paresthesia 3 (6) 3 (6) Respiratory Cough Increased 3 (6) 0 Pharyngitis 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 To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.com
adverse reactions table <table width="99.9%" cellspacing="0" cellpadding="0" border="1"><col width="100%"/><col/><col/><tbody><tr><td colspan="3" styleCode=" Botrule Toprule Lrule Rrule"><paragraph><content styleCode="bold">Table 1. Incidence of All Adverse Events* and Application Site Adverse Events with Incidence ≥5% for All Application Frequencies of Bexarotene Gel in the Multicenter CTCL Study</content></paragraph></td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule"/><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph><content styleCode="bold">All Adverse Events</content></paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph><content styleCode="bold">Application Site Adverse Events</content></paragraph></td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>COSTART 5 Body System/Preferred Term </paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>N = 50 n (%)</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>N = 50 n (%)</paragraph></td></tr><tr><td colspan="3" styleCode=" Botrule Toprule Lrule Rrule"><paragraph>Skin and Appendages</paragraph></td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>Contact Dermatitis<sup>1</sup></paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>7 (14)</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>4 (8)</paragraph></td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>Exfoliative Dermatitis </paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>3 (6)</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>0</paragraph></td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>Pruritus<sup>2</sup></paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>18 (36)</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>9 (18)</paragraph></td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>Rash<sup>3</sup></paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>36 (72)</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>28 (56)</paragraph></td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>Maculopapular Rash </paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>3 (6)</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>0</paragraph></td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>Skin Disorder (NOS)<sup>4</sup></paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>13 (26)</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>9 (18)</paragraph></td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>Sweating </paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>3 (6)</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>0</paragraph></td></tr><tr><td colspan="3" styleCode=" Botrule Toprule Lrule Rrule"><paragraph>Body as a Whole</paragraph></td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>Asthenia </paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>3 (6)</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>0</paragraph></td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>Headache </paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>7 (14)</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>0</paragraph></td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>Infection </paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>9 (18)</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>0</paragraph></td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>Pain </paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>15 (30)</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>9 (18)</paragraph></td></tr><tr><td colspan="3" styleCode=" Botrule Toprule Lrule Rrule"><paragraph>Cardiovascular</paragraph></td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>Edema </paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>5 (10)</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>0</paragraph></td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>Peripheral Edema </paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>3 (6)</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>0</paragraph></td></tr><tr><td colspan="3" styleCode=" Botrule Toprule Lrule Rrule"><paragraph>Hemic and Lymphatic</paragraph></td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>Leukopenia </paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>3 (6)</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>0</paragraph></td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>Lymphadenopathy </paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>3 (6)</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>0</paragraph></td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>WBC Abnormal </paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>3 (6)</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>0</paragraph></td></tr><tr><td colspan="3" styleCode=" Botrule Toprule Lrule Rrule"><paragraph>Metabolic and Nutritional</paragraph></td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>Hyperlipemia </paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>5 (10)</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>0</paragraph></td></tr><tr><td colspan="3" styleCode=" Botrule Toprule Lrule Rrule"><paragraph>Nervous</paragraph></td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>Paresthesia </paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>3 (6)</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>3 (6)</paragraph></td></tr><tr><td colspan="3" styleCode=" Botrule Toprule Lrule Rrule"><paragraph>Respiratory</paragraph></td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>Cough Increased </paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>3 (6)</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>0</paragraph></td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>Pharyngitis </paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>3 (6)</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>0</paragraph></td></tr><tr><td colspan="3" styleCode=" Botrule Toprule Lrule Rrule"><paragraph>* Regardless of association with treatment</paragraph></td></tr><tr><td colspan="3" styleCode=" Botrule Toprule Lrule Rrule"><paragraph>Includes Investigator terms such as:</paragraph></td></tr><tr><td colspan="3" styleCode=" Botrule Toprule Lrule Rrule"><paragraph><sup>1</sup> Contact dermatitis, irritant contact dermatitis, irritant dermatitis</paragraph></td></tr><tr><td colspan="3" styleCode=" Botrule Toprule Lrule Rrule"><paragraph><sup>2</sup> Pruritus, itching, itching of lesion</paragraph></td></tr><tr><td colspan="3" styleCode=" Botrule Toprule Lrule Rrule"><paragraph><sup>3</sup> Erythema, scaling, irritation, redness, rash, dermatitis</paragraph></td></tr><tr><td colspan="3" styleCode=" Botrule Toprule Lrule Rrule"><paragraph><sup>4</sup> Skin inflammation, excoriation, sticky or tacky sensation of skin; NOS = Not Otherwise Specified</paragraph></td></tr></tbody></table>
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