Applies to bexarotene: oral capsule, oral capsule liquid filled.

Serious side effects of Bexarotene

Along with its needed effects, bexarotene may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Since this medication is given in varying doses, the actual frequency of side effects may vary. In general, side effects are less common with lower doses than with higher doses.

Check with your doctor as soon as possible if any of the following side effects occur while taking bexarotene:

More common

• Unusual tiredness or weakness
• skin rash or other skin and mucous membrane lesions
• fever
• increase in lipid or cholesterol levels
• coldness, dry, puffy skin or weight gain
• chills, cough, hoarseness, lower back or side pain or painful or difficult urination
• swelling of the arms, feet, hands, or legs

Less Common

• Severe stomach pain with nausea or vomiting
• shortness of breath
• yellow eyes or skin

Other side effects of Bexarotene

Some side effects of bexarotene may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Abdominal pain
• hair loss
• loss of appetite
• loss of strength or energy, tiredness or weakness
• back pain
• diarrhea
• dry skin
• general feeling of discomfort or illness
• trouble in sleeping
• headache
• nausea or vomiting

For Healthcare Professionals

Applies to bexarotene: oral capsule.

Metabolic

Very common (10% or more): Decreased HDL cholesterol (up to 90%), hyperlipemia (up to 79%), elevated cholesterol (up to 75%), elevated triglycerides (up to 70%), hypercholesterolemia (up to 62%), hypocholesterolemia (up to 28%), anorexia (up to 23%), increased lactic dehydrogenase (up to 13%)

Common (1% to 10%): Weight gain, hypoproteinemia

Uncommon (0.1% to 1%): Gout

Frequency not reported: Elevated LDL cholesterol, decreased weight, dehydration, increased alkaline phosphatase, hypercalcemia, hypocalcemia, hypernatremia, hyponatremia, hyperkalemia, hypokalemia, hypolipemia, hypomagnesemia, increased appetite, thirst, hypovolemia^[Ref]

Endocrine

Very common (10% or more): Decreased TSH (up to 60%), hypothyroidism (up to 53%), decreased total T4 (up to 45%)

Common (1% to 10%): Thyroid disorder, altered hormone level

Uncommon (0.1% to 1%): Hyperthyroidism

Frequency not reported: Hyperglycemia, decreased libido, increased and decreased gonadotropic luteinizing hormone^[Ref]

Hematologic

Very common (10% or more): Leukopenia (up to 47%), anemia (up to 25%), hypochromic anemia (up to 13%)

Common (1% to 10%): Lymphoma-like reaction, lymphadenopathy

Uncommon (0.1% to 1%): Blood dyscrasia, coagulation disorder, increased coagulation time, thrombocytopenia, thrombocythemia, eosinophilia, leukocytosis, lymphocytosis, abnormal erythrocytes

Frequency not reported: Neutropenia, decreased thromboplastin, bone marrow suppression, decreased absolute neutrophil count, decreased absolute lymphocyte count, decrease white blood cell count, decreased hemoglobin^[Ref]

Other

Very common (10% or more): Asthenia (up to 45%), infection (up to 23%), fever (up to 17%), bacterial infection (up to 13%), chills (up to 13%), flu syndrome (up to 13%), peripheral edema (up to 13%), pain (up to 12%)

Common (1% to 10%): Deafness

Uncommon (0.1% to 1%): Ear disorder, parasitic infection, edema, mucous membrane disorder, abnormal lab test

Frequency not reported: Chest pain, breast pain, breast enlargement, sepsis, ear pain, otitis externa, tinnitus, malaise, viral infection^[Ref]

Gastrointestinal

Very common (10% or more): Diarrhea (up to 42%), nausea (up to 16%), vomiting (up to 13%), abdominal pain (up to 11%)

Common (1% to 10%): Cheilitis, constipation, dry mouth, flatulence

Uncommon (0.1% to 1%): Pancreatitis, gastrointestinal disorder

Frequency not reported: Colitis, melena, dyspepsia, gastroenteritis, gingivitis, increased amylase, increased lipase, stomatitis, abnormal stools, tenesmus, pelvic pain, eructation, enlarged abdomen, dysphagia, mouth ulceration, oral moniliasis, gingivitis^[Ref]

Nervous system

Very common (10% or more): Headache (up to 42%)

Common (1% to 10%): Dizziness, hypesthesia

Uncommon (0.1% to 1%): Ataxia, neuropathy, vertigo, hyperesthesia

Frequency not reported: Syncope, cerebrovascular accident, subdural hematoma, migraine, peripheral neuritis, paresthesia, somnolence, stupor, circumoral paresthesia, taste perversion^[Ref]

Dermatologic

Very common (10% or more): Exfoliative dermatitis (up to 28%), rash (up to 23%), pruritus (up to 20%), dry skin (up to 17%), alopecia (up to 11%)

Common (1% to 10%): Skin ulcer, skin hypertrophy, skin nodule, acne, sweating, skin disorder

Uncommon (0.1% to 1%): Purpura, serous drainage, herpes simplex, pustular rash, cellulitis, skin discoloration, hair disorder, nail disorder

Frequency not reported: Maculopapular rash, vesicular bullous rash, ecchymosis, petechia, pallor, psoriasis, furunculosis, contact dermatitis, herpes zoster, seborrhea, lichenoid dermatitis, photosensitivity reaction, face edema, body odor^[Ref]

Ocular

Very common (10% or more): Cataracts/lens opacities (up to 19%)

Common (1% to 10%): Dry eyes, eye disorder

Uncommon (0.1% to 1%): Amblyopia, visual field defect, corneal lesion, abnormal vision, blepharitis, conjunctivitis

Frequency not reported: Keratitis, night blindness, nystagmus, lacrimation disorder, eye pain^[Ref]

Musculoskeletal

Very common (10% or more): Back pain (up to 11%)

Common (1% to 10%): Arthralgia, myalgia, bone pain

Uncommon (0.1% to 1%): Myasthenia

Frequency not reported: Arthrosis, increased creatinine phosphokinase, hypertonia, leg cramps, abnormal gait, arthritis, joint disorder^[Ref]

Psychiatric

Very common (10% or more): Insomnia (up to 11%)

Uncommon (0.1% to 1%): Depression, agitation

Frequency not reported: Anxiety, emotional lability, abnormal thinking, confusion, nervousness^[Ref]

General

Due to its primarily retinoid X receptor (RXR)-binding activity, this drug is less likely to cause adverse effects (arthralgia; myalgia; and mucocutaneous, nail, and hair toxicities) frequently reported with retinoic acid receptor (RAR)-binding agents.^[Ref]

Hepatic

Common (1% to 10%): Increased SGPT/ALT, increased SGOT/AST, increased bilirubin

Uncommon (0.1% to 1%): Bilirubinemia, liver failure

Frequency not reported: Cholestasis, cholecystitis, liver damage, jaundice^[Ref]

Immunologic

Common (1% to 10%): Allergic reaction^[Ref]

Renal

Common (1% to 10%): Increased creatinine

Uncommon (0.1% to 1%): Increased BUN, abnormal kidney function^[Ref]

Cardiovascular

Uncommon (0.1% to 1%): Tachycardia, hemorrhage, hypertension, vasodilation, varicose vein

Frequency not reported: Angina pectoris, right heart failure, arrhythmia, peripheral vascular disorder, decreased prothrombin, congestive heart failure, palpitation, vascular anomaly, vascular disorder^[Ref]

Genitourinary

Uncommon (0.1% to 1%): Albuminuria

Frequency not reported: Hematuria, urinary incontinence, urinary tract infection, urinary urgency, dysuria, monilia infection, hyperuricemia, urinary retention, impaired urination, polyuria, nocturia, urine abnormality^[Ref]

Oncologic

Uncommon (0.1% to 1%): Neoplasm

Frequency not reported: Carcinoma^[Ref]

Respiratory

Frequency not reported: Pharyngitis, rhinitis, dyspnea, pleural effusion, bronchitis, increased cough, lung edema, hemoptysis, hypoxia, pneumonia, sinusitis, epistaxis, respiratory disorder, lung disorder, pleural disorder, laryngismus^[Ref]