Bexarotene Side Effects

Brand Names: Targretin

Please note - some side effects for Bexarotene may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Bexarotene - for the Consumer

Bexarotene

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 Bexarotene:

Diarrhea; dizziness; dry skin; headache; loss of appetite; nausea; trouble sleeping; weakness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloating or swelling of ankles, feet, or hands; changes in vision; chest pain; chills; confusion; dark urine or pale stools; fever; severe stomach or back pain with continuing nausea or vomiting; red, swollen, or blistered skin; sore throat; unusual fatigue; yellowing of the skin or eyes.

Bexarotene Gel

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 Bexarotene Gel:

Headache; pain or itching at the application site.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); fever, chills, or sore throat; irritation at the application site; numbness or tingling of the skin; swelling.

Side Effects by Body System

Metabolic

Metabolic side effects have included hyperlipidemia (79%), hypercholesterolemia (32% to 62%), and increased lactic dehydrogenase (7% to 13%).

Endocrine

Endocrine side effects have included hypothyroidism (29% to 53%).

Hematologic

Hematologic side effects have included leukopenia (17% to 47%), anemia (6% to 24%), hypochromic anemia (4% to 13%), and high-grade hypertriglyceridemia. One fatal case of subdural hematoma has also been reported.

General

General side effects have included headache (30% to 42%), asthenia (20% to 45%), infection (13% to 22%), abdominal pain (4% to 11%), chills (10% to 13%), fever (5% to 17%), flu syndrome (4% to 13%), back pain (2% to 11%), and bacterial infection (1% to 13%).

Dermatologic

Dermatologic side effects have included rash (17% to 23%), dry skin (9% to 11%), exfoliative dermatitis (10% to 28%), alopecia (4% to 11%), and photosensitivity.

Gastrointestinal

Gastrointestinal side effects have included nausea (8% to 16%), diarrhea (7% to 42%), vomiting (4% to 13%), and anorexia (2% to 23%). Ten cases of acute pancreatitis (including one fatal case) have also been reported.

Cardiovascular

Cardiovascular side effects have included peripheral edema (11% to 13%).

Nervous system

Nervous system side effects have included insomnia (5% to 11%).

Hepatic

Hepatic side effects have included one fatal case of liver failure. Elevations in liver function tests have included SGPT/ALT (2% to 9%), SGOT/AST (5% to 7%), and bilirubin (up to 6%).

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