Targretin Side Effects

Generic name: bexarotene

Note: This document contains side effect information about bexarotene. Some of the dosage forms listed on this page may not apply to the brand name Targretin.

Some side effects of Targretin may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to bexarotene: oral capsule

Get emergency medical help if you have any of these signs of an allergic reaction while taking bexarotene (the active ingredient contained in Targretin) hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using bexarotene and call your doctor at once if you have:

• fever, chills, body aches, flu symptoms, sores in your mouth and throat;

• pale skin, easy bruising, unusual bleeding, feeling light-headed or short of breath, rapid heart rate, trouble concentrating;

• blurred vision, eye pain, or seeing halos around lights;

• severe pain in your upper stomach spreading to your back, nausea and vomiting;

• feeling tired or unusually cold; or

• stabbing chest pain, wheezing, cough with yellow or green mucus.

Common side effects may include:

• temporary hair loss;

• nausea, vomiting, diarrhea, stomach pain;

• confusion, headache, weakness, muscle spasm;

• rash, dry or peeling skin;

• sleep problems (insomnia); or

• swelling in your hands or feet.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to bexarotene: oral capsule

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

In a phase III trial on the use of bexarotene (the active ingredient contained in Targretin) for the treatment of non-small-cell lung cancer, a subgroup (32%) of bexarotene-treated patients developing high-grade hyperglyceridemia appeared to have better survival than controls. Therefore, triglyceride response may be a biomarker of survival benefit with bexarotene.

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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