Dacarbazine Side Effects

Please note - some side effects for Dacarbazine 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 Dacarbazine - for the Consumer

Dacarbazine

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 Dacarbazine:

Facial flushing, numbness, or tingling; loss of appetite; metallic taste in mouth; muscle pain or weakness; nausea; temporary hair loss; vomiting.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); dark urine; fever, chills, or sore throat; joint pain; pain, redness, or swelling at injection site; severe nausea and vomiting; stomach pain; unusual bruising or bleeding; unusual tiredness or weakness; yellowing of skin or eyes.

Side Effects by Body System

Hematologic

Hematologic side effects including hematopoietic depression (involving primarily the leukocytes and platelets) are the most commonly reported toxicity. Severe cases of leukopenia and thrombocytopenia resulting in fatality have been reported. Anemia has also been reported.

Hematologic side effects may be delayed for 2 to 4 weeks after dosage administration.

Gastrointestinal

Gastrointestinal side effects including anorexia, nausea, and vomiting have been reported frequently. Diarrhea has rarely been reported.

Anorexia, nausea, and vomiting may begin within 1 to 12 hours of dosage administration. Over 90% of patients are affected within the first few doses. Intractable nausea and vomiting have rarely necessitated discontinuation of therapy. Vomiting has been reported to last for 1 to 2 hours and be incompletely and unpredictably palliated with phenobarbital and/or prochlorperazine. Some clinicians have recommended the use of serotonin receptor antagonist to control the nausea and vomiting. The rapid toleration of nausea and vomiting may suggest a central nervous system mechanism. Usually these symptoms subside after the first day or two. In a trial of high-dose dacarbazine, of 28 dosages equal to or greater than 1,380 mg/m2, all caused nausea and vomiting. At 1,380 mg/m2, 12 of 14 patients experienced diarrhea. Of 13 dosages greater than 1,380 mg/m2, all caused diarrhea.

Hepatic

The manufacturer states that hepatic toxicity has occurred primarily when dacarbazine has been administered concomitantly with other antineoplastic agents.

In one study, fatal massive hepatic necrosis with widespread thrombotic occlusion of the small hepatic veins developed in two of 68 patients (3%). The study notes 13 similar reactions in patients receiving dacarbazine as single agent therapy to have been reported in the literature. Hepatic toxicity may be delayed.

Hepatic side effects including hepatic vein thrombosis and fatal hepatocellular necrosis have been reported (0.01%).

Cardiovascular

Because the hypotension was reversible by either stopping the infusion or administration of calcium chloride, it has been suggested that the citric acid preservative may have been the cause of the hypotension.

Cardiovascular side effects including dose-limiting hypotension have been reported during high dose therapy.

Hypersensitivity

Hypersensitivity side effects including anaphylaxis have been reported.

Dermatologic

Dermatologic side effects including erythematous and urticarial rashes, facial flushing, phototoxic dermatitis, facial paresthesia, alopecia, facial flushing, and photosensitivity have been reported.

Ten cases of photosensitivity have been reported.

Other

The influenza-like syndrome usually occurs after large single doses, and may occur with successive treatments. Onset may occur after approximately 7 days and symptoms generally resolve after 1 to 3 weeks.

Other side effects including an influenza-like syndrome (fever to 39 degrees Celsius, myalgias, and malaise) have been reported. Metallic taste has also been reported.

Local

Local side effects including extravasation of the drug subcutaneously during intravenous administration have been reported to have resulted in local pain (occasionally severe), burning sensation, irritation and tissue damage.

Oncologic

Oncologic side effects have been reported in animal studies.

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