Dacarbazine Side Effects

Not all side effects for dacarbazine may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to dacarbazine: powder for solution, powder for suspension

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

Also, because of the way these medicines act on the body, there is a chance that they might cause other unwanted effects that may not occur until months or years after the medicine is used. These delayed effects may include certain types of cancer, such as leukemia. Discuss these possible effects with your doctor.

Check with your doctor immediately if any of the following side effects occur while taking dacarbazine:

More common
  • Redness, pain, or swelling at place of injection
Less common
  • Black, tarry stools
  • blood in urine or stools
  • cough or hoarseness, accompanied by fever or chills
  • fever or chills
  • lower back or side pain, accompanied by fever or chills
  • painful or difficult urination, accompanied by fever or chills
  • pinpoint red spots on skin
  • unusual bleeding or bruising
Rare
  • Shortness of breath
  • stomach pain
  • swelling of face
  • yellow eyes or skin

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

Rare
  • Sores in mouth and on lips

Some side effects of dacarbazine 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
  • Loss of appetite
  • nausea or vomiting (should lessen after 1 or 2 days)
Less common
  • Feelings of uneasiness
  • flushing of face
  • muscle pain
  • numbness of face

This medicine may cause a temporary loss of hair in some people. After treatment with dacarbazine has ended, normal hair growth should return.

After you stop using this medicine, it may still produce some side effects that need attention. During this period of time, check with your doctor immediately if you notice the following side effects:

  • Black, tarry stools
  • blood in urine or stools
  • cough or hoarseness, accompanied by fever or chills
  • fever or chills
  • lower back or side pain, accompanied by fever or chills
  • painful or difficult urination, accompanied by fever or chills
  • pinpoint red spots on skin
  • unusual bleeding or bruising

For Healthcare Professionals

Applies to dacarbazine: intravenous powder for injection

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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