Matulane Side Effects

Generic name: procarbazine

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

Some side effects of Matulane 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 procarbazine: oral capsule

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

Call your doctor at once if you have:

• diarrhea that is watery;

• a light-headed feeling, like you might pass out;

• numbness, burning pain, or tingly feeling;

• confusion, hallucinations, problems with vision or speech, trouble with walking or daily activities;

• feeling unsteady, loss of balance or coordination;

• tremors, seizure (convulsions);

• cough, chest pain, trouble breathing;

• fever, chills, body aches, flu symptoms;

• easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;

• white patches or sores inside your mouth or on your lips;

• jaundice (yellowing of the skin or eyes); or

• bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds.

Common side effects may include:

• mild nausea, vomiting, loss of appetite, stomach pain;

• dry mouth, constipation, mild diarrhea;

• mild itching or rash, temporary hair loss;

• muscle of joint pain;

• headache, dizziness, feeling tired;

• urinating more than usual; or

• changes in your menstrual periods.

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 procarbazine: oral capsule

Hematologic

Hematologic side effects are dose limiting and recovery may be delayed. Leukopenia, anemia, and thrombocytopenia have been reported to occur frequently. Pancytopenia, eosinophilia, hemolytic anemia, and bleeding tendencies including petechiae, purpura, epistaxis, hematuria and hemoptysis have also been reported.

Hematologic toxicity, common to many hydrazine derivatives, include hemolysis, eosinophilia, anisocytosis, poikilocytosis, lymphocytosis and the appearance of Heinz-Ehrlich inclusion bodies in erythrocytes.

Gastrointestinal

Most of the nausea and vomiting occur with initial drug administration. In one study, 15 of 43 patients suffered severe gastrointestinal toxicity.

Gastrointestinal side effects including nausea and vomiting are the most commonly reported. Hepatic dysfunction, jaundice, stomatitis, hematemesis, melena, diarrhea, dysphagia, anorexia, abdominal pain, constipation, and dry mouth have also been reported.

Nervous system

Nervous system side effects including leukoencephalopathy, coma, convulsions, neuropathy, ataxia, paresthesia, nystagmus, diminished reflexes, falling, foot drop, headache, dizziness, chills, weakness, fatigue, hallucinations and unsteadiness have been reported.

In one study, peripheral neuropathy with paresthesia of the extremities and depressed deep tendon reflexes were reported to occur in 17% of patients. These effects, as well as ataxia, have been known to be reversible in some patients even as administration of the drug was continued.

Cardiovascular

Cardiovascular side effects including hypotension, tachycardia, and syncope have been reported.

Ocular

Ocular side effects including retinal hemorrhage, papilledema, photophobia, diplopia and inability to focus have been reported.

Respiratory

Respiratory side effects including pneumonitis, pleural effusion, and cough have been reported.

Dermatologic

Dermatologic side effects including herpes, dermatitis, pruritus, alopecia, hyperpigmentation, rash, urticaria, and flushing have been reported.

If a rash develops that is self limiting, it may be prevented during subsequent courses of therapy by administration of steroids.

Hypersensitivity

In one study, 12 of 68 patients receiving procarbazine (the active ingredient contained in Matulane) experienced a hypersensitivity reaction. Other studies have reported less frequent occurrences. One study noted 2 rashes out of 24 patients and another study noted 1 rash and 1 case of urticaria out of 129 patients.

Hypersensitivity side effects have been reported.

Genitourinary

Genitourinary side effects including hematuria, urinary frequency, and nocturia have been reported.

Musculoskeletal

Musculoskeletal side effects including pain (myalgia and arthralgia) and tremors have been reported.

Psychiatric

Psychiatric side effects including hallucinations, depression, apprehension, agitation, psychosis, nervousness, confusion, mania and nightmares have been reported.

Endocrine

Endocrine side effects including gynecomastia in prepuberal and early puberal boys have been reported.

Oncologic

Oncologic side effects with instances of a secondary nonlymphoid malignancy, including lung cancer, acute myelocytic leukemia, and malignant myelosclerosis have been reported in patients with Hodgkin's disease treated with procarbazine (the active ingredient contained in Matulane) in combination with other chemotherapy and/or radiation.

The risks of secondary lung cancer from treatment appear to be multiplied by tobacco use.

The carcinogenicity of procarbazine in mice, rats, and monkeys has been reported in a considerable number of studies.

Other

Other side effects including azoospermia, intercurrent infections, hearing loss, pyrexia, diaphoresis, lethargy, weakness, fatigue, edema, chills, insomnia, slurred speech, hoarseness, hyperpyrexia, and drowsiness have been reported.

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