Purinethol Side Effects

Generic name: mercaptopurine

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

Some side effects of Purinethol 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 mercaptopurine: oral tablet

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

Stop using mercaptopurine and call your doctor right away if you have any of these symptoms of lymphoma:

• fever, night sweats, weight loss, tiredness;

• feeling full after eating only a small amount;

• pain in your upper stomach that may spread to your shoulder;

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

• nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Stop using mercaptopurine and call your doctor at once if you have any of these other serious side effects:

• signs of infection (fever, chills, sore throat, body aches, weakness, muscle pain, flu symptoms);

• severe nausea, vomiting, or diarrhea;

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

• pain or burning with urination; or

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

Less serious side effects of mercaptopurine may include:

• vomiting, mild diarrhea;

• hair loss;

• mild itching or skin rash; or

• darkened skin color.

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 mercaptopurine: oral tablet

Hematologic

Hematologic effects including myelosuppression have been reported. Myelosuppression is the most frequent adverse reaction reported with the use of mercaptopurine (the active ingredient contained in Purinethol) Anemia, leukopenia, and thrombocytopenia have also been reported frequently.

Renal

Hyperuricemia may occur as a consequence of rapid cell lysis. Adverse effects may be minimized by increasing hydration, urine alkalinization, and the prophylactic administration of a xanthine oxidase inhibitor (such as allopurinol).

Renal effects including hyperuricemia have been reported.

Gastrointestinal

Gastrointestinal effects including intestinal ulceration have been reported. Nausea, vomiting, and anorexia have been infrequently reported during initial administration. Mild diarrhea and sprue-like symptoms have been reported occasionally. Oral lesions have been reported rarely. An increased risk of pancreatitis may be associated with the investigational use of mercaptopurine (the active ingredient contained in Purinethol) in inflammatory bowel disease.

The mild diarrhea and sprue-like symptoms are not necessarily related to the mercaptopurine.

Oral lesions resemble thrush rather than antifolic ulcerations.

Hepatic

Hepatic effects including a small number of deaths which may have been attributed to hepatic necrosis have been reported.

Dermatologic

Dermatologic effects have included skin rashes, alopecia, and hyperpigmentation.

Genitourinary

Genitourinary side effects including oligospermia have been reported.

Other

Other effects including drug fever have been reported very rarely.

Before the drug fever is assumed to be caused by mercaptopurine, the clinician should exclude more common causes of pyrexia such as sepsis in patients with acute leukemia.

Oncologic

Oncologic side effects have included hepatosplenic T-cell lymphoma.

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