Daunorubicin Side Effects

Some side effects of daunorubicin 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 daunorubicin: intravenous powder for injection, intravenous solution

Get emergency medical help if you have any of these signs of an allergic reaction while taking daunorubicin: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• chest pain, shortness of breath (even with mild exertion), swelling, rapid weight gain;

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

• easy bruising, unusual bleeding (nose, mouth, vagina, or rectum);

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

• pain, burning, irritation, or skin changes where the injection was given.

Common side effects may include:

• mild nausea, vomiting, diarrhea, stomach pain;

• temporary hair loss, mild itching or rash; or

• red colored urine for 1 or 2 days following a dose.

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 daunorubicin: intravenous powder for injection, intravenous solution

General

In general, two main dose-limiting toxicities have been reported: myelosuppression and cumulative cardiotoxicity. Acute febrile drug reactions have occurred in up to 50% of patients (probably represent reactions to histamine release), but are not generally observed with steroid and other premedications.

The main metabolite, daunorubicinol, has only approximately one tenth the toxicity of the parent compound.

Hematologic

Hematologic side effects can be expected after therapeutic doses. Daunorubicin is a potent bone marrow suppressant, and can cause significant reductions in all bone marrow cell lines for one to two weeks after therapy. Persistent, severe myelosuppression may result in superinfection, hemorrhage, and/or death.

Cardiovascular

Cardiovascular side effects usually present as congestive heart failure, especially after total doses of 550 mg/m2 (400 mg/m2 if there is a history of radiation therapy that included the heart or the area around it). Large retrospective studies have shown that the incidence of heart failure averages 1% to 6% and 14% after cumulative doses of 600 and 1,050 mg/m2, respectively. Daunorubicin-induced heart failure can present months to years after termination of therapy. Early effects of anthracyclines include pericarditis-myocarditis (which can rarely affect patients without a history of cardiac disease and which carries a high mortality rate of about 20%), left ventricular dysfunction (which may lead to clinically significant heart failure in patients with limited cardiac reserve), and arrhythmias, the most common of which is sinus tachycardia (usually asymptomatic and transient). Isolated cases of symptomatic supraventricular tachycardia, heart block, and ventricular arrhythmias have been reported.

While total doses may need to be decreased in patients with previous or concomitant therapy with any potentially cardiotoxic drugs or related compounds such as doxorubicin, there is no reliable method for predicting which patients will develop heart failure. However, a decrease of at least 30% in the QRS voltage in the limb leads of the ECG, nonspecific ST-T wave changes, or a significant decrease in systolic ejection fraction (MUGA scanning) are signs that have been most commonly associated with cardiotoxicity.

Early clinical detection of heart failure appears to be essential for successful treatment with digitalis, diuretics, sodium restriction, and bed rest.

Dermatologic

Dermatologic side effects have included reversible alopecia (common), urticaria, chemical thrombophlebitis, and local necrosis (in cases of extravasation). Hyperpigmentation of skin and nails and rare cases of anaphylactic reactions have been reported. One case of generalized hyperpigmentation which involved many sun-protected areas has also been reported.

Gastrointestinal

Gastrointestinal side effects including upset stomach, nausea, or vomiting (all usually mild) have been reported to occur in approximately 50% of patients. Diarrhea is rare. Stomatitis or mucositis may occur in up to 40% of patients 3 to 7 days after administration.

Local

Intramuscular or subcutaneous administration is NEVER recommended.

Local side effects including local tissue inflammation, thrombophlebitis, and necrosis following IV site extravasation have been reported.

Hypersensitivity

Hypersensitivity side effects have rarely been reported. They have included fever, chills, rash, fulminant hyperpyrexia, and general anaphylaxis.

Hepatic

Hepatic side effects including serum transaminase and bilirubin concentration elevations have been transiently observed.

Renal

Renal side effects including new or worsened renal insufficiency probably associated with hyperuricemia and/or dehydration have been rarely reported in large clinical trials. Nephrotic syndrome has been associated with the use of daunorubicin in patients with acute myelogenous leukemias.

Genitourinary

Genitourinary side effects including a red-orange discoloration of the urine have been reported.

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