Daunorubicin Side Effects

Brand Names: Cerubidine

Please note - some side effects for Daunorubicin may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Daunorubicin - for the Consumer

Daunorubicin

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 Daunorubicin:

Diarrhea; hair loss; loss of appetite; mouth pain; nausea; sore throat; stomach pain; tiredness; weakness.

Seek medical attention right away if any of these SEVERE side effects occur when using Daunorubicin:

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, tarry stools; blood in the stools; chest pain; chills; cough or sore throat; excessive bleeding; fever; flushing; irregular heartbeat; pain, redness, or swelling at the injection site; shortness of breath; sores on the mouth or lips; unusual bruising or bleeding.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Daunorubicin Liposomal

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 Daunorubicin Liposomal:

Diarrhea; hair loss; loss of appetite; mouth pain; nausea; sore throat; stomach pain; tiredness; weakness.

Seek medical attention right away if any of these SEVERE side effects occur when using Daunorubicin Liposomal:

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); back pain; black, tarry stools; blood in the stools; chest pain; chills; cough or sore throat; excessive bleeding; fever; flushing; irregular heartbeat; pain, redness, or swelling at the injection site; shortness of breath; sores on the mouth or lips; unusual bruising or bleeding.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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Daunorubicin Side Effects - for the Professional

Daunorubicin

Dose-limiting toxicity includes myelosuppression and cardiotoxicity. Other reactions include:

Cutaneous

Reversible alopecia occurs in most patients. Rash, contact dermatitis and urticaria have occurred rarely.

Gastrointestinal

Acute nausea and vomiting occur but are usually mild. Antiemetic therapy may be of some help. Mucositis may occur 3 to 7 days after administration. Diarrhea and abdominal pain have occasionally been reported.

Local

If extravasation occurs during administration, severe local tissue necrosis, severe cellulitis, thrombophlebitis, or painful induration can result.

Acute Reactions

Rarely, anaphylactoid reaction, fever, and chills can occur. Hyperuricemia may occur, especially in patients with leukemia, and serum uric acid levels should be monitored.

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Side Effects by Body System - for Healthcare Professionals

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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