Daunorubicin Side Effects

Not all side effects for daunorubicin 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 daunorubicin: intravenous powder for solution, intravenous solution

In addition to its needed effects, some unwanted effects may be caused by daunorubicin. In the event that any of these side effects do occur, they may require 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.

You should check with your doctor immediately if any of these side effects occur when taking daunorubicin:

Less common
  • Cough or hoarseness
  • fever or chills
  • irregular heartbeat
  • lower back or side pain
  • pain at place of injection
  • painful or difficult urination
  • shortness of breath
  • swelling of feet and lower legs
Rare
  • Black, tarry stools
  • blood in urine or stools
  • pinpoint red spots on skin
  • unusual bleeding or bruising

If any of the following side effects occur while taking daunorubicin, check with your doctor or nurse as soon as possible:

More common
  • Sores in mouth and on lips
Less common
  • Joint pain
Rare
  • Skin rash or itching

Some of the side effects that can occur with daunorubicin may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

More common
  • Nausea and vomiting
Less common or rare
  • Darkening or redness of skin
  • diarrhea

Daunorubicin causes the urine to turn reddish in color, which may stain clothes. This is not blood. It is perfectly normal and lasts for only 1 or 2 days after each dose is given.

This medicine often causes a temporary and total loss of hair. After treatment with daunorubicin has ended, normal hair growth should return.

After you stop taking this drug, it is possible that you may still experience side effects that need medical attention. If you notice any of the following side effects check with your doctor immediately:

  • Irregular heartbeat
  • shortness of breath
  • swelling of feet and lower legs

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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