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Cerubidine Side Effects

Generic Name: daunorubicin

Medically reviewed by Drugs.com. Last updated on July 31, 2020.

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

For the Consumer

Applies to daunorubicin: intravenous powder for solution, intravenous solution

Warning

Intravenous route (Solution; Powder for Solution)

Must be given into a rapidly flowing IV infusion and must never be given by the IM or subQ route, as severe local tissue necrosis will occur if there is extravasation during administration. Myocardial toxicity manifested in its most severe form by potentially fatal congestive heart failure may occur either during therapy or months to years after termination of therapy. The incidence of myocardial toxicity increases after a total cumulative dose exceeding 400 to 550 mg/m(2) in adults, 300 mg/m(2) in children more than 2 years of age, or 10 mg/kg in children less than 2 years of age. Severe myelosuppression occurs when used in therapeutic doses; this may lead to infection or hemorrhage. Dosage should be reduced in patients with impaired hepatic or renal function.

Side effects requiring immediate medical attention

Along with its needed effects, daunorubicin (the active ingredient contained in Cerubidine) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need 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.

Check with your doctor immediately if any of the following side effects occur while 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

Check with your doctor as soon as possible if any of the following side effects occur while taking daunorubicin:

More common

  • Sores in mouth and on lips

Less common

  • Joint pain

Rare

Side effects not requiring immediate medical attention

Some side effects of daunorubicin may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Less common or rare

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 using this medicine, it may still produce some side effects that need attention. During this period of time, Check with your doctor immediately if you notice the following side effects:

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

For Healthcare Professionals

Applies to daunorubicin: intravenous powder for injection, intravenous solution

Hematologic

Very common (10% or more): Bone marrow failure, leukopenia, granulocytopenia, neutropenia, thrombocytopenia, anemia[Ref]

Cardiovascular

Very common (10% or more): Cardiomyopathy (e.g., dyspnea, cyanosis, dependent edema, hepatomegaly, ascites, pleural effusion, congestive cardiac failure), hemorrhage

Common (1% to 10%): Electrocardiogram abnormal (electrocardiogram ST-T change, electrocardiogram QRS complex abnormal, electrocardiogram T wave abnormal)

Uncommon (0.1% to 1%): Myocardial infarction

Frequency not reported: Myocardial ischemia (angina pectoris), endomyocardial fibrosis, pericarditis/myocarditis, supraventricular tachyarrhythmias (i.e., sinus tachycardia, ventricular extrasystoles, atrioventricular block), flushing, shock, thrombophlebitis, phlebosclerosis[Ref]

Dermatologic

Very common (10% or more): Alopecia, erythema, rash

Frequency not reported: Dermatitis contact, recall phenomenon, pruritus, skin/nail hyperpigmentation, urticaria[Ref]

Gastrointestinal

Very common (10% or more): Nausea/vomiting, diarrhea, esophagitis, mucositis/stomatitis (pain or burning sensation, erythema, ulcer, hemorrhage) infection

Common (1% to 10%): Abdominal pain

Frequency not reported: Colitis[Ref]

Local

Common (1% to 10%): Infusion site phlebitis

Frequency not reported: Venous sclerosi (from injection of the drug into a small vessel or from repeated injections into the same vein), infusion site extravasation (e.g., infusion site pain/burning sensation, cellulitis, skin ulcer, necrosis)[Ref]

Hypersensitivity

Frequency not reported: Anaphylactic reaction/anaphylactoid reaction[Ref]

Hepatic

Very common (10% or more): Blood bilirubin increased, aspartate aminotransferase increased, blood alkaline phosphatase increased[Ref]

Genitourinary

Frequency not reported: Chromaturia (red color of urine for 1 to 2 days after administration), amenorrhea, azoospermia[Ref]

Immunologic

Very common (10% or more): Sepsis/septicemia, infection

Frequency not reported: Septic shock[Ref]

Metabolic

Very common (10% or more): Dehydration, acute hyperuricemia (with possible impairment of renal function especially in the presence of elevated pretreatment white blood cell counts)[Ref]

Oncologic

Uncommon (0.1% to 1%): Acute myeloid leukemia

Frequency not reported: Myelodysplastic syndrome[Ref]

Respiratory

Frequency not reported: Hypoxia[Ref]

Other

Very common (10% or more): Pyrexia, pain

Frequency not reported: Death, hyperpyrexia, chills[Ref]

References

1. "Product Information. DAUNOrubicin Hydrochloride (DAUNOrubicin)." Hikma USA (formerly West-Ward Pharmaceutical Corporation), Eatontown, NJ.

Frequently asked questions

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.