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Daunorubicin Side Effects

Medically reviewed by Last updated on Jun 28, 2023.

Applies to daunorubicin: intravenous solution.


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.

Serious side effects of Daunorubicin

Along with its needed effects, daunorubicin 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


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

More common

Less common


Other side effects of Daunorubicin

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:

For Healthcare Professionals

Applies to daunorubicin: intravenous powder for injection, intravenous solution.


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


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]


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

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


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]


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]


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


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


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


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

Frequency not reported: Septic shock[Ref]


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]


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

Frequency not reported: Myelodysplastic syndrome[Ref]


Frequency not reported: Hypoxia[Ref]


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

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

Frequently asked questions


1. (2019) "Product Information. DAUNOrubicin Hydrochloride (daunorubicin)." Hikma USA (formerly West-Ward Pharmaceutical Corporation)

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.