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Idarubicin Side Effects

Medically reviewed by Last updated on Oct 1, 2020.

In Summary

Commonly reported side effects of idarubicin include: infection and hemorrhage. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to idarubicin: intravenous solution


Intravenous route (Solution)

Administer slowly into a freely flowing intravenous infusion. If extravasation occurs during administration, severe local tissue necrosis will occur; never administer via IM or subQ routes. Administer only under the supervision of a physician who is experienced in leukemia chemotherapy and in facilities that can monitor for drug tolerance and toxicity. The physician and institution must be able to respond to severe hemorrhagic conditions or overwhelming infection. Like other anthracyclines, idarubicin hydrochloride injection can cause myocardial toxicity leading to congestive heart failure. Cardiac toxicity is more common in patients who have received prior anthracyclines or who have preexisting cardiac disease. Severe myelosuppression will occur with idarubicin hydrochloride when used at therapeutic doses and dose reductions are required for patients with impaired hepatic or renal function

Side effects requiring immediate medical attention

Along with its needed effects, idarubicin may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking idarubicin:

More common

  • Black, tarry stools
  • bleeding gums
  • blood in the urine or stools
  • coughing up blood
  • cough or hoarseness
  • difficulty with breathing or swallowing
  • dizziness
  • fever or chills
  • increased menstrual flow or vaginal bleeding
  • lower back or side pain
  • nosebleeds
  • painful or difficult urination
  • paralysis
  • pinpoint red spots on the skin
  • prolonged bleeding from cuts
  • red or dark brown urine
  • red or black, tarry stools
  • sores in the mouth and on the lips
  • unusual bleeding or bruising

Less common

  • Fast or irregular heartbeat
  • joint pain
  • pain at the injection site
  • swelling of the feet and lower legs


Side effects not requiring immediate medical attention

Some side effects of idarubicin 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

  • Darkening or redness of the skin (after x-ray treatment)
  • numbness or tingling of the fingers, toes, or face

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:

  • Fast or irregular heartbeat
  • shortness of breath
  • swelling of the feet and lower legs

For Healthcare Professionals

Applies to idarubicin: intravenous powder for injection, intravenous solution


Very common (10% or more): Hemorrhage (up to 63%), anemia, severe leukopenia, severe neutropenia, thrombocytopenia

Frequency not reported: Bone marrow depression (dose dependent), pancytopenia[Ref]

For induction therapy for AML, a median WBC nadir of < 500/mm3 (ANC) usually occurs at 10 to 12 days, with recovery at around 15 to 20 days. Idarubicin monotherapy typically induces an absolute neutrophil count of 3000/mm3. Thrombocytopenia is less commonly encountered, with platelet nadirs occurring on days 10 to 15 over a median duration of approximately 25 days. Anemia is rare. Although prolonged myelosuppression is rarely observed, full hematologic recovery is typically observed in all cases.[Ref]


Very common (10% or more): Nausea/vomiting (up to 82%), abdominal cramps/diarrhea (up to 73%), burning sensation, mucositis/stomatitis, anorexia

Common (1% to 10%): GI tract bleeding

Uncommon (0.1% to 1%): Dehydration, esophagitis, colitis (including severe enterocolitis/neutropenic enterocolitis with perforation)

Very rare (less than 0.01%): Gastric erosions or ulcerations[Ref]

-Idarubicin-induced nausea and vomiting can be seen as early as 15 to 30 minutes after IV dosing, and can be easily controlled with appropriate antiemetic therapy.

-Mucositis can be severe, especially in patients receiving multiple leukemia induction courses.

-Gastrointestinal perforation should be suspected in patients with severe abdominal pain.[Ref]


Very common (10% or more): Alopecia (up to 77%)

Common (1% to 10%): Rash, itch, hypersensitivity of irradiated skin (radiation recall reaction)

Uncommon (0.1% to 1%): Skin and nail hyperpigmentation, urticaria, cellulitis (can be severe), tissue necrosis

Very rare (less than 0.01%): Acral erythema (bullous erythrodermatous rash of the palms and soles)

Frequency not reported: Hives, local toxicity[Ref]

Nervous system

Very common (10% or more): Headache (up to 20%)

Common (1% to 10%): Seizure[Ref]


Congestive heart failure (frequently attributed to fluid overload), serious arrhythmias including atrial fibrillation, chest pain, myocardial infarction and asymptomatic declines in LVEF have been reported in patients undergoing induction therapy for acute myeloid leukemia (AML). Myocardial insufficiency and arrhythmias were usually reversible and occurred in the setting of sepsis, anemia, and aggressive IV fluid administration. The events were reported more frequently in patients over age 60 years and in those with preexisting cardiac disease.[Ref]

Common (1% to 10%): Bradycardia, sinus tachycardia, tachyarrhythmias, asymptomatic reduction of left ventricular ejection fraction, congestive heart failure, cardiomyopathies, local phlebitis, thrombophlebitis

Uncommon (0.1% to 1%): ECG abnormalities (e.g., nonspecific ST segment changes), myocardial infarction, shock

Rare (0.01% to 0.1%): Cerebral hemorrhage

Very rare (less than 0.01%): Pericarditis, myocarditis, atrioventricular and bundle branch block

Frequency not reported: Serious arrhythmias including atrial fibrillation, chest pain, myocardial infarction, myocardial insufficiency, asymptomatic declines in LVEF, ECG changes, hot flushes, phlebitis, thrombophlebitis, thromboembolism[Ref]


Frequency not reported: Local skin irritation, extravasation (resulting in inflammation, thrombophlebitis, and/or tissue necrosis)[Ref]

In cases of extravasation most experts recommend topical ice packs to the affected area. Topical DMSO has been shown to be useful in cases of extravasation involving other anthracyclines; its usefulness in cases of idarubicin extravasation is unknown.[Ref]


Changes in hepatic function tests have been observed. These changes were usually transient and occurred in the setting of sepsis and while patients were receiving potentially hepatotoxic antibiotics and antifungal agents. Severe changes in hepatic function (equivalent to WHO Grade 4) occurred in less than 5% of patients.[Ref]

Very common (10% or more): Bilirubin and serum transaminase elevations (20% to 40%)[Ref]


Renal side effects including new or worsened renal insufficiency (perhaps associated with hyperuricemia), concomitant potentially nephrotoxic antimicrobial therapy, and/or dehydration has been reported in less than 5% of patients in large clinical trials. The nephrotic syndrome has been associated with the use of other anthracyclines in patients with acute myelogenous leukemias.[Ref]


Very rare (less than 0.01%): Anaphylaxis[Ref]


Very common (10% or more): Red coloration of the urine for 1 to 2 days after treatment[Ref]


Very common (10% or more): Infection (up to 95%)

Uncommon (0.1% to 1%): Sepsis/septicemia[Ref]


Uncommon (0.1% to 1%): Hyperuricamia

Frequency not reported: Tumor lysis syndrome[Ref]


Uncommon (0.1% to 1%): Secondary leukemia (acute myeloid leukemia and myelodysplastic syndrome)[Ref]


Very common (10% or more): Fever (up to 26%), chills[Ref]


Common (1% to 10%): Pulmonary allergy[Ref]


1. "Product Information. Idamycin (idarubicin)." Pharmacia and Upjohn, Kalamazoo, MI.

2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

3. Pharmaceutical Society of Australia "APPGuide online. Australian prescription products guide online. Available from: URL:" ([2006]):

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.