Skip to Content

Idamycin PFS Side Effects

Generic Name: idarubicin

Note: This page contains information about the side effects of idarubicin. Some of the dosage forms included on this document may not apply to the brand name Idamycin PFS.

For the Consumer

Applies to idarubicin: intravenous powder for solution, intravenous solution

In addition to its needed effects, some unwanted effects may be caused by idarubicin (the active ingredient contained in Idamycin PFS). In the event that any of these side effects do occur, they may require medical attention.

If any of the following side effects occur while taking idarubicin, check with your doctor or nurse immediately:

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
  • Skin rash or hives
  • stomach pain (severe)

Minor Side Effects

Some of the side effects that can occur with idarubicin 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:
  • Abdominal or stomach cramps
  • diarrhea
  • headache
  • nausea and vomiting
Less common:
  • Darkening or redness of the skin (after x-ray treatment)
  • numbness or tingling of the fingers, toes, or face

Side Effects: Post Treatment

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:

  • 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]


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]

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]


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]):

Not all side effects for Idamycin PFS may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.