Idamycin PFS Side Effects

Generic name: idarubicin

Medically reviewed by Drugs.com. Last updated on Apr 17, 2025.

Note: This document provides detailed information about Idamycin PFS Side Effects associated with idarubicin. Some dosage forms listed on this page may not apply specifically to the brand name Idamycin PFS.

Applies to idarubicin: intravenous solution.

Precautions

It is very important that your doctor check you closely to make sure that this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. It may also cause birth defects if the father is using it when his sexual partner becomes pregnant. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting treatment. Use an effective form of birth control during treatment and for 6 ½ months after the last dose. Males with female partners who are able to become pregnant should use an effective form of birth control during treatment and for at least 3 ½ months after the last dose. If you think you have become pregnant, tell your doctor right away.

Your doctor may monitor your heart while you are getting treatments with this medicine. Check with your doctor right away if you have chest pain or discomfort, fast or irregular heartbeat, swelling of the feet and lower legs, or trouble breathing after receiving this medicine. These may be symptoms of serious heart problems.

Idarubicin can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

• If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
• Check with your doctor immediately if you notice any unusual bleeding or bruising, black, tarry stools, blood in the urine or stools, or pinpoint red spots on your skin.
• Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.
• Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
• Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.
• Avoid contact sports or other situations where bruising or injury could occur.

If idarubicin (the active ingredient contained in Idamycin PFS) accidentally seeps out of the vein into which it is injected, it may damage some tissues and cause scarring. Tell your right away if you notice redness, pain, or swelling at the injection site.

While you are being treated with idarubicin, and after you stop treatment with it, do not have any immunizations (vaccinations) without your doctor's approval. Idarubicin may lower your body's resistance, and there is a chance you might get the infection the immunization is meant to prevent. In addition, other persons living in your household should not take oral polio vaccine since there is a chance they could pass the polio virus on to you. Also, avoid persons who have taken oral polio vaccine. Do not get close to them, and do not stay in the same room with them for very long. If you cannot take these precautions, you should consider wearing a protective face mask that covers the nose and mouth.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Serious side effects of Idamycin PFS

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:

Other side effects of Idamycin PFS

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:

For healthcare professionals

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

Hematologic adverse events

• 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 (the active ingredient contained in Idamycin PFS) 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]

Gastrointestinal

• 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]

Dermatologic

• 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]

Cardiovascular

• 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]

Local

• 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]

Hepatic

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

Renal

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]

Hypersensitivity

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

Genitourinary

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

Immunologic

• Very common (10% or more): Infection (up to 95%)
• Uncommon (0.1% to 1%): Sepsis/septicemia^[Ref]

Metabolic

• Uncommon (0.1% to 1%): Hyperuricamia
• Frequency not reported: Tumor lysis syndrome^[Ref]

Oncologic

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

Other

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

Respiratory

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

See also:

Further information

Idamycin PFS side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

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