Idarubicin
Pronunciation: (eye-da-ROO-bi-sin).
- Generic name
- idarubicin
- Brand names
- Idarubicin Accord, Idamycin, Idarex, Idarubicin Ebewe, Idarubicin Sandoz, Idacin
- Drug class
- Cancer & Oncology
Availability and supply rules vary by country
Trade names by country: United States · Canada
Australia: · Full directory
What idarubicin is and how it works
Uses, formulations, monitoring, and supply rules can differ by patient, product, and country. Follow the exact local product information and professional advice.
Mechanism of action: how idarubicin works
Idarubicin is an anthracycline antibiotic that exerts its antineoplastic effects by intercalating into DNA, inhibiting the enzyme topoisomerase II, and generating free radicals. This leads to DNA strand breaks, inhibition of DNA and RNA synthesis, and ultimately cell death, particularly in rapidly dividing malignant cells. (1) (2)
What idarubicin is used for
Acute myeloid leukemia (AML) in adults — FDA-approved indication, used as part of combination chemotherapy
Acute myeloid leukemia (AML) in adults — FDA-approved indication, used as part of combination chemotherapy (2)
Acute lymphoblastic leukemia (ALL) — NOT an FDA-approved indication; occasionally used off-label in specific protocols at the treating oncologist's discretion
Acute lymphoblastic leukemia (ALL) — NOT an FDA-approved indication; occasionally used off-label in specific protocols at the treating oncologist's discretion (2)
Before taking idarubicin
Do not take / not appropriate for
- Contraindicated in patients with hypersensitivity to idarubicin or other anthracyclines, severe hepatic impairment, severe myocardial insufficiency, recent myocardial infarction, uncontrolled infections, or persistent myelosuppression. (Contraindication) (2)
Tell your clinician about
(2)How to take idarubicin
- General Instructions: Idarubicin is administered by a healthcare professional as an intravenous (IV) injection over 10-15 minutes. Do not self-administer.. Adult Dosing: The FDA-labeled adult dose for AML is 12 mg/m² IV on days 1, 2, and 3 of the induction cycle, typically combined with cytarabine. Dose and schedule may vary based on protocol and patient factors, and treatment may be repeated if response is not achieved after the first cycle.. Pediatric Dosing: Safety and effectiveness in children have not been established; if used off-label, dosing is based on body surface area and specific treatment protocols, carefully individualized by the treating oncologist, who will also weigh a possibly greater risk of cardiotoxicity in children.. Administration: Given as a slow IV injection or infusion in a hospital or clinic. Idarubicin must not be mixed with other drugs or infused together with heparin. The injection site and patient will be monitored closely for extravasation and other reactions.. If Severe Side Effects Occur: Seek medical attention promptly; the oncologist managing your care will decide whether to continue, adjust, or stop treatment. Do not stop or change your treatment schedule on your own.. Storage: Handled and stored by healthcare professionals only, refrigerated at 2-8°C (36-46°F), protected from light. Patients do not store this medication at home.
- This page does not provide a dose calculator. Dosing must follow the prescriber, pharmacist, or product label.
Procedures and treatment changes
Tell the treating team before surgery, procedures, or any medicine change. Do not alter treatment without the responsible clinician. (2)
Missed dose
If you miss a scheduled dose, contact your healthcare provider immediately. Do not attempt to make up the dose yourself.
Overdose
Overdose can cause severe bone marrow suppression, heart toxicity, and mucositis. Seek emergency medical attention if overdose is suspected. Supportive care and monitoring in a hospital setting are required. (2)
Side effects
Side effects and their urgency vary; report severe, persistent, or concerning symptoms to a healthcare professional.
Myelosuppression
Incidence: Reported in the clinician-authored database; frequency not established
Nausea and vomiting
Incidence: Reported in the clinician-authored database; frequency not established
Cardiotoxicity
Incidence: Reported in the clinician-authored database; frequency not established
Alopecia
Incidence: Reported in the clinician-authored database; frequency not established
Stomatitis
Incidence: Reported in the clinician-authored database; frequency not established
Diarrhea
Incidence: Reported in the clinician-authored database; frequency not established
Fever
Incidence: Reported in the clinician-authored database; frequency not established
Serious warnings
BOXED WARNING (FDA), three components — serious
Symptoms: BOXED WARNING (FDA), three components: (1) Cardiomyopathy — myocardial damage leading to potentially fatal congestive heart failure can occur. (2) Secondary malignancies — secondary acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) occur at higher incidence in patients treated with anthracyclines like idarubicin. (3) Extravasation — if the drug leaks outside the vein during administration, it can cause local tissue injury and necrosis; the infusion site is monitored closely by the treating team.
Action: Follow the urgency stated and seek prompt or emergency care when indicated. (2)
May cause severe bone marrow suppression — serious
Symptoms: May cause severe bone marrow suppression. Can increase risk of infections. Not recommended during pregnancy; effective contraception is advised during treatment and for 6.5 months after the last dose. Breastfeeding is not recommended during treatment and for 14 days after the last dose.
Action: Follow the urgency stated and seek prompt or emergency care when indicated. (2)
Precautions recorded in the clinician database (the current FDA label does not list a separate formal contraindications section, but treats these as important cautions) — serious
Symptoms: Precautions recorded in the clinician database (the current FDA label does not list a separate formal contraindications section, but treats these as important cautions): hypersensitivity to idarubicin or other anthracyclines, severe hepatic impairment, severe myocardial insufficiency, recent myocardial infarction, uncontrolled infections, or persistent myelosuppression. Use with caution in patients with prior anthracycline exposure, pre-existing cardiac disease, or impaired renal function.
Action: Follow the urgency stated and seek prompt or emergency care when indicated. (2)
Interactions
| Medicine or test | Effect | Action |
|---|---|---|
| Recorded interactions | Idarubicin may interact with other chemotherapy agents, drugs that affect liver enzymes (such as certain antifungals and anticonvulsants), and medications that affect heart function. Always inform your healthcare provider of all medicines and supplements you are taking. | (1) |
| Heparin and other drugs (during infusion) | Idarubicin must not be physically mixed with other drugs or co-infused with heparin — this is a preparation/administration safety rule followed by the healthcare team, not something a patient needs to manage. | (2) |
Pregnancy, breastfeeding, kidney/liver function, age
Pregnancy
Idarubicin can cause fetal harm. Effective contraception is advised for anyone of reproductive potential during treatment and for 6.5 months after the last dose. Anyone who is pregnant or planning pregnancy should discuss this with the treating oncologist before starting or continuing treatment. (2)
Breastfeeding
Breastfeeding is not recommended during idarubicin treatment and for 14 days after the last dose, because of the potential for the drug to pass into breast milk and harm a nursing infant. (2)
Children
Safety and effectiveness in pediatric patients have not been established. Frequency: Not applicable.. Weight Based: Not recommended for pediatric use.. Max Daily Dose: Not established.. Max Single Dose: Not established.. Age Restrictions: If used off-label, children may face a greater risk of cardiotoxicity than adults; dosing must be individualized by a pediatric oncologist. (2)
Renal_impairment
The clinician record advises caution with severe hepatic impairment and impaired renal function, but no validated fixed dose-adjustment table for organ impairment was found in the independent literature reviewed; dosing in organ impairment is individualized by the treating oncologist. (2)
Hepatic_impairment
The clinician record advises caution with severe hepatic impairment and impaired renal function, but no validated fixed dose-adjustment table for organ impairment was found in the independent literature reviewed; dosing in organ impairment is individualized by the treating oncologist. (2)
Monitoring
(2)Storage
Handled and stored by healthcare professionals only, refrigerated at 2-8°C (36-46°F), protected from light. Patients do not store this medication at home.
Professional information
Clinician-facing context only. This section does not replace current product labeling.
General — FDA label (Idamycin PFS)
Indication: Acute myeloid leukemia (AML) in adults
Dose summary: 12 mg/m² IV over 10-15 minutes on days 1, 2, and 3 of the induction cycle, typically combined with cytarabine (100 mg/m² continuous infusion x7 days, or 25 mg/m² bolus then 200 mg/m² continuous infusion x5 days). May repeat if response not achieved after the first cycle. NOTE: this replaces the DB's original 'days 1, 3, and 5' figure, which did not match the FDA label or the DB's own administration-section text.
Renal context: No validated fixed renal-dose-adjustment table found; dosing individualized with close monitoring. (2)
Frequently asked questions
What is idarubicin used for?
Idarubicin is FDA-approved to treat acute myeloid leukemia (AML) in adults, as part of combination chemotherapy. It is occasionally used off-label in other leukemias at an oncologist's discretion, but AML is its only approved use.
How is idarubicin given?
It is given as an intravenous injection or infusion in a hospital or clinic by a healthcare professional.
What are the most common side effects?
Common side effects include nausea, vomiting, diarrhea, mouth sores, hair loss, and low blood counts.
Can idarubicin affect the heart?
Yes, idarubicin can cause serious heart problems, including heart failure. Your doctor will monitor your heart function before and during treatment.
Is it safe during pregnancy or breastfeeding?
No. Idarubicin can cause fetal harm, and effective contraception is advised during treatment and for 6.5 months after the last dose. Breastfeeding is not recommended during treatment and for 14 days after the last dose.
What should I do if I miss a dose?
Contact your healthcare provider right away. Do not try to make up the dose on your own.
Are there any foods or medicines I should avoid?
Avoid live vaccines, and always inform your doctor about any other medicines or supplements you are taking.
What happens if I take too much Idarubicin?
Taking too much Idarubicin can lead to severe and potentially life-threatening side effects, including profound myelosuppression, cardiac toxicity, and gastrointestinal issues. If an overdose is suspected, it is crucial to seek immediate emergency medical attention. Healthcare professionals will provide supportive care and manage symptoms accordingly.
Can I drink alcohol while taking Idarubicin?
It is generally recommended to avoid alcohol consumption while undergoing treatment with Idarubicin. Alcohol can exacerbate certain side effects, particularly liver toxicity and gastrointestinal upset, which are already potential concerns with anthracycline antibiotics. Always consult your healthcare provider for personalized advice regarding alcohol intake during your treatment.
Is Idarubicin safe during pregnancy?
Idarubicin is generally considered unsafe during pregnancy due to its potential to cause harm to the developing fetus. It falls into a pregnancy category that advises against its use unless the potential benefits outweigh the risks. It is imperative to discuss your pregnancy status or plans with your healthcare provider before starting or continuing Idarubicin treatment.
What is the mechanism of action of idarubicin?
Idarubicin is an anthracycline antibiotic that exerts its antineoplastic effects by intercalating into DNA, inhibiting the enzyme topoisomerase II, and generating free radicals. This leads to DNA strand breaks, inhibition of DNA and RNA synthesis, and ultimately cell death, particularly in rapidly dividing malignant cells. (1) (2)
What is the generic name of Idarubicin?
The generic name is idarubicin. It is sold under brand names including Idarubicin Accord, Idamycin, Idarex, Idarubicin Ebewe, Idarubicin Sandoz, Idacin.
What class of drug is idarubicin?
Idarubicin is classed as: Cancer & Oncology.
References
- Idarubicin — Medicine RecordMedGuideGlobal clinician-authored medicine record · United States · accessed 2026-08-06 · source 1
- IDAMYCIN PFS (idarubicin hydrochloride injection) prescribing informationU.S. Food and Drug Administration (DailyMed) · United States · accessed 2026-08-06 · source 2
- Idarubicin Injection — patient drug information (MedlinePlus)U.S. National Library of Medicine (MedlinePlus) · US · accessed 2026-08-14 · source 3
- Idamycin PFS — FDA approval record (Drugs@FDA NDA050734)U.S. Food and Drug Administration · US · accessed 2026-08-14 · source 4
- idarubicin — RxNorm normalized drug concept (RXCUI 5650)U.S. National Library of Medicine (RxNorm) · US · accessed 2026-08-14 · source 5
Brand names by country
Single-ingredient idarubicin names are shown separately by country. Product availability, strengths, and supply rules can change; combination products are not included here.
Priority countries
United States
- Idamycin PFS1 mg/mL · pfizer laboratories div pfizer inc
Canada
- IDAMYCIN PFS