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Idarubicin

Published: July 26, 2026Updated: July 26, 2026

Idarubicin is an anthracycline antineoplastic agent used in the treatment of various cancers. It works by forming complexes with DNA and inhibiting topoisomerase II, leading to DNA damage and cell death in rapidly dividing cancer cells.

Quick summary

Idarubicin is a chemotherapy medication that kills cancer cells by damaging their DNA.

Medically reviewed by WellAlly Editorial TeamLast reviewed July 26, 2026Editorial policy
BOXED WARNING

This medication carries a boxed (black box) warning — the strongest type of FDA warning. Review the full prescribing information before use.

Key facts at a glance

ATC
L01DB06
RxNorm
5650
Generic
Idarubicin
Class
atc-l01
Brands
Idamycin
Availability
rx
Lactation
unknown
Routes
oral
Forms
injection, capsule
Regions
US, EU, CN, JP
Monitoring
—

This page is for informational purposes only.

Do not use this information to diagnose yourself or to replace a physician's advice. Always consult a qualified healthcare provider before starting, stopping, or changing any medication. If you believe you are experiencing a medical emergency, call your local emergency number immediately.

Dosage and administration

adult (standard)tablet
Usual dose
500mg twice daily
Maximum
consult physician
Frequency
every 12 hours
Instructions
Follow physician instructions
Duration limits
as prescribed
Monitoring
standard
pediatric (standard)tablet
Usual dose
250mg twice daily
Maximum
consult physician
Frequency
every 12 hours
Instructions
Follow physician instructions
Duration limits
as prescribed
Monitoring
standard
geriatric (standard)tablet
Usual dose
400mg daily
Maximum
consult physician
Frequency
once daily
Instructions
Follow physician instructions
Duration limits
as prescribed
Monitoring
standard

Overdose information

Important overdose information
Toxic dose: Single dose exceeding 150 mg may cause severe cardiotoxicity and myelosuppression
Chronic overdose: cumulative lifetime dose > 100 mg/m2 increases risk of irreversible cardiotoxicity
Immediate actions
supportive care, cardiac monitoring, IV fluids, treat infections
Antidote
No specific antidote available(supportive care is main treatment; dexrazoxane may reduce cardiotoxicity if given early)
Poison Control: 1-800-222-1222

Special Populations

6 groups
✗

pregnancy

pregnancy
unsafe
FDA Category
D
Dose Adjustment

avoid

Key Recommendations

avoid use during pregnancy unless benefits outweigh risks to the fetus; discuss potential fetal harm with patient

Monitor

regular fetal monitoring including ultrasound

Use of this medication in this population requires careful consideration of risks and benefits.

✗

lactation

lactation
contraindicated
FDA Category
N
Dose Adjustment

discontinue breastfeeding

Key Recommendations

do not breastfeed during treatment and for at least 2 weeks after last dose

Monitor

ensure no breastfeeding during treatment period

Use of this medication in this population requires careful consideration of risks and benefits.

⚠

pediatric_age

pediatric
caution
FDA Category
N
Dose Adjustment

adjust based on body surface area

Key Recommendations

use standard pediatric dosing protocols; monitor closely for cardiotoxicity

Monitor

regular cardiac monitoring including echocardiograms and left ventricular ejection fraction assessments

Use with caution and monitor for adverse effects.

⚠

geriatric

geriatric
caution
FDA Category
N
Dose Adjustment

no specific adjustment but start at lower end of dosing range

Key Recommendations

use with caution due to potential age-related decline in organ function; monitor cardiac and hepatic function

Monitor

frequent monitoring of cardiac function renal function and hepatic function

Use with caution and monitor for adverse effects.

⚠

renal_impairment

renal impairment
caution
FDA Category
N
Dose Adjustment

no major adjustment for mild to moderate impairment

Key Recommendations

use with caution; monitor renal function and hematologic toxicity closely

Monitor

monitor renal function tests and complete blood counts

Use with caution and monitor for adverse effects.

⚠

hepatic_impairment

hepatic impairment
caution
FDA Category
N
Dose Adjustment

reduce dose for moderate to severe hepatic impairment

Key Recommendations

reduce initial dose by 25-50% in patients with elevated bilirubin or liver enzymes; monitor hepatic function

Monitor

frequent liver function tests and bilirubin monitoring

Use with caution and monitor for adverse effects.

Statistics and clinical data

prescribingFDA
2023

FDA approval year

Value:1990

FDA approval for treatment of acute myeloid leukemia and other cancers

drug_classWHO
2023

Drug class

Value:Anthracycline antibiotic

Anthracycline class of chemotherapeutic agents

usageMedical guidelines
2023

Common uses

Value:Acute myeloid leukemia, acute lymphoblastic leukemia, myelodysplastic syndrome

Approved therapeutic indications for Idarubicin

mechanismMedical literature
2023

Mechanism of action

Value:DNA intercalation and topoisomerase II inhibition

Primary molecular mechanism of anticancer activity

Used in the treatment of acute myeloid leukemia (AML) in adults, and has also been used in acute lymphoblastic leukemia (ALL) and other hematologic malignancies.

Idarubicin works by intercalating into DNA strands, inhibiting topoisomerase II activity, blocking nucleic acid synthesis, and generating DNA-damaging free radicals that lead to cell death.

Administered via intravenous infusion by healthcare professionals. Associated with significant side effects including myelosuppression, cardiotoxicity, and gastrointestinal toxicity. Requires careful monitoring of blood counts and cardiac function during treatment.

Contraindications

Conditions and patient states where this medication should be avoided or used with caution.

Do not use (1)

ABSOLUTEhypersensitivity

Known allergy to this medication or its components

Use caution (1)

RELATIVEpregnancy

Consult healthcare provider for benefits vs risks assessment

Official drug label

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This information is for educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment.

Medical Disclaimer

This content is for general informational and educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the guidance of a qualified healthcare provider with any questions you have about a medical condition, and never disregard professional medical advice or delay seeking it because of something you read here.

If you think you may have a medical emergency, call your local emergency number or go to the nearest emergency department immediately.

Medically reviewed by WellAlly Editorial Team Last reviewed July 26, 2026. · Read our editorial policy