Idarubicin hydrochloride

What Idarubicin hydrochloride is used for

Quoted from the “Indications and Usage” section of the FDA-approved label.

Idarubicin Hydrochloride Injection in combination with other approved antileukemic drugs is indicated for the treatment of acute myeloid leukemia (AML) in adults. This includes French-American-British (FAB) classifications M1 through M7.

— FDA label: Idarubicin Hydrochloride, Meitheal Pharmaceuticals Inc., effective May 9, 2025. Read the full label on DailyMed →

Label quoted: the one for the most common form (injection, solution, intravenous), Idarubicin Hydrochloride, Meitheal Pharmaceuticals Inc.; it covers 3 products in the FDA NDC Directory. The side effects, interactions, dosage and pregnancy quotes below come from this same label.

The FDA has 4 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.

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Conditions named on the label

These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.

Related medical specialties

Boxed warning

A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.

This label has a boxed warning. Read it on the full label →

4 of 4 FDA labels for this medicine have a boxed warning.

Idarubicin hydrochloride boxed warning: what the label says

Quoted from the boxed warning of the FDA-approved label.

WARNINGS 1. Idarubicin Hydrochloride Injection should be given slowly into a freely flowing intravenous infusion. It must never be given intramuscularly or subcutaneously. Severe local tissue necrosis can occur if there is extravasation during administration. 2. As is the case with other anthracyclines the use of Idarubicin Hydrochloride Injection can cause myocardial toxicity leading to congestive heart failure.

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Cardiac toxicity is more common in patients who have received prior anthracyclines or who have pre-existing cardiac disease. 3. As is usual with antileukemic agents, severe myelosuppression occurs when Idarubicin Hydrochloride Injection is used at effective therapeutic doses. 4. It is recommended that Idarubicin Hydrochloride Injection be administered only under the supervision of a physician who is experienced in leukemia chemotherapy and in facilities with laboratory and supportive resources adequate to monitor drug tolerance and protect and maintain a patient compromised by drug toxicity. The physician and institution must be capable of responding rapidly and completely to severe hemorrhagic conditions and/or overwhelming infection. 5. Dosage should be reduced in patients with impaired hepatic or renal function (see DOSAGE AND ADMINISTRATION).

— FDA label: Idarubicin Hydrochloride, Meitheal Pharmaceuticals Inc., effective May 9, 2025. Read the full label on DailyMed →

Idarubicin hydrochloride side effects

Quoted from the “Adverse Reactions” section of the FDA-approved label. Tell your doctor about any side effect that worries you.

Approximately 550 patients with AML have received idarubicin in combination with cytarabine in controlled clinical trials worldwide. In addition, over 550 patients with acute leukemia have been treated in uncontrolled trials utilizing idarubicin as a single agent or in combination. The table below lists the adverse experiences reported in U.S. Study 2 (see CLINICAL STUDIES) and is representative of the experiences in other studies.

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These adverse experiences constitute all reported or observed experiences, including those not considered to be drug related. Patients undergoing induction therapy for AML are seriously ill due to their disease, are receiving multiple transfusions, and concomitant medications including potentially toxic antibiotics and antifungal agents. The contribution of the study drug to the adverse experience profile is difficult to establish. Induction Phase Percentage of Patients Adverse Experiences IDR (N=110) DNR (N=118) Infection 95% 97% Nausea & Vomiting 82% 80% Hair Loss 77% 72% Abdominal Cramps/Diarrhea 73% 68% Hemorrhage 63% 65% Mucositis 50% 55% Dermatologic 46% 40% Mental Status 41% 34% Pulmonary-Clinical 39% 39% Fever (not elsewhere classified) 26% 28% Headache 20% 24% Cardiac-Clinical 16% 24% Neurologic-Peripheral Nerves 7% 9% Pulmonary Allergy 2% 4% Seizure 4% 5% Cerebellar 4% 4% Abbreviations: IDR=Idarubicin; DNR=Daunorubicin The duration of aplasia and incidence of mucositis were greater on the IDR arm than the DNR arm, especially during consolidation in some U.S. controlled trials (see CLINICAL STUDIES). The following information reflects experience based on U.S. controlled clinical trials. Myelosuppression Severe myelosuppression is the major toxicity associated with idarubicin therapy, but this effect of the drug is required in order to eradicate the leukemic clone. During the period of myelosuppression, patients are at risk of developing infection and bleeding which may be life-threatening or fatal. Gastrointestinal Nausea and/or vomiting, mucositis, abdominal pain and diarrhea were reported frequently, but were severe (equivalent to WHO Grade 4) in less than 5% of patients. Severe enterocolitis with perforation has been reported rarely. The risk of perforation may be increased by instrumental intervention. The possibility of perforation should be considered in patients who develop severe abdominal pain and appropriate steps for diagnosis and management should be taken. Dermatologic Alopecia was reported frequently and dermatologic reactions including generalized rash, urticaria and a bullous erythrodermatous rash of the palms and soles have occurred. The dermatologic reactions were usually attributed to concomitant antibiotic therapy. Local reactions including hives at the injection site have been reported. Recall of skin reaction due to prior radiotherapy has occurred with idarubicin administration. Hepatic and Renal Changes in hepatic and renal function tests have been observed. These changes were usually transient and occurred in the setting of sepsis and while patients were receiving potentially hepatotoxic and nephrotoxic antibiotics and antifungal agents.

— FDA label: Idarubicin Hydrochloride, Meitheal Pharmaceuticals Inc., effective May 9, 2025. This is part of the section. Read the full label on DailyMed →

Idarubicin hydrochloride dosage

Quoted from the “Dosage and Administration” section of the FDA-approved label. Your own dose is the one your doctor prescribes: do not change it on your own.

(See WARNINGS) For induction therapy in adult patients with AML the following dose schedule is recommended: Idarubicin Hydrochloride Injection 12 mg/m 2 daily for 3 days by slow (10 to 15 min) intravenous injection in combination with cytarabine. The cytarabine may be given as 100 mg/m 2 daily by continuous infusion for 7 days or as cytarabine 25 mg/m 2 intravenous bolus followed by cytarabine 200 mg/m 2 daily for 5 days continuous infusion.

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In patients with unequivocal evidence of leukemia after the first induction course, a second course may be administered. Administration of the second course should be delayed in patients who experience severe mucositis, until recovery from this toxicity has occurred, and a dose reduction of 25% is recommended. In patients with hepatic and/or renal impairment, a dose reduction of Idarubicin Hydrochloride Injection should be considered. Idarubicin Hydrochloride Injection should not be administered if the bilirubin level exceeds 5 mg% (see WARNINGS). The benefit of consolidation in prolonging the duration of remissions and survival is not proven. There is no consensus regarding optional regimens to be used for consolidation (see CLINICAL STUDIES for doses used in U.S. Clinical studies). Preparation and Administration Precautions Caution in handling the solution must be exercised as skin reactions associated with Idarubicin Hydrochloride Injection may occur. Skin accidentally exposed to Idarubicin Hydrochloride Injection should be washed thoroughly with soap and water and if the eyes are involved, standard irrigation techniques should be used immediately. The use of goggles, gloves, and protective gowns is recommended during preparation and administration of the drug. Care in the administration of Idarubicin Hydrochloride Injection will reduce the chance of perivenous infiltration. It may also decrease the chance of local reactions such as urticaria and erythematous streaking. During intravenous administration of Idarubicin Hydrochloride Injection extravasation may occur with or without an accompanying stinging or burning sensation even if blood returns well on aspiration of the infusion needle. If any signs or symptoms of extravasation have occurred, the injection or infusion should be immediately terminated and restarted in another vein. If it is known or suspected that subcutaneous extravasation has occurred, it is recommended that intermittent ice packs (1/2 hour immediately, then 1/2 hour 4 times per day for 3 days) be placed over the area of extravasation and that the affected extremity be elevated. Because of the progressive nature of extravasation reactions, the area of injection should be frequently examined and plastic surgery consultation obtained early if there is any sign of a local reaction such as pain, erythema, edema or vesication. If ulceration begins or there is severe persistent pain at the site of extravasation, early wide excision of the involved area should be considered. Idarubicin Hydrochloride Injection should be administered slowly (over 10 to 15 minutes) into the tubing of a freely running intravenous infusion of Sodium Chloride Injection, USP (0.9%) or 5% Dextrose Injection, USP.

— FDA label: Idarubicin Hydrochloride, Meitheal Pharmaceuticals Inc., effective May 9, 2025. This is part of the section. Read the full label on DailyMed →

Idarubicin hydrochloride and breastfeeding

Quoted from the nursing mothers / lactation part of the FDA-approved label.

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from idarubicin, mothers should discontinue nursing prior to taking this drug and do not breastfeed during treatment and for 14 days after last dose.

— FDA label: Idarubicin Hydrochloride, Meitheal Pharmaceuticals Inc., effective May 9, 2025. Read the full label on DailyMed →

Idarubicin hydrochloride overdose

Quoted from the “Overdosage” section of the FDA-approved label. If someone may have taken too much, call Poison Help at 1-800-222-1222 (or 911 in an emergency).

There is no known antidote to idarubicin. Two cases of fatal overdosage in patients receiving therapy for AML have been reported. The doses were 135 mg/m 2 over 3 days and 45 mg/m 2 of idarubicin and 90 mg/m 2 of daunorubicin over a three day period. It is anticipated that overdosage with idarubicin will result in severe and prolonged myelosuppression and possibly in increased severity of gastrointestinal toxicity.

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Adequate supportive care including platelet transfusions, antibiotics and symptomatic treatment of mucositis is required. The effect of acute overdose on cardiac function is not fully known, but severe arrhythmia occurred in 1 of the 2 patients exposed. It is anticipated that very high doses of idarubicin may cause acute cardiac toxicity and may be associated with a higher incidence of delayed cardiac failure. Disposition studies with idarubicin in patients undergoing dialysis have not been carried out. The profound multicompartment behavior, extensive extravascular distribution and tissue binding, coupled with the low unbound fraction available in the plasma pool make it unlikely that therapeutic efficacy or toxicity would be altered by conventional peritoneal or hemodialysis.

— FDA label: Idarubicin Hydrochloride, Meitheal Pharmaceuticals Inc., effective May 9, 2025. Read the full label on DailyMed →

Forms and how it is given

Companies that list this medicine

Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.

• Hikma Pharmaceuticals USA Inc.6 products
• Meitheal Pharmaceuticals Inc.3 products
• Pfizer Laboratories Div Pfizer Inc3 products

FDA approval history

• NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
• ANDA: Abbreviated New Drug Application: how a generic version is approved.

Generic approvals (2)

• ANDA065036Meitheal · May 1, 2002
• ANDA065275Hikma · December 14, 2006

Shortage status

The FDA drug shortage list does not show these products.

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Recalls

No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.

Official identifiers

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Sources

1. FDA-approved label on DailyMed (National Library of Medicine) — Idarubicin Hydrochloride, Meitheal Pharmaceuticals Inc., effective May 9, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
2. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
3. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
4. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
5. Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026

openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →

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