Idarubicin
Idarubicin is a chemotherapy drug used to treat acute myeloid leukemia (AML) in adults, given intravenously as part of a combination regimen.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 4 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾
Idarubicin (Idamycin PFS) carries three serious boxed warnings — the FDA's highest level of alert:
- Heart damage (cardiomyopathy): This drug can damage the heart muscle, including causing acute left ventricular failure (the heart's main pumping chamber failing). The risk is higher in people who have received anthracycline chemotherapy before or who already have heart disease. Heart function must be evaluated before, during, and after treatment.
- Secondary cancers: Patients treated with idarubicin have a higher risk of later developing a new, treatment-related leukemia (AML) or a pre-leukemic blood disorder called myelodysplastic syndrome (MDS).
- Tissue destruction if the IV leaks (extravasation): If idarubicin leaks out of the vein during infusion, it can cause severe local tissue injury and even tissue death (necrosis). If leakage occurs, the infusion must be stopped immediately and treated right away.
📖 Idarubicin: Patient Information Guide
A plain-language walkthrough of Idarubicin — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.
🎯What it's used for▾
Idarubicin is a chemotherapy drug approved for treating acute myeloid leukemia (AML) in adults. It is always used as part of a combination regimen with other anti-leukemia medicines.
- Idamycin PFS (intravenous solution): Indicated for adult patients with AML as a component of combination chemotherapy
- Idarubicin Hydrochloride injection: Indicated for AML in adults, including French-American-British (FAB) subtypes M1 through M7, in combination with other approved antileukemic drugs
⚙️How it works▾
Idarubicin is an anthracycline — a class of chemotherapy drugs that attack cancer cells in two key ways. First, it inserts itself into the DNA double helix (a process called DNA intercalation), physically jamming the genetic machinery. Second, it blocks an enzyme called topoisomerase II that cancer cells rely on to unwind, copy, and repair their DNA. Without this enzyme, cancer cells can't divide and they die.
Idarubicin's chemical structure — specifically the absence of a methoxy group compared to related drugs — makes it highly lipophilic (fat-soluble), meaning it penetrates cell membranes more readily and reaches high concentrations inside cancer cells faster than other anthracyclines. Inside the body, it is converted to an active metabolite called idarubicinol, which also has cancer-killing activity and stays in the body for a prolonged period.
💊How it's taken▾
Idarubicin is given only intravenously (through a vein) by a healthcare professional — it is not available in an oral form. It is infused slowly over 10 to 15 minutes, typically on set days of an induction cycle, as part of a combination regimen. Your oncology team will determine the exact schedule based on your disease, response to treatment, and kidney and liver function.
- Idamycin PFS is administered over 10–15 minutes into the tubing of a running IV line; it should not be mixed with other drugs or further diluted before use
- Idarubicin Hydrochloride injection is similarly infused slowly into the tubing of a running IV line of normal saline or dextrose solution
- Doses may be reduced or delayed if you develop serious side effects such as heart problems, severe bone marrow suppression, or severe mouth sores
- Kidney or liver problems also require dose adjustments — always keep your care team updated on your full medical history
🤒Side effects — in detail▾
Because idarubicin is a powerful chemotherapy agent, side effects are common and expected. Most are managed by your care team.
- Nausea and vomiting
- Hair loss (alopecia)
- Mouth sores (mucositis)
- Diarrhea or abdominal cramps
- Skin rash, hives, or redness — including at the injection site
- Fever
- Headache
- Bleeding or bruising due to low platelet counts
- Infections due to suppressed immune function
Serious reactions requiring prompt medical attention include signs of heart damage (chest pain, irregular heartbeat, shortness of breath), severe abdominal pain (which may signal a bowel complication), and any pain, swelling, or skin changes at the IV site that could mean the drug has leaked into surrounding tissue.
⚠️Warnings & precautions▾
- Heart damage (cardiomyopathy): Idarubicin can injure heart muscle, sometimes causing heart failure or dangerous arrhythmias. Heart function must be assessed before, during, and after treatment. Risk is highest in those with pre-existing heart disease or prior anthracycline use.
- Severe bone marrow suppression (myelosuppression): This drug will severely reduce the production of blood cells in everyone who takes a therapeutic dose. This is necessary to fight the leukemia, but it also puts patients at serious risk of life-threatening infections and bleeding. Blood counts must be monitored closely throughout treatment.
- Secondary cancers: Treatment with anthracyclines like idarubicin is associated with a higher risk of later developing a new leukemia (AML) or a blood disorder called myelodysplastic syndrome (MDS).
- IV leakage (extravasation): If the drug leaks out of the vein during infusion, it can destroy surrounding tissue. The infusion must be stopped immediately if this happens.
- Tumor lysis syndrome: As cancer cells are rapidly destroyed, they can release substances into the bloodstream that damage the kidneys and other organs. Blood chemistries are monitored during treatment.
- Pregnancy: This drug can cause serious fetal harm. Effective contraception is required during and for months after treatment for both men and women.
🔀What it interacts with▾
Idarubicin has important interactions with several drugs and treatments that can increase the risk of serious side effects:
- Cardiotoxic drugs (e.g., trastuzumab, cyclophosphamide, paclitaxel): Combining these with idarubicin raises the risk of heart damage significantly — idarubicin should be avoided until at least 5 half-lives after stopping the other drug, and specifically up to 7 months after stopping trastuzumab
- Heparin: Causes a physical precipitation (clumping) reaction when mixed with idarubicin — these must never be combined in the same IV line
- Alkaline IV solutions: Prolonged contact with alkaline-pH solutions will chemically break down (degrade) idarubicin — care is taken during preparation to avoid this
- Prior chest radiation: Previous radiation to the chest area increases the risk of heart toxicity when idarubicin is added
- Potentially hepatotoxic or nephrotoxic drugs: Because idarubicin is processed by the liver and kidneys, drugs that also stress these organs may affect how idarubicin is cleared and increase toxicity
This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.
📋Before taking it▾
- Heart disease or prior anthracycline chemotherapy: These significantly increase the risk of heart damage — your doctor will weigh the risks and benefits carefully and monitor heart function closely
- Liver impairment: The drug is processed primarily through the liver; doses must be reduced in moderate impairment, and the drug should be avoided if bilirubin levels are too high
- Kidney impairment: Kidney function should be checked before and during treatment; dose reductions are needed for significant kidney impairment or patients on dialysis
- Pregnancy: Idarubicin can cause fetal harm, including birth defects and embryo death; it should be used during pregnancy only if the benefit clearly outweighs the risk
- Breastfeeding: Do not breastfeed during treatment or for 14 days after the last dose — the drug may cause serious harm (including bone marrow suppression, heart toxicity, and cancer risk) in a nursing infant
- Fertility: Idarubicin may impair fertility in both men and women; discuss fertility preservation with your doctor before starting treatment
- Children (pediatric patients): Safety and effectiveness have not been established in pediatric patients; children may face a higher risk of heart-related toxicity
- Pre-existing bone marrow suppression: Idarubicin should not be given to patients who already have bone marrow suppression from prior drug treatment or radiation unless the benefit clearly outweighs the risk
🚑If you take too much▾
There is no known antidote to idarubicin. Overdose is expected to cause severe and prolonged bone marrow suppression — dramatically raising the risk of serious infection and bleeding — and may worsen stomach and intestinal side effects. Very high doses may also cause serious heart toxicity including dangerous arrhythmias and delayed heart failure. Treatment of overdose focuses on supportive care: managing infections with antibiotics, platelet transfusions for bleeding, and treating mouth sores as needed.
📡Pharmacodynamics — effects in the body▾
Idarubicin's exposure-response relationship — meaning the precise link between drug levels in the blood and its effects on the body — has not been fully defined. What is known is that it kills cancer cells by disrupting DNA synthesis and blocking topoisomerase II. Because its effects on cancer cells and on normal blood cell production are both powerful, all patients receiving therapeutic doses will experience significant bone marrow suppression.
🔬Pharmacokinetics — how your body processes it▾
After intravenous infusion, idarubicin distributes very rapidly and widely throughout the body, reaching very high concentrations inside blood and bone marrow cells — more than 100 times the levels found in the blood plasma. The drug has a relatively long half-life averaging about 22 hours, and its main active breakdown product, idarubicinol, stays in the body even longer — with levels sustained for more than 8 days. Idarubicin and idarubicinol are both highly bound to proteins in the blood (around 97% and 94%, respectively). The drug is cleared primarily through bile (via the liver) and to a lesser extent through the kidneys, mostly as idarubicinol; liver or kidney impairment can slow this process and lead to higher drug levels in the body.
📦How to store it▾
Store refrigerated at 2ºC to 8ºC (36ºF to 46ºF). Store and dispense in the original carton until time of use to protect from light.
📄 Written from Idarubicin’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →
Supplements & herbs that interact with Idarubicin
24 supplements and herbal products have documented interactions with Idarubicin in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 1
- Moderate · 14
- Minor · 9
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
🩺 Pharmacist Counseling Corner
Quick, plain-English answers to the questions patients ask most about Idarubicin — the kind of thing our pharmacy team would talk through with you at the counter.
What exactly is idarubicin being used to treat? ▾
How will I receive this medication? Will I have to take pills at home? ▾
What side effects should I expect, and which ones mean I need to call my doctor right away? ▾
I've heard this drug can affect the heart. Should I be worried? ▾
Can I get pregnant or father a child while on this drug? ▾
Are there any drugs or treatments I need to tell my doctor about before starting? ▾
Is Idarubicin available over the counter? ▾
When was Idarubicin first available? ▾
Who makes Idarubicin? ▾
💬 Answers drafted from Idarubicin’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →
🧰 Keep exploring
💊 How Idarubicin comes
Idarubicin is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Injection
How this form is used
- Idamycin PFS (intravenous) is indicated to treat acute myeloid leukemia (AML) in adults as part of a combination chemotherapy regimen
- Idarubicin Hydrochloride injection is indicated for AML in adults (FAB classifications M1–M7) in combination with other approved antileukemic drugs
- Idamycin PFS is given by slow intravenous infusion over 10 to 15 minutes into the tubing of a freely running IV line of normal saline or 5% dextrose; do not further dilute before administration
- Idamycin PFS must not be mixed with other drugs or with heparin; avoid contact with alkaline solutions
- Idarubicin Hydrochloride injection is administered slowly (over 10 to 15 minutes) into the tubing of a freely running IV line of 0.9% sodium chloride or 5% dextrose
- For both products: monitor the IV site closely during infusion and stop the infusion immediately if any sign of leakage (extravasation) occurs
📊 Idarubicin across the U.S. market
How Idarubicin appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
Also listed with the FDA, not a patient dose form: Powder (3) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
🔍 Compare Idarubicin products
A representative set of FDA-listed product records for Idarubicin — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Injection | ||||
| 1 mg/mL | Intravenous | Hikma Pharmaceuticals USA Inc. × 12 listings | ANDA | View NDC → |
| 1 mg/mL | Intravenous | Meitheal Pharmaceuticals Inc. × 3 listings | ANDA | View NDC → |
| 1 mg/mL | Intravenous | Pfizer Laboratories Div Pfizer Inc × 9 listings | NDA | View NDC → |
| 1 mg/mL | Intravenous | Teva Parenteral Medicines, Inc. × 4 listings | ANDA | View NDC → |
| 💊Bulk drug substance | ||||
| 1 g/g | — | Gemini PharmChem Mannheim GmbH | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Olon S.p.A. | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Sicor S.r.l. | BULK INGREDIENT | View NDC → |
Showing 31 of 31 products — FDA National Drug Code Directory. See every product, package size and price: browse all 31 Idarubicin NDCs →
📈 What people report — real-world data (FDA FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Idarubicin — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Idarubicin in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
🏛️ The road to your pharmacy
How Idarubicin went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
🚨 Recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
Source: openFDA drug enforcement (recall) reports.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 5650 2 dose forms · 6 strengths
-
Dose form (SCDF) Injection RxCUI 1791492In current FDA listingsClinical drug / strength (SCD) 5 ML idarubicin hydrochloride 1 MG/MLRxCUI 179150010 ML idarubicin hydrochloride 1 MG/MLRxCUI 179149820 ML idarubicin hydrochloride 1 MG/MLRxCUI 1791493 -
Dose form (SCDF) Oral Capsule RxCUI 372458No current FDA listingClinical drug / strength (SCD) hydrochloride 10 MGRxCUI 996156hydrochloride 25 MGRxCUI 996158hydrochloride 5 MGRxCUI 996160
Look up RxCUI 5650 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
📦 Supply & shortage status
Whether Idarubicin is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
🏷️ Sold under these brand names
🏭 Manufacturers & labelers
RxNorm drug class
Idarubicin belongs to the Anthracycline Topoisomerase Inhibitor class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
🔬 Where this comes from
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How we combine label and product data
HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 4 FDA-filed SPL label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.
For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Pfizer Laboratories Div Pfizer Inc is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.
This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.