Idarubicin: uses, dosing, side effects & brands
Idarubicin is an anthracycline topoisomerase inhibitor sold in the U.S. under 3 brand and generic names, for breast neoplasms, bcr-abl positive chronic myelogenous leukemia and acute myeloid leukemia. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Drug class
- Anthracycline Topoisomerase Inhibitor
- Treats (across its forms)
- Breast Neoplasms, Bcr-Abl Positive Chronic Myelogenous Leukemia and Acute Myeloid Leukemia
- Available as
- Injectable · Powder · Solution
- Sold as
- 3 products — Idarubicin Hydrochloride, Idamycin and Idamycin Pfs
- Prescription?
- Prescription only
- Generic available?
- Yes
- Boxed warning
- Boxed warning
How Idamycin Pfs is dosed
From the FDA label for Idamycin Pfs (application NDA050734). Other idarubicin products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Induction Therapy • 12 mg/m 2 intravenously over 10 to 15 minutes on days 1, 2, and 3 of induction in combination with cytarabine 100 mg/m 2 by continuous intravenous infusion daily for 7 days or cytarabine 25 mg/m 2 intravenous bolus followed by cytarabine 200 mg/m 2 continuous intravenous infusion daily for 5 days. (2.1) • IDAMYCIN PFS can be given as part of a combination regimen with other chemotherapeutic drugs. (2.1) • Renal Impairment: Assess renal function prior to therapy. Reduce dosage in renal impairment. ( 2.3 , 8.6 ) • Hepatic Impairment: Assess hepatic function prior to therapy. Avoid or reduce dosage in hepatic impairment. ( 2.4 , 8.7 ) See full prescribing information for preparation and administration instructions. (2.5 , 2.6) 2.1 Recommended Dosage Administer IDAMYCIN PFS 12 mg/m 2 intravenously over 10 to 15 minutes on days 1, 2, and 3 of induction in combination with cytarabine. The cytarabine may be given as 100 mg/m 2 by continuous intravenous infusion daily for 7 days or as cytarabine 25 mg/m 2 intravenous bolus followed by cytarabine 200 mg/m 2 continuous intravenous infusion daily for 5 days. If a response is not achieved with the first induction cycle, a second induction cycle may be administered. Other dosage regimens may be used for a second induction cycle. Individualize the dose and dosing schedule of IDAMYCIN PFS based on the specific regimen…
Everything below is the FDA label for Idamycin Pfs (solution). Idarubicin is also sold as injectable and powder, and those are different medicines to take — follow the label for the one you were prescribed.
Idamycin Pfs side effects
The following clinically significant adverse reactions are described elsewhere in the labeling: • Cardiomyopathy [see Warnings and Precautions (5.1) ] • Secondary Malignancies [see Warnings and Precautions (5.2) ] • Severe Local Tissue Necrosis with Extravasation [see Warnings and Precautions (5.3) ] • Severe Myelosuppression [see Warnings and Precautions (5.4) ] • Tumor Lysis Syndrome [see Warnings and Precautions (5.5) ] • Hypersensitivity [see Warnings and Precautions (5.6) ] Most common adverse reactions (≥30%) are infection, nausea/vomiting, alopecia, abdominal pain/diarrhea, hemorrhage, mucositis, dermatologic, mental status changes, and pulmonary disorders. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Pfizer at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials and Postmarketing Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of IDAMYCIN PFS in combination with cytarabine has been evaluated in four controlled clinical studies with 823 patients with AML randomized to receive idarubicin hydrochloride (n=401) or daunorubicin (n=422) [see Clinical Studies (14) ] . Southeastern Cancer Study Group…
Who shouldn’t take Idamycin Pfs
None. None. (4)
Every idarubicin product we track (3)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Pharmacy pays | |
|---|---|---|---|---|---|---|---|
| 1 | 72/100 | Prescription | Injectable | No data | — | View → | |
| 2 | 64/100 | Prescription | Powder | No data | — | View → | |
| 3 | 64/100 | Prescription | Solution | No data | — | View → |
How long idarubicin keeps
No idarubicin label we read sets a separate limit for after opening, but they do specify how it must be stored — and the stability behind any date assumes those conditions.
Does idarubicin expire? The in-use limits and storage rules from its labelsWhat people report to the FDA about idarubicin
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 1,279 reports naming idarubicin, and the FDA flagged 99% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:
- febrile neutropenia193 reports
- myelosuppression180 reports
- pyrexia102 reports
- pneumonia76 reports
- neutropenia60 reports
- white blood cell count decreased59 reports
- infection55 reports
- platelet count decreased50 reports
Read these as a signal, not a rate. A report does not mean idarubicin caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label section above.
Source: openFDA drug/event (FAERS), retrieved August 25, 2026.
Related calculators
Frequently asked questions
What is Idamycin Pfs?
Idamycin Pfs (Idarubicin Hydrochloride) is an anthracycline topoisomerase inhibitor used to treat Breast Neoplasms, Bcr-Abl Positive Chronic Myelogenous Leukemia, Acute Myeloid Leukemia, Precursor Cell Lymphoblastic Leukemia-Lymphoma.
What kind of drug is idarubicin?
The FDA classifies idarubicin as an anthracycline topoisomerase inhibitor. These chemotherapy drugs slip between the strands of a cancer cell's DNA and jam an enzyme called topoisomerase II that the cell needs to copy its DNA. This leaves the DNA broken and unrepairable, so the cancer cell stops dividing and dies. If you are checking whether it is safe to combine with something else, the class is what matters — two drugs from the same class usually should not be stacked.
Can you take idarubicin with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run idarubicin against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What brand names is idarubicin sold under?
We track 3 idarubicin-containing products in the U.S.: Idarubicin Hydrochloride, Idamycin and Idamycin Pfs. They are the same active ingredient; they differ in form, manufacturer, price and FDA recall record.
What forms does idarubicin come in?
Across the brands we track, idarubicin is currently marketed as injectable, powder and solution, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic idarubicin?
Yes. Our catalog lists 1 generic idarubicin product alongside the brand versions. A generic has the same active ingredient and must meet the FDA's bioequivalence standard; it usually costs less. Ask your pharmacist which one your plan covers.
Cite this page
- APA
- pharmaranks. (2026, July 24). Idarubicin: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/idarubicin
- MLA
- “Idarubicin: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/idarubicin.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Read the full FDA label for idarubicin on DailyMed (NIH) ↗ — including its boxed warning in full.