Prescription medicine
Idarubicin Brand names: Idamycin
Idarubicin (Idamycin) is a prescription medicine with an FDA approval on record since 1990. FDA's NDC Directory lists it from 2 generic labelers.
- Generic listed
- Boxed warning
Check it at the source: the idarubicin FDA label on DailyMed (effective May 9, 2025, Meitheal Pharmaceuticals Inc.); the NDA 50661 record on Drugs@FDA; every idarubicin label on DailyMed.
Highlights of the record
FDA label of May 9, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
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. 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 ).
Used for
From the label: indications and usageIdarubicin Hydrochloride Injection in combination with other approved antileukemic drugs is indicated for the treatment of acute myeloid leukemia (AML) in adults.
Forms and strengths
- 1 mg/ml
Injection (solution); solution.
On the market
- Earliest approval on file
- September 27, 1990 Idamycin, Pfizer; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 7 first May 1, 2002; 3 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 3 of which 2 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 1 since 2021 0 Class I among all firms' recalls; latest July 29, 2021
- FAERS reports
- 1,119 through July 30, 2026
What is idarubicin used for?
From the label: indications and usageIdarubicin 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.
Conditions named in the indications of idarubicin's FDA labels, with every medicine labeled for each:
From other idarubicin labelsLeukemia, lymphoma and myeloma: INDICATIONS AND USAGE Idarubicin Hydrochloride Injection in combination with other approved antileukemic drugs is indicated for the treatment of acute myeloid leukemia (AML) in adults.
FDA pharmacologic class: Anthracycline Topoisomerase Inhibitor.
Source: FDA drug label (Idarubicin Hydrochloride), Meitheal Pharmaceuticals Inc., effective May 9, 2025 (SPL set d31254be-6bd2-4ac1-acab-bc00e2209d28), via openFDA; the full label on DailyMed
Is there a generic for idarubicin (Idamycin)?
The FDA approved the first generic idarubicin on May 1, 2002. 7 generic applications are approved; 3 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists idarubicin from 2 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1990 earliest approval on file
- 2002 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Has idarubicin been recalled?
The FDA's Enforcement Report lists 1 recall naming idarubicin since 2021: 0 Class I (the most serious), 1 Class II, 0 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| July 29, 2021 | Class II | Teva Pharmaceuticals USA | Lack of Assurance of Sterility |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the idarubicin label say about other medicines?
The idarubicin label names 4 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Allopurinol | warnings and precautions | Hydration, urine alkalinization, and prophylaxis with allopurinol to prevent hyperuricemia may minimize potential complications of tumor lysis syndrome. |
| Cyclophosphamide | warnings | … concomitant use of drugs with the ability to suppress cardiac contractility or cardiotoxic drugs (e.g., trastuzumab, cyclophosphamide and paclitaxel). |
| Paclitaxel | warnings | … the ability to suppress cardiac contractility or cardiotoxic drugs (e.g., trastuzumab, cyclophosphamide and paclitaxel). |
| Trastuzumab | warnings | … and concomitant use of drugs with the ability to suppress cardiac contractility or cardiotoxic drugs (e.g., trastuzumab, cyclophosphamide and paclitaxel). |
Source: FDA drug label (Idarubicin Hydrochloride), Meitheal Pharmaceuticals Inc., effective May 9, 2025 (SPL set d31254be-6bd2-4ac1-acab-bc00e2209d28), via openFDA; the full label on DailyMed
What do FAERS reports show for idarubicin?
The FDA Adverse Event Reporting System holds 1,119 reports that list idarubicin among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 249 are coded as a death and 458 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as idarubicin?
36 other medicines are given the same way (intravenous) and in the same FDA class as idarubicin or labeled mainly for the same use (leukemia, lymphoma and myeloma), the same class first. Leukemia, lymphoma and myeloma lists all 98 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (intravenous) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Doxorubicin | Leukemia, lymphoma and myeloma | 16 labelers | n/a | No current entry |
| Daunorubicin | Leukemia, lymphoma and myeloma | 2 labelers | n/a | No current entry |
| Cytarabine and daunorubicin | Leukemia, lymphoma and myeloma | none listed | n/a | No current entry |
| Cyclophosphamide | Leukemia, lymphoma and myeloma | 15 labelers | n/a | No current entry |
| Bortezomib | Leukemia, lymphoma and myeloma | 22 labelers | n/a | No current entry |
| Arsenic trioxide | Leukemia, lymphoma and myeloma | 16 labelers | n/a | A presentation being discontinued |
| Bendamustine | Leukemia, lymphoma and myeloma | 4 labelers | n/a | A presentation being discontinued |
| Nelarabine | Leukemia, lymphoma and myeloma | 12 labelers | n/a | No current entry |
Every medicine labeled for the same conditions as idarubicin
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does idarubicin compare with medicines for the same use?
1 side-by-side page set idarubicin beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to idarubicin
- 36 medicines for the same use
- Other anthracycline topoisomerase inhibitors
- the pharmacologic class, with prices and generics
- Idarubicin side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other