Two medicines, side by side
Idarubicin vs doxorubicin
Idarubicin and doxorubicin are both labeled for leukemia and lymphoma and myeloma. Drugs@FDA records approvals of idarubicin since 1990 and of doxorubicin since 1974. How each works, in its label's words: Idarubicin, “Mechanism of Action Idarubicin hydrochloride is a DNA-intercalating analog of daunorubicin which has an inhibitory effect on nucleic acid synthesis and interacts with the enzyme topoisomerase II.”; Doxorubicin, “The cytotoxic effect of doxorubicin hydrochloride on malignant cells and its toxic effects on various organs are thought to be related to nucleotide base intercalation and cell membrane lipid binding …”
Check it at the source: the idarubicin FDA label on DailyMed (effective May 9, 2025); the doxorubicin FDA label on DailyMed (effective May 5, 2026).
Highlights of the idarubicin record
Idarubicin (Idamycin) · label of May 9, 2025
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.
Used for
From the label: indicationsIdarubicin 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.
On the market
- Earliest approval on file
- September 27, 1990
- Generic labelers
- 2 labelers
- Pharmacy cost
- Not in the survey
Supply and safety
- Shortage
- No current entry
- Recalls
- 1
Highlights of the doxorubicin record
Doxorubicin (Doxil) · label of May 5, 2026
CARDIOMYOPATHY, SECONDARY MALIGNANCIES, EXTRAVASATION AND TISSUE NECROSIS, and SEVERE MYELOSUPPRESSION
Cardiomyopathy: Myocardial damage, including acute left ventricular failure, can occur with doxorubicin hydrochloride. The risk of cardiomyopathy is proportional to the cumulative exposure with incidence rates from 1%–20% for cumulative doses ranging from 300 mg/m 2 to 500 mg/m 2 when doxorubicin hydrochloride is administered every 3 weeks.
Used for
From the label: indicationsDoxorubicin Hydrochloride Injection is an anthracycline topoisomerase inhibitor indicated: • as a component of multi‑agent adjuvant chemotherapy for treatment of women with axillary lymph node involvement following resection of primary breast cancer ( 1.1 ) • for the treatment of: acute lymphoblastic leukemia, acute myeloblastic leukemia, Hodgkin lymphoma, Non-Hodgkin lymphoma, metastatic breast cancer, metastatic […]
On the market
- Earliest approval on file
- August 7, 1974
- Generic labelers
- 16 labelers
- Pharmacy cost
- Not in the survey
Supply and safety
- Shortage
- No current entry
- Recalls
- 5
Source: FDA drug labels via openFDA (Idarubicin label of May 9, 2025, Doxorubicin label of May 5, 2026); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)
How do idarubicin and doxorubicin differ on the record?
How each works, in its label's words: Idarubicin, “Mechanism of Action Idarubicin hydrochloride is a DNA-intercalating analog of daunorubicin which has an inhibitory effect on nucleic acid synthesis and interacts with the enzyme topoisomerase II.”; Doxorubicin, “The cytotoxic effect of doxorubicin hydrochloride on malignant cells and its toxic effects on various organs are thought to be related to nucleotide base intercalation and cell membrane lipid binding …”
Both are in FDA's class anthracycline topoisomerase inhibitors.
Half-life, in each label's words: Idarubicin, “The elimination rate of idarubicin from plasma is slow with an estimated mean terminal half-life of 22 hours (range, 4 …”; Doxorubicin, “Distribution The distribution half-life is approximately 5 minutes.”
Both labels carry a boxed warning; the records quote them.
Generics: idarubicin since 2002; doxorubicin since 1989 (Drugs@FDA).
| Idarubicin | Doxorubicin | |
|---|---|---|
| Labeled for | Leukemia, lymphoma and myeloma | Leukemia, lymphoma and myeloma, Breast cancer |
| Pharmacologic class | Anthracycline Topoisomerase Inhibitor | Anthracycline Topoisomerase Inhibitor |
| How it works (label) | Mechanism of Action Idarubicin hydrochloride is a DNA-intercalating analog of daunorubicin which has an inhibitory effect on nucleic acid synthesis and interacts with the enzyme topoisomerase II. | The cytotoxic effect of doxorubicin hydrochloride on malignant cells and its toxic effects on various organs are thought to be related to nucleotide base intercalation and cell membrane lipid binding activities of doxorubicin. |
| Half-life (label) | The elimination rate of idarubicin from plasma is slow with an estimated mean terminal half-life of 22 hours (range, 4 to 48 hours) when used as a single agent and 20 hours (range, 7 to 38 hours) when used in … | Distribution The distribution half-life is approximately 5 minutes. |
| Earliest approval on file (Drugs@FDA) | September 27, 1990 | August 7, 1974 |
| First generic approved | May 1, 2002 | March 17, 1989 |
| Generic labelers (NDC) | 2 labelers | 16 labelers |
| Pharmacy cost (NADAC, each one's most listed form; strengths differ) | n/a | n/a |
| 12-month price change | n/a | n/a |
| Boxed warning | Yes | Yes |
| Shortage now | No current entry | No current entry |
| Recalls recorded | 1 | 5 |
| FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used) | 1,119 | 95,404 |
| DEA schedule | none | none |
Source: Drugs@FDA, FDA NDC Directory, CMS NADAC of October 7, 2026, FDA shortages and recalls, FAERS via openFDA (FDA files October 8, 2026)
What next?
- Alternatives to idarubicin
- every medicine labeled for the same conditions