Quick answers
- What is Daunorubicin hydrochloride used for?
- The FDA-approved label (Daunorubicin Hydrochloride, Hisun Pharmaceuticals USA, Inc., January 19, 2026) says: “Daunorubicin hydrochloride injection in combination with other approved anticancer drugs is indicated for remission induction in acute nonlymphocytic leukemia (myelogenous, monocytic, erythroid) of adults and for remission induction in acute lymphocytic leukemia of children and adults.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- What are the side effects of Daunorubicin hydrochloride?
- The “Adverse Reactions” section of the FDA label (Daunorubicin Hydrochloride, Hisun Pharmaceuticals USA, Inc., January 19, 2026) begins: “Dose-limiting toxicity includes myelosuppression and cardiotoxicity (see WARNINGS section). Other reactions include: Cutaneous Reversible alopecia occurs in most patients. Rash, contact dermatitis and urticaria have occurred rarely. Gastrointestinal Acute nausea and vomiting occur but are usually mild. Antiemetic therapy may be of some help. Mucositis may occur 3 to 7 days after administration. Diarrhea and abdominal pain have occasionally been reported.” … This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- What are the drug interactions of Daunorubicin hydrochloride?
- The “Drug Interactions” section of the FDA label (Daunorubicin Hydrochloride, Hisun Pharmaceuticals USA, Inc., January 19, 2026) begins: “Use of daunorubicin in a patient who has previously received doxorubicin increases the risk of cardiotoxicity. Daunorubicin hydrochloride should not be used in patients who have previously received the recommended maximum cumulative doses of doxorubicin or daunorubicin hydrochloride. Cyclophosphamide used concurrently with daunorubicin hydrochloride may also result in increased cardiotoxicity.” … This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Daunorubicin hydrochloride have a boxed warning?
- Yes. The FDA label for Daunorubicin Hydrochloride has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Daunorubicin hydrochloride?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Daunorubicin hydrochloride been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Daunorubicin hydrochloride?
- 3 companies list prescription products of Daunorubicin hydrochloride in the FDA NDC Directory, including Hisun Pharmaceuticals USA, Inc., Hikma Pharmaceuticals USA Inc. and Meitheal Pharmaceuticals Inc.
What Daunorubicin hydrochloride is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Daunorubicin hydrochloride injection in combination with other approved anticancer drugs is indicated for remission induction in acute nonlymphocytic leukemia (myelogenous, monocytic, erythroid) of adults and for remission induction in acute lymphocytic leukemia of children and adults.
— FDA label: Daunorubicin Hydrochloride, Hisun Pharmaceuticals USA, Inc., effective January 19, 2026. Read the full label on DailyMed →
Label quoted: the one for the most common form (injection, solution, intravenous), Daunorubicin Hydrochloride, Hisun Pharmaceuticals USA, Inc.; it covers 2 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.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
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.
Daunorubicin hydrochloride boxed warning: what the label says
Quoted from the boxed warning of the FDA-approved label.
WARNING Daunorubicin Hydrochloride Injection must be given into a rapidly flowing intravenous infusion. It must never be given by the intramuscular or subcutaneous route. Severe local tissue necrosis will occur if there is extravasation during administration. Myocardial toxicity manifested in its most severe form by potentially fatal congestive heart failure may occur either during therapy or months to years after termination of therapy.
Read more of this section
The incidence of myocardial toxicity increases after a total cumulative dose exceeding 400 to 550 mg/m 2 in adults, 300 mg/m 2 in children more than 2 years of age, or 10 mg/kg in children less than 2 years of age. Severe myelosuppression occurs when used in therapeutic doses; this may lead to infection or hemorrhage. It is recommended that daunorubicin hydrochloride be administered only by physicians who are 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. Dosage should be reduced in patients with impaired hepatic or renal function.
— FDA label: Daunorubicin Hydrochloride, Hisun Pharmaceuticals USA, Inc., effective January 19, 2026. Read the full label on DailyMed →
Daunorubicin hydrochloride side effects
Quoted from the “Adverse Reactions” section of the FDA-approved label. Tell your doctor about any side effect that worries you.
Dose-limiting toxicity includes myelosuppression and cardiotoxicity (see WARNINGS section). Other reactions include: Cutaneous Reversible alopecia occurs in most patients. Rash, contact dermatitis and urticaria have occurred rarely. Gastrointestinal Acute nausea and vomiting occur but are usually mild. Antiemetic therapy may be of some help. Mucositis may occur 3 to 7 days after administration. Diarrhea and abdominal pain have occasionally been reported.
Read more of this section
Local If extravasation occurs during administration, severe local tissue necrosis, severe cellulitis, thrombophlebitis, or painful induration can result. Acute Reactions Rarely, anaphylactoid reaction, fever, and chills can occur. Hyperuricemia may occur, especially in patients with leukemia, and serum uric acid levels should be monitored.
— FDA label: Daunorubicin Hydrochloride, Hisun Pharmaceuticals USA, Inc., effective January 19, 2026. Read the full label on DailyMed →
Daunorubicin hydrochloride drug interactions
Quoted from the “Drug Interactions” section of the FDA-approved label. Tell your pharmacist about every medicine, vitamin and herbal product you take.
Use of daunorubicin in a patient who has previously received doxorubicin increases the risk of cardiotoxicity. Daunorubicin hydrochloride should not be used in patients who have previously received the recommended maximum cumulative doses of doxorubicin or daunorubicin hydrochloride. Cyclophosphamide used concurrently with daunorubicin hydrochloride may also result in increased cardiotoxicity.
Read more of this section
Dosage reduction of daunorubicin hydrochloride may be required when used concurrently with other myelosuppressive agents. Hepatotoxic medications, such as high-dose methotrexate, may impair liver function and increase the risk of toxicity.
— FDA label: Daunorubicin Hydrochloride, Hisun Pharmaceuticals USA, Inc., effective January 19, 2026. Read the full label on DailyMed →
Daunorubicin 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.
Parenteral drug products should be inspected visually for particulate matter prior to administration, whenever solution and container permit. Principles In order to eradicate the leukemic cells and induce a complete remission, a profound suppression of the bone marrow is usually required. Evaluation of both the peripheral blood and bone marrow is mandatory in the formulation of appropriate treatment plans.
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It is recommended that the dosage of daunorubicin hydrochloride injection be reduced in instances of hepatic or renal impairment. For example, using serum bilirubin and serum creatinine as indicators of liver and kidney function, the following dose modifications are recommended: Serum Bilirubin Serum Creatinine Dose Reduction 1.2 to 3 mg% — 25% >3 mg% — 50% — >3 mg% 50% Representative Dose Schedules and Combination for the Approved Indication of Remission Induction in Adult Acute Nonlymphocytic Leukemia: In Combination For patients under age 60, daunorubicin hydrochloride injection 45 mg/m 2 /day IV on days 1, 2, and 3 of the first course and on days 1, 2 of subsequent courses AND cytosine arabinoside 100 mg/m 2 /day IV infusion daily for 7 days for the first course and for 5 days for subsequent courses. For patients 60 years of age and above, daunorubicin hydrochloride injection 30 mg/m 2 /day IV on days 1, 2, and 3 of the first course and on days 1, 2 of subsequent courses AND cytosine arabinoside 100 mg/m 2 /day IV infusion daily for 7 days for the first course and for 5 days for subsequent courses. This daunorubicin hydrochloride injection dose-reduction is based on a single study and may not be appropriate if optimal supportive care is available. The attainment of a normal-appearing bone marrow may require up to three courses of induction therapy. Evaluation of the bone marrow following recovery from the previous course of induction therapy determines whether a further course of induction treatment is required. Representative Dose Schedule and Combination for the Approved Indication of Remission Induction in Pediatric Acute Lymphocytic Leukemia: In Combination Daunorubicin hydrochloride injection 25 mg/m 2 IV on day 1 every week, vincristine 1.5 mg/m 2 IV on day 1 every week, prednisone 40 mg/m 2 PO daily. Generally, a complete remission will be obtained within four such courses of therapy; however, if after four courses the patient is in partial remission, an additional one or, if necessary, two courses may be given in an effort to obtain a complete remission. In children less than 2 years of age or below 0.5 m2 body surface area, it has been recommended that the daunorubicin hydrochloride injection dosage calculation should be based on weight (1 mg/kg) instead of body surface area. Representative Dose Schedules and Combination for the Approved Indication of Remission Induction in Adult Acute Lymphocytic Leukemia: In Combination Daunorubicin hydrochloride injection 45 mg/m 2 /day IV on days 1, 2, and 3 AND vincristine 2 mg IV on days 1, 8, and 15; prednisone 40 mg/m 2 /day PO on days 1 through 22, then tapered between days 22 to 29; L-asparaginase 500 IU/kg/day x 10 days IV on days 22 through 32.
Table from the label
| Serum Bilirubin | Serum Creatinine | Dose Reduction |
|---|---|---|
| 1.2 to 3 mg% | — | 25% |
| >3 mg% | — | 50% |
| — | >3 mg% | 50% |
— FDA label: Daunorubicin Hydrochloride, Hisun Pharmaceuticals USA, Inc., effective January 19, 2026. This is part of the section. Read the full label on DailyMed →
Daunorubicin hydrochloride in pregnancy
Quoted from the pregnancy part of the FDA-approved label. Ask your doctor before you take any medicine while pregnant or planning a pregnancy.
Daunorubicin hydrochloride may cause fetal harm when administered to a pregnant woman. An increased incidence of fetal abnormalities (parieto-occipital cranioschisis, umbilical hernias, or rachischisis) and abortions was reported in rabbits at doses of 0.05 mg/kg/day or approximately 1/100th of the highest recommended human dose on a body surface area basis.
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Rats showed an increased incidence of esophageal, cardiovascular and urogenital abnormalities as well as rib fusions at doses of 4 mg/kg/day or approximately 1/2 the human dose on a body surface area basis. Decreases in fetal birth weight and post-delivery growth rate were observed in mice. There are no adequate and well-controlled studies in pregnant women. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus. Women of childbearing potential should be advised to avoid becoming pregnant.
— FDA label: Daunorubicin Hydrochloride, Hisun Pharmaceuticals USA, Inc., effective January 19, 2026. Read the full label on DailyMed →
Daunorubicin 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 daunorubicin, mothers should be advised to discontinue nursing during daunorubicin therapy.
— FDA label: Daunorubicin Hydrochloride, Hisun Pharmaceuticals USA, Inc., effective January 19, 2026. Read the full label on DailyMed →
When Daunorubicin hydrochloride should not be used
Quoted from the “Contraindications” section of the FDA-approved label.
Daunorubicin hydrochloride injection is contraindicated in patients who have shown a hypersensitivity to it.
— FDA label: Daunorubicin Hydrochloride, Hisun Pharmaceuticals USA, Inc., effective January 19, 2026. Read the full label on DailyMed →
Forms and how it is given
| Dosage forms | Injection, solution · Injection |
|---|---|
| Route | Intravenous |
| Prescription products | 5 in the FDA NDC Directory |
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.
- Hisun Pharmaceuticals USA, Inc.3 products
- Hikma Pharmaceuticals USA Inc.2 products
- Meitheal Pharmaceuticals Inc.1 product
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.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA050731 DAUNORUBICIN HYDROCHLORIDE | Hikma | January 30, 1998 | 4, latest September 27, 2018 2018: UNKNOWN · 2002: Manufacturing (CMC) · 2001: Manufacturing (CMC) |
Generic approvals (2)
- ANDA065035Meitheal · January 24, 2000
- ANDA208759Hisun Pharm Hangzhou · April 12, 2019
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 309650, 2002002 |
|---|---|
| SPL set ID of the quoted label | 9705fa12-499e-41a3-8fb4-f6df0858b851 |
| FDA labels (SPL) | 4 |
| FDA applications | NDA050731, 2 ANDA |
| Active ingredients (FDA) | DAUNORUBICIN |
Next steps
- Find a pharmacy near youAsk which price applies to you and whether your product is affected by a recall
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- Acute Lymphocytic LeukemiaCondition named on the label: hospitals that treat it
- Hisun Pharmaceuticals USA, Inc.Maker or distributor
- Hikma Pharmaceuticals USA Inc.Maker or distributor
- Meitheal Pharmaceuticals Inc.Maker or distributor
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Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Daunorubicin Hydrochloride, Hisun Pharmaceuticals USA, Inc., effective January 19, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- 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 →