What the label lists and what reports show
Daunorubicin side effects
Daunorubicin's FDA label lists its adverse reactions in its own words. FAERS holds 1,580 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is febrile neutropenia (194 reports).
- Generic listed
- Boxed warning
Check it at the source: the daunorubicin FDA label on DailyMed (effective January 19, 2026, Hisun Pharmaceuticals USA, Inc.); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsDose-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. 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.
Source: FDA drug label, Hisun Pharmaceuticals USA, Inc., effective January 19, 2026 (SPL set 9705fa12-499e-41a3-8fb4-f6df0858b851), via openFDA; the full label on DailyMed
What do FAERS reports show?
1,580 reports list daunorubicin among the medicines taken, each a report of something that happened, not proof the medicine caused it; 394 are coded as a death and 729 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. Of the 22 reactions below, 2 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Daunorubicin: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions