What the label lists and what reports show
Cytarabine and daunorubicin side effects
Cytarabine and daunorubicin's FDA label: “The most common adverse reactions (incidence ≥ 25%) are hemorrhagic events, febrile neutropenia, rash, edema, nausea, mucositis, diarrhea, constipation, musculoskeletal pain, fatigue, abdominal pain, dyspnea, headache, cough, decreased appetite, arrhythmia …” FAERS holds 2,336 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 (502 reports).
- No generic listed
- Boxed warning
Check it at the source: the cytarabine and daunorubicin FDA label on DailyMed (effective January 30, 2026, Jazz Pharmaceuticals, Inc.); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsThe most common adverse reactions (incidence ≥ 25%) are hemorrhagic events, febrile neutropenia, rash, edema, nausea, mucositis, diarrhea, constipation, musculoskeletal pain, fatigue, abdominal pain, dyspnea, headache, cough, decreased appetite, arrhythmia, pneumonia, bacteremia, chills, sleep disorders, and vomiting.
Table 3: Common Adverse Reactions (≥ 10% Incidence in the VYXEOS arm) During the Induction Phase
| Reaction | VYXEOS N=153 n (%) | 7+3 N=151 n (%) | VYXEOS N=153 n (%) | 7+3 N=151 n (%) |
|---|---|---|---|---|
| Hemorrhage a | 107 (70) | 74 (49) | 15 (10) | 9 (6) |
| Febrile Neutropenia | 104 (68) | 103 (68) | 101 (66) | 102 (68) |
| Rash a | 82 (54) | 55 (36) | 8 (5) | 2 (1) |
| Edema a | 78 (51) | 90 (60) | 2 (2) | 5 (3) |
| Nausea | 72 (47) | 79 (52) | 1 (1) | 1 (1) |
| Diarrhea/Colitis a | 69 (45) | 100 (66) | 4 (3) | 10 (7) |
| Mucositis a | 67 (44) | 69 (46) | 2 (1) | 7 (5) |
| Constipation | 61 (40) | 57 (38) | 0 | 0 |
| Musculoskeletal pain a | 58 (38) | 52 (34) | 5 (3) | 4 (3) |
| Abdominal pain a | 51 (33) | 45 (30) | 3 (2) | 3 (2) |
| Cough a | 51 (33) | 34 (23) | 0 | 1 (1) |
| Headache a | 51 (33) | 36 (24) | 2 (1) | 1 (1) |
| Dyspnea a | 49 (32) | 51 (34) | 17 (11) | 15 (10) |
| Fatigue a | 49 (32) | 58 (38) | 8 (5) | 8 (5) |
| Arrhythmia a | 46 (30) | 41 (27) | 10 (7) | 7 (5) |
| Decreased appetite | 44 (29) | 57 (38) | 2 (1) | 5 (3) |
| Pneumonia (excluding fungal) a | 39 (26) | 35 (23) | 30 (20) | 26 (17) |
| Sleep disorders a | 38 (25) | 42 (28) | 2 (1) | 1 (1) |
| Bacteremia (excluding sepsis) a | 37 (24) | 37 (25) | 35 (23) | 31 (21) |
| Vomiting a | 37 (24) | 33 (22) | 0 | 0 |
| Chills | 35 (23) | 38 (25) | 0 | 0 |
| Hypotension a | 30 (20) | 32 (21) | 7 (5) | 1 (1) |
| Non-conduction cardiotoxicity a | 31 (20) | 27 (18) | 13 (9) | 15 (10) |
| Dizziness a | 27 (18) | 26 (17) | 1 (1) | 0 |
| Fungal infection a | 27 (18) | 19 (13) | 11 (7) | 9 (6) |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following adverse reactions are discussed in greater detail in other sections of the labeling: • Hemorrhage [see Warnings and Precautions ( 5.2 )] • Cardiotoxicity [see Warnings and Precautions ( 5.3 )] • Hypersensitivity Reactions [see Warnings and Precautions ( 5.4 )] • Copper Overload [see Warnings and Precautions ( 5.5 )] • Tissue Necrosis [see Warnings and Precautions ( 5.6 )] The most common adverse reactions (incidence ≥ 25%) are hemorrhagic events, febrile neutropenia, rash, edema, nausea, mucositis, diarrhea, constipation, musculoskeletal pain, fatigue, abdominal pain, dyspnea, headache, cough, decreased appetite, arrhythmia, pneumonia, bacteremia, chills, sleep disorders, and vomiting. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Jazz Pharmaceuticals, Inc. at 1-800-520-5568 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials 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. …
Source: FDA drug label, Jazz Pharmaceuticals, Inc., effective January 30, 2026 (SPL set 7ea701ce-e7d3-4349-a9c2-642a501d45c8), via openFDA; the full label on DailyMed
What do FAERS reports show?
2,336 reports list cytarabine and daunorubicin among the medicines taken, each a report of something that happened, not proof the medicine caused it; 771 are coded as a death and 560 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 20 reactions below, 13 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?
- Cytarabine and 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