What the label lists and what reports show
Clofarabine side effects
Clofarabine's FDA label: “Most common adverse reactions (≥25%): vomiting, nausea, diarrhea, febrile neutropenia, pruritus, headache, bacteremia, pyrexia, rash, tachycardia, abdominal pain, chills, fatigue, anorexia, pain in extremity, hypotension, epistaxis, and petechiae.” FAERS holds 2,271 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 (270 reports).
- Generic listed
Check it at the source: the clofarabine FDA label on DailyMed (effective December 12, 2022, Meitheal Pharmaceuticals Inc.); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsMost common adverse reactions (≥25%): vomiting, nausea, diarrhea, febrile neutropenia, pruritus, headache, bacteremia, pyrexia, rash, tachycardia, abdominal pain, chills, fatigue, anorexia, pain in extremity, hypotension, epistaxis, and petechiae.
Table 2: Incidence of Treatment-Emergent Laboratory Abnormalities after Clofarabine Administration
| Parameter | Any Grade | Grade 3 or higher |
|---|---|---|
| Anemia (N=114) | 83% | 75% |
| Leukopenia (N=114) | 88% | 88% |
| Lymphopenia (N=113) | 82% | 82% |
| Neutropenia (N=113) | 64% | 64% |
| Thrombocytopenia (N=114) | 81% | 80% |
| Elevated Creatinine (N=115) | 50% | 8% |
| Elevated SGOT (N=100) | 74% | 36% |
| Elevated SGPT (N=113) | 81% | 43% |
| Elevated Total Bilirubin (N=114) | 45% | 13% |
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 clinically significant adverse reactions are discussed in greater detail in other sections of the label: Myelosuppression [see Warnings and Precautions ( 5.1 )] Hemorrhage [see Warnings and Precautions ( 5.2 )] Serious Infections [see Warnings and Precautions ( 5.3 )] Hyperuricemia (tumor lysis syndrome) [see Warnings and Precautions ( 5.4 )] Systemic Inflammatory Response Syndrome (SIRS) and Capillary Leak Syndrome [see Warnings and Precautions ( 5.5 )] Venous Occlusive Disease of the Liver [see Warnings and Precautions ( 5.6 )] Hepatotoxicity [see Warnings and Precautions ( 5.7 )] Renal Toxicity [see Warnings and Precautions ( 5.8 )] Enterocolitis [see Warnings and Precautions ( 5.9 )] Skin Reactions [see Warnings and Precautions ( 5.10 )] Most common adverse reactions (≥25%): vomiting, nausea, diarrhea, febrile neutropenia, pruritus, headache, bacteremia, pyrexia, rash, tachycardia, abdominal pain, chills, fatigue, anorexia, pain in extremity, hypotension, epistaxis, and petechiae. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Meitheal Pharmaceuticals Inc. at 1-844-824-8426 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. …
Source: FDA drug label, Meitheal Pharmaceuticals Inc., effective December 12, 2022 (SPL set 54436453-882e-406b-87a3-049d150101c6), via openFDA; the full label on DailyMed
What do FAERS reports show?
2,271 reports list clofarabine among the medicines taken, each a report of something that happened, not proof the medicine caused it; 900 are coded as a death and 717 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 21 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?
- Clofarabine: 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