Drug
Clofarabine
Important: Reactions below are the flagged terms from this drug’s
FAERS report history (min. 3 co-reports per term) — PRR/ROR indicate
disproportionality in spontaneous reporting, not causation.
Data from FDA FAERS via openFDA. Last recalculated: 2026-09-14.
| Reaction | Co-reports (a) | PRR | ROR | Signal | |
|---|---|---|---|---|---|
| 1 | Haematotoxicity | 71 | 71.2 | 73.5 | signal |
| 2 | Mucosal Inflammation | 125 | 44.5 | 47.0 | signal |
| 3 | Febrile Neutropenia | 270 | 37.8 | 42.8 | signal |
| 4 | Hyperbilirubinaemia | 42 | 37.8 | 38.5 | signal |
| 5 | Bone Marrow Failure | 82 | 37.2 | 38.5 | signal |
| 6 | Multi-organ Failure | 68 | 35.9 | 37.0 | signal |
| 7 | Acute Myeloid Leukaemia | 60 | 35.7 | 36.7 | signal |
| 8 | Blood Bilirubin Increased | 97 | 33.2 | 34.6 | signal |
| 9 | Multiple Organ Dysfunction Syndrome | 89 | 29.5 | 30.7 | signal |
| 10 | Nephropathy Toxic | 33 | 27.4 | 27.8 | signal |
| 11 | Palmar-plantar Erythrodysaesthesia Syndrome | 68 | 26.9 | 27.7 | signal |
| 12 | Hepatotoxicity | 60 | 25.1 | 25.7 | signal |
| 13 | Transaminases Increased | 52 | 21.7 | 22.1 | signal |
| 14 | Posterior Reversible Encephalopathy Syndrome | 20 | 19.4 | 19.6 | signal |
| 15 | Pancytopenia | 100 | 16.6 | 17.3 | signal |
| 16 | Septic Shock | 73 | 15.6 | 16.1 | signal |
| 17 | Cytomegalovirus Infection | 27 | 15.0 | 15.2 | signal |
| 18 | Staphylococcal Infection | 51 | 14.2 | 14.5 | signal |
| 19 | Aspartate Aminotransferase Increased | 81 | 14.1 | 14.6 | signal |
| 20 | Bacterial Infection | 28 | 13.9 | 14.1 | signal |
| 21 | Encephalopathy | 36 | 13.6 | 13.8 | signal |
| 22 | Oedema | 79 | 13.5 | 13.9 | signal |
| 23 | Bacteraemia | 17 | 13.4 | 13.4 | signal |
| 24 | Sepsis | 159 | 13.2 | 14.1 | signal |
| 25 | Alanine Aminotransferase Increased | 86 | 12.9 | 13.4 | signal |
| 26 | Cytokine Release Syndrome | 26 | 12.6 | 12.7 | signal |
| 27 | Toxic Epidermal Necrolysis | 20 | 12.3 | 12.4 | signal |
| 28 | Renal Failure Acute | 54 | 11.6 | 11.9 | signal |
| 29 | Neurotoxicity | 19 | 10.1 | 10.2 | signal |
| 30 | Coagulopathy | 18 | 10.0 | 10.1 | signal |
| 31 | Lung Infection | 17 | 10.0 | 10.0 | signal |
| 32 | Respiratory Failure | 76 | 9.6 | 9.9 | signal |
| 33 | Thrombotic Microangiopathy | 10 | 9.5 | 9.6 | signal |
| 34 | Acute Respiratory Distress Syndrome | 18 | 9.4 | 9.5 | signal |
| 35 | Fluid Overload | 15 | 9.4 | 9.4 | signal |
| 36 | Disseminated Intravascular Coagulation | 14 | 9.2 | 9.2 | signal |
| 37 | Generalised Oedema | 12 | 9.0 | 9.0 | signal |
| 38 | Atelectasis | 9 | 8.6 | 8.6 | signal |
| 39 | Pneumocystis Jirovecii Pneumonia | 9 | 8.3 | 8.3 | signal |
| 40 | Myelodysplastic Syndrome | 13 | 8.3 | 8.3 | signal |
| 41 | Neutropenia | 121 | 8.3 | 8.7 | signal |
| 42 | Drug Resistance | 22 | 7.9 | 8.0 | signal |
| 43 | Dialysis | 12 | 7.8 | 7.8 | signal |
| 44 | Fungal Infection | 28 | 7.8 | 7.9 | signal |
| 45 | Malnutrition | 9 | 7.5 | 7.5 | signal |
| 46 | Hypoxia | 28 | 7.4 | 7.5 | signal |
| 47 | Respiratory Distress | 21 | 7.0 | 7.1 | signal |
| 48 | Clostridium Difficile Colitis | 8 | 7.0 | 7.0 | signal |
| 49 | Thrombocytopenia | 81 | 6.7 | 6.9 | signal |
| 50 | Ascites | 21 | 6.6 | 6.6 | signal |
| 51 | Device Related Infection | 11 | 6.6 | 6.6 | signal |
| 52 | Pleural Effusion | 43 | 6.5 | 6.6 | signal |
| 53 | Pericardial Effusion | 16 | 6.4 | 6.5 | signal |
| 54 | Hepatic Failure | 21 | 6.4 | 6.5 | signal |
| 55 | Rash Maculo-papular | 15 | 6.3 | 6.3 | signal |
| 56 | Cerebral Haemorrhage | 24 | 6.2 | 6.3 | signal |
| 57 | No Therapeutic Response | 8 | 6.0 | 6.0 | signal |
| 58 | Leukaemia | 6 | 5.9 | 5.9 | signal |
| 59 | Therapy Non-responder | 28 | 5.8 | 5.9 | signal |
| 60 | Subdural Haematoma | 9 | 5.8 | 5.8 | signal |
| 61 | Renal Tubular Necrosis | 6 | 5.6 | 5.6 | signal |
| 62 | Eyelid Oedema | 7 | 5.5 | 5.5 | signal |
| 63 | Splenomegaly | 7 | 5.5 | 5.5 | signal |
| 64 | Tachypnoea | 8 | 5.5 | 5.5 | signal |
| 65 | Polyneuropathy | 7 | 5.4 | 5.4 | signal |
| 66 | Circulatory Collapse | 10 | 5.4 | 5.4 | signal |
| 67 | Mental Status Changes | 16 | 5.3 | 5.3 | signal |
| 68 | Ileus | 7 | 5.3 | 5.3 | signal |
| 69 | Colitis | 21 | 5.1 | 5.2 | signal |
| 70 | Disease Progression | 65 | 5.1 | 5.2 | signal |
| 71 | Candida Infection | 9 | 5.0 | 5.0 | signal |
| 72 | Acute Hepatic Failure | 7 | 4.8 | 4.8 | signal |
| 73 | Pulmonary Oedema | 23 | 4.7 | 4.8 | signal |
| 74 | Stomatitis | 31 | 4.7 | 4.8 | signal |
| 75 | Drug Eruption | 9 | 4.7 | 4.7 | signal |
| 76 | Haemorrhage Intracranial | 7 | 4.3 | 4.3 | signal |
| 77 | Clostridium Difficile Infection | 10 | 4.3 | 4.3 | signal |
| 78 | Metabolic Acidosis | 14 | 4.1 | 4.1 | signal |
| 79 | Drug Ineffective For Unapproved Indication | 24 | 4.0 | 4.0 | signal |
| 80 | Hepatocellular Injury | 6 | 3.9 | 3.9 | signal |
| 81 | Myelosuppression | 14 | 3.8 | 3.8 | signal |
| 82 | Hepatic Function Abnormal | 15 | 3.7 | 3.8 | signal |
| 83 | Treatment Failure | 33 | 3.7 | 3.8 | signal |
| 84 | Neoplasm Progression | 14 | 3.7 | 3.7 | signal |
| 85 | Subarachnoid Haemorrhage | 4 | 3.6 | 3.6 | signal |
| 86 | Neutrophil Count Decreased | 15 | 3.4 | 3.4 | signal |
| 87 | Pneumonitis | 10 | 3.4 | 3.4 | signal |
| 88 | Pericarditis | 6 | 3.3 | 3.3 | signal |
| 89 | Grand Mal Convulsion | 3 | 3.0 | 3.0 | no signal |
| 90 | Eye Haemorrhage | 4 | 2.8 | 2.8 | no signal |
| 91 | Toxic Skin Eruption | 3 | 2.7 | 2.7 | no signal |
| 92 | Drug Toxicity | 4 | 2.7 | 2.7 | no signal |
| 93 | Pulmonary Arterial Hypertension | 4 | 2.5 | 2.5 | no signal |
| 94 | Convulsion | 15 | 2.4 | 2.4 | signal |
| 95 | Cytopenia | 3 | 2.3 | 2.3 | no signal |
| 96 | Hepatitis C | 3 | 2.3 | 2.3 | no signal |
| 97 | Tuberculosis | 3 | 2.2 | 2.2 | no signal |