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Drug

Clofarabine

97 flagged reaction(s) · 3,183 total co-reports · max PRR 71.2
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