fludarabine phosphate Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
arabinofuranosyl derivatives 1189 75607-67-9

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • fludarabine 5'-monophosphate
  • fludarabine phosphate
  • fludura
  • fludara
  • 2-F-ara-AMP
  • Molecular weight: 365.21
  • Formula: C10H13FN5O7P
  • CLOGP: -3.93
  • LIPINSKI: 1
  • HAC: 12
  • HDO: 5
  • TPSA: 186.07
  • ALOGS: -2.09
  • ROTB: 4

  • Status: OFP

  • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

None

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 1 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 3.53 mg/mL Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 2.66 µM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 57.50 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H

Approvals:

DateAgencyCompanyOrphan
April 18, 1991 FDA

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Acute graft versus host disease 1480.61 21.80 372 31629 3945 53313120
Cytokine release syndrome 1356.93 21.80 397 31604 7732 53309333
Cytomegalovirus infection 980.31 21.80 387 31614 19152 53297913
Graft versus host disease 875.71 21.80 275 31726 6847 53310218
Febrile neutropenia 797.66 21.80 590 31411 104346 53212719
Chronic graft versus host disease 781.44 21.80 211 31790 3017 53314048
Acute graft versus host disease in skin 763.70 21.80 208 31793 3078 53313987
Adenovirus infection 609.30 21.80 174 31827 3088 53313977
Graft versus host disease in skin 565.86 21.80 157 31844 2496 53314569
Graft versus host disease in gastrointestinal tract 464.16 21.80 138 31863 2836 53314229
Cytomegalovirus infection reactivation 431.89 21.80 126 31875 2418 53314647
Venoocclusive liver disease 429.43 21.80 144 31857 4428 53312637
Cytomegalovirus viraemia 409.31 21.80 142 31859 4849 53312216
Human herpesvirus 6 infection 406.18 21.80 120 31881 2410 53314655
Acute graft versus host disease in intestine 402.58 21.80 110 31891 1646 53315419
Thrombotic microangiopathy 399.20 21.80 165 31836 9172 53307893
Product use in unapproved indication 381.69 21.80 400 31601 111889 53205176
Hypogammaglobulinaemia 368.00 21.80 138 31863 5912 53311153
Myelodysplastic syndrome 362.46 21.80 184 31817 16476 53300589
Neurotoxicity 361.83 21.80 179 31822 15170 53301895
Progressive multifocal leukoencephalopathy 339.05 21.80 159 31842 11970 53305095
Acute myeloid leukaemia 336.60 21.80 176 31825 16756 53300309
Cystitis haemorrhagic 326.45 21.80 113 31888 3831 53313234
Neutropenia 317.35 21.80 432 31569 158753 53158312
Pyrexia 315.37 21.80 724 31277 402469 52914596
Epstein-Barr virus infection 310.03 21.80 129 31872 7289 53309776
Acute lymphocytic leukaemia recurrent 306.45 21.80 94 31907 2154 53314911
BK virus infection 299.49 21.80 100 31901 3032 53314033
Pancytopenia 291.23 21.80 314 31687 90614 53226451
Post transplant lymphoproliferative disorder 281.55 21.80 104 31897 4267 53312798
Acute myeloid leukaemia recurrent 279.33 21.80 80 31921 1433 53315632
Haemophagocytic lymphohistiocytosis 271.59 21.80 125 31876 9012 53308053
Bronchopulmonary aspergillosis 262.12 21.80 120 31881 8545 53308520
Premature menopause 253.96 21.80 65 31936 743 53316322
Immune effector cell-associated neurotoxicity syndrome 252.58 21.80 69 31932 1031 53316034
Encephalitis viral 232.52 21.80 71 31930 1601 53315464
Multiple organ dysfunction syndrome 223.02 21.80 217 31784 55460 53261605
Transplant failure 221.80 21.80 67 31934 1455 53315610
Viral haemorrhagic cystitis 219.33 21.80 57 31944 695 53316370
Pain 210.65 21.80 48 31953 588350 52728715
Thrombocytopenia 204.66 21.80 327 31674 138400 53178665
Viraemia 191.44 21.80 56 31945 1084 53315981
Mucosal inflammation 190.82 21.80 177 31824 42607 53274458
Cytomegalovirus test positive 189.64 21.80 70 31931 2865 53314200
Cytopenia 187.01 21.80 97 31904 9073 53307992
Posterior reversible encephalopathy syndrome 179.32 21.80 115 31886 16045 53301020
Aspergillus infection 175.35 21.80 87 31914 7409 53309656
Venoocclusive disease 174.40 21.80 60 31941 1995 53315070
Bone marrow failure 160.89 21.80 138 31863 29977 53287088
Engraft failure 150.61 21.80 37 31964 353 53316712
Sepsis 143.66 21.80 289 31712 146140 53170925
Neutrophil count decreased 142.21 21.80 161 31840 48937 53268128
Acute graft versus host disease in liver 139.17 21.80 39 31962 643 53316422
Chronic graft versus host disease in skin 137.51 21.80 39 31962 673 53316392
Epstein-Barr viraemia 135.13 21.80 40 31961 808 53316257
Lymphocyte count decreased 134.71 21.80 121 31880 27931 53289134
Pre-engraftment immune reaction 129.85 21.80 30 31971 214 53316851
Cytomegalovirus chorioretinitis 127.81 21.80 45 31956 1604 53315461
Fall 126.46 21.80 30 31971 358410 52958655
Leukoencephalopathy 123.04 21.80 57 31944 4167 53312898
Stem cell transplant 122.87 21.80 45 31956 1800 53315265
Platelet count decreased 121.43 21.80 226 31775 107873 53209192
Fatigue 120.26 21.80 158 31843 730348 52586717
Bacterial sepsis 120.21 21.80 55 31946 3907 53313158
Systemic mycosis 116.98 21.80 38 31963 1054 53316011
White blood cell count decreased 116.50 21.80 241 31760 124234 53192831
Engraftment syndrome 115.04 21.80 30 31971 371 53316694
Epstein-Barr virus infection reactivation 113.66 21.80 31 31970 460 53316605
Dizziness 113.33 21.80 41 31960 372218 52944847
Joint swelling 113.02 21.80 7 31994 234631 53082434
JC virus infection 112.03 21.80 42 31959 1795 53315270
Drug hypersensitivity 109.01 21.80 15 31986 265227 53051838
Bacteraemia 105.66 21.80 82 31919 15467 53301598
Second primary malignancy 102.78 21.80 60 31941 7072 53309993
Alopecia 101.94 21.80 11 31990 234572 53082493
Epstein-Barr virus associated lymphoproliferative disorder 100.75 21.80 38 31963 1652 53315413
Diffuse large B-cell lymphoma 98.83 21.80 57 31944 6568 53310497
Abdominal discomfort 96.99 21.80 10 31991 221052 53096013
Drug resistance 95.62 21.80 86 31915 19876 53297189
Nasopharyngitis 94.85 21.80 5 31996 192290 53124775
B-cell type acute leukaemia 93.60 21.80 21 31980 129 53316936
Adenoviral hepatitis 90.90 21.80 23 31978 250 53316815
Autoimmune haemolytic anaemia 90.30 21.80 47 31954 4424 53312641
Staphylococcal sepsis 89.96 21.80 57 31944 7783 53309282
Fusarium infection 89.12 21.80 27 31974 592 53316473
Pain in extremity 89.09 21.80 30 31971 285020 53032045
Varicella zoster virus infection 88.67 21.80 39 31962 2524 53314541
Chronic lymphocytic leukaemia 87.51 21.80 41 31960 3075 53313990
Encephalopathy 87.24 21.80 109 31892 36699 53280366
Neoplasm recurrence 87.03 21.80 38 31963 2416 53314649
Peripheral swelling 86.22 21.80 11 31990 206097 53110968
Headache 86.20 21.80 118 31883 536703 52780362
Herpes simplex 85.72 21.80 55 31946 7674 53309391
Arthralgia 84.18 21.80 84 31917 439699 52877366
Pneumonia fungal 82.90 21.80 45 31956 4611 53312454
Growth failure 81.84 21.80 22 31979 308 53316757
Upper respiratory fungal infection 81.81 21.80 19 31982 139 53316926
Off label use 80.65 21.80 521 31480 471691 52845374
Haematocrit decreased 79.75 21.80 105 31896 37226 53279839
Anxiety 78.74 21.80 12 31989 196692 53120373
Septic shock 77.32 21.80 136 31865 62093 53254972
Pruritus 77.22 21.80 40 31961 293792 53023273
Cystitis viral 76.12 21.80 17 31984 102 53316963
Blood follicle stimulating hormone increased 75.87 21.80 18 31983 146 53316919
Dyspnoea 75.35 21.80 149 31852 586083 52730982
Heart rate abnormal 74.97 21.80 40 31961 3960 53313105
Respiratory failure 74.13 21.80 177 31824 100335 53216730
Leukaemia recurrent 74.03 21.80 29 31972 1398 53315667
Swelling 73.50 21.80 13 31988 191092 53125973
Pneumocystis jirovecii pneumonia 73.43 21.80 68 31933 16310 53300755
Rhinovirus infection 73.42 21.80 39 31962 3826 53313239
Lymphadenitis 73.17 21.80 35 31966 2750 53314315
Meningoencephalitis herpetic 72.99 21.80 27 31974 1111 53315954
Chronic lymphocytic leukaemia recurrent 71.79 21.80 18 31983 188 53316877
Fungaemia 71.69 21.80 32 31969 2145 53314920
Hypersensitivity 71.55 21.80 19 31982 210646 53106419
Pulmonary haemorrhage 71.16 21.80 47 31954 6886 53310179
Lymphopenia 69.91 21.80 67 31934 16776 53300289
Malaise 69.89 21.80 67 31934 357550 52959515
Pneumonia cytomegaloviral 68.57 21.80 31 31970 2141 53314924
Adenovirus reactivation 68.34 21.80 15 31986 82 53316983
Staphylococcal infection 68.19 21.80 99 31902 38449 53278616
Aplasia 67.72 21.80 38 31963 4154 53312911
Nausea 67.47 21.80 231 31770 755860 52561205
Disseminated mucormycosis 66.88 21.80 16 31985 135 53316930
Minimal residual disease 66.47 21.80 15 31986 95 53316970
Enterococcal bacteraemia 65.22 21.80 26 31975 1313 53315752
Depression 65.08 21.80 15 31986 183037 53134028
Fungal infection 64.74 21.80 88 31913 32158 53284907
Condition aggravated 63.67 21.80 51 31950 297083 53019982
Encephalitis 63.09 21.80 46 31955 7898 53309167
Lymphadenopathy 62.52 21.80 92 31909 36163 53280902
Contraindicated product administered 62.50 21.80 5 31996 135624 53181441
Acute respiratory distress syndrome 61.63 21.80 73 31928 23259 53293806
Graft versus host disease in lung 61.16 21.80 18 31983 356 53316709
Bone marrow transplant 60.86 21.80 21 31980 704 53316361
Toxoplasmosis 60.07 21.80 25 31976 1411 53315654
Hypoxia 59.46 21.80 114 31887 55566 53261499
Malignant neoplasm progression 59.36 21.80 132 31869 71409 53245656
Diffuse large B-cell lymphoma recurrent 59.29 21.80 26 31975 1670 53315395
Disease progression 59.13 21.80 164 31837 101756 53215309
Alternaria infection 57.63 21.80 15 31986 184 53316881
Infection reactivation 57.35 21.80 22 31979 1002 53316063
Feeling abnormal 57.09 21.80 7 31994 135294 53181771
Transplant dysfunction 56.89 21.80 36 31965 4902 53312163
Arthropathy 55.75 21.80 9 31992 141444 53175621
Blood stem cell transplant failure 55.68 21.80 14 31987 148 53316917
Enterococcal infection 53.65 21.80 41 31960 7557 53309508
Constipation 53.60 21.80 26 31975 198386 53118679
Myelosuppression 53.18 21.80 51 31950 12777 53304288
Disseminated intravascular coagulation 52.58 21.80 62 31939 19657 53297408
Drug intolerance 52.44 21.80 29 31972 205464 53111601
Tumour lysis syndrome 52.35 21.80 41 31960 7833 53309232
Muscle spasms 52.18 21.80 9 31992 134786 53182279
Nodular melanoma 51.80 21.80 11 31990 50 53317015
Exposure during pregnancy 51.38 21.80 7 31994 124853 53192212
Graft versus host disease in liver 51.29 21.80 17 31984 503 53316562
Systemic candida 50.17 21.80 28 31973 3029 53314036
Clostridium difficile infection 48.40 21.80 71 31930 27822 53289243
Insomnia 48.31 21.80 26 31975 187046 53130019
Back pain 47.94 21.80 42 31959 234205 53082860
Blood pressure increased 47.05 21.80 13 31988 140466 53176599
Haemolysis 45.75 21.80 35 31966 6461 53310604
Gait disturbance 45.74 21.80 19 31982 158823 53158242
Escherichia bacteraemia 45.48 21.80 27 31974 3281 53313784
Refractory cytopenia with unilineage dysplasia 45.21 21.80 16 31985 579 53316486
Urinary tract infection 44.46 21.80 47 31954 239856 53077209
Aplastic anaemia 44.14 21.80 38 31963 8283 53308782
Weight increased 43.92 21.80 35 31966 204532 53112533
Cerebral toxoplasmosis 43.82 21.80 17 31984 798 53316267
Contusion 43.73 21.80 7 31994 110725 53206340
Therapeutic product effect decreased 43.27 21.80 11 31990 125644 53191421
Candida sepsis 43.24 21.80 20 31981 1456 53315609
Bacterial infection 43.23 21.80 53 31948 17494 53299571
Drug interaction 42.89 21.80 41 31960 219288 53097777
Clostridium difficile colitis 42.83 21.80 56 31945 19709 53297356
Rash 42.63 21.80 132 31869 446059 52871006
Human herpesvirus 6 encephalitis 42.48 21.80 11 31990 132 53316933
Myocardial infarction 42.25 21.80 5 31996 99349 53217716
Blood magnesium decreased 41.64 21.80 43 31958 11771 53305294
Muscle twitching 41.09 21.80 50 31951 16376 53300689
Malignant transformation 40.63 21.80 13 31988 343 53316722
Wound 40.48 21.80 4 31997 91553 53225512
Hepatic failure 40.31 21.80 75 31926 35731 53281334
Abdominal pain upper 40.24 21.80 25 31976 166266 53150799
Mucosal disorder 39.49 21.80 21 31980 2065 53315000
Bone marrow transplant rejection 39.48 21.80 9 31992 60 53317005
Human polyomavirus infection 39.27 21.80 12 31989 271 53316794
Palpitations 39.24 21.80 7 31994 102341 53214724
Neutropenic sepsis 38.96 21.80 46 31955 14603 53302462
Cryptosporidiosis infection 38.86 21.80 12 31989 281 53316784
Staphylococcal bacteraemia 38.63 21.80 29 31972 5204 53311861
Pseudomonal sepsis 38.63 21.80 21 31980 2158 53314907
Acute lymphocytic leukaemia 38.39 21.80 23 31978 2842 53314223
Infusion related reaction 38.36 21.80 23 31978 155934 53161131
Pericardial effusion 38.33 21.80 63 31938 27215 53289850
Infection 38.28 21.80 204 31797 172001 53145064
Respiratory syncytial virus infection 38.16 21.80 29 31972 5299 53311766
Urticaria 37.93 21.80 17 31984 135868 53181197
Klebsiella infection 37.66 21.80 34 31967 7892 53309173
Vomiting 37.65 21.80 162 31839 496977 52820088
Stenotrophomonas infection 37.22 21.80 19 31982 1717 53315348
Refractory cytopenia with multilineage dysplasia 37.20 21.80 10 31991 140 53316925
Pseudomonas infection 36.83 21.80 38 31963 10390 53306675
Toxic leukoencephalopathy 36.30 21.80 14 31987 647 53316418
Immune thrombocytopenia 36.27 21.80 36 31965 9402 53307663
Haematotoxicity 35.81 21.80 33 31968 7864 53309201
Cough 35.78 21.80 62 31939 256831 53060234
Immune reconstitution inflammatory syndrome 35.75 21.80 30 31971 6316 53310749
B-cell aplasia 35.68 21.80 8 31993 49 53317016
Scedosporium infection 35.66 21.80 13 31988 513 53316552
Disseminated toxoplasmosis 35.56 21.80 9 31992 98 53316967
Gastrooesophageal reflux disease 35.55 21.80 4 31997 82659 53234406
Alpha haemolytic streptococcal infection 35.46 21.80 15 31986 882 53316183
Mucormycosis 35.17 21.80 21 31980 2579 53314486
Asthenia 34.69 21.80 99 31902 343491 52973574
Mobility decreased 34.61 21.80 3 31998 76268 53240797
Serum amyloid A protein increased 34.53 21.80 9 31992 111 53316954
Febrile bone marrow aplasia 34.47 21.80 31 31970 7158 53309907
Graft versus host disease in eye 34.27 21.80 8 31993 60 53317005
Aphasia 34.06 21.80 64 31937 30714 53286351
Metastatic malignant melanoma 33.65 21.80 17 31984 1503 53315562
Hepatic enzyme increased 33.36 21.80 17 31984 126178 53190887
Recurrent cancer 33.34 21.80 18 31983 1824 53315241
Gene mutation 33.33 21.80 16 31985 1267 53315798
Geotrichum infection 33.25 21.80 12 31989 460 53316605
Dedifferentiated liposarcoma 32.76 21.80 7 31994 33 53317032
Chronic graft versus host disease in intestine 32.69 21.80 8 31993 75 53316990
Microsporidia infection 31.84 21.80 10 31991 248 53316817
Chronic graft versus host disease in liver 31.54 21.80 10 31991 256 53316809
Musculoskeletal pain 31.44 21.80 4 31997 75196 53241869
Cerebrovascular accident 31.21 21.80 12 31989 105162 53211903
Erythema 31.07 21.80 29 31972 156940 53160125
Skin toxicity 30.92 21.80 23 31978 4070 53312995
Retinal haemorrhage 30.74 21.80 25 31976 5040 53312025
Brain oedema 30.29 21.80 39 31962 13519 53303546
Myocarditis 30.16 21.80 31 31970 8437 53308628
Delayed engraftment 29.96 21.80 8 31993 109 53316956
Myalgia 29.70 21.80 22 31979 133469 53183596
Hepatitis B 29.69 21.80 22 31979 3870 53313195
Polyomavirus viraemia 29.52 21.80 11 31990 462 53316603
Mycobacterium kansasii infection 29.31 21.80 8 31993 119 53316946
Capillary leak syndrome 29.24 21.80 17 31984 1987 53315078
Gastroenteritis norovirus 29.10 21.80 16 31985 1681 53315384
Myeloid leukaemia 28.87 21.80 10 31991 339 53316726
Disseminated tuberculosis 28.48 21.80 19 31982 2830 53314235
Dysplasia 28.25 21.80 12 31989 713 53316352
B-cell small lymphocytic lymphoma 27.79 21.80 6 31995 30 53317035
Metastases to diaphragm 27.46 21.80 6 31995 32 53317033
Enterobacter bacteraemia 27.13 21.80 9 31992 267 53316798
Diarrhoea 26.93 21.80 243 31758 625303 52691762
Bronchitis 26.82 21.80 17 31984 111882 53205183
Haemoglobin decreased 26.73 21.80 157 31844 137150 53179915
Liver disorder 26.69 21.80 68 31933 40087 53276978
Peritoneal mesothelioma malignant 26.61 21.80 5 31996 10 53317055
Escherichia sepsis 26.52 21.80 22 31979 4559 53312506
Adrenal haemorrhage 26.46 21.80 10 31991 437 53316628
Gastritis fungal 26.38 21.80 7 31994 93 53316972
Systemic inflammatory response syndrome 26.34 21.80 24 31977 5636 53311429
Pleural effusion 26.22 21.80 114 31887 88465 53228600
Blood glucose increased 26.19 21.80 7 31994 77354 53239711
Blindness cortical 25.81 21.80 10 31991 468 53316597
Cardiac failure 25.81 21.80 111 31890 85733 53231332
Gastrointestinal toxicity 25.77 21.80 22 31979 4740 53312325
Venous haemorrhage 25.68 21.80 8 31993 193 53316872
Wrong technique in product usage process 25.57 21.80 3 31998 60029 53257036
Bronchiolitis 25.53 21.80 17 31984 2523 53314542
Lymphoproliferative disorder 25.41 21.80 18 31983 2954 53314111
B-lymphocyte count abnormal 25.04 21.80 6 31995 51 53317014
Fungal sepsis 24.60 21.80 13 31988 1262 53315803
Neoplasm progression 24.56 21.80 55 31946 29864 53287201
Idiopathic pneumonia syndrome 24.50 21.80 9 31992 363 53316702
Dyspepsia 24.48 21.80 8 31993 77592 53239473
Acquired gene mutation 24.24 21.80 11 31990 766 53316299
Graft complication 24.22 21.80 8 31993 234 53316831
Lung consolidation 24.22 21.80 20 31981 4118 53312947
Syncope 24.22 21.80 19 31982 111974 53205091
Hyperhidrosis 24.18 21.80 14 31987 96779 53220286
Leukoerythroblastosis 24.16 21.80 8 31993 236 53316829
Endothelial dysfunction 24.05 21.80 7 31994 133 53316932
Encephalitis cytomegalovirus 24.03 21.80 10 31991 564 53316501
Guillain-Barre syndrome 23.68 21.80 19 31982 3756 53313309
Hyperbilirubinaemia 23.42 21.80 31 31970 11038 53306027
Impaired healing 23.32 21.80 5 31996 64200 53252865
Haemolytic anaemia 23.27 21.80 30 31971 10409 53306656
Out of specification test results 23.25 21.80 6 31995 71 53316994
Gastroenteritis adenovirus 23.21 21.80 7 31994 151 53316914
Sinusitis 23.16 21.80 41 31960 168523 53148542
Hilar lymphadenopathy 23.12 21.80 12 31989 1123 53315942
Growth retardation 23.03 21.80 12 31989 1132 53315933
Hepatic function abnormal 23.00 21.80 61 31940 36838 53280227
Primary mediastinal large B-cell lymphoma 22.99 21.80 5 31996 26 53317039
Dry mouth 22.98 21.80 4 31997 59546 53257519
Refractory anaemia with an excess of blasts 22.97 21.80 9 31992 434 53316631
Hepatic vein occlusion 22.87 21.80 6 31995 76 53316989
Septic embolus 22.78 21.80 11 31990 882 53316183
Cytomegalovirus enterocolitis 22.73 21.80 10 31991 647 53316418
Hypoglycaemia 22.69 21.80 4 31997 59009 53258056
Neutropenic infection 22.61 21.80 12 31989 1175 53315890
Hepatic necrosis 22.22 21.80 22 31979 5728 53311337
Dehydration 22.21 21.80 42 31959 168368 53148697
Blood bilirubin increased 22.20 21.80 59 31942 35671 53281394
Acute promyelocytic leukaemia 22.17 21.80 11 31990 936 53316129
Chest pain 22.08 21.80 51 31950 190134 53126931
Metastases to bone marrow 22.03 21.80 8 31993 312 53316753
Obliterative bronchiolitis 21.93 21.80 14 31987 1936 53315129

FDA Adverse Event Reporting System (Male)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Cytokine release syndrome 1579.10 17.21 633 47308 12902 32452683
Acute graft versus host disease 1527.20 17.21 507 47434 5863 32459722
Acute graft versus host disease in skin 1130.16 17.21 380 47561 4577 32461008
Cytomegalovirus infection 1084.23 17.21 593 47348 24871 32440714
Graft versus host disease 836.23 17.21 378 47563 10428 32455157
Chronic graft versus host disease 722.95 17.21 265 47676 4175 32461410
Febrile neutropenia 644.50 17.21 835 47106 118731 32346854
Hypogammaglobulinaemia 581.21 17.21 248 47693 5928 32459657
Graft versus host disease in gastrointestinal tract 581.08 17.21 211 47730 3230 32462355
Adenovirus infection 561.81 17.21 224 47717 4480 32461105
Epstein-Barr virus infection 526.22 17.21 241 47700 6849 32458736
Acute graft versus host disease in intestine 495.76 17.21 174 47767 2399 32463186
Graft versus host disease in skin 470.30 17.21 183 47758 3421 32462164
Venoocclusive liver disease 465.29 17.21 224 47717 7141 32458444
Cystitis haemorrhagic 450.44 17.21 196 47745 4918 32460667
Neurotoxicity 429.67 17.21 271 47670 14799 32450786
Progressive multifocal leukoencephalopathy 407.95 17.21 223 47718 9308 32456277
Pyrexia 384.45 17.21 1186 46755 318782 32146803
Mucosal inflammation 360.94 17.21 337 47604 33097 32432488
Myelodysplastic syndrome 355.30 17.21 269 47672 19769 32445816
BK virus infection 349.90 17.21 162 47779 4719 32460866
Haemophagocytic lymphohistiocytosis 331.01 17.21 207 47734 11128 32454457
Cytomegalovirus viraemia 328.92 17.21 172 47769 6555 32459030
Cytopenia 327.61 17.21 197 47744 9867 32455718
Product use in unapproved indication 314.53 17.21 504 47437 86700 32378885
Human herpesvirus 6 infection 311.37 17.21 116 47825 1914 32463671
Thrombotic microangiopathy 307.08 17.21 185 47756 9297 32456288
Cytomegalovirus infection reactivation 305.70 17.21 132 47809 3247 32462338
Post transplant lymphoproliferative disorder 287.60 17.21 150 47791 5684 32459901
Acute myeloid leukaemia recurrent 284.05 17.21 107 47834 1823 32463762
Venoocclusive disease 270.68 17.21 114 47827 2632 32462953
Acute myeloid leukaemia 270.38 17.21 225 47716 18949 32446636
Acute lymphocytic leukaemia recurrent 261.60 17.21 115 47826 2957 32462628
Neutropenia 246.42 17.21 604 47337 141571 32324014
Immune effector cell-associated neurotoxicity syndrome 241.95 17.21 90 47851 1478 32464107
Lymphocyte count decreased 233.84 17.21 216 47725 20903 32444682
Posterior reversible encephalopathy syndrome 230.68 17.21 155 47786 9421 32456164
Multiple organ dysfunction syndrome 229.12 17.21 387 47554 69467 32396118
Bone marrow failure 226.64 17.21 251 47690 30153 32435432
Acute graft versus host disease in liver 223.67 17.21 82 47859 1290 32464295
Transplant failure 220.86 17.21 99 47842 2669 32462916
Diffuse large B-cell lymphoma 218.42 17.21 143 47798 8319 32457266
Autoimmune haemolytic anaemia 202.92 17.21 108 47833 4266 32461319
Fatigue 195.68 17.21 140 47801 350561 32115024
Bronchopulmonary aspergillosis 189.58 17.21 159 47782 13528 32452057
Chronic graft versus host disease in skin 186.26 17.21 63 47878 771 32464814
Fall 176.87 17.21 37 47904 196164 32269421
Pancytopenia 173.34 17.21 402 47539 90833 32374752
Chronic lymphocytic leukaemia 173.00 17.21 101 47840 4784 32460801
Viral haemorrhagic cystitis 171.59 17.21 61 47880 874 32464711
Leukaemia recurrent 171.47 17.21 71 47870 1568 32464017
Engraftment syndrome 167.62 17.21 60 47881 878 32464707
Dizziness 154.70 17.21 58 47883 209560 32256025
Dyspnoea 142.65 17.21 196 47745 361849 32103736
Chronic lymphocytic leukaemia recurrent 142.31 17.21 44 47897 395 32465190
Drug interaction 139.61 17.21 74 47867 218111 32247474
JC virus infection 136.90 17.21 64 47877 1905 32463680
Cystitis viral 134.81 17.21 44 47897 478 32465107
Asthenia 134.21 17.21 92 47849 235852 32229733
Epstein-Barr viraemia 132.89 17.21 52 47889 986 32464599
Haematocrit decreased 132.12 17.21 196 47745 31466 32434119
Epstein-Barr virus associated lymphoproliferative disorder 130.38 17.21 61 47880 1819 32463766
Bacteraemia 130.35 17.21 145 47796 17488 32448097
Aspergillus infection 127.34 17.21 118 47823 11456 32454129
Completed suicide 122.15 17.21 3 47938 92514 32373071
B-cell type acute leukaemia 120.20 17.21 36 47905 287 32465298
Arthralgia 120.08 17.21 35 47906 148413 32317172
Toxoplasmosis 119.72 17.21 52 47889 1297 32464288
Off label use 117.32 17.21 812 47129 305508 32160077
Myocardial infarction 116.71 17.21 22 47919 125654 32339931
Neutrophil count decreased 112.62 17.21 228 47713 46911 32418674
Fungal infection 111.99 17.21 125 47816 15130 32450455
Pain 109.45 17.21 71 47870 187485 32278100
Herpes simplex 108.69 17.21 77 47864 5097 32460488
Graft versus host disease in liver 108.67 17.21 46 47895 1075 32464510
Pneumonia cytomegaloviral 106.69 17.21 62 47879 2910 32462675
Rhinovirus infection 104.52 17.21 64 47877 3309 32462276
Overdose 104.17 17.21 6 47935 87071 32378514
Cytomegalovirus test positive 103.90 17.21 67 47874 3795 32461790
Bone marrow transplant rejection 103.24 17.21 29 47912 179 32465406
Fusarium infection 99.80 17.21 43 47898 1051 32464534
Engraft failure 99.14 17.21 34 47907 435 32465150
Constipation 98.21 17.21 32 47909 126341 32339244
Encephalitis viral 95.06 17.21 43 47898 1184 32464401
Second primary malignancy 94.79 17.21 80 47861 6861 32458724
Anxiety 93.06 17.21 15 47926 95990 32369595
Encephalitis cytomegalovirus 89.60 17.21 33 47908 526 32465059
Pain in extremity 89.11 17.21 32 47909 118869 32346716
Lymphopenia 88.65 17.21 108 47833 14348 32451237
Encephalitis 87.69 17.21 77 47864 6967 32458618
Mucormycosis 87.32 17.21 70 47871 5584 32460001
Nausea 85.32 17.21 220 47721 320629 32144956
Sepsis 85.26 17.21 460 47481 158374 32307211
Lymphadenopathy 84.63 17.21 147 47794 26935 32438650
Respiratory failure 84.32 17.21 347 47594 106835 32358750
Stem cell transplant 84.05 17.21 48 47893 2179 32463406
Human herpesvirus 6 encephalitis 83.18 17.21 25 47916 202 32465383
Death 82.57 17.21 289 47652 382228 32083357
Microsporidia infection 82.35 17.21 32 47909 595 32464990
Insomnia 82.31 17.21 23 47918 100325 32365260
Respiratory syncytial virus infection 80.61 17.21 57 47884 3761 32461824
Malaise 79.97 17.21 86 47855 177052 32288533
Weight decreased 78.97 17.21 76 47865 164742 32300843
Pneumonia fungal 78.88 17.21 69 47872 6211 32459374
Systemic mycosis 76.70 17.21 39 47902 1399 32464186
Chest pain 73.71 17.21 46 47895 124091 32341494
Pruritus 71.96 17.21 51 47890 128651 32336934
Cytomegalovirus chorioretinitis 71.84 17.21 52 47889 3560 32462025
Nasopharyngitis 71.62 17.21 6 47935 63781 32401804
Bacterial infection 70.69 17.21 95 47846 13911 32451674
Gait disturbance 70.63 17.21 16 47925 80392 32385193
Chronic graft versus host disease in liver 70.34 17.21 24 47917 302 32465283
Encephalopathy 68.30 17.21 154 47787 34103 32431482
Idiopathic pneumonia syndrome 68.16 17.21 22 47919 230 32465355
Thrombocytopenia 68.05 17.21 412 47529 147887 32317698
Epstein-Barr virus infection reactivation 67.28 17.21 26 47915 476 32465109
Minimal residual disease 65.97 17.21 23 47918 310 32465275
Cerebral aspergillosis 65.49 17.21 35 47906 1393 32464192
Varicella zoster virus infection 65.31 17.21 36 47905 1525 32464060
Dehydration 63.46 17.21 58 47883 128900 32336685
Pseudomonas infection 62.72 17.21 83 47858 11973 32453612
Cerebral toxoplasmosis 62.34 17.21 35 47906 1537 32464048
Platelet count decreased 62.17 17.21 333 47608 114258 32351327
Diffuse large B-cell lymphoma recurrent 62.07 17.21 42 47899 2580 32463005
Depression 61.83 17.21 33 47908 97027 32368558
Blood pressure increased 61.78 17.21 20 47921 79334 32386251
Parainfluenzae virus infection 61.53 17.21 40 47901 2297 32463288
Peripheral swelling 61.23 17.21 13 47928 68332 32397253
White blood cell count decreased 60.80 17.21 281 47660 90917 32374668
Hypoxia 60.76 17.21 192 47749 51940 32413645
Meningoencephalitis herpetic 60.02 17.21 28 47913 829 32464756
Chronic lymphocytic leukaemia transformation 59.62 17.21 19 47922 190 32465395
Infection 59.43 17.21 265 47676 84450 32381135
Adenoviral haemorrhagic cystitis 59.02 17.21 23 47918 431 32465154
Septic shock 58.72 17.21 229 47712 68760 32396825
Bacterial sepsis 58.15 17.21 54 47887 5254 32460331
Muscle spasms 57.99 17.21 16 47925 70402 32395183
Stenotrophomonas infection 57.58 17.21 35 47906 1785 32463800
Feeling abnormal 57.29 17.21 10 47931 60413 32405172
Hypoglycaemia 56.17 17.21 7 47934 54375 32411210
Syncope 55.43 17.21 32 47909 90092 32375493
Blood glucose increased 55.29 17.21 14 47927 65227 32400358
Rhabdomyolysis 54.06 17.21 16 47925 67249 32398336
Disseminated intravascular coagulation 54.00 17.21 111 47830 23065 32442520
Pneumonia respiratory syncytial viral 53.75 17.21 26 47915 836 32464749
Chronic obstructive pulmonary disease 53.60 17.21 5 47936 48748 32416837
Obliterative bronchiolitis 53.36 17.21 29 47912 1194 32464391
Leukoencephalopathy 53.17 17.21 46 47895 4079 32461506
Toxicity to various agents 52.83 17.21 115 47826 177926 32287659
Staphylococcal sepsis 52.73 17.21 69 47872 9844 32455741
Hepatic failure 52.69 17.21 143 47798 35537 32430048
Chronic graft versus host disease in intestine 52.58 17.21 18 47923 229 32465356
Graft versus host disease in eye 52.15 17.21 18 47923 235 32465350
B-cell aplasia 51.99 17.21 14 47927 72 32465513
Capillary leak syndrome 50.84 17.21 33 47908 1890 32463695
Toxic leukoencephalopathy 50.68 17.21 18 47923 257 32465328
Joint swelling 50.29 17.21 8 47933 51727 32413858
Vomiting 49.97 17.21 179 47762 235378 32230207
Pre-engraftment immune reaction 49.90 17.21 14 47927 86 32465499
Asthma 49.86 17.21 4 47937 44061 32421524
Foetal exposure during pregnancy 48.90 17.21 3 47938 41298 32424287
Cerebrovascular accident 48.49 17.21 34 47907 86286 32379299
Chronic lymphocytic leukaemia refractory 48.20 17.21 14 47927 99 32465486
Drug hypersensitivity 48.15 17.21 24 47917 73376 32392209
Diarrhoea 48.12 17.21 328 47613 364474 32101111
Pneumatosis intestinalis 47.89 17.21 40 47901 3380 32462205
Adenovirus reactivation 47.37 17.21 14 47927 106 32465479
Polyomavirus viraemia 47.29 17.21 22 47919 647 32464938
Autoimmune lymphoproliferative syndrome 46.89 17.21 15 47926 152 32465433
Tumour lysis syndrome 46.79 17.21 80 47861 14467 32451118
Mucosal disorder 46.52 17.21 30 47911 1699 32463886
Acute respiratory distress syndrome 46.45 17.21 110 47831 25143 32440442
Back pain 45.67 17.21 58 47883 110995 32354590
Nephropathy toxic 45.62 17.21 71 47870 11875 32453710
Aphasia 45.32 17.21 97 47844 20731 32444854
Acute lymphocytic leukaemia 44.88 17.21 39 47902 3479 32462106
Enterococcal infection 44.57 17.21 61 47880 9086 32456499
Out of specification test results 43.61 17.21 10 47931 22 32465563
B-lymphocyte count abnormal 43.46 17.21 9 47932 9 32465576
Blood stem cell transplant failure 43.11 17.21 18 47923 406 32465179
Pulmonary embolism 43.10 17.21 36 47905 83623 32381962
Haemolysis 42.92 17.21 55 47886 7686 32457899
Klebsiella sepsis 42.77 17.21 29 47912 1787 32463798
Enterococcal sepsis 42.49 17.21 28 47913 1645 32463940
Pneumocystis jirovecii pneumonia 42.35 17.21 89 47852 18781 32446804
Candida sepsis 42.24 17.21 25 47916 1214 32464371
Lymphoproliferative disorder 41.94 17.21 33 47908 2562 32463023
Weight increased 41.88 17.21 37 47904 83626 32381959
5q minus syndrome 41.71 17.21 14 47927 167 32465418
Decreased appetite 41.28 17.21 112 47829 160701 32304884
Candida infection 40.95 17.21 82 47859 16721 32448864
Viral sinusitis 40.78 17.21 11 47930 57 32465528
Autoimmune neutropenia 40.76 17.21 16 47925 306 32465279
Aplastic anaemia 40.28 17.21 52 47889 7321 32458264
Haemolytic anaemia 40.10 17.21 63 47878 10621 32454964
Blood creatine phosphokinase increased 40.02 17.21 9 47932 45467 32420118
Hyperhidrosis 40.01 17.21 28 47913 71140 32394445
Serum ferritin increased 39.86 17.21 47 47894 6032 32459553
Abdominal discomfort 39.66 17.21 14 47927 52610 32412975
Pulmonary haemorrhage 39.63 17.21 60 47881 9797 32455788
Acute myocardial infarction 39.35 17.21 16 47925 55133 32410452
Rash 39.29 17.21 167 47774 209166 32256419
Staphylococcal infection 39.19 17.21 121 47820 32318 32433267
Suicidal ideation 39.09 17.21 5 47936 38078 32427507
Leukaemic infiltration 39.01 17.21 11 47930 69 32465516
Immune thrombocytopenia 38.91 17.21 55 47886 8442 32457143
Neurological decompensation 38.70 17.21 32 47909 2666 32462919
Coronary artery disease 37.85 17.21 13 47928 49693 32415892
Blood fibrinogen decreased 37.67 17.21 22 47919 1042 32464543
Hyperkalaemia 37.19 17.21 29 47912 69721 32395864
Neutropenic sepsis 37.16 17.21 67 47874 12632 32452953
Malignant neoplasm progression 37.15 17.21 220 47721 78276 32387309
Meningomyelitis herpes 36.77 17.21 9 47932 29 32465556
Organic brain syndrome 36.70 17.21 14 47927 247 32465338
Condition aggravated 36.59 17.21 113 47828 155548 32310037
Intentional product misuse 36.36 17.21 5 47936 36046 32429539
Hepatic vein occlusion 36.31 17.21 12 47929 136 32465449
Aggression 36.30 17.21 7 47934 39382 32426203
Glomerulosclerosis 35.74 17.21 19 47922 748 32464837
Splenomegaly 35.70 17.21 71 47870 14406 32451179
Meningitis cryptococcal 35.50 17.21 28 47913 2181 32463404
Bradycardia 35.39 17.21 32 47909 71530 32394055
Loss of consciousness 35.25 17.21 42 47899 82665 32382920
Dyspepsia 34.76 17.21 4 47937 33051 32432534
Headache 34.71 17.21 160 47781 196037 32269548
Therapeutic product effect decreased 34.58 17.21 3 47938 31014 32434571
Post transplant distal limb syndrome 34.28 17.21 14 47927 298 32465287
Escherichia sepsis 34.28 17.21 37 47904 4311 32461274
Herpes virus infection 33.84 17.21 30 47911 2748 32462837
Hepatitis B reactivation 33.81 17.21 33 47908 3416 32462169
Cardiac disorder 33.56 17.21 10 47931 41856 32423729
Chimerism 33.54 17.21 13 47928 240 32465345
Musculoskeletal pain 33.19 17.21 4 47937 31893 32433692
Hypoaesthesia 32.74 17.21 23 47918 58330 32407255
Mucosal toxicity 32.48 17.21 12 47929 193 32465392
Somnolence 32.47 17.21 65 47876 103732 32361853
Non-Hodgkin's lymphoma recurrent 32.18 17.21 8 47933 28 32465557
Transplant rejection 32.17 17.21 55 47886 9944 32455641
Viraemia 31.74 17.21 21 47920 1242 32464343
Systemic candida 31.68 17.21 30 47911 2991 32462594
Aplasia pure red cell 31.59 17.21 41 47900 5801 32459784
Stomatitis 31.37 17.21 130 47811 40099 32425486
Chronic kidney disease 31.23 17.21 10 47931 39965 32425620
Infection reactivation 30.94 17.21 20 47921 1137 32464448
Apoptosis 30.89 17.21 12 47929 223 32465362
Unevaluable event 30.88 17.21 6 47935 33580 32432005
Chloroma 30.57 17.21 15 47926 498 32465087
Respiratory tract infection fungal 30.44 17.21 17 47924 739 32464846
Acute erythroid leukaemia 30.42 17.21 11 47930 166 32465419
Myelitis 30.39 17.21 17 47924 741 32464844
Musculoskeletal stiffness 30.36 17.21 10 47931 39254 32426331
Gastrooesophageal reflux disease 30.31 17.21 7 47934 34731 32430854
Urticaria 30.27 17.21 26 47915 59588 32405997
Lymphocytosis 30.14 17.21 25 47916 2092 32463493
Disseminated toxoplasmosis 30.06 17.21 8 47933 39 32465546
Refractory anaemia with an excess of blasts 30.06 17.21 14 47927 413 32465172
Human herpesvirus 6 infection reactivation 29.89 17.21 10 47931 118 32465467
Poikiloderma 29.54 17.21 11 47930 181 32465404
Rubulavirus test positive 29.50 17.21 6 47935 5 32465580
Treatment noncompliance 29.35 17.21 3 47938 27199 32438386
Hypokalaemia 29.25 17.21 23 47918 55071 32410514
Fungal sepsis 29.02 17.21 18 47923 952 32464633
Angioedema 28.49 17.21 9 47932 36280 32429305
Myelosuppression 28.47 17.21 57 47884 11619 32453966
Coronavirus infection 28.24 17.21 31 47910 3681 32461904
Urge incontinence 28.22 17.21 14 47927 476 32465109
Plasma cell myeloma 28.20 17.21 26 47915 57588 32407997
International normalised ratio increased 27.94 17.21 19 47922 49016 32416569
Organising pneumonia 27.85 17.21 38 47903 5643 32459942
Roseolovirus test positive 27.72 17.21 9 47932 96 32465489
Stenotrophomonas sepsis 27.55 17.21 9 47932 98 32465487
Transient ischaemic attack 27.43 17.21 3 47938 25791 32439794
Autoimmune pancytopenia 27.31 17.21 9 47932 101 32465484
Haemoglobin decreased 27.26 17.21 283 47658 119388 32346197
Cytokine storm 27.07 17.21 15 47926 642 32464943
Aplasia 26.92 17.21 33 47908 4409 32461176
Epstein-Barr virus test positive 26.89 17.21 14 47927 528 32465057
Neoplasm recurrence 26.73 17.21 23 47918 2024 32463561
CNS ventriculitis 26.68 17.21 11 47930 240 32465345
Eccrine squamous syringometaplasia 26.67 17.21 7 47934 32 32465553
Chest discomfort 26.63 17.21 21 47920 50209 32415376
Hyponatraemia 26.58 17.21 43 47898 74470 32391115
Diabetes mellitus 26.42 17.21 17 47924 45156 32420429
Pneumonia adenoviral 26.40 17.21 10 47931 173 32465412
Dry skin 26.32 17.21 3 47938 24975 32440610
Bladder hypertrophy 26.32 17.21 14 47927 552 32465033
Neoplasm progression 26.27 17.21 76 47865 19582 32446003
Graft versus host disease in lung 26.22 17.21 14 47927 556 32465029
Achromobacter infection 26.16 17.21 8 47933 69 32465516
Pseudomonal sepsis 26.05 17.21 27 47914 3002 32462583
Bronchiolitis obliterans syndrome 25.98 17.21 10 47931 181 32465404
Bordetella infection 25.97 17.21 9 47932 119 32465466
Enterococcal bacteraemia 25.92 17.21 21 47920 1700 32463885
Cardiac failure congestive 25.79 17.21 54 47887 84798 32380787
Thrombosis 25.71 17.21 18 47923 45736 32419849
Haptoglobin decreased 25.46 17.21 14 47927 590 32464995
Kidney fibrosis 25.34 17.21 23 47918 2172 32463413
Myeloid leukaemia 25.27 17.21 12 47929 370 32465215
Viral myocarditis 25.25 17.21 9 47932 130 32465455
Abdominal pain 25.21 17.21 124 47817 149405 32316180
Pneumonia viral 24.99 17.21 26 47915 2904 32462681
Meningitis viral 24.99 17.21 16 47925 895 32464690
NPM1 gene mutation 24.94 17.21 9 47932 135 32465450
Primary amyloidosis 24.87 17.21 9 47932 136 32465449
Upper gastrointestinal haemorrhage 24.79 17.21 3 47938 23846 32441739
Palpitations 24.75 17.21 11 47930 35958 32429627
Retinitis viral 24.50 17.21 8 47933 87 32465498
Cardiac arrest 24.35 17.21 68 47873 96708 32368877
Complications of bone marrow transplant 24.31 17.21 10 47931 217 32465368
Angina pectoris 24.30 17.21 8 47933 31418 32434167
Mobility decreased 24.24 17.21 6 47935 28403 32437182
Pleural effusion 24.14 17.21 199 47742 78793 32386792
Sleep disorder 24.13 17.21 5 47936 26747 32438838
Reticulocytosis 24.11 17.21 11 47930 309 32465276
Arthritis 24.05 17.21 5 47936 26687 32438898
Chronic myelomonocytic leukaemia 24.01 17.21 14 47927 661 32464924
Pulmonary alveolar haemorrhage 23.98 17.21 40 47901 7089 32458496
Clostridium difficile infection 23.97 17.21 69 47872 17727 32447858
Oedema peripheral 23.93 17.21 87 47854 114004 32351581
Plasmablastic lymphoma 23.85 17.21 11 47930 317 32465268
Clostridium difficile colitis 23.76 17.21 60 47881 14271 32451314
Cryptosporidiosis infection 23.69 17.21 12 47929 427 32465158
Meningitis tuberculous 23.59 17.21 14 47927 683 32464902
Dysbiosis 23.21 17.21 12 47929 446 32465139
Hyperbilirubinaemia 23.17 17.21 68 47873 17662 32447923
Medication error 23.02 17.21 3 47938 22532 32443053
Swelling 22.88 17.21 14 47927 38208 32427377
Chronic myeloid leukaemia recurrent 22.84 17.21 9 47932 174 32465411
Meningeal neoplasm 22.82 17.21 7 47934 61 32465524
Heart rate increased 22.79 17.21 17 47924 41811 32423774
Skin toxicity 22.62 17.21 28 47913 3778 32461807
Hepatitis viral 22.41 17.21 13 47928 608 32464977
Flushing 22.25 17.21 9 47932 31118 32434467
Cardio-respiratory arrest 22.22 17.21 30 47911 55959 32409626
Evans syndrome 22.18 17.21 10 47931 273 32465312
Refractory cytopenia with unilineage dysplasia 22.13 17.21 12 47929 492 32465093
Myalgia 22.01 17.21 55 47886 81175 32384410
Rectal haemorrhage 22.00 17.21 14 47927 37409 32428176
Contusion 21.85 17.21 11 47930 33457 32432128
Non-Hodgkin's lymphoma 21.71 17.21 19 47922 1711 32463874
Balance disorder 21.55 17.21 16 47925 39443 32426142
Paraneoplastic pemphigus 21.53 17.21 7 47934 75 32465510
Dysphagia 21.43 17.21 36 47905 61440 32404145
Cytomegalovirus gastroenteritis 21.23 17.21 9 47932 211 32465374
Hallucination 21.08 17.21 28 47913 52591 32412994
Varicella 20.97 17.21 18 47923 1579 32464006
Transplantation associated food allergy 20.96 17.21 6 47935 40 32465545
Device related infection 20.83 17.21 66 47875 17867 32447718
Influenza like illness 20.83 17.21 7 47934 27133 32438452
Precursor T-lymphoblastic lymphoma/leukaemia 20.82 17.21 7 47934 84 32465501
Premature ageing 20.82 17.21 7 47934 84 32465501
Blood bilirubin unconjugated increased 20.73 17.21 13 47928 701 32464884
Gallbladder adenocarcinoma 20.70 17.21 5 47936 15 32465570
Hepatosplenomegaly 20.50 17.21 27 47914 3876 32461709
Refractory cytopenia with multilineage dysplasia 20.48 17.21 8 47933 151 32465434
Injury 20.39 17.21 4 47937 22241 32443344
Disseminated Bacillus Calmette-Guerin infection 20.37 17.21 9 47932 234 32465351
Paraesthesia 20.11 17.21 35 47906 58909 32406676
Wheezing 20.07 17.21 15 47926 36859 32428726
Cerebral fungal infection 20.06 17.21 9 47932 243 32465342
Adenoviral hepatitis 20.02 17.21 9 47932 244 32465341
Abnormal behaviour 20.01 17.21 7 47934 26459 32439126
Hypersensitivity 19.97 17.21 34 47907 57724 32407861
Lung infiltration 19.96 17.21 53 47888 12995 32452590
Drug withdrawal syndrome 19.95 17.21 3 47938 20228 32445357
Neutrophil Pelger-Huet anomaly present 19.86 17.21 9 47932 249 32465336
Polymyositis 19.83 17.21 17 47924 1489 32464096
Gastroenteritis norovirus 19.77 17.21 17 47924 1495 32464090
Gait inability 19.70 17.21 3 47938 20044 32445541
Arrhythmia 19.68 17.21 14 47927 35289 32430296
Adenomatous polyposis coli 19.64 17.21 8 47933 169 32465416
Arthritis fungal 19.64 17.21 7 47934 101 32465484
Spirochaetal infection 19.39 17.21 5 47936 21 32465564
Drug resistance 19.32 17.21 76 47865 22889 32442696
Haematoma 19.06 17.21 7 47934 25677 32439908
Retinal infiltrates 19.03 17.21 5 47936 23 32465562
Drug intolerance 18.85 17.21 28 47913 50207 32415378
Bronchitis 18.85 17.21 20 47921 41487 32424098
Coombs direct test positive 18.76 17.21 9 47932 284 32465301
Infection in an immunocompromised host 18.74 17.21 12 47929 671 32464914
Citrobacter infection 18.70 17.21 11 47930 528 32465057
Product quality issue 18.63 17.21 3 47938 19230 32446355
Osteonecrosis of jaw 18.54 17.21 3 47938 19163 32446422
Acute kidney injury 18.49 17.21 313 47628 293155 32172430
Diffuse alveolar damage 18.43 17.21 19 47922 2100 32463485
B-cell lymphoma 18.40 17.21 28 47913 4591 32460994
Pneumonia parainfluenzae viral 18.33 17.21 7 47934 124 32465461
Cytomegalovirus colitis 18.28 17.21 21 47920 2621 32462964
Karyotype analysis abnormal 18.23 17.21 6 47935 67 32465518
Paraparesis 18.17 17.21 18 47923 1897 32463688
Haematemesis 18.17 17.21 9 47932 27626 32437959
Gastroenteritis sapovirus 18.07 17.21 7 47934 129 32465456
Gout 17.96 17.21 3 47938 18725 32446860
Gastrointestinal infection 17.93 17.21 26 47915 4085 32461500
Growth retardation 17.72 17.21 17 47924 1722 32463863
Corynebacterium infection 17.69 17.21 10 47931 445 32465140
Staphylococcal bacteraemia 17.64 17.21 36 47905 7440 32458145
Human herpes virus 6 serology positive 17.59 17.21 7 47934 139 32465446
Generalised oedema 17.39 17.21 49 47892 12434 32453151
Fungaemia 17.26 17.21 20 47921 2519 32463066

Pharmacologic Action:

SourceCodeDescription
FDA MoA N0000000233 Nucleic Acid Synthesis Inhibitors
FDA EPC N0000175595 Nucleoside Metabolic Inhibitor
MeSH PA D000970 Antineoplastic Agents
MeSH PA D000963 Antimetabolites
MeSH PA D000964 Antimetabolites, Antineoplastic
MeSH PA D007155 Immunologic Factors
MeSH PA D007166 Immunosuppressive Agents
MeSH PA D009676 Noxae
CHEBI has role CHEBI:22587 antiviral agents
CHEBI has role CHEBI:35221 antimetabolite
CHEBI has role CHEBI:35610 cytostatic
CHEBI has role CHEBI:35705 immunosuppressant
CHEBI has role CHEBI:50266 Prodrugs
CHEBI has role CHEBI:59517 DNA synthesis inhibitors

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Chronic lymphoid leukemia, disease indication 92814006
Low-grade B cell non-Hodgkin lymphoma indication 118601006
Mantle cell lymphoma indication 443487006
Acute myeloid leukemia, disease off-label use 91861009
Waldenström macroglobulinemia off-label use 190818004 DOID:0050747
Follicular non-Hodgkin's lymphoma off-label use 308121000
Mycosis contraindication 3218000 DOID:1564
Herpes zoster contraindication 4740000 DOID:8536
Acquired hemolytic anemia contraindication 4854004
Acquired factor VIII deficiency disease contraindication 14230004
Progressive multifocal leukoencephalopathy contraindication 22255007 DOID:643
Feeling agitated contraindication 24199005
Idiopathic thrombocytopenic purpura contraindication 32273002 DOID:8924
Extrinsic allergic alveolitis contraindication 37471005 DOID:841
Conduction disorder of the heart contraindication 44808001
Acute nephropathy contraindication 58574008
Acute infectious disease contraindication 63171007
Interstitial pneumonia contraindication 64667001
Optic neuritis contraindication 66760008 DOID:1210
Evans syndrome contraindication 75331009 DOID:8931
Disorder of optic nerve contraindication 77157004 DOID:1891
Bacterial infectious disease contraindication 87628006
Pancytopenia contraindication 127034005 DOID:12450
Autoimmune thrombocytopenia contraindication 128091003
Seizure disorder contraindication 128613002
Liver function tests abnormal contraindication 166603001
Decompensated cardiac failure contraindication 195111005
Impaired renal function disorder contraindication 197663003
Edema contraindication 267038008
Anemia contraindication 271737000 DOID:2355
Uric acid renal calculus contraindication 274401005
Pregnancy, function contraindication 289908002
Neutropenic disorder contraindication 303011007 DOID:1227
Bone marrow depression contraindication 307762000
Coma contraindication 371632003
Impaired cognition contraindication 386806002
Visual impairment contraindication 397540003
Autoimmune hemolytic anemia contraindication 413603009 DOID:718
Breastfeeding (mother) contraindication 413712001
Chemotherapy-Induced Hyperuricemia contraindication
CNS Toxicity contraindication

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 1.31 acidic
pKa2 6.36 acidic
pKa3 12.46 acidic
pKa4 13.04 acidic
pKa5 2.93 Basic
pKa6 2.33 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
10MG OFORTA SANOFI AVENTIS US N022273 Dec. 18, 2008 DISCN TABLET ORAL 7148207 Dec. 20, 2022 TREATMENT OF PATIENTS WITH B-CELL CHRONIC LYMPHOCYTIC LEUKEMIA (CLL)

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
DNA polymerase alpha catalytic subunit Enzyme INHIBITOR WOMBAT-PK DRUG LABEL
Ribonucleoside-diphosphate reductase subunit M2 Enzyme INHIBITOR IC50 6 IUPHAR
Carbonic anhydrase 5A, mitochondrial Enzyme Ki 6.88 CHEMBL
Ribonucleoside-diphosphate reductase large subunit Enzyme INHIBITOR IC50 6 IUPHAR
Adenosine receptor A2a GPCR Ki 7.55 CHEMBL
Adenosine receptor A3 GPCR Ki 4.98 CHEMBL
Adenosine receptor A1 GPCR Ki 8.23 CHEMBL

External reference:

IDSource
4020528 VUID
N0000148244 NUI
D01907 KEGG_DRUG
21679-14-1 SECONDARY_CAS_RN
4020177 VANDF
4020528 VANDF
C0060483 UMLSCUI
CHEBI:63599 CHEBI
CHEMBL1096882 ChEMBL_ID
C042382 MESH_SUPPLEMENTAL_RECORD_UI
C024352 MESH_SUPPLEMENTAL_RECORD_UI
4802 IUPHAR_LIGAND_ID
5214 INN_ID
1X9VK9O1SC UNII
30751 PUBCHEM_CID
657237 PUBCHEM_CID
DB01073 DRUGBANK_ID
P2K93U8740 UNII
24698 RXNORM
110964 MMSL
1862 MMSL
4734 MMSL
d01346 MMSL
003618 NDDF
004817 NDDF
108763009 SNOMEDCT_US
108765002 SNOMEDCT_US
386907005 SNOMEDCT_US
C0059985 UMLSCUI

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
fludarabine phosphate HUMAN PRESCRIPTION DRUG LABEL 1 24201-237 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 25 mg INTRAVENOUS ANDA 24 sections
Fludarabine Phosphate HUMAN PRESCRIPTION DRUG LABEL 1 25021-242 INJECTION, SOLUTION 25 mg INTRAVENOUS ANDA 28 sections
Fludarabine phosphate HUMAN PRESCRIPTION DRUG LABEL 1 45963-609 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 50 mg INTRAVENOUS ANDA 21 sections
Fludarabine phosphate HUMAN PRESCRIPTION DRUG LABEL 1 45963-621 INJECTION, SOLUTION 25 mg INTRAVENOUS ANDA 19 sections
Fludarabine Phosphate HUMAN PRESCRIPTION DRUG LABEL 1 59923-604 INJECTION 25 mg INTRAVENOUS ANDA 28 sections
Fludarabine HUMAN PRESCRIPTION DRUG LABEL 1 63323-192 INJECTION, SOLUTION 25 mg INTRAVENOUS ANDA 14 sections