fludarabine phosphate 🐶 Veterinary Use | 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: -3.13
  • 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) 9.20 mg/mL Bocci G, Oprea TI, Benet LZ
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
Jan. 26, 2007 PMDA Nihon Schering K.K.

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
Cytokine release syndrome 2067.80 23.05 611 33920 13703 63440788
Acute graft versus host disease 1258.28 23.05 322 34209 4106 63450385
Cytomegalovirus infection 1015.52 23.05 394 34137 20558 63433933
Febrile neutropenia 841.38 23.05 615 33916 117834 63336657
Graft versus host disease 830.49 23.05 255 34276 6508 63447983
Acute graft versus host disease in skin 768.96 23.05 207 34324 3245 63451246
Chronic graft versus host disease 667.41 23.05 181 34350 2921 63451570
Adenovirus infection 660.38 23.05 185 34346 3386 63451105
Cytomegalovirus infection reactivation 654.73 23.05 188 34343 3775 63450716
Graft versus host disease in skin 632.00 23.05 171 34360 2734 63451757
Hypogammaglobulinaemia 560.95 23.05 192 34339 6963 63447528
Graft versus host disease in gastrointestinal tract 554.44 23.05 158 34373 3083 63451408
Immune effector cell-associated neurotoxicity syndrome 547.16 23.05 145 34386 2132 63452359
Human herpesvirus 6 infection 536.79 23.05 151 34380 2806 63451685
Neurotoxicity 477.78 23.05 217 34314 16773 63437718
Venoocclusive liver disease 467.62 23.05 152 34379 4683 63449808
Thrombotic microangiopathy 435.92 23.05 177 34354 10384 63444107
Cytomegalovirus viraemia 432.72 23.05 149 34382 5500 63448991
Product use in unapproved indication 391.56 23.05 484 34047 178596 63275895
Epstein-Barr virus infection 370.68 23.05 146 34385 7904 63446587
Neutropenia 369.77 23.05 465 34066 174540 63279951
Haemophagocytic lymphohistiocytosis 364.20 23.05 156 34375 10471 63444020
Myelodysplastic syndrome 363.55 23.05 179 34352 16575 63437916
BK virus infection 361.94 23.05 114 34417 3165 63451326
Post transplant lymphoproliferative disorder 359.50 23.05 126 34405 4905 63449586
Acute graft versus host disease in intestine 352.68 23.05 97 34434 1652 63452839
Cystitis haemorrhagic 348.12 23.05 117 34414 4006 63450485
Progressive multifocal leukoencephalopathy 331.28 23.05 155 34376 12816 63441675
Acute myeloid leukaemia 327.41 23.05 168 34363 16979 63437512
Pyrexia 317.06 23.05 751 33780 469727 62984764
Acute lymphocytic leukaemia recurrent 314.66 23.05 94 34437 2175 63452316
Pancytopenia 309.01 23.05 319 34212 96614 63357877
Mucosal inflammation 295.19 23.05 227 34304 46701 63407790
Multiple organ dysfunction syndrome 291.99 23.05 244 34287 56508 63397983
Acute myeloid leukaemia recurrent 286.03 23.05 81 34450 1542 63452949
Bronchopulmonary aspergillosis 277.02 23.05 121 34410 8514 63445977
Viral haemorrhagic cystitis 270.43 23.05 68 34463 801 63453690
Pain 254.55 23.05 48 34483 740580 62713911
Premature menopause 254.33 23.05 65 34466 821 63453670
Thrombocytopenia 253.50 23.05 359 34172 150798 63303693
Cytopenia 234.07 23.05 118 34413 11483 63443008
Viraemia 228.85 23.05 65 34466 1251 63453240
Encephalitis viral 228.28 23.05 69 34462 1663 63452828
Transplant failure 221.24 23.05 66 34465 1519 63452972
Lymphocyte count decreased 213.86 23.05 157 34374 30100 63424391
Venoocclusive disease 212.45 23.05 68 34463 1990 63452501
Posterior reversible encephalopathy syndrome 210.22 23.05 126 34405 17219 63437272
Aspergillus infection 192.17 23.05 92 34439 8001 63446490
Neutrophil count decreased 187.50 23.05 190 34341 56216 63398275
Platelet count decreased 167.39 23.05 257 34274 115865 63338626
Epstein-Barr virus infection reactivation 164.32 23.05 45 34486 753 63453738
Chronic graft versus host disease in skin 162.22 23.05 44 34487 709 63453782
Systemic mycosis 154.81 23.05 47 34484 1150 63453341
Epstein-Barr viraemia 153.84 23.05 45 34486 965 63453526
Bone marrow failure 152.76 23.05 127 34404 29163 63425328
Joint swelling 152.30 23.05 6 34525 327660 63126831
Sepsis 149.50 23.05 285 34246 152838 63301653
Fatigue 147.75 23.05 160 34371 887868 62566623
Cytomegalovirus chorioretinitis 143.94 23.05 49 34482 1744 63452747
Cytomegalovirus test positive 139.83 23.05 55 34476 2963 63451528
White blood cell count decreased 139.60 23.05 262 34269 138842 63315649
Alopecia 139.28 23.05 12 34519 337524 63116967
Abdominal discomfort 136.32 23.05 10 34521 320875 63133616
Pre-engraftment immune reaction 133.51 23.05 30 34501 208 63454283
Adenoviral hepatitis 132.87 23.05 33 34498 368 63454123
Leukoencephalopathy 132.36 23.05 59 34472 4354 63450137
Septic shock 126.18 23.05 168 34363 66461 63388030
Off label use 124.75 23.05 706 33825 673756 62780735
Respiratory failure 122.92 23.05 208 34323 101650 63352841
Bacterial sepsis 122.19 23.05 54 34477 3904 63450587
Nasopharyngitis 120.38 23.05 4 34527 254253 63200238
Fall 119.26 23.05 33 34498 392301 63062190
Bacteraemia 118.02 23.05 88 34443 17260 63437231
Diffuse large B-cell lymphoma 117.30 23.05 62 34469 6650 63447841
Drug hypersensitivity 115.60 23.05 16 34515 310671 63143820
JC virus infection 115.17 23.05 43 34488 2008 63452483
Drug resistance 114.54 23.05 97 34434 22836 63431655
Arthralgia 114.36 23.05 86 34445 569624 62884867
Second primary malignancy 112.82 23.05 64 34467 7889 63446602
Acute graft versus host disease in liver 111.54 23.05 32 34499 639 63453852
Cystitis viral 110.82 23.05 24 34507 137 63454354
Herpes simplex 110.48 23.05 64 34467 8207 63446284
Dizziness 108.75 23.05 49 34482 429876 63024615
Pneumonia fungal 108.60 23.05 55 34476 5400 63449091
Engraftment syndrome 106.24 23.05 29 34502 479 63454012
Maternal exposure during pregnancy 105.83 23.05 3 34528 220059 63234432
Swelling 105.27 23.05 13 34518 275365 63179126
Stem cell transplant 105.25 23.05 39 34492 1783 63452708
Rhinovirus infection 103.02 23.05 50 34481 4479 63450012
Headache 102.94 23.05 116 34415 633125 62821366
Hypersensitivity 102.24 23.05 18 34513 292667 63161824
Pruritus 101.57 23.05 35 34496 361418 63093073
Peripheral swelling 100.57 23.05 13 34518 265929 63188562
Fusarium infection 99.35 23.05 29 34502 617 63453874
Pain in extremity 98.63 23.05 29 34502 331457 63123034
Contraindicated product administered 97.74 23.05 5 34526 217643 63236848
Systemic lupus erythematosus 96.42 23.05 4 34527 208914 63245577
Hypoxia 95.60 23.05 139 34392 59653 63394838
Varicella zoster virus infection 93.83 23.05 40 34491 2649 63451842
Toxoplasmosis 93.14 23.05 34 34497 1489 63453002
Arthropathy 92.43 23.05 10 34521 234782 63219709
Encephalopathy 91.60 23.05 109 34422 38511 63415980
Engraft failure 91.22 23.05 24 34507 342 63454149
Epstein-Barr virus associated lymphoproliferative disorder 89.45 23.05 35 34496 1859 63452632
Drug intolerance 88.24 23.05 29 34502 308632 63145859
Fungaemia 88.02 23.05 37 34494 2366 63452125
Neoplasm recurrence 87.96 23.05 38 34493 2600 63451891
Upper respiratory fungal infection 86.72 23.05 20 34511 158 63454333
Adenovirus reactivation 84.52 23.05 19 34512 132 63454359
Anxiety 83.78 23.05 10 34521 217531 63236960
Encephalitis 83.66 23.05 55 34476 8825 63445666
Haematocrit decreased 83.52 23.05 105 34426 39235 63415256
Growth failure 83.39 23.05 22 34509 317 63454174
B-cell type acute leukaemia 83.33 23.05 20 34511 191 63454300
Disease progression 83.17 23.05 197 34334 122561 63331930
Staphylococcal sepsis 83.11 23.05 53 34478 8075 63446416
Malaise 83.08 23.05 63 34468 415891 63038600
Cytokine increased 82.13 23.05 16 34515 48 63454443
Staphylococcal infection 81.12 23.05 106 34425 41150 63413341
Graft versus host disease in lung 80.79 23.05 22 34509 360 63454131
Human herpesvirus 6 encephalitis 80.20 23.05 20 34511 227 63454264
Enterococcal infection 79.81 23.05 51 34480 7797 63446694
Leukaemia recurrent 78.61 23.05 29 34502 1309 63453182
Mucormycosis 78.54 23.05 36 34495 2835 63451656
Nausea 78.11 23.05 224 34307 854247 62600244
Discomfort 77.91 23.05 3 34528 167371 63287120
Blood follicle stimulating hormone increased 77.73 23.05 18 34513 145 63454346
Aplastic anaemia 77.57 23.05 54 34477 9515 63444976
Malignant neoplasm progression 76.54 23.05 150 34381 81971 63372520
Fungal infection 76.03 23.05 97 34434 36777 63417714
Diffuse large B-cell lymphoma recurrent 75.99 23.05 33 34498 2287 63452204
Wound 75.74 23.05 3 34528 163260 63291231
Chronic lymphocytic leukaemia recurrent 75.46 23.05 19 34512 225 63454266
Clostridium difficile infection 75.19 23.05 87 34444 29835 63424656
Dyspnoea 73.97 23.05 156 34375 661157 62793334
Aplasia 73.45 23.05 39 34492 4220 63450271
Enterococcal bacteraemia 72.58 23.05 28 34503 1431 63453060
Acute respiratory distress syndrome 72.24 23.05 76 34455 23458 63431033
Campylobacter infection 69.46 23.05 25 34506 1051 63453440
Therapeutic product effect decreased 69.38 23.05 11 34520 193176 63261315
Condition aggravated 69.32 23.05 70 34461 402147 63052344
Graft versus host disease in liver 69.01 23.05 22 34509 635 63453856
Lymphopenia 68.77 23.05 66 34465 18261 63436230
Klebsiella infection 68.64 23.05 48 34483 8518 63445973
Exposure during pregnancy 68.49 23.05 4 34527 155543 63298948
Systemic candida 68.36 23.05 34 34497 3211 63451280
Lymphadenitis 68.06 23.05 34 34497 3241 63451250
Heart rate abnormal 67.99 23.05 39 34492 4908 63449583
Depression 66.61 23.05 13 34518 196479 63258012
Autoimmune haemolytic anaemia 65.19 23.05 37 34494 4564 63449927
Disseminated mucormycosis 64.78 23.05 16 34515 174 63454317
Minimal residual disease 63.91 23.05 15 34516 129 63454362
Transplant dysfunction 63.22 23.05 37 34494 4835 63449656
Geotrichum infection 62.96 23.05 19 34512 455 63454036
Meningoencephalitis herpetic 62.71 23.05 24 34507 1200 63453291
Feeling abnormal 61.89 23.05 5 34526 148387 63306104
Infusion related reaction 60.41 23.05 29 34502 245492 63208999
Alternaria infection 60.36 23.05 16 34515 235 63454256
Pneumocystis jirovecii pneumonia 59.88 23.05 59 34472 16855 63437636
Constipation 59.39 23.05 24 34507 224919 63229572
Pulmonary haemorrhage 59.32 23.05 41 34490 7140 63447351
Pseudomonas infection 59.23 23.05 49 34482 11164 63443327
Blood pressure increased 58.70 23.05 9 34522 162053 63292438
Polyomavirus viraemia 58.69 23.05 20 34511 714 63453777
Pneumonia adenoviral 58.59 23.05 14 34517 131 63454360
Pneumonia cytomegaloviral 58.19 23.05 27 34504 2187 63452304
Weight increased 58.03 23.05 35 34496 260757 63193734
Lymphadenopathy 57.99 23.05 87 34444 38371 63416120
Hepatic enzyme increased 57.79 23.05 19 34512 202309 63252182
Tumour lysis syndrome 57.58 23.05 44 34487 8946 63445545
Rash 56.41 23.05 140 34391 560731 62893760
Infection reactivation 56.07 23.05 22 34509 1177 63453314
Muscle spasms 55.81 23.05 9 34522 156141 63298350
Urticaria 54.06 23.05 12 34519 165790 63288701
Human herpesvirus 6 infection reactivation 54.05 23.05 16 34515 358 63454133
Back pain 53.97 23.05 39 34492 264106 63190385
Neutropenic infection 53.27 23.05 22 34509 1345 63453146
Abdominal pain upper 52.93 23.05 23 34508 206421 63248070
Contusion 52.84 23.05 9 34522 150035 63304456
Nodular melanoma 52.70 23.05 11 34520 51 63454440
Blood stem cell transplant failure 52.34 23.05 13 34518 145 63454346
Escherichia bacteraemia 51.73 23.05 30 34501 3853 63450638
Gait disturbance 50.93 23.05 18 34513 183160 63271331
Mobility decreased 50.75 23.05 4 34527 121155 63333336
Gastroenteritis adenovirus 50.53 23.05 14 34517 245 63454246
Clostridium difficile colitis 50.32 23.05 59 34472 20510 63433981
Pseudomonal sepsis 50.11 23.05 25 34506 2376 63452115
Vomiting 50.01 23.05 148 34383 559469 62895022
Myelosuppression 49.88 23.05 63 34468 23640 63430851
Pericardial effusion 49.66 23.05 71 34460 29987 63424504
Insomnia 49.13 23.05 28 34503 215224 63239267
Arthritis 48.07 23.05 4 34527 115917 63338574
B-cell aplasia 47.79 23.05 11 34520 86 63454405
Human polyomavirus infection 47.18 23.05 14 34517 316 63454175
Bacterial infection 46.16 23.05 55 34476 19444 63435047
Cerebral toxoplasmosis 45.93 23.05 18 34513 960 63453531
Neutropenic sepsis 45.04 23.05 50 34481 16388 63438103
Disseminated toxoplasmosis 43.94 23.05 11 34520 127 63454364
Immune reconstitution inflammatory syndrome 43.93 23.05 32 34499 6052 63448439
Skin toxicity 43.92 23.05 29 34502 4685 63449806
Urinary tract infection 43.37 23.05 48 34483 264636 63189855
Toxic leukoencephalopathy 43.10 23.05 16 34515 735 63453756
Pulmonary mucormycosis 42.74 23.05 13 34518 320 63454171
Chronic graft versus host disease in intestine 42.20 23.05 10 34521 90 63454401
Hypoalbuminaemia 41.45 23.05 41 34490 11764 63442727
Acute myeloid leukaemia refractory 41.43 23.05 10 34521 98 63454393
Impaired healing 41.27 23.05 4 34527 102538 63351953
Aphasia 40.56 23.05 68 34463 32932 63421559
Cytomegalovirus urinary tract infection 40.10 23.05 9 34522 62 63454429
Bone marrow transplant rejection 39.98 23.05 9 34522 63 63454428
Myocardial infarction 39.93 23.05 4 34527 99889 63354602
Respiratory syncytial virus infection 39.87 23.05 32 34499 6986 63447505
Graft versus host disease in eye 39.73 23.05 9 34522 65 63454426
Hepatic failure 39.28 23.05 70 34461 35586 63418905
Stenotrophomonas infection 39.07 23.05 20 34511 2007 63452484
Cryptosporidiosis infection 39.01 23.05 12 34519 307 63454184
Musculoskeletal pain 38.77 23.05 3 34528 92274 63362217
Haemolysis 38.75 23.05 31 34500 6737 63447754
Brain oedema 38.58 23.05 43 34488 14152 63440339
Erythema 38.50 23.05 24 34507 175727 63278764
Refractory cytopenia with multilineage dysplasia 38.30 23.05 10 34521 138 63454353
Muscle twitching 37.82 23.05 50 34481 19618 63434873
Gastrooesophageal reflux disease 37.79 23.05 4 34527 95635 63358856
Acute lymphocytic leukaemia 37.72 23.05 21 34510 2495 63451996
Blood magnesium decreased 37.64 23.05 41 34490 13157 63441334
Bronchitis 36.97 23.05 11 34520 124924 63329567
Asthenia 36.76 23.05 98 34433 383506 63070985
Gene mutation 36.72 23.05 18 34513 1647 63452844
Ascites 36.25 23.05 73 34458 40655 63413836
Sinusitis 36.15 23.05 42 34489 226611 63227880
Cough 36.12 23.05 65 34466 292678 63161813
Bone marrow transplant 36.06 23.05 14 34517 728 63453763
Disseminated intravascular coagulation 35.97 23.05 48 34483 19003 63435488
Malignant transformation 35.85 23.05 12 34519 405 63454086
Microsporidia infection 35.59 23.05 11 34520 286 63454205
Retinal haemorrhage 35.57 23.05 26 34505 4943 63449548
Staphylococcal bacteraemia 35.27 23.05 27 34504 5503 63448988
Disseminated tuberculosis 35.17 23.05 21 34510 2846 63451645
Palpitations 35.10 23.05 9 34522 112761 63341730
Alpha haemolytic streptococcal infection 35.01 23.05 16 34515 1251 63453240
Urinary tract infection viral 34.71 23.05 8 34523 63 63454428
Mycobacterium kansasii infection 34.49 23.05 9 34522 124 63454367
Diarrhoea 34.43 23.05 238 34293 715128 62739363
Delayed engraftment 34.16 23.05 9 34522 129 63454362
Candida sepsis 33.71 23.05 16 34515 1364 63453127
Klebsiella bacteraemia 33.64 23.05 17 34514 1661 63452830
Idiopathic pneumonia syndrome 33.51 23.05 11 34520 349 63454142
Systemic inflammatory response syndrome 32.72 23.05 26 34505 5595 63448896
Serum ferritin increased 32.62 23.05 27 34504 6155 63448336
Dedifferentiated liposarcoma 32.46 23.05 7 34524 39 63454452
Blister 32.41 23.05 15 34516 129799 63324692
Scedosporium infection 32.33 23.05 12 34519 551 63453940
Left ventricular dysfunction 32.04 23.05 36 34495 11952 63442539
Haematotoxicity 31.88 23.05 32 34499 9344 63445147
Chronic graft versus host disease in liver 31.72 23.05 10 34521 278 63454213
Pericarditis 31.64 23.05 16 34515 131563 63322928
Pleural effusion 31.61 23.05 117 34414 93093 63361398
Parvovirus infection 31.49 23.05 10 34521 285 63454206
Dehydration 31.16 23.05 29 34502 173325 63281166
Hyperhidrosis 31.00 23.05 10 34521 107826 63346665
Wheezing 30.99 23.05 7 34524 95588 63358903
Bronchiolitis 30.81 23.05 19 34512 2728 63451763
Ureaplasma infection 30.63 23.05 12 34519 639 63453852
Febrile bone marrow aplasia 30.59 23.05 28 34503 7297 63447194
Lung consolidation 30.37 23.05 22 34509 4126 63450365
Dyspepsia 30.23 23.05 9 34522 102187 63352304
Loss of personal independence in daily activities 29.83 23.05 8 34523 97282 63357209
Capillary leak syndrome 29.31 23.05 17 34514 2183 63452308
Human herpesvirus 7 infection 29.31 23.05 8 34523 132 63454359
Haemoglobin decreased 29.11 23.05 156 34375 145329 63309162
Disseminated Bacillus Calmette-Guerin infection 29.08 23.05 6 34525 26 63454465
Cellulitis staphylococcal 29.02 23.05 12 34519 736 63453755
Dry mouth 28.93 23.05 4 34527 77859 63376632
Fungal sepsis 28.82 23.05 14 34517 1256 63453235
Myeloid leukaemia 28.65 23.05 10 34521 384 63454107
Metastases to diaphragm 28.21 23.05 6 34525 31 63454460
Myalgia 28.16 23.05 23 34508 146506 63307985
Growth retardation 28.10 23.05 14 34517 1327 63453164
Cerebrovascular accident 27.72 23.05 12 34519 108012 63346479
Gastroenteritis norovirus 27.61 23.05 16 34515 2052 63452439
Myocarditis 27.59 23.05 31 34500 10294 63444197
Blood fibrinogen decreased 27.50 23.05 12 34519 841 63453650
Hypotension 27.47 23.05 247 34284 272357 63182134
Parainfluenzae viral bronchitis 27.44 23.05 5 34526 9 63454482
Neoplasm progression 27.44 23.05 61 34470 36367 63418124
Adrenal haemorrhage 27.39 23.05 10 34521 438 63454053
Streptococcal bacteraemia 27.10 23.05 15 34516 1762 63452729
Peritoneal mesothelioma malignant 27.10 23.05 5 34526 10 63454481
Immune thrombocytopenia 27.03 23.05 31 34500 10525 63443966
Klebsiella sepsis 27.02 23.05 14 34517 1441 63453050
Escherichia sepsis 26.69 23.05 22 34509 4985 63449506
Dysplasia 26.51 23.05 12 34519 918 63453573
Transplant rejection 26.50 23.05 31 34500 10749 63443742
Hilar lymphadenopathy 26.32 23.05 13 34518 1209 63453282
Gastritis fungal 26.27 23.05 7 34524 105 63454386
Serum amyloid A protein increased 26.26 23.05 9 34522 327 63454164
Hepatic necrosis 26.24 23.05 23 34508 5664 63448827
Actinomycotic sepsis 26.09 23.05 7 34524 108 63454383
Sphingomonas paucimobilis infection 25.95 23.05 6 34525 48 63454443
Parainfluenzae virus infection 25.86 23.05 16 34515 2311 63452180
Blindness cortical 25.81 23.05 10 34521 517 63453974
Recurrent cancer 25.54 23.05 15 34516 1972 63452519
Drug interaction 25.53 23.05 54 34477 229077 63225414
Cardiotoxicity 25.44 23.05 27 34504 8411 63446080
Hepatitis B 25.17 23.05 19 34512 3793 63450698
Lower respiratory tract infection 25.14 23.05 21 34510 132286 63322205
Leukoerythroblastosis 25.09 23.05 8 34523 231 63454260
Hypophosphataemia 25.04 23.05 31 34500 11395 63443096
Obliterative bronchiolitis 24.81 23.05 15 34516 2080 63452411
B-lymphocyte count abnormal 24.75 23.05 6 34525 60 63454431
Neck pain 24.74 23.05 4 34527 69314 63385177
Cardiac failure 24.67 23.05 105 34426 89037 63365454
Infusion site eschar 24.55 23.05 5 34526 20 63454471
Nephropathy toxic 24.54 23.05 28 34503 9451 63445040
B-cell lymphoma recurrent 24.44 23.05 9 34522 404 63454087
Mucosal disorder 24.32 23.05 15 34516 2154 63452337
Primary mediastinal large B-cell lymphoma 24.17 23.05 5 34526 22 63454469
Paraesthesia 24.04 23.05 30 34501 156936 63297555
Enterobacter infection 23.96 23.05 15 34516 2212 63452279
Enterobacter bacteraemia 23.95 23.05 9 34522 428 63454063
Polyomavirus-associated nephropathy 23.88 23.05 14 34517 1834 63452657
Paraparesis 23.83 23.05 15 34516 2233 63452258
Septic embolus 23.76 23.05 11 34520 886 63453605
Status epilepticus 23.73 23.05 35 34496 15198 63439293
Blood glucose increased 23.66 23.05 8 34523 83748 63370743
Wrong technique in product usage process 23.65 23.05 3 34528 62337 63392154
Metapneumovirus pneumonia 23.64 23.05 5 34526 25 63454466
Ejection fraction decreased 23.52 23.05 43 34488 22289 63432202
Cardiac tamponade 23.43 23.05 20 34511 4755 63449736
Venous haemorrhage 23.38 23.05 8 34523 289 63454202

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 2231.30 18.17 942 50880 21935 34883174
Acute graft versus host disease 1229.66 18.17 434 51388 6069 34899040
Cytomegalovirus infection 1063.82 18.17 592 51230 25543 34879566
Acute graft versus host disease in skin 1032.59 18.17 360 51462 4841 34900268
Hypogammaglobulinaemia 790.92 18.17 330 51492 7410 34897699
Graft versus host disease 722.98 18.17 340 51482 10229 34894880
Febrile neutropenia 663.53 18.17 910 50912 135939 34769170
Graft versus host disease in gastrointestinal tract 628.82 18.17 228 51594 3455 34901654
Chronic graft versus host disease 615.74 18.17 235 51587 4138 34900971
Adenovirus infection 608.10 18.17 245 51577 5012 34900097
Venoocclusive liver disease 565.58 18.17 263 51559 7703 34897406
Acute graft versus host disease in intestine 527.96 18.17 185 51637 2523 34902586
Epstein-Barr virus infection 520.39 18.17 245 51577 7383 34897726
Graft versus host disease in skin 517.18 18.17 201 51621 3724 34901385
Cytomegalovirus infection reactivation 505.31 18.17 213 51609 4905 34900204
Cystitis haemorrhagic 500.22 18.17 218 51604 5461 34899648
Immune effector cell-associated neurotoxicity syndrome 492.26 18.17 191 51631 3522 34901587
Neurotoxicity 487.43 18.17 314 51508 17696 34887413
BK virus infection 443.53 18.17 201 51621 5537 34899572
Mucosal inflammation 435.97 18.17 400 51422 38222 34866887
Progressive multifocal leukoencephalopathy 404.49 18.17 224 51598 9540 34895569
Cytopenia 402.57 18.17 245 51577 12478 34892631
Pyrexia 395.55 18.17 1234 50588 331779 34573330
Product use in unapproved indication 377.04 18.17 646 51176 116853 34788256
Post transplant lymphoproliferative disorder 350.28 18.17 178 51644 6350 34898759
Haemophagocytic lymphohistiocytosis 343.12 18.17 223 51599 12750 34892359
Myelodysplastic syndrome 341.81 18.17 259 51563 18949 34886160
Human herpesvirus 6 infection 333.56 18.17 123 51699 1958 34903151
Acute myeloid leukaemia recurrent 303.22 18.17 116 51706 2054 34903055
Cytomegalovirus viraemia 301.01 18.17 168 51654 7262 34897847
Venoocclusive disease 291.95 18.17 122 51700 2745 34902364
Thrombotic microangiopathy 291.63 18.17 187 51635 10443 34894666
Lymphocyte count decreased 274.19 18.17 244 51578 22378 34882731
Diffuse large B-cell lymphoma 261.94 18.17 153 51669 7217 34897892
Bone marrow failure 249.48 18.17 260 51562 28993 34876116
Acute graft versus host disease in liver 245.24 18.17 91 51731 1475 34903634
Chronic graft versus host disease in skin 242.68 18.17 80 51742 894 34904215
Posterior reversible encephalopathy syndrome 241.11 18.17 162 51660 9792 34895317
Multiple organ dysfunction syndrome 236.10 18.17 414 51408 76152 34828957
Neutropenia 228.18 18.17 626 51196 156152 34748957
Transplant failure 223.60 18.17 108 51714 3445 34901664
Bronchopulmonary aspergillosis 220.42 18.17 179 51643 14480 34890629
Acute lymphocytic leukaemia recurrent 214.43 18.17 100 51722 2944 34902165
Fatigue 202.39 18.17 153 51669 370500 34534609
Acute myeloid leukaemia 197.78 18.17 185 51637 18085 34887024
Pancytopenia 192.26 18.17 431 51391 94726 34810383
Epstein-Barr viraemia 186.41 18.17 71 51751 1241 34903868
Leukaemia recurrent 185.78 18.17 75 51747 1540 34903569
Viral haemorrhagic cystitis 182.69 18.17 68 51754 1112 34903997
Fall 176.73 18.17 42 51780 202843 34702266
Engraftment syndrome 174.92 18.17 63 51759 934 34904175
Autoimmune haemolytic anaemia 174.87 18.17 99 51723 4397 34900712
Off label use 159.05 18.17 1113 50709 418411 34486698
Bacteraemia 158.73 18.17 170 51652 19547 34885562
Dizziness 158.45 18.17 63 51759 218458 34686651
Dyspnoea 155.44 18.17 199 51623 376583 34528526
JC virus infection 147.71 18.17 70 51752 2138 34902971
Epstein-Barr virus infection reactivation 147.04 18.17 57 51765 1047 34904062
Aspergillus infection 142.16 18.17 129 51693 12125 34892984
Arthralgia 140.74 18.17 39 51783 170002 34735107
Drug interaction 138.18 18.17 82 51740 225864 34679245
Neutrophil count decreased 133.01 18.17 257 51565 50847 34854262
Chronic lymphocytic leukaemia recurrent 132.29 18.17 41 51781 369 34904740
Completed suicide 131.08 18.17 3 51819 98165 34806944
Cystitis viral 127.96 18.17 43 51779 512 34904597
Encephalitis cytomegalovirus 127.29 18.17 44 51778 574 34904535
Graft versus host disease in liver 125.24 18.17 53 51769 1231 34903878
Pain 122.71 18.17 76 51746 204599 34700510
Myocardial infarction 122.69 18.17 17 51805 121068 34784041
Human herpesvirus 6 encephalitis 119.88 18.17 37 51785 328 34904781
B-cell type acute leukaemia 119.68 18.17 36 51786 290 34904819
Herpes simplex 119.32 18.17 84 51738 5475 34899634
Asthenia 116.80 18.17 115 51707 245136 34659973
Haematocrit decreased 116.19 18.17 187 51635 32029 34873080
Toxoplasmosis 114.16 18.17 50 51772 1266 34903843
Lymphadenopathy 110.65 18.17 171 51651 28292 34876817
Constipation 108.58 18.17 34 51788 136948 34768161
Encephalitis viral 108.23 18.17 47 51775 1165 34903944
Pneumonia cytomegaloviral 107.44 18.17 63 51759 2991 34902118
Epstein-Barr virus associated lymphoproliferative disorder 103.72 18.17 53 51769 1911 34903198
Rhinovirus infection 101.77 18.17 69 51753 4230 34900879
Second primary malignancy 99.37 18.17 87 51735 7799 34897310
Diffuse large B-cell lymphoma recurrent 99.08 18.17 61 51761 3167 34901942
Bone marrow transplant rejection 98.69 18.17 28 51794 179 34904930
Respiratory failure 98.53 18.17 369 51453 108203 34796906
Anxiety 98.29 18.17 15 51807 99413 34805696
Pain in extremity 97.44 18.17 33 51789 126480 34778629
Thrombocytopenia 96.18 18.17 472 51350 155775 34749334
Varicella zoster virus infection 96.14 18.17 49 51773 1757 34903352
Overdose 94.09 18.17 12 51810 91047 34814062
Fusarium infection 93.95 18.17 42 51780 1118 34903991
Weight decreased 93.06 18.17 75 51747 176226 34728883
Microsporidia infection 92.43 18.17 36 51786 670 34904439
Malaise 92.07 18.17 84 51738 185741 34719368
Nausea 91.89 18.17 233 51589 339675 34565434
Encephalitis 91.12 18.17 80 51742 7197 34897912
Fungal infection 90.72 18.17 115 51707 15820 34889289
Stenotrophomonas infection 88.97 18.17 49 51773 2061 34903048
Pneumonia fungal 88.80 18.17 78 51744 7022 34898087
Mucormycosis 88.11 18.17 72 51750 5870 34899239
Chronic graft versus host disease in liver 88.08 18.17 31 51791 428 34904681
Insomnia 87.46 18.17 23 51799 103884 34801225
Death 87.28 18.17 301 51521 397748 34507361
Pseudomonas infection 86.25 18.17 99 51723 12283 34892826
Chest pain 86.25 18.17 40 51782 126722 34778387
Pruritus 86.02 18.17 52 51770 141929 34763180
Sepsis 85.85 18.17 479 51343 166082 34739027
Aplastic anaemia 80.34 18.17 85 51737 9631 34895478
Septic shock 79.70 18.17 261 51561 71573 34833536
White blood cell count decreased 78.08 18.17 314 51508 95131 34809978
Pneumatosis intestinalis 76.67 18.17 56 51766 3867 34901242
Nasopharyngitis 75.31 18.17 8 51814 69960 34835149
B-cell aplasia 74.96 18.17 20 51802 98 34905011
Idiopathic pneumonia syndrome 74.65 18.17 24 51798 246 34904863
Platelet count decreased 74.56 18.17 363 51459 119354 34785755
Cytomegalovirus test positive 72.63 18.17 54 51768 3832 34901277
Cytomegalovirus chorioretinitis 71.89 18.17 52 51770 3537 34901572
Cytokine increased 71.75 18.17 16 51806 29 34905080
Blood pressure increased 71.34 18.17 21 51801 88081 34817028
Toxicity to various agents 71.34 18.17 117 51705 200245 34704864
Cerebral aspergillosis 70.89 18.17 37 51785 1395 34903714
Diarrhoea 70.66 18.17 318 51504 389594 34515515
Systemic mycosis 70.40 18.17 38 51784 1535 34903574
Gait disturbance 69.48 18.17 20 51802 85120 34819989
Hypoxia 69.20 18.17 209 51613 54886 34850223
Respiratory syncytial virus infection 67.61 18.17 56 51766 4653 34900456
Lymphopenia 67.51 18.17 101 51721 16234 34888875
Chronic graft versus host disease in intestine 67.12 18.17 22 51800 241 34904868
Minimal residual disease 66.98 18.17 25 51797 412 34904697
Muscle spasms 66.23 18.17 15 51807 74986 34830123
Parainfluenzae virus infection 65.98 18.17 45 51777 2785 34902324
Dehydration 65.22 18.17 58 51764 129911 34775198
Syncope 65.12 18.17 27 51795 91424 34813685
Engraft failure 64.34 18.17 25 51797 462 34904647
Peripheral swelling 64.29 18.17 17 51805 76524 34828585
Joint swelling 64.07 18.17 7 51815 59883 34845226
Encephalopathy 62.45 18.17 152 51670 35167 34869942
Rash 62.17 18.17 150 51672 222602 34682507
Cerebral toxoplasmosis 61.85 18.17 36 51786 1685 34903424
Staphylococcal infection 61.17 18.17 144 51678 32616 34872493
Depression 61.00 18.17 34 51788 97064 34808045
Polyomavirus viraemia 60.28 18.17 29 51793 916 34904193
Vomiting 59.87 18.17 179 51643 247442 34657667
Blood glucose increased 59.60 18.17 13 51809 66705 34838404
Stem cell transplant 59.56 18.17 38 51784 2101 34903008
Myelosuppression 57.74 18.17 103 51719 19162 34885947
Serum ferritin increased 56.65 18.17 57 51765 6089 34899020
Graft versus host disease in eye 55.88 18.17 19 51803 235 34904874
Rhabdomyolysis 55.63 18.17 16 51806 68147 34836962
Drug hypersensitivity 55.38 18.17 25 51797 80504 34824605
Infection 55.37 18.17 274 51548 90641 34814468
Hepatic failure 55.17 18.17 143 51679 34388 34870721
Feeling abnormal 55.12 18.17 13 51809 63222 34841887
Bacterial infection 54.73 18.17 94 51728 16969 34888140
Aphasia 54.67 18.17 107 51715 21347 34883762
Back pain 54.59 18.17 60 51762 121729 34783380
Bacterial sepsis 54.57 18.17 52 51770 5198 34899911
Hypoglycaemia 54.53 18.17 8 51814 54632 34850477
Meningoencephalitis herpetic 54.41 18.17 26 51796 809 34904300
Candida infection 53.46 18.17 95 51727 17620 34887489
Skin toxicity 52.82 18.17 49 51773 4735 34900374
Abdominal discomfort 52.76 18.17 12 51810 59823 34845286
Disseminated intravascular coagulation 52.23 18.17 106 51716 21710 34883399
Leukoencephalopathy 52.09 18.17 46 51776 4169 34900940
Pneumonia respiratory syncytial viral 51.93 18.17 26 51796 897 34904212
Asthma 51.13 18.17 3 51819 42653 34862456
Tumour lysis syndrome 50.86 18.17 91 51731 16968 34888141
Toxic leukoencephalopathy 50.67 18.17 20 51802 386 34904723
Viraemia 50.14 18.17 28 51794 1210 34903899
Adenovirus reactivation 50.09 18.17 17 51805 209 34904900
Pre-engraftment immune reaction 49.96 18.17 14 51808 85 34905024
Intentional product misuse 49.63 18.17 5 51817 45606 34859503
Enterococcal infection 49.57 18.17 65 51757 9241 34895868
Nephropathy toxic 49.42 18.17 76 51746 12512 34892597
Condition aggravated 49.30 18.17 135 51687 192061 34713048
Chronic obstructive pulmonary disease 49.20 18.17 7 51815 48911 34856198
Pulmonary haemorrhage 47.36 18.17 67 51755 10237 34894872
Cerebrovascular accident 47.35 18.17 34 51788 84777 34820332
Malignant neoplasm progression 47.12 18.17 256 51566 87790 34817319
Adenoviral haemorrhagic cystitis 46.84 18.17 19 51803 395 34904714
Hyperhidrosis 46.82 18.17 27 51795 75665 34829444
Pneumocystis jirovecii pneumonia 46.27 18.17 95 51727 19615 34885494
Pulmonary embolism 45.06 18.17 40 51782 89706 34815403
Cytomegalovirus hepatitis 44.78 18.17 19 51803 444 34904665
5q minus syndrome 44.50 18.17 14 51808 133 34904976
Out of specification test results 44.30 18.17 11 51811 38 34905071
Klebsiella sepsis 44.22 18.17 31 51791 2006 34903103
Chronic lymphocytic leukaemia 44.14 18.17 42 51780 4190 34900919
Chronic lymphocytic leukaemia transformation 44.01 18.17 15 51807 187 34904922
Hyperkalaemia 44.00 18.17 24 51798 69365 34835744
Weight increased 43.73 18.17 44 51778 92989 34812120
Capillary leak syndrome 43.60 18.17 32 51790 2226 34902883
B-lymphocyte count abnormal 43.42 18.17 9 51813 9 34905100
Hepatitis B reactivation 43.24 18.17 40 51782 3851 34901258
Autoimmune lymphoproliferative syndrome 42.82 18.17 14 51808 152 34904957
Dyspepsia 42.78 18.17 3 51819 36729 34868380
Suicidal ideation 42.49 18.17 5 51817 40383 34864726
Decreased appetite 41.82 18.17 118 51704 166274 34738835
Blood creatine phosphokinase increased 41.59 18.17 8 51814 44849 34860260
Chimerism 41.30 18.17 15 51807 228 34904881
Leukaemic infiltration 41.09 18.17 13 51809 126 34904983
Escherichia sepsis 40.40 18.17 42 51780 4662 34900447
Neurological decompensation 39.95 18.17 34 51788 2932 34902177
Blood stem cell transplant failure 39.77 18.17 17 51805 405 34904704
Blood fibrinogen decreased 39.68 18.17 24 51798 1206 34903903
Bradycardia 38.60 18.17 33 51789 75385 34829724
Coronary artery disease 38.21 18.17 12 51810 48293 34856816
Aggression 38.20 18.17 6 51816 38958 34866151
Staphylococcal sepsis 38.03 18.17 59 51763 9785 34895324
Acute myocardial infarction 38.00 18.17 16 51806 53703 34851406
Hyponatraemia 37.85 18.17 40 51782 82651 34822458
Viral sinusitis 37.55 18.17 11 51811 80 34905029
Chronic lymphocytic leukaemia refractory 37.31 18.17 11 51811 82 34905027
Cytokine storm 37.03 18.17 19 51803 691 34904418
Gastrooesophageal reflux disease 36.82 18.17 6 51816 37918 34867191
Meningomyelitis herpes 36.72 18.17 9 51813 29 34905080
Myelitis 36.62 18.17 20 51802 827 34904282
Hypoaesthesia 36.48 18.17 23 51799 61421 34843688
Acute respiratory distress syndrome 35.92 18.17 102 51720 25867 34879242
Organic brain syndrome 35.87 18.17 14 51808 262 34904847
Post transplant distal limb syndrome 34.97 18.17 14 51808 281 34904828
Mucosal disorder 34.55 18.17 25 51797 1701 34903408
Musculoskeletal stiffness 34.50 18.17 13 51809 46667 34858442
Obliterative bronchiolitis 34.24 18.17 22 51800 1231 34903878
Glomerulosclerosis 34.17 18.17 19 51803 814 34904295
Candida sepsis 33.83 18.17 22 51800 1257 34903852
Respiratory tract infection fungal 33.76 18.17 18 51804 709 34904400
Fungal sepsis 33.53 18.17 19 51803 845 34904264
Musculoskeletal pain 33.51 18.17 4 51818 31959 34873150
Haemolysis 33.37 18.17 50 51772 8044 34897065
Meningitis cryptococcal 33.29 18.17 28 51794 2376 34902733
Chloroma 33.12 18.17 16 51806 510 34904599
Diabetes mellitus 33.09 18.17 14 51808 46859 34858250
Enterococcal sepsis 32.97 18.17 24 51798 1648 34903461
Dry skin 32.60 18.17 4 51818 31283 34873826
Post-depletion B-cell recovery 32.41 18.17 7 51815 10 34905099
Urticaria 32.27 18.17 27 51795 62350 34842759
Angioedema 31.95 18.17 8 51814 37366 34867743
Meningitis tuberculous 31.92 18.17 17 51805 668 34904441
Neutropenic sepsis 31.89 18.17 66 51756 13701 34891408
Staphylococcal bacteraemia 31.74 18.17 50 51772 8402 34896707
Cytomegalovirus colitis 31.68 18.17 29 51793 2755 34902354
Loss of consciousness 31.53 18.17 46 51776 82621 34822488
Treatment noncompliance 30.78 18.17 3 51819 28097 34877012
Transplant rejection 30.72 18.17 55 51767 10256 34894853
Human herpesvirus 6 infection reactivation 30.60 18.17 11 51811 162 34904947
Arthritis 30.34 18.17 5 51817 31341 34873768
Acute erythroid leukaemia 30.30 18.17 11 51811 167 34904942
Somnolence 30.01 18.17 76 51746 111040 34794069
Poikiloderma 29.94 18.17 11 51811 173 34904936
Clostridium difficile infection 29.91 18.17 78 51744 18820 34886289
Dysphagia 29.89 18.17 29 51793 62352 34842757
Aplasia pure red cell 29.86 18.17 41 51781 6091 34899018
Unevaluable event 29.82 18.17 6 51816 32584 34872525
Neoplasm progression 29.81 18.17 89 51733 23211 34881898
Mucosal toxicity 29.60 18.17 12 51810 249 34904860
Mycobacterial infection 29.52 18.17 26 51796 2348 34902761
Rubulavirus test positive 29.46 18.17 6 51816 5 34905104
Herpes virus infection 29.25 18.17 28 51794 2814 34902295
Evans syndrome 29.21 18.17 12 51810 258 34904851
Bronchiolitis obliterans syndrome 28.73 18.17 11 51811 195 34904914
Sleep disorder 28.65 18.17 6 51816 31682 34873427
Abdominal pain 28.56 18.17 135 51687 163483 34741626
Infection reactivation 28.41 18.17 21 51801 1477 34903632
Angina pectoris 28.23 18.17 6 51816 31357 34873752
Enterococcal bacteraemia 28.15 18.17 23 51799 1874 34903235
Palpitations 28.13 18.17 12 51810 39974 34865135
Clostridium difficile colitis 28.12 18.17 68 51754 15662 34889447
Heart rate increased 27.99 18.17 17 51805 46326 34858783
Stomatitis 27.92 18.17 131 51691 42383 34862726
Swelling 27.82 18.17 14 51808 42352 34862757
Splenomegaly 27.72 18.17 66 51756 15051 34890058
International normalised ratio increased 27.70 18.17 18 51804 47309 34857800
Lymphocytosis 27.69 18.17 26 51796 2551 34902558
Aplasia 27.52 18.17 34 51788 4554 34900555
Refractory anaemia with an excess of blasts 27.22 18.17 13 51809 404 34904705
Generalised oedema 27.02 18.17 58 51764 12350 34892759
Meningeal neoplasm 26.98 18.17 8 51814 61 34905048
Rectal haemorrhage 26.88 18.17 13 51809 40236 34864873
Achromobacter infection 26.86 18.17 8 51814 62 34905047
Hepatosplenomegaly 26.81 18.17 32 51790 4137 34900972
Polymyositis 26.73 18.17 20 51802 1433 34903676
Neoplasm recurrence 26.71 18.17 24 51798 2225 34902884
Wheezing 26.71 18.17 14 51808 41388 34863721
Mobility decreased 26.63 18.17 6 51816 30122 34874987
Urge incontinence 26.62 18.17 14 51808 536 34904573
Pulmonary alveolar haemorrhage 26.24 18.17 43 51779 7469 34897640
Multisystem inflammatory syndrome in children 26.20 18.17 6 51816 13 34905096
Lymphoproliferative disorder 26.18 18.17 26 51796 2733 34902376
Eccrine squamous syringometaplasia 26.12 18.17 7 51815 35 34905074
NPM1 gene mutation 26.06 18.17 9 51813 117 34904992
Flushing 25.73 18.17 8 51814 32412 34872697
Spirochaetal infection 25.60 18.17 6 51816 15 34905094
Roseolovirus test positive 25.52 18.17 8 51814 75 34905034
Disseminated Bacillus Calmette-Guerin infection 25.48 18.17 10 51812 190 34904919
Reticulocytosis 25.47 18.17 11 51811 269 34904840
Contusion 25.44 18.17 11 51811 36353 34868756
Disseminated toxoplasmosis 25.43 18.17 8 51814 76 34905033
Autoimmune neutropenia 25.43 18.17 11 51811 270 34904839
Retinopathy haemorrhagic 25.34 18.17 7 51815 40 34905069
Stenotrophomonas sepsis 25.33 18.17 9 51813 128 34904981
Primary amyloidosis 25.26 18.17 9 51813 129 34904980
Haemoglobin decreased 25.26 18.17 282 51540 120490 34784619
CNS ventriculitis 25.17 18.17 11 51811 277 34904832
Oedema peripheral 25.17 18.17 92 51730 119720 34785389
Chronic kidney disease 25.05 18.17 15 51807 41195 34863914
Kidney fibrosis 24.94 18.17 23 51799 2205 34902904
Pneumonia viral 24.88 18.17 27 51795 3147 34901962
Hepatitis B 24.72 18.17 37 51785 5946 34899163
Pneumoretroperitoneum 24.71 18.17 9 51813 138 34904971
Apoptosis 24.38 18.17 12 51810 399 34904710
Enterocolitis viral 24.30 18.17 8 51814 89 34905020
Pleural effusion 24.23 18.17 205 51617 81341 34823768
Retinitis viral 24.21 18.17 8 51814 90 34905019
Gastrointestinal infection 24.17 18.17 36 51786 5762 34899347
Acute lymphocytic leukaemia 24.16 18.17 26 51796 3003 34902106
Toxic erythema of chemotherapy 24.13 18.17 8 51814 91 34905018
Myeloid leukaemia 24.05 18.17 12 51810 411 34904698
Fungaemia 24 18.17 24 51798 2544 34902565
Device related bacteraemia 23.97 18.17 12 51810 414 34904695
Bladder hypertrophy 23.94 18.17 14 51808 661 34904448
Cardio-respiratory arrest 23.90 18.17 28 51794 55245 34849864
Pneumonia parainfluenzae viral 23.85 18.17 9 51813 153 34904956
Headache 23.77 18.17 187 51635 200448 34704661
Immune thrombocytopenia 23.74 18.17 46 51776 9106 34896003
Gastroenteritis norovirus 23.70 18.17 19 51803 1507 34903602
Haematotoxicity 23.51 18.17 43 51779 8151 34896958
Viral myocarditis 23.48 18.17 9 51813 160 34904949
Autoimmune pancytopenia 23.24 18.17 8 51814 103 34905006
Hypoglobulinaemia 23.21 18.17 5 51817 7 34905102
Hyperfibrinogenaemia 23.20 18.17 7 51815 57 34905052
Norovirus infection 23.13 18.17 9 51813 167 34904942
Bordetella infection 23.10 18.17 8 51814 105 34905004
Balance disorder 23.07 18.17 16 51806 40638 34864471
Haemolytic anaemia 22.83 18.17 49 51773 10430 34894679
Coronavirus infection 22.81 18.17 30 51792 4277 34900832
Cerebellar tumour 22.68 18.17 7 51815 62 34905047
Hepatic vein occlusion 22.65 18.17 9 51813 177 34904932
Hydrocephalus 22.55 18.17 33 51789 5199 34899910
Metabolic acidosis 22.48 18.17 19 51803 43661 34861448
Cryptosporidiosis infection 22.48 18.17 12 51810 474 34904635
Device related infection 22.20 18.17 66 51756 17171 34887938
Blood immunoglobulin G decreased 22.16 18.17 18 51804 1455 34903654
Therapy partial responder 22.16 18.17 46 51776 9570 34895539
Abnormal behaviour 22.02 18.17 5 51817 24964 34880145
Chronic myeloid leukaemia recurrent 21.84 18.17 9 51813 195 34904914
Bacillus infection 21.74 18.17 10 51812 285 34904824
Dysbiosis 21.63 18.17 12 51810 512 34904597
Urinary tract infection 21.56 18.17 59 51763 84022 34821087
Drug reaction with eosinophilia and systemic symptoms 21.53 18.17 11 51811 33001 34872108
Disease progression 21.53 18.17 250 51572 107827 34797282
Nephrolithiasis 21.50 18.17 9 51813 30324 34874785
Herpes zoster reactivation 21.48 18.17 10 51812 293 34904816
Refractory cytopenia with multilineage dysplasia 21.42 18.17 8 51814 132 34904977
Cardiac arrest 21.42 18.17 72 51750 96087 34809022
Lactobacillus infection 21.39 18.17 10 51812 296 34904813
Thrombosis 21.35 18.17 26 51796 50432 34854677
Stenotrophomonas bacteraemia 21.25 18.17 7 51815 78 34905031
Premature ageing 21.09 18.17 7 51815 80 34905029
Klebsiella infection 21.07 18.17 42 51780 8489 34896620
Alpha haemolytic streptococcal infection 21.00 18.17 16 51806 1178 34903931
Serratia sepsis 20.93 18.17 7 51815 82 34905027
Transplantation associated food allergy 20.93 18.17 6 51816 40 34905069
Cardiac failure congestive 20.93 18.17 59 51763 83211 34821898
Haematoma 20.90 18.17 6 51816 25599 34879510
Dyspnoea exertional 20.87 18.17 20 51802 43259 34861850
Escherichia infection 20.85 18.17 41 51781 8204 34896905
Haptoglobin decreased 20.84 18.17 12 51810 550 34904559
Gait inability 20.80 18.17 3 51819 20755 34884354
Plasma cell myeloma 20.77 18.17 19 51803 42018 34863091
Prostate cancer 20.71 18.17 17 51805 39632 34865477
Gallbladder adenocarcinoma 20.67 18.17 5 51817 15 34905094
Epstein-Barr virus test positive 20.63 18.17 12 51810 561 34904548
Complications of bone marrow transplant 20.40 18.17 9 51813 232 34904877
Adenomatous polyposis coli 20.38 18.17 8 51814 152 34904957
Hallucination 20.28 18.17 28 51794 51470 34853639
Chest discomfort 20.15 18.17 31 51791 54499 34850610
Drug resistance 20.13 18.17 84 51738 25843 34879266
Erythema 20.10 18.17 66 51756 88714 34816395
Pneumomediastinum 20.09 18.17 21 51801 2346 34902763
Arthritis fungal 20.06 18.17 7 51815 94 34905015
Abdominal pain upper 19.99 18.17 48 51774 71442 34833667
Emphysematous cholecystitis 19.98 18.17 6 51816 48 34905061
Influenza like illness 19.91 18.17 8 51814 27626 34877483
Neutrophil Pelger-Huet anomaly present 19.91 18.17 9 51813 246 34904863
Campylobacter infection 19.85 18.17 14 51808 915 34904194
Plasma cell myeloma refractory 19.84 18.17 12 51810 603 34904506
Toxic epidermal necrolysis 19.77 18.17 4 51818 21642 34883467
Plasmablastic lymphoma 19.66 18.17 10 51812 357 34904752
Paraesthesia 19.65 18.17 41 51781 64131 34840978
Portal hypertension 19.54 18.17 27 51795 4035 34901074
Oxygen saturation decreased 19.50 18.17 31 51791 53787 34851322
Immunodeficiency common variable 19.43 18.17 8 51814 173 34904936
Non-Hodgkin's lymphoma recurrent 19.37 18.17 5 51817 21 34905088
Peritoneal lesion 19.36 18.17 7 51815 105 34905004
Chronic graft versus host disease in eye 19.36 18.17 7 51815 105 34905004
Respiratory distress 19.26 18.17 104 51718 35561 34869548
Organising pneumonia 19.25 18.17 33 51789 5946 34899163
Pseudomonal sepsis 19.24 18.17 25 51797 3522 34901587
Retinal infiltrates 19.18 18.17 5 51817 22 34905087
Citrobacter infection 19.15 18.17 11 51811 502 34904607
Arrhythmia 19.14 18.17 15 51807 35793 34869316
Medication error 19.09 18.17 7 51815 25558 34879551
Feeling hot 18.95 18.17 3 51819 19369 34885740
Infection in an immunocompromised host 18.91 18.17 12 51810 657 34904452
Epistaxis 18.88 18.17 36 51786 58215 34846894
Depressed mood 18.88 18.17 3 51819 19314 34885795
Gout 18.79 18.17 3 51819 19250 34885859
Pneumonia pseudomonal 18.76 18.17 26 51796 3896 34901213
Cerebral fungal infection 18.74 18.17 9 51813 283 34904826
Growth retardation 18.63 18.17 18 51804 1830 34903279
Injury 18.53 18.17 4 51818 20683 34884426
Bronchitis 18.42 18.17 21 51801 41942 34863167
Therapy non-responder 18.40 18.17 110 51712 39036 34866073
Paraparesis 18.29 18.17 18 51804 1871 34903238

FDA Adverse Event Reporting System (Geriatric)

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 4096.70 17.72 1489 78597 34509 79629793
Acute graft versus host disease 2378.90 17.72 725 79361 9442 79654860
Cytomegalovirus infection 2148.70 17.72 984 79102 41660 79622642
Acute graft versus host disease in skin 1761.04 17.72 539 79547 7119 79657183
Graft versus host disease 1487.97 17.72 562 79524 14464 79649838
Febrile neutropenia 1371.65 17.72 1408 78678 229591 79434711
Adenovirus infection 1263.72 17.72 429 79657 8018 79656284
Chronic graft versus host disease 1228.85 17.72 398 79688 6383 79657919
Hypogammaglobulinaemia 1151.82 17.72 448 79638 12503 79651799
Venoocclusive liver disease 1121.09 17.72 428 79658 11343 79652959
Cytomegalovirus infection reactivation 1043.65 17.72 375 79711 8341 79655961
Graft versus host disease in gastrointestinal tract 1042.60 17.72 346 79740 6010 79658292
Graft versus host disease in skin 1009.78 17.72 334 79752 5739 79658563
Immune effector cell-associated neurotoxicity syndrome 957.84 17.72 318 79768 5530 79658772
Neurotoxicity 914.74 17.72 506 79580 32012 79632290
Epstein-Barr virus infection 880.26 17.72 381 79705 14035 79650267
Product use in unapproved indication 876.44 17.72 1164 78922 249195 79415107
Acute graft versus host disease in intestine 859.47 17.72 268 79818 3773 79660529
Cystitis haemorrhagic 846.51 17.72 326 79760 8846 79655456
Human herpesvirus 6 infection 784.60 17.72 268 79818 5102 79659200
BK virus infection 745.56 17.72 294 79792 8510 79655792
Post transplant lymphoproliferative disorder 739.45 17.72 315 79771 11149 79653153
Mucosal inflammation 691.28 17.72 587 79499 74993 79589309
Pyrexia 689.46 17.72 1852 78234 676857 78987445
Thrombotic microangiopathy 679.70 17.72 354 79732 19815 79644487
Myelodysplastic syndrome 628.36 17.72 387 79699 29914 79634388
Cytomegalovirus viraemia 620.34 17.72 288 79798 12533 79651769
Cytopenia 614.08 17.72 332 79754 20051 79644251
Haemophagocytic lymphohistiocytosis 595.38 17.72 333 79753 21504 79642798
Progressive multifocal leukoencephalopathy 585.89 17.72 323 79763 20277 79644025
Acute myeloid leukaemia recurrent 526.29 17.72 177 79909 3206 79661096
Acute myeloid leukaemia 510.51 17.72 342 79744 30543 79633759
Multiple organ dysfunction syndrome 505.13 17.72 613 79473 119633 79544669
Lymphocyte count decreased 477.30 17.72 389 79697 46900 79617402
Acute lymphocytic leukaemia recurrent 475.79 17.72 179 79907 4545 79659757
Neutropenia 473.61 17.72 951 79135 286759 79377543
Viral haemorrhagic cystitis 422.84 17.72 133 79953 1928 79662374
Pancytopenia 415.76 17.72 659 79427 165086 79499216
Pain 409.66 17.72 102 79984 703700 78960602
Chronic graft versus host disease in skin 405.56 17.72 121 79965 1453 79662849
Acute graft versus host disease in liver 401.70 17.72 126 79960 1809 79662493
Bronchopulmonary aspergillosis 400.29 17.72 260 79826 22034 79642268
Venoocclusive disease 384.64 17.72 152 79934 4421 79659881
Transplant failure 382.47 17.72 152 79934 4489 79659813
Posterior reversible encephalopathy syndrome 382.27 17.72 269 79817 26012 79638290
Bone marrow failure 360.40 17.72 343 79743 50764 79613538
Diffuse large B-cell lymphoma 344.04 17.72 190 79896 11959 79652343
Fatigue 341.60 17.72 262 79824 929465 78734837
Neutrophil count decreased 314.19 17.72 428 79658 93531 79570771
Chronic lymphocytic leukaemia recurrent 300.81 17.72 79 80007 569 79663733
Fall 296.62 17.72 64 80022 487565 79176737
Arthralgia 295.66 17.72 103 79983 571700 79092602
Herpes simplex 287.06 17.72 169 79917 12018 79652284
Aspergillus infection 285.34 17.72 199 79887 18962 79645340
Autoimmune haemolytic anaemia 284.87 17.72 148 79938 8232 79656070
Thrombocytopenia 283.84 17.72 740 79346 264519 79399783
Encephalitis viral 279.01 17.72 103 79983 2476 79661826
Off label use 278.56 17.72 1705 78381 905510 78758792
Bacteraemia 277.67 17.72 244 79842 32580 79631722
Dizziness 268.38 17.72 97 79989 526344 79137958
Engraftment syndrome 264.58 17.72 85 80001 1324 79662978
Leukaemia recurrent 260.91 17.72 100 79986 2674 79661628
Joint swelling 246.70 17.72 10 80076 288636 79375666
Dyspnoea 245.43 17.72 301 79785 856724 78807578
JC virus infection 244.79 17.72 105 79981 3776 79660526
Epstein-Barr virus infection reactivation 243.81 17.72 86 80000 1806 79662496
Epstein-Barr viraemia 242.00 17.72 89 79997 2116 79662186
Cystitis viral 236.46 17.72 67 80019 661 79663641
Platelet count decreased 236.33 17.72 570 79516 194094 79470208
Premature menopause 232.93 17.72 64 80022 558 79663744
Product dose omission issue 232.72 17.72 3 80083 247534 79416768
Completed suicide 230.96 17.72 3 80083 245764 79418538
Respiratory failure 219.86 17.72 530 79556 180381 79483921
Nasopharyngitis 219.66 17.72 8 80078 253873 79410429
Fusarium infection 216.14 17.72 78 80008 1754 79662548
Sepsis 213.65 17.72 675 79411 268753 79395549
White blood cell count decreased 213.35 17.72 537 79549 187751 79476551
Nausea 212.56 17.72 400 79686 956796 78707506
Pain in extremity 209.36 17.72 54 80032 364484 79299818
Toxoplasmosis 207.24 17.72 84 80002 2613 79661689
Drug hypersensitivity 206.24 17.72 28 80058 298888 79365414
Malaise 204.95 17.72 119 79967 489750 79174552
Human herpesvirus 6 encephalitis 200.50 17.72 58 80028 620 79663682
Pruritus 200.49 17.72 73 80013 394575 79269727
Septic shock 198.01 17.72 403 79683 122398 79541904
Abdominal discomfort 194.84 17.72 15 80071 250712 79413590
Systemic mycosis 194.49 17.72 80 80006 2586 79661716
Rheumatoid arthritis 193.89 17.72 3 80083 208467 79455835
Second primary malignancy 190.55 17.72 139 79947 14211 79650091
B-cell type acute leukaemia 190.13 17.72 53 80033 490 79663812
Haematocrit decreased 183.60 17.72 265 79821 61047 79603255
Peripheral swelling 181.90 17.72 27 80059 269590 79394712
Rhinovirus infection 178.71 17.72 107 79979 7846 79656456
Pneumonia cytomegaloviral 175.34 17.72 90 79996 4879 79659423
Pre-engraftment immune reaction 170.01 17.72 44 80042 297 79664005
Epstein-Barr virus associated lymphoproliferative disorder 169.74 17.72 79 80007 3453 79660849
Pneumonia fungal 168.24 17.72 117 79969 11093 79653209
Cytomegalovirus chorioretinitis 166.89 17.72 90 79996 5400 79658902
Leukoencephalopathy 166.14 17.72 102 79984 7827 79656475
Alopecia 163.58 17.72 20 80066 231335 79432967
Viraemia 162.64 17.72 72 80014 2797 79661505
Graft versus host disease in liver 160.56 17.72 62 80024 1692 79662610
Malignant neoplasm progression 159.37 17.72 393 79693 135597 79528705
Constipation 158.53 17.72 44 80042 283006 79381296
Anxiety 158.46 17.72 29 80057 248483 79415819
Diffuse large B-cell lymphoma recurrent 156.61 17.72 79 80007 4128 79660174
Asthenia 156.57 17.72 170 79916 511519 79152783
Encephalitis 156.41 17.72 125 79961 14635 79649667
Bacterial sepsis 155.49 17.72 99 79987 8099 79656203
Arthropathy 155.20 17.72 5 80081 177106 79487196
Cytomegalovirus test positive 154.75 17.72 88 79998 5859 79658443
Encephalitis cytomegalovirus 150.96 17.72 53 80033 1097 79663205
Headache 150.28 17.72 267 79819 653505 79010797
Aplastic anaemia 147.21 17.72 131 79955 17774 79646528
Pseudomonas infection 146.73 17.72 140 79946 20763 79643539
Cytokine increased 143.95 17.72 32 80054 99 79664203
Fungal infection 143.74 17.72 193 79893 41555 79622747
Hypoxia 143.48 17.72 319 79767 102924 79561378
Mucormycosis 142.81 17.72 95 79991 8374 79655928
Stem cell transplant 142.13 17.72 71 80015 3633 79660669
Lymphopenia 141.66 17.72 164 79922 30393 79633909
Vomiting 141.55 17.72 285 79801 665543 78998759
Varicella zoster virus infection 141.17 17.72 75 80011 4366 79659936
Meningoencephalitis herpetic 139.39 17.72 58 80028 1931 79662371
Swelling 138.77 17.72 25 80061 216686 79447616
Encephalopathy 138.05 17.72 245 79841 67152 79597150
Overdose 137.66 17.72 13 80073 184193 79480109
Microsporidia infection 136.37 17.72 47 80039 919 79663383
Blood pressure increased 136.17 17.72 24 80062 211336 79452966
Contraindicated product administered 136.09 17.72 5 80081 157533 79506769
Bone marrow transplant rejection 134.25 17.72 35 80051 244 79664058
Engraft failure 133.82 17.72 43 80043 670 79663632
Drug interaction 133.65 17.72 132 79954 415051 79249251
Synovitis 132.98 17.72 4 80082 150730 79513572
Lymphadenopathy 130.89 17.72 210 79876 53037 79611265
Staphylococcal infection 129.95 17.72 220 79866 58075 79606227
Musculoskeletal stiffness 129.07 17.72 13 80073 174995 79489307
Chronic graft versus host disease in liver 128.37 17.72 41 80045 626 79663676
Myocardial infarction 127.52 17.72 17 80069 184112 79480190
Adenovirus reactivation 127.24 17.72 36 80050 353 79663949
Adenoviral hepatitis 126.59 17.72 44 80042 883 79663419
Minimal residual disease 126.40 17.72 38 80048 469 79663833
Condition aggravated 123.98 17.72 195 79891 500929 79163373
Therapeutic product effect decreased 123.95 17.72 11 80075 163852 79500450
Insomnia 123.30 17.72 46 80040 245124 79419178
Maternal exposure during pregnancy 122.77 17.72 3 80083 136535 79527767
Idiopathic pneumonia syndrome 120.34 17.72 38 80048 558 79663744
Cerebral toxoplasmosis 120.29 17.72 55 80031 2307 79661995
Weight increased 119.27 17.72 65 80021 277321 79386981
Skin toxicity 118.31 17.72 84 80002 8230 79656072
Asthma 117.69 17.72 4 80082 135091 79529211
Back pain 117.28 17.72 81 80005 304099 79360203
Depression 117.14 17.72 36 80050 216754 79447548
Hypersensitivity 116.36 17.72 59 80027 262180 79402122
Enterococcal infection 112.03 17.72 106 79980 15554 79648748
Rash 111.69 17.72 261 79825 578097 79086205
Drug resistance 109.98 17.72 171 79915 42042 79622260
Staphylococcal sepsis 109.81 17.72 102 79984 14624 79649678
Inappropriate schedule of product administration 109.66 17.72 6 80080 133622 79530680
Drug intolerance 107.69 17.72 66 80020 264053 79400249
Gait disturbance 107.62 17.72 37 80049 207469 79456833
Feeling abnormal 107.18 17.72 16 80070 159183 79505119
Chronic graft versus host disease in intestine 106.94 17.72 31 80055 334 79663968
Respiratory syncytial virus infection 106.89 17.72 83 80003 9319 79654983
Diarrhoea 105.97 17.72 490 79596 879999 78784303
Muscle spasms 105.89 17.72 23 80063 174707 79489595
Contusion 104.79 17.72 13 80073 148763 79515539
B-cell aplasia 102.86 17.72 27 80059 194 79664108
Discomfort 101.97 17.72 6 80080 125611 79538691
Tumour lysis syndrome 101.89 17.72 123 79963 23816 79640486
Chest pain 101.29 17.72 81 80005 282223 79382079
Polyomavirus viraemia 100.51 17.72 44 80042 1663 79662639
Myelosuppression 100.50 17.72 160 79926 40136 79624166
Urticaria 99.60 17.72 31 80055 185170 79479132
Wound 99.26 17.72 4 80082 116175 79548127
Hepatic failure 98.72 17.72 201 79885 61011 79603291
Graft versus host disease in eye 97.50 17.72 28 80058 291 79664011
Pulmonary haemorrhage 96.58 17.72 95 79991 14622 79649680
Blood stem cell transplant failure 95.25 17.72 31 80055 504 79663798
Aplasia 93.20 17.72 71 80015 7749 79656553
Dehydration 93.13 17.72 68 80018 248119 79416183
Disseminated intravascular coagulation 93.10 17.72 145 79941 35697 79628605
Serum ferritin increased 93.01 17.72 78 80008 9769 79654533
Neoplasm recurrence 92.88 17.72 56 80030 4158 79660144
Aphasia 91.99 17.72 167 79919 46565 79617737
Weight decreased 91.83 17.72 134 79952 355064 79309238
Infection reactivation 90.51 17.72 47 80039 2610 79661692
Acute respiratory distress syndrome 89.97 17.72 160 79926 43907 79620395
Clostridium difficile infection 89.76 17.72 157 79929 42528 79621774
Arthritis 88.83 17.72 7 80079 114873 79549429
Exposure during pregnancy 88.06 17.72 3 80083 101129 79563173
Stenotrophomonas infection 88.00 17.72 52 80034 3721 79660581
Infusion related reaction 87.80 17.72 62 80024 230175 79434127
Mobility decreased 87.71 17.72 10 80076 122165 79542137
Parainfluenzae virus infection 86.89 17.72 60 80026 5622 79658680
Disease progression 85.21 17.72 389 79697 183973 79480329
Gastrooesophageal reflux disease 84.55 17.72 5 80081 104241 79560061
Campylobacter infection 84.38 17.72 40 80046 1823 79662479
Autoimmune neutropenia 83.90 17.72 29 80057 572 79663730
Capillary leak syndrome 83.53 17.72 51 80035 3874 79660428
Abdominal pain upper 83.09 17.72 62 80024 223757 79440545
Toxic leukoencephalopathy 82.05 17.72 34 80052 1120 79663182
Hospitalisation 81.34 17.72 3 80083 94233 79570069
Pneumocystis jirovecii pneumonia 80.96 17.72 129 79957 32379 79631923
Bacterial infection 80.49 17.72 126 79960 31154 79633148
Musculoskeletal pain 79.81 17.72 6 80080 102348 79561954
Fungaemia 78.61 17.72 52 80034 4539 79659763
Enterococcal bacteraemia 76.08 17.72 44 80042 3024 79661278
Gastroenteritis adenovirus 75.72 17.72 24 80062 357 79663945
Hyperhidrosis 75.17 17.72 29 80057 151463 79512839
Syncope 74.30 17.72 44 80042 179405 79484897
Palpitations 74.04 17.72 18 80068 126592 79537710
Klebsiella sepsis 73.71 17.72 44 80042 3208 79661094
Human herpesvirus 6 infection reactivation 73.57 17.72 26 80060 549 79663753
Urinary tract infection 73.46 17.72 101 79985 274411 79389891
Immune thrombocytopenia 73.36 17.72 90 79996 17715 79646587
Staphylococcal bacteraemia 73.07 17.72 75 80011 12143 79652159
Dyspepsia 72.97 17.72 11 80075 108676 79555626
Loss of personal independence in daily activities 72.14 17.72 9 80077 102571 79561731
Graft versus host disease in lung 72.12 17.72 29 80057 883 79663419
Pneumonia respiratory syncytial viral 71.84 17.72 36 80050 1854 79662448
Systemic candida 71.49 17.72 57 80029 6649 79657653
Hypoglycaemia 71.23 17.72 9 80077 101585 79562717
Nephropathy toxic 71.19 17.72 95 79991 20324 79643978
Chronic lymphocytic leukaemia 71.17 17.72 50 80036 4816 79659486
Blood cholesterol increased 71.12 17.72 3 80083 83717 79580585
Sleep disorder 69.81 17.72 4 80082 85673 79578629
Mucoepidermoid carcinoma of salivary gland 68.88 17.72 17 80069 92 79664210
Candida sepsis 67.58 17.72 38 80048 2475 79661827
Wheezing 67.41 17.72 17 80069 116647 79547655
Cerebrovascular accident 67.27 17.72 36 80050 155256 79509046
Transplant rejection 67.10 17.72 90 79996 19347 79644955
Clostridium difficile colitis 66.91 17.72 118 79968 32165 79632137
Geotrichum infection 66.71 17.72 28 80058 953 79663349
Injection site erythema 65.77 17.72 3 80083 78194 79586108
Acute lymphocytic leukaemia 65.66 17.72 48 80038 4921 79659381
Escherichia sepsis 65.51 17.72 60 80026 8448 79655854
Pneumatosis intestinalis 65.28 17.72 53 80033 6344 79657958
Bronchitis 64.83 17.72 25 80061 130619 79533683
Cerebral aspergillosis 64.73 17.72 33 80053 1763 79662539
Disseminated toxoplasmosis 64.70 17.72 19 80067 215 79664087
Blood fibrinogen decreased 64.54 17.72 34 80052 1945 79662357
Chimerism 64.48 17.72 20 80066 276 79664026
Haematotoxicity 63.22 17.72 78 80008 15441 79648861
Pseudomonal sepsis 62.68 17.72 51 80035 6123 79658179
Wrong technique in product usage process 61.60 17.72 3 80083 73872 79590430
Neoplasm progression 61.15 17.72 150 79936 51532 79612770
Candida infection 61.03 17.72 125 79961 38089 79626213
Upper respiratory fungal infection 60.90 17.72 20 80066 335 79663967
Klebsiella infection 60.83 17.72 77 80009 15643 79648659
Migraine 60.74 17.72 8 80078 87485 79576817
Blood glucose increased 60.46 17.72 20 80066 114955 79549347
Lymphoproliferative disorder 60.44 17.72 48 80038 5567 79658735
Out of specification test results 60.24 17.72 17 80069 165 79664137
Neutropenic sepsis 60.11 17.72 102 79984 26962 79637340
Erythema 59.88 17.72 82 80004 223208 79441094
Injury 59.14 17.72 5 80081 77491 79586811
Hypoaesthesia 58.79 17.72 56 80030 179296 79485006
Pneumonia adenoviral 57.42 17.72 21 80065 491 79663811
Haemoglobin decreased 56.86 17.72 400 79686 221719 79442583
Chronic lymphocytic leukaemia refractory 56.76 17.72 15 80071 111 79664191
Intentional product misuse 56.68 17.72 13 80073 95152 79569150
Pleural effusion 56.65 17.72 292 79794 144970 79519332
Bradycardia 56.44 17.72 33 80053 135524 79528778
Osteoarthritis 56.01 17.72 10 80076 87299 79577003
Pulmonary alveolar haemorrhage 55.64 17.72 63 80023 11394 79652908
Neutropenic infection 55.43 17.72 33 80053 2394 79661908
Lymphadenitis 54.89 17.72 42 80044 4613 79659689
Abdominal pain 54.61 17.72 204 79882 389365 79274937
Transplant dysfunction 53.80 17.72 50 80036 7171 79657131
Alpha haemolytic streptococcal infection 53.67 17.72 32 80054 2328 79661974
Refractory cytopenia with multilineage dysplasia 53.56 17.72 17 80069 254 79664048
Adenoviral haemorrhagic cystitis 53.25 17.72 20 80066 505 79663797
Infection 53.20 17.72 420 79666 241292 79423010
Hepatic enzyme increased 53.17 17.72 63 80023 182547 79481755
Haemolysis 53.17 17.72 65 80021 12747 79651555
Cytomegalovirus colitis 52.48 17.72 41 80045 4644 79659658
Chronic obstructive pulmonary disease 52.23 17.72 11 80075 85408 79578894
Cytokine storm 52.15 17.72 24 80062 1022 79663280
Blood pressure systolic increased 52.01 17.72 4 80082 66982 79597320
Meningomyelitis herpes 51.97 17.72 13 80073 75 79664227
B-lymphocyte count abnormal 51.54 17.72 13 80073 78 79664224
Mucosal disorder 51.02 17.72 36 80050 3492 79660810
Human polyomavirus infection 50.87 17.72 24 80062 1082 79663220
Hyperkalaemia 50.31 17.72 26 80060 114372 79549930
Escherichia bacteraemia 49.98 17.72 46 80040 6516 79657786
Leukaemic infiltration 49.78 17.72 14 80072 134 79664168
Blood follicle stimulating hormone increased 49.68 17.72 17 80069 325 79663977
Hepatitis B 49.56 17.72 51 80035 8281 79656021
Chloroma 49.11 17.72 21 80065 749 79663553
Toxicity to various agents 49.07 17.72 237 79849 421303 79242999
Cough 48.88 17.72 196 79890 366593 79297709
Decreased appetite 48.84 17.72 178 79908 342240 79322062
Influenza like illness 48.72 17.72 7 80079 71700 79592602
Blister 48.45 17.72 30 80056 119446 79544856
5q minus syndrome 48.23 17.72 16 80070 277 79664025
Angioedema 48.15 17.72 9 80077 76026 79588276
Paraesthesia 48.03 17.72 64 80022 176259 79488043
Feeling hot 48.02 17.72 3 80083 59731 79604571
Gastroenteritis norovirus 47.97 17.72 33 80053 3073 79661229
Loss of consciousness 47.77 17.72 59 80027 167884 79496418
Rhabdomyolysis 47.53 17.72 22 80064 103109 79561193
Microangiopathy 46.92 17.72 27 80059 1838 79662464
Heart rate increased 46.67 17.72 32 80054 120692 79543610
Rotavirus infection 46.55 17.72 20 80066 722 79663580
Autoimmune lymphoproliferative syndrome 46.40 17.72 14 80072 175 79664127
Obliterative bronchiolitis 46.36 17.72 32 80054 2996 79661306
Oedema peripheral 46.08 17.72 117 79969 252171 79412131
Pathogen resistance 45.87 17.72 64 80022 14278 79650024
Viral sinusitis 45.80 17.72 15 80071 249 79664053
Chronic lymphocytic leukaemia transformation 45.69 17.72 15 80071 251 79664051
Type 2 diabetes mellitus 45.53 17.72 3 80083 57119 79607183
Pericardial effusion 45.26 17.72 125 79961 46112 79618190
Hepatitis B reactivation 44.94 17.72 42 80044 6066 79658236
Mycobacterium kansasii infection 44.92 17.72 16 80070 346 79663956
Alternaria infection 44.82 17.72 19 80067 663 79663639
Gait inability 44.41 17.72 4 80082 58913 79605389
Meningitis cryptococcal 44.37 17.72 33 80053 3473 79660829
Myalgia 44.14 17.72 74 80012 185567 79478735
Myeloid leukaemia 43.50 17.72 19 80067 714 79663588
Herpes virus infection 43.48 17.72 44 80042 7005 79657297
Growth retardation 43.28 17.72 26 80060 1917 79662385
Cryptosporidiosis infection 43.26 17.72 19 80067 724 79663578
Myelitis 43.18 17.72 28 80058 2363 79661939
Rubulavirus test positive 42.95 17.72 9 80077 19 79664283
Respiratory tract infection fungal 42.88 17.72 22 80064 1191 79663111
Rectal haemorrhage 42.40 17.72 12 80074 76288 79588014
Bronchiolitis obliterans syndrome 42.13 17.72 15 80071 324 79663978
Fungal sepsis 42.10 17.72 25 80061 1805 79662497
Paraparesis 41.99 17.72 33 80053 3770 79660532
Nephrolithiasis 41.89 17.72 3 80083 53288 79611014
Burning sensation 41.57 17.72 5 80081 58627 79605675
Scedosporium infection 41.52 17.72 23 80063 1455 79662847
Unevaluable event 41.30 17.72 4 80082 55581 79608721
Hyperbilirubinaemia 41.29 17.72 82 80004 24436 79639866
Balance disorder 41.24 17.72 24 80062 98833 79565469
Blood immunoglobulin G decreased 40.73 17.72 31 80055 3378 79660924
Hot flush 40.64 17.72 4 80082 54873 79609429
Injection site reaction 40.55 17.72 4 80082 54781 79609521
Delayed engraftment 40.42 17.72 14 80072 278 79664024
Flushing 40.41 17.72 19 80067 88249 79576053
Post transplant distal limb syndrome 40.38 17.72 17 80069 583 79663719
Renal failure 40.32 17.72 342 79744 200626 79463676
Chronic graft versus host disease oral 40.14 17.72 12 80074 145 79664157
Impaired healing 39.93 17.72 19 80067 87636 79576666
Hepatic vein occlusion 39.68 17.72 13 80073 216 79664086
Refractory anaemia with an excess of blasts 39.65 17.72 19 80067 887 79663415
Heart rate abnormal 39.56 17.72 39 80047 6018 79658284
Blood creatine phosphokinase increased 39.41 17.72 9 80077 66081 79598221
Hypoalbuminaemia 39.26 17.72 74 80012 21223 79643079
Bone marrow transplant 39.22 17.72 22 80064 1426 79662876
Cytomegalovirus hepatitis 39.12 17.72 18 80068 766 79663536
Device related infection 38.95 17.72 98 79988 34196 79630106
Suicidal ideation 38.89 17.72 14 80072 76326 79587976
Post-depletion B-cell recovery 38.80 17.72 8 80078 15 79664287
Treatment noncompliance 38.21 17.72 4 80082 52264 79612038
Neck pain 38.13 17.72 14 80072 75403 79588899
General physical health deterioration 37.98 17.72 145 79941 275093 79389209
Sedation 37.86 17.72 4 80082 51891 79612411
Medication error 37.77 17.72 11 80075 68631 79595671
International normalised ratio increased 37.63 17.72 19 80067 84702 79579600
Dysphonia 37.61 17.72 6 80080 56866 79607436
Enterococcal sepsis 37.54 17.72 27 80059 2699 79661603
Escherichia infection 37.52 17.72 66 80020 17951 79646351
Depressed mood 37.34 17.72 3 80083 48477 79615825
Mucosal toxicity 37.07 17.72 16 80070 584 79663718
Death 37.03 17.72 377 79709 566137 79098165
Hyponatraemia 36.89 17.72 77 80009 177771 79486531
Splenomegaly 36.88 17.72 71 80015 20683 79643619
Disseminated mucormycosis 36.78 17.72 17 80069 731 79663571
Rash pruritic 36.72 17.72 13 80073 71616 79592686
Mycobacterial infection 36.61 17.72 30 80056 3638 79660664
Vertigo 36.34 17.72 12 80074 69070 79595232
Respiratory distress 36.31 17.72 135 79951 58204 79606098
Myelopathy 36.31 17.72 33 80053 4600 79659702
Acute myocardial infarction 36.17 17.72 16 80070 77020 79587282
Chronic graft versus host disease in eye 36.06 17.72 11 80075 143 79664159
Oropharyngeal pain 35.99 17.72 34 80052 109319 79554983
Pericarditis 35.99 17.72 31 80055 104205 79560097
Complications of bone marrow transplant 35.94 17.72 16 80070 630 79663672
Acute myeloid leukaemia refractory 35.86 17.72 11 80075 146 79664156
Dry mouth 35.83 17.72 22 80064 87997 79576305
Somnolence 35.54 17.72 122 79964 238859 79425443
Illness 35.49 17.72 3 80083 46508 79617794
Citrobacter infection 35.47 17.72 18 80068 952 79663350
Dry skin 35.44 17.72 12 80074 67983 79596319
Coronary artery disease 35.11 17.72 11 80075 65463 79598839
Transformation to acute myeloid leukaemia 35.01 17.72 18 80068 979 79663323
Lung consolidation 34.89 17.72 44 80042 8903 79655399
Chest discomfort 34.72 17.72 53 80033 137991 79526311
Aplasia pure red cell 34.66 17.72 41 80045 7769 79656533
Coronavirus infection 34.34 17.72 40 80046 7457 79656845
Nasal congestion 34.25 17.72 17 80069 76535 79587767
Pulmonary embolism 34.20 17.72 76 80010 171578 79492724
Ureaplasma infection 34.13 17.72 18 80068 1032 79663270
Cytomegalovirus gastroenteritis 34.10 17.72 14 80072 450 79663852
Diffuse large B-cell lymphoma refractory 34.05 17.72 20 80066 1415 79662887
Stenotrophomonas sepsis 33.90 17.72 11 80075 177 79664125
Dysphagia 33.59 17.72 44 80042 122092 79542210
Parvovirus B19 infection 33.48 17.72 20 80066 1460 79662842
Gastrointestinal toxicity 33.42 17.72 41 80045 8068 79656234
Gene mutation 33.36 17.72 25 80061 2661 79661641
Enterocolitis viral 32.83 17.72 13 80073 380 79663922
NPM1 gene mutation 32.79 17.72 10 80076 130 79664172
Neurological decompensation 32.78 17.72 33 80053 5220 79659082
Multisystem inflammatory syndrome in children 32.62 17.72 8 80078 42 79664260
Cardiotoxicity 32.46 17.72 50 80036 12189 79652113
Chronic myeloid leukaemia recurrent 32.32 17.72 12 80074 293 79664009
Retinitis viral 32.31 17.72 10 80076 137 79664165
Disseminated Bacillus Calmette-Guerin infection 32.06 17.72 11 80075 212 79664090
Leukoerythroblastosis 32.06 17.72 12 80074 300 79664002
Cytomegalovirus urinary tract infection 32.02 17.72 9 80077 86 79664216
Meningitis tuberculous 31.81 17.72 18 80068 1187 79663115
Transient ischaemic attack 31.77 17.72 7 80079 52688 79611614
Dysbiosis 31.61 17.72 18 80068 1201 79663101
B-cell lymphoma 31.59 17.72 35 80051 6180 79658122
Norovirus infection 31.53 17.72 15 80071 689 79663613
Pneumonia pseudomonal 31.28 17.72 34 80052 5877 79658425
Cerebral fungal infection 31.21 17.72 13 80073 434 79663868
Lower respiratory tract infection 31.18 17.72 51 80035 129169 79535133
Transplantation complication 31.12 17.72 12 80074 326 79663976
Portal hypertension 31.03 17.72 37 80049 7071 79657231
Neurological symptom 30.82 17.72 41 80045 8742 79655560
Enterovirus infection 30.81 17.72 21 80065 1926 79662376
Hepatosplenomegaly 30.54 17.72 34 80052 6035 79658267
Drug ineffective 30.54 17.72 1351 78735 1079562 78584740
Refractory cytopenia with unilineage dysplasia 30.47 17.72 16 80070 909 79663393
Generalised oedema 30.40 17.72 71 80015 23638 79640664
Sinusitis 30.30 17.72 98 79988 195403 79468899
Throat irritation 30.28 17.72 3 80083 40943 79623359
Aggression 30.26 17.72 7 80079 50951 79613351
Glomerulosclerosis 30.26 17.72 17 80069 1105 79663197
Lymphocytosis 30.24 17.72 30 80056 4663 79659639
Folliculitis 30.24 17.72 9 80077 55371 79608931
Dysgraphia 30.20 17.72 28 80058 4004 79660298
Oxygen saturation decreased 30.15 17.72 52 80034 128995 79535307
Memory impairment 29.97 17.72 41 80045 111693 79552609
Disease recurrence 29.94 17.72 105 79981 44004 79620298
Electrocardiogram QT prolonged 29.87 17.72 28 80058 90358 79573944
Reticulocytosis 29.58 17.72 13 80073 496 79663806
Acute erythroid leukaemia 29.58 17.72 11 80075 270 79664032
Eccrine squamous syringometaplasia 29.52 17.72 7 80079 31 79664271
Apoptosis 29.31 17.72 13 80073 507 79663795
Malignant transformation 28.96 17.72 17 80069 1201 79663101
Recurrent cancer 28.94 17.72 23 80063 2670 79661632
Hydrocephalus 28.89 17.72 40 80046 8860 79655442
Neutropenic colitis 28.77 17.72 32 80054 5675 79658627
Klebsiella bacteraemia 28.75 17.72 24 80062 2986 79661316
Swelling face 28.70 17.72 18 80068 71194 79593108
Polymyositis 28.57 17.72 24 80062 3012 79661290
Roseolovirus test positive 28.53 17.72 10 80076 206 79664096
Central nervous system leukaemia 28.44 17.72 12 80074 414 79663888
Achromobacter infection 28.32 17.72 9 80077 135 79664167
Retinal haemorrhage 28.29 17.72 38 80048 8179 79656123
Dysgeusia 28.26 17.72 11 80075 57166 79607136
Femur fracture 28.15 17.72 3 80083 38649 79625653
Anti-platelet antibody positive 27.99 17.72 11 80075 315 79663987
Refractoriness to platelet transfusion 27.96 17.72 9 80077 141 79664161
Gastrointestinal infection 27.87 17.72 45 80041 11416 79652886
Lip swelling 27.78 17.72 4 80082 40907 79623395
Graft complication 27.69 17.72 14 80072 735 79663567
Primary amyloidosis 27.67 17.72 9 80077 146 79664156
Spirochaetal infection 27.65 17.72 6 80080 16 79664286
Brain oedema 27.45 17.72 71 80015 25192 79639110
Retinal infiltrates 27.21 17.72 7 80079 46 79664256
Pneumonia bacterial 27.13 17.72 60 80026 19271 79645031
Pulmonary mucormycosis 27.02 17.72 16 80070 1149 79663153
Gastric disorder 27.02 17.72 3 80083 37430 79626872
Hepatomegaly 26.96 17.72 59 80027 18815 79645487
Head injury 26.96 17.72 3 80083 37366 79626936
Dysplasia 26.94 17.72 17 80069 1369 79662933
Iron overload 26.91 17.72 19 80067 1845 79662457
Blindness cortical 26.75 17.72 15 80071 972 79663330
Immunodeficiency common variable 26.70 17.72 11 80075 357 79663945
Organising pneumonia 26.67 17.72 43 80043 10896 79653406
Cerebellar tumour 26.66 17.72 8 80078 98 79664204
Immune reconstitution inflammatory syndrome 26.64 17.72 49 80037 13792 79650510
Accidental overdose 26.57 17.72 4 80082 39577 79624725
B-cell lymphoma recurrent 26.56 17.72 15 80071 985 79663317
Pneumoretroperitoneum 26.35 17.72 9 80077 171 79664131
Bordetella infection 26.09 17.72 8 80078 106 79664196
Red blood cell sedimentation rate increased 25.95 17.72 7 80079 45935 79618367
Therapy non-responder 25.83 17.72 170 79916 92135 79572167
Poikiloderma 25.73 17.72 11 80075 392 79663910
Leukaemic infiltration extramedullary 25.65 17.72 9 80077 186 79664116
Device related bacteraemia 25.59 17.72 13 80073 689 79663613
Therapy partial responder 25.55 17.72 55 80031 17342 79646960
Lung infiltration 25.52 17.72 65 80021 22847 79641455
Angina pectoris 25.49 17.72 10 80076 51722 79612580
Human metapneumovirus test positive 25.21 17.72 9 80077 196 79664106
Tumour flare 24.95 17.72 15 80071 1108 79663194
Sinusitis fungal 24.92 17.72 20 80066 2354 79661948
Ascites 24.80 17.72 145 79941 75417 79588885
Evans syndrome 24.78 17.72 11 80075 430 79663872
Bacille Calmette-Guerin scar reactivation 24.71 17.72 6 80080 30 79664272
Autoimmune pancytopenia 24.59 17.72 9 80077 211 79664091
Retinopathy haemorrhagic 24.53 17.72 7 80079 71 79664231
Pulmonary fibrosis 24.39 17.72 7 80079 44105 79620197
Parainfluenzae viral bronchitis 24.38 17.72 5 80081 9 79664293
Dyspnoea exertional 24.32 17.72 31 80055 87042 79577260
Pulmonary veno-occlusive disease 24.26 17.72 17 80069 1631 79662671
Anaphylactic reaction 24.24 17.72 29 80057 83714 79580588
Clonal evolution 24.12 17.72 9 80077 223 79664079
Polyomavirus-associated nephropathy 24.08 17.72 29 80057 5598 79658704
Blood lactate dehydrogenase increased 23.84 17.72 90 79996 39080 79625222
Disseminated tuberculosis 23.79 17.72 25 80061 4158 79660144
Enterobacter infection 23.72 17.72 26 80060 4536 79659766
Neutrophil Pelger-Huet anomaly present 23.38 17.72 10 80076 357 79663945
Chromosome analysis abnormal 23.36 17.72 9 80077 244 79664058
Premature ageing 23.31 17.72 7 80079 86 79664216
Urinary retention 23.26 17.72 14 80072 56616 79607686
Joint range of motion decreased 23.20 17.72 3 80083 33279 79631023
Diffuse alveolar damage 23.15 17.72 23 80063 3581 79660721
Chronic myelomonocytic leukaemia 23.03 17.72 13 80073 853 79663449
Abdominal distension 23.00 17.72 54 80032 119596 79544706
Embryonal rhabdomyosarcoma 22.99 17.72 6 80080 42 79664260
Leukaemia 22.89 17.72 29 80057 5896 79658406
Diabetes mellitus 22.85 17.72 27 80059 78363 79585939
Serum sickness 22.82 17.72 23 80063 3643 79660659
Ear pain 22.82 17.72 3 80083 32866 79631436
Lactobacillus infection 22.69 17.72 10 80076 384 79663918
Enterobacter bacteraemia 22.67 17.72 13 80073 879 79663423
Nodular melanoma 22.59 17.72 8 80078 170 79664132
Metastases to diaphragm 22.52 17.72 6 80080 46 79664256
Squamous cell carcinoma 22.50 17.72 49 80037 15573 79648729
Haptoglobin decreased 22.44 17.72 15 80071 1332 79662970
Incorrect route of product administration 22.40 17.72 4 80082 34925 79629377
Rhinorrhoea 22.39 17.72 26 80060 76048 79588254
Colitis herpes 22.36 17.72 5 80081 16 79664286
Glomerulonephritis membranous 22.24 17.72 16 80070 1600 79662702
Epstein-Barr virus test positive 22.21 17.72 14 80072 1125 79663177
Adult T-cell lymphoma/leukaemia recurrent 22.13 17.72 5 80081 17 79664285
Deep vein thrombosis 22.12 17.72 56 80030 120863 79543439
Cord blood transplant therapy 22.08 17.72 6 80080 50 79664252
Gastroenteritis rotavirus 22.06 17.72 10 80076 411 79663891
Hyperfibrinogenaemia 22.03 17.72 7 80079 105 79664197
Herpes zoster meningoencephalitis 21.81 17.72 12 80074 749 79663553
Kidney fibrosis 21.68 17.72 22 80064 3513 79660789
CNS ventriculitis 21.68 17.72 10 80076 428 79663874
Interleukin level increased 21.59 17.72 11 80075 587 79663715
Infusion site eschar 21.50 17.72 5 80081 20 79664282
Blindness 21.41 17.72 70 80016 28313 79635989
Breast cancer 21.38 17.72 4 80082 33777 79630525
Therapeutic product effect incomplete 21.26 17.72 72 80014 141573 79522729
Metapneumovirus pneumonia 21.19 17.72 6 80080 59 79664243
Hepatic necrosis 21.14 17.72 35 80051 9065 79655237
CSF protein increased 21.12 17.72 14 80072 1226 79663076
Precursor B-lymphoblastic lymphoma recurrent 21.11 17.72 5 80081 22 79664280
Emphysematous cholecystitis 21.10 17.72 6 80080 60 79664242
Lymphoma transformation 21.05 17.72 9 80077 321 79663981
Human herpes virus 6 serology positive 21.04 17.72 8 80078 209 79664093
Serratia sepsis 21.01 17.72 8 80078 210 79664092
Vision blurred 20.99 17.72 47 80039 105851 79558451
Metastases to bone marrow 20.95 17.72 12 80074 810 79663492
Non-Hodgkin's lymphoma recurrent 20.93 17.72 5 80081 23 79664279
Sciatica 20.89 17.72 4 80082 33218 79631084
Organic brain syndrome 20.73 17.72 10 80076 474 79663828
Cardiac tamponade 20.65 17.72 35 80051 9241 79655061
Hepatitis viral 20.62 17.72 13 80073 1045 79663257
Bacterial translocation 20.53 17.72 11 80075 651 79663651
Arthritis fungal 20.45 17.72 7 80079 134 79664168
Fluid retention 20.39 17.72 24 80062 69785 79594517
Respirovirus test positive 20.35 17.72 7 80079 136 79664166
Limbic encephalitis 20.25 17.72 12 80074 863 79663439
Polyserositis 20.18 17.72 11 80075 674 79663628
Urinary tract infection viral 20.11 17.72 6 80080 72 79664230
Viral myocarditis 20.08 17.72 10 80076 508 79663794
Skin ulcer 20.07 17.72 15 80071 54135 79610167
Parvovirus infection 20.06 17.72 11 80075 682 79663620
Haematemesis 20.00 17.72 14 80072 52250 79612052
Primary mediastinal large B-cell lymphoma 19.97 17.72 5 80081 29 79664273
Cardiomyopathy 19.96 17.72 69 80017 28705 79635597
Meningitis enteroviral 19.96 17.72 6 80080 74 79664228
Adenomatous polyposis coli 19.94 17.72 8 80078 242 79664060
Dyskinesia 19.94 17.72 10 80076 44763 79619539
Haematochezia 19.85 17.72 36 80050 87609 79576693
Toxic erythema of chemotherapy 19.79 17.72 8 80078 247 79664055
Prescribed underdose 19.77 17.72 3 80083 29511 79634791
Growth failure 19.76 17.72 8 80078 248 79664054
Paraneoplastic pemphigus 19.75 17.72 7 80079 149 79664153
Pneumonia viral 19.66 17.72 34 80052 9124 79655178
Gastroenteritis clostridial 19.60 17.72 12 80074 916 79663386
Streptococcal bacteraemia 19.53 17.72 21 80065 3585 79660717
Periorbital cellulitis 19.51 17.72 12 80074 923 79663379
Gastroenteritis sapovirus 19.45 17.72 7 80079 156 79664146
Diverticulitis 19.37 17.72 11 80075 45925 79618377
Central nervous system enteroviral infection 19.33 17.72 6 80080 83 79664219
Organ failure 19.28 17.72 22 80064 4011 79660291
Cardio-respiratory arrest 19.27 17.72 51 80035 108459 79555843
Cataract subcapsular 19.21 17.72 12 80074 949 79663353
Brain herniation 19.11 17.72 30 80056 7433 79656869
Gastrointestinal disorder 19.11 17.72 61 80025 122144 79542158
Inflammation 19.09 17.72 41 80045 93712 79570590
Hepatitis E 19.08 17.72 19 80067 2967 79661335
Arrhythmia 19.07 17.72 20 80066 61252 79603050
Orthostatic hypotension 19.03 17.72 17 80069 56147 79608155
Serratia infection 18.73 17.72 15 80071 1761 79662541
Lactic acidosis 18.68 17.72 26 80060 70333 79593969
Hypophosphataemia 18.66 17.72 53 80033 19860 79644442
Haematoma 18.66 17.72 15 80071 52180 79612122
Juvenile chronic myelomonocytic leukaemia 18.62 17.72 4 80082 10 79664292
Blood bilirubin increased 18.54 17.72 122 79964 66110 79598192
Cataract 18.53 17.72 21 80065 62099 79602203
Heart rate irregular 18.42 17.72 5 80081 32674 79631628
Blood potassium decreased 18.41 17.72 12 80074 46500 79617802
Restlessness 18.40 17.72 12 80074 46480 79617822
Adrenal haemorrhage 18.39 17.72 10 80076 610 79663692
Blood bilirubin unconjugated increased 18.37 17.72 12 80074 1025 79663277
Pneumonia klebsiella 18.36 17.72 24 80062 5030 79659272
Rib fracture 18.36 17.72 3 80083 27944 79636358
Haemolytic anaemia 18.26 17.72 49 80037 17771 79646531
Transplantation associated food allergy 18.24 17.72 6 80080 101 79664201
Actinomycotic sepsis 18.24 17.72 6 80080 101 79664201
Pneumonia parainfluenzae viral 18.18 17.72 8 80078 306 79663996
Vaccination failure 18.17 17.72 15 80071 1838 79662464
Tinnitus 18.15 17.72 11 80075 44322 79619980
Gastritis fungal 18.13 17.72 7 80079 191 79664111
Product administered to patient of inappropriate age 18.09 17.72 25 80061 5528 79658774
Lineage switch leukaemia 18.09 17.72 4 80082 12 79664290
Sphingomonas paucimobilis infection 18.08 17.72 6 80080 104 79664198
Amnesia 18.08 17.72 22 80064 63035 79601267
Pulmonary toxicity 18.03 17.72 40 80046 12874 79651428
Abnormal behaviour 18.01 17.72 7 80079 36414 79627888
Apraxia 17.87 17.72 18 80068 2849 79661453
Agranulocytosis 17.87 17.72 91 79995 44939 79619363
Bladder hypertrophy 17.82 17.72 10 80076 649 79663653

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC L01BB05 ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
ANTINEOPLASTIC AGENTS
ANTIMETABOLITES
Purine analogues
FDA MoA N0000000233 Nucleic Acid Synthesis Inhibitors
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
FDA EPC N0000175595 Nucleoside Metabolic Inhibitor
CHEBI has role CHEBI:22587 antiviral agents
CHEBI has role CHEBI:35221 antimetabolite
CHEBI has role CHEBI:35610 antineoplastic agents
CHEBI has role CHEBI:35705 immunosuppressive agents
CHEBI has role CHEBI:50266 Prodrugs
CHEBI has role CHEBI:59517 DNA synthesis inhibitors

Drug Use | Suggest Off label Use Form| |View source of the data|

DiseaseRelationSNOMED_IDDOID
Acute myeloid leukemia, disease indication 91861009
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
CNS Toxicity contraindication
Chemotherapy-Induced Hyperuricemia contraindication




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

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)

None

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
4020177 VANDF
4020528 VANDF
C0060483 UMLSCUI
CHEBI:63599 CHEBI
CHEMBL1096882 ChEMBL_ID
C042382 MESH_SUPPLEMENTAL_RECORD_UI
C024352 MESH_SUPPLEMENTAL_RECORD_UI
1X9VK9O1SC UNII
30751 PUBCHEM_CID
DB01073 DRUGBANK_ID
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
5214 INN_ID
21679-14-1 SECONDARY_CAS_RN
657237 PUBCHEM_CID
4802 IUPHAR_LIGAND_ID
P2K93U8740 UNII

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Fludarabine Phosphate HUMAN PRESCRIPTION DRUG LABEL 1 0480-9772 INJECTION, SOLUTION 25 mg INTRAVENOUS Unapproved drug for use in drug shortage 3 sections
Fludarabine Phosphate HUMAN PRESCRIPTION DRUG LABEL 1 0527-1242 INJECTION 25 mg INTRAVENOUS ANDA 28 sections
FLUDARABINE PHOSPHATE HUMAN PRESCRIPTION DRUG LABEL 1 16729-131 INJECTION 25 mg INTRAVENOUS Unapproved drug for use in drug shortage 2 sections
FLUDARABINE PHOSPHATE HUMAN PRESCRIPTION DRUG LABEL 1 16729-131 INJECTION 25 mg INTRAVENOUS Unapproved drug for use in drug shortage 2 sections
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 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 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 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