fludarabine phosphate 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | 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) 58 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
azlogd74 LogD at pH 7.4 -2.174 Moderate 0.65
caco2-efflux Caco-2 efflux ratio (BA/AB) 4.875 Moderate 0.65
caco2-intrinsic-papp Caco-2 intrinsic apparent permeability 0.086 10^-6 cm/s Moderate 0.65
dh-clint Dog hepatocyte intrinsic clearance 9.183 uL/min/10^6 cells Moderate 0.65
dppb Dog plasma protein binding (% unbound) 38.910 % Moderate 0.65
fcs-ppb Fetal calf serum protein binding (% unbound) 15.520 % Moderate 0.65
herg hERG pIC50 4.310 pIC50 Moderate 0.65
hh-clint Human hepatocyte intrinsic clearance 3.597 uL/min/10^6 cells Moderate 0.65
hlm-clint Human liver microsomal intrinsic clearance 3.690 uL/min/mg protein Moderate 0.65
hppb Human plasma protein binding (% unbound) 34.060 % Moderate 0.65
kinase-safety-class ACVR2A,ACVR2B,ACVRL1,AURKA,AXL,BRAF,CAMK2D,CDK4,CDK5,CDK9,DDR1,DYRK1B,EIF2AK3,ERBB2,FLT3,GRK2,ITK,MAP2K6,MAP3K21,MAPK10,MAPK7,NTRK1,NTRK2,PDK1,PDK2,PIK3CD,PRKDC,SIK2,STK33,TEK 30
kinase-selectivity-class AXL,BRAF,CDK9,ERBB2,GRK2,MAP2K6,PIK3CD,PRKDC,SYK,TEK,ZAP70 11
mdck-mdr1-efflux MDCK-MDR1 efflux ratio 0.313 Moderate 0.65
mh-clint Mouse hepatocyte intrinsic clearance 77.446 Moderate 0.65
mppb Mouse plasma protein binding (% unbound) 78.170 Moderate 0.65
nih-mdck-mdr1-efflux NIH MDCK-MDR1 efflux ratio 0.254 Moderate 0.65
pfas-class PFAS structural alert (1 = True, 0 = False) 0
pld-class Phospholipidosis risk class (1 = positive, 0 = negative) 0 Moderate 0.71
pppb Pig plasma protein binding (% unbound) 28.240 % Moderate 0.65
rh-clint Rat hepatocyte intrinsic clearance 30.903 uL/min/10^6 cells Moderate 0.65
rh-fuinc Rat hepatocyte fraction unbound in incubation 90.020 % Moderate 0.65
rppb Rat plasma protein binding (% unbound) 53.960 % Moderate 0.65
solubility-dd Solubility at pH 7.4 in DMSO 810.961 uM Moderate 0.65

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 3038.03 26.48 950 46480 27023 90553994
Acute graft versus host disease 1585.51 26.48 401 47029 5067 90575950
Cytomegalovirus infection reactivation 1403.02 26.48 392 47038 7408 90573609
Febrile neutropenia 1293.50 26.48 882 46548 157467 90423550
Acute graft versus host disease in skin 1242.48 26.48 321 47109 4435 90576582
Cytomegalovirus infection 1189.60 26.48 467 46963 26135 90554882
Graft versus host disease 1037.05 26.48 313 47117 7831 90573186
Immune effector cell-associated neurotoxicity syndrome 983.16 26.48 278 47152 5490 90575527
Graft versus host disease in skin 914.43 26.48 241 47189 3612 90577405
Adenovirus infection 907.96 26.48 249 47181 4373 90576644
Chronic graft versus host disease 887.90 26.48 239 47191 3900 90577117
Graft versus host disease in gastrointestinal tract 781.93 26.48 219 47211 4169 90576848
Thrombotic microangiopathy 780.41 26.48 298 47132 15445 90565572
Hypogammaglobulinaemia 767.91 26.48 266 47164 10408 90570609
Mucosal inflammation 670.80 26.48 402 47028 57223 90523794
Myelodysplastic syndrome 649.34 26.48 283 47147 20620 90560397
Neutropenia 591.79 26.48 656 46774 224248 90356769
BK virus infection 586 26.48 176 47254 4322 90576695
Human herpesvirus 6 infection 582.93 26.48 165 47265 3267 90577750
Venoocclusive liver disease 576.87 26.48 186 47244 5807 90575210
Cytomegalovirus viraemia 553.17 26.48 191 47239 7395 90573622
Epstein-Barr virus infection 498.95 26.48 192 47238 10152 90570865
Acute graft versus host disease in intestine 492.83 26.48 130 47300 1953 90579064
Neurotoxicity 482.18 26.48 232 47198 21235 90559782
Acute myeloid leukaemia 478.62 26.48 228 47202 20412 90560605
Haemophagocytic lymphohistiocytosis 475.86 26.48 208 47222 15251 90565766
Viral haemorrhagic cystitis 474.98 26.48 118 47312 1375 90579642
Cystitis haemorrhagic 465.62 26.48 155 47275 5358 90575659
Pancytopenia 447.21 26.48 423 47007 119840 90461177
Multiple organ dysfunction syndrome 437.77 26.48 329 47101 68007 90513010
Progressive multifocal leukoencephalopathy 431.66 26.48 195 47235 15460 90565557
Post transplant lymphoproliferative disorder 408.08 26.48 149 47281 6800 90574217
Product use in unapproved indication 405.68 26.48 671 46759 335565 90245452
Bronchopulmonary aspergillosis 375.79 26.48 161 47269 11237 90569780
Chronic graft versus host disease in skin 374.46 26.48 94 47336 1146 90579871
Cytopenia 354.16 26.48 176 47254 17273 90563744
Posterior reversible encephalopathy syndrome 351.79 26.48 190 47240 22149 90558868
Thrombocytopenia 350.19 26.48 486 46944 208239 90372778
Acute myeloid leukaemia recurrent 331.78 26.48 95 47335 1962 90579055
Acute lymphocytic leukaemia recurrent 330.95 26.48 101 47329 2620 90578397
Pain 327.52 26.48 63 47367 996278 89584739
Sepsis 321.69 26.48 432 46998 179382 90401635
Epstein-Barr virus infection reactivation 315.92 26.48 87 47343 1550 90579467
Pyrexia 306.31 26.48 896 46534 659589 89921428
Viraemia 295.94 26.48 83 47347 1586 90579431
Venoocclusive disease 293.80 26.48 90 47340 2365 90578652
Off label use 285.85 26.48 1234 46196 1101018 89479999
Transplant failure 282.37 26.48 83 47347 1886 90579131
Encephalitis viral 263.77 26.48 78 47352 1811 90579206
Bacteraemia 255.19 26.48 154 47276 22146 90558871
Lymphocyte count decreased 251.97 26.48 181 47249 34869 90546148
Aspergillus infection 240.05 26.48 116 47314 10707 90570310
Neutrophil count decreased 236.38 26.48 236 47194 71296 90509721
Joint swelling 231.70 26.48 7 47423 503293 90077724
Premature menopause 230.68 26.48 65 47365 1264 90579753
Systemic candida 228.28 26.48 89 47341 4870 90576147
Septic shock 218.19 26.48 244 47186 83916 90497101
JC virus infection 208.08 26.48 71 47359 2648 90578369
Fatigue 205.54 26.48 182 47248 1153841 89427176
Infection reactivation 202.25 26.48 64 47366 1876 90579141
Platelet count decreased 198.83 26.48 298 47132 136671 90444346
Respiratory failure 198.72 26.48 276 47154 118142 90462875
Herpes simplex 198.64 26.48 100 47330 10081 90570936
Epstein-Barr viraemia 197.85 26.48 59 47371 1411 90579606
Bone marrow failure 194.88 26.48 150 47280 32071 90548946
Nasopharyngitis 193.62 26.48 4 47426 407100 90173917
Disease progression 191.62 26.48 315 47115 156300 90424717
Alopecia 191.06 26.48 19 47411 495052 90085965
Bacterial sepsis 190.15 26.48 78 47352 4877 90576140
Abdominal discomfort 187.69 26.48 17 47413 477311 90103706
Varicella zoster virus infection 187.06 26.48 72 47358 3805 90577212
Systemic mycosis 182.70 26.48 56 47374 1474 90579543
Drug hypersensitivity 180.98 26.48 17 47413 463592 90117425
Acute graft versus host disease in liver 179.70 26.48 48 47382 758 90580259
Pneumonia fungal 179.38 26.48 83 47347 6948 90574069
Aplastic anaemia 176.44 26.48 101 47329 13168 90567849
Drug resistance 176.00 26.48 138 47292 30311 90550706
Diffuse large B-cell lymphoma 171.85 26.48 86 47344 8559 90572458
Rheumatoid arthritis 170.70 26.48 4 47426 362610 90218407
Arthralgia 169.38 26.48 99 47331 778423 89802594
Staphylococcal bacteraemia 168.50 26.48 81 47349 7388 90573629
White blood cell count decreased 167.73 26.48 308 47122 166801 90414216
Peripheral swelling 167.09 26.48 13 47417 413093 90167924
Systemic lupus erythematosus 166.58 26.48 5 47425 361891 90219126
Hypersensitivity 166.47 26.48 21 47409 454656 90126361
Headache 165.82 26.48 126 47304 862620 89718397
Adenoviral hepatitis 165.47 26.48 40 47390 412 90580605
Cytokine increased 165.17 26.48 31 47399 75 90580942
Leukoencephalopathy 164.46 26.48 70 47360 4803 90576214
Cytomegalovirus test positive 163.71 26.48 64 47366 3527 90577490
Second primary malignancy 162.60 26.48 88 47342 10290 90570727
Swelling 161.86 26.48 16 47414 419042 90161975
Pruritus 161.84 26.48 42 47388 541483 90039534
Cytomegalovirus chorioretinitis 161.31 26.48 57 47373 2362 90578655
Dizziness 160.99 26.48 54 47376 589230 89991787
Cystitis viral 159.26 26.48 35 47395 226 90580791
Pre-engraftment immune reaction 158.34 26.48 35 47395 233 90580784
Arthropathy 152.49 26.48 10 47420 366232 90214785
Staphylococcal infection 151.18 26.48 155 47275 48284 90532733
Human herpesvirus 6 encephalitis 148.38 26.48 36 47394 377 90580640
Contraindicated product administered 145.26 26.48 5 47425 320134 90260883
Fall 144.64 26.48 37 47393 481773 90099244
Wound 143.92 26.48 3 47427 302977 90278040
Maternal exposure during pregnancy 133.29 26.48 16 47414 360047 90220970
Drug intolerance 129.38 26.48 37 47393 447554 90133463
Discomfort 129.18 26.48 3 47427 274332 90306685
Pain in extremity 128.83 26.48 38 47392 450491 90130526
Infusion related reaction 127.01 26.48 31 47399 416749 90164268
Rhinovirus infection 126.48 26.48 62 47368 5901 90575116
Fungaemia 126.05 26.48 52 47378 3298 90577719
Enterococcal bacteraemia 124.70 26.48 45 47385 1983 90579034
Urticaria 123.22 26.48 11 47419 312723 90268294
Mucormycosis 119.46 26.48 52 47378 3769 90577248
Protothecosis 119.12 26.48 31 47399 440 90580577
Anxiety 119.12 26.48 12 47418 309760 90271257
Pseudomonas infection 118.97 26.48 82 47348 14783 90566234
Toxoplasmosis 118.79 26.48 42 47388 1743 90579274
Malaise 118.38 26.48 81 47349 585905 89995112
Adenovirus reactivation 116.72 26.48 27 47403 226 90580791
Engraftment syndrome 114.76 26.48 33 47397 692 90580325
Lymphopenia 113.80 26.48 95 47335 22786 90558231
Mobility decreased 113.43 26.48 4 47426 250730 90330287
Staphylococcal sepsis 113.04 26.48 67 47363 9316 90571701
Fungal infection 112.76 26.48 125 47305 42536 90538481
Dyspnoea 112.59 26.48 180 47250 880775 89700242
Depression 112.13 26.48 13 47417 300588 90280429
Clostridium difficile colitis 110.83 26.48 100 47330 26606 90554411
Encephalopathy 110.73 26.48 129 47301 46315 90534702
Neoplasm recurrence 110.59 26.48 47 47383 3212 90577805
Impaired healing 105.03 26.48 4 47426 234195 90346822
Chronic lymphocytic leukaemia recurrent 104.49 26.48 27 47403 372 90580645
Exposure during pregnancy 103.84 26.48 5 47425 238405 90342612
Disseminated mucormycosis 103.79 26.48 30 47400 641 90580376
Nausea 103.63 26.48 272 47158 1110044 89470973
Polyomavirus viraemia 103.16 26.48 35 47395 1282 90579735
Encephalitis 102.49 26.48 67 47363 11067 90569950
Clostridium difficile infection 102.40 26.48 110 47320 36135 90544882
Fusarium infection 101.73 26.48 33 47397 1049 90579968
Enterococcal infection 101.57 26.48 64 47366 9927 90571090
Engraft failure 101.11 26.48 26 47404 351 90580666
Therapeutic product effect decreased 101.07 26.48 13 47417 277558 90303459
Stem cell transplant 100.35 26.48 39 47391 2115 90578902
Hepatic enzyme increased 100.25 26.48 32 47398 360704 90220313
Epstein-Barr virus associated lymphoproliferative disorder 99.00 26.48 41 47389 2626 90578391
Muscle spasms 98.82 26.48 9 47421 251874 90329143
Wheezing 97.59 26.48 7 47423 238073 90342944
Transplant dysfunction 97.55 26.48 50 47380 5232 90575785
Myelosuppression 97.53 26.48 130 47300 53461 90527556
Contusion 95.87 26.48 10 47420 251206 90329811
Weight increased 95.23 26.48 50 47380 417877 90163140
Hypoxia 94.42 26.48 150 47280 72249 90508768
Type 2 diabetes mellitus 92.78 26.48 3 47427 203241 90377776
Bronchiolitis obliterans syndrome 89.38 26.48 24 47406 387 90580630
Graft versus host disease in liver 89.04 26.48 29 47401 934 90580083
Malignant neoplasm progression 88.84 26.48 182 47248 106688 90474329
Human herpesvirus 6 infection reactivation 87.73 26.48 26 47404 608 90580409
Rash 87.01 26.48 179 47251 795921 89785096
Abdominal pain upper 86.43 26.48 33 47397 332641 90248376
Campylobacter infection 86.34 26.48 30 47400 1182 90579835
Acute respiratory distress syndrome 86.25 26.48 90 47340 28596 90552421
Escherichia bacteraemia 85.32 26.48 47 47383 5688 90575329
Leukaemia recurrent 84.42 26.48 31 47399 1436 90579581
Bacterial infection 84.19 26.48 81 47349 23363 90557654
Geotrichum infection 84.10 26.48 25 47405 591 90580426
Pericardial effusion 83.97 26.48 100 47330 36733 90544284
Vomiting 83 26.48 181 47249 788112 89792905
Blood stem cell transplant failure 82.82 26.48 20 47410 205 90580812
Graft versus host disease in lung 82.46 26.48 24 47406 526 90580491
Systemic inflammatory response syndrome 82.37 26.48 48 47382 6468 90574549
Retinitis viral 82.33 26.48 21 47409 274 90580743
Growth failure 81.23 26.48 22 47408 367 90580650
Insomnia 80.33 26.48 37 47393 333437 90247580
Blister 79.53 26.48 18 47412 254980 90326037
Immune reconstitution inflammatory syndrome 79.06 26.48 48 47382 6971 90574046
B-cell aplasia 79.05 26.48 20 47410 252 90580765
Alpha haemolytic streptococcal infection 79.04 26.48 31 47399 1723 90579294
Upper respiratory fungal infection 78.92 26.48 19 47411 192 90580825
Pulmonary haemorrhage 78.14 26.48 50 47380 7963 90573054
Idiopathic pneumonia syndrome 78.01 26.48 22 47408 429 90580588
Autoimmune haemolytic anaemia 77.81 26.48 44 47386 5601 90575416
Pseudomonal sepsis 77.36 26.48 40 47390 4262 90576755
Inappropriate antidiuretic hormone secretion 76.95 26.48 71 47359 19434 90561583
Dry mouth 76.62 26.48 5 47425 184054 90396963
Blood follicle stimulating hormone increased 74.85 26.48 18 47412 181 90580836
Cerebral toxoplasmosis 74.65 26.48 28 47402 1377 90579640
Hypoaesthesia 73.93 26.48 36 47394 314174 90266843
Musculoskeletal pain 73.26 26.48 4 47426 171247 90409770
Pericarditis 73.21 26.48 25 47405 270126 90310891
Pneumocystis jirovecii pneumonia 72.61 26.48 72 47358 21544 90559473
Chronic graft versus host disease in eye 72.57 26.48 18 47412 208 90580809
Lower respiratory tract infection 71.84 26.48 21 47409 250638 90330379
Aplasia 71.45 26.48 37 47393 3954 90577063
Sinusitis 71.10 26.48 46 47384 343042 90237975
Condition aggravated 71.02 26.48 127 47303 595418 89985599
Gait disturbance 70.77 26.48 24 47406 260472 90320545
Norovirus infection 70.66 26.48 29 47401 1815 90579202
Dyspepsia 70.41 26.48 10 47420 198150 90382867
Diffuse large B-cell lymphoma recurrent 69.85 26.48 35 47395 3491 90577526
Klebsiella infection 69.03 26.48 51 47379 10246 90570771
Feeling abnormal 68.28 26.48 5 47425 167230 90413787
Pneumonia cytomegaloviral 67.94 26.48 33 47397 3078 90577939
Constipation 67.69 26.48 31 47399 280364 90300653
Chronic graft versus host disease in intestine 67.54 26.48 16 47414 150 90580867
Malignant transformation 67.51 26.48 21 47409 581 90580436
Meningoencephalitis herpetic 66.50 26.48 26 47404 1433 90579584
Pneumonia adenoviral 66.08 26.48 17 47413 230 90580787
Arthritis 65.55 26.48 6 47424 167309 90413708
Tumour lysis syndrome 65.41 26.48 51 47379 11101 90569916
Gastrooesophageal reflux disease 65.07 26.48 6 47424 166331 90414686
Klebsiella sepsis 64.83 26.48 27 47403 1754 90579263
Therapy partial responder 64.20 26.48 68 47362 21975 90559042
Overdose 63.58 26.48 5 47425 157704 90423313
Heart rate abnormal 62.58 26.48 39 47391 5932 90575085
Capillary leak syndrome 62.39 26.48 30 47400 2737 90578280
Liver injury 62.04 26.48 8 47422 170559 90410458
Lymphadenitis 61.81 26.48 34 47396 4103 90576914
Acute lymphocytic leukaemia 61.56 26.48 30 47400 2818 90578199
Growth retardation 61.45 26.48 26 47404 1757 90579260
Hypoalbuminaemia 61.04 26.48 57 47373 15840 90565177
Gait inability 60.89 26.48 4 47426 146452 90434565
Gene mutation 60.18 26.48 27 47403 2103 90578914
Serum ferritin increased 59.73 26.48 41 47389 7340 90573677
Blood pressure increased 59.36 26.48 15 47415 197202 90383815
Pulmonary mucormycosis 59.27 26.48 19 47411 581 90580436
Brain oedema 58.56 26.48 58 47372 17327 90563690
Lymphadenopathy 58.51 26.48 94 47336 45681 90535336
Cellulitis staphylococcal 58.26 26.48 21 47409 922 90580095
Haematotoxicity 58.13 26.48 50 47380 12485 90568532
Product administered to patient of inappropriate age 58.08 26.48 34 47396 4619 90576398
Gastroenteritis adenovirus 57.68 26.48 16 47414 293 90580724
Nephropathy toxic 57.60 26.48 50 47380 12638 90568379
Immune thrombocytopenia 57.47 26.48 51 47379 13275 90567742
Acute kidney injury 57.36 26.48 324 47106 320063 90260954
Chronic graft versus host disease oral 57.06 26.48 15 47415 222 90580795
Drug ineffective 56.83 26.48 1027 46403 1383271 89197746
Minimal residual disease 56.59 26.48 17 47413 417 90580600
Asthenia 56.53 26.48 122 47308 533629 90047388
Neutropenic sepsis 56.52 26.48 58 47372 18072 90562945
Human polyomavirus infection 56.21 26.48 17 47413 427 90580590
Parainfluenzae virus infection 56.05 26.48 28 47402 2775 90578242
Disseminated toxoplasmosis 55.59 26.48 14 47416 173 90580844
Klebsiella bacteraemia 55.12 26.48 27 47403 2565 90578452
Cytomegalovirus urinary tract infection 54.80 26.48 12 47418 76 90580941
N-terminal prohormone brain natriuretic peptide increased 54.59 26.48 28 47402 2934 90578083
Alternaria infection 54.57 26.48 16 47414 360 90580657
Gastroenteritis norovirus 54.30 26.48 26 47404 2350 90578667
Back pain 53.77 26.48 52 47378 317123 90263894
Haematocrit decreased 53.60 26.48 86 47344 41746 90539271
Escherichia sepsis 53.53 26.48 35 47395 5781 90575236
Pleural effusion 53.48 26.48 154 47276 111837 90469180
Scedosporium infection 53.32 26.48 19 47411 807 90580210
General physical health deterioration 52.72 26.48 65 47365 355050 90225967
Blood immunoglobulin G decreased 52.65 26.48 29 47401 3509 90577508
Paraesthesia 52.61 26.48 33 47397 250293 90330724
Cryptosporidiosis infection 52.60 26.48 16 47414 410 90580607
Disseminated Bacillus Calmette-Guerin infection 52.27 26.48 11 47419 56 90580961
Memory impairment 52.14 26.48 19 47411 197225 90383792
Neutropenic infection 51.33 26.48 23 47407 1786 90579231
Ascites 50.37 26.48 90 47340 47650 90533367
Hepatic failure 49.98 26.48 81 47349 39647 90541370
Nodular melanoma 49.66 26.48 11 47419 74 90580943
Dysbiosis 49.44 26.48 22 47408 1680 90579337
Urinary tract infection viral 49.16 26.48 11 47419 78 90580939
Drug ineffective for unapproved indication 49.00 26.48 108 47322 66536 90514481
Bone marrow transplant rejection 48.91 26.48 11 47419 80 90580937
Skin toxicity 48.67 26.48 35 47395 6744 90574273
Pneumonia klebsiella 47.98 26.48 26 47404 3046 90577971
Disease recurrence 47.68 26.48 77 47353 37576 90543441
Pathogen resistance 47.35 26.48 37 47393 8078 90572939
Chronic graft versus host disease in liver 47.05 26.48 14 47416 332 90580685
B-cell type acute leukaemia 46.72 26.48 16 47414 603 90580414
Actinomycotic sepsis 46.41 26.48 13 47417 247 90580770
Escherichia infection 46.23 26.48 49 47381 15846 90565171
Gastrointestinal disorder 45.97 26.48 40 47390 256647 90324370
Squamous cell carcinoma of skin 45.73 26.48 35 47395 7414 90573603
Transplant rejection 45.66 26.48 44 47386 12714 90568303
Obliterative bronchiolitis 45.55 26.48 24 47406 2657 90578360
Ill-defined disorder 45.29 26.48 20 47410 184871 90396146
Acute myeloid leukaemia refractory 44.76 26.48 11 47419 122 90580895
Ureaplasma infection 44.35 26.48 17 47413 888 90580129
Leukoerythroblastosis 44.15 26.48 13 47417 297 90580720
Stenotrophomonas infection 44.00 26.48 23 47407 2506 90578511
Dysplasia 43.67 26.48 19 47411 1375 90579642
Guillain-Barre syndrome 43.05 26.48 28 47402 4584 90576433
Pneumatosis intestinalis 42.60 26.48 25 47405 3412 90577605
Renal failure 42.55 26.48 158 47272 130849 90450168
Neck pain 42.28 26.48 5 47425 113958 90467059
Disseminated intravascular coagulation 41.89 26.48 54 47376 21484 90559533
Toxic leukoencephalopathy 41.72 26.48 16 47414 837 90580180
Bronchitis 41.67 26.48 14 47416 152913 90428104
Loss of personal independence in daily activities 41.64 26.48 10 47420 136095 90444922
Polyomavirus-associated nephropathy 41.49 26.48 22 47408 2468 90578549
Myeloid leukaemia 41.47 26.48 14 47416 505 90580512
Gastritis fungal 41.40 26.48 11 47419 170 90580847
Myocardial infarction 40.97 26.48 4 47426 105968 90475049
Organising pneumonia 40.82 26.48 33 47397 7564 90573453
Herpes zoster infection neurological 40.75 26.48 14 47416 533 90580484
Urinary tract infection 40.25 26.48 61 47369 305571 90275446
Retinal haemorrhage 39.66 26.48 29 47401 5735 90575282
Enterovirus infection 39.47 26.48 18 47412 1456 90579561
Cough 39.30 26.48 84 47346 368878 90212139
Septic embolus 39.29 26.48 16 47414 981 90580036
Hepatitis B reactivation 39.25 26.48 25 47405 3949 90577068
Refractory cytopenia with multilineage dysplasia 39.24 26.48 10 47420 130 90580887
Chest pain 39.09 26.48 67 47363 319578 90261439
Acquired macroglossia 39.08 26.48 11 47419 213 90580804
Renal tubular injury 39.05 26.48 17 47413 1232 90579785
Soft tissue infection 38.37 26.48 22 47408 2875 90578142
Parvovirus infection 38.06 26.48 13 47417 486 90580531
Streptococcal bacteraemia 38.02 26.48 20 47410 2207 90578810
Metastases to diaphragm 37.97 26.48 8 47422 41 90580976
Dedifferentiated liposarcoma 37.81 26.48 8 47422 42 90580975
BK polyomavirus test positive 37.67 26.48 10 47420 154 90580863
Arteritis infective 37.65 26.48 9 47421 88 90580929
Haemolysis 37.55 26.48 33 47397 8477 90572540
Renal impairment 37.51 26.48 131 47299 105290 90475727
Adverse event 37.17 26.48 8 47422 117410 90463607
Pulmonary fibrosis 36.86 26.48 6 47424 107497 90473520
Autoimmune thyroiditis 36.86 26.48 28 47402 5865 90575152
Primary mediastinal large B-cell lymphoma 36.76 26.48 8 47422 49 90580968
Dehydration 36.41 26.48 29 47401 194418 90386599
Weight decreased 36.05 26.48 92 47338 379818 90201199
Pulmonary veno-occlusive disease 35.66 26.48 17 47413 1521 90579496
Candida infection 35.66 26.48 64 47366 33993 90547024
Fungal sepsis 35.63 26.48 17 47413 1524 90579493
Graft versus host disease in eye 35.46 26.48 9 47421 115 90580902
Respiratory syncytial virus infection 35.36 26.48 35 47395 10445 90570572
Decreased appetite 35.10 26.48 92 47338 376448 90204569
Bronchiolitis 35.04 26.48 22 47408 3390 90577627
Neoplasm progression 34.88 26.48 74 47356 44412 90536605
Delayed engraftment 34.70 26.48 9 47421 126 90580891
Bone marrow transplant 34.58 26.48 14 47416 846 90580171
Diarrhoea 34.50 26.48 320 47110 938870 89642147
Microsporidia infection 34.36 26.48 11 47419 335 90580682
Injection site reaction 34.26 26.48 4 47426 92076 90488941
Mycobacterium kansasii infection 34.18 26.48 9 47421 134 90580883
Myocarditis 33.99 26.48 39 47391 13767 90567250
Obesity 33.78 26.48 7 47423 105500 90475517
Gastroenteritis astroviral 33.58 26.48 8 47422 77 90580940
Neutropenic colitis 33.49 26.48 23 47407 4120 90576897
Aphasia 33.32 26.48 71 47359 42741 90538276
Hypophosphataemia 33.31 26.48 40 47390 14814 90566203
Disseminated tuberculosis 33.20 26.48 21 47409 3278 90577739
Human herpesvirus 7 infection 33.13 26.48 9 47421 152 90580865
Human metapneumovirus test positive 32.95 26.48 8 47422 84 90580933
Transformation to acute myeloid leukaemia 32.82 26.48 11 47419 388 90580629
Muscle twitching 32.72 26.48 51 47379 24151 90556866
Enterobacter infection 32.57 26.48 19 47411 2564 90578453
Paraspinal abscess 32.56 26.48 10 47420 265 90580752
Focal nodular hyperplasia 32.53 26.48 13 47417 759 90580258
Lung consolidation 32.51 26.48 24 47406 4816 90576201
Hepatosplenomegaly 32.41 26.48 20 47410 2989 90578028
Leukaemic infiltration extramedullary 32.38 26.48 9 47421 166 90580851
Drug abuse 32.12 26.48 3 47427 82344 90498673
Left ventricular dysfunction 32.08 26.48 39 47391 14630 90566387
Splenic vein thrombosis 31.94 26.48 11 47419 422 90580595
Hepatomegaly 31.73 26.48 37 47393 13289 90567728
Blood magnesium decreased 31.55 26.48 40 47390 15653 90565364
Candida sepsis 31.55 26.48 16 47414 1637 90579380
Cerebral artery thrombosis 31.43 26.48 11 47419 443 90580574
Graft complication 31.25 26.48 10 47420 304 90580713
Blood glucose increased 31.16 26.48 6 47424 95240 90485777
Microangiopathy 30.99 26.48 16 47414 1699 90579318
Erythema 30.91 26.48 45 47385 229201 90351816
Cerebrovascular accident 30.83 26.48 13 47417 123520 90457497
Recurrent cancer 30.78 26.48 18 47412 2441 90578576
Incorrect dose administered 30.46 26.48 3 47427 78927 90502090
Citrobacter infection 30.24 26.48 12 47418 688 90580329
Palpitations 30.15 26.48 17 47413 136711 90444306
Febrile bone marrow aplasia 30.07 26.48 31 47399 9707 90571310
Cytomegalovirus gastroenteritis 30.04 26.48 10 47420 345 90580672
Feeling hot 30.01 26.48 3 47427 78005 90503012
COVID-19 pneumonia 29.90 26.48 42 47388 18135 90562882
Night sweats 29.88 26.48 15 47415 128751 90452266
Post transplant distal limb syndrome 29.72 26.48 10 47420 357 90580660
Haematuria 29.60 26.48 60 47370 34877 90546140
Fat necrosis 29.40 26.48 12 47418 740 90580277
American trypanosomiasis 29.18 26.48 9 47421 242 90580775
Cerebral haemorrhage 28.91 26.48 59 47371 34463 90546554
Mantle cell lymphoma recurrent 28.68 26.48 10 47420 398 90580619
Prescribed underdose 28.56 26.48 3 47427 75016 90506001
Sphingomonas paucimobilis infection 28.54 26.48 7 47423 77 90580940
Wound infection 28.54 26.48 10 47420 106392 90474625
Hepatic necrosis 28.48 26.48 25 47405 6413 90574604
Confusional state 28.46 26.48 105 47325 386100 90194917
Haemoglobin decreased 28.42 26.48 163 47267 161793 90419224
Enterobacter bacteraemia 28.32 26.48 12 47418 814 90580203
Abdominal pain 28.24 26.48 109 47321 395612 90185405
Metastases to bone marrow 28.10 26.48 11 47419 608 90580409
Choroidal detachment 27.93 26.48 9 47421 280 90580737
Vitiligo 27.88 26.48 16 47414 2094 90578923
Subclavian vein thrombosis 27.84 26.48 16 47414 2100 90578917
Drug effective for unapproved indication 27.75 26.48 27 47403 7891 90573126
Device related infection 27.69 26.48 49 47381 25737 90555280
Hypotension 27.69 26.48 276 47154 325121 90255896
Parainfluenzae viral bronchitis 27.64 26.48 5 47425 9 90581008
Product use issue 27.51 26.48 85 47345 329834 90251183
Anal infection 27.40 26.48 7 47423 92 90580925
Blood fibrinogen decreased 27.34 26.48 13 47417 1157 90579860
Portal vein embolism 27.33 26.48 7 47423 93 90580924
Peritoneal mesothelioma malignant 27.29 26.48 5 47425 10 90581007
Venous haemorrhage 27.28 26.48 9 47421 302 90580715
Ejection fraction decreased 27.06 26.48 49 47381 26204 90554813
Urinary tract infection bacterial 26.99 26.48 24 47406 6261 90574756
Autoimmune disorder 26.95 26.48 4 47426 76740 90504277
Wrong technique in product usage process 26.90 26.48 3 47427 71568 90509449
Chronic lymphocytic leukaemia 26.58 26.48 18 47412 3152 90577865
Immune-mediated cytopenia 26.54 26.48 7 47423 105 90580912
Parotitis 26.52 26.48 15 47415 1910 90579107

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 3063.19 18.32 1494 70375 43033 42506433
Acute graft versus host disease 1617.13 18.32 584 71285 7631 42541835
Acute graft versus host disease in skin 1518.54 18.32 543 71326 6881 42542585
Cytomegalovirus infection reactivation 1343.16 18.32 555 71314 10623 42538843
Cytomegalovirus infection 1154.98 18.32 704 71165 31602 42517864
Graft versus host disease 972.05 18.32 462 71407 12463 42537003
Febrile neutropenia 952.20 18.32 1356 70513 184347 42365119
BK virus infection 944.18 18.32 403 71466 8381 42541085
Immune effector cell-associated neurotoxicity syndrome 918.63 18.32 404 71465 9057 42540409
Chronic graft versus host disease 892.72 18.32 348 71521 5677 42543789
Graft versus host disease in gastrointestinal tract 865.70 18.32 326 71543 4817 42544649
Venoocclusive liver disease 857.37 18.32 395 71474 9907 42539559
Hypogammaglobulinaemia 854.50 18.32 412 71457 11479 42537987
Cystitis haemorrhagic 826.72 18.32 348 71521 6981 42542485
Adenovirus infection 824.23 18.32 340 71529 6469 42542997
Acute graft versus host disease in intestine 773.92 18.32 280 71589 3671 42545795
Mucosal inflammation 720.20 18.32 625 71244 48749 42500717
Graft versus host disease in skin 705.41 18.32 282 71587 4930 42544536
Epstein-Barr virus infection 577.52 18.32 296 71573 9422 42540044
Myelodysplastic syndrome 542.16 18.32 385 71484 22360 42527106
Neurotoxicity 455.12 18.32 352 71517 23299 42526167
Post transplant lymphoproliferative disorder 432.42 18.32 239 71630 8881 42540585
Product use in unapproved indication 419.01 18.32 945 70924 183511 42365955
Pyrexia 415.86 18.32 1530 70339 392512 42156954
Acute myeloid leukaemia recurrent 403.46 18.32 169 71700 3343 42546123
Chronic graft versus host disease in skin 399.47 18.32 136 71733 1470 42547996
Haemophagocytic lymphohistiocytosis 398.94 18.32 293 71576 17929 42531537
Cytopenia 393.60 18.32 286 71583 17211 42532255
Human herpesvirus 6 infection 388.69 18.32 150 71719 2375 42547091
Progressive multifocal leukoencephalopathy 382.83 18.32 240 71629 11296 42538170
Cytomegalovirus viraemia 377.72 18.32 229 71640 10148 42539318
Epstein-Barr viraemia 377.55 18.32 143 71726 2146 42547320
Pancytopenia 371.01 18.32 691 71178 117052 42432414
Epstein-Barr virus infection reactivation 365.39 18.32 145 71724 2482 42546984
Thrombotic microangiopathy 363.26 18.32 255 71614 14527 42534939
Venoocclusive disease 363.22 18.32 162 71707 3753 42545713
Viral haemorrhagic cystitis 350.40 18.32 128 71741 1726 42547740
Acute graft versus host disease in liver 329.01 18.32 124 71745 1834 42547632
Bone marrow failure 328.98 18.32 339 71530 32754 42516712
Encephalitis cytomegalovirus 328.18 18.32 110 71759 1129 42548337
Transplant failure 320.60 18.32 150 71719 3894 42545572
Fatigue 316.56 18.32 171 71698 435470 42113996
Diffuse large B-cell lymphoma 304.46 18.32 193 71676 9261 42540205
Bronchopulmonary aspergillosis 297.27 18.32 253 71616 19176 42530290
Acute myeloid leukaemia 281.12 18.32 260 71609 21996 42527470
Multiple organ dysfunction syndrome 280.25 18.32 549 71320 96486 42452980
Off label use 274.35 18.32 1923 69946 636412 41913054
Engraftment syndrome 270.26 18.32 98 71771 1292 42548174
Posterior reversible encephalopathy syndrome 242.60 18.32 189 71680 12632 42536834
Cystitis viral 239.37 18.32 87 71782 1155 42548311
Neutropenia 233.74 18.32 803 71066 198628 42350838
Fall 230.80 18.32 56 71813 234464 42315002
Leukaemia recurrent 228.04 18.32 94 71775 1782 42547684
Lymphocyte count decreased 225.71 18.32 256 71613 27553 42521913
Dizziness 222.12 18.32 72 71797 249182 42300284
Acute lymphocytic leukaemia recurrent 217.99 18.32 112 71757 3579 42545887
Dyspnoea 212.78 18.32 261 71608 442360 42107106
Arthralgia 203.88 18.32 48 71821 205190 42344276
Drug interaction 194.66 18.32 104 71765 266895 42282571
Autoimmune haemolytic anaemia 190.68 18.32 119 71750 5552 42543914
Aspergillus infection 190.33 18.32 180 71689 15657 42533809
Aplastic anaemia 188.86 18.32 161 71708 12223 42537243
Pain 176.07 18.32 97 71772 244751 42304715
Human herpesvirus 6 encephalitis 169.71 18.32 56 71813 545 42548921
Herpes simplex 168.72 18.32 120 71749 6975 42542491
Thrombocytopenia 167.14 18.32 699 71170 189580 42359886
Bacteraemia 166.09 18.32 208 71661 24832 42524634
Graft versus host disease in liver 162.27 18.32 71 71798 1568 42547898
Pruritus 162.03 18.32 58 71811 188713 42360753
Constipation 155.21 18.32 41 71828 162250 42387216
Nephropathy toxic 152.13 18.32 164 71705 16674 42532792
Idiopathic pneumonia syndrome 151.80 18.32 49 71820 442 42549024
JC virus infection 151.42 18.32 82 71787 2922 42546544
Lymphadenopathy 150.33 18.32 230 71639 33135 42516331
Death 148.48 18.32 363 71506 470822 42078644
Asthenia 146.10 18.32 155 71714 280638 42268828
Encephalitis viral 144.20 18.32 64 71805 1464 42548002
Completed suicide 144.02 18.32 4 71865 96461 42453005
Chronic graft versus host disease in liver 143.27 18.32 51 71818 635 42548831
Inappropriate schedule of product administration 143.09 18.32 4 71865 95898 42453568
Myocardial infarction 142.41 18.32 20 71849 123989 42425477
Malaise 139.94 18.32 93 71776 212063 42337403
Cytokine increased 139.05 18.32 34 71835 91 42549375
Anxiety 136.43 18.32 19 71850 118541 42430925
Overdose 136.10 18.32 11 71858 105253 42444213
Nausea 135.97 18.32 292 71577 396507 42152959
Rhinovirus infection 135.88 18.32 102 71767 6446 42543020
Epstein-Barr virus associated lymphoproliferative disorder 135.29 18.32 71 71798 2372 42547094
Pain in extremity 134.90 18.32 43 71826 150561 42398905
Pseudomonas infection 129.88 18.32 147 71722 15776 42533690
Chronic lymphocytic leukaemia recurrent 129.50 18.32 47 71822 621 42548845
Fungal infection 123.15 18.32 159 71710 19563 42529903
Neutrophil count decreased 122.94 18.32 306 71563 63109 42486357
Pneumonia cytomegaloviral 119.94 18.32 79 71790 4047 42545419
Second primary malignancy 119.20 18.32 111 71758 9464 42540002
Fusarium infection 119.06 18.32 57 71812 1559 42547907
Insomnia 118.62 18.32 27 71842 118226 42431240
Chest pain 116.10 18.32 45 71824 139485 42409981
Toxoplasmosis 113.31 18.32 55 71814 1552 42547914
Engraft failure 112.95 18.32 41 71828 542 42548924
Mucormycosis 111.23 18.32 94 71775 7049 42542417
Microsporidia infection 111.12 18.32 49 71820 1103 42548363
Septic shock 110.48 18.32 373 71496 91299 42458167
Bone marrow transplant rejection 108.26 18.32 32 71837 208 42549258
Weight decreased 107.83 18.32 115 71754 207833 42341633
Chronic graft versus host disease in intestine 106.55 18.32 37 71832 426 42549040
Nasopharyngitis 105.25 18.32 10 71859 83986 42465480
Encephalitis 104.17 18.32 101 71768 9057 42540409
Respiratory failure 104.09 18.32 460 71409 127672 42421794
Myelosuppression 103.63 18.32 218 71651 40243 42509223
Human polyomavirus infection 102.25 18.32 48 71821 1255 42548211
Toxicity to various agents 101.65 18.32 143 71726 228993 42320473
Pneumonia fungal 100.54 18.32 99 71770 9047 42540419
Blood pressure increased 98.83 18.32 25 71844 101903 42447563
Cytomegalovirus chorioretinitis 98.29 18.32 73 71796 4538 42544928
Viraemia 96.76 18.32 51 71818 1719 42547747
Sepsis 96.28 18.32 620 71249 198714 42350752
Enterococcal infection 96.24 18.32 110 71759 11929 42537537
Rash 96.21 18.32 202 71667 276752 42272714
Infection 96.11 18.32 409 71460 111659 42437807
Muscle spasms 93.93 18.32 16 71853 86028 42463438
Peripheral swelling 93.80 18.32 19 71850 90251 42459215
Varicella zoster virus infection 93.59 18.32 57 71812 2544 42546922
Generalised oedema 93.19 18.32 122 71747 15214 42534252
Systemic mycosis 92.86 18.32 55 71814 2332 42547134
Depression 92.48 18.32 36 71833 111327 42438139
Asthma 91.48 18.32 3 71866 62311 42487155
Candida infection 89.03 18.32 143 71726 21467 42527999
Cerebral toxoplasmosis 88.64 18.32 51 71818 2047 42547419
Polyomavirus viraemia 88.32 18.32 51 71818 2061 42547405
Joint swelling 88.21 18.32 7 71862 68015 42481451
Drug hypersensitivity 87.85 18.32 29 71840 99360 42450106
Chronic graft versus host disease oral 87.52 18.32 31 71838 380 42549086
Dehydration 87.03 18.32 67 71802 141700 42407766
Pulmonary embolism 86.40 18.32 47 71822 119565 42429901
Staphylococcal infection 85.22 18.32 193 71676 37450 42512016
Adenovirus reactivation 84.90 18.32 30 71839 365 42549101
Pre-engraftment immune reaction 81.59 18.32 24 71845 153 42549313
Respiratory syncytial virus infection 81.58 18.32 79 71790 7073 42542393
Lymphopenia 81.16 18.32 137 71732 21426 42528040
Syncope 81.12 18.32 33 71836 99373 42450093
Back pain 80.86 18.32 72 71797 141704 42407762
Chronic obstructive pulmonary disease 80.44 18.32 7 71862 63107 42486359
Abdominal discomfort 79.95 18.32 15 71854 75240 42474226
Stenotrophomonas infection 79.76 18.32 59 71810 3645 42545821
Klebsiella sepsis 79.20 18.32 52 71817 2649 42546817
Adenoviral haemorrhagic cystitis 79.11 18.32 31 71838 512 42548954
Pneumatosis intestinalis 79.10 18.32 65 71804 4687 42544779
Feeling abnormal 78.36 18.32 12 71857 69774 42479692
Vomiting 77.67 18.32 241 71628 289482 42259984
Diarrhoea 77.14 18.32 459 71410 460390 42089076
Bacterial sepsis 76.58 18.32 73 71796 6409 42543057
Incorrect dose administered 76.20 18.32 3 71866 52971 42496495
Diffuse large B-cell lymphoma recurrent 75.46 18.32 64 71805 4822 42544644
Skin toxicity 74.06 18.32 72 71797 6477 42542989
Cytomegalovirus test positive 73.83 18.32 60 71809 4259 42545207
Staphylococcal sepsis 72.78 18.32 93 71776 11321 42538145
Hypoglycaemia 72.71 18.32 8 71861 59846 42489620
Serum ferritin increased 71.76 18.32 74 71795 7145 42542321
Parainfluenzae virus infection 71.72 18.32 55 71814 3588 42545878
Gait disturbance 71.51 18.32 38 71831 97962 42451504
Hyperhidrosis 70.73 18.32 32 71837 90480 42458986
Disease progression 70.62 18.32 449 71420 143207 42406259
B-cell type acute leukaemia 70.38 18.32 32 71837 776 42548690
Graft versus host disease in eye 70.17 18.32 25 71844 312 42549154
Hepatic failure 69.78 18.32 180 71689 37920 42511546
Blood glucose increased 69.67 18.32 19 71850 73680 42475786
Cerebral aspergillosis 69.27 18.32 41 71828 1736 42547730
Rhabdomyolysis 68.53 18.32 23 71846 77996 42471470
Loss of personal independence in daily activities 67.87 18.32 4 71865 49812 42499654
Decreased appetite 67.72 18.32 140 71729 192997 42356469
Acute respiratory distress syndrome 66.63 18.32 153 71716 29955 42519511
Cerebrovascular accident 66.14 18.32 41 71828 97119 42452347
Enterocolitis viral 65.18 18.32 26 71843 451 42549015
Malignant genitourinary tract neoplasm 65.06 18.32 15 71854 28 42549438
Haematocrit decreased 64.01 18.32 165 71704 34743 42514723
Somnolence 63.56 18.32 87 71782 141018 42408448
Enterococcal bacteraemia 63.15 18.32 45 71824 2622 42546844
Escherichia sepsis 62.78 18.32 62 71807 5685 42543781
Encephalopathy 62.48 18.32 182 71687 41151 42508315
Suicidal ideation 62.31 18.32 5 71864 48156 42501310
Weight increased 61.35 18.32 55 71814 107928 42441538
Platelet count decreased 61.35 18.32 422 71447 138159 42411307
Pneumonia respiratory syncytial viral 60.96 18.32 35 71834 1399 42548067
Graft complication 60.87 18.32 28 71841 698 42548768
Leukoencephalopathy 60.83 18.32 57 71812 4897 42544569
Pulmonary haemorrhage 60.63 18.32 85 71784 11312 42538154
Disseminated intravascular coagulation 60.48 18.32 131 71738 24663 42524803
Hyperkalaemia 60.48 18.32 30 71839 80428 42469038
Intentional product misuse 60.33 18.32 15 71854 61885 42487581
Meningoencephalitis herpetic 59.97 18.32 31 71838 1003 42548463
Diabetes mellitus 59.66 18.32 14 71855 60073 42489393
Sleep disorder 59.52 18.32 6 71863 48089 42501377
White blood cell count decreased 59.23 18.32 353 71516 110043 42439423
Product administered to patient of inappropriate age 58.89 18.32 55 71814 4706 42544760
Minimal residual disease 58.56 18.32 26 71843 595 42548871
Chronic graft versus host disease in eye 58.45 18.32 21 71848 269 42549197
Musculoskeletal stiffness 58.27 18.32 13 71856 57752 42491714
Condition aggravated 57.76 18.32 235 71634 260519 42288947
Dyspepsia 57.32 18.32 3 71866 41349 42508117
Clostridium difficile colitis 57.32 18.32 117 71752 21135 42528331
B-cell aplasia 56.06 18.32 17 71852 122 42549344
Post transplant distal limb syndrome 55.88 18.32 23 71846 434 42549032
Tumour lysis syndrome 54.84 18.32 118 71751 22113 42527353
Hypoxia 54.68 18.32 248 71621 69538 42479928
Respiratory distress 54.66 18.32 175 71694 41645 42507821
Klebsiella infection 53.69 18.32 80 71789 11252 42538214
Squamous cell carcinoma of skin 53.49 18.32 85 71784 12641 42536825
Hepatitis B reactivation 53.02 18.32 51 71818 4527 42544939
Blood creatine phosphokinase increased 52.71 18.32 9 71860 48329 42501137
Dry skin 52.71 18.32 9 71860 48329 42501137
Autoimmune lymphoproliferative syndrome 52.49 18.32 18 71851 199 42549267
Cytomegalovirus hepatitis 52.47 18.32 23 71846 510 42548956
Coronary artery disease 52.39 18.32 13 71856 53707 42495759
Bacterial infection 52.38 18.32 133 71736 27746 42521720
Cerebellar tumour 52.27 18.32 16 71853 119 42549347
Leukaemic infiltration 52.02 18.32 17 71852 160 42549306
Wheezing 52.00 18.32 14 71855 54767 42494699
Infection reactivation 51.91 18.32 37 71832 2157 42547309
Chronic lymphocytic leukaemia transformation 51.78 18.32 18 71851 208 42549258
Aggression 50.95 18.32 7 71862 44156 42505310
Device related infection 50.44 18.32 108 71761 20171 42529295
Obliterative bronchiolitis 49.97 18.32 31 71838 1430 42548036
Gastrooesophageal reflux disease 49.95 18.32 8 71861 45015 42504451
Short stature 49.95 18.32 21 71848 419 42549047
Acute myocardial infarction 49.61 18.32 18 71851 58147 42491319
Urticaria 49.34 18.32 32 71837 74004 42475462
Capillary leak syndrome 49.24 18.32 39 71830 2668 42546798
Chronic lymphocytic leukaemia 48.90 18.32 50 71819 4779 42544687
Growth retardation 48.50 18.32 37 71832 2395 42547071
Haematotoxicity 48.43 18.32 75 71794 10910 42538556
Disseminated toxoplasmosis 48.33 18.32 18 71851 257 42549209
Palpitations 48.18 18.32 13 71856 50784 42498682
Bradycardia 48.00 18.32 44 71825 85440 42464026
Stem cell transplant 47.54 18.32 38 71831 2634 42546832
Hypoaesthesia 47.47 18.32 31 71838 71432 42478034
Aphasia 47.46 18.32 117 71752 23966 42525500
Hyponatraemia 47.26 18.32 61 71808 101401 42448065
Malignant neoplasm progression 46.71 18.32 328 71541 108072 42441394
Angioedema 46.12 18.32 8 71861 42469 42506997
Chimerism 45.75 18.32 17 71852 241 42549225
Toxic leukoencephalopathy 45.66 18.32 23 71846 704 42548762
Candida sepsis 45.27 18.32 29 71840 1416 42548050
Drug ineffective 45.05 18.32 1384 70485 628813 41920653
Polymyositis 44.50 18.32 31 71838 1742 42547724
Herpes simplex pneumonia 44.28 18.32 17 71852 265 42549201
Blood immunoglobulin G decreased 43.52 18.32 34 71835 2280 42547186
5q minus syndrome 43.40 18.32 14 71855 126 42549340
International normalised ratio increased 42.64 18.32 14 71855 48154 42501312
Alpha haemolytic streptococcal infection 42.54 18.32 31 71838 1871 42547595
Staphylococcal bacteraemia 42.30 18.32 71 71798 11050 42538416
Human herpesvirus 6 infection reactivation 42.27 18.32 19 71850 448 42549018
Headache 42.26 18.32 234 71635 239135 42310331
Out of specification test results 42.03 18.32 11 71858 42 42549424
Neurological decompensation 41.62 18.32 41 71828 3748 42545718
Thrombosis 41.22 18.32 33 71836 68478 42480988
Cryptosporidiosis infection 41.11 18.32 22 71847 765 42548701
Pneumocystis jirovecii pneumonia 41.09 18.32 114 71755 25067 42524399
Cytokine storm 40.85 18.32 23 71846 885 42548581
Herpes virus infection 40.64 18.32 40 71829 3652 42545814
Spinal instability 40.29 18.32 20 71849 593 42548873
Stomatitis 40.27 18.32 180 71689 50149 42499317
Oedema peripheral 40.17 18.32 108 71761 135968 42413498
Achromobacter infection 39.94 18.32 14 71855 166 42549300
Hepatosplenomegaly 39.67 18.32 44 71825 4616 42544850
Lactobacillus infection 39.63 18.32 17 71852 357 42549109
Arthritis 39.45 18.32 11 71858 42054 42507412
Contusion 39.34 18.32 11 71858 41974 42507492
Meningomyelitis herpes 39.34 18.32 10 71859 33 42549433
Dysphagia 38.99 18.32 39 71830 72680 42476786
Mucosal disorder 38.85 18.32 31 71838 2143 42547323
Enterococcal sepsis 38.37 18.32 30 71839 2014 42547452
Aplasia 38.28 18.32 44 71825 4799 42544667
Unevaluable event 38.24 18.32 6 71863 34282 42515184
Acute erythroid leukaemia 38.21 18.32 15 71854 249 42549217
Cytomegalovirus colitis 38.12 18.32 40 71829 3941 42545525
Retinopathy haemorrhagic 37.69 18.32 11 71858 68 42549398
Organic brain syndrome 37.66 18.32 16 71853 328 42549138
Drug reaction with eosinophilia and systemic symptoms 37.65 18.32 12 71857 42063 42507403
Serratia sepsis 37.65 18.32 13 71856 147 42549319
Loss of consciousness 37.62 18.32 61 71808 92293 42457173
Mobility decreased 37.57 18.32 7 71862 35299 42514167
Swelling 37.56 18.32 23 71846 54862 42494604
Cardio-respiratory arrest 36.86 18.32 27 71842 58609 42490857
Musculoskeletal pain 36.81 18.32 6 71863 33334 42516132
Paraesthesia 36.49 18.32 42 71827 73417 42476049
Human herpes virus 6 serology positive 36.01 18.32 13 71856 169 42549297
Primary amyloidosis 35.96 18.32 14 71855 227 42549239
Bronchiolitis obliterans syndrome 35.83 18.32 15 71854 296 42549170
Blood stem cell transplant failure 35.81 18.32 17 71852 456 42549010
Nephrolithiasis 35.74 18.32 9 71860 36821 42512645
Abdominal pain 35.37 18.32 183 71686 190288 42359178
Chronic lymphocytic leukaemia refractory 35.24 18.32 11 71858 88 42549378
Emphysematous cholecystitis 35.02 18.32 11 71858 90 42549376
Haemolysis 34.86 18.32 60 71809 9529 42539937
Myelitis 34.79 18.32 22 71847 1050 42548416
Abdominal distension 34.58 18.32 42 71827 71693 42477773
Meningeal neoplasm 34.50 18.32 11 71858 95 42549371
Clostridium difficile infection 34.45 18.32 100 71769 22559 42526907
Medication error 34.38 18.32 7 71862 33147 42516319
Flushing 34.14 18.32 10 71859 37018 42512448
Blood cholesterol increased 33.97 18.32 3 71866 26738 42522728
Lip ulceration 33.46 18.32 21 71848 989 42548477
Gout 33.44 18.32 4 71865 28051 42521415
Streptococcal sepsis 33.41 18.32 27 71842 1901 42547565
Hydrocephalus 33.33 18.32 46 71823 6032 42543434
Blood fibrinogen decreased 33.32 18.32 25 71844 1578 42547888
Treatment noncompliance 33.25 18.32 11 71858 37661 42511805
Central nervous system viral infection 33.24 18.32 12 71857 156 42549310
Gastroenteritis astroviral 32.71 18.32 10 71859 74 42549392
Chloroma 32.61 18.32 17 71852 560 42548906
Mucosal toxicity 32.55 18.32 14 71855 296 42549170
Disease recurrence 32.44 18.32 117 71752 29561 42519905
Respiratory tract infection fungal 32.19 18.32 19 71850 800 42548666
Cardiogenic shock 32.18 18.32 10 71859 35630 42513836
Cardiac arrest 32.08 18.32 87 71782 109233 42440233
Angina pectoris 31.99 18.32 8 71861 32888 42516578
Fungal sepsis 31.92 18.32 21 71848 1073 42548393
Meningitis viral 31.73 18.32 21 71848 1084 42548382
Gastroenteritis rotavirus 31.71 18.32 14 71855 316 42549150
Stenotrophomonas sepsis 31.62 18.32 12 71857 181 42549285
Flatulence 31.48 18.32 3 71866 25149 42524317
Epistaxis 31.29 18.32 40 71829 66786 42482680
Lymphoproliferative disorder 31.26 18.32 33 71836 3274 42546192
Herpes zoster reactivation 31.20 18.32 15 71854 414 42549052
Roseolovirus test positive 31.20 18.32 10 71859 88 42549378
Illness 31.13 18.32 3 71866 24927 42524539
Viral infection 31.13 18.32 96 71773 22387 42527079
Glomerulosclerosis 31.05 18.32 19 71850 855 42548611
Escherichia infection 31.04 18.32 63 71806 11333 42538133
Neutropenic sepsis 30.92 18.32 77 71792 15869 42533597
Juvenile chronic myelomonocytic leukaemia 30.68 18.32 8 71861 30 42549436
Basal cell carcinoma 30.49 18.32 96 71773 22637 42526829
Genitourinary tract neoplasm 30.38 18.32 7 71862 13 42549453
Dyspnoea exertional 30.36 18.32 24 71845 50124 42499342
Drug ineffective for unapproved indication 30.33 18.32 156 71713 46007 42503459
Incorrect route of product administration 30.15 18.32 3 71866 24302 42525164
Urge incontinence 29.83 18.32 16 71853 559 42548907
Vision blurred 29.71 18.32 28 71841 53671 42495795
Rectal haemorrhage 29.71 18.32 24 71845 49582 42499884
Transient ischaemic attack 29.52 18.32 10 71859 33729 42515737
Apoptosis 29.36 18.32 16 71853 577 42548889
Plasma cell myeloma refractory 29.33 18.32 22 71847 1388 42548078
Hyperfibrinogenaemia 29.29 18.32 10 71859 109 42549357
Kidney fibrosis 29.05 18.32 29 71840 2693 42546773
Viral sinusitis 29.05 18.32 9 71860 70 42549396
Neoplasm recurrence 29.04 18.32 29 71840 2695 42546771
Oxygen saturation decreased 28.98 18.32 40 71829 64647 42484819
Feeling hot 28.87 18.32 3 71866 23479 42525987
Abdominal pain upper 28.81 18.32 60 71809 82549 42466917
Depressed mood 28.71 18.32 3 71866 23381 42526085
Vertigo 28.66 18.32 11 71858 34336 42515130
Influenza like illness 28.63 18.32 9 71860 31831 42517635
Pneumonia pseudomonal 28.20 18.32 38 71831 4871 42544595
Neoplasm progression 28.10 18.32 110 71759 28890 42520576
Lichenoid keratosis 28.09 18.32 34 71835 3916 42545550
Erythema 28.01 18.32 92 71777 108701 42440765
Gait inability 27.85 18.32 3 71866 22830 42526636
Parenteral nutrition 27.76 18.32 16 71853 644 42548822
Aplasia pure red cell 27.58 18.32 46 71823 7120 42542346
Metabolic acidosis 27.58 18.32 28 71841 51830 42497636
Myeloproliferative neoplasm 27.49 18.32 17 71852 780 42548686
Neuralgia 27.47 18.32 5 71864 25642 42523824
Balance disorder 27.37 18.32 24 71845 47621 42501845
Haematochezia 27.34 18.32 35 71834 58401 42491065
Transformation to acute myeloid leukaemia 26.99 18.32 19 71850 1086 42548380
Therapy non-responder 26.92 18.32 168 71701 53191 42496275
Haematoma 26.90 18.32 7 71862 28016 42521450
Serratia infection 26.84 18.32 20 71849 1249 42548217
Abnormal behaviour 26.58 18.32 6 71863 26445 42523021
Electrocardiogram QT prolonged 26.53 18.32 25 71844 47920 42501546
Reticulocytosis 26.50 18.32 12 71857 288 42549178
CNS ventriculitis 26.39 18.32 13 71856 379 42549087
Drug resistance 26.28 18.32 121 71748 34127 42515339
Meningitis cryptococcal 26.24 18.32 30 71839 3253 42546213
Retinitis viral 26.22 18.32 10 71859 153 42549313
Drug level increased 26.21 18.32 6 71863 26194 42523272
Pneumonia viral 25.96 18.32 34 71835 4240 42545226
Mycobacterial infection 25.89 18.32 27 71842 2641 42546825
Lactic acidosis 25.75 18.32 23 71846 45238 42504228
Transplant rejection 25.70 18.32 65 71804 13523 42535943
Interstitial lung disease 25.70 18.32 59 71810 78403 42471063
Frequent bowel movements 25.64 18.32 3 71866 21404 42528062
Streptococcal bacteraemia 25.44 18.32 27 71842 2695 42546771
Multisystem inflammatory syndrome in children 25.43 18.32 6 71863 13 42549453
Bladder hypertrophy 25.43 18.32 16 71853 757 42548709
Evans syndrome 25.25 18.32 13 71856 417 42549049
Lymphodepletion 25.23 18.32 7 71862 35 42549431
Poikiloderma 25.20 18.32 12 71857 324 42549142
Fat tissue increased 25.07 18.32 14 71855 530 42548936
NPM1 gene mutation 24.93 18.32 9 71860 117 42549349
Dysbiosis 24.90 18.32 16 71853 785 42548681
Hypoglobulinaemia 24.83 18.32 6 71863 15 42549451
Citrobacter infection 24.82 18.32 15 71854 660 42548806
Immune thrombocytopenia 24.81 18.32 57 71812 11159 42538307
Discomfort 24.78 18.32 6 71863 25213 42524253
Splenomegaly 24.73 18.32 74 71795 16973 42532493
Hepatic vein occlusion 24.73 18.32 11 71858 253 42549213
Injury 24.67 18.32 4 71865 22312 42527154
Pseudomonal bacteraemia 24.61 18.32 25 71844 2371 42547095
Eccrine squamous syringometaplasia 24.60 18.32 7 71862 39 42549427
Pseudomonal sepsis 24.57 18.32 33 71836 4216 42545250
Bronchitis 24.52 18.32 26 71843 47175 42502291
Head injury 24.37 18.32 3 71866 20579 42528887
Glomerulonephritis membranous 24.36 18.32 20 71849 1440 42548026
Ejection fraction abnormal 24.29 18.32 19 71850 1276 42548190
Haemolytic anaemia 23.98 18.32 59 71810 12068 42537398
Prostate cancer 23.86 18.32 24 71845 44619 42504847
Premature baby 23.77 18.32 5 71864 23148 42526318
Injection site erythema 23.77 18.32 3 71866 20192 42529274
Peripheral T-cell lymphoma unspecified 23.67 18.32 14 71855 592 42548874
Memory impairment 23.57 18.32 30 71839 50192 42499274
Acute lymphocytic leukaemia 23.54 18.32 29 71840 3402 42546064
Gastroenteritis adenovirus 23.54 18.32 10 71859 205 42549261
Toxic epidermal necrolysis 23.28 18.32 8 71861 26742 42522724
Guillain-Barre syndrome 23.26 18.32 43 71826 7220 42542246
Cystitis 23.22 18.32 57 71812 11641 42537825
Upper gastrointestinal haemorrhage 23.21 18.32 11 71858 30288 42519178
Chest discomfort 23.21 18.32 45 71824 63571 42485895
Hyperbilirubinaemia 23.10 18.32 82 71787 20553 42528913
Stenotrophomonas bacteraemia 23.06 18.32 9 71860 147 42549319
Lymphocytosis 23.06 18.32 27 71842 3004 42546462
Premature ageing 23.05 18.32 8 71861 92 42549374
Pneumoretroperitoneum 22.89 18.32 9 71860 150 42549316
Spirochaetal infection 22.71 18.32 6 71863 24 42549442
Autoimmune pancytopenia 22.52 18.32 8 71861 99 42549367
Cord blood transplant therapy 22.42 18.32 7 71862 56 42549410
Viral test positive 22.36 18.32 10 71859 233 42549233
Stevens-Johnson syndrome 22.34 18.32 5 71864 22173 42527293
Hepatitis E 22.33 18.32 27 71842 3107 42546359
Gingivitis ulcerative 22.32 18.32 10 71859 234 42549232
Fungaemia 22.31 18.32 27 71842 3109 42546357
Cardiac failure congestive 22.30 18.32 72 71797 85530 42463936
Dysphonia 22.30 18.32 10 71859 28440 42521026
Myalgia 22.23 18.32 85 71784 95995 42453471
Device related bacteraemia 22.20 18.32 14 71855 665 42548801
Meningitis tuberculous 22.20 18.32 14 71855 665 42548801
Diffuse large B-cell lymphoma stage IV 22.19 18.32 13 71856 540 42548926
Coronavirus infection 22.15 18.32 35 71834 5179 42544287
Productive cough 22.00 18.32 33 71836 51534 42497932
Interleukin-2 receptor increased 21.86 18.32 9 71860 170 42549296
Hepatitis B 21.83 18.32 40 71829 6671 42542795
Transplantation associated food allergy 21.80 18.32 7 71862 62 42549404
Aspergillus test positive 21.79 18.32 14 71855 687 42548779
Lymphadenitis viral 21.79 18.32 6 71863 29 42549437
Refractory anaemia with an excess of blasts 21.71 18.32 11 71858 341 42549125
Urethral polyp 21.70 18.32 7 71862 63 42549403
Gastrointestinal infection 21.69 18.32 40 71829 6703 42542763
Geotrichum infection 21.68 18.32 13 71856 564 42548902
Adenomatous polyposis coli 21.62 18.32 9 71860 175 42549291
Haematemesis 21.59 18.32 12 71857 30187 42519279
Autoimmune neutropenia 21.53 18.32 11 71858 347 42549119
Gastroenteritis sapovirus 21.48 18.32 9 71860 178 42549288
Oropharyngeal pain 21.44 18.32 24 71845 42486 42506980
Migraine 21.44 18.32 8 71861 25406 42524060
Oral disorder 21.41 18.32 33 71836 4779 42544687
Pericardial effusion 21.41 18.32 102 71767 29173 42520293
BK polyomavirus test positive 21.32 18.32 7 71862 67 42549399
Herpes zoster 21.26 18.32 125 71744 38752 42510714
Scedosporium infection 21.22 18.32 19 71850 1539 42547927
Bacillus infection 20.99 18.32 14 71855 732 42548734
Myeloid leukaemia 20.98 18.32 12 71857 476 42548990
Autoimmune thyroiditis 20.97 18.32 19 71850 1563 42547903
Heart rate increased 20.91 18.32 36 71833 53219 42496247
Campylobacter infection 20.76 18.32 18 71851 1397 42548069
Intestinal obstruction 20.59 18.32 10 71859 27148 42522318
Deep vein thrombosis 20.56 18.32 64 71805 76893 42472573
Dysplasia 20.51 18.32 16 71853 1070 42548396
Ischaemic stroke 20.50 18.32 6 71863 22227 42527239
Refractory cytopenia with multilineage dysplasia 20.42 18.32 8 71861 132 42549334
Disseminated Bacillus Calmette-Guerin infection 20.38 18.32 10 71859 289 42549177
Neutropenic colitis 20.38 18.32 31 71838 4439 42545027
Systemic candida 20.28 18.32 34 71835 5285 42544181
Intracranial tumour haemorrhage 20.28 18.32 11 71858 393 42549073
Product quality issue 20.24 18.32 3 71866 17879 42531587
Rotavirus infection 20.23 18.32 12 71857 510 42548956
Ventricular tachycardia 20.13 18.32 13 71856 30147 42519319
Gallbladder adenocarcinoma 20.03 18.32 5 71864 15 42549451
Troponin increased 19.81 18.32 4 71865 19058 42530408
Osteonecrosis of jaw 19.79 18.32 4 71865 19045 42530421
Dyskinesia 19.79 18.32 9 71860 25381 42524085
Plasma cell myeloma 19.77 18.32 31 71838 47547 42501919
Blood potassium decreased 19.74 18.32 5 71864 20379 42529087
No adverse event 19.71 18.32 22 71847 38999 42510467
Contraindicated product administered 19.63 18.32 9 71860 25263 42524203
Gastroenteritis norovirus 19.59 18.32 19 71850 1704 42547762
General physical health deterioration 19.58 18.32 162 71707 151084 42398382
MAGIC syndrome 19.56 18.32 6 71863 45 42549421
Peritoneal lesion 19.48 18.32 8 71861 150 42549316
Viral myocarditis 19.43 18.32 9 71860 228 42549238
Corneal lesion 19.39 18.32 7 71862 91 42549375
Amnesia 19.34 18.32 12 71857 28425 42521041
Respiratory arrest 19.32 18.32 12 71857 28412 42521054
Respiratory tract inflammation 19.29 18.32 11 71858 434 42549032
Enamel anomaly 19.29 18.32 9 71860 232 42549234
Myelopathy 19.13 18.32 24 71845 2867 42546599
Toxic erythema of chemotherapy 19.10 18.32 8 71861 158 42549308
Mastication disorder 19.10 18.32 19 71850 1757 42547709
Scleroderma 19.08 18.32 19 71850 1759 42547707
Complications of bone marrow transplant 19.08 18.32 9 71860 238 42549228
Metapneumovirus infection 19.02 18.32 16 71853 1192 42548274
Arrhythmia 19.01 18.32 24 71845 40293 42509173
Psychotic disorder 18.95 18.32 13 71856 29195 42520271
Diabetic ketoacidosis 18.93 18.32 7 71862 22360 42527106
Colitis herpes 18.92 18.32 5 71864 20 42549446
Corynebacterium infection 18.86 18.32 14 71855 869 42548597
Haptoglobin decreased 18.78 18.32 13 71856 723 42548743
Pleural effusion 18.69 18.32 248 71621 96918 42452548
Chronic inflammatory demyelinating polyradiculoneuropathy 18.66 18.32 16 71853 1223 42548243
Tooth hypoplasia 18.64 18.32 9 71860 251 42549215
Chronic myeloid leukaemia recurrent 18.64 18.32 9 71860 251 42549215
Urinary tract infection 18.63 18.32 95 71774 99189 42450277
Graft versus host disease in lung 18.59 18.32 13 71856 735 42548731
Anaphylactic reaction 18.58 18.32 27 71842 42716 42506750
Retinal infiltrates 18.54 18.32 5 71864 22 42549444
Brain abscess 18.54 18.32 29 71840 4255 42545211
Arthritis fungal 18.48 18.32 7 71862 105 42549361
Dysarthria 18.45 18.32 24 71845 39783 42509683
Bordetella infection 18.44 18.32 8 71861 173 42549293
Eosinophilia 18.38 18.32 17 71852 32882 42516584
Neutrophil Pelger-Huet anomaly present 18.38 18.32 9 71860 259 42549207

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 6168.39 19.34 2407 109330 67899 110409663
Acute graft versus host disease 3091.31 19.34 938 110799 11943 110465619
Cytomegalovirus infection reactivation 2624.83 19.34 902 110835 17431 110460131
Cytomegalovirus infection 2529.11 19.34 1190 110547 53254 110424308
Acute graft versus host disease in skin 2516.71 19.34 768 110969 9972 110467590
Febrile neutropenia 2162.14 19.34 2088 109649 314679 110162883
Graft versus host disease 1987.66 19.34 739 110998 18067 110459495
Immune effector cell-associated neurotoxicity syndrome 1918.12 19.34 676 111061 14106 110463456
Chronic graft versus host disease 1755.08 19.34 566 111171 8891 110468671
Adenovirus infection 1746.49 19.34 585 111152 10409 110467153
Graft versus host disease in gastrointestinal tract 1551.67 19.34 509 111228 8459 110469103
Venoocclusive liver disease 1535.48 19.34 578 111159 14629 110462933
Graft versus host disease in skin 1515.34 19.34 490 111247 7764 110469798
BK virus infection 1465.77 19.34 537 111200 12569 110464993
Hypogammaglobulinaemia 1403.35 19.34 585 111152 19491 110458071
Mucosal inflammation 1355.76 19.34 967 110770 95174 110382388
Cystitis haemorrhagic 1320.13 19.34 488 111249 11721 110465841
Acute graft versus host disease in intestine 1268.78 19.34 391 111346 5248 110472314
Myelodysplastic syndrome 1130.24 19.34 612 111125 36872 110440690
Epstein-Barr virus infection 1120.90 19.34 489 111248 18249 110459313
Thrombotic microangiopathy 1073.05 19.34 544 111193 28605 110448957
Product use in unapproved indication 939.70 19.34 1646 110091 445731 110031831
Neurotoxicity 931.02 19.34 562 111175 41645 110435917
Human herpesvirus 6 infection 911.23 19.34 316 111421 6265 110471297
Post transplant lymphoproliferative disorder 883.84 19.34 392 111345 15221 110462341
Cytomegalovirus viraemia 829.24 19.34 390 111347 17374 110460188
Haemophagocytic lymphohistiocytosis 768.55 19.34 448 111289 31111 110446451
Cytopenia 753.25 19.34 435 111302 29681 110447881
Acute myeloid leukaemia 747.76 19.34 471 111266 37639 110439923
Viral haemorrhagic cystitis 732.24 19.34 228 111509 3171 110474391
Pyrexia 727.94 19.34 2271 109466 895994 109581568
Multiple organ dysfunction syndrome 720.55 19.34 826 110911 150884 110326678
Pancytopenia 703.68 19.34 959 110778 208654 110268908
Acute myeloid leukaemia recurrent 696.99 19.34 243 111494 4896 110472666
Chronic graft versus host disease in skin 693.91 19.34 206 111531 2413 110475149
Neutropenia 693.85 19.34 1306 110431 373314 110104248
Progressive multifocal leukoencephalopathy 663.07 19.34 375 111362 24581 110452981
Epstein-Barr virus infection reactivation 599.96 19.34 205 111532 3879 110473683
Bronchopulmonary aspergillosis 593.14 19.34 372 111365 29491 110448071
Transplant failure 571.62 19.34 215 111522 5420 110472142
Pain 561.57 19.34 138 111599 954817 109522745
Off label use 547.00 19.34 2961 108776 1497224 108980338
Acute graft versus host disease in liver 532.43 19.34 164 111573 2195 110475367
Acute lymphocytic leukaemia recurrent 519.57 19.34 202 111535 5585 110471977
Bone marrow failure 511.35 19.34 442 111295 57406 110420156
Fatigue 503.87 19.34 304 111433 1215654 109261908
Venoocclusive disease 497.94 19.34 201 111536 6149 110471413
Posterior reversible encephalopathy syndrome 496.20 19.34 349 111388 33512 110444050
Lymphocyte count decreased 493.12 19.34 431 111306 56812 110420750
Diffuse large B-cell lymphoma 491.39 19.34 264 111473 15634 110461928
Epstein-Barr viraemia 480.62 19.34 168 111569 3411 110474151
Thrombocytopenia 475.13 19.34 1072 110665 347813 110129749
Arthralgia 442.05 19.34 121 111616 779511 109698051
Herpes simplex 440.80 19.34 245 111492 15519 110462043
Bacteraemia 420.11 19.34 346 111391 42044 110435518
Aspergillus infection 412.92 19.34 280 111457 25336 110452226
Cystitis viral 412.73 19.34 121 111616 1352 110476210
Joint swelling 396.53 19.34 11 111726 442834 110034728
Dizziness 387.07 19.34 113 111624 698080 109779482
Sepsis 375.33 19.34 941 110796 326405 110151157
Encephalitis cytomegalovirus 373.47 19.34 119 111618 1791 110475771
Engraftment syndrome 372.13 19.34 119 111618 1813 110475749
Neutrophil count decreased 370.58 19.34 530 111207 120411 110357151
Aplastic anaemia 364.19 19.34 254 111483 24054 110453508
Fall 362.47 19.34 83 111654 603399 109874163
Nasopharyngitis 352.28 19.34 10 111727 394351 110083211
Encephalitis viral 346.46 19.34 126 111611 2881 110474681
Drug hypersensitivity 339.76 19.34 33 111704 454057 110023505
JC virus infection 339.02 19.34 145 111592 5145 110472417
Pruritus 337.46 19.34 86 111651 581474 109896088
Septic shock 333.85 19.34 583 111154 156945 110320617
Autoimmune haemolytic anaemia 330.83 19.34 177 111560 10390 110467172
Leukaemia recurrent 330.47 19.34 123 111614 3008 110474554
Chronic lymphocytic leukaemia recurrent 324.22 19.34 93 111644 956 110476606
Dyspnoea 324.16 19.34 386 111351 1106486 109371076
Respiratory failure 323.80 19.34 689 111048 214643 110262919
Human herpesvirus 6 encephalitis 317.61 19.34 92 111645 982 110476580
Malaise 309.71 19.34 146 111591 671673 109805889
Product dose omission issue 308.53 19.34 3 111734 321779 110155783
Abdominal discomfort 304.38 19.34 25 111712 393833 110083729
Cytokine increased 303.54 19.34 67 111670 197 110477365
Peripheral swelling 303.18 19.34 29 111708 404005 110073557
Viraemia 298.23 19.34 123 111614 3979 110473583
Nausea 287.09 19.34 507 111230 1235183 109242379
Pain in extremity 278.75 19.34 74 111663 487044 109990518
Rheumatoid arthritis 277.60 19.34 5 111732 299608 110177954
Platelet count decreased 277.17 19.34 675 111062 229768 110247794
Alopecia 271.49 19.34 27 111710 364726 110112836
Adenovirus reactivation 262.20 19.34 73 111664 667 110476895
Arthropathy 261.59 19.34 6 111731 287516 110190046
Disease progression 258.26 19.34 681 111056 243353 110234209
Fusarium infection 256.83 19.34 99 111638 2672 110474890
Rhinovirus infection 254.72 19.34 155 111582 11634 110465928
Pseudomonas infection 252.51 19.34 216 111521 27637 110449925
Second primary malignancy 250.30 19.34 180 111557 17888 110459674
Systemic mycosis 248.83 19.34 106 111631 3723 110473839
Synovitis 248.27 19.34 6 111731 274086 110203476
Headache 246.16 19.34 319 111418 882058 109595504
Pneumonia fungal 244.28 19.34 164 111573 14590 110462972
Systemic lupus erythematosus 240.92 19.34 3 111734 254335 110223227
Anxiety 240.68 19.34 32 111705 345046 110132516
Asthma 236.87 19.34 3 111734 250288 110227274
Bacterial sepsis 235.38 19.34 141 111596 10285 110467277
Graft versus host disease in liver 235.38 19.34 90 111647 2375 110475187
Toxoplasmosis 235.06 19.34 97 111640 3142 110474420
Swelling 234.51 19.34 37 111700 351004 110126558
Infection reactivation 232.63 19.34 103 111634 3978 110473584
White blood cell count decreased 232.47 19.34 630 111107 228760 110248802
Idiopathic pneumonia syndrome 231.63 19.34 69 111668 818 110476744
Pre-engraftment immune reaction 227.39 19.34 59 111678 400 110477162
Musculoskeletal stiffness 226.97 19.34 14 111723 279808 110197754
Staphylococcal infection 225.23 19.34 314 111423 69630 110407932
Completed suicide 224.70 19.34 4 111733 242377 110235185
Cytomegalovirus chorioretinitis 222.03 19.34 119 111618 7009 110470553
Nephropathy toxic 216.91 19.34 197 111540 27281 110450281
Wound 216.79 19.34 4 111733 234433 110243129
Epstein-Barr virus associated lymphoproliferative disorder 216.60 19.34 103 111634 4699 110472863
Fungal infection 216.59 19.34 262 111475 50544 110427018
Pneumonia cytomegaloviral 216.34 19.34 116 111621 6838 110470724
Contraindicated product administered 215.55 19.34 8 111729 248259 110229303
Mucormycosis 215.03 19.34 134 111603 10494 110467068
Varicella zoster virus infection 214.46 19.34 112 111625 6256 110471306
Asthenia 213.52 19.34 229 111508 688770 109788792
Lymphopenia 211.45 19.34 231 111506 39939 110437623
Vomiting 210.77 19.34 374 111363 910301 109567261
Urticaria 209.85 19.34 35 111702 318822 110158740
Leukoencephalopathy 209.27 19.34 125 111612 9070 110468492
Depression 201.94 19.34 38 111699 317297 110160265
Engraft failure 201.65 19.34 61 111676 765 110476797
Weight increased 201.31 19.34 86 111651 419558 110058004
Premature menopause 199.95 19.34 64 111673 978 110476584
Insomnia 198.34 19.34 59 111678 360531 110117031
Muscle spasms 198.29 19.34 24 111713 278133 110199429
Maternal exposure during pregnancy 197.33 19.34 16 111721 254867 110222695
Therapeutic product effect decreased 195.83 19.34 13 111724 244303 110233259
Mobility decreased 195.22 19.34 11 111726 237411 110240151
Staphylococcal bacteraemia 192.60 19.34 149 111588 16539 110461023
Wheezing 192.22 19.34 18 111719 255212 110222350
Myelosuppression 191.81 19.34 343 111394 93997 110383565
Chronic graft versus host disease in liver 190.86 19.34 60 111677 862 110476700
Systemic candida 189.88 19.34 121 111616 9853 110467709
Discomfort 189.61 19.34 6 111731 214701 110262861
Infusion related reaction 189.49 19.34 74 111663 381088 110096474
Encephalitis 189.18 19.34 155 111582 18684 110458878
Constipation 188.83 19.34 63 111674 357723 110119839
Staphylococcal sepsis 186.69 19.34 149 111588 17305 110460257
Drug resistance 184.36 19.34 255 111482 56119 110421443
Contusion 182.47 19.34 14 111723 233347 110244215
Rash 182.01 19.34 346 111391 820618 109656944
Cerebral toxoplasmosis 181.35 19.34 80 111657 3062 110474500
Sleep disorder 181.22 19.34 4 111733 198640 110278922
Malignant neoplasm progression 180.37 19.34 483 111254 174084 110303478
Cytomegalovirus test positive 179.51 19.34 103 111634 6933 110470629
Overdose 177.36 19.34 16 111721 233778 110243784
Polyomavirus viraemia 173.65 19.34 80 111657 3394 110474168
Chronic graft versus host disease in intestine 172.93 19.34 52 111685 638 110476924
Human polyomavirus infection 172.81 19.34 66 111671 1736 110475826
Enterococcal infection 172.61 19.34 152 111585 20214 110457348
Hypersensitivity 169.38 19.34 99 111638 403899 110073663
Adenoviral hepatitis 169.21 19.34 56 111681 956 110476606
Drug ineffective 167.89 19.34 2302 109435 1518238 108959324
Blood cholesterol increased 167.48 19.34 4 111733 184781 110292781
Microsporidia infection 164.67 19.34 60 111677 1379 110476183
Drug abuse 164.12 19.34 3 111734 177408 110300154
Enterococcal bacteraemia 163.33 19.34 83 111654 4378 110473184
Inappropriate schedule of product administration 162.70 19.34 11 111726 203626 110273936
Blood stem cell transplant failure 162.39 19.34 50 111687 668 110476894
Drug intolerance 161.57 19.34 106 111631 406406 110071156
Encephalopathy 161.31 19.34 292 111445 80763 110396799
Type 2 diabetes mellitus 160.00 19.34 4 111733 177228 110300334
Lymphadenopathy 158.82 19.34 254 111483 63581 110413981
Blood pressure increased 157.98 19.34 34 111703 258339 110219223
Bone marrow transplant rejection 156.75 19.34 41 111696 288 110477274
Injury 156.35 19.34 5 111732 177260 110300302
Acute respiratory distress syndrome 153.90 19.34 227 111510 52971 110424591
Drug interaction 151.76 19.34 169 111568 500014 109977548
Hypoaesthesia 151.27 19.34 64 111673 314159 110163403
Meningoencephalitis herpetic 151.15 19.34 65 111672 2337 110475225
Chest pain 151.12 19.34 97 111640 376278 110101284
Chronic graft versus host disease oral 149.38 19.34 43 111694 448 110477114
Gastrooesophageal reflux disease 148.99 19.34 8 111729 179968 110297594
Musculoskeletal pain 148.86 19.34 9 111728 183014 110294548
Abdominal pain upper 148.53 19.34 84 111653 349027 110128535
Candida infection 147.83 19.34 211 111526 47798 110429764
Dyspepsia 147.76 19.34 12 111725 190953 110286609
Exposure during pregnancy 146.68 19.34 5 111732 167419 110310143
Skin toxicity 146.53 19.34 110 111627 11673 110465889
Clostridium difficile colitis 146.11 19.34 200 111537 43578 110433984
Hypoxia 145.69 19.34 370 111367 129145 110348417
Klebsiella sepsis 145.47 19.34 75 111662 4078 110473484
Diffuse large B-cell lymphoma recurrent 144.31 19.34 86 111651 6213 110471349
Osteoarthritis 139.86 19.34 12 111725 182611 110294951
Serum ferritin increased 139.39 19.34 107 111630 11740 110465822
Human herpesvirus 6 infection reactivation 136.40 19.34 49 111688 1080 110476482
Hepatic failure 135.97 19.34 247 111490 68492 110409070
Back pain 135.28 19.34 106 111631 370890 110106672
Migraine 135.02 19.34 10 111727 171642 110305920
Arthritis 131.15 19.34 10 111727 167576 110309986
Blister 130.95 19.34 34 111703 227342 110250220
Feeling abnormal 130.23 19.34 15 111722 180696 110296866
Condition aggravated 129.94 19.34 350 111387 734486 109743076
Pulmonary haemorrhage 129.91 19.34 118 111619 16338 110461224
Product administered to patient of inappropriate age 129.86 19.34 88 111649 7948 110469614
Stem cell transplant 129.78 19.34 71 111666 4356 110473206
Haematocrit decreased 128.78 19.34 236 111501 65881 110411681
Myocardial infarction 128.76 19.34 20 111717 192063 110285499
Gait disturbance 127.12 19.34 61 111676 278147 110199415
Tumour lysis syndrome 126.66 19.34 156 111581 30645 110446917
Impaired healing 126.30 19.34 23 111714 196694 110280868
Folliculitis 125.74 19.34 12 111725 167641 110309921
Hospitalisation 125.73 19.34 4 111733 142489 110335073
Squamous cell carcinoma of skin 125.43 19.34 118 111619 17085 110460477
Haematotoxicity 124.69 19.34 129 111608 20953 110456609
Respiratory syncytial virus infection 124.54 19.34 109 111628 14375 110463187
Chronic graft versus host disease in eye 123.87 19.34 36 111701 389 110477173
Hepatic enzyme increased 123.02 19.34 87 111650 320805 110156757
Bronchiolitis obliterans syndrome 122.69 19.34 40 111697 650 110476912
Clostridium difficile infection 122.30 19.34 202 111535 51927 110425635
B-cell aplasia 122.08 19.34 35 111702 359 110477203
Disseminated intravascular coagulation 120.62 19.34 177 111560 41109 110436453
Intentional overdose 119.56 19.34 3 111734 132498 110345064
Capillary leak syndrome 117.65 19.34 69 111668 4839 110472723
Weight decreased 117.50 19.34 182 111555 467875 110009687
Aplasia 117.28 19.34 82 111655 7791 110469771
Dry mouth 116.87 19.34 29 111708 199919 110277643
Parainfluenzae virus infection 116.60 19.34 78 111659 6896 110470666
Gait inability 116.29 19.34 5 111732 136371 110341191
Neoplasm recurrence 116.14 19.34 70 111667 5162 110472400
Escherichia sepsis 114.81 19.34 90 111647 10182 110467380
Paraesthesia 114.09 19.34 69 111668 276452 110201110
Minimal residual disease 113.78 19.34 41 111696 912 110476650
Pneumatosis intestinalis 113.64 19.34 83 111654 8446 110469116
B-cell type acute leukaemia 113.60 19.34 46 111691 1418 110476144
Bacterial infection 111.53 19.34 181 111556 45855 110431707
Lower respiratory tract infection 111.52 19.34 53 111684 243053 110234509
Protothecosis 110.13 19.34 35 111702 522 110477040
Joint range of motion decreased 109.02 19.34 3 111734 121829 110355733
Graft versus host disease in eye 108.14 19.34 33 111704 427 110477135
Generalised oedema 106.60 19.34 143 111594 30561 110447001
Adenoviral haemorrhagic cystitis 106.49 19.34 36 111701 658 110476904
Fungaemia 106.42 19.34 70 111667 6016 110471546
Diarrhoea 105.95 19.34 696 111041 1138809 109338753
Dehydration 105.54 19.34 77 111660 279434 110198128
Loss of personal independence in daily activities 104.31 19.34 14 111723 150006 110327556
Alpha haemolytic streptococcal infection 103.61 19.34 57 111680 3536 110474026
Disseminated toxoplasmosis 102.75 19.34 32 111705 445 110477117
Immune thrombocytopenia 102.44 19.34 120 111617 22374 110455188
Blood immunoglobulin G decreased 101.52 19.34 65 111672 5335 110472227
Campylobacter infection 101.14 19.34 49 111688 2330 110475232
Pericarditis 100.14 19.34 48 111689 219066 110258496
Retinitis viral 99.74 19.34 31 111706 428 110477134
Stenotrophomonas infection 99.10 19.34 66 111671 5792 110471770
Respiratory distress 97.21 19.34 215 111522 68659 110408903
Decreased appetite 95.52 19.34 212 111525 475634 110001928
Pneumocystis jirovecii pneumonia 95.45 19.34 162 111575 42573 110434989
Geotrichum infection 93.76 19.34 38 111699 1174 110476388
Graft complication 92.78 19.34 37 111700 1095 110476467
Pericardial effusion 91.59 19.34 188 111549 57029 110420533
Incorrect dose administered 91.11 19.34 3 111734 103638 110373924
Chronic lymphocytic leukaemia 90.87 19.34 63 111674 5905 110471657
Post transplant distal limb syndrome 90.64 19.34 34 111703 850 110476712
Transplant dysfunction 88.86 19.34 71 111666 8257 110469305
Pneumonia respiratory syncytial viral 88.73 19.34 47 111690 2702 110474860
Gastroenteritis adenovirus 88.51 19.34 28 111709 411 110477151
Device related infection 87.19 19.34 149 111588 39370 110438192
Autoimmune neutropenia 86.43 19.34 31 111706 680 110476882
Acute lymphocytic leukaemia 85.77 19.34 60 111677 5705 110471857
Cytomegalovirus colitis 85.77 19.34 65 111672 6996 110470566
Palpitations 85.76 19.34 27 111710 159185 110318377
Memory impairment 85.72 19.34 46 111691 196898 110280664
Klebsiella infection 84.95 19.34 103 111634 19906 110457656
Transplant rejection 84.65 19.34 114 111623 24453 110453109
Syncope 84.28 19.34 50 111687 202486 110275076
Hyperhidrosis 84.11 19.34 42 111695 187256 110290306
Toxic leukoencephalopathy 83.21 19.34 38 111699 1579 110475983
Malignant genitourinary tract neoplasm 83.02 19.34 17 111720 30 110477532
Disease recurrence 82.70 19.34 187 111550 60597 110416965
Injection site erythema 81.82 19.34 3 111734 94173 110383389
Aphasia 80.82 19.34 182 111555 58815 110418747
Infection 80.13 19.34 633 111104 361567 110115995
Candida sepsis 79.99 19.34 45 111692 2916 110474646
Disseminated mucormycosis 79.56 19.34 40 111697 2062 110475500
Pleural effusion 78.69 19.34 372 111365 177337 110300225
Lymphoproliferative disorder 78.00 19.34 62 111675 7156 110470406
Hypoglycaemia 78 19.34 12 111725 116092 110361470
Obesity 77.80 19.34 11 111726 113340 110364222
Sciatica 76.79 19.34 4 111733 92395 110385167
Cerebrovascular accident 76.50 19.34 44 111693 181240 110296322
Enterocolitis viral 76.42 19.34 30 111707 851 110476711
Hepatitis B reactivation 76.03 19.34 62 111675 7422 110470140
Feeling hot 75.54 19.34 4 111733 91102 110386460
Bronchitis 75.50 19.34 32 111705 157000 110320562
Prescribed overdose 75.37 19.34 3 111734 87578 110389984
Renal failure 75.31 19.34 438 111299 226136 110251426
Wrong technique in product usage process 75.14 19.34 3 111734 87345 110390217
Pulmonary fibrosis 74.69 19.34 8 111729 102034 110375528
Pneumonia adenoviral 74.41 19.34 27 111710 613 110476949
Chronic obstructive pulmonary disease 73.98 19.34 11 111726 109147 110368415
General physical health deterioration 73.96 19.34 204 111533 425091 110052471
Adverse event 73.66 19.34 11 111726 108798 110368764
Scedosporium infection 73.66 19.34 40 111697 2418 110475144
Pseudomonal sepsis 73.64 19.34 66 111671 8980 110468582
Injection site reaction 73.57 19.34 4 111733 89066 110388496
Hypoalbuminaemia 73.03 19.34 116 111621 28858 110448704
Cryptosporidiosis infection 72.15 19.34 31 111706 1112 110476450
Graft versus host disease in lung 72.02 19.34 32 111705 1246 110476316
Neutropenic sepsis 71.92 19.34 119 111618 30627 110446935
Dry skin 70.36 19.34 12 111725 107641 110369921
Neck pain 69.75 19.34 19 111718 123111 110354451
Escherichia infection 69.41 19.34 102 111635 23714 110453848
Abdominal pain 69.28 19.34 275 111462 512714 109964848
Drug ineffective for unapproved indication 69.15 19.34 245 111492 102593 110374969
Blood glucose increased 68.67 19.34 24 111713 132472 110345090
Night sweats 68.20 19.34 25 111712 133958 110343604
Neoplasm progression 67.93 19.34 180 111557 64415 110413147
Sinusitis 67.34 19.34 123 111614 296565 110180997
Escherichia bacteraemia 67.08 19.34 66 111671 10098 110467464
Illness 66.92 19.34 4 111733 82167 110395395
Chimerism 66.91 19.34 21 111716 300 110477262
Norovirus infection 66.86 19.34 37 111700 2322 110475240
Gastrointestinal disorder 66.66 19.34 88 111649 241864 110235698
Growth retardation 66.41 19.34 38 111699 2544 110475018
Medication error 66.16 19.34 13 111724 105353 110372209
Intentional product misuse 65.65 19.34 26 111711 132878 110344684
Oedema peripheral 65.43 19.34 147 111590 328513 110149049
Rectal haemorrhage 65.11 19.34 20 111717 119813 110357749
Cerebral aspergillosis 64.95 19.34 36 111701 2266 110475296
Mucoepidermoid carcinoma of salivary gland 63.62 19.34 17 111720 131 110477431
Leukaemic infiltration 63.56 19.34 18 111719 176 110477386
Therapy partial responder 63.16 19.34 125 111612 36936 110440626
Hyperbilirubinaemia 62.92 19.34 112 111625 30559 110447003
Ill-defined disorder 62.11 19.34 41 111696 156812 110320750
Blood pressure systolic increased 62.06 19.34 6 111731 82985 110394577
Influenza like illness 62.06 19.34 8 111729 88404 110389158
Dysbiosis 61.96 19.34 34 111703 2098 110475464
Systemic inflammatory response syndrome 61.77 19.34 71 111666 12972 110464590
Urinary tract infection 61.70 19.34 150 111587 326132 110151430
Out of specification test results 60.80 19.34 17 111720 158 110477404
Erythema 60.79 19.34 127 111610 291320 110186242
Obliterative bronchiolitis 60.71 19.34 41 111696 3682 110473880
Herpes virus infection 60.59 19.34 58 111679 8580 110468982
Wound infection 60.36 19.34 12 111725 96453 110381109
Angioedema 60.10 19.34 13 111724 98487 110379075
Autoimmune lymphoproliferative syndrome 60.00 19.34 18 111719 219 110477343
Liver injury 59.99 19.34 39 111698 150374 110327188
Blood fibrinogen decreased 59.92 19.34 36 111701 2639 110474923
Pathogen resistance 59.36 19.34 81 111656 17591 110459971
Cerebellar tumour 59.15 19.34 17 111720 176 110477386
Mucosal disorder 58.88 19.34 43 111694 4374 110473188
Inflammation 58.83 19.34 65 111672 193173 110284389
Cytokine storm 58.30 19.34 29 111708 1461 110476101
Sedation 57.96 19.34 3 111734 69680 110407882
Citrobacter infection 57.74 19.34 28 111709 1334 110476228
Transformation to acute myeloid leukaemia 57.70 19.34 29 111708 1494 110476068
Chloroma 56.84 19.34 24 111713 824 110476738
Organising pneumonia 56.73 19.34 71 111666 14172 110463390
Frequent bowel movements 56.58 19.34 4 111733 71386 110406176
Chronic lymphocytic leukaemia transformation 56.24 19.34 18 111719 275 110477287
Chronic lymphocytic leukaemia refractory 56.20 19.34 15 111722 115 110477447
Meningomyelitis herpes 56.15 19.34 14 111723 79 110477483
Hyperkalaemia 55.82 19.34 34 111703 135762 110341800
Hypercholesterolaemia 55.39 19.34 12 111725 90825 110386737
Enterococcal sepsis 55.26 19.34 37 111700 3275 110474287
Oedema 55.19 19.34 79 111658 209897 110267665
Herpes simplex pneumonia 54.89 19.34 19 111718 374 110477188
Rotavirus infection 54.78 19.34 24 111713 903 110476659
Lymphadenitis 54.74 19.34 45 111692 5448 110472114
Gastroenteritis norovirus 54.70 19.34 38 111699 3573 110473989
Nephrolithiasis 54.60 19.34 3 111734 66209 110411353
Refractory cytopenia with multilineage dysplasia 53.96 19.34 17 111720 246 110477316
Peripheral venous disease 53.62 19.34 10 111727 84107 110393455
Prescribed underdose 53.60 19.34 3 111734 65171 110412391
Upper respiratory fungal infection 53.35 19.34 19 111718 408 110477154
Pulmonary alveolar haemorrhage 52.62 19.34 82 111655 20068 110457494
Flushing 52.54 19.34 20 111717 104716 110372846
Immune reconstitution inflammatory syndrome 52.44 19.34 73 111664 16153 110461409
Bradycardia 52.26 19.34 48 111689 155469 110322093
Haemoglobin decreased 51.87 19.34 429 111308 248298 110229264
Malignant transformation 51.86 19.34 27 111710 1498 110476064
Polymyositis 51.49 19.34 37 111700 3671 110473891
Myelitis 51.48 19.34 35 111702 3178 110474384
Hepatosplenomegaly 51.48 19.34 48 111689 6871 110470691
Enterovirus infection 51.23 19.34 33 111704 2737 110474825
Cough 51.22 19.34 266 111471 461375 110016187
Rhabdomyolysis 51.11 19.34 29 111708 120372 110357190
BK polyomavirus test positive 51.11 19.34 17 111720 295 110477267
Abdominal distension 51.03 19.34 61 111676 175042 110302520
N-terminal prohormone brain natriuretic peptide increased 50.50 19.34 45 111692 6076 110471486
Loss of consciousness 50.47 19.34 75 111662 196231 110281331
Blood follicle stimulating hormone increased 50.26 19.34 18 111719 393 110477169
Guillain-Barre syndrome 50.06 19.34 58 111679 10686 110466876
Parvovirus B19 infection 50.04 19.34 33 111704 2848 110474714
Hydrocephalus 50.01 19.34 57 111680 10318 110467244
Haemolysis 50.00 19.34 70 111667 15569 110461993
Somnolence 49.96 19.34 145 111592 297304 110180258
Dysplasia 49.69 19.34 28 111709 1820 110475742
Gastroenteritis astroviral 49.52 19.34 15 111722 189 110477373
Microangiopathy 49.11 19.34 33 111704 2939 110474623
Cytomegalovirus hepatitis 48.87 19.34 22 111715 884 110476678
Neutropenic infection 48.81 19.34 34 111703 3211 110474351
Rash pruritic 48.74 19.34 19 111718 98050 110379512
Streptococcal bacteraemia 48.10 19.34 39 111698 4630 110472932
5q minus syndrome 48.08 19.34 16 111721 278 110477284
Basal cell carcinoma 47.45 19.34 126 111611 45144 110432418
Nasal congestion 47.28 19.34 20 111717 98262 110379300
Fungal sepsis 47.27 19.34 29 111708 2208 110475354
Stenotrophomonas sepsis 47.24 19.34 15 111722 223 110477339
Burning sensation 46.84 19.34 7 111730 69205 110408357
Gastroenteritis rotavirus 46.82 19.34 19 111718 589 110476973
Amnesia 46.77 19.34 24 111713 105384 110372178
Respiratory tract infection fungal 46.63 19.34 24 111713 1300 110476262
Mycobacterium kansasii infection 46.56 19.34 17 111720 393 110477169
Dysphonia 46.36 19.34 10 111727 75919 110401643
Oropharyngeal pain 46.35 19.34 41 111696 135235 110342327
Hot flush 46.29 19.34 6 111731 66030 110411532
International normalised ratio increased 46.21 19.34 15 111722 86757 110390805
Brain oedema 46.06 19.34 99 111638 30999 110446563
Suicidal ideation 45.38 19.34 19 111718 93918 110383644
Neutropenic colitis 45.28 19.34 48 111689 8017 110469545
Hepatitis B 44.97 19.34 52 111685 9560 110468002
Red blood cell sedimentation rate increased 44.50 19.34 12 111725 78290 110399272
Incorrect route of product administration 44.47 19.34 6 111731 64055 110413507
Pneumonia pseudomonal 44.31 19.34 46 111691 7500 110470062
Delayed engraftment 44.23 19.34 15 111722 277 110477285
Myelopathy 44.04 19.34 40 111697 5536 110472026
Achromobacter infection 43.93 19.34 15 111722 283 110477279
Depressed mood 43.91 19.34 5 111732 60804 110416758
Blood creatine phosphokinase increased 43.86 19.34 10 111727 73067 110404495
Cytomegalovirus urinary tract infection 43.66 19.34 12 111725 104 110477458
Death 43.44 19.34 474 111263 698395 109779167
Pulmonary mucormycosis 43.30 19.34 27 111710 2116 110475446
Cardiotoxicity 43.11 19.34 68 111669 16813 110460749
Emphysematous cholecystitis 43.06 19.34 12 111725 110 110477452
Vertigo 42.89 19.34 17 111720 86853 110390709
Balance disorder 42.82 19.34 33 111704 116527 110361035
Chronic inflammatory demyelinating polyradiculoneuropathy 42.70 19.34 27 111710 2168 110475394
Hepatic vein occlusion 42.65 19.34 15 111722 310 110477252
Lactobacillus infection 42.63 19.34 17 111720 503 110477059
Myeloid leukaemia 42.62 19.34 20 111717 885 110476677
Gene mutation 42.61 19.34 32 111705 3397 110474165
Klebsiella bacteraemia 42.58 19.34 37 111700 4832 110472730
Throat irritation 42.44 19.34 3 111734 53549 110424013
Viral infection 42.28 19.34 134 111603 53005 110424557
Human herpes virus 6 serology positive 42.03 19.34 14 111723 244 110477318
Bladder hypertrophy 41.40 19.34 21 111716 1103 110476459
Autoimmune disorder 41.28 19.34 8 111729 65475 110412087
Meningitis cryptococcal 41.27 19.34 36 111701 4726 110472836
Dysphagia 41.15 19.34 57 111680 153543 110324019
Flatulence 41.10 19.34 3 111734 52146 110425416
Serratia sepsis 40.96 19.34 14 111723 265 110477297
Mucosal toxicity 40.82 19.34 18 111719 688 110476874
Central nervous system leukaemia 40.53 19.34 17 111720 574 110476988
Viral diarrhoea 40.45 19.34 17 111720 577 110476985
Ureaplasma infection 40.42 19.34 23 111714 1523 110476039
Acute myeloid leukaemia refractory 40.33 19.34 14 111723 278 110477284
Acute erythroid leukaemia 40.10 19.34 15 111722 372 110477190
Unevaluable event 40.06 19.34 6 111731 59221 110418341
Myalgia 39.87 19.34 105 111632 222276 110255286
Roseolovirus test positive 39.83 19.34 14 111723 289 110477273
Retinopathy haemorrhagic 39.56 19.34 11 111726 100 110477462
Polyomavirus-associated nephropathy 39.44 19.34 45 111692 8156 110469406
Ear pain 39.40 19.34 4 111733 53222 110424340
Primary amyloidosis 39.34 19.34 14 111723 300 110477262
Diffuse large B-cell lymphoma refractory 39.29 19.34 27 111710 2494 110475068
Coronary artery disease 38.88 19.34 12 111725 71678 110405884
Complications of bone marrow transplant 38.77 19.34 17 111720 641 110476921
Coronavirus infection 38.68 19.34 48 111689 9497 110468065
Juvenile chronic myelomonocytic leukaemia 38.44 19.34 9 111728 37 110477525
Therapeutic product effect incomplete 38.38 19.34 108 111629 223697 110253865
Lung infiltration 38.32 19.34 80 111657 24548 110453014
Disseminated Bacillus Calmette-Guerin infection 38.25 19.34 14 111723 326 110477236
Treatment noncompliance 38.20 19.34 13 111724 72977 110404585
Skin discolouration 38.15 19.34 3 111734 49043 110428519
Human metapneumovirus test positive 38.13 19.34 13 111724 244 110477318
Hyponatraemia 38.09 19.34 104 111633 217549 110260013
Alternaria infection 37.55 19.34 19 111718 993 110476569
Splenomegaly 37.45 19.34 79 111658 24419 110453143
Hepatomegaly 37.42 19.34 73 111664 21341 110456221
Autoimmune thyroiditis 37.38 19.34 39 111698 6395 110471167
Retinal haemorrhage 37.26 19.34 47 111690 9454 110468108
Demyelinating polyneuropathy 37.23 19.34 25 111712 2224 110475338
Cytomegalovirus gastroenteritis 37.17 19.34 17 111720 709 110476853
Apoptosis 37.17 19.34 17 111720 709 110476853
Serratia infection 37.13 19.34 25 111712 2234 110475328
Swelling face 36.72 19.34 24 111713 92297 110385265
Lung consolidation 36.68 19.34 49 111688 10427 110467135
Gastrointestinal infection 36.58 19.34 57 111680 13948 110463614
Pulmonary embolism 36.41 19.34 104 111633 214370 110263192
Bone marrow transplant 36.31 19.34 22 111715 1638 110475924
Pneumonia bacterial 35.95 19.34 81 111656 26180 110451382
Therapy non-responder 35.87 19.34 277 111460 157030 110320532
Viral sinusitis 35.87 19.34 13 111724 294 110477268
Acute myocardial infarction 35.81 19.34 20 111717 83757 110393805
Aggression 35.74 19.34 8 111729 59202 110418360
Accidental overdose 35.64 19.34 5 111732 51829 110425733
Mycobacterial infection 35.51 19.34 32 111705 4385 110473177
Diabetes mellitus 35.42 19.34 29 111708 99352 110378210
Aplasia pure red cell 35.39 19.34 46 111691 9532 110468030
Confusional state 35.38 19.34 303 111434 468377 110009185
Taste disorder 35.36 19.34 11 111726 65376 110412186
Hepatitis E 35.24 19.34 32 111705 4427 110473135
Oxygen saturation decreased 34.78 19.34 66 111671 156916 110320646
Refractory anaemia with an excess of blasts 34.67 19.34 17 111720 830 110476732
Paraparesis 34.59 19.34 32 111705 4534 110473028
Primary mediastinal large B-cell lymphoma 34.56 19.34 9 111728 62 110477500
Angina pectoris 34.56 19.34 10 111727 62285 110415277
Leukoerythroblastosis 34.39 19.34 13 111724 332 110477230
Toxicity to various agents 34.37 19.34 315 111422 480240 109997322
Renal tubular injury 34.23 19.34 27 111710 3081 110474481
Leukaemic infiltration extramedullary 34.14 19.34 13 111724 339 110477223
Heart rate increased 34.09 19.34 58 111679 143776 110333786
Peripheral T-cell lymphoma unspecified 33.85 19.34 17 111720 874 110476688
Diffuse large B-cell lymphoma stage IV 33.73 19.34 17 111720 881 110476681
Blood lactate dehydrogenase increased 33.64 19.34 110 111627 44224 110433338
Lymphocytosis 33.61 19.34 34 111703 5377 110472185
Heart rate abnormal 33.60 19.34 39 111698 7199 110470363
Streptococcal sepsis 33.59 19.34 33 111704 5039 110472523
Neurological decompensation 33.49 19.34 38 111699 6845 110470717
Pulmonary veno-occlusive disease 33.47 19.34 23 111714 2125 110475437
Post-depletion B-cell recovery 33.29 19.34 7 111730 15 110477547
Urethral polyp 33.17 19.34 9 111728 74 110477488
Pneumonia klebsiella 32.93 19.34 37 111700 6595 110470967
Haematochezia 32.85 19.34 41 111696 115483 110362079
Lichenoid keratosis 32.74 19.34 36 111701 6266 110471296
NPM1 gene mutation 32.73 19.34 10 111727 130 110477432
Blindness cortical 32.71 19.34 18 111719 1117 110476445
Chronic myeloid leukaemia recurrent 32.62 19.34 13 111724 384 110477178
Glomerulonephritis membranous 32.52 19.34 22 111715 1981 110475581
Ascites 32.50 19.34 182 111555 92626 110384936
Lip ulceration 32.48 19.34 25 111712 2753 110474809
Head injury 32.45 19.34 3 111734 43014 110434548
Large granular lymphocytosis 32.38 19.34 14 111723 510 110477052
Colitis ulcerative 32.31 19.34 19 111718 77344 110400218
Chest discomfort 31.99 19.34 81 111656 173767 110303795
Recurrent cancer 31.95 19.34 27 111710 3396 110474166
Pseudomonal bacteraemia 31.90 19.34 30 111707 4341 110473221
Dysgraphia 31.88 19.34 31 111706 4674 110472888
Kidney fibrosis 31.77 19.34 30 111707 4362 110473200
Accidental exposure to product 31.75 19.34 6 111731 50002 110427560
Cellulitis staphylococcal 31.73 19.34 19 111718 1384 110476178
Lymphodepletion 31.67 19.34 8 111729 48 110477514
Enterobacter infection 31.59 19.34 34 111703 5777 110471785
Soft tissue infection 31.56 19.34 32 111705 5075 110472487
Gastrointestinal toxicity 31.41 19.34 47 111690 11101 110466461
Blood potassium decreased 31.31 19.34 8 111729 54106 110423456
Tinnitus 31.31 19.34 11 111726 60529 110417033
Central nervous system viral infection 31.19 19.34 12 111725 322 110477240
Colitis herpes 30.90 19.34 7 111730 24 110477538
Refractory cytopenia with unilineage dysplasia 30.88 19.34 16 111721 879 110476683
Multisystem inflammatory syndrome in children 30.86 19.34 8 111729 54 110477508
Parenteral nutrition 30.79 19.34 16 111721 884 110476678
COVID-19 pneumonia 30.78 19.34 95 111642 37048 110440514
Sinusitis fungal 30.76 19.34 24 111713 2696 110474866
Anti-platelet antibody positive 30.65 19.34 12 111725 338 110477224
Transplantation complication 30.64 19.34 13 111724 452 110477110
Limb discomfort 30.42 19.34 3 111734 40851 110436711
Hyperfibrinogenaemia 30.42 19.34 10 111727 167 110477395
Acquired macroglossia 30.02 19.34 11 111726 257 110477305
Reticulocytosis 29.70 19.34 14 111723 626 110476936
Metastases to diaphragm 29.68 19.34 8 111729 64 110477498
B-cell lymphoma recurrent 29.67 19.34 17 111720 1141 110476421
Rhinorrhoea 29.65 19.34 36 111701 102630 110374932
Portal hypertension 29.63 19.34 40 111697 8597 110468965
Cardiac tamponade 29.50 19.34 46 111691 11261 110466301
Chromosome analysis abnormal 29.36 19.34 11 111726 274 110477288
Visual impairment 29.36 19.34 57 111680 134371 110343191
Agranulocytosis 29.32 19.34 132 111605 61628 110415934
Blood bilirubin increased 29.32 19.34 153 111584 75819 110401743
Eccrine squamous syringometaplasia 29.30 19.34 7 111730 32 110477530
Tumour pseudoprogression 29.26 19.34 19 111718 1597 110475965
Interleukin level increased 29.21 19.34 19 111718 1602 110475960
Herpes zoster infection neurological 29.14 19.34 13 111724 511 110477051
Dyskinesia 29.02 19.34 8 111729 51438 110426124
Brain abscess 28.97 19.34 35 111702 6739 110470823
Femur fracture 28.96 19.34 5 111732 44464 110433098
Mantle cell lymphoma recurrent 28.82 19.34 16 111721 1010 110476552
Vision blurred 28.80 19.34 54 111683 128968 110348594
Actinomycotic sepsis 28.74 19.34 10 111727 200 110477362
Device related bacteraemia 28.71 19.34 17 111720 1213 110476349
Polyserositis 28.71 19.34 16 111721 1018 110476544
Dyspnoea exertional 28.49 19.34 38 111699 104022 110373540
Blepharospasm 28.31 19.34 10 111727 54841 110422721
Cerebral fungal infection 28.22 19.34 14 111723 701 110476861
Enterobacter bacteraemia 28.17 19.34 18 111719 1472 110476090
Glomerulosclerosis 28.12 19.34 17 111720 1260 110476302
Anaphylactic reaction 28.10 19.34 45 111692 114255 110363307
Herpes zoster meningoencephalitis 28.09 19.34 16 111721 1062 110476500
Gastritis fungal 27.79 19.34 11 111726 319 110477243
Transient ischaemic attack 27.74 19.34 15 111722 63967 110413595
Electrocardiogram QT prolonged 27.64 19.34 42 111695 108918 110368644
B-cell lymphoma 27.44 19.34 35 111702 7119 110470443
Cord blood transplant therapy 27.40 19.34 8 111729 88 110477474
Refractoriness to platelet transfusion 27.12 19.34 10 111727 238 110477324
Clonal evolution 26.96 19.34 10 111727 242 110477320
Rubulavirus test positive 26.85 19.34 6 111731 19 110477543
High-grade B-cell lymphoma 26.85 19.34 10 111727 245 110477317
Drug reaction with eosinophilia and systemic symptoms 26.80 19.34 26 111711 82069 110395493
Hepatic necrosis 26.78 19.34 41 111696 9881 110467681
Poikiloderma 26.70 19.34 12 111725 480 110477082
Allogenic stem cell transplantation 26.69 19.34 10 111727 249 110477313
Urinary tract infection viral 26.69 19.34 8 111729 97 110477465
Herpes simplex test positive 26.66 19.34 13 111724 627 110476935
Retinal infiltrates 26.54 19.34 7 111730 51 110477511
Premature ageing 26.47 19.34 8 111729 100 110477462
Lactic acidosis 26.33 19.34 33 111704 92778 110384784
Metastases to bone marrow 26.28 19.34 15 111722 999 110476563
Intentional product use issue 26.27 19.34 145 111592 247761 110229801
Adult T-cell lymphoma/leukaemia recurrent 26.08 19.34 7 111730 55 110477507
Gingivitis ulcerative 26.07 19.34 12 111725 508 110477054
Arteritis infective 26.01 19.34 9 111728 177 110477385
Varicella 25.93 19.34 25 111712 3730 110473832
Spirochaetal infection 25.56 19.34 6 111731 25 110477537
Delirium 25.56 19.34 62 111675 134963 110342599
Viral test positive 25.51 19.34 14 111723 864 110476698
Rhinocerebral mucormycosis 25.44 19.34 17 111720 1500 110476062
Squamous cell carcinoma 25.33 19.34 57 111680 18406 110459156
Pneumoretroperitoneum 25.28 19.34 9 111728 193 110477369
Nervous system disorder 25.24 19.34 80 111657 31641 110445921
Lineage switch leukaemia 25.24 19.34 7 111730 63 110477499
Genitourinary tract neoplasm 25.04 19.34 7 111730 65 110477497
Tumour flare 24.94 19.34 17 111720 1550 110476012
Osteoporosis 24.71 19.34 31 111706 87121 110390441
Skin ulcer 24.70 19.34 17 111720 63628 110413934
Human herpesvirus 7 infection 24.69 19.34 9 111728 207 110477355
Organic brain syndrome 24.68 19.34 12 111725 575 110476987
Bacille Calmette-Guerin scar reactivation 24.67 19.34 6 111731 30 110477532
Neurological symptom 24.64 19.34 51 111686 15557 110462005
Meningitis viral 24.63 19.34 20 111717 2379 110475183
Autoimmune pancytopenia 24.53 19.34 9 111728 211 110477351
Parvovirus infection 24.47 19.34 14 111723 937 110476625
Drug effective for unapproved indication 24.40 19.34 48 111689 14119 110463443
Ocular hyperaemia 24.34 19.34 5 111732 39281 110438281
Gastroenteritis sapovirus 24.22 19.34 9 111728 219 110477343
Hypertension 24.21 19.34 366 111371 509718 109967844
Myeloproliferative neoplasm 24.18 19.34 16 111721 1389 110476173
Device related sepsis 24.11 19.34 34 111703 7613 110469949
Acute kidney injury 24.05 19.34 825 110912 634605 109842957
Haematemesis 24.01 19.34 15 111722 59093 110418469
Blindness 23.90 19.34 86 111651 36273 110441289
Hypofibrinogenaemia 23.86 19.34 20 111717 2487 110475075
Influenza 23.84 19.34 89 111648 169012 110308550
Rib fracture 23.83 19.34 3 111734 33767 110443795
American trypanosomiasis 23.81 19.34 12 111725 622 110476940
Intestinal obstruction 23.79 19.34 12 111725 53215 110424347
Haemolytic anaemia 23.74 19.34 60 111677 20860 110456702
Parotitis 23.70 19.34 22 111715 3131 110474431
Leukaemia cutis 23.59 19.34 9 111728 236 110477326
Immunodeficiency common variable 23.45 19.34 12 111725 642 110476920
Gastric disorder 23.45 19.34 3 111734 33354 110444208
Angiocentric lymphoma 23.31 19.34 15 111722 1242 110476320
Pneumonia viral 23.22 19.34 41 111696 11116 110466446
Aspergillus test positive 23.18 19.34 14 111723 1036 110476526
Nocardiosis 23.18 19.34 33 111704 7453 110470109
Azoospermia 23.14 19.34 9 111728 249 110477313
Meningitis tuberculous 23.08 19.34 15 111722 1263 110476299
Leukaemia 23.07 19.34 33 111704 7485 110470077
Mesangioproliferative glomerulonephritis 23.07 19.34 9 111728 251 110477311
Brain herniation 23.05 19.34 36 111701 8827 110468735
Urinary retention 22.83 19.34 22 111715 69661 110407901
Orthostatic hypotension 22.79 19.34 20 111717 66229 110411333
Acute graft versus host disease oral 22.70 19.34 7 111730 94 110477468
Disseminated tuberculosis 22.68 19.34 27 111710 5119 110472443
Hepatotoxicity 22.64 19.34 125 111612 63275 110414287
Epstein-Barr virus test positive 22.57 19.34 15 111722 1311 110476251
Diffuse alveolar damage 22.57 19.34 24 111713 4023 110473539
Neutrophil Pelger-Huet anomaly present 22.56 19.34 10 111727 387 110477175
Immunoglobulins decreased 22.55 19.34 19 111718 2380 110475182
Fat tissue increased 22.49 19.34 14 111723 1094 110476468
Donor leukocyte infusion 22.37 19.34 6 111731 47 110477515
Portal vein embolism 22.24 19.34 7 111730 101 110477461
Iron overload 22.23 19.34 18 111719 2133 110475429
Stenotrophomonas bacteraemia 22.12 19.34 9 111728 281 110477281
Cholelithiasis 21.99 19.34 19 111718 63403 110414159
Gout 21.95 19.34 5 111732 36561 110441001
Dementia 21.90 19.34 3 111734 31670 110445892
Dysgeusia 21.89 19.34 23 111714 69962 110407600
Paraspinal abscess 21.89 19.34 10 111727 416 110477146
Embryonal rhabdomyosarcoma 21.83 19.34 6 111731 52 110477510
Vaccination failure 21.83 19.34 19 111718 2487 110475075
Herpes zoster reactivation 21.80 19.34 10 111727 420 110477142
Evans syndrome 21.58 19.34 12 111725 760 110476802
Meningitis enterococcal 21.48 19.34 8 111729 196 110477366
Infusion site eschar 21.47 19.34 5 111732 20 110477542
Corynebacterium bacteraemia 21.40 19.34 8 111729 198 110477364
Parainfluenzae viral bronchitis 21.27 19.34 5 111732 21 110477541
Corynebacterium infection 21.23 19.34 17 111720 1983 110475579
Haemorrhage intracranial 21.19 19.34 71 111666 28898 110448664
Herpes simplex reactivation 21.19 19.34 15 111722 1453 110476109
Central nervous system infection 21.16 19.34 16 111721 1716 110475846
Haptoglobin decreased 21.09 19.34 16 111721 1725 110475837
Limbic encephalitis 21.07 19.34 12 111725 796 110476766
Septic embolus 21.00 19.34 18 111719 2308 110475254
Adenomatous polyposis coli 20.99 19.34 9 111728 321 110477241
Cardiomyopathy 20.94 19.34 78 111659 33447 110444115
Serum sickness 20.89 19.34 24 111713 4382 110473180
Cataract subcapsular 20.83 19.34 14 111723 1247 110476315
Primary mediastinal large B-cell lymphoma recurrent 20.81 19.34 7 111730 126 110477436
Cataract 20.78 19.34 30 111707 79455 110398107
Hyperplasia 20.74 19.34 15 111722 1503 110476059
Psychotic disorder 20.59 19.34 13 111724 50924 110426638
CNS ventriculitis 20.58 19.34 11 111726 644 110476918
Fluid retention 20.58 19.34 40 111697 94267 110383295
Chronic myelomonocytic leukaemia 20.49 19.34 13 111724 1050 110476512
Lower respiratory tract infection fungal 20.41 19.34 12 111725 845 110476717
Non-Hodgkin's lymphoma recurrent 20.40 19.34 5 111732 26 110477536
Sphingomonas paucimobilis infection 20.36 19.34 7 111730 135 110477427
Gastroenteritis clostridial 20.32 19.34 13 111724 1065 110476497
Tooth hypoplasia 20.31 19.34 9 111728 348 110477214
Serositis 20.30 19.34 15 111722 1554 110476008
T-cell lymphoma 20.24 19.34 15 111722 1561 110476001
Metapneumovirus infection 20.23 19.34 18 111719 2426 110475136
Bordetella infection 20.21 19.34 8 111729 232 110477330
Transplantation associated food allergy 20.21 19.34 7 111730 138 110477424
Electrocardiogram T wave biphasic 20.18 19.34 8 111729 233 110477329
Periorbital cellulitis 20.17 19.34 13 111724 1079 110476483
Troponin increased 20.16 19.34 3 111734 29763 110447799
Cyanosis 20.14 19.34 3 111734 29738 110447824
Lymphocyte adoptive therapy 20.12 19.34 7 111730 140 110477422
Precursor B-lymphoblastic lymphoma recurrent 20.09 19.34 5 111732 28 110477534
Enamel anomaly 20.08 19.34 8 111729 236 110477326
Respiratory paralysis 20.07 19.34 7 111730 141 110477421
Rash macular 20.05 19.34 7 111730 38679 110438883
Pharyngeal ulceration 20.05 19.34 14 111723 1327 110476235
Lymphoma 19.99 19.34 55 111682 20116 110457446
Heart rate irregular 19.96 19.34 5 111732 34269 110443293
Ventricular tachycardia 19.89 19.34 13 111724 49996 110427566
Severe acute respiratory syndrome 19.87 19.34 8 111729 243 110477319
Tenderness 19.86 19.34 3 111734 29434 110448128
Venous haemorrhage 19.84 19.34 9 111728 368 110477194
Coagulopathy 19.84 19.34 88 111649 40823 110436739
Chromaturia 19.79 19.34 3 111734 29357 110448205
Corynebacterium sepsis 19.71 19.34 8 111729 248 110477314
Papilloma 19.61 19.34 10 111727 531 110477031
Muscle spasticity 19.49 19.34 6 111731 35909 110441653

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 agent
CHEBI has role CHEBI:35221 antimetabolite
CHEBI has role CHEBI:35610 antineoplastic agent
CHEBI has role CHEBI:35705 immunosuppressive agent
CHEBI has role CHEBI:50266 prodrug
CHEBI has role CHEBI:59517 DNA synthesis inhibitor
CHEBI has role CHEBI:75835 anti-anaemic agent
CHEBI has role CHEBI:233423 antifibrotic agent

Related Drugs by ATC class:

L01BB Purine analogues 5 drugs
cladribineclofarabinemercaptopurinenelarabinethioguanine

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
CHEMBL1096882 ChEMBL_ID
C042382 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
CHEBI:63599 CHEBI
CHEMBL1568 ChEMBL_ID
21679-14-1 SECONDARY_CAS_RN
657237 PUBCHEM_CID
4802 IUPHAR_LIGAND_ID
5214 INN_ID
C024352 MESH_SUPPLEMENTAL_RECORD_UI
P2K93U8740 UNII
CHEBI:94701 CHEBI
1X9VK9O1SC INXIGHT DRUGS
P2K93U8740 INXIGHT DRUGS

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Fludarabine Phosphate HUMAN PRESCRIPTION DRUG LABEL 1 0527-1242 INJECTION 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 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