busulfan 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |

Stem definitionDrug idCAS RN
antineoplastic, alkylating agents, methanesulfonates 438 55-98-1

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • busilvex
  • busulfan
  • busulfex
  • busulphan
  • citosulfan
  • glyzophrol
  • leucosulfan
  • sulphabutin
An alkylating agent having a selective immunosuppressive effect on BONE MARROW. It has been used in the palliative treatment of chronic myeloid leukemia (MYELOID LEUKEMIA, CHRONIC), but although symptomatic relief is provided, no permanent remission is brought about. According to the Fourth Annual Report on Carcinogens (NTP 85-002, 1985), busulfan is listed as a known carcinogen.
  • Molecular weight: 246.29
  • Formula: C6H14O6S2
  • CLOGP: -0.59
  • LIPINSKI: 0
  • HAC: 6
  • HDO: 0
  • TPSA: 86.74
  • ALOGS: -1.68
  • ROTB: 7
  • 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) 0.03 mg/mL Bocci G, Oprea TI, Benet LZ
EoM (Fraction excreted unchanged in urine) 1 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 0.23 µM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 70 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 0.55 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 2.40 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 1 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 3.40 hours Lombardo F, Berellini G, Obach RS

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
kinase-safety-class ACVR2A,ACVR2B,AXL,BRAF,CAMK2D,CDK5,CDK9,DDR1,DYRK1B,EIF2AK3,ERBB2,GRK2,ITK,MAP2K6,MAP3K21,MAPK7,NTRK2,PDK1,PDK2,PDK4,PIK3CG,PRKDC,STK33,TEK 24
kinase-selectivity-class AURKA,AXL,BRAF,CAMK2D,CDK1,CDK4,CDK6,CDK9,DDR1,EPHB4,ERBB2,FLT3,GRK2,GSK3B,IRAK1,IRAK3,MAP2K6,MAP3K21,MAPK7,PIK3CD,PIK3CG,PRKDC,SIK2,SYK,TEK,ZAP70 26
pfas-class PFAS structural alert (1 = True, 0 = False) 0

Approvals:

DateAgencyCompanyOrphan
March 25, 2020 PMDA Otsuka Pharmaceutical Co., Ltd
June 26, 1954 FDA ASPEN GLOBAL

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Acute graft versus host disease 1256.69 37.55 283 20289 5185 90602690
Chronic graft versus host disease 1064.94 37.55 235 20337 3904 90603971
Venoocclusive liver disease 1030.22 37.55 245 20327 5748 90602127
Graft versus host disease 1024.54 37.55 259 20313 7885 90599990
Acute graft versus host disease in skin 984.05 37.55 226 20346 4530 90603345
Cytomegalovirus infection 848.59 37.55 292 20280 26310 90581565
Mucosal inflammation 842.76 37.55 358 20214 57267 90550608
Graft versus host disease in skin 706.37 37.55 166 20406 3687 90604188
Product use in unapproved indication 654.33 37.55 568 20004 335668 90272207
Venoocclusive disease 596.17 37.55 133 20439 2322 90605553
Cytomegalovirus infection reactivation 581.10 37.55 164 20408 7636 90600239
Graft versus host disease in gastrointestinal tract 558.81 37.55 141 20431 4247 90603628
Cystitis haemorrhagic 493.94 37.55 134 20438 5379 90602496
Viral haemorrhagic cystitis 475 37.55 101 20471 1392 90606483
Cytomegalovirus viraemia 473.53 37.55 139 20433 7447 90600428
Thrombotic microangiopathy 456.24 37.55 161 20411 15582 90592293
Ovarian failure 366.17 37.55 83 20489 1560 90606315
Acute graft versus host disease in intestine 362.14 37.55 86 20486 1997 90605878
BK virus infection 345.98 37.55 97 20475 4401 90603474
Febrile neutropenia 340.48 37.55 284 20288 158065 90449810
Posterior reversible encephalopathy syndrome 287.46 37.55 127 20445 22212 90585663
Aplastic anaemia 260.53 37.55 102 20470 13167 90594708
Transplant failure 259.23 37.55 65 20507 1904 90605971
Human herpesvirus 6 infection 254.80 37.55 72 20500 3360 90604515
Epstein-Barr virus infection 251.70 37.55 93 20479 10251 90597624
Acute myeloid leukaemia recurrent 251.48 37.55 64 20508 1993 90605882
Adenovirus infection 237.88 37.55 73 20499 4549 90603326
Off label use 237.52 37.55 663 19909 1101589 89506286
Chronic graft versus host disease in skin 224.96 37.55 53 20519 1187 90606688
Primary hypogonadism 210.55 37.55 37 20535 166 90607709
Premature menopause 205.88 37.55 50 20522 1279 90606596
Acute graft versus host disease in liver 192.00 37.55 43 20529 763 90607112
Multiple organ dysfunction syndrome 179.50 37.55 138 20434 68198 90539677
Ovarian atrophy 178.76 37.55 29 20543 70 90607805
Post transplant lymphoproliferative disorder 174.67 37.55 64 20508 6885 90600990
Bacteraemia 171.39 37.55 89 20483 22211 90585664
Acute lymphocytic leukaemia recurrent 165.98 37.55 49 20523 2672 90605203
Idiopathic pneumonia syndrome 157.73 37.55 33 20539 418 90607457
Thrombocytopenia 153.70 37.55 212 20360 208513 90399362
Bacterial sepsis 152.39 37.55 53 20519 4902 90602973
Acute myeloid leukaemia 143.37 37.55 77 20495 20563 90587312
Epstein-Barr virus infection reactivation 138.25 37.55 38 20534 1599 90606276
Herpes simplex 131.31 37.55 58 20514 10123 90597752
Blood follicle stimulating hormone increased 126.67 37.55 24 20548 175 90607700
Cystitis viral 126.20 37.55 25 20547 236 90607639
Cytomegalovirus chorioretinitis 123.59 37.55 38 20534 2381 90605494
Blood luteinising hormone increased 123.38 37.55 22 20550 109 90607766
Haemophagocytic lymphohistiocytosis 122.53 37.55 63 20509 15396 90592479
Inappropriate antidiuretic hormone secretion 122.28 37.55 68 20504 19437 90588438
Pain 121.25 37.55 38 20534 996303 89611572
Bronchiolitis obliterans syndrome 120.49 37.55 26 20546 385 90607490
Transplant dysfunction 115.76 37.55 44 20528 5238 90602637
Systemic mycosis 113.12 37.55 32 20540 1498 90606377
Fatigue 113.05 37.55 61 20511 1153962 89453913
Cytomegalovirus test positive 112.70 37.55 39 20533 3552 90604323
JC virus infection 111.03 37.55 36 20536 2683 90605192
Pulmonary haemorrhage 110.97 37.55 48 20524 7965 90599910
Mucormycosis 110.33 37.55 39 20533 3782 90604093
Polyomavirus viraemia 108.58 37.55 30 20542 1287 90606588
Headache 106.52 37.55 32 20540 862714 89745161
Varicella zoster virus infection 106.00 37.55 38 20534 3839 90604036
Septic shock 101.87 37.55 110 20462 84050 90523825
Dizziness 100.85 37.55 9 20563 589275 90018600
Respiratory failure 98.89 37.55 128 20444 118290 90489585
Neutropenia 98.28 37.55 180 20392 224724 90383151
Systemic candida 96.89 37.55 38 20534 4921 90602954
Leukaemia recurrent 96.44 37.55 28 20544 1439 90606436
Bone marrow failure 95.52 37.55 70 20502 32151 90575724
Toxoplasmosis 95.28 37.55 29 20543 1756 90606119
Upper respiratory fungal infection 94.74 37.55 19 20553 192 90607683
Retinitis viral 94.06 37.55 20 20552 275 90607600
Arthralgia 94.04 37.55 30 20542 778492 89829383
Staphylococcal infection 91.87 37.55 81 20491 48358 90559517
Obliterative bronchiolitis 91.48 37.55 31 20541 2650 90605225
Bronchopulmonary aspergillosis 89.02 37.55 46 20526 11352 90596523
Pain in extremity 88.92 37.55 3 20569 450526 90157349
Drug hypersensitivity 88.41 37.55 4 20568 463605 90144270
Ascites 86.90 37.55 78 20494 47662 90560213
Hypersensitivity 86.45 37.55 4 20568 454673 90153202
Pulmonary veno-occlusive disease 86.44 37.55 26 20546 1512 90606363
Sepsis 85.04 37.55 149 20423 179665 90428210
Fall 83.38 37.55 7 20565 481803 90126072
Renal tubular injury 82.82 37.55 24 20548 1225 90606650
Disseminated mucormycosis 82.62 37.55 21 20551 650 90607225
Staphylococcal sepsis 82.43 37.55 41 20531 9342 90598533
Graft versus host disease in lung 81.66 37.55 20 20552 530 90607345
Neurotoxicity 80.82 37.55 54 20518 21413 90586462
Acute respiratory distress syndrome 77.61 37.55 59 20513 28627 90579248
Pericardial effusion 76.74 37.55 65 20507 36768 90571107
Infection reactivation 76.43 37.55 25 20547 1915 90605960
Progressive multifocal leukoencephalopathy 75.39 37.55 46 20526 15609 90592266
Adenoviral hepatitis 75.12 37.55 18 20554 434 90607441
Drug resistance 74.49 37.55 59 20513 30390 90577485
Hepatomegaly 74.20 37.55 43 20529 13283 90594592
Cellulitis staphylococcal 70.97 37.55 20 20552 923 90606952
Neoplasm recurrence 70.88 37.55 27 20545 3232 90604643
Arthropathy 70.33 37.55 3 20569 366239 90241636
Alternaria infection 67.83 37.55 16 20556 360 90607515
Drug intolerance 66.35 37.55 11 20561 447580 90160295
Focal nodular hyperplasia 65.56 37.55 18 20554 754 90607121
Haematuria 65.40 37.55 58 20514 34879 90572996
Human polyomavirus infection 65.19 37.55 16 20556 428 90607447
Pruritus 65.07 37.55 21 20551 541504 90066371
Cytomegalovirus urinary tract infection 64.80 37.55 12 20560 76 90607799
Bone marrow transplant rejection 64.40 37.55 12 20560 79 90607796
Engraft failure 62.59 37.55 15 20557 362 90607513
Growth retardation 62.35 37.55 21 20551 1762 90606113
Encephalitis cytomegalovirus 62.08 37.55 17 20555 705 90607170
Demyelinating polyneuropathy 62.02 37.55 18 20554 924 90606951
Alopecia 61.63 37.55 18 20554 495053 90112822
Laryngitis fungal 60.66 37.55 13 20559 186 90607689
Aspergillus infection 60.46 37.55 35 20537 10788 90597087
Nodular melanoma 58.83 37.55 11 20561 74 90607801
Epstein-Barr viraemia 58.14 37.55 19 20553 1451 90606424
Actinomycotic sepsis 57.20 37.55 13 20559 247 90607628
Myelodysplastic syndrome 56.56 37.55 43 20529 20860 90587015
Rash 56.03 37.55 59 20513 796041 89811834
Disseminated toxoplasmosis 55.78 37.55 12 20560 175 90607700
Product administered to patient of inappropriate age 55.18 37.55 25 20547 4628 90603247
Device related infection 54.73 37.55 46 20526 25740 90582135
Pneumonia klebsiella 54.64 37.55 22 20550 3050 90604825
Pyrexia 53.75 37.55 293 20279 660192 89947683
Hypogammaglobulinaemia 53.03 37.55 32 20540 10642 90597233
Fungaemia 52.80 37.55 22 20550 3328 90604547
Pancytopenia 52.13 37.55 96 20476 120167 90487708
Drug effective for unapproved indication 50.70 37.55 28 20544 7890 90599985
Gastritis fungal 50.53 37.55 11 20561 170 90607705
Citrobacter bacteraemia 50.02 37.55 8 20564 17 90607858
Enterococcal infection 49.76 37.55 30 20542 9961 90597914
Sinusitis 49.57 37.55 9 20563 343079 90264796
Maternal exposure during pregnancy 48.79 37.55 11 20561 360052 90247823
Recurrent cancer 48.59 37.55 19 20553 2440 90605435
Fungal infection 48.53 37.55 54 20518 42607 90565268
Acquired macroglossia 48.20 37.55 11 20561 213 90607662
Pneumonia fungal 48.17 37.55 26 20546 7005 90600870
Confusional state 48.12 37.55 14 20558 386191 90221684
Depression 47.74 37.55 6 20566 300595 90307280
Anxiety 47.26 37.55 7 20565 309765 90298110
Nausea 47.26 37.55 115 20457 1110201 89497674
Weight decreased 46.91 37.55 14 20558 379896 90227979
Hypouricaemia 46.40 37.55 11 20561 253 90607622
Malaise 46.38 37.55 39 20533 585947 90021928
Muscle spasms 45.41 37.55 3 20569 251880 90355995
Clostridium difficile colitis 45.39 37.55 42 20530 26664 90581211
Arteritis infective 45.14 37.55 9 20563 88 90607787
Complications of bone marrow transplant 44.76 37.55 12 20560 459 90607416
Autoimmune haemolytic anaemia 44.71 37.55 23 20549 5622 90602253
Hepatic necrosis 44.64 37.55 24 20548 6414 90601461
Dedifferentiated liposarcoma 44.48 37.55 8 20564 42 90607833
Escherichia bacteraemia 44.36 37.55 23 20549 5712 90602163
Immune thrombocytopenia 44.18 37.55 31 20541 13295 90594580
Stem cell transplant 43.82 37.55 17 20555 2137 90605738
Hypoaesthesia 43.79 37.55 9 20563 314201 90293674
Organising pneumonia 43.59 37.55 25 20547 7572 90600303
Transplant rejection 43.05 37.55 30 20542 12728 90595147
Hypogonadism 43.01 37.55 9 20563 114 90607761
Herpes zoster infection neurological 42.98 37.55 12 20560 535 90607340
Seizure 42.90 37.55 102 20470 152527 90455348
Blood stem cell transplant failure 42.82 37.55 10 20562 215 90607660
Colitis erosive 42.52 37.55 10 20562 222 90607653
Wheezing 42.43 37.55 3 20569 238077 90369798
Hepatic cytolysis 42.00 37.55 43 20529 30873 90577002
Gait disturbance 41.85 37.55 5 20567 260491 90347384
Insomnia 41.69 37.55 12 20560 333462 90274413
Systemic inflammatory response syndrome 41.60 37.55 23 20549 6493 90601382
Spinal cord disorder 41.51 37.55 15 20557 1550 90606325
Enterococcal bacteraemia 41.24 37.55 16 20556 2012 90605863
Splenic vein thrombosis 41.00 37.55 11 20561 422 90607453
Lower respiratory tract infection fungal 40.87 37.55 10 20562 264 90607611
Paraspinal abscess 40.83 37.55 10 20562 265 90607610
Rhinovirus infection 40.71 37.55 22 20550 5941 90601934
Blister 40.71 37.55 5 20567 254993 90352882
Cerebral artery thrombosis 40.48 37.55 11 20561 443 90607432
Chronic graft versus host disease in intestine 40.32 37.55 9 20563 157 90607718
Epstein-Barr virus associated lymphoproliferative disorder 40.31 37.55 17 20555 2650 90605225
Guillain-Barre syndrome 40.05 37.55 20 20552 4592 90603283
Metapneumovirus infection 39.97 37.55 14 20558 1321 90606554
Septic embolus 39.89 37.55 13 20559 984 90606891
Capillary leak syndrome 39.71 37.55 17 20555 2750 90605125
Engraftment syndrome 39.64 37.55 12 20560 713 90607162
Growth hormone deficiency 39.45 37.55 9 20563 174 90607701
Pneumatosis intestinalis 39.28 37.55 18 20554 3419 90604456
Drug ineffective for unapproved indication 39.23 37.55 61 20511 66583 90541292
Dyspnoea 39.22 37.55 89 20483 880866 89727009
Fat necrosis 39.21 37.55 12 20560 740 90607135
Encephalitis viral 38.76 37.55 15 20557 1874 90606001
Back pain 38.58 37.55 12 20560 317163 90290712
Haemorrhage urinary tract 38.44 37.55 13 20559 1104 90606771
Acute promyelocytic leukaemia 38.30 37.55 13 20559 1116 90606759
Asthenia 38.12 37.55 39 20533 533712 90074163

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
Venoocclusive liver disease 1265.44 24.93 403 26775 9899 42584258
Acute graft versus host disease 1230.07 24.93 374 26804 7841 42586316
Graft versus host disease 1113.54 24.93 387 26791 12538 42581619
Acute graft versus host disease in skin 980.25 24.93 307 26871 7117 42587040
Mucosal inflammation 920.90 24.93 501 26677 48873 42545284
Product use in unapproved indication 905.04 24.93 823 26355 183633 42410524
Chronic graft versus host disease 853.57 24.93 263 26915 5762 42588395
Cytomegalovirus infection 824.66 24.93 405 26773 31901 42562256
Cytomegalovirus infection reactivation 752.64 24.93 279 26899 10899 42583258
Venoocclusive disease 701.92 24.93 205 26973 3710 42590447
Cystitis haemorrhagic 552.90 24.93 199 26979 7130 42587027
BK virus infection 499.96 24.93 194 26984 8590 42585567
Acute graft versus host disease in intestine 465.91 24.93 150 27028 3801 42590356
Graft versus host disease in gastrointestinal tract 461.84 24.93 159 27019 4984 42589173
Graft versus host disease in skin 409.96 24.93 146 27032 5066 42589091
Acute myeloid leukaemia recurrent 384.31 24.93 126 27052 3386 42590771
Thrombotic microangiopathy 375.72 24.93 185 26993 14597 42579560
Epstein-Barr virus infection 334.57 24.93 150 27028 9568 42584589
Viral haemorrhagic cystitis 309.94 24.93 92 27086 1762 42592395
Transplant failure 298.15 24.93 108 27070 3936 42590221
Cytomegalovirus viraemia 297.29 24.93 141 27037 10236 42583921
Adenovirus infection 276.26 24.93 118 27060 6691 42587466
Post transplant lymphoproliferative disorder 270.71 24.93 127 27051 8993 42585164
Posterior reversible encephalopathy syndrome 269.02 24.93 141 27037 12680 42581477
Febrile neutropenia 243.44 24.93 429 26749 185274 42408883
Epstein-Barr virus infection reactivation 238.84 24.93 82 27096 2545 42591612
Aplastic anaemia 220.12 24.93 122 27056 12262 42581895
Chronic graft versus host disease in skin 201.74 24.93 64 27114 1542 42592615
Acute graft versus host disease in liver 201.17 24.93 67 27111 1891 42592266
Fatigue 189.02 24.93 27 27151 435614 42158543
Bronchopulmonary aspergillosis 174.25 24.93 124 27054 19305 42574852
Cystitis viral 153.96 24.93 49 27129 1193 42592964
Off label use 150.50 24.93 800 26378 637535 41956622
Multiple organ dysfunction syndrome 139.69 24.93 234 26944 96801 42497356
Bacteraemia 138.20 24.93 120 27058 24920 42569237
Pancytopenia 134.94 24.93 257 26921 117486 42476671
Bone marrow failure 131.34 24.93 132 27046 32961 42561196
Engraftment syndrome 128.73 24.93 44 27134 1346 42592811
Chronic graft versus host disease in liver 127.66 24.93 37 27141 649 42593508
Engraft failure 124.46 24.93 35 27143 548 42593609
Respiratory failure 124.43 24.93 261 26917 127871 42466286
Human herpesvirus 6 encephalitis 123.41 24.93 35 27143 566 42593591
Herpes simplex 118.18 24.93 67 27111 7028 42587129
Dizziness 116.34 24.93 12 27166 249242 42344915
JC virus infection 115.06 24.93 50 27128 2954 42591203
Graft versus host disease in liver 106.86 24.93 40 27138 1599 42592558
Stomatitis 106.00 24.93 145 27033 50184 42543973
Pneumonia cytomegaloviral 105.84 24.93 52 27126 4074 42590083
Bone marrow transplant rejection 102.56 24.93 25 27153 215 42593942
Progressive multifocal leukoencephalopathy 101.97 24.93 73 27105 11463 42582694
Human herpesvirus 6 infection 99.89 24.93 43 27135 2482 42591675
Dyspnoea 99.63 24.93 82 27096 442539 42151618
Fall 98.11 24.93 16 27162 234504 42359653
Leukaemia recurrent 98.11 24.93 39 27139 1837 42592320
Arthralgia 98.05 24.93 9 27169 205229 42388928
Cytomegalovirus test positive 97.74 24.93 50 27128 4269 42589888
Death 93.42 24.93 98 27080 471087 42123070
Autoimmune haemolytic anaemia 92.96 24.93 53 27125 5618 42588539
Chronic graft versus host disease in intestine 90.74 24.93 26 27152 437 42593720
Short stature 87.54 24.93 25 27153 415 42593742
End stage renal disease 86.63 24.93 77 27101 16481 42577676
Skin toxicity 85.89 24.93 53 27125 6496 42587661
Human polyomavirus infection 85.68 24.93 32 27146 1271 42592886
Product dose omission issue 85.13 24.93 3 27175 154362 42439795
Acute myeloid leukaemia 83.23 24.93 86 27092 22170 42571987
Cerebral toxoplasmosis 80.61 24.93 35 27143 2063 42592094
Asthenia 77.97 24.93 41 27137 280752 42313405
Obliterative bronchiolitis 75.11 24.93 30 27148 1431 42592726
Epstein-Barr viraemia 74.52 24.93 34 27144 2255 42591902
Haematotoxicity 73.78 24.93 59 27119 10926 42583231
Pulmonary haemorrhage 71.87 24.93 59 27119 11338 42582819
Polyomavirus viraemia 70.74 24.93 32 27146 2080 42592077
Pruritus 70.29 24.93 17 27161 188754 42405403
Constipation 70.28 24.93 10 27168 162281 42431876
Autoimmune lymphoproliferative syndrome 69.77 24.93 18 27160 199 42593958
Weight decreased 69.53 24.93 23 27155 207925 42386232
Epstein-Barr virus associated lymphoproliferative disorder 69.33 24.93 33 27145 2410 42591747
Blood follicle stimulating hormone increased 69.20 24.93 18 27160 206 42593951
Idiopathic pneumonia syndrome 67.64 24.93 21 27157 470 42593687
Candida infection 67.62 24.93 76 27102 21534 42572623
Thrombocytopenia 64.52 24.93 266 26912 190013 42404144
Klebsiella infection 63.90 24.93 55 27123 11277 42582880
Haemophagocytic lymphohistiocytosis 63.82 24.93 68 27110 18154 42576003
Growth retardation 63.42 24.93 31 27147 2401 42591756
Mucormycosis 60.38 24.93 44 27134 7099 42587058
Lactobacillus infection 60.07 24.93 18 27160 356 42593801
Chronic graft versus host disease in eye 60.05 24.93 17 27161 273 42593884
Pain in extremity 59.21 24.93 12 27166 150592 42443565
Spinal instability 59.10 24.93 20 27158 593 42593564
Rash 57.72 24.93 55 27123 276899 42317258
Anxiety 57.11 24.93 5 27173 118555 42475602
Blood luteinising hormone increased 56.86 24.93 13 27165 82 42594075
Stenotrophomonas infection 56.40 24.93 33 27145 3671 42590486
Disseminated toxoplasmosis 56.40 24.93 16 27162 259 42593898
Human herpesvirus 6 infection reactivation 56.14 24.93 18 27160 449 42593708
Product administered to patient of inappropriate age 56.08 24.93 36 27142 4725 42589432
Aspergillus infection 55.29 24.93 59 27119 15778 42578379
Enterococcal bacteraemia 54.97 24.93 29 27149 2638 42591519
Malaise 54.52 24.93 34 27144 212122 42382035
Chronic graft versus host disease oral 54.20 24.93 17 27161 394 42593763
Blood pressure increased 49.91 24.93 4 27174 101924 42492233
Enterobacter sepsis 49.66 24.93 20 27158 975 42593182
Hepatic failure 49.63 24.93 88 27090 38012 42556145
Toxoplasmosis 49.59 24.93 23 27155 1584 42592573
Enterococcal infection 49.54 24.93 49 27129 11990 42582167
Glomerulonephritis minimal lesion 49.35 24.93 18 27160 668 42593489
Overdose 49.21 24.93 5 27173 105259 42488898
Chest pain 49.19 24.93 14 27164 139516 42454641
Retinopathy haemorrhagic 48.30 24.93 11 27167 68 42594089
Depression 47.87 24.93 7 27171 111356 42482801
Acute respiratory distress syndrome 47.83 24.93 76 27102 30032 42564125
Pyrexia 47.05 24.93 419 26759 393623 42200534
Myocardial infarction 46.46 24.93 11 27167 123998 42470159
Pain 46.07 24.93 53 27125 244795 42349362
Inappropriate antidiuretic hormone secretion 44.77 24.93 54 27124 16487 42577670
Complications of bone marrow transplant 44.53 24.93 13 27165 234 42593923
Clostridium difficile colitis 44.36 24.93 61 27117 21191 42572966
Myalgia 43.80 24.93 5 27173 96075 42498082
Dehydration 43.45 24.93 18 27160 141749 42452408
Insomnia 43.31 24.93 11 27167 118242 42475915
Somnolence 43.11 24.93 18 27160 141087 42453070
Osteopenia 42.76 24.93 34 27144 6244 42587913
Hypogammaglobulinaemia 42.75 24.93 45 27133 11846 42582311
Blood bilirubin increased 41.99 24.93 87 27091 42165 42551992
Sertoli-cell-only syndrome 41.64 24.93 9 27169 42 42594115
Graft complication 41.15 24.93 16 27162 710 42593447
Hypotension 41.09 24.93 63 27115 257568 42336589
Encephalitis 40.92 24.93 39 27139 9119 42585038
Serratia sepsis 40.59 24.93 11 27167 149 42594008
Hyperhidrosis 40.54 24.93 5 27173 90507 42503650
Cardiotoxicity 39.69 24.93 35 27143 7410 42586747
Gastrointestinal toxicity 39.40 24.93 27 27151 3952 42590205
Glomerulonephritis membranous 39.24 24.93 19 27159 1441 42592716
Hyperfibrinogenaemia 38.89 24.93 10 27168 109 42594048
Meningitis tuberculous 38.61 24.93 15 27163 664 42593493
Bacterial infection 38.39 24.93 66 27112 27813 42566344
Lymphadenopathy 38.33 24.93 73 27105 33292 42560865
Drug interaction 38.23 24.93 70 27108 266929 42327228
Cushingoid 38.16 24.93 25 27153 3397 42590760
Pseudomonal sepsis 37.80 24.93 27 27151 4222 42589935
Cerebrovascular accident 37.63 24.93 8 27170 97152 42497005
Pericardial effusion 37.33 24.93 67 27111 29208 42564949
Chloroma 37.32 24.93 14 27164 563 42593594
Pulmonary embolism 36.95 24.93 15 27163 119597 42474560
Abdominal discomfort 36.71 24.93 3 27175 75252 42518905
Post transplant distal limb syndrome 36.67 24.93 13 27165 444 42593713
Septic shock 36.56 24.93 135 27043 91537 42502620
Poikiloderma 36.52 24.93 12 27166 324 42593833
Graft versus host disease in eye 36.49 24.93 12 27166 325 42593832
Tooth development disorder 36.19 24.93 7 27171 16 42594141
Cytopenia 36.18 24.93 50 27128 17447 42576710
Back pain 36.01 24.93 23 27155 141753 42452404
Encephalitis cytomegalovirus 35.97 24.93 17 27161 1222 42592935
Gastrointestinal mucosal disorder 35.65 24.93 13 27165 482 42593675
Staphylococcal infection 35.65 24.93 76 27102 37567 42556590
Hepatic vein occlusion 35.15 24.93 11 27167 253 42593904
Condition aggravated 35.02 24.93 71 27107 260683 42333474
Ascites 34.98 24.93 97 27081 56581 42537576
Acute lymphocytic leukaemia recurrent 34.09 24.93 24 27154 3667 42590490
Reticulocytosis 33.76 24.93 11 27167 289 42593868
Pathogen resistance 33.67 24.93 39 27139 11411 42582746
Stem cell transplant 33.46 24.93 21 27157 2651 42591506
Urticaria 33.37 24.93 4 27174 74032 42520125
Rhinovirus infection 33.35 24.93 30 27148 6518 42587639
Oedema peripheral 33.31 24.93 23 27155 136053 42458104
Bone marrow transplant 33.30 24.93 16 27162 1193 42592964
Nausea 32.85 24.93 136 27042 396663 42197494
Guillain-Barre syndrome 32.58 24.93 31 27147 7232 42586925
Hyponatraemia 32.53 24.93 12 27166 101450 42492707
Diffuse alveolar damage 31.52 24.93 20 27158 2572 42591585
Varicella zoster virus infection 31.46 24.93 20 27158 2581 42591576
Eccrine squamous syringometaplasia 31.36 24.93 7 27171 39 42594118
Tooth hypoplasia 31.16 24.93 10 27168 250 42593907
Chronic myeloid leukaemia recurrent 31.16 24.93 10 27168 250 42593907
Haptoglobin decreased 30.65 24.93 13 27165 723 42593434
Candida sepsis 30.60 24.93 16 27162 1429 42592728
Hyperkalaemia 30.40 24.93 7 27171 80451 42513706
Nephropathy toxic 30.24 24.93 45 27133 16793 42577364
Sepsis 30.20 24.93 224 26954 199110 42395047
Adenomatous polyposis coli 30.18 24.93 9 27169 175 42593982
Renal tubular injury 30.16 24.93 17 27161 1762 42592395
Pneumonia fungal 30.04 24.93 33 27145 9113 42585044
Evans syndrome 29.89 24.93 11 27167 419 42593738
Staphylococcal bacteraemia 29.59 24.93 36 27142 11085 42583072
Cardiac failure congestive 29.40 24.93 9 27169 85593 42508564
Infection reactivation 29.39 24.93 18 27160 2176 42591981
Bradycardia 29.34 24.93 9 27169 85475 42508682
Rhabdomyolysis 29.06 24.93 7 27171 78012 42516145
Atrial fibrillation 28.70 24.93 28 27150 139565 42454592
Portal hypertension 28.55 24.93 24 27154 4763 42589394
Paraesthesia 28.54 24.93 6 27172 73453 42520704
Coombs direct test positive 28.36 24.93 10 27168 336 42593821
Device related bacteraemia 28.30 24.93 12 27166 667 42593490
Pseudomonas infection 27.81 24.93 42 27136 15881 42578276
Enamel anomaly 27.79 24.93 9 27169 232 42593925
Gait disturbance 27.59 24.93 14 27164 97986 42496171
Pneumocystis jirovecii pneumonia 27.58 24.93 54 27124 25127 42569030
Hypoglycaemia 27.56 24.93 3 27175 59851 42534306
Adenoviral haemorrhagic cystitis 27.39 24.93 11 27167 532 42593625
Stenotrophomonas bacteraemia 27.20 24.93 8 27170 148 42594009
Graft versus host disease in lung 27.18 24.93 12 27166 736 42593421
Transplant dysfunction 26.91 24.93 20 27158 3323 42590834
Transplantation complication 26.91 24.93 9 27169 257 42593900
Transplant rejection 26.86 24.93 38 27140 13550 42580607
Anti-platelet antibody positive 26.49 24.93 9 27169 270 42593887
Dysbiosis 26.39 24.93 12 27166 789 42593368
Refractoriness to platelet transfusion 26.38 24.93 7 27171 87 42594070
Platelet transfusion 25.55 24.93 15 27163 1679 42592478
Hypodontia 25.43 24.93 4 27174 0 42594157
Cytomegalovirus chorioretinitis 25.22 24.93 22 27156 4589 42589568
Cystitis 25.05 24.93 34 27144 11664 42582493

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
Venoocclusive liver disease 2477.20 26.07 671 44825 14536 110529267
Acute graft versus host disease 2365.91 26.07 625 44871 12256 110531547
Graft versus host disease 2180.36 26.07 636 44860 18170 110525633
Chronic graft versus host disease 1895.76 26.07 492 45004 8965 110534838
Mucosal inflammation 1878.69 26.07 874 44622 95267 110448536
Cytomegalovirus infection 1771.59 26.07 710 44786 53734 110490069
Acute graft versus host disease in skin 1678.96 26.07 459 45037 10281 110533522
Product use in unapproved indication 1624.72 26.07 1392 44104 445985 110097818
Cytomegalovirus infection reactivation 1346.55 26.07 437 45059 17896 110525907
Venoocclusive disease 1098.21 26.07 294 45202 6056 110537747
Cystitis haemorrhagic 1040.53 26.07 326 45170 11883 110531920
Graft versus host disease in skin 995.14 26.07 288 45208 7966 110535837
Graft versus host disease in gastrointestinal tract 928.08 26.07 278 45218 8690 110535113
Thrombotic microangiopathy 807.03 26.07 339 45157 28810 110514993
BK virus infection 792.82 26.07 270 45226 12836 110530967
Acute graft versus host disease in intestine 743.48 26.07 211 45285 5428 110538375
Viral haemorrhagic cystitis 681.57 26.07 177 45319 3222 110540581
Epstein-Barr virus infection 677.30 26.07 264 45232 18474 110525329
Cytomegalovirus viraemia 658.82 26.07 255 45241 17509 110526294
Acute myeloid leukaemia recurrent 635.81 26.07 183 45313 4956 110538847
Febrile neutropenia 563.84 26.07 672 44824 316095 110227708
Post transplant lymphoproliferative disorder 522.22 26.07 208 45288 15405 110528398
Adenovirus infection 510.17 26.07 186 45310 10808 110532995
Posterior reversible encephalopathy syndrome 500.91 26.07 255 45241 33606 110510197
Aplastic anaemia 476.71 26.07 222 45274 24086 110519717
Transplant failure 444.87 26.07 142 45354 5493 110538310
Chronic graft versus host disease in skin 395.43 26.07 109 45387 2510 110541293
Off label use 369.92 26.07 1399 44097 1498786 109045017
Acute graft versus host disease in liver 369.23 26.07 101 45395 2258 110541545
Herpes simplex 334.18 26.07 152 45344 15612 110528191
Multiple organ dysfunction syndrome 323.73 26.07 354 45142 151356 110392447
Bacteraemia 322.95 26.07 207 45289 42183 110501620
Epstein-Barr virus infection reactivation 302.26 26.07 98 45398 3986 110539817
Human herpesvirus 6 infection 300.33 26.07 110 45386 6471 110537332
Cystitis viral 287.05 26.07 75 45421 1398 110542405
Fatigue 262.95 26.07 87 45409 1215871 109327932
Pancytopenia 250.18 26.07 366 45130 209247 110334556
Ovarian failure 230.87 26.07 58 45438 918 110542885
Acute myeloid leukaemia 220.62 26.07 157 45339 37953 110505850
Bronchopulmonary aspergillosis 220.46 26.07 143 45353 29720 110514083
Thrombocytopenia 219.22 26.07 459 45037 348426 110195377
Respiratory failure 217.47 26.07 348 45148 214984 110328819
Dizziness 217.43 26.07 19 45477 698174 109845629
Bone marrow failure 216.42 26.07 184 45312 57664 110486139
Idiopathic pneumonia syndrome 211.25 26.07 53 45443 834 110542969
Arthralgia 204.72 26.07 37 45459 779595 109764208
JC virus infection 203.41 26.07 78 45418 5212 110538591
Leukaemia recurrent 199.09 26.07 67 45429 3064 110540739
Pulmonary haemorrhage 184.26 26.07 103 45393 16353 110527450
Engraftment syndrome 178.86 26.07 55 45441 1877 110541926
Human polyomavirus infection 178.34 26.07 54 45442 1748 110542055
Blood follicle stimulating hormone increased 173.38 26.07 39 45457 372 110543431
Acute lymphocytic leukaemia recurrent 172.50 26.07 71 45425 5716 110538087
Cytomegalovirus test positive 172.05 26.07 75 45421 6961 110536842
Fall 171.11 26.07 23 45473 603459 109940344
Engraft failure 170.36 26.07 44 45452 782 110543021
Premature menopause 169.53 26.07 46 45450 996 110542807
Joint swelling 167.22 26.07 3 45493 442842 110100961
Blood luteinising hormone increased 166.92 26.07 34 45462 191 110543612
Pain 165.42 26.07 94 45402 954861 109588942
Haemophagocytic lymphohistiocytosis 164.44 26.07 122 45374 31437 110512366
Ovarian atrophy 162.72 26.07 29 45467 66 110543737
Polyomavirus viraemia 161.97 26.07 59 45437 3415 110540388
Drug hypersensitivity 160.54 26.07 6 45490 454084 110089719
Bone marrow transplant rejection 159.58 26.07 35 45461 294 110543509
Progressive multifocal leukoencephalopathy 156.52 26.07 108 45388 24848 110518955
Chronic graft versus host disease in liver 156.10 26.07 42 45454 880 110542923
Toxoplasmosis 154.71 26.07 56 45440 3183 110540620
Pain in extremity 152.23 26.07 13 45483 487105 110056698
Peripheral swelling 151.47 26.07 3 45493 404031 110139772
Human herpesvirus 6 encephalitis 145.21 26.07 41 45455 1033 110542770
Abdominal discomfort 143.50 26.07 4 45492 393854 110149949
Chronic graft versus host disease in intestine 143.50 26.07 37 45459 653 110543150
Nasopharyngitis 140.11 26.07 5 45491 394356 110149447
Mucormycosis 139.76 26.07 74 45422 10554 110533249
Pruritus 139.38 26.07 34 45462 581526 109962277
Infusion related reaction 138.39 26.07 4 45492 381158 110162645
Pneumonia cytomegaloviral 134.70 26.07 63 45433 6891 110536912
Dyspnoea 133.24 26.07 156 45340 1106716 109437087
Epstein-Barr viraemia 131.29 26.07 51 45445 3528 110540275
Acute respiratory distress syndrome 130.83 26.07 134 45362 53064 110490739
Graft versus host disease in liver 130.51 26.07 46 45450 2419 110541384
Transplant dysfunction 126.82 26.07 64 45432 8264 110535539
Primary hypogonadism 123.94 26.07 27 45469 219 110543584
Cerebral toxoplasmosis 123.21 26.07 47 45449 3095 110540708
Bacterial sepsis 121.49 26.07 67 45429 10359 110533444
Staphylococcal infection 120.05 26.07 146 45350 69798 110474005
Swelling 119.54 26.07 6 45490 351035 110192768
Asthenia 118.89 26.07 68 45428 688931 109854872
Haematotoxicity 117.74 26.07 85 45411 20997 110522806
Septic shock 117.66 26.07 223 45273 157305 110386498
Pericardial effusion 117.53 26.07 131 45365 57086 110486717
Headache 116.50 26.07 115 45381 882262 109661541
Hypersensitivity 115.38 26.07 15 45481 403983 110139820
Autoimmune haemolytic anaemia 115.20 26.07 65 45431 10502 110533301
Cytomegalovirus chorioretinitis 115.10 26.07 57 45439 7071 110536732
Bronchiolitis obliterans syndrome 114.79 26.07 31 45465 659 110543144
Sepsis 114.71 26.07 345 45151 327001 110216802
Product dose omission issue 114.56 26.07 4 45492 321778 110222025
Epstein-Barr virus associated lymphoproliferative disorder 113.56 26.07 50 45446 4752 110539051
Product administered to patient of inappropriate age 111.49 26.07 58 45438 7978 110535825
Disseminated toxoplasmosis 111.10 26.07 28 45468 449 110543354
Urticaria 110.02 26.07 5 45491 318852 110224951
Rash 109.50 26.07 106 45390 820858 109722945
Aspergillus infection 109.37 26.07 88 45408 25528 110518275
Malaise 109.35 26.07 71 45425 671748 109872055
Anxiety 108.33 26.07 9 45487 345069 110198734
Renal tubular injury 102.48 26.07 41 45455 3067 110540736
Ascites 101.91 26.07 156 45340 92652 110451151
Graft versus host disease in lung 100.01 26.07 32 45464 1246 110542557
Obliterative bronchiolitis 98.63 26.07 42 45454 3681 110540122
End stage renal disease 98.61 26.07 77 45419 21396 110522407
Pulmonary veno-occlusive disease 98.36 26.07 36 45460 2112 110541691
Weight decreased 98.15 26.07 35 45461 468022 110075781
Varicella zoster virus infection 97.15 26.07 49 45447 6319 110537484
Drug resistance 95.64 26.07 117 45379 56257 110487546
Synovitis 95.54 26.07 4 45492 274088 110269715
Chronic graft versus host disease in eye 94.31 26.07 24 45472 401 110543402
Encephalitis cytomegalovirus 91.14 26.07 33 45463 1877 110541926
Pyrexia 90.93 26.07 656 44840 897609 109646194
Skin toxicity 90.83 26.07 58 45438 11725 110532078
Adenoviral hepatitis 90.26 26.07 28 45468 984 110542819
Depression 90.06 26.07 12 45484 317323 110226480
Staphylococcal sepsis 89.85 26.07 67 45429 17387 110526416
Neurotoxicity 89.03 26.07 98 45398 42109 110501694
Nausea 89.03 26.07 240 45256 1235450 109308353
Stem cell transplant 88.51 26.07 41 45455 4386 110539417
Neutropenia 88.34 26.07 346 45150 374274 110169529
Systemic candida 86.73 26.07 53 45443 9921 110533882
Lower respiratory tract infection 86.60 26.07 3 45493 243103 110300700
Chronic graft versus host disease oral 86.11 26.07 23 45473 468 110543335
Infection reactivation 85.37 26.07 39 45457 4042 110539761
Contraindicated product administered 85.28 26.07 4 45492 248263 110295540
Enterococcal bacteraemia 85.12 26.07 40 45456 4421 110539382
Insomnia 84.53 26.07 22 45474 360568 110183235
Asthma 82.95 26.07 5 45491 250286 110293517
Clostridium difficile colitis 82.73 26.07 96 45400 43682 110500121
Blood stem cell transplant failure 81.84 26.07 24 45472 694 110543109
Hepatic failure 81.82 26.07 120 45376 68619 110475184
Transplant rejection 81.49 26.07 73 45423 24494 110519309
Constipation 79.83 26.07 24 45472 357762 110186041
Complications of bone marrow transplant 79.45 26.07 23 45473 635 110543168
Chest pain 79.13 26.07 28 45468 376347 110167456
Human herpesvirus 6 infection reactivation 79.12 26.07 26 45470 1103 110542700
Neoplasm recurrence 79.06 26.07 40 45456 5192 110538611
Candida infection 78.79 26.07 98 45398 47911 110495892
Cytomegalovirus urinary tract infection 77.09 26.07 16 45480 100 110543703
Pneumonia fungal 76.76 26.07 57 45439 14697 110529106
Autoimmune lymphoproliferative syndrome 76.03 26.07 18 45478 219 110543584
Sinusitis 75.74 26.07 15 45481 296673 110247130
Systemic mycosis 75.12 26.07 35 45461 3794 110540009
Gastrointestinal toxicity 74.06 26.07 50 45446 11098 110532705
Hypoaesthesia 73.97 26.07 19 45477 314204 110229599
Somnolence 73.94 26.07 16 45480 297433 110246370
Retinitis viral 73.45 26.07 20 45476 439 110543364
Guillain-Barre syndrome 73.32 26.07 49 45447 10695 110533108
Myelodysplastic syndrome 72.17 26.07 83 45413 37401 110506402
Device related infection 71.91 26.07 85 45411 39434 110504369
Maternal exposure during pregnancy 71.46 26.07 10 45486 254873 110288930
Growth retardation 71.30 26.07 30 45466 2552 110541251
Blood pressure increased 70.44 26.07 11 45485 258362 110285441
Alopecia 70.33 26.07 31 45465 364722 110179081
Upper respiratory fungal infection 70.17 26.07 19 45477 408 110543395
Hepatomegaly 69.78 26.07 63 45433 21351 110522452
Gait disturbance 69.08 26.07 15 45481 278193 110265610
Demyelinating polyneuropathy 68.41 26.07 28 45468 2221 110541582
Back pain 67.73 26.07 34 45462 370962 110172841
Organising pneumonia 67.41 26.07 52 45444 14191 110529612
Syncope 67.25 26.07 4 45492 202532 110341271
Wheezing 67.07 26.07 12 45484 255218 110288585
Myalgia 66.57 26.07 7 45489 222374 110321429
Stenotrophomonas infection 66.48 26.07 37 45459 5821 110537982
Hepatic vein occlusion 65.51 26.07 17 45479 308 110543495
Confusional state 65.34 26.07 58 45438 468622 110075181
Muscle spasms 65.12 26.07 17 45479 278140 110265663
Memory impairment 65.05 26.07 4 45492 196940 110346863
Mucosal disorder 64.50 26.07 33 45463 4384 110539419
Candida sepsis 64.16 26.07 29 45467 2932 110540871
Tooth hypoplasia 63.92 26.07 17 45479 340 110543463
Abdominal pain upper 63.71 26.07 32 45464 349079 110194724
Immune thrombocytopenia 63.32 26.07 61 45435 22433 110521370
Seizure 62.76 26.07 217 45279 220968 110322835
Lactobacillus infection 62.00 26.07 18 45478 502 110543301
Myelitis 61.89 26.07 29 45467 3184 110540619
Cardiotoxicity 61.68 26.07 53 45443 16828 110526975
Fungal infection 60.90 26.07 89 45407 50717 110493086
Encephalitis 60.55 26.07 55 45441 18784 110525019
Condition aggravated 60.42 26.07 133 45363 734703 109809100
Injury 60.41 26.07 3 45493 177262 110366541
Cytopenia 60.20 26.07 68 45428 30048 110513755
Staphylococcal bacteraemia 60.18 26.07 52 45444 16636 110527167
Rhinovirus infection 60.11 26.07 45 45451 11744 110532059
Musculoskeletal pain 59.61 26.07 4 45492 183019 110360784
Blister 59.07 26.07 11 45485 227365 110316438
Enterococcal infection 58.79 26.07 56 45440 20310 110523493
Feeling abnormal 58.71 26.07 4 45492 180707 110363096
Hypotension 58.45 26.07 78 45418 523771 110020032
Dyspepsia 57.19 26.07 6 45490 190959 110352844
Arthritis 56.59 26.07 3 45493 167583 110376220
Capillary leak syndrome 55.70 26.07 31 45465 4877 110538926
Graft complication 55.67 26.07 20 45476 1112 110542691
General physical health deterioration 55.32 26.07 56 45440 425239 110118564
Sleep disorder 55.19 26.07 8 45488 198636 110345167
Renal failure 54.75 26.07 211 45285 226363 110317440
Pneumocystis jirovecii pneumonia 54.35 26.07 77 45419 42658 110501145
Pseudomonas infection 54.17 26.07 62 45434 27791 110516012
Paraesthesia 54.08 26.07 23 45473 276498 110267305
Dehydration 53.48 26.07 24 45472 279487 110264316
Overdose 53.38 26.07 15 45481 233779 110310024
Respiratory distress 53.24 26.07 99 45397 68775 110475028
Dysbiosis 53.02 26.07 23 45473 2109 110541694
Mobility decreased 52.80 26.07 16 45480 237406 110306397
Hyperbilirubinaemia 52.57 26.07 64 45432 30607 110513196
Pseudomonal sepsis 51.72 26.07 37 45459 9009 110534794
Bone marrow transplant 51.63 26.07 21 45475 1639 110542164
Recurrent cancer 51.23 26.07 26 45470 3397 110540406
Glomerulonephritis membranous 51.09 26.07 22 45474 1981 110541822
Hepatic necrosis 50.87 26.07 38 45458 9884 110533919
Graft versus host disease in eye 50.78 26.07 15 45481 445 110543358
Drug ineffective for unapproved indication 50.65 26.07 123 45373 102715 110441088
Gastrooesophageal reflux disease 50.58 26.07 7 45489 179969 110363834
Klebsiella infection 50.27 26.07 51 45445 19958 110523845
Stomatitis 50.00 26.07 232 45264 270010 110273793
Pulmonary hypertension 49.92 26.07 85 45411 55135 110488668
Migraine 49.87 26.07 6 45490 171646 110372157
Bronchitis 49.52 26.07 4 45492 157028 110386775
Chloroma 49.42 26.07 17 45479 831 110542972
Retinopathy haemorrhagic 49.37 26.07 11 45485 100 110543703
Chronic inflammatory demyelinating polyradiculoneuropathy 49.16 26.07 22 45474 2173 110541630
Glomerulonephritis minimal lesion 48.90 26.07 18 45478 1073 110542730
Drug effective for unapproved indication 48.78 26.07 43 45453 14124 110529679
Cerebrovascular accident 48.77 26.07 8 45488 181276 110362527
Laryngitis fungal 48.49 26.07 12 45484 178 110543625
Myocardial infarction 48.40 26.07 10 45486 192073 110351730
Folliculitis 48.36 26.07 6 45490 167647 110376156
Pathogen resistance 48.01 26.07 47 45449 17625 110526178
Aplasia pure red cell 47.59 26.07 36 45460 9542 110534261
Meningoencephalitis herpetic 47.26 26.07 22 45474 2380 110541423
Fungaemia 47.01 26.07 30 45466 6056 110537747
Disseminated mucormycosis 46.86 26.07 21 45475 2081 110541722
Nephropathy toxic 46.55 26.07 57 45439 27421 110516382
Pulmonary alveolar haemorrhage 46.37 26.07 49 45447 20101 110523702
Sertoli-cell-only syndrome 46.12 26.07 9 45487 39 110543764
Respiratory tract infection fungal 45.51 26.07 18 45478 1306 110542497
Encephalitis viral 45.47 26.07 23 45473 2984 110540819
Blood bilirubin increased 45.30 26.07 98 45398 75874 110467929
Transfusion 45.04 26.07 54 45442 25418 110518385
Adenoviral haemorrhagic cystitis 44.71 26.07 15 45481 679 110543124
Hyperhidrosis 44.69 26.07 11 45485 187287 110356516
Focal nodular hyperplasia 44.41 26.07 16 45480 897 110542906
Gait inability 44.35 26.07 3 45493 136373 110407430
Autoimmune thyroiditis 43.08 26.07 29 45467 6405 110537398
Hypogammaglobulinaemia 43 26.07 47 45449 20029 110523774
Drug intolerance 42.85 26.07 63 45433 406449 110137354
Blood glucose increased 42.84 26.07 3 45493 132493 110411310
Disease recurrence 42.83 26.07 84 45412 60700 110483103
Alternaria infection 42.80 26.07 16 45480 996 110542807
Gastroenteritis adenovirus 42.78 26.07 13 45483 426 110543377
Cardiac tamponade 42.33 26.07 36 45460 11271 110532532
Transplantation complication 42.04 26.07 13 45483 452 110543351
Myelosuppression 41.39 26.07 108 45388 94232 110449571
Poikiloderma 41.32 26.07 13 45483 479 110543324
Endocrine disorder 41.17 26.07 16 45480 1108 110542695
Post transplant distal limb syndrome 41.16 26.07 15 45481 869 110542934
Palpitations 40.72 26.07 8 45488 159204 110384599
Drug ineffective 40.55 26.07 862 44634 1519678 109024125
Bacterial infection 40.48 26.07 70 45426 45966 110497837
Dry mouth 40.11 26.07 16 45480 199932 110343871
Pericarditis 40.08 26.07 20 45476 219094 110324709
Microangiopathy 39.94 26.07 21 45475 2951 110540852
Ill-defined disorder 39.86 26.07 8 45488 156845 110386958
Acquired macroglossia 39.74 26.07 11 45485 257 110543546
Sweat gland tumour 39.35 26.07 13 45483 561 110543242
Serratia sepsis 39.31 26.07 11 45485 268 110543535
Hyperfibrinogenaemia 39.30 26.07 10 45486 167 110543636
Diffuse alveolar damage 39.06 26.07 23 45473 4024 110539779
Enterobacter sepsis 38.26 26.07 16 45480 1340 110542463
Leukoencephalopathy 38 26.07 31 45465 9164 110534639
Actinomycotic sepsis 37.60 26.07 10 45486 200 110543603
Gastritis fungal 37.48 26.07 11 45485 319 110543484
Colitis herpes 37.17 26.07 7 45489 24 110543779
Herpes zoster infection neurological 36.45 26.07 12 45484 512 110543291
Refractoriness to platelet transfusion 35.95 26.07 10 45486 238 110543565
Night sweats 35.84 26.07 6 45490 133977 110409826
Meningitis tuberculous 35.79 26.07 15 45481 1263 110542540
Eccrine squamous syringometaplasia 35.57 26.07 7 45489 32 110543771
Oedema peripheral 35.55 26.07 50 45446 328610 110215193
Bradycardia 35.45 26.07 10 45486 155507 110388296
Haematuria 35.37 26.07 94 45402 82911 110460892
Pneumonia klebsiella 35.35 26.07 26 45470 6606 110537197
Heart rate increased 35.19 26.07 8 45488 143826 110399977
Vomiting 35.17 26.07 225 45271 910450 109633353
Cough 35.12 26.07 87 45409 461554 110082249
Colitis erosive 34.54 26.07 10 45486 276 110543527
Cellulitis staphylococcal 34.44 26.07 15 45481 1388 110542415
Haptoglobin decreased 34.42 26.07 16 45480 1725 110542078
Reticulocytosis 34.10 26.07 12 45484 628 110543175
Disseminated intravascular coagulation 34.00 26.07 61 45435 41225 110502578
Hyponatraemia 33.99 26.07 24 45472 217629 110326174
Arteritis infective 33.98 26.07 9 45487 177 110543626
Hypoglycaemia 33.87 26.07 4 45492 116100 110427703
BK polyomavirus test positive 33.69 26.07 10 45486 302 110543501
Pneumatosis intestinalis 33.67 26.07 28 45468 8501 110535302
Pulmonary toxicity 33.66 26.07 39 45457 17707 110526096
Disease progression 33.63 26.07 193 45303 243841 110299962
Alpha haemolytic streptococcal infection 33.58 26.07 20 45476 3573 110540230
Lymphoproliferative disorder 33.39 26.07 26 45470 7192 110536611
Product administration error 33.26 26.07 57 45439 37160 110506643
Gastrointestinal inflammation 33.12 26.07 29 45467 9440 110534363
Pneumonia respiratory syncytial viral 32.95 26.07 18 45478 2731 110541072
Anti-platelet antibody positive 32.55 26.07 10 45486 340 110543463
Medication error 32.35 26.07 3 45493 105363 110438440
Coombs direct test positive 32.29 26.07 11 45485 522 110543281
Lymphadenopathy 32.12 26.07 77 45419 63758 110480045
Flushing 32.11 26.07 3 45493 104733 110439070
Weight increased 31.98 26.07 79 45417 419565 110124238
Muscular weakness 31.96 26.07 33 45463 248435 110295368
Haemorrhage urinary tract 31.84 26.07 18 45478 2918 110540885
Hypouricaemia 31.42 26.07 11 45485 567 110543236
Aplasia 31.40 26.07 26 45470 7847 110535956
Citrobacter bacteraemia 31.13 26.07 6 45490 24 110543779
Mesangioproliferative glomerulonephritis 31 26.07 9 45487 251 110543552
Klebsiella sepsis 30.91 26.07 20 45476 4133 110539670
Spinal cord disorder 30.88 26.07 16 45480 2182 110541621
Decreased appetite 30.76 26.07 97 45399 475749 110068054
Tooth development disorder 30.64 26.07 7 45489 72 110543731
Paraspinal abscess 30.62 26.07 10 45486 416 110543387
Road traffic accident 30.59 26.07 4 45492 107394 110436409
Pulmonary arterial hypertension 30.59 26.07 51 45445 32517 110511286
Blood bilirubin unconjugated increased 30.22 26.07 13 45483 1168 110542635
Hyperplasia 30.17 26.07 14 45482 1504 110542299
Neutropenic infection 30.16 26.07 18 45478 3227 110540576
Chest discomfort 30.13 26.07 17 45479 173831 110369972
Parenteral nutrition 30.11 26.07 12 45484 888 110542915
Delayed engraftment 29.97 26.07 9 45487 283 110543520
Amnesia 29.85 26.07 4 45492 105404 110438399
Angioedema 29.73 26.07 3 45493 98497 110445306
Hypothalamo-pituitary disorder 29.66 26.07 17 45479 2829 110540974
Roseolovirus test positive 29.64 26.07 9 45487 294 110543509
Reticulocyte count increased 29.41 26.07 14 45482 1592 110542211
Fat necrosis 29.34 26.07 12 45484 950 110542853
Chimerism 29.13 26.07 9 45487 312 110543491
Varicocele 29.12 26.07 6 45490 36 110543767
Cranial nerve disorder 29.05 26.07 13 45483 1284 110542519
Adenomatous polyposis coli 28.88 26.07 9 45487 321 110543482
Neutropenic colitis 28.81 26.07 25 45471 8040 110535763
Donor leukocyte infusion 27.73 26.07 6 45490 47 110543756
Venous haemorrhage 27.70 26.07 9 45487 368 110543435
Escherichia bacteraemia 27.55 26.07 27 45469 10137 110533666
Inappropriate schedule of product administration 27.39 26.07 26 45470 203611 110340192
Skin hyperpigmentation 27.19 26.07 25 45471 8671 110535132
Enamel anomaly 27.13 26.07 8 45488 236 110543567
Rhinocerebral mucormycosis 27.10 26.07 13 45483 1504 110542299
Platelet transfusion 27.01 26.07 16 45480 2830 110540973
Acanthamoeba infection 26.90 26.07 10 45486 613 110543190
Adverse event 26.72 26.07 6 45490 108803 110435000
Rash maculo-papular 26.66 26.07 79 45417 74143 110469660
Rotavirus infection 26.36 26.07 11 45485 916 110542887
Dry skin 26.31 26.07 6 45490 107647 110436156
Oxygen saturation decreased 26.28 26.07 16 45480 156966 110386837
Brain abscess 26.25 26.07 22 45474 6752 110537051
Pleural effusion 26.10 26.07 143 45353 177566 110366237

FDA Adverse Event Reporting System (Pediatric)

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
Paternal exposure timing unspecified 28.67 18.28 4 4 18 113927

Pharmacologic Action:

SourceCodeDescription
ATC L01AB01 ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
ANTINEOPLASTIC AGENTS
ALKYLATING AGENTS
Alkyl sulfonates
FDA MoA N0000000236 Alkylating Activity
FDA EPC N0000175558 Alkylating Drug
MeSH PA D000477 Alkylating Agents
MeSH PA D000970 Antineoplastic Agents
MeSH PA D007155 Immunologic Factors
MeSH PA D007166 Immunosuppressive Agents
MeSH PA D018906 Antineoplastic Agents, Alkylating
MeSH PA D019653 Myeloablative Agonists
CHEBI has role CHEBI:22333 alkylating agent
CHEBI has role CHEBI:35610 antineoplastic agent
CHEBI has role CHEBI:50249 anticoagulant
CHEBI has role CHEBI:50903 carcinogenic agent
CHEBI has role CHEBI:50905 teratogenic agent
CHEBI has role CHEBI:64946 anti-HIV agent
CHEBI has role CHEBI:67105 insect sterilant
CHEBI has role CHEBI:75835 anti-anaemic agent
CHEBI has role CHEBI:233423 antifibrotic agent

Related Drugs by ATC class:

L01AB Alkyl sulfonates 2 drugs
mannosulfantreosulfan

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

DiseaseRelationSNOMED_IDDOID
Allogeneic bone marrow transplantation indication 58390007
Malignant lymphoma indication 118600007 DOID:0060058
Neuroblastoma indication 432328008 DOID:769
Autologous hematopoietic stem-cell transplantation for Ewing's sarcoma family of tumors indication 709115004
Philadelphia Chromosome Positive Chronic Myelocytic Leukemia indication
Mycosis contraindication 3218000 DOID:1564
Fanconi's anemia contraindication 30575002 DOID:13636
Viral disease contraindication 34014006 DOID:934
Hyperuricemia contraindication 35885006 DOID:1920
Hypokalemia contraindication 43339004
Fibrosis of lung contraindication 51615001 DOID:3770
Portal vein obstruction contraindication 57348003
Hyperglycemia contraindication 80394007 DOID:4195
Epilepsy contraindication 84757009 DOID:1826
Bacterial infectious disease contraindication 87628006
Radiation oncology AND/OR radiotherapy contraindication 108290001
Hypomagnesemia contraindication 190855004
Anemia contraindication 271737000 DOID:2355
Pregnancy, function contraindication 289908002
Thrombocytopenic disorder contraindication 302215000 DOID:1588
Neutropenic disorder contraindication 303011007 DOID:1227
Breastfeeding (mother) contraindication 413712001
Severe Bone Marrow Depression contraindication




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

None

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
Matrix metalloproteinase-9 Enzyme IC50 5.28 DRUG MATRIX

External reference:

IDSource
4018773 VUID
N0000147076 NUI
D00248 KEGG_DRUG
1828 RXNORM
C0006463 UMLSCUI
CHEBI:28901 CHEBI
CHEMBL820 ChEMBL_ID
DB01008 DRUGBANK_ID
D002066 MESH_DESCRIPTOR_UI
2478 PUBCHEM_CID
7136 IUPHAR_LIGAND_ID
564 INN_ID
G1LN9045DK UNII
121305 MMSL
37850 MMSL
399931 MMSL
4309 MMSL
d00183 MMSL
2571007 SNOMEDCT_US
387138002 SNOMEDCT_US
4018773 VANDF
002638 NDDF

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
BUSULFAN HUMAN PRESCRIPTION DRUG LABEL 1 0409-1112 INJECTION, SOLUTION 6 mg INTRAVENOUS ANDA 28 sections
Busulfan HUMAN PRESCRIPTION DRUG LABEL 1 16729-351 INJECTION 6 mg INTRAVENOUS ANDA 27 sections
Busulfan HUMAN PRESCRIPTION DRUG LABEL 1 25021-241 INJECTION, SOLUTION, CONCENTRATE 6 mg INTRAVENOUS ANDA 27 sections
Busulfan HUMAN PRESCRIPTION DRUG LABEL 1 51817-170 INJECTION 6 mg INTRAVENOUS ANDA 28 sections
Busulfan Human Prescription Drug Label 1 55150-395 INJECTION, SOLUTION 6 mg INTRAVENOUS ANDA 27 sections
BUSULFEX HUMAN PRESCRIPTION DRUG LABEL 1 59148-070 INJECTION 6 mg INTRAVENOUS NDA 28 sections
Busulfan HUMAN PRESCRIPTION DRUG LABEL 1 70121-1244 INJECTION 6 mg INTRAVENOUS ANDA 27 sections
Busulfan HUMAN PRESCRIPTION DRUG LABEL 1 71288-116 INJECTION, SOLUTION 6 mg INTRAVENOUS ANDA 27 sections
Busulfan HUMAN PRESCRIPTION DRUG LABEL 1 71288-158 INJECTION, SOLUTION 6 mg INTRAVENOUS ANDA 28 sections
MYLERAN HUMAN PRESCRIPTION DRUG LABEL 1 80725-620 TABLET, FILM COATED 2 mg ORAL NDA 23 sections