melphalan 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
1678 148-82-3

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • melphalan hydrochloride
  • melphalan
  • alkeran
  • levofalan
  • levofolan
  • levopholan
  • melfalan
  • phenylalanine mustard
  • sarcoclorin
  • melphalan HCl
An alkylating nitrogen mustard that is used as an antineoplastic in the form of the levo isomer - MELPHALAN, the racemic mixture - MERPHALAN, and the dextro isomer - MEDPHALAN; toxic to bone marrow, but little vesicant action; potential carcinogen.
  • Molecular weight: 305.20
  • Formula: C13H18Cl2N2O2
  • CLOGP: -0.21
  • LIPINSKI: 0
  • HAC: 4
  • HDO: 2
  • TPSA: 66.56
  • ALOGS: -2.93
  • ROTB: 8
  • Status: OFP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

None

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 2 Bocci G, Oprea TI, Benet LZ
S (Water solubility) 0.01 mg/mL Bocci G, Oprea TI, Benet LZ
EoM (Fraction excreted unchanged in urine) 12 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 0.33 µM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 71 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 0.48 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 7 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.14 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 1 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
Jan. 17, 1964 FDA GLAXOSMITHKLINE

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
Mucosal inflammation 657.39 19.47 337 25024 46591 63417070
Acute graft versus host disease 608.46 19.47 170 25191 4258 63459403
Graft versus host disease 471.80 19.47 154 25207 6609 63457052
Venoocclusive liver disease 457.70 19.47 139 25222 4696 63458965
Myelodysplastic syndrome 436.41 19.47 185 25176 16569 63447092
Adenovirus infection 435.87 19.47 125 25236 3446 63460215
Thrombotic microangiopathy 426.40 19.47 160 25201 10401 63453260
Febrile neutropenia 419.79 19.47 360 25001 118089 63345572
Acute graft versus host disease in skin 321.40 19.47 98 25263 3354 63460307
Neutropenia 304.90 19.47 362 24999 174643 63289018
Cytomegalovirus infection 291.67 19.47 150 25211 20802 63442859
Chronic graft versus host disease 288.53 19.47 88 25273 3014 63460647
Cytomegalovirus infection reactivation 263.30 19.47 87 25274 3876 63459785
Thrombocytopenia 260.40 19.47 311 25050 150846 63312815
Acute myeloid leukaemia 248.06 19.47 126 25235 17021 63446640
Post transplant lymphoproliferative disorder 239.20 19.47 86 25275 4945 63458716
Pancytopenia 230.05 19.47 236 25125 96697 63366964
Acute graft versus host disease in intestine 207.95 19.47 60 25301 1689 63461972
Venoocclusive disease 202.61 19.47 61 25300 1997 63461664
Osteonecrosis 190.67 19.47 120 25241 24410 63439251
Plasma cell myeloma 189.08 19.47 138 25223 35767 63427894
Epstein-Barr virus infection 183.68 19.47 81 25280 7969 63455692
Sepsis 178.19 19.47 260 25101 152863 63310798
Graft versus host disease in skin 177.96 19.47 60 25301 2845 63460816
BK virus infection 167.03 19.47 59 25302 3220 63460441
Product use in unapproved indication 163.62 19.47 272 25089 178808 63284853
Graft versus host disease in gastrointestinal tract 160.09 19.47 57 25304 3184 63460477
Cystitis haemorrhagic 157.44 19.47 60 25301 4063 63459598
Viraemia 151.36 19.47 44 25317 1272 63462389
Bone marrow failure 143.92 19.47 108 25253 29182 63434479
Engraftment syndrome 140.35 19.47 34 25327 474 63463187
Haemophagocytic lymphohistiocytosis 139.00 19.47 73 25288 10554 63453107
Human herpesvirus 6 infection 138.50 19.47 50 25311 2907 63460754
Plasma cell myeloma recurrent 138.13 19.47 51 25310 3162 63460499
Headache 134.63 19.47 43 25318 633198 62830463
Cytomegalovirus viraemia 129.38 19.47 57 25304 5592 63458069
Arthralgia 127.79 19.47 35 25326 569675 62893986
Stem cell transplant 121.02 19.47 40 25321 1782 63461879
Osteonecrosis of jaw 114.53 19.47 102 25259 35021 63428640
Pain 108.26 19.47 83 25278 740545 62723116
Joint swelling 106.70 19.47 6 25355 327660 63136001
Neuropathy peripheral 105.49 19.47 174 25187 113493 63350168
Multiple organ dysfunction syndrome 102.83 19.47 120 25241 56632 63407029
Posterior reversible encephalopathy syndrome 101.23 19.47 71 25290 17274 63446387
Off label use 100.76 19.47 532 24829 673930 62789731
Mucosal disorder 99.06 19.47 36 25325 2133 63461528
Acute lymphocytic leukaemia 97.45 19.47 37 25324 2479 63461182
Fatigue 96.26 19.47 129 25232 887899 62575762
Retinal pigment epitheliopathy 95.69 19.47 22 25339 241 63463420
Abdominal discomfort 95.55 19.47 9 25352 320876 63142785
Malignant transformation 95.47 19.47 24 25337 393 63463268
Drug hypersensitivity 94.44 19.47 8 25353 310679 63152982
Septic shock 92.08 19.47 123 25238 66506 63397155
Engraft failure 88.46 19.47 22 25339 344 63463317
Progressive multifocal leukoencephalopathy 87.33 19.47 58 25303 12913 63450748
Pyrexia 87.19 19.47 395 24966 470083 62993578
Epstein-Barr viraemia 86.91 19.47 27 25334 983 63462678
Chronic graft versus host disease in skin 85.82 19.47 25 25336 728 63462933
Polyneuropathy 85.79 19.47 60 25301 14529 63449132
Second primary malignancy 85.55 19.47 48 25313 7905 63455756
Malaise 85.17 19.47 30 25331 415924 63047737
Prothrombin level increased 84.79 19.47 20 25341 247 63463414
Cytopenia 83.28 19.47 54 25307 11547 63452114
Varicella zoster virus infection 81.12 19.47 33 25328 2656 63461005
Epstein-Barr virus infection reactivation 80.04 19.47 24 25337 774 63462887
Vitreous haemorrhage 78.87 19.47 30 25331 2020 63461641
Alopecia 78.86 19.47 19 25342 337517 63126144
Enterococcal infection 78.05 19.47 45 25316 7803 63455858
Nasopharyngitis 76.02 19.47 7 25354 254250 63209411
Arthropathy 74.29 19.47 5 25356 234787 63228874
Viral haemorrhagic cystitis 73.81 19.47 23 25338 846 63462815
Disease progression 73.80 19.47 156 25205 122602 63341059
Premature menopause 73.37 19.47 23 25338 863 63462798
Renal failure 71.29 19.47 150 25211 117502 63346159
Cytomegalovirus test positive 70.88 19.47 31 25330 2987 63460674
Acute graft versus host disease in liver 70.86 19.47 21 25340 650 63463011
Encephalitis viral 68.99 19.47 26 25335 1706 63461955
Hypogammaglobulinaemia 68.43 19.47 40 25321 7115 63456546
Pneumonia fungal 67.17 19.47 36 25325 5419 63458242
Acute myeloid leukaemia recurrent 66.97 19.47 25 25336 1598 63462063
Aplasia 66.57 19.47 33 25328 4226 63459435
Bronchopulmonary aspergillosis 66.46 19.47 42 25319 8593 63455068
Peripheral swelling 66.10 19.47 13 25348 265929 63197732
Disturbance in social behaviour 65.58 19.47 32 25329 3961 63459700
Eye excision 65.54 19.47 12 25349 35 63463626
Dizziness 64.14 19.47 47 25314 429878 63033783
Iris atrophy 64.06 19.47 13 25348 74 63463587
Fall 63.75 19.47 39 25322 392295 63071366
Cardiac failure 62.76 19.47 121 25240 89021 63374640
Adenoviral hepatitis 62.47 19.47 17 25344 384 63463277
JC virus infection 61.29 19.47 25 25336 2026 63461635
Bone debridement 60.59 19.47 15 25346 230 63463431
Pericardial effusion 60.25 19.47 67 25294 29991 63433670
Pruritus 60.02 19.47 35 25326 361418 63102243
Infusion related reaction 58.95 19.47 13 25348 245508 63218153
Refractory cytopenia with multilineage dysplasia 57.17 19.47 13 25348 135 63463526
Chronic myelomonocytic leukaemia 55.75 19.47 15 25346 324 63463337
Disease recurrence 55.36 19.47 62 25299 27968 63435693
Tooth extraction 55.24 19.47 40 25321 10224 63453437
Product dose omission issue 55.06 19.47 13 25348 234300 63229361
Plasma cell myeloma refractory 54.90 19.47 15 25346 344 63463317
Hepatitis B reactivation 54.11 19.47 26 25335 3111 63460550
Nasal abscess 53.34 19.47 13 25348 186 63463475
Cardiomyopathy 53.24 19.47 49 25312 17535 63446126
Pneumococcal sepsis 53.11 19.47 17 25344 683 63462978
Wound 53.06 19.47 3 25358 163260 63300401
Choroidal infarction 52.62 19.47 11 25350 74 63463587
Febrile bone marrow aplasia 52.34 19.47 34 25327 7291 63456370
Pneumonia adenoviral 52.06 19.47 12 25349 133 63463528
Enterococcal sepsis 51.86 19.47 20 25341 1398 63462263
Bacterial sepsis 51.21 19.47 27 25334 3931 63459730
Cytomegalovirus chorioretinitis 50.67 19.47 21 25340 1772 63461889
Gastrointestinal fungal infection 50.64 19.47 14 25347 336 63463325
Idiopathic pneumonia syndrome 50.25 19.47 14 25347 346 63463315
Pain in extremity 49.71 19.47 36 25325 331450 63132211
Transplant failure 49.70 19.47 20 25341 1565 63462096
Epstein-Barr virus associated lymphoproliferative disorder 49.56 19.47 21 25340 1873 63461788
Plasmacytoma 49.47 19.47 23 25338 2556 63461105
Bacteraemia 48.03 19.47 46 25315 17302 63446359
Lymphopenia 47.75 19.47 47 25314 18280 63445381
Hypogonadism female 46.52 19.47 8 25353 14 63463647
Encephalopathy 45.41 19.47 66 25295 38554 63425107
Gastroenteritis adenovirus 45.15 19.47 12 25349 247 63463414
Plasma cell leukaemia 45.14 19.47 17 25344 1113 63462548
Chest pain 45.13 19.47 15 25346 215944 63247717
Mucocutaneous ulceration 44.53 19.47 11 25350 167 63463494
Sinus polyp 44.19 19.47 13 25348 392 63463269
Acute kidney injury 44.09 19.47 215 25146 263200 63200461
Hypersensitivity 43.59 19.47 32 25329 292653 63171008
Eyelid oedema 43.53 19.47 35 25326 10444 63453217
Klebsiella infection 42.98 19.47 32 25329 8534 63455127
Haematotoxicity 42.57 19.47 33 25328 9343 63454318
Diffuse large B-cell lymphoma recurrent 42.37 19.47 20 25341 2300 63461361
Extraocular muscle disorder 42.36 19.47 10 25351 124 63463537
Paranoia 42.25 19.47 36 25325 11643 63452018
Condition aggravated 41.77 19.47 60 25301 402157 63061504
Morganella infection 41.65 19.47 14 25347 657 63463004
Leukopenia 41.61 19.47 94 25267 77196 63386465
Leukaemia 41.50 19.47 24 25337 4184 63459477
Respiratory failure 41.19 19.47 111 25250 101747 63361914
Swelling 41.15 19.47 30 25331 275348 63188313
Dyspnoea 40.93 19.47 132 25229 661181 62802480
Therapy partial responder 40.92 19.47 34 25327 10624 63453037
Tonsillar haemorrhage 40.35 19.47 11 25350 250 63463411
Eyelid rash 40.23 19.47 10 25351 156 63463505
Contusion 40.18 19.47 6 25355 150038 63313623
Bone disorder 40.12 19.47 46 25315 21280 63442381
Meningitis pneumococcal 39.75 19.47 11 25350 265 63463396
Neutropenic colitis 39.72 19.47 21 25340 3074 63460587
Feeling abnormal 39.59 19.47 6 25355 148386 63315275
Urticaria 39.33 19.47 9 25352 165793 63297868
Anxiety 39.10 19.47 19 25342 217522 63246139
Hepatic enzyme increased 38.99 19.47 16 25345 202312 63261349
Herpes zoster 38.64 19.47 95 25266 82367 63381294
Jaw operation 38.38 19.47 14 25347 838 63462823
Osteolysis 38.31 19.47 20 25341 2854 63460807
Endocarditis bacterial 38.30 19.47 13 25348 629 63463032
Weight increased 38.20 19.47 29 25332 260763 63202898
Oesophagitis 38.19 19.47 38 25323 14970 63448691
Stomatitis 38.10 19.47 132 25229 138593 63325068
Acute respiratory distress syndrome 38.07 19.47 47 25314 23487 63440174
Cardiac failure acute 37.85 19.47 31 25330 9492 63454169
Retinal degeneration 37.80 19.47 14 25347 875 63462786
Pneumonia cytomegaloviral 37.13 19.47 18 25343 2196 63461465
Respiratory syncytial virus infection 36.97 19.47 27 25334 6991 63456670
Cerebral toxoplasmosis 36.50 19.47 14 25347 964 63462697
Ovarian failure 35.86 19.47 15 25346 1295 63462366
Blister 35.20 19.47 5 25356 129809 63333852
Sequestrectomy 35.09 19.47 13 25348 813 63462848
Heterochromia iridis 35.08 19.47 6 25355 10 63463651
Blood pressure increased 34.30 19.47 11 25350 162051 63301610
Infection 34.09 19.47 181 25180 228992 63234669
Pseudomembranous colitis 34.06 19.47 19 25342 3093 63460568
Mucosal erosion 33.75 19.47 15 25346 1501 63462160
Infection reactivation 33.74 19.47 14 25347 1185 63462476
Growth failure 33.16 19.47 10 25351 329 63463332
Depression 32.61 19.47 19 25342 196473 63267188
Overdose 32.24 19.47 4 25357 115074 63348587
Follicular thyroid cancer 32.21 19.47 7 25354 58 63463603
Gastrointestinal mucosal disorder 32.13 19.47 12 25349 768 63462893
Drug intolerance 32.06 19.47 46 25315 308615 63155046
Pulmonary haemorrhage 32.01 19.47 25 25336 7156 63456505
Treatment failure 31.98 19.47 20 25341 199023 63264638
Clostridium difficile colitis 31.55 19.47 40 25321 20529 63443132
Neuralgic amyotrophy 31.51 19.47 6 25355 23 63463638
Plastic surgery 30.59 19.47 7 25354 75 63463586
Adenoviral haemorrhagic cystitis 30.56 19.47 8 25353 155 63463506
Schistocytosis 30.39 19.47 6 25355 29 63463632
Gastrointestinal toxicity 30.35 19.47 25 25336 7716 63455945
Asthma 30.10 19.47 7 25354 127554 63336107
Complications of bone marrow transplant 29.92 19.47 10 25351 461 63463200
Infection in an immunocompromised host 29.26 19.47 11 25350 717 63462944
Chronic graft versus host disease in intestine 29.20 19.47 7 25354 93 63463568
Bronchospasm 28.74 19.47 35 25326 17245 63446416
Atrial fibrillation 28.63 19.47 107 25254 116529 63347132
Myelosuppression 28.58 19.47 41 25320 23662 63439999
B-cell type acute leukaemia 28.51 19.47 8 25353 203 63463458
Colitis 28.35 19.47 61 25300 48467 63415194
Arthritis 28.08 19.47 6 25355 115915 63347746
Weight decreased 28.01 19.47 42 25319 276756 63186905
Hepatitis B 27.99 19.47 18 25343 3794 63459867
Klebsiella sepsis 27.98 19.47 13 25348 1442 63462219
Peritonitis viral 27.79 19.47 6 25355 48 63463613
Insomnia 27.78 19.47 27 25334 215225 63248436
Abdominal pain upper 27.69 19.47 25 25336 206419 63257242
Escherichia bacteraemia 27.68 19.47 18 25343 3865 63459796
Abdominal compartment syndrome 27.67 19.47 10 25351 583 63463078
Eyelid ptosis 27.52 19.47 23 25338 7244 63456417
Rhinovirus infection 27.50 19.47 19 25342 4510 63459151
Aspergillus infection 27.35 19.47 24 25337 8069 63455592
Gait disturbance 27.29 19.47 20 25341 183158 63280503
Enophthalmos 27.16 19.47 6 25355 54 63463607
Febrile infection 27.14 19.47 13 25348 1544 63462117
Ventricular hypokinesia 27.07 19.47 19 25342 4625 63459036
Rash 26.89 19.47 124 25237 560747 62902914
Loss of consciousness 26.86 19.47 7 25354 118114 63345547
Acute promyelocytic leukaemia 26.68 19.47 11 25350 916 63462745
Platelet count decreased 26.42 19.47 104 25257 116018 63347643
Transplantation complication 26.29 19.47 7 25354 145 63463516
Klebsiella bacteraemia 26.22 19.47 13 25348 1665 63461996
Memory impairment 26.07 19.47 5 25356 104253 63359408
Blood stem cell transplant failure 26.03 19.47 7 25354 151 63463510
Drug interaction 25.97 19.47 32 25329 229099 63234562
Loss of personal independence in daily activities 25.79 19.47 4 25357 97286 63366375
Hepatic vein occlusion 25.75 19.47 6 25355 70 63463591
Abnormal behaviour 25.74 19.47 37 25324 21389 63442272
Endothelial dysfunction 25.72 19.47 7 25354 158 63463503
Fungal oesophagitis 25.46 19.47 10 25351 734 63462927
Encephalitis 25.44 19.47 24 25337 8856 63454805
Actinomycosis 25.36 19.47 11 25350 1039 63462622
Sinusitis 25.32 19.47 32 25329 226621 63237040
Retinal detachment 24.93 19.47 20 25341 5949 63457712
Hypoperfusion 24.82 19.47 12 25349 1455 63462206
Bone sequestrum 24.77 19.47 12 25349 1462 63462199
Toxic skin eruption 24.58 19.47 28 25333 12857 63450804
Nausea 24.55 19.47 221 25140 854250 62609411
Purulent discharge 24.55 19.47 18 25343 4688 63458973
Iris neovascularisation 24.41 19.47 5 25356 30 63463631
Graft versus host disease in lung 23.83 19.47 8 25353 374 63463287
Oral fungal infection 23.70 19.47 15 25346 3076 63460585
Oral disorder 23.61 19.47 23 25338 8831 63454830
Hyperhidrosis 23.38 19.47 7 25354 107829 63355832
Renal impairment 23.32 19.47 83 25278 88272 63375389
Ureaplasma infection 23.16 19.47 9 25352 642 63463019
Myalgia 23.15 19.47 15 25346 146514 63317147
Graft versus host disease in liver 23.08 19.47 9 25352 648 63463013
Human herpesvirus 6 encephalitis 22.93 19.47 7 25354 240 63463421
Pericarditis 22.87 19.47 12 25349 131567 63332094
Myocardial infarction 22.56 19.47 6 25355 99887 63363774
Acute lymphocytic leukaemia recurrent 22.53 19.47 13 25348 2256 63461405
Chronic myeloid leukaemia 22.27 19.47 13 25348 2305 63461356
Inappropriate schedule of product administration 22.09 19.47 7 25354 103958 63359703
Urethritis 21.87 19.47 7 25354 281 63463380
Fungaemia 21.84 19.47 13 25348 2390 63461271
Retinal depigmentation 21.76 19.47 7 25354 286 63463375
Toxicity to various agents 21.73 19.47 171 25190 247079 63216582
Osteomyelitis 21.67 19.47 38 25323 25982 63437679
Pleural effusion 21.62 19.47 84 25277 93126 63370535
Palpitations 21.58 19.47 9 25352 112761 63350900
Culture stool positive 21.55 19.47 7 25354 295 63463366
Pulmonary veno-occlusive disease 21.51 19.47 10 25351 1111 63462550
Escherichia infection 21.48 19.47 26 25335 12728 63450933
Aspartate aminotransferase increased 21.47 19.47 82 25279 90195 63373466
Clostridial sepsis 21.40 19.47 8 25353 513 63463148
Mobility decreased 21.13 19.47 11 25350 121148 63342513
Atrial rupture 21.10 19.47 5 25356 63 63463598
Oesophageal squamous cell carcinoma stage IV 21.08 19.47 4 25357 15 63463646
Acinetobacter infection 21.05 19.47 11 25350 1572 63462089
Osteoarthritis 21.02 19.47 6 25355 95337 63368324
Diarrhoea 20.89 19.47 401 24960 714965 62748696
Cerebral vasoconstriction 20.80 19.47 10 25351 1198 63462463
Gastrointestinal injury 20.68 19.47 8 25353 564 63463097
Primary hypogonadism 20.65 19.47 6 25355 173 63463488
Heart rate increased 20.65 19.47 6 25355 94232 63369429
Osteitis 20.50 19.47 14 25347 3260 63460401
Pneumonia 20.45 19.47 275 25086 456492 63007169
Ascites 20.22 19.47 48 25313 40680 63422981
Sleep disorder 20.21 19.47 4 25357 81562 63382099
Ischaemia 19.95 19.47 16 25345 4756 63458905
Leukaemia recurrent 19.83 19.47 10 25351 1328 63462333
Refractory cancer 19.82 19.47 5 25356 83 63463578
Dyspepsia 19.81 19.47 8 25353 102188 63361473
Lymphodepletion 19.68 19.47 4 25357 23 63463638
Muscle spasms 19.66 19.47 20 25341 156130 63307531
Parainfluenzae virus infection 19.63 19.47 12 25349 2315 63461346
Staphylococcal sepsis 19.61 19.47 20 25341 8108 63455553
Periorbital oedema 19.50 19.47 17 25344 5667 63457994

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 619.05 16.63 242 31036 7724 34917929
Acute graft versus host disease 614.98 16.63 228 31050 6275 34919378
Mucosal inflammation 606.42 16.63 396 30882 38226 34887427
Myelodysplastic syndrome 564.92 16.63 296 30982 18912 34906741
Acute myeloid leukaemia 435.45 16.63 245 31033 18025 34907628
Febrile neutropenia 371.68 16.63 530 30748 136319 34789334
Graft versus host disease 360.25 16.63 180 31098 10389 34915264
Acute graft versus host disease in skin 324.56 16.63 135 31143 5066 34920587
Chronic graft versus host disease 241.21 16.63 104 31174 4269 34921384
Thrombotic microangiopathy 217.09 16.63 129 31149 10501 34915152
Venoocclusive disease 215.22 16.63 85 31193 2782 34922871
Graft versus host disease in gastrointestinal tract 211.07 16.63 90 31188 3593 34922060
Adenovirus infection 210.53 16.63 100 31178 5157 34920496
Acute graft versus host disease in intestine 184.94 16.63 75 31203 2633 34923020
Second primary malignancy 183.02 16.63 104 31174 7782 34917871
Plasma cell myeloma 175.59 16.63 202 31076 41835 34883818
Graft versus host disease in skin 173.68 16.63 80 31198 3845 34921808
Cytomegalovirus infection 173.31 16.63 161 31117 25974 34899679
Epstein-Barr virus infection 170.06 16.63 98 31180 7530 34918123
Human herpesvirus 6 infection 164.31 16.63 64 31214 2017 34923636
Malignant transformation 164.23 16.63 51 31227 800 34924853
Off label use 153.16 16.63 759 30519 418765 34506888
Osteonecrosis 148.53 16.63 116 31162 14774 34910879
Post transplant lymphoproliferative disorder 130.09 16.63 78 31200 6450 34919203
Pancytopenia 129.63 16.63 272 31006 94885 34830768
Product use in unapproved indication 128.86 16.63 308 30970 117191 34808462
Neutropenia 128.03 16.63 368 30910 156410 34769243
Progressive multifocal leukoencephalopathy 121.80 16.63 87 31191 9677 34915976
Acute lymphocytic leukaemia 119.38 16.63 57 31221 2972 34922681
Thrombocytopenia 117.31 16.63 356 30922 155891 34769762
Engraftment syndrome 116.86 16.63 41 31237 956 34924697
Drug interaction 115.41 16.63 30 31248 225916 34699737
Polyneuropathy 112.96 16.63 99 31179 14797 34910856
Plasma cell myeloma recurrent 106.60 16.63 60 31218 4405 34921248
Multiple organ dysfunction syndrome 104.38 16.63 219 31059 76347 34849306
Stem cell transplant 102.20 16.63 46 31232 2093 34923560
Sepsis 101.97 16.63 354 30924 166207 34759446
Mucosal disorder 101.62 16.63 43 31235 1683 34923970
Retinal degeneration 99.89 16.63 31 31247 485 34925168
Cytomegalovirus viraemia 99.16 16.63 69 31209 7361 34918292
Retinal pigment epitheliopathy 95.21 16.63 25 31253 205 34925448
Tooth extraction 92.92 16.63 56 31222 4672 34920981
Acute graft versus host disease in liver 92.15 16.63 39 31239 1527 34924126
Therapy partial responder 91.76 16.63 73 31205 9543 34916110
Epstein-Barr viraemia 88.43 16.63 36 31242 1276 34924377
Aspergillus infection 88.05 16.63 79 31199 12175 34913478
Dizziness 87.77 16.63 43 31235 218478 34707175
Bronchopulmonary aspergillosis 87.05 16.63 85 31193 14574 34911079
Headache 86.01 16.63 36 31242 200599 34725054
Neuropathy peripheral 84.51 16.63 212 31066 83051 34842602
Fatigue 84.39 16.63 126 31152 370527 34555126
Haematotoxicity 84.23 16.63 65 31213 8129 34917524
Product dose omission issue 83.98 16.63 6 31272 119705 34805948
Bone disorder 83.60 16.63 58 31220 6157 34919496
Pyrexia 82.42 16.63 544 30734 332469 34593184
Cytopenia 81.65 16.63 77 31201 12646 34913007
Choroidal dystrophy 80.90 16.63 16 31262 26 34925627
Choroidal infarction 78.49 16.63 18 31260 77 34925576
Chronic graft versus host disease in skin 77.05 16.63 30 31248 944 34924709
Arthralgia 77.00 16.63 28 31250 170013 34755640
Stomatitis 75.46 16.63 136 31142 42378 34883275
Bacterial sepsis 75.36 16.63 51 31227 5199 34920454
Haemophagocytic lymphohistiocytosis 74.75 16.63 74 31204 12899 34912754
Basal cell carcinoma 74.60 16.63 90 31188 19568 34906085
Cytomegalovirus infection reactivation 74.14 16.63 50 31228 5068 34920585
Refractory anaemia with an excess of blasts 72.17 16.63 23 31255 394 34925259
Malaise 70.98 16.63 39 31239 185786 34739867
BK virus infection 68.97 16.63 50 31228 5688 34919965
Cystitis haemorrhagic 67.16 16.63 49 31229 5630 34920023
Neutropenic colitis 66.38 16.63 39 31239 3105 34922548
Dyspnoea 66.22 16.63 150 31128 376632 34549021
Fall 66.06 16.63 51 31227 202834 34722819
Engraft failure 64.72 16.63 22 31256 465 34925188
Blood stem cell transplant failure 63.77 16.63 21 31257 401 34925252
Epstein-Barr virus infection reactivation 63.32 16.63 27 31251 1077 34924576
Extraocular muscle disorder 60.77 16.63 17 31261 181 34925472
Disease progression 59.45 16.63 222 31056 107855 34817798
B precursor type acute leukaemia 59.38 16.63 17 31261 198 34925455
JC virus infection 59.11 16.63 32 31246 2176 34923477
Aplasia 57.48 16.63 41 31237 4547 34921106
Overdose 57.38 16.63 7 31271 91052 34834601
Septic shock 56.90 16.63 167 31111 71667 34853986
Weight decreased 55.26 16.63 46 31232 176255 34749398
Vitreous haemorrhage 54.25 16.63 31 31247 2342 34923311
Chest pain 53.85 16.63 23 31255 126739 34798914
Neutropenic sepsis 53.82 16.63 64 31214 13703 34911950
Sequestrectomy 53.53 16.63 16 31262 219 34925434
Parainfluenzae virus infection 51.72 16.63 32 31246 2798 34922855
Bacteraemia 51.24 16.63 75 31203 19642 34906011
Bone debridement 51.18 16.63 15 31263 191 34925462
Epstein-Barr virus associated lymphoproliferative disorder 48.53 16.63 27 31251 1937 34923716
Blood pressure increased 48.26 16.63 10 31268 88092 34837561
Debridement 48.23 16.63 21 31257 882 34924771
Peripheral swelling 47.94 16.63 6 31272 76535 34849118
Herpes zoster 47.51 16.63 99 31179 34300 34891353
Bacterial infection 47.40 16.63 67 31211 16996 34908657
Staphylococcal sepsis 47.40 16.63 51 31227 9793 34915860
Pneumonia cytomegaloviral 47.04 16.63 31 31247 3023 34922630
Bone sequestrum 46.30 16.63 18 31260 564 34925089
Bone marrow failure 46.16 16.63 89 31189 29164 34896489
Acute respiratory distress syndrome 45.96 16.63 83 31195 25886 34899767
Death 45.34 16.63 193 31085 397856 34527797
Transplant failure 45.09 16.63 32 31246 3521 34922132
Cytomegalovirus test positive 44.75 16.63 33 31245 3853 34921800
Transformation to acute myeloid leukaemia 44.62 16.63 19 31259 755 34924898
Drug hypersensitivity 44.40 16.63 9 31269 80520 34845133
Prothrombin level increased 44.39 16.63 13 31265 165 34925488
Juvenile melanoma benign 44.19 16.63 11 31267 71 34925582
Stenotrophomonas infection 44.09 16.63 26 31252 2084 34923569
Depression 43.89 16.63 16 31262 97082 34828571
Retinopathy proliferative 43.54 16.63 11 31267 76 34925577
Rhabdomyolysis 43.53 16.63 5 31273 68158 34857495
Posterior reversible encephalopathy syndrome 43.48 16.63 49 31229 9905 34915748
Cerebral toxoplasmosis 43.46 16.63 24 31254 1697 34923956
Idiopathic pneumonia syndrome 43.08 16.63 14 31264 256 34925397
Eyelid oedema 42.79 16.63 36 31242 5088 34920565
Human herpesvirus 6 encephalitis 42.74 16.63 15 31263 350 34925303
Anxiety 42.28 16.63 18 31260 99410 34826243
Gastrointestinal mucosal disorder 42.15 16.63 15 31263 365 34925288
Osteosarcoma 41.96 16.63 14 31264 279 34925374
Plasma cell myeloma refractory 41.87 16.63 17 31261 598 34925055
Hepatitis B 41.85 16.63 38 31240 5945 34919708
Somnolence 41.40 16.63 24 31254 111092 34814561
Pain 41.37 16.63 75 31203 204600 34721053
Apoptosis 41.00 16.63 15 31263 396 34925257
Hyperhidrosis 40.62 16.63 9 31269 75683 34849970
Condition aggravated 40.13 16.63 69 31209 192127 34733526
Cerebrovascular accident 40.01 16.63 13 31265 84798 34840855
Viral haemorrhagic cystitis 39.89 16.63 20 31258 1160 34924493
Asthenia 39.52 16.63 102 31176 245149 34680504
Myocardial infarction 38.65 16.63 31 31247 121054 34804599
Autoimmune haemolytic anaemia 38.40 16.63 32 31246 4464 34921189
Feeling abnormal 37.16 16.63 6 31272 63229 34862424
Ameloblastoma 36.87 16.63 10 31268 94 34925559
Squamous cell carcinoma of skin 36.75 16.63 47 31231 10834 34914819
Pneumonia 36.48 16.63 489 30789 362138 34563515
Myalgia 36.12 16.63 15 31263 84095 34841558
Meningomyelitis herpes 35.72 16.63 8 31270 30 34925623
Bone sarcoma 35.04 16.63 9 31269 67 34925586
Osteolysis 34.61 16.63 26 31252 3122 34922531
Hepatic infection fungal 34.54 16.63 11 31267 188 34925465
Keratopathy 34.45 16.63 15 31263 630 34925023
Pruritus 34.42 16.63 46 31232 141935 34783718
Refractory cytopenia with multilineage dysplasia 33.93 16.63 10 31268 130 34925523
Iris atrophy 33.05 16.63 9 31269 86 34925567
Plasmacytoma 33.04 16.63 27 31251 3664 34921989
Eyelid rash 32.78 16.63 8 31270 47 34925606
Joint swelling 32.37 16.63 7 31271 59883 34865770
Chorioretinal disorder 32.09 16.63 8 31270 52 34925601
Metastases to retroperitoneum 31.82 16.63 11 31267 245 34925408
Infection 31.74 16.63 163 31115 90752 34834901
Actinomycosis 31.74 16.63 13 31265 468 34925185
Eye excision 31.31 16.63 7 31271 26 34925627
Lymphopenia 31.21 16.63 54 31224 16281 34909372
Autoimmune neutropenia 30.82 16.63 11 31267 270 34925383
Systemic candida 30.75 16.63 26 31252 3700 34921953
Meningoencephalitis herpetic 30.74 16.63 15 31263 820 34924833
Pain in extremity 30.64 16.63 41 31237 126472 34799181
Enteritis 30.43 16.63 37 31241 8105 34917548
Gastrointestinal wall thickening 30.10 16.63 18 31260 1480 34924173
Bone marrow transplant rejection 30.08 16.63 10 31268 197 34925456
Candida sepsis 30.02 16.63 17 31261 1262 34924391
Bradycardia 29.97 16.63 15 31263 75403 34850250
Graft versus host disease in liver 29.96 16.63 17 31261 1267 34924386
B-cell type acute leukaemia 29.22 16.63 11 31267 315 34925338
Nasopharyngitis 29.21 16.63 13 31265 69955 34855698
Metastases to muscle 28.42 16.63 10 31268 235 34925418
Musculoskeletal stiffness 28.41 16.63 4 31274 46676 34878977
Metapneumovirus infection 28.20 16.63 14 31264 795 34924858
Hospitalisation 28.14 16.63 8 31270 56894 34868759
Short stature 28.12 16.63 8 31270 91 34925562
Osteomyelitis 27.82 16.63 51 31227 16085 34909568
Carbamoyl phosphate synthetase deficiency 27.82 16.63 6 31272 18 34925635
Hepatitis B reactivation 27.77 16.63 25 31253 3866 34921787
Asthma 27.56 16.63 3 31275 42653 34883000
Coronary artery disease 27.46 16.63 5 31273 48300 34877353
Myelosuppression 27.24 16.63 56 31222 19209 34906444
Myositis 27.23 16.63 43 31235 12027 34913626
Hepatic vein occlusion 27.08 16.63 9 31269 177 34925476
Febrile bone marrow aplasia 27.00 16.63 35 31243 8174 34917479
Urticaria 26.98 16.63 11 31267 62366 34863287
Blood glucose increased 26.92 16.63 13 31265 66705 34858948
Insomnia 26.90 16.63 32 31246 103875 34821778
Pneumonia respiratory syncytial viral 26.45 16.63 14 31264 909 34924744
Hypoglycaemia 26.44 16.63 8 31270 54632 34871021
Chest discomfort 26.35 16.63 8 31270 54522 34871131
Staphylococcal bacteraemia 26.20 16.63 35 31243 8417 34917236
Balance disorder 25.91 16.63 3 31275 40651 34885002
Human herpesvirus 8 infection 25.73 16.63 14 31264 961 34924692
Inflammatory myofibroblastic tumour 25.55 16.63 8 31270 129 34925524
Hypogammaglobulinaemia 25.46 16.63 33 31245 7707 34917946
Viraemia 25.20 16.63 15 31263 1223 34924430
Neoplasm skin 25.09 16.63 13 31265 808 34924845
Hyperbilirubinaemia 25.05 16.63 50 31228 16793 34908860
Obliterative bronchiolitis 25.03 16.63 15 31263 1238 34924415
Atrophy of globe 24.92 16.63 6 31272 33 34925620
Stenotrophomonas bacteraemia 24.73 16.63 7 31271 78 34925575
Product use issue 24.66 16.63 117 31161 63099 34862554
Adenocarcinoma of colon 24.63 16.63 22 31256 3369 34922284
Acute lymphocytic leukaemia recurrent 24.62 16.63 21 31257 3023 34922630
Premature ageing 24.57 16.63 7 31271 80 34925573
Injection site pain 24.56 16.63 3 31275 39002 34886651
Gait disturbance 24.50 16.63 24 31254 85116 34840537
Pneumonia fungal 24.50 16.63 31 31247 7069 34918584
Ureaplasma infection 24.39 16.63 10 31268 361 34925292
Leukaemia 24.21 16.63 25 31253 4578 34921075
Tremor 24.09 16.63 23 31255 82564 34843089
Chronic graft versus host disease in intestine 24.03 16.63 9 31269 254 34925399
Electrocardiogram QT prolonged 23.80 16.63 4 31274 40948 34884705
Blood lactate dehydrogenase increased 23.76 16.63 59 31219 22931 34902722
Purulent discharge 23.67 16.63 20 31258 2843 34922810
Vision blurred 23.60 16.63 6 31272 45957 34879696
Cystitis viral 23.58 16.63 11 31267 544 34925109
Respiratory failure 23.50 16.63 172 31106 108400 34817253
Fungaemia 23.44 16.63 19 31259 2549 34923104
Back pain 23.36 16.63 46 31232 121743 34803910
Haemolytic uraemic syndrome 23.20 16.63 18 31260 2268 34923385
Lymphocytic leukaemia 23.15 16.63 8 31270 178 34925475
Bone lesion 23.07 16.63 20 31258 2943 34922710
Neurological decompensation 23.05 16.63 20 31258 2946 34922707
Peritoneal lesion 22.83 16.63 7 31271 105 34925548
Klebsiella sepsis 22.79 16.63 17 31261 2020 34923633
Constipation 22.77 16.63 56 31222 136926 34788727
Blood creatine phosphokinase increased 22.75 16.63 6 31272 44851 34880802
Neurotoxicity 22.75 16.63 50 31228 17960 34907693
Mycobacterial infection 22.59 16.63 18 31260 2356 34923297
B-cell lymphoma recurrent 22.49 16.63 12 31266 792 34924861
Gastrointestinal toxicity 22.49 16.63 19 31259 2700 34922953
Iris neovascularisation 22.49 16.63 5 31273 18 34925635
Gingival erythema 22.47 16.63 7 31271 111 34925542
Delayed engraftment 22.35 16.63 7 31271 113 34925540
Jaw operation 22.35 16.63 8 31270 198 34925455
Gastrointestinal injury 22.30 16.63 10 31268 451 34925202
Enterococcal infection 22.17 16.63 34 31244 9272 34916381
Abdominal discomfort 22.16 16.63 13 31265 59822 34865831
Metastases to spleen 22.13 16.63 10 31268 459 34925194
Blood bilirubin increased 22.13 16.63 80 31198 38216 34887437
Device related infection 21.94 16.63 48 31230 17189 34908464
Myelitis 21.91 16.63 12 31266 835 34924818
Laryngeal cancer metastatic 21.88 16.63 6 31272 59 34925594
Expanded disability status scale score increased 21.87 16.63 9 31269 328 34925325
Muscle spasms 21.74 16.63 21 31257 74980 34850673
Confusional state 21.64 16.63 62 31216 144098 34781555
Heterochromia iridis 21.31 16.63 4 31274 4 34925649
Neoplasm recurrence 21.29 16.63 17 31261 2232 34923421
Cytogenetic abnormality 21.29 16.63 12 31266 883 34924770
Capillary leak syndrome 21.23 16.63 17 31261 2241 34923412
Complications of bone marrow transplant 21.13 16.63 8 31270 233 34925420
Disease recurrence 21.01 16.63 54 31224 21436 34904217
Pulmonary haemorrhage 20.92 16.63 35 31243 10269 34915384
Metastases to bone marrow 20.82 16.63 10 31268 528 34925125
Neuromuscular toxicity 20.72 16.63 6 31272 73 34925580
Tooth impacted 20.72 16.63 6 31272 73 34925580
Hyperbaric oxygen therapy 20.69 16.63 5 31273 28 34925625
Agitation 20.52 16.63 13 31265 57386 34868267
Inflammatory pseudotumour 20.40 16.63 5 31273 30 34925623
Heart rate increased 20.32 16.63 8 31270 46335 34879318
Respiratory syncytial virus infection 20.26 16.63 23 31255 4686 34920967
Adenocarcinoma gastric 20.17 16.63 13 31265 1220 34924433
Pulmonary alveolar haemorrhage 20.13 16.63 29 31249 7483 34918170
Exophthalmos 20.06 16.63 10 31268 573 34925080
Monoclonal immunoglobulin increased 19.92 16.63 7 31271 164 34925489
Pneumocystis jirovecii pneumonia 19.76 16.63 50 31228 19660 34905993
Genotoxicity 19.61 16.63 5 31273 36 34925617
Abdominal pain upper 19.61 16.63 21 31257 71469 34854184
Retinal toxicity 19.56 16.63 9 31269 431 34925222
Hyperkalaemia 19.46 16.63 20 31258 69369 34856284
Enterococcal bacteraemia 19.39 16.63 15 31263 1882 34923771
Gastrooesophageal reflux disease 19.37 16.63 5 31273 37919 34887734
Flushing 19.21 16.63 3 31275 32417 34893236
Cardiac failure congestive 19.14 16.63 28 31250 83242 34842411
Palpitations 19.08 16.63 6 31272 39980 34885673
Transplantation associated food allergy 19.04 16.63 5 31273 41 34925612
Pneumonia mycoplasmal 18.89 16.63 10 31268 650 34925003
Herpes zoster meningoencephalitis 18.86 16.63 8 31270 315 34925338
Autoimmune pancytopenia 18.71 16.63 6 31272 105 34925548
Heart rate decreased 18.67 16.63 3 31275 31742 34893911
Colitis 18.63 16.63 75 31203 37675 34887978
Mycobacterium kansasii infection 18.62 16.63 8 31270 325 34925328
Metastases to chest wall 18.61 16.63 7 31271 200 34925453
Activated partial thromboplastin time shortened 18.58 16.63 9 31269 484 34925169
Osteonecrosis of jaw 18.58 16.63 46 31232 17843 34907810
VIth nerve paresis 18.53 16.63 5 31273 46 34925607
Dyspepsia 18.46 16.63 5 31273 36727 34888926
Fusarium infection 18.41 16.63 12 31266 1148 34924505
Drug resistance 18.37 16.63 58 31220 25869 34899784
Autologous haematopoietic stem cell transplant 18.16 16.63 5 31273 50 34925603
Retinal artery stenosis 18.06 16.63 3 31275 0 34925653
International normalised ratio increased 17.93 16.63 10 31268 47317 34878336
Amyloidosis 17.90 16.63 15 31263 2108 34923545
Adenosquamous cell lung cancer 17.86 16.63 4 31274 15 34925638
Varicella zoster virus infection 17.85 16.63 14 31264 1792 34923861
Acute myeloid leukaemia recurrent 17.61 16.63 15 31263 2155 34923498
Spirochaetal infection 17.46 16.63 4 31274 17 34925636
Hepatic failure 17.36 16.63 69 31209 34462 34891191
Bronchospasm 17.35 16.63 33 31245 10698 34914955
Blindness cortical 17.35 16.63 8 31270 385 34925268
Retinal haemorrhage 17.21 16.63 22 31256 5067 34920586
Meningitis bacterial 17.11 16.63 12 31266 1295 34924358
Cardiac arrest 17.02 16.63 38 31240 96121 34829532
Leukaemia recurrent 17.01 16.63 13 31265 1602 34924051
Dysarthria 16.99 16.63 5 31273 34777 34890876
Loss of consciousness 16.93 16.63 30 31248 82637 34843016
Blast crisis in myelogenous leukaemia 16.86 16.63 9 31269 595 34925058
Medulloblastoma recurrent 16.82 16.63 5 31273 67 34925586
Wheezing 16.80 16.63 8 31270 41394 34884259
Intentional product misuse 16.76 16.63 10 31268 45601 34880052
Device related bacteraemia 16.73 16.63 8 31270 418 34925235
Hepatic enzyme increased 16.72 16.63 7 31271 39073 34886580

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
Acute graft versus host disease 1106.06 16.62 360 48763 9807 79685458
Venoocclusive liver disease 1038.68 16.62 356 48767 11415 79683850
Mucosal inflammation 1019.54 16.62 614 48509 74966 79620299
Myelodysplastic syndrome 914.26 16.62 422 48701 29879 79665386
Graft versus host disease 774.64 16.62 306 48817 14720 79680545
Acute graft versus host disease in skin 622.83 16.62 218 48905 7440 79687825
Acute myeloid leukaemia 611.67 16.62 323 48800 30562 79664703
Febrile neutropenia 599.62 16.62 724 48399 230275 79464990
Thrombotic microangiopathy 559.00 16.62 265 48858 19904 79675361
Adenovirus infection 539.05 16.62 201 48922 8246 79687019
Chronic graft versus host disease 520.80 16.62 185 48938 6596 79688669
Cytomegalovirus infection 426.21 16.62 287 48836 42357 79652908
Acute graft versus host disease in intestine 398.78 16.62 133 48990 3908 79691357
Neutropenia 366.38 16.62 644 48479 287066 79408199
Post transplant lymphoproliferative disorder 343.45 16.62 159 48964 11305 79683960
Graft versus host disease in gastrointestinal tract 315.46 16.62 126 48997 6230 79689035
Venoocclusive disease 314.51 16.62 115 49008 4458 79690807
Epstein-Barr virus infection 308.84 16.62 159 48964 14257 79681008
Thrombocytopenia 306.01 16.62 569 48554 264690 79430575
Plasma cell myeloma 305.33 16.62 257 48866 53002 79642263
Product use in unapproved indication 302.61 16.62 548 48575 249811 79445454
Pancytopenia 290.02 16.62 429 48694 165316 79529949
Off label use 288.74 16.62 1211 47912 906004 78789261
Graft versus host disease in skin 272.57 16.62 112 49011 5961 79689304
Plasma cell myeloma recurrent 272.25 16.62 106 49017 4895 79690370
Human herpesvirus 6 infection 268.40 16.62 107 49016 5263 79690002
Osteonecrosis 260.82 16.62 188 48935 30907 79664358
Second primary malignancy 252.99 16.62 139 48984 14211 79681054
Malignant transformation 243.77 16.62 69 49054 1149 79694116
Cytomegalovirus infection reactivation 233.72 16.62 112 49011 8604 79686661
Arthralgia 217.68 16.62 44 49079 571759 79123506
Vitreous haemorrhage 217.45 16.62 83 49040 3630 79691635
BK virus infection 214.64 16.62 106 49017 8698 79686567
Engraftment syndrome 212.14 16.62 64 49059 1345 79693920
Headache 209.63 16.62 71 49052 653701 79041564
Cystitis haemorrhagic 207.59 16.62 105 49018 9067 79686198
Acute lymphocytic leukaemia 190.74 16.62 82 49041 4887 79690378
Sepsis 190.36 16.62 474 48649 268954 79426311
Neuropathy peripheral 188.14 16.62 323 48800 140982 79554283
Retinal pigment epitheliopathy 187.06 16.62 46 49077 428 79694837
Multiple organ dysfunction syndrome 183.10 16.62 292 48831 119954 79575311
Stem cell transplant 178.86 16.62 72 49051 3632 79691633
Cytopenia 170.36 16.62 123 49000 20260 79675005
Fatigue 168.01 16.62 196 48927 929531 78765734
Progressive multifocal leukoencephalopathy 166.93 16.62 122 49001 20478 79674787
Acute graft versus host disease in liver 164.67 16.62 57 49066 1878 79693387
Polyneuropathy 162.49 16.62 128 48995 24023 79671242
Malaise 157.21 16.62 53 49070 489816 79205449
Mucosal disorder 151.33 16.62 63 49060 3465 79691800
Pain 149.13 16.62 129 48994 703673 78991592
Chronic graft versus host disease in skin 148.14 16.62 50 49073 1524 79693741
Cytomegalovirus viraemia 146.78 16.62 94 49029 12727 79682538
Dizziness 144.58 16.62 72 49051 526369 79168896
Joint swelling 142.25 16.62 9 49114 288637 79406628
Bone marrow failure 138.33 16.62 164 48959 50943 79644322
Therapy partial responder 136.38 16.62 101 49022 17296 79677969
Drug hypersensitivity 134.36 16.62 14 49109 298902 79396363
Retinal degeneration 134.24 16.62 44 49079 1222 79694043
Haemophagocytic lymphohistiocytosis 132.60 16.62 109 49014 21728 79673537
Choroidal infarction 131.92 16.62 29 49094 155 79695110
Bronchopulmonary aspergillosis 128.55 16.62 108 49015 22186 79673079
Fall 126.07 16.62 72 49051 487557 79207708
Prothrombin level increased 124.80 16.62 33 49090 420 79694845
Bacterial sepsis 124.42 16.62 72 49051 8126 79687139
Septic shock 123.61 16.62 249 48874 122552 79572713
Aplasia 122.20 16.62 70 49053 7750 79687515
Pyrexia 122.08 16.62 774 48349 677935 79017330
Epstein-Barr virus infection reactivation 120.59 16.62 45 49078 1847 79693418
Posterior reversible encephalopathy syndrome 118.98 16.62 111 49012 26170 79669095
Engraft failure 118.69 16.62 35 49088 678 79694587
Tooth extraction 117 16.62 77 49046 10918 79684347
Plasma cell myeloma refractory 111.92 16.62 33 49090 639 79694626
Peripheral swelling 110.56 16.62 17 49106 269600 79425665
Drug interaction 107.71 16.62 61 49062 415122 79280143
Varicella zoster virus infection 106.85 16.62 53 49070 4388 79690877
Extraocular muscle disorder 105.87 16.62 27 49096 295 79694970
Bone debridement 105.83 16.62 29 49094 426 79694839
Dyspnoea 105.25 16.62 233 48890 856792 78838473
Bacteraemia 105.21 16.62 115 49008 32709 79662556
Disease progression 104.36 16.62 299 48824 184063 79511202
Viral haemorrhagic cystitis 102.76 16.62 41 49082 2020 79693245
Idiopathic pneumonia syndrome 102.47 16.62 30 49093 566 79694699
Abdominal discomfort 102.37 16.62 16 49107 250711 79444554
Nasopharyngitis 101.87 16.62 17 49106 253864 79441401
Choroidal dystrophy 100.95 16.62 19 49104 37 79695228
Product dose omission issue 100.60 16.62 16 49107 247521 79447744
Aspergillus infection 98.65 16.62 87 49036 19074 79676191
Epstein-Barr viraemia 96.68 16.62 40 49083 2165 79693100
Haematotoxicity 95.34 16.62 78 49045 15441 79679824
Pruritus 94.02 16.62 64 49059 394584 79300681
JC virus infection 92.43 16.62 46 49077 3835 79691430
Alopecia 91.69 16.62 16 49107 231339 79463926
Chest pain 91.39 16.62 30 49093 282274 79412991
Epstein-Barr virus associated lymphoproliferative disorder 90.49 16.62 44 49079 3488 79691777
Osteonecrosis of jaw 90.41 16.62 122 49001 43104 79652161
Pain in extremity 88.33 16.62 58 49065 364480 79330785
Overdose 87.09 16.62 7 49116 184199 79511066
Eye excision 85.56 16.62 18 49105 75 79695190
Basal cell carcinoma 83.58 16.62 109 49014 37266 79657999
Viraemia 83.45 16.62 39 49084 2830 79692435
Arthropathy 82.98 16.62 7 49116 177104 79518161
Refractory anaemia with an excess of blasts 82.20 16.62 28 49095 878 79694387
Transplant failure 81.91 16.62 45 49078 4596 79690669
Neutropenic colitis 81.01 16.62 48 49075 5659 79689606
Pneumonia cytomegaloviral 79.04 16.62 45 49078 4924 79690341
Atrophy of globe 78.94 16.62 16 49107 53 79695212
Condition aggravated 76.63 16.62 119 49004 501005 79194260
Cytomegalovirus test positive 76.62 16.62 47 49076 5900 79689365
Weight decreased 76.37 16.62 64 49059 355134 79340131
Eyelid oedema 76.22 16.62 65 49058 13622 79681643
Refractory cytopenia with multilineage dysplasia 75.89 16.62 20 49103 251 79695014
Hepatitis B reactivation 75.46 16.62 47 49076 6061 79689204
Blood stem cell transplant failure 74.98 16.62 23 49100 512 79694753
Anxiety 74.35 16.62 30 49093 248482 79446783
Plasmacytoma 73.07 16.62 41 49082 4362 79690903
Leukaemia 71.71 16.62 45 49078 5880 79689385
Mucoepidermoid carcinoma of salivary gland 71.65 16.62 16 49107 93 79695172
Lymphopenia 71.27 16.62 91 49032 30466 79664799
B precursor type acute leukaemia 71.20 16.62 21 49102 407 79694858
Blood pressure increased 71.01 16.62 21 49102 211339 79483926
Human herpesvirus 6 encephalitis 69.62 16.62 23 49100 655 79694610
Eyelid rash 69.43 16.62 17 49106 155 79695110
Enterococcal infection 68.68 16.62 65 49058 15595 79679670
Autoimmune neutropenia 68.24 16.62 22 49101 579 79694686
Infection reactivation 67.77 16.62 33 49090 2624 79692641
Renal failure 67.72 16.62 274 48849 200694 79494571
Debridement 67.64 16.62 29 49094 1716 79693549
Injection site pain 67.19 16.62 3 49120 129835 79565430
Urticaria 66.75 16.62 16 49107 185185 79510080
Adenoviral hepatitis 66.30 16.62 24 49099 903 79694362
Acute myeloid leukaemia recurrent 65.83 16.62 35 49088 3348 79691917
Feeling abnormal 65.32 16.62 10 49113 159189 79536076
Parainfluenzae virus infection 63.41 16.62 41 49082 5641 79689624
Hypersensitivity 63.11 16.62 42 49081 262197 79433068
Bone disorder 63.05 16.62 68 49055 19045 79676220
Disease recurrence 62.82 16.62 104 49019 44005 79651260
Contusion 61.83 16.62 9 49114 148767 79546498
Iris atrophy 60.29 16.62 15 49108 147 79695118
Myelosuppression 60.08 16.62 97 49026 40199 79655066
Hepatitis B 60.03 16.62 46 49077 8286 79686979
Bone sequestrum 59.72 16.62 24 49099 1205 79694060
Premature menopause 59.49 16.62 20 49103 602 79694663
Somnolence 59.24 16.62 37 49086 238944 79456321
Gastrointestinal toxicity 58.93 16.62 45 49078 8064 79687201
Acute respiratory distress syndrome 58.91 16.62 101 49022 43966 79651299
Depression 57.38 16.62 31 49092 216759 79478506
Squamous cell carcinoma of skin 57.30 16.62 56 49067 13977 79681288
Febrile bone marrow aplasia 57.02 16.62 54 49069 12966 79682299
Abdominal pain upper 56.39 16.62 34 49089 223785 79471480
Hepatic enzyme increased 56.33 16.62 21 49102 182589 79512676
Myalgia 56.18 16.62 22 49101 185619 79509646
Pneumonia fungal 55.91 16.62 50 49073 11160 79684105
Stomatitis 55.03 16.62 207 48916 146550 79548715
Graft versus host disease in liver 54.62 16.62 25 49098 1729 79693536
Asthma 54.26 16.62 9 49114 135086 79560179
Infusion related reaction 53.89 16.62 38 49085 230199 79465066
Retinal detachment 53.72 16.62 45 49078 9202 79686063
Pneumonia 53.36 16.62 631 48492 659615 79035650
Wound 53.31 16.62 5 49118 116174 79579091
Herpes zoster 52.64 16.62 151 48972 92932 79602333
Chronic graft versus host disease in intestine 52.47 16.62 16 49107 349 79694916
Pneumonia adenoviral 51.10 16.62 17 49106 495 79694770
Respiratory syncytial virus infection 51.03 16.62 44 49079 9358 79685907
Gastrointestinal fungal infection 50.78 16.62 17 49106 505 79694760
Klebsiella sepsis 50.51 16.62 29 49094 3223 79692042
Respiratory failure 50.44 16.62 233 48890 180678 79514587
Rash 50.34 16.62 185 48938 578173 79117092
Jaw operation 50.23 16.62 19 49104 810 79694455
B-cell type acute leukaemia 50.12 16.62 17 49106 526 79694739
Staphylococcal sepsis 49.65 16.62 53 49070 14673 79680592
Pericardial effusion 49.18 16.62 96 49027 46141 79649124
Hyperhidrosis 49.17 16.62 16 49107 151476 79543789
Discomfort 49.07 16.62 9 49114 125608 79569657
Balance disorder 48.90 16.62 3 49120 98854 79596411
Diffuse large B-cell lymphoma recurrent 48.53 16.62 31 49092 4176 79691089
Nasal abscess 48.15 16.62 13 49110 180 79695085
Actinomycosis 48.05 16.62 20 49103 1099 79694166
Plasma cell leukaemia 48.03 16.62 23 49100 1763 79693502
Cerebral toxoplasmosis 47.56 16.62 25 49098 2337 79692928
Staphylococcal bacteraemia 46.63 16.62 47 49076 12171 79683094
Infection 46.54 16.62 281 48842 241431 79453834
Drug abuse 46.46 16.62 21 49102 162670 79532595
Disturbance in social behaviour 46.17 16.62 32 49091 4938 79690327
Hypogammaglobulinaemia 46.13 16.62 48 49075 12903 79682362
Cerebrovascular accident 46.01 16.62 19 49104 155273 79539992
Sequestrectomy 45.96 16.62 18 49105 844 79694421
Ureaplasma infection 45.87 16.62 19 49104 1031 79694234
Palpitations 45.49 16.62 11 49112 126599 79568666
Arthritis 45.37 16.62 8 49115 114872 79580393
Myocardial infarction 44.95 16.62 29 49094 184100 79511165
Insomnia 44.76 16.62 51 49072 245119 79450146
Nausea 44.49 16.62 377 48746 956819 78738446
Osteolysis 44.24 16.62 30 49093 4468 79690797
Pneumocystis jirovecii pneumonia 44.09 16.62 75 49048 32433 79662832
Iris neovascularisation 44.09 16.62 10 49113 63 79695202
Gait disturbance 43.81 16.62 38 49085 207468 79487797
Colitis 43.48 16.62 121 49002 73186 79622079
Gastroenteritis adenovirus 43.48 16.62 14 49109 367 79694898
Weight increased 43.16 16.62 65 49058 277321 79417944
Hypogonadism female 43.06 16.62 8 49115 14 79695251
Retinopathy proliferative 42.98 16.62 11 49112 122 79695143
Malignant neoplasm progression 42.31 16.62 181 48942 135809 79559456
Migraine 42.26 16.62 3 49120 87490 79607775
Osteomyelitis 42.19 16.62 74 49049 32791 79662474
Swelling 41.87 16.62 43 49080 216668 79478597
Retinal haemorrhage 41.67 16.62 37 49086 8180 79687085
Pneumonia respiratory syncytial viral 40.91 16.62 21 49102 1869 79693396
Bone sarcoma 40.86 16.62 10 49113 91 79695174
Retinopathy 40.79 16.62 27 49096 3864 79691401
Chest discomfort 40.72 16.62 17 49106 138027 79557238
Ameloblastoma 40.57 16.62 10 49113 94 79695171
Retinogram abnormal 40.40 16.62 13 49110 340 79694925
Unevaluable event 40.39 16.62 99 49024 55486 79639779
Bronchospasm 40.04 16.62 62 49061 24797 79670468
Blister 39.87 16.62 12 49111 119464 79575801
Complications of bone marrow transplant 39.84 16.62 15 49108 631 79694634
Bacterial infection 39.60 16.62 70 49053 31210 79664055
Gastrointestinal wall thickening 39.43 16.62 23 49100 2634 79692631
Clostridium difficile colitis 39.27 16.62 71 49052 32212 79663053
Osteosarcoma 39.19 16.62 13 49110 375 79694890
Metapneumovirus infection 39.13 16.62 20 49103 1764 79693501
Bone marrow transplant rejection 39.13 16.62 12 49111 267 79694998
Enterococcal sepsis 38.88 16.62 23 49100 2703 79692562
Heart rate increased 38.73 16.62 13 49110 120711 79574554
Sinusitis 38.67 16.62 38 49085 195463 79499802
Delayed engraftment 38.59 16.62 12 49111 280 79694985
Leukaemia recurrent 38.51 16.62 23 49100 2751 79692514
Acute lymphocytic leukaemia recurrent 38.31 16.62 28 49095 4696 79690569
Drug intolerance 38.16 16.62 65 49058 264054 79431211
Human herpesvirus 6 infection reactivation 37.83 16.62 14 49109 561 79694704
Mobility decreased 37.75 16.62 14 49109 122161 79573104
Back pain 37.73 16.62 82 49041 304098 79391167
Eyelid ptosis 37.67 16.62 40 49083 11004 79684261
Follicular thyroid cancer 37.48 16.62 9 49114 75 79695190
Retinal depigmentation 37.32 16.62 12 49111 313 79694952
Meningoencephalitis herpetic 37.08 16.62 20 49103 1969 79693296
Meningomyelitis herpes 37.06 16.62 9 49114 79 79695186
Rhabdomyolysis 36.97 16.62 9 49114 103122 79592143
Osteoarthritis 36.93 16.62 5 49118 87304 79607961
Muscle spasms 36.88 16.62 32 49091 174698 79520567
Klebsiella bacteraemia 36.77 16.62 23 49100 2987 79692278
Fungaemia 36.75 16.62 27 49096 4564 79690701
Asthenia 36.26 16.62 177 48946 511512 79183753
Leukopenia 36.18 16.62 155 48968 116358 79578907
Blood glucose increased 35.82 16.62 13 49110 114962 79580303
Ovarian failure 35.63 16.62 14 49109 662 79694603
Apoptosis 35.47 16.62 13 49110 507 79694758
Autoimmune haemolytic anaemia 35.26 16.62 34 49089 8346 79686919
Neurotoxicity 35.17 16.62 68 49055 32450 79662815
Loss of consciousness 35.15 16.62 31 49092 167912 79527353
Dry mouth 35.04 16.62 6 49117 88013 79607252
Sinus polyp 35.04 16.62 13 49110 525 79694740
Blood cholesterol increased 34.93 16.62 5 49118 83715 79611550
Cytogenetic abnormality 34.92 16.62 16 49107 1109 79694156
Drug resistance 34.82 16.62 79 49044 42134 79653131
Neuralgic amyotrophy 34.50 16.62 11 49112 279 79694986
Retinal toxicity 34.42 16.62 17 49106 1394 79693871
Dyspepsia 34.35 16.62 12 49111 108675 79586590
Oesophagitis 34.22 16.62 57 49066 24232 79671033
Platelet count decreased 34.14 16.62 221 48902 194443 79500822
Gastrooesophageal reflux disease 33.84 16.62 11 49112 104235 79591030
Haemolytic uraemic syndrome 33.01 16.62 25 49098 4424 79690841
Vision blurred 32.95 16.62 12 49111 105886 79589379
Hepatic vein occlusion 32.75 16.62 10 49113 219 79695046
Neck pain 32.67 16.62 4 49119 75413 79619852
Mycobacterial infection 32.63 16.62 23 49100 3645 79691620
Hypoglycaemia 32.49 16.62 11 49112 101583 79593682
Heart rate decreased 32.32 16.62 3 49120 70313 79624952
Chronic graft versus host disease in liver 32.32 16.62 13 49110 654 79694611
Adenocarcinoma of colon 32.26 16.62 27 49096 5514 79689751
Neutropenic sepsis 32.26 16.62 59 49064 27005 79668260
Electrocardiogram QT prolonged 32.18 16.62 8 49115 90378 79604887
Morganella infection 31.79 16.62 15 49108 1112 79694153
Heterochromia iridis 31.45 16.62 6 49117 13 79695252
Cystitis viral 31.22 16.62 13 49110 715 79694550
Flushing 31.06 16.62 8 49115 88260 79607005
Keratopathy 30.97 16.62 15 49108 1179 79694086
Mucocutaneous ulceration 30.85 16.62 11 49112 396 79694869
Cytomegalovirus chorioretinitis 30.42 16.62 26 49097 5464 79689801
Blood pressure systolic increased 30.42 16.62 3 49120 66983 79628282
Carbamoyl phosphate synthetase deficiency 30.05 16.62 6 49117 18 79695247
Oral disorder 29.99 16.62 34 49089 10061 79685204
Hyperbilirubinaemia 29.92 16.62 54 49069 24464 79670801
Psoriatic arthropathy 29.58 16.62 6 49117 77993 79617272
Gastrointestinal mucosal disorder 29.09 16.62 14 49109 1085 79694180
Chronic myelomonocytic leukaemia 29.05 16.62 13 49110 853 79694412
Inappropriate schedule of product administration 28.77 16.62 24 49099 133604 79561661
Blood lactate dehydrogenase increased 28.71 16.62 70 49053 39100 79656165
Encephalopathy 28.58 16.62 99 49024 67298 79627967
Rhinorrhoea 28.55 16.62 6 49117 76068 79619197
Cardiomyopathy 28.50 16.62 58 49065 28716 79666549
Neutrophil count decreased 28.40 16.62 124 48999 93835 79601430
Plastic surgery 28.38 16.62 7 49116 66 79695199
Metastases to muscle 28.31 16.62 10 49113 350 79694915
Influenza like illness 28.29 16.62 5 49118 71702 79623563
Hepatic infection fungal 28.20 16.62 9 49114 229 79695036
Psoriasis 28.13 16.62 10 49113 89577 79605688
Adenoviral haemorrhagic cystitis 28.12 16.62 11 49112 514 79694751
Klebsiella infection 27.86 16.62 41 49082 15679 79679586
Escherichia infection 27.71 16.62 44 49079 17973 79677292
Candida sepsis 27.71 16.62 18 49105 2495 79692770
Human herpesvirus 8 infection 27.70 16.62 14 49109 1206 79694059
Rotavirus infection 27.67 16.62 12 49111 730 79694535
Wheezing 27.62 16.62 19 49104 116645 79578620
Renal impairment 27.57 16.62 179 48944 157604 79537661
Hepatomegaly 27.54 16.62 45 49078 18829 79676436
Gastrointestinal injury 27.47 16.62 13 49110 970 79694295
Transformation to acute myeloid leukaemia 27.30 16.62 13 49110 984 79694281
Encephalitis viral 27.29 16.62 18 49105 2561 79692704
B-cell lymphoma recurrent 27.26 16.62 13 49110 987 79694278
Metastases to retroperitoneum 27.18 16.62 10 49113 394 79694871
Hospitalisation 27.16 16.62 12 49111 94224 79601041
Retinal ischaemia 26.98 16.62 12 49111 776 79694489
Capillary leak syndrome 26.82 16.62 21 49102 3904 79691361
Enterococcal bacteraemia 26.74 16.62 19 49104 3049 79692216
Premature ageing 26.70 16.62 7 49116 86 79695179
Inflammatory myofibroblastic tumour 26.65 16.62 8 49115 165 79695100
VIth nerve paralysis 26.62 16.62 15 49108 1609 79693656
Pulmonary alveolar haemorrhage 26.52 16.62 34 49089 11423 79683842
Cardiotoxicity 26.28 16.62 35 49088 12204 79683061
Ileus paralytic 26.23 16.62 31 49092 9589 79685676
Sleep disorder 26.16 16.62 10 49113 85667 79609598
Lung infiltration 26.12 16.62 49 49074 22863 79672402
Lymphoproliferative disorder 25.95 16.62 24 49099 5591 79689674
Swelling face 25.95 16.62 6 49117 71206 79624059
Embryonal rhabdomyosarcoma 25.91 16.62 6 49117 42 79695223
Chronic myeloid leukaemia 25.89 16.62 20 49103 3644 79691621
Oral surgery 25.85 16.62 13 49110 1108 79694157
Autonomic nervous system imbalance 25.80 16.62 22 49101 4608 79690657
Wound treatment 25.79 16.62 8 49115 185 79695080
Myositis 25.70 16.62 44 49079 19124 79676141
Candida infection 25.60 16.62 66 49057 38148 79657117
Retinal artery occlusion 25.53 16.62 19 49104 3275 79691990
Pulmonary haemorrhage 25.53 16.62 38 49085 14679 79680586
Encephalitis 25.45 16.62 38 49085 14722 79680543
Memory impairment 25.40 16.62 19 49104 111715 79583550
Stenotrophomonas infection 25.38 16.62 20 49103 3753 79691512
Dental care 25.23 16.62 12 49111 906 79694359
Transplantation complication 25.11 16.62 9 49114 329 79694936
Schistocytosis 25.09 16.62 6 49117 49 79695216
Nasal congestion 24.98 16.62 8 49115 76544 79618721
Bone lesion 24.88 16.62 24 49099 5895 79689370
Endocarditis bacterial 24.73 16.62 14 49109 1515 79693750
Ascites 24.60 16.62 102 49021 75460 79619805
Hyperbaric oxygen therapy 24.38 16.62 6 49117 56 79695209
Peritonitis viral 24.28 16.62 6 49117 57 79695208
Herpes zoster meningoencephalitis 24.18 16.62 11 49112 750 79694515
Amyloidosis 24.15 16.62 17 49106 2689 79692576
Systemic candida 24.15 16.62 25 49098 6681 79688584
Myelitis transverse 24.10 16.62 15 49108 1932 79693333
Mucosal erosion 24.09 16.62 16 49107 2302 79692963
Injection site erythema 24.09 16.62 9 49114 78188 79617077
Malignant melanoma 24.07 16.62 37 49086 14704 79680561
Administration related reaction 24.04 16.62 8 49115 233 79695032
Lymphocytic leukaemia 23.82 16.62 8 49115 240 79695025
Musculoskeletal pain 23.79 16.62 17 49106 102337 79592928
Hodgkin's disease recurrent 23.73 16.62 5 49118 21 79695244
Pericarditis 23.34 16.62 18 49105 104218 79591047
Herpes virus infection 23.11 16.62 25 49098 7024 79688241
Abscess jaw 23.00 16.62 14 49109 1733 79693532
Enteritis 22.96 16.62 36 49087 14547 79680718
Escherichia bacteraemia 22.80 16.62 24 49099 6538 79688727
Metastases to spleen 22.67 16.62 10 49113 634 79694631
Encephalitis cytomegalovirus 22.67 16.62 12 49111 1138 79694127
Rectal adenocarcinoma 22.52 16.62 13 49110 1460 79693805
Type 2 diabetes mellitus 22.50 16.62 4 49119 57118 79638147
Rash pruritic 22.48 16.62 8 49115 71621 79623644
Fusarium infection 22.38 16.62 14 49109 1818 79693447
Tonsillar haemorrhage 22.38 16.62 8 49115 290 79694975
Graft versus host disease in lung 22.28 16.62 11 49112 901 79694364
Type III immune complex mediated reaction 22.18 16.62 10 49113 668 79694597
Gastroenteritis clostridial 22.10 16.62 11 49112 917 79694348
Blood bilirubin increased 22.03 16.62 90 49033 66142 79629123
Feeling hot 21.83 16.62 5 49118 59729 79635536
Meningitis bacterial 21.72 16.62 16 49107 2716 79692549
Growth retardation 21.63 16.62 14 49109 1929 79693336
Minimal residual disease 21.56 16.62 9 49114 498 79694767
Folliculitis 21.55 16.62 4 49119 55376 79639889
Rhegmatogenous retinal detachment 21.54 16.62 7 49116 189 79695076
Cough 21.50 16.62 135 48988 366654 79328611
Blood creatine phosphokinase increased 21.40 16.62 7 49116 66083 79629182
Pleural effusion 21.36 16.62 158 48965 145104 79550161
Oral fungal infection 21.30 16.62 18 49105 3725 79691540
Renal tubular disorder 21.26 16.62 23 49100 6463 79688802
Inflammation 21.23 16.62 16 49107 93737 79601528
Diarrhoea 21.21 16.62 700 48423 879789 78815476
Vertigo 21.20 16.62 8 49115 69074 79626191
Constipation 21.13 16.62 96 49027 282954 79412311
POEMS syndrome 21.12 16.62 5 49118 39 79695226
Mycobacterium kansasii infection 20.86 16.62 8 49115 354 79694911
General physical health deterioration 20.76 16.62 93 49030 275145 79420120
Anaphylactic reaction 20.68 16.62 13 49110 83730 79611535
Rhinovirus infection 20.65 16.62 25 49098 7928 79687337
Injury 20.61 16.62 11 49112 77485 79617780
Dysarthria 20.47 16.62 8 49115 67614 79627651
Adenocarcinoma gastric 20.37 16.62 13 49110 1748 79693517
Metastases to bone marrow 20.34 16.62 10 49113 812 79694453
Dysphonia 20.31 16.62 5 49118 56867 79638398
Oxygen saturation decreased 20.28 16.62 30 49093 129017 79566248
Peripheral sensory neuropathy 20.28 16.62 32 49091 13001 79682264
Treatment failure 20.27 16.62 47 49076 170439 79524826
Autologous haematopoietic stem cell transplant 20.19 16.62 5 49118 48 79695217
Endothelial dysfunction 20.18 16.62 7 49116 232 79695033
Post transplant distal limb syndrome 20.10 16.62 9 49114 591 79694674
Laryngeal cancer metastatic 20.01 16.62 5 49118 50 79695215
Retinal vascular occlusion 20.00 16.62 9 49114 598 79694667
Urinary tract infection 19.96 16.62 94 49029 274418 79420847
Streptococcal bacteraemia 19.82 16.62 17 49106 3589 79691676
Culture stool positive 19.81 16.62 9 49114 612 79694653
Cardiac failure 19.77 16.62 163 48960 154679 79540586
Cardiac failure acute 19.76 16.62 39 49084 18890 79676375
Coronary artery disease 19.40 16.62 8 49115 65466 79629799
Oesophageal squamous cell carcinoma stage IV 19.35 16.62 4 49119 15 79695250
Visual impairment 19.28 16.62 17 49106 92114 79603151
Hot flush 19.26 16.62 5 49118 54872 79640393
Atrial rupture 19.25 16.62 5 49118 59 79695206
Lung adenocarcinoma 19.25 16.62 24 49099 7840 79687425
Respiratory distress 19.18 16.62 79 49044 58260 79637005
Antibiotic prophylaxis 19.18 16.62 3 49120 0 79695265
Diffuse large B-cell lymphoma 19.14 16.62 30 49093 12119 79683146
Leukoencephalopathy 19.10 16.62 24 49099 7905 79687360
Ureteric compression 19.02 16.62 7 49116 276 79694989
Chronic graft versus host disease in eye 18.98 16.62 6 49117 148 79695117
Inflammatory pseudotumour 18.88 16.62 5 49118 64 79695201
Chronic graft versus host disease oral 18.86 16.62 6 49117 151 79695114
Renal amyloidosis 18.79 16.62 6 49117 153 79695112
Spirochaetal infection 18.76 16.62 4 49119 18 79695247
Red cell fragmentation syndrome 18.67 16.62 5 49118 67 79695198
Pulmonary veno-occlusive disease 18.66 16.62 12 49111 1636 79693629
Fungal oesophagitis 18.60 16.62 10 49113 978 79694287
Red blood cell sedimentation rate increased 18.57 16.62 3 49120 45939 79649326
Osteitis 18.51 16.62 17 49106 3926 79691339
Cognitive disorder 18.48 16.62 10 49113 69916 79625349
Chromosomal deletion 18.46 16.62 6 49117 162 79695103
Gastrointestinal inflammation 18.43 16.62 23 49100 7521 79687744
Nephrolithiasis 18.43 16.62 5 49118 53286 79641979
Hyperammonaemia 18.33 16.62 28 49095 11065 79684200
Hypoglobulinaemia 18.27 16.62 5 49118 73 79695192
Pseudomonas infection 18.22 16.62 40 49083 20863 79674402
Peripheral sensorimotor neuropathy 18.22 16.62 15 49108 2995 79692270
Central nervous system haemorrhage 18.17 16.62 7 49116 314 79694951
Infection in an immunocompromised host 18.10 16.62 11 49112 1357 79693908
Malignant neoplasm of unknown primary site 18.07 16.62 9 49114 751 79694514
Treatment noncompliance 17.89 16.62 5 49118 52263 79643002
Neurological decompensation 17.87 16.62 19 49104 5234 79690031
Meningitis listeria 17.86 16.62 10 49113 1059 79694206
Hypoaesthesia 17.86 16.62 54 49069 179298 79515967
Primary hypogonadism 17.83 16.62 6 49117 181 79695084
Device related infection 17.82 16.62 54 49069 34240 79661025
Blood pressure decreased 17.80 16.62 21 49102 99445 79595820
Herpes simplex 17.70 16.62 29 49094 12158 79683107
Embolic pneumonia 17.57 16.62 5 49118 85 79695180
Human polyomavirus infection 17.55 16.62 10 49113 1096 79694169
Pseudomembranous colitis 17.51 16.62 19 49104 5355 79689910
Disseminated cryptococcosis 17.49 16.62 12 49111 1822 79693443
Purulent discharge 17.36 16.62 20 49103 6019 79689246
Pulmonary hypertension 17.33 16.62 67 49056 48013 79647252
Staphyloma 17.27 16.62 4 49119 28 79695237
Acute promyelocytic leukaemia 17.23 16.62 11 49112 1480 79693785
Bronchitis 17.21 16.62 34 49089 130610 79564655
Papilloma 17.13 16.62 7 49116 367 79694898
Neuroblastoma recurrent 17.01 16.62 6 49117 209 79695056
Paraesthesia 16.91 16.62 54 49069 176269 79518996
Autoimmune pancytopenia 16.88 16.62 6 49117 214 79695051
Clostridium colitis 16.87 16.62 14 49109 2825 79692440
Adenosquamous cell lung cancer 16.80 16.62 4 49119 32 79695233
Abdominal distension 16.76 16.62 30 49093 119620 79575645
Pallor 16.75 16.62 5 49118 50057 79645208
Swollen tongue 16.73 16.62 3 49120 42567 79652698
Transplantation associated food allergy 16.71 16.62 5 49118 102 79695163
Skin toxicity 16.67 16.62 23 49100 8291 79686974
Activated partial thromboplastin time shortened 16.65 16.62 9 49114 890 79694375

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC L01AA03 ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
ANTINEOPLASTIC AGENTS
ALKYLATING AGENTS
Nitrogen mustard analogues
FDA MoA N0000000236 Alkylating Activity
FDA EPC N0000175558 Alkylating Drug
MeSH PA D000477 Alkylating Agents
MeSH PA D000970 Antineoplastic Agents
MeSH PA D018906 Antineoplastic Agents, Alkylating
MeSH PA D007155 Immunologic Factors
MeSH PA D007166 Immunosuppressive Agents
MeSH PA D019653 Myeloablative Agonists
MeSH PA D009676 Noxae
CHEBI has role CHEBI:35610 antineoplastic agents
CHEBI has role CHEBI:35705 immunosuppressive agents
CHEBI has role CHEBI:50903 carcinogen
CHEBI has role CHEBI:88188 allergenic drug

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

DiseaseRelationSNOMED_IDDOID
Multiple myeloma indication 109989006 DOID:9538
Malignant tumor of ovary indication 363443007 DOID:2394
Allogeneic bone marrow transplantation off-label use 58390007
Diffuse non-Hodgkin's lymphoma, large cell off-label use 109969005
Acute hemorrhage contraindication 8573003
Vasculitis contraindication 31996006 DOID:865
Fibrosis of lung contraindication 51615001 DOID:3770
Portal vein obstruction contraindication 57348003
Hemolytic anemia contraindication 61261009 DOID:583
Acute infectious disease contraindication 63171007
Interstitial pneumonia contraindication 64667001
Leukopenia contraindication 84828003 DOID:615
Kidney disease contraindication 90708001 DOID:557
Radiation oncology AND/OR radiotherapy contraindication 108290001
Liver function tests abnormal contraindication 166603001
Drug-induced hepatitis contraindication 235876009
Anemia contraindication 271737000 DOID:2355
Pregnancy, function contraindication 289908002
Thrombocytopenic disorder contraindication 302215000 DOID:1588
Bone marrow depression contraindication 307762000
Breastfeeding (mother) contraindication 413712001
Granulocytopenic disorder contraindication 417672002




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 2.27 acidic
pKa2 9.25 Basic
pKa3 4.94 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
EQ 50MG BASE/VIAL EVOMELA ACROTECH BIOPHARMA N207155 March 10, 2016 RX POWDER INTRAVENOUS 10940128 June 14, 2030 FOR HIGH-DOSE CONDITIONING TREATMENT PRIOR TO HEMATOPOIETIC PROGENITOR (STEM) CELL TRANSPLANTATION IN PATIENTS WITH MULTIPLE MYELOMA

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
EQ 50MG BASE/VIAL EVOMELA ACROTECH BIOPHARMA N207155 March 10, 2016 RX POWDER INTRAVENOUS March 10, 2023 FOR HIGH-DOSE CONDITIONING TREATMENT PRIOR TO HEMATOPOIETIC PROGENITOR (STEM) CELL TRANSPLANTATION IN PATIENTS WITH MULTIPLE MYELOMA

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
L-type amino acid transporter 1 Transporter Ki 4.26 CHEMBL

External reference:

IDSource
4020558 VUID
N0000022818 NUI
D00369 KEGG_DRUG
3223-07-2 SECONDARY_CAS_RN
4018763 VANDF
4020558 VANDF
C0025241 UMLSCUI
CHEBI:28876 CHEBI
CHEMBL852 ChEMBL_ID
CHEMBL250892 ChEMBL_ID
CHEMBL1200863 ChEMBL_ID
DB01042 DRUGBANK_ID
D008558 MESH_DESCRIPTOR_UI
460612 PUBCHEM_CID
7620 IUPHAR_LIGAND_ID
745 INN_ID
Q41OR9510P UNII
151325 RXNORM
167596 MMSL
1789 MMSL
31570 MMSL
5038 MMSL
d00287 MMSL
002633 NDDF
004144 NDDF
387297002 SNOMEDCT_US
426388000 SNOMEDCT_US
544002 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Melphalan HUMAN PRESCRIPTION DRUG LABEL 1 47781-200 TABLET 2 mg ORAL ANDA 22 sections
Melphalan HUMAN PRESCRIPTION DRUG LABEL 1 47781-200 TABLET 2 mg ORAL ANDA 22 sections
ALKERAN HUMAN PRESCRIPTION DRUG LABEL 1 52609-0001 TABLET, FILM COATED 2 mg ORAL NDA 24 sections
EVOMELA Human Prescription Drug Label 1 68152-109 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 50 mg INTRAVENOUS NDA 26 sections
Melphalan Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 71681-002 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 50 mg INTRAVENOUS ANDA 26 sections
EVOMELA Human Prescription Drug Label 1 72893-001 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 50 mg INTRAVENOUS NDA 26 sections
EVOMELA Human Prescription Drug Label 1 72893-001 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 50 mg INTRAVENOUS NDA 26 sections
EVOMELA Human Prescription Drug Label 1 72893-001 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 50 mg INTRAVENOUS NDA 26 sections
EVOMELA Human Prescription Drug Label 1 72893-001 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 50 mg INTRAVENOUS NDA 26 sections