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

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
kinase-safety-class ACVR2A,ACVR2B,AKT2,AKT3,AURKA,AXL,BRAF,BTK,CAMK2B,CAMK2D,CDK4,CDK5,CDK9,DDR1,DYRK1B,EGFR,EIF2AK3,EPHB4,ERBB2,FLT3,GRK2,IKBKB,ITK,JAK2,JAK3,KDR,MAP2K6,MAP3K14,MAP3K21,MAP3K7,MAPK10,MAPK7,MAPK9,MAPKAPK2,MTOR,NTRK1,NTRK2,PDK1,PDK2,PDK4,PIK3CA,PIK3CB,PIM2,PRKCD,PRKDC,SIK2,SIK3,STK33,SYK,TEK,TGFBR1,TTK,ZAP70 53
kinase-selectivity-class AXL,EIF2AK3,GRK2,MAP2K6,PDK4 5
pfas-class PFAS structural alert (1 = True, 0 = False) 0

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 896.01 22.27 414 28532 57211 90542290
Acute graft versus host disease 675.28 22.27 184 28762 5284 90594217
Thrombotic microangiopathy 586.97 22.27 212 28734 15531 90583970
Adenovirus infection 568.24 22.27 155 28791 4467 90595034
Myelodysplastic syndrome 559.89 22.27 221 28725 20682 90578819
Graft versus host disease 531.13 22.27 167 28779 7977 90591524
Febrile neutropenia 511.38 22.27 415 28531 157934 90441567
Venoocclusive liver disease 458.89 22.27 139 28807 5854 90593647
Neutropenia 453.73 22.27 452 28494 224452 90375049
Acute graft versus host disease in skin 423.65 22.27 124 28822 4632 90594869
Chronic graft versus host disease 386.74 22.27 112 28834 4027 90595474
Thrombocytopenia 367.40 22.27 390 28556 208335 90391166
Cytomegalovirus infection reactivation 367.19 22.27 125 28821 7675 90591826
Acute myeloid leukaemia 335.08 22.27 153 28793 20487 90579014
Cytomegalovirus infection 306.87 22.27 156 28790 26446 90573055
Post transplant lymphoproliferative disorder 294.65 22.27 103 28843 6846 90592655
Acute graft versus host disease in intestine 289.62 22.27 77 28869 2006 90597495
Pancytopenia 249.98 22.27 246 28700 120017 90479484
Plasma cell myeloma 249.55 22.27 158 28788 40670 90558831
Off label use 248.50 22.27 842 28104 1101410 89498091
Venoocclusive disease 236.33 22.27 68 28878 2387 90597114
Epstein-Barr virus infection 230.90 22.27 96 28850 10248 90589253
BK virus infection 223.17 22.27 75 28871 4423 90595078
Sepsis 218.69 22.27 278 28668 179536 90419965
Cytopenia 217.89 22.27 108 28838 17341 90582160
Engraftment syndrome 213.66 22.27 49 28897 676 90598825
Graft versus host disease in gastrointestinal tract 209.17 22.27 71 28875 4317 90595184
Graft versus host disease in skin 206.12 22.27 68 28878 3785 90595716
Viraemia 205.24 22.27 56 28890 1613 90597888
Posterior reversible encephalopathy syndrome 181.95 22.27 104 28842 22235 90577266
Product use in unapproved indication 170.74 22.27 349 28597 335887 90263614
Epstein-Barr virus infection reactivation 165.00 22.27 47 28899 1590 90597911
Neuropathy peripheral 163.65 22.27 210 28736 136760 90462741
Cystitis haemorrhagic 160.63 22.27 62 28884 5451 90594050
Disease progression 159.36 22.27 222 28724 156393 90443108
Haemophagocytic lymphohistiocytosis 159.10 22.27 84 28862 15375 90584126
Polyneuropathy 157.40 22.27 90 28856 19251 90580250
Cytomegalovirus viraemia 154.60 22.27 66 28880 7520 90591981
Plasma cell myeloma recurrent 154 22.27 56 28890 4172 90595329
Headache 153.62 22.27 43 28903 862703 89736798
Multiple organ dysfunction syndrome 151.67 22.27 145 28801 68191 90531310
Osteonecrosis 151.50 22.27 98 28848 26143 90573358
Hypogammaglobulinaemia 151.10 22.27 72 28874 10602 90588899
Bacteraemia 150.63 22.27 92 28854 22208 90577293
Arthralgia 149.82 22.27 33 28913 778489 89821012
Progressive multifocal leukoencephalopathy 149.69 22.27 81 28865 15574 90583927
Human herpesvirus 6 infection 145.98 22.27 51 28895 3381 90596120
Bone marrow failure 144.70 22.27 103 28843 32118 90567383
Viral haemorrhagic cystitis 137.68 22.27 40 28906 1453 90598048
Plasma cell myeloma refractory 137.18 22.27 37 28909 1019 90598482
Joint swelling 135.44 22.27 6 28940 503294 90096207
Protothecosis 134.34 22.27 31 28915 440 90599061
Malignant transformation 126.78 22.27 31 28915 571 90598930
Osteonecrosis of jaw 124.84 22.27 102 28844 39001 90560500
Pain 124.64 22.27 83 28863 996258 89603243
Therapy partial responder 119.14 22.27 79 28867 21964 90577537
Malaise 118.53 22.27 22 28924 585964 90013537
Abdominal discomfort 115.56 22.27 10 28936 477318 90122183
Septic shock 114.84 22.27 138 28808 84022 90515479
Renal failure 113.27 22.27 172 28774 130835 90468666
Drug hypersensitivity 111.45 22.27 10 28936 463599 90135902
Iris atrophy 109.80 22.27 21 28925 109 90599392
Chronic graft versus host disease in skin 108.96 22.27 32 28914 1208 90598293
Second primary malignancy 108.51 22.27 57 28889 10321 90589180
Acute lymphocytic leukaemia 108.51 22.27 39 28907 2809 90596692
Nasopharyngitis 105.84 22.27 6 28940 407098 90192403
Stem cell transplant 103.24 22.27 35 28911 2119 90597382
Epstein-Barr viraemia 99.38 22.27 31 28915 1439 90598062
Retinal pigment epitheliopathy 98.83 22.27 22 28924 263 90599238
Acute kidney injury 98.71 22.27 274 28672 320113 90279388
Staphylococcal bacteraemia 98.51 22.27 48 28898 7421 90592080
Fatigue 96.93 22.27 137 28809 1153886 89445615
Arthropathy 96.43 22.27 5 28941 366237 90233264
Disease recurrence 95.31 22.27 86 28860 37567 90561934
JC virus infection 95.26 22.27 35 28911 2684 90596817
Alopecia 95.05 22.27 21 28925 495050 90104451
Pruritus 90.76 22.27 30 28916 541495 90058006
Peripheral swelling 89.06 22.27 13 28933 413093 90186408
Premature menopause 85.56 22.27 27 28919 1302 90598199
Acute myeloid leukaemia recurrent 85.31 22.27 30 28916 2027 90597474
Prothrombin level increased 85.27 22.27 20 28926 306 90599195
Acute graft versus host disease in liver 85.11 22.27 24 28922 782 90598719
Bronchopulmonary aspergillosis 84.67 22.27 50 28896 11348 90588153
Enterococcal infection 82.65 22.27 47 28899 9944 90589557
Engraft failure 82.38 22.27 20 28926 357 90599144
Varicella zoster virus infection 79.89 22.27 34 28912 3843 90595658
Adenoviral hepatitis 78.77 22.27 20 28926 432 90599069
Encephalitis viral 76.25 22.27 27 28919 1862 90597639
Cardiac failure 75.82 22.27 130 28816 109366 90490135
Therapeutic product effect decreased 75.62 22.27 3 28943 277568 90321933
Vitreous haemorrhage 74.60 22.27 29 28917 2597 90596904
Idiopathic pneumonia syndrome 73.91 22.27 19 28927 432 90599069
Cytomegalovirus test positive 72.37 22.27 31 28915 3560 90595941
Urticaria 71.83 22.27 8 28938 312726 90286775
Swelling 70.55 22.27 23 28923 419035 90180466
Eye excision 70.46 22.27 12 28934 27 90599474
Pericardial effusion 70.26 22.27 72 28874 36761 90562740
Weight increased 68.51 22.27 24 28922 417903 90181598
Infusion related reaction 68.21 22.27 24 28922 416756 90182745
Disturbance in social behaviour 67.79 22.27 31 28915 4157 90595344
Dizziness 67.10 22.27 54 28892 589230 90010271
Pneumonia fungal 66.15 22.27 36 28910 6995 90592506
Aplasia 66.04 22.27 30 28916 3961 90595540
Respiratory failure 66.01 22.27 128 28818 118290 90481211
Rhinovirus infection 65.92 22.27 34 28912 5929 90593572
Febrile bone marrow aplasia 65.30 22.27 40 28906 9698 90589803
Myelosuppression 65.23 22.27 83 28863 53508 90545993
Toxicity to various agents 64.18 22.27 220 28726 287626 90311875
Pain in extremity 64.01 22.27 32 28914 450497 90149004
Hepatic enzyme increased 63.96 22.27 18 28928 360718 90238783
Pneumonia adenoviral 63.80 22.27 15 28931 232 90599269
Fall 62.97 22.27 38 28908 481772 90117729
Osteolysis 62.93 22.27 28 28918 3522 90595979
Systemic candida 62.80 22.27 31 28915 4928 90594573
Encephalitis 60.39 22.27 40 28906 11094 90588407
Hepatitis B reactivation 59.91 22.27 28 28918 3946 90595555
Blister 59.89 22.27 6 28940 254992 90344509
Pyrexia 59.32 22.27 387 28559 660098 89939403
Cytomegalovirus chorioretinitis 59.25 22.27 24 28922 2395 90597106
Hypersensitivity 59.22 22.27 36 28910 454641 90144860
B-cell type acute leukaemia 58.92 22.27 17 28929 602 90598899
Contusion 58.77 22.27 6 28940 251210 90348291
Chest pain 58.46 22.27 15 28931 319630 90279871
Leukopenia 57.52 22.27 110 28836 100600 90498901
Lymphopenia 57.38 22.27 52 28894 22829 90576672
Transplant failure 56.84 22.27 22 28924 1947 90597554
Cardiomyopathy 56.82 22.27 49 28897 20157 90579344
Haematotoxicity 56.09 22.27 40 28906 12495 90587006
Plasmacytoma 55.92 22.27 24 28922 2769 90596732
Neutropenic colitis 55.76 22.27 27 28919 4116 90595385
Refractory cytopenia with multilineage dysplasia 55.16 22.27 12 28934 128 90599373
Product dose omission issue 54.67 22.27 13 28933 291674 90307827
Bone debridement 54.31 22.27 13 28933 218 90599283
Enterococcal sepsis 53.67 22.27 20 28926 1596 90597905
Asthma 53.61 22.27 7 28939 242153 90357348
Chronic graft versus host disease in intestine 53.12 22.27 12 28934 154 90599347
Folliculitis 53.10 22.27 3 28943 204350 90395151
Oesophagitis 52.96 22.27 44 28902 17205 90582296
Type 2 diabetes mellitus 52.76 22.27 3 28943 203241 90396260
Pneumococcal sepsis 52.32 22.27 17 28929 901 90598600
Choroidal infarction 51.57 22.27 11 28935 106 90599395
Nasal abscess 51.44 22.27 12 28934 179 90599322
Gastrointestinal inflammation 51.38 22.27 30 28916 6666 90592835
Chronic myelomonocytic leukaemia 51.34 22.27 14 28932 402 90599099
Bacterial sepsis 51.19 22.27 27 28919 4928 90594573
Klebsiella infection 51.08 22.27 35 28911 10262 90589239
Aspiration bone marrow 50.72 22.27 12 28934 191 90599310
Gastroenteritis adenovirus 50.55 22.27 13 28933 296 90599205
Candida infection 49.99 22.27 58 28888 33999 90565502
Heterochromia iridis 49.91 22.27 8 28938 10 90599491
Nephropathy toxic 48.90 22.27 37 28909 12651 90586850
Migraine 48.84 22.27 3 28943 190389 90409112
Herpes zoster 48.76 22.27 99 28847 94545 90504956
Bacterial infection 48.70 22.27 48 28898 23396 90576105
Hypogonadism female 48.31 22.27 8 28938 14 90599487
Sleep disorder 48.27 22.27 4 28942 198026 90401475
Abdominal pain upper 48.18 22.27 23 28923 332651 90266850
Memory impairment 48.03 22.27 4 28942 197240 90402261
Depression 47.98 22.27 18 28928 300583 90298918
Pseudomonas infection 47.90 22.27 39 28907 14826 90584675
Osteoarthritis 47.58 22.27 4 28942 195726 90403775
Renal tubular injury 47.19 22.27 17 28929 1232 90598269
Epstein-Barr virus associated lymphoproliferative disorder 47.16 22.27 21 28925 2646 90596855
Anaemia 47.03 22.27 230 28716 352572 90246929
Pericarditis 46.91 22.27 14 28932 270137 90329364
Insomnia 46.86 22.27 24 28922 333450 90266051
Parainfluenzae virus infection 46.16 22.27 21 28925 2782 90596719
Gastrointestinal fungal infection 45.94 22.27 13 28933 429 90599072
Pneumonia respiratory syncytial viral 45.89 22.27 17 28929 1334 90598167
Wheezing 45.83 22.27 10 28936 238070 90361431
Injury 45.42 22.27 5 28941 197344 90402157
Mobility decreased 45.39 22.27 12 28934 250722 90348779
Tooth extraction 45.32 22.27 34 28912 11479 90588022
Retinal toxicity 45.04 22.27 17 28929 1405 90598096
Plasma cell leukaemia 44.65 22.27 16 28930 1142 90598359
Diffuse large B-cell lymphoma recurrent 44.52 22.27 22 28924 3504 90595997
Pneumonia cytomegaloviral 44.07 22.27 21 28925 3090 90596411
Anxiety 43.97 22.27 22 28924 309750 90289751
Infection reactivation 43.27 22.27 18 28928 1922 90597579
Mucocutaneous ulceration 43.22 22.27 11 28935 240 90599261
Eyelid oedema 43.05 22.27 33 28913 11501 90588000
Drug intolerance 42.73 22.27 48 28898 447543 90151958
Leukaemia 42.68 22.27 24 28922 4968 90594533
Tonsillar haemorrhage 42.63 22.27 11 28935 254 90599247
Morganella infection 42.04 22.27 14 28932 802 90598699
Extraocular muscle disorder 41.98 22.27 10 28936 164 90599337
Sinus polyp 41.98 22.27 12 28934 411 90599090
Colitis 41.92 22.27 78 28868 69864 90529637
Paranoia 41.87 22.27 34 28912 12874 90586627
Atrial fibrillation 41.77 22.27 115 28831 133496 90466005
Renal impairment 41.52 22.27 99 28847 105322 90494179
Acute promyelocytic leukaemia 41.29 22.27 15 28931 1114 90598387
Dyspnoea 41.24 22.27 144 28802 880811 89718690
Endocarditis bacterial 41.09 22.27 13 28933 632 90598869
Sinusitis 40.83 22.27 30 28916 343058 90256443
Encephalopathy 40.12 22.27 61 28885 46383 90553118
Escherichia bacteraemia 39.59 22.27 24 28922 5711 90593790
Overdose 38.95 22.27 3 28943 157706 90441795
Growth failure 38.44 22.27 11 28935 378 90599123
Clostridium difficile colitis 38.39 22.27 45 28901 26661 90572840
Cytokine release syndrome 38.34 22.27 46 28900 27927 90571574
Retinal detachment 38.19 22.27 25 28921 6797 90592704
Liver injury 37.58 22.27 5 28941 170562 90428939
Ill-defined disorder 37.17 22.27 7 28939 184884 90414617
Respiratory syncytial virus infection 36.97 22.27 29 28917 10451 90589050
Ureaplasma infection 36.77 22.27 13 28933 892 90598609
Anal squamous cell carcinoma 36.70 22.27 12 28934 649 90598852
Feeling abnormal 36.61 22.27 5 28941 167230 90432271
Blood pressure increased 36.53 22.27 9 28937 197208 90402293
Renal amyloidosis 36.48 22.27 10 28936 293 90599208
Condition aggravated 36.14 22.27 86 28860 595459 90004042
Meningitis pneumococcal 36.00 22.27 11 28935 476 90599025
Muscle spasms 35.57 22.27 18 28928 251865 90347636
COVID-19 pneumonia 35.51 22.27 36 28910 18141 90581360
Pneumonia 35.10 22.27 334 28612 637725 89961776
Cerebral toxoplasmosis 34.62 22.27 14 28932 1391 90598110
Blood stem cell transplant failure 34.55 22.27 9 28937 216 90599285
Acute lymphocytic leukaemia recurrent 34.42 22.27 17 28929 2704 90596797
Pathogen resistance 34.26 22.27 25 28921 8090 90591411
Retinal degeneration 34.19 22.27 13 28933 1096 90598405
Hepatitis E 33.73 22.27 15 28931 1884 90597617
Loss of consciousness 33.71 22.27 3 28943 140235 90459266
Jaw operation 33.45 22.27 12 28934 859 90598642
Gait disturbance 33.36 22.27 21 28925 260475 90339026
Eyelid rash 33.25 22.27 10 28936 410 90599091
Dyspepsia 33.09 22.27 11 28935 198149 90401352
Gastrointestinal toxicity 32.98 22.27 26 28920 9441 90590060
Weight decreased 32.81 22.27 44 28902 379866 90219635
Ovarian failure 32.50 22.27 14 28932 1629 90597872
Pulmonary haemorrhage 32.29 22.27 24 28922 7989 90591512
Arthritis 32.25 22.27 7 28939 167308 90432193
Complications of bone marrow transplant 32.12 22.27 10 28936 461 90599040
Aspergillus infection 31.97 22.27 27 28919 10796 90588705
Gastroenteritis astroviral 31.89 22.27 7 28939 78 90599423
Neuralgic amyotrophy 31.73 22.27 6 28940 29 90599472
Adenoviral haemorrhagic cystitis 31.50 22.27 8 28938 173 90599328
Inflammation 31.46 22.27 9 28937 178583 90420918
Klebsiella sepsis 31.42 22.27 14 28932 1767 90597734
Hypoperfusion 31.39 22.27 14 28932 1770 90597731
Musculoskeletal pain 31.36 22.27 8 28938 171243 90428258
Bursitis 31.16 22.27 3 28943 131651 90467850
Acute respiratory distress syndrome 31.13 22.27 42 28904 28644 90570857
Dry mouth 31.12 22.27 10 28936 184049 90415452
Lower respiratory tract infection 31.02 22.27 21 28925 250638 90348863
Bladder hypertrophy 30.87 22.27 10 28936 525 90598976
Pulmonary oedema 30.86 22.27 64 28882 62016 90537485
Pleural effusion 30.74 22.27 92 28854 111899 90487602
Chronic graft versus host disease in liver 30.71 22.27 9 28937 337 90599164
Pneumatosis intestinalis 30.68 22.27 17 28929 3420 90596081
Abnormal behaviour 30.67 22.27 37 28909 22591 90576910
Enterovirus infection 30.61 22.27 13 28933 1461 90598040
Haemorrhage urinary tract 30.55 22.27 12 28934 1105 90598396
Gastrointestinal mucosal disorder 29.98 22.27 11 28935 840 90598661
Cardiac failure acute 29.69 22.27 27 28919 11902 90587599
Peripheral sensorimotor neuropathy 29.57 22.27 14 28932 2031 90597470
Febrile infection 29.41 22.27 14 28932 2055 90597446
Infection in an immunocompromised host 29.31 22.27 11 28935 895 90598606
Human herpesvirus 6 encephalitis 29.14 22.27 9 28937 404 90599097
Schistocytosis 29.13 22.27 6 28940 48 90599453
Peritonitis viral 29.13 22.27 6 28940 48 90599453
Graft versus host disease in liver 28.66 22.27 11 28935 952 90598549
Ventricular hypokinesia 28.51 22.27 19 28927 5322 90594179
Enophthalmos 28.50 22.27 6 28940 54 90599447
Fungaemia 28.35 22.27 16 28930 3334 90596167
Mucosal erosion 27.81 22.27 13 28933 1832 90597669
Loss of personal independence in daily activities 27.68 22.27 5 28941 136100 90463401
Follicular thyroid cancer 27.66 22.27 6 28940 63 90599438
Jugular vein occlusion 27.66 22.27 6 28940 63 90599438
Gastrointestinal disorder 27.35 22.27 25 28921 256662 90342839
Retinal depigmentation 27.26 22.27 8 28938 301 90599200
Abdominal compartment syndrome 27.14 22.27 10 28936 773 90598728
Sequestrectomy 27.06 22.27 10 28936 779 90598722
Acute erythroid leukaemia 27.03 22.27 7 28939 164 90599337
Pulmonary veno-occlusive disease 26.84 22.27 12 28934 1526 90597975
Bronchospasm 26.67 22.27 33 28913 20676 90578825
Enterococcal bacteraemia 26.64 22.27 13 28933 2015 90597486
Gait inability 26.51 22.27 7 28939 146449 90453052
Klebsiella bacteraemia 26.42 22.27 14 28932 2578 90596923
Hepatitis B 26.37 22.27 17 28929 4502 90594999
Malignant neoplasm progression 25.82 22.27 84 28862 106786 90492715
Opportunistic infection 25.68 22.27 13 28933 2180 90597321
Hyperhidrosis 25.67 22.27 6 28940 136299 90463202
Inappropriate schedule of product administration 25.60 22.27 8 28938 149925 90449576
Endothelial dysfunction 25.57 22.27 7 28939 204 90599297
Pneumocystis jirovecii pneumonia 25.54 22.27 33 28913 21583 90577918
Myalgia 25.50 22.27 12 28934 175113 90424388
Skin maceration 25.34 22.27 7 28939 211 90599290
Transplantation complication 25.34 22.27 7 28939 211 90599290
Bone disorder 25.32 22.27 34 28912 23086 90576415
Subacute sclerosing panencephalitis 25.25 22.27 5 28941 32 90599469
Mantle cell lymphoma recurrent 25.07 22.27 8 28938 400 90599101
Bronchiolitis obliterans syndrome 25.01 22.27 8 28938 403 90599098
Escherichia infection 24.90 22.27 28 28918 15867 90583634
Fungal infection 24.84 22.27 47 28899 42614 90556887
Drug ineffective 24.84 22.27 597 28349 1383701 89215800
Gastrooesophageal reflux disease 24.84 22.27 11 28935 166326 90433175
Plastic surgery 24.77 22.27 6 28940 106 90599395
Parvovirus B19 infection 24.70 22.27 10 28936 996 90598505
Acute respiratory failure 24.64 22.27 47 28899 42871 90556630
Treatment failure 24.45 22.27 37 28909 303891 90295610
Gastric cancer 24.40 22.27 17 28929 5119 90594382
B precursor type acute leukaemia 24.02 22.27 7 28939 257 90599244
Palpitations 23.88 22.27 7 28939 136721 90462780
Ornithine transcarbamoylase deficiency 23.81 22.27 4 28942 8 90599493
Acinetobacter infection 23.79 22.27 12 28934 1996 90597505
Eyelid ptosis 23.63 22.27 21 28925 8985 90590516
Aplastic anaemia 23.62 22.27 25 28921 13244 90586257
Clostridium colitis 23.59 22.27 12 28934 2033 90597468
Neck pain 23.58 22.27 4 28942 113959 90485542
Ascites 23.47 22.27 49 28897 47691 90551810
Fungal oesophagitis 23.43 22.27 9 28937 780 90598721
Herpes simplex 23.32 22.27 22 28924 10159 90589342
Heart rate increased 23.28 22.27 4 28942 112898 90486603
Oral fungal infection 23.14 22.27 14 28932 3318 90596183
Hyperammonaemia 23.02 22.27 18 28928 6457 90593044
Iris neovascularisation 23.01 22.27 5 28941 53 90599448
Graft versus host disease in lung 22.73 22.27 8 28938 542 90598959
Adverse event 22.45 22.27 5 28941 117413 90482088
Clostridial sepsis 22.41 22.27 8 28938 565 90598936
Skin toxicity 22.29 22.27 18 28928 6761 90592740

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
Acute graft versus host disease 732.98 17.65 270 34851 7945 42578269
Mucosal inflammation 698.87 17.65 460 34661 48914 42537300
Venoocclusive liver disease 697.93 17.65 277 34844 10025 42576189
Myelodysplastic syndrome 636.67 17.65 330 34791 22415 42563799
Acute myeloid leukaemia 459.26 17.65 264 34857 21992 42564222
Graft versus host disease 421.37 17.65 208 34913 12717 42573497
Acute graft versus host disease in skin 371.97 17.65 161 34960 7263 42578951
Febrile neutropenia 335.10 17.65 570 34551 185133 42401081
Chronic graft versus host disease 332.72 17.65 140 34981 5885 42580329
Adenovirus infection 262.57 17.65 123 34998 6686 42579528
Second primary malignancy 250.81 17.65 133 34988 9442 42576772
Venoocclusive disease 246.75 17.65 100 35021 3815 42582399
Off label use 238.57 17.65 1095 34026 637240 41948974
Cytomegalovirus infection 226.34 17.65 198 34923 32108 42554106
Graft versus host disease in gastrointestinal tract 220.48 17.65 100 35021 5043 42581171
Acute graft versus host disease in intestine 215.44 17.65 91 35030 3860 42582354
Thrombotic microangiopathy 211.82 17.65 139 34982 14643 42571571
Graft versus host disease in skin 203.58 17.65 95 35026 5117 42581097
Engraftment syndrome 182.68 17.65 61 35060 1329 42584885
Plasma cell myeloma 182.06 17.65 210 34911 47368 42538846
Malignant transformation 173.91 17.65 54 35067 924 42585290
Epstein-Barr virus infection 170.79 17.65 104 35017 9614 42576600
Human herpesvirus 6 infection 167.77 17.65 67 35054 2458 42583756
Cytomegalovirus infection reactivation 167.22 17.65 108 35013 11070 42575144
Post transplant lymphoproliferative disorder 166.46 17.65 100 35021 9020 42577194
Product use in unapproved indication 164.03 17.65 424 34697 184032 42402182
Polyneuropathy 154.58 17.65 126 34995 18535 42567679
Chronic graft versus host disease in skin 151.36 17.65 55 35066 1551 42584663
Neutropenia 144.14 17.65 425 34696 199006 42387208
Epstein-Barr virus infection reactivation 141.54 17.65 60 35061 2567 42583647
Plasma cell myeloma recurrent 139.63 17.65 76 35045 5681 42580533
Multiple organ dysfunction syndrome 136.60 17.65 268 34853 96767 42489447
Drug interaction 128.77 17.65 31 35090 266968 42319246
Acute lymphocytic leukaemia 126.18 17.65 60 35061 3371 42582843
Therapy partial responder 122.99 17.65 114 35007 19907 42566307
Progressive multifocal leukoencephalopathy 121.91 17.65 90 35031 11446 42574768
Thrombocytopenia 117.49 17.65 384 34737 189895 42396319
Disease progression 117.18 17.65 320 34801 143336 42442878
Cytopenia 114.05 17.65 103 35018 17394 42568820
Acute graft versus host disease in liver 113.12 17.65 47 35074 1911 42584303
Osteonecrosis 108.58 17.65 96 35025 15769 42570445
Pancytopenia 106.89 17.65 273 34848 117470 42468744
Stem cell transplant 105.26 17.65 49 35072 2623 42583591
Product dose omission issue 103.09 17.65 6 35115 154359 42431855
Epstein-Barr viraemia 102.84 17.65 46 35075 2243 42583971
Bacterial sepsis 97.85 17.65 63 35058 6419 42579795
Neuropathy peripheral 95.38 17.65 239 34882 101614 42484600
Retinal pigment epitheliopathy 94.99 17.65 25 35096 227 42585987
Haematotoxicity 94.83 17.65 76 35045 10909 42575305
Headache 93.78 17.65 40 35081 239329 42346885
Arthralgia 92.87 17.65 27 35094 205211 42381003
Retinal degeneration 92.54 17.65 31 35090 682 42585532
Fatigue 91.69 17.65 136 34985 435505 42150709
Bronchopulmonary aspergillosis 90.26 17.65 95 35026 19334 42566880
Dizziness 89.44 17.65 47 35074 249207 42337007
B-cell type acute leukaemia 88.74 17.65 31 35090 777 42585437
Malaise 87.09 17.65 33 35088 212123 42374091
Neutropenic colitis 86.74 17.65 51 35070 4419 42581795
Choroidal dystrophy 85.59 17.65 16 35105 18 42586196
Aspergillus infection 83.67 17.65 83 35038 15754 42570460
BK virus infection 82.77 17.65 64 35057 8720 42577494
Fall 81.53 17.65 46 35075 234474 42351740
Sepsis 81.06 17.65 352 34769 198982 42387232
Choroidal infarction 79.96 17.65 18 35103 77 42586137
Basal cell carcinoma 79.69 17.65 96 35025 22637 42563577
Plasma cell myeloma refractory 78.61 17.65 33 35088 1377 42584837
Engraft failure 78.26 17.65 26 35095 557 42585657
Transplant failure 78.11 17.65 46 35075 3998 42582216
Blood stem cell transplant failure 75.28 17.65 24 35097 449 42585765
Stomatitis 73.16 17.65 141 34980 50188 42536026
Pyrexia 70.17 17.65 559 34562 393483 42192731
Cytomegalovirus viraemia 69.42 17.65 62 35059 10315 42575899
Haemophagocytic lymphohistiocytosis 67.24 17.65 79 35042 18143 42568071
B precursor type acute leukaemia 67.17 17.65 19 35102 231 42585983
Acute respiratory distress syndrome 67.10 17.65 102 35019 30006 42556208
Dyspnoea 67.05 17.65 168 34953 442453 42143761
Bacteraemia 66.23 17.65 92 35029 24948 42561266
Cystitis haemorrhagic 66.02 17.65 52 35069 7277 42578937
Bone marrow failure 65.27 17.65 106 35015 32987 42553227
Overdose 64.81 17.65 6 35115 105258 42480956
Diffuse large B-cell lymphoma recurrent 62.89 17.65 43 35078 4843 42581371
Human herpesvirus 6 encephalitis 61.97 17.65 22 35099 579 42585635
Aplasia 60.87 17.65 42 35079 4801 42581413
JC virus infection 60.20 17.65 35 35086 2969 42583245
Pruritus 58.75 17.65 42 35079 188729 42397485
Hypogammaglobulinaemia 58.56 17.65 60 35061 11831 42574383
Tooth extraction 58.44 17.65 43 35078 5437 42580777
Extraocular muscle disorder 58.44 17.65 17 35104 230 42585984
Vitreous haemorrhage 57.70 17.65 33 35088 2714 42583500
Pain 56.85 17.65 71 35050 244777 42341437
Chest pain 56.72 17.65 22 35099 139508 42446706
Septic shock 56.42 17.65 185 34936 91487 42494727
Disease recurrence 55.75 17.65 93 35028 29585 42556629
Cytomegalovirus test positive 55.56 17.65 38 35083 4281 42581933
Somnolence 54.53 17.65 24 35097 141081 42445133
Death 53.47 17.65 204 34917 470981 42115233
Drug hypersensitivity 53.10 17.65 9 35112 99380 42486834
Anxiety 52.84 17.65 16 35105 118544 42467670
Neutropenic sepsis 52.10 17.65 65 35056 15881 42570333
Staphylococcal sepsis 49.81 17.65 54 35067 11360 42574854
Cystitis viral 49.61 17.65 23 35098 1219 42584995
Bone disorder 49.24 17.65 42 35079 6571 42579643
Rhabdomyolysis 49.23 17.65 4 35117 78015 42508199
Transformation to acute myeloid leukaemia 48.98 17.65 22 35099 1083 42585131
Peripheral swelling 48.61 17.65 8 35113 90262 42495952
Pneumonia 48.57 17.65 546 34575 421603 42164611
Human herpesvirus 8 infection 48.48 17.65 24 35097 1473 42584741
Refractory anaemia with an excess of blasts 48.46 17.65 16 35105 336 42585878
Plasmacytoma 48.25 17.65 35 35086 4329 42581885
Iris atrophy 48.10 17.65 12 35109 86 42586128
Depression 47.90 17.65 16 35105 111347 42474867
Epstein-Barr virus associated lymphoproliferative disorder 47.73 17.65 28 35093 2415 42583799
Febrile bone marrow aplasia 47.67 17.65 50 35071 10131 42576083
Blood pressure increased 46.81 17.65 13 35108 101915 42484299
Parainfluenzae virus infection 46.74 17.65 32 35089 3611 42582603
Gastrointestinal inflammation 46.66 17.65 35 35086 4557 42581657
Hyperhidrosis 46.61 17.65 9 35112 90503 42495711
Asthenia 45.26 17.65 103 35018 280690 42305524
Juvenile melanoma benign 45.09 17.65 11 35110 71 42586143
Condition aggravated 45.05 17.65 92 35029 260662 42325552
Pain in extremity 44.91 17.65 35 35086 150569 42435645
Apoptosis 43.83 17.65 17 35104 576 42585638
Herpes zoster 43.67 17.65 98 35023 38779 42547435
Cerebral toxoplasmosis 43.52 17.65 25 35096 2073 42584141
Cerebrovascular accident 43.49 17.65 13 35108 97147 42489067
Retinopathy proliferative 43.48 17.65 11 35110 84 42586130
Prothrombin level increased 43.20 17.65 13 35108 199 42586015
Feeling abnormal 42.88 17.65 4 35117 69782 42516432
Myalgia 42.75 17.65 13 35108 96067 42490147
Hepatitis B reactivation 42.36 17.65 33 35088 4545 42581669
Bone sequestrum 42.15 17.65 16 35105 511 42585703
Osteosarcoma 41.96 17.65 14 35107 304 42585910
Ameloblastoma 41.59 17.65 11 35110 102 42586112
Bone debridement 41.41 17.65 12 35109 160 42586054
Meningomyelitis herpes 40.87 17.65 9 35112 34 42586180
Weight decreased 40.66 17.65 68 35053 207880 42378334
Systemic mycosis 40.53 17.65 25 35096 2362 42583852
Eyelid oedema 40.03 17.65 35 35086 5660 42580554
Intentional product use issue 39.81 17.65 140 34981 71693 42514521
Ejection fraction abnormal 39.69 17.65 20 35101 1275 42584939
Idiopathic pneumonia syndrome 39.60 17.65 15 35106 476 42585738
Mastication disorder 39.10 17.65 22 35099 1754 42584460
Joint swelling 39.01 17.65 5 35116 68017 42518197
Debridement 38.79 17.65 18 35103 956 42585258
Pneumonia cytomegaloviral 38.73 17.65 30 35091 4096 42582118
Myocardial infarction 38.02 17.65 28 35093 123981 42462233
Graft versus host disease in liver 37.98 17.65 21 35100 1618 42584596
Osteolysis 37.97 17.65 28 35093 3552 42582662
Hospitalisation 37.01 17.65 8 35113 74322 42511892
Autologous haematopoietic stem cell transplant 36.86 17.65 10 35111 103 42586111
Posterior reversible encephalopathy syndrome 36.77 17.65 49 35072 12772 42573442
Viraemia 36.47 17.65 21 35100 1749 42584465
Nasopharyngitis 36.23 17.65 12 35109 83984 42502230
Autoimmune haemolytic anaemia 36.19 17.65 33 35088 5638 42580576
Enterococcal infection 36.05 17.65 47 35074 11992 42574222
Gastrointestinal mucosal disorder 35.91 17.65 14 35107 481 42585733
Squamous cell carcinoma of skin 35.52 17.65 48 35073 12678 42573536
Drug resistance 34.80 17.65 83 35038 34165 42552049
Refractory cytopenia with multilineage dysplasia 34.74 17.65 10 35111 130 42586084
Infection 34.62 17.65 183 34938 111885 42474329
Atrophy of globe 34.35 17.65 8 35113 41 42586173
Musculoskeletal stiffness 33.72 17.65 4 35117 57761 42528453
Gingivitis ulcerative 33.23 17.65 11 35110 233 42585981
Eye excision 32.78 17.65 7 35114 22 42586192
Stenotrophomonas infection 32.76 17.65 26 35095 3678 42582536
Chorioretinal disorder 32.74 17.65 8 35113 52 42586162
Constipation 32.71 17.65 52 35069 162239 42423975
Myositis 32.60 17.65 50 35071 14816 42571398
Pre-engraftment immune reaction 32.43 17.65 10 35111 167 42586047
Bradycardia 32.28 17.65 15 35106 85469 42500745
Bacterial infection 32.12 17.65 71 35050 27808 42558406
Metastases to retroperitoneum 32.05 17.65 11 35110 261 42585953
Back pain 31.94 17.65 42 35079 141734 42444480
Retinal toxicity 31.62 17.65 13 35108 514 42585700
Hepatitis B 31.49 17.65 33 35088 6678 42579536
Keratopathy 31.27 17.65 14 35107 684 42585530
Metastatic lymphoma 31.10 17.65 12 35109 401 42585813
Product use issue 30.68 17.65 135 34986 76616 42509598
Coronary artery disease 30.67 17.65 4 35117 53716 42532498
Viral haemorrhagic cystitis 30.42 17.65 19 35102 1835 42584379
Actinomycosis 30.34 17.65 13 35108 571 42585643
Mucosal disorder 30.05 17.65 20 35101 2154 42584060
Rash 29.97 17.65 122 34999 276832 42309382
Insomnia 29.87 17.65 32 35089 118221 42467993
Chronic graft versus host disease in intestine 29.77 17.65 12 35109 451 42585763
Muscle spasms 29.67 17.65 17 35104 86027 42500187
Tremor 29.55 17.65 22 35099 96907 42489307
Urticaria 29.53 17.65 12 35109 74024 42512190
Bone marrow transplant rejection 29.43 17.65 10 35111 230 42585984
Pulmonary arterial hypertension 29.31 17.65 39 35082 10148 42576066
Obliterative bronchiolitis 29.22 17.65 17 35104 1444 42584770
Autoimmune neutropenia 29.10 17.65 11 35110 347 42585867
Metastases to muscle 28.99 17.65 10 35111 241 42585973
Pulmonary haemorrhage 28.83 17.65 41 35080 11356 42574858
Premature ageing 28.69 17.65 8 35113 92 42586122
Papilloma 28.58 17.65 11 35110 365 42585849
Balance disorder 28.57 17.65 3 35118 47642 42538572
Hepatic infection fungal 28.43 17.65 10 35111 256 42585958
Lymphopenia 28.41 17.65 58 35063 21505 42564709
Capillary leak syndrome 28.32 17.65 21 35100 2686 42583528
Carbamoyl phosphate synthetase deficiency 28.31 17.65 6 35115 18 42586196
Gastrointestinal wall thickening 28.06 17.65 18 35103 1821 42584393
Adenoviral haemorrhagic cystitis 27.92 17.65 12 35109 531 42585683
Chronic graft versus host disease oral 27.63 17.65 11 35110 400 42585814
Enteritis 27.49 17.65 39 35082 10777 42575437
Suicide attempt 27.39 17.65 3 35118 46097 42540117
Confusional state 27.34 17.65 61 35060 167536 42418678
Abdominal discomfort 27.21 17.65 14 35107 75241 42510973
Myelosuppression 27.00 17.65 84 35037 40377 42545837
Eyelid rash 26.80 17.65 8 35113 119 42586095
Hypoglycaemia 26.79 17.65 8 35113 59846 42526368
Metapneumovirus infection 26.69 17.65 15 35106 1193 42585021
Blood creatine phosphokinase increased 26.66 17.65 4 35117 48334 42537880
Iris discolouration 26.57 17.65 5 35116 6 42586208
Post transplant distal limb syndrome 26.50 17.65 11 35110 446 42585768
Electrocardiogram QT prolonged 26.37 17.65 4 35117 47941 42538273
Palpitations 26.25 17.65 5 35116 50792 42535422
Meningoencephalitis herpetic 26.04 17.65 14 35107 1020 42585194
Blood pressure decreased 25.75 17.65 8 35113 58324 42527890
Hepatitis E 25.60 17.65 21 35100 3113 42583101
B-cell lymphoma recurrent 25.50 17.65 13 35108 849 42585365
Staphylococcal bacteraemia 25.22 17.65 38 35083 11083 42575131
Herpes zoster meningoencephalitis 25.19 17.65 11 35110 506 42585708
Inflammatory myofibroblastic tumour 25.18 17.65 8 35113 148 42586066
Colitis 25.13 17.65 90 35031 46482 42539732
Peritoneal lesion 25.08 17.65 8 35113 150 42586064
Abdominal pain upper 24.86 17.65 19 35102 82590 42503624
Blood glucose increased 24.78 17.65 15 35106 73684 42512530
Visceral leishmaniasis 24.61 17.65 14 35107 1140 42585074
Cytogenetic abnormality 24.56 17.65 13 35108 918 42585296
Vision blurred 24.36 17.65 7 35114 53692 42532522
Gastrooesophageal reflux disease 24.21 17.65 4 35117 45019 42541195
Enterococcal bacteraemia 24.19 17.65 19 35102 2648 42583566
Blood lactate dehydrogenase increased 24.15 17.65 61 35060 26020 42560194
Interleukin-2 receptor increased 24.10 17.65 8 35113 171 42586043
Genotoxicity 24.05 17.65 6 35115 43 42586171
Klebsiella sepsis 23.97 17.65 19 35102 2682 42583532
Adenocarcinoma of colon 23.80 17.65 22 35099 3825 42582389
Cryptosporidiosis infection 23.67 17.65 12 35109 775 42585439
Device related sepsis 23.60 17.65 22 35099 3865 42582349
Hyperkalaemia 23.59 17.65 19 35102 80439 42505775
Monoclonal immunoglobulin increased 23.36 17.65 10 35111 438 42585776
Renal failure 23.32 17.65 200 34921 143526 42442688
Ureteric compression 23.29 17.65 9 35112 302 42585912
Pulmonary toxicity 23.18 17.65 32 35089 8623 42577591
Cytomegalovirus colitis 23.15 17.65 22 35099 3959 42582255
Human polyomavirus infection 23.03 17.65 14 35107 1289 42584925
Chest discomfort 22.75 17.65 12 35109 63604 42522610
Neurotoxicity 22.62 17.65 56 35065 23595 42562619
Hypersensitivity 22.61 17.65 16 35105 72354 42513860
Neuromuscular toxicity 22.58 17.65 7 35114 119 42586095
Neoplasm skin 22.56 17.65 13 35108 1084 42585130
Sequestrectomy 22.37 17.65 8 35113 215 42585999
Laryngeal cancer metastatic 22.37 17.65 6 35115 59 42586155
Chronic graft versus host disease in liver 22.22 17.65 11 35110 675 42585539
Neurological decompensation 22.15 17.65 21 35100 3768 42582446
Metastases to spleen 22.14 17.65 10 35111 499 42585715
Mycobacterial infection 22.05 17.65 18 35103 2650 42583564
Lymphocytic leukaemia 22.03 17.65 8 35113 225 42585989
Transplantation associated food allergy 22.01 17.65 6 35115 63 42586151
Adenocarcinoma gastric 21.94 17.65 14 35107 1404 42584810
Bone sarcoma 21.93 17.65 6 35115 64 42586150
Mycobacterium kansasii infection 21.77 17.65 9 35112 361 42585853
Agitation 21.75 17.65 13 35108 64301 42521913
Neoplasm recurrence 21.72 17.65 18 35103 2706 42583508
Heterochromia iridis 21.64 17.65 4 35117 4 42586210
Complications of bone marrow transplant 21.58 17.65 8 35113 239 42585975
Iris neovascularisation 21.57 17.65 5 35116 25 42586189
Acute myeloid leukaemia recurrent 21.56 17.65 20 35101 3492 42582722
Peripheral sensory neuropathy 21.40 17.65 31 35090 8731 42577483
Metastases to bone marrow 21.36 17.65 10 35111 542 42585672
Leukaemia 21.25 17.65 25 35096 5747 42580467
Respiratory failure 21.15 17.65 179 34942 127953 42458261
Stenotrophomonas bacteraemia 21.11 17.65 7 35114 149 42586065
Haemolytic uraemic syndrome 21.07 17.65 17 35104 2462 42583752
Chronic obstructive pulmonary disease 21.01 17.65 13 35108 63101 42523113
Hepatic angiosarcoma 20.99 17.65 6 35115 76 42586138
Leukaemia recurrent 20.64 17.65 15 35106 1861 42584353
Metastases to chest wall 20.52 17.65 8 35113 275 42585939
Staphylococcal skin infection 20.41 17.65 12 35109 1039 42585175
Varicella zoster virus infection 20.35 17.65 17 35104 2584 42583630
Thrombosis 20.30 17.65 16 35105 68495 42517719
Intentional product misuse 20.26 17.65 13 35108 61887 42524327
Fungal infection 20.25 17.65 48 35073 19674 42566540
Loss of consciousness 20.14 17.65 28 35093 92326 42493888
Wheezing 20.09 17.65 10 35111 54771 42531443
Human herpes virus 6 serology positive 20.05 17.65 7 35114 175 42586039
Inflammatory pseudotumour 20.02 17.65 5 35116 36 42586178
Ureaplasma infection 20.01 17.65 10 35111 626 42585588
Expanded disability status scale score increased 20.00 17.65 9 35112 445 42585769
Arthritis 19.99 17.65 5 35116 42060 42544154
Therapeutic product effect decreased 19.92 17.65 4 35117 39146 42547068
Exophthalmos 19.90 17.65 11 35110 847 42585367
Cutaneous T-cell lymphoma 19.79 17.65 15 35106 1983 42584231
Human herpesvirus 6 infection reactivation 19.76 17.65 9 35112 458 42585756
Cardiac failure congestive 19.64 17.65 25 35096 85577 42500637
Hypotension 19.64 17.65 128 34993 257503 42328711
Lichenoid keratosis 19.57 17.65 20 35101 3930 42582284
Dyspepsia 19.49 17.65 5 35116 41347 42544867
Autoimmune pancytopenia 19.41 17.65 6 35115 101 42586113
Device related bacteraemia 19.39 17.65 10 35111 669 42585545
Device related infection 19.37 17.65 48 35073 20231 42565983
Pneumonia respiratory syncytial viral 19.36 17.65 13 35108 1421 42584793
Cardiac arrest 19.32 17.65 38 35083 109282 42476932
Activated partial thromboplastin time shortened 19.31 17.65 9 35112 483 42585731
Gingival erythema 19.30 17.65 6 35115 103 42586111
Candida sepsis 19.27 17.65 13 35108 1432 42584782
Escherichia infection 19.15 17.65 34 35087 11362 42574852
Vomiting 19.14 17.65 150 34971 289573 42296641
Paresis 18.88 17.65 16 35105 2480 42583734
Adenosquamous cell lung cancer 18.87 17.65 4 35117 12 42586202
Delayed engraftment 18.83 17.65 6 35115 112 42586102
Hyperbilirubinaemia 18.83 17.65 48 35073 20587 42565627
Acanthamoeba infection 18.78 17.65 9 35112 514 42585700
Graft complication 18.76 17.65 10 35111 716 42585498
Staphylococcal scalded skin syndrome 18.66 17.65 8 35113 352 42585862
Azoospermia 18.60 17.65 9 35112 525 42585689
Respiratory syncytial virus infection 18.49 17.65 26 35095 7126 42579088
Flushing 18.40 17.65 4 35117 37024 42549190
VIth nerve paresis 18.22 17.65 5 35116 54 42586160
Pneumonia mycoplasmal 18.09 17.65 10 35111 770 42585444
Toxoplasmosis 18.02 17.65 13 35108 1594 42584620
Retinal haemorrhage 18.02 17.65 23 35098 5747 42580467
Vasogenic cerebral oedema 17.97 17.65 11 35110 1025 42585189
Systemic candida 17.88 17.65 22 35099 5297 42580917
Skin neoplasm bleeding 17.79 17.65 4 35117 17 42586197
Hypoglobulinaemia 17.79 17.65 4 35117 17 42586197

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 1358.27 18.97 429 57824 12452 110518594
Mucosal inflammation 1326.33 18.97 750 57503 95391 110435655
Venoocclusive liver disease 1161.89 18.97 397 57856 14810 110516236
Myelodysplastic syndrome 1144.08 18.97 502 57751 36982 110494064
Graft versus host disease 933.64 18.97 357 57896 18449 110512597
Acute graft versus host disease in skin 779.94 18.97 270 57983 10470 110520576
Febrile neutropenia 779.76 18.97 895 57358 315872 110215174
Acute myeloid leukaemia 749.84 18.97 377 57876 37733 110493313
Adenovirus infection 724.07 18.97 257 57996 10737 110520309
Thrombotic microangiopathy 720.13 18.97 337 57916 28812 110502234
Chronic graft versus host disease 710.98 18.97 244 58009 9213 110521833
Cytomegalovirus infection 530.26 18.97 340 57913 54104 110476942
Off label use 528.94 18.97 1856 56397 1498329 109032717
Neutropenia 518.84 18.97 799 57454 373821 110157225
Acute graft versus host disease in intestine 497.03 18.97 164 58089 5475 110525571
Cytomegalovirus infection reactivation 480.88 18.97 221 58032 18112 110512934
Post transplant lymphoproliferative disorder 434.05 18.97 196 58057 15417 110515629
Graft versus host disease in gastrointestinal tract 405.02 18.97 159 58094 8809 110522237
Plasma cell myeloma 403.43 18.97 304 57949 62632 110468414
Thrombocytopenia 389.03 18.97 675 57578 348210 110182836
Graft versus host disease in skin 371.56 18.97 146 58107 8108 110522938
Venoocclusive disease 367.70 18.97 135 58118 6215 110524831
Epstein-Barr virus infection 355.65 18.97 181 58072 18557 110512489
Plasma cell myeloma recurrent 343.35 18.97 132 58121 6910 110524136
Product use in unapproved indication 333.16 18.97 730 57523 446647 110084399
Cytopenia 323.01 18.97 200 58053 29916 110501130
Engraftment syndrome 314.49 18.97 90 58163 1842 110529204
Second primary malignancy 312.59 18.97 164 58089 17904 110513142
Pancytopenia 300.75 18.97 455 57798 209158 110321888
Human herpesvirus 6 infection 291.28 18.97 115 58138 6466 110524580
Epstein-Barr virus infection reactivation 282.31 18.97 99 58154 3985 110527061
Multiple organ dysfunction syndrome 280.77 18.97 372 57881 151338 110379708
Malignant transformation 279.76 18.97 78 58175 1447 110529599
BK virus infection 276.41 18.97 136 58117 12970 110518076
Polyneuropathy 265.68 18.97 181 58072 31831 110499215
Arthralgia 265.12 18.97 46 58207 779586 109751460
Sepsis 253.50 18.97 543 57710 326803 110204243
Neuropathy peripheral 252.63 18.97 386 57867 178891 110352155
Headache 247.08 18.97 79 58174 882298 109648748
Therapy partial responder 239.60 18.97 180 58073 36881 110494165
Disease progression 228.33 18.97 438 57815 243596 110287450
Plasma cell myeloma refractory 224.81 18.97 70 58183 1931 110529115
Malaise 218.98 18.97 44 58209 671775 109859271
Progressive multifocal leukoencephalopathy 218.80 18.97 146 58107 24810 110506236
Osteonecrosis 218.39 18.97 164 58089 33577 110497469
Bacteraemia 214.05 18.97 178 58075 42212 110488834
Vitreous haemorrhage 212.44 18.97 83 58170 4537 110526509
Cystitis haemorrhagic 211.70 18.97 111 58142 12098 110518948
Acute lymphocytic leukaemia 211.36 18.97 88 58165 5677 110525369
Chronic graft versus host disease in skin 210.23 18.97 71 58182 2548 110528498
Acute graft versus host disease in liver 209.45 18.97 69 58184 2290 110528756
Joint swelling 202.17 18.97 7 58246 442838 110088208
Pain 195.62 18.97 132 58121 954823 109576223
Retinal pigment epitheliopathy 189.11 18.97 46 58207 484 110530562
Fatigue 188.02 18.97 219 58034 1215739 109315307
Posterior reversible encephalopathy syndrome 181.03 18.97 147 58106 33714 110497332
Drug hypersensitivity 180.35 18.97 16 58237 454074 110076972
Viraemia 179.15 18.97 71 58182 4031 110527015
Haemophagocytic lymphohistiocytosis 175.07 18.97 140 58113 31419 110499627
Stem cell transplant 173.91 18.97 71 58182 4356 110526690
Septic shock 163.82 18.97 296 57957 157232 110373814
Dizziness 161.92 18.97 83 58170 698110 109832936
Bacterial sepsis 161.67 18.97 88 58165 10338 110520708
Bone marrow failure 159.80 18.97 174 58079 57674 110473372
Cytomegalovirus viraemia 158.31 18.97 105 58148 17659 110513387
Pruritus 155.71 18.97 56 58197 581504 109949542
Bronchopulmonary aspergillosis 154.09 18.97 127 58126 29736 110501310
Peripheral swelling 153.19 18.97 17 58236 404017 110127029
Viral haemorrhagic cystitis 152.53 18.97 60 58193 3339 110527707
Disease recurrence 151.04 18.97 173 58080 60611 110470435
Nasopharyngitis 151.03 18.97 16 58237 394345 110136701
Fall 144.02 18.97 69 58184 603413 109927633
Abdominal discomfort 143.35 18.97 19 58234 393839 110137207
Hypogammaglobulinaemia 137.56 18.97 101 58152 19975 110511071
Transplant failure 135.54 18.97 64 58189 5571 110525475
B-cell type acute leukaemia 134.73 18.97 44 58209 1420 110529626
Engraft failure 132.30 18.97 38 58215 788 110530258
Choroidal infarction 131.41 18.97 29 58224 190 110530856
Alopecia 129.43 18.97 19 58234 364734 110166312
Aplasia 129.19 18.97 69 58184 7804 110523242
Retinal degeneration 129.14 18.97 44 58209 1622 110529424
Renal failure 128.43 18.97 333 57920 226241 110304805
Neutropenic colitis 124.85 18.97 68 58185 7997 110523049
JC virus infection 123.93 18.97 59 58194 5231 110525815
Prothrombin level increased 123.27 18.97 33 58220 522 110530524
Arthropathy 123.11 18.97 7 58246 287515 110243531
Idiopathic pneumonia syndrome 120.88 18.97 36 58217 851 110530195
Pain in extremity 120.36 18.97 53 58200 487065 110043981
Epstein-Barr viraemia 119.09 18.97 51 58202 3528 110527518
Product dose omission issue 115.94 18.97 16 58237 321766 110209280
Haematotoxicity 115.81 18.97 93 58160 20989 110510057
Iris atrophy 115.46 18.97 26 58227 189 110530857
Blood stem cell transplant failure 114.86 18.97 33 58220 685 110530361
Protothecosis 113.77 18.97 31 58222 526 110530520
Urticaria 112.22 18.97 17 58236 318840 110212206
Staphylococcal bacteraemia 112.19 18.97 83 58170 16605 110514441
Pyrexia 111.86 18.97 832 57421 897433 109633613
Therapeutic product effect decreased 110.94 18.97 4 58249 244312 110286734
Chest pain 108.13 18.97 32 58221 376343 110154703
Varicella zoster virus infection 107.85 18.97 57 58196 6311 110524735
Choroidal dystrophy 107.65 18.97 19 58234 27 110531019
Aspergillus infection 105.92 18.97 96 58157 25520 110505526
Wound 105.89 18.97 4 58249 234433 110296613
Dyspnoea 103.73 18.97 273 57980 1106599 109424447
Drug interaction 103.70 18.97 68 58185 500115 110030931
Plasmacytoma 103.24 18.97 52 58201 5210 110525836
Extraocular muscle disorder 100.74 18.97 27 58226 429 110530617
Hypersensitivity 99.70 18.97 44 58209 403954 110127092
Hepatitis B reactivation 99.23 18.97 57 58196 7427 110523619
Asthma 98.81 18.97 9 58244 250282 110280764
Hepatic enzyme increased 98.36 18.97 24 58229 320868 110210178
Human herpesvirus 6 encephalitis 97.71 18.97 32 58221 1042 110530004
Pneumonia cytomegaloviral 97.68 18.97 55 58198 6899 110524147
Pneumonia 94.72 18.97 786 57467 875928 109655118
Anxiety 94.38 18.97 32 58221 345046 110186000
Epstein-Barr virus associated lymphoproliferative disorder 92.89 18.97 47 58206 4755 110526291
Abdominal pain upper 92.70 18.97 34 58219 349077 110181969
Osteonecrosis of jaw 92.21 18.97 120 58133 47897 110483149
Swelling 91.85 18.97 35 58218 351006 110180040
Febrile bone marrow aplasia 91.61 18.97 75 58178 17390 110513656
Enterococcal infection 91.50 18.97 80 58173 20286 110510760
Adenoviral hepatitis 91.45 18.97 30 58223 982 110530064
Eye excision 90.85 18.97 18 58235 63 110530983
Overdose 90.72 18.97 9 58244 233785 110297261
Contusion 90.51 18.97 9 58244 233352 110297694
Tooth extraction 90.46 18.97 66 58187 12925 110518121
Cytomegalovirus test positive 89.07 18.97 52 58201 6984 110524062
B precursor type acute leukaemia 89.05 18.97 25 58228 476 110530570
Myelosuppression 88.91 18.97 170 58083 94170 110436876
Bone debridement 88.59 18.97 24 58229 398 110530648
Basal cell carcinoma 88.28 18.97 114 58139 45156 110485890
Acute respiratory distress syndrome 85.56 18.97 122 58131 53076 110477970
Acute myeloid leukaemia recurrent 84.21 18.97 45 58208 5094 110525952
Depression 84.08 18.97 31 58222 317304 110213742
Diffuse large B-cell lymphoma recurrent 83.58 18.97 48 58205 6251 110524795
Blood cholesterol increased 80.64 18.97 4 58249 184781 110346265
Psoriatic arthropathy 80.63 18.97 6 58247 196755 110334291
Respiratory failure 80.43 18.97 273 57980 215059 110315987
Type 2 diabetes mellitus 80.11 18.97 3 58250 177229 110353817
Drug ineffective 79.82 18.97 1181 57072 1519359 109011687
Lymphopenia 79.65 18.97 102 58151 40068 110490978
Osteoarthritis 79.55 18.97 4 58249 182619 110348427
Weight increased 79.18 18.97 63 58190 419581 110111465
Parainfluenzae virus infection 79.05 18.97 48 58205 6926 110524120
Discomfort 78.93 18.97 10 58243 214697 110316349
Wheezing 78.38 18.97 19 58234 255211 110275835
Mobility decreased 78.36 18.97 15 58238 237407 110293639
Graft versus host disease in liver 78.32 18.97 34 58219 2431 110528615
Blister 78 18.97 13 58240 227363 110303683
Retinal toxicity 76.96 18.97 30 58223 1629 110529417
Cystitis viral 76.79 18.97 29 58224 1444 110529602
Insomnia 76.09 18.97 48 58205 360542 110170504
Blood pressure increased 75.97 18.97 21 58232 258352 110272694
Condition aggravated 75.15 18.97 173 58080 734663 109796383
Eyelid oedema 74.77 18.97 63 58190 15199 110515847
Refractory cytopenia with multilineage dysplasia 74.64 18.97 19 58234 244 110530802
Dry mouth 74.26 18.97 9 58244 199939 110331107
Migraine 74.01 18.97 4 58249 171648 110359398
Atrophy of globe 73.55 18.97 15 58238 63 110530983
Human herpesvirus 6 infection reactivation 72.82 18.97 26 58227 1103 110529943
Systemic candida 72.47 18.97 52 58201 9922 110521124
Folliculitis 71.99 18.97 4 58249 167649 110363397
Bacterial infection 71.73 18.97 104 58149 45932 110485114
Sleep disorder 71.23 18.97 10 58243 198634 110332412
Leukaemia 70.78 18.97 46 58207 7472 110523574
Muscle spasms 70.66 18.97 29 58224 278128 110252918
Mucosal disorder 70.48 18.97 38 58215 4379 110526667
Pneumonia adenoviral 70.27 18.97 22 58231 618 110530428
Mucoepidermoid carcinoma of salivary gland 69.27 18.97 16 58237 132 110530914
Chronic graft versus host disease in intestine 68.64 18.97 22 58231 668 110530378
Infusion related reaction 68.48 18.97 60 58193 381102 110149944
Autoimmune neutropenia 67.99 18.97 22 58231 689 110530357
Drug resistance 67.77 18.97 113 58140 56261 110474785
Infection reactivation 67.62 18.97 36 58217 4045 110527001
Feeling abnormal 67.44 18.97 8 58245 180703 110350343
Premature menopause 67.22 18.97 24 58229 1018 110530028
Candida infection 66.99 18.97 103 58150 47906 110483140
Malignant neoplasm progression 66.66 18.97 223 58030 174344 110356702
Somnolence 66.40 18.97 37 58216 297412 110233634
Osteolysis 65.15 18.97 39 58214 5484 110525562
Weight decreased 65.06 18.97 91 58162 467966 110063080
Drug intolerance 64.93 18.97 71 58182 406441 110124605
Refractory anaemia with an excess of blasts 64.21 18.97 22 58231 825 110530221
Herpes zoster 64.15 18.97 162 58091 108217 110422829
Myalgia 63.66 18.97 19 58234 222362 110308684
Injury 63.38 18.97 9 58244 177256 110353790
Hepatitis E 61.91 18.97 35 58218 4424 110526622
Retinal detachment 61.03 18.97 49 58204 11051 110519995
Pericarditis 60.44 18.97 20 58233 219094 110311952
Gastrooesophageal reflux disease 60.17 18.97 11 58242 179965 110351081
Rash 60.16 18.97 226 58027 820738 109710308
Encephalitis 59.72 18.97 61 58192 18778 110512268
Colitis 59.57 18.97 152 58101 102171 110428875
Arthritis 58.78 18.97 9 58244 167577 110363469
Squamous cell carcinoma of skin 58.75 18.97 58 58195 17145 110513901
Klebsiella sepsis 58.75 18.97 33 58220 4120 110526926
Pneumonia fungal 58.47 18.97 54 58199 14700 110516346
Cytomegalovirus chorioretinitis 58.40 18.97 40 58213 7088 110523958
Staphylococcal sepsis 58.05 18.97 58 58195 17396 110513650
Pericardial effusion 57.50 18.97 106 58147 57111 110473935
Dyspepsia 57.11 18.97 15 58238 190950 110340096
Pneumonia respiratory syncytial viral 56.39 18.97 28 58225 2721 110528325
Inflammation 56.25 18.97 16 58237 193222 110337824
Hyperhidrosis 55.47 18.97 15 58238 187283 110343763
Musculoskeletal pain 55.45 18.97 14 58239 183009 110348037
Eyelid rash 54.94 18.97 17 58236 459 110530587
Palpitations 54.83 18.97 9 58244 159203 110371843
Ureaplasma infection 54.66 18.97 23 58230 1523 110529523
Memory impairment 54.28 18.97 18 58235 196926 110334120
Hepatitis B 54.06 18.97 43 58210 9569 110521477
Human herpesvirus 8 infection 53.61 18.97 24 58229 1847 110529199
Bursitis 53.11 18.97 4 58249 129914 110401132
Mantle cell lymphoma recurrent 52.77 18.97 20 58233 1006 110530040
Bone sequestrum 52.65 18.97 21 58232 1212 110529834
Gastrointestinal toxicity 52.53 18.97 45 58208 11103 110519943
Adenoviral haemorrhagic cystitis 52.51 18.97 18 58235 676 110530370
Gastrointestinal inflammation 52.49 18.97 42 58211 9427 110521619
Gastroenteritis adenovirus 52.02 18.97 16 58237 423 110530623
Respiratory syncytial virus infection 51.65 18.97 50 58203 14434 110516612
Adenovirus reactivation 51.38 18.97 18 58235 722 110530324
Nausea 50.51 18.97 413 57840 1235277 109295769
Gastrointestinal fungal infection 50.47 18.97 18 58235 761 110530285
Neck pain 49.75 18.97 4 58249 123126 110407920
Asthenia 49.58 18.97 191 58062 688808 109842238
Balance disorder 49.37 18.97 3 58250 116557 110414489
Acute kidney injury 49.10 18.97 531 57722 634899 109896147
Bone disorder 48.76 18.97 58 58195 21134 110509912
Sinusitis 48.27 18.97 51 58202 296637 110234409
Psoriasis 48.01 18.97 8 58245 139985 110391061
Pneumocystis jirovecii pneumonia 47.85 18.97 83 58170 42652 110488394
Disturbance in social behaviour 47.75 18.97 31 58222 5027 110526019
Unevaluable event 47.72 18.97 100 58153 59127 110471919
Clostridium difficile colitis 47.68 18.97 84 58169 43694 110487352
Bone marrow transplant rejection 47.66 18.97 14 58239 315 110530731
Chronic graft versus host disease in liver 47.52 18.97 18 58235 904 110530142
Metapneumovirus infection 47.50 18.97 24 58229 2420 110528626
Leukaemia recurrent 47.36 18.97 26 58227 3105 110527941
Cerebral toxoplasmosis 47.27 18.97 26 58227 3116 110527930
Debridement 47.18 18.97 22 58231 1861 110529185
Back pain 46.83 18.97 77 58176 370919 110160127
Hypoaesthesia 46.80 18.97 58 58195 314165 110216881
Ameloblastoma 46.47 18.97 11 58242 102 110530944
Retinopathy 46.42 18.97 29 58224 4400 110526646
Enterococcal bacteraemia 46.23 18.97 29 58224 4432 110526614
Inappropriate schedule of product administration 45.91 18.97 25 58228 203612 110327434
Complications of bone marrow transplant 45.66 18.97 16 58237 642 110530404
Infection 45.13 18.97 336 57917 361864 110169182
Systemic mycosis 45.07 18.97 27 58226 3802 110527244
Gait disturbance 45.06 18.97 48 58205 278160 110252886
Plasma cell leukaemia 45.01 18.97 22 58231 2066 110528980
Oesophagitis 44.92 18.97 65 58188 28650 110502396
Nasal abscess 44.87 18.97 12 58241 189 110530857
Fungaemia 44.84 18.97 32 58221 6054 110524992
Heterochromia iridis 44.68 18.97 8 58245 13 110531033
Hypogonadism female 44.31 18.97 8 58245 14 110531032
Iris neovascularisation 43.56 18.97 10 58243 80 110530966
Haemolytic uraemic syndrome 43.29 18.97 29 58224 4956 110526090
Meningomyelitis herpes 43.24 18.97 10 58243 83 110530963
Retinopathy proliferative 42.74 18.97 11 58242 148 110530898
Cerebrovascular accident 42.73 18.97 21 58232 181263 110349783
Rhinovirus infection 42.61 18.97 41 58212 11748 110519298
Retinal haemorrhage 42.03 18.97 37 58216 9464 110521582
Retinal depigmentation 41.94 18.97 13 58240 353 110530693
Jaw operation 41.78 18.97 16 58237 828 110530218
Joint range of motion decreased 41.69 18.97 7 58246 121825 110409221
Leukopenia 41.64 18.97 172 58081 148619 110382427
Aspiration bone marrow 41.27 18.97 11 58242 171 110530875
Retinogram abnormal 41.26 18.97 13 58240 373 110530673
Drug abuse 41.15 18.97 21 58232 177390 110353656
Intentional product use issue 41.13 18.97 247 58006 247659 110283387
Night sweats 41.07 18.97 10 58243 133973 110397073
Toxicity to various agents 41.07 18.97 410 57843 480145 110050901
Neurotoxicity 40.91 18.97 77 58176 42130 110488916
Autologous haematopoietic stem cell transplant 40.79 18.97 10 58243 109 110530937
Osteosarcoma 39.91 18.97 13 58240 416 110530630
Pleural effusion 39.62 18.97 192 58061 177517 110353529
Cytogenetic abnormality 39.57 18.97 17 58236 1185 110529861
Acute lymphocytic leukaemia recurrent 39.38 18.97 29 58224 5758 110525288
VIth nerve paralysis 39.24 18.97 19 58234 1748 110529298
Klebsiella bacteraemia 39.13 18.97 27 58226 4842 110526204
Pre-engraftment immune reaction 39.04 18.97 13 58240 446 110530600
Peripheral sensory neuropathy 38.95 18.97 46 58207 16634 110514412
Capillary leak syndrome 38.93 18.97 27 58226 4881 110526165
Loss of consciousness 38.87 18.97 28 58225 196278 110334768
Transformation to acute myeloid leukaemia 38.80 18.97 18 58235 1505 110529541
Gastrointestinal mucosal disorder 38.54 18.97 17 58236 1263 110529783
Inflammatory myofibroblastic tumour 38.53 18.97 11 58242 223 110530823
Lip dry 38.42 18.97 4 58249 100079 110430967
Cytokine release syndrome 38.41 18.97 102 58151 70204 110460842
Confusional state 38.32 18.97 123 58130 468557 110062489
Chronic graft versus host disease oral 38.19 18.97 13 58240 478 110530568
Renal impairment 38.06 18.97 198 58055 188247 110342799
Lymphoproliferative disorder 37.86 18.97 31 58222 7187 110523859
Actinomycosis 37.80 18.97 17 58236 1323 110529723
Hospitalisation 37.58 18.97 14 58239 142479 110388567
Rash pruritic 37.44 18.97 4 58249 98065 110432981
Vomiting 37.30 18.97 304 57949 910371 109620675
Myocardial infarction 37.25 18.97 28 58225 192055 110338991
Rhabdomyolysis 36.87 18.97 9 58244 120392 110410654
Rotavirus infection 36.86 18.97 15 58238 912 110530134
Klebsiella infection 36.85 18.97 49 58204 19960 110511086
Chest discomfort 36.84 18.97 23 58230 173825 110357221
Apoptosis 36.79 18.97 14 58239 712 110530334
Autoimmune haemolytic anaemia 36.78 18.97 36 58217 10531 110520515
Pulmonary toxicity 36.66 18.97 46 58207 17700 110513346
Gait inability 36.64 18.97 13 58240 136363 110394683
Pseudomonas infection 36.41 18.97 58 58195 27795 110503251
Gastrointestinal wall thickening 36.16 18.97 23 58230 3600 110527446
Delayed engraftment 36.12 18.97 11 58242 281 110530765
Escherichia infection 35.93 18.97 53 58200 23763 110507283
Bronchospasm 35.52 18.97 60 58193 30179 110500867
Enterococcal sepsis 35.51 18.97 22 58231 3290 110527756
Vision blurred 35.18 18.97 12 58241 129010 110402036
Cardiomyopathy 34.81 18.97 63 58190 33462 110497584
Neutropenic sepsis 34.79 18.97 60 58193 30686 110500360
Renal amyloidosis 34.70 18.97 11 58242 322 110530724
Swelling face 34.66 18.97 4 58249 92317 110438729
Escherichia bacteraemia 34.21 18.97 34 58219 10130 110520916
Mastication disorder 34.17 18.97 22 58231 3516 110527530
Cryptosporidiosis infection 33.84 18.97 15 58238 1128 110529918
Meningoencephalitis herpetic 33.74 18.97 19 58234 2383 110528663
Neuralgic amyotrophy 33.65 18.97 11 58242 356 110530690
B-cell lymphoma recurrent 33.65 18.97 15 58238 1143 110529903
Blood lactate dehydrogenase increased 33.58 18.97 73 58180 44261 110486785
Adenocarcinoma of colon 33.43 18.97 27 58226 6141 110524905
Fungal infection 33.30 18.97 79 58174 50727 110480319
Eyelid ptosis 33.20 18.97 38 58215 13289 110517757
Human polyomavirus infection 33.00 18.97 17 58236 1785 110529261
Pulmonary haemorrhage 32.95 18.97 42 58211 16414 110514632
Drug ineffective for unapproved indication 32.90 18.97 124 58129 102714 110428332
Diffuse large B-cell lymphoma 32.51 18.97 41 58212 15857 110515189
Follicular thyroid cancer 32.32 18.97 8 58245 91 110530955
Hyperbilirubinaemia 32.30 18.97 58 58195 30613 110500433
Platelet count decreased 32.29 18.97 220 58033 230223 110300823
Cytomegalovirus colitis 32.25 18.97 28 58225 7033 110524013
Mycobacterial infection 32.03 18.97 23 58230 4394 110526652
Peripheral sensorimotor neuropathy 32.00 18.97 22 58231 3921 110527125
Blood glucose increased 31.76 18.97 15 58238 132481 110398565
Feeling hot 31.70 18.97 5 58248 91101 110439945
Premature ageing 31.63 18.97 8 58245 100 110530946
Sequestrectomy 31.45 18.97 13 58240 823 110530223
Herpes zoster meningoencephalitis 31.44 18.97 14 58239 1064 110529982
Encephalopathy 31.32 18.97 104 58149 80951 110450095
Hypoglycaemia 31.31 18.97 11 58242 116093 110414953
Metastatic lymphoma 31.17 18.97 12 58241 630 110530416
Morganella infection 31.14 18.97 15 58238 1364 110529682
Transplantation complication 31.10 18.97 11 58242 454 110530592
Pulmonary arterial hypertension 31.05 18.97 59 58194 32509 110498537
Carbamoyl phosphate synthetase deficiency 30.99 18.97 6 58247 18 110531028
Neutrophil count decreased 30.89 18.97 136 58117 120805 110410241
Post transplant distal limb syndrome 30.75 18.97 13 58240 871 110530175
Sinus polyp 30.65 18.97 12 58241 659 110530387
Hyperammonaemia 30.63 18.97 37 58216 13695 110517351
Amnesia 30.17 18.97 9 58244 105399 110425647
Lower respiratory tract infection 30.15 18.97 51 58202 243055 110287991
Gingivitis ulcerative 29.90 18.97 11 58242 509 110530537
Encephalitis viral 29.79 18.97 19 58234 2988 110528058
Ejection fraction abnormal 29.74 18.97 20 58233 3440 110527606
Aplastic anaemia 29.58 18.97 49 58204 24259 110506787
Ovarian failure 29.51 18.97 13 58240 963 110530083
Papilloma 29.47 18.97 11 58242 530 110530516
Renal tubular injury 29.22 18.97 19 58234 3089 110527957
Metastases to muscle 29.19 18.97 10 58243 375 110530671
Lung infiltration 29.10 18.97 49 58204 24579 110506467
Paraesthesia 29.08 18.97 64 58189 276457 110254589
Liver injury 29.07 18.97 22 58231 150391 110380655
Cardiotoxicity 29.05 18.97 40 58213 16841 110514205
Nasal congestion 28.85 18.97 8 58245 98274 110432772
Iris discolouration 28.81 18.97 5 58248 6 110531040
C-reactive protein increased 28.64 18.97 44 58209 217875 110313171
Viral diarrhoea 28.47 18.97 11 58242 583 110530463
Chronic myelomonocytic leukaemia 28.45 18.97 13 58240 1050 110529996
Device related sepsis 28.40 18.97 27 58226 7620 110523426
Rhegmatogenous retinal detachment 28.34 18.97 9 58244 265 110530781
Stomatitis 28.32 18.97 241 58012 270001 110261045
Chronic graft versus host disease in eye 28.22 18.97 10 58243 415 110530631
Keratopathy 28.21 18.97 14 58239 1359 110529687
Metastases to retroperitoneum 28.15 18.97 10 58243 418 110530628
Pharyngeal inflammation 28.06 18.97 15 58238 1699 110529347
Cardiac failure 28.02 18.97 182 58071 187444 110343602
Myositis 27.99 18.97 55 58198 31061 110499985
Anal squamous cell carcinoma 27.88 18.97 12 58241 840 110530206
Oral disorder 27.86 18.97 33 58220 11970 110519076
Constipation 27.78 18.97 96 58157 357690 110173356
Pneumatosis intestinalis 27.73 18.97 28 58225 8501 110522545
Graft complication 27.66 18.97 13 58240 1119 110529927
Deep vein thrombosis 27.57 18.97 146 58107 139741 110391305
Malignant melanoma 27.54 18.97 39 58214 16852 110514194
Pulmonary veno-occlusive disease 27.52 18.97 16 58237 2132 110528914
Abdominal distension 27.47 18.97 31 58222 175072 110355974
Ascites 27.32 18.97 109 58144 92699 110438347
Ureteric compression 27.14 18.97 9 58244 305 110530741
Pneumonia parainfluenzae viral 27.01 18.97 11 58242 670 110530376
Abdominal pain 27.00 18.97 159 58094 512830 110018216
Dysphonia 26.80 18.97 4 58249 75925 110455121
Acute promyelocytic leukaemia 26.64 18.97 15 58238 1881 110529165
Cytomegalovirus enterocolitis 26.63 18.97 16 58237 2265 110528781
Ototoxicity 26.54 18.97 20 58233 4111 110526935
Amyloidosis 26.41 18.97 18 58235 3163 110527883
Ventricular hypokinesia 26.31 18.97 31 58222 11183 110519863
Sedation 26.20 18.97 3 58250 69680 110461366
Pathogen resistance 26.19 18.97 39 58214 17633 110513413
Cardiac tamponade 26.10 18.97 31 58222 11276 110519770
Retinal ischaemia 25.96 18.97 12 58241 995 110530051
Embryonal rhabdomyosarcoma 25.71 18.97 6 58247 52 110530994
Mucocutaneous ulceration 25.64 18.97 11 58242 764 110530282
Oxygen saturation decreased 25.50 18.97 27 58226 156955 110374091
Injection site erythema 25.26 18.97 9 58244 94167 110436879
Gastroenteritis clostridial 25.18 18.97 12 58241 1066 110529980
Osteomyelitis 25.17 18.97 58 58195 36542 110494504
Ileus paralytic 25.17 18.97 31 58222 11706 110519340
Peritonitis viral 25.12 18.97 6 58247 58 110530988
Herpes simplex 25.12 18.97 36 58217 15728 110515318
Joint stiffness 25.02 18.97 3 58250 67240 110463806
Visceral leishmaniasis 24.97 18.97 14 58239 1742 110529304
Mycobacterium kansasii infection 24.79 18.97 9 58244 401 110530645
Blood pressure decreased 24.69 18.97 15 58238 115076 110415970
Blood bilirubin increased 24.63 18.97 92 58161 75880 110455166
Endocarditis bacterial 24.61 18.97 14 58239 1791 110529255
Autonomic nervous system imbalance 24.56 18.97 22 58231 5758 110525288
Nephrolithiasis 24.53 18.97 3 58250 66209 110464837
POEMS syndrome 24.51 18.97 6 58247 65 110530981
Influenza like illness 24.49 18.97 8 58245 88404 110442642
Lower limb fracture 24.34 18.97 5 58248 75343 110455703
Myeloma cast nephropathy 24.29 18.97 8 58245 265 110530781
Neoplasm progression 24.17 18.97 82 58171 64513 110466533
Nephropathy toxic 24.03 18.97 48 58205 27430 110503616
Iris adhesions 23.95 18.97 10 58243 649 110530397
Vertigo 23.82 18.97 8 58245 86862 110444184
Tonsillar haemorrhage 23.61 18.97 8 58245 290 110530756
Minimal residual disease 23.46 18.97 11 58242 942 110530104
Schistocytosis 23.43 18.97 6 58247 79 110530967
Myelitis transverse 23.36 18.97 15 58238 2386 110528660
Blood creatine phosphokinase increased 23.30 18.97 5 58248 73072 110457974
Graft versus host disease in lung 23.24 18.97 12 58241 1266 110529780
Lymphocytic leukaemia 23.22 18.97 8 58245 305 110530741
Hepatomegaly 23.20 18.97 41 58212 21373 110509673
Administration related reaction 23.17 18.97 8 58245 307 110530739
Gastrointestinal disorder 23.05 18.97 59 58194 241893 110289153
Scedosporium infection 23.04 18.97 15 58238 2443 110528603
Hepatic failure 22.92 18.97 84 58169 68655 110462391
Jugular vein occlusion 22.90 18.97 6 58247 87 110530959
Enterocolitis 22.79 18.97 38 58215 18911 110512135
Adenocarcinoma gastric 22.77 18.97 14 58239 2065 110528981
Microangiopathy 22.76 18.97 16 58237 2956 110528090
Coronary artery disease 22.66 18.97 5 58248 71685 110459361
Hepatic infection fungal 22.60 18.97 8 58245 331 110530715
Rhinorrhoea 22.56 18.97 13 58240 102653 110428393
Bone lesion 22.56 18.97 23 58230 7064 110523982
Frequent bowel movements 22.53 18.97 5 58248 71385 110459661
COVID-19 pneumonia 22.47 18.97 56 58197 37087 110493959
Cognitive disorder 22.41 18.97 9 58244 87502 110443544
Growth retardation 22.37 18.97 15 58238 2567 110528479
Stenotrophomonas infection 22.36 18.97 21 58232 5837 110525209
Streptococcal bacteraemia 22.31 18.97 19 58234 4650 110526396
Endothelial dysfunction 22.28 18.97 8 58245 345 110530701
Device related infection 22.26 18.97 58 58195 39461 110491585
Adverse event 22.22 18.97 15 58238 108794 110422252
Herpes virus infection 22.15 18.97 25 58228 8613 110522433
Pleuroparenchymal fibroelastosis 22.06 18.97 8 58245 355 110530691
Flushing 21.99 18.97 14 58239 104722 110426324
Visual impairment 21.97 18.97 23 58230 134405 110396641
Autoimmune disorder 21.88 18.97 4 58249 65479 110465567
Retinal artery occlusion 21.77 18.97 18 58235 4231 110526815
Immune system disorder 21.76 18.97 31 58222 13470 110517576
Hyperammonaemic encephalopathy 21.75 18.97 20 58233 5414 110525632
Bladder hypertrophy 21.74 18.97 11 58242 1113 110529933
Chronic myeloid leukaemia 21.68 18.97 18 58235 4255 110526791
White blood cell count increased 21.66 18.97 12 58241 96830 110434216
Hepatic angiosarcoma 21.58 18.97 6 58247 110 110530936
Metastases to spleen 21.58 18.97 10 58243 834 110530212
Fusarium infection 21.41 18.97 15 58238 2756 110528290
Pneumonia pseudomonal 21.36 18.97 23 58230 7523 110523523
Gastrointestinal injury 21.32 18.97 13 58240 1890 110529156
Neurological decompensation 21.30 18.97 22 58231 6861 110524185
Ill-defined disorder 21.26 18.97 31 58222 156822 110374224
Enteritis 21.17 18.97 37 58216 19119 110511927
Respiratory distress 21.17 18.97 82 58171 68792 110462254
Monoclonal immunoglobulin increased 21.16 18.97 9 58244 612 110530434
Acanthamoeba infection 21.13 18.97 9 58244 614 110530432
Atrial fibrillation 21.08 18.97 199 58054 229443 110301603
Retinal vascular occlusion 21.06 18.97 9 58244 619 110530427
Lichenoid keratosis 21.06 18.97 21 58232 6281 110524765
Eczema 21.00 18.97 6 58247 72287 110458759
Dysarthria 20.98 18.97 9 58244 84112 110446934
Electrocardiogram QT prolonged 20.97 18.97 16 58237 108944 110422102
Leukoencephalopathy 20.88 18.97 25 58228 9170 110521876
Device related bacteraemia 20.80 18.97 11 58242 1219 110529827
Laryngeal cancer metastatic 20.78 18.97 5 58248 50 110530996
Anaemia 20.78 18.97 404 57849 546682 109984364
Herpes zoster reactivation 20.74 18.97 8 58245 422 110530624
Human herpes virus 6 serology positive 20.73 18.97 7 58246 251 110530795
Azoospermia 20.73 18.97 7 58246 251 110530795
Osteoporosis 20.68 18.97 10 58243 87142 110443904
Anaphylactic reaction 20.49 18.97 18 58235 114282 110416764
Tumour lysis syndrome 20.30 18.97 48 58205 30753 110500293
Transplantation associated food allergy 20.26 18.97 6 58247 139 110530907
Central nervous system haemorrhage 20.20 18.97 8 58245 453 110530593
Hyperbaric oxygen therapy 20.11 18.97 5 58248 58 110530988
Atrial rupture 20.03 18.97 5 58248 59 110530987
Oesophageal squamous cell carcinoma stage IV 19.97 18.97 4 58249 15 110531031
Injection site reaction 19.97 18.97 11 58242 89059 110441987
Metastases to bone marrow 19.83 18.97 10 58243 1004 110530042
Pulmonary alveolar haemorrhage 19.82 18.97 37 58216 20113 110510933
Haematochezia 19.75 18.97 19 58234 115505 110415541
Meningitis bacterial 19.73 18.97 15 58238 3124 110527922
Pulmonary hypertension 19.70 18.97 69 58184 55151 110475895
IIIrd nerve paralysis 19.49 18.97 11 58242 1386 110529660
Type III immune complex mediated reaction 19.48 18.97 10 58243 1043 110530003
Red cell fragmentation syndrome 19.45 18.97 5 58248 67 110530979
Toxoplasmosis 19.32 18.97 15 58238 3224 110527822
Malignant neoplasm of unknown primary site 19.18 18.97 9 58244 772 110530274
Lower respiratory tract infection viral 19.17 18.97 11 58242 1430 110529616
Acute leukaemia 19.11 18.97 12 58241 1837 110529209
Organising pneumonia 19.09 18.97 30 58223 14213 110516833
Liposarcoma 19.09 18.97 7 58246 321 110530725
Rectal haemorrhage 19.03 18.97 21 58232 119812 110411234
Clostridium colitis 19.01 18.97 15 58238 3300 110527746
Neuroblastoma recurrent 18.98 18.97 8 58245 532 110530514

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 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 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:35705 immunosuppressive agent
CHEBI has role CHEBI:50903 carcinogenic agent
CHEBI has role CHEBI:67079 anti-inflammatory agent
CHEBI has role CHEBI:75835 anti-anaemic agent
CHEBI has role CHEBI:88188 drug allergen
CHEBI has role CHEBI:233423 antifibrotic agent

Related Drugs by ATC class:

L01AA Nitrogen mustard analogues 8 drugs
bendamustinechlorambucilcyclophosphamideifosfamidemechlorethaminemelphalan flufenamideprednimustinetrofosfamide

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
EQ 50MG BASE/VIAL HEPZATO DELCATH SYSTEMS INC N201848 Aug. 14, 2023 RX POWDER INTRA-ARTERIAL 10569004 Nov. 7, 2032 A METHOD FOR TREATING A SUBJECT WITH UVEAL MELANOMA WITH UNRESECTABLE HEPATIC METASTASES
EQ 50MG BASE/VIAL HEPZATO DELCATH SYSTEMS INC N201848 Aug. 14, 2023 RX POWDER INTRA-ARTERIAL 10569004 Nov. 7, 2032 A METHOD OF TREATING A PATIENT WITH UVEAL MELANOMA WITH UNRESECTABLE HEPATIC METASTASES
EQ 50MG BASE/VIAL HEPZATO DELCATH SYSTEMS INC N201848 Aug. 14, 2023 RX POWDER INTRA-ARTERIAL 11633528 Nov. 7, 2032 A PERCUTANEOUS HEPATIC PERFUSION PROCEDURE FOR TREATING A PATIENT WITH UVEAL MELANOMA WITH UNRESECTABLE HEPATIC METASTASES

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
EQ 50MG BASE/VIAL HEPZATO DELCATH SYSTEMS INC N201848 Aug. 14, 2023 RX POWDER INTRA-ARTERIAL Aug. 14, 2026 NEW PRODUCT
EQ 50MG BASE/VIAL HEPZATO DELCATH SYSTEMS INC N201848 Aug. 14, 2023 RX POWDER INTRA-ARTERIAL Aug. 14, 2030 AS A LIVER-DIRECTED TREATMENT FOR ADULT PATIENTS WITH UVEAL MELANOMA WITH UNRESECTABLE HEPATIC METASTASES AFFECTING LESS THAN 50% OF THE LIVER AND NO EXTRAHEPATIC DISEASE OR EXTRAHEPATIC DISEASE LIMITED TO THE BONE, LYMPH NODES, SUBCUTANEOUS TISSUES, OR LUNG THAT IS AMENABLE TO RESECTION OR RADIATION

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
VUC PDB_CHEM_ID
CHEMBL852 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
IVRA HUMAN PRESCRIPTION DRUG LABEL 1 60505-6414 INJECTION, SOLUTION 90 mg INTRAVENOUS NDA 26 sections
EVOMELA Human Prescription Drug Label 1 72893-001 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 50 mg INTRAVENOUS NDA 26 sections
IVRA HUMAN PRESCRIPTION DRUG LABEL 1 80978-641 INJECTION 90 mg INTRAVENOUS NDA 18 sections