cytarabine ๐Ÿถ Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
nucleosides antiviral or antineoplastic agents, cytarabine or azacitidine derivatives 770 147-94-4

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • cytarabine hydrochloride
  • cytarabine
  • arabinocytosine
  • Arabinoside C
  • aracytidine
  • cyclocide
  • cytarabin
  • cytarabinoside
  • cytosine beta-D-arabinofuranoside
  • cytarabine liposome
  • cytarabine HCl
A pyrimidine nucleoside analog that is used mainly in the treatment of leukemia, especially acute non-lymphoblastic leukemia. Cytarabine is an antimetabolite antineoplastic agent that inhibits the synthesis of DNA. Its actions are specific for the S phase of the cell cycle. It also has antiviral and immunosuppressant properties. (From Martindale, The Extra Pharmacopoeia, 30th ed, p472)
  • Molecular weight: 243.22
  • Formula: C9H13N3O5
  • CLOGP: -2.19
  • LIPINSKI: 0
  • HAC: 8
  • HDO: 4
  • TPSA: 128.61
  • ALOGS: -0.74
  • ROTB: 2

  • Status: OFP

  • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

None

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 1 Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 11 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 11.10 ยตM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 20 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 0.67 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 41.67 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.87 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 0.17 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
Aug. 21, 2020 PMDA Nippon Shinyaku Co., Ltd.
June 17, 1969 FDA
July 11, 2001 EMA PACIRA LIMITED

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
Febrile neutropenia 3938.73 18.51 1958 53369 116491 63317204
Mucosal inflammation 720.18 18.51 470 54857 46458 63387237
Neutropenia 714.19 18.51 819 54508 174186 63259509
Febrile bone marrow aplasia 710.78 18.51 260 55067 7065 63426630
Bone marrow failure 700.07 18.51 390 54937 28900 63404795
Pancytopenia 649.45 18.51 593 54734 96340 63337355
Thrombocytopenia 620.80 18.51 710 54617 150447 63283248
Venoocclusive liver disease 603.74 18.51 207 55120 4628 63429067
Septic shock 599.93 18.51 483 54844 66146 63367549
Sepsis 526.22 18.51 657 54670 152466 63281229
Haematotoxicity 496.63 18.51 215 55112 9161 63424534
Disease progression 399.69 18.51 513 54814 122245 63311450
Acute myeloid leukaemia 397.80 18.51 224 55103 16923 63416772
Neurotoxicity 375.43 18.51 215 55112 16775 63416920
Neutropenic colitis 368.90 18.51 128 55199 2967 63430728
Posterior reversible encephalopathy syndrome 352.80 18.51 208 55119 17137 63416558
Acute myeloid leukaemia recurrent 344.47 18.51 104 55223 1519 63432176
Myelosuppression 340.55 18.51 228 55099 23475 63410220
Multiple organ dysfunction syndrome 338.92 18.51 326 55001 56426 63377269
Pain 329.44 18.51 118 55209 740510 62693185
Arthralgia 322.23 18.51 55 55272 569655 62864040
Myelodysplastic syndrome 312.42 18.51 190 55137 16564 63417131
Pyrexia 307.50 18.51 1003 54324 469475 62964220
Fatigue 304.90 18.51 201 55126 887827 62545868
Aplasia 300.96 18.51 120 55207 4139 63429556
Bronchopulmonary aspergillosis 276.96 18.51 140 55187 8495 63425200
Leukoencephalopathy 276.33 18.51 114 55213 4299 63429396
Acute lymphocytic leukaemia recurrent 274.91 18.51 95 55232 2174 63431521
Joint swelling 269.60 18.51 3 55324 327663 63106032
Hypofibrinogenaemia 261.38 18.51 78 55249 1092 63432603
Diffuse large B-cell lymphoma recurrent 253.72 18.51 90 55237 2230 63431465
Neoplasm recurrence 220.63 18.51 84 55243 2554 63431141
Myelopathy 218.54 18.51 85 55242 2741 63430954
Alopecia 215.77 18.51 22 55305 337514 63096181
Abdominal discomfort 215.65 18.51 17 55310 320868 63112827
Mucormycosis 213.72 18.51 84 55243 2787 63430908
Tumour lysis syndrome 209.98 18.51 118 55209 8872 63424823
Bacteraemia 207.20 18.51 149 55178 17199 63416496
Haemophagocytic lymphohistiocytosis 207.10 18.51 124 55203 10503 63423192
Leukaemia recurrent 205.63 18.51 67 55260 1271 63432424
Enterococcal infection 199.72 18.51 109 55218 7739 63425956
Second primary malignancy 198.36 18.51 109 55218 7844 63425851
Blood culture positive 197.80 18.51 92 55235 4643 63429052
Fall 196.55 18.51 50 55277 392284 63041411
Graft versus host disease 194.79 18.51 102 55225 6661 63427034
Pneumonia fungal 191.36 18.51 94 55233 5361 63428334
Colitis 190.35 18.51 223 55104 48305 63385390
Product dose omission issue 184.82 18.51 4 55323 234309 63199386
Dizziness 183.09 18.51 73 55254 429852 63003843
Aspergillus infection 183.00 18.51 104 55223 7989 63425706
Hyperbilirubinaemia 182.39 18.51 117 55210 11197 63422498
Cardiotoxicity 176.31 18.51 103 55224 8335 63425360
Nasopharyngitis 174.98 18.51 12 55315 254245 63179450
Arthropathy 174.34 18.51 7 55320 234785 63198910
Platelet count decreased 173.76 18.51 340 54987 115782 63317913
Product use in unapproved indication 171.83 18.51 439 54888 178641 63255054
Fungaemia 167.33 18.51 67 55260 2336 63431359
Systemic lupus erythematosus 167.03 18.51 3 55324 208915 63224780
Diffuse large B-cell lymphoma refractory 166.63 18.51 56 55271 1174 63432521
Venoocclusive disease 166.61 18.51 64 55263 1994 63431701
Peripheral swelling 163.16 18.51 20 55307 265922 63167773
Cytopenia 160.39 18.51 109 55218 11492 63422203
Malaise 159.32 18.51 82 55245 415872 63017823
Acute respiratory distress syndrome 159.25 18.51 145 55182 23389 63410306
Neutropenic sepsis 158.06 18.51 124 55203 16314 63417381
Human herpesvirus 6 infection 157.18 18.51 68 55259 2889 63430806
Drug hypersensitivity 156.67 18.51 39 55288 310648 63123047
Neutrophil count decreased 156.13 18.51 218 55109 56188 63377507
Fusarium infection 144.02 18.51 43 55284 603 63433092
Swelling 143.89 18.51 32 55295 275346 63158349
Respiratory failure 143.65 18.51 291 55036 101567 63332128
Geotrichum infection 143.35 18.51 40 55287 434 63433261
Staphylococcal sepsis 138.35 18.51 87 55240 8041 63425654
Dyspnoea 135.20 18.51 231 55096 661082 62772613
Neoplasm progression 133.94 18.51 162 55165 36266 63397429
Pulmonary haemorrhage 132.72 18.51 81 55246 7100 63426595
Escherichia bacteraemia 130.52 18.51 65 55262 3818 63429877
Cytomegalovirus infection 129.99 18.51 123 55204 20829 63412866
Acute graft versus host disease 128.14 18.51 67 55260 4361 63429334
Discomfort 127.65 18.51 4 55323 167370 63266325
Insomnia 127.65 18.51 18 55309 215234 63218461
Ejection fraction decreased 125.19 18.51 124 55203 22208 63411487
Drug intolerance 123.95 18.51 57 55270 308604 63125091
Pruritus 123.12 18.51 82 55245 361371 63072324
Disseminated intravascular coagulation 122.33 18.51 114 55213 18937 63414758
Infusion related reaction 117.71 18.51 34 55293 245487 63188208
Cystitis haemorrhagic 115.37 18.51 61 55266 4062 63429633
Cytokine release syndrome 114.49 18.51 97 55230 14217 63419478
Clostridium difficile colitis 113.06 18.51 113 55214 20456 63413239
Musculoskeletal stiffness 112.90 18.51 14 55313 184604 63249091
Therapeutic product effect decreased 112.58 18.51 17 55310 193170 63240525
Bacterial infection 112.52 18.51 110 55217 19389 63414306
Hypersensitivity 111.51 18.51 58 55269 292627 63141068
Pleural effusion 111.41 18.51 249 55078 92961 63340734
Cardiomyopathy 108.64 18.51 103 55224 17481 63416214
Off label use 108.63 18.51 977 54350 673485 62760210
Drug resistance 108.07 18.51 116 55211 22817 63410878
Herpes simplex 107.93 18.51 75 55252 8196 63425499
Acute graft versus host disease in skin 107.86 18.51 55 55272 3397 63430298
Condition aggravated 105.63 18.51 117 55210 402100 63031595
Feeling abnormal 102.04 18.51 7 55320 148385 63285310
Anxiety 99.10 18.51 33 55294 217508 63216187
Hepatocellular injury 97.77 18.51 120 55207 27261 63406434
Blood bilirubin increased 97.51 18.51 140 55187 37000 63396695
Therapy partial responder 97.32 18.51 78 55249 10580 63423115
Blood lactate dehydrogenase increased 95.25 18.51 109 55218 23007 63410688
Hypertriglyceridaemia 94.19 18.51 62 55265 6197 63427498
Stem cell transplant 93.90 18.51 41 55286 1781 63431914
Muscle spasms 92.69 18.51 13 55314 156137 63277558
Systemic mycosis 92.54 18.51 36 55291 1161 63432534
Enterococcal bacteraemia 92.39 18.51 38 55289 1421 63432274
Lymphoma 92.21 18.51 80 55247 12107 63421588
Encephalopathy 91.90 18.51 139 55188 38481 63395214
Staphylococcal infection 91.88 18.51 144 55183 41112 63392583
Systemic candida 90.77 18.51 48 55279 3197 63430498
Leukopenia 89.59 18.51 204 55123 77086 63356609
Pseudomonal sepsis 89.09 18.51 43 55284 2358 63431337
Lower respiratory tract infection 88.79 18.51 7 55320 132300 63301395
Rhinovirus infection 88.63 18.51 53 55274 4476 63429219
Differentiation syndrome 88.21 18.51 34 55293 1069 63432626
Weight decreased 87.39 18.51 68 55259 276730 63156965
Weight increased 86.29 18.51 61 55266 260731 63172964
Depression 85.73 18.51 32 55295 196460 63237235
Arthritis 84.19 18.51 4 55323 115917 63317778
Hypogammaglobulinaemia 82.11 18.51 60 55267 7095 63426600
Disease recurrence 81.53 18.51 111 55216 27919 63405776
Urticaria 81.22 18.51 22 55305 165780 63267915
Alpha haemolytic streptococcal infection 80.23 18.51 33 55294 1234 63432461
Fungal infection 79.75 18.51 127 55200 36747 63396948
Blood lactate dehydrogenase abnormal 79.45 18.51 24 55303 351 63433344
Sinusitis 79.02 18.51 50 55277 226603 63207092
Gene mutation 77.87 18.51 35 55292 1630 63432065
Neutropenic infection 77.81 18.51 33 55294 1334 63432361
Pseudomonas infection 77.64 18.51 70 55257 11143 63422552
Mobility decreased 77.03 18.51 8 55319 121151 63312544
Aplastic anaemia 76.84 18.51 65 55262 9504 63424191
Blood pressure increased 76.61 18.51 23 55304 162039 63271656
Klebsiella sepsis 75.83 18.51 33 55294 1422 63432273
Graft versus host disease in skin 75.72 18.51 41 55286 2864 63430831
Streptococcal sepsis 75.70 18.51 36 55291 1910 63431785
Bronchitis 75.09 18.51 10 55317 124925 63308770
Bacterial sepsis 74.05 18.51 45 55282 3913 63429782
Enterobacter infection 74.02 18.51 37 55290 2190 63431505
Escherichia infection 73.68 18.51 72 55255 12682 63421013
Vasogenic cerebral oedema 73.02 18.51 28 55299 868 63432827
Malignant transformation 72.77 18.51 23 55304 394 63433301
Streptococcal bacteraemia 72.59 18.51 34 55293 1743 63431952
Upper respiratory fungal infection 72.51 18.51 19 55308 159 63433536
Capillary leak syndrome 71.50 18.51 36 55291 2164 63431531
Hypoalbuminaemia 70.74 18.51 68 55259 11737 63421958
Chronic graft versus host disease 70.49 18.51 40 55287 3062 63430633
Quadriplegia 69.11 18.51 33 55294 1767 63431928
Pharyngeal inflammation 69.08 18.51 25 55302 657 63433038
Human bocavirus infection 68.85 18.51 22 55305 391 63433304
Bone marrow disorder 68.35 18.51 36 55291 2378 63431317
Malignant neoplasm progression 68.20 18.51 191 55136 81930 63351765
Thrombotic microangiopathy 67.42 18.51 63 55264 10498 63423197
Impaired healing 67.22 18.51 6 55321 102536 63331159
Device related infection 67.08 18.51 92 55235 23300 63410395
Alanine aminotransferase increased 67.07 18.51 221 55106 103549 63330146
Escherichia sepsis 66.73 18.51 46 55281 4961 63428734
Chloroma 66.65 18.51 19 55308 224 63433471
Pain in extremity 66.39 18.51 117 55210 331369 63102326
Hypoxia 66.18 18.51 155 55172 59637 63374058
Inappropriate schedule of product administration 65.74 18.51 7 55320 103958 63329737
Adenovirus infection 65.27 18.51 40 55287 3531 63430164
Agranulocytosis 64.88 18.51 94 55233 25040 63408655
Hepatotoxicity 64.73 18.51 116 55211 36925 63396770
Acute lymphocytic leukaemia 64.16 18.51 35 55292 2481 63431214
Haemoglobin abnormal 63.73 18.51 45 55282 5043 63428652
Abdominal pain upper 63.51 18.51 52 55275 206392 63227303
Central nervous system haemorrhage 63.48 18.51 17 55310 156 63433539
Blood cholesterol increased 63.01 18.51 5 55322 94027 63339668
Pyomyositis 62.61 18.51 20 55307 355 63433340
Hepatic enzyme increased 62.20 18.51 51 55276 202277 63231418
Neuropathy peripheral 62.12 18.51 229 55098 113438 63320257
Klebsiella bacteraemia 62.11 18.51 30 55297 1648 63432047
Urinary tract infection 62.00 18.51 84 55243 264600 63169095
Contusion 61.26 18.51 27 55300 150017 63283678
Philadelphia chromosome positive 61.05 18.51 20 55307 386 63433309
Overdose 60.79 18.51 13 55314 115065 63318630
Loss of personal independence in daily activities 60.38 18.51 7 55320 97283 63336412
Duodenal ulcer perforation 60.27 18.51 4 55323 87205 63346490
Psoriasis 60.06 18.51 4 55323 86953 63346742
Stenotrophomonas infection 59.59 18.51 31 55296 1996 63431699
Post transplant lymphoproliferative disorder 59.58 18.51 43 55284 4988 63428707
Lung infiltration 59.25 18.51 68 55259 14395 63419300
Headache 59.05 18.51 318 55009 632923 62800772
Rash 58.97 18.51 270 55057 560601 62873094
Left ventricular dysfunction 58.88 18.51 62 55265 11926 63421769
Sleep disorder 58.63 18.51 3 55324 81563 63352132
Graft versus host disease in gastrointestinal tract 58.46 18.51 36 55291 3205 63430490
White blood cell count decreased 58.27 18.51 258 55069 138846 63294849
Chest pain 57.50 18.51 62 55265 215897 63217798
Alternaria infection 57.22 18.51 17 55310 234 63433461
Injection site erythema 56.94 18.51 4 55323 83170 63350525
Osteoarthritis 56.41 18.51 8 55319 95335 63338360
Arachnoiditis 56.12 18.51 18 55309 324 63433371
Ascites 55.75 18.51 115 55212 40613 63393082
Hospitalisation 55.70 18.51 5 55322 85076 63348619
Epstein-Barr virus infection 55.23 18.51 50 55277 8000 63425695
Blister 55.18 18.51 22 55305 129792 63303903
Mantle cell lymphoma recurrent 54.98 18.51 16 55311 204 63433491
Pneumonia 54.60 18.51 623 54704 456144 62977551
Hepatitis B reactivation 54.45 18.51 34 55293 3103 63430592
Subacute combined cord degeneration 54.28 18.51 16 55311 214 63433481
Paraplegia 54.19 18.51 32 55295 2640 63431055
Dyspepsia 53.06 18.51 12 55315 102184 63331511
Skin toxicity 52.89 18.51 39 55288 4675 63429020
Pseudomonas test positive 52.58 18.51 21 55306 727 63432968
Toxic leukoencephalopathy 52.50 18.51 21 55306 730 63432965
Pericardial effusion 52.35 18.51 94 55233 29964 63403731
Secondary immunodeficiency 52.02 18.51 25 55302 1358 63432337
Pneumatosis intestinalis 51.85 18.51 30 55297 2383 63431312
Pericarditis 51.66 18.51 25 55302 131554 63302141
Staphylococcal bacteraemia 51.61 18.51 41 55286 5489 63428206
Progressive multifocal leukoencephalopathy 51.48 18.51 60 55267 12911 63420784
White blood cell count abnormal 51.36 18.51 43 55284 6199 63427496
Pneumocystis jirovecii pneumonia 50.74 18.51 68 55259 16846 63416849
Wheezing 50.08 18.51 11 55316 95584 63338111
Palpitations 49.78 18.51 18 55309 112752 63320943
Perineal necrosis 49.07 18.51 13 55314 114 63433581
Candida sepsis 49.05 18.51 24 55303 1356 63432339
Clostridium test positive 48.87 18.51 32 55295 3169 63430526
Cytomegalovirus viraemia 48.73 18.51 40 55287 5609 63428086
Hemiparesis 48.71 18.51 79 55248 23203 63410492
Appendicitis 48.55 18.51 47 55280 8182 63425513
Cerebellar syndrome 48.31 18.51 33 55294 3506 63430189
Palmar-plantar erythrodysaesthesia syndrome 48.02 18.51 78 55249 22937 63410758
Myocardial infarction 47.52 18.51 14 55313 99879 63333816
Hepatosplenic candidiasis 47.51 18.51 15 55312 256 63433439
Hepatic infarction 47.48 18.51 19 55308 661 63433034
Cardiac failure 47.36 18.51 178 55149 88964 63344731
Toxic erythema of chemotherapy 47.36 18.51 13 55314 132 63433563
Metastases to bone marrow 47.04 18.51 17 55310 445 63433250
Perineal infection 46.76 18.51 13 55314 139 63433556
Retinal haemorrhage 46.72 18.51 37 55290 4932 63428763
Enterocolitis 46.58 18.51 45 55282 7813 63425882
Adverse drug reaction 46.44 18.51 7 55320 79707 63353988
Gastrooesophageal reflux disease 46.23 18.51 13 55314 95626 63338069
Back pain 46.14 18.51 101 55226 264044 63169651
Respiratory distress 45.45 18.51 95 55232 33856 63399839
Memory impairment 45.41 18.51 17 55310 104241 63329454
Gastroenteritis norovirus 45.21 18.51 26 55301 2042 63431653
Dry mouth 44.99 18.51 7 55320 77856 63355839
Superior sagittal sinus thrombosis 44.71 18.51 19 55308 772 63432923
Left atrial hypertrophy 44.40 18.51 10 55317 40 63433655
Polyneuropathy 44.29 18.51 59 55268 14530 63419165
Blast crisis in myelogenous leukaemia 43.94 18.51 17 55310 540 63433155
Neurological symptom 43.82 18.51 38 55289 5745 63427950
Treatment failure 43.79 18.51 66 55261 198977 63234718
Musculoskeletal pain 43.77 18.51 13 55314 92264 63341431
Encephalitis 43.74 18.51 46 55281 8834 63424861
Cholestasis 43.73 18.51 86 55241 29348 63404347
Toxic skin eruption 43.63 18.51 55 55272 12830 63420865
Cytomegalovirus chorioretinitis 43.13 18.51 24 55303 1769 63431926
Immune effector cell-associated neurotoxicity syndrome 42.88 18.51 26 55301 2251 63431444
Wrong technique in product usage process 42.66 18.51 3 55324 62337 63371358
Hyperglycaemia 42.52 18.51 105 55222 41762 63391933
Chronic graft versus host disease in skin 42.27 18.51 18 55309 735 63432960
Nausea 42.11 18.51 510 54817 853961 62579734
Subclavian vein thrombosis 41.95 18.51 24 55303 1866 63431829
Hyperhidrosis 41.55 18.51 21 55306 107815 63325880
Injury 41.39 18.51 7 55320 73240 63360455
Hepatic failure 41.16 18.51 94 55233 35562 63398133
Cerebral haemorrhage 41.15 18.51 86 55241 30643 63403052
Ileus 40.84 18.51 57 55270 14668 63419027
Hepatomegaly 40.66 18.51 51 55276 11838 63421857
Cytomegalovirus infection reactivation 40.49 18.51 31 55296 3932 63429763
Platelet count abnormal 40.40 18.51 29 55298 3335 63430360
Gastrointestinal necrosis 40.37 18.51 27 55300 2771 63430924
Chronic obstructive pulmonary disease 40.19 18.51 4 55323 62682 63371013
Jugular vein thrombosis 40.04 18.51 28 55299 3090 63430605
Human rhinovirus test positive 39.38 18.51 12 55315 181 63433514
Pulmonary oedema 39.20 18.51 121 55206 54752 63378943
Enteritis 39.18 18.51 42 55285 8244 63425451
Myalgia 39.06 18.51 42 55285 146487 63287208
Intussusception 38.80 18.51 16 55311 602 63433093
Intentional product misuse 38.77 18.51 4 55323 60913 63372782
Venous thrombosis 38.75 18.51 33 55294 4869 63428826
Osteoporosis 38.55 18.51 3 55324 57335 63376360
Central nervous system leukaemia 38.41 18.51 11 55316 132 63433563
Trichosporon infection 38.39 18.51 13 55314 279 63433416
Minimal residual disease 38.33 18.51 11 55316 133 63433562
Klebsiella infection 38.03 18.51 42 55285 8524 63425171
Enterovirus test positive 37.06 18.51 11 55316 151 63433544
Bacillus infection 36.95 18.51 17 55310 836 63432859
Leukoerythroblastosis 36.86 18.51 12 55315 227 63433468
Cerebral fungal infection 36.85 18.51 10 55317 97 63433598
Enterobacter bacteraemia 36.85 18.51 14 55313 423 63433272
Antithrombin III 36.72 18.51 11 55316 156 63433539
Flushing 36.68 18.51 10 55317 75077 63358618
Guillain-Barre syndrome 36.62 18.51 29 55298 3864 63429831
White matter lesion 36.62 18.51 22 55305 1873 63431822
Lower respiratory tract infection fungal 36.49 18.51 13 55314 326 63433369
Subdural hygroma 36 18.51 12 55315 245 63433450
Primary hypogonadism 35.97 18.51 11 55316 168 63433527
Gastroenteritis adenovirus 35.91 18.51 12 55315 247 63433448
Congestive cardiomyopathy 35.89 18.51 35 55292 6147 63427548
Antithrombin III decreased 35.64 18.51 12 55315 253 63433442
Paraparesis 35.61 18.51 23 55304 2225 63431470
Incorrect dose administered 35.55 18.51 5 55322 59963 63373732
Areflexia 35.44 18.51 26 55301 3092 63430603
Cardiac dysfunction 35.00 18.51 23 55304 2292 63431403
Renal failure 34.92 18.51 198 55129 117454 63316241
Systemic inflammatory response syndrome 34.86 18.51 33 55294 5588 63428107
Sinusitis fungal 34.72 18.51 21 55306 1810 63431885
Enterococcus test positive 34.66 18.51 18 55309 1155 63432540
Amnesia 34.48 18.51 4 55323 55581 63378114
Therapeutic response delayed 34.41 18.51 15 55312 649 63433046
Hypokalaemia 34.38 18.51 180 55147 103624 63330071
Myelitis 34.35 18.51 19 55308 1384 63432311
Seizure 34.11 18.51 215 55112 132419 63301276
Anaemia 33.97 18.51 398 54929 293032 63140663
Pulse waveform abnormal 33.86 18.51 9 55318 80 63433615
Ankle brachial index decreased 33.86 18.51 9 55318 80 63433615
Aspartate aminotransferase increased 33.75 18.51 162 55165 90115 63343580
Enterocolitis haemorrhagic 33.57 18.51 19 55308 1447 63432248
Angiokeratoma 33.51 18.51 10 55317 140 63433555
Carotid intima-media thickness increased 33.47 18.51 9 55318 84 63433611
Chest discomfort 33.42 18.51 28 55299 109941 63323754
Transaminases increased 33.27 18.51 80 55247 31287 63402408
Tachycardia 33.21 18.51 196 55131 117960 63315735
Blast cell count increased 33.02 18.51 13 55314 433 63433262
Toxic epidermal necrolysis 32.88 18.51 70 55257 25264 63408431
Pneumonia moraxella 32.85 18.51 8 55319 48 63433647
Ovarian failure 32.79 18.51 18 55309 1292 63432403
Neutrophil count abnormal 32.61 18.51 24 55303 2868 63430827
Acute kidney injury 32.61 18.51 362 54965 263053 63170642
Toxic encephalopathy 32.26 18.51 34 55293 6545 63427150
Ventricular hypokinesia 32.16 18.51 29 55298 4615 63429080
Hypotension 32.11 18.51 371 54956 272233 63161462
BK virus infection 32.09 18.51 25 55302 3254 63430441
Acute febrile neutrophilic dermatosis 32.01 18.51 24 55303 2950 63430745
Respiratory tract infection fungal 31.99 18.51 13 55314 471 63433224
Tonsillar haemorrhage 31.90 18.51 11 55316 250 63433445
Mucocutaneous ulceration 31.82 18.51 10 55317 168 63433527
Inappropriate antidiuretic hormone secretion 31.71 18.51 52 55275 15410 63418285
Asthenia 31.20 18.51 201 55126 383403 63050292
Peripheral motor neuropathy 31.16 18.51 19 55308 1662 63432033
Cytogenetic abnormality 31.11 18.51 13 55314 506 63433189
Hyperammonaemia 31.09 18.51 30 55297 5202 63428493
Acute graft versus host disease in liver 31.05 18.51 14 55313 657 63433038
Confusional state 31.01 18.51 104 55223 236276 63197419
Stomatococcal infection 30.84 18.51 9 55318 116 63433579
Hidradenitis 30.71 18.51 23 55304 2823 63430872
Refractoriness to platelet transfusion 30.70 18.51 7 55320 30 63433665
Drug clearance decreased 30.69 18.51 18 55309 1466 63432229
Cerebellar stroke 30.61 18.51 11 55316 283 63433412
Leukaemia 30.58 18.51 27 55300 4181 63429514
Subdural haematoma 30.49 18.51 49 55278 14279 63419416
Blood pressure systolic increased 30.45 18.51 3 55324 47394 63386301
Feeling hot 30.31 18.51 4 55323 50350 63383345
Maternal exposure during pregnancy 30.13 18.51 95 55232 219967 63213728
Blood glucose increased 29.82 18.51 18 55309 83738 63349957
Cystitis 29.47 18.51 6 55321 54985 63378710
C-reactive protein abnormal 29.40 18.51 3 55324 46093 63387602
Coagulopathy 29.28 18.51 59 55268 20485 63413210
Bone marrow necrosis 29.26 18.51 8 55319 80 63433615
Haemodynamic instability 29.19 18.51 38 55289 9152 63424543
Dedifferentiated liposarcoma 29.18 18.51 7 55320 39 63433656
Rhinocerebral mucormycosis 29.07 18.51 12 55315 453 63433242
Somnolence 29.02 18.51 71 55256 178614 63255081
Chronic myeloid leukaemia recurrent 28.92 18.51 10 55317 229 63433466
Lung consolidation 28.92 18.51 26 55301 4122 63429573
Sinusitis aspergillus 28.74 18.51 8 55319 86 63433609
Cerebral venous sinus thrombosis 28.38 18.51 19 55308 1953 63431742
Ureaplasma infection 28.28 18.51 13 55314 638 63433057
Diffuse large B-cell lymphoma 28.24 18.51 32 55295 6680 63427015
Folliculitis 28.14 18.51 13 55314 70304 63363391
Nervous system disorder 28.08 18.51 55 55272 18711 63414984
Procalcitonin abnormal 27.98 18.51 6 55321 18 63433677
Central nervous system lymphoma 27.90 18.51 17 55310 1485 63432210
Mucosal toxicity 27.89 18.51 11 55316 368 63433327
Candida infection 27.63 18.51 70 55257 28281 63405414
Myeloid leukaemia 27.48 18.51 11 55316 383 63433312
Acute respiratory failure 27.43 18.51 79 55248 34406 63399289
Leukaemia cutis 27.42 18.51 8 55319 103 63433592
Escherichia test positive 27.37 18.51 20 55307 2364 63431331
Haemorrhage intracranial 27.35 18.51 45 55282 13374 63420321
Sweat gland tumour 27.28 18.51 8 55319 105 63433590
Electrocardiogram PR shortened 27.27 18.51 10 55317 273 63433422
Myelomalacia 27.22 18.51 7 55320 54 63433641
Cough 27.18 18.51 147 55180 292596 63141099
Cataract 27.12 18.51 8 55319 57045 63376650
Pleuroparenchymal fibroelastosis 27.07 18.51 8 55319 108 63433587
Constipation 26.82 18.51 103 55224 224840 63208855
Unevaluable event 26.73 18.51 6 55321 51380 63382315
Bone marrow transplant 26.66 18.51 13 55314 729 63432966
Intracranial hypotension 26.58 18.51 10 55317 294 63433401
Eosinophilic cystitis 26.57 18.51 7 55320 60 63433635
Breast cancer 26.52 18.51 5 55322 48378 63385317
Oedema peripheral 26.51 18.51 81 55246 189430 63244265
Enterocolitis infectious 26.36 18.51 17 55310 1641 63432054
Pulmonary alveolar haemorrhage 26.30 18.51 26 55301 4642 63429053
Adverse event 26.26 18.51 13 55314 67546 63366149
Abscess fungal 26.07 18.51 7 55320 65 63433630
Enterobacter sepsis 26.05 18.51 10 55317 311 63433384
Suicidal ideation 25.83 18.51 11 55316 62410 63371285
Influenza like illness 25.76 18.51 13 55314 66811 63366884
Continuous haemodiafiltration 25.60 18.51 14 55313 997 63432698
Enterovirus infection 25.56 18.51 14 55313 1000 63432695
Parainfluenzae virus infection 25.54 18.51 19 55308 2308 63431387
Peripheral sensory neuropathy 25.54 18.51 32 55295 7419 63426276
Quadriparesis 25.54 18.51 18 55309 2011 63431684
Acute graft versus host disease in intestine 25.53 18.51 17 55310 1732 63431963
Disseminated trichosporonosis 25.42 18.51 7 55320 72 63433623
Laryngeal inflammation 25.42 18.51 8 55319 135 63433560
Metastases to diaphragm 25.39 18.51 6 55321 31 63433664
Blast cells present 25.38 18.51 11 55316 469 63433226
Pneumonia bacterial 25.30 18.51 36 55291 9429 63424266
Dry skin 25.23 18.51 9 55318 56878 63376817
Gait disturbance 25.12 18.51 79 55248 183099 63250596
Nasal congestion 24.97 18.51 13 55314 65647 63368048
Peritoneal mesothelioma malignant 24.75 18.51 5 55322 10 63433685
Viraemia 24.71 18.51 15 55312 1301 63432394
Cytarabine syndrome 24.60 18.51 7 55320 82 63433613
Ataxia 24.53 18.51 46 55281 15149 63418546
Leukaemic lymphoma 24.52 18.51 7 55320 83 63433612
Sinoatrial block 24.45 18.51 13 55314 875 63432820
Aspergilloma 24.43 18.51 9 55318 249 63433446
Pathogen resistance 24.40 18.51 29 55298 6369 63427326
Cardiac disorder 24.38 18.51 7 55320 50809 63382886
Abdominal wall wound 24.37 18.51 7 55320 85 63433610
Cardiomyopathy acute 24.26 18.51 9 55318 254 63433441
Pneumonia cytomegaloviral 24.13 18.51 18 55309 2196 63431499
Paralysis 24.06 18.51 36 55291 9864 63423831
Myeloblast percentage decreased 23.96 18.51 6 55321 41 63433654
Influenza 23.94 18.51 36 55291 108686 63325009
Acute promyelocytic leukaemia 23.93 18.51 13 55314 914 63432781
Adenoviral hepatitis 23.89 18.51 10 55317 391 63433304
Balance disorder 23.85 18.51 23 55304 84399 63349296
Encephalitis cytomegalovirus 23.74 18.51 11 55316 550 63433145
Brain herniation 23.59 18.51 22 55305 3655 63430040
Sedation 23.56 18.51 3 55324 38806 63394889
Hypoaesthesia 23.53 18.51 72 55255 168321 63265374
Rhinorrhoea 23.47 18.51 14 55313 65563 63368132
Granulicatella infection 23.39 18.51 7 55320 99 63433596
Erythema 23.26 18.51 77 55250 175674 63258021
Acquired gene mutation 23.21 18.51 13 55314 970 63432725
Chromosomal deletion 23.20 18.51 7 55320 102 63433593
Ear infection 23.09 18.51 3 55324 38210 63395485
Strongyloidiasis 22.86 18.51 14 55313 1234 63432461
Epstein Barr virus positive mucocutaneous ulcer 22.84 18.51 10 55317 437 63433258
Axonal neuropathy 22.74 18.51 13 55314 1009 63432686
Encopresis 22.65 18.51 7 55320 111 63433584
Haematocolpos 22.61 18.51 6 55321 53 63433642
Cryptosporidiosis infection 22.58 18.51 9 55318 310 63433385
Treatment noncompliance 22.38 18.51 3 55324 37322 63396373
Nephropathy toxic 22.37 18.51 34 55293 9445 63424250
Infusion site eschar 22.20 18.51 5 55322 20 63433675
Genotoxicity 22.20 18.51 5 55322 20 63433675
Vocal cord paralysis 22.01 18.51 17 55310 2184 63431511
Pregnancy 22.00 18.51 3 55324 36833 63396862
Hydrocephalus 21.84 18.51 25 55302 5275 63428420
Acute monocytic leukaemia 21.72 18.51 7 55320 128 63433567
Streptococcal infection 21.69 18.51 26 55301 5761 63427934
Hypophosphataemia 21.53 18.51 37 55290 11389 63422306
Cardiogenic shock 21.50 18.51 48 55279 17884 63415811
Hepatosplenomegaly 21.49 18.51 18 55309 2596 63431099
Intentional product use issue 21.41 18.51 50 55277 127842 63305853
Lipase increased 21.26 18.51 34 55293 9866 63423829
Perirectal abscess 21.24 18.51 12 55315 911 63432784
Chronic myeloid leukaemia 21.23 18.51 17 55310 2301 63431394
Enterococcal sepsis 21.22 18.51 14 55313 1404 63432291
Cytomegalovirus test positive 21.20 18.51 19 55308 2999 63430696
Leukaemic infiltration 21.13 18.51 5 55322 26 63433669
Graft versus host disease in lung 21.01 18.51 9 55318 373 63433322
Transient acantholytic dermatosis 20.95 18.51 6 55321 72 63433623
Product use issue 20.86 18.51 110 55217 220410 63213285
Generalised oedema 20.86 18.51 44 55283 15774 63417921
JC virus infection 20.86 18.51 16 55311 2035 63431660
Gastrointestinal inflammation 20.68 18.51 25 55302 5587 63428108
Pneumonia klebsiella 20.60 18.51 17 55310 2402 63431293
Visual impairment 20.56 18.51 26 55301 84420 63349275
Schistocytosis 20.53 18.51 5 55322 30 63433665
Skin ulcer 20.52 18.51 6 55321 43039 63390656
Renal replacement therapy 20.51 18.51 6 55321 78 63433617
Brain oedema 20.51 18.51 41 55286 14154 63419541
Intracranial pressure increased 20.44 18.51 24 55303 5203 63428492
VIth nerve paresis 20.44 18.51 6 55321 79 63433616
Acute lymphocytic leukaemia refractory 20.44 18.51 6 55321 79 63433616
Suicide attempt 20.44 18.51 14 55313 60904 63372791
Throat irritation 20.40 18.51 4 55323 37643 63396052
B-cell lymphoma recurrent 20.33 18.51 9 55318 404 63433291
Hepatic lesion 20.29 18.51 23 55304 4802 63428893
Soft tissue infection 20.28 18.51 16 55311 2121 63431574
Dehydration 20.26 18.51 80 55247 173274 63260421
Stenotrophomonas sepsis 20.25 18.51 5 55322 32 63433663
Fusobacterium infection 20.25 18.51 5 55322 32 63433663
Aphasia 20.16 18.51 69 55258 32931 63400764
Abdominal compartment syndrome 20.15 18.51 10 55317 583 63433112
Mental status changes 20.14 18.51 78 55249 39521 63394174
Sciatica 20.02 18.51 3 55324 34321 63399374
Platelet transfusion 19.97 18.51 11 55316 795 63432900
Shock haemorrhagic 19.92 18.51 33 55294 9862 63423833
Bacillus bacteraemia 19.91 18.51 6 55321 87 63433608
Prescribed overdose 19.89 18.51 3 55324 34150 63399545
Gastrointestinal disorder 19.88 18.51 54 55273 131185 63302510
Acinetobacter bacteraemia 19.85 18.51 6 55321 88 63433607
Diverticulitis 19.83 18.51 5 55322 39552 63394143
Epstein-Barr virus associated lymphoproliferative disorder 19.76 18.51 15 55312 1879 63431816
Porphyria non-acute 19.71 18.51 8 55319 289 63433406
Ileus paralytic 19.66 18.51 22 55305 4529 63429166
Haemodialysis 19.59 18.51 31 55296 8916 63424779
Neck pain 19.45 18.51 19 55308 69299 63364396
Jaw operation 19.40 18.51 11 55316 841 63432854
Hepatic infection fungal 19.39 18.51 5 55322 39 63433656
Blood fibrinogen decreased 19.38 18.51 11 55316 842 63432853
Foetal anaemia 19.36 18.51 6 55321 96 63433599
Bacillus test positive 19.28 18.51 5 55322 40 63433655
Cytotoxic oedema 19.27 18.51 7 55320 186 63433509
Hepatitis B 19.23 18.51 20 55307 3792 63429903
Blastic plasmacytoid dendritic cell neoplasia 19.18 18.51 4 55323 10 63433685
Oophoritis 19.14 18.51 6 55321 100 63433595
Glioma 19.13 18.51 8 55319 312 63433383
Product quality issue 19.04 18.51 4 55323 35861 63397834
Acute myeloid leukaemia refractory 19.02 18.51 6 55321 102 63433593
Cerebral haemangioma 18.97 18.51 6 55321 103 63433592
Sensorimotor disorder 18.93 18.51 9 55318 477 63433218
Heart rate decreased 18.90 18.51 8 55319 45552 63388143
Tremor 18.86 18.51 56 55271 132183 63301512
Pulmonary mucormycosis 18.82 18.51 8 55319 325 63433370
Cytomegalovirus colitis 18.81 18.51 16 55311 2356 63431339
Aborted pregnancy 18.76 18.51 5 55322 45 63433650

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
Febrile neutropenia 4012.20 14.08 2900 74073 133949 34746009
Neutropenia 764.24 14.08 1292 75681 155486 34724472
Venoocclusive liver disease 737.01 14.08 357 76616 7609 34872349
Bone marrow failure 708.42 14.08 556 76417 28697 34851261
Mucosal inflammation 692.60 14.08 617 76356 38005 34841953
Myelosuppression 593.16 14.08 423 76550 18842 34861116
Febrile bone marrow aplasia 564.17 14.08 301 76672 7908 34872050
Haematotoxicity 539.46 14.08 292 76681 7902 34872056
Pancytopenia 497.14 14.08 810 76163 94347 34785611
Thrombocytopenia 464.37 14.08 1046 75927 155201 34724757
Septic shock 435.50 14.08 655 76318 71179 34808779
Sepsis 398.04 14.08 1025 75948 165536 34714422
Acute myeloid leukaemia 376.05 14.08 316 76657 17954 34862004
Disease progression 369.25 14.08 766 76207 107311 34772647
Leukoencephalopathy 357.24 14.08 178 76795 4037 34875921
Pyrexia 345.55 14.08 1547 75426 331466 34548492
Myelodysplastic syndrome 342.30 14.08 306 76667 18902 34861056
Acute myeloid leukaemia recurrent 327.65 14.08 137 76836 2033 34877925
Aplasia 320.18 14.08 170 76803 4418 34875540
Bronchopulmonary aspergillosis 317.14 14.08 261 76712 14398 34865560
Myelopathy 312.36 14.08 138 76835 2359 34877599
Fatigue 302.24 14.08 226 76747 370427 34509531
Posterior reversible encephalopathy syndrome 279.94 14.08 207 76766 9747 34870211
Fungal infection 276.29 14.08 250 76723 15685 34864273
Neutropenic colitis 264.16 14.08 132 76841 3012 34876946
Aspergillus infection 241.96 14.08 207 76766 12047 34867911
Dizziness 237.95 14.08 92 76881 218429 34661529
Product dose omission issue 235.33 14.08 6 76967 119705 34760253
Cytopenia 227.25 14.08 203 76770 12520 34867438
Off label use 224.43 14.08 1633 75340 417891 34462067
Neoplasm progression 220.07 14.08 264 76709 23036 34856922
Venoocclusive disease 213.61 14.08 111 76862 2756 34877202
Dyspnoea 211.33 14.08 315 76658 376467 34503491
Pneumonia fungal 209.47 14.08 152 76821 6948 34873010
Fall 208.60 14.08 93 76880 202792 34677166
Leukaemia recurrent 207.65 14.08 91 76882 1524 34878434
Product use in unapproved indication 204.82 14.08 646 76327 116853 34763105
Hyperbilirubinaemia 200.13 14.08 215 76758 16628 34863330
Completed suicide 196.49 14.08 4 76969 98164 34781794
Tumour lysis syndrome 196.12 14.08 214 76759 16845 34863113
Bacteraemia 193.78 14.08 228 76745 19489 34860469
Diffuse large B-cell lymphoma recurrent 193.04 14.08 108 76865 3120 34876838
Multiple organ dysfunction syndrome 188.31 14.08 477 76496 76089 34803869
Neutropenic sepsis 185.54 14.08 188 76785 13579 34866379
Acute lymphocytic leukaemia recurrent 185.18 14.08 103 76870 2941 34877017
Neurotoxicity 184.91 14.08 213 76760 17797 34862161
Second primary malignancy 182.33 14.08 146 76827 7740 34872218
Malaise 168.90 14.08 100 76873 185725 34694233
Colitis 163.35 14.08 296 76677 37454 34842504
Arthralgia 155.22 14.08 91 76882 169950 34710008
Neoplasm recurrence 153.16 14.08 82 76891 2167 34877791
Stomatitis 151.53 14.08 307 76666 42207 34837751
Mucormycosis 150.29 14.08 116 76857 5826 34874132
Insomnia 148.72 14.08 25 76948 103882 34776076
Blood culture positive 147.04 14.08 105 76868 4678 34875280
Death 146.66 14.08 423 76550 397626 34482332
Myocardial infarction 145.49 14.08 43 76930 121042 34758916
Hypofibrinogenaemia 145.22 14.08 72 76901 1614 34878344
Graft versus host disease 141.81 14.08 144 76829 10425 34869533
Cystitis haemorrhagic 141.75 14.08 110 76863 5569 34874389
Blood lactate dehydrogenase increased 140.98 14.08 211 76762 22779 34857179
Depression 139.76 14.08 23 76950 97075 34782883
Peripheral swelling 136.32 14.08 8 76965 76533 34803425
Blood bilirubin increased 132.27 14.08 273 76700 38023 34841935
Hypogammaglobulinaemia 131.32 14.08 120 76853 7620 34872338
Pain 128.69 14.08 157 76816 204518 34675440
Diffuse large B-cell lymphoma refractory 120.85 14.08 58 76915 1208 34878750
Respiratory failure 119.78 14.08 515 76458 108057 34771901
Overdose 119.57 14.08 27 76946 91032 34788926
Weight decreased 113.16 14.08 133 76840 176168 34703790
Neutrophil count decreased 111.89 14.08 305 76668 50799 34829159
Skin toxicity 111.50 14.08 89 76884 4695 34875263
Hypertriglyceridaemia 109.53 14.08 113 76860 8335 34871623
Inappropriate schedule of product administration 109.46 14.08 7 76966 62289 34817669
Escherichia sepsis 108.55 14.08 87 76886 4617 34875341
Malignant transformation 106.33 14.08 47 76926 804 34879154
Acute graft versus host disease 104.86 14.08 98 76875 6405 34873553
Mantle cell lymphoma recurrent 104.64 14.08 45 76928 718 34879240
Joint swelling 104.42 14.08 7 76966 59883 34820075
Systemic candida 103.65 14.08 77 76896 3649 34876309
Haemophagocytic lymphohistiocytosis 103.30 14.08 135 76838 12838 34867120
Escherichia infection 101.01 14.08 107 76866 8138 34871820
Blood pressure increased 100.95 14.08 34 76939 88068 34791890
Nasopharyngitis 99.72 14.08 17 76956 69951 34810007
Asthenia 98.81 14.08 249 76724 245002 34634956
Muscle spasms 96.94 14.08 23 76950 74978 34804980
Platelet count decreased 95.94 14.08 518 76455 119199 34760759
Anxiety 95.28 14.08 50 76923 99378 34780580
Arachnoiditis 93.33 14.08 34 76939 340 34879618
Acute graft versus host disease in skin 92.88 14.08 83 76890 5118 34874840
Pruritus 92.26 14.08 106 76867 141875 34738083
Bacterial sepsis 92.21 14.08 83 76890 5167 34874791
Cardiac failure congestive 92.21 14.08 34 76939 83236 34796722
Abdominal discomfort 91.09 14.08 12 76961 59823 34820135
Cytomegalovirus infection 91.04 14.08 187 76786 25948 34854010
Cytomegalovirus chorioretinitis 90.62 14.08 70 76903 3519 34876439
Rash 90.61 14.08 225 76748 222527 34657431
Hepatotoxicity 89.78 14.08 166 76807 21319 34858639
Systemic mycosis 89.64 14.08 51 76922 1522 34878436
Fusarium infection 89.55 14.08 46 76927 1114 34878844
Feeling abnormal 88.72 14.08 16 76957 63219 34816739
Hospitalisation 87.62 14.08 11 76962 56891 34823067
Escherichia bacteraemia 87.27 14.08 66 76907 3214 34876744
Enterococcal infection 87.10 14.08 105 76868 9201 34870757
Cytokine release syndrome 86.03 14.08 169 76804 22708 34857250
Therapy partial responder 85.95 14.08 106 76867 9510 34870448
Staphylococcal infection 85.59 14.08 209 76764 32551 34847407
Constipation 85.03 14.08 106 76867 136876 34743082
Infection 83.68 14.08 409 76564 90506 34789452
Somnolence 83.57 14.08 73 76900 111043 34768915
Chest pain 83.04 14.08 94 76879 126668 34753290
Stem cell transplant 82.45 14.08 54 76919 2085 34877873
Bacterial infection 81.80 14.08 140 76833 16923 34863035
Chronic obstructive pulmonary disease 81.65 14.08 7 76966 48911 34831047
Intentional product misuse 80.49 14.08 5 76968 45606 34834352
Cardiotoxicity 79.52 14.08 79 76894 5569 34874389
Candida infection 79.26 14.08 141 76832 17574 34862384
Rhabdomyolysis 78.61 14.08 26 76947 68137 34811821
Staphylococcal bacteraemia 78.51 14.08 95 76878 8357 34871601
Asthma 77.35 14.08 4 76969 42652 34837306
Hyperhidrosis 77.16 14.08 35 76938 75657 34804301
Disease recurrence 76.30 14.08 155 76818 21335 34858623
Device related infection 75.59 14.08 136 76837 17101 34862857
Suicide attempt 73.10 14.08 3 76970 39113 34840845
Clostridium difficile colitis 72.70 14.08 127 76846 15603 34864355
Suicidal ideation 72.57 14.08 4 76969 40384 34839574
Myalgia 72.52 14.08 48 76925 84062 34795896
Chloroma 72.06 14.08 31 76942 495 34879463
Urticaria 71.57 14.08 24 76949 62353 34817605
B-cell lymphoma recurrent 71.22 14.08 35 76938 769 34879189
Lymphadenopathy 70.56 14.08 178 76795 28285 34851673
Geotrichum infection 70.03 14.08 30 76943 474 34879484
Incorrect dose administered 69.85 14.08 5 76968 40510 34839448
Musculoskeletal stiffness 69.54 14.08 10 76963 46670 34833288
Chronic graft versus host disease 68.77 14.08 65 76908 4308 34875650
Stenotrophomonas infection 68.75 14.08 48 76925 2062 34877896
Coronary artery disease 68.24 14.08 12 76961 48293 34831665
Differentiation syndrome 67.18 14.08 41 76932 1397 34878561
Nervous system disorder 66.67 14.08 117 76856 14426 34865532
Pain in extremity 66.55 14.08 110 76863 126403 34753555
Gastrointestinal toxicity 66.41 14.08 52 76921 2667 34877291
Blood fibrinogen decreased 65.08 14.08 38 76935 1192 34878766
Staphylococcal sepsis 64.15 14.08 93 76880 9751 34870207
Injection site pain 63.96 14.08 6 76967 38999 34840959
Acute promyelocytic leukaemia 63.45 14.08 28 76945 477 34879481
Syncope 62.99 14.08 65 76908 91386 34788572
Wheezing 61.37 14.08 9 76964 41393 34838565
Viral haemorrhagic cystitis 61.24 14.08 36 76937 1144 34878814
Tremor 61.18 14.08 55 76918 82532 34797426
Graft versus host disease in skin 61.08 14.08 58 76915 3867 34876091
Transformation to acute myeloid leukaemia 60.64 14.08 31 76942 743 34879215
Oedema peripheral 59.52 14.08 108 76865 119704 34760254
Capillary leak syndrome 59.11 14.08 45 76928 2213 34877745
Cerebellar syndrome 59.04 14.08 46 76927 2342 34877616
Dehydration 58.65 14.08 124 76849 129845 34750113
Epstein-Barr virus infection 58.59 14.08 78 76895 7550 34872408
Plasma cell myeloma 58.18 14.08 11 76962 42026 34837932
Sweat gland tumour 57.29 14.08 25 76948 414 34879544
Multiple-drug resistance 57.21 14.08 64 76909 5175 34874783
Drug hypersensitivity 56.87 14.08 56 76917 80473 34799485
Dyspepsia 56.79 14.08 7 76966 36725 34843233
Cytomegalovirus infection reactivation 56.71 14.08 63 76910 5055 34874903
Arthritis 56.64 14.08 3 76970 31343 34848615
Hyperkalaemia 56.63 14.08 42 76931 69347 34810611
Klebsiella infection 56.18 14.08 81 76892 8450 34871508
Acute respiratory distress syndrome 55.81 14.08 154 76819 25815 34854143
Prostate cancer 55.68 14.08 10 76963 39639 34840319
Cerebrovascular accident 55.39 14.08 63 76910 84748 34795210
Hallucination 55.37 14.08 22 76951 51476 34828482
Wrong technique in product usage process 55.29 14.08 7 76966 35979 34843979
Superior sagittal sinus thrombosis 54.15 14.08 21 76952 253 34879705
Lymphoma 53.97 14.08 98 76875 12409 34867549
Central nervous system leukaemia 53.28 14.08 21 76952 265 34879693
Hepatosplenic candidiasis 52.72 14.08 20 76953 226 34879732
Osteonecrosis 52.38 14.08 107 76866 14783 34865175
Aggression 52.24 14.08 11 76962 38953 34841005
Post transplant lymphoproliferative disorder 52.07 14.08 68 76905 6460 34873498
Pulmonary haemorrhage 51.31 14.08 86 76887 10218 34869740
Blood glucose increased 51.15 14.08 43 76930 66675 34813283
Cytomegalovirus viraemia 51.07 14.08 72 76901 7358 34872600
Cytogenetic abnormality 50.95 14.08 29 76944 866 34879092
Aplastic anaemia 50.94 14.08 83 76890 9633 34870325
Progressive multifocal leukoencephalopathy 50.64 14.08 83 76890 9681 34870277
Drug resistance 50.13 14.08 148 76825 25779 34854179
Agranulocytosis 49.95 14.08 140 76833 23681 34856277
Alanine aminotransferase increased 49.45 14.08 326 76647 80489 34799469
Paraplegia 49.12 14.08 45 76928 2866 34877092
Sleep disorder 49.08 14.08 6 76967 31682 34848276
Thrombosis 48.86 14.08 25 76948 50433 34829525
Influenza like illness 48.84 14.08 3 76970 27631 34852327
Adenovirus infection 48.68 14.08 59 76914 5198 34874760
Chest discomfort 48.52 14.08 30 76943 54500 34825458
Unevaluable event 48.50 14.08 7 76966 32583 34847375
Psoriasis 48.02 14.08 13 76960 38799 34841159
Back pain 47.89 14.08 125 76848 121664 34758294
Fungaemia 47.88 14.08 42 76931 2526 34877432
Memory impairment 47.41 14.08 18 76955 43300 34836658
Graft versus host disease in gastrointestinal tract 47.26 14.08 49 76924 3634 34876324
Hypersensitivity 47.20 14.08 39 76934 60996 34818962
Loss of consciousness 46.18 14.08 69 76904 82598 34797360
Leukopenia 45.64 14.08 265 76708 62591 34817367
Thymus hypoplasia 45.60 14.08 21 76952 397 34879561
Lymphoid tissue hypoplasia 45.60 14.08 21 76952 397 34879561
Blood creatine phosphokinase increased 45.30 14.08 21 76952 44836 34835122
Pseudostroke 44.89 14.08 12 76961 36 34879922
Minimal residual disease 44.71 14.08 21 76952 416 34879542
Abdominal pain upper 44.65 14.08 55 76918 71435 34808523
Disseminated intravascular coagulation 44.55 14.08 127 76846 21689 34858269
Parainfluenzae virus infection 44.38 14.08 42 76931 2788 34877170
Pneumonia escherichia 44.12 14.08 21 76952 429 34879529
Swelling 44.09 14.08 19 76954 42347 34837611
Gastrointestinal wall thickening 44.02 14.08 32 76941 1466 34878492
Acute lymphocytic leukaemia 43.81 14.08 43 76930 2986 34876972
Drug interaction 43.52 14.08 305 76668 225641 34654317
Cytarabine syndrome 43.50 14.08 9 76964 3 34879955
Lower respiratory tract infection fungal 43.40 14.08 23 76950 595 34879363
Cerebral venous sinus thrombosis 43.35 14.08 22 76951 519 34879439
Acute febrile neutrophilic dermatosis 43.29 14.08 30 76943 1273 34878685
Herpes simplex 42.94 14.08 57 76916 5502 34874456
Diffuse large B-cell lymphoma 42.84 14.08 66 76907 7304 34872654
Gastrooesophageal reflux disease 42.78 14.08 15 76958 37909 34842049
Malignant neoplasm progression 42.78 14.08 336 76637 87710 34792248
Central nervous system fungal infection 42.67 14.08 19 76954 331 34879627
Granulocyte count decreased 42.65 14.08 25 76948 790 34879168
Gallbladder oedema 42.40 14.08 17 76956 225 34879733
Arthropathy 41.91 14.08 5 76968 26902 34853056
Weight increased 41.75 14.08 89 76884 92944 34787014
Candida sepsis 41.45 14.08 29 76944 1250 34878708
Diabetes mellitus 41.40 14.08 26 76947 46847 34833111
Lymphopenia 40.31 14.08 102 76871 16233 34863725
Pleural effusion 40.05 14.08 312 76661 81234 34798724
Encephalopathy 39.99 14.08 169 76804 35150 34844808
Adverse drug reaction 39.92 14.08 8 76965 29334 34850624
Respiratory distress 39.88 14.08 170 76803 35495 34844463
Pneumonia cytomegaloviral 39.85 14.08 41 76932 3013 34876945
Toxicity to various agents 39.79 14.08 268 76705 200094 34679864
Trichosporon infection 39.69 14.08 23 76950 711 34879247
Therapy non-responder 39.53 14.08 181 76792 38965 34840993
Blood stem cell transplant failure 39.27 14.08 19 76954 403 34879555
Retinal haemorrhage 39.03 14.08 52 76921 5037 34874921
Pneumonia aspiration 38.76 14.08 22 76951 41881 34838077
Stomatococcal infection 38.70 14.08 14 76959 137 34879821
Blood pressure fluctuation 38.57 14.08 5 76968 25244 34854714
Hepatic infection fungal 38.44 14.08 15 76958 184 34879774
Disseminated aspergillosis 38.40 14.08 23 76950 757 34879201
Acute graft versus host disease in intestine 38.35 14.08 38 76935 2670 34877288
Nausea 37.97 14.08 524 76449 339384 34540574
Angina pectoris 37.87 14.08 11 76962 31352 34848606
Nephrolithiasis 37.82 14.08 10 76963 30323 34849635
Central nervous system neoplasm 37.57 14.08 12 76961 77 34879881
Klebsiella sepsis 37.35 14.08 33 76940 2004 34877954
Neutropenic infection 37.34 14.08 29 76944 1469 34878489
Respiratory tract infection fungal 37.26 14.08 22 76951 705 34879253
Condition aggravated 37.20 14.08 259 76714 191937 34688021
Heart rate decreased 36.78 14.08 12 76961 31733 34848225
Clostridium difficile infection 36.64 14.08 108 76865 18790 34861168
Cerebral venous thrombosis 36.51 14.08 22 76951 732 34879226
Aeromonas infection 36.50 14.08 16 76957 268 34879690
Refractory anaemia with an excess of blasts 36.48 14.08 18 76955 399 34879559
Epstein-Barr virus associated lymphoproliferative disorder 36.38 14.08 32 76941 1932 34878026
Sinusitis fungal 36.37 14.08 20 76953 558 34879400
Toxic erythema of chemotherapy 36.32 14.08 12 76961 87 34879871
Lentigo 36.08 14.08 19 76954 485 34879473
Enterocolitis 36.05 14.08 64 76909 7962 34871996
Bacillus infection 35.92 14.08 16 76957 279 34879679
Streptococcal bacteraemia 35.67 14.08 32 76941 1983 34877975
Glioma 35.51 14.08 17 76956 352 34879606
Neurological decompensation 35.46 14.08 38 76935 2928 34877030
Hypoglycaemia 35.22 14.08 41 76932 54599 34825359
Decreased appetite 34.83 14.08 219 76754 166173 34713785
Pneumocystis jirovecii pneumonia 34.81 14.08 109 76864 19601 34860357
Pseudomonal sepsis 34.80 14.08 41 76932 3506 34876452
Bronchitis 34.75 14.08 25 76948 41938 34838020
Medication error 34.72 14.08 7 76966 25558 34854400
Transient ischaemic attack 34.63 14.08 9 76964 27604 34852354
Drug clearance decreased 34.43 14.08 30 76943 1788 34878170
Osteoarthritis 34.31 14.08 3 76970 20639 34859319
Erectile dysfunction 34.30 14.08 3 76970 20634 34859324
Diarrhoea 34.21 14.08 629 76344 389283 34490675
Palpitations 34.20 14.08 23 76950 39963 34839995
Urinary tract infection 34.04 14.08 85 76888 83996 34795962
Mobility decreased 33.84 14.08 12 76961 30116 34849842
Autoimmune lymphoproliferative syndrome 33.79 14.08 13 76960 153 34879805
Musculoskeletal pain 33.79 14.08 14 76959 31949 34848009
Treatment noncompliance 33.67 14.08 10 76963 28090 34851868
Human rhinovirus test positive 33.64 14.08 14 76959 205 34879753
Nephropathy toxic 33.60 14.08 81 76892 12507 34867451
Hypoxia 33.53 14.08 222 76751 54873 34825085
Blast cells present 33.30 14.08 18 76955 485 34879473
Gait disturbance 32.98 14.08 88 76885 85052 34794906
White blood cell count decreased 32.87 14.08 338 76635 95107 34784851
Contusion 32.35 14.08 20 76953 36344 34843614
Leukaemic infiltration 32.33 14.08 12 76961 127 34879831
Clostridium bacteraemia 32.29 14.08 13 76960 174 34879784
Dry mouth 32.24 14.08 13 76960 30152 34849806
Philadelphia chromosome positive 32.21 14.08 16 76957 360 34879598
Blood pressure systolic increased 31.77 14.08 6 76967 22946 34857012
Hepatitis B reactivation 31.76 14.08 41 76932 3850 34876108
Enterococcal bacteraemia 31.37 14.08 29 76944 1868 34878090
Pseudomonas infection 31.27 14.08 78 76895 12304 34867654
Hepatitis B 31.22 14.08 51 76922 5932 34874026
Contraindicated product administered 31.08 14.08 5 76968 21476 34858482
Blood HIV RNA increased 31.07 14.08 24 76949 1206 34878752
Haematochezia 30.99 14.08 34 76939 46500 34833458
Acute myocardial infarction 30.81 14.08 44 76929 53675 34826283
Pseudomonas test positive 30.66 14.08 23 76950 1106 34878852
Dysphonia 30.53 14.08 7 76966 23376 34856582
Pneumonia klebsiella 30.50 14.08 37 76936 3263 34876695
Blast crisis in myelogenous leukaemia 30.23 14.08 18 76955 586 34879372
Drug withdrawal syndrome 30.12 14.08 4 76969 19830 34860128
Meningitis chemical 29.97 14.08 10 76963 75 34879883
Therapeutic product effect decreased 29.69 14.08 20 76953 34723 34845235
Dry skin 29.55 14.08 16 76957 31271 34848687
Aspartate aminotransferase increased 29.32 14.08 252 76721 67531 34812427
Diabetic ketoacidosis 28.97 14.08 3 76970 18029 34861929
Metastases to spleen 28.88 14.08 16 76957 453 34879505
Loss of personal independence in daily activities 28.49 14.08 19 76954 33160 34846798
Atypical haemolytic uraemic syndrome 28.35 14.08 14 76959 311 34879647
Hypertension 28.32 14.08 180 76793 136263 34743695
Cough 28.22 14.08 204 76769 149936 34730022
Lung infiltration 28.19 14.08 77 76896 12828 34867130
Cardiac disorder 28.18 14.08 32 76941 43094 34836864
Acute graft versus host disease in liver 27.98 14.08 25 76948 1541 34878417
Guillain-Barre syndrome 27.93 14.08 49 76924 6038 34873920
Chronic kidney disease 27.56 14.08 30 76943 41180 34838778
Gastrointestinal haemorrhage 27.53 14.08 101 76872 88376 34791582
Dyspnoea exertional 27.33 14.08 33 76940 43246 34836712
Lower respiratory tract infection 27.32 14.08 18 76955 31619 34848339
Neuropathy peripheral 27.32 14.08 292 76681 82971 34796987
Haemoglobin abnormal 27.26 14.08 38 76935 3842 34876116
Flushing 27.26 14.08 19 76954 32401 34847557
Acute monocytic leukaemia 26.96 14.08 14 76959 347 34879611
Depressed mood 26.84 14.08 5 76968 19312 34860646
Hepatomegaly 26.79 14.08 66 76907 10330 34869628
Balance disorder 26.74 14.08 30 76943 40624 34839334
Sleep apnoea syndrome 26.70 14.08 6 76967 20315 34859643
Coagulopathy 26.67 14.08 100 76873 19689 34860269
Hot flush 26.60 14.08 4 76969 18062 34861896
Peripheral motor neuropathy 26.56 14.08 26 76947 1800 34878158
Septic embolus 26.25 14.08 22 76951 1243 34878715
Bradycardia 26.25 14.08 82 76891 75336 34804622
Serotonin syndrome 25.96 14.08 6 76967 19927 34860031
Central nervous system lymphoma 25.84 14.08 20 76953 1008 34878950
B-cell lymphoma refractory 25.78 14.08 11 76962 172 34879786
Meningitis tuberculous 25.69 14.08 17 76956 668 34879290
Pseudomonal bacteraemia 25.63 14.08 23 76950 1426 34878532
Transaminases increased 25.59 14.08 122 76851 26701 34853257
Intestinal atresia 25.54 14.08 9 76964 81 34879877
Haematopoietic neoplasm 25.50 14.08 8 76965 48 34879910
Injury 25.45 14.08 7 76966 20680 34859278
Facial paralysis 25.42 14.08 66 76907 10668 34869290
Toxic leukoencephalopathy 25.41 14.08 14 76959 392 34879566
Enterobacter infection 25.37 14.08 29 76944 2401 34877557
Cataract 25.31 14.08 13 76960 26173 34853785
Pathogen resistance 25.29 14.08 61 76912 9421 34870537
Alpha haemolytic streptococcal infection 25.27 14.08 21 76952 1173 34878785
Enterococcus test positive 25.15 14.08 20 76953 1049 34878909
Vascular access complication 24.75 14.08 13 76960 330 34879628
Loss of CAR T-cell persistence 24.64 14.08 7 76966 28 34879930
Recurrent cancer 24.50 14.08 22 76951 1365 34878593
Klebsiella bacteraemia 24.48 14.08 22 76951 1366 34878592
Congenital pneumonia 24.44 14.08 9 76964 93 34879865
Fungal sepsis 24.35 14.08 18 76955 846 34879112
Engraftment syndrome 24.20 14.08 19 76954 978 34878980
Noninfectious myelitis 24.16 14.08 6 76967 12 34879946
Angioedema 24.13 14.08 28 76945 37346 34842612
International normalised ratio increased 24.07 14.08 42 76931 47285 34832673
Hypoalbuminaemia 24.01 14.08 70 76903 12104 34867854
Refractory cancer 23.99 14.08 10 76963 147 34879811
Periorbital infection 23.99 14.08 10 76963 147 34879811
Bone marrow disorder 23.93 14.08 24 76949 1711 34878247
Escherichia test positive 23.90 14.08 20 76953 1128 34878830
Confusional state 23.76 14.08 203 76770 143957 34736001
Cytomegalovirus hepatitis 23.70 14.08 14 76959 449 34879509
Bacillus bacteraemia 23.64 14.08 8 76965 63 34879895
Hypertensive hydrocephalus 23.53 14.08 8 76965 64 34879894
Hippocampal sclerosis 23.47 14.08 9 76964 105 34879853
Pericardial effusion 23.40 14.08 112 76861 24550 34855408
Dyskinesia 23.40 14.08 10 76963 22403 34857555
Chromosome analysis abnormal 23.28 14.08 10 76963 159 34879799
Abnormal behaviour 23.25 14.08 13 76960 24956 34855002
Eczema 23.13 14.08 6 76967 18430 34861528
Lung neoplasm malignant 23.13 14.08 5 76968 17390 34862568
Pneumonia 23.11 14.08 997 75976 361630 34518328
Haematopoietic stem cell mobilisation 23.06 14.08 10 76963 163 34879795
Burning sensation 23.05 14.08 6 76967 18388 34861570
Candida endophthalmitis 22.95 14.08 9 76964 112 34879846
Vertigo 22.78 14.08 14 76959 25522 34854436
Palmar-plantar erythrodysaesthesia syndrome 22.74 14.08 85 76888 16710 34863248
Platelet transfusion 22.70 14.08 22 76951 1504 34878454
Influenza 22.70 14.08 47 76926 49619 34830339
Acute lymphocytic leukaemia refractory 22.66 14.08 9 76964 116 34879842
Pulmonary embolism 22.64 14.08 111 76862 89635 34790323
Eosinophilia 22.53 14.08 15 76958 26207 34853751
Adenoviral haemorrhagic cystitis 22.46 14.08 13 76960 401 34879557
Product quality issue 22.44 14.08 5 76968 17030 34862928
Hepatosplenomegaly 22.38 14.08 36 76937 4133 34875825
Encephalitis cytomegalovirus 22.36 14.08 15 76958 603 34879355
Personality change due to a general medical condition 22.32 14.08 7 76966 42 34879916
Chronic myeloid leukaemia 22.31 14.08 26 76947 2198 34877760
BK virus infection 22.31 14.08 43 76930 5695 34874263
Glioblastoma multiforme 22.22 14.08 16 76957 722 34879236
Acute myeloid leukaemia refractory 22.18 14.08 7 76966 43 34879915
Adverse event 22.10 14.08 7 76966 18870 34861088
Human herpesvirus 6 infection 22.00 14.08 25 76948 2056 34877902
Haemorrhagic pneumonia 21.93 14.08 9 76964 127 34879831
Bacillus test positive 21.87 14.08 8 76965 81 34879877
Bone marrow necrosis 21.86 14.08 10 76963 186 34879772
Encephalitis 21.80 14.08 49 76924 7228 34872730
Anal inflammation 21.75 14.08 20 76953 1280 34878678
Gamma-glutamyltransferase increased 21.70 14.08 124 76849 29107 34850851
Dysgeusia 21.66 14.08 16 76957 26481 34853477
Superior mesenteric artery syndrome 21.61 14.08 8 76965 84 34879874
Morphoea 21.39 14.08 10 76963 196 34879762
Nephritis allergic 21.38 14.08 13 76960 440 34879518
Enteritis 21.31 14.08 52 76921 8090 34871868
Infection in an immunocompromised host 21.29 14.08 15 76958 654 34879304
Autoimmune neutropenia 21.28 14.08 11 76962 270 34879688
Immune effector cell-associated neurotoxicity syndrome 21.23 14.08 33 76940 3680 34876278
Enterococcal sepsis 21.01 14.08 22 76951 1650 34878308
Cerebral fungal infection 20.88 14.08 11 76962 281 34879677
Central nervous system haemorrhage 20.81 14.08 8 76965 94 34879864
Blast cell crisis 20.73 14.08 8 76965 95 34879863
Staphylococcus test positive 20.61 14.08 30 76943 3156 34876802
Streptococcal sepsis 20.55 14.08 21 76952 1531 34878427
Hypothalamo-pituitary disorder 20.54 14.08 16 76957 814 34879144
Engraft failure 20.51 14.08 13 76960 474 34879484
Septal panniculitis 20.48 14.08 7 76966 57 34879901
Blindness cortical 20.42 14.08 12 76961 381 34879577
Psoriatic arthropathy 20.40 14.08 9 76964 19789 34860169
Enterobacter sepsis 20.31 14.08 16 76957 828 34879130
Osteonecrosis of jaw 20.30 14.08 7 76966 17882 34862076
Mucosal infection 20.30 14.08 10 76963 221 34879737
Gallbladder empyema 20.27 14.08 7 76966 59 34879899
Heart rate increased 20.22 14.08 45 76928 46298 34833660
Procalcitonin increased 20.17 14.08 22 76951 1729 34878229
Ichthyosis 20.15 14.08 8 76965 103 34879855
Graft versus host disease in liver 20.03 14.08 19 76954 1265 34878693
Spinal cord disorder 20.02 14.08 16 76957 845 34879113
Meningeal neoplasm 19.96 14.08 7 76966 62 34879896
Cerebellar tumour 19.96 14.08 7 76966 62 34879896
Illness 19.91 14.08 3 76970 13526 34866432
Arrhythmia 19.87 14.08 30 76943 35778 34844180
Xanthogranuloma 19.77 14.08 7 76966 64 34879894
Metastases to muscle 19.74 14.08 10 76963 235 34879723
Intracranial pressure increased 19.68 14.08 33 76940 3922 34876036
Platelet count abnormal 19.61 14.08 28 76945 2894 34877064
Agitation 19.55 14.08 63 76910 57336 34822622
Immunosuppression 19.51 14.08 43 76930 6261 34873697
Intussusception 19.44 14.08 14 76959 632 34879326
Disease susceptibility 19.39 14.08 7 76966 68 34879890
Aphasia 19.33 14.08 96 76877 21358 34858600
Metastases to retroperitoneum 19.32 14.08 10 76963 246 34879712
Amnesia 19.29 14.08 18 76955 26545 34853413
Anorectal cellulitis 19.27 14.08 6 76967 35 34879923
Abscess fungal 19.18 14.08 10 76963 250 34879708
Splenic candidiasis 18.95 14.08 7 76966 73 34879885
Body temperature decreased 18.93 14.08 3 76970 13031 34866927
Ejection fraction decreased 18.91 14.08 88 76885 19066 34860892
Blast cell count increased 18.84 14.08 17 76956 1061 34878897
Hidradenitis 18.79 14.08 17 76956 1065 34878893
Klebsiella test positive 18.78 14.08 14 76959 667 34879291
Acute myelomonocytic leukaemia 18.75 14.08 8 76965 125 34879833
Emotional distress 18.64 14.08 5 76968 15021 34864937
Peripheral sensory neuropathy 18.58 14.08 44 76929 6716 34873242
Candida pneumonia 18.56 14.08 12 76961 453 34879505
Stenotrophomonas sepsis 18.53 14.08 8 76965 129 34879829
Cranial nerve disorder 18.44 14.08 13 76960 567 34879391
Urethral obstruction 18.43 14.08 9 76964 195 34879763
Premature ageing 18.38 14.08 7 76966 80 34879878
Pneumonia adenoviral 18.26 14.08 11 76962 366 34879592
Papilloedema 18.22 14.08 26 76947 2687 34877271
Vision blurred 18.18 14.08 47 76926 45916 34834042
Feeling hot 18.16 14.08 10 76963 19362 34860596
Clostridium test positive 18.13 14.08 29 76944 3313 34876645
Enterovirus infection 18.13 14.08 16 76957 970 34878988
Body mass index decreased 18.10 14.08 9 76964 203 34879755
Accidental overdose 18.02 14.08 11 76962 20129 34859829
Aspergillus test positive 17.88 14.08 12 76961 483 34879475
Swollen tongue 17.86 14.08 5 76968 14600 34865358
Device related thrombosis 17.84 14.08 17 76956 1138 34878820
Streptococcus test positive 17.73 14.08 16 76957 999 34878959
Quadriplegia 17.73 14.08 21 76952 1806 34878152
Candida test positive 17.60 14.08 11 76962 391 34879567
Ileus paralytic 17.54 14.08 40 76933 5957 34874001
Headache 17.41 14.08 324 76649 200311 34679647
Arthritis fungal 17.37 14.08 7 76966 94 34879864
Large intestine infection 17.36 14.08 19 76954 1499 34878459
Respiratory depression 17.36 14.08 7 76966 16238 34863720
Psychotic disorder 17.25 14.08 17 76956 24435 34855523
Blood glucose decreased 17.21 14.08 4 76969 13233 34866725
Mental disorder 17.18 14.08 6 76967 15203 34864755
General physical health deterioration 17.17 14.08 190 76783 128079 34751879
Posturing 17.05 14.08 12 76961 522 34879436
Bone marrow transplant 17.03 14.08 16 76957 1052 34878906
Pulmonary veno-occlusive disease 17.03 14.08 12 76961 523 34879435
Vasogenic cerebral oedema 16.97 14.08 13 76960 645 34879313
Metastases to bone marrow 16.97 14.08 12 76961 526 34879432
Raoultella ornithinolytica infection 16.93 14.08 6 76967 55 34879903
Mixed anxiety and depressive disorder 16.85 14.08 7 76966 102 34879856
Metastases to bone 16.84 14.08 3 76970 11967 34867991
Antithrombin III decreased 16.84 14.08 10 76963 324 34879634
Gene mutation 16.76 14.08 18 76955 1390 34878568
Peritoneal lesion 16.67 14.08 7 76966 105 34879853
Total lung capacity decreased 16.60 14.08 15 76958 938 34879020
Gout 16.56 14.08 11 76962 19242 34860716
Restlessness 16.54 14.08 19 76954 25463 34854495
Diverticulitis 16.45 14.08 12 76961 19992 34859966
Swelling face 16.38 14.08 16 76957 23089 34856869
Capnocytophaga infection 16.37 14.08 7 76966 110 34879848
Cardiac ventricular disorder 16.34 14.08 9 76964 252 34879706
Human herpesvirus 8 infection 16.31 14.08 15 76958 960 34878998
Colitis ulcerative 16.27 14.08 8 76965 16512 34863446
Haemodynamic instability 16.20 14.08 52 76921 9471 34870487
Hepatic cirrhosis 16.14 14.08 9 76964 17305 34862653
Ecthyma 15.99 14.08 11 76962 461 34879497
Gastrointestinal mucormycosis 15.83 14.08 8 76965 187 34879771
Flatulence 15.83 14.08 14 76959 21184 34858774
Multiple lentigines syndrome 15.80 14.08 5 76968 31 34879927
Enterovirus test positive 15.80 14.08 6 76967 68 34879890
Diabetes mellitus inadequate control 15.75 14.08 5 76968 13459 34866499
Rhinorrhoea 15.75 14.08 20 76953 25648 34854310
Enterocolitis infectious 15.66 14.08 19 76954 1676 34878282
Congenital cardiovascular anomaly 15.64 14.08 8 76965 192 34879766
Skin discolouration 15.61 14.08 10 76963 17835 34862123
Therapy cessation 15.57 14.08 9 76964 16964 34862994
Type 2 diabetes mellitus 15.43 14.08 8 76965 16024 34863934
Acral lentiginous melanoma 15.41 14.08 5 76968 34 34879924
Lewis-Sumner syndrome 15.41 14.08 5 76968 34 34879924
Rectal haemorrhage 15.28 14.08 42 76931 40207 34839751
Transfusion reaction 15.20 14.08 14 76959 898 34879060
Localised infection 15.19 14.08 10 76963 17577 34862381
Interstitial lung disease 15.19 14.08 83 76890 65199 34814759
Abdominal neoplasm 15.15 14.08 10 76963 391 34879567
Pneumatosis 15.15 14.08 11 76962 503 34879455
Leptotrichia infection 15.13 14.08 6 76967 77 34879881
Oxygen saturation decreased 15.10 14.08 64 76909 53754 34826204
B precursor type acute leukaemia 15.09 14.08 8 76965 207 34879751
Limb discomfort 15.05 14.08 3 76970 11044 34868914
Eccrine squamous syringometaplasia 15.04 14.08 5 76968 37 34879921
Migraine 15.01 14.08 10 76963 17468 34862490
Pulmonary mucormycosis 14.99 14.08 13 76960 770 34879188
Cytomegalovirus test positive 14.96 14.08 29 76944 3857 34876101
Wound 14.94 14.08 7 76966 14857 34865101
Apoptosis 14.93 14.08 10 76963 401 34879557
Leukaemia 14.93 14.08 32 76941 4571 34875387
Lower motor neurone lesion 14.93 14.08 5 76968 38 34879920
Chronic myelomonocytic leukaemia 14.88 14.08 12 76961 642 34879316
Neuroendocrine carcinoma of the skin 14.87 14.08 13 76960 778 34879180
5q minus syndrome 14.84 14.08 7 76966 140 34879818
Arteriosclerosis 14.82 14.08 4 76969 11964 34867994
Pneumonia mycoplasmal 14.79 14.08 12 76961 648 34879310
Leukaemic infiltration pulmonary 14.72 14.08 4 76969 13 34879945
Hallucination, auditory 14.72 14.08 4 76969 11913 34868045
Anger 14.66 14.08 4 76969 11880 34868078
Metapneumovirus infection 14.62 14.08 13 76960 796 34879162
Post procedural fistula 14.60 14.08 6 76967 85 34879873
Laboratory test abnormal 14.59 14.08 14 76959 20377 34859581
Adenoviral hepatitis 14.59 14.08 11 76962 533 34879425
Accidental exposure to product 14.55 14.08 5 76968 12797 34867161
Prothrombin level abnormal 14.53 14.08 6 76967 86 34879872
Positron emission tomogram abnormal 14.53 14.08 7 76966 147 34879811
Gastrointestinal inflammation 14.50 14.08 27 76946 3484 34876474
Precursor B-lymphoblastic lymphoma recurrent 14.50 14.08 4 76969 14 34879944
Stomatitis necrotising 14.47 14.08 6 76967 87 34879871
Extramedullary haemopoiesis 14.41 14.08 6 76967 88 34879870
Cystitis viral 14.39 14.08 11 76962 544 34879414
Infusion related reaction 14.33 14.08 64 76909 52993 34826965
Limb injury 14.30 14.08 4 76969 11685 34868273
Foetal exposure during pregnancy 14.28 14.08 40 76933 38061 34841897
Adenomatous polyposis coli 14.28 14.08 7 76966 153 34879805
Intracranial tumour haemorrhage 14.25 14.08 9 76964 326 34879632
Expanded disability status scale score increased 14.20 14.08 9 76964 328 34879630
Chronic myeloid leukaemia transformation 14.19 14.08 7 76966 155 34879803
Renal replacement therapy 14.09 14.08 5 76968 46 34879912
Chorioretinitis 14.09 14.08 10 76963 441 34879517
Lip swelling 14.08 14.08 9 76964 16071 34863887

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
Febrile neutropenia 7330.64 14.95 4460 115815 226539 79397574
Bone marrow failure 1369.54 14.95 891 119384 50216 79573897
Neutropenia 1363.60 14.95 1910 118365 285800 79338313
Mucosal inflammation 1221.82 14.95 969 119306 74611 79549502
Pancytopenia 1030.62 14.95 1259 119016 164486 79459627
Haematotoxicity 1012.43 14.95 486 119789 15033 79609080
Thrombocytopenia 1002.99 14.95 1585 118690 263674 79360439
Venoocclusive liver disease 924.00 14.95 419 119856 11352 79612761
Septic shock 915.14 14.95 1024 119251 121777 79502336
Myelosuppression 903.05 14.95 629 119646 39667 79584446
Febrile bone marrow aplasia 859.19 14.95 411 119864 12609 79611504
Sepsis 853.28 14.95 1487 118788 267941 79356172
Acute myeloid leukaemia 743.66 14.95 504 119771 30381 79593732
Myelodysplastic syndrome 627.87 14.95 451 119824 29850 79594263
Pyrexia 608.08 14.95 2319 117956 676390 78947723
Myelopathy 598.33 14.95 235 120040 4398 79619715
Acute myeloid leukaemia recurrent 598.33 14.95 216 120059 3167 79620946
Bronchopulmonary aspergillosis 597.54 14.95 389 119886 21905 79602208
Leukoencephalopathy 593.18 14.95 273 120002 7656 79616457
Posterior reversible encephalopathy syndrome 588.12 14.95 410 119865 25871 79598242
Neutropenic colitis 564.22 14.95 239 120036 5468 79618645
Fatigue 560.06 14.95 358 119917 929369 78694744
Aplasia 531.61 14.95 252 120023 7568 79616545
Disease progression 507.03 14.95 958 119317 183404 79440709
Arthralgia 481.15 14.95 134 120141 571669 79052444
Multiple organ dysfunction syndrome 476.18 14.95 735 119540 119511 79504602
Pain 470.50 14.95 238 120037 703564 78920549
Neurotoxicity 470.23 14.95 391 119884 32127 79591986
Aspergillus infection 450.04 14.95 308 119967 18853 79605260
Dizziness 409.36 14.95 142 120133 526299 79097814
Fall 399.49 14.95 120 120155 487509 79136604
Acute lymphocytic leukaemia recurrent 398.87 14.95 177 120098 4547 79619566
Product use in unapproved indication 391.05 14.95 1038 119237 249321 79374792
Second primary malignancy 390.91 14.95 253 120022 14097 79610016
Joint swelling 388.37 14.95 10 120265 288636 79335477
Pneumonia fungal 382.25 14.95 228 120047 10982 79613131
Leukaemia recurrent 373.36 14.95 145 120130 2629 79621484
Tumour lysis syndrome 367.36 14.95 298 119977 23641 79600472
Bacteraemia 366.91 14.95 341 119934 32483 79591630
Malaise 352.73 14.95 149 120126 489720 79134393
Completed suicide 349.12 14.95 4 120271 245763 79378350
Diffuse large B-cell lymphoma recurrent 343.58 14.95 154 120121 4053 79620060
Fungal infection 341.52 14.95 366 119909 41382 79582731
Venoocclusive disease 340.64 14.95 157 120118 4416 79619697
Cytopenia 334.65 14.95 264 120011 20119 79603994
Product dose omission issue 331.38 14.95 9 120266 247528 79376585
Dyspnoea 325.15 14.95 495 119780 856530 78767583
Peripheral swelling 312.53 14.95 25 120250 269592 79354521
Colitis 311.15 14.95 463 119812 72844 79551269
Mucormycosis 306.45 14.95 179 120096 8290 79615823
Hyperbilirubinaemia 305.97 14.95 271 120004 24247 79599866
Neoplasm recurrence 305.55 14.95 142 120133 4072 79620041
Off label use 304.41 14.95 2370 117905 904845 78719268
Bacterial infection 296.86 14.95 297 119978 30983 79593130
Graft versus host disease 293.80 14.95 216 120059 14810 79609303
Nasopharyngitis 284.84 14.95 27 120248 253854 79370259
Neutropenic sepsis 279.25 14.95 269 120006 26795 79597318
Blood culture positive 278.48 14.95 168 120107 8261 79615852
Abdominal discomfort 277.78 14.95 28 120247 250699 79373414
Haemophagocytic lymphohistiocytosis 265.81 14.95 238 120037 21599 79602514
Neoplasm progression 264.51 14.95 357 119918 51325 79572788
Insomnia 250.39 14.95 36 120239 245134 79378979
Drug hypersensitivity 249.20 14.95 71 120204 298845 79325268
Cystitis haemorrhagic 248.07 14.95 161 120114 9011 79615102
Clostridium difficile colitis 246.55 14.95 273 120002 32010 79592103
Fusarium infection 240.33 14.95 94 120181 1738 79622375
Platelet count decreased 236.65 14.95 738 119537 193926 79430187
Respiratory failure 235.95 14.95 703 119572 180208 79443905
Neutrophil count decreased 232.06 14.95 467 119808 93492 79530621
Arthropathy 231.34 14.95 8 120267 177103 79447010
Pruritus 228.46 14.95 158 120117 394490 79229623
Enterococcal infection 227.79 14.95 189 120086 15471 79608642
Human herpesvirus 6 infection 222.49 14.95 124 120151 5246 79618867
Cytomegalovirus infection 221.92 14.95 297 119978 42347 79581766
Secondary immunodeficiency 216.07 14.95 103 120172 3131 79620982
Acute graft versus host disease 212.07 14.95 152 120123 10015 79614098
Blood bilirubin increased 210.75 14.95 367 119908 65865 79558248
Cardiotoxicity 210.59 14.95 163 120112 12076 79612037
Contraindicated product administered 209.76 14.95 6 120269 157532 79466581
Geotrichum infection 205.33 14.95 71 120204 910 79623203
Hypofibrinogenaemia 205.08 14.95 86 120189 1916 79622197
Cytomegalovirus chorioretinitis 201.18 14.95 117 120158 5373 79618740
Fungaemia 201.17 14.95 110 120165 4481 79619632
Hypersensitivity 196.25 14.95 75 120200 262164 79361949
Alopecia 192.69 14.95 55 120220 231300 79392813
Musculoskeletal stiffness 192.60 14.95 20 120255 174988 79449125
Systemic candida 191.95 14.95 122 120153 6584 79617529
Swelling 190.98 14.95 46 120229 216665 79407448
Escherichia bacteraemia 189.38 14.95 120 120155 6442 79617671
Arachnoiditis 188.74 14.95 63 120212 720 79623393
Asthma 188.27 14.95 3 120272 135092 79489021
Depression 185.29 14.95 49 120226 216741 79407372
Acute respiratory distress syndrome 183.60 14.95 276 119999 43791 79580322
Staphylococcal infection 181.54 14.95 320 119955 57975 79566138
Blood lactate dehydrogenase increased 178.62 14.95 256 120019 38914 79585199
Weight decreased 176.99 14.95 165 120110 355033 79269080
Parainfluenzae virus infection 174.27 14.95 108 120167 5574 79618539
Pseudomonal sepsis 173.44 14.95 111 120164 6063 79618050
Muscle spasms 170.77 14.95 29 120246 174701 79449412
Feeling abnormal 170.61 14.95 20 120255 159179 79464934
Anxiety 170.09 14.95 81 120194 248431 79375682
Cytokine release syndrome 169.65 14.95 239 120036 35759 79588354
Blood pressure increased 169.20 14.95 54 120221 211306 79412807
Malignant transformation 168.66 14.95 65 120210 1153 79622960
Systemic mycosis 163.28 14.95 80 120195 2586 79621527
Pain in extremity 162.78 14.95 186 120089 364352 79259761
Injection site pain 162.39 14.95 8 120267 129830 79494283
Hypertriglyceridaemia 161.30 14.95 142 120133 12598 79611515
Acute graft versus host disease in skin 160.89 14.95 115 120160 7543 79616570
Bacterial sepsis 160.60 14.95 118 120157 8080 79616033
Pulmonary haemorrhage 158.87 14.95 150 120125 14567 79609546
Inappropriate schedule of product administration 158.71 14.95 11 120264 133617 79490496
Therapeutic product effect decreased 158.37 14.95 28 120247 163835 79460278
Urticaria 157.99 14.95 42 120233 185159 79438954
Diffuse large B-cell lymphoma refractory 154.93 14.95 64 120211 1371 79622742
Stem cell transplant 154.74 14.95 86 120189 3618 79620495
Skin toxicity 154.65 14.95 116 120159 8198 79615915
Therapy partial responder 153.78 14.95 159 120116 17238 79606875
Overdose 151.14 14.95 45 120230 184161 79439952
Hypogammaglobulinaemia 147.50 14.95 136 120139 12815 79611298
Arthritis 147.21 14.95 6 120269 114874 79509239
Disease recurrence 146.31 14.95 249 120026 43860 79580253
Escherichia sepsis 145.70 14.95 113 120162 8395 79615718
Cytomegalovirus viraemia 144.79 14.95 134 120141 12687 79611426
Malignant neoplasm progression 143.92 14.95 492 119783 135498 79488615
Escherichia infection 143.87 14.95 156 120119 17861 79606252
Staphylococcal sepsis 143.72 14.95 142 120133 14584 79609529
Pleural effusion 142.90 14.95 513 119762 144749 79479364
Wound 142.65 14.95 8 120267 116171 79507942
Discomfort 141.76 14.95 13 120262 125604 79498509
Condition aggravated 141.75 14.95 344 119931 500780 79123333
Infusion related reaction 141.51 14.95 86 120189 230151 79393962
Drug resistance 139.62 14.95 238 120037 41975 79582138
Drug intolerance 138.34 14.95 117 120158 264002 79360111
Chloroma 135.54 14.95 49 120226 721 79623392
Chest pain 134.92 14.95 136 120139 282168 79341945
Myocardial infarction 133.86 14.95 55 120220 184074 79440039
Rash 133.35 14.95 438 119837 577920 79046193
Stenotrophomonas infection 131.91 14.95 78 120197 3695 79620418
Herpes simplex 131.14 14.95 124 120151 12063 79612050
Cerebellar syndrome 130.81 14.95 89 120186 5391 79618722
Staphylococcal bacteraemia 128.97 14.95 123 120152 12095 79612018
Device related infection 127.75 14.95 204 120071 34090 79590023
Lower respiratory tract infection 127.24 14.95 21 120254 129199 79494914
Agranulocytosis 127.23 14.95 237 120038 44793 79579320
Contusion 126.38 14.95 34 120241 148742 79475371
Differentiation syndrome 126.11 14.95 66 120209 2458 79621655
Aplastic anaemia 125.77 14.95 145 120130 17760 79606353
Weight increased 125.43 14.95 140 120135 277246 79346867
Mobility decreased 124.52 14.95 18 120257 122157 79501956
Disseminated intravascular coagulation 123.74 14.95 206 120069 35636 79588477
Intentional product misuse 121.83 14.95 5 120270 95160 79528953
Ejection fraction decreased 121.08 14.95 200 120075 34377 79589736
Thymus hypoplasia 120.88 14.95 48 120227 925 79623188
Hepatotoxicity 119.36 14.95 249 120026 51103 79573010
Wheezing 117.03 14.95 18 120257 116646 79507467
Abdominal pain upper 116.15 14.95 100 120175 223719 79400394
Chronic graft versus host disease 115.98 14.95 90 120185 6691 79617422
Neuropathy peripheral 115.90 14.95 471 119804 140834 79483279
Lymphoid tissue hypoplasia 112.48 14.95 45 120230 885 79623228
Urinary tract infection 112.03 14.95 150 120125 274362 79349751
Encephalopathy 110.61 14.95 285 119990 67112 79557001
Pneumonia 109.72 14.95 1496 118779 658750 78965363
Paraplegia 108.73 14.95 77 120198 4976 79619137
Adenovirus infection 108.63 14.95 95 120180 8352 79615761
Leukopenia 108.26 14.95 404 119871 116109 79508004
Bronchitis 106.99 14.95 32 120243 130612 79493501
Myalgia 106.37 14.95 75 120200 185566 79438547
Enterococcal bacteraemia 106.14 14.95 63 120212 3005 79621108
Neutropenic infection 105.92 14.95 58 120217 2369 79621744
Rhinovirus infection 105.42 14.95 91 120184 7862 79616251
Asthenia 104.89 14.95 407 119868 511282 79112831
Dyspepsia 104.07 14.95 19 120256 108668 79515445
Capillary leak syndrome 103.94 14.95 68 120207 3857 79620256
Myelodysplastic syndrome transformation 103.43 14.95 39 120236 650 79623463
Candida infection 102.84 14.95 197 120078 38017 79586096
Hyperhidrosis 102.65 14.95 50 120225 151442 79472671
Graft versus host disease in skin 102.56 14.95 80 120195 5993 79618120
Mycobacterium chelonae infection 102.53 14.95 57 120218 2399 79621714
Epstein-Barr virus infection 101.68 14.95 117 120158 14299 79609814
Nausea 100.99 14.95 941 119334 956255 78667858
Enterobacter infection 99.28 14.95 70 120205 4492 79619621
Migraine 98.86 14.95 9 120266 87484 79536629
Acute lymphocytic leukaemia 98.41 14.95 72 120203 4897 79619216
Hospitalisation 98.11 14.95 13 120262 94223 79529890
Injection site erythema 97.19 14.95 5 120270 78192 79545921
Pathogen resistance 97.14 14.95 114 120161 14228 79609885
Human bocavirus infection 96.93 14.95 38 120237 707 79623406
Sleep disorder 96.30 14.95 9 120266 85668 79538445
Osteoarthritis 95.97 14.95 10 120265 87299 79536814
Psoriatic arthropathy 93.84 14.95 6 120269 77993 79546120
Chronic obstructive pulmonary disease 93.33 14.95 10 120265 85409 79538704
Headache 92.66 14.95 592 119683 653180 78970933
Alanine aminotransferase increased 92.62 14.95 487 119788 162083 79462030
Cytomegalovirus infection reactivation 92.48 14.95 88 120187 8628 79615485
Somnolence 92.10 14.95 136 120139 238845 79385268
Klebsiella infection 91.92 14.95 116 120159 15604 79608509
Streptococcal bacteraemia 91.91 14.95 61 120214 3545 79620568
Psoriasis 91.75 14.95 13 120262 89574 79534539
Hepatosplenic candidiasis 90.87 14.95 34 120241 554 79623559
Progressive multifocal leukoencephalopathy 90.06 14.95 132 120143 20468 79603645
Pseudomonas infection 90.02 14.95 133 120142 20770 79603343
Mantle cell lymphoma recurrent 89.93 14.95 34 120241 571 79623542
Encephalitis 89.63 14.95 111 120164 14649 79609464
White blood cell count decreased 89.36 14.95 537 119738 187751 79436362
Pneumocystis jirovecii pneumonia 89.22 14.95 169 120106 32339 79591774
Retinal haemorrhage 89.16 14.95 84 120191 8133 79615980
Philadelphia chromosome positive 89.09 14.95 35 120240 655 79623458
Palpitations 88.53 14.95 40 120235 126570 79497543
Chest discomfort 88.42 14.95 49 120226 137995 79486118
Minimal residual disease 88.26 14.95 32 120243 475 79623638
Cytogenetic abnormality 88.11 14.95 40 120235 1085 79623028
Back pain 88.10 14.95 206 120069 303974 79320139
Post transplant lymphoproliferative disorder 87.60 14.95 97 120178 11367 79612746
Sweat gland tumour 86.99 14.95 32 120243 496 79623617
Lymphoma 86.85 14.95 119 120156 17341 79606772
Klebsiella sepsis 85.28 14.95 56 120219 3196 79620917
Stomatitis 85.23 14.95 442 119833 146315 79477798
Blister 84.71 14.95 37 120238 119439 79504674
Gastrooesophageal reflux disease 84.51 14.95 26 120249 104220 79519893
Nervous system disorder 84.33 14.95 148 120127 26708 79597405
Loss of personal independence in daily activities 84.22 14.95 25 120250 102555 79521558
Musculoskeletal pain 83.93 14.95 25 120250 102329 79521784
Superior sagittal sinus thrombosis 83.90 14.95 38 120237 1025 79623088
Incorrect dose administered 83.65 14.95 9 120266 76621 79547492
B-cell lymphoma recurrent 82.91 14.95 37 120238 963 79623150
Graft versus host disease in gastrointestinal tract 82.78 14.95 72 120203 6284 79617829
Trichosporon infection 82.63 14.95 37 120238 971 79623142
Constipation 80.92 14.95 193 120082 282857 79341256
Lower respiratory tract infection fungal 80.56 14.95 35 120240 853 79623260
Acute promyelocytic leukaemia 80.29 14.95 41 120234 1450 79622663
Memory impairment 80.18 14.95 34 120241 111700 79512413
Duodenal ulcer perforation 79.93 14.95 5 120270 66206 79557907
Wrong technique in product usage process 79.82 14.95 9 120266 73866 79550247
Toxic erythema of chemotherapy 79.75 14.95 25 120250 230 79623883
Viraemia 79.15 14.95 51 120224 2818 79621295
Blood pressure fluctuation 78.35 14.95 6 120269 67139 79556974
Cardiomyopathy 78.24 14.95 149 120126 28625 79595488
Lung infiltration 78.16 14.95 131 120144 22781 79601332
Alpha haemolytic streptococcal infection 77.85 14.95 47 120228 2313 79621800
Injury 77.61 14.95 12 120263 77484 79546629
Vasogenic cerebral oedema 77.34 14.95 40 120235 1453 79622660
Blood cholesterol increased 77.27 14.95 16 120259 83704 79540409
Dry mouth 76.87 14.95 19 120256 88000 79536113
Suicide attempt 76.23 14.95 16 120259 82916 79541197
Viral haemorrhagic cystitis 75.72 14.95 44 120231 2017 79622096
Central nervous system leukaemia 74.58 14.95 27 120248 399 79623714
Hypoxia 74.45 14.95 331 119944 102912 79521201
Helicobacter infection 74.05 14.95 9 120266 69695 79554418
Oedema peripheral 73.73 14.95 170 120105 252118 79371995
Streptococcal sepsis 73.67 14.95 49 120226 2858 79621255
Enteritis 73.46 14.95 100 120175 14483 79609630
Klebsiella bacteraemia 72.12 14.95 49 120226 2961 79621152
Blast crisis in myelogenous leukaemia 71.42 14.95 32 120243 841 79623272
Hepatitis B reactivation 71.23 14.95 65 120210 6043 79618070
Transformation to acute myeloid leukaemia 70.43 14.95 33 120242 964 79623149
Blood pressure systolic increased 70.30 14.95 9 120266 66977 79557136
Hepatic enzyme increased 70.26 14.95 104 120171 182506 79441607
Central nervous system haemorrhage 70.17 14.95 24 120251 297 79623816
Gene mutation 69.82 14.95 46 120229 2640 79621473
Bone marrow disorder 69.76 14.95 50 120225 3293 79620820
Acute febrile neutrophilic dermatosis 69.74 14.95 53 120222 3819 79620294
Suicidal ideation 69.61 14.95 15 120260 76325 79547788
Burning sensation 69.10 14.95 5 120270 58627 79565486
Candida sepsis 67.67 14.95 44 120231 2469 79621644
Respiratory tract infection fungal 67.19 14.95 34 120241 1179 79622934
Hot flush 66.68 14.95 4 120271 54873 79569240
Pseudomonas test positive 66.62 14.95 39 120236 1813 79622300
Hypoalbuminaemia 66.39 14.95 117 120158 21180 79602933
Syncope 66.35 14.95 105 120170 179344 79444769
Toxic leukoencephalopathy 65.84 14.95 33 120242 1121 79622992
Infection 65.75 14.95 604 119671 241108 79383005
Enterocolitis 64.90 14.95 94 120181 14418 79609695
Flushing 64.71 14.95 26 120249 88242 79535871
Hyperkalaemia 64.48 14.95 47 120228 114351 79509762
Cystitis bacterial 64.46 14.95 28 120247 682 79623431
Respiratory distress 64.25 14.95 214 120061 58125 79565988
Blood fibrinogen decreased 64.22 14.95 39 120236 1940 79622173
Palmar-plantar erythrodysaesthesia syndrome 63.79 14.95 149 120126 32985 79591128
Abscess bacterial 63.26 14.95 29 120246 805 79623308
Quadriplegia 62.76 14.95 47 120228 3313 79620800
Adverse drug reaction 62.71 14.95 12 120263 66380 79557733
Tremor 62.42 14.95 100 120175 169983 79454130
Sedation 62.40 14.95 4 120271 51891 79572222
Pneumonia cytomegaloviral 62.13 14.95 55 120220 4914 79619199
Dehydration 61.96 14.95 181 120094 248006 79376107
Lymphadenopathy 61.94 14.95 199 120076 53048 79571065
Influenza like illness 61.61 14.95 16 120259 71691 79552422
Pyomyositis 61.19 14.95 26 120249 599 79623514
Pseudostroke 61.17 14.95 16 120259 70 79624043
Sinusitis 61.01 14.95 127 120148 195374 79428739
Disseminated aspergillosis 60.95 14.95 31 120244 1087 79623026
C-reactive protein abnormal 60.40 14.95 3 120272 48364 79575749
Human rhinovirus test positive 60.32 14.95 24 120251 465 79623648
Rhabdomyolysis 59.93 14.95 41 120234 103090 79521023
Norovirus test positive 59.75 14.95 26 120249 636 79623477
Stomatococcal infection 59.70 14.95 21 120254 284 79623829
Multiple-drug resistance 59.63 14.95 70 120205 8738 79615375
Thrombotic microangiopathy 59.28 14.95 108 120167 20061 79604052
Impaired healing 59.26 14.95 29 120246 87626 79536487
Hepatomegaly 59.24 14.95 104 120171 18770 79605343
Cough 58.82 14.95 319 119956 366470 79257643
Drug clearance decreased 58.74 14.95 45 120230 3282 79620831
Immune effector cell-associated neurotoxicity syndrome 58.19 14.95 57 120218 5791 79618322
Glioma 58.01 14.95 25 120250 597 79623516
Sinusitis fungal 57.72 14.95 39 120236 2335 79621778
Blood glucose increased 57.65 14.95 53 120222 114922 79509191
Gastrointestinal toxicity 57.50 14.95 66 120209 8043 79616070
Pneumatosis intestinalis 57.49 14.95 59 120216 6338 79617775
Coronary artery disease 57.43 14.95 14 120261 65460 79558653
Acute graft versus host disease in intestine 57.16 14.95 48 120227 3993 79620120
Bacillus infection 57.13 14.95 30 120245 1125 79622988
Guillain-Barre syndrome 56.99 14.95 69 120206 8896 79615217
Leukaemic infiltration 56.88 14.95 17 120258 131 79623982
Pericardial effusion 56.72 14.95 176 120099 46061 79578052
Cerebral venous sinus thrombosis 56.57 14.95 38 120237 2253 79621860
Lymphopenia 55.14 14.95 134 120141 30423 79593690
Myelitis 55.10 14.95 38 120237 2353 79621760
Left ventricular dysfunction 54.80 14.95 102 120173 19259 79604854
Illness 54.71 14.95 4 120271 46507 79577606
Pharyngeal inflammation 54.52 14.95 28 120247 1002 79623111
Granulocyte count decreased 54.52 14.95 34 120241 1774 79622339
Aspartate aminotransferase increased 54.43 14.95 377 119898 138264 79485849
Epstein-Barr virus associated lymphoproliferative disorder 54.23 14.95 44 120231 3488 79620625
Cardiac failure congestive 53.90 14.95 82 120193 142320 79481793
Subacute combined cord degeneration 53.73 14.95 20 120255 321 79623792
Road traffic accident 53.61 14.95 3 120272 43661 79580452
Nephropathy toxic 53.38 14.95 104 120171 20315 79603798
Hidradenitis 53.36 14.95 41 120234 3003 79621110
Diffuse large B-cell lymphoma 53.32 14.95 78 120197 12071 79612042
Cytarabine syndrome 53.28 14.95 15 120260 91 79624022
Appendicitis 53.26 14.95 105 120170 20689 79603424
Maternal exposure during pregnancy 53.26 14.95 77 120198 136461 79487652
Upper respiratory fungal infection 52.95 14.95 20 120255 335 79623778
Heart rate decreased 52.72 14.95 20 120255 70296 79553817
Drug interaction 52.72 14.95 388 119887 414795 79209318
Unevaluable event 52.60 14.95 10 120265 55575 79568538
Enterococcus test positive 52.20 14.95 35 120240 2069 79622044
Depressed mood 52.14 14.95 6 120269 48474 79575639
Feeling hot 51.95 14.95 13 120262 59721 79564392
Nephrolithiasis 51.69 14.95 9 120266 53282 79570831
Pneumonia klebsiella 51.68 14.95 50 120225 5004 79619109
BK virus infection 51.53 14.95 65 120210 8739 79615374
Intussusception 51.17 14.95 28 120247 1142 79622971
Hepatitis B 51.14 14.95 63 120212 8269 79615844
Transaminases increased 51.05 14.95 183 120092 51560 79572553
Balance disorder 50.24 14.95 45 120230 98812 79525301
Hepatocellular injury 50.13 14.95 172 120103 47421 79576692
Loss of consciousness 49.98 14.95 112 120163 167831 79456282
Hallucination 49.94 14.95 34 120241 85711 79538402
Dry skin 49.89 14.95 20 120255 67975 79556138
Product prescribing error 49.59 14.95 5 120270 44808 79579305
Drug dependence 49.44 14.95 3 120272 40766 79583347
Hepatic infection fungal 48.94 14.95 17 120258 221 79623892
Leukaemia 48.52 14.95 52 120223 5873 79618240
Cerebral fungal infection 48.48 14.95 20 120255 427 79623686
Osteonecrosis 48.45 14.95 129 120146 30966 79593147
Enterobacter sepsis 47.97 14.95 27 120248 1164 79622949
Exposure during pregnancy 47.94 14.95 49 120226 101083 79523030
Gait disturbance 47.76 14.95 157 120118 207349 79416764
Metastases to spleen 47.62 14.95 22 120253 622 79623491
Diarrhoea 47.40 14.95 991 119284 879498 78744615
Central nervous system lymphoma 47.22 14.95 34 120241 2255 79621858
Hepatic failure 46.98 14.95 200 120075 61012 79563101
Influenza 46.80 14.95 77 120198 129529 79494584
Transient ischaemic attack 46.74 14.95 11 120264 52684 79571429
Joint stiffness 46.66 14.95 4 120271 40826 79583287
Dysphonia 46.42 14.95 14 120261 56858 79567255
Bone marrow necrosis 45.78 14.95 17 120258 271 79623842
Bone marrow transplant 45.62 14.95 28 120247 1420 79622693
Peripheral motor neuropathy 45.59 14.95 39 120236 3328 79620785
Diffuse alveolar damage 45.28 14.95 40 120235 3564 79620549
Serotonin syndrome 45.02 14.95 7 120268 45020 79579093
Blood stem cell transplant failure 45.01 14.95 20 120255 515 79623598
Treatment noncompliance 44.26 14.95 12 120263 52256 79571857
Hepatosplenomegaly 44.05 14.95 50 120225 6019 79618094
Cerebral haemorrhage 43.92 14.95 188 120087 57485 79566628
Clostridium bacteraemia 43.82 14.95 18 120257 380 79623733
Adverse event 43.71 14.95 18 120257 60196 79563917
Femur fracture 43.59 14.95 4 120271 38648 79585465
Chronic graft versus host disease in skin 43.47 14.95 28 120247 1546 79622567
Encephalitis cytomegalovirus 43.44 14.95 25 120250 1125 79622988
Confusional state 43.37 14.95 291 119984 317706 79306407
Lentigo 43.03 14.95 19 120256 482 79623631
Acute graft versus host disease in liver 42.83 14.95 30 120245 1905 79622208
Enterovirus infection 42.66 14.95 30 120245 1917 79622196
Areflexia 42.58 14.95 47 120228 5487 79618626
Blast cells present 42.58 14.95 23 120252 914 79623199
Coagulopathy 42.27 14.95 135 120140 35871 79588242
Ataxia 42.22 14.95 107 120168 24932 79599181
Acute monocytic leukaemia 41.69 14.95 19 120256 520 79623593
Clostridium test positive 41.56 14.95 50 120225 6404 79617709
Ascites 41.38 14.95 224 120051 75338 79548775
Obesity 41.37 14.95 3 120272 35122 79588991
Cataract 41.31 14.95 21 120254 62099 79562014
Enterovirus test positive 41.25 14.95 16 120259 289 79623824
Perineal necrosis 41.24 14.95 13 120262 122 79623991
Nasal congestion 41.16 14.95 33 120242 76519 79547594
Gastroenteritis adenovirus 41.16 14.95 17 120258 364 79623749
Hypoaesthesia 41.06 14.95 136 120139 179216 79444897
Systemic inflammatory response syndrome 41.05 14.95 67 120208 11398 79612715
Facial paralysis 40.82 14.95 95 120180 20977 79603136
Autoimmune lymphoproliferative syndrome 40.80 14.95 14 120261 175 79623938
Chronic myeloid leukaemia 40.80 14.95 38 120237 3626 79620487
Vertigo 40.76 14.95 27 120248 69055 79555058
Diabetes mellitus 40.66 14.95 35 120240 78355 79545758
Cerebellar tumour 39.98 14.95 12 120263 94 79624019
Neck pain 39.94 14.95 33 120242 75384 79548729
Hypertension 39.78 14.95 314 119961 330678 79293435
Fungal sepsis 39.64 14.95 28 120247 1802 79622311
Swollen tongue 39.56 14.95 8 120267 42562 79581551
Throat irritation 39.53 14.95 7 120268 40939 79583174
Breast cancer 39.46 14.95 3 120272 33778 79590335
Angioedema 39.37 14.95 34 120241 76001 79548112
Mucosal infection 39.22 14.95 18 120257 501 79623612
Hippocampal sclerosis 38.99 14.95 13 120262 148 79623965
Blast cell count increased 38.74 14.95 25 120250 1385 79622728
Abscess fungal 38.68 14.95 16 120259 344 79623769
Subclavian vein thrombosis 38.56 14.95 31 120244 2426 79621687
Plasma cell myeloma 38.53 14.95 16 120259 53243 79570870
Angina pectoris 38.31 14.95 15 120260 51717 79572396
Pseudomonal bacteraemia 38.31 14.95 34 120241 3048 79621065
Hemiparesis 38.26 14.95 125 120150 33608 79590505
Recurrent cancer 38.12 14.95 32 120243 2661 79621452
Erythema 38.11 14.95 190 120085 223100 79401013
Drug withdrawal syndrome 38.09 14.95 4 120271 34714 79589399
Aeromonas infection 38.01 14.95 16 120259 360 79623753
Heart rate increased 38.00 14.95 78 120197 120646 79503467
Folliculitis 37.92 14.95 18 120257 55362 79568751
Pneumonia escherichia 37.88 14.95 21 120254 879 79623234
Prescribed overdose 37.63 14.95 6 120269 37877 79586236
Left atrial hypertrophy 37.14 14.95 10 120265 50 79624063
Gastric disorder 37.02 14.95 6 120269 37427 79586686
Metastases to bone marrow 36.86 14.95 20 120255 802 79623311
Amnesia 36.72 14.95 25 120250 63032 79561081
Neurological symptom 36.55 14.95 55 120220 8728 79615385
Subdural hygroma 36.43 14.95 17 120258 492 79623621
Clostridium difficile infection 36.33 14.95 144 120131 42541 79581572
Nervousness 36.27 14.95 4 120271 33411 79590702
Decreased appetite 36.15 14.95 336 119939 342082 79282031
Hydrocephalus 36.00 14.95 55 120220 8845 79615268
Enterococcal sepsis 35.74 14.95 31 120244 2695 79621418
Anaemia 35.71 14.95 901 119374 444114 79179999
Cerebral venous thrombosis 35.48 14.95 31 120244 2722 79621391
Lip swelling 35.39 14.95 9 120266 40902 79583211
Therapy non-responder 35.04 14.95 249 120026 92056 79532057
Spinal cord disorder 35.01 14.95 26 120249 1809 79622304
Blood creatine phosphokinase increased 34.90 14.95 29 120246 66061 79558052
Peripheral sensory neuropathy 34.83 14.95 67 120208 12966 79611147
Meningitis chemical 34.57 14.95 13 120262 215 79623898
Alternaria infection 34.55 14.95 18 120257 664 79623449
Central nervous system neoplasm 34.54 14.95 11 120264 107 79624006
Body temperature decreased 34.51 14.95 4 120271 32141 79591972
Intracranial pressure increased 34.47 14.95 52 120223 8270 79615843
Acute lymphocytic leukaemia refractory 34.41 14.95 12 120263 158 79623955
Hypothyroidism 34.41 14.95 18 120257 52374 79571739
Enterocolitis infectious 34.37 14.95 31 120244 2838 79621275
Glioblastoma multiforme 34.30 14.95 22 120253 1206 79622907
Hypoglycaemia 34.27 14.95 63 120212 101531 79522582
Ileus 34.23 14.95 102 120173 26109 79598004
Thrombosis 34.21 14.95 46 120229 84054 79540059
Refractory cancer 34.13 14.95 13 120262 223 79623890
Gastrointestinal inflammation 33.93 14.95 49 120226 7495 79616618
Engraftment syndrome 33.91 14.95 23 120252 1386 79622727
Renal failure 33.85 14.95 457 119818 200511 79423602
Aphasia 33.80 14.95 150 120125 46582 79577531
Antithrombin III decreased 33.63 14.95 16 120259 484 79623629
Sleep apnoea syndrome 33.60 14.95 7 120268 36471 79587642
Streptococcal infection 33.53 14.95 53 120222 8777 79615336
Platelet transfusion 33.50 14.95 28 120247 2314 79621799
Polyneuropathy 33.47 14.95 96 120179 24055 79600058
Limb injury 33.45 14.95 3 120272 29525 79594588
Myeloid leukaemia 33.33 14.95 18 120257 715 79623398
Seizure 33.29 14.95 433 119842 188401 79435712
Stenotrophomonas sepsis 33.23 14.95 12 120263 176 79623937
Limb discomfort 33.09 14.95 5 120270 32845 79591268
Oxygen saturation decreased 33.00 14.95 93 120182 128954 79495159
Cardiac failure 32.96 14.95 368 119907 154474 79469639
Pulmonary mucormycosis 32.86 14.95 21 120254 1144 79622969
International normalised ratio increased 32.81 14.95 48 120227 84673 79539440
Ileus paralytic 32.81 14.95 55 120220 9565 79614548
Aggression 32.74 14.95 18 120257 50940 79573173
Gastrointestinal necrosis 32.43 14.95 41 120234 5524 79618589
Refractory anaemia with an excess of blasts 32.38 14.95 19 120256 887 79623226
Product quality issue 32.34 14.95 6 120269 33934 79590179
Productive cough 32.33 14.95 52 120223 88279 79535834
Ureaplasma infection 32.31 14.95 20 120255 1030 79623083
Anorectal cellulitis 32.29 14.95 10 120265 88 79624025
Sinusitis aspergillus 32.29 14.95 13 120262 260 79623853
Leukaemia cutis 32.27 14.95 12 120263 192 79623921
Paraparesis 32.25 14.95 34 120241 3769 79620344
Bacillus test positive 32.24 14.95 11 120264 135 79623978
Cerebrovascular accident 32.05 14.95 123 120152 155169 79468944
Carotid intima-media thickness increased 32.00 14.95 10 120265 91 79624022
Central nervous system fungal infection 31.80 14.95 15 120260 445 79623668
Acute kidney injury 31.77 14.95 1016 119259 518388 79105725
Candida pneumonia 31.74 14.95 17 120258 664 79623449
Bacillus bacteraemia 31.74 14.95 11 120264 142 79623971
Medication error 31.69 14.95 34 120241 68608 79555505
Escherichia test positive 31.69 14.95 31 120244 3144 79620969
Pleuroparenchymal fibroelastosis 31.60 14.95 11 120264 144 79623969
Injection site reaction 31.53 14.95 22 120253 54763 79569350
Joint range of motion decreased 31.46 14.95 6 120269 33276 79590837
Pericarditis 31.43 14.95 69 120206 104167 79519946
Neurological decompensation 31.09 14.95 39 120236 5214 79618899
Accidental exposure to product 31.02 14.95 5 120270 31317 79592796
Engraft failure 31.01 14.95 17 120258 696 79623417
Frequent bowel movements 30.92 14.95 4 120271 29535 79594578
Chromosomal deletion 30.73 14.95 11 120264 157 79623956
Cytotoxic oedema 30.73 14.95 14 120261 383 79623730
Heart rate irregular 30.66 14.95 6 120269 32673 79591440
Jugular vein thrombosis 30.61 14.95 36 120239 4502 79619611
Haemorrhage intracranial 30.56 14.95 98 120177 26095 79598018
Restlessness 30.49 14.95 16 120259 46476 79577637
Streptococcus test positive 30.46 14.95 26 120249 2212 79621901
Septic embolus 30.34 14.95 25 120250 2026 79622087
Venous thrombosis 30.24 14.95 45 120230 7071 79617042
Atypical haemolytic uraemic syndrome 30.10 14.95 19 120256 1013 79623100
Renal replacement therapy 29.87 14.95 11 120264 171 79623942
Meningitis bacterial 29.78 14.95 28 120247 2704 79621409
Chromosome analysis abnormal 29.76 14.95 12 120263 241 79623872
Xanthogranuloma 29.71 14.95 9 120266 73 79624040
Pregnancy 29.70 14.95 3 120272 26848 79597265
Primary hypogonadism 29.58 14.95 11 120264 176 79623937
Cytomegalovirus hepatitis 29.50 14.95 17 120258 767 79623346
Dyspnoea exertional 29.36 14.95 54 120221 87019 79537094
Therapy cessation 29.32 14.95 10 120265 37552 79586561
Serum ferritin increased 29.28 14.95 53 120222 9794 79614319
Quadriparesis 29.15 14.95 31 120244 3470 79620643
Death 29.11 14.95 642 119633 565872 79058241
Ocular hyperaemia 29.09 14.95 4 120271 28202 79595911
Perineal infection 29.04 14.95 17 120258 790 79623323
Ankle brachial index decreased 28.98 14.95 9 120266 80 79624033
Ear infection 28.98 14.95 8 120267 34424 79589689
Swelling face 28.92 14.95 39 120236 71173 79552940
Therapy interrupted 28.89 14.95 6 120269 31335 79592778
Haemorrhagic pneumonia 28.86 14.95 10 120265 129 79623984
Tooth disorder 28.83 14.95 3 120272 26230 79597883
Cytomegalovirus test positive 28.78 14.95 40 120235 5907 79618206
Blood HIV RNA increased 28.77 14.95 23 120252 1785 79622328
Pulse waveform abnormal 28.69 14.95 9 120266 83 79624030
Platelet count abnormal 28.62 14.95 36 120239 4826 79619287
Prescribed underdose 28.59 14.95 5 120270 29509 79594604
Diabetic ketoacidosis 28.58 14.95 8 120267 34114 79589999
Inappropriate antidiuretic hormone secretion 28.50 14.95 96 120179 26217 79597896
Haematopoietic neoplasm 28.50 14.95 9 120266 85 79624028
Cardiac dysfunction 28.29 14.95 33 120242 4091 79620022
Osteoporosis 28.25 14.95 24 120251 54088 79570025
Refractoriness to platelet transfusion 28.11 14.95 10 120265 140 79623973
Mucosal toxicity 28.03 14.95 15 120260 585 79623528
Orthostatic hypotension 28.02 14.95 26 120249 56138 79567975
Oesophageal candidiasis 27.90 14.95 50 120225 9168 79614945
Gamma-glutamyltransferase increased 27.87 14.95 159 120116 54521 79569592
Cardiac disorder 27.74 14.95 35 120240 65722 79558391
Lung consolidation 27.69 14.95 49 120226 8898 79615215
Acute myeloid leukaemia refractory 27.67 14.95 10 120265 147 79623966
Flatulence 27.58 14.95 15 120260 42709 79581404
Prostate cancer 27.50 14.95 8 120267 33260 79590853
Enterobacter bacteraemia 27.47 14.95 17 120258 875 79623238
Blood pressure diastolic decreased 27.42 14.95 6 120269 30210 79593903
Transient acantholytic dermatosis 27.36 14.95 10 120265 152 79623961
Leukoerythroblastosis 27.34 14.95 12 120263 300 79623813
Papilloedema 27.33 14.95 40 120235 6193 79617920
Pulmonary oedema 27.31 14.95 227 120048 88027 79536086
Pancreatitis 27.20 14.95 187 120088 68388 79555725
Eosinophilic cystitis 27.11 14.95 9 120266 101 79624012
Intracranial hypotension 27.03 14.95 13 120262 403 79623710
Adenoviral haemorrhagic cystitis 27.01 14.95 14 120261 511 79623602
Aspergillus test positive 26.98 14.95 16 120259 762 79623351
Haemodynamic instability 26.97 14.95 72 120203 17310 79606803
Atelectasis 26.79 14.95 108 120167 32149 79591964
Anal inflammation 26.70 14.95 20 120255 1410 79622703
Type 2 diabetes mellitus 26.70 14.95 28 120247 57094 79567019
Candida endophthalmitis 26.56 14.95 10 120265 166 79623947
Intestinal atresia 26.51 14.95 8 120267 64 79624049
Cytomegalovirus colitis 26.49 14.95 34 120241 4651 79619462
Haematochezia 26.43 14.95 58 120217 87587 79536526
Metastases to bone 26.32 14.95 3 120272 24424 79599689
Cholestasis 26.22 14.95 151 120124 51958 79572155
Paralysis 26.18 14.95 60 120215 13117 79610996
Skin ulcer 25.93 14.95 26 120249 54124 79569989
Emotional distress 25.85 14.95 14 120261 39955 79584158
Rhinorrhoea 25.81 14.95 47 120228 76027 79548086
Splenic candidiasis 25.48 14.95 8 120267 74 79624039
Klebsiella test positive 25.48 14.95 21 120254 1702 79622411
Brain oedema 25.47 14.95 90 120185 25173 79598940
Visual impairment 25.36 14.95 64 120211 92067 79532046
Cerebral haemangioma 25.30 14.95 9 120266 126 79623987
Viral infection 25.25 14.95 130 120145 42886 79581227
Immunosuppression 25.11 14.95 58 120217 12745 79611368
Gastrointestinal disorder 25.08 14.95 97 120178 122108 79502005
Eosinophilia 25.07 14.95 19 120256 45326 79578787
Oropharyngeal pain 24.97 14.95 83 120192 109270 79514843
Pneumonia aspiration 24.91 14.95 39 120236 66928 79557185
Human herpesvirus 8 infection 24.89 14.95 18 120257 1202 79622911
JC virus infection 24.88 14.95 30 120245 3851 79620262
Hyperammonaemia 24.85 14.95 53 120222 11040 79613073
Cauda equina syndrome 24.82 14.95 19 120256 1384 79622729
Hepatic infarction 24.59 14.95 16 120259 899 79623214
Haematopoietic stem cell mobilisation 24.57 14.95 10 120265 206 79623907
Brain herniation 24.56 14.95 42 120233 7421 79616692
Abortion spontaneous 24.56 14.95 7 120268 29500 79594613
Hypersomnia 24.47 14.95 3 120272 23083 79601030
Noninfectious myelitis 24.46 14.95 6 120269 19 79624094
Diverticulitis 24.44 14.95 20 120255 45916 79578197
Adenoviral hepatitis 24.40 14.95 16 120259 911 79623202
Necrosis 24.39 14.95 48 120227 9445 79614668
Chronic myeloid leukaemia recurrent 24.38 14.95 11 120264 294 79623819
Lung neoplasm malignant 24.26 14.95 6 120269 27786 79596327
Colitis ulcerative 24.24 14.95 11 120264 34731 79589382
Blood glucose decreased 24.23 14.95 5 120270 26229 79597884
Gastrointestinal protozoal infection 24.16 14.95 8 120267 89 79624024
Acute myocardial infarction 24.05 14.95 50 120225 76986 79547127
Precursor T-lymphoblastic lymphoma/leukaemia 24.00 14.95 8 120267 91 79624022
Sciatica 24.00 14.95 10 120265 33212 79590901
Ventricular hypokinesia 23.94 14.95 47 120228 9232 79614881
Disseminated trichosporonosis 23.92 14.95 9 120266 149 79623964
Liver abscess 23.91 14.95 37 120238 6017 79618096
Skin laceration 23.87 14.95 7 120268 28955 79595158
Night sweats 23.83 14.95 26 120249 52069 79572044
Diabetes mellitus inadequate control 23.75 14.95 4 120271 24260 79599853
Ovarian failure 23.70 14.95 14 120261 662 79623451
Angiokeratoma 23.67 14.95 10 120265 227 79623886
Ichthyosis 23.65 14.95 9 120266 154 79623959
Toxicity to various agents 23.60 14.95 471 119804 421069 79203044
Cerebellar stroke 23.41 14.95 13 120262 546 79623567
Loss of CAR T-cell persistence 23.37 14.95 6 120269 24 79624089
Metastases to meninges 23.35 14.95 28 120247 3573 79620540
Temporal lobe epilepsy 23.25 14.95 12 120263 434 79623679
Gastroenteritis norovirus 23.25 14.95 26 120249 3080 79621033
Abnormal behaviour 23.21 14.95 13 120262 36408 79587705
Upper respiratory tract infection 23.08 14.95 66 120209 91102 79533011
Vision blurred 23.08 14.95 82 120193 105816 79518297
Withdrawal syndrome 23.05 14.95 6 120269 26848 79597265
Infection reactivation 22.97 14.95 24 120251 2633 79621480
Gastrointestinal wall thickening 22.97 14.95 24 120251 2633 79621480
Pneumonia moraxella 22.96 14.95 8 120267 105 79624008
Head injury 22.87 14.95 14 120261 37355 79586758
Tachycardia 22.84 14.95 386 119889 177382 79446731
Meningitis tuberculous 22.83 14.95 17 120258 1188 79622925
Granulicatella infection 22.76 14.95 8 120267 108 79624005
Bradycardia 22.74 14.95 116 120159 135441 79488672
Atypical pneumonia 22.71 14.95 38 120237 6598 79617515
Eczema 22.70 14.95 17 120258 40801 79583312
Chronic myeloid leukaemia transformation 22.67 14.95 10 120265 253 79623860
Accidental overdose 22.64 14.95 16 120259 39565 79584548
Pulmonary alveolar haemorrhage 22.57 14.95 52 120223 11405 79612708
Pneumatosis 22.56 14.95 15 120260 874 79623239
Cardiac ventricular disorder 22.47 14.95 11 120264 355 79623758
Herpes simplex reactivation 22.44 14.95 12 120263 467 79623646
Perirectal abscess 22.40 14.95 21 120254 2020 79622093
CSF protein increased 22.39 14.95 17 120258 1223 79622890
Procalcitonin increased 22.22 14.95 25 120250 2981 79621132
Procedural pain 22.17 14.95 4 120271 23080 79601033
Toxic skin eruption 22.12 14.95 79 120196 22214 79601899
Fluid retention 22.05 14.95 45 120230 69764 79554349
Hypertensive hydrocephalus 22.01 14.95 5 120270 10 79624103
Aspergilloma 22.00 14.95 13 120262 615 79623498
Rash pruritic 21.93 14.95 47 120228 71582 79552531
Coronavirus infection 21.85 14.95 40 120235 7457 79616656
Scedosporium infection 21.83 14.95 18 120257 1460 79622653
Hepatobiliary disease 21.82 14.95 14 120261 768 79623345
Cranial nerve disorder 21.79 14.95 16 120259 1094 79623019
Pneumonia adenoviral 21.69 14.95 12 120263 500 79623613
Skin discolouration 21.67 14.95 18 120257 41016 79583097
5q minus syndrome 21.63 14.95 10 120265 283 79623830
Dysgeusia 21.55 14.95 33 120242 57144 79566969
Apoptosis 21.52 14.95 12 120263 508 79623605
Meningitis aseptic 21.51 14.95 38 120237 6890 79617223
Inflammation 21.51 14.95 71 120204 93682 79530431
Chronic kidney disease 21.45 14.95 42 120233 66112 79558001
Laryngeal inflammation 21.40 14.95 9 120266 202 79623911
Mucocutaneous ulceration 21.36 14.95 11 120264 396 79623717
Necrotising fasciitis 21.18 14.95 35 120240 6015 79618098
Blindness cortical 21.14 14.95 15 120260 972 79623141
Enterocolitis haemorrhagic 21.12 14.95 21 120254 2173 79621940
Myeloproliferative neoplasm 21.12 14.95 15 120260 974 79623139
Graft versus host disease in liver 21.11 14.95 19 120256 1735 79622378
Human herpesvirus 6 encephalitis 21.08 14.95 13 120262 665 79623448
Hip fracture 21.06 14.95 10 120265 30751 79593362
Hepatic candidiasis 21.05 14.95 7 120268 79 79624034
Electrocardiogram PR shortened 20.94 14.95 10 120265 305 79623808
Infective aneurysm 20.86 14.95 15 120260 993 79623120
Pulmonary mass 20.85 14.95 93 120182 28941 79595172
Metapneumovirus infection 20.83 14.95 19 120256 1765 79622348
General physical health deterioration 20.81 14.95 291 119984 274947 79349166
Hyperglycaemia 20.75 14.95 179 120096 70156 79553957
Radiculopathy 20.74 14.95 43 120232 8781 79615332
Cardiomyopathy acute 20.71 14.95 10 120265 313 79623800
Myeloblast percentage decreased 20.70 14.95 6 120269 41 79624072
Acute myelomonocytic leukaemia 20.68 14.95 10 120265 314 79623799
Leukaemic lymphoma 20.66 14.95 7 120268 84 79624029
Anti-platelet antibody positive 20.62 14.95 10 120265 316 79623797
Abdominal compartment syndrome 20.61 14.95 18 120257 1579 79622534
Mental status changes 20.60 14.95 172 120103 66787 79557326
Blast cell crisis 20.55 14.95 8 120267 146 79623967
Chronic graft versus host disease in eye 20.55 14.95 8 120267 146 79623967
Premature ageing 20.51 14.95 7 120268 86 79624027
Lymphoma transformation 20.50 14.95 10 120265 320 79623793
Gastroenteritis viral 20.47 14.95 6 120269 24825 79599288
Axonal neuropathy 20.40 14.95 20 120255 2034 79622079
B-cell lymphoma refractory 20.40 14.95 8 120267 149 79623964
Sputum discoloured 20.38 14.95 4 120271 21739 79602374
Rhinocerebral mucormycosis 20.21 14.95 15 120260 1043 79623070
Nephritis allergic 20.20 14.95 13 120262 717 79623396
Metastases to diaphragm 20.10 14.95 6 120269 46 79624067
Strongyloidiasis 20.04 14.95 27 120248 3871 79620242
Movement disorder 20.02 14.95 8 120267 27251 79596862
Haematocolpos 19.99 14.95 6 120269 47 79624066
Vocal cord paralysis 19.95 14.95 22 120253 2565 79621548
Clostridium colitis 19.95 14.95 23 120252 2816 79621297
Acne 19.94 14.95 8 120267 27182 79596931
Clostridial infection 19.93 14.95 33 120242 5681 79618432
Subdural haematoma 19.86 14.95 97 120178 31337 79592776
Abdominal wall wound 19.81 14.95 7 120268 96 79624017
White blood cell count abnormal 19.80 14.95 33 120242 5712 79618401
Ecthyma 19.78 14.95 13 120262 743 79623370
Parametritis 19.76 14.95 4 120271 3 79624110
Chemotherapeutic drug level increased 19.76 14.95 10 120265 347 79623766
Gallbladder empyema 19.75 14.95 7 120268 97 79624016
Leukaemic infiltration pulmonary 19.68 14.95 5 120270 19 79624094
Metastases to muscle 19.68 14.95 10 120265 350 79623763
Carpal tunnel syndrome 19.60 14.95 3 120272 19525 79604588
Large intestine infection 19.51 14.95 24 120251 3145 79620968
Infusion site eschar 19.48 14.95 5 120270 20 79624093
Osmotic demyelination syndrome 19.42 14.95 17 120258 1496 79622617
Toxic encephalopathy 19.40 14.95 49 120226 11391 79612722
Facial paresis 19.39 14.95 32 120243 5494 79618619
Lacrimation increased 19.34 14.95 5 120270 22472 79601641
Loss of proprioception 19.32 14.95 13 120262 773 79623340
Leptotrichia infection 19.26 14.95 6 120269 54 79624059
Bronchiectasis 19.22 14.95 5 120270 22381 79601732
Throat tightness 19.21 14.95 9 120266 27898 79596215
Localised infection 19.21 14.95 17 120258 37558 79586555
Precursor B-lymphoblastic lymphoma recurrent 19.09 14.95 5 120270 22 79624091
Therapeutic product effect incomplete 19.09 14.95 130 120145 141515 79482598
Bone disorder 19.04 14.95 3 120272 19110 79605003
Urethral obstruction 18.96 14.95 9 120266 271 79623842
Intervertebral disc protrusion 18.94 14.95 6 120269 23615 79600498
Continuous haemodiafiltration 18.86 14.95 19 120256 1997 79622116
Superior mesenteric artery syndrome 18.84 14.95 8 120267 184 79623929
Infection in an immunocompromised host 18.84 14.95 16 120259 1352 79622761
Myelofibrosis 18.84 14.95 21 120254 2479 79621634
Periorbital infection 18.77 14.95 7 120268 113 79624000
Pneumonia bacterial 18.75 14.95 68 120207 19263 79604850
Leukaemic infiltration extramedullary 18.72 14.95 8 120267 187 79623926
Transfusion reaction 18.71 14.95 18 120257 1788 79622325
Raoultella ornithinolytica infection 18.69 14.95 6 120269 60 79624053
Cytogenetic analysis abnormal 18.64 14.95 15 120260 1175 79622938
Metastases to retroperitoneum 18.59 14.95 10 120265 394 79623719
Acinetobacter sepsis 18.52 14.95 6 120269 62 79624051
Soft tissue infection 18.46 14.95 26 120249 3886 79620227
CSF test abnormal 18.39 14.95 11 120264 532 79623581
Thirst 18.38 14.95 3 120272 18616 79605497
Human metapneumovirus test positive 18.34 14.95 8 120267 197 79623916
Paresis 18.18 14.95 27 120248 4234 79619879
Chronic myelomonocytic leukaemia 18.18 14.95 13 120262 853 79623260
Cerebral toxoplasmosis 18.07 14.95 20 120255 2342 79621771
Muscle spasticity 18.05 14.95 5 120270 21470 79602643
Pneumonia respiratory syncytial viral 18.02 14.95 18 120257 1872 79622241
Capnocytophaga infection 17.97 14.95 7 120268 128 79623985
Musculoskeletal discomfort 17.87 14.95 4 120271 19831 79604282
CNS ventriculitis 17.83 14.95 10 120265 428 79623685
Device related sepsis 17.82 14.95 33 120242 6207 79617906
Bone marrow leukaemic cell infiltration 17.81 14.95 5 120270 30 79624083
Glaucoma 17.77 14.95 4 120271 19757 79604356
Gastrointestinal mucormycosis 17.75 14.95 10 120265 432 79623681
Activated partial thromboplastin time shortened 17.74 14.95 13 120262 886 79623227
Mucoepidermoid carcinoma 17.71 14.95 6 120269 72 79624041
Wound infection 17.69 14.95 7 120268 23984 79600129
Sneezing 17.67 14.95 4 120271 19679 79604434
Arthritis fungal 17.67 14.95 7 120268 134 79623979
Device related thrombosis 17.63 14.95 21 120254 2662 79621451
Morphoea 17.60 14.95 10 120265 439 79623674
Hepatic cirrhosis 17.60 14.95 16 120259 34890 79589223
Cryptosporidiosis infection 17.57 14.95 12 120263 731 79623382
Spinal cord injury 17.53 14.95 15 120260 1280 79622833
Candida test positive 17.45 14.95 14 120261 1092 79623021
Epstein-Barr viraemia 17.44 14.95 19 120256 2186 79621927
Respiratory depression 17.41 14.95 10 120265 27620 79596493
Eccrine squamous syringometaplasia 17.40 14.95 5 120270 33 79624080
Myelomalacia 17.39 14.95 7 120268 140 79623973
Autoimmune neutropenia 17.36 14.95 11 120264 590 79623523
Bone erosion 17.34 14.95 3 120272 17844 79606269
Haemoglobin abnormal 17.32 14.95 35 120240 7019 79617094
Sinus tachycardia 17.31 14.95 105 120170 36803 79587310
Speech disorder 17.28 14.95 35 120240 54410 79569703
Lower motor neurone lesion 17.27 14.95 5 120270 34 79624079
Therapeutic response delayed 17.06 14.95 14 120261 1128 79622985
Pain in jaw 17.05 14.95 27 120248 46124 79577989
Eye irritation 17.04 14.95 5 120270 20676 79603437
Genotoxicity 17.03 14.95 5 120270 36 79624077
Chronic graft versus host disease oral 16.94 14.95 7 120268 150 79623963
Febrile infection 16.93 14.95 23 120252 3323 79620790
Staphylococcus test positive 16.93 14.95 33 120242 6448 79617665
Splenomegaly 16.85 14.95 69 120206 20685 79603428
Tachypnoea 16.84 14.95 94 120181 31969 79592144
Blastic plasmacytoid dendritic cell neoplasia 16.80 14.95 6 120269 85 79624028
Hypokalaemia 16.79 14.95 308 119967 143732 79480381
Disturbance in attention 16.69 14.95 32 120243 50769 79573344
Rectal haemorrhage 16.68 14.95 59 120216 76241 79547872
Antithrombin III 16.68 14.95 6 120269 87 79624026
Intracardiac thrombus 16.62 14.95 26 120249 4267 79619846
Respiratory arrest 16.61 14.95 39 120236 57511 79566602
Hepatic cytolysis 16.60 14.95 83 120192 27068 79597045
Pulmonary embolism 16.59 14.95 172 120103 171482 79452631
Lewis-Sumner syndrome 16.57 14.95 5 120270 40 79624073
Oophoritis 16.55 14.95 6 120269 89 79624024
CSF red blood cell count positive 16.55 14.95 6 120269 89 79624024
Crying 16.54 14.95 7 120268 23036 79601077
Hepatic calcification 16.54 14.95 9 120266 363 79623750
Paraesthesia 16.51 14.95 178 120097 176145 79447968
Pancreatic infarction 16.50 14.95 3 120272 0 79624113
Myeloblast percentage increased 16.50 14.95 3 120272 0 79624113
Jaw operation 16.39 14.95 12 120263 817 79623296
Obstructive airways disorder 16.37 14.95 14 120261 31445 79592668
Bronchoalveolar lavage abnormal 16.32 14.95 8 120267 259 79623854
Costal cartilage fracture 16.26 14.95 8 120267 261 79623852
Radiation myelopathy 16.23 14.95 4 120271 13 79624100
Anaphylactic reaction 16.22 14.95 68 120207 83675 79540438
Gait inability 16.16 14.95 41 120234 58876 79565237
Monoparesis 16.08 14.95 23 120252 3488 79620625
Histiocytosis 16.05 14.95 5 120270 45 79624068
Aborted pregnancy 16.05 14.95 5 120270 45 79624068
Lipase increased 16.04 14.95 58 120217 16408 79607705
Muscle rigidity 16.03 14.95 5 120270 19877 79604236
CSF myelin basic protein increased 16.00 14.95 4 120271 14 79624099
Vascular access complication 15.88 14.95 18 120257 2164 79621949
Sinus disorder 15.85 14.95 7 120268 22457 79601656
B-cell type acute leukaemia 15.84 14.95 10 120265 533 79623580
Respiratory moniliasis 15.77 14.95 8 120267 279 79623834
Anal infection 15.76 14.95 7 120268 180 79623933
Autologous haematopoietic stem cell transplant 15.76 14.95 5 120270 48 79624065
Acinetobacter bacteraemia 15.72 14.95 8 120267 281 79623832
Adrenomegaly 15.70 14.95 9 120266 402 79623711
Acral lentiginous melanoma 15.67 14.95 5 120270 49 79624064
Acute leukaemia 15.66 14.95 16 120259 1710 79622403
Generalised oedema 15.58 14.95 74 120201 23635 79600478
Sensorimotor disorder 15.58 14.95 12 120263 882 79623231
CSF culture positive 15.58 14.95 5 120270 50 79624063
Tessellated fundus 15.58 14.95 5 120270 50 79624063
Schistocytosis 15.58 14.95 5 120270 50 79624063
Lung opacity 15.58 14.95 28 120247 5146 79618967
Muscle twitching 15.55 14.95 9 120266 24755 79599358
Right ventricular failure 15.54 14.95 8 120267 23489 79600624
Joint effusion 15.51 14.95 4 120271 18010 79606103
Tonsillar haemorrhage 15.48 14.95 8 120267 290 79623823
Myeloblast count increased 15.39 14.95 4 120271 17 79624096
Human polyomavirus infection 15.36 14.95 13 120262 1093 79623020
Cognitive disorder 15.33 14.95 54 120221 69872 79554241
Hiatus hernia 15.32 14.95 8 120267 23304 79600809
Hallucination, auditory 15.32 14.95 6 120269 20687 79603426
Hepatic lesion 15.30 14.95 33 120242 6926 79617187
Agitation 15.25 14.95 88 120187 99627 79524486
Fusobacterium infection 15.24 14.95 6 120269 113 79624000
Haemodialysis 15.22 14.95 61 120214 18107 79606006
Pneumocystis test positive 15.20 14.95 4 120271 18 79624095
Blood test abnormal 15.12 14.95 4 120271 17706 79606407
Blast cell count decreased 15.03 14.95 4 120271 19 79624094
Hip deformity 15.02 14.95 7 120268 202 79623911
Idiopathic pneumonia syndrome 14.99 14.95 10 120265 586 79623527
Refusal of treatment by relative 14.98 14.95 11 120264 752 79623361
Hypoproteinaemia 14.97 14.95 24 120251 4022 79620091
Hypoglossal nerve paresis 14.95 14.95 6 120269 119 79623994

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC L01BC01 ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
ANTINEOPLASTIC AGENTS
ANTIMETABOLITES
Pyrimidine analogues
ATC L01XY01 ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
ANTINEOPLASTIC AGENTS
OTHER ANTINEOPLASTIC AGENTS
Combinations of antineoplastic agents
FDA MoA N0000000233 Nucleic Acid Synthesis Inhibitors
FDA EPC N0000175595 Nucleoside Metabolic Inhibitor
MeSH PA D000890 Anti-Infective Agents
MeSH PA D000963 Antimetabolites
MeSH PA D000964 Antimetabolites, Antineoplastic
MeSH PA D000970 Antineoplastic Agents
MeSH PA D000998 Antiviral Agents
MeSH PA D007155 Immunologic Factors
MeSH PA D007166 Immunosuppressive Agents
MeSH PA D009676 Noxae
CHEBI has role CHEBI:22587 antiviral agents
CHEBI has role CHEBI:35221 antimetabolite
CHEBI has role CHEBI:35610 antineoplastic agents
CHEBI has role CHEBI:35705 immunosuppressive agents

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

DiseaseRelationSNOMED_IDDOID
Acute lymphoid leukemia indication 91857003 DOID:9952
Acute myeloid leukemia, disease indication 91861009
Acute promyelocytic leukemia, FAB M3 indication 110004001
Lymphomatous meningitis indication 426128009
Meningeal Leukemia indication
Allogeneic bone marrow transplantation off-label use 58390007
Chronic myeloid leukemia off-label use 92818009 DOID:8552
Diffuse non-Hodgkin's lymphoma, large cell off-label use 109969005
Myelodysplastic syndrome off-label use 109995007
Burkitt's lymphoma off-label use 118617000
Progressive Diffuse Large B-Cell Lymphoma off-label use
Adjunct for CNS Disease Prevention in Non-Hodgkin's Lymphoma off-label use
Necrotizing enterocolitis in fetus OR newborn contraindication 2707005
Mycosis contraindication 3218000 DOID:1564
Pulmonary edema contraindication 19242006 DOID:11396
Viral disease contraindication 34014006 DOID:934
Hyperuricemia contraindication 35885006 DOID:1920
Gastrointestinal ulcer contraindication 40845000
Stomatitis contraindication 61170000 DOID:9637
Diarrhea contraindication 62315008
Adult respiratory distress syndrome contraindication 67782005 DOID:11394
Leukopenia contraindication 84828003 DOID:615
Cardiomyopathy contraindication 85898001 DOID:0050700
Bacterial infectious disease contraindication 87628006
Kidney disease contraindication 90708001 DOID:557
Infectious disease of central nervous system contraindication 128117002
Acute pancreatitis contraindication 197456007 DOID:2913
Disease of liver contraindication 235856003 DOID:409
Anemia contraindication 271737000 DOID:2355
Pregnancy, function contraindication 289908002
Thrombocytopenic disorder contraindication 302215000 DOID:1588
Peripheral nerve disease contraindication 302226006
Bone marrow depression contraindication 307762000
Coma contraindication 371632003
Breastfeeding (mother) contraindication 413712001
Acute cerebellar syndrome contraindication 417017003
Granulocytopenic disorder contraindication 417672002
Vomiting contraindication 422400008
Protozoal Infection contraindication
Intestinal Ischemic Necrosis contraindication




๐Ÿถ Veterinary Drug Use

None

๐Ÿถ Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 11.91 acidic
pKa2 12.58 acidic
pKa3 12.97 acidic
pKa4 4.04 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
100MG;44MG VYXEOS CELATOR PHARMS N209401 Aug. 3, 2017 RX POWDER INTRAVENOUS 8431806 April 22, 2025 FOR THE TREATMENT OF NEWLY-DIAGNOSED THERAPY-RELATED ACUTE MYELOID LEUKEMIA (T-AML) OR AML WITH MYELODYSPLASIA-RELATED CHANGES (AML-MRC) IN ADULTS AND PEDIATRIC PATIENTS 1 YEAR AND OLDER
100MG;44MG VYXEOS CELATOR PHARMS N209401 Aug. 3, 2017 RX POWDER INTRAVENOUS 7850990 Jan. 23, 2027 FOR THE TREATMENT OF NEWLY-DIAGNOSED THERAPY-RELATED ACUTE MYELOID LEUKEMIA (T-AML) OR AML WITH MYELODYSPLASIA-RELATED CHANGES (AML-MRC) IN ADULTS AND PEDIATRIC PATIENTS 1 YEAR AND OLDER
100MG;44MG VYXEOS CELATOR PHARMS N209401 Aug. 3, 2017 RX POWDER INTRAVENOUS 8022279 Sept. 14, 2027 FOR THE TREATMENT OF NEWLY-DIAGNOSED THERAPY-RELATED ACUTE MYELOID LEUKEMIA (T-AML) OR AML WITH MYELODYSPLASIA-RELATED CHANGES (AML-MRC) IN ADULTS AND PEDIATRIC PATIENTS 1 YEAR AND OLDER
100MG;44MG VYXEOS CELATOR PHARMS N209401 Aug. 3, 2017 RX POWDER INTRAVENOUS 8092828 April 1, 2029 FOR THE TREATMENT OF NEWLY-DIAGNOSED THERAPY-RELATED ACUTE MYELOID LEUKEMIA (T-AML) OR AML WITH MYELODYSPLASIA-RELATED CHANGES (AML-MRC) IN ADULTS AND PEDIATRIC PATIENTS 1 YEAR AND OLDER
100MG;44MG VYXEOS CELATOR PHARMS N209401 Aug. 3, 2017 RX POWDER INTRAVENOUS 10028912 Oct. 15, 2032 METHOD OF ADMINISTERING A RECONSTITUTED LIPOSOMAL COMPOSITION CONTAINING CYTARABINE AND DAUNORUBICIN TO TREAT NEWLY-DIAGNOSED THERAPY-RELATED AML (T-AML) OR AML WITH MYELODYSPLASIA-RELATED CHANGES (AML-MRC) IN PATIENTS 1 YEAR AND OLDER
100MG;44MG VYXEOS CELATOR PHARMS N209401 Aug. 3, 2017 RX POWDER INTRAVENOUS 10028912 Oct. 15, 2032 METHOD OF RECONSTITUTING A LYOPHILIZED LIPOSOMAL COMPOSITION FOR ADMINISTERING CYTARABINE AND DAUNORUBICIN TO TREAT NEWLY-DIAGNOSED THERAPY-RELATED AML (T-AML) OR AML WITH MYELODYSPLASIA-RELATED CHANGES (AML-MRC) IN PATIENTS 1 YEAR AND OLDER
100MG;44MG VYXEOS CELATOR PHARMS N209401 Aug. 3, 2017 RX POWDER INTRAVENOUS 10166184 Oct. 15, 2032 METHOD OF RECONSTITUTING A LYOPHILIZED LIPOSOMAL COMPOSITION FOR ADMINISTERING CYTARABINE AND DAUNORUBICIN TO TREAT NEWLY-DIAGNOSED THERAPY-RELATED AML (T-AML) OR AML WITH MYELODYSPLASIA-RELATED CHANGES (AML-MRC) IN PATIENTS 1 YEAR AND OLDER
100MG;44MG VYXEOS CELATOR PHARMS N209401 Aug. 3, 2017 RX POWDER INTRAVENOUS 10835492 Oct. 15, 2032 METHOD OF ADMINISTERING A RECONSTITUTED LIPOSOMAL COMPOSITION CONTAINING CYTARABINE AND DAUNORUBICIN TO TREAT NEWLY-DIAGNOSED THERAPY-RELATED AML (T-AML) OR AML WITH MYELODYSPLASIA-RELATED CHANGES (AML-MRC) IN PATIENTS 1 YEAR AND OLDER

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
100MG;44MG VYXEOS CELATOR PHARMS N209401 Aug. 3, 2017 RX POWDER INTRAVENOUS March 30, 2024 NEW PATIENT POPULATION
100MG;44MG VYXEOS CELATOR PHARMS N209401 Aug. 3, 2017 RX POWDER INTRAVENOUS Aug. 3, 2024 TREATMENT OF ADULTS WITH NEWLY DIAGNOSED THERAPY-RELATED ACUTE MYELOID LEUKEMIA (T-AML) OR AML WITH MYELODYSPLASIA-RELATED CHANGES (AML-MRC)
100MG;44MG VYXEOS CELATOR PHARMS N209401 Aug. 3, 2017 RX POWDER INTRAVENOUS March 30, 2028 TREATMENT OF NEWLY-DIAGNOSED THERAPY-RELATED ACUTE MYELOID LEUKEMIA (T-AML) OR AML WITH MYELODYSPLASIA-RELATED CHANGES (AML-MRC) IN PEDIATRIC PATIENTS AGES 1 YEAR AND OLDER

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
DNA polymerase (alpha/delta/epsilon) Enzyme INHIBITOR CHEMBL CHEMBL
Prostatic acid phosphatase Enzyme GI50 7 WOMBAT-PK
DNA polymerase beta Enzyme WOMBAT-PK
E3 ubiquitin-protein ligase Mdm2 Nuclear other IC50 7.70 CHEMBL
Enoyl-[acyl-carrier-protein] reductase [NADH] Enzyme IC50 4.23 CHEMBL

External reference:

IDSource
4018080 VUID
N0000146419 NUI
D00168 KEGG_DRUG
69-74-9 SECONDARY_CAS_RN
3041 RXNORM
4018080 VANDF
4021182 VANDF
C0010711 UMLSCUI
CHEBI:28680 CHEBI
AR3 PDB_CHEM_ID
CHEMBL803 ChEMBL_ID
CHEMBL596186 ChEMBL_ID
CHEMBL2092816 ChEMBL_ID
DB00987 DRUGBANK_ID
CHEMBL1256472 ChEMBL_ID
D003561 MESH_DESCRIPTOR_UI
6253 PUBCHEM_CID
4827 IUPHAR_LIGAND_ID
1709 INN_ID
04079A1RDZ UNII
17070 MMSL
372 MMSL
4526 MMSL
d00201 MMSL
d04834 MMSL
002649 NDDF
007798 NDDF
017308 NDDF
116089003 SNOMEDCT_US
387511003 SNOMEDCT_US
89265009 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
cytarabine HUMAN PRESCRIPTION DRUG LABEL 1 25021-223 INJECTION, SOLUTION 100 mg INTRAVENOUS ANDA 24 sections
cytarabine HUMAN PRESCRIPTION DRUG LABEL 1 25021-229 INJECTION, SOLUTION 20 mg INTRAVENOUS ANDA 24 sections
CYTARABINE HUMAN PRESCRIPTION DRUG LABEL 1 61703-303 INJECTION, SOLUTION 20 mg INTRAVENOUS ANDA 22 sections
CYTARABINE HUMAN PRESCRIPTION DRUG LABEL 1 61703-303 INJECTION, SOLUTION 20 mg INTRAVENOUS ANDA 22 sections
Cytarabine HUMAN PRESCRIPTION DRUG LABEL 1 61703-304 INJECTION, SOLUTION 20 mg INTRAVENOUS ANDA 24 sections
Cytarabine HUMAN PRESCRIPTION DRUG LABEL 1 61703-304 INJECTION, SOLUTION 20 mg INTRAVENOUS ANDA 24 sections
Cytarabine HUMAN PRESCRIPTION DRUG LABEL 1 61703-305 INJECTION, SOLUTION 20 mg INTRAVENOUS ANDA 24 sections
Cytarabine HUMAN PRESCRIPTION DRUG LABEL 1 61703-305 INJECTION, SOLUTION 20 mg INTRAVENOUS ANDA 24 sections
Cytarabine HUMAN PRESCRIPTION DRUG LABEL 1 61703-319 INJECTION, SOLUTION 100 mg INTRAVENOUS ANDA 16 sections
Cytarabine HUMAN PRESCRIPTION DRUG LABEL 1 61703-319 INJECTION, SOLUTION 100 mg INTRAVENOUS ANDA 16 sections
Cytarabine HUMAN PRESCRIPTION DRUG LABEL 1 63323-120 INJECTION, SOLUTION 100 mg INTRAVENOUS ANDA 24 sections
Cytarabine HUMAN PRESCRIPTION DRUG LABEL 1 67457-452 INJECTION 2 g INTRATHECAL ANDA 20 sections
cytarabine HUMAN PRESCRIPTION DRUG LABEL 1 67457-455 INJECTION 100 mg INTRAVENOUS ANDA 23 sections
Cytarabine Human Prescription Drug Label 1 68083-337 INJECTION, SOLUTION 100 mg INTRAVENOUS ANDA 23 sections
Cytarabine Human Prescription Drug Label 1 68083-343 INJECTION, SOLUTION 20 mg INTRAVENOUS ANDA 22 sections
VYXEOS HUMAN PRESCRIPTION DRUG LABEL 2 68727-745 INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION 100 mg INTRAVENOUS NDA 28 sections
VYXEOS HUMAN PRESCRIPTION DRUG LABEL 2 68727-745 INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION 100 mg INTRAVENOUS NDA 28 sections
Cytarabine HUMAN PRESCRIPTION DRUG LABEL 1 71288-108 INJECTION, SOLUTION 20 mg INTRAVENOUS ANDA 23 sections
Cytarabine HUMAN PRESCRIPTION DRUG LABEL 1 71288-109 INJECTION, SOLUTION 2 g INTRAVENOUS ANDA 24 sections
Cytarabine HUMAN PRESCRIPTION DRUG LABEL 1 71288-168 INJECTION, SOLUTION 20 mg INTRAVENOUS ANDA 24 sections
Cytarabine HUMAN PRESCRIPTION DRUG LABEL 1 71288-168 INJECTION, SOLUTION 20 mg INTRAVENOUS ANDA 24 sections
Cytarabine HUMAN PRESCRIPTION DRUG LABEL 1 71288-169 INJECTION, SOLUTION 20 mg INTRAVENOUS ANDA 24 sections
Cytarabine HUMAN PRESCRIPTION DRUG LABEL 1 71288-169 INJECTION, SOLUTION 20 mg INTRAVENOUS ANDA 24 sections