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

Stem definitionDrug idCAS RN
antineoplastics, taxane derivatives 939 114977-28-5

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • docetaxel hydrate
  • docetaxel
  • docetaxol
  • docetere
  • taxotel
  • taxotere
  • docetaxel anhydrous
  • RP 56976
  • RP-56976
A semisynthetic analog of PACLITAXEL used in the treatment of locally advanced or metastatic BREAST NEOPLASMS and NON-SMALL CELL LUNG CANCER.
  • Molecular weight: 807.89
  • Formula: C43H53NO14
  • CLOGP: 3.23
  • LIPINSKI: 2
  • HAC: 15
  • HDO: 5
  • TPSA: 224.45
  • ALOGS: -4.80
  • ROTB: 13
  • Status: OFP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

None

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 2 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 0.01 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 5 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 0.15 µM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 0 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 2.10 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 14 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.04 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 11 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
May 14, 1996 FDA SANOFI AVENTIS US

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 1669.12 14.07 1347 85567 104198 56100955
Neutropenia 1446.97 14.07 1484 85430 156683 56048470
Palmar-plantar erythrodysaesthesia syndrome 1008.37 14.07 539 86375 20526 56184627
Myelosuppression 1006.14 14.07 506 86408 16949 56188204
Diarrhoea 996.74 14.07 2674 84240 635833 55569320
Malignant neoplasm progression 931.13 14.07 827 86087 72760 56132393
Disease progression 858.84 14.07 930 85984 104243 56100910
Mucosal inflammation 769.18 14.07 590 86324 42220 56162933
Ejection fraction decreased 742.77 14.07 432 86482 19409 56185744
Neuropathy peripheral 652.86 14.07 799 86115 102094 56103059
Metastases to bone 626.85 14.07 385 86529 19123 56186030
Bone marrow failure 591.10 14.07 427 86487 27859 56177294
Rheumatoid arthritis 568.74 14.07 4 86910 382600 55822553
Metastases to liver 549.79 14.07 368 86546 21218 56183935
Drug ineffective 420.52 14.07 483 86431 918506 55286647
Metastases to central nervous system 403.86 14.07 245 86669 11891 56193262
Metastases to lung 401.40 14.07 241 86673 11477 56193676
Breast cancer metastatic 356.55 14.07 248 86666 15221 56189932
Agranulocytosis 354.47 14.07 288 86626 22371 56182782
Metastases to lymph nodes 343.98 14.07 186 86728 7237 56197916
Cardiotoxicity 311.42 14.07 176 86738 7474 56197679
Neutropenic sepsis 305.24 14.07 224 86690 14961 56190192
Joint swelling 304.67 14.07 43 86871 289757 55915396
Neoplasm progression 276.41 14.07 292 86622 31724 56173429
Polyneuropathy 267.95 14.07 195 86719 12855 56192298
Leukopenia 264.08 14.07 427 86487 70513 56134640
Skin toxicity 261.71 14.07 128 86786 4025 56201128
Contraindicated product administered 247.89 14.07 9 86905 186277 56018876
Systemic lupus erythematosus 245.69 14.07 7 86907 180071 56025082
Peripheral sensory neuropathy 238.05 14.07 143 86771 6813 56198340
Arthropathy 226.93 14.07 23 86891 200252 56004901
Therapeutic product effect decreased 226.10 14.07 8 86906 169444 56035709
Fall 225.07 14.07 137 86777 357373 55847780
Pleural effusion 224.76 14.07 442 86472 85038 56120115
Breast cancer recurrent 222.61 14.07 114 86800 3961 56201192
Product dose omission issue 211.31 14.07 32 86882 204721 56000432
Breast cancer 211.12 14.07 315 86599 48518 56156635
Neutrophil count decreased 207.74 14.07 316 86598 49506 56155647
Vomiting 205.67 14.07 1393 85521 496835 55708318
Haematotoxicity 201.64 14.07 138 86776 8245 56196908
Acute myeloid leukaemia 200.97 14.07 184 86730 16788 56188365
Alopecia areata 200.35 14.07 78 86836 1389 56203764
Left ventricular dysfunction 190.20 14.07 149 86765 10974 56194179
Bone pain 189.33 14.07 304 86610 49881 56155272
Nausea 187.67 14.07 1899 85015 762279 55442874
Sinusitis 184.20 14.07 40 86874 197541 56007612
Completed suicide 183.26 14.07 5 86909 133828 56071325
Hand deformity 180.62 14.07 6 86908 134486 56070667
Colitis 179.71 14.07 269 86645 41542 56163611
Abdominal discomfort 177.56 14.07 104 86810 277170 55927983
Decreased appetite 175.08 14.07 736 86178 218495 55986658
Drug hypersensitivity 172.32 14.07 106 86808 275099 55930054
Pyrexia 171.46 14.07 1169 85745 417604 55787549
Neutropenic colitis 168.23 14.07 83 86831 2660 56202493
White blood cell count decreased 168.03 14.07 501 86413 125489 56079664
Metastasis 167.99 14.07 100 86814 4684 56200469
Madarosis 167.94 14.07 83 86831 2670 56202483
Onycholysis 166.00 14.07 67 86847 1317 56203836
Hair colour changes 163.99 14.07 83 86831 2812 56202341
Maternal exposure during pregnancy 163.76 14.07 45 86869 189508 56015645
Condition aggravated 163.51 14.07 175 86739 344723 55860430
Nail disorder 163.33 14.07 138 86776 11313 56193840
Aortitis 163.31 14.07 61 86853 965 56204188
Stomatitis 162.62 14.07 482 86432 120328 56084825
Interstitial lung disease 160.88 14.07 304 86610 56759 56148394
Flushing 147.52 14.07 331 86583 69769 56135384
Erythema 144.01 14.07 548 86366 155391 56049762
Metastases to skin 142.54 14.07 61 86853 1397 56203756
Hair texture abnormal 140.96 14.07 83 86831 3809 56201344
Second primary malignancy 139.35 14.07 105 86809 7297 56197856
Wound 137.98 14.07 24 86890 138780 56066373
Anaemia 137.48 14.07 792 86122 266719 55938434
Treatment failure 135.40 14.07 47 86867 170345 56034808
Glossodynia 133.92 14.07 35 86879 152423 56052730
Gastrointestinal toxicity 133.25 14.07 95 86819 6061 56199092
Musculoskeletal stiffness 131.10 14.07 39 86875 155968 56049185
Product use issue 130.48 14.07 62 86852 185979 56019174
Confusional state 130.47 14.07 80 86834 208075 55997078
Neutropenic infection 130.37 14.07 53 86861 1062 56204091
Injection site pain 128.64 14.07 15 86899 117103 56088050
Recall phenomenon 128.27 14.07 44 86870 536 56204617
Skin exfoliation 127.65 14.07 215 86699 36685 56168468
Lymphoedema 126.29 14.07 115 86799 10415 56194738
Weight increased 125.92 14.07 102 86812 229601 55975552
Neurotoxicity 125.64 14.07 138 86776 15657 56189496
Nail toxicity 124.60 14.07 38 86876 308 56204845
Pain 123.63 14.07 566 86348 662618 55542535
Somnolence 116.84 14.07 53 86861 163360 56041793
Dysgeusia 114.09 14.07 217 86697 40698 56164455
Epistaxis 108.42 14.07 286 86628 66737 56138416
Swelling 107.67 14.07 127 86787 239644 55965509
Thrombocytopenia 107.54 14.07 456 86458 135768 56069385
Biopsy lung abnormal 104.36 14.07 28 86886 134 56205019
Hepatic enzyme increased 103.09 14.07 69 86845 171315 56033838
Metastases to pleura 100.48 14.07 47 86867 1335 56203818
Paronychia 99.83 14.07 73 86841 4845 56200308
Dehydration 99.68 14.07 497 86417 158328 56046825
Lacrimation increased 99.53 14.07 132 86782 18216 56186937
Helicobacter infection 99.31 14.07 3 86911 73265 56131888
Capillary leak syndrome 98.78 14.07 52 86862 1914 56203239
Contusion 97.66 14.07 38 86876 128392 56076761
Overdose 95.42 14.07 23 86891 105807 56099346
Hypokalaemia 93.04 14.07 339 86575 94098 56111055
Drug abuse 90.80 14.07 3 86911 67607 56137546
Pericarditis 90.09 14.07 28 86886 108895 56096258
Exposure during pregnancy 88.78 14.07 50 86864 136292 56068861
Pneumonitis 88.73 14.07 168 86746 31396 56173757
Lymphangiosis carcinomatosa 86.27 14.07 41 86873 1208 56203945
Organising pneumonia 85.92 14.07 69 86845 5266 56199887
Dermatitis 85.24 14.07 111 86803 15046 56190107
Headache 84.47 14.07 512 86402 558532 55646621
Drug intolerance 82.32 14.07 179 86735 264639 55940514
Myalgia 81.30 14.07 411 86503 131614 56073539
Nail dystrophy 80.62 14.07 36 86878 916 56204237
Radiation skin injury 80.11 14.07 35 86879 844 56204309
Injection site erythema 80.06 14.07 12 86902 77436 56127717
Invasive ductal breast carcinoma 78.84 14.07 73 86841 6753 56198400
Arthritis 78.50 14.07 28 86886 99824 56105329
Osteoarthritis 77.36 14.07 15 86899 80281 56124872
Duodenal ulcer perforation 76.94 14.07 8 86906 68334 56136819
Vascular device infection 76.91 14.07 66 86848 5524 56199629
Myositis 76.20 14.07 79 86835 8389 56196764
Injury 75.89 14.07 4 86910 59847 56145306
Blood cholesterol increased 75.59 14.07 11 86903 72568 56132585
Acute promyelocytic leukaemia 74.90 14.07 34 86880 900 56204253
Psoriasis 74.58 14.07 25 86889 92667 56112486
Hospitalisation 74.43 14.07 13 86901 74987 56130166
Disease recurrence 73.35 14.07 132 86782 23728 56181425
Discomfort 72.69 14.07 67 86847 141694 56063459
Nail discolouration 71.93 14.07 46 86868 2450 56202703
Febrile bone marrow aplasia 71.52 14.07 68 86846 6504 56198649
Large intestine perforation 70.21 14.07 73 86841 7778 56197375
Multifocal micronodular pneumocyte hyperplasia 69.50 14.07 18 86896 73 56205080
Bronchial polyp 69.50 14.07 18 86896 73 56205080
Metastases to spine 69.04 14.07 48 86866 2941 56202212
Irritable bowel syndrome 67.64 14.07 12 86902 68446 56136707
Loss of personal independence in daily activities 67.13 14.07 21 86893 81348 56123805
Metastases to peritoneum 66.49 14.07 47 86867 2957 56202196
Mobility decreased 66.33 14.07 35 86879 98956 56106197
Inappropriate schedule of product administration 64.50 14.07 24 86890 83363 56121790
Dermatitis acneiform 63.28 14.07 53 86861 4291 56200862
Feeling abnormal 62.93 14.07 68 86846 133534 56071619
Erysipelas 62.60 14.07 66 86848 7147 56198006
Suicide attempt 62.04 14.07 8 86906 57828 56147325
Myocardial infarction 61.98 14.07 33 86881 92837 56112316
Cardiomyopathy 61.98 14.07 99 86815 16159 56188994
Ascites 61.49 14.07 161 86753 37383 56167770
Cerebrovascular accident 60.97 14.07 39 86875 99231 56105922
HER2 positive breast cancer 60.65 14.07 23 86891 380 56204773
Hepatic function abnormal 60.54 14.07 152 86762 34406 56170747
Device related thrombosis 60.00 14.07 35 86879 1578 56203575
Pseudocirrhosis 59.97 14.07 26 86888 615 56204538
Constipation 59.57 14.07 523 86391 201420 56003733
Plasma cell myeloma 59.51 14.07 3 86911 46643 56158510
Adverse drug reaction 59.00 14.07 14 86900 65118 56140035
Depression 58.23 14.07 119 86795 179998 56025155
Migraine 57.69 14.07 31 86883 86766 56118387
Injection site reaction 55.61 14.07 8 86906 53239 56151914
Blood lactate dehydrogenase increased 55.59 14.07 108 86806 20567 56184586
Congestive cardiomyopathy 55.47 14.07 56 86858 5763 56199390
Asthenia 55.15 14.07 788 86126 342185 55862968
Injection site swelling 54.98 14.07 3 86911 43575 56161578
Dyspnoea 54.08 14.07 1245 85669 591332 55613821
Asthma 53.54 14.07 57 86857 112713 56092440
Enterocolitis infectious 52.57 14.07 32 86882 1561 56203592
Intentional product use issue 52.48 14.07 46 86868 99687 56105466
Incorrect dose administered 52.37 14.07 9 86905 52538 56152615
Impaired healing 52.13 14.07 35 86879 86806 56118347
Therapy partial responder 51.75 14.07 62 86852 7723 56197430
Performance status decreased 51.44 14.07 42 86872 3281 56201872
Periarticular thenar erythema with onycholysis 51.22 14.07 11 86903 14 56205139
Gastrointestinal necrosis 51.10 14.07 38 86876 2588 56202565
Ventricular hypokinesia 50.61 14.07 46 86868 4155 56200998
Device related infection 50.17 14.07 107 86807 21773 56183380
Dermatomyositis 49.88 14.07 38 86876 2684 56202469
Hot flush 49.64 14.07 172 86742 46554 56158599
Injection site pruritus 49.63 14.07 4 86910 41927 56163226
Metastases to meninges 49.05 14.07 35 86879 2235 56202918
Arthralgia 48.95 14.07 517 86397 501152 55704001
Lumbosacral radiculoplexus neuropathy 48.86 14.07 11 86903 20 56205133
Blood pressure systolic increased 48.04 14.07 4 86910 40832 56164321
Enterocolitis 47.92 14.07 57 86857 7047 56198106
Cellulitis 46.57 14.07 234 86680 74715 56130438
Alopecia totalis 46.26 14.07 18 86896 320 56204833
Nasopharyngitis 46.22 14.07 180 86734 220779 55984374
Back pain 46.01 14.07 564 86350 236606 55968547
Chest discomfort 45.08 14.07 284 86630 98573 56106580
Drug interaction 45.08 14.07 169 86745 209586 55995567
Pericardial effusion 44.98 14.07 117 86797 27058 56178095
Osteonecrosis of jaw 44.72 14.07 133 86781 33225 56171928
Type 2 diabetes mellitus 44.62 14.07 9 86905 46853 56158300
Tonsillar disorder 44.14 14.07 25 86889 1065 56204088
Metastases to the mediastinum 43.49 14.07 19 86895 458 56204695
Cystoid macular oedema 43.41 14.07 28 86886 1513 56203640
Desmoplastic small round cell tumour 43.34 14.07 15 86899 188 56204965
Death 42.59 14.07 752 86162 340674 55864479
Sedation 42.17 14.07 3 86911 34851 56170302
Influenza 42.12 14.07 51 86863 95210 56109943
Onychalgia 41.36 14.07 22 86892 827 56204326
Cardiac failure 41.33 14.07 242 86672 81851 56123302
Blood uric acid decreased 41.02 14.07 21 86893 729 56204424
Suicidal ideation 40.81 14.07 19 86895 57723 56147430
Nasal congestion 40.70 14.07 18 86896 56352 56148801
Myelodysplastic syndrome 39.68 14.07 82 86832 16324 56188829
Excessive eye blinking 39.65 14.07 23 86891 1026 56204127
Computerised tomogram thorax abnormal 39.59 14.07 26 86888 1449 56203704
Sepsis 39.57 14.07 359 86555 139481 56065672
Pulmonary mass 39.00 14.07 93 86821 20377 56184776
Wheezing 38.99 14.07 35 86879 74991 56130162
Paraesthesia 38.95 14.07 339 86575 130175 56074978
Granulocyte count decreased 38.89 14.07 22 86892 935 56204218
Onychomadesis 38.85 14.07 42 86872 4679 56200474
Metastases to adrenals 38.81 14.07 20 86894 704 56204449
Dacryostenosis acquired 38.78 14.07 18 86896 502 56204651
Acute leukaemia 38.60 14.07 23 86891 1079 56204074
Odynophagia 38.44 14.07 50 86864 6768 56198385
Hallucination 38.25 14.07 14 86900 49135 56156018
Hyperfibrinogenaemia 38.18 14.07 9 86905 22 56205131
Bone marrow infiltration 38.14 14.07 18 86896 522 56204631
Nephrolithiasis 38.09 14.07 6 86908 37329 56167824
Breast pain 38.05 14.07 54 86860 7940 56197213
Blood creatinine decreased 37.43 14.07 43 86871 5123 56200030
Cardiac dysfunction 37.20 14.07 28 86886 1942 56203211
Radiation necrosis 37.12 14.07 16 86898 373 56204780
Ear infection 36.99 14.07 3 86911 31292 56173861
Hypocalcaemia 36.98 14.07 113 86801 28647 56176506
Pregnancy 36.83 14.07 4 86910 33029 56172124
Adverse event 36.47 14.07 20 86894 55356 56149797
Mastectomy 36.35 14.07 25 86889 1505 56203648
Anxiety 36.27 14.07 164 86750 193008 56012145
Obstructive shock 36.12 14.07 9 86905 30 56205123
Cataract 36.00 14.07 17 86897 51230 56153923
Cystitis noninfective 35.87 14.07 21 86893 953 56204200
Purtscher retinopathy 35.83 14.07 7 86907 3 56205150
Metastases to chest wall 35.80 14.07 17 86897 500 56204653
Bradycardia 35.67 14.07 31 86883 67473 56137680
Drug resistance 35.60 14.07 90 86824 20452 56184701
COVID-19 35.55 14.07 38 86876 75020 56130133
Electrocardiogram QT prolonged 35.54 14.07 20 86894 54568 56150585
Mucosal infection 35.30 14.07 12 86902 142 56205011
Eosinophil percentage increased 35.28 14.07 21 86893 983 56204170
Carotidynia 35.22 14.07 12 86902 143 56205010
Medication error 34.78 14.07 11 86903 42324 56162829
Acute interstitial pneumonitis 34.58 14.07 18 86896 647 56204506
Urticaria 34.13 14.07 112 86802 144564 56060589
Gait inability 34.12 14.07 11 86903 41807 56163346
Bronchitis 33.95 14.07 77 86837 112234 56092919
Systemic scleroderma 33.84 14.07 20 86894 924 56204229
Ejection fraction 33.78 14.07 25 86889 1690 56203463
Abortion spontaneous 33.15 14.07 13 86901 43740 56161413
Intestinal ischaemia 33.13 14.07 47 86867 6908 56198245
Nail infection 32.82 14.07 28 86886 2325 56202828
Tumour embolism 32.76 14.07 11 86903 125 56205028
Alanine aminotransferase increased 32.63 14.07 252 86662 93410 56111743
Fatigue 32.46 14.07 1507 85407 787045 55418108
Gastric disorder 32.42 14.07 6 86908 33204 56171949
Osteolysis 32.24 14.07 29 86885 2584 56202569
Road traffic accident 32.13 14.07 3 86911 27924 56177229
Hepatitis B reactivation 32.09 14.07 28 86886 2396 56202757
Nephritis bacterial 32.03 14.07 8 86906 27 56205126
Unevaluable event 31.73 14.07 17 86897 47670 56157483
Bursitis 31.64 14.07 3 86911 27579 56177574
Coronary artery disease 31.30 14.07 5 86909 30791 56174362
EGFR gene mutation 31.28 14.07 13 86901 276 56204877
Osteoporosis 31.20 14.07 21 86893 52031 56153122
Foetal exposure during pregnancy 31.17 14.07 7 86907 33816 56171337
Mastitis 31.08 14.07 28 86886 2500 56202653
Scleroderma renal crisis 30.94 14.07 13 86901 284 56204869
Dysuria 30.81 14.07 111 86803 30618 56174535
Swollen tongue 30.65 14.07 5 86909 30319 56174834
Intentional product misuse 30.58 14.07 21 86893 51483 56153670
Abdominal pain 30.46 14.07 565 86349 258240 55946913
Blood alkaline phosphatase increased 30.39 14.07 130 86784 38815 56166338
International normalised ratio increased 30.34 14.07 15 86899 44026 56161127
Hyperpyrexia 30.33 14.07 31 86883 3237 56201916
Peripheral swelling 30.27 14.07 225 86689 234501 55970652
Oral candidiasis 30.25 14.07 80 86834 18683 56186470
Hepatic lesion 30.13 14.07 35 86879 4220 56200933
Gait disturbance 29.86 14.07 140 86774 163181 56041972
Uterine leiomyosarcoma 29.69 14.07 8 86906 39 56205114
Gas gangrene 29.67 14.07 10 86904 115 56205038
Biliary sepsis 29.61 14.07 18 86896 876 56204277
Troponin I increased 29.51 14.07 25 86889 2056 56203097
Perforation 29.45 14.07 19 86895 1027 56204126
Multiple sclerosis 29.44 14.07 4 86910 27798 56177355
Barotrauma 29.33 14.07 11 86903 176 56204977
Red blood cell sedimentation rate increased 29.23 14.07 10 86904 36613 56168540
Metastatic neoplasm 29.07 14.07 33 86881 3880 56201273
Tremor 29.07 14.07 93 86821 120996 56084157
Toxic optic neuropathy 28.99 14.07 11 86903 182 56204971
Vulvovaginal candidiasis 28.95 14.07 29 86885 2957 56202196
Therapy interrupted 28.83 14.07 3 86911 25622 56179531
Autonomic neuropathy 28.82 14.07 19 86895 1066 56204087
Therapy cessation 28.69 14.07 4 86910 27260 56177893
Gamma-glutamyltransferase increased 28.58 14.07 109 86805 30896 56174257
Pruritus 28.54 14.07 332 86582 316291 55888862
Coma 28.48 14.07 30 86884 59625 56145528
Blood glucose increased 28.44 14.07 45 86869 75106 56130047
Hypertension 28.33 14.07 241 86673 244037 55961116
Basal cell carcinoma 28.26 14.07 3 86911 25218 56179935
Invasive lobular breast carcinoma 28.25 14.07 17 86897 812 56204341
Vascular fragility 28.22 14.07 10 86904 135 56205018
Malignant pleural effusion 28.22 14.07 26 86888 2390 56202763
Folliculitis 28.14 14.07 26 86888 54953 56150200
Left ventricular dilatation 27.86 14.07 14 86900 467 56204686
Lactic acidosis 27.62 14.07 10 86904 35336 56169817
Vein discolouration 27.40 14.07 11 86903 213 56204940
Systolic dysfunction 27.25 14.07 21 86893 1509 56203644
Triple negative breast cancer 27.17 14.07 11 86903 218 56204935
Asthenopia 27.12 14.07 24 86890 2093 56203060
Dyskinesia 26.87 14.07 6 86908 29102 56176051
Intestinal perforation 26.76 14.07 55 86859 10904 56194249
Nasal disorder 26.74 14.07 26 86888 2556 56202597
Vessel puncture site bruise 26.45 14.07 13 86901 413 56204740
Tongue coated 26.42 14.07 19 86895 1228 56203925
Palmar erythema 26.11 14.07 21 86893 1606 56203547
Septic shock 26.02 14.07 172 86742 60663 56144490
Subclavian vein thrombosis 25.96 14.07 22 86892 1810 56203343
Panophthalmitis 25.89 14.07 8 86906 68 56205085
Vulvovaginal dryness 25.87 14.07 25 86889 2440 56202713
Full blood count decreased 25.60 14.07 3 86911 23346 56181807
Irritability 25.56 14.07 7 86907 29581 56175572
Clostridium bacteraemia 25.43 14.07 10 86904 183 56204970
Vascular pain 25.30 14.07 15 86899 697 56204456
Insomnia 25.16 14.07 183 86731 191677 56013476
Thrombotic microangiopathy 25.10 14.07 49 86865 9362 56195791
Therapeutic product effect incomplete 25.06 14.07 82 86832 105949 56099204
Axillary pain 25.03 14.07 21 86893 1704 56203449
Retinal toxicity 24.84 14.07 18 86896 1178 56203975
Nervousness 24.81 14.07 7 86907 29008 56176145
Agitation 24.76 14.07 30 86884 56006 56149147
Alopecia 24.63 14.07 610 86304 292848 55912305
Toxicity to various agents 24.51 14.07 225 86689 224339 55980814
Sclerema 24.44 14.07 5 86909 4 56205149
Nail bed bleeding 24.38 14.07 11 86903 287 56204866
Hepatotoxicity 24.31 14.07 104 86810 31049 56174104
Joint injury 24.27 14.07 5 86909 25649 56179504
Treatment noncompliance 24.21 14.07 10 86904 32613 56172540
Hypertransaminasaemia 24.20 14.07 33 86881 4674 56200479
Acoustic stimulation tests abnormal 24.06 14.07 8 86906 88 56205065
Injection site haemorrhage 23.98 14.07 3 86911 22198 56182955
Recurrent cancer 23.97 14.07 21 86893 1807 56203346
Pneumonia salmonella 23.92 14.07 5 86909 5 56205148
Menopausal disorder 23.84 14.07 7 86907 49 56205104
Metastases to thorax 23.82 14.07 10 86904 218 56204935
Metastases to soft tissue 23.61 14.07 9 86905 151 56205002
PIK3CA-activated mutation 23.58 14.07 16 86898 942 56204211
Balance disorder 23.50 14.07 52 86862 76468 56128685
Pancreatitis 23.45 14.07 21 86893 45059 56160094
Foot fracture 23.42 14.07 3 86911 21806 56183347
Pneumocystis jirovecii pneumonia 23.36 14.07 65 86849 15636 56189517
Full blood count abnormal 23.35 14.07 6 86908 26456 56178697
Ovarian necrosis 23.23 14.07 6 86908 24 56205129
Portal hypertension 23.21 14.07 28 86886 3513 56201640
Depressed level of consciousness 23.10 14.07 32 86882 56401 56148752
Embolism 22.96 14.07 41 86873 7323 56197830
Extravasation 22.95 14.07 22 86892 2125 56203028
Herpes zoster 22.95 14.07 52 86862 75837 56129316
Salmonella sepsis 22.82 14.07 10 86904 243 56204910
Folate deficiency 22.70 14.07 22 86892 2155 56202998
Chronic kidney disease 22.60 14.07 19 86895 42037 56163116
Pneumothorax 22.57 14.07 62 86852 14805 56190348
Malaise 22.57 14.07 416 86498 367444 55837709
Choroidal effusion 22.44 14.07 12 86902 456 56204697
Joint neoplasm 22.30 14.07 7 86907 63 56205090
Feeling hot 22.21 14.07 125 86789 41662 56163491
Eastern Cooperative Oncology Group performance status worsened 22.18 14.07 15 86899 878 56204275
Femur fracture 22.05 14.07 17 86897 39278 56165875
Osteitis condensans 21.98 14.07 6 86908 31 56205122
Blister 21.92 14.07 90 86824 108797 56096356
Platelet count decreased 21.91 14.07 256 86658 106127 56099026
Nail bed tenderness 21.86 14.07 11 86903 368 56204785
Post-traumatic pain 21.83 14.07 11 86903 369 56204784
Foot deformity 21.81 14.07 5 86909 23820 56181333
Blood creatine increased 21.81 14.07 33 86881 5140 56200013
Generalised oedema 21.54 14.07 60 86854 14441 56190712
Metastases to ovary 21.53 14.07 11 86903 380 56204773
Accidental overdose 21.53 14.07 3 86911 20458 56184695
Diabetes mellitus 21.48 14.07 30 86884 52705 56152448
Soft tissue neoplasm 21.47 14.07 7 86907 72 56205081
Metastases to nervous system 21.37 14.07 6 86908 35 56205118
Neck pain 21.32 14.07 39 86875 61516 56143637
Breast inflammation 21.28 14.07 8 86906 129 56205024
Acral peeling skin syndrome 21.27 14.07 5 86909 12 56205141
Malignant neoplasm of pleura 21.22 14.07 7 86907 75 56205078
Lymphadenopathy 21.21 14.07 109 86805 35099 56170054
Surgery 21.00 14.07 12 86902 32474 56172679
Muscle spasticity 20.83 14.07 3 86911 19957 56185196
Monocyte count decreased 20.80 14.07 20 86894 1940 56203213
Blood pressure fluctuation 20.76 14.07 19 86895 40341 56164812
Lymphangitis 20.70 14.07 14 86900 820 56204333
Hyperkalaemia 20.66 14.07 29 86885 50836 56154317
Red cell distribution width increased 20.64 14.07 45 86869 9295 56195858
Hypoglycaemia 20.57 14.07 34 86880 55781 56149372
Neuromuscular toxicity 20.57 14.07 8 86906 142 56205011
Lung infiltration 20.56 14.07 57 86857 13681 56191472
Hiccups 20.56 14.07 20 86894 1968 56203185
Eye pain 20.51 14.07 11 86903 30836 56174317
Vasculitis 20.47 14.07 60 86854 14863 56190290
Hip fracture 20.45 14.07 8 86906 26965 56178188
Transaminases 20.43 14.07 7 86907 85 56205068
Hypothalamo-pituitary disorder 20.42 14.07 13 86901 687 56204466
Epidermolysis 20.34 14.07 9 86905 224 56204929
Mucosal disorder 20.24 14.07 20 86894 2006 56203147
Chromosomal mutation 20.22 14.07 5 86909 16 56205137
Chronic obstructive pulmonary disease 20.22 14.07 36 86878 57379 56147774
Cough 20.22 14.07 535 86379 259426 55945727
Miller Fisher syndrome 20.21 14.07 7 86907 88 56205065
Leukaemia cutis 20.21 14.07 7 86907 88 56205065
Acute respiratory distress syndrome 20.14 14.07 77 86837 21849 56183304
White blood cell count abnormal 20.03 14.07 34 86880 5833 56199320
Pituitary tumour 20.03 14.07 14 86900 865 56204288
Hypoalbuminaemia 20.02 14.07 48 86866 10551 56194602
Leukocytosis 19.80 14.07 81 86833 23710 56181443
Hepatic failure 19.71 14.07 103 86811 33383 56171770
Kidney infection 19.69 14.07 4 86910 20721 56184432
Muscle necrosis 19.57 14.07 12 86902 593 56204560
Chemical peritonitis 19.52 14.07 7 86907 98 56205055
Chemotherapy 19.45 14.07 17 86897 1458 56203695
Breast oedema 19.42 14.07 6 86908 51 56205102
Aggression 19.40 14.07 5 86909 22001 56183152
Seroma 19.34 14.07 19 86895 1892 56203261
Retinitis pigmentosa 19.33 14.07 7 86907 101 56205052
Peritonitis 19.30 14.07 62 86852 16140 56189013
General physical health deterioration 19.23 14.07 369 86545 169641 56035512
Paralysis recurrent laryngeal nerve 19.22 14.07 6 86908 53 56205100
Paraparesis 19.22 14.07 20 86894 2133 56203020
Retinal detachment 19.20 14.07 32 86882 5409 56199744
Congenital syphilitic osteochondritis 19.16 14.07 5 86909 21 56205132
Distichiasis 19.16 14.07 5 86909 21 56205132
Ear pain 19.14 14.07 12 86902 30878 56174275
Dizziness 19.03 14.07 439 86475 375701 55829452
Overflow diarrhoea 19.02 14.07 7 86907 106 56205047
Chills 18.99 14.07 242 86672 102362 56102791
Intervertebral disc protrusion 18.99 14.07 5 86909 21689 56183464
Neutrophil count abnormal 18.97 14.07 22 86892 2648 56202505
Skin laceration 18.92 14.07 4 86910 20152 56185001
Gastrointestinal perforation 18.88 14.07 24 86890 3175 56201978
Drug ineffective for unapproved indication 18.87 14.07 8 86906 25685 56179468
Tympanic membrane disorder 18.82 14.07 8 86906 180 56204973
Dysarthria 18.75 14.07 20 86894 39530 56165623
Phlebitis 18.61 14.07 34 86880 6182 56198971
Hydrothorax 18.60 14.07 13 86901 803 56204350
Onychoclasis 18.59 14.07 32 86882 5553 56199600
Gastritis 18.57 14.07 104 86810 34598 56170555
Vulvitis 18.51 14.07 9 86905 279 56204874
Hydrocephalus 18.49 14.07 30 86884 4959 56200194
Aspartate aminotransferase increased 18.46 14.07 202 86712 82400 56122753
Inflammatory carcinoma of the breast 18.38 14.07 6 86908 62 56205091
Granulocytopenia 18.29 14.07 31 86883 5313 56199840
Appendiceal abscess 18.19 14.07 8 86906 196 56204957
Hyperchlorhydria 18.13 14.07 17 86897 1598 56203555
Underdose 18.09 14.07 7 86907 23750 56181403
Vena cava thrombosis 18.07 14.07 19 86895 2050 56203103
Non-small cell lung cancer 17.84 14.07 25 86889 3633 56201520
Blood pressure increased 17.83 14.07 141 86773 145035 56060118
Merycism 17.75 14.07 8 86906 208 56204945
No adverse event 17.69 14.07 18 86896 36356 56168797
Acquired gene mutation 17.63 14.07 13 86901 874 56204279
Staphylococcal impetigo 17.52 14.07 4 86910 8 56205145
Vaginal prolapse 17.49 14.07 10 86904 434 56204719
Product quality issue 17.47 14.07 14 86900 31722 56173431
Metastases to muscle 17.42 14.07 7 86907 136 56205017
Meibomian gland dysfunction 17.32 14.07 7 86907 138 56205015
Stress 17.30 14.07 41 86873 58869 56146284
Gallbladder disorder 17.20 14.07 3 86911 17331 56187822
Axillary vein thrombosis 17.10 14.07 9 86905 331 56204822
Neoplasm recurrence 17.00 14.07 20 86894 2444 56202709
Oral pain 16.97 14.07 83 86831 26210 56178943
Clostridial infection 16.90 14.07 26 86888 4109 56201044
Seasonal allergy 16.89 14.07 3 86911 17105 56188048
Metastases to uterus 16.73 14.07 6 86908 84 56205069
Abdominal rigidity 16.69 14.07 17 86897 1768 56203385
Injection site rash 16.69 14.07 3 86911 16955 56188198
Emotional distress 16.55 14.07 13 86901 29750 56175403
Memory impairment 16.52 14.07 73 86841 86484 56118669
Pain in extremity 16.51 14.07 342 86572 297089 55908064
Skin reaction 16.49 14.07 51 86863 13012 56192141
Cannabinoid hyperemesis syndrome 16.45 14.07 5 86909 40 56205113
ALK gene rearrangement positive 16.43 14.07 3 86911 0 56205153
Astringent therapy 16.43 14.07 3 86911 0 56205153
Labia enlarged 16.43 14.07 3 86911 0 56205153
Pulmonary embolism 16.30 14.07 244 86670 106880 56098273
Therapy non-responder 16.25 14.07 45 86869 61310 56143843
Limb injury 16.25 14.07 7 86907 22263 56182890
Clostridium difficile infection 16.24 14.07 84 86830 27114 56178039
Dandy-Walker syndrome 16.23 14.07 6 86908 92 56205061
Product administration error 16.22 14.07 6 86908 20923 56184230
Sleep disorder 16.21 14.07 52 86862 67611 56137542
Hormone receptor positive breast cancer 16.17 14.07 10 86904 502 56204651
Tumour marker increased 16.17 14.07 26 86888 4267 56200886
Laboratory test abnormal 16.14 14.07 9 86905 24686 56180467
Pulmonary hypertension 16.14 14.07 19 86895 35925 56169228
Rash follicular 16.13 14.07 5 86909 43 56205110
Herpes simplex sepsis 16.13 14.07 5 86909 43 56205110
Frequent bowel movements 15.96 14.07 3 86911 16421 56188732
Hyperaemia 15.94 14.07 18 86896 2104 56203049
Cytotoxic oedema 15.94 14.07 7 86907 171 56204982
Pseudomembranous colitis 15.92 14.07 21 86893 2882 56202271
Transient ischaemic attack 15.89 14.07 17 86897 33560 56171593
Prescribed underdose 15.82 14.07 6 86908 20611 56184542
Pneumonia aspiration 15.80 14.07 16 86898 32395 56172758
Entropion 15.74 14.07 5 86909 47 56205106
Necrosis 15.73 14.07 28 86886 4988 56200165
Grip strength decreased 15.73 14.07 3 86911 16253 56188900
Dysaesthesia 15.60 14.07 25 86889 4091 56201062
Cardiac tamponade 15.58 14.07 26 86888 4400 56200753
Caesarean section 15.51 14.07 3 86911 16088 56189065
Coating in mouth 15.50 14.07 7 86907 183 56204970
Radiation pneumonitis 15.43 14.07 15 86899 1474 56203679
Hypervolaemia 15.42 14.07 11 86903 26447 56178706
Colitis ischaemic 15.42 14.07 42 86872 9978 56195175
Vasogenic cerebral oedema 15.38 14.07 10 86904 548 56204605
Viral infection 15.32 14.07 16 86898 31930 56173223
Pleural disorder 15.31 14.07 10 86904 552 56204601
Mouth ulceration 15.31 14.07 88 86826 29552 56175601
Anal erythema 15.26 14.07 7 86907 190 56204963
Vision blurred 15.20 14.07 71 86843 82872 56122281
Sarcoidosis 15.19 14.07 29 86885 5451 56199702
Soft tissue infection 15.18 14.07 17 86897 1970 56203183
Cardiac arrest 15.17 14.07 75 86839 86239 56118914
Vagus nerve disorder 15.15 14.07 6 86908 112 56205041
Joint dislocation 15.07 14.07 3 86911 15770 56189383
Dermatitis bullous 15.07 14.07 35 86879 7538 56197615
Arachnoid cyst 15.06 14.07 7 86907 196 56204957
Adenocarcinoma 15.04 14.07 20 86894 2765 56202388
Sarcoma 15.01 14.07 10 86904 571 56204582
Necrotising myositis 14.99 14.07 9 86905 428 56204725
Peripheral motor neuropathy 14.94 14.07 15 86899 1533 56203620
Upper limb fracture 14.93 14.07 4 86910 17151 56188002
Monocytopenia 14.80 14.07 5 86909 58 56205095
Hypomagnesaemia 14.76 14.07 77 86837 24938 56180215
Disorientation 14.74 14.07 21 86893 36592 56168561
Atypical pneumonia 14.72 14.07 24 86890 3984 56201169
Faeces discoloured 14.72 14.07 4 86910 16992 56188161
Appendicitis 14.72 14.07 34 86880 7298 56197855
Arteritis 14.69 14.07 10 86904 592 56204561
Naevus haemorrhage 14.63 14.07 6 86908 123 56205030
Urogenital prolapse 14.60 14.07 4 86910 21 56205132
Carcinoembryonic antigen increased 14.43 14.07 15 86899 1597 56203556
Subretinal hyperreflective exudation 14.35 14.07 3 86911 3 56205150
Non-small cell lung cancer metastatic 14.35 14.07 10 86904 615 56204538
Therapy responder 14.23 14.07 8 86906 336 56204817
Left ventricular enlargement 14.21 14.07 5 86909 66 56205087

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
Malignant neoplasm progression 1225.18 16.00 915 38907 78083 31579439
Febrile neutropenia 573.93 16.00 734 39088 121115 31536407
Osteonecrosis of jaw 540.51 16.00 310 39512 16761 31640761
Prostatic specific antigen increased 407.61 16.00 238 39584 13300 31644222
Hormone-refractory prostate cancer 380.25 16.00 123 39699 1544 31655978
Neutropenia 361.45 16.00 638 39184 139726 31517796
Disease progression 360.76 16.00 503 39319 89961 31567561
Metastases to bone 356.69 16.00 202 39620 10646 31646876
Prostate cancer metastatic 348.85 16.00 164 39658 5840 31651682
Diarrhoea 295.45 16.00 1040 38782 351369 31306153
Mucosal inflammation 203.08 16.00 233 39589 34194 31623328
Metastases to lymph nodes 177.81 16.00 93 39729 4175 31653347
Neutropenic sepsis 159.63 16.00 129 39693 12250 31645272
Stomatitis 157.87 16.00 220 39602 39218 31618304
Interstitial lung disease 156.04 16.00 278 39544 61125 31596397
Neutrophil count decreased 154.13 16.00 237 39585 46157 31611365
Neoplasm progression 143.42 16.00 151 39671 20121 31637401
Onycholysis 142.05 16.00 46 39776 579 31656943
Alopecia 140.84 16.00 151 39671 20544 31636978
Leukopenia 140.78 16.00 257 39565 57571 31599951
Pneumonitis 137.88 16.00 181 39641 30471 31627051
Metastases to lung 124.18 16.00 95 39727 8327 31649195
Prostate cancer 119.16 16.00 188 39634 37413 31620109
Metastases to liver 108.70 16.00 105 39717 12622 31644900
Palmar-plantar erythrodysaesthesia syndrome 107.15 16.00 114 39708 15369 31642153
Dehydration 105.35 16.00 359 39463 118752 31538770
Haematotoxicity 101.93 16.00 79 39743 7058 31650464
Anaemia 101.40 16.00 532 39290 212990 31444532
Nausea 91.48 16.00 680 39142 307267 31350255
Product dose omission issue 89.63 16.00 13 39809 105573 31551949
Metastases to central nervous system 88.88 16.00 75 39747 7561 31649961
Drug interaction 88.71 16.00 79 39743 208464 31449058
Skin toxicity 86.87 16.00 58 39764 4101 31653421
Fall 83.41 16.00 67 39755 186022 31471500
Portal venous gas 80.16 16.00 26 39796 329 31657193
Bone marrow failure 79.15 16.00 133 39689 27875 31629647
Septic shock 78.48 16.00 221 39601 65937 31591585
Hypocalcaemia 78.21 16.00 116 39706 21862 31635660
White blood cell count decreased 75.08 16.00 261 39561 87137 31570385
Non-small cell lung cancer 73.30 16.00 52 39770 4057 31653465
Decreased appetite 71.38 16.00 380 39442 152837 31504685
Neuropathy peripheral 68.54 16.00 230 39592 75419 31582103
Peripheral sensory neuropathy 63.36 16.00 57 39765 6258 31651264
Bacterial translocation 62.16 16.00 21 39801 304 31657218
Recall phenomenon 61.26 16.00 24 39798 540 31656982
Overdose 60.16 16.00 16 39806 84648 31572874
Headache 58.16 16.00 88 39734 183564 31473958
Bone pain 57.49 16.00 94 39728 19257 31638265
Osteonecrosis 56.32 16.00 78 39744 13806 31643716
Plasma cell myeloma 55.57 16.00 4 39818 56527 31600995
Nasopharyngitis 55.52 16.00 7 39815 63238 31594284
Tremor 55.14 16.00 14 39808 76406 31581116
Pleural effusion 54.44 16.00 212 39610 74708 31582814
Polyneuropathy 54.09 16.00 74 39748 12948 31644574
Nail disorder 53.54 16.00 32 39790 1863 31655659
Oesophagobronchial fistula 53.09 16.00 16 39806 156 31657366
General physical health deterioration 52.53 16.00 281 39541 113154 31544368
Oesophageal fistula 52.06 16.00 17 39805 220 31657302
Vomiting 51.92 16.00 468 39354 223505 31434017
Metastasis 51.49 16.00 40 39782 3584 31653938
Fatigue 49.18 16.00 639 39183 334567 31322955
Bone lesion 48.87 16.00 35 39787 2772 31654750
Pulmonary toxicity 47.11 16.00 45 39777 5332 31652190
Weight increased 46.54 16.00 23 39799 82924 31574598
Agitation 45.18 16.00 7 39815 54162 31603360
Reproductive toxicity 44.90 16.00 9 39813 9 31657513
Therapy partial responder 44.83 16.00 48 39774 6514 31651008
Urinary tract toxicity 44.42 16.00 9 39813 10 31657512
Radiation skin injury 43.48 16.00 20 39802 676 31656846
Neutropenic colitis 43.31 16.00 32 39790 2660 31654862
Prostate cancer recurrent 43.22 16.00 22 39800 932 31656590
Depression 42.79 16.00 31 39791 90784 31566738
Pyrexia 42.76 16.00 575 39247 303265 31354257
Colon cancer stage III 42.00 16.00 14 39808 194 31657328
Asthma 41.92 16.00 3 39819 42608 31614914
Onychomadesis 41.63 16.00 18 39804 524 31656998
Rhabdomyolysis 41.55 16.00 14 39808 63567 31593955
Insomnia 40.15 16.00 36 39786 94800 31562722
Metastases to skin 38.61 16.00 16 39806 418 31657104
Lung adenocarcinoma 38.44 16.00 37 39785 4425 31653097
Neoplasm recurrence 38.28 16.00 27 39795 2087 31655435
Rheumatoid arthritis 38.05 16.00 7 39815 47802 31609720
Gastric perforation 37.85 16.00 28 39794 2331 31655191
Cardiac failure congestive 37.52 16.00 27 39795 79360 31578162
Disseminated intravascular coagulation 36.37 16.00 80 39742 20457 31637065
Paronychia 36.20 16.00 31 39791 3187 31654335
Musculoskeletal stiffness 35.24 16.00 5 39817 41320 31616202
Erythema 35.05 16.00 196 39626 80209 31577313
Acute motor-sensory axonal neuropathy 34.83 16.00 11 39811 127 31657395
Gastrointestinal toxicity 34.28 16.00 26 39796 2248 31655274
Exposed bone in jaw 33.99 16.00 22 39800 1475 31656047
Dermatitis 33.11 16.00 47 39775 8509 31649013
Somnolence 33.05 16.00 46 39776 99399 31558123
Hallucination 32.52 16.00 9 39813 46401 31611121
Myocardial infarction 32.47 16.00 58 39764 113396 31544126
Pneumatosis intestinalis 32.40 16.00 31 39791 3680 31653842
Second primary malignancy 32.33 16.00 42 39780 6990 31650532
Metastases to spine 32.03 16.00 25 39797 2255 31655267
Metastases to soft tissue 31.89 16.00 12 39810 241 31657281
Inappropriate schedule of product administration 31.82 16.00 12 39810 50811 31606711
Metastases to meninges 31.76 16.00 20 39802 1279 31656243
Necrotising retinitis 31.75 16.00 17 39805 800 31656722
Carbohydrate antigen 15-3 increased 31.67 16.00 9 39813 70 31657452
Bone disorder 31.54 16.00 38 39784 5861 31651661
Nail toxicity 31.50 16.00 8 39814 38 31657484
Drug hypersensitivity 31.39 16.00 27 39795 72572 31584950
Pneumothorax 31.23 16.00 67 39755 16843 31640679
Joint swelling 31.22 16.00 14 39808 53417 31604105
Hypophagia 30.50 16.00 78 39744 21964 31635558
Dizziness 30.24 16.00 138 39684 199009 31458513
Metastases to pleura 30.05 16.00 13 39809 379 31657143
Injection site pain 29.98 16.00 4 39818 34630 31622892
Suicidal ideation 29.69 16.00 5 39817 36401 31621121
Flushing 29.40 16.00 94 39728 30034 31627488
Anxiety 29.37 16.00 43 39779 90990 31566532
Urticaria 29.28 16.00 18 39804 57499 31600023
Death 29.22 16.00 624 39198 359945 31297577
Intestinal ischaemia 29.20 16.00 40 39782 7005 31650517
Muscle spasms 28.82 16.00 26 39796 68292 31589230
Eubacterium infection 28.40 16.00 5 39817 0 31657522
Karnofsky scale worsened 28.40 16.00 5 39817 0 31657522
Gastrointestinal ischaemia 28.34 16.00 10 39812 166 31657356
Blood pressure increased 28.34 16.00 35 39787 79598 31577924
Cerebrovascular accident 27.18 16.00 36 39786 79448 31578074
Colitis 27.16 16.00 99 39723 33788 31623734
Macroenzyme creatine kinase 26.31 16.00 6 39816 16 31657506
Superior mesenteric artery syndrome 26.10 16.00 8 39814 83 31657439
Mediastinitis 26.07 16.00 14 39808 663 31656859
Carotid artery aneurysm 26.06 16.00 7 39815 43 31657479
Drug ineffective 25.98 16.00 346 39476 395227 31262295
Contusion 25.93 16.00 5 39817 33023 31624499
Sinusitis 25.93 16.00 7 39815 36689 31620833
Atypical haemolytic uraemic syndrome 25.56 16.00 10 39812 224 31657298
Acute febrile neutrophilic dermatosis 25.34 16.00 17 39805 1211 31656311
Pancreatitis viral 24.95 16.00 5 39817 5 31657517
Blood glucose increased 24.88 16.00 24 39798 61059 31596463
Nicotinic acid deficiency 24.83 16.00 8 39814 99 31657423
Hypophosphataemia 24.80 16.00 41 39781 8473 31649049
Rash 24.77 16.00 150 39672 201336 31456186
Dysphagia 24.72 16.00 140 39682 57536 31599986
Nail ridging 24.06 16.00 8 39814 110 31657412
Tooth extraction 23.09 16.00 28 39794 4347 31653175
Transdifferentiation of neoplasm 22.98 16.00 7 39815 71 31657451
Hyponatraemia 22.89 16.00 165 39657 73634 31583888
Cholangitis sclerosing 22.73 16.00 16 39806 1233 31656289
Chemotherapy 22.52 16.00 12 39810 559 31656963
Pharyngeal abscess 22.45 16.00 11 39811 429 31657093
Osteoradionecrosis 22.39 16.00 7 39815 78 31657444
Agranulocytosis 22.30 16.00 68 39754 21179 31636343
Hydronephrosis 21.97 16.00 41 39781 9320 31648202
Oesophagitis 21.57 16.00 48 39774 12368 31645154
Tracheal fistula 21.48 16.00 7 39815 90 31657432
Feeling abnormal 21.40 16.00 24 39798 56978 31600544
Arthralgia 21.18 16.00 108 39714 151316 31506206
Aorto-oesophageal fistula 21.07 16.00 6 39816 47 31657475
Tracheal stenosis 20.97 16.00 8 39814 167 31657355
Myelosuppression 20.85 16.00 53 39769 14867 31642655
Bronchial fistula 20.80 16.00 8 39814 171 31657351
Acute respiratory distress syndrome 20.78 16.00 73 39749 24467 31633055
Tumour pain 20.50 16.00 14 39808 1027 31656495
Free prostate-specific antigen positive 20.49 16.00 4 39818 3 31657519
Seizure 20.46 16.00 61 39761 99707 31557815
Ischaemic enteritis 20.38 16.00 5 39817 20 31657502
Hypokalaemia 20.36 16.00 126 39696 53448 31604074
Blood creatine phosphokinase increased 20.19 16.00 14 39808 41960 31615562
Metastases to bladder 20.05 16.00 6 39816 57 31657465
Abnormal behaviour 20.04 16.00 3 39819 23825 31633697
Delusion of grandeur 19.98 16.00 12 39810 705 31656817
Trigeminal nerve paresis 19.96 16.00 4 39818 4 31657518
Infusion site plaque 19.96 16.00 4 39818 4 31657518
Capillary leak syndrome 19.86 16.00 18 39804 1995 31655527
Gastrointestinal necrosis 19.79 16.00 22 39800 3112 31654410
Hospitalisation 19.78 16.00 20 39802 49787 31607735
Sarcoma 19.77 16.00 10 39812 418 31657104
Polyserositis 19.63 16.00 8 39814 200 31657322
Dacryostenosis acquired 19.60 16.00 8 39814 201 31657321
Laryngeal oedema 19.32 16.00 22 39800 3195 31654327
Periorbital disorder 19.00 16.00 5 39817 28 31657494
Irritability 18.98 16.00 3 39819 22886 31634636
Scleroderma 18.85 16.00 15 39807 1392 31656130
Metastases to peritoneum 18.69 16.00 16 39806 1644 31655878
Malignant sweat gland neoplasm 18.69 16.00 4 39818 7 31657515
Disturbance in attention 18.49 16.00 3 39819 22447 31635075
Aneurysm ruptured 18.48 16.00 10 39812 481 31657041
Oral pain 18.38 16.00 39 39783 9726 31647796
Coating in mouth 18.35 16.00 6 39816 78 31657444
Metastases to the mediastinum 18.34 16.00 8 39814 238 31657284
Psoriasis 18.28 16.00 19 39803 46700 31610822
Coma 18.15 16.00 15 39807 41135 31616387
Memory impairment 17.96 16.00 13 39809 38117 31619405
Nephrolithiasis 17.89 16.00 6 39816 27333 31630189
Lacrimation increased 17.85 16.00 33 39789 7449 31650073
Enteritis 17.81 16.00 32 39790 7067 31650455
Acute interstitial pneumonitis 17.80 16.00 9 39813 376 31657146
Pruritus 17.65 16.00 89 39733 125078 31532444
Adenocarcinoma 17.64 16.00 16 39806 1775 31655747
Malignant neoplasm of pleura 17.60 16.00 7 39815 164 31657358
Neutropenic infection 17.48 16.00 14 39808 1311 31656211
Toxic erythema of chemotherapy 17.38 16.00 6 39816 93 31657429
Cranial nerve disorder 17.38 16.00 10 39812 542 31656980
Influenza 17.38 16.00 18 39804 44307 31613215
Hypovolaemic shock 17.34 16.00 30 39792 6432 31651090
Oral candidiasis 17.23 16.00 41 39781 11036 31646486
Hyperchromasia 17.04 16.00 3 39819 0 31657522
Carotidynia 17.04 16.00 3 39819 0 31657522
Foetal exposure during pregnancy 16.71 16.00 16 39806 40860 31616662
Tracheo-oesophageal fistula 16.61 16.00 9 39813 434 31657088
Traumatic lung injury 16.60 16.00 13 39809 1178 31656344
PO2 increased 16.53 16.00 10 39812 595 31656927
Portosplenomesenteric venous thrombosis 16.51 16.00 4 39818 15 31657507
Oesophageal perforation 16.45 16.00 12 39810 978 31656544
Polyneuropathy in malignant disease 16.40 16.00 6 39816 111 31657411
Lactic acidosis 16.24 16.00 10 39812 31927 31625595
Retroperitoneal lymphadenopathy 16.24 16.00 11 39811 796 31656726

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
Malignant neoplasm progression 1714.99 13.14 1438 105344 120301 70701361
Febrile neutropenia 1430.90 13.14 1646 105136 202672 70618990
Neutropenia 1254.09 13.14 1729 105053 255427 70566235
Diarrhoea 1114.69 13.14 3122 103660 780219 70041443
Disease progression 891.05 13.14 1137 105645 155535 70666127
Palmar-plantar erythrodysaesthesia syndrome 756.58 13.14 505 106277 29742 70791920
Metastases to bone 740.60 13.14 446 106336 21930 70799732
Myelosuppression 717.39 13.14 488 106294 29657 70792005
Mucosal inflammation 697.61 13.14 672 106110 67178 70754484
Neuropathy peripheral 634.54 13.14 865 105917 126031 70695631
Bone marrow failure 554.52 13.14 512 106270 48498 70773164
Metastases to liver 513.64 13.14 375 106407 25503 70796159
Metastases to lung 435.81 13.14 285 106497 16199 70805463
Metastases to central nervous system 424.73 13.14 271 106511 14763 70806899
Rheumatoid arthritis 412.82 13.14 5 106777 291800 70529862
Osteonecrosis of jaw 396.71 13.14 393 106389 40609 70781053
Neutropenic sepsis 396.27 13.14 316 106466 24514 70797148
Metastases to lymph nodes 396.05 13.14 218 106564 9020 70812642
Ejection fraction decreased 376.56 13.14 336 106446 30426 70791236
Neoplasm progression 357.50 13.14 389 106393 44839 70776823
Agranulocytosis 322.69 13.14 349 106433 39949 70781713
Leukopenia 313.86 13.14 570 106212 105990 70715672
Neutrophil count decreased 302.70 13.14 490 106292 83066 70738596
Fall 278.14 13.14 162 106620 443934 70377728
Polyneuropathy 274.23 13.14 240 106542 21175 70800487
Breast cancer metastatic 269.59 13.14 176 106606 9970 70811692
Skin toxicity 268.31 13.14 155 106627 7043 70814619
Prostatic specific antigen increased 265.79 13.14 170 106612 9296 70812366
Stomatitis 263.17 13.14 591 106191 127920 70693742
Interstitial lung disease 253.01 13.14 515 106267 104170 70717492
Onycholysis 252.64 13.14 97 106685 1706 70819956
White blood cell count decreased 247.81 13.14 687 106095 169454 70652208
Nausea 240.42 13.14 2138 104644 849950 69971712
Joint swelling 236.35 13.14 47 106735 253164 70568498
Haematotoxicity 231.01 13.14 180 106602 13494 70808168
Drug ineffective 219.01 13.14 708 106074 939044 69882618
Decreased appetite 210.96 13.14 963 105819 303817 70517845
Product dose omission issue 207.95 13.14 38 106744 217430 70604232
Peripheral sensory neuropathy 205.85 13.14 160 106622 11950 70809712
Drug abuse 197.95 13.14 5 106777 147251 70674411
Pleural effusion 197.85 13.14 541 106241 132323 70689339
Neutropenic colitis 195.62 13.14 112 106670 5002 70816660
Alopecia areata 194.01 13.14 78 106704 1558 70820104
Flushing 191.13 13.14 398 106384 81774 70739888
Recall phenomenon 188.82 13.14 68 106714 991 70820671
Arthropathy 181.88 13.14 11 106771 150046 70671616
Pneumonitis 181.30 13.14 308 106474 54289 70767373
Bone pain 178.50 13.14 294 106488 50528 70771134
Therapeutic product effect decreased 177.94 13.14 9 106773 143009 70678653
Madarosis 176.82 13.14 83 106699 2440 70819222
Vomiting 176.44 13.14 1507 105275 591604 70230058
Colitis 173.55 13.14 330 106452 63484 70758178
Metastasis 169.66 13.14 109 106673 6005 70815657
Contraindicated product administered 162.74 13.14 10 106772 134602 70687060
Aortitis 159.51 13.14 65 106717 1346 70820316
Hair texture abnormal 158.60 13.14 83 106699 3097 70818565
Nail disorder 158.50 13.14 129 106653 10295 70811367
Anaemia 154.74 13.14 1088 105694 402335 70419327
Erythema 151.86 13.14 649 106133 198914 70622748
Pyrexia 151.42 13.14 1485 105297 605467 70216195
Overdose 151.20 13.14 35 106747 169710 70651952
Sinusitis 148.51 13.14 36 106746 169159 70652503
Hormone-refractory prostate cancer 147.81 13.14 56 106726 948 70820714
Breast cancer recurrent 145.32 13.14 75 106707 2718 70818944
Hair colour changes 144.94 13.14 84 106698 3839 70817823
Cardiotoxicity 141.58 13.14 124 106658 10946 70810716
Metastases to skin 139.63 13.14 61 106721 1510 70820152
Alopecia 136.99 13.14 627 106155 197863 70623799
Gastrointestinal toxicity 134.30 13.14 96 106686 6309 70815353
Drug hypersensitivity 133.68 13.14 119 106663 262340 70559322
Drug interaction 133.45 13.14 231 106551 381210 70440452
Weight increased 133.16 13.14 102 106680 242229 70579433
Dehydration 130.73 13.14 679 106103 225463 70596199
Nail toxicity 128.32 13.14 39 106743 321 70821341
Systemic lupus erythematosus 128.07 13.14 6 106776 101896 70719766
Acute myeloid leukaemia 128.03 13.14 193 106589 30747 70790915
Musculoskeletal stiffness 126.65 13.14 33 106749 147727 70673935
Prostate cancer metastatic 125.82 13.14 77 106705 3892 70817770
Somnolence 123.31 13.14 87 106695 215519 70606143
Injection site pain 122.73 13.14 16 106766 117603 70704059
Second primary malignancy 122.31 13.14 123 106659 12928 70808734
Confusional state 119.10 13.14 152 106630 284246 70537416
Capillary leak syndrome 117.06 13.14 70 106712 3392 70818270
Paronychia 114.90 13.14 91 106691 6983 70814679
Left ventricular dysfunction 112.43 13.14 137 106645 17820 70803842
Dermatitis 111.73 13.14 142 106640 19275 70802387
Lymphoedema 111.59 13.14 109 106673 11060 70810602
Myocardial infarction 110.98 13.14 60 106722 171585 70650077
Pemphigus 110.89 13.14 3 106779 83033 70738629
Radiation skin injury 108.54 13.14 49 106733 1314 70820348
Hand deformity 105.81 13.14 6 106776 86476 70735186
Biopsy lung abnormal 104.05 13.14 28 106754 140 70821522
Product use issue 102.36 13.14 73 106709 179864 70641798
Condition aggravated 101.30 13.14 319 106463 427316 70394346
Breast cancer 99.34 13.14 180 106602 33369 70788293
Dysgeusia 98.25 13.14 225 106557 49277 70772385
Lacrimation increased 96.75 13.14 134 106648 19765 70801897
Abdominal discomfort 95.92 13.14 109 106673 214549 70607113
Contusion 94.80 13.14 37 106745 127999 70693663
Headache 93.10 13.14 504 106278 579901 70241761
Metastases to pleura 91.26 13.14 43 106739 1275 70820387
Plasma cell myeloma 89.79 13.14 5 106777 73196 70748466
Therapy partial responder 89.42 13.14 102 106680 12372 70809290
Cerebrovascular accident 88.66 13.14 53 106729 143417 70678245
Suicide attempt 87.47 13.14 9 106773 79501 70742161
Portal venous gas 86.03 13.14 29 106753 343 70821319
Fatigue 85.17 13.14 1725 105057 822594 69999068
Nail dystrophy 84.88 13.14 37 106745 911 70820751
Metastases to meninges 84.77 13.14 55 106727 3081 70818581
Wound 82.80 13.14 23 106759 98709 70722953
Septic shock 82.16 13.14 361 106421 111897 70709765
Depression 81.55 13.14 108 106674 198866 70622796
Inappropriate schedule of product administration 81.43 13.14 30 106752 107525 70714137
Maternal exposure during pregnancy 81.09 13.14 36 106746 115309 70706353
Myositis 77.97 13.14 113 106669 17376 70804286
Skin exfoliation 77.33 13.14 203 106579 48423 70773239
Lymphangiosis carcinomatosa 76.39 13.14 43 106739 1858 70819804
Hepatic enzyme increased 74.24 13.14 76 106706 156914 70664748
Neutropenic infection 74.17 13.14 43 106739 1966 70819696
Prostate cancer 72.48 13.14 151 106631 31012 70790650
Hypokalaemia 72.35 13.14 389 106393 130799 70690863
Hypocalcaemia 72.08 13.14 188 106594 44671 70776991
Acute promyelocytic leukaemia 71.49 13.14 38 106744 1464 70820198
Feeling abnormal 70.65 13.14 66 106716 142253 70679409
Intentional product use issue 70.62 13.14 47 106735 120095 70701567
Metastases to peritoneum 70.48 13.14 53 106729 3766 70817896
Injury 70.20 13.14 8 106774 65237 70756425
Pain 70.01 13.14 608 106174 628208 70193454
Blood pressure systolic increased 69.95 13.14 4 106778 57255 70764407
Multifocal micronodular pneumocyte hyperplasia 69.95 13.14 18 106764 73 70821589
Bronchial polyp 69.56 13.14 18 106764 75 70821587
Non-small cell lung cancer 69.19 13.14 65 106717 6282 70815380
Arthritis 68.22 13.14 31 106751 97949 70723713
Pseudocirrhosis 66.85 13.14 28 106754 623 70821039
Mobility decreased 66.56 13.14 36 106746 102963 70718699
Dermatitis acneiform 65.57 13.14 74 106708 8871 70812791
Injection site erythema 64.97 13.14 15 106767 72909 70748753
Nail discolouration 64.78 13.14 44 106738 2662 70819000
Febrile bone marrow aplasia 64.77 13.14 85 106697 11906 70809756
Tremor 64.23 13.14 84 106698 155540 70666122
Loss of personal independence in daily activities 63.74 13.14 24 106758 84886 70736776
Organising pneumonia 63.44 13.14 77 106705 9973 70811689
Intestinal ischaemia 62.83 13.14 84 106698 11980 70809682
Hospitalisation 62.55 13.14 23 106759 82545 70739117
Intentional product misuse 62.30 13.14 21 106761 79574 70742088
Dacryostenosis acquired 62.04 13.14 24 106758 431 70821231
Arthralgia 61.79 13.14 474 106308 502916 70318746
Metastases to spine 61.64 13.14 49 106733 3780 70817882
Toxicity to various agents 61.08 13.14 332 106450 381840 70439822
Osteoarthritis 60.82 13.14 18 106764 74129 70747533
Blood cholesterol increased 60.19 13.14 12 106770 64592 70757070
Asthma 59.97 13.14 56 106726 120737 70700925
Hallucination 59.90 13.14 20 106762 76240 70745422
Large intestine perforation 58.45 13.14 85 106697 13110 70808552
Sedation 57.91 13.14 3 106779 46728 70774934
Helicobacter infection 57.03 13.14 8 106774 55648 70766014
Gastrointestinal necrosis 56.92 13.14 53 106729 5065 70816597
Injection site reaction 56.53 13.14 5 106777 49847 70771815
Pulmonary toxicity 55.95 13.14 75 106707 10723 70810939
Anxiety 55.93 13.14 159 106623 220171 70601491
Agitation 55.59 13.14 36 106746 93339 70728323
International normalised ratio increased 55.48 13.14 26 106756 80700 70740962
Psoriasis 54.56 13.14 41 106741 98392 70723270
Aggression 54.56 13.14 5 106777 48441 70773221
Medication error 54.23 13.14 10 106772 56902 70764760
Neurotoxicity 54.20 13.14 131 106651 29695 70791967
Nasal congestion 53.76 13.14 16 106766 65656 70756006
Drug reaction with eosinophilia and systemic symptoms 53.57 13.14 11 106771 58002 70763660
Thrombocytopenia 53.08 13.14 572 106210 238538 70583124
Invasive ductal breast carcinoma 53.06 13.14 54 106728 5755 70815907
Dyspnoea 52.77 13.14 1524 105258 768536 70053126
Bradycardia 52.73 13.14 66 106716 124549 70697113
Exposure during pregnancy 51.97 13.14 34 106748 87683 70733979
Electrocardiogram QT prolonged 51.37 13.14 31 106751 83486 70738176
Coma 51.24 13.14 38 106744 91806 70729856
Drug intolerance 50.81 13.14 172 106610 225515 70596147
Enterocolitis 50.52 13.14 79 106703 12987 70808675
Nephrolithiasis 50.42 13.14 6 106776 47317 70774345
Alopecia totalis 50.29 13.14 19 106763 319 70821343
Suicidal ideation 50.06 13.14 21 106761 69575 70752087
Acute interstitial pneumonitis 49.80 13.14 27 106755 1083 70820579
Periarticular thenar erythema with onycholysis 49.49 13.14 11 106771 19 70821643
HER2 positive breast cancer 49.08 13.14 19 106763 342 70821320
Pericarditis 48.62 13.14 34 106748 84671 70736991
Bacterial translocation 48.25 13.14 21 106761 515 70821147
Oesophageal fistula 48.18 13.14 19 106763 360 70821302
Injection site swelling 47.17 13.14 5 106777 43152 70778510
Migraine 47.03 13.14 25 106757 72213 70749449
Carotidynia 46.85 13.14 15 106767 149 70821513
Back pain 46.70 13.14 618 106164 270534 70551128
Glossodynia 46.69 13.14 37 106745 86450 70735212
Vascular device infection 46.63 13.14 59 106723 7971 70813691
Pneumothorax 46.41 13.14 113 106669 25733 70795929
Insomnia 46.35 13.14 170 106612 217636 70604026
Nasopharyngitis 46.26 13.14 175 106607 222031 70599631
Irritable bowel syndrome 46.22 13.14 10 106772 50840 70770822
Lactic acidosis 46.16 13.14 20 106762 65004 70756658
Muscle injury 46.08 13.14 3 106779 38491 70783171
Blood pressure fluctuation 45.44 13.14 16 106766 58996 70762666
Metastases to chest wall 45.35 13.14 19 106763 423 70821239
Epistaxis 45.32 13.14 287 106495 102340 70719322
Treatment failure 45.28 13.14 93 106689 144049 70677613
Oesophagobronchial fistula 45.28 13.14 16 106766 220 70821442
Metastases to the mediastinum 44.73 13.14 20 106762 524 70821138
Onychomadesis 44.71 13.14 42 106740 4059 70817603
Tonsillar disorder 44.65 13.14 25 106757 1069 70820593
Rhabdomyolysis 44.53 13.14 47 106735 95713 70725949
Discomfort 44.44 13.14 56 106726 105380 70716282
Injection site pruritus 44.28 13.14 4 106778 39206 70782456
Neoplasm recurrence 44.19 13.14 41 106741 3900 70817762
Breast pain 44.14 13.14 55 106727 7316 70814346
Device related thrombosis 43.73 13.14 33 106749 2357 70819305
Metastases to soft tissue 43.54 13.14 18 106764 387 70821275
C-reactive protein abnormal 43.39 13.14 4 106778 38575 70783087
Bone lesion 43.39 13.14 47 106735 5383 70816279
Urticaria 43.35 13.14 115 106667 162934 70658728
COVID-19 42.70 13.14 58 106724 105699 70715963
Cystoid macular oedema 42.64 13.14 30 106752 1922 70819740
Erysipelas 42.61 13.14 63 106719 9861 70811801
Onychalgia 42.20 13.14 22 106760 814 70820848
Performance status decreased 42.19 13.14 47 106735 5554 70816108
Hepatic lesion 42.13 13.14 49 106733 6068 70815594
Wheezing 41.83 13.14 48 106734 94122 70727540
Desmoplastic small round cell tumour 41.50 13.14 15 106767 221 70821441
General physical health deterioration 41.49 13.14 540 106242 235491 70586171
Influenza 41.38 13.14 67 106715 113633 70708029
Hot flush 41.36 13.14 166 106616 49418 70772244
Hypertension 41.01 13.14 269 106513 295764 70525898
Hypoglycaemia 40.95 13.14 49 106733 94315 70727347
Swelling 40.87 13.14 146 106636 188393 70633269
Blood lactate dehydrogenase increased 40.74 13.14 131 106651 34996 70786666
Computerised tomogram thorax abnormal 40.70 13.14 30 106752 2068 70819594
PIK3CA-activated mutation 40.58 13.14 19 106763 555 70821107
Chemotherapy 40.42 13.14 27 106755 1589 70820073
Odynophagia 40.01 13.14 62 106720 10113 70811549
Lumbosacral radiculoplexus neuropathy 39.78 13.14 11 106771 62 70821600
Congestive cardiomyopathy 39.41 13.14 64 106718 10862 70810800
Incorrect dose administered 39.33 13.14 26 106756 66693 70754969
Basal cell carcinoma 39.26 13.14 3 106779 33695 70787967
Product prescribing error 38.98 13.14 6 106776 38946 70782716
Dizziness 38.74 13.14 480 106302 463661 70358001
Swollen tongue 38.73 13.14 5 106777 37041 70784621
Dermatomyositis 38.67 13.14 36 106746 3439 70818223
Accidental overdose 38.56 13.14 4 106778 35117 70786545
Enterocolitis infectious 38.16 13.14 32 106750 2662 70819000
Mucosal infection 38.00 13.14 17 106765 446 70821216
Road traffic accident 37.95 13.14 4 106778 34678 70786984
Angioedema 37.88 13.14 27 106755 66583 70755079
Drug resistance 37.76 13.14 135 106647 38055 70783607
Lung adenocarcinoma 37.70 13.14 52 106730 7638 70814024
Coronary artery disease 37.59 13.14 24 106758 62712 70758950
Paraesthesia 37.46 13.14 359 106423 145178 70676484
Constipation 37.28 13.14 560 106222 251878 70569784
Blood glucose increased 37.18 13.14 61 106721 102921 70718741
Adverse drug reaction 36.93 13.14 17 106765 53327 70768335
Full blood count abnormal 36.83 13.14 4 106778 33874 70787788
Stress 36.78 13.14 29 106753 67937 70753725
EGFR gene mutation 36.66 13.14 16 106766 395 70821267
Cardiac arrest 36.51 13.14 121 106661 159713 70661949
Oral candidiasis 36.48 13.14 101 106681 24851 70796811
Gait disturbance 35.84 13.14 150 106632 184956 70636706
Duodenal ulcer perforation 35.84 13.14 16 106766 51096 70770566
Systemic scleroderma 35.75 13.14 22 106760 1123 70820539
Device related infection 34.62 13.14 117 106665 32068 70789594
Feeling hot 34.44 13.14 155 106627 48515 70773147
Mastectomy 34.43 13.14 21 106761 1055 70820607
Acute respiratory distress syndrome 34.31 13.14 138 106644 41116 70780546
Exposed bone in jaw 34.27 13.14 34 106748 3515 70818147
Unevaluable event 33.92 13.14 18 106764 52045 70769617
Irritability 33.77 13.14 8 106774 38217 70783445
Adenocarcinoma 33.44 13.14 34 106748 3619 70818043
Blood pressure increased 33.34 13.14 158 106624 188359 70633303
Coating in mouth 33.32 13.14 13 106769 239 70821423
Metastatic neoplasm 33.30 13.14 38 106744 4610 70817052
Asthenopia 33.01 13.14 27 106755 2169 70819493
Acoustic stimulation tests abnormal 32.95 13.14 8 106774 24 70821638
Gastrointestinal haemorrhage 32.79 13.14 102 106680 137306 70684356
Myelodysplastic syndrome 32.68 13.14 109 106673 29676 70791986
Malignant neoplasm of pleura 32.58 13.14 12 106770 187 70821475
Obstructive shock 32.36 13.14 9 106773 52 70821610
Prostate cancer recurrent 32.33 13.14 18 106764 761 70820901
Gastric perforation 32.21 13.14 34 106748 3781 70817881
Treatment noncompliance 32.00 13.14 15 106767 46559 70775103
Mastitis 31.99 13.14 26 106756 2070 70819592
Pulmonary mass 31.95 13.14 99 106683 25934 70795728
Purtscher retinopathy 31.91 13.14 7 106775 11 70821651
Tongue coated 31.88 13.14 21 106761 1207 70820455
Dyskinesia 31.86 13.14 11 106771 41063 70780599
Osteoporosis 31.73 13.14 17 106765 48890 70772772
Ejection fraction 31.51 13.14 24 106758 1738 70819924
Drug level increased 31.51 13.14 8 106774 36461 70785201
Vulvovaginal dryness 30.99 13.14 24 106758 1782 70819880
Eosinophilia 30.92 13.14 11 106771 40308 70781354
Pruritus 30.86 13.14 352 106430 345208 70476454
Impaired healing 30.82 13.14 40 106742 74334 70747328
Dysarthria 30.79 13.14 29 106753 62284 70759378
Drug dependence 30.71 13.14 9 106773 37312 70784350
Nervousness 30.67 13.14 5 106777 31115 70790547
Type 2 diabetes mellitus 30.59 13.14 14 106768 44066 70777596
Uterine leiomyosarcoma 30.42 13.14 8 106774 36 70821626
Bronchitis 30.17 13.14 84 106698 117159 70704503
Nephritis bacterial 29.90 13.14 8 106774 39 70821623
Blood uric acid decreased 29.89 13.14 20 106762 1180 70820482
Myalgia 29.85 13.14 385 106397 167507 70654155
Invasive lobular breast carcinoma 29.83 13.14 16 106766 628 70821034
Scleroderma renal crisis 29.65 13.14 14 106768 417 70821245
Osteonecrosis 29.61 13.14 104 106678 29056 70792606
Sarcoma 29.59 13.14 18 106764 900 70820762
Periorbital disorder 29.56 13.14 8 106774 41 70821621
Pericardial effusion 29.52 13.14 133 106649 41643 70780019
Vulvovaginal candidiasis 29.25 13.14 26 106756 2340 70819322
White blood cell count abnormal 29.12 13.14 38 106744 5292 70816370
Barotrauma 28.99 13.14 11 106771 187 70821475
Vascular fragility 28.95 13.14 10 106772 128 70821534
Perforation 28.94 13.14 20 106762 1245 70820417
Asthenia 28.84 13.14 897 105885 456769 70364893
Hyperfibrinogenaemia 28.61 13.14 9 106773 84 70821578
Cystitis noninfective 28.57 13.14 20 106762 1271 70820391
Cellulitis 28.47 13.14 250 106532 98678 70722984
Diabetes mellitus 28.37 13.14 40 106742 71784 70749878
Tumour embolism 28.07 13.14 10 106772 141 70821521
Ascites 28.03 13.14 186 106596 67361 70754301
Skin reaction 28.02 13.14 64 106718 13985 70807677
Blood creatinine decreased 27.81 13.14 44 106738 7305 70814357
Injection site haemorrhage 27.79 13.14 3 106779 25524 70796138
Meibomian gland dysfunction 27.56 13.14 10 106772 149 70821513
Karnofsky scale worsened 27.50 13.14 5 106777 0 70821662
Eubacterium infection 27.50 13.14 5 106777 0 70821662
Gastric disorder 27.49 13.14 8 106774 33314 70788348
Radiation necrosis 27.42 13.14 13 106769 391 70821271
Cataract 27.37 13.14 26 106756 55619 70766043
Hiccups 27.34 13.14 49 106733 9003 70812659
Chest discomfort 27.31 13.14 297 106485 124084 70697578
Cardiac dysfunction 27.19 13.14 30 106752 3507 70818155
Laryngeal oedema 27.17 13.14 44 106738 7451 70814211
Bursitis 26.94 13.14 4 106778 26669 70794993
Disseminated intravascular coagulation 26.84 13.14 111 106671 33487 70788175
Bone marrow infiltration 26.76 13.14 14 106768 522 70821140
Balance disorder 26.75 13.14 60 106722 90068 70731594
Cardiomyopathy 26.73 13.14 94 106688 26279 70795383
Excessive eye blinking 26.52 13.14 20 106762 1427 70820235
Eosinophil percentage increased 26.49 13.14 20 106762 1430 70820232
Nicotinic acid deficiency 26.46 13.14 10 106772 168 70821494
Colitis ulcerative 26.46 13.14 9 106773 33914 70787748
Neck pain 26.45 13.14 37 106745 66620 70755042
Toxic erythema of chemotherapy 26.42 13.14 11 106771 241 70821421
Blood creatine phosphokinase increased 26.37 13.14 32 106750 61231 70760431
Superior mesenteric artery syndrome 26.25 13.14 10 106772 172 70821490
Pneumatosis intestinalis 26.18 13.14 38 106744 5849 70815813
Therapy cessation 26.15 13.14 9 106773 33667 70787995
Mucosal disorder 26.11 13.14 28 106754 3170 70818492
Peripheral swelling 26.09 13.14 229 106553 236334 70585328
Tumour pain 25.82 13.14 23 106759 2075 70819587
Retinal detachment 25.79 13.14 46 106736 8421 70813241
Limb injury 25.69 13.14 4 106778 25748 70795914
Gait inability 25.69 13.14 20 106762 47155 70774507
Gas gangrene 25.69 13.14 11 106771 259 70821403
Axillary pain 25.59 13.14 22 106760 1893 70819769
Ischaemic enteritis 25.52 13.14 9 106773 123 70821539
Emotional distress 25.51 13.14 12 106770 37176 70784486
Peritonitis 25.46 13.14 92 106690 26067 70795595
Arteritis 25.44 13.14 16 106766 849 70820813
Hydrothorax 25.43 13.14 19 106763 1337 70820325
Prescribed overdose 25.42 13.14 5 106777 27176 70794486
Menopausal disorder 25.23 13.14 7 106775 40 70821622
Vessel puncture site bruise 25.11 13.14 13 106769 474 70821188
Joint injury 25.09 13.14 5 106777 26927 70794735
Multiple sclerosis 25.06 13.14 4 106778 25281 70796381
Sopor 24.90 13.14 8 106774 31259 70790403
Malignant pleural effusion 24.78 13.14 27 106755 3112 70818550
Palmar erythema 24.68 13.14 21 106761 1782 70819880
Metastases to ovary 24.68 13.14 11 106771 286 70821376
Pancreatitis 24.66 13.14 35 106747 62633 70759029
Product administration error 24.51 13.14 7 106775 29516 70792146
Intestinal perforation 24.51 13.14 66 106716 15978 70805684
Cytokine release syndrome 24.47 13.14 5 106777 26462 70795200
Granulocyte count decreased 24.45 13.14 19 106763 1418 70820244
Delirium 24.40 13.14 47 106735 74567 70747095
Ventricular hypokinesia 24.23 13.14 44 106738 8168 70813494
Blood alkaline phosphatase increased 24.20 13.14 161 106621 58360 70763302
Troponin I increased 23.56 13.14 30 106752 4078 70817584
Haemolytic uraemic syndrome 23.43 13.14 30 106752 4100 70817562
Respiratory arrest 23.40 13.14 28 106754 53905 70767757
Vein discolouration 23.38 13.14 11 106771 325 70821337
Oesophageal perforation 23.37 13.14 18 106764 1326 70820336
Mediastinitis 23.24 13.14 15 106767 833 70820829
Retinal toxicity 23.22 13.14 18 106764 1338 70820324
Dysphagia 23.20 13.14 266 106516 112568 70709094
Lymphadenopathy 23.13 13.14 139 106643 48652 70773010
Cardiac failure congestive 23.09 13.14 115 106667 135342 70686320
Hepatic encephalopathy 23.08 13.14 3 106779 22115 70799547
Cytomegalovirus oesophagitis 23.05 13.14 14 106768 698 70820964
Osteoradionecrosis 22.98 13.14 8 106774 105 70821557
Hip fracture 22.92 13.14 7 106775 28256 70793406
Sepsis 22.85 13.14 505 106277 244040 70577622
Necrotising retinitis 22.78 13.14 17 106765 1194 70820468
Metastases to thorax 22.75 13.14 9 106773 172 70821490
Renal failure 22.67 13.14 179 106603 188891 70632771
No adverse event 22.64 13.14 10 106772 32143 70789519
Abnormal behaviour 22.61 13.14 12 106770 34697 70786965
Pulmonary hypertension 22.59 13.14 22 106760 46514 70775148
Eastern Cooperative Oncology Group performance status worsened 22.57 13.14 19 106763 1589 70820073
Carbohydrate antigen 15-3 increased 22.51 13.14 16 106766 1042 70820620
Joint neoplasm 22.48 13.14 7 106775 63 70821599
Panophthalmitis 22.44 13.14 8 106774 113 70821549
Acute kidney injury 22.33 13.14 544 106238 474080 70347582
Oesophagitis 22.33 13.14 80 106702 22572 70799090
Sclerema 22.30 13.14 6 106776 30 70821632
Therapy interrupted 22.29 13.14 5 106777 24797 70796865
Liver function test abnormal 22.27 13.14 36 106746 61110 70760552
Breast inflammation 22.25 13.14 8 106774 116 70821546
Osteitis condensans 22.13 13.14 6 106776 31 70821631
Hyperkalaemia 22.13 13.14 84 106698 106507 70715155
Metastases to gastrointestinal tract 22.06 13.14 8 106774 119 70821543
Nail bed bleeding 22.05 13.14 12 106770 485 70821177
Gout 22.01 13.14 4 106778 23002 70798660
Herpes zoster 21.98 13.14 61 106721 85174 70736488
Acquired gene mutation 21.94 13.14 21 106761 2077 70819585
Joint range of motion decreased 21.93 13.14 6 106776 26020 70795642
Epidermolysis 21.85 13.14 12 106770 494 70821168
Biliary sepsis 21.65 13.14 18 106764 1480 70820182
Oral pain 21.64 13.14 94 106688 28972 70792690
Dysaesthesia 21.51 13.14 33 106749 5335 70816327
Depressed level of consciousness 21.50 13.14 64 106718 87367 70734295
Poisoning 21.49 13.14 4 106778 22618 70799044
Cytomegalovirus infection 21.47 13.14 17 106765 39741 70781921
Colitis ischaemic 21.44 13.14 58 106724 14079 70807583
Gastrointestinal ischaemia 21.43 13.14 11 106771 394 70821268
Hypophagia 21.37 13.14 121 106661 41449 70780213
Mucocutaneous disorder 21.36 13.14 8 106774 131 70821531
Pharyngeal abscess 21.31 13.14 13 106769 653 70821009
Pleural disorder 21.28 13.14 14 106768 803 70820859
Post-traumatic pain 21.28 13.14 11 106771 400 70821262
Nail infection 21.17 13.14 21 106761 2170 70819492
Clostridium bacteraemia 21.14 13.14 10 106772 299 70821363
Acute motor-sensory axonal neuropathy 21.10 13.14 11 106771 407 70821255
Tumour haemorrhage 21.06 13.14 27 106755 3695 70817967
Metabolic acidosis 20.86 13.14 51 106731 74295 70747367
Night sweats 20.80 13.14 21 106761 43663 70777999
Unintentional medical device removal 20.80 13.14 38 106744 7086 70814576
Necrotising fasciitis 20.79 13.14 33 106749 5493 70816169
Pain in extremity 20.79 13.14 358 106424 327724 70493938
Osteolysis 20.66 13.14 26 106756 3493 70818169
Soft tissue neoplasm 20.60 13.14 7 106775 85 70821577
Vascular pain 20.60 13.14 14 106768 848 70820814
Macroenzyme creatine kinase 20.59 13.14 5 106777 15 70821647
Vulvitis 20.59 13.14 9 106773 223 70821439
Nail ridging 20.57 13.14 11 106771 429 70821233
Therapy responder 20.48 13.14 11 106771 433 70821229
Hormone receptor positive breast cancer 20.43 13.14 10 106772 323 70821339
Nasal disorder 20.28 13.14 25 106757 3289 70818373
Hypervolaemia 20.18 13.14 18 106764 39688 70781974
Pancreatitis viral 20.12 13.14 5 106777 17 70821645
Hypovolaemic shock 20.12 13.14 48 106734 10789 70810873
Status epilepticus 20.03 13.14 6 106776 24520 70797142
Viral infection 20.00 13.14 17 106765 38374 70783288
Skin laceration 19.95 13.14 7 106775 25871 70795791
Laboratory test abnormal 19.88 13.14 7 106775 25816 70795846
Muscle spasms 19.81 13.14 143 106639 153903 70667759
Muscle spasticity 19.77 13.14 3 106779 19686 70801976
Transdifferentiation of neoplasm 19.76 13.14 7 106775 97 70821565
Blood triglycerides increased 19.74 13.14 3 106779 19661 70802001
Radiation pneumonitis 19.67 13.14 26 106756 3667 70817995
Ear infection 19.66 13.14 9 106773 28327 70793335
Toxic optic neuropathy 19.64 13.14 15 106767 1091 70820571
Obstruction gastric 19.54 13.14 17 106765 1487 70820175
Heart rate decreased 19.47 13.14 40 106742 61975 70759687
Metastases to nervous system 19.47 13.14 6 106776 52 70821610
Salmonellosis 19.35 13.14 17 106765 1506 70820156
Recurrent cancer 19.28 13.14 21 106761 2420 70819242
Trigeminal nerve paresis 19.23 13.14 4 106778 4 70821658
Infusion site plaque 19.23 13.14 4 106778 4 70821658
Metastases to heart 19.22 13.14 9 106773 263 70821399
Bone disorder 19.18 13.14 64 106718 17426 70804236
Salmonella sepsis 19.13 13.14 10 106772 372 70821290
Overflow diarrhoea 19.13 13.14 7 106775 107 70821555
Adverse event 19.09 13.14 28 106754 49433 70772229
Nail bed tenderness 19.08 13.14 10 106772 374 70821288
Non-small cell lung cancer metastatic 19.06 13.14 14 106768 960 70820702
Tympanic membrane disorder 19.02 13.14 8 106774 180 70821482
Choroidal effusion 18.97 13.14 12 106770 643 70821019
Pulmonary embolism 18.97 13.14 335 106447 155532 70666130
Ovarian necrosis 18.92 13.14 5 106777 23 70821639
Foot deformity 18.90 13.14 4 106778 20651 70801011
Soft tissue infection 18.88 13.14 25 106757 3532 70818130
Enteritis 18.82 13.14 52 106730 12779 70808883
Monocyte count decreased 18.72 13.14 23 106759 3016 70818646
Appendiceal abscess 18.67 13.14 9 106773 281 70821381
Chronic kidney disease 18.65 13.14 40 106742 61017 70760645
Surgery 18.62 13.14 11 106771 29978 70791684
Hepatic function abnormal 18.62 13.14 170 106612 67826 70753836
Disorientation 18.49 13.14 37 106745 57886 70763776
Neuromuscular toxicity 18.46 13.14 8 106774 194 70821468
Retinitis pigmentosa 18.39 13.14 7 106775 120 70821542
Left ventricular dilatation 18.38 13.14 14 106768 1014 70820648
Vaginal prolapse 18.27 13.14 9 106773 295 70821367
Metastases to uterus 18.19 13.14 6 106776 66 70821596
Acute myocardial infarction 18.18 13.14 53 106729 72834 70748828
Restlessness 18.14 13.14 22 106760 42106 70779556
Necrosis 18.13 13.14 40 106742 8541 70813121
Metastases to adrenals 18.10 13.14 15 106767 1227 70820435
Subclavian vein thrombosis 18.02 13.14 20 106762 2354 70819308
Inflammatory carcinoma of the breast 17.96 13.14 5 106777 29 70821633
Chromosomal mutation 17.96 13.14 5 106777 29 70821633
Throat tightness 17.93 13.14 80 106702 24942 70796720
Mental status changes 17.93 13.14 43 106739 63058 70758604
Red blood cell sedimentation rate increased 17.92 13.14 19 106763 38623 70783039
Renal impairment 17.84 13.14 135 106647 143802 70677860
Abdominal pain 17.82 13.14 656 106126 341471 70480191
Drug ineffective for unapproved indication 17.82 13.14 19 106763 38519 70783143
Breast neoplasm 17.73 13.14 13 106769 889 70820773
Tumour marker increased 17.62 13.14 25 106757 3769 70817893
Hypothalamo-pituitary disorder 17.60 13.14 14 106768 1081 70820581
Metastases to muscle 17.59 13.14 9 106773 320 70821342
Procedural pain 17.51 13.14 3 106779 18006 70803656
Mucosal toxicity 17.47 13.14 11 106771 585 70821077
Aorto-oesophageal fistula 17.43 13.14 6 106776 76 70821586
Hyperpyrexia 17.41 13.14 30 106752 5344 70816318
Transaminases 17.35 13.14 6 106776 77 70821585
Memory impairment 17.35 13.14 76 106706 92565 70729097
Aspergillus infection 17.32 13.14 3 106779 17865 70803797
Sleep disorder 17.28 13.14 51 106731 69821 70751841
Eye swelling 17.18 13.14 7 106775 23607 70798055
Infection 17.16 13.14 219 106563 210566 70611096
Hypersomnia 17.10 13.14 5 106777 20759 70800903
Merycism 17.08 13.14 8 106774 234 70821428
Psychotic disorder 16.97 13.14 19 106763 37682 70783980
Administration site extravasation 16.94 13.14 14 106768 1141 70820521
Breast oedema 16.92 13.14 5 106777 37 70821625
Hydronephrosis 16.91 13.14 56 106726 15186 70806476
Ocular hyperaemia 16.83 13.14 8 106774 24631 70797031
Traumatic lung injury 16.78 13.14 19 106763 2286 70819376
Staphylococcal impetigo 16.73 13.14 4 106778 11 70821651
Eye pain 16.69 13.14 16 106766 34086 70787576
Osteosclerosis 16.60 13.14 24 106758 3681 70817981
Hyperchlorhydria 16.57 13.14 17 106765 1829 70819833
Spinal pain 16.56 13.14 52 106730 13718 70807944
Transfusion 16.53 13.14 4 106778 18832 70802830
Iron deficiency anaemia 16.53 13.14 7 106775 23065 70798597
Liposarcoma metastatic 16.50 13.14 3 106779 0 70821662
Labia enlarged 16.50 13.14 3 106779 0 70821662
ALK gene rearrangement positive 16.50 13.14 3 106779 0 70821662
Cannabinoid hyperemesis syndrome 16.47 13.14 5 106777 41 70821621
Mouth ulceration 16.37 13.14 98 106684 34251 70787411
Clostridial infection 16.29 13.14 29 106753 5300 70816362
Haematoma 16.27 13.14 30 106752 48388 70773274
Intervertebral disc protrusion 16.26 13.14 6 106776 21497 70800165
Gastrointestinal perforation 16.20 13.14 30 106752 5651 70816011
Amnesia 16.07 13.14 34 106748 52121 70769541
Generalised oedema 16.01 13.14 70 106712 21638 70800024
Herpes simplex sepsis 15.96 13.14 5 106777 46 70821616
Ear pain 15.94 13.14 11 106771 27588 70794074
Hypoalbuminaemia 15.93 13.14 64 106718 19058 70802604
Vasculitis 15.92 13.14 65 106717 19493 70802169
Nasal discomfort 15.81 13.14 27 106755 4774 70816888
Leukaemia cutis 15.78 13.14 7 106775 180 70821482
Dandy-Walker syndrome 15.77 13.14 5 106777 48 70821614
Colony stimulating factor therapy 15.76 13.14 10 106772 539 70821123
Therapeutic response unexpected 15.75 13.14 4 106778 18227 70803435
Cranial nerve disorder 15.69 13.14 13 106769 1063 70820599
Tracheo-oesophageal fistula 15.64 13.14 10 106772 546 70821116
Glaucoma 15.57 13.14 4 106778 18088 70803574
Haematochezia 15.55 13.14 57 106725 73024 70748638
Miller Fisher syndrome 15.50 13.14 7 106775 188 70821474
Atypical pneumonia 15.49 13.14 30 106752 5845 70815817
Dysuria 15.46 13.14 120 106662 45674 70775988
Delusion of grandeur 15.45 13.14 12 106770 895 70820767
Osteosarcoma recurrent 15.41 13.14 5 106777 52 70821610
Cachexia 15.40 13.14 41 106741 9859 70811803
Portosplenomesenteric venous thrombosis 15.39 13.14 4 106778 17 70821645
Injection site rash 15.38 13.14 3 106779 16407 70805255
Underdose 15.32 13.14 13 106769 29370 70792292
Hallucination, visual 15.27 13.14 13 106769 29324 70792338
Hepatotoxicity 15.26 13.14 116 106666 43870 70777792
Cholangitis sclerosing 15.24 13.14 18 106764 2265 70819397
Subdural haematoma 15.23 13.14 13 106769 29285 70792377
Extravasation 15.21 13.14 22 106760 3375 70818287
Renal disorder 15.18 13.14 21 106761 37988 70783674
Infusion site vesicles 15.03 13.14 9 106773 437 70821225
Distichiasis 15.03 13.14 4 106778 19 70821643
Scleroderma 15.01 13.14 27 106755 4974 70816688
Upper limb fracture 15.00 13.14 3 106779 16116 70805546
Bronchiectasis 14.97 13.14 3 106779 16094 70805568
Tracheal stenosis 14.94 13.14 8 106774 313 70821349
Pituitary tumour 14.93 13.14 13 106769 1138 70820524
Cholestasis 14.93 13.14 31 106751 47841 70773821
Bone cancer metastatic 14.90 13.14 7 106775 206 70821456
Naevus haemorrhage 14.78 13.14 6 106776 123 70821539
Paralysis recurrent laryngeal nerve 14.78 13.14 6 106776 123 70821539
Pneumonia salmonella 14.77 13.14 5 106777 60 70821602
Abortion spontaneous 14.70 13.14 11 106771 26468 70795194
Urogenital prolapse 14.70 13.14 4 106778 21 70821641
Ventricular tachycardia 14.67 13.14 20 106762 36403 70785259
Haemodialysis 14.64 13.14 4 106778 17362 70804300
Tubulointerstitial nephritis 14.53 13.14 17 106765 33059 70788603
Bladder cancer 14.48 13.14 4 106778 17238 70804424
Chills 14.48 13.14 302 106480 144484 70677178
Tracheal fistula 14.47 13.14 6 106776 130 70821532
Necrotising colitis 14.47 13.14 12 106770 983 70820679
Hyperchromasia 14.43 13.14 3 106779 3 70821659
Non-pitting oedema 14.43 13.14 3 106779 3 70821659
Subretinal hyperreflective exudation 14.43 13.14 3 106779 3 70821659
Blood pressure systolic inspiratory decreased 14.43 13.14 3 106779 3 70821659
Sarcomatosis 14.43 13.14 3 106779 3 70821659
Metastatic lymphoma 14.42 13.14 7 106775 222 70821440
Femur fracture 14.39 13.14 20 106762 36112 70785550
Acne 14.38 13.14 10 106772 24979 70796683
Respiratory failure 14.37 13.14 344 106438 168391 70653271
Thrombotic microangiopathy 14.28 13.14 59 106723 17789 70803873
Vaginitis gardnerella 14.25 13.14 4 106778 24 70821638
Abdominal rigidity 14.25 13.14 19 106763 2702 70818960
Sinus bradycardia 14.20 13.14 9 106773 23614 70798048
Hydrocephalus 14.14 13.14 35 106747 8050 70813612
Folate deficiency 14.12 13.14 20 106762 3010 70818652
Loss of consciousness 14.12 13.14 158 106624 155558 70666104
Face oedema 14.10 13.14 76 106706 25563 70796099
Parkinsonism 13.95 13.14 3 106779 15322 70806340
Carotid artery aneurysm 13.92 13.14 7 106775 240 70821422
Fear 13.84 13.14 7 106775 20804 70800858
Metastases to bladder 13.81 13.14 7 106775 244 70821418
Kidney infection 13.78 13.14 6 106776 19449 70802213
Breast necrosis 13.75 13.14 5 106777 75 70821587
Hypersensitivity pneumonitis 13.66 13.14 21 106761 3401 70818261
Chondritis 13.64 13.14 6 106776 151 70821511
Polyneuropathy in malignant disease 13.53 13.14 6 106776 154 70821508
Acute hepatic failure 13.52 13.14 13 106769 27659 70794003
Head injury 13.50 13.14 19 106763 34122 70787540
Joint stiffness 13.49 13.14 20 106762 35156 70786506
Neutrophil count abnormal 13.47 13.14 20 106762 3141 70818521
Angiosarcoma 13.45 13.14 9 106773 531 70821131
Metastases to abdominal cavity 13.44 13.14 9 106773 532 70821130
Hernia 13.35 13.14 3 106779 14857 70806805
Impaired work ability 13.34 13.14 4 106778 16336 70805326
Gallbladder disorder 13.30 13.14 5 106777 17707 70803955
Red cell distribution width increased 13.26 13.14 48 106734 13609 70808053
Respiratory tract congestion 13.23 13.14 5 106777 17648 70804014
HER2 positive salivary gland cancer 13.21 13.14 3 106779 6 70821656
Pneumocystis jirovecii pneumonia 13.19 13.14 84 106698 29998 70791664
Lymphangitis 13.17 13.14 13 106769 1336 70820326

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC L01CD02 ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
ANTINEOPLASTIC AGENTS
PLANT ALKALOIDS AND OTHER NATURAL PRODUCTS
Taxanes
FDA PE N0000175085 Microtubule Inhibition
FDA EPC N0000175592 Microtubule Inhibitor
CHEBI has role CHEBI:35610 antineoplastic agents
CHEBI has role CHEBI:38068 antimalarials
CHEBI has role CHEBI:47868 photosensitising agent
MeSH PA D050256 Antimitotic Agents
MeSH PA D000970 Antineoplastic Agents
MeSH PA D050257 Tubulin Modulators

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

DiseaseRelationSNOMED_IDDOID
Non-small cell lung cancer indication 254637007 DOID:3908
Carcinoma of breast indication 254838004 DOID:3459
Malignant tumor of head and/or neck indication 255056009
Malignant tumor of stomach indication 363349007 DOID:10534
Malignant tumor of prostate indication 399068003 DOID:10283
Metastatic Breast Carcinoma indication
Ewing's sarcoma off-label use 76909002 DOID:3369
Small cell carcinoma of lung off-label use 254632001 DOID:5409
Malignant tumor of esophagus off-label use 363402007
Malignant tumor of ovary off-label use 363443007 DOID:2394
Invasive Bladder Malignancy off-label use
Refractory Osteosarcoma off-label use
Asthenia contraindication 13791008
Hyperbilirubinemia contraindication 14783006 DOID:2741
Pulmonary edema contraindication 19242006 DOID:11396
Cardiac tamponade contraindication 35304003 DOID:115
Body fluid retention contraindication 43498006
Stomatitis contraindication 61170000 DOID:9637
Diarrhea contraindication 62315008
Acute infectious disease contraindication 63171007
Peripheral motor neuropathy contraindication 95663000 DOID:683
Liver function tests abnormal contraindication 166603001
Disease of liver contraindication 235856003 DOID:409
Anemia contraindication 271737000 DOID:2355
Peripheral edema contraindication 271809000
Pregnancy, function contraindication 289908002
Thrombocytopenic disorder contraindication 302215000 DOID:1588
Peripheral nerve disease contraindication 302226006
Neutropenic disorder contraindication 303011007 DOID:1227
Bone marrow depression contraindication 307762000
Ascites contraindication 389026000
Breastfeeding (mother) contraindication 413712001
Pleural Effusions contraindication




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 9.9 acidic
pKa2 11.64 acidic
pKa3 12.4 acidic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
160MG/8ML (20MG/ML) DOCETAXEL SHILPA N205934 Dec. 22, 2015 RX INJECTABLE INJECTION 10842770 Aug. 7, 2031 METHOD OF ADMINISTERING DOCETAXEL TO A SUBJECT COMBINING THE DOCETAXEL PRO-EMULSION FORMULATION WITH AN AQUEOUS MEDIUM TO PRODUCE DOCETAXEL EMULSION
20MG/ML (20MG/ML) DOCETAXEL SHILPA N205934 Dec. 22, 2015 RX INJECTABLE INJECTION 10842770 Aug. 7, 2031 METHOD OF ADMINISTERING DOCETAXEL TO A SUBJECT COMBINING THE DOCETAXEL PRO-EMULSION FORMULATION WITH AN AQUEOUS MEDIUM TO PRODUCE DOCETAXEL EMULSION
80MG/4ML (20MG/ML) DOCETAXEL SHILPA N205934 Dec. 22, 2015 RX INJECTABLE INJECTION 10842770 Aug. 7, 2031 METHOD OF ADMINISTERING DOCETAXEL TO A SUBJECT COMBINING THE DOCETAXEL PRO-EMULSION FORMULATION WITH AN AQUEOUS MEDIUM TO PRODUCE DOCETAXEL EMULSION
160MG/8ML (20MG/ML) DOCETAXEL SHILPA N205934 Dec. 22, 2015 RX INJECTABLE INJECTION 8940786 Sept. 30, 2033 METHOD OF ADMINISTERING AN ETHANOL-FREE TAXANE LIQUID NANODISPERSION FORMULATION TO A SUBJECT COMBINING THE FORMULATION WITH AN AQUEOUS MEDIUM TO PROVIDE AN ETHANOL-FREE TAXANE DILUTED SOLUTION
160MG/8ML (20MG/ML) DOCETAXEL SHILPA N205934 Dec. 22, 2015 RX INJECTABLE INJECTION 9763880 Sept. 30, 2033 TREATMENT OF ADVANCED GASTRIC ADENOCARCINOMA IN COMBINATION WITH CISPLATIN AND FLUOROURACIL IN PATIENTS THAT HAVE NOT RECEIVED PRIOR CHEMOTHERAPY
160MG/8ML (20MG/ML) DOCETAXEL SHILPA N205934 Dec. 22, 2015 RX INJECTABLE INJECTION 9763880 Sept. 30, 2033 TREATMENT OF PATIENTS WITH ANDROGEN INDEPENDENT (HORMONE REFRACTORY) METASTATIC PROSTATE CANCER IN COMBINATION WITH PREDNISONE
160MG/8ML (20MG/ML) DOCETAXEL SHILPA N205934 Dec. 22, 2015 RX INJECTABLE INJECTION 9763880 Sept. 30, 2033 TREATMENT OF PATIENTS WITH LOCALLY ADVANCED METASTATIC BREAST CANCER AFTER FAILURE OF PRIOR CHEMOTHERAPY
160MG/8ML (20MG/ML) DOCETAXEL SHILPA N205934 Dec. 22, 2015 RX INJECTABLE INJECTION 9763880 Sept. 30, 2033 TREATMENT OF PATIENTS WITH LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER AFTER FAILURE OF PRIOR PLATINUM-BASED CHEMOTHERAPY
160MG/8ML (20MG/ML) DOCETAXEL SHILPA N205934 Dec. 22, 2015 RX INJECTABLE INJECTION 9763880 Sept. 30, 2033 TREATMENT OF PATIENTS WITH LOCALLY ADVANCED SQUAMOUS CELL CARCINOMA OF THE HEAD AND NECK IN COMBINATION WITH CISPLATIN AND FLUOROURACIL
160MG/8ML (20MG/ML) DOCETAXEL SHILPA N205934 Dec. 22, 2015 RX INJECTABLE INJECTION 9763880 Sept. 30, 2033 USE IN COMBINATION WITH CISPLATIN FOR TREATMENT OF UNRESECTABLE, LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER WITHOUT PRIOR CHEMOTHERAPY TREATMENT
160MG/8ML (20MG/ML) DOCETAXEL SHILPA N205934 Dec. 22, 2015 RX INJECTABLE INJECTION 9763880 Sept. 30, 2033 USE IN COMBINATION WITH DOXORUBICIN AND CYCLOPHOSPHAMIDE FOR ADJUVANT TREATMENT OF PATIENTS WITH OPERABLE NODE-POSITIVE BREAST CANCER
20MG/ML (20MG/ML) DOCETAXEL SHILPA N205934 Dec. 22, 2015 RX INJECTABLE INJECTION 8940786 Sept. 30, 2033 METHOD OF ADMINISTERING AN ETHANOL-FREE TAXANE LIQUID NANODISPERSION FORMULATION TO A SUBJECT COMBINING THE FORMULATION WITH AN AQUEOUS MEDIUM TO PROVIDE AN ETHANOL-FREE TAXANE DILUTED SOLUTION
20MG/ML (20MG/ML) DOCETAXEL SHILPA N205934 Dec. 22, 2015 RX INJECTABLE INJECTION 9763880 Sept. 30, 2033 TREATMENT OF ADVANCED GASTRIC ADENOCARCINOMA IN COMBINATION WITH CISPLATIN AND FLUOROURACIL IN PATIENTS THAT HAVE NOT RECEIVED PRIOR CHEMOTHERAPY
20MG/ML (20MG/ML) DOCETAXEL SHILPA N205934 Dec. 22, 2015 RX INJECTABLE INJECTION 9763880 Sept. 30, 2033 TREATMENT OF PATIENTS WITH ANDROGEN INDEPENDENT (HORMONE REFRACTORY) METASTATIC PROSTATE CANCER IN COMBINATION WITH PREDNISONE
20MG/ML (20MG/ML) DOCETAXEL SHILPA N205934 Dec. 22, 2015 RX INJECTABLE INJECTION 9763880 Sept. 30, 2033 TREATMENT OF PATIENTS WITH LOCALLY ADVANCED METASTATIC BREAST CANCER AFTER FAILURE OF PRIOR CHEMOTHERAPY
20MG/ML (20MG/ML) DOCETAXEL SHILPA N205934 Dec. 22, 2015 RX INJECTABLE INJECTION 9763880 Sept. 30, 2033 TREATMENT OF PATIENTS WITH LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER AFTER FAILURE OF PRIOR PLATINUM-BASED CHEMOTHERAPY
20MG/ML (20MG/ML) DOCETAXEL SHILPA N205934 Dec. 22, 2015 RX INJECTABLE INJECTION 9763880 Sept. 30, 2033 TREATMENT OF PATIENTS WITH LOCALLY ADVANCED SQUAMOUS CELL CARCINOMA OF THE HEAD AND NECK IN COMBINATION WITH CISPLATIN AND FLUOROURACIL
20MG/ML (20MG/ML) DOCETAXEL SHILPA N205934 Dec. 22, 2015 RX INJECTABLE INJECTION 9763880 Sept. 30, 2033 USE IN COMBINATION WITH CISPLATIN FOR TREATMENT OF UNRESECTABLE, LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER WITHOUT PRIOR CHEMOTHERAPY TREATMENT
20MG/ML (20MG/ML) DOCETAXEL SHILPA N205934 Dec. 22, 2015 RX INJECTABLE INJECTION 9763880 Sept. 30, 2033 USE IN COMBINATION WITH DOXORUBICIN AND CYCLOPHOSPHAMIDE FOR ADJUVANT TREATMENT OF PATIENTS WITH OPERABLE NODE-POSITIVE BREAST CANCER
80MG/4ML (20MG/ML) DOCETAXEL SHILPA N205934 Dec. 22, 2015 RX INJECTABLE INJECTION 8940786 Sept. 30, 2033 METHOD OF ADMINISTERING AN ETHANOL-FREE TAXANE LIQUID NANODISPERSION FORMULATION TO A SUBJECT COMBINING THE FORMULATION WITH AN AQUEOUS MEDIUM TO PROVIDE AN ETHANOL-FREE TAXANE DILUTED SOLUTION
80MG/4ML (20MG/ML) DOCETAXEL SHILPA N205934 Dec. 22, 2015 RX INJECTABLE INJECTION 9763880 Sept. 30, 2033 TREATMENT OF ADVANCED GASTRIC ADENOCARCINOMA IN COMBINATION WITH CISPLATIN AND FLUOROURACIL IN PATIENTS THAT HAVE NOT RECEIVED PRIOR CHEMOTHERAPY
80MG/4ML (20MG/ML) DOCETAXEL SHILPA N205934 Dec. 22, 2015 RX INJECTABLE INJECTION 9763880 Sept. 30, 2033 TREATMENT OF PATIENTS WITH ANDROGEN INDEPENDENT (HORMONE REFRACTORY) METASTATIC PROSTATE CANCER IN COMBINATION WITH PREDNISONE
80MG/4ML (20MG/ML) DOCETAXEL SHILPA N205934 Dec. 22, 2015 RX INJECTABLE INJECTION 9763880 Sept. 30, 2033 TREATMENT OF PATIENTS WITH LOCALLY ADVANCED METASTATIC BREAST CANCER AFTER FAILURE OF PRIOR CHEMOTHERAPY
80MG/4ML (20MG/ML) DOCETAXEL SHILPA N205934 Dec. 22, 2015 RX INJECTABLE INJECTION 9763880 Sept. 30, 2033 TREATMENT OF PATIENTS WITH LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER AFTER FAILURE OF PRIOR PLATINUM-BASED CHEMOTHERAPY
80MG/4ML (20MG/ML) DOCETAXEL SHILPA N205934 Dec. 22, 2015 RX INJECTABLE INJECTION 9763880 Sept. 30, 2033 TREATMENT OF PATIENTS WITH LOCALLY ADVANCED SQUAMOUS CELL CARCINOMA OF THE HEAD AND NECK IN COMBINATION WITH CISPLATIN AND FLUOROURACIL
80MG/4ML (20MG/ML) DOCETAXEL SHILPA N205934 Dec. 22, 2015 RX INJECTABLE INJECTION 9763880 Sept. 30, 2033 USE IN COMBINATION WITH CISPLATIN FOR TREATMENT OF UNRESECTABLE, LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER WITHOUT PRIOR CHEMOTHERAPY TREATMENT
80MG/4ML (20MG/ML) DOCETAXEL SHILPA N205934 Dec. 22, 2015 RX INJECTABLE INJECTION 9763880 Sept. 30, 2033 USE IN COMBINATION WITH DOXORUBICIN AND CYCLOPHOSPHAMIDE FOR ADJUVANT TREATMENT OF PATIENTS WITH OPERABLE NODE-POSITIVE BREAST CANCER

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
Tubulin beta Tumour-associated antigen INHIBITOR ID50 6.70 WOMBAT-PK CHEMBL
Multidrug resistance protein 1 Transporter WOMBAT-PK
Multidrug resistance-associated protein 7 Transporter WOMBAT-PK
Epidermal growth factor receptor Kinase INHIBITOR Kd 9.09 WOMBAT-PK
Substance-K receptor GPCR Ki 6.28 DRUG MATRIX
Growth hormone-releasing hormone receptor GPCR IC50 9.85 CHEMBL
Cytochrome P450 3A4 Enzyme IC50 5.70 DRUG MATRIX
Nucleotide-binding oligomerization domain-containing protein 2 Cytosolic other IC50 5.30 CHEMBL

External reference:

IDSource
4020968 VUID
N0000148441 NUI
D02165 KEGG_DRUG
148408-66-6 SECONDARY_CAS_RN
1299922 RXNORM
4020968 VANDF
C0246415 UMLSCUI
CHEBI:59809 CHEBI
TXL PDB_CHEM_ID
CHEMBL3545252 ChEMBL_ID
CHEMBL92 ChEMBL_ID
D000077143 MESH_DESCRIPTOR_UI
DB01248 DRUGBANK_ID
6809 IUPHAR_LIGAND_ID
15H5577CQD UNII
148124 PUBCHEM_CID
178776 MMSL
180476 MMSL
4626 MMSL
5984 MMSL
d04009 MMSL
005187 NDDF
005188 NDDF
108806006 SNOMEDCT_US
386918005 SNOMEDCT_US
6621 INN_ID

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Docetaxel HUMAN PRESCRIPTION DRUG LABEL 1 0143-9204 INJECTION, SOLUTION, CONCENTRATE 20 mg INTRAVENOUS ANDA 30 sections
Docetaxel HUMAN PRESCRIPTION DRUG LABEL 1 0143-9205 INJECTION, SOLUTION, CONCENTRATE 20 mg INTRAVENOUS ANDA 30 sections
Docetaxel HUMAN PRESCRIPTION DRUG LABEL 1 0409-0016 INJECTION, SOLUTION 10 mg INTRAVENOUS NDA 33 sections
Docetaxel HUMAN PRESCRIPTION DRUG LABEL 1 0409-0201 INJECTION, SOLUTION 10 mg INTRAVENOUS NDA 31 sections
Docetaxel HUMAN PRESCRIPTION DRUG LABEL 1 0409-0365 INJECTION, SOLUTION 20 mg INTRAVENOUS NDA 33 sections
Docetaxel HUMAN PRESCRIPTION DRUG LABEL 1 0409-0366 INJECTION, SOLUTION 20 mg INTRAVENOUS NDA 31 sections
Docetaxel HUMAN PRESCRIPTION DRUG LABEL 1 0409-0367 INJECTION, SOLUTION 20 mg INTRAVENOUS NDA 31 sections
Docetaxel HUMAN PRESCRIPTION DRUG LABEL 1 0409-0368 INJECTION, SOLUTION 20 mg INTRAVENOUS NDA 31 sections
Docetaxel HUMAN PRESCRIPTION DRUG LABEL 1 0409-1732 INJECTION, SOLUTION 10 mg INTRAVENOUS NDA 33 sections
Docetaxel HUMAN PRESCRIPTION DRUG LABEL 1 0409-2026 INJECTION, SOLUTION 10 mg INTRAVENOUS NDA 33 sections
Docetaxel HUMAN PRESCRIPTION DRUG LABEL 1 0409-2956 INJECTION, SOLUTION 10 mg INTRAVENOUS NDA 33 sections
Docetaxel HUMAN PRESCRIPTION DRUG LABEL 1 0409-4235 INJECTION, SOLUTION 20 mg INTRAVENOUS NDA 33 sections
Docetaxel HUMAN PRESCRIPTION DRUG LABEL 1 0409-5068 INJECTION, SOLUTION 20 mg INTRAVENOUS NDA 33 sections
Docetaxel HUMAN PRESCRIPTION DRUG LABEL 1 0409-7870 INJECTION, SOLUTION 10 mg INTRAVENOUS NDA 33 sections
Docetaxel HUMAN PRESCRIPTION DRUG LABEL 1 0955-1020 INJECTION, SOLUTION, CONCENTRATE 20 mg INTRAVENOUS NDA authorized generic 30 sections
Docetaxel HUMAN PRESCRIPTION DRUG LABEL 1 0955-1020 INJECTION, SOLUTION, CONCENTRATE 20 mg INTRAVENOUS NDA authorized generic 30 sections
Docetaxel HUMAN PRESCRIPTION DRUG LABEL 1 0955-1021 INJECTION, SOLUTION, CONCENTRATE 80 mg INTRAVENOUS NDA authorized generic 30 sections
Docetaxel HUMAN PRESCRIPTION DRUG LABEL 1 0955-1021 INJECTION, SOLUTION, CONCENTRATE 80 mg INTRAVENOUS NDA authorized generic 30 sections
Docetaxel HUMAN PRESCRIPTION DRUG LABEL 1 0955-1022 INJECTION, SOLUTION, CONCENTRATE 160 mg INTRAVENOUS NDA authorized generic 30 sections
Docetaxel HUMAN PRESCRIPTION DRUG LABEL 1 0955-1022 INJECTION, SOLUTION, CONCENTRATE 160 mg INTRAVENOUS NDA authorized generic 30 sections
DOCETAXEL HUMAN PRESCRIPTION DRUG LABEL 1 16729-231 INJECTION, SOLUTION, CONCENTRATE 20 mg INTRAVENOUS NDA 30 sections
DOCETAXEL HUMAN PRESCRIPTION DRUG LABEL 1 16729-231 INJECTION, SOLUTION, CONCENTRATE 20 mg INTRAVENOUS NDA 30 sections
DOCETAXEL HUMAN PRESCRIPTION DRUG LABEL 1 16729-267 INJECTION, SOLUTION, CONCENTRATE 20 mg INTRAVENOUS NDA 30 sections
DOCETAXEL HUMAN PRESCRIPTION DRUG LABEL 1 16729-267 INJECTION, SOLUTION, CONCENTRATE 20 mg INTRAVENOUS NDA 30 sections
Docetaxel HUMAN PRESCRIPTION DRUG LABEL 1 25021-245 INJECTION, SOLUTION 20 mg INTRAVENOUS ANDA 29 sections
Docetaxel HUMAN PRESCRIPTION DRUG LABEL 1 25021-245 INJECTION, SOLUTION 20 mg INTRAVENOUS ANDA 29 sections
Docetaxel HUMAN PRESCRIPTION DRUG LABEL 1 43066-001 INJECTION, SOLUTION 10 mg INTRAVENOUS NDA 28 sections
Docetaxel HUMAN PRESCRIPTION DRUG LABEL 1 43066-006 INJECTION, SOLUTION 10 mg INTRAVENOUS NDA 28 sections
Docetaxel HUMAN PRESCRIPTION DRUG LABEL 1 43066-010 INJECTION, SOLUTION 10 mg INTRAVENOUS NDA 28 sections
Docetaxel HUMAN PRESCRIPTION DRUG LABEL 1 43598-258 INJECTION, SOLUTION 20 mg INTRAVENOUS ANDA 26 sections