docetaxel ๐Ÿถ 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 ยตM/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
Nov. 27, 1995 EMA Sanofi Mature IP
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 1686.49 14.34 1390 91413 117059 63279160
Neutropenia 1510.99 14.34 1552 91251 173453 63222766
Myelosuppression 1492.57 14.34 717 92086 22986 63373233
Diarrhoea 1076.24 14.34 2855 89948 712511 62683708
Palmar-plantar erythrodysaesthesia syndrome 1041.51 14.34 557 92246 22458 63373761
Disease progression 1031.50 14.34 1074 91729 121684 63274535
Malignant neoplasm progression 1020.31 14.34 892 91911 81229 63314990
Ejection fraction decreased 860.23 14.34 486 92317 21846 63374373
Mucosal inflammation 841.77 14.34 632 92171 46296 63349923
Neuropathy peripheral 719.33 14.34 858 91945 112809 63283410
Metastases to bone 712.55 14.34 421 92382 20598 63375621
Metastases to liver 627.15 14.34 405 92398 23234 63372985
Bone marrow failure 603.29 14.34 429 92374 28861 63367358
Metastases to central nervous system 458.58 14.34 268 92535 12837 63383382
Agranulocytosis 427.25 14.34 328 92475 24806 63371413
Metastases to lung 420.61 14.34 251 92552 12499 63383720
Drug ineffective 416.57 14.34 554 92249 1044211 62352008
Metastases to lymph nodes 404.52 14.34 210 92593 7948 63388271
Cardiotoxicity 397.84 14.34 210 92593 8228 63387991
Rheumatoid arthritis 349.62 14.34 4 92799 253815 63142404
Neutropenic sepsis 343.55 14.34 243 92560 16195 63380024
Neoplasm progression 327.46 14.34 331 92472 36097 63360122
Joint swelling 321.54 14.34 48 92755 327618 63068601
Leukopenia 295.28 14.34 457 92346 76833 63319386
Polyneuropathy 294.13 14.34 211 92592 14378 63381841
Neutrophil count decreased 272.91 14.34 373 92430 56033 63340186
Contraindicated product administered 270.64 14.34 11 92792 217637 63178582
Systemic lupus erythematosus 268.72 14.34 8 92795 208910 63187309
Skin toxicity 261.78 14.34 131 92672 4583 63391636
Arthropathy 258.59 14.34 23 92780 234769 63161450
Pleural effusion 257.58 14.34 477 92326 92733 63303486
White blood cell count decreased 252.35 14.34 599 92204 138505 63257714
Peripheral sensory neuropathy 243.95 14.34 146 92657 7305 63388914
Therapeutic product effect decreased 242.77 14.34 9 92794 193178 63203041
Breast cancer recurrent 239.19 14.34 120 92683 4221 63391998
Product dose omission issue 235.16 14.34 32 92771 234281 63161938
Fall 223.29 14.34 150 92653 392184 63004035
Vomiting 216.13 14.34 1477 91326 558140 62838079
Bone pain 209.90 14.34 324 92479 54317 63341902
Haematotoxicity 208.49 14.34 144 92659 9232 63386987
Acute myeloid leukaemia 208.00 14.34 184 92619 16963 63379256
Alopecia areata 207.94 14.34 82 92721 1603 63394616
Hand deformity 205.40 14.34 6 92797 159451 63236768
Nausea 205.34 14.34 2024 90779 852447 62543772
Metastasis 205.14 14.34 115 92688 5082 63391137
Sinusitis 205.09 14.34 41 92762 226612 63169607
Abdominal discomfort 198.77 14.34 111 92692 320774 63075445
Aortitis 196.60 14.34 70 92733 1017 63395202
Left ventricular dysfunction 196.16 14.34 153 92650 11835 63384384
Nail disorder 193.48 14.34 157 92646 12858 63383361
Completed suicide 189.41 14.34 5 92798 145668 63250551
Maternal exposure during pregnancy 188.57 14.34 45 92758 220017 63176202
Decreased appetite 186.00 14.34 793 92010 250259 63145960
Condition aggravated 185.30 14.34 189 92614 402028 62994191
Pyrexia 185.14 14.34 1248 91555 469230 62926989
Interstitial lung disease 181.32 14.34 325 92478 61583 63334636
Madarosis 181.10 14.34 89 92714 2992 63393227
Drug hypersensitivity 180.44 14.34 116 92687 310571 63085648
Hair colour changes 179.85 14.34 89 92714 3038 63393181
Neutropenic colitis 177.74 14.34 88 92715 3007 63393212
Colitis 175.62 14.34 280 92523 48248 63347971
Recall phenomenon 173.25 14.34 56 92747 594 63395625
Anaemia 173.14 14.34 867 91936 292563 63103656
Onycholysis 172.17 14.34 71 92732 1565 63394654
Flushing 167.12 14.34 351 92452 74736 63321483
Metastases to skin 164.32 14.34 69 92734 1594 63394625
Wound 159.77 14.34 24 92779 163239 63232980
Erythema 157.22 14.34 589 92214 175162 63221057
Musculoskeletal stiffness 155.71 14.34 39 92764 184579 63211640
Stomatitis 154.51 14.34 500 92303 138225 63257994
Glossodynia 152.39 14.34 37 92766 178839 63217380
Hair texture abnormal 151.65 14.34 88 92715 4155 63392064
Second primary malignancy 148.88 14.34 110 92693 7843 63388376
Treatment failure 148 14.34 53 92750 198990 63197229
Confusional state 145.95 14.34 82 92721 236298 63159921
Weight increased 142.53 14.34 104 92699 260688 63135531
Product use issue 141.26 14.34 73 92730 220447 63175772
Metastases to pleura 140.85 14.34 61 92742 1524 63394695
Breast cancer metastatic 137.92 14.34 125 92678 11893 63384326
Pain 137.01 14.34 588 92215 740040 62656179
Injection site pain 134.33 14.34 16 92787 129784 63266435
Lymphoedema 132.98 14.34 121 92682 11571 63384648
Neurotoxicity 130.50 14.34 142 92661 16848 63379371
Skin exfoliation 127.11 14.34 227 92576 42875 63353344
Gastrointestinal toxicity 127.09 14.34 99 92704 7642 63388577
Nail toxicity 126.32 14.34 38 92765 311 63395908
Neutropenic infection 126.04 14.34 54 92749 1313 63394906
Swelling 126.00 14.34 130 92673 275248 63120971
Thrombocytopenia 124.02 14.34 493 92310 150664 63245555
Epistaxis 122.99 14.34 305 92498 72420 63323799
Hepatic enzyme increased 122.29 14.34 72 92731 202256 63193963
Helicobacter infection 121.29 14.34 3 92800 92782 63303437
Lacrimation increased 119.27 14.34 149 92654 20482 63375737
Somnolence 119.18 14.34 56 92747 178629 63217590
Dysgeusia 114.13 14.34 227 92576 46483 63349736
Capillary leak syndrome 107.24 14.34 56 92747 2144 63394075
Biopsy lung abnormal 105.88 14.34 28 92775 134 63396085
Pericarditis 104.89 14.34 31 92772 131548 63264671
Contusion 103.21 14.34 45 92758 149999 63246220
Exposure during pregnancy 101.81 14.34 50 92753 155497 63240722
Organising pneumonia 101.68 14.34 77 92726 5699 63390520
Overdose 99.56 14.34 23 92780 115055 63281164
Hypokalaemia 99.56 14.34 356 92447 103448 63292771
Paronychia 97.55 14.34 74 92729 5491 63390728
Duodenal ulcer perforation 97.40 14.34 8 92795 87201 63309018
Dehydration 96.99 14.34 505 92298 172849 63223370
Pneumonitis 96.88 14.34 180 92623 35042 63361177
Vascular device infection 95.80 14.34 82 92721 7230 63388989
Drug intolerance 95.50 14.34 192 92611 308469 63087750
Drug abuse 92.36 14.34 3 92800 72515 63323704
Dermatitis acneiform 91.05 14.34 68 92735 4928 63391291
Myalgia 90.51 14.34 439 92364 146090 63250129
Injury 89.98 14.34 4 92799 73243 63322976
Osteoarthritis 88.82 14.34 16 92787 95327 63300892
Arthritis 87.61 14.34 30 92773 115891 63280328
Blood cholesterol increased 87.12 14.34 16 92787 94016 63302203
Discomfort 85.98 14.34 71 92732 167303 63228916
Headache 85.95 14.34 558 92245 632683 62763536
Lymphangiosis carcinomatosa 85.70 14.34 42 92761 1403 63394816
Mobility decreased 83.85 14.34 36 92767 121123 63275096
Disease recurrence 83.11 14.34 148 92655 27882 63368337
Nail dystrophy 82.53 14.34 37 92766 1006 63395213
Hospitalisation 82.07 14.34 13 92790 85068 63311151
Metastases to spine 82.04 14.34 54 92749 3195 63393024
Hepatic function abnormal 81.86 14.34 173 92630 36969 63359250
Dermatitis 81.74 14.34 112 92691 16846 63379373
Irritable bowel syndrome 80.85 14.34 12 92791 82400 63313819
Radiation skin injury 79.59 14.34 35 92768 908 63395311
Myositis 79.23 14.34 82 92721 9184 63387035
Loss of personal independence in daily activities 79.23 14.34 22 92781 97268 63298951
Metastases to peritoneum 79.20 14.34 54 92749 3388 63392831
Cardiomyopathy 78.60 14.34 112 92691 17472 63378747
Ascites 77.66 14.34 179 92624 40549 63355670
Acute promyelocytic leukaemia 76.93 14.34 34 92769 893 63395326
Nail discolouration 75.07 14.34 48 92755 2702 63393517
Inappropriate schedule of product administration 75.01 14.34 29 92774 103936 63292283
Adverse drug reaction 72.91 14.34 14 92789 79700 63316519
Asthenia 72.52 14.34 868 91935 382736 63013483
Injection site erythema 71.19 14.34 17 92786 83157 63313062
Intentional product use issue 71.10 14.34 50 92753 127842 63268377
Large intestine perforation 70.62 14.34 74 92729 8408 63387811
Multifocal micronodular pneumocyte hyperplasia 70.47 14.34 18 92785 73 63396146
Bronchial polyp 70.47 14.34 18 92785 73 63396146
Febrile bone marrow aplasia 70.29 14.34 69 92734 7256 63388963
Hepatitis B reactivation 69.32 14.34 48 92755 3089 63393130
Device related thrombosis 69.09 14.34 39 92764 1746 63394473
Congestive cardiomyopathy 66.46 14.34 62 92741 6120 63390099
Erysipelas 65.88 14.34 69 92734 7836 63388383
Migraine 64.95 14.34 35 92768 103311 63292908
Gastrointestinal necrosis 64.63 14.34 44 92759 2754 63393465
Impaired healing 64.05 14.34 35 92768 102507 63293712
Myocardial infarction 64.01 14.34 33 92770 99860 63296359
Feeling abnormal 63.44 14.34 74 92729 148318 63247901
Therapy partial responder 63.24 14.34 78 92725 10580 63385639
Suicide attempt 61.80 14.34 8 92795 60910 63335309
Depression 61.77 14.34 121 92682 196371 63199848
Type 2 diabetes mellitus 61.06 14.34 10 92793 63858 63332361
Metastases to meninges 60.30 14.34 41 92762 2561 63393658
Cerebrovascular accident 59.04 14.34 43 92760 107981 63288238
Pseudocirrhosis 58.89 14.34 26 92777 681 63395538
Psoriasis 58.33 14.34 27 92776 86930 63309289
Incorrect dose administered 58.20 14.34 9 92794 59959 63336260
Osteonecrosis of jaw 57.98 14.34 146 92657 34977 63361242
Chest discomfort 57.79 14.34 315 92488 109654 63286565
Hot flush 57.42 14.34 185 92618 50974 63345245
Blood lactate dehydrogenase increased 57.24 14.34 113 92690 23003 63373216
Arthralgia 57.15 14.34 545 92258 569165 62827054
Injection site swelling 57.13 14.34 3 92800 47569 63348650
Dermatomyositis 56.95 14.34 41 92762 2807 63393412
COVID-19 56.81 14.34 49 92754 113054 63283165
Metastases to chest wall 56.57 14.34 24 92779 569 63395650
Injection site reaction 56.31 14.34 9 92794 58515 63337704
Mucosal infection 56.28 14.34 18 92785 184 63396035
Asthma 56.28 14.34 62 92741 127499 63268720
Illness 56.19 14.34 4 92799 49055 63347164
Granulocyte count decreased 56.01 14.34 30 92773 1210 63395009
Device related infection 55.11 14.34 112 92691 23280 63372939
Constipation 54.97 14.34 536 92267 224407 63171812
Cardiac failure 54.95 14.34 267 92536 88875 63307344
Blood pressure systolic increased 53.90 14.34 4 92799 47393 63348826
Nasopharyngitis 53.68 14.34 191 92612 254066 63142153
Dyspnoea 53.02 14.34 1302 91501 660011 62736208
Enterocolitis infectious 53.01 14.34 32 92771 1626 63394593
Alopecia totalis 52.39 14.34 20 92783 357 63395862
Hyperfibrinogenaemia 51.95 14.34 12 92791 28 63396191
Systemic scleroderma 50.78 14.34 26 92777 955 63395264
Injection site pruritus 50.76 14.34 4 92799 45112 63351107
Ventricular hypokinesia 50.74 14.34 47 92756 4597 63391622
Performance status decreased 49.72 14.34 42 92761 3636 63392583
Odynophagia 49.69 14.34 58 92745 7428 63388791
Lumbosacral radiculoplexus neuropathy 49.46 14.34 11 92792 20 63396199
Back pain 48.22 14.34 594 92209 263551 63132668
Sepsis 47.78 14.34 385 92418 152738 63243481
Enterocolitis 47.42 14.34 58 92745 7800 63388419
Death 46.87 14.34 788 92015 373593 63022626
Adverse event 46.85 14.34 20 92783 67539 63328680
Tonsillar disorder 46.83 14.34 26 92777 1127 63395092
Cellulitis 46.63 14.34 240 92563 81718 63314501
Pericardial effusion 46.57 14.34 122 92681 29936 63366283
Drug interaction 46.47 14.34 175 92628 228956 63167263
Nasal congestion 46.24 14.34 19 92784 65641 63330578
Drug resistance 46.17 14.34 103 92700 22830 63373389
Wheezing 46.11 14.34 43 92760 95552 63300667
Metastatic neoplasm 46.02 14.34 43 92760 4252 63391967
Cardiac dysfunction 45.55 14.34 33 92770 2282 63393937
Breast pain 45.29 14.34 60 92743 8738 63387481
Gait inability 44.97 14.34 11 92792 52948 63343271
Sedation 44.92 14.34 3 92800 38806 63357413
Acute leukaemia 44.50 14.34 25 92778 1109 63395110
Cystoid macular oedema 44.26 14.34 28 92775 1547 63394672
Medication error 44.13 14.34 11 92792 52273 63343946
Ear infection 44.10 14.34 3 92800 38210 63358009
Metastases to the mediastinum 44.08 14.34 19 92784 469 63395750
Myelodysplastic syndrome 44.04 14.34 84 92719 16670 63379549
Blood creatinine decreased 43.72 14.34 47 92756 5498 63390721
Periarticular thenar erythema with onycholysis 43.59 14.34 11 92792 42 63396177
Onychalgia 42.48 14.34 23 92780 948 63395271
Bursitis 42.48 14.34 3 92800 37038 63359181
Suicidal ideation 42.46 14.34 19 92784 62402 63333817
Road traffic accident 41.91 14.34 3 92800 36629 63359590
Mastitis 41.77 14.34 33 92770 2599 63393620
Excessive eye blinking 41.68 14.34 25 92778 1255 63394964
Blood uric acid decreased 40.80 14.34 21 92782 780 63395439
Dacryostenosis acquired 40.05 14.34 19 92784 590 63395629
Onychomadesis 40.02 14.34 46 92757 5794 63390425
Hallucination 40.02 14.34 15 92788 54802 63341417
Invasive ductal breast carcinoma 39.81 14.34 50 92753 6908 63389311
Hypocalcaemia 39.58 14.34 119 92684 31594 63364625
Pregnancy 39.46 14.34 4 92799 36832 63359387
Nephrolithiasis 39.19 14.34 7 92796 41977 63354242
Metastases to adrenals 38.80 14.34 20 92783 745 63395474
Influenza 38.61 14.34 62 92741 108660 63287559
Folliculitis 38.40 14.34 28 92775 70289 63325930
Plasma cell myeloma 38.20 14.34 4 92799 35901 63360318
Anxiety 37.99 14.34 176 92627 217365 63178854
Bone marrow infiltration 37.95 14.34 19 92784 665 63395554
Cataract 37.82 14.34 18 92785 57035 63339184
Bradycardia 37.65 14.34 31 92772 73196 63323023
Alanine aminotransferase increased 37.45 14.34 270 92533 103500 63292719
Radiation necrosis 37.38 14.34 16 92787 388 63395831
Pulmonary mass 37.37 14.34 94 92709 22502 63373717
Peripheral swelling 37.12 14.34 232 92571 265710 63130509
Computerised tomogram thorax abnormal 36.68 14.34 26 92777 1737 63394482
Fatigue 36.43 14.34 1615 91188 886413 62509806
Cystitis noninfective 36.37 14.34 21 92782 982 63395237
Electrocardiogram QT prolonged 36.19 14.34 21 92782 59509 63336710
Therapy interrupted 36.17 14.34 3 92800 32452 63363767
Mastectomy 36.11 14.34 25 92778 1608 63394611
Eosinophil percentage increased 35.87 14.34 21 92782 1008 63395211
Carotidynia 35.86 14.34 12 92791 143 63396076
Bronchitis 35.83 14.34 81 92722 124854 63271365
Gait disturbance 35.78 14.34 142 92661 183036 63213183
Malignant pleural effusion 35.73 14.34 30 92773 2576 63393643
Gastric disorder 35.38 14.34 6 92797 37363 63358856
HER2 positive breast cancer 35.15 14.34 15 92788 361 63395858
Blood alkaline phosphatase increased 35.06 14.34 140 92663 42827 63353392
Obstructive shock 34.57 14.34 9 92794 40 63396179
Acute interstitial pneumonitis 34.54 14.34 18 92785 686 63395533
Nail infection 34.50 14.34 29 92774 2494 63393725
Hyperpyrexia 34.45 14.34 34 92769 3598 63392621
Abortion spontaneous 34.31 14.34 13 92790 47182 63349037
Swollen tongue 34.28 14.34 5 92798 34795 63361424
Intestinal perforation 33.97 14.34 62 92741 11901 63384318
Red blood cell sedimentation rate increased 33.88 14.34 11 92792 43971 63352248
Gamma-glutamyltransferase increased 33.70 14.34 118 92685 33913 63362306
Gas gangrene 33.67 14.34 11 92792 121 63396098
Troponin I increased 33.26 14.34 27 92776 2211 63394008
Osteolysis 33.18 14.34 30 92773 2844 63393375
Folate deficiency 32.92 14.34 28 92775 2447 63393772
Hypertension 32.90 14.34 256 92547 279047 63117172
Urticaria 32.71 14.34 128 92675 165674 63230545
Tumour embolism 32.66 14.34 11 92792 134 63396085
Intestinal ischaemia 32.54 14.34 47 92756 7421 63388798
Nephritis bacterial 32.47 14.34 8 92795 27 63396192
EGFR gene mutation 31.63 14.34 13 92790 284 63395935
Pruritus 31.55 14.34 357 92446 361096 63035123
Platelet count decreased 31.48 14.34 283 92520 115839 63280380
Unevaluable event 31.41 14.34 18 92785 51368 63344851
Hepatic lesion 31.39 14.34 37 92766 4788 63391431
Osteoporosis 31.09 14.34 23 92780 57315 63338904
Foetal exposure during pregnancy 30.56 14.34 5 92798 31957 63364262
Blister 30.48 14.34 93 92710 129721 63266498
Malaise 30.28 14.34 427 92376 415527 62980692
Basal cell carcinoma 30.08 14.34 3 92800 27988 63368231
Dysuria 30.03 14.34 113 92690 33625 63362594
Scleroderma renal crisis 29.93 14.34 13 92790 327 63395892
Breast inflammation 29.92 14.34 11 92792 176 63396043
Barotrauma 29.86 14.34 11 92792 177 63396042
Biliary sepsis 29.84 14.34 18 92785 913 63395306
Systolic dysfunction 29.67 14.34 22 92781 1577 63394642
Toxic optic neuropathy 29.47 14.34 11 92792 184 63396035
Abdominal pain 29.13 14.34 596 92207 292860 63103359
Vulvovaginal candidiasis 28.78 14.34 29 92774 3146 63393073
Lactic acidosis 28.76 14.34 10 92793 38277 63357942
Vascular fragility 28.75 14.34 10 92793 135 63396084
Coma 28.69 14.34 31 92772 64333 63331886
Autonomic neuropathy 28.62 14.34 19 92784 1140 63395079
Therapy cessation 28.60 14.34 5 92798 30452 63365767
Blood glucose increased 28.59 14.34 49 92754 83707 63312512
Perforation 28.27 14.34 19 92784 1164 63395055
Left ventricular dilatation 28.04 14.34 14 92789 487 63395732
Lymphadenopathy 28.00 14.34 121 92682 38337 63357882
Tongue coated 27.97 14.34 20 92783 1355 63394864
Hypertransaminasaemia 27.93 14.34 41 92762 6568 63389651
Invasive lobular breast carcinoma 27.91 14.34 17 92786 878 63395341
Palmar erythema 27.71 14.34 22 92781 1745 63394474
Treatment noncompliance 27.60 14.34 10 92793 37315 63358904
Ejection fraction 27.55 14.34 25 92778 2381 63393838
Intentional product misuse 27.53 14.34 29 92774 60888 63335331
Nasal disorder 27.52 14.34 27 92776 2837 63393382
Joint injury 27.45 14.34 5 92798 29567 63366652
International normalised ratio increased 27.34 14.34 17 92786 46408 63349811
Paraesthesia 27.32 14.34 350 92453 156616 63239603
Eastern Cooperative Oncology Group performance status worsened 27.27 14.34 19 92784 1235 63394984
Vulvovaginal dryness 27.23 14.34 27 92776 2874 63393345
Vein discolouration 27.16 14.34 11 92792 231 63395988
Coronary artery disease 26.96 14.34 7 92796 32370 63363849
Hyperchlorhydria 26.89 14.34 22 92781 1822 63394397
Onychoclasis 26.88 14.34 39 92764 6183 63390036
Dizziness 26.66 14.34 455 92348 429470 62966749
Hepatotoxicity 26.55 14.34 116 92687 36925 63359294
Dyskinesia 26.49 14.34 7 92796 31995 63364224
Vessel puncture site bruise 26.45 14.34 13 92790 437 63395782
Subclavian vein thrombosis 26.41 14.34 22 92781 1868 63394351
Breast cancer 26.35 14.34 140 92663 48243 63347976
Asthenopia 26.21 14.34 24 92779 2313 63393906
Metastases to soft tissue 26.17 14.34 10 92793 179 63396040
Full blood count abnormal 26.14 14.34 7 92796 31710 63364509
Balance disorder 25.64 14.34 53 92750 84369 63311850
Axillary pain 25.49 14.34 22 92781 1961 63394258
Aspartate aminotransferase increased 25.48 14.34 222 92581 90055 63306164
Clostridium bacteraemia 25.33 14.34 10 92793 196 63396023
Alopecia 25.27 14.34 659 92144 336877 63059342
Foot deformity 25.24 14.34 5 92798 27848 63368371
Nervousness 25.22 14.34 7 92796 30972 63365247
Hiccups 25.19 14.34 23 92780 2208 63394011
Granulocytopenia 25.16 14.34 36 92767 5636 63390583
Injection site haemorrhage 25.13 14.34 3 92800 24311 63371908
Pancreatitis 24.93 14.34 21 92782 49034 63347185
Vascular pain 24.72 14.34 15 92788 769 63395450
Retinal toxicity 24.69 14.34 18 92785 1257 63394962
Blood pressure fluctuation 24.57 14.34 19 92784 46298 63349921
Pneumocystis jirovecii pneumonia 24.53 14.34 67 92736 16847 63379372
Toxicity to various agents 24.49 14.34 237 92566 247013 63149206
Acoustic stimulation tests abnormal 24.49 14.34 8 92795 88 63396131
Oral candidiasis 24.28 14.34 81 92722 22717 63373502
Menopausal disorder 24.22 14.34 7 92796 49 63396170
Pneumonia salmonella 24.19 14.34 5 92798 5 63396214
Mouth ulceration 24.18 14.34 104 92699 32880 63363339
Leukocytosis 24.03 14.34 88 92715 25847 63370372
Acquired gene mutation 24 14.34 16 92787 967 63395252
Extravasation 23.99 14.34 23 92780 2349 63393870
Nail bed bleeding 23.98 14.34 11 92792 316 63395903
Septic shock 23.82 14.34 173 92630 66456 63329763
Accidental overdose 23.79 14.34 3 92800 23306 63372913
Prescribed underdose 23.63 14.34 7 92796 29682 63366537
Metastases to thorax 23.61 14.34 10 92793 236 63395983
Ovarian necrosis 23.56 14.34 6 92797 24 63396195
Cough 23.51 14.34 577 92226 292166 63104053
Recurrent cancer 23.45 14.34 21 92782 1966 63394253
Frequent bowel movements 23.40 14.34 3 92800 23019 63373200
Depressed level of consciousness 23.38 14.34 34 92769 62044 63334175
Panophthalmitis 23.35 14.34 8 92795 103 63396116
Cannabinoid hyperemesis syndrome 23.30 14.34 7 92796 57 63396162
Generalised oedema 23.28 14.34 63 92740 15755 63380464
Adenocarcinoma 23.25 14.34 25 92778 2925 63393294
Metastases to bone marrow 23.21 14.34 12 92791 450 63395769
Thrombotic microangiopathy 23.04 14.34 49 92754 10512 63385707
Peritonitis 22.96 14.34 66 92737 17088 63379131
PIK3CA-activated mutation 22.92 14.34 16 92787 1043 63395176
Meibomian gland dysfunction 22.91 14.34 9 92794 174 63396045
Multiple sclerosis 22.88 14.34 4 92799 24368 63371851
Choroidal effusion 22.87 14.34 12 92791 464 63395755
Hepatic failure 22.83 14.34 108 92695 35548 63360671
Portal hypertension 22.74 14.34 28 92775 3791 63392428
Salmonella sepsis 22.68 14.34 10 92793 261 63395958
Joint neoplasm 22.68 14.34 7 92796 63 63396156
Overflow diarrhoea 22.61 14.34 8 92795 114 63396105
Embolism 22.48 14.34 41 92762 7865 63388354
Tremor 22.47 14.34 108 92695 132131 63264088
Grip strength decreased 22.43 14.34 3 92800 22284 63373935
Hydrothorax 22.36 14.34 15 92788 916 63395303
Neck pain 22.36 14.34 42 92761 69276 63326943
Osteitis condensans 22.31 14.34 6 92797 31 63396188
Foot fracture 22.29 14.34 4 92799 23910 63372309
Agitation 22.24 14.34 33 92770 59724 63336495
Pneumothorax 22.19 14.34 63 92740 16198 63380021
Lipoprotein increased 22.17 14.34 5 92798 10 63396209
Inflammatory carcinoma of the breast 22.03 14.34 7 92796 70 63396149
Pleural disorder 22.02 14.34 13 92790 634 63395585
Chronic obstructive pulmonary disease 22.01 14.34 36 92767 62650 63333569
Oral pain 21.96 14.34 91 92712 28303 63367916
Therapeutic product effect incomplete 21.91 14.34 101 92702 124955 63271264
Insomnia 21.88 14.34 205 92598 215047 63181172
Soft tissue neoplasm 21.85 14.34 7 92796 72 63396147
Muscle spasticity 21.77 14.34 3 92800 21791 63374428
Nail bed tenderness 21.63 14.34 11 92792 398 63395821
Herpes zoster 21.63 14.34 56 92747 82406 63313813
Hip fracture 21.62 14.34 8 92795 29466 63366753
Diabetes mellitus 21.58 14.34 30 92773 55780 63340439
Sclerema 21.55 14.34 5 92798 12 63396207
Acral peeling skin syndrome 21.55 14.34 5 92798 12 63396207
Stress 21.40 14.34 41 92762 67126 63329093
Hormone receptor positive breast cancer 21.37 14.34 12 92791 532 63395687
Surgery 21.36 14.34 13 92790 35899 63360320
Kidney infection 21.34 14.34 4 92799 23172 63373047
Blood pressure increased 21.26 14.34 144 92659 161918 63234301
Paraparesis 21.24 14.34 21 92782 2227 63393992
Blood creatine increased 21.19 14.34 33 92770 5568 63390651
Post-traumatic pain 21.11 14.34 11 92792 419 63395800
Irritability 21.00 14.34 10 92793 31684 63364535
Retinal detachment 20.97 14.34 34 92769 5935 63390284
Underdose 20.92 14.34 7 92796 27449 63368770
Red cell distribution width increased 20.88 14.34 47 92756 10477 63385742
Transaminases 20.80 14.34 7 92796 85 63396134
Lipidosis 20.76 14.34 6 92797 42 63396177
Neuromuscular toxicity 20.74 14.34 8 92795 147 63396072
No adverse event 20.71 14.34 18 92785 41387 63354832
Lung infiltration 20.68 14.34 57 92746 14406 63381813
Seasonal allergy 20.66 14.34 3 92800 20947 63375272
Hypoglycaemia 20.62 14.34 35 92768 60030 63336189
Hypomagnesaemia 20.60 14.34 90 92713 28647 63367572
Miller Fisher syndrome 20.51 14.34 7 92796 89 63396130
Chromosomal mutation 20.50 14.34 5 92798 16 63396203
Metastases to ovary 20.46 14.34 11 92792 447 63395772
Hypoalbuminaemia 20.46 14.34 50 92753 11755 63384464
Purtscher retinopathy 20.37 14.34 7 92796 91 63396128
Lymphangitis 20.33 14.34 14 92789 893 63395326
Seroma 20.31 14.34 20 92783 2111 63394108
Hypothalamo-pituitary disorder 20.20 14.34 13 92790 740 63395479
Neutrophil count abnormal 20.19 14.34 23 92780 2869 63393350
Neoplasm recurrence 20.17 14.34 22 92781 2616 63393603
Monocyte count decreased 20.13 14.34 20 92783 2133 63394086
Hyperkalaemia 20.11 14.34 30 92773 54173 63342046
Mucosal disorder 20.01 14.34 20 92783 2149 63394070
Intervertebral disc protrusion 19.98 14.34 5 92798 23704 63372515
Product quality issue 19.95 14.34 14 92789 35851 63360368
White blood cell count abnormal 19.85 14.34 34 92769 6208 63390011
Pituitary tumour 19.77 14.34 14 92789 934 63395285
Hydrocephalus 19.74 14.34 31 92772 5269 63390950
Aggression 19.72 14.34 5 92798 23493 63372726
Infection 19.72 14.34 227 92576 228946 63167273
Retinitis pigmentosa 19.70 14.34 7 92796 101 63396118
Gastritis 19.68 14.34 107 92696 37196 63359023
Dysarthria 19.67 14.34 20 92783 42691 63353528
Pulmonary toxicity 19.63 14.34 43 92760 9412 63386807
Sciatica 19.62 14.34 13 92790 34311 63361908
Therapy non-responder 19.56 14.34 52 92751 75849 63320370
Carcinoembryonic antigen increased 19.55 14.34 18 92785 1747 63394472
Leukaemia cutis 19.51 14.34 7 92796 104 63396115
Chemical peritonitis 19.45 14.34 7 92796 105 63396114
Acute respiratory distress syndrome 19.45 14.34 77 92726 23457 63372762
Breast oedema 19.44 14.34 6 92797 54 63396165
Oestradiol abnormal 19.44 14.34 6 92797 54 63396165
Congenital syphilitic osteochondritis 19.44 14.34 5 92798 21 63396198
Arteritis 19.35 14.34 12 92791 640 63395579
Procedural pain 19.27 14.34 4 92799 21565 63374654
Paralysis recurrent laryngeal nerve 19.25 14.34 6 92797 56 63396163
Full blood count decreased 19.20 14.34 7 92796 26017 63370202
Muscle necrosis 19.08 14.34 12 92791 656 63395563
Ear pain 18.93 14.34 15 92788 36103 63360116
Tympanic membrane disorder 18.81 14.34 8 92795 191 63396028
Sleep disorder 18.74 14.34 59 92744 81507 63314712
Distichiasis 18.73 14.34 5 92798 25 63396194
Chills 18.55 14.34 250 92553 113128 63283091
Limb injury 18.55 14.34 7 92796 25470 63370749
Amnesia 18.53 14.34 33 92770 55552 63340667
Carbohydrate antigen 15-3 increased 18.48 14.34 16 92787 1432 63394787
Gastrointestinal perforation 18.26 14.34 24 92779 3467 63392752
Metastases to nervous system 18.20 14.34 6 92797 68 63396151
Feeling hot 18.14 14.34 131 92672 50223 63345996
Vena cava thrombosis 18.06 14.34 19 92784 2168 63394051
Drug ineffective for unapproved indication 18.04 14.34 14 92789 34049 63362170
Phlebitis 18.03 14.34 34 92769 6690 63389529
Vulvitis 18.00 14.34 9 92794 314 63395905
Vaginitis gardnerella 17.96 14.34 5 92798 30 63396189
Gallbladder disorder 17.89 14.34 3 92800 18839 63377380
Joint dislocation 17.84 14.34 3 92800 18797 63377422
Dysaesthesia 17.81 14.34 27 92776 4451 63391768
Memory impairment 17.80 14.34 85 92718 104173 63292046
Staphylococcal impetigo 17.74 14.34 4 92799 8 63396211
Emotional distress 17.72 14.34 13 92790 32536 63363683
Toxic erythema of chemotherapy 17.69 14.34 7 92796 138 63396081
Femur fracture 17.64 14.34 21 92782 41735 63354484
Metastases to muscle 17.55 14.34 7 92796 141 63396078
Vaginal prolapse 17.51 14.34 10 92793 458 63395761
Axillary vein thrombosis 17.44 14.34 9 92794 336 63395883
Chemotherapy 17.29 14.34 16 92787 1563 63394656
Radiation pneumonitis 17.25 14.34 16 92787 1567 63394652
Viral infection 17.24 14.34 16 92787 35647 63360572
Laboratory test abnormal 17.07 14.34 9 92794 26903 63369316
Catheter site bruise 17.06 14.34 10 92793 481 63395738
Duodenal ulcer 16.94 14.34 36 92767 7720 63388499
Delirium 16.85 14.34 30 92773 50511 63345708
Ill-defined disorder 16.84 14.34 62 92741 81693 63314526
Clostridial infection 16.79 14.34 26 92777 4366 63391853
Sensory disturbance 16.77 14.34 51 92752 13621 63382598
Metastases to uterus 16.67 14.34 6 92797 90 63396129
Breast neoplasm 16.64 14.34 15 92788 1417 63394802
ALK gene rearrangement positive 16.59 14.34 3 92800 0 63396219
Astringent therapy 16.59 14.34 3 92800 0 63396219
Labia enlarged 16.59 14.34 3 92800 0 63396219
Product administration error 16.56 14.34 6 92797 22391 63373828
Appendiceal abscess 16.55 14.34 8 92795 259 63395960
Cardiac tamponade 16.51 14.34 27 92776 4748 63391471
Herpes simplex sepsis 16.40 14.34 5 92798 43 63396176
Rash follicular 16.40 14.34 5 92798 43 63396176
Joint range of motion decreased 16.33 14.34 14 92789 32414 63363805
Vasculitis 16.21 14.34 61 92742 18148 63378071
Muscle spasms 16.17 14.34 148 92655 156002 63240217
Merycism 16.17 14.34 8 92795 273 63395946
Colitis ischaemic 16.11 14.34 43 92760 10665 63385554
Pneumonia aspiration 16.11 14.34 16 92787 34524 63361695
Dandy-Walker syndrome 16.04 14.34 6 92797 101 63396118
Skin reaction 16.03 14.34 53 92750 14796 63381423
Chronic kidney disease 16.01 14.34 26 92777 45372 63350847
Upper limb fracture 15.99 14.34 4 92799 18964 63377255
Hypervolaemia 15.92 14.34 11 92792 28402 63367817
Clostridium difficile infection 15.90 14.34 86 92717 29836 63366383
Hyperaemia 15.83 14.34 18 92785 2241 63393978
Ischaemic enteritis 15.82 14.34 5 92798 49 63396170
Injection site rash 15.79 14.34 4 92799 18805 63377414
Cytotoxic oedema 15.76 14.34 7 92796 186 63396033
Device dislocation 15.72 14.34 9 92794 25696 63370523
Immunodeficiency 15.72 14.34 5 92798 20249 63375970
Abdominal rigidity 15.69 14.34 17 92786 2007 63394212
Abdominal pain upper 15.68 14.34 210 92593 206234 63189985
Pseudomembranous colitis 15.67 14.34 21 92782 3091 63393128
Pain in extremity 15.65 14.34 367 92436 331119 63065100
Joint effusion 15.59 14.34 3 92800 17057 63379162
Caesarean section 15.55 14.34 3 92800 17029 63379190
Appendicitis 15.50 14.34 36 92767 8193 63388026
Disorientation 15.46 14.34 21 92782 39431 63356788
Vagus nerve disorder 15.42 14.34 6 92797 113 63396106
Anal erythema 15.13 14.34 7 92796 205 63396014
Coating in mouth 15.10 14.34 7 92796 206 63396013
Pulmonary embolism 15.06 14.34 247 92556 116437 63279782
Necrosis 15.03 14.34 28 92775 5459 63390760
Soft tissue infection 14.93 14.34 17 92786 2120 63394099
Naevus haemorrhage 14.86 14.34 6 92797 125 63396094
Salmonellosis 14.85 14.34 13 92790 1181 63395038
Blood glucose decreased 14.85 14.34 6 92797 20946 63375273
Monocytopenia 14.84 14.34 5 92798 61 63396158
Urogenital prolapse 14.82 14.34 4 92799 21 63396198
Pleomorphic adenoma 14.66 14.34 4 92799 22 63396197
Therapy responder 14.66 14.34 8 92795 335 63395884
Tumour marker increased 14.63 14.34 26 92777 4889 63391330
Creatinine renal clearance decreased 14.62 14.34 3 92800 16305 63379914
Tumour necrosis 14.60 14.34 11 92792 808 63395411
Peripheral motor neuropathy 14.59 14.34 15 92788 1666 63394553
Night sweats 14.52 14.34 31 92772 48783 63347436
Arachnoid cyst 14.42 14.34 7 92796 229 63395990
Neutrophil count increased 14.41 14.34 55 92748 16472 63379747
Left ventricular enlargement 14.41 14.34 5 92798 67 63396152
Product use in unapproved indication 14.39 14.34 180 92623 178900 63217319
Cardiac arrest 14.35 14.34 78 92725 92467 63303752

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 1273.03 16.56 965 41519 87081 34827366
Febrile neutropenia 585.32 16.56 773 41711 136076 34778371
Osteonecrosis of jaw 547.19 16.56 314 42170 17575 34896872
Prostatic specific antigen increased 474.01 16.56 267 42217 14413 34900034
Disease progression 454.61 16.56 606 41878 107471 34806976
Metastases to bone 417.28 16.56 229 42255 11741 34902706
Neutropenia 384.95 16.56 685 41799 156093 34758354
Diarrhoea 320.49 16.56 1118 41366 388794 34525653
Mucosal inflammation 248.16 16.56 269 42215 38353 34876094
Metastases to lymph nodes 211.77 16.56 107 42377 4621 34909826
Leukopenia 177.83 16.56 293 42191 62563 34851884
Neoplasm progression 172.30 16.56 175 42309 23125 34891322
Alopecia 167.61 16.56 176 42308 24179 34890268
Stomatitis 165.49 16.56 230 42254 42284 34872163
Hormone-refractory prostate cancer 163.98 16.56 53 42431 687 34913760
Neutrophil count decreased 163.47 16.56 252 42232 50852 34863595
Interstitial lung disease 160.57 16.56 286 42198 64996 34849451
Pneumonitis 159.17 16.56 201 42283 33677 34880770
Prostate cancer metastatic 154.01 16.56 93 42391 5710 34908737
Metastases to lung 153.79 16.56 111 42373 9209 34905238
Neutropenic sepsis 151.37 16.56 129 42355 13638 34900809
Onycholysis 137.92 16.56 47 42437 725 34913722
Metastases to liver 122.34 16.56 114 42370 13549 34900898
Palmar-plantar erythrodysaesthesia syndrome 114.87 16.56 121 42363 16674 34897773
Anaemia 109.00 16.56 565 41919 232770 34681677
Nausea 101.66 16.56 733 41751 339175 34575272
Product dose omission issue 101.30 16.56 13 42471 119698 34794749
Dehydration 99.18 16.56 365 42119 129604 34784843
Portal venous gas 94.99 16.56 30 42454 359 34914088
Haematotoxicity 94.63 16.56 79 42405 8115 34906332
Metastases to central nervous system 94.53 16.56 79 42405 8126 34906321
Septic shock 91.30 16.56 241 42243 71593 34842854
Drug interaction 86.87 16.56 88 42396 225858 34688589
Bone marrow failure 86.20 16.56 139 42345 29114 34885333
Decreased appetite 85.39 16.56 414 42070 165978 34748469
Neuropathy peripheral 84.96 16.56 258 42226 83005 34831442
Fall 83.86 16.56 74 42410 202811 34711636
White blood cell count decreased 82.18 16.56 279 42205 95166 34819281
Skin toxicity 81.26 16.56 58 42426 4726 34909721
Polyneuropathy 75.73 16.56 92 42392 14804 34899643
Hypocalcaemia 75.12 16.56 118 42366 24171 34890276
Peripheral sensory neuropathy 67.55 16.56 60 42424 6700 34907747
Headache 63.42 16.56 91 42393 200544 34713903
Recall phenomenon 61.74 16.56 24 42460 547 34913900
Metastasis 60.81 16.56 46 42438 4098 34910349
Bacterial translocation 60.74 16.56 21 42463 339 34914108
General physical health deterioration 59.97 16.56 311 42173 127958 34786489
Prostate cancer 59.76 16.56 142 42342 39507 34874940
Tremor 58.88 16.56 14 42470 82573 34831874
Nasopharyngitis 58.20 16.56 8 42476 69960 34844487
Bone pain 57.83 16.56 96 42388 20590 34893857
Oesophagobronchial fistula 56.67 16.56 17 42467 169 34914278
Pneumatosis intestinalis 56.36 16.56 43 42441 3880 34910567
Fatigue 55.81 16.56 691 41793 369962 34544485
Osteonecrosis 55.57 16.56 79 42405 14811 34899636
Delusion of grandeur 54.13 16.56 27 42457 1133 34913314
Weight increased 51.96 16.56 24 42460 93009 34821438
Nail disorder 51.78 16.56 32 42452 2047 34912400
Pleural effusion 51.55 16.56 216 42268 81330 34833117
Bone lesion 50.50 16.56 36 42448 2927 34911520
Radiation skin injury 49.10 16.56 22 42462 723 34913724
Oesophageal fistula 48.69 16.56 17 42467 283 34914164
Pulmonary toxicity 46.93 16.56 47 42437 6100 34908347
Agitation 46.71 16.56 7 42477 57392 34857055
Vomiting 45.89 16.56 481 42003 247140 34667307
Depression 45.66 16.56 31 42453 97067 34817380
Reproductive toxicity 45.20 16.56 9 42475 9 34914438
Insomnia 45.20 16.56 36 42448 103871 34810576
Therapy partial responder 45.03 16.56 57 42427 9559 34904888
Urinary tract toxicity 44.71 16.56 9 42475 10 34914437
Rhabdomyolysis 44.01 16.56 14 42470 68149 34846298
Colon cancer stage III 43.06 16.56 14 42470 185 34914262
Inappropriate schedule of product administration 41.65 16.56 12 42472 62284 34852163
Pyrexia 41.02 16.56 599 41885 332414 34582033
Onychomadesis 40.85 16.56 18 42466 568 34913879
Myelosuppression 40.53 16.56 79 42405 19186 34895261
Neutropenic colitis 39.84 16.56 32 42452 3112 34911335
Prostate cancer recurrent 39.80 16.56 21 42463 992 34913455
Musculoskeletal stiffness 39.62 16.56 5 42479 46675 34867772
Somnolence 39.60 16.56 46 42438 111070 34803377
Rhinalgia 39.04 16.56 21 42463 1032 34913415
Cardiac failure congestive 38.59 16.56 27 42457 83243 34831204
Metastases to skin 38.50 16.56 16 42468 436 34914011
Intentional product misuse 38.43 16.56 5 42479 45606 34868841
Asthma 37.62 16.56 4 42480 42652 34871795
Paronychia 37.60 16.56 32 42452 3373 34911074
Gastric perforation 37.03 16.56 28 42456 2492 34911955
Plasma cell myeloma 36.93 16.56 4 42480 42033 34872414
Overdose 36.61 16.56 34 42450 91025 34823422
Hallucination 36.17 16.56 9 42475 51489 34862958
Drug hypersensitivity 36.16 16.56 27 42457 80502 34833945
Metastases to meninges 35.25 16.56 22 42462 1432 34913015
Erythema 35.23 16.56 206 42278 88574 34825873
Acute motor-sensory axonal neuropathy 35.19 16.56 11 42473 127 34914320
Disseminated intravascular coagulation 34.90 16.56 80 42404 21736 34892711
Dizziness 34.85 16.56 142 42342 218379 34696068
Colitis 34.79 16.56 113 42371 37637 34876810
Joint swelling 34.13 16.56 15 42469 59875 34854572
Injection site pain 33.54 16.56 4 42480 39001 34875446
Dermatitis 33.52 16.56 49 42435 9419 34905028
Exposed bone in jaw 33.50 16.56 22 42462 1564 34912883
Agranulocytosis 33.41 16.56 83 42401 23738 34890709
Hypophagia 32.95 16.56 83 42401 23939 34890508
Suicidal ideation 32.69 16.56 5 42479 40383 34874064
Carbohydrate antigen 15-3 increased 32.08 16.56 9 42475 69 34914378
Blood pressure increased 31.89 16.56 36 42448 88066 34826381
Necrotising retinitis 31.80 16.56 17 42467 825 34913622
Nail toxicity 31.77 16.56 8 42476 38 34914409
Myocardial infarction 31.65 16.56 62 42422 121023 34793424
Anxiety 31.46 16.56 45 42439 99383 34815064
Second primary malignancy 31.15 16.56 43 42441 7843 34906604
Bone disorder 30.96 16.56 38 42446 6177 34908270
Gastrointestinal toxicity 30.94 16.56 26 42458 2693 34911754
Urticaria 30.56 16.56 19 42465 62358 34852089
Pneumothorax 30.52 16.56 70 42414 19022 34895425
Muscle spasms 30.15 16.56 28 42456 74973 34839474
Polyneuropathy in malignant disease 29.00 16.56 11 42473 234 34914213
Lymphocyte count abnormal 28.72 16.56 18 42466 1180 34913267
Eubacterium infection 28.57 16.56 5 42479 0 34914447
Karnofsky scale worsened 28.57 16.56 5 42479 0 34914447
Contusion 28.32 16.56 5 42479 36359 34878088
Metastases to pleura 28.30 16.56 13 42471 453 34913994
Flushing 28.05 16.56 95 42389 32325 34882122
Metastases to spine 27.95 16.56 24 42460 2560 34911887
BRCA1 gene mutation 27.67 16.56 7 42477 34 34914413
Cerebrovascular accident 27.20 16.56 38 42446 84773 34829674
Intestinal ischaemia 27.10 16.56 40 42444 7754 34906693
Macroenzyme creatine kinase 26.51 16.56 6 42478 16 34914431
Gastrointestinal ischaemia 26.49 16.56 10 42474 210 34914237
Carotid artery aneurysm 26.29 16.56 7 42477 43 34914404
Superior mesenteric artery syndrome 26.28 16.56 8 42476 84 34914363
Mediastinitis 26.14 16.56 14 42470 682 34913765
Metastases to soft tissue 25.97 16.56 12 42472 424 34914023
Sinusitis 25.85 16.56 9 42475 41393 34873054
Death 25.49 16.56 648 41836 397401 34517046
Pancreatitis viral 25.11 16.56 5 42479 5 34914442
Feeling abnormal 24.95 16.56 24 42460 63211 34851236
Acute febrile neutrophilic dermatosis 24.94 16.56 17 42467 1286 34913161
Rash 24.65 16.56 164 42320 222588 34691859
Nicotinic acid deficiency 24.45 16.56 8 42476 108 34914339
Rheumatoid arthritis 24.41 16.56 8 42476 38230 34876217
VIth nerve paralysis 23.77 16.56 14 42470 820 34913627
Arthralgia 23.77 16.56 116 42368 169925 34744522
Dysphagia 23.61 16.56 143 42341 62238 34852209
Blood glucose increased 23.35 16.56 28 42456 66690 34847757
Prostatic specific antigen abnormal 22.99 16.56 13 42471 705 34913742
Transdifferentiation of neoplasm 22.95 16.56 7 42477 74 34914373
Nail ridging 22.76 16.56 8 42476 136 34914311
Atypical haemolytic uraemic syndrome 22.71 16.56 10 42474 315 34914132
Tumour pain 22.64 16.56 15 42469 1082 34913365
Osteoradionecrosis 22.62 16.56 7 42477 78 34914369
Hydronephrosis 22.46 16.56 43 42441 10303 34904144
Affective disorder 22.27 16.56 27 42457 4333 34910114
Pharyngeal abscess 22.24 16.56 11 42473 453 34913994
BRCA2 gene mutation 22.24 16.56 6 42478 39 34914408
Tooth extraction 22.10 16.56 28 42456 4700 34909747
Chemotherapy 21.81 16.56 12 42472 617 34913830
Enteritis 21.70 16.56 37 42447 8105 34906342
Disturbance in attention 21.48 16.56 3 42481 25942 34888505
Memory impairment 21.48 16.56 13 42471 43305 34871142
Cholangitis sclerosing 21.35 16.56 16 42468 1405 34913042
Aorto-oesophageal fistula 21.27 16.56 6 42478 47 34914400
Non-small cell lung cancer 21.11 16.56 25 42459 3915 34910532
Intentional product use issue 21.04 16.56 25 42459 59791 34854656
Bronchial fistula 20.63 16.56 8 42476 181 34914266
Free prostate-specific antigen positive 20.62 16.56 4 42480 3 34914444
Influenza 20.60 16.56 18 42466 49648 34864799
Oesophagitis 20.51 16.56 48 42436 13213 34901234
Hypokalaemia 20.50 16.56 131 42353 58083 34856364
Gastrointestinal necrosis 20.46 16.56 23 42461 3406 34911041
Abnormal behaviour 20.41 16.56 3 42481 24966 34889481
Blood creatine phosphokinase increased 20.18 16.56 15 42469 44842 34869605
Trigeminal nerve paresis 20.09 16.56 4 42480 4 34914443
Infusion site plaque 20.09 16.56 4 42480 4 34914443
Laryngeal oedema 20.03 16.56 23 42461 3485 34910962
Nephrolithiasis 19.98 16.56 6 42478 30327 34884120
Hyponatraemia 19.92 16.56 170 42314 82521 34831926
Metastases to bladder 19.88 16.56 6 42478 61 34914386
Ischaemic enteritis 19.81 16.56 5 42479 24 34914423
Acute respiratory distress syndrome 19.80 16.56 73 42411 25896 34888551
Tracheal fistula 19.59 16.56 7 42477 125 34914322
Eosinophilia 19.58 16.56 4 42480 26218 34888229
Metastatic neoplasm 19.42 16.56 21 42463 2979 34911468
Pruritus 19.18 16.56 98 42386 141883 34772564
Oral candidiasis 18.91 16.56 44 42440 12066 34902381
Tracheal stenosis 18.82 16.56 8 42476 231 34914216
Oral pain 18.77 16.56 41 42443 10786 34903661
Hospitalisation 18.74 16.56 25 42459 56877 34857570
Neoplasm recurrence 18.66 16.56 18 42466 2231 34912216
Polyserositis 18.63 16.56 8 42476 237 34914210
Capillary leak syndrome 18.60 16.56 18 42466 2240 34912207
Periorbital disorder 18.60 16.56 5 42479 32 34914415
SARS-CoV-2 test positive 18.58 16.56 29 42455 5904 34908543
Neutropenic infection 18.46 16.56 15 42469 1483 34912964
Coma 18.41 16.56 17 42467 45661 34868786
Aneurysm ruptured 18.41 16.56 10 42474 501 34913946
Hypophosphataemia 18.26 16.56 41 42443 10985 34903462
Coating in mouth 18.07 16.56 6 42478 85 34914362
Heart rate decreased 18.01 16.56 8 42476 31737 34882710
Irritability 17.95 16.56 4 42480 24686 34889761
Lactic acidosis 17.86 16.56 10 42474 34762 34879685
Dacryostenosis acquired 17.85 16.56 8 42476 263 34914184
Loss of personal independence in daily activities 17.84 16.56 9 42475 33170 34881277
Scleroderma 17.82 16.56 15 42469 1557 34912890
Metastases to peritoneum 17.69 16.56 16 42468 1828 34912619
Toxic erythema of chemotherapy 17.58 16.56 6 42478 93 34914354
Vascular pseudoaneurysm 17.34 16.56 17 42467 2150 34912297
Neutrophil count increased 17.33 16.56 53 42431 17093 34897354
Metastases to the mediastinum 17.31 16.56 8 42476 283 34914164
Cranial nerve disorder 17.23 16.56 10 42474 570 34913877
Carotidynia 17.14 16.56 3 42481 0 34914447
Hyperchromasia 17.14 16.56 3 42481 0 34914447
Toxicity to various agents 16.82 16.56 159 42325 200203 34714244
Pain in extremity 16.70 16.56 88 42396 126425 34788022
Acute interstitial pneumonitis 16.57 16.56 9 42475 451 34913996

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 1801.82 13.37 1522 113366 134468 79495032
Febrile neutropenia 1456.33 13.37 1726 113162 229273 79400227
Neutropenia 1315.31 13.37 1833 113055 285877 79343623
Diarrhoea 1205.79 13.37 3365 111523 877124 78752376
Myelosuppression 1120.14 13.37 707 114181 39589 79589911
Disease progression 1117.26 13.37 1351 113537 183011 79446489
Metastases to bone 841.83 13.37 492 114396 23935 79605565
Mucosal inflammation 800.26 13.37 746 114142 74834 79554666
Palmar-plantar erythrodysaesthesia syndrome 789.74 13.37 528 114360 32606 79596894
Neuropathy peripheral 722.50 13.37 952 113936 140353 79489147
Metastases to liver 572.91 13.37 408 114480 27906 79601594
Bone marrow failure 570.98 13.37 520 114368 50587 79578913
Metastases to central nervous system 471.58 13.37 294 114594 16081 79613419
Metastases to lung 468.07 13.37 304 114584 17859 79611641
Ejection fraction decreased 460.81 13.37 389 114499 34188 79595312
Metastases to lymph nodes 454.89 13.37 245 114643 10152 79619348
Neutropenic sepsis 427.04 13.37 336 114552 26728 79602772
Osteonecrosis of jaw 423.60 13.37 409 114479 42817 79586683
Neoplasm progression 420.28 13.37 442 114446 51240 79578260
Agranulocytosis 400.27 13.37 404 114484 44626 79584874
Leukopenia 377.34 13.37 634 114254 115879 79513621
Neutrophil count decreased 374.18 13.37 562 114326 93397 79536103
White blood cell count decreased 337.70 13.37 800 114088 187488 79442012
Prostatic specific antigen increased 315.62 13.37 193 114695 10193 79619307
Polyneuropathy 314.16 13.37 268 114620 23883 79605617
Fall 275.89 13.37 182 114706 487447 79142053
Interstitial lung disease 273.46 13.37 541 114347 112059 79517441
Rheumatoid arthritis 271.24 13.37 6 114882 208464 79421036
Nausea 265.03 13.37 2311 112577 954885 78674615
Onycholysis 257.18 13.37 101 114787 1982 79627518
Skin toxicity 256.49 13.37 156 114732 8158 79621342
Stomatitis 255.93 13.37 617 114271 146140 79483360
Joint swelling 254.25 13.37 53 114835 288593 79340907
Decreased appetite 238.59 13.37 1051 113837 341367 79288133
Product dose omission issue 233.98 13.37 38 114850 247499 79382001
Recall phenomenon 232.75 13.37 80 114808 1057 79628443
Haematotoxicity 228.41 13.37 185 114703 15334 79614166
Pleural effusion 217.03 13.37 576 114312 144686 79484814
Peripheral sensory neuropathy 214.65 13.37 166 114722 12867 79616633
Drug abuse 210.38 13.37 5 114883 162686 79466814
Arthropathy 209.84 13.37 11 114877 177100 79452400
Flushing 208.14 13.37 419 114469 87849 79541651
Pneumonitis 201.99 13.37 335 114553 60525 79568975
Alopecia areata 201.96 13.37 82 114806 1761 79627739
Neutropenic colitis 201.95 13.37 117 114771 5590 79623910
Bone pain 196.06 13.37 315 114573 55427 79574073
Therapeutic product effect decreased 194.69 13.37 10 114878 163853 79465647
Metastasis 194.22 13.37 122 114766 6758 79622742
Drug ineffective 191.19 13.37 856 114032 1080057 78549443
Aortitis 189.33 13.37 74 114814 1433 79628067
Madarosis 187.27 13.37 88 114800 2714 79626786
Anaemia 183.47 13.37 1182 113706 443833 79185667
Cardiotoxicity 182.45 13.37 147 114741 12092 79617408
Vomiting 181.17 13.37 1603 113285 664225 78965275
Colitis 180.05 13.37 354 114534 72953 79556547
Contraindicated product administered 179.89 13.37 12 114876 157526 79471974
Hair texture abnormal 167.90 13.37 88 114800 3446 79626054
Sinusitis 167.80 13.37 38 114850 195463 79434037
Erythema 164.22 13.37 697 114191 222593 79406907
Nail disorder 161.27 13.37 135 114753 11717 79617783
Hair colour changes 158.41 13.37 90 114798 4142 79625358
Breast cancer recurrent 158.39 13.37 80 114808 2897 79626603
Pyrexia 157.59 13.37 1580 113308 677129 78952371
Weight increased 157.37 13.37 103 114785 277283 79352217
Alopecia 152.55 13.37 699 114189 230656 79398844
Metastases to skin 152.42 13.37 66 114822 1673 79627827
Musculoskeletal stiffness 152.24 13.37 33 114855 174975 79454525
Drug hypersensitivity 151.43 13.37 125 114763 298791 79330709
Systemic lupus erythematosus 145.15 13.37 7 114881 121142 79508358
Drug interaction 137.72 13.37 242 114646 414941 79214559
Acute myeloid leukaemia 136.25 13.37 194 114694 30691 79598809
Somnolence 135.18 13.37 89 114799 238892 79390608
Injection site pain 131.84 13.37 16 114872 129822 79499678
Confusional state 131.27 13.37 159 114729 317838 79311662
Nail toxicity 129.69 13.37 39 114849 324 79629176
Pemphigus 128.95 13.37 3 114885 99579 79529921
Overdose 128.83 13.37 52 114836 184154 79445346
Condition aggravated 128.10 13.37 338 114550 500786 79128714
Gastrointestinal toxicity 126.42 13.37 100 114788 8009 79621491
Second primary malignancy 126.09 13.37 128 114760 14222 79615278
Hand deformity 124.51 13.37 6 114882 103913 79525587
Dehydration 124.29 13.37 694 114194 247493 79382007
Capillary leak syndrome 121.97 13.37 74 114814 3851 79625649
Left ventricular dysfunction 118.68 13.37 143 114745 19218 79610282
Breast cancer metastatic 117.07 13.37 98 114790 8504 79620996
Lymphoedema 116.95 13.37 115 114773 12298 79617202
Paronychia 114.72 13.37 93 114795 7715 79621785
Radiation skin injury 114.59 13.37 51 114837 1383 79628117
Abdominal discomfort 113.72 13.37 116 114772 250611 79378889
Lacrimation increased 112.40 13.37 150 114738 22327 79607173
Therapy partial responder 110.76 13.37 131 114757 17266 79612234
Metastases to pleura 110.67 13.37 51 114837 1503 79627997
Myocardial infarction 110.45 13.37 64 114824 184065 79445435
Dermatitis 109.25 13.37 144 114744 21177 79608323
Biopsy lung abnormal 105.27 13.37 28 114860 140 79629360
Product use issue 104.66 13.37 89 114799 209733 79419767
Inappropriate schedule of product administration 101.43 13.37 33 114855 133595 79495905
Contusion 100.80 13.37 44 114844 148732 79480768
Portal venous gas 100.20 13.37 33 114855 379 79629121
Headache 99.96 13.37 544 114344 653228 78976272
Maternal exposure during pregnancy 99.69 13.37 36 114852 136502 79492998
Metastases to meninges 99.50 13.37 63 114825 3538 79625962
Wound 98.82 13.37 23 114865 116156 79513344
Dysgeusia 98.06 13.37 239 114649 56938 79572562
Fatigue 97.39 13.37 1878 113010 927849 78701651
Intentional product use issue 93.92 13.37 51 114837 152061 79477439
Hepatic enzyme increased 90.41 13.37 78 114810 182532 79446968
Cerebrovascular accident 87.55 13.37 58 114830 155234 79474266
Dermatitis acneiform 87.55 13.37 89 114799 9904 79619596
Nail dystrophy 87.33 13.37 38 114850 975 79628525
Suicide attempt 87.26 13.37 9 114879 82923 79546577
Septic shock 86.84 13.37 379 114509 122422 79507078
Depression 86.67 13.37 111 114777 216679 79412821
Injury 82.61 13.37 8 114880 77488 79552012
Myositis 82.48 13.37 119 114769 19049 79610451
Acute promyelocytic leukaemia 82.06 13.37 41 114847 1450 79628050
Pain 81.95 13.37 636 114252 703166 78926334
Metastases to peritoneum 81.55 13.37 60 114828 4312 79625188
Mobility decreased 81.39 13.37 37 114851 122138 79507362
Skin exfoliation 80.68 13.37 217 114671 54883 79574617
Blood pressure systolic increased 79.81 13.37 4 114884 66982 79562518
Arthritis 79.37 13.37 33 114855 114847 79514653
Loss of personal independence in daily activities 78.43 13.37 25 114863 102555 79526945
Hypokalaemia 76.20 13.37 409 114479 143631 79485869
Lymphangiosis carcinomatosa 75.79 13.37 44 114844 2110 79627390
Feeling abnormal 75.21 13.37 71 114817 159128 79470372
Organising pneumonia 74.02 13.37 85 114803 10854 79618646
Neutropenic infection 73.47 13.37 45 114843 2382 79627118
Helicobacter infection 72.22 13.37 8 114880 69696 79559804
Arthralgia 71.62 13.37 506 114382 571297 79058203
Hypocalcaemia 71.48 13.37 195 114693 49729 79579771
Osteoarthritis 70.92 13.37 19 114869 87290 79542210
Multifocal micronodular pneumocyte hyperplasia 70.73 13.37 18 114870 73 79629427
Blood cholesterol increased 70.35 13.37 17 114871 83703 79545797
Bronchial polyp 70.34 13.37 18 114870 75 79629425
Gastrointestinal necrosis 68.79 13.37 60 114828 5505 79623995
Pseudocirrhosis 66.86 13.37 28 114860 652 79628848
Nail discolouration 66.69 13.37 46 114842 2985 79626515
Hormone-refractory prostate cancer 66.42 13.37 25 114863 435 79629065
Medication error 66.01 13.37 10 114878 68632 79560868
Prostate cancer metastatic 65.89 13.37 51 114837 3956 79625544
Metastases to chest wall 65.79 13.37 26 114862 519 79628981
Hallucination 65.37 13.37 21 114867 85724 79543776
Vascular device infection 64.78 13.37 77 114811 10199 79619301
Metastases to spine 64.58 13.37 52 114836 4272 79625228
Pulmonary toxicity 64.28 13.37 86 114802 12828 79616672
Febrile bone marrow aplasia 63.73 13.37 86 114802 12934 79616566
Hospitalisation 63.61 13.37 28 114860 94208 79535292
Toxicity to various agents 62.52 13.37 354 114534 421186 79208314
Exposure during pregnancy 62.28 13.37 34 114854 101098 79528402
Sedation 62.14 13.37 3 114885 51892 79577608
Asthma 61.78 13.37 62 114826 135033 79494467
Nasal congestion 61.54 13.37 17 114871 76535 79552965
Pericarditis 61.40 13.37 37 114851 104199 79525301
Drug intolerance 60.83 13.37 187 114701 263932 79365568
Anxiety 60.82 13.37 171 114717 248341 79381159
Thrombocytopenia 60.48 13.37 616 114272 264643 79364857
Tremor 60.12 13.37 95 114793 169988 79459512
Intestinal ischaemia 59.47 13.37 84 114804 13186 79616314
Neurotoxicity 59.06 13.37 139 114749 32379 79597121
Intentional product misuse 58.59 13.37 32 114856 95133 79534367
Dacryostenosis acquired 58.57 13.37 24 114864 528 79628972
Injection site erythema 58.12 13.37 20 114868 78177 79551323
Irritable bowel syndrome 57.76 13.37 10 114878 62231 79567269
COVID-19 57.72 13.37 86 114802 157588 79471912
Glossodynia 57.69 13.37 39 114849 103298 79526202
Muscle injury 57.53 13.37 3 114885 48558 79580942
Injection site reaction 57.49 13.37 6 114882 54779 79574721
Epistaxis 57.18 13.37 314 114574 111201 79518299
Mucosal infection 56.55 13.37 23 114865 496 79629004
Large intestine perforation 56.30 13.37 86 114802 14481 79615019
Drug reaction with eosinophilia and systemic symptoms 56.07 13.37 12 114876 64232 79565268
Alopecia totalis 55.55 13.37 21 114867 370 79629130
Plasma cell myeloma 55.46 13.37 6 114882 53253 79576247
Aggression 55.00 13.37 5 114883 50953 79578547
Migraine 54.48 13.37 29 114859 87464 79542036
C-reactive protein abnormal 54.27 13.37 4 114884 48363 79581137
Suicidal ideation 54.25 13.37 21 114867 76319 79553181
Odynophagia 54.20 13.37 74 114814 11253 79618247
Agitation 53.86 13.37 39 114849 99676 79529824
Discomfort 53.70 13.37 61 114827 125556 79503944
Nasopharyngitis 53.45 13.37 187 114701 253694 79375806
Congestive cardiomyopathy 53.43 13.37 75 114813 11705 79617795
Electrocardiogram QT prolonged 53.35 13.37 32 114856 90354 79539146
Swelling 53.11 13.37 149 114739 216562 79412938
Nephrolithiasis 53.03 13.37 7 114881 53284 79576216
Dyspnoea 52.35 13.37 1609 113279 855416 78774084
Treatment failure 52.33 13.37 104 114784 170382 79459118
Blood pressure fluctuation 51.97 13.37 16 114872 67129 79562371
Metastatic neoplasm 51.81 13.37 49 114839 4993 79624507
Systemic scleroderma 51.77 13.37 28 114860 1169 79628331
Illness 51.75 13.37 4 114884 46507 79582993
Dizziness 51.67 13.37 497 114391 525944 79103556
International normalised ratio increased 51.42 13.37 29 114859 84692 79544808
Coma 51.01 13.37 42 114846 100607 79528893
Duodenal ulcer perforation 50.85 13.37 16 114872 66195 79563305
Wheezing 50.59 13.37 56 114832 116608 79512892
Breast pain 50.57 13.37 61 114827 8204 79621296
Bradycardia 50.53 13.37 73 114815 135484 79494016
Device related thrombosis 50.45 13.37 37 114851 2646 79626854
Injection site swelling 49.88 13.37 5 114883 47127 79582373
Adverse drug reaction 49.31 13.37 17 114871 66375 79563125
Lactic acidosis 48.94 13.37 20 114868 70339 79559161
Hot flush 48.86 13.37 182 114706 54695 79574805
Oesophagobronchial fistula 48.49 13.37 17 114871 239 79629261
Acute interstitial pneumonitis 48.46 13.37 27 114861 1196 79628304
Enterocolitis 48.28 13.37 80 114808 14432 79615068
Road traffic accident 47.90 13.37 4 114884 43660 79585840
Carotidynia 47.50 13.37 15 114873 149 79629351
Back pain 47.48 13.37 657 114231 303523 79325977
Pneumothorax 47.07 13.37 117 114771 28206 79601294
Onychomadesis 46.49 13.37 47 114841 5195 79624305
Drug resistance 46.27 13.37 150 114738 42063 79587437
Injection site pruritus 46.04 13.37 4 114884 42279 79587221
Stress 45.85 13.37 29 114859 79583 79549917
Pneumatosis intestinalis 45.48 13.37 51 114837 6346 79623154
Hepatic lesion 45.29 13.37 53 114835 6906 79622594
Rhabdomyolysis 45.27 13.37 49 114839 103082 79526418
Bone lesion 45.21 13.37 49 114839 5870 79623630
Oesophageal fistula 45.07 13.37 19 114869 450 79629050
Tonsillar disorder 44.91 13.37 26 114862 1240 79628260
Bacterial translocation 44.89 13.37 21 114867 641 79628859
Hypertension 44.81 13.37 286 114602 330706 79298794
Angioedema 44.76 13.37 27 114861 76008 79553492
Erysipelas 44.71 13.37 66 114822 10784 79618716
Dermatomyositis 44.66 13.37 39 114849 3584 79625916
Asthenia 44.58 13.37 1007 113881 510682 79118818
Delusion of grandeur 44.50 13.37 27 114861 1405 79628095
Insomnia 44.29 13.37 192 114696 244978 79384522
Swollen tongue 43.81 13.37 5 114883 42565 79586935
Cystoid macular oedema 43.45 13.37 30 114858 1950 79627550
Metastases to the mediastinum 43.38 13.37 20 114868 590 79628910
Onychalgia 43.22 13.37 23 114865 929 79628571
Mastitis 42.98 13.37 31 114857 2160 79627340
Periarticular thenar erythema with onycholysis 42.77 13.37 11 114877 47 79629453
Blood lactate dehydrogenase increased 42.76 13.37 139 114749 39031 79590469
Urticaria 42.71 13.37 131 114757 185070 79444430
Performance status decreased 42.21 13.37 48 114840 6065 79623435
Basal cell carcinoma 42.20 13.37 3 114885 37372 79592128
Product prescribing error 42.03 13.37 7 114881 44806 79584694
Type 2 diabetes mellitus 41.78 13.37 15 114873 57107 79572393
Influenza 41.57 13.37 77 114811 129529 79499971
Gait disturbance 40.93 13.37 157 114731 207349 79422151
Hypoglycaemia 40.59 13.37 52 114836 101542 79527958
PIK3CA-activated mutation 40.49 13.37 19 114869 584 79628916
Adenocarcinoma 40.38 13.37 38 114850 3848 79625652
Impaired healing 40.33 13.37 40 114848 87615 79541885
Metastases to soft tissue 40.31 13.37 19 114869 590 79628910
Lumbosacral radiculoplexus neuropathy 39.96 13.37 11 114877 64 79629436
Hyperfibrinogenaemia 39.87 13.37 12 114876 100 79629400
Accidental overdose 39.87 13.37 5 114883 39576 79589924
Blood pressure increased 39.73 13.37 163 114725 211197 79418303
Chemotherapy 39.45 13.37 27 114861 1730 79627770
Psoriasis 38.84 13.37 43 114845 89544 79539956
Full blood count abnormal 38.68 13.37 6 114882 40468 79589032
Device related infection 38.62 13.37 123 114765 34171 79595329
Myelodysplastic syndrome 38.15 13.37 113 114775 30188 79599312
Chest discomfort 38.12 13.37 334 114554 137710 79491790
Computerised tomogram thorax abnormal 38.07 13.37 30 114858 2389 79627111
Prescribed overdose 37.64 13.37 5 114883 37878 79591622
Enterocolitis infectious 37.63 13.37 32 114856 2837 79626663
Bursitis 37.42 13.37 4 114884 35840 79593660
Cardiac arrest 37.40 13.37 125 114763 171971 79457529
Granulocyte count decreased 36.43 13.37 26 114862 1782 79627718
Blood glucose increased 36.26 13.37 69 114819 114906 79514594
Treatment noncompliance 36.12 13.37 15 114873 52253 79577247
Cardiomyopathy 35.93 13.37 107 114781 28667 79600833
EGFR gene mutation 35.48 13.37 16 114872 448 79629052
Prostate cancer 35.37 13.37 117 114771 33151 79596349
General physical health deterioration 35.35 13.37 575 114313 274663 79354837
Cytokine release syndrome 35.18 13.37 5 114883 35993 79593507
Tongue coated 35.16 13.37 23 114865 1366 79628134
Gait inability 34.57 13.37 21 114867 58896 79570604
Peripheral swelling 34.44 13.37 237 114651 269380 79360120
Exposed bone in jaw 34.18 13.37 34 114854 3686 79625814
Mastectomy 33.96 13.37 21 114867 1131 79628369
Unevaluable event 33.76 13.37 19 114869 55566 79573934
Toxic erythema of chemotherapy 33.73 13.37 13 114875 242 79629258
Pruritus 33.61 13.37 385 114503 394263 79235237
Coronary artery disease 33.57 13.37 27 114861 65447 79564053
Myalgia 33.56 13.37 412 114476 185229 79444271
Drug level increased 33.41 13.37 8 114880 39643 79589857
Cellulitis 33.36 13.37 270 114618 108790 79520710
Dysarthria 33.30 13.37 29 114859 67593 79561907
Acoustic stimulation tests abnormal 33.30 13.37 8 114880 24 79629476
Constipation 32.95 13.37 582 114306 282468 79347032
Blood creatinine decreased 32.82 13.37 48 114840 7777 79621723
Acute respiratory distress syndrome 32.66 13.37 138 114750 43929 79585571
Coating in mouth 32.64 13.37 13 114875 265 79629235
Dyskinesia 32.34 13.37 12 114876 44761 79584739
Oral candidiasis 32.21 13.37 105 114783 29523 79599977
Meibomian gland dysfunction 31.87 13.37 12 114876 209 79629291
Gastric perforation 31.85 13.37 34 114854 4003 79625497
Nervousness 31.83 13.37 5 114883 33410 79596090
Ascites 31.77 13.37 202 114686 75360 79554140
Asthenopia 31.69 13.37 27 114861 2400 79627100
Vulvovaginal dryness 31.64 13.37 26 114862 2198 79627302
Hiccups 31.64 13.37 54 114834 9977 79619523
Gastrointestinal haemorrhage 31.61 13.37 108 114780 147611 79481889
Frequent bowel movements 31.61 13.37 3 114885 29536 79599964
Cardiac dysfunction 31.26 13.37 34 114854 4090 79625410
Carbohydrate antigen 15-3 increased 31.02 13.37 20 114868 1159 79628341
Gastric disorder 30.67 13.37 8 114880 37425 79592075
Breast inflammation 30.66 13.37 11 114877 166 79629334
Neoplasm recurrence 30.65 13.37 34 114854 4180 79625320
Diabetes mellitus 30.42 13.37 41 114847 78349 79551151
Disseminated intravascular coagulation 30.35 13.37 117 114771 35725 79593775
Nephritis bacterial 30.24 13.37 8 114880 39 79629461
Infusion site plaque 30.21 13.37 6 114882 4 79629496
Cataract 30.16 13.37 27 114861 62093 79567407
Arteritis 30.16 13.37 18 114870 909 79628591
Osteonecrosis 30.11 13.37 106 114782 30989 79598511
Pulmonary mass 29.88 13.37 101 114787 28933 79600567
Non-small cell lung cancer 29.60 13.37 41 114847 6319 79623181
Prostate cancer recurrent 29.55 13.37 17 114871 801 79628699
Joint range of motion decreased 29.49 13.37 6 114882 33276 79596224
Blood uric acid decreased 29.41 13.37 20 114868 1268 79628232
Vascular fragility 29.38 13.37 10 114878 128 79629372
Injection site haemorrhage 29.38 13.37 3 114885 27867 79601633
Barotrauma 29.35 13.37 11 114877 189 79629311
Hydrothorax 29.32 13.37 21 114867 1447 79628053
Peritonitis 29.27 13.37 98 114790 27938 79601562
Gas gangrene 29.16 13.37 12 114876 267 79629233
Therapy interrupted 29.16 13.37 5 114883 31336 79598164
Joint injury 29.15 13.37 5 114883 31330 79598170
Limb injury 29.09 13.37 4 114884 29524 79599976
Eastern Cooperative Oncology Group performance status worsened 29.08 13.37 24 114864 2041 79627459
Invasive lobular breast carcinoma 29.00 13.37 16 114872 695 79628805
Balance disorder 28.89 13.37 62 114826 98795 79530705
Vulvovaginal candidiasis 28.87 13.37 26 114862 2488 79627012
Ischaemic enteritis 28.83 13.37 10 114878 136 79629364
Incorrect dose administered 28.81 13.37 41 114847 76589 79552911
Excessive eye blinking 28.74 13.37 22 114866 1679 79627821
Periorbital disorder 28.72 13.37 8 114880 49 79629451
Neck pain 28.70 13.37 40 114848 75377 79554123
Cystitis noninfective 28.69 13.37 20 114868 1320 79628180
Obstructive shock 28.63 13.37 9 114879 88 79629412
Blood alkaline phosphatase increased 28.53 13.37 173 114715 63491 79566009
Eosinophilia 28.27 13.37 15 114873 45330 79584170
White blood cell count abnormal 28.20 13.37 38 114850 5707 79623793
Irritability 28.12 13.37 12 114876 41132 79588368
Karnofsky scale worsened 27.72 13.37 5 114883 0 79629500
Eubacterium infection 27.72 13.37 5 114883 0 79629500
Dysaesthesia 27.67 13.37 38 114850 5810 79623690
Bronchitis 27.62 13.37 96 114792 130548 79498952
Perforation 27.57 13.37 20 114868 1406 79628094
Pancreatitis 27.49 13.37 35 114853 68540 79560960
Dysphagia 27.49 13.37 283 114605 121853 79507647
Invasive ductal breast carcinoma 27.45 13.37 38 114850 5854 79623646
Acquired gene mutation 27.45 13.37 24 114864 2209 79627291
Delirium 27.38 13.37 50 114838 84577 79544923
Lymphadenopathy 27.32 13.37 150 114738 53097 79576403
Laryngeal oedema 27.29 13.37 45 114843 8084 79621416
Therapy cessation 27.24 13.37 10 114878 37552 79591948
Feeling hot 27.20 13.37 163 114725 59571 79569929
Ejection fraction 27.12 13.37 24 114864 2245 79627255
Adverse event 27.10 13.37 28 114860 60186 79569314
Oral pain 27.09 13.37 104 114784 31694 79597806
HER2 positive breast cancer 26.94 13.37 12 114876 326 79629174
Intestinal perforation 26.89 13.37 70 114818 17356 79612144
Hepatic function abnormal 26.86 13.37 189 114699 72918 79556582
Retinal detachment 26.85 13.37 48 114840 9199 79620301
Tumour pain 26.85 13.37 24 114864 2275 79627225
Pleural disorder 26.83 13.37 17 114871 956 79628544
No adverse event 26.81 13.37 10 114878 37182 79592318
Emotional distress 26.77 13.37 12 114876 39957 79589543
Radiation necrosis 26.77 13.37 13 114875 432 79629068
Sepsis 26.54 13.37 540 114348 268888 79360612
Eosinophil percentage increased 26.45 13.37 20 114868 1498 79628002
Skin reaction 26.31 13.37 66 114822 16002 79613498
Pericardial effusion 26.29 13.37 134 114754 46103 79583397
Axillary pain 26.22 13.37 23 114865 2126 79627374
Blood creatine phosphokinase increased 26.22 13.37 34 114854 66056 79563444
Superior mesenteric artery syndrome 26.15 13.37 10 114878 182 79629318
Nicotinic acid deficiency 26.15 13.37 10 114878 182 79629318
Drug dependence 26.14 13.37 13 114875 40756 79588744
Palmar erythema 26.12 13.37 22 114866 1925 79627575
Hormone receptor positive breast cancer 26.00 13.37 12 114876 355 79629145
Malignant pleural effusion 25.85 13.37 28 114860 3352 79626148
Scleroderma renal crisis 25.83 13.37 14 114874 587 79628913
Product administration error 25.73 13.37 7 114881 31839 79597661
Metastases to gastrointestinal tract 25.71 13.37 9 114879 126 79629374
Colitis ulcerative 25.62 13.37 9 114879 34733 79594767
Menopausal disorder 25.54 13.37 7 114881 40 79629460
Polyneuropathy in malignant disease 25.47 13.37 11 114877 277 79629223
Tumour embolism 25.42 13.37 10 114878 197 79629303
Sopor 25.30 13.37 8 114880 33002 79596498
Ear infection 25.25 13.37 9 114879 34423 79595077
Vessel puncture site bruise 25.04 13.37 13 114875 499 79629001
Hyperchlorhydria 24.87 13.37 22 114866 2057 79627443
Mucosal disorder 24.86 13.37 28 114860 3500 79626000
Sleep disorder 24.81 13.37 54 114834 85623 79543877
Paraesthesia 24.76 13.37 374 114514 175949 79453551
Acute kidney injury 24.70 13.37 565 114323 518839 79110661
Muscle spasms 24.64 13.37 149 114739 174581 79454919
Osteoporosis 24.54 13.37 25 114863 54087 79575413
Hip fracture 24.41 13.37 7 114881 30754 79598746
Troponin I increased 24.27 13.37 32 114856 4706 79624794
Neutrophil count increased 24.11 13.37 95 114793 29301 79600199
Hypophagia 24.09 13.37 129 114759 45238 79584262
Depressed level of consciousness 24.00 13.37 66 114822 96586 79532914
Mouth ulceration 23.77 13.37 114 114774 38280 79591220
Night sweats 23.70 13.37 24 114864 52071 79577429
Unintentional medical device removal 23.65 13.37 41 114847 7671 79621829
Mediastinitis 23.58 13.37 15 114873 849 79628651
Retinal toxicity 23.29 13.37 18 114870 1393 79628107
Vein discolouration 23.26 13.37 11 114877 344 79629156
Heart rate decreased 23.23 13.37 41 114847 70275 79559225
Metastases to ovary 23.21 13.37 11 114877 346 79629154
Osteoradionecrosis 23.05 13.37 8 114880 109 79629391
Procedural pain 23.04 13.37 3 114885 23081 79606419
Necrotising retinitis 23.03 13.37 17 114871 1228 79628272
Bone marrow infiltration 23.01 13.37 14 114874 732 79628768
Ventricular hypokinesia 22.99 13.37 45 114843 9234 79620266
Viral infection 22.99 13.37 17 114871 42999 79586501
Gout 22.91 13.37 4 114884 24745 79604755
Cannabinoid hyperemesis syndrome 22.88 13.37 7 114881 62 79629438
Joint neoplasm 22.78 13.37 7 114881 63 79629437
Liver function test abnormal 22.78 13.37 36 114852 64439 79565061
Cytomegalovirus oesophagitis 22.77 13.37 14 114874 746 79628754
Haemolytic uraemic syndrome 22.71 13.37 30 114858 4419 79625081
Cytomegalovirus infection 22.60 13.37 17 114871 42627 79586873
Folate deficiency 22.55 13.37 26 114862 3334 79626166
Gastrointestinal ischaemia 22.54 13.37 12 114876 485 79629015
Amnesia 22.48 13.37 35 114853 63022 79566478
Respiratory arrest 22.43 13.37 30 114858 57520 79571980
Osteitis condensans 22.39 13.37 6 114882 31 79629469
Lymphocyte count abnormal 22.29 13.37 18 114870 1485 79628015
Red blood cell sedimentation rate increased 22.26 13.37 20 114868 45922 79583578
Lipoprotein increased 22.24 13.37 5 114883 10 79629490
Nail infection 22.18 13.37 22 114866 2377 79627123
Bronchiectasis 22.13 13.37 3 114885 22383 79607117
Foot deformity 22.05 13.37 4 114884 24070 79605430
Metastases to thorax 21.96 13.37 9 114879 198 79629302
Enteritis 21.91 13.37 58 114830 14525 79614975
Metastases to bone marrow 21.76 13.37 14 114874 808 79628692
Oesophageal perforation 21.59 13.37 18 114870 1553 79627947
Poisoning 21.49 13.37 5 114883 25267 79604233
Full blood count decreased 21.47 13.37 6 114882 26813 79602687
Abnormal behaviour 21.34 13.37 13 114875 36408 79593092
Herpes zoster 21.33 13.37 66 114822 93017 79536483
Acute motor-sensory axonal neuropathy 21.29 13.37 11 114877 418 79629082
Infection 21.26 13.37 234 114654 241478 79388022
Pharyngeal abscess 21.24 13.37 13 114875 687 79628813
Oestradiol abnormal 21.23 13.37 6 114882 39 79629461
Oesophagitis 21.15 13.37 80 114808 24209 79605291
Biliary sepsis 21.14 13.37 18 114870 1599 79627901
Mucocutaneous disorder 21.11 13.37 8 114880 142 79629358
Lipidosis 21.10 13.37 6 114882 40 79629460
Salmonellosis 21.09 13.37 19 114869 1819 79627681
Hyperkalaemia 21.00 13.37 89 114799 114309 79515191
Colitis ischaemic 21.00 13.37 59 114829 15300 79614200
Muscle spasticity 20.94 13.37 3 114885 21472 79608028
Haematochezia 20.91 13.37 61 114827 87584 79541916
Soft tissue neoplasm 20.90 13.37 7 114881 85 79629415
Sclerema 20.85 13.37 6 114882 42 79629458
Radiation pneumonitis 20.82 13.37 27 114861 3906 79625594
Macroenzyme creatine kinase 20.81 13.37 5 114883 15 79629485
Therapy responder 20.72 13.37 11 114877 442 79629058
Aplasia 20.70 13.37 39 114849 7781 79621719
Panophthalmitis 20.66 13.37 8 114880 151 79629349
Rhinalgia 20.59 13.37 21 114867 2346 79627154
Post-traumatic pain 20.54 13.37 11 114877 450 79629050
Vulvitis 20.43 13.37 9 114879 238 79629262
Vascular pain 20.40 13.37 14 114874 901 79628599
Blood triglycerides increased 20.38 13.37 3 114885 21037 79608463
Throat tightness 20.37 13.37 87 114801 27820 79601680
Pancreatitis viral 20.34 13.37 5 114883 17 79629483
Breast neoplasm 20.16 13.37 14 114874 918 79628582
Nasal disorder 20.15 13.37 26 114862 3743 79625757
Hepatic encephalopathy 20.12 13.37 5 114883 24161 79605339
Pain in extremity 20.11 13.37 387 114501 364151 79265349
Overflow diarrhoea 20.05 13.37 8 114880 164 79629336
Renal failure 19.97 13.37 189 114699 200779 79428721
Spinal pain 19.95 13.37 58 114830 15334 79614166
Memory impairment 19.85 13.37 88 114800 111646 79517854
Transdifferentiation of neoplasm 19.80 13.37 7 114881 101 79629399
Multiple sclerosis 19.78 13.37 4 114884 22278 79607222
Nail ridging 19.75 13.37 11 114877 487 79629013
Tumour haemorrhage 19.72 13.37 27 114861 4117 79625383
Toxic optic neuropathy 19.67 13.37 15 114873 1138 79628362
Necrotising fasciitis 19.65 13.37 33 114855 6017 79623483
Ocular hyperaemia 19.64 13.37 8 114880 28198 79601302
Delusion 19.58 13.37 3 114885 20420 79609080
Disorientation 19.50 13.37 38 114850 62738 79566762
Hyperpyrexia 19.49 13.37 33 114855 6059 79623441
Laboratory test abnormal 19.46 13.37 8 114880 28040 79601460
Trigeminal nerve paresis 19.41 13.37 4 114884 4 79629496
Eye swelling 19.27 13.37 7 114881 26461 79603039
Tympanic membrane disorder 19.23 13.37 8 114880 183 79629317
Colony stimulating factor therapy 19.23 13.37 11 114877 513 79628987
Clostridium bacteraemia 19.16 13.37 10 114878 388 79629112
Ovarian necrosis 19.14 13.37 5 114883 23 79629477
Choroidal effusion 19.09 13.37 12 114876 665 79628835
VIth nerve paralysis 19.06 13.37 17 114871 1607 79627893
Hypervolaemia 19.04 13.37 20 114868 42670 79586830
Nail bed bleeding 18.95 13.37 12 114876 674 79628826
Metastases to heart 18.90 13.37 9 114879 286 79629214
Onychoclasis 18.89 13.37 31 114857 5547 79623953
Salmonella sepsis 18.84 13.37 10 114878 402 79629098
Nail bed tenderness 18.79 13.37 10 114878 404 79629096
Surgery 18.78 13.37 12 114876 32754 79596746
Purtscher retinopathy 18.75 13.37 7 114881 119 79629381
Retinitis pigmentosa 18.69 13.37 7 114881 120 79629380
Metastases to nervous system 18.62 13.37 6 114882 64 79629436
Vaginal prolapse 18.59 13.37 9 114879 297 79629203
Monocyte count decreased 18.57 13.37 23 114865 3178 79626322
Vaginitis gardnerella 18.48 13.37 5 114883 27 79629473
Hepatic cytolysis 18.42 13.37 8 114880 27143 79602357
Bladder cancer 18.42 13.37 3 114885 19523 79609977
Restlessness 18.36 13.37 24 114864 46468 79583032
Recurrent cancer 18.35 13.37 21 114867 2672 79626828
Iron deficiency anaemia 18.34 13.37 7 114881 25665 79603835
Subclavian vein thrombosis 18.17 13.37 20 114868 2437 79627063
Left ventricular dilatation 18.08 13.37 14 114874 1087 79628413
Abdominal pain 18.03 13.37 709 114179 388860 79240640
Metastases to uterus 17.98 13.37 6 114882 72 79629428
Mental status changes 17.94 13.37 44 114844 66915 79562585
Soft tissue infection 17.88 13.37 25 114863 3887 79625613
Metabolic acidosis 17.88 13.37 60 114828 82469 79547031
Mucosal toxicity 17.84 13.37 11 114877 589 79628911
Catheter site bruise 17.84 13.37 10 114878 448 79629052
Sarcoma 17.81 13.37 13 114875 923 79628577
Obstruction gastric 17.80 13.37 17 114871 1753 79627747
Pulmonary hypertension 17.80 13.37 26 114862 48054 79581446
Metastases to adrenals 17.78 13.37 15 114873 1315 79628185
Cardiac failure congestive 17.76 13.37 126 114762 142276 79487224
Inflammatory carcinoma of the breast 17.76 13.37 5 114883 32 79629468
Aorto-oesophageal fistula 17.68 13.37 6 114882 76 79629424
Neuromuscular toxicity 17.64 13.37 8 114880 227 79629273
Haematoma 17.64 13.37 30 114858 52165 79577335
Chromosomal mutation 17.63 13.37 5 114883 33 79629467
Intervertebral disc protrusion 17.62 13.37 6 114882 23615 79605885
Hypovolaemic shock 17.61 13.37 48 114840 12228 79617272
Transaminases 17.61 13.37 6 114882 77 79629423
Respiratory failure 17.60 13.37 362 114526 180549 79448951
Osteosclerosis 17.59 13.37 25 114863 3946 79625554
Bone disorder 17.52 13.37 64 114824 19049 79610451
Hallucination, visual 17.41 13.37 13 114875 32716 79596784
Acute myocardial infarction 17.39 13.37 55 114833 76981 79552519
Lip swelling 17.33 13.37 20 114868 40891 79588609
Grip strength decreased 17.31 13.37 5 114883 21864 79607636
Pulmonary embolism 17.21 13.37 345 114543 171309 79458191
Metastases to muscle 17.20 13.37 9 114879 351 79629149
Appendiceal abscess 17.13 13.37 9 114879 354 79629146
Hypothalamo-pituitary disorder 17.07 13.37 14 114874 1180 79628320
Hypersomnia 16.99 13.37 6 114882 23080 79606420
Traumatic lung injury 16.89 13.37 19 114869 2372 79627128
Platelet count decreased 16.85 13.37 383 114505 194281 79435219
Therapeutic response unexpected 16.85 13.37 4 114884 19942 79609558
Drug ineffective for unapproved indication 16.82 13.37 30 114858 51208 79578292
Breast oedema 16.79 13.37 5 114883 40 79629460
Malignant neoplasm of pleura 16.75 13.37 7 114881 162 79629338
Merycism 16.75 13.37 8 114880 256 79629244
Gastrointestinal perforation 16.73 13.37 31 114857 6106 79623394
Sciatica 16.66 13.37 14 114874 33208 79596292
Abortion spontaneous 16.65 13.37 11 114877 29496 79600004
ALK gene rearrangement positive 16.63 13.37 3 114885 0 79629500
Labia enlarged 16.63 13.37 3 114885 0 79629500
Necrosis 16.61 13.37 40 114848 9453 79620047
Generalised oedema 16.61 13.37 73 114815 23636 79605864
Osteolysis 16.61 13.37 26 114862 4472 79625028
Necrotising colitis 16.59 13.37 13 114875 1027 79628473
Underdose 16.59 13.37 14 114874 33137 79596363
Impaired work ability 16.52 13.37 4 114884 19677 79609823
Hydronephrosis 16.47 13.37 59 114829 17395 79612105
Upper limb fracture 16.42 13.37 3 114885 17964 79611536
Carcinoembryonic antigen increased 16.37 13.37 18 114870 2191 79627309
Renal disorder 16.35 13.37 22 114866 42083 79587417
Ear pain 16.30 13.37 14 114874 32855 79596645
Cancer pain 16.23 13.37 28 114860 5217 79624283
Tumour marker increased 16.20 13.37 25 114863 4247 79625253
Hepatotoxicity 16.17 13.37 128 114760 51224 79578276
Subdural haematoma 16.07 13.37 13 114875 31421 79598079
Skin laceration 16.06 13.37 11 114877 28951 79600549
Dandy-Walker syndrome 15.99 13.37 5 114883 48 79629452
Breast cancer 15.90 13.37 93 114795 33688 79595812
Cranial nerve disorder 15.84 13.37 13 114875 1097 79628403
Clostridial infection 15.75 13.37 29 114859 5685 79623815
Blister 15.75 13.37 104 114784 119372 79510128
Extravasation 15.72 13.37 23 114865 3727 79625773
Granulocytopenia 15.71 13.37 44 114844 11387 79618113
Administration site extravasation 15.64 13.37 14 114874 1329 79628171
Kidney infection 15.54 13.37 6 114882 21845 79607655
Acne 15.52 13.37 10 114878 27180 79602320
Hypertransaminasaemia 15.52 13.37 45 114843 11879 79617621
Dysuria 15.49 13.37 126 114762 50825 79578675
Leukaemia cutis 15.49 13.37 7 114881 197 79629303
Immunodeficiency 15.44 13.37 6 114882 21762 79607738
Herpes simplex sepsis 15.38 13.37 5 114883 55 79629445
Nasal discomfort 15.33 13.37 28 114860 5455 79624045
Hernia 15.27 13.37 3 114885 17056 79612444
Tracheo-oesophageal fistula 15.26 13.37 10 114878 596 79628904
Epidermolysis 15.22 13.37 12 114876 956 79628544
Staphylococcal impetigo 15.21 13.37 4 114884 19 79629481
Metastases to pituitary gland 15.21 13.37 4 114884 19 79629481
Joint dislocation 15.12 13.37 3 114885 16936 79612564
Product quality issue 15.03 13.37 16 114872 33924 79595576
Respiratory tract congestion 15.01 13.37 5 114883 19949 79609551
Pneumonia salmonella 14.98 13.37 5 114883 60 79629440
Naevus haemorrhage 14.94 13.37 6 114882 125 79629375
Urogenital prolapse 14.88 13.37 4 114884 21 79629479
Sinus bradycardia 14.81 13.37 9 114879 25238 79604262
Glaucoma 14.78 13.37 5 114883 19756 79609744
Pituitary tumour 14.75 13.37 13 114875 1209 79628291
Distichiasis 14.72 13.37 4 114884 22 79629478
Paralysis recurrent laryngeal nerve 14.68 13.37 6 114882 131 79629369
Parkinsonism 14.67 13.37 3 114885 16581 79612919
Haemodialysis 14.66 13.37 4 114884 18164 79611336
Hyperchromasia 14.56 13.37 3 114885 3 79629497
Subretinal hyperreflective exudation 14.56 13.37 3 114885 3 79629497
Sarcomatosis 14.56 13.37 3 114885 3 79629497
Malaise 14.50 13.37 568 114320 489301 79140199
Hypoalbuminaemia 14.48 13.37 65 114823 21232 79608268
Metastases to abdominal cavity 14.43 13.37 10 114878 654 79628846
Injection site rash 14.40 13.37 4 114884 17950 79611550
Chronic kidney disease 14.39 13.37 48 114840 66106 79563394
Folliculitis 14.36 13.37 37 114851 55343 79574157
Hypersensitivity pneumonitis 14.34 13.37 22 114866 3717 79625783
Glycosylated haemoglobin increased 14.18 13.37 5 114883 19255 79610245
Portosplenomesenteric venous thrombosis 14.15 13.37 4 114884 26 79629474
Fear 14.11 13.37 7 114881 21979 79607521
Infusion site vesicles 14.09 13.37 9 114879 513 79628987
Bone cancer metastatic 14.08 13.37 7 114881 245 79629255
Scleroderma 13.99 13.37 27 114861 5483 79624017
Hydrocephalus 13.99 13.37 36 114852 8864 79620636
Neutrophil count abnormal 13.89 13.37 21 114867 3505 79625995
Atypical pneumonia 13.87 13.37 30 114858 6606 79622894
Tooth extraction 13.83 13.37 41 114847 10954 79618546
Loss of consciousness 13.82 13.37 165 114723 167778 79461722
Cholangitis sclerosing 13.80 13.37 18 114870 2619 79626881
Liver injury 13.80 13.37 39 114849 56575 79572925
Chills 13.78 13.37 315 114573 159919 79469581
Hypomagnesaemia 13.72 13.37 115 114773 46796 79582704
Spinal stenosis 13.67 13.37 3 114885 15788 79613712
Breast necrosis 13.67 13.37 5 114883 80 79629420
Cachexia 13.63 13.37 41 114847 11042 79618458
Circulatory collapse 13.61 13.37 97 114791 37571 79591929
Chondritis 13.61 13.37 6 114882 159 79629341
Acute hepatic failure 13.55 13.37 14 114874 30099 79599401
Cardio-respiratory arrest 13.54 13.37 96 114792 108414 79521086
Tracheal stenosis 13.53 13.37 8 114880 397 79629103
Miller Fisher syndrome 13.52 13.37 7 114881 267 79629233

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




๐Ÿถ Veterinary Drug Use

None

๐Ÿถ Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 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
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
148408-66-6 SECONDARY_CAS_RN

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 0409-0016 INJECTION, SOLUTION 10 mg INTRAVENOUS NDA 33 sections
Docetaxel HUMAN PRESCRIPTION DRUG LABEL 1 0409-0201 INJECTION, SOLUTION 10 mg INTRAVENOUS NDA 32 sections
Docetaxel HUMAN PRESCRIPTION DRUG LABEL 1 0409-0201 INJECTION, SOLUTION 10 mg INTRAVENOUS NDA 32 sections
Docetaxel HUMAN PRESCRIPTION DRUG LABEL 1 0409-0365 INJECTION, SOLUTION 20 mg INTRAVENOUS NDA 33 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 0409-0366 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 0409-0367 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 0409-0368 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 0409-1732 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 0409-2026 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 0409-4235 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 0409-5068 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 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 0955-1020 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