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

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

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

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

Drug dosage:

None

ADMET properties:

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

Approvals:

DateAgencyCompanyOrphan
May 14, 1996 FDA SANOFI AVENTIS US

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Febrile neutropenia 1638.93 13.47 1316 80614 96351 50426843
Neutropenia 1394.84 13.47 1442 80488 146523 50376671
Palmar-plantar erythrodysaesthesia syndrome 991.39 13.47 533 81397 19565 50503629
Diarrhoea 935.11 13.47 2556 79374 585920 49937274
Malignant neoplasm progression 892.42 13.47 797 81133 67327 50455867
Mucosal inflammation 753.92 13.47 579 81351 39563 50483631
Myelosuppression 750.30 13.47 388 81542 13129 50510065
Disease progression 717.95 13.47 829 81101 95037 50428157
Ejection fraction decreased 693.22 13.47 410 81520 18110 50505084
Neuropathy peripheral 603.92 13.47 763 81167 95994 50427200
Metastases to bone 585.01 13.47 364 81566 17631 50505563
Bone marrow failure 570.78 13.47 422 81508 27202 50495992
Metastases to liver 509.73 13.47 348 81582 19756 50503438
Drug ineffective 434.40 13.47 415 81515 818918 49704276
Metastases to lung 368.47 13.47 227 81703 10793 50512401
Metastases to central nervous system 356.01 13.47 224 81706 11058 50512136
Metastases to lymph nodes 334.21 13.47 182 81748 6842 50516352
Rheumatoid arthritis 306.95 13.47 4 81926 202546 50320648
Neutropenic sepsis 298.59 13.47 219 81711 13928 50509266
Agranulocytosis 288.72 13.47 255 81675 21166 50502028
Cardiotoxicity 277.14 13.47 161 81769 6866 50516328
Polyneuropathy 265.57 13.47 192 81738 11939 50511255
Skin toxicity 260.18 13.47 127 81803 3786 50519408
Joint swelling 259.30 13.47 43 81887 245243 50277951
Neoplasm progression 251.87 13.47 272 81658 28885 50494309
Leukopenia 243.15 13.47 411 81519 67117 50456077
Fall 239.35 13.47 122 81808 334810 50188384
Peripheral sensory neuropathy 226.01 13.47 138 81792 6453 50516741
Contraindicated product administered 206.25 13.47 8 81922 148950 50374244
Pleural effusion 204.75 13.47 425 81505 81029 50442165
Acute myeloid leukaemia 204.22 13.47 180 81750 14894 50508300
Haematotoxicity 198.46 13.47 136 81794 7759 50515435
Systemic lupus erythematosus 196.59 13.47 7 81923 140615 50382579
Breast cancer recurrent 196.07 13.47 104 81826 3704 50519490
Product dose omission issue 194.70 13.47 32 81898 183806 50339388
Alopecia areata 191.42 13.47 75 81855 1293 50521901
Completed suicide 190.02 13.47 5 81925 131884 50391310
Therapeutic product effect decreased 189.40 13.47 7 81923 136043 50387151
Stomatitis 186.12 13.47 467 81463 100877 50422317
Vomiting 182.49 13.47 1322 80608 459436 50063758
Bone pain 181.41 13.47 296 81634 46933 50476261
Arthropathy 177.59 13.47 23 81907 157883 50365311
Left ventricular dysfunction 176.44 13.47 142 81788 10364 50512830
Decreased appetite 171.17 13.47 711 81219 200212 50322982
Drug hypersensitivity 171.01 13.47 97 81833 250913 50272281
Pyrexia 168.12 13.47 1121 80809 379082 50144112
Neutrophil count decreased 166.76 13.47 281 81649 45745 50477449
Sinusitis 165.12 13.47 37 81893 170521 50352673
Colitis 162.44 13.47 252 81678 38277 50484917
Onycholysis 162.17 13.47 66 81864 1262 50521932
Nausea 161.36 13.47 1795 80135 703603 49819591
Madarosis 158.04 13.47 79 81851 2481 50520713
Condition aggravated 156.84 13.47 150 81780 296908 50226286
Hair colour changes 156.29 13.47 80 81850 2644 50520550
Nail disorder 156.25 13.47 128 81802 9580 50513614
Interstitial lung disease 152.21 13.47 293 81637 52883 50470311
Neutropenic colitis 150.43 13.47 75 81855 2342 50520852
Metastasis 145.91 13.47 90 81840 4285 50518909
Maternal exposure during pregnancy 142.45 13.47 41 81889 159737 50363457
Abdominal discomfort 141.99 13.47 101 81829 231540 50291654
Gastrointestinal toxicity 140.39 13.47 90 81840 4587 50518607
Second primary malignancy 139.07 13.47 104 81826 6810 50516384
Hand deformity 136.59 13.47 6 81924 100193 50423001
Hair texture abnormal 134.26 13.47 80 81850 3576 50519618
Aortitis 133.36 13.47 51 81879 821 50522373
Metastases to skin 129.77 13.47 57 81873 1326 50521868
Neutropenic infection 129.24 13.47 53 81877 1034 50522160
Somnolence 128.85 13.47 45 81885 154940 50368254
Injection site pain 127.66 13.47 15 81915 111009 50412185
Erythema 126.83 13.47 521 81409 145893 50377301
Skin exfoliation 124.12 13.47 207 81723 33405 50489789
Nail toxicity 123.47 13.47 38 81892 302 50522892
Breast cancer metastatic 119.35 13.47 113 81817 10251 50512943
Flushing 116.91 13.47 303 81627 66712 50456482
Weight increased 116.05 13.47 94 81836 201797 50321397
Confusional state 115.31 13.47 80 81850 185848 50337346
Neurotoxicity 114.30 13.47 130 81800 14610 50508584
Lymphoedema 111.87 13.47 103 81827 9019 50514175
Treatment failure 109.29 13.47 43 81887 137594 50385600
Anaemia 109.27 13.47 741 81189 251715 50271479
Recall phenomenon 108.89 13.47 39 81891 517 50522677
White blood cell count decreased 108.77 13.47 425 81505 116297 50406897
Musculoskeletal stiffness 105.59 13.47 38 81892 128443 50394751
Dysgeusia 104.75 13.47 209 81721 38707 50484487
Epistaxis 100.29 13.47 278 81652 63676 50459518
Wound 100.25 13.47 24 81906 105770 50417424
Product use issue 99.93 13.47 59 81871 149416 50373778
Glossodynia 98.74 13.47 32 81898 115537 50407657
Paronychia 97.06 13.47 71 81859 4493 50518701
Lacrimation increased 96.37 13.47 128 81802 16864 50506330
Biopsy lung abnormal 95.41 13.47 26 81904 126 50523068
Overdose 93.75 13.47 23 81907 99704 50423490
Dehydration 93.20 13.47 490 81440 151959 50371235
Capillary leak syndrome 92.76 13.47 50 81880 1840 50521354
Pain 92.34 13.47 555 81375 578348 49944846
Metastases to pleura 91.68 13.47 44 81886 1262 50521932
Thrombocytopenia 88.34 13.47 425 81505 127248 50395946
Swelling 86.84 13.47 119 81811 200753 50322441
Hepatic enzyme increased 86.63 13.47 58 81872 137322 50385872
Lymphangiosis carcinomatosa 86.11 13.47 41 81889 1155 50522039
Contusion 85.89 13.47 37 81893 112146 50411048
Hypokalaemia 85.71 13.47 325 81605 87667 50435527
Headache 84.78 13.47 478 81452 506057 50017137
Injection site erythema 83.99 13.47 11 81919 74925 50448269
Pneumonitis 83.67 13.47 162 81768 29348 50493846
Drug abuse 83.52 13.47 3 81927 59843 50463351
Organising pneumonia 83.30 13.47 66 81864 4708 50518486
Exposure during pregnancy 79.15 13.47 49 81881 120966 50402228
Radiation skin injury 79.14 13.47 35 81895 828 50522366
Dermatitis 78.74 13.47 106 81824 14145 50509049
Acute promyelocytic leukaemia 75.14 13.47 34 81896 850 50522344
Myalgia 74.86 13.47 398 81532 123921 50399273
Myositis 73.88 13.47 77 81853 7843 50515351
Disease recurrence 71.90 13.47 122 81808 19959 50503235
Febrile bone marrow aplasia 71.13 13.47 68 81862 6243 50516951
Nail discolouration 69.92 13.47 45 81885 2309 50520885
Metastases to spine 69.34 13.47 48 81882 2783 50520411
Hospitalisation 69.29 13.47 13 81917 67924 50455270
Helicobacter infection 67.64 13.47 3 81927 49699 50473495
Arthritis 67.34 13.47 28 81902 86693 50436501
Vascular device infection 66.79 13.47 56 81874 4328 50518866
Osteoarthritis 66.10 13.47 15 81915 68591 50454603
Multifocal micronodular pneumocyte hyperplasia 64.82 13.47 17 81913 69 50523125
Bronchial polyp 64.82 13.47 17 81913 69 50523125
Metastases to peritoneum 64.65 13.47 46 81884 2787 50520407
Myocardial infarction 64.05 13.47 32 81898 88995 50434199
Injury 63.30 13.47 4 81926 48921 50474273
Large intestine perforation 63.09 13.47 69 81861 7425 50515769
Nail dystrophy 62.07 13.47 29 81901 782 50522412
Pericarditis 61.75 13.47 25 81905 78664 50444530
Cerebrovascular accident 60.99 13.47 39 81891 94641 50428553
Feeling abnormal 60.86 13.47 68 81862 125424 50397770
Drug intolerance 60.64 13.47 169 81761 218935 50304259
Ascites 60.32 13.47 160 81770 35701 50487493
Pseudocirrhosis 59.22 13.47 26 81904 604 50522590
Cardiomyopathy 58.88 13.47 97 81833 15489 50507705
Inappropriate schedule of product administration 57.72 13.47 22 81908 71809 50451385
Loss of personal independence in daily activities 57.05 13.47 21 81909 70029 50453165
Device related thrombosis 57.04 13.47 32 81898 1275 50521919
Suicide attempt 57.00 13.47 8 81922 51724 50471470
Congestive cardiomyopathy 55.74 13.47 56 81874 5462 50517732
Blood cholesterol increased 55.38 13.47 11 81919 55204 50467990
Injection site swelling 55.31 13.47 3 81927 41770 50481424
Drug interaction 55.21 13.47 154 81776 199467 50323727
Injection site reaction 54.51 13.47 8 81922 50024 50473170
Depression 54.07 13.47 117 81813 165306 50357888
Constipation 53.19 13.47 496 81434 185212 50337982
Dermatomyositis 51.43 13.47 36 81894 2125 50521069
Hepatic function abnormal 51.15 13.47 142 81788 32539 50490655
Enterocolitis infectious 50.80 13.47 31 81899 1447 50521747
Periarticular thenar erythema with onycholysis 50.70 13.47 11 81919 14 50523180
Injection site pruritus 50.27 13.47 4 81926 40407 50482787
Mobility decreased 50.04 13.47 34 81896 79914 50443280
Incorrect dose administered 49.93 13.47 9 81921 48405 50474789
Migraine 49.88 13.47 30 81900 75250 50447944
Gastrointestinal necrosis 49.85 13.47 38 81892 2560 50520634
Adverse drug reaction 49.48 13.47 14 81916 55208 50467986
Enterocolitis 49.36 13.47 57 81873 6510 50516684
Psoriasis 49.33 13.47 25 81905 68975 50454219
Lumbosacral radiculoplexus neuropathy 48.34 13.47 11 81919 20 50523174
Duodenal ulcer perforation 48.09 13.47 8 81922 45603 50477591
Irritable bowel syndrome 48.07 13.47 12 81918 51429 50471765
Therapy partial responder 47.52 13.47 56 81874 6535 50516659
Performance status decreased 47.00 13.47 40 81890 3155 50520039
Metastases to meninges 46.83 13.47 33 81897 1969 50521225
Dermatitis acneiform 46.26 13.47 44 81886 4013 50519181
Influenza 46.22 13.47 46 81884 89492 50433702
Discomfort 45.99 13.47 65 81865 108315 50414879
Ventricular hypokinesia 45.07 13.47 43 81887 3937 50519257
Asthma 44.86 13.47 47 81883 89290 50433904
Asthenia 44.71 13.47 745 81185 318297 50204897
Cystoid macular oedema 44.68 13.47 28 81902 1371 50521823
Dyspnoea 44.47 13.47 1180 80750 546428 49976766
Tonsillar disorder 44.27 13.47 25 81905 1009 50522185
Erysipelas 44.13 13.47 54 81876 6554 50516640
Device related infection 43.85 13.47 101 81829 20634 50502560
Hot flush 42.86 13.47 163 81767 44006 50479188
Cellulitis 42.81 13.47 227 81703 70571 50452623
Alopecia totalis 42.76 13.47 17 81913 305 50522889
Cardiac failure 42.74 13.47 239 81691 75801 50447393
Blood lactate dehydrogenase increased 42.16 13.47 96 81834 19466 50503728
Blood uric acid decreased 41.96 13.47 21 81909 661 50522533
Onychalgia 41.74 13.47 22 81908 773 50522421
Onychomadesis 41.56 13.47 39 81891 3497 50519697
Suicidal ideation 41.22 13.47 19 81911 55366 50467828
Ejection fraction 40.82 13.47 25 81905 1175 50522019
Nasal congestion 40.50 13.47 16 81914 51104 50472090
Alopecia 39.92 13.47 587 81343 244460 50278734
Pericardial effusion 39.86 13.47 111 81819 25478 50497716
Metastases to the mediastinum 39.71 13.47 18 81912 452 50522742
Cardiac dysfunction 39.70 13.47 28 81902 1673 50521521
Osteonecrosis of jaw 39.27 13.47 129 81801 32397 50490797
Plasma cell myeloma 39.24 13.47 3 81927 31319 50491875
Metastases to adrenals 38.71 13.47 20 81910 674 50522520
Electrocardiogram QT prolonged 38.30 13.47 18 81912 51868 50471326
Odynophagia 38.26 13.47 50 81880 6482 50516712
Sedation 38.16 13.47 3 81927 30607 50492587
Fatigue 38.08 13.47 1451 80479 706150 49817044
Acute leukaemia 38.02 13.47 23 81907 1057 50522137
Myelodysplastic syndrome 38.01 13.47 79 81851 15053 50508141
Hallucination 37.96 13.47 14 81916 46643 50476551
Hyperfibrinogenaemia 37.75 13.47 9 81921 22 50523172
Computerised tomogram thorax abnormal 37.56 13.47 25 81905 1358 50521836
Nasopharyngitis 37.26 13.47 173 81757 192754 50330440
Impaired healing 37.01 13.47 35 81895 69751 50453443
Bradycardia 36.96 13.47 30 81900 64396 50458798
Nephrolithiasis 36.76 13.47 6 81924 34687 50488507
Back pain 36.59 13.47 529 81401 219501 50303693
Mastectomy 36.19 13.47 25 81905 1444 50521750
Invasive ductal breast carcinoma 35.74 13.47 46 81884 5875 50517319
Hypocalcaemia 35.71 13.47 110 81820 26706 50496488
Obstructive shock 35.70 13.47 9 81921 30 50523164
Cataract 35.55 13.47 16 81914 47284 50475910
Excessive eye blinking 35.52 13.47 21 81909 925 50522269
Purtscher retinopathy 35.50 13.47 7 81923 3 50523191
Blood creatinine decreased 35.42 13.47 42 81888 4934 50518260
Eosinophil percentage increased 35.27 13.47 21 81909 937 50522257
Dacryostenosis acquired 35.06 13.47 17 81913 499 50522695
Sepsis 35.05 13.47 349 81581 132576 50390618
Carotidynia 34.89 13.47 12 81918 140 50523054
COVID-19 34.73 13.47 16 81914 46646 50476548
Hypoglycaemia 34.59 13.47 22 81908 53559 50469635
Arthralgia 34.32 13.47 502 81428 438200 50084994
Breast pain 34.12 13.47 51 81879 7493 50515701
Unevaluable event 33.97 13.47 16 81914 46050 50477144
Therapeutic product effect incomplete 33.97 13.47 60 81870 91455 50431739
Pregnancy 33.97 13.47 4 81926 29573 50493621
Paraesthesia 33.81 13.47 320 81610 119923 50403271
Bronchitis 33.74 13.47 74 81856 104085 50419109
Abortion spontaneous 33.21 13.47 13 81917 41759 50481435
Pulmonary mass 33.03 13.47 85 81845 18620 50504574
Cystitis noninfective 33.02 13.47 19 81911 795 50522399
Chest discomfort 33 13.47 260 81670 92462 50430732
Intentional product use issue 32.76 13.47 46 81884 76872 50446322
Anxiety 32.69 13.47 162 81768 177444 50345750
Intestinal ischaemia 32.46 13.47 47 81883 6710 50516484
Tumour embolism 32.40 13.47 11 81919 123 50523071
EGFR gene mutation 32.26 13.47 13 81917 242 50522952
Systemic scleroderma 32.07 13.47 19 81911 840 50522354
Intentional product misuse 31.84 13.47 18 81912 46716 50476478
Coronary artery disease 31.82 13.47 5 81925 29721 50493473
International normalised ratio increased 31.80 13.47 15 81915 43137 50480057
Radiation necrosis 31.74 13.47 14 81916 329 50522865
Mucosal infection 31.70 13.47 11 81919 132 50523062
Nephritis bacterial 31.66 13.47 8 81922 27 50523167
Osteolysis 31.60 13.47 29 81901 2528 50520666
Gas gangrene 31.50 13.47 10 81920 89 50523105
Urticaria 31.48 13.47 106 81824 129455 50393739
Therapy cessation 31.20 13.47 3 81927 26008 50497186
Ear infection 31.13 13.47 3 81927 25967 50497227
Wheezing 30.75 13.47 33 81897 62014 50461180
Gait inability 30.31 13.47 11 81919 37016 50486178
Type 2 diabetes mellitus 30.27 13.47 9 81921 34366 50488828
Swollen tongue 30.23 13.47 5 81925 28625 50494569
Death 30.12 13.47 714 81216 324665 50198529
Blood glucose increased 30.03 13.47 43 81887 71281 50451913
Coma 29.60 13.47 29 81901 56850 50466344
Nail infection 29.55 13.47 25 81905 1956 50521238
Gastric disorder 29.39 13.47 6 81924 29542 50493652
Tremor 29.30 13.47 92 81838 114811 50408383
Gait disturbance 29.25 13.47 134 81796 149871 50373323
Drug resistance 29.21 13.47 82 81848 18907 50504287
Medication error 29.09 13.47 11 81919 36093 50487101
Hyperpyrexia 29.08 13.47 30 81900 3019 50520175
Barotrauma 28.82 13.47 11 81919 176 50523018
Hepatic lesion 28.81 13.47 34 81896 3974 50519220
Road traffic accident 28.71 13.47 3 81927 24349 50498845
Vascular fragility 28.67 13.47 10 81920 122 50523072
Foetal exposure during pregnancy 28.40 13.47 5 81925 27354 50495840
Pruritus 28.30 13.47 308 81622 283260 50239934
Hypertransaminasaemia 28.25 13.47 32 81898 3579 50519615
Nasal disorder 28.18 13.47 26 81904 2282 50520912
Agitation 28.04 13.47 27 81903 53357 50469837
Malignant pleural effusion 27.97 13.47 26 81904 2304 50520890
Granulocyte count decreased 27.95 13.47 17 81913 789 50522405
Vessel puncture site bruise 27.91 13.47 13 81917 348 50522846
Vein discolouration 27.38 13.47 11 81919 203 50522991
Asthenopia 27.35 13.47 24 81906 1973 50521221
Metastases to chest wall 27.31 13.47 14 81916 464 50522730
Scleroderma renal crisis 27.28 13.47 12 81918 280 50522914
Metastatic neoplasm 27.24 13.47 32 81898 3722 50519472
Basal cell carcinoma 27.22 13.47 3 81927 23353 50499841
Lactic acidosis 27.15 13.47 10 81920 33345 50489849
Vulvovaginal dryness 27.12 13.47 25 81905 2192 50521002
Systolic dysfunction 27.08 13.47 21 81909 1451 50521743
Dyskinesia 27.01 13.47 6 81924 27855 50495339
Autonomic neuropathy 26.76 13.47 18 81912 995 50522199
Dysuria 26.67 13.47 104 81826 28400 50494794
Intestinal perforation 26.66 13.47 55 81875 10424 50512770
Insomnia 26.48 13.47 170 81760 174695 50348499
Tongue coated 26.43 13.47 19 81911 1170 50522024
Alanine aminotransferase increased 26.26 13.47 238 81692 88121 50435073
Mastitis 25.90 13.47 25 81905 2322 50520872
General physical health deterioration 25.89 13.47 348 81582 142086 50381108
Irritability 25.85 13.47 7 81923 28419 50494775
Thrombotic microangiopathy 25.82 13.47 49 81881 8742 50514452
Toxicity to various agents 25.77 13.47 220 81710 212279 50310915
Full blood count decreased 25.72 13.47 3 81927 22343 50500851
Osteoporosis 25.61 13.47 21 81909 44858 50478336
Adverse event 25.57 13.47 20 81910 43743 50479451
Toxic optic neuropathy 25.54 13.47 10 81920 172 50523022
Bursitis 25.40 13.47 3 81927 22132 50501062
Subclavian vein thrombosis 25.40 13.47 22 81908 1777 50521417
PIK3CA-activated mutation 25.34 13.47 16 81914 794 50522400
Vascular pain 25.22 13.47 15 81915 668 50522526
Hepatotoxicity 25.20 13.47 99 81831 27127 50496067
Perforation 25.16 13.47 17 81913 947 50522247
Clostridium bacteraemia 25.07 13.47 10 81920 181 50523013
Abdominal pain 24.86 13.47 528 81402 235700 50287494
Sclerema 24.79 13.47 5 81925 3 50523191
Nervousness 24.79 13.47 7 81923 27644 50495550
Biliary sepsis 24.63 13.47 16 81914 834 50522360
Depressed level of consciousness 24.25 13.47 29 81901 51924 50471270
Injection site haemorrhage 24.23 13.47 3 81927 21343 50501851
Retinal toxicity 24.18 13.47 18 81912 1170 50522024
Troponin I increased 24.10 13.47 22 81908 1904 50521290
Oral candidiasis 24.04 13.47 71 81859 16844 50506350
Nail bed bleeding 23.98 13.47 11 81919 284 50522910
Palmar erythema 23.88 13.47 20 81910 1543 50521651
Recurrent cancer 23.83 13.47 21 81909 1736 50521458
Folate deficiency 23.82 13.47 22 81908 1933 50521261
Acoustic stimulation tests abnormal 23.68 13.47 8 81922 88 50523106
Axillary pain 23.65 13.47 20 81910 1564 50521630
Septic shock 23.55 13.47 166 81764 57009 50466185
Metastases to thorax 23.53 13.47 10 81920 214 50522980
Menopausal disorder 23.52 13.47 7 81923 49 50523145
Chronic kidney disease 23.46 13.47 18 81912 39753 50483441
Pneumocystis jirovecii pneumonia 23.22 13.47 64 81866 14599 50508595
Metastases to soft tissue 23.19 13.47 9 81921 151 50523043
Portal hypertension 23.11 13.47 28 81902 3364 50519830
Pancreatitis 23.03 13.47 21 81909 42593 50480601
Balance disorder 22.98 13.47 50 81880 70540 50452654
Multiple sclerosis 22.97 13.47 3 81927 20490 50502704
Treatment noncompliance 22.97 13.47 10 81920 30140 50493054
Gamma-glutamyltransferase increased 22.95 13.47 102 81828 29521 50493673
Ovarian necrosis 22.95 13.47 6 81924 24 50523170
Left ventricular dilatation 22.91 13.47 12 81918 416 50522778
Therapy interrupted 22.47 13.47 3 81927 20149 50503045
Foot fracture 22.38 13.47 3 81927 20088 50503106
Choroidal effusion 22.25 13.47 12 81918 442 50522752
Metastases to ovary 22.19 13.47 11 81919 339 50522855
Femur fracture 22.04 13.47 17 81913 37447 50485747
Red blood cell sedimentation rate increased 22.03 13.47 10 81920 29406 50493788
Peripheral swelling 22.03 13.47 220 81710 205716 50317478
Panophthalmitis 21.98 13.47 7 81923 63 50523131
Embolism 21.92 13.47 40 81890 6928 50516266
Bone marrow infiltration 21.91 13.47 12 81918 456 50522738
Osteitis condensans 21.70 13.47 6 81924 31 50523163
Accidental overdose 21.56 13.47 3 81927 19530 50503664
Metastases to nervous system 21.54 13.47 6 81924 32 50523162
Herpes zoster 21.54 13.47 52 81878 70734 50452460
Extravasation 21.48 13.47 21 81909 1981 50521213
Post-traumatic pain 21.45 13.47 11 81919 365 50522829
Hypertension 21.21 13.47 229 81701 210974 50312220
Diabetes mellitus 21.20 13.47 29 81901 49004 50474190
Blood alkaline phosphatase increased 21.11 13.47 118 81812 37408 50485786
Vasculitis 21.11 13.47 60 81870 13931 50509263
Acral peeling skin syndrome 21.04 13.47 5 81925 12 50523182
Eastern Cooperative Oncology Group performance status worsened 20.96 13.47 13 81917 625 50522569
Muscle necrosis 20.90 13.47 12 81918 500 50522694
Product quality issue 20.85 13.47 12 81918 30846 50492348
Generalised oedema 20.83 13.47 59 81871 13672 50509522
Full blood count abnormal 20.82 13.47 6 81924 23382 50499812
Eye pain 20.79 13.47 10 81920 28439 50494755
White blood cell count abnormal 20.74 13.47 34 81896 5406 50517788
Hip fracture 20.73 13.47 8 81922 25923 50497271
Red cell distribution width increased 20.70 13.47 44 81886 8515 50514679
Monocyte count decreased 20.64 13.47 20 81910 1866 50521328
Blood creatine increased 20.63 13.47 32 81898 4855 50518339
Skin laceration 20.55 13.47 3 81927 18839 50504355
Joint injury 20.51 13.47 5 81925 21784 50501410
HER2 positive breast cancer 20.39 13.47 10 81920 301 50522893
Dizziness 20.37 13.47 417 81513 345952 50177242
Neuromuscular toxicity 20.36 13.47 8 81922 139 50523055
Lymphangitis 20.31 13.47 14 81916 806 50522388
Epidermolysis 20.31 13.47 9 81921 214 50522980
Hyperkalaemia 20.23 13.47 29 81901 48060 50475134
Transaminases 20.10 13.47 7 81923 85 50523109
Hypothalamo-pituitary disorder 20.07 13.47 13 81917 674 50522520
Surgery 20.05 13.47 12 81918 30193 50493001
Vision blurred 20.03 13.47 63 81867 78584 50444610
Chromosomal mutation 19.99 13.47 5 81925 16 50523178
Miller Fisher syndrome 19.88 13.47 7 81923 88 50523106
Leukaemia cutis 19.88 13.47 7 81923 88 50523106
Nail bed tenderness 19.86 13.47 10 81920 319 50522875
Neck pain 19.77 13.47 39 81891 57028 50466166
Hypoalbuminaemia 19.72 13.47 47 81883 9813 50513381
Neutrophil count abnormal 19.59 13.47 22 81908 2437 50520757
Aggression 19.58 13.47 5 81925 21111 50502083
Dysarthria 19.54 13.47 19 81911 37384 50485810
Phlebitis 19.48 13.47 34 81896 5686 50517508
Chemical peritonitis 19.46 13.47 7 81923 94 50523100
Hydrothorax 19.34 13.47 13 81917 718 50522476
Seroma 19.18 13.47 19 81911 1822 50521372
Paraparesis 19.13 13.47 20 81910 2044 50521150
Malaise 19.13 13.47 406 81524 335126 50188068
Ear pain 19.11 13.47 11 81919 28272 50494922
Retinitis pigmentosa 19.00 13.47 7 81923 101 50523093
Chronic obstructive pulmonary disease 18.96 13.47 36 81894 53399 50469795
Paralysis recurrent laryngeal nerve 18.94 13.47 6 81924 53 50523141
Congenital syphilitic osteochondritis 18.93 13.47 5 81925 21 50523173
Lung infiltration 18.82 13.47 56 81874 13337 50509857
Mucosal disorder 18.71 13.47 19 81911 1876 50521318
Intervertebral disc protrusion 18.58 13.47 5 81925 20388 50502806
Vulvitis 18.53 13.47 9 81921 265 50522929
Tympanic membrane disorder 18.50 13.47 8 81922 179 50523015
Blood pressure increased 18.37 13.47 133 81797 132999 50390195
Merycism 18.33 13.47 8 81922 183 50523011
Pneumonia aspiration 18.33 13.47 14 81916 30990 50492204
Kidney infection 18.25 13.47 4 81926 18742 50504452
Hyperchlorhydria 18.24 13.47 17 81913 1511 50521683
Breast inflammation 18.23 13.47 7 81923 114 50523080
Vaginal prolapse 18.21 13.47 10 81920 382 50522812
Muscle spasticity 18.14 13.47 3 81927 17181 50506013
Eosinophilia 18.12 13.47 4 81926 18648 50504546
Renal failure 18.07 13.47 100 81830 106533 50416661
Vulvovaginal candidiasis 17.98 13.47 22 81908 2670 50520524
Drug ineffective for unapproved indication 17.97 13.47 6 81924 21275 50501919
Cardiac arrest 17.97 13.47 72 81858 83579 50439615
Lymphadenopathy 17.96 13.47 104 81826 33395 50489799
Appendiceal abscess 17.87 13.47 8 81922 195 50522999
Onychoclasis 17.85 13.47 31 81899 5165 50518029
Chemotherapy 17.85 13.47 16 81914 1353 50521841
Blood pressure fluctuation 17.80 13.47 19 81911 35804 50487390
Vena cava thrombosis 17.70 13.47 19 81911 2002 50521192
Meibomian gland dysfunction 17.69 13.47 7 81923 124 50523070
Leukocytosis 17.68 13.47 78 81852 22501 50500693
Cytotoxic oedema 17.64 13.47 7 81923 125 50523069
Pulmonary toxicity 17.58 13.47 32 81898 5530 50517664
Gallbladder disorder 17.51 13.47 3 81927 16739 50506455
Pituitary tumour 17.37 13.47 13 81917 852 50522342
Staphylococcal impetigo 17.33 13.47 4 81926 8 50523186
Amnesia 17.27 13.47 26 81904 42234 50480960
Gastrointestinal perforation 17.26 13.47 23 81907 3038 50520156
Transient ischaemic attack 17.25 13.47 16 81914 32194 50491000
Hypervolaemia 17.11 13.47 10 81920 25489 50497705
Metastases to muscle 17.10 13.47 7 81923 136 50523058
Metastases to uterus 17.07 13.47 6 81924 75 50523119
Platelet count decreased 17.03 13.47 243 81687 100483 50422711
Cough 16.99 13.47 511 81419 240753 50282441
Foot deformity 16.97 13.47 5 81925 19205 50503989
Emotional distress 16.87 13.47 13 81917 28650 50494544
Gastritis 16.78 13.47 101 81829 32882 50490312
Axillary vein thrombosis 16.70 13.47 9 81921 331 50522863
Injection site rash 16.69 13.47 3 81927 16174 50507020
Abdominal rigidity 16.67 13.47 17 81913 1687 50521507
Clostridial infection 16.67 13.47 26 81904 3964 50519230
Underdose 16.64 13.47 6 81924 20272 50502922
Faeces discoloured 16.62 13.47 3 81927 16121 50507073
Acute respiratory distress syndrome 16.61 13.47 73 81857 21026 50502168
Dysaesthesia 16.53 13.47 25 81905 3710 50519484
Hepatic failure 16.52 13.47 99 81831 32184 50491010
No adverse event 16.48 13.47 18 81912 33560 50489634
Hiccups 16.38 13.47 17 81913 1722 50521472
Pneumothorax 16.35 13.47 55 81875 13979 50509215
Acute interstitial pneumonitis 16.29 13.47 11 81919 612 50522582
Labia enlarged 16.28 13.47 3 81927 0 50523194
Astringent therapy 16.28 13.47 3 81927 0 50523194
Chills 16.25 13.47 233 81697 96454 50426740
Radiation pneumonitis 16.22 13.47 15 81915 1320 50521874
Breast cancer 16.21 13.47 122 81808 42768 50480426
Hormone receptor positive breast cancer 16.21 13.47 10 81920 476 50522718
Muscle spasms 16.10 13.47 128 81802 125425 50397769
Tumour marker increased 16.01 13.47 25 81905 3815 50519379
Dandy-Walker syndrome 15.96 13.47 6 81924 92 50523102
Herpes simplex sepsis 15.90 13.47 5 81925 43 50523151
Rash follicular 15.90 13.47 5 81925 43 50523151
Product administration error 15.87 13.47 6 81924 19693 50503501
Coating in mouth 15.85 13.47 7 81923 165 50523029
Pseudomembranous colitis 15.82 13.47 21 81909 2764 50520430
Necrotising myositis 15.76 13.47 9 81921 371 50522823
Laboratory test abnormal 15.72 13.47 9 81921 23199 50499995
Nodular regenerative hyperplasia 15.64 13.47 8 81922 264 50522930
Colitis ischaemic 15.62 13.47 42 81888 9441 50513753
Retinal detachment 15.57 13.47 29 81901 5100 50518094
Atypical pneumonia 15.42 13.47 24 81906 3651 50519543
Vagus nerve disorder 15.34 13.47 6 81924 103 50523091
Disorientation 15.32 13.47 21 81909 35463 50487731
Cardio-respiratory arrest 15.30 13.47 41 81889 53851 50469343
Acne pustular 15.28 13.47 6 81924 104 50523090
Neoplasm recurrence 15.24 13.47 19 81911 2350 50520844
Dermatitis bullous 15.23 13.47 35 81895 7138 50516056
Pulmonary hypertension 15.23 13.47 19 81911 33398 50489796
Anal erythema 15.22 13.47 7 81923 182 50523012
Stress 15.22 13.47 41 81889 53752 50469442
Granulocytopenia 15.17 13.47 29 81901 5202 50517992
Pleural disorder 15.11 13.47 10 81920 538 50522656
Limb injury 14.98 13.47 7 81923 20243 50502951
Inflammatory carcinoma of the breast 14.89 13.47 5 81925 54 50523140
Memory impairment 14.81 13.47 72 81858 79288 50443906
Viral infection 14.80 13.47 16 81914 29970 50493224
Sarcoidosis 14.78 13.47 28 81902 4989 50518205
Arachnoid cyst 14.74 13.47 7 81923 196 50522998
Monocytopenia 14.56 13.47 5 81925 58 50523136
Seasonal allergy 14.56 13.47 3 81927 14673 50508521
Hypomagnesaemia 14.51 13.47 75 81855 23081 50500113
Left ventricular enlargement 14.49 13.47 5 81925 59 50523135
Hydrocephalus 14.45 13.47 27 81903 4761 50518433
Urogenital prolapse 14.41 13.47 4 81926 21 50523173
Mouth ulceration 14.38 13.47 86 81844 27938 50495256
Folliculitis 14.30 13.47 26 81904 39199 50483995
Oral pain 14.27 13.47 79 81851 24954 50498240
Upper limb fracture 14.26 13.47 4 81926 15869 50507325
Cardiac tamponade 14.21 13.47 25 81905 4207 50518987
Subretinal hyperreflective exudation 14.21 13.47 3 81927 3 50523191
Delirium 14.20 13.47 25 81905 38167 50485027
Fibrous histiocytoma 14.19 13.47 9 81921 450 50522744
Borrelia infection 14.18 13.47 6 81924 127 50523067
Pulmonary embolism 14.00 13.47 237 81693 101467 50421727
Feeling hot 13.98 13.47 110 81820 39092 50484102
Therapy responder 13.96 13.47 8 81922 332 50522862
Liver function test abnormal 13.94 13.47 32 81898 44307 50478887
Blood glucose decreased 13.94 13.47 6 81924 18205 50504989
Pain in extremity 13.88 13.47 336 81594 272529 50250665
Vein disorder 13.85 13.47 25 81905 4294 50518900
Sleep disorder 13.81 13.47 47 81883 57236 50465958
Iron deficiency anaemia 13.78 13.47 5 81925 16829 50506365
Respiratory arrest 13.74 13.47 17 81913 29992 50493202
Crying 13.71 13.47 8 81922 20408 50502786
Device dislocation 13.69 13.47 9 81921 21537 50501657
Clostridium difficile infection 13.65 13.47 79 81851 25360 50497834
Therapy non-responder 13.61 13.47 40 81890 50982 50472212
Peripheral motor neuropathy 13.50 13.47 14 81916 1417 50521777
Acute respiratory failure 13.50 13.47 16 81914 28766 50494428
Frequent bowel movements 13.49 13.47 3 81927 13915 50509279
Peritoneal abscess 13.49 13.47 6 81924 144 50523050
Oesophagitis 13.48 13.47 50 81880 13333 50509861

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 1198.65 15.55 881 36482 72978 29464186
Febrile neutropenia 568.52 15.55 703 36660 111537 29425627
Osteonecrosis of jaw 535.13 15.55 305 37058 16205 29520959
Prostatic specific antigen increased 385.39 15.55 224 37139 12340 29524824
Metastases to bone 356.35 15.55 196 37167 9702 29527462
Neutropenia 339.76 15.55 601 36762 131110 29406054
Disease progression 313.56 15.55 448 36915 81468 29455696
Diarrhoea 301.41 15.55 1011 36352 331687 29205477
Mucosal inflammation 190.75 15.55 217 37146 31378 29505786
Metastases to lymph nodes 173.97 15.55 90 37273 3927 29533237
Hormone-refractory prostate cancer 170.44 15.55 53 37310 576 29536588
Neutropenic sepsis 165.17 15.55 129 37234 11598 29525566
Stomatitis 164.29 15.55 218 37145 36895 29500269
Interstitial lung disease 162.18 15.55 274 37089 57444 29479720
Neutrophil count decreased 148.65 15.55 226 37137 43341 29493823
Prostate cancer metastatic 148.13 15.55 87 37276 4879 29532285
Neoplasm progression 126.37 15.55 136 37227 18476 29518688
Leukopenia 125.50 15.55 239 37124 54964 29482200
Metastases to lung 122.89 15.55 92 37271 7763 29529401
Alopecia 120.11 15.55 134 37229 18950 29518214
Pneumonitis 118.37 15.55 161 37202 27883 29509281
Palmar-plantar erythrodysaesthesia syndrome 111.17 15.55 114 37249 14645 29522519
Onycholysis 106.44 15.55 35 37328 461 29536703
Dehydration 104.92 15.55 351 37012 114397 29422767
Metastases to liver 103.04 15.55 99 37264 11757 29525407
Anaemia 99.12 15.55 508 36855 200443 29336721
Skin toxicity 91.76 15.55 58 37305 3713 29533451
Metastases to central nervous system 90.90 15.55 74 37289 7057 29530107
Haematotoxicity 88.53 15.55 71 37292 6628 29530536
Nausea 84.54 15.55 639 36724 288616 29248548
Hypocalcaemia 81.73 15.55 115 37248 20550 29516614
Drug interaction 81.11 15.55 78 37285 197307 29339857
Portal venous gas 80.82 15.55 26 37337 318 29536846
Product dose omission issue 79.84 15.55 13 37350 96370 29440794
Fall 76.35 15.55 67 37296 177111 29360053
Bone marrow failure 75.27 15.55 129 37234 27320 29509844
Decreased appetite 73.33 15.55 370 36993 144972 29392192
Bacterial translocation 70.49 15.55 21 37342 195 29536969
Septic shock 67.73 15.55 203 37160 62357 29474807
Prostate cancer 66.12 15.55 117 37246 25410 29511754
White blood cell count decreased 64.91 15.55 242 37121 83120 29454044
Peripheral sensory neuropathy 64.10 15.55 56 37307 5883 29531281
Recall phenomenon 62.36 15.55 24 37339 511 29536653
Neuropathy peripheral 61.94 15.55 214 37149 70813 29466351
Bone pain 60.45 15.55 94 37269 18358 29518806
Overdose 59.30 15.55 14 37349 79805 29457359
Osteonecrosis 57.60 15.55 78 37285 13441 29523723
Headache 56.24 15.55 83 37280 173924 29363240
Vomiting 55.27 15.55 457 36906 211803 29325361
Oesophageal fistula 55.06 15.55 17 37346 180 29536984
Oesophagobronchial fistula 54.35 15.55 16 37347 142 29537022
Tremor 52.49 15.55 14 37349 73524 29463640
Nasopharyngitis 51.80 15.55 7 37356 59658 29477506
Bone lesion 49.87 15.55 35 37328 2669 29534495
Nail disorder 49.31 15.55 30 37333 1794 29535370
Metastasis 48.87 15.55 38 37325 3391 29533773
Pleural effusion 48.84 15.55 200 37163 71708 29465456
Fatigue 48.74 15.55 612 36751 316209 29220955
General physical health deterioration 48.43 15.55 257 37106 102600 29434564
Colon cancer stage III 48.19 15.55 14 37349 118 29537046
Polyneuropathy 45.64 15.55 66 37297 12086 29525078
Reproductive toxicity 44.85 15.55 9 37354 9 29537155
Urinary tract toxicity 44.37 15.55 9 37354 10 29537154
Radiation skin injury 43.82 15.55 20 37343 660 29536504
Agitation 42.28 15.55 7 37356 51297 29485867
Onychomadesis 42.18 15.55 18 37345 504 29536660
Neutropenic colitis 41.68 15.55 30 37333 2381 29534783
Metastases to skin 41.51 15.55 16 37347 342 29536822
Prostate cancer recurrent 41.05 15.55 21 37342 894 29536270
Weight increased 40.86 15.55 23 37340 76644 29460520
Pyrexia 39.74 15.55 545 36818 287077 29250087
Rhabdomyolysis 39.04 15.55 14 37349 60794 29476370
Insomnia 38.85 15.55 33 37330 88728 29448436
Depression 38.08 15.55 31 37332 85116 29452048
Cardiac failure congestive 37.99 15.55 25 37338 76556 29460608
Disseminated intravascular coagulation 37.56 15.55 80 37283 19900 29517264
Somnolence 37.50 15.55 38 37325 93917 29443247
Pulmonary toxicity 37.22 15.55 38 37325 4852 29532312
Pneumatosis intestinalis 36.46 15.55 31 37332 3138 29534026
Dermatitis 36.31 15.55 47 37316 7751 29529413
Gastrointestinal toxicity 35.66 15.55 26 37337 2105 29535059
Gastric perforation 35.07 15.55 26 37337 2160 29535004
Acute motor-sensory axonal neuropathy 35.01 15.55 11 37352 124 29537040
Exposed bone in jaw 34.03 15.55 22 37341 1464 29535700
Plasma cell myeloma 33.07 15.55 4 37359 37111 29500053
Metastases to meninges 33.04 15.55 20 37343 1185 29535979
Nail toxicity 32.98 15.55 8 37355 30 29537134
Death 32.83 15.55 610 36753 341474 29195690
Necrotising retinitis 32.65 15.55 17 37346 751 29536413
Metastases to soft tissue 32.44 15.55 12 37351 228 29536936
Carbohydrate antigen 15-3 increased 31.73 15.55 9 37354 69 29537095
Pneumothorax 31.61 15.55 65 37298 15777 29521387
Nail ridging 31.46 15.55 8 37355 38 29537126
Musculoskeletal stiffness 31.11 15.55 5 37358 37453 29499711
Hallucination 30.99 15.55 9 37354 44703 29492461
Erythema 30.95 15.55 182 37181 75424 29461740
Metastases to pleura 30.91 15.55 13 37350 351 29536813
Myocardial infarction 30.60 15.55 58 37305 110238 29426926
Second primary malignancy 30.57 15.55 40 37323 6665 29530499
Drug hypersensitivity 30.46 15.55 25 37338 68381 29468783
Blood pressure increased 29.27 15.55 30 37333 73773 29463391
Intestinal ischaemia 29.09 15.55 39 37324 6653 29530511
Atypical haemolytic uraemic syndrome 28.86 15.55 10 37353 156 29537008
Drug ineffective 28.77 15.55 307 37056 362863 29174301
Hypophagia 28.76 15.55 74 37289 20798 29516366
Bone disorder 28.73 15.55 36 37327 5747 29531417
Gastrointestinal ischaemia 28.62 15.55 10 37353 160 29537004
Metastases to spine 28.61 15.55 23 37340 2153 29535011
Eubacterium infection 28.38 15.55 5 37358 0 29537164
Karnofsky scale worsened 28.38 15.55 5 37358 0 29537164
Suicidal ideation 28.02 15.55 5 37358 34711 29502453
Dizziness 27.90 15.55 134 37229 189550 29347614
Joint swelling 27.74 15.55 14 37349 49616 29487548
Injection site pain 27.70 15.55 4 37359 32442 29504722
Cerebrovascular accident 27.52 15.55 34 37329 76877 29460287
Inappropriate schedule of product administration 27.27 15.55 11 37352 44461 29492703
Anxiety 27.25 15.55 41 37322 85324 29451840
Urticaria 26.89 15.55 18 37345 54642 29482522
Nicotinic acid deficiency 26.88 15.55 8 37355 74 29537090
Mediastinitis 26.71 15.55 14 37349 627 29536537
Muscle spasms 26.33 15.55 26 37337 65056 29472108
Macroenzyme creatine kinase 26.28 15.55 6 37357 16 29537148
Colitis 26.21 15.55 93 37270 31155 29506009
Incorrect dose administered 26.09 15.55 5 37358 32979 29504185
Carotid artery aneurysm 26.02 15.55 7 37356 43 29537121
Hyponatraemia 25.89 15.55 160 37203 67473 29469691
Dysphagia 25.64 15.55 137 37226 54789 29482375
Hypophosphataemia 25.43 15.55 40 37323 7884 29529280
Cholangitis sclerosing 24.93 15.55 16 37347 1051 29536113
Pancreatitis viral 24.92 15.55 5 37358 5 29537159
Tooth extraction 24.28 15.55 28 37335 4101 29533063
Seizure 24.08 15.55 51 37312 93072 29444092
Contusion 23.99 15.55 5 37358 31090 29506074
Sinusitis 23.64 15.55 7 37356 34343 29502821
Blood glucose increased 23.36 15.55 24 37339 58960 29478204
Pharyngeal abscess 23.26 15.55 11 37352 394 29536770
Flushing 23.22 15.55 85 37278 28907 29508257
Rheumatoid arthritis 23.16 15.55 6 37357 32146 29505018
Transdifferentiation of neoplasm 22.94 15.55 7 37356 71 29537093
Chemotherapy 22.80 15.55 12 37351 542 29536622
Hypokalaemia 22.61 15.55 124 37239 50079 29487085
Hydronephrosis 22.57 15.55 40 37323 8690 29528474
Paronychia 22.57 15.55 23 37340 2930 29534234
Acute respiratory distress syndrome 22.54 15.55 72 37291 22863 29514301
Tracheal fistula 22.51 15.55 7 37356 76 29537088
Rash 22.49 15.55 144 37219 189675 29347489
Therapy partial responder 22.14 15.55 30 37333 5169 29531995
Tumour pain 22.06 15.55 14 37349 902 29536262
Hospitalisation 21.49 15.55 16 37347 45972 29491192
Tracheal stenosis 21.48 15.55 8 37355 155 29537009
Bronchial fistula 21.16 15.55 8 37355 162 29537002
Aorto-oesophageal fistula 21.04 15.55 6 37357 47 29537117
Capillary leak syndrome 20.68 15.55 18 37345 1881 29535283
Blood creatine phosphokinase increased 20.51 15.55 13 37350 40631 29496533
Free prostate-specific antigen positive 20.47 15.55 4 37359 3 29537161
Metastases to bladder 20.40 15.55 6 37357 53 29537111
Gastrointestinal necrosis 20.35 15.55 22 37341 3000 29534164
Trigeminal nerve paresis 19.93 15.55 4 37359 4 29537160
Infusion site plaque 19.93 15.55 4 37359 4 29537160
Metastases to peritoneum 19.85 15.55 16 37347 1504 29535660
Feeling abnormal 19.54 15.55 24 37339 54421 29482743
Scleroderma 19.44 15.55 15 37348 1323 29535841
Abnormal behaviour 19.40 15.55 3 37360 23124 29514040
Lacrimation increased 19.38 15.55 33 37330 6947 29530217
Oesophagitis 19.32 15.55 45 37318 11878 29525286
Periorbital disorder 18.98 15.55 5 37358 28 29537136
Metastases to the mediastinum 18.85 15.55 8 37355 221 29536943
Superior mesenteric artery syndrome 18.75 15.55 6 37357 72 29537092
Cranial nerve disorder 18.73 15.55 10 37353 465 29536699
Enteritis 18.71 15.55 32 37331 6759 29530405
Hypovolaemic shock 18.59 15.55 30 37333 6042 29531122
Aneurysm ruptured 18.56 15.55 10 37353 474 29536690
Osteoradionecrosis 18.53 15.55 6 37357 75 29537089
Irritability 18.30 15.55 3 37360 22149 29515015
Oral candidiasis 17.96 15.55 41 37322 10681 29526483
Memory impairment 17.95 15.55 12 37351 36458 29500706
Acute interstitial pneumonitis 17.93 15.55 9 37354 368 29536796
Bradycardia 17.76 15.55 35 37328 65594 29471570
Neutropenic infection 17.58 15.55 14 37349 1293 29535871
Disturbance in attention 17.48 15.55 3 37360 21421 29515743
Agranulocytosis 17.45 15.55 61 37302 20279 29516885
Oral pain 17.18 15.55 37 37326 9270 29527894
Carotidynia 17.03 15.55 3 37360 0 29537164
Hyperchromasia 17.03 15.55 3 37360 0 29537164
Arthralgia 16.99 15.55 105 37258 139512 29397652
Adenocarcinoma 16.89 15.55 15 37348 1610 29535554
Pruritus 16.89 15.55 83 37280 116766 29420398
Oesophageal perforation 16.85 15.55 11 37352 744 29536420
Coma 16.84 15.55 15 37348 39435 29497729
Retroperitoneal lymphadenopathy 16.83 15.55 11 37352 746 29536418
Dacryostenosis acquired 16.82 15.55 7 37356 184 29536980
Tracheo-oesophageal fistula 16.81 15.55 9 37354 421 29536743
Thrombocytopenia 16.74 15.55 251 37112 134572 29402592
PO2 increased 16.65 15.55 10 37353 584 29536580
Traumatic lung injury 16.65 15.55 13 37350 1167 29535997
International normalised ratio increased 16.52 15.55 19 37344 44353 29492811
Portosplenomesenteric venous thrombosis 16.49 15.55 4 37359 15 29537149
Vascular pseudoaneurysm 16.41 15.55 16 37347 1933 29535231
Polyneuropathy in malignant disease 16.37 15.55 6 37357 111 29537053
Enterovesical fistula 16.33 15.55 10 37353 605 29536559
Psychotic disorder 16.28 15.55 3 37360 20351 29516813
Nephrolithiasis 15.97 15.55 6 37357 25328 29511836

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 1659.70 13.20 1385 98844 111486 64287017
Febrile neutropenia 1406.82 13.20 1590 98639 186067 64212436
Neutropenia 1198.88 13.20 1658 98571 237966 64160537
Diarrhoea 1076.62 13.20 2988 97241 719716 63678787
Palmar-plantar erythrodysaesthesia syndrome 749.78 13.20 499 99730 28320 64370183
Disease progression 738.11 13.20 1001 99228 140679 64257824
Metastases to bone 720.40 13.20 429 99800 20006 64378497
Mucosal inflammation 668.36 13.20 642 99587 61942 64336561
Neuropathy peripheral 588.65 13.20 815 99414 116710 64281793
Myelosuppression 547.09 13.20 382 99847 23448 64375055
Bone marrow failure 532.95 13.20 503 99726 47449 64351054
Metastases to liver 485.75 13.20 356 99873 23585 64374918
Metastases to lung 415.57 13.20 272 99957 14992 64383511
Neutropenic sepsis 396.89 13.20 312 99917 22960 64375543
Metastases to central nervous system 386.31 13.20 251 99978 13661 64384842
Metastases to lymph nodes 384.85 13.20 212 100017 8505 64389998
Osteonecrosis of jaw 379.33 13.20 384 99845 39441 64359062
Ejection fraction decreased 343.72 13.20 314 99915 28393 64370110
Neoplasm progression 319.19 13.20 355 99874 40609 64357894
Stomatitis 295.73 13.20 575 99654 109030 64289473
Fall 281.02 13.20 149 100080 416677 63981826
Leukopenia 279.08 13.20 536 99693 100706 64297797
Skin toxicity 273.51 13.20 154 100075 6448 64392055
Polyneuropathy 262.69 13.20 230 99999 19664 64378839
Agranulocytosis 258.59 13.20 308 99921 37921 64360582
Neutrophil count decreased 256.22 13.20 443 99786 76753 64321750
Interstitial lung disease 249.46 13.20 501 99728 97231 64301272
Prostatic specific antigen increased 245.52 13.20 159 100070 8601 64389902
Rheumatoid arthritis 235.00 13.20 4 100225 164290 64234213
Drug ineffective 233.92 13.20 610 99619 839637 63558866
Onycholysis 216.40 13.20 85 100144 1541 64396962
Haematotoxicity 213.62 13.20 170 100059 12726 64385777
Nausea 212.97 13.20 2004 98225 783796 63614707
Decreased appetite 208.96 13.20 928 99301 280361 64118142
Joint swelling 195.85 13.20 47 100182 215335 64183168
Peripheral sensory neuropathy 194.94 13.20 153 100076 11225 64387278
Alopecia areata 186.36 13.20 75 100154 1453 64397050
Product dose omission issue 186.13 13.20 38 100191 194709 64203794
Drug abuse 182.32 13.20 5 100224 132369 64266134
Pleural effusion 180.85 13.20 518 99711 126041 64272462
White blood cell count decreased 178.17 13.20 595 99634 157242 64241261
Neutropenic colitis 176.71 13.20 102 100127 4479 64394024
Bone pain 176.45 13.20 287 99942 47285 64351218
Recall phenomenon 171.45 13.20 63 100166 943 64397560
Madarosis 168.19 13.20 79 100150 2251 64396252
Vomiting 160.16 13.20 1428 98801 549689 63848814
Flushing 157.96 13.20 366 99863 78282 64320221
Pneumonitis 157.94 13.20 282 99947 50083 64348420
Colitis 155.91 13.20 306 99923 58368 64340135
Alopecia 155.59 13.20 588 99641 165102 64233401
Nail disorder 152.14 13.20 118 100111 8506 64389997
Hair texture abnormal 152.00 13.20 80 100149 2924 64395579
Metastasis 151.37 13.20 100 100129 5595 64392908
Overdose 148.64 13.20 33 100196 159533 64238970
Therapeutic product effect decreased 146.52 13.20 8 100221 115343 64283160
Arthropathy 145.91 13.20 11 100218 120956 64277547
Pyrexia 142.50 13.20 1408 98821 557236 63841267
Drug interaction 140.47 13.20 216 100013 361867 64036636
Metastases to skin 139.11 13.20 60 100169 1392 64397111
Hair colour changes 138.50 13.20 81 100148 3646 64394857
Somnolence 138.16 13.20 72 100157 203573 64194930
Gastrointestinal toxicity 135.54 13.20 91 100138 5231 64393272
Acute myeloid leukaemia 135.03 13.20 189 100040 27274 64371229
Erythema 133.32 13.20 610 99619 186460 64212043
Anaemia 133.23 13.20 1025 99204 377655 64020848
Contraindicated product administered 132.37 13.20 9 100220 107820 64290683
Sinusitis 128.44 13.20 34 100195 145894 64252609
Cardiotoxicity 128.08 13.20 115 100114 10159 64388344
Drug hypersensitivity 127.81 13.20 109 100120 237706 64160797
Nail toxicity 127.53 13.20 39 100190 317 64398186
Dehydration 124.70 13.20 665 99564 216098 64182405
Second primary malignancy 121.15 13.20 121 100108 12216 64386287
Aortitis 120.47 13.20 50 100179 1051 64397452
Breast cancer recurrent 120.03 13.20 65 100164 2518 64395985
Weight increased 119.34 13.20 94 100135 213254 64185249
Injection site pain 119.15 13.20 16 100213 111392 64287111
Capillary leak syndrome 115.56 13.20 69 100160 3228 64395275
Myocardial infarction 111.90 13.20 59 100170 165762 64232741
Confusional state 109.87 13.20 147 100082 260997 64137506
Dermatitis 108.52 13.20 137 100092 17892 64380611
Radiation skin injury 108.20 13.20 49 100180 1281 64397222
Left ventricular dysfunction 103.91 13.20 130 100099 16824 64381679
Musculoskeletal stiffness 102.34 13.20 32 100197 123174 64275329
Breast cancer metastatic 100.93 13.20 86 100143 7083 64391420
Paronychia 97.84 13.20 81 100148 6411 64392092
Systemic lupus erythematosus 96.67 13.20 6 100223 77606 64320897
Lacrimation increased 95.81 13.20 130 100099 18216 64380287
Biopsy lung abnormal 95.47 13.20 26 100203 132 64398371
Dysgeusia 94.48 13.20 219 100010 46828 64351675
Condition aggravated 93.72 13.20 283 99946 372143 64026360
Lymphoedema 93.33 13.20 95 100134 9810 64388693
Fatigue 90.40 13.20 1648 98581 747082 63651421
Headache 90.22 13.20 470 99759 528997 63869506
Metastases to pleura 88.60 13.20 42 100187 1222 64397281
Cerebrovascular accident 88.41 13.20 52 100177 137531 64260972
Portal venous gas 86.70 13.20 29 100200 323 64398180
Contusion 83.84 13.20 36 100193 113929 64284574
Metastases to meninges 83.60 13.20 53 100176 2762 64395741
Product use issue 83.36 13.20 68 100161 151647 64246856
Pemphigus 81.03 13.20 3 100226 60698 64337805
Suicide attempt 78.84 13.20 9 100220 70998 64327505
Lymphangiosis carcinomatosa 76.84 13.20 43 100186 1778 64396725
Skin exfoliation 76.34 13.20 196 100033 44689 64353814
Depression 76.21 13.20 104 100125 183187 64215316
Septic shock 75.16 13.20 344 99885 105093 64293410
Hand deformity 74.86 13.20 6 100223 62765 64335738
Acute promyelocytic leukaemia 73.18 13.20 38 100191 1350 64397153
Abdominal discomfort 72.29 13.20 107 100122 182215 64216288
Inappropriate schedule of product administration 71.39 13.20 27 100202 92259 64306244
Myositis 70.72 13.20 106 100123 16271 64382232
Hypocalcaemia 70.67 13.20 182 100047 41571 64356932
Metastases to peritoneum 70.23 13.20 52 100177 3495 64395008
Hypokalaemia 70.01 13.20 374 99855 121529 64276974
Hormone-refractory prostate cancer 69.75 13.20 25 100204 347 64398156
Neutropenic infection 68.55 13.20 41 100188 1924 64396579
Injection site erythema 67.20 13.20 14 100215 70786 64327717
Febrile bone marrow aplasia 66.90 13.20 85 100144 11170 64387333
Nail dystrophy 66.29 13.20 30 100199 783 64397720
Pseudocirrhosis 66.24 13.20 28 100201 617 64397886
Feeling abnormal 66.08 13.20 66 100163 133536 64264967
Multifocal micronodular pneumocyte hyperplasia 65.51 13.20 17 100212 69 64398434
Bronchial polyp 65.13 13.20 17 100212 71 64398432
Nail discolouration 64.27 13.20 43 100186 2457 64396046
Blood pressure systolic increased 64.15 13.20 3 100226 49450 64349053
Hospitalisation 63.40 13.20 19 100210 75188 64323315
Maternal exposure during pregnancy 63.37 13.20 35 100194 95849 64302654
Organising pneumonia 62.92 13.20 74 100155 8981 64389522
Tremor 62.73 13.20 83 100146 148147 64250356
Prostate cancer metastatic 62.21 13.20 47 100182 3257 64395246
Intestinal ischaemia 62.08 13.20 83 100146 11466 64387037
Therapy partial responder 61.87 13.20 78 100151 10170 64388333
Toxicity to various agents 59.96 13.20 326 99903 363187 64035316
Injury 59.95 13.20 8 100221 55984 64342519
Intentional product misuse 59.62 13.20 19 100210 72276 64326227
Hepatic enzyme increased 58.92 13.20 69 100160 129874 64268629
Hallucination 58.50 13.20 20 100209 72768 64325735
International normalised ratio increased 58.23 13.20 25 100204 79142 64319361
Metastases to spine 58.15 13.20 47 100182 3596 64394907
Wound 58.12 13.20 23 100206 76454 64322049
Bradycardia 57.77 13.20 59 100170 118160 64280343
Arthritis 57.73 13.20 29 100200 83785 64314718
Agitation 57.32 13.20 33 100196 88334 64310169
Gastrointestinal necrosis 56.62 13.20 53 100176 4939 64393564
Incorrect dose administered 55.68 13.20 13 100216 60752 64337751
Dacryostenosis acquired 54.86 13.20 22 100207 422 64398081
Pulmonary toxicity 54.63 13.20 67 100162 8494 64390009
Injection site reaction 54.17 13.20 5 100224 46659 64351844
Hypoglycaemia 53.59 13.20 37 100192 89855 64308648
Aggression 53.54 13.20 5 100224 46227 64352276
Plasma cell myeloma 53.31 13.20 5 100224 46070 64352433
Drug reaction with eosinophilia and systemic symptoms 52.97 13.20 10 100219 54207 64344296
Electrocardiogram QT prolonged 52.49 13.20 29 100200 79419 64319084
Sedation 52.25 13.20 3 100226 41459 64357044
Neurotoxicity 52.22 13.20 125 100104 27279 64371224
Enterocolitis 52.19 13.20 78 100151 11940 64386563
Large intestine perforation 52.18 13.20 80 100149 12524 64385979
Bacterial translocation 51.93 13.20 21 100208 412 64398091
Mobility decreased 51.61 13.20 35 100194 85805 64312698
Loss of personal independence in daily activities 51.53 13.20 24 100205 72430 64326073
Dermatitis acneiform 50.56 13.20 64 100165 8379 64390124
Nasal congestion 50.42 13.20 15 100214 59643 64338860
Anxiety 50.16 13.20 155 100074 202494 64196009
Osteoarthritis 49.87 13.20 18 100211 63318 64335185
Onychomadesis 49.87 13.20 39 100190 2845 64395658
Coma 49.70 13.20 38 100191 87577 64310926
Periarticular thenar erythema with onycholysis 49.15 13.20 11 100218 19 64398484
Suicidal ideation 48.96 13.20 21 100208 66521 64331982
Asthma 48.28 13.20 46 100183 95179 64303324
Rhabdomyolysis 48.06 13.20 43 100186 91683 64306820
Nephrolithiasis 47.35 13.20 6 100223 43677 64354826
Intentional product use issue 47.27 13.20 47 100182 95317 64303186
Medication error 47.17 13.20 10 100219 49956 64348547
Carotidynia 46.66 13.20 15 100214 146 64398357
Injection site swelling 46.51 13.20 5 100224 41348 64357155
Thrombocytopenia 46.45 13.20 542 99687 223259 64175244
Tonsillar disorder 45.99 13.20 25 100204 976 64397527
Pain 45.85 13.20 596 99633 552915 63845588
Oesophagobronchial fistula 45.74 13.20 16 100213 206 64398297
Insomnia 45.72 13.20 156 100073 197680 64200823
Metastases to the mediastinum 44.48 13.20 20 100209 514 64397989
Cystoid macular oedema 44.38 13.20 30 100199 1744 64396759
Lactic acidosis 44.21 13.20 20 100209 61390 64337113
Injection site pruritus 44.05 13.20 4 100225 37822 64360681
Prostate cancer 44.04 13.20 96 100133 19699 64378804
Alopecia totalis 43.96 13.20 17 100212 295 64398208
Exposure during pregnancy 43.67 13.20 34 100195 77641 64320862
Metastases to soft tissue 43.56 13.20 18 100211 374 64398129
Blood cholesterol increased 43.39 13.20 12 100217 50054 64348449
General physical health deterioration 43.28 13.20 497 99732 203928 64194575
Dyspnoea 43.08 13.20 1439 98790 717235 63681268
Arthralgia 42.84 13.20 460 99769 441800 63956703
Influenza 42.71 13.20 62 100167 106469 64292034
Migraine 42.70 13.20 22 100207 62655 64335848
Bone lesion 42.55 13.20 46 100183 5091 64393412
Onychalgia 42.54 13.20 22 100207 775 64397728
PIK3CA-activated mutation 41.63 13.20 19 100210 506 64397997
Epistaxis 41.51 13.20 278 99951 97853 64300650
Chemotherapy 41.36 13.20 27 100202 1480 64397023
Pneumothorax 41.20 13.20 106 100123 24192 64374311
Hepatic lesion 41.14 13.20 48 100181 5776 64392727
Odynophagia 41.05 13.20 62 100167 9579 64388924
Oesophageal fistula 40.48 13.20 16 100213 295 64398208
Vascular device infection 40.47 13.20 49 100180 6131 64392372
Angioedema 40.22 13.20 23 100206 61798 64336705
Dermatomyositis 40.19 13.20 34 100195 2772 64395731
Device related thrombosis 40.01 13.20 30 100199 2055 64396448
Breast pain 39.89 13.20 52 100177 7009 64391494
Eosinophilia 39.45 13.20 6 100223 38070 64360433
Cardiac arrest 39.43 13.20 116 100113 153948 64244555
Lumbosacral radiculoplexus neuropathy 39.43 13.20 11 100218 62 64398441
Computerised tomogram thorax abnormal 39.28 13.20 29 100200 1940 64396563
Performance status decreased 39.22 13.20 45 100184 5319 64393184
Back pain 38.99 13.20 575 99654 249596 64148907
Blood pressure fluctuation 38.76 13.20 16 100213 51855 64346648
EGFR gene mutation 38.05 13.20 16 100213 348 64398155
Nasopharyngitis 37.97 13.20 166 100063 195907 64202596
Dizziness 37.89 13.20 457 99772 429706 63968797
Accidental overdose 37.89 13.20 4 100225 33553 64364950
Constipation 37.68 13.20 532 99697 228805 64169698
Enterocolitis infectious 37.67 13.20 31 100198 2433 64396070
Ejection fraction 37.66 13.20 24 100205 1262 64397241
Blood glucose increased 37.46 13.20 59 100170 98014 64300489
Swollen tongue 37.40 13.20 5 100224 34949 64363554
Coronary artery disease 37.19 13.20 24 100205 60409 64338094
Metastases to chest wall 36.94 13.20 16 100213 375 64398128
Urticaria 36.93 13.20 112 100117 147205 64251298
Basal cell carcinoma 36.62 13.20 3 100226 30835 64367668
Congestive cardiomyopathy 36.44 13.20 61 100168 10283 64388220
COVID-19 36 13.20 29 100200 65111 64333392
Systemic scleroderma 35.97 13.20 21 100208 942 64397561
Helicobacter infection 35.56 13.20 8 100221 38354 64360149
Product prescribing error 35.55 13.20 6 100223 35263 64363240
Paraesthesia 35.49 13.20 342 99887 134180 64264323
Drug intolerance 35.30 13.20 161 100068 187831 64210672
Hot flush 35.29 13.20 154 100075 46081 64352422
Gastrointestinal haemorrhage 35.05 13.20 98 100131 132214 64266289
Mastectomy 34.89 13.20 21 100208 997 64397506
Wheezing 34.20 13.20 45 100184 80534 64317969
Unevaluable event 33.98 13.20 18 100211 50471 64348032
Asthenopia 33.93 13.20 27 100202 2020 64396483
Road traffic accident 33.87 13.20 4 100225 30741 64367762
Exposed bone in jaw 33.86 13.20 34 100195 3453 64395050
Irritability 33.39 13.20 8 100221 36738 64361765
Gait disturbance 33.18 13.20 146 100083 172009 64226494
Blood pressure increased 32.86 13.20 147 100082 172405 64226098
Vulvovaginal dryness 32.80 13.20 24 100205 1584 64396919
Acoustic stimulation tests abnormal 32.70 13.20 8 100221 24 64398479
Psychotic disorder 32.48 13.20 7 100222 34571 64363932
Full blood count abnormal 32.46 13.20 4 100225 29753 64368750
Adverse drug reaction 32.42 13.20 15 100214 45449 64353054
Acute respiratory distress syndrome 32.29 13.20 133 100096 38802 64359701
Hypertension 32.29 13.20 253 99976 259008 64139495
Obstructive shock 32.08 13.20 9 100220 52 64398451
Metastatic neoplasm 32.03 13.20 37 100192 4405 64394098
Acute interstitial pneumonitis 31.81 13.20 20 100209 1027 64397476
Purtscher retinopathy 31.69 13.20 7 100222 11 64398492
Drug resistance 31.58 13.20 123 100106 34979 64363524
Blood lactate dehydrogenase increased 31.48 13.20 118 100111 32960 64365543
C-reactive protein abnormal 31.45 13.20 4 100225 29043 64369460
Dyskinesia 31.34 13.20 11 100218 39377 64359126
Oral candidiasis 31.17 13.20 93 100136 23119 64375384
White blood cell count abnormal 30.99 13.20 38 100191 4816 64393687
Stress 30.96 13.20 29 100200 60505 64337998
Dysarthria 30.93 13.20 28 100201 59378 64339125
Blood uric acid decreased 30.80 13.20 20 100209 1086 64397417
Pericarditis 30.76 13.20 31 100198 62485 64336018
Treatment failure 30.58 13.20 87 100142 116729 64281774
Irritable bowel syndrome 30.49 13.20 10 100219 37359 64361144
Nephritis bacterial 30.35 13.20 8 100221 35 64398468
Coating in mouth 30.27 13.20 12 100217 223 64398280
Muscle injury 30.24 13.20 3 100226 26434 64372069
Treatment noncompliance 30.01 13.20 15 100214 43467 64355036
Drug level increased 30.00 13.20 8 100221 34188 64364315
Gastric perforation 29.98 13.20 32 100197 3491 64395012
Nervousness 29.85 13.20 5 100224 29551 64368952
Prostate cancer recurrent 29.83 13.20 17 100212 728 64397775
Pruritus 29.77 13.20 326 99903 312074 64086429
Device related infection 29.77 13.20 110 100119 30516 64367987
Cardiac dysfunction 29.64 13.20 30 100199 3076 64395427
Swelling 29.60 13.20 138 100091 160080 64238423
Adenocarcinoma 29.51 13.20 31 100198 3320 64395183
Psoriasis 29.46 13.20 41 100188 71662 64326841
Hyperfibrinogenaemia 29.34 13.20 9 100220 74 64398429
Periorbital disorder 29.31 13.20 8 100221 41 64398462
Vascular fragility 29.22 13.20 10 100219 120 64398383
Mucosal infection 28.80 13.20 14 100215 431 64398072
Cardiac failure congestive 28.79 13.20 105 100124 130475 64268028
Pneumatosis intestinalis 28.75 13.20 38 100191 5191 64393312
Tumour embolism 28.71 13.20 10 100219 127 64398376
Barotrauma 28.65 13.20 11 100218 187 64398316
Erysipelas 28.65 13.20 51 100178 9030 64389473
Meibomian gland dysfunction 28.64 13.20 10 100219 128 64398375
Glossodynia 28.63 13.20 35 100194 64661 64333842
Bronchitis 28.46 13.20 81 100148 108662 64289841
Myelodysplastic syndrome 28.46 13.20 101 100128 27478 64371025
Ascites 28.26 13.20 179 100050 61822 64336681
Nicotinic acid deficiency 28.22 13.20 10 100219 134 64398369
Acute kidney injury 28.16 13.20 510 99719 448730 63949773
Therapy cessation 27.76 13.20 8 100221 32481 64366022
Pulmonary mass 27.45 13.20 91 100138 23925 64374578
Tongue coated 27.41 13.20 19 100210 1151 64397352
Karnofsky scale worsened 27.34 13.20 5 100224 0 64398503
Eubacterium infection 27.34 13.20 5 100224 0 64398503
Diabetes mellitus 27.32 13.20 38 100191 66436 64332067
Injection site haemorrhage 27.14 13.20 3 100226 24275 64374228
Osteonecrosis 27.11 13.20 101 100128 28128 64370375
Scleroderma renal crisis 27.09 13.20 13 100216 389 64398114
Drug dependence 27.03 13.20 9 100220 33303 64365200
Discomfort 26.95 13.20 53 100176 80825 64317678
Myalgia 26.86 13.20 370 99859 158247 64240256
Tumour pain 26.83 13.20 23 100206 1910 64396593
Blood creatinine decreased 26.76 13.20 43 100186 7007 64391496
Blood creatine phosphokinase increased 26.63 13.20 31 100198 58527 64339976
Mastitis 26.61 13.20 23 100206 1931 64396572
Gas gangrene 26.56 13.20 11 100218 230 64398273
Vessel puncture site bruise 26.43 13.20 13 100216 411 64398092
Pericardial effusion 26.42 13.20 126 100103 39128 64359375
Mucosal disorder 26.39 13.20 28 100201 3034 64395469
Balance disorder 26.27 13.20 57 100172 83869 64314634
Eosinophil percentage increased 26.24 13.20 20 100209 1404 64397099
Hydrothorax 26.18 13.20 19 100210 1238 64397265
Renal failure 26.16 13.20 170 100059 181518 64216985
Feeling hot 26.12 13.20 140 100089 45523 64352980
Cystitis noninfective 26.00 13.20 18 100211 1088 64397415
Cataract 25.70 13.20 25 100204 51237 64347266
Metastases to ovary 25.67 13.20 11 100218 251 64398252
Disseminated intravascular coagulation 25.65 13.20 109 100120 32239 64366264
Emotional distress 25.53 13.20 12 100217 36026 64362477
Osteoporosis 25.50 13.20 17 100212 42063 64356440
Cardiomyopathy 25.43 13.20 92 100137 25264 64373239
Perforation 25.39 13.20 18 100211 1130 64397373
Malignant pleural effusion 25.34 13.20 27 100202 2940 64395563
Delirium 25.14 13.20 43 100186 69151 64329352
Intestinal perforation 25.13 13.20 66 100163 15247 64383256
Menopausal disorder 25.01 13.20 7 100222 40 64398463
Axillary pain 24.84 13.20 21 100208 1711 64396792
Osteolysis 24.81 13.20 26 100203 2777 64395726
Cytomegalovirus oesophagitis 24.64 13.20 14 100215 596 64397907
Necrotising retinitis 24.29 13.20 17 100212 1046 64397457
Nail ridging 24.17 13.20 11 100218 291 64398212
Respiratory arrest 24.15 13.20 28 100201 52957 64345546
Sopor 24.09 13.20 8 100221 29653 64368850
Excessive eye blinking 23.89 13.20 18 100211 1242 64397261
Disorientation 23.87 13.20 31 100198 55797 64342706
Invasive ductal breast carcinoma 23.74 13.20 34 100195 5008 64393495
Limb injury 23.68 13.20 4 100225 23501 64375002
Pancreatitis 23.58 13.20 35 100194 59572 64338931
Neck pain 23.51 13.20 37 100192 61496 64337007
Gastric disorder 23.50 13.20 8 100221 29189 64369314
Vein discolouration 23.49 13.20 11 100218 311 64398192
Nail bed bleeding 23.49 13.20 11 100218 311 64398192
Mediastinitis 23.45 13.20 15 100214 794 64397709
Neoplasm recurrence 23.44 13.20 29 100200 3710 64394793
Asthenia 23.27 13.20 848 99381 427196 63971307
Product administration error 23.26 13.20 7 100222 27636 64370867
Radiation necrosis 23.17 13.20 11 100218 321 64398182
Carbohydrate antigen 15-3 increased 23.05 13.20 16 100213 971 64397532
Retinal toxicity 23.03 13.20 18 100211 1312 64397191
Palmar erythema 23.03 13.20 20 100209 1690 64396813
Muscle spasms 22.90 13.20 127 100102 140896 64257607
Retinal detachment 22.89 13.20 43 100186 7933 64390570
Sepsis 22.86 13.20 493 99736 229848 64168655
Pulmonary hypertension 22.86 13.20 20 100209 43119 64355384
Hiccups 22.61 13.20 44 100185 8332 64390171
Abnormal behaviour 22.60 13.20 12 100217 33610 64364893
Hepatic encephalopathy 22.57 13.20 3 100226 21063 64377440
Hip fracture 22.56 13.20 7 100222 27092 64371411
Metastases to thorax 22.47 13.20 9 100220 172 64398331
Nasal disorder 22.46 13.20 25 100204 2859 64395644
Liver function test abnormal 22.43 13.20 36 100193 59365 64339138
Pleural disorder 22.28 13.20 14 100215 718 64397785
Sclerema 22.28 13.20 6 100223 29 64398474
Colitis ischaemic 22.21 13.20 58 100171 13356 64385147
Epidermolysis 22.08 13.20 12 100217 468 64398035
Gait inability 22.02 13.20 20 100209 42348 64356155
Osteitis condensans 21.94 13.20 6 100223 31 64398472
Metastases to gastrointestinal tract 21.88 13.20 8 100221 118 64398385
Eastern Cooperative Oncology Group performance status worsened 21.85 13.20 17 100212 1231 64397272
Pharyngeal abscess 21.68 13.20 13 100216 613 64397890
Type 2 diabetes mellitus 21.64 13.20 13 100216 34007 64364496
Bone marrow infiltration 21.58 13.20 12 100217 490 64398013
Clostridium bacteraemia 21.45 13.20 10 100219 280 64398223
Poisoning 21.44 13.20 4 100225 21875 64376628
Dysphagia 21.38 13.20 257 99972 106555 64291948
Gastrointestinal ischaemia 21.26 13.20 11 100218 388 64398115
Hypervolaemia 21.21 13.20 17 100212 38268 64360235
Ventricular hypokinesia 21.20 13.20 41 100188 7728 64390775
Hyperkalaemia 21.19 13.20 83 100146 101046 64297457
Mucocutaneous disorder 21.17 13.20 8 100221 130 64398373
Radiation pneumonitis 21.16 13.20 26 100203 3302 64395201
Post-traumatic pain 21.13 13.20 11 100218 393 64398110
Vulvitis 20.94 13.20 9 100220 207 64398296
Acute motor-sensory axonal neuropathy 20.92 13.20 11 100218 401 64398102
Bursitis 20.90 13.20 4 100225 21481 64377022
Skin laceration 20.88 13.20 6 100223 24411 64374092
Joint injury 20.84 13.20 5 100224 22942 64375561
Cellulitis 20.83 13.20 230 99999 93427 64305076
Gout 20.81 13.20 4 100225 21409 64377094
Vascular pain 20.74 13.20 14 100215 812 64397691
Hormone receptor positive breast cancer 20.57 13.20 10 100219 308 64398195
Chest discomfort 20.53 13.20 273 99956 115833 64282670
Oesophagitis 20.45 13.20 77 100152 21553 64376950
Macroenzyme creatine kinase 20.43 13.20 5 100224 15 64398488
Metastases to heart 20.39 13.20 9 100220 221 64398282
Depressed level of consciousness 20.33 13.20 62 100167 81374 64317129
Therapy responder 20.22 13.20 11 100218 430 64398073
Unintentional medical device removal 20.20 13.20 37 100192 6697 64391806
Tumour haemorrhage 20.16 13.20 26 100203 3467 64395036
Viral infection 20.08 13.20 16 100213 36124 64362379
Haematochezia 20.02 13.20 46 100183 66327 64332176
Cytomegalovirus infection 20.01 13.20 17 100212 37182 64361321
Pancreatitis viral 19.96 13.20 5 100224 17 64398486
Metabolic acidosis 19.96 13.20 51 100178 70907 64327596
Troponin I increased 19.83 13.20 27 100202 3794 64394709
Impaired healing 19.82 13.20 40 100189 60433 64338070
Enteritis 19.77 13.20 52 100177 12025 64386478
Hypophagia 19.75 13.20 117 100112 39470 64359033
Hypovolaemic shock 19.74 13.20 47 100182 10219 64388284
Obstruction gastric 19.65 13.20 17 100212 1429 64397074
Superior mesenteric artery syndrome 19.60 13.20 8 100221 161 64398342
Metastases to nervous system 19.59 13.20 6 100223 49 64398454
Peritonitis 19.59 13.20 84 100145 24939 64373564
Multiple sclerosis 19.59 13.20 3 100226 18938 64379565
Transdifferentiation of neoplasm 19.54 13.20 7 100222 97 64398406
No adverse event 19.49 13.20 10 100219 28551 64369952
Blood triglycerides increased 19.48 13.20 3 100226 18863 64379640
Vaginal prolapse 19.47 13.20 9 100220 247 64398256
Amnesia 19.43 13.20 28 100201 48241 64350262
Granulocyte count decreased 19.39 13.20 16 100213 1260 64397243
Choroidal effusion 19.37 13.20 12 100217 600 64397903
Monocyte count decreased 19.27 13.20 23 100206 2834 64395669
Herpes zoster 19.27 13.20 61 100168 79126 64319377
Osteoradionecrosis 19.22 13.20 7 100222 102 64398401
Panophthalmitis 19.22 13.20 7 100222 102 64398401
Recurrent cancer 19.22 13.20 21 100208 2352 64396151
Trigeminal nerve paresis 19.11 13.20 4 100225 4 64398499
Infusion site plaque 19.11 13.20 4 100225 4 64398499
Mucosal toxicity 19.10 13.20 11 100218 481 64398022
Toxic optic neuropathy 19.01 13.20 14 100215 933 64397570
Tympanic membrane disorder 18.98 13.20 8 100221 175 64398328
Lymphadenopathy 18.98 13.20 131 100098 46555 64351948
Metastases to uterus 18.89 13.20 6 100223 56 64398447
Breast inflammation 18.85 13.20 7 100222 108 64398395
Non-small cell lung cancer 18.80 13.20 30 100199 4860 64393643
Haemolytic uraemic syndrome 18.77 13.20 27 100202 3994 64394509
Ovarian necrosis 18.77 13.20 5 100224 23 64398480
Bone disorder 18.70 13.20 63 100166 16696 64381807
Laboratory test abnormal 18.67 13.20 7 100222 24056 64374447
Appendiceal abscess 18.64 13.20 9 100220 273 64398230
Duodenal ulcer perforation 18.41 13.20 16 100213 34609 64363894
Chronic kidney disease 18.40 13.20 39 100190 57880 64340623
Oral pain 18.32 13.20 88 100141 27405 64371098
Neuromuscular toxicity 18.30 13.20 8 100221 192 64398311
Metastases to adrenals 18.26 13.20 15 100214 1174 64397329
Necrotising fasciitis 18.22 13.20 31 100198 5295 64393208
Acute myocardial infarction 18.19 13.20 52 100177 69666 64328837
Retinitis pigmentosa 18.18 13.20 7 100222 120 64398383
Peripheral swelling 18.06 13.20 223 100006 208930 64189573
Skin reaction 18.04 13.20 51 100178 12301 64386202
Cytokine release syndrome 18.03 13.20 5 100224 20824 64377679
Mental status changes 17.95 13.20 43 100186 61119 64337384
Nail infection 17.92 13.20 18 100211 1829 64396674
Subclavian vein thrombosis 17.92 13.20 20 100209 2294 64396209
Biliary sepsis 17.83 13.20 16 100213 1412 64397091
Chromosomal mutation 17.80 13.20 5 100224 29 64398474
Hypothalamo-pituitary disorder 17.80 13.20 14 100215 1030 64397473
Cranial nerve disorder 17.78 13.20 13 100216 857 64397646
Surgery 17.64 13.20 11 100218 28202 64370301
Administration site extravasation 17.62 13.20 14 100215 1045 64397458
Iron deficiency anaemia 17.61 13.20 6 100223 21883 64376620
Vasculitis 17.59 13.20 65 100164 18030 64380473
Merycism 17.56 13.20 8 100221 212 64398291
Aorto-oesophageal fistula 17.53 13.20 6 100223 72 64398431
Vulvovaginal candidiasis 17.51 13.20 19 100210 2111 64396392
Hydronephrosis 17.48 13.20 55 100174 14070 64384433
Metastases to muscle 17.40 13.20 9 100220 317 64398186
Prescribed overdose 17.38 13.20 5 100224 20326 64378177
Cholangitis sclerosing 17.34 13.20 18 100211 1901 64396602
Tumour marker increased 17.34 13.20 24 100205 3426 64395077
Blood alkaline phosphatase increased 17.33 13.20 148 100081 56131 64342372
Status epilepticus 17.32 13.20 6 100223 21657 64376846
Intervertebral disc protrusion 17.20 13.20 5 100224 20186 64378317
Nail bed tenderness 17.20 13.20 9 100220 325 64398178
Transaminases 17.17 13.20 6 100223 77 64398426
Osteosclerosis 17.14 13.20 24 100205 3462 64395041
Restlessness 17.10 13.20 22 100207 39763 64358740
Leukaemia cutis 17.09 13.20 7 100222 142 64398361
Therapy interrupted 16.99 13.20 5 100224 20031 64378472
Pain in extremity 16.85 13.20 351 99878 302734 64095769
Acquired gene mutation 16.83 13.20 18 100211 1968 64396535
Abdominal pain 16.74 13.20 618 99611 311757 64086746
Hyperpyrexia 16.64 13.20 29 100200 5048 64393455
Malignant neoplasm of pleura 16.61 13.20 7 100222 153 64398350
Staphylococcal impetigo 16.60 13.20 4 100225 11 64398492
Hypersomnia 16.58 13.20 5 100224 19712 64378791
Hyperchlorhydria 16.48 13.20 17 100212 1782 64396721
Head injury 16.48 13.20 16 100213 32826 64365677
Traumatic lung injury 16.48 13.20 19 100210 2257 64396246
Night sweats 16.48 13.20 19 100210 36027 64362476
Clostridial infection 16.47 13.20 29 100200 5090 64393413
Cachexia 16.45 13.20 41 100188 9176 64389327
Miller Fisher syndrome 16.45 13.20 7 100222 157 64398346
Muscle spasticity 16.44 13.20 3 100226 16666 64381837
Eye swelling 16.44 13.20 7 100222 22274 64376229
Spinal pain 16.41 13.20 50 100179 12571 64385932
Labia enlarged 16.41 13.20 3 100226 0 64398503
Generalised oedema 16.33 13.20 70 100159 20783 64377720
Mouth ulceration 16.25 13.20 96 100133 32348 64366155
Renal impairment 16.21 13.20 133 100096 134884 64263619
Herpes simplex sepsis 16.20 13.20 5 100224 42 64398461
Transfusion 16.19 13.20 4 100225 17990 64380513
Colony stimulating factor therapy 16.05 13.20 10 100219 505 64397998
Aspergillus infection 16.04 13.20 3 100226 16376 64382127
Hypoalbuminaemia 15.95 13.20 62 100167 17612 64380891
Tracheo-oesophageal fistula 15.95 13.20 10 100219 511 64397992
Therapeutic product effect incomplete 15.83 13.20 95 100134 103387 64295116
Infusion site vesicles 15.82 13.20 9 100220 384 64398119
Oesophageal perforation 15.71 13.20 13 100216 1028 64397475
Memory impairment 15.70 13.20 74 100155 85608 64312895
Dysaesthesia 15.69 13.20 28 100201 4967 64393536
Haematoma 15.67 13.20 30 100199 46220 64352283
Dandy-Walker syndrome 15.61 13.20 5 100224 48 64398455
Bone cancer metastatic 15.60 13.20 7 100222 179 64398324
Tubulointerstitial nephritis 15.58 13.20 15 100214 30894 64367609
Hepatotoxicity 15.58 13.20 111 100118 39851 64358652
Soft tissue infection 15.57 13.20 22 100207 3201 64395302
Product quality issue 15.57 13.20 14 100215 29785 64368718
Thrombotic microangiopathy 15.50 13.20 59 100170 16596 64381907
Portosplenomesenteric venous thrombosis 15.46 13.20 4 100225 16 64398487
Ear pain 15.44 13.20 10 100219 25126 64373377
Ocular hyperaemia 15.25 13.20 8 100221 22556 64375947
Tracheal stenosis 15.21 13.20 8 100221 292 64398211
Eye pain 15.20 13.20 16 100213 31609 64366894
Injection site rash 15.17 13.20 3 100226 15739 64382764
Heart rate decreased 15.16 13.20 40 100189 55027 64343476
Scleroderma 15.12 13.20 27 100202 4791 64393712
Pulmonary embolism 15.07 13.20 315 99914 146041 64252462
Folate deficiency 15.07 13.20 20 100209 2743 64395760
Pituitary tumour 15.02 13.20 13 100216 1093 64397410
Tracheal fistula 15.01 13.20 6 100223 114 64398389
Hypertransaminasaemia 15.01 13.20 34 100195 7157 64391346
Haemodialysis 14.97 13.20 4 100225 17073 64381430
Inflammatory carcinoma of the breast 14.91 13.20 4 100225 19 64398484
Therapeutic response unexpected 14.87 13.20 4 100225 16997 64381506
Subdural haematoma 14.87 13.20 13 100216 28041 64370462
Procedural pain 14.85 13.20 3 100226 15505 64382998
Left ventricular dilatation 14.82 13.20 12 100217 920 64397583
Ear infection 14.80 13.20 9 100220 23395 64375108
Metastatic lymphoma 14.76 13.20 7 100222 204 64398299
Paralysis recurrent laryngeal nerve 14.64 13.20 6 100223 122 64398381
Hallucination, visual 14.63 13.20 13 100216 27821 64370682
Urogenital prolapse 14.58 13.20 4 100225 21 64398482
Cholestasis 14.44 13.20 30 100199 44842 64353661
Joint range of motion decreased 14.39 13.20 6 100223 19337 64379166
Red cell distribution width increased 14.39 13.20 47 100182 12262 64386241
Colitis ulcerative 14.37 13.20 9 100220 23019 64375484
Neutrophil count abnormal 14.33 13.20 20 100209 2876 64395627
Sarcomatosis 14.33 13.20 3 100226 3 64398500
Hyperchromasia 14.33 13.20 3 100226 3 64398500
Blood pressure systolic inspiratory decreased 14.33 13.20 3 100226 3 64398500
Subretinal hyperreflective exudation 14.33 13.20 3 100226 3 64398500
Non-pitting oedema 14.33 13.20 3 100226 3 64398500
Extravasation 14.33 13.20 21 100208 3159 64395344
Abdominal rigidity 14.30 13.20 19 100210 2608 64395895
Dysuria 14.24 13.20 113 100116 41944 64356559
Foot deformity 14.22 13.20 4 100225 16500 64382003
Face oedema 14.21 13.20 76 100153 24685 64373818
Sinus bradycardia 14.21 13.20 9 100220 22884 64375619
Metastases to bladder 14.15 13.20 7 100222 224 64398279
Laryngeal oedema 14.15 13.20 33 100196 7080 64391423
Abortion spontaneous 14.13 13.20 11 100218 25132 64373371
Borrelia infection 14.12 13.20 6 100223 134 64398369
Hypersensitivity pneumonitis 14.07 13.20 21 100208 3211 64395292
Gastrointestinal perforation 14.05 13.20 28 100201 5396 64393107
Glaucoma 14.01 13.20 4 100225 16344 64382159
Upper limb fracture 13.98 13.20 3 100226 14863 64383640
Acute hepatic failure 13.96 13.20 12 100217 26100 64372403
Carotid artery aneurysm 13.93 13.20 7 100222 232 64398271
Adverse event 13.92 13.20 25 100204 39464 64359039
Muscle necrosis 13.90 13.20 13 100216 1210 64397293
Fear 13.85 13.20 7 100222 20164 64378339
Sleep disorder 13.83 13.20 47 100182 59662 64338841
Metastases to abdominal cavity 13.81 13.20 9 100220 492 64398011
Diabetes mellitus inadequate control 13.77 13.20 8 100221 21313 64377190
Renal disorder 13.76 13.20 21 100208 35344 64363159
Papilloedema 13.76 13.20 28 100201 5477 64393026
Ventricular tachycardia 13.67 13.20 20 100209 34245 64364258
Underdose 13.65 13.20 12 100217 25817 64372686
Chondritis 13.65 13.20 6 100223 146 64398357
Drug ineffective for unapproved indication 13.61 13.20 17 100212 31116 64367387
Breast necrosis 13.60 13.20 5 100224 75 64398428
Cancer pain 13.55 13.20 24 100205 4233 64394270
Femur fracture 13.54 13.20 20 100209 34115 64364388
Non-small cell lung cancer metastatic 13.54 13.20 11 100218 848 64397655
Tooth extraction 13.40 13.20 39 100190 9562 64388941
Atypical haemolytic uraemic syndrome 13.38 13.20 10 100219 682 64397821
Generalised tonic-clonic seizure 13.38 13.20 26 100203 39831 64358672
Diabetic ketoacidosis 13.36 13.20 16 100213 29829 64368674
Polyneuropathy in malignant disease 13.35 13.20 6 100223 154 64398349
Parkinsonism 13.31 13.20 3 100226 14370 64384133
Postural orthostatic tachycardia syndrome 13.25 13.20 9 100220 527 64397976
Fibrous histiocytoma 13.21 13.20 9 100220 530 64397973

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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

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

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




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

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

Orange Book patent data (new drug applications)

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

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

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

External reference:

IDSource
4020968 VUID
N0000148441 NUI
D02165 KEGG_DRUG
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 0409-0201 INJECTION, SOLUTION 10 mg INTRAVENOUS NDA 31 sections
Docetaxel HUMAN PRESCRIPTION DRUG LABEL 1 0409-0365 INJECTION, SOLUTION 20 mg INTRAVENOUS NDA 33 sections
Docetaxel HUMAN PRESCRIPTION DRUG LABEL 1 0409-0366 INJECTION, SOLUTION 20 mg INTRAVENOUS NDA 31 sections
Docetaxel HUMAN PRESCRIPTION DRUG LABEL 1 0409-0367 INJECTION, SOLUTION 20 mg INTRAVENOUS NDA 31 sections
Docetaxel HUMAN PRESCRIPTION DRUG LABEL 1 0409-0368 INJECTION, SOLUTION 20 mg INTRAVENOUS NDA 31 sections
Docetaxel HUMAN PRESCRIPTION DRUG LABEL 1 0409-1732 INJECTION, SOLUTION 10 mg INTRAVENOUS NDA 33 sections
Docetaxel HUMAN PRESCRIPTION DRUG LABEL 1 0409-2026 INJECTION, SOLUTION 10 mg INTRAVENOUS NDA 33 sections
Docetaxel HUMAN PRESCRIPTION DRUG LABEL 1 0409-2956 INJECTION, SOLUTION 10 mg INTRAVENOUS NDA 33 sections
Docetaxel HUMAN PRESCRIPTION DRUG LABEL 1 0409-4235 INJECTION, SOLUTION 20 mg INTRAVENOUS NDA 33 sections
Docetaxel HUMAN PRESCRIPTION DRUG LABEL 1 0409-5068 INJECTION, SOLUTION 20 mg INTRAVENOUS NDA 33 sections
Docetaxel HUMAN PRESCRIPTION DRUG LABEL 1 0409-7870 INJECTION, SOLUTION 10 mg INTRAVENOUS NDA 33 sections
Docetaxel HUMAN PRESCRIPTION DRUG LABEL 1 0955-1020 INJECTION, SOLUTION, CONCENTRATE 20 mg INTRAVENOUS NDA authorized generic 30 sections
Docetaxel HUMAN PRESCRIPTION DRUG LABEL 1 0955-1021 INJECTION, SOLUTION, CONCENTRATE 80 mg INTRAVENOUS NDA authorized generic 30 sections
Docetaxel HUMAN PRESCRIPTION DRUG LABEL 1 0955-1022 INJECTION, SOLUTION, CONCENTRATE 160 mg INTRAVENOUS NDA authorized generic 30 sections
DOCETAXEL HUMAN PRESCRIPTION DRUG LABEL 1 16729-231 INJECTION, SOLUTION, CONCENTRATE 20 mg INTRAVENOUS NDA 30 sections
DOCETAXEL HUMAN PRESCRIPTION DRUG LABEL 1 16729-267 INJECTION, SOLUTION, CONCENTRATE 20 mg INTRAVENOUS NDA 30 sections
Docetaxel HUMAN PRESCRIPTION DRUG LABEL 1 25021-245 INJECTION, SOLUTION 20 mg INTRAVENOUS ANDA 29 sections
Docetaxel HUMAN PRESCRIPTION DRUG LABEL 1 43066-001 INJECTION, SOLUTION 10 mg INTRAVENOUS NDA 28 sections
Docetaxel HUMAN PRESCRIPTION DRUG LABEL 1 43066-006 INJECTION, SOLUTION 10 mg INTRAVENOUS NDA 28 sections
Docetaxel HUMAN PRESCRIPTION DRUG LABEL 1 43066-010 INJECTION, SOLUTION 10 mg INTRAVENOUS NDA 28 sections
Docetaxel HUMAN PRESCRIPTION DRUG LABEL 1 43598-258 INJECTION, SOLUTION 20 mg INTRAVENOUS ANDA 26 sections
Docetaxel HUMAN PRESCRIPTION DRUG LABEL 1 43598-259 INJECTION, SOLUTION 80 mg INTRAVENOUS ANDA 26 sections
Docetaxel HUMAN PRESCRIPTION DRUG LABEL 1 43598-389 INJECTION, SOLUTION 160 mg INTRAVENOUS ANDA 26 sections
Docetaxel HUMAN PRESCRIPTION DRUG LABEL 1 43598-610 INJECTION, SOLUTION 80 mg INTRAVENOUS ANDA 26 sections
Docetaxel HUMAN PRESCRIPTION DRUG LABEL 1 43598-611 INJECTION, SOLUTION 20 mg INTRAVENOUS ANDA 26 sections
Docetaxel HUMAN PRESCRIPTION DRUG LABEL 1 45963-734 INJECTION, SOLUTION, CONCENTRATE 20 mg INTRAVENOUS NDA 22 sections
Docetaxel HUMAN PRESCRIPTION DRUG LABEL 1 45963-765 INJECTION, SOLUTION, CONCENTRATE 20 mg INTRAVENOUS NDA 22 sections