docetaxel 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: 4.08
  • 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 ┬ÁM/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 1742.87 12.48 1429 85811 93198 46505624
Neutropenia 1351.56 12.48 1494 85746 141710 46457112
Palmar-plantar erythrodysaesthesia syndrome 1095.00 12.48 601 86639 19850 46578972
Mucosal inflammation 769.46 12.48 614 86626 38362 46560460
Malignant neoplasm progression 769.24 12.48 766 86474 64160 46534662
Diarrhoea 701.83 12.48 2460 84780 557142 46041680
Disease progression 662.59 12.48 834 86406 90466 46508356
Ejection fraction decreased 653.51 12.48 411 86829 17526 46581296
Metastases to bone 566.34 12.48 372 86868 17104 46581718
Bone marrow failure 561.23 12.48 456 86784 29213 46569609
Metastases to liver 548.89 12.48 381 86859 19204 46579618
Drug ineffective 436.13 12.48 378 86862 677460 45921362
Rheumatoid arthritis 427.14 12.48 4 87236 240211 46358611
Neuropathy peripheral 407.07 12.48 660 86580 90233 46508589
Metastases to central nervous system 349.30 12.48 233 87007 10988 46587834
Metastases to lung 320.71 12.48 217 87023 10479 46588343
Neutropenic sepsis 306.56 12.48 223 87017 12101 46586721
Stomatitis 301.64 12.48 493 86747 67804 46531018
Skin toxicity 265.87 12.48 132 87108 3522 46595300
Fall 258.85 12.48 147 87093 328950 46269872
Cardiotoxicity 257.27 12.48 159 87081 6563 46592259
Pleural effusion 254.30 12.48 511 86729 82441 46516381
Breast cancer metastatic 249.64 12.48 206 87034 13472 46585350
Completed suicide 248.09 12.48 5 87235 145915 46452907
Polyneuropathy 243.65 12.48 190 87050 11454 46587368
Metastases to lymph nodes 234.06 12.48 149 87091 6482 46592340
Leukopenia 228.85 12.48 437 86803 67906 46530916
Bone pain 217.21 12.48 346 86894 46544 46552278
Drug hypersensitivity 206.23 12.48 99 87141 243726 46355096
Onycholysis 201.87 12.48 78 87162 1110 46597712
Product dose omission issue 196.99 12.48 38 87202 168482 46430340
Pyrexia 196.56 12.48 1217 86023 347585 46251237
Agranulocytosis 195.54 12.48 224 87016 21961 46576861
Breast cancer 194.71 12.48 324 86916 45194 46553628
Colitis 187.47 12.48 286 86954 37061 46561761
Acute myeloid leukaemia 186.22 12.48 186 87054 15592 46583230
Peripheral sensory neuropathy 186.19 12.48 129 87111 6474 46592348
Myelosuppression 183.91 12.48 136 87104 7567 46591255
Neutropenic colitis 181.50 12.48 87 87153 2145 46596677
Joint swelling 176.92 12.48 46 87194 166027 46432795
Breast cancer recurrent 176.87 12.48 103 87137 3808 46595014
Neoplasm progression 170.15 12.48 229 87011 26454 46572368
Condition aggravated 152.59 12.48 140 87100 244912 46353910
Haematotoxicity 151.30 12.48 116 87124 6817 46592005
Somnolence 151.00 12.48 52 87188 156469 46442353
Erythema 150.35 12.48 596 86644 142224 46456598
Injection site pain 146.56 12.48 15 87225 107137 46491685
Metastasis 145.03 12.48 94 87146 4218 46594604
Metastases to skin 144.14 12.48 64 87176 1316 46597506
Interstitial lung disease 139.29 12.48 310 86930 53639 46545183
Nail disorder 138.01 12.48 116 87124 7780 46591042
Skin exfoliation 136.23 12.48 231 87009 32707 46566115
Neutrophil count decreased 135.93 12.48 270 86970 43156 46555666
Neutropenic infection 135.89 12.48 58 87182 1080 46597742
Vomiting 135.49 12.48 1365 85875 451429 46147393
Flushing 135.10 12.48 342 86898 64272 46534550
Left ventricular dysfunction 132.41 12.48 127 87113 10128 46588694
Gastrointestinal toxicity 130.13 12.48 88 87152 4243 46594579
Dehydration 126.86 12.48 612 86628 158928 46439894
Headache 126.71 12.48 464 86776 477888 46120934
Osteonecrosis 124.75 12.48 194 87046 25550 46573272
Therapeutic product effect decreased 122.80 12.48 8 87232 82593 46516229
Second primary malignancy 121.88 12.48 100 87140 6484 46592338
Overdose 121.23 12.48 22 87218 101957 46496865
Contraindicated product administered 118.09 12.48 8 87232 79939 46518883
Aortitis 117.64 12.48 46 87194 677 46598145
Lymphoedema 117.58 12.48 110 87130 8502 46590320
Nail toxicity 116.60 12.48 38 87202 316 46598506
Decreased appetite 113.65 12.48 684 86556 193152 46405670
Sinusitis 110.63 12.48 52 87188 129716 46469106
Capillary leak syndrome 110.47 12.48 59 87181 1838 46596984
Alopecia 106.17 12.48 590 86650 161824 46436998
Drug abuse 104.54 12.48 3 87237 63405 46535417
Recall phenomenon 101.96 12.48 39 87201 539 46598283
Neurotoxicity 101.93 12.48 127 87113 13590 46585232
Lacrimation increased 99.39 12.48 135 87105 15726 46583096
Pneumonitis 96.61 12.48 183 87057 28237 46570585
Injection site erythema 95.36 12.48 13 87227 74414 46524408
Lymphangiosis carcinomatosa 93.52 12.48 45 87195 1119 46597703
Systemic lupus erythematosus 92.09 12.48 8 87232 65172 46533650
Maternal exposure during pregnancy 90.67 12.48 39 87201 102510 46496312
Dysgeusia 89.53 12.48 219 87021 40272 46558550
Arthropathy 89.11 12.48 24 87216 84676 46514146
Weight increased 88.74 12.48 106 87134 164367 46434455
Drug interaction 88.73 12.48 152 87088 202942 46395880
Biopsy lung abnormal 88.05 12.48 25 87215 122 46598700
White blood cell count decreased 88.02 12.48 429 86811 111802 46487020
Febrile bone marrow aplasia 84.86 12.48 83 87157 6779 46592043
Nausea 84.62 12.48 1774 85466 685680 45913142
Radiation skin injury 83.94 12.48 38 87202 819 46598003
Metastases to pleura 83.92 12.48 41 87199 1055 46597767
Gastrointestinal necrosis 81.67 12.48 56 87184 2762 46596060
Metastases to spine 81.56 12.48 55 87185 2639 46596183
Treatment failure 81.35 12.48 36 87204 93051 46505771
Confusional state 81.09 12.48 108 87132 159784 46439038
Epistaxis 80.59 12.48 284 86956 64021 46534801
Exposure during pregnancy 79.72 12.48 52 87188 108160 46490662
Hospitalisation 76.79 12.48 13 87227 63372 46535450
Abdominal discomfort 76.76 12.48 102 87138 151063 46447759
Musculoskeletal stiffness 76.49 12.48 44 87196 97949 46500873
Psoriasis 75.95 12.48 26 87214 78578 46520244
Myocardial infarction 74.41 12.48 45 87195 97483 46501339
Paronychia 73.51 12.48 64 87176 4502 46594320
Myalgia 71.17 12.48 433 86807 122655 46476167
Tooth extraction 70.40 12.48 91 87149 10102 46588720
Product use issue 70.37 12.48 45 87195 94599 46504223
Cerebrovascular accident 69.86 12.48 52 87188 100987 46497835
Disease recurrence 67.87 12.48 123 87117 18348 46580474
Suicide attempt 67.30 12.48 11 87229 55025 46543797
Myositis 66.59 12.48 78 87162 7826 46590996
Migraine 66.22 12.48 24 87216 70002 46528820
Arthritis 65.84 12.48 31 87209 77285 46521537
Influenza 65.61 12.48 43 87197 89227 46509595
Cardiomyopathy 65.48 12.48 112 87128 15961 46582861
Hypokalaemia 65.11 12.48 331 86909 87693 46511129
Dermatitis 64.58 12.48 104 87136 14104 46584718
Contusion 64.49 12.48 42 87198 87445 46511377
Depression 64.08 12.48 139 87101 169965 46428857
Inappropriate schedule of product administration 63.68 12.48 21 87219 64992 46533830
Ascites 63.67 12.48 181 87059 36403 46562419
Intentional product misuse 63.38 12.48 7 87233 47121 46551701
Injection site swelling 62.72 12.48 3 87237 40324 46558498
Asthma 62.15 12.48 48 87192 91494 46507328
Plasma cell myeloma 61.38 12.48 6 87234 44472 46554350
Onychomadesis 60.49 12.48 47 87193 2816 46596006
Blood cholesterol increased 59.09 12.48 4 87236 40009 46558813
Multifocal micronodular pneumocyte hyperplasia 58.72 12.48 16 87224 65 46598757
Bronchial polyp 58.72 12.48 16 87224 65 46598757
Pericardial effusion 58.43 12.48 140 87100 25403 46573419
Large intestine perforation 57.63 12.48 71 87169 7509 46591313
Injection site reaction 57.54 12.48 10 87230 47839 46550983
Invasive ductal breast carcinoma 57.26 12.48 64 87176 6104 46592718
Intestinal perforation 57.12 12.48 85 87155 10766 46588056
Toxicity to various agents 56.76 12.48 204 87036 211562 46387260
Anaemia 56.22 12.48 727 86513 255052 46343770
Metastatic neoplasm 55.12 12.48 49 87191 3544 46595278
Feeling abnormal 55.12 12.48 93 87147 124967 46473855
Thrombocytopenia 55.02 12.48 415 86825 126166 46472656
Dyspnoea 54.83 12.48 1304 85936 514244 46084578
Osteonecrosis of jaw 53.00 12.48 163 87077 34239 46564583
Incorrect dose administered 51.64 12.48 11 87229 45539 46553283
Lung infiltration 50.94 12.48 93 87147 13950 46584872
Injection site pruritus 50.76 12.48 7 87233 39736 46559086
Pseudocirrhosis 50.48 12.48 25 87215 663 46598159
Bone disorder 50.42 12.48 114 87126 19919 46578903
Fibromyalgia 50.10 12.48 5 87235 36458 46562364
Vascular device infection 50.09 12.48 46 87194 3471 46595351
Pain 50.04 12.48 611 86629 476337 46122485
Device related thrombosis 49.44 12.48 30 87210 1197 46597625
Periarticular thenar erythema with onycholysis 49.13 12.48 11 87229 14 46598808
Metastases to peritoneum 48.55 12.48 40 87200 2608 46596214
Electrocardiogram QT prolonged 47.83 12.48 18 87222 51307 46547515
Nail discolouration 47.47 12.48 37 87203 2227 46596595
Enterocolitis 47.26 12.48 58 87182 6110 46592712
Osteolysis 46.94 12.48 39 87201 2573 46596249
Nail dystrophy 46.76 12.48 21 87219 444 46598378
Intestinal ischaemia 46.54 12.48 61 87179 6864 46591958
Mastectomy 46.48 12.48 31 87209 1460 46597362
Acute leukaemia 46.31 12.48 28 87212 1110 46597712
Enterocolitis infectious 46.07 12.48 31 87209 1482 46597340
Agitation 45.98 12.48 23 87217 55392 46543430
Therapeutic product effect incomplete 45.81 12.48 47 87193 78106 46520716
Abortion spontaneous 44.71 12.48 13 87227 43633 46555189
Hand deformity 44.37 12.48 6 87234 34568 46564254
Loss of personal independence in daily activities 44.15 12.48 26 87214 57157 46541665
Organising pneumonia 44.03 12.48 50 87190 4852 46593970
Dacryostenosis acquired 43.80 12.48 20 87220 440 46598382
Performance status decreased 43.52 12.48 41 87199 3196 46595626
Bradycardia 43.44 12.48 36 87204 66262 46532560
Suicidal ideation 43.01 12.48 26 87214 56356 46542466
Coronary artery disease 42.97 12.48 6 87234 33746 46565076
Insomnia 42.77 12.48 161 87079 164763 46434059
Tremor 42.28 12.48 96 87144 115543 46483279
Ejection fraction 41.92 12.48 21 87219 571 46598251
Metastases to adrenals 41.73 12.48 22 87218 667 46598155
Bronchitis 41.22 12.48 85 87155 105894 46492928
Cystoid macular oedema 40.95 12.48 29 87211 1507 46597315
Ventricular hypokinesia 40.78 12.48 44 87196 4034 46594788
General physical health deterioration 39.80 12.48 360 86880 115409 46483413
Hallucination 39.58 12.48 22 87218 49929 46548893
Anxiety 39.57 12.48 190 87050 181767 46417055
Nephrolithiasis 39.54 12.48 7 87233 33044 46565778
Blood glucose increased 39.24 12.48 46 87194 71967 46526855
Cataract 38.98 12.48 18 87222 45397 46553425
Gas gangrene 38.74 12.48 12 87228 83 46598739
Acute promyelocytic leukaemia 38.35 12.48 23 87217 898 46597924
Therapy cessation 38.35 12.48 3 87237 26626 46572196
Dermatomyositis 38.04 12.48 31 87209 1990 46596832
Osteoarthritis 37.85 12.48 36 87204 61989 46536833
Hepatic enzyme increased 37.73 12.48 59 87181 81728 46517094
Metastases to meninges 37.21 12.48 30 87210 1897 46596925
Nasal congestion 36.96 12.48 22 87218 48091 46550731
Injury 36.94 12.48 18 87222 44009 46554813
Hypoglycaemia 36.24 12.48 29 87211 54320 46544502
Blood lactate dehydrogenase increased 36.22 12.48 102 87138 20398 46578424
Erysipelas 36.02 12.48 54 87186 6884 46591938
Mobility decreased 36.01 12.48 36 87204 60558 46538264
Foetal exposure during pregnancy 35.73 12.48 7 87233 30740 46568082
Obstructive shock 35.39 12.48 9 87231 26 46598796
Congestive cardiomyopathy 34.84 12.48 48 87192 5665 46593157
Blood pressure systolic increased 34.65 12.48 6 87234 28781 46570041
Asthenia 34.52 12.48 792 86448 310283 46288539
Adverse drug reaction 34.48 12.48 20 87220 44342 46554480
Bone sequestrum 34.34 12.48 27 87213 1646 46597176
Metastases to chest wall 34.11 12.48 17 87223 457 46598365
Cardiac failure 34.09 12.48 261 86979 79687 46519135
Hypertension 33.49 12.48 222 87018 196134 46402688
Carotidynia 33.21 12.48 12 87228 140 46598682
Sepsis 33.00 12.48 394 86846 135620 46463202
Unevaluable event 32.90 12.48 23 87217 46152 46552670
Chest discomfort 32.71 12.48 284 86956 89985 46508837
Mastitis 32.62 12.48 30 87210 2268 46596554
Multiple sclerosis 32.54 12.48 4 87236 24787 46574035
Muscle spasms 32.03 12.48 120 87120 122993 46475829
Nephritis bacterial 32.01 12.48 8 87232 21 46598801
Pregnancy 31.92 12.48 6 87234 27131 46571691
Sedation 31.85 12.48 3 87237 22907 46575915
Lactic acidosis 31.41 12.48 12 87228 33897 46564925
Gastric disorder 31.20 12.48 6 87234 26699 46572123
Dizziness 30.91 12.48 449 86791 339965 46258857
Cellulitis 30.82 12.48 231 87009 70057 46528765
Irritability 30.81 12.48 8 87232 28938 46569884
Extravasation 30.78 12.48 28 87212 2087 46596735
Triple negative breast cancer 30.62 12.48 11 87229 126 46598696
Diabetes mellitus 30.61 12.48 29 87211 50036 46548786
Myelodysplastic syndrome 30.58 12.48 81 87159 15630 46583192
Sequestrectomy 30.51 12.48 21 87219 1042 46597780
Tumour embolism 30.31 12.48 11 87229 130 46598692
Tonsillar disorder 30.10 12.48 20 87220 936 46597886
Vision blurred 30.09 12.48 65 87175 79643 46519179
Hypocalcaemia 29.91 12.48 114 87126 26671 46572151
Hot flush 29.64 12.48 160 87080 43357 46555465
Chronic kidney disease 29.59 12.48 20 87220 40851 46557971
Ear infection 29.51 12.48 4 87236 23009 46575813
Drug intolerance 29.43 12.48 158 87082 146891 46451931
Bone lesion 29.43 12.48 41 87199 4890 46593932
Product quality issue 29.27 12.48 15 87225 35633 46563189
Odynophagia 29.24 12.48 48 87192 6614 46592208
Dermatitis acneiform 29.15 12.48 37 87203 4033 46594789
Chronic obstructive pulmonary disease 29.11 12.48 39 87201 57594 46541228
Malaise 28.99 12.48 440 86800 330792 46268030
Mucosal infection 28.96 12.48 10 87230 101 46598721
Blood pressure increased 28.86 12.48 130 87110 126536 46472286
Muscle necrosis 28.58 12.48 16 87224 548 46598274
Hepatic failure 28.53 12.48 131 87109 33285 46565537
Medication error 28.53 12.48 11 87229 30900 46567922
Bone debridement 28.42 12.48 14 87226 367 46598455
Road traffic accident 28.38 12.48 5 87235 23686 46575136
Nasopharyngitis 28.37 12.48 170 87070 153828 46444994
Full blood count decreased 28.16 12.48 4 87236 22207 46576615
Gait disturbance 28.02 12.48 158 87082 145105 46453717
Stress 28.00 12.48 33 87207 51518 46547304
Coma 27.96 12.48 41 87199 58308 46540514
International normalised ratio increased 27.69 12.48 28 87212 46855 46551967
Purtscher retinopathy 27.56 12.48 6 87234 6 46598816
Tongue coated 27.49 12.48 21 87219 1227 46597595
Hepatic lesion 27.23 12.48 35 87205 3862 46594960
Dyskinesia 27.19 12.48 10 87230 28915 46569907
Wheezing 27.09 12.48 36 87204 53350 46545472
Barotrauma 27.07 12.48 11 87229 180 46598642
Cystitis noninfective 27.04 12.48 18 87222 845 46597977
Back pain 26.87 12.48 546 86694 209493 46389329
Vessel puncture site bruise 26.84 12.48 13 87227 328 46598494
Embolism 26.81 12.48 48 87192 7090 46591732
Acute respiratory distress syndrome 26.74 12.48 96 87144 21826 46576996
Hepatic function abnormal 26.53 12.48 131 87109 34290 46564532
Nervousness 26.50 12.48 10 87230 28465 46570357
Vascular fragility 26.36 12.48 10 87230 135 46598687
Infusion related reaction 26.24 12.48 297 86943 100911 46497911
Pneumothorax 26.05 12.48 73 87167 14556 46584266
Memory impairment 26.05 12.48 67 87173 77270 46521552
Onychalgia 26.04 12.48 16 87224 653 46598169
Debridement 26.03 12.48 21 87219 1329 46597493
Swollen tongue 26.01 12.48 11 87229 29221 46569601
Computerised tomogram thorax abnormal 25.88 12.48 21 87219 1340 46597482
Metastases to the mediastinum 25.73 12.48 14 87226 453 46598369
Sensory disturbance 25.68 12.48 65 87175 12202 46586620
Urticaria 25.67 12.48 123 87117 117769 46481053
Injection site haemorrhage 25.63 12.48 4 87236 20705 46578117
Amnesia 25.59 12.48 24 87216 41607 46557215
Portal hypertension 25.48 12.48 32 87208 3451 46595371
Joint injury 25.46 12.48 3 87237 19206 46579616
Osteoporosis 25.44 12.48 23 87217 40585 46558237
Desmoplastic small round cell tumour 25.40 12.48 10 87230 150 46598672
Morphoea 25.14 12.48 12 87228 293 46598529
Herpes zoster 25.08 12.48 56 87184 67816 46531006
Recurrent cancer 25.04 12.48 23 87217 1736 46597086
Vein discolouration 24.93 12.48 10 87230 158 46598664
Perforation 24.85 12.48 18 87222 969 46597853
Generalised oedema 24.81 12.48 71 87169 14328 46584494
Colitis ischaemic 24.76 12.48 57 87183 10075 46588747
Aggression 24.76 12.48 6 87234 22738 46576084
Device related infection 24.70 12.48 91 87149 20950 46577872
Gait inability 24.47 12.48 18 87222 35185 46563637
Blood creatine increased 24.22 12.48 36 87204 4554 46594268
Ovarian necrosis 24.22 12.48 6 87234 15 46598807
Pulmonary mass 24.22 12.48 81 87159 17776 46581046
Cardiac dysfunction 24.21 12.48 21 87219 1470 46597352
Lymphangitis 24.18 12.48 17 87223 873 46597949
Paraesthesia 24.15 12.48 330 86910 117107 46481715
Clostridial infection 24.14 12.48 35 87205 4330 46594492
Subclavian vein thrombosis 24.09 12.48 23 87217 1823 46596999
Sclerema 24.08 12.48 5 87235 3 46598819
Pruritus 23.99 12.48 314 86926 242038 46356784
Chromosomal mutation 23.94 12.48 6 87234 16 46598806
Hyperkalaemia 23.94 12.48 36 87204 50673 46548149
Panophthalmitis 23.89 12.48 7 87233 39 46598783
Malignant pleural effusion 23.67 12.48 26 87214 2432 46596390
Blood creatinine decreased 23.55 12.48 36 87204 4668 46594154
Retinal toxicity 23.51 12.48 18 87222 1055 46597767
Delirium 23.43 12.48 21 87219 37207 46561615
Seroma 23.32 12.48 24 87216 2083 46596739
Metastases to thorax 23.15 12.48 10 87230 192 46598630
Eosinophilia 23.14 12.48 4 87236 19213 46579609
Basal cell carcinoma 23.11 12.48 5 87235 20482 46578340
Dysaesthesia 22.98 12.48 29 87211 3142 46595680
Neoplasm recurrence 22.67 12.48 25 87215 2348 46596474
Neck pain 22.66 12.48 43 87197 55263 46543559
Fatigue 22.62 12.48 1370 85870 607327 45991495
Excessive eye blinking 22.58 12.48 14 87226 581 46598241
White blood cell count abnormal 22.55 12.48 37 87203 5095 46593727
Gallbladder disorder 22.54 12.48 3 87237 17495 46581327
Glossodynia 22.43 12.48 30 87210 44343 46554479
Arthralgia 22.35 12.48 515 86725 364088 46234734
Abdominal pain 22.26 12.48 575 86665 229456 46369366
Vulvovaginal dryness 22.23 12.48 24 87216 2201 46596621
Metastases to soft tissue 22.11 12.48 9 87231 148 46598674
Septic shock 21.94 12.48 184 87056 57709 46541113
No adverse event 21.91 12.48 19 87221 34212 46564610
Drug level increased 21.85 12.48 4 87236 18437 46580385
Balance disorder 21.65 12.48 56 87184 64465 46534357
Underdose 21.61 12.48 5 87235 19553 46579269
Oral candidiasis 21.57 12.48 77 87163 17455 46581367
Hypoalbuminaemia 21.55 12.48 54 87186 10073 46588749
Pancreatitis 21.55 12.48 30 87210 43597 46555225
Blood uric acid decreased 21.42 12.48 13 87227 519 46598303
Constipation 21.40 12.48 450 86790 173647 46425175
Radiation necrosis 21.34 12.48 11 87229 318 46598504
Bone marrow infiltration 21.30 12.48 12 87228 416 46598406
Menopausal disorder 21.29 12.48 7 87233 60 46598762
Choroidal effusion 21.15 12.48 12 87228 422 46598400
Breast pain 21.13 12.48 45 87195 7549 46591273
Asthenopia 21.05 12.48 22 87218 1944 46596878
Epidermolysis 20.92 12.48 10 87230 245 46598577
Pneumonia aspiration 20.90 12.48 17 87223 31588 46567234
Gingival swelling 20.87 12.48 31 87209 3919 46594903
Skin reaction 20.86 12.48 56 87184 10890 46587932
Osteitis condensans 20.85 12.48 6 87234 31 46598791
Femur fracture 20.83 12.48 23 87217 36974 46561848
Blood glucose decreased 20.54 12.48 5 87235 18887 46579935
Accidental overdose 20.51 12.48 6 87234 20060 46578762
Hepatitis 20.48 12.48 18 87222 32197 46566625
Lymphadenopathy mediastinal 20.47 12.48 24 87216 2410 46596412
Acral peeling skin syndrome 20.33 12.48 5 87235 12 46598810
Superior vena cava syndrome 20.28 12.48 13 87227 572 46598250
Acoustic stimulation tests abnormal 20.26 12.48 8 87232 121 46598701
Vasculitis 20.22 12.48 64 87176 13647 46585175
Post-traumatic pain 20.07 12.48 11 87229 361 46598461
Malignant neoplasm of pleura 19.99 12.48 7 87233 74 46598748
Mucosal disorder 19.84 12.48 21 87219 1883 46596939
Nail bed bleeding 19.83 12.48 10 87230 276 46598546
Wound 19.61 12.48 31 87209 42771 46556051
Therapy partial responder 19.56 12.48 33 87207 4649 46594173
Paraparesis 19.53 12.48 21 87219 1918 46596904
Transaminases 19.50 12.48 7 87233 80 46598742
Monocyte count decreased 19.42 12.48 20 87220 1737 46597085
Merycism 19.35 12.48 8 87232 137 46598685
Transient ischaemic attack 19.32 12.48 22 87218 34881 46563941
Invasive lobular breast carcinoma 19.18 12.48 13 87227 629 46598193
Madarosis 19.15 12.48 20 87220 1766 46597056
Faeces discoloured 19.14 12.48 4 87236 16783 46582039
Intentional product use issue 19.13 12.48 44 87196 52736 46546086
Viral infection 19.09 12.48 17 87223 30218 46568604
Tumour marker increased 19.01 12.48 28 87212 3513 46595309
Radiation pneumonitis 19.00 12.48 17 87223 1240 46597582
Nasal disorder 18.90 12.48 22 87218 2192 46596630
Neuromuscular toxicity 18.84 12.48 8 87232 147 46598675
Caesarean section 18.84 12.48 4 87236 16599 46582223
Dysuria 18.73 12.48 102 87138 27731 46571091
HER2 positive breast cancer 18.69 12.48 7 87233 91 46598731
Drug resistance 18.64 12.48 73 87167 17295 46581527
Device issue 18.62 12.48 7 87233 19973 46578849
Cardio-respiratory arrest 18.56 12.48 54 87186 59815 46539007
Non-small cell lung cancer 18.55 12.48 26 87214 3118 46595704
Eye pain 18.51 12.48 15 87225 27925 46570897
Upper respiratory tract infection 18.51 12.48 59 87181 63497 46535325
Hypothalamo-pituitary disorder 18.50 12.48 13 87227 667 46598155
Tympanic membrane disorder 18.50 12.48 8 87232 154 46598668
Granulocyte count decreased 18.35 12.48 14 87226 816 46598006
Nail bed tenderness 18.28 12.48 7 87233 97 46598725
Necrotising colitis 18.24 12.48 12 87228 552 46598270
Leukaemia cutis 18.22 12.48 7 87233 98 46598724
Chemical peritonitis 18.22 12.48 7 87233 98 46598724
Product administration error 18.17 12.48 7 87233 19674 46579148
Device dislocation 18.16 12.48 9 87231 21793 46577029
Exposed bone in jaw 18.15 12.48 26 87214 3182 46595640
Oral pain 18.14 12.48 93 87147 24704 46574118
Cardiac tamponade 18.09 12.48 31 87209 4423 46594399
Skin laceration 18.07 12.48 6 87234 18496 46580326
Uterine leiomyosarcoma 18.03 12.48 5 87235 22 46598800
Miller Fisher syndrome 18.03 12.48 7 87233 101 46598721
Leukocytosis 17.99 12.48 89 87151 23309 46575513
Metastases to ovary 17.95 12.48 10 87230 339 46598483
Chemotherapy 17.94 12.48 17 87223 1335 46597487
Hip fracture 17.92 12.48 14 87226 26542 46572280
Systemic scleroderma 17.83 12.48 14 87226 852 46597970
Depressed level of consciousness 17.78 12.48 39 87201 47530 46551292
Osteosclerosis 17.73 12.48 27 87213 3489 46595333
Inflammatory carcinoma of the breast 17.71 12.48 6 87234 57 46598765
Fluid overload 17.51 12.48 15 87225 27170 46571652
Vulvitis 17.44 12.48 9 87231 261 46598561
Emotional distress 17.39 12.48 19 87221 30688 46568134
Retinitis pigmentosa 17.37 12.48 7 87233 112 46598710
Fistula 17.35 12.48 43 87197 7967 46590855
Nail infection 17.30 12.48 19 87221 1777 46597045
Myoclonus 17.25 12.48 3 87237 14349 46584473
Alopecia areata 17.25 12.48 12 87228 606 46598216
Seizure 17.22 12.48 147 87093 122907 46475915
Axillary vein thrombosis 17.21 12.48 10 87230 368 46598454
Metastases to uterus 17.17 12.48 6 87234 63 46598759
Neutrophil count abnormal 17.11 12.48 22 87218 2428 46596394
Blood pressure fluctuation 17.07 12.48 19 87221 30429 46568393
Appendiceal abscess 17.04 12.48 8 87232 188 46598634
Clostridium bacteraemia 17.00 12.48 8 87232 189 46598633
Oral surgery 16.96 12.48 15 87225 1077 46597745
Metastases to nervous system 16.89 12.48 5 87235 29 46598793
Cytotoxic oedema 16.87 12.48 7 87233 121 46598701
Metastases to muscle 16.82 12.48 7 87233 122 46598700
Staphylococcal impetigo 16.76 12.48 4 87236 8 46598814
Peripheral motor neuropathy 16.68 12.48 17 87223 1459 46597363
Peripheral swelling 16.67 12.48 202 87038 157869 46440953
Renal failure 16.66 12.48 134 87106 113460 46485362
Chills 16.64 12.48 262 86978 95770 46503052
Drug ineffective for unapproved indication 16.61 12.48 5 87235 16408 46582414
Hyperpyrexia 16.51 12.48 23 87217 2743 46596079
Pain in extremity 16.50 12.48 363 86877 258317 46340505
Foot fracture 16.43 12.48 8 87232 19574 46579248
Troponin I increased 16.42 12.48 19 87221 1881 46596941
Vascular pain 16.41 12.48 12 87228 656 46598166
Skin fissures 16.39 12.48 41 87199 7639 46591183
Adverse event 16.39 12.48 24 87216 34160 46564662
Fear 16.23 12.48 5 87235 16167 46582655
Gastrointestinal haemorrhage 16.10 12.48 82 87158 77291 46521531
Hypersensitivity pneumonitis 16.09 12.48 21 87219 2352 46596470
Acne pustular 16.09 12.48 6 87234 77 46598745
Acute interstitial pneumonitis 16.06 12.48 12 87228 678 46598144
Calcium ionised increased 16.03 12.48 7 87233 138 46598684
Swelling 15.99 12.48 152 87088 124359 46474463
Vena cava thrombosis 15.91 12.48 20 87220 2159 46596663
Astringent therapy 15.85 12.48 3 87237 0 46598822
Limb injury 15.84 12.48 8 87232 19166 46579656
Eosinophil percentage increased 15.75 12.48 13 87227 850 46597972
Muscle twitching 15.72 12.48 4 87236 14668 46584154
Hyperaemia 15.70 12.48 19 87221 1973 46596849
Autonomic neuropathy 15.68 12.48 12 87228 703 46598119
Breast inflammation 15.67 12.48 7 87233 146 46598676
Injection site rash 15.67 12.48 5 87235 15808 46583014
Vaginal prolapse 15.64 12.48 10 87230 438 46598384
Necrotising myositis 15.59 12.48 9 87231 327 46598495
Oral cavity fistula 15.58 12.48 12 87228 710 46598112
Seasonal allergy 15.57 12.48 3 87237 13331 46585491
Pleural disorder 15.54 12.48 11 87229 571 46598251
Upper limb fracture 15.51 12.48 5 87235 15708 46583114
Kidney infection 15.45 12.48 6 87234 16783 46582039
Left ventricular enlargement 15.40 12.48 5 87235 41 46598781
Palmar erythema 15.40 12.48 16 87224 1404 46597418
Bursitis 15.34 12.48 9 87231 19833 46578989
Procedural pain 15.31 12.48 3 87237 13176 46585646
Red cell distribution width increased 15.28 12.48 40 87200 7664 46591158
Chemical burn 15.28 12.48 9 87231 340 46598482
PIK3CA-activated mutation 15.22 12.48 11 87229 590 46598232
Coating in mouth 15.21 12.48 7 87233 157 46598665
Oesophagitis 15.16 12.48 58 87182 13593 46585229
Pituitary tumour 15.08 12.48 13 87227 902 46597920
Skin hypopigmentation 15.02 12.48 9 87231 351 46598471
Subdural haematoma 15.02 12.48 3 87237 12994 46585828
Dandy-Walker syndrome 15.00 12.48 6 87234 94 46598728
Carbohydrate antigen 15-3 increased 14.97 12.48 13 87227 911 46597911
Brachial plexopathy 14.94 12.48 6 87234 95 46598727
Ejection fraction abnormal 14.89 12.48 11 87229 611 46598211
Incorrect route of product administration 14.84 12.48 6 87234 16377 46582445
Renal impairment 14.81 12.48 80 87160 74292 46524530
Adenocarcinoma 14.66 12.48 20 87220 2339 46596483
Lymphadenopathy 14.64 12.48 110 87130 33378 46565444
Dysarthria 14.63 12.48 30 87210 37468 46561354
Nodular regenerative hyperplasia 14.56 12.48 8 87232 264 46598558
Iron deficiency anaemia 14.48 12.48 7 87233 17199 46581623
Ear pain 14.46 12.48 12 87228 22080 46576742
Necrotising fasciitis 14.46 12.48 21 87219 2602 46596220
Osteotomy 14.37 12.48 8 87232 271 46598551
Rhabdomyolysis 14.34 12.48 36 87204 41873 46556949
Red blood cell sedimentation rate increased 14.30 12.48 13 87227 22876 46575946
Paralysis recurrent laryngeal nerve 14.27 12.48 5 87235 53 46598769
Salmonella bacteraemia 14.19 12.48 6 87234 109 46598713
Facial discomfort 14.18 12.48 4 87236 19 46598803
Metastases to breast 14.16 12.48 8 87232 279 46598543
Glaucoma 14.15 12.48 6 87234 15915 46582907
Vagus nerve disorder 14.14 12.48 6 87234 110 46598712
Pancreatic atrophy 14.09 12.48 6 87234 111 46598711
Cancer pain 14.07 12.48 20 87220 2430 46596392
Neutrophil count 14.05 12.48 8 87232 283 46598539
Disorientation 14.01 12.48 30 87210 36888 46561934
Cachexia 14.01 12.48 29 87211 4770 46594052
Blood count abnormal 13.98 12.48 8 87232 17870 46580952
Sopor 13.96 12.48 10 87230 19818 46579004
Pneumocystis jirovecii pneumonia 13.93 12.48 61 87179 15187 46583635
Eastern Cooperative Oncology Group performance status worsened 13.92 12.48 9 87231 402 46598420
Anal erythema 13.92 12.48 7 87233 192 46598630
Acute kidney injury 13.90 12.48 335 86905 235520 46363302
Purulent discharge 13.88 12.48 29 87211 4801 46594021
Urogenital prolapse 13.85 12.48 4 87236 21 46598801
Acute myocardial infarction 13.81 12.48 24 87216 31900 46566922
Osteomyelitis chronic 13.80 12.48 9 87231 408 46598414
Metastases to heart 13.79 12.48 5 87235 59 46598763
Subretinal hyperreflective exudation 13.78 12.48 3 87237 3 46598819
Meningeal neoplasm 13.78 12.48 3 87237 3 46598819
Gastrointestinal perforation 13.77 12.48 23 87217 3214 46595608
Phlebitis 13.75 12.48 33 87207 5993 46592829
Sense of oppression 13.66 12.48 13 87227 1026 46597796
Left ventricular dilatation 13.66 12.48 8 87232 299 46598523
Liver function test abnormal 13.64 12.48 43 87197 46444 46552378
Obstruction gastric 13.54 12.48 12 87228 864 46597958
Hypersomnia 13.43 12.48 6 87234 15433 46583389
Foot deformity 13.41 12.48 6 87234 15419 46583403
Hormone receptor positive breast cancer 13.36 12.48 9 87231 431 46598391
Streptococcal sepsis 13.31 12.48 16 87224 1649 46597173
Skin disorder 13.27 12.48 79 87161 22184 46576638
Sinus congestion 13.25 12.48 4 87236 13105 46585717
Immunodeficiency 13.25 12.48 4 87236 13102 46585720
Skin hyperpigmentation 13.22 12.48 30 87210 5252 46593570
Gastrooesophageal reflux disease 13.19 12.48 83 87157 74261 46524561
Treatment noncompliance 13.18 12.48 22 87218 29709 46569113
Borrelia infection 13.14 12.48 6 87234 132 46598690
Abnormal behaviour 13.10 12.48 12 87228 21046 46577776
Eye swelling 13.06 12.48 11 87229 20092 46578730
Generalised tonic-clonic seizure 13.05 12.48 19 87221 27103 46571719
Feeling hot 13.04 12.48 118 87122 37810 46561012
Arachnoid cyst 12.99 12.48 7 87233 222 46598600
Monocytopenia 12.95 12.48 5 87235 71 46598751
Sciatica 12.86 12.48 10 87230 19010 46579812
Axillary pain 12.84 12.48 14 87226 1299 46597523
Type 2 diabetes mellitus 12.76 12.48 11 87229 19864 46578958
Rash pustular 12.76 12.48 35 87205 6894 46591928
Rotator cuff syndrome 12.72 12.48 3 87237 11580 46587242
Osteitis 12.72 12.48 22 87218 3163 46595659
Dermatitis exfoliative 12.71 12.48 31 87209 5685 46593137
Loss of consciousness 12.71 12.48 135 87105 108103 46490719
Pseudomembranous colitis 12.67 12.48 22 87218 3173 46595649
Soft tissue infection 12.62 12.48 17 87223 1963 46596859
Wrist fracture 12.59 12.48 3 87237 11500 46587322
Therapy responder 12.58 12.48 8 87232 347 46598475
Periodontitis 12.58 12.48 23 87217 3453 46595369
Muscle oedema 12.57 12.48 3 87237 6 46598816
Sinus bradycardia 12.56 12.48 5 87235 13777 46585045
Thermal burn 12.54 12.48 28 87212 4849 46593973
Tooth development disorder 12.52 12.48 4 87236 31 46598791
Frequent bowel movements 12.51 12.48 4 87236 12628 46586194
Muscle spasticity 12.49 12.48 3 87237 11437 46587385

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 734.18 13.79 699 42880 71588 29837311
Febrile neutropenia 640.59 13.79 781 42798 105912 29802987
Osteonecrosis of jaw 566.20 13.79 347 43232 18271 29890628
Neutropenia 390.24 13.79 682 42897 127858 29781041
Interstitial lung disease 328.85 13.79 421 43158 59776 29849123
Diarrhoea 289.64 13.79 1101 42478 333002 29575897
Disease progression 248.63 13.79 429 43150 79445 29829454
Mucosal inflammation 237.57 13.79 256 43323 30238 29878661
Metastases to bone 203.02 13.79 143 43436 9515 29899384
Osteonecrosis 202.30 13.79 176 43403 15959 29892940
Neutropenic sepsis 181.73 13.79 143 43436 11266 29897633
Stomatitis 173.07 13.79 241 43338 37038 29871861
Dehydration 171.28 13.79 479 43100 123060 29785839
Prostatic specific antigen increased 150.58 13.79 131 43448 11873 29897026
Neutrophil count decreased 146.52 13.79 239 43340 42215 29866684
Pneumonitis 122.21 13.79 174 43405 27280 29881619
Leukopenia 119.56 13.79 257 43322 55902 29852997
Tooth extraction 117.10 13.79 78 43501 4733 29904166
Bone disorder 110.60 13.79 86 43493 6655 29902244
Neoplasm progression 107.69 13.79 132 43447 17891 29891008
Metastases to lung 106.83 13.79 90 43489 7805 29901094
Hypocalcaemia 106.41 13.79 143 43436 21233 29887666
Onycholysis 105.83 13.79 34 43545 355 29908544
Drug abuse 105.51 13.79 3 43576 82069 29826830
Drug interaction 100.20 13.79 86 43493 199482 29709417
Prostate cancer metastatic 97.23 13.79 71 43508 4996 29903903
Prostate cancer 95.27 13.79 144 43435 23813 29885086
Product dose omission issue 92.59 13.79 12 43567 91619 29817280
Alopecia 91.47 13.79 126 43453 19149 29889750
Palmar-plantar erythrodysaesthesia syndrome 90.60 13.79 110 43469 14760 29894139
Bone marrow failure 87.30 13.79 156 43423 29629 29879270
White blood cell count decreased 85.86 13.79 293 43286 83654 29825245
Drug ineffective 83.61 13.79 238 43341 340149 29568750
Headache 81.63 13.79 87 43492 182219 29726680
Septic shock 79.60 13.79 238 43341 63369 29845530
Portal venous gas 79.06 13.79 26 43553 294 29908605
Fall 78.99 13.79 89 43490 181783 29727116
Anaemia 78.93 13.79 545 43034 207447 29701452
Metastases to liver 76.98 13.79 91 43488 11874 29897025
Metastases to lymph nodes 76.93 13.79 56 43523 3921 29904978
Decreased appetite 74.45 13.79 421 43158 149489 29759410
Overdose 72.23 13.79 17 43562 84320 29824579
Nausea 68.72 13.79 696 42883 296261 29612638
Non-small cell lung cancer 68.71 13.79 51 43528 3679 29905220
Pleural effusion 68.38 13.79 250 43329 73816 29835083
Skin toxicity 68.01 13.79 48 43531 3201 29905698
Recall phenomenon 66.58 13.79 27 43552 572 29908327
Bacterial translocation 63.50 13.79 21 43558 242 29908657
Haematotoxicity 61.10 13.79 59 43520 6111 29902788
Pyrexia 60.96 13.79 675 42904 293814 29615085
Metastases to central nervous system 59.93 13.79 63 43516 7221 29901678
Peripheral sensory neuropathy 59.51 13.79 57 43522 5844 29903055
Plasma cell myeloma 59.12 13.79 5 43574 53457 29855442
Nasopharyngitis 58.73 13.79 8 43571 58841 29850058
General physical health deterioration 58.65 13.79 294 43285 99650 29809249
Bone pain 57.47 13.79 101 43478 18925 29889974
Vomiting 54.03 13.79 522 43057 219296 29689603
Metastasis 53.93 13.79 42 43537 3256 29905643
Nail disorder 53.84 13.79 33 43546 1732 29907167
Oesophagobronchial fistula 53.04 13.79 16 43563 133 29908766
Disseminated intravascular coagulation 52.43 13.79 106 43473 22065 29886834
Tremor 52.40 13.79 22 43557 75341 29833558
Oesophageal fistula 52.11 13.79 17 43562 187 29908712
Onychomadesis 49.48 13.79 21 43558 501 29908398
Hormone-refractory prostate cancer 47.70 13.79 22 43557 643 29908256
Pneumothorax 46.39 13.79 84 43495 16109 29892790
Agitation 46.08 13.79 11 43568 54062 29854837
Radiation pneumonitis 45.32 13.79 31 43548 1965 29906934
Exposed bone in jaw 45.18 13.79 30 43549 1810 29907089
Depression 44.05 13.79 40 43539 90397 29818502
Radiation skin injury 43.86 13.79 21 43558 669 29908230
Reproductive toxicity 43.58 13.79 9 43570 9 29908890
Urinary tract toxicity 43.58 13.79 9 43570 9 29908890
Gastrointestinal toxicity 42.80 13.79 30 43549 1978 29906921
Bone sequestrum 42.66 13.79 21 43558 712 29908187
Pulmonary toxicity 42.50 13.79 42 43537 4474 29904425
Aggression 42.07 13.79 3 43576 36904 29871995
Somnolence 41.23 13.79 48 43531 96715 29812184
Insomnia 41.19 13.79 45 43534 93291 29815608
Hyponatraemia 41.03 13.79 200 43379 67002 29841897
Weight increased 40.36 13.79 30 43549 74883 29834016
Rheumatoid arthritis 40.16 13.79 6 43573 41191 29867708
Hypokalaemia 39.40 13.79 161 43418 50031 29858868
Pneumatosis intestinalis 39.16 13.79 32 43547 2658 29906241
Prostate cancer recurrent 39.14 13.79 20 43559 735 29908164
Intentional product misuse 39.00 13.79 3 43576 34664 29874235
Blood pressure increased 38.50 13.79 29 43550 71899 29837000
Hallucination 38.02 13.79 12 43567 49047 29859852
Musculoskeletal stiffness 37.96 13.79 4 43575 35877 29873022
Acute respiratory distress syndrome 37.42 13.79 96 43483 23376 29885523
Neuropathy peripheral 36.94 13.79 201 43378 70274 29838625
Nail toxicity 36.66 13.79 9 43570 30 29908869
Respiratory failure 36.43 13.79 261 43318 100381 29808518
Rhabdomyolysis 36.18 13.79 24 43555 63556 29845343
Polyneuropathy 36.01 13.79 63 43516 11760 29897139
Mediastinitis 35.99 13.79 17 43562 525 29908374
Myocardial infarction 35.98 13.79 81 43498 125544 29783355
Erythema 35.42 13.79 213 43366 77238 29831661
Gastric perforation 35.11 13.79 27 43552 2054 29906845
Metastases to skin 35.07 13.79 15 43564 365 29908534
Drug hypersensitivity 34.94 13.79 29 43550 68490 29840409
Cardiac failure congestive 34.76 13.79 43 43536 84364 29824535
Seizure 34.76 13.79 56 43523 98419 29810480
Hypophagia 34.47 13.79 90 43489 22146 29886753
Angioedema 33.53 13.79 5 43574 34379 29874520
Urticaria 33.31 13.79 19 43560 54587 29854312
Acute motor-sensory axonal neuropathy 33.01 13.79 11 43568 130 29908769
Influenza 32.95 13.79 11 43568 43387 29865512
Dermatitis 32.43 13.79 49 43530 8093 29900806
Joint swelling 32.15 13.79 14 43565 46932 29861967
Osteomyelitis 32.13 13.79 68 43511 14613 29894286
Rash 31.98 13.79 157 43422 191732 29717167
Cerebrovascular accident 31.84 13.79 45 43534 83432 29825467
Gingivitis 31.61 13.79 30 43549 3040 29905859
Atypical haemolytic uraemic syndrome 31.60 13.79 10 43569 99 29908800
Dyspnoea 31.60 13.79 669 42910 332626 29576273
Necrotising retinitis 31.32 13.79 17 43562 708 29908191
Muscle spasms 31.18 13.79 29 43550 64809 29844090
Neoplasm recurrence 31.01 13.79 24 43555 1843 29907056
Pruritus 30.85 13.79 80 43499 118124 29790775
Carbohydrate antigen 15-3 increased 30.82 13.79 9 43570 66 29908833
Nail ridging 30.69 13.79 8 43571 36 29908863
Drug reaction with eosinophilia and systemic symptoms 30.59 13.79 3 43576 28485 29880414
Dysphagia 30.58 13.79 163 43416 56535 29852364
Nicotinic acid deficiency 29.92 13.79 9 43570 74 29908825
Intestinal ischaemia 29.62 13.79 43 43536 6854 29902045
Suicidal ideation 29.51 13.79 8 43571 36106 29872793
Contusion 29.49 13.79 5 43574 31275 29877624
Anxiety 29.07 13.79 54 43525 89817 29819082
Metastases to pleura 29.00 13.79 13 43566 355 29908544
Capillary leak syndrome 28.88 13.79 22 43557 1650 29907249
Toxicity to various agents 28.36 13.79 147 43432 177036 29731863
Neutropenic infection 28.25 13.79 18 43561 1012 29907887
Oral pain 28.24 13.79 50 43529 9419 29899480
Hypoxia 28.18 13.79 141 43438 47713 29861186
Incorrect dose administered 27.89 13.79 6 43573 31680 29877219
Haemoptysis 27.88 13.79 104 43475 30974 29877925
Eubacterium infection 27.67 13.79 5 43574 0 29908899
Karnofsky scale worsened 27.67 13.79 5 43574 0 29908899
Bone lesion 27.43 13.79 26 43553 2631 29906268
Bronchial fistula 27.07 13.79 10 43569 163 29908736
Psoriasis 27.07 13.79 14 43565 42492 29866407
Metastases to spine 27.02 13.79 24 43555 2234 29906665
Inappropriate schedule of product administration 26.96 13.79 12 43567 39716 29869183
Pain in jaw 26.25 13.79 56 43523 12100 29896799
Hospitalisation 26.21 13.79 16 43563 44303 29864596
Oesophageal perforation 25.89 13.79 13 43566 460 29908439
Tracheal fistula 25.57 13.79 8 43571 76 29908823
Bradycardia 25.31 13.79 35 43544 65491 29843408
Neutropenic colitis 25.30 13.79 23 43556 2207 29906692
Dizziness 25.22 13.79 173 43406 194736 29714163
Cholangitis sclerosing 25.04 13.79 16 43563 904 29907995
Gastrointestinal ischaemia 24.92 13.79 10 43569 206 29908693
Therapeutic product effect decreased 24.60 13.79 6 43573 29070 29879829
PCO2 decreased 24.57 13.79 19 43560 1457 29907442
Lung adenocarcinoma 24.44 13.79 30 43549 4069 29904830
Abnormal behaviour 24.36 13.79 4 43575 25619 29883280
Memory impairment 24.04 13.79 12 43567 37162 29871737
Splenic vein thrombosis 23.87 13.79 11 43568 321 29908578
Dental care 23.70 13.79 10 43569 235 29908664
Irritability 23.31 13.79 3 43576 23047 29885852
Feeling abnormal 23.26 13.79 29 43550 56727 29852172
Pharyngeal abscess 23.21 13.79 12 43567 452 29908447
Toothache 23.19 13.79 35 43544 5776 29903123
Sequestrectomy 22.99 13.79 11 43568 350 29908549
Sinusitis 22.74 13.79 10 43569 33335 29875564
Hypophosphataemia 22.64 13.79 42 43537 8203 29900696
Fatigue 22.55 13.79 618 42961 320055 29588844
Injection site pain 22.46 13.79 8 43571 30302 29878597
Diabetes mellitus 22.24 13.79 17 43562 41848 29867051
Pancreatitis viral 22.19 13.79 5 43574 10 29908889
Lacrimation increased 22.17 13.79 38 43541 6978 29901921
Eosinophilia 22.13 13.79 3 43576 22157 29886742
Osteitis 22.05 13.79 18 43561 1493 29907406
Lactic acidosis 21.86 13.79 9 43570 31204 29877695
Superior mesenteric artery syndrome 21.79 13.79 7 43572 73 29908826
Chemotherapy 21.50 13.79 12 43567 528 29908371
Tumour pain 21.45 13.79 15 43564 985 29907914
Pharyngeal fistula 21.29 13.79 5 43574 13 29908886
Metastases to meninges 21.21 13.79 16 43563 1183 29907716
Gastrointestinal necrosis 21.12 13.79 25 43554 3264 29905635
Bone debridement 21.02 13.79 10 43569 314 29908585
Hypertension 20.94 13.79 98 43481 121256 29787643
Aorto-oesophageal fistula 20.79 13.79 6 43573 42 29908857
Macroenzyme creatine kinase 20.76 13.79 5 43574 15 29908884
Dacryostenosis acquired 20.48 13.79 8 43571 153 29908746
Colitis 20.45 13.79 94 43485 30726 29878173
Peripheral swelling 20.36 13.79 36 43543 61038 29847861
Flushing 20.35 13.79 91 43488 29401 29879498
Hypovolaemic shock 20.27 13.79 35 43544 6465 29902434
Tumour necrosis 20.26 13.79 15 43564 1078 29907821
Disturbance in attention 19.86 13.79 4 43575 22125 29886774
Biopsy site unspecified abnormal 19.77 13.79 6 43573 51 29908848
Tracheal stenosis 19.75 13.79 8 43571 169 29908730
Pain in extremity 19.62 13.79 88 43491 110133 29798766
Metastases to peritoneum 19.53 13.79 17 43562 1540 29907359
Trigeminal nerve paresis 19.37 13.79 4 43575 4 29908895
Infusion site plaque 19.37 13.79 4 43575 4 29908895
Jaw disorder 19.35 13.79 20 43559 2247 29906652
Soft tissue infection 19.09 13.79 17 43562 1588 29907311
Cranial nerve disorder 18.88 13.79 10 43569 396 29908503
Purulent discharge 18.68 13.79 22 43557 2857 29906042
Enteritis 18.43 13.79 34 43545 6611 29902288
Blood creatine phosphokinase increased 18.39 13.79 22 43557 43826 29865073
Gingival swelling 18.32 13.79 15 43564 1249 29907650
Tracheo-oesophageal fistula 18.32 13.79 10 43569 421 29908478
Foetal exposure during pregnancy 18.30 13.79 16 43563 36855 29872044
Transdifferentiation of neoplasm 18.00 13.79 6 43573 71 29908828
Metastases to adrenals 17.92 13.79 13 43566 905 29907994
Hydronephrosis 17.82 13.79 40 43539 8943 29899956
Arthralgia 17.81 13.79 120 43459 135671 29773228
Scleroderma 17.69 13.79 15 43564 1312 29907587
Tumour haemorrhage 17.55 13.79 20 43559 2508 29906391
Periorbital disorder 17.45 13.79 5 43574 34 29908865
Portosplenomesenteric venous thrombosis 17.14 13.79 4 43575 10 29908889
Cytomegalovirus oesophagitis 17.12 13.79 8 43571 241 29908658
Enterovesical fistula 17.11 13.79 11 43568 628 29908271
Oesophagitis 17.09 13.79 45 43534 11126 29897773
Osteoradionecrosis 17.08 13.79 6 43573 84 29908815
Pulmonary embolism 16.92 13.79 181 43398 77954 29830945
Debridement 16.87 13.79 13 43566 992 29907907
Sarcoma 16.64 13.79 9 43570 372 29908527
Carotidynia 16.60 13.79 3 43576 0 29908899
Oral candidiasis 16.33 13.79 44 43535 11027 29897872
Retroperitoneal lymphadenopathy 16.21 13.79 11 43568 688 29908211
Blood pressure fluctuation 16.06 13.79 3 43576 17500 29891399
Coronary artery disease 15.95 13.79 30 43549 49682 29859217
Metastases to the mediastinum 15.93 13.79 7 43572 182 29908717
Intestinal perforation 15.87 13.79 37 43542 8482 29900417
Gout 15.81 13.79 3 43576 17312 29891587
Radiation mucositis 15.80 13.79 6 43573 106 29908793
Cardiac disorder 15.71 13.79 21 43558 39872 29869027
Dermatitis acneiform 15.64 13.79 29 43550 5660 29903239
Product quality issue 15.64 13.79 4 43575 18770 29890129
Road traffic accident 15.50 13.79 3 43576 17068 29891831
PO2 increased 15.49 13.79 10 43569 575 29908324
Polyneuropathy in malignant disease 15.40 13.79 6 43573 114 29908785
Breakthrough pain 15.37 13.79 10 43569 583 29908316
Fistula 15.21 13.79 27 43552 5095 29903804
Chest X-ray abnormal 15.16 13.79 22 43557 3505 29905394
Blood calcium decreased 15.12 13.79 39 43540 9523 29899376
Haematoma 15.09 13.79 8 43571 23945 29884954
Traumatic lung injury 15.03 13.79 13 43566 1168 29907731
Electrocardiogram QT prolonged 15.01 13.79 18 43561 35817 29873082
Prostate cancer stage IV 14.98 13.79 7 43572 211 29908688
Human chorionic gonadotropin increased 14.84 13.79 4 43575 21 29908878
Cytomegalovirus infection 14.77 13.79 8 43571 23666 29885233
Metastases to soft tissue 14.71 13.79 7 43572 220 29908679
Nodular rash 14.64 13.79 5 43574 64 29908835
Performance status decreased 14.62 13.79 23 43556 3934 29904965
Product use issue 14.56 13.79 28 43551 45988 29862911
Bone trimming 14.53 13.79 4 43575 23 29908876
Hyperchromasia 14.53 13.79 3 43576 3 29908896
Idiosyncratic drug reaction 14.37 13.79 9 43570 491 29908408
Abdominal discomfort 14.32 13.79 31 43548 48760 29860139
Hypoalbuminaemia 14.32 13.79 42 43537 11050 29897849
Pneumonia 14.24 13.79 608 42971 333698 29575201
Adverse drug reaction 14.18 13.79 8 43571 23137 29885762
Vascular pseudoaneurysm 14.18 13.79 16 43563 1984 29906915
Arthritis 14.16 13.79 9 43570 24392 29884507
Cardiotoxicity 14.07 13.79 24 43555 4390 29904509
Laboratory test abnormal 13.99 13.79 4 43575 17438 29891461
Adenocarcinoma 13.99 13.79 15 43564 1758 29907141
No adverse event 13.96 13.79 4 43575 17415 29891484
Clostridium difficile infection 13.86 13.79 3 43576 15780 29893119
Chondritis 13.84 13.79 6 43573 151 29908748
Malignant pleural effusion 13.83 13.79 13 43566 1301 29907598
Psychotic disorder 13.83 13.79 7 43572 21508 29887391
Paraneoplastic pemphigus 13.80 13.79 5 43574 77 29908822

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 cytostatic
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 (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

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)

None

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
Epidermal growth factor receptor Kinase INHIBITOR Kd 9.09 WOMBAT-PK
Cytochrome P450 3A4 Enzyme IC50 5.70 DRUG MATRIX
Substance-K receptor GPCR Ki 6.28 DRUG MATRIX
Multidrug resistance-associated protein 7 Transporter WOMBAT-PK
Multidrug resistance protein 1 Transporter WOMBAT-PK
Growth hormone-releasing hormone receptor GPCR IC50 9.85 CHEMBL

External reference:

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

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Docetaxel HUMAN PRESCRIPTION DRUG LABEL 1 0143-9204 INJECTION, SOLUTION, CONCENTRATE 20 mg INTRAVENOUS ANDA 31 sections
Docetaxel HUMAN PRESCRIPTION DRUG LABEL 1 0143-9205 INJECTION, SOLUTION, CONCENTRATE 20 mg INTRAVENOUS ANDA 31 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 0409-2956 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
Docetaxel HUMAN PRESCRIPTION DRUG LABEL 1 45963-790 INJECTION, SOLUTION, CONCENTRATE 20 mg INTRAVENOUS NDA 22 sections
Docetaxel Human Prescription Drug Label 1 47335-323 INJECTION, SOLUTION 20 mg INTRAVENOUS NDA 30 sections