docetaxel 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | 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

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
azlogd74 LogD at pH 7.4 3.434 High 1
caco2-efflux Caco-2 efflux ratio (BA/AB) 6.950 High 1
caco2-intrinsic-papp Caco-2 intrinsic apparent permeability 30.130 10^-6 cm/s High 1
dh-clint Dog hepatocyte intrinsic clearance 15.812 uL/min/10^6 cells High 1
dppb Dog plasma protein binding (% unbound) 6 % High 1
fcs-ppb Fetal calf serum protein binding (% unbound) 16.990 % High 1
herg hERG pIC50 4.644 pIC50 High 1
hh-clint Human hepatocyte intrinsic clearance 4.887 uL/min/10^6 cells High 1
hlm-clint Human liver microsomal intrinsic clearance 33.884 uL/min/mg protein High 1
hppb Human plasma protein binding (% unbound) 9.880 % High 1
mdck-mdr1-bcrp-efflux MDCK-MDR1-BCRP efflux ratio 0.653 Moderate 0.79
mdck-mdr1-efflux MDCK-MDR1 efflux ratio 11.272 High 1
mh-clint Mouse hepatocyte intrinsic clearance 37.154 High 1
mppb Mouse plasma protein binding (% unbound) 4.340 High 1
nih-mdck-mdr1-efflux NIH MDCK-MDR1 efflux ratio 70.795 High 1
pfas-class PFAS structural alert (1 = True, 0 = False) 0
pppb Pig plasma protein binding (% unbound) 10.210 % High 1
rat-kpuu-brain Rat brain Kpuu 0.011 % Moderate 0.79
rh-clint Rat hepatocyte intrinsic clearance 21.135 uL/min/10^6 cells High 1
rh-fuinc Rat hepatocyte fraction unbound in incubation 33.540 % High 1
rppb Rat plasma protein binding (% unbound) 6.510 % High 1
solubility-dd Solubility at pH 7.4 in DMSO 20.464 uM High 1

Approvals:

DateAgencyCompanyOrphan
May 14, 1996 FDA SANOFI AVENTIS US
Nov. 27, 1995 EMA Sanofi Mature IP

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
Myelosuppression 2837.75 14.30 1337 103596 52254 90471260
Febrile neutropenia 1840.22 14.30 1498 103435 156851 90366663
Neutropenia 1666.07 14.30 1650 103283 223254 90300260
Disease progression 1457.95 14.30 1305 103628 155310 90368204
Diarrhoea 1282.43 14.30 3126 101807 936064 89587450
Malignant neoplasm progression 1246.47 14.30 1014 103919 105856 90417658
Palmar-plantar erythrodysaesthesia syndrome 1231.37 14.30 616 104317 27407 90496107
Ejection fraction decreased 988.08 14.30 520 104413 25733 90497781
Mucosal inflammation 939.37 14.30 668 104265 56957 90466557
Metastases to bone 900.10 14.30 484 104449 25021 90498493
Neuropathy peripheral 881.82 14.30 933 104000 136037 90387477
Metastases to liver 839.63 14.30 482 104451 28325 90495189
Metastases to central nervous system 690.09 14.30 358 104575 17184 90506330
Bone marrow failure 639.71 14.30 422 104511 31799 90491715
Metastases to lung 596.64 14.30 315 104618 15676 90507838
Metastases to lymph nodes 561.02 14.30 273 104660 11416 90512098
Agranulocytosis 500.42 14.30 375 104558 34627 90488887
Cardiotoxicity 496.08 14.30 249 104684 11140 90512374
White blood cell count decreased 443.55 14.30 737 104196 166372 90357142
Neutrophil count decreased 427.74 14.30 469 104464 71063 90452451
Neutropenic sepsis 423.14 14.30 263 104670 17867 90505647
Joint swelling 416.27 14.30 48 104885 503252 90020262
Neoplasm progression 409.58 14.30 369 104564 44117 90479397
Rheumatoid arthritis 398.06 14.30 4 104929 362610 90160904
Leukopenia 394.45 14.30 533 104400 100177 90423337
Systemic lupus erythematosus 380.16 14.30 8 104925 361888 90161626
Pleural effusion 369.45 14.30 546 104387 111445 90412069
Arthropathy 331.89 14.30 24 104909 366218 90157296
Polyneuropathy 330.67 14.30 231 104702 19110 90504404
Nausea 323.76 14.30 2292 102641 1108024 89415490
Contraindicated product administered 321.60 14.30 11 104922 320128 90203386
Hand deformity 313.40 14.30 6 104927 296356 90227158
Skin toxicity 312.34 14.30 154 104779 6625 90516889
Breast cancer recurrent 305.22 14.30 142 104791 5361 90518153
Bone pain 286.29 14.30 356 104577 61627 90461887
Drug ineffective 283.67 14.30 754 104179 1383544 89139970
Therapeutic product effect decreased 280.67 14.30 9 104924 277562 90245952
Acute myeloid leukaemia 277.01 14.30 213 104720 20427 90503087
Flushing 275.48 14.30 420 104513 88071 90435443
Peripheral sensory neuropathy 272.68 14.30 156 104777 9094 90514420
Wound 262.94 14.30 24 104909 302956 90220558
Haematotoxicity 260.49 14.30 169 104764 12366 90511148
Anaemia 258.31 14.30 946 103987 351856 90171658
Sinusitis 254.83 14.30 45 104888 343043 90180471
Interstitial lung disease 254.03 14.30 374 104559 76031 90447483
Metastasis 252.14 14.30 129 104804 6008 90517506
Abdominal discomfort 251.83 14.30 119 104814 477209 90046305
Glossodynia 246.08 14.30 39 104894 321740 90201774
Maternal exposure during pregnancy 243.14 14.30 59 104874 360004 90163510
Helicobacter infection 242.24 14.30 4 104929 226846 90296668
Breast cancer metastatic 238.50 14.30 172 104761 14960 90508554
Recall phenomenon 238.16 14.30 72 104861 777 90522737
Vomiting 236.94 14.30 1641 103292 786652 89736862
Left ventricular dysfunction 234.09 14.30 168 104765 14501 90509013
Product dose omission issue 226.11 14.30 34 104899 291653 90231861
Weight increased 225.35 14.30 101 104832 417826 90105688
Aortitis 224.67 14.30 77 104856 1273 90522241
Duodenal ulcer perforation 220.78 14.30 8 104925 221280 90302234
Pyrexia 218.16 14.30 1408 103525 659077 89864437
Confusional state 216.73 14.30 88 104845 386117 90137397
Drug hypersensitivity 213.46 14.30 137 104796 463472 90060042
Condition aggravated 211.35 14.30 227 104706 595318 89928196
Injury 208.56 14.30 4 104929 197345 90326169
Pericarditis 208.21 14.30 32 104901 270119 90253395
Erythema 207.36 14.30 660 104273 228586 90294928
Musculoskeletal stiffness 207.32 14.30 45 104888 296487 90227027
Alopecia areata 201.62 14.30 79 104854 1936 90521578
Neutropenic colitis 199.49 14.30 97 104836 4046 90519468
Madarosis 196.18 14.30 92 104841 3537 90519977
Hepatic enzyme increased 193.15 14.30 88 104845 360648 90162866
Irritable bowel syndrome 192.48 14.30 12 104921 207436 90316078
Onycholysis 190.45 14.30 78 104855 2152 90521362
Fall 190.17 14.30 167 104766 481643 90041871
Colitis 186.02 14.30 309 104624 69633 90453881
Product use issue 185.35 14.30 75 104858 329844 90193670
Hair colour changes 184.02 14.30 87 104846 3407 90520107
Second primary malignancy 182.18 14.30 126 104807 10252 90513262
Blood cholesterol increased 181.70 14.30 16 104917 207996 90315518
Metastases to skin 179.86 14.30 74 104859 2066 90521448
Mobility decreased 179.47 14.30 36 104897 250698 90272816
Type 2 diabetes mellitus 179.26 14.30 15 104918 203229 90320285
Treatment failure 174.16 14.30 67 104866 303861 90219653
Swelling 173.01 14.30 139 104794 418919 90104595
Thrombocytopenia 171.74 14.30 582 104351 208143 90315371
Lymphoedema 169.55 14.30 135 104798 13618 90509896
Epistaxis 168.81 14.30 331 104602 84794 90438720
Osteoarthritis 168.42 14.30 16 104917 195714 90327800
Impaired healing 166.84 14.30 34 104899 234165 90289349
Decreased appetite 166.58 14.30 868 104065 375672 90147842
Hepatic function abnormal 166.12 14.30 235 104698 46053 90477461
Metastases to pleura 162.73 14.30 68 104865 1976 90521538
Contusion 162.18 14.30 45 104888 251171 90272343
Paronychia 159.17 14.30 105 104828 7901 90515613
Hair texture abnormal 157.08 14.30 86 104847 4601 90518913
Gastrointestinal toxicity 156.99 14.30 111 104822 9356 90514158
Hypokalaemia 155.49 14.30 416 104517 130700 90392814
Neurotoxicity 155.48 14.30 156 104777 21311 90502203
Dehydration 151.94 14.30 533 104400 193914 90329600
Nail toxicity 150.43 14.30 43 104890 375 90523139
Capillary leak syndrome 149.12 14.30 70 104863 2697 90520817
Wheezing 145.76 14.30 47 104886 238033 90285481
Completed suicide 145.51 14.30 5 104928 145053 90378461
Folliculitis 144.86 14.30 30 104903 204323 90319191
Pain 142.60 14.30 632 104301 995709 89527805
Vascular device infection 142.40 14.30 115 104818 11837 90511677
Injection site pain 142.28 14.30 17 104916 173682 90349832
Dysgeusia 142.15 14.30 234 104699 52326 90471188
Bursitis 137.76 14.30 3 104930 131651 90391863
Neutropenic infection 133.42 14.30 57 104876 1752 90521762
Exposure during pregnancy 132.55 14.30 55 104878 238355 90285159
Lacrimation increased 132.29 14.30 160 104773 26902 90496612
Pneumonitis 130.88 14.30 205 104728 43965 90479549
Lymphangiosis carcinomatosa 124.36 14.30 53 104880 1619 90521895
Myalgia 123.21 14.30 464 104469 174661 90348853
Dermatitis acneiform 123.09 14.30 82 104851 6272 90517242
Migraine 121.20 14.30 35 104898 190357 90333157
Asthma 120.59 14.30 65 104868 242095 90281419
Cardiomyopathy 119.85 14.30 132 104801 20074 90503440
Organising pneumonia 118.91 14.30 86 104847 7511 90516003
Gait inability 118.31 14.30 15 104918 146441 90377073
Discomfort 118.23 14.30 87 104846 274248 90249266
Metastases to spine 118.08 14.30 66 104867 3677 90519837
Biopsy lung abnormal 112.87 14.30 28 104905 131 90523383
Road traffic accident 110.50 14.30 3 104930 107623 90415891
Congestive cardiomyopathy 110.00 14.30 81 104852 7273 90516241
Skin exfoliation 109.93 14.30 243 104690 67670 90455844
Overdose 108.01 14.30 25 104908 157684 90365830
Ascites 107.47 14.30 196 104737 47544 90475970
Osteonecrosis of jaw 106.96 14.30 175 104758 38928 90484586
Joint range of motion decreased 106.92 14.30 15 104918 135628 90387886
Sepsis 105.32 14.30 450 104483 179364 90344150
Nasopharyngitis 104.61 14.30 195 104738 406909 90116605
Drug intolerance 104.26 14.30 227 104706 447364 90076150
Arthritis 102.44 14.30 33 104900 167282 90356232
Disease recurrence 102.30 14.30 168 104765 37485 90486029
Asthenia 101.43 14.30 1003 103930 532748 89990766
Hospitalisation 101.36 14.30 14 104919 128086 90395428
Radiation skin injury 99.16 14.30 40 104893 1060 90522454
Chest discomfort 98.45 14.30 368 104565 137997 90385517
Systemic scleroderma 94.36 14.30 43 104890 1546 90521968
Grip strength decreased 93.51 14.30 3 104930 92573 90430941
Back pain 92.80 14.30 657 104276 316518 90206996
Nail dystrophy 92.18 14.30 40 104893 1278 90522236
Dermatitis 92.11 14.30 121 104812 22099 90501415
Depression 91.24 14.30 129 104804 300472 90223042
Somnolence 90.46 14.30 66 104867 209018 90314496
Erysipelas 89.06 14.30 78 104855 8974 90514540
Psoriasis 88.94 14.30 30 104903 147724 90375790
Cardiac failure 88.80 14.30 304 104629 109192 90414322
Metastases to peritoneum 88.74 14.30 57 104876 4098 90519416
Gastrointestinal necrosis 88.70 14.30 52 104881 3173 90520341
Hepatitis B reactivation 88.56 14.30 56 104877 3918 90519596
Invasive ductal breast carcinoma 88.46 14.30 73 104860 7745 90515769
Metastases to meninges 86.67 14.30 54 104879 3681 90519833
Large intestine perforation 86.28 14.30 79 104854 9633 90513881
Metastases to adrenals 86.22 14.30 35 104898 943 90522571
Device related thrombosis 85.99 14.30 44 104889 2049 90521465
Headache 85.83 14.30 616 104317 862130 89661384
Loss of personal independence in daily activities 84.82 14.30 26 104907 136079 90387435
Sleep disorder 82.48 14.30 65 104868 197965 90325549
Hypercholesterolaemia 82.29 14.30 10 104923 100882 90422632
Granulocyte count decreased 82.19 14.30 45 104888 2407 90521107
Drug abuse 82.01 14.30 3 104930 82344 90441170
Urticaria 81.90 14.30 148 104785 312586 90210928
Adverse drug reaction 80.90 14.30 18 104915 116683 90406831
Blister 80.83 14.30 106 104827 254892 90268622
Ventricular hypokinesia 80.28 14.30 59 104874 5282 90518232
Intentional product use issue 79.75 14.30 80 104853 216812 90306702
Device related infection 79.63 14.30 122 104811 25664 90497850
Inappropriate schedule of product administration 79.49 14.30 37 104896 149896 90373618
Enterocolitis 79.23 14.30 78 104855 10412 90513102
Dermatomyositis 78.90 14.30 49 104884 3321 90520193
Pericardial effusion 78.85 14.30 148 104785 36685 90486829
Retinitis pigmentosa 78.79 14.30 21 104912 137 90523377
Febrile bone marrow aplasia 78.41 14.30 75 104858 9663 90513851
Live birth 78.37 14.30 3 104930 79104 90444410
Sciatica 75.83 14.30 13 104920 101369 90422145
Acute promyelocytic leukaemia 74.86 14.30 33 104900 1096 90522418
Multifocal micronodular pneumocyte hyperplasia 74.64 14.30 18 104915 73 90523441
Bronchial polyp 74.64 14.30 18 104915 73 90523441
Peripheral venous disease 74.50 14.30 6 104927 83915 90439599
Therapy partial responder 73.35 14.30 108 104825 21935 90501579
Nail discolouration 73.03 14.30 46 104887 3196 90520318
Injection site reaction 72.99 14.30 10 104923 92070 90431444
Hot flush 72.76 14.30 191 104742 59297 90464217
Constipation 72.42 14.30 564 104369 279831 90243683
Dyspnoea 72.27 14.30 1425 103508 879530 89643984
Peripheral swelling 71.02 14.30 243 104690 412863 90110651
Death 70.82 14.30 824 104109 455727 90067787
Adverse event 70.39 14.30 24 104909 117394 90406120
Illness 69.70 14.30 7 104926 81962 90441552
Metastases to chest wall 69.58 14.30 27 104906 644 90522870
Mastitis 68.76 14.30 43 104890 2950 90520564
Periarticular thenar erythema with onycholysis 68.65 14.30 16 104917 54 90523460
Arthralgia 68.40 14.30 575 104358 777947 89745567
Blood lactate dehydrogenase increased 68.15 14.30 114 104819 25818 90497696
Ear infection 67.94 14.30 3 104930 69772 90453742
Night sweats 67.91 14.30 32 104901 128734 90394780
Cellulitis 67.53 14.30 246 104687 91091 90432423
Myelodysplastic syndrome 66.10 14.30 100 104833 20803 90502711
Performance status decreased 65.96 14.30 48 104885 4232 90519282
Hypertension 64.69 14.30 291 104642 457241 90066273
Pseudocirrhosis 63.91 14.30 28 104905 916 90522598
Stomatitis 63.61 14.30 539 104394 274159 90249355
Red blood cell sedimentation rate increased 63.09 14.30 10 104923 82585 90440929
Metastatic neoplasm 63.09 14.30 49 104884 4766 90518748
Fatigue 61.93 14.30 1760 103173 1152263 89371251
Cardiac dysfunction 61.56 14.30 43 104890 3554 90519960
Injection site erythema 61.04 14.30 19 104914 98483 90425031
Suicide attempt 60.21 14.30 8 104925 75391 90448123
Alanine aminotransferase increased 60.12 14.30 284 104649 118054 90405460
Prescribed underdose 59.81 14.30 8 104925 75011 90448503
Incorrect dose administered 59.29 14.30 10 104923 78920 90444594
Autoimmune disorder 59.28 14.30 9 104924 76735 90446779
Platelet count decreased 59.19 14.30 314 104619 136655 90386859
Medication error 58.79 14.30 13 104920 84639 90438875
Blood creatinine decreased 57.88 14.30 53 104880 6462 90517052
Nail bed inflammation 57.48 14.30 32 104901 1769 90521745
Ill-defined disorder 57.41 14.30 78 104855 184813 90338701
Mucosal infection 57.22 14.30 17 104916 172 90523342
Liver injury 57.07 14.30 68 104865 170499 90353015
Enterocolitis infectious 56.28 14.30 33 104900 2014 90521500
Left ventricular dilatation 55.90 14.30 23 104910 642 90522872
Memory impairment 55.60 14.30 89 104844 197155 90326359
Lymphadenopathy 54.99 14.30 146 104787 45629 90477885
Tonsillar disorder 54.46 14.30 27 104906 1175 90522339
Pulmonary toxicity 54.44 14.30 67 104866 11464 90512050
Wound infection 53.76 14.30 28 104905 106374 90417140
Frequent bowel movements 53.67 14.30 3 104930 56932 90466582
Pregnancy 53.54 14.30 5 104928 62042 90461472
Odynophagia 53.49 14.30 59 104874 8984 90514530
Cystitis haemorrhagic 53.23 14.30 47 104886 5466 90518048
Cystoid macular oedema 52.91 14.30 32 104901 2068 90521446
Gamma-glutamyltransferase increased 52.83 14.30 128 104805 37824 90485690
Streptococcal sepsis 52.54 14.30 39 104894 3545 90519969
Dacryostenosis acquired 52.39 14.30 23 104910 756 90522758
Lumbosacral radiculoplexus neuropathy 51.67 14.30 11 104922 21 90523493
Gait disturbance 51.27 14.30 144 104789 260352 90263162
Injection site swelling 51.16 14.30 5 104928 59834 90463680
Hepatic failure 51.09 14.30 130 104803 39598 90483916
Foot deformity 50.96 14.30 5 104928 59646 90463868
Intestinal ischaemia 50.90 14.30 57 104876 8826 90514688
Alopecia totalis 50.35 14.30 19 104914 419 90523095
Pruritus 50.21 14.30 394 104539 541131 89982383
Infection 50.13 14.30 232 104701 361862 90161652
Obesity 50.08 14.30 30 104903 105477 90418037
Metastases to the mediastinum 49.44 14.30 21 104912 636 90522878
Portal hypertension 49.27 14.30 42 104891 4659 90518855
Inflammation 49.01 14.30 82 104851 178510 90345004
Hepatotoxicity 48.90 14.30 140 104793 45702 90477812
Hyperpyrexia 48.81 14.30 42 104891 4719 90518795
Acute leukaemia 48.72 14.30 25 104908 1171 90522343
Breast pain 48.33 14.30 60 104873 10358 90513156
Mastectomy 47.83 14.30 30 104903 2069 90521445
Pleural disorder 47.70 14.30 21 104912 695 90522819
Intestinal perforation 47.62 14.30 69 104864 13812 90509702
Feeling abnormal 47.56 14.30 75 104858 167160 90356354
Granulocytopenia 46.99 14.30 47 104886 6394 90517120
Blood alkaline phosphatase increased 46.68 14.30 142 104791 47937 90475577
Aspartate aminotransferase increased 46.55 14.30 239 104694 102698 90420816
Blepharospasm 46.45 14.30 5 104928 55440 90468074
Product quality issue 46.20 14.30 17 104916 79308 90444206
Nail disorder 46.14 14.30 162 104771 58905 90464609
Breast cancer 45.99 14.30 152 104781 53609 90469905
Amnesia 45.94 14.30 35 104898 108470 90415044
Dry mouth 45.60 14.30 90 104843 183969 90339545
Excessive eye blinking 45.49 14.30 25 104908 1347 90522167
Osteoporosis 45.04 14.30 28 104905 96503 90427011
Delirium 45.04 14.30 33 104900 104326 90419188
Anxiety 44.96 14.30 195 104738 309577 90213937
Lupus-like syndrome 44.76 14.30 3 104930 48843 90474671
Injection site pruritus 44.73 14.30 5 104928 53829 90469685
Blood pressure systolic increased 44.70 14.30 7 104926 58338 90465176
Blood uric acid decreased 44.19 14.30 21 104912 832 90522682
COVID-19 44.08 14.30 80 104853 168763 90354751
Sedation 44.02 14.30 3 104930 48168 90475346
Hypocalcaemia 43.85 14.30 128 104805 42240 90481274
Onychalgia 43.79 14.30 23 104910 1131 90522383
Drug resistance 43.78 14.30 104 104829 30345 90493169
Skin fissures 43.77 14.30 83 104850 20726 90502788
Insomnia 43.63 14.30 218 104715 333256 90190258
Therapy interrupted 43.33 14.30 4 104929 50104 90473410
Malignant pleural effusion 42.88 14.30 32 104901 2932 90520582
Hepatic lesion 42.50 14.30 42 104891 5631 90517883
Pseudomonal sepsis 42.18 14.30 37 104896 4265 90519249
Pulmonary mass 42.16 14.30 99 104834 28673 90494841
Therapy non-responder 42.10 14.30 58 104875 136646 90386868
Nasal congestion 42.06 14.30 22 104911 83392 90440122
Neuromuscular toxicity 41.78 14.30 15 104918 286 90523228
Gastrointestinal disorder 41.40 14.30 155 104778 256532 90266982
Nasal mucosal disorder 40.96 14.30 26 104907 1831 90521683
Lung disorder 40.95 14.30 69 104864 149814 90373700
Myositis 40.93 14.30 88 104845 24040 90499474
Paraparesis 40.91 14.30 31 104902 2907 90520607
Neck pain 40.78 14.30 43 104890 113920 90409594
Eosinophil percentage increased 40.74 14.30 21 104912 993 90522521
Hallucination 40.37 14.30 13 104920 65946 90457568
Pulmonary fibrosis 40.25 14.30 39 104894 107464 90416050
Myocardial infarction 40.19 14.30 38 104895 105934 90417580
Joint dislocation 40.09 14.30 3 104930 44579 90478935
Abdominal pain 40.00 14.30 662 104271 395059 90128455
Product use in unapproved indication 38.91 14.30 229 104704 336007 90187507
Carotidynia 38.77 14.30 12 104921 141 90523373
HER2 positive breast cancer 38.64 14.30 16 104917 454 90523060
Septic shock 38.46 14.30 196 104737 83964 90439550
Computerised tomogram thorax abnormal 38.19 14.30 26 104907 2061 90521453
Systolic dysfunction 37.92 14.30 25 104908 1879 90521635
Dysuria 37.90 14.30 116 104817 39285 90484229
Subclavian vein thrombosis 37.87 14.30 26 104907 2090 90521424
Nail infection 37.73 14.30 28 104905 2544 90520970
Metastases to bone marrow 37.55 14.30 17 104916 602 90522912
Muscle spasms 37.50 14.30 157 104776 251726 90271788
Cerebrovascular accident 37.45 14.30 53 104880 123480 90400034
Cough 37.19 14.30 617 104316 368345 90155169
Suicidal ideation 36.47 14.30 20 104913 73835 90449679
Bone lesion 36.36 14.30 41 104892 6396 90517118
Chills 36.00 14.30 269 104664 131712 90391802
Neoplasm recurrence 35.97 14.30 30 104903 3229 90520285
Acute interstitial pneumonitis 35.93 14.30 18 104915 801 90522713
Osteolysis 35.75 14.30 31 104902 3519 90519995
Bone marrow infiltration 35.46 14.30 18 104915 824 90522690
Leukocytosis 35.37 14.30 97 104836 30893 90492621
Lower limb fracture 35.26 14.30 28 104905 84985 90438529
Generalised oedema 35.24 14.30 72 104861 18981 90504533
Microvascular coronary artery disease 35.04 14.30 13 104920 273 90523241
Cystitis noninfective 34.85 14.30 21 104912 1348 90522166
PIK3CA-activated mutation 34.67 14.30 20 104913 1184 90522330
Influenza 34.57 14.30 68 104865 139196 90384318
Pancreatitis 34.35 14.30 19 104914 69807 90453707
Malaise 34.32 14.30 475 104458 585511 89938003
Underdose 34.22 14.30 10 104923 54007 90469507
Intentional product misuse 34.13 14.30 32 104901 89572 90433942
Peritonitis 33.57 14.30 72 104861 19633 90503881
Bronchitis 33.55 14.30 80 104853 152847 90370667
Troponin I increased 33.47 14.30 26 104907 2529 90520985
Candida infection 33.44 14.30 101 104832 33956 90489558
Obstructive shock 33.34 14.30 9 104924 62 90523452
Nephrolithiasis 33.16 14.30 8 104925 49077 90474437
Radiation necrosis 33.13 14.30 16 104917 657 90522857
Pulmonary embolism 33.09 14.30 262 104671 130558 90392956
Palmar erythema 33.07 14.30 23 104910 1888 90521626
Central vision loss 32.98 14.30 9 104924 65 90523449
Tumour embolism 32.96 14.30 11 104922 167 90523347
Biliary sepsis 32.79 14.30 18 104915 968 90522546
Barotrauma 32.66 14.30 11 104922 172 90523342
Folate deficiency 32.61 14.30 28 104905 3137 90520377
EGFR gene mutation 32.49 14.30 13 104920 337 90523177
Oral pain 32.17 14.30 97 104836 32586 90490928
Recurrent cancer 32.16 14.30 25 104908 2434 90521080
Breast inflammation 31.76 14.30 11 104922 188 90523326
Nasal disorder 31.65 14.30 28 104905 3264 90520250
Mouth ulceration 31.53 14.30 110 104823 39864 90483650
Immunodeficiency 31.34 14.30 6 104927 43228 90480286
Hemianopia 31.29 14.30 23 104910 2059 90521455
Axillary pain 31.24 14.30 24 104909 2297 90521217
Axillary vein thrombosis 31.13 14.30 13 104920 377 90523137
Foetal exposure during pregnancy 31.08 14.30 6 104927 42969 90480545
Plasma cell myeloma 31.05 14.30 5 104928 40823 90482691
Metastases to soft tissue 30.74 14.30 12 104921 291 90523223
Coeliac disease 30.67 14.30 7 104926 44603 90478911
Therapeutic product effect incomplete 30.66 14.30 118 104815 193778 90329736
Sclerema 30.66 14.30 7 104926 21 90523493
Drug interaction 30.55 14.30 191 104742 276262 90247252
Tongue coated 30.54 14.30 21 104912 1692 90521822
Hyperchlorhydria 30.44 14.30 22 104911 1919 90521595
Abdominal pain upper 30.34 14.30 243 104690 332431 90191083
Hypersensitivity 30.14 14.30 359 104574 454318 90069196
Muscle spasticity 30.07 14.30 3 104930 35319 90488195
Electrocardiogram QT prolonged 29.87 14.30 24 104909 72432 90451082
Gas gangrene 29.77 14.30 10 104923 155 90523359
Ejection fraction 29.73 14.30 26 104907 2985 90520529
Breast neoplasm 29.67 14.30 20 104913 1560 90521954
Spinal pain 29.66 14.30 60 104873 15707 90507807
Vulvovaginal candidiasis 29.45 14.30 29 104904 3871 90519643
Invasive lobular breast carcinoma 29.38 14.30 17 104916 1012 90522502
Hydrothorax 29.32 14.30 17 104916 1016 90522498
Hypoalbuminaemia 29.31 14.30 60 104873 15837 90507677
Scleroderma renal crisis 29.29 14.30 13 104920 439 90523075
Vessel puncture site bruise 29.18 14.30 13 104920 443 90523071
Abortion spontaneous 29.17 14.30 13 104920 54043 90469471
Toxic optic neuropathy 29.13 14.30 11 104922 243 90523271
Autonomic neuropathy 29.06 14.30 19 104914 1408 90522106
Onychoclasis 28.68 14.30 39 104894 7360 90516154
Cardiac tamponade 28.67 14.30 34 104899 5598 90517916
Treatment noncompliance 28.61 14.30 12 104921 51715 90471799
Soft tissue infection 28.57 14.30 25 104908 2872 90520642
Lung infiltration 28.56 14.30 58 104875 15224 90508290
Distichiasis 28.53 14.30 7 104926 31 90523483
Bradycardia 28.49 14.30 33 104900 83814 90439700
Bone marrow oedema syndrome 28.38 14.30 8 104925 66 90523448
Swollen tongue 28.23 14.30 9 104924 45947 90477567
Nephritis bacterial 28.17 14.30 7 104926 33 90523481
Hypomagnesaemia 28.13 14.30 98 104835 35490 90488024
Serotonin syndrome 28.02 14.30 5 104928 37882 90485632
Basal cell carcinoma 28.00 14.30 3 104930 33386 90490128
Gastritis 27.98 14.30 109 104824 41644 90481870
Infusion site vesicles 27.89 14.30 14 104919 626 90522888
Vascular pain 27.75 14.30 16 104917 946 90522568
Hiccups 27.63 14.30 25 104908 3001 90520513
Mucosal disorder 27.51 14.30 24 104909 2747 90520767
Vascular fragility 27.18 14.30 10 104923 205 90523309
Cardiac failure chronic 26.97 14.30 33 104900 5613 90517901
Nail bed bleeding 26.77 14.30 12 104921 415 90523099
Radiation pneumonitis 26.75 14.30 20 104913 1838 90521676
Vein discolouration 26.70 14.30 11 104922 308 90523206
Retinal toxicity 26.70 14.30 18 104915 1404 90522110
Embolism 26.69 14.30 43 104890 9438 90514076
Laryngeal tremor 26.47 14.30 5 104928 3 90523511
Adenocarcinoma 26.46 14.30 25 104908 3171 90520343
Asthenopia 26.46 14.30 24 104909 2890 90520624
Clostridium difficile infection 26.25 14.30 97 104836 36148 90487366
Acoustic stimulation tests abnormal 26 14.30 8 104925 92 90523422
Pneumothorax 25.99 14.30 64 104869 19103 90504411
Musculoskeletal pain 25.94 14.30 106 104827 171145 90352369
Dysphagia 25.78 14.30 220 104713 112058 90411456
Phlebitis 25.58 14.30 37 104896 7393 90516121
Metastases to abdominal cavity 25.57 14.30 13 104920 597 90522917
Procedural pain 25.56 14.30 4 104929 33356 90490158
Clostridium bacteraemia 25.56 14.30 10 104923 244 90523270
Device adhesion issue 25.53 14.30 35 104898 6656 90516858
Pneumonia salmonella 25.35 14.30 5 104928 5 90523509
Acute respiratory distress syndrome 25.33 14.30 82 104851 28604 90494910
Ear pain 25.21 14.30 18 104915 57684 90465830
Skin reaction 25.21 14.30 62 104871 18491 90505023
Pneumocystis jirovecii pneumonia 25.00 14.30 68 104865 21548 90501966
Nail bed tenderness 24.90 14.30 11 104922 367 90523147
Throat tightness 24.89 14.30 83 104850 29401 90494113
Sensory disturbance 24.76 14.30 55 104878 15358 90508156
Gastrooesophageal reflux disease 24.55 14.30 104 104829 166233 90357281
Necrotising myositis 24.45 14.30 14 104919 817 90522697
Upper respiratory tract infection 24.44 14.30 72 104861 128246 90395268
Blood creatine increased 24.44 14.30 35 104898 6932 90516582
Therapy cessation 24.42 14.30 6 104927 36355 90487159
Large intestine infection 24.36 14.30 22 104911 2635 90520879
Metastases to breast 24.33 14.30 11 104922 388 90523126
Joint neoplasm 24.29 14.30 7 104926 63 90523451
Pseudomembranous colitis 24.21 14.30 26 104907 3842 90519672
Extravasation 24.19 14.30 23 104910 2941 90520573
Salmonella sepsis 24.18 14.30 10 104923 283 90523231
Acute hepatic failure 24.15 14.30 69 104864 22492 90501022
Anal inflammation 24.10 14.30 11 104922 397 90523117
Eastern Cooperative Oncology Group performance status worsened 23.83 14.30 19 104914 1920 90521594
Lower respiratory tract infection 23.82 14.30 181 104752 250478 90273036
Inflammatory carcinoma of the breast 23.81 14.30 7 104926 68 90523446
Hypertransaminasaemia 23.79 14.30 55 104878 15770 90507744
Pancytopenia 23.71 14.30 228 104705 120035 90403479
Osteitis condensans 23.70 14.30 6 104927 31 90523483
Menopausal disorder 23.63 14.30 7 104926 70 90523444
Colitis ulcerative 23.57 14.30 21 104912 60245 90463269
Hyperfibrinogenaemia 23.54 14.30 6 104927 32 90523482
Osteosclerosis 23.53 14.30 27 104906 4293 90519221
Orthopnoea 23.48 14.30 34 104899 6801 90516713
Overflow diarrhoea 23.47 14.30 8 104925 130 90523384
Gastrointestinal perforation 23.47 14.30 27 104906 4305 90519209
Mitral valve incompetence 23.26 14.30 68 104865 22456 90501058
Aortic wall hypertrophy 23.08 14.30 6 104927 35 90523479
Staphylococcal impetigo 23.01 14.30 5 104928 11 90523503
Pituitary tumour 23.00 14.30 14 104919 915 90522599
Unevaluable event 22.82 14.30 18 104915 54830 90468684
Transaminases 22.79 14.30 7 104926 80 90523434
Joint injury 22.71 14.30 5 104928 32659 90490855
Acral peeling skin syndrome 22.71 14.30 5 104928 12 90523502
Ultrasound foetal abnormal 22.66 14.30 8 104925 145 90523369
Carcinoembryonic antigen increased 22.62 14.30 20 104913 2330 90521184
B-cell type acute leukaemia 22.53 14.30 12 104921 607 90522907
Solid organ transplant rejection 22.53 14.30 6 104927 39 90523475
Amenorrhoea 22.52 14.30 45 104888 11677 90511837
White blood cell count abnormal 22.46 14.30 35 104898 7469 90516045
Lipoprotein increased 22.42 14.30 5 104928 13 90523501
Red cell distribution width increased 22.42 14.30 46 104887 12161 90511353
Dysaesthesia 22.37 14.30 29 104904 5226 90518288
Post-traumatic pain 22.22 14.30 11 104922 477 90523037
Lymphangitis 22.20 14.30 14 104919 975 90522539
Hypereosinophilic syndrome 22.19 14.30 10 104923 350 90523164
Coma 22.17 14.30 31 104902 72601 90450913
Ovarian necrosis 22.15 14.30 6 104927 42 90523472
Respiratory failure 22.13 14.30 222 104711 118196 90405318
Clostridial infection 21.99 14.30 27 104906 4609 90518905
Visual impairment 21.93 14.30 79 104854 132286 90391228
Thrombotic microangiopathy 21.80 14.30 53 104880 15690 90507824
Adverse reaction 21.80 14.30 4 104929 29708 90493806
Seroma 21.72 14.30 22 104911 3038 90520476
Meibomian gland dysfunction 21.68 14.30 9 104924 257 90523257
Lipidosis 21.67 14.30 6 104927 46 90523468
Chromosomal mutation 21.66 14.30 5 104928 16 90523498
Gastric disorder 21.48 14.30 6 104927 33378 90490136
Peripheral motor neuropathy 21.44 14.30 18 104915 1955 90521559
Neutrophil count increased 21.44 14.30 60 104873 19330 90504184
Metastases to ovary 21.42 14.30 11 104922 516 90522998
Osmotic demyelination syndrome 21.38 14.30 14 104919 1040 90522474
Cytopenia 21.30 14.30 56 104877 17393 90506121
Perforation 21.28 14.30 18 104915 1976 90521538
Arteritis 21.23 14.30 12 104921 683 90522831
Metastases to thorax 21.18 14.30 9 104924 273 90523241
Soft tissue neoplasm 21.17 14.30 7 104926 103 90523411
Laboratory test abnormal 21.16 14.30 11 104922 41843 90481671
Chemical peritonitis 21.11 14.30 7 104926 104 90523410
Triple negative breast cancer 21.09 14.30 10 104923 394 90523120
Vasculitis 21.07 14.30 66 104867 22627 90500887
Full blood count abnormal 21.04 14.30 8 104925 36589 90486925
Dyskinesia 20.98 14.30 8 104925 36526 90486988
Monocyte count decreased 20.94 14.30 20 104913 2571 90520943
Oral candidiasis 20.93 14.30 89 104844 35366 90488148
No adverse event 20.77 14.30 29 104904 67953 90455561
Oesophagitis 20.69 14.30 55 104878 17194 90506320
Entropion 20.69 14.30 7 104926 111 90523403
Retinal detachment 20.67 14.30 32 104901 6790 90516724
Hyperaemia 20.61 14.30 20 104913 2622 90520892
Congenital syphilitic osteochondritis 20.59 14.30 5 104928 21 90523493
Chemotherapy 20.54 14.30 17 104916 1810 90521704
Tympanic membrane disorder 20.49 14.30 8 104925 194 90523320
Hydrocephalus 20.48 14.30 30 104903 6064 90517450
Catheter site bruise 20.36 14.30 11 104922 573 90522941
Nervousness 20.34 14.30 7 104926 34049 90489465
Retinal fovea disorder 20.28 14.30 4 104929 4 90523510
Cannabinoid hyperemesis syndrome 20.26 14.30 6 104927 60 90523454
Infusion related reaction 20.24 14.30 350 104583 416430 90107084
Gastrointestinal candidiasis 20.16 14.30 9 104924 308 90523206
Transaminases increased 20.16 14.30 91 104842 37101 90486413
Dizziness 20.10 14.30 524 104409 588760 89934754
Oestradiol abnormal 19.99 14.30 6 104927 63 90523451
Unintentional medical device removal 19.95 14.30 32 104901 6998 90516516
Breast oedema 19.91 14.30 6 104927 64 90523450
Multiple sclerosis 19.89 14.30 4 104929 27836 90495678
Pancreatic atrophy 19.84 14.30 9 104924 320 90523194
Vulvovaginal dryness 19.63 14.30 22 104911 3409 90520105
Neutrophil count abnormal 19.51 14.30 24 104909 4104 90519410
Brain oedema 19.42 14.30 54 104879 17331 90506183
Toxic erythema of chemotherapy 19.35 14.30 8 104925 226 90523288
Vena cava thrombosis 19.32 14.30 19 104914 2533 90520981
Miller Fisher syndrome 19.19 14.30 7 104926 140 90523374
Pain in extremity 19.19 14.30 387 104546 450142 90073372
Carbohydrate antigen 15-3 increased 19.16 14.30 17 104916 1990 90521524
Stress 19.13 14.30 41 104892 81354 90442160
Noninfective conjunctivitis 19.12 14.30 5 104928 30 90523484
International normalised ratio increased 19.10 14.30 16 104917 47300 90476214
Muscle necrosis 19.07 14.30 12 104921 832 90522682
Purtscher retinopathy 19.05 14.30 7 104926 143 90523371
Acquired gene mutation 18.93 14.30 14 104919 1265 90522249
Leukaemia cutis 18.87 14.30 7 104926 147 90523367
Polyneuropathy chronic 18.66 14.30 4 104929 8 90523506
Foot fracture 18.64 14.30 4 104929 26602 90496912
Necrosis 18.64 14.30 30 104903 6580 90516934
Vulvitis 18.49 14.30 9 104924 376 90523138
Injection site haemorrhage 18.39 14.30 5 104928 28313 90495201
Chronic obstructive pulmonary disease 18.36 14.30 36 104897 73793 90449721
Incorrect route of product administration 18.22 14.30 19 104914 50607 90472907
Metastases to muscle 18.12 14.30 7 104926 165 90523349
Metastases to nervous system 18.11 14.30 6 104927 89 90523425
Lactic acidosis 18.09 14.30 19 104914 50444 90473070
Osteonecrosis 17.99 14.30 69 104864 26172 90497342
Kidney infection 17.95 14.30 4 104929 25912 90497602
Limb injury 17.93 14.30 7 104926 31501 90492013
Chronic myelomonocytic leukaemia 17.83 14.30 9 104924 407 90523107
Hip fracture 17.78 14.30 8 104925 33069 90490445
Vaginal prolapse 17.73 14.30 10 104923 567 90522947
Abdominal rigidity 17.72 14.30 18 104915 2494 90521020
Varicose vein 17.66 14.30 31 104902 7296 90516218
Toxic skin eruption 17.63 14.30 49 104884 15725 90507789
Lymphadenopathy mediastinal 17.60 14.30 20 104913 3147 90520367
Colitis ischaemic 17.57 14.30 42 104891 12304 90511210
Necrotising fasciitis 17.44 14.30 22 104911 3858 90519656
Appendiceal abscess 17.44 14.30 8 104925 292 90523222
Blood pressure fluctuation 17.41 14.30 21 104912 52392 90471122
Labia enlarged 17.29 14.30 3 104930 0 90523514
Astringent therapy 17.29 14.30 3 104930 0 90523514
Infusion site plaque 17.29 14.30 3 104930 0 90523514
ALK gene rearrangement positive 17.29 14.30 3 104930 0 90523514
Tumour marker increased 17.26 14.30 27 104906 5780 90517734
Impaired quality of life 17.23 14.30 3 104930 23141 90500373
Tumour necrosis 17.21 14.30 12 104921 989 90522525
Arachnoid cyst 17.12 14.30 8 104925 305 90523209
Taste disorder 17.11 14.30 28 104905 61518 90461996
Seasonal allergy 17.07 14.30 3 104930 22980 90500534
Meibomianitis 17.06 14.30 5 104928 48 90523466
Herpes simplex sepsis 17.06 14.30 5 104928 48 90523466
Metastases to pituitary gland 17.05 14.30 4 104929 14 90523500
Lymphangiopathy 17.05 14.30 4 104929 14 90523500
Embolism venous 17.03 14.30 21 104912 3599 90519915
Dandy-Walker syndrome 17.03 14.30 6 104927 108 90523406
Blood glucose increased 17.03 14.30 55 104878 95191 90428323
Sarcoid-like reaction 17.03 14.30 7 104926 195 90523319
Tumour lysis syndrome 17.03 14.30 39 104894 11113 90512401
Feeling hot 16.94 14.30 151 104782 77857 90445657
Coating in mouth 16.93 14.30 7 104926 198 90523316
Cytotoxic oedema 16.93 14.30 7 104926 198 90523316
Dermatitis exfoliative 16.82 14.30 26 104907 5510 90518004
Glossopharyngeal nerve paralysis 16.79 14.30 5 104928 51 90523463
Metastases to uterus 16.73 14.30 6 104927 114 90523400
Upper respiratory fungal infection 16.73 14.30 7 104926 204 90523310
Merycism 16.69 14.30 8 104925 323 90523191
Metastases to heart 16.67 14.30 7 104926 206 90523308
Therapy responder 16.62 14.30 8 104925 326 90523188
Salmonellosis 16.58 14.30 13 104920 1282 90522232
Liver disorder 16.58 14.30 78 104855 121191 90402323
Accidental overdose 16.56 14.30 6 104927 28267 90495247
Skin hyperpigmentation 16.53 14.30 29 104904 6822 90516692
Naevus haemorrhage 16.49 14.30 6 104927 119 90523395
Agitation 16.44 14.30 33 104900 67065 90456449
Bronchiectasis 16.40 14.30 3 104930 22327 90501187
Blood bilirubin increased 16.33 14.30 96 104837 43374 90480140
Vagus nerve disorder 16.22 14.30 6 104927 125 90523389
Joint stiffness 16.19 14.30 42 104891 78000 90445514
Apical granuloma 16.06 14.30 5 104928 60 90523454
Chemical burn 16.03 14.30 9 104924 506 90523008
Surgery 15.98 14.30 17 104916 44870 90478644
Metastatic lymphoma 15.98 14.30 7 104926 229 90523285
Papilloedema 15.92 14.30 23 104910 4592 90518922
Cutaneous symptom 15.90 14.30 9 104924 514 90523000
Megacolon 15.86 14.30 16 104917 2198 90521316
Appendicitis 15.86 14.30 36 104897 10195 90513319
Acute lymphocytic leukaemia 15.85 14.30 18 104915 2830 90520684
Ovarian failure 15.85 14.30 14 104919 1629 90521885
Rash follicular 15.84 14.30 5 104928 63 90523451
Nightmare 15.78 14.30 3 104930 21722 90501792
Jaundice 15.75 14.30 77 104856 32440 90491074
Respiratory tract congestion 15.75 14.30 6 104927 27404 90496110
Urogenital prolapse 15.74 14.30 4 104929 21 90523493
Uterine leiomyosarcoma 15.74 14.30 4 104929 21 90523493
Cerebral haematoma 15.71 14.30 22 104911 4267 90519247
Leukonychia 15.55 14.30 5 104928 67 90523447
Vein disorder 15.44 14.30 25 104908 5511 90518003
Normal newborn 15.41 14.30 4 104929 23358 90500156
Vaginitis gardnerella 15.35 14.30 5 104928 70 90523444
Drug ineffective for unapproved indication 15.31 14.30 34 104899 66610 90456904
Intestinal haemorrhage 15.10 14.30 22 104911 4425 90519089
Aggression 15.05 14.30 6 104927 26662 90496852
Paralysis recurrent laryngeal nerve 15.04 14.30 5 104928 75 90523439
Administration site extravasation 15.00 14.30 12 104921 1218 90522296
Angioedema 14.98 14.30 33 104900 64843 90458671
Hyperproteinaemia 14.98 14.30 6 104927 156 90523358
Blood pressure increased 14.92 14.30 151 104782 197066 90326448
Face oedema 14.92 14.30 60 104873 23258 90500256
Left ventricular enlargement 14.92 14.30 5 104928 77 90523437
Choroidal effusion 14.84 14.30 10 104923 779 90522735
Colony stimulating factor therapy 14.82 14.30 8 104925 416 90523098
Hepatic cyst 14.82 14.30 27 104906 6541 90516973
Panophthalmitis 14.80 14.30 6 104927 161 90523353
Acute biphenotypic leukaemia 14.80 14.30 5 104928 79 90523435
Pleomorphic adenoma 14.76 14.30 4 104929 28 90523486
Foetal death 14.76 14.30 3 104930 20720 90502794
Balance disorder 14.75 14.30 60 104873 97020 90426494
Hepatitis 14.73 14.30 38 104895 70701 90452813
Herpes zoster 14.69 14.30 58 104875 94586 90428928
Retracted nipple 14.64 14.30 4 104929 29 90523485
Salmonella bacteraemia 14.63 14.30 6 104927 166 90523348
Alopecia 14.61 14.30 707 104226 494364 90029150
Hyperthermia 14.53 14.30 35 104898 10300 90513214
Fibrous histiocytoma 14.48 14.30 9 104924 611 90522903
Depressed level of consciousness 14.48 14.30 40 104893 72744 90450770
Irritability 14.47 14.30 12 104921 35650 90487864
Lacrimal disorder 14.46 14.30 7 104926 289 90523225
Oxygen saturation decreased 14.44 14.30 189 104744 107294 90416220
Viral infection 14.39 14.30 16 104917 41398 90482116
Injection site rash 14.38 14.30 5 104928 24168 90499346
Tremor 14.36 14.30 111 104822 153062 90370452
Breast angiosarcoma 14.35 14.30 3 104930 5 90523509
Anal erythema 14.35 14.30 7 104926 294 90523220

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 1432.71 15.39 1116 49502 107284 42463433
Disease progression 662.83 15.39 833 49785 142823 42427894
Prostatic specific antigen increased 645.54 15.39 341 50277 16584 42554133
Metastases to bone 606.58 15.39 313 50305 14496 42556221
Febrile neutropenia 585.14 15.39 896 49722 184807 42385910
Osteonecrosis of jaw 553.95 15.39 321 50297 18728 42551989
Neutropenia 518.63 15.39 882 49736 198549 42372168
Diarrhoea 333.77 15.39 1249 49369 459600 42111117
Metastases to lymph nodes 275.35 15.39 137 50481 5861 42564856
Neoplasm progression 270.57 15.39 245 50373 28755 42541962
Mucosal inflammation 263.81 15.39 309 50309 49065 42521652
Hormone-refractory prostate cancer 253.54 15.39 79 50539 925 42569792
Metastases to lung 236.31 15.39 155 50463 11269 42559448
Neutrophil count decreased 233.51 15.39 330 50288 63085 42507632
Interstitial lung disease 221.80 15.39 361 50257 78101 42492616
Leukopenia 219.61 15.39 350 50268 74396 42496321
Alopecia 206.35 15.39 212 50406 29064 42541653
Pneumonitis 206.21 15.39 251 50367 41467 42529250
Prostate cancer metastatic 193.35 15.39 112 50506 6517 42564200
Metastases to liver 178.50 15.39 151 50467 16175 42554542
Neuropathy peripheral 155.25 15.39 361 50257 101492 42469225
Anaemia 153.80 15.39 699 49919 279579 42291138
Stomatitis 152.33 15.39 239 50379 50090 42520627
Neutropenic sepsis 137.56 15.39 129 50489 15817 42554900
Product dose omission issue 131.06 15.39 15 50603 154350 42416367
Myelosuppression 120.83 15.39 191 50427 40270 42530447
Nausea 118.73 15.39 841 49777 395958 42174759
Metastases to central nervous system 113.64 15.39 96 50522 10259 42560458
Palmar-plantar erythrodysaesthesia syndrome 108.47 15.39 128 50490 20454 42550263
Onycholysis 105.21 15.39 41 50577 964 42569753
Fall 99.12 15.39 80 50538 234440 42336277
Drug interaction 94.29 15.39 107 50511 266892 42303825
Dehydration 94.09 15.39 375 50243 141392 42429325
Prostate cancer 84.76 15.39 173 50445 44470 42526247
Portal venous gas 83.86 15.39 29 50589 480 42570237
Decreased appetite 82.43 15.39 449 50169 192688 42378029
Septic shock 81.64 15.39 267 50351 91405 42479312
White blood cell count decreased 80.55 15.39 301 50317 110095 42460622
Delusion of grandeur 78.26 15.39 41 50577 1955 42568762
Haematotoxicity 78.17 15.39 80 50538 10905 42559812
Metastasis 76.38 15.39 55 50563 4650 42566067
Headache 76.02 15.39 104 50514 239265 42331452
Polyneuropathy 75.94 15.39 102 50516 18559 42552158
Inappropriate schedule of product administration 74.99 15.39 12 50606 95890 42474827
Peripheral sensory neuropathy 73.87 15.39 70 50548 8692 42562025
Skin toxicity 72.44 15.39 61 50557 6488 42564229
Bone marrow failure 70.98 15.39 135 50483 32958 42537759
Pleural effusion 69.27 15.39 263 50355 96903 42473814
Pulmonary toxicity 68.91 15.39 67 50551 8588 42562129
Hypocalcaemia 68.35 15.39 126 50492 30047 42540670
Tremor 67.64 15.39 16 50602 96913 42473804
Nasopharyngitis 66.83 15.39 10 50608 83986 42486731
General physical health deterioration 66.78 15.39 355 50263 150891 42419826
Bone pain 65.13 15.39 108 50510 23684 42547033
Nail disorder 64.38 15.39 38 50580 2289 42568428
Recall phenomenon 64.02 15.39 25 50593 591 42570126
Fatigue 63.36 15.39 792 49826 434849 42135868
Osteonecrosis 58.95 15.39 83 50535 15782 42554935
Rhinalgia 58.72 15.39 33 50585 1811 42568906
Lymphocyte count abnormal 58.64 15.39 35 50583 2152 42568565
Somnolence 58.47 15.39 49 50569 141056 42429661
Vomiting 56.81 15.39 559 50059 289164 42281553
Weight increased 56.23 15.39 29 50589 107954 42462763
Asthma 55.58 15.39 5 50613 62309 42508408
Oesophageal fistula 55.48 15.39 19 50599 305 42570412
Nail toxicity 55.20 15.39 13 50605 45 42570672
Radiation skin injury 54.89 15.39 24 50594 761 42569956
Pneumatosis intestinalis 54.09 15.39 45 50573 4707 42566010
Bone lesion 50.59 15.39 38 50580 3428 42567289
Injection site pain 50.59 15.39 5 50613 57793 42512924
Insomnia 50.30 15.39 40 50578 118213 42452504
Musculoskeletal stiffness 48.02 15.39 6 50612 57759 42512958
BRCA2 gene mutation 47.58 15.39 12 50606 59 42570658
Flushing 47.55 15.39 123 50495 36905 42533812
Prostate cancer recurrent 47.52 15.39 24 50594 1059 42569658
Oesophagobronchial fistula 47.50 15.39 15 50603 184 42570533
BRCA1 gene mutation 47.09 15.39 12 50606 62 42570655
Depression 46.95 15.39 38 50580 111325 42459392
Bacterial translocation 45.78 15.39 20 50598 633 42570084
Reproductive toxicity 45.41 15.39 9 50609 9 42570708
Rhabdomyolysis 45.22 15.39 18 50600 78001 42492716
Metastases to skin 45.10 15.39 19 50599 549 42570168
Anxiety 44.56 15.39 45 50573 118515 42452202
Agitation 44.11 15.39 11 50607 64303 42506414
Metastases to bladder 42.48 15.39 12 50606 97 42570620
Gastrointestinal toxicity 41.84 15.39 36 50582 3943 42566774
Drug hypersensitivity 41.79 15.39 34 50584 99355 42471362
Pyrexia 41.77 15.39 678 49940 393364 42177353
Polyneuropathy in malignant disease 41.71 15.39 16 50602 360 42570357
Affective disorder 41.67 15.39 43 50575 5917 42564800
Hallucination 41.09 15.39 9 50609 57498 42513219
Pneumothorax 40.89 15.39 88 50530 23455 42547262
Aggression 40.89 15.39 3 50615 44160 42526557
Therapy partial responder 40.87 15.39 80 50538 19941 42550776
Suicidal ideation 40.04 15.39 5 50613 48156 42522561
Dermatitis 39.56 15.39 59 50559 11816 42558901
Urinary tract toxicity 38.03 15.39 9 50609 32 42570685
Onychomadesis 37.94 15.39 18 50600 692 42570025
Metastases to spine 36.82 15.39 30 50588 3047 42567670
Intestinal ischaemia 36.20 15.39 50 50568 9338 42561379
Lung lobectomy 36.06 15.39 10 50608 75 42570642
Dizziness 35.94 15.39 163 50455 249091 42321626
Joint swelling 35.80 15.39 18 50600 68004 42502713
Plasma cell myeloma 34.91 15.39 7 50611 47571 42523146
SARS-CoV-2 test positive 34.91 15.39 46 50572 8214 42562503
Blood pressure increased 34.66 15.39 42 50576 101886 42468831
Metastases to meninges 34.32 15.39 24 50594 1937 42568780
Muscle spasms 34.26 15.39 31 50587 86013 42484704
Exposed bone in jaw 33.92 15.39 22 50596 1567 42569150
Angioedema 33.91 15.39 5 50613 42472 42528245
Acute motor-sensory axonal neuropathy 33.84 15.39 11 50607 149 42570568
Disseminated intravascular coagulation 33.53 15.39 84 50534 24710 42546007
Contusion 33.38 15.39 5 50613 41980 42528737
Colitis 33.10 15.39 126 50492 46446 42524271
Neutropenic colitis 32.61 15.39 33 50585 4437 42566280
Gastric perforation 32.55 15.39 28 50590 3065 42567652
Carbohydrate antigen 15-3 increased 32.28 15.39 9 50609 69 42570648
Rash 32.15 15.39 195 50423 276759 42293958
Cerebrovascular accident 32.02 15.39 41 50577 97119 42473598
Agranulocytosis 31.68 15.39 94 50524 30518 42540199
Capillary leak syndrome 31.57 15.39 26 50592 2681 42568036
Urticaria 31.53 15.39 25 50593 74011 42496706
Gastric stenosis 31.07 15.39 10 50608 131 42570586
Metastases to pleura 30.70 15.39 15 50603 616 42570101
Prostatic specific antigen abnormal 30.69 15.39 17 50601 907 42569810
Pruritus 30.57 15.39 118 50500 188653 42382064
Laryngeal oedema 30.00 15.39 30 50588 3978 42566739
Bone disorder 29.77 15.39 38 50580 6575 42564142
Cardiac failure congestive 29.39 15.39 35 50583 85567 42485150
Gastrointestinal necrosis 29.25 15.39 30 50588 4098 42566619
Drug reaction with eosinophilia and systemic symptoms 29.23 15.39 7 50611 42068 42528649
Erythema 29.10 15.39 225 50393 108568 42462149
Influenza 29.08 15.39 19 50599 62156 42508561
Hypophagia 29.07 15.39 84 50534 26872 42543845
Necrotising retinitis 28.97 15.39 17 50601 1013 42569704
Vasogenic cerebral oedema 28.87 15.39 17 50601 1019 42569698
Karnofsky scale worsened 28.69 15.39 5 50613 0 42570717
Intentional product use issue 28.45 15.39 26 50592 71807 42498910
Pharyngeal abscess 28.15 15.39 13 50605 470 42570247
Non-small cell lung cancer 27.98 15.39 32 50586 4942 42565775
Rheumatoid arthritis 27.70 15.39 8 50610 42432 42528285
Intentional product misuse 27.51 15.39 20 50598 61880 42508837
Sinusitis 27.25 15.39 11 50607 47281 42523436
Second primary malignancy 26.92 15.39 44 50574 9531 42561186
Myocardial infarction 26.79 15.39 68 50550 123941 42446776
Arthralgia 26.79 15.39 139 50479 205099 42365618
Macroenzyme creatine kinase 26.65 15.39 6 50612 16 42570701
Overdose 26.58 15.39 53 50565 105211 42465506
Blood glucose increased 26.53 15.39 29 50589 73670 42497047
Loss of personal independence in daily activities 26.48 15.39 13 50605 49803 42520914
Hot flush 26.41 15.39 72 50546 22279 42548438
Cytokine release syndrome 26.25 15.39 10 50608 44517 42526200
Hydronephrosis 26.17 15.39 49 50569 11816 42558901
No adverse event 26.13 15.39 7 50611 39014 42531703
Metastases to soft tissue 25.65 15.39 12 50606 447 42570270
Toxic erythema of chemotherapy 25.59 15.39 9 50609 157 42570560
Gastrointestinal anastomotic leak 25.48 15.39 13 50605 586 42570131
Superior mesenteric artery syndrome 25.34 15.39 8 50610 98 42570619
Disturbance in attention 25.07 15.39 3 50615 29863 42540854
Thrombocytopenia 25.00 15.39 340 50278 189939 42380778
Paronychia 25.00 15.39 28 50590 4227 42566490
Neutrophil count increased 24.61 15.39 65 50553 19739 42550978
Oesophageal-pulmonary fistula 24.60 15.39 6 50612 25 42570692
Carotid artery aneurysm 24.32 15.39 7 50611 61 42570656
Condition aggravated 24.15 15.39 196 50422 260558 42310159
Memory impairment 23.96 15.39 15 50603 50207 42520510
Arthritis 23.89 15.39 10 50608 42055 42528662
Hospitalisation 23.84 15.39 32 50586 74298 42496419
Eosinophilia 23.80 15.39 5 50613 32894 42537823
Nicotinic acid deficiency 23.62 15.39 8 50610 124 42570593
Sleep disorder 23.45 15.39 14 50604 48081 42522636
Accidental overdose 23.40 15.39 3 50615 28327 42542390
Gastrointestinal ischaemia 23.23 15.39 10 50608 305 42570412
Pain in extremity 23.19 15.39 96 50522 150508 42420209
Cytomegalovirus infection 23.19 15.39 5 50613 32301 42538416
Dacryostenosis acquired 23.02 15.39 10 50608 312 42570405
Treatment noncompliance 22.98 15.39 8 50610 37664 42533053
Eubacterium infection 22.95 15.39 4 50614 0 42570717
Osteoradionecrosis 22.69 15.39 7 50611 79 42570638
VIth nerve paralysis 22.59 15.39 14 50604 921 42569796
Pancreatitis viral 22.58 15.39 5 50613 12 42570705
Schizophrenia 22.56 15.39 43 50575 10507 42560210
Metastatic neoplasm 22.46 15.39 24 50594 3437 42567280
Feeling abnormal 22.42 15.39 30 50588 69756 42500961
Nail ridging 22.26 15.39 8 50610 149 42570568
Medication error 22.10 15.39 6 50612 33148 42537569
Adenocarcinoma 22.05 15.39 19 50599 2085 42568632
Chemotherapy 21.86 15.39 13 50605 794 42569923
Spinal cord compression 21.80 15.39 26 50592 4198 42566519
Neuroendocrine carcinoma of prostate 21.75 15.39 6 50612 44 42570673
Asthenia 21.60 15.39 460 50158 280333 42290384
Neoplasm recurrence 21.52 15.39 21 50597 2703 42568014
Hypokalaemia 21.25 15.39 152 50466 71569 42499148
Aorto-oesophageal fistula 21.08 15.39 6 50612 50 42570667
Blood creatine phosphokinase increased 20.98 15.39 16 50602 48322 42522395
Tooth socket haemorrhage 20.98 15.39 6 50612 51 42570666
Free prostate-specific antigen positive 20.71 15.39 4 50614 3 42570714
Tracheo-oesophageal fistula 20.60 15.39 11 50607 545 42570172
Allodynia 20.58 15.39 14 50604 1080 42569637
Colon cancer stage III 20.57 15.39 8 50610 187 42570530
Nephrolithiasis 20.52 15.39 9 50609 36821 42533896
Dysphagia 20.34 15.39 152 50466 72567 42498150
Nasal congestion 20.31 15.39 5 50613 29496 42541221
Heart rate decreased 20.24 15.39 9 50609 36523 42534194
Trigeminal nerve paresis 20.18 15.39 4 50614 4 42570713
Abdominal distension 19.99 15.39 34 50584 71701 42499016
Sarcoma 19.95 15.39 10 50608 434 42570283
Oesophagitis 19.93 15.39 51 50567 15196 42555521
Peripheral swelling 19.88 15.39 49 50569 90221 42480496
Neutropenic infection 19.80 15.39 17 50601 1856 42568861
Hereditary optic atrophy 19.76 15.39 6 50612 64 42570653
Performance status decreased 19.50 15.39 26 50592 4694 42566023
Tooth extraction 19.37 15.39 28 50590 5452 42565265
Coma 19.35 15.39 21 50597 53533 42517184
Mobility decreased 19.09 15.39 9 50609 35297 42535420
Bronchial fistula 19.03 15.39 8 50610 230 42570487
Metastases to the mediastinum 18.97 15.39 9 50609 346 42570371
Haematochezia 18.89 15.39 25 50593 58411 42512306
Gout 18.84 15.39 5 50613 28050 42542667
Fasciitis 18.83 15.39 9 50609 352 42570365
Full blood count abnormal 18.83 15.39 6 50612 29870 42540847
Mediastinitis 18.78 15.39 13 50605 1032 42569685
Blood pressure systolic increased 18.76 15.39 5 50613 27963 42542754
Respiratory failure 18.50 15.39 233 50385 127899 42442818
Idiosyncratic drug reaction 18.36 15.39 10 50608 516 42570201
Tracheal fistula 18.23 15.39 7 50611 158 42570559
Diabetes mellitus 18.14 15.39 27 50591 60060 42510657
Abdominal discomfort 18.06 15.39 39 50579 75216 42495501
Periorbital disorder 17.97 15.39 5 50613 38 42570679
Ischaemic enteritis 17.97 15.39 5 50613 38 42570679
Vascular pseudoaneurysm 17.94 15.39 19 50599 2693 42568024
PO2 increased 17.89 15.39 10 50608 543 42570174
Gastrointestinal stenosis 17.83 15.39 7 50611 168 42570549
Metastases to peritoneum 17.72 15.39 18 50600 2431 42568286
Acute febrile neutrophilic dermatosis 17.72 15.39 16 50602 1868 42568849
Illness 17.61 15.39 4 50614 24926 42545791
Amnesia 17.41 15.39 6 50612 28431 42542286
Pyelonephritis acute 17.41 15.39 18 50600 2482 42568235
Confusional state 17.38 15.39 122 50496 167475 42403242
Metastases to pelvis 17.37 15.39 9 50609 419 42570298
Hormone-dependent prostate cancer 17.33 15.39 5 50613 44 42570673
Acute interstitial pneumonitis 17.32 15.39 10 50608 578 42570139
Abdominal infection 17.30 15.39 18 50600 2501 42568216
Abnormal behaviour 17.23 15.39 5 50613 26446 42544271
Carotidynia 17.21 15.39 3 50615 0 42570717
Neurone-specific enolase increased 17.21 15.39 3 50615 0 42570717
Hyperchromasia 17.21 15.39 3 50615 0 42570717
Malignant pleural effusion 17.21 15.39 16 50602 1939 42568778
Death 17.19 15.39 703 49915 470482 42100235
Wheezing 17.14 15.39 24 50594 54757 42515960
Cranial nerve disorder 17.11 15.39 10 50608 591 42570126
Irritability 17.11 15.39 6 50612 28122 42542595
Drug level increased 16.98 15.39 5 50613 26195 42544522
Hypovolaemic shock 16.95 15.39 34 50584 8625 42562092
Aneurysm ruptured 16.94 15.39 10 50608 602 42570115
Balance disorder 16.86 15.39 19 50599 47626 42523091
Tracheal stenosis 16.76 15.39 8 50610 312 42570405
Cardiotoxicity 16.74 15.39 31 50587 7414 42563303
Radiation pneumonitis 16.72 15.39 19 50599 2914 42567803
COVID-19 16.57 15.39 76 50542 115872 42454845
Lymphadenopathy 16.56 15.39 81 50537 33284 42537433
Psoriasis 16.54 15.39 20 50598 48584 42522133
Scleroderma 16.52 15.39 15 50603 1763 42568954
Aortitis 16.30 15.39 10 50608 646 42570071
Sleep apnoea syndrome 16.23 15.39 3 50615 21605 42549112
Tumour pain 16.18 15.39 13 50605 1294 42569423
Hyperlipidaemia 16.13 15.39 3 50615 21513 42549204
Lactic acidosis 16.07 15.39 18 50600 45243 42525474
Acute kidney injury 16.00 15.39 324 50294 367013 42203704
Traumatic lung injury 15.97 15.39 13 50605 1319 42569398
Blood pressure fluctuation 15.93 15.39 6 50612 26902 42543815
Biopsy site unspecified abnormal 15.81 15.39 4 50614 20 42570697
Haemolytic uraemic syndrome 15.75 15.39 17 50601 2462 42568255
Cholangitis sclerosing 15.66 15.39 15 50603 1887 42568830
Benign prostatic hyperplasia 15.65 15.39 3 50615 21049 42549668
Tubulointerstitial nephritis 15.64 15.39 9 50609 31539 42539178
Bone sequestrum 15.62 15.39 9 50609 518 42570199
Congenital mitral valve incompetence 15.56 15.39 6 50612 137 42570580
Embolism 15.50 15.39 33 50585 8730 42561987
Bradycardia 15.44 15.39 51 50567 85433 42485284

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
Myelosuppression 2511.21 13.71 1514 133249 92826 110361710
Malignant neoplasm progression 2178.53 13.71 1759 133004 172808 110281728
Disease progression 1672.97 13.71 1759 133004 242275 110212261
Febrile neutropenia 1593.83 13.71 1944 132819 314823 110139713
Neutropenia 1580.63 13.71 2106 132657 372514 110082022
Diarrhoea 1403.37 13.71 3768 130995 1135737 109318799
Metastases to bone 1160.85 13.71 625 134138 30747 110423789
Neuropathy peripheral 925.53 13.71 1116 133647 178161 110276375
Palmar-plantar erythrodysaesthesia syndrome 922.29 13.71 592 134171 40433 110414103
Mucosal inflammation 894.55 13.71 820 133943 95321 110359215
Metastases to liver 796.31 13.71 511 134252 34875 110419661
Metastases to lung 701.49 13.71 404 134359 22659 110431877
Metastases to central nervous system 694.83 13.71 400 134363 22417 110432119
Metastases to lymph nodes 671.87 13.71 340 134423 14692 110439844
Neoplasm progression 591.01 13.71 546 134217 64049 110390487
Neutrophil count decreased 578.67 13.71 725 134038 120216 110334320
Bone marrow failure 568.47 13.71 509 134254 57339 110397197
Ejection fraction decreased 534.29 13.71 424 134339 40456 110414080
Osteonecrosis of jaw 516.90 13.71 445 134318 47572 110406964
White blood cell count decreased 514.42 13.71 967 133796 228423 110226113
Leukopenia 503.10 13.71 754 134009 148037 110306499
Neutropenic sepsis 487.88 13.71 358 134405 30388 110424148
Prostatic specific antigen increased 478.78 13.71 255 134508 12256 110442280
Agranulocytosis 453.99 13.71 463 134300 61297 110393239
Interstitial lung disease 387.84 13.71 646 134117 138688 110315848
Nausea 387.77 13.71 2700 132063 1232990 109221546
Joint swelling 357.65 13.71 56 134707 442789 110011747
Polyneuropathy 339.07 13.71 294 134469 31718 110422818
Rheumatoid arthritis 334.93 13.71 6 134757 299607 110154929
Pleural effusion 321.20 13.71 685 134078 177024 110277512
Flushing 316.37 13.71 504 134259 104232 110350304
Arthropathy 298.31 13.71 12 134751 287510 110167026
Recall phenomenon 296.95 13.71 97 134666 1299 110453237
Skin toxicity 292.14 13.71 181 134582 11602 110442934
Anaemia 291.11 13.71 1378 133385 545708 109908828
Pneumonitis 287.79 13.71 408 134355 76123 110378413
Haematotoxicity 269.72 13.71 216 134547 20866 110433670
Systemic lupus erythematosus 259.25 13.71 12 134751 254326 110200210
Bone pain 257.94 13.71 356 134407 64777 110389759
Product dose omission issue 256.75 13.71 42 134721 321740 110132796
Therapeutic product effect decreased 254.09 13.71 10 134753 244306 110210230
Contraindicated product administered 252.12 13.71 12 134751 248255 110206281
Fall 248.48 13.71 222 134541 603260 109851276
Onycholysis 248.05 13.71 102 134661 2697 110451839
Pemphigus 245.32 13.71 3 134760 214567 110239969
Cardiotoxicity 244.22 13.71 186 134577 16695 110437841
Weight increased 240.76 13.71 105 134658 419539 110034997
Peripheral sensory neuropathy 239.58 13.71 183 134580 16497 110438039
Hand deformity 237.76 13.71 6 134757 218500 110236036
Decreased appetite 232.47 13.71 1170 133593 474676 109979860
Metastasis 230.71 13.71 137 134626 8130 110446406
Sinusitis 225.24 13.71 44 134719 296644 110157892
Aortitis 215.21 13.71 84 134679 1931 110452605
Vomiting 213.49 13.71 1862 132901 908813 109545723
Musculoskeletal stiffness 213.47 13.71 41 134722 279781 110174755
Neutropenic colitis 207.87 13.71 127 134636 7938 110446598
Drug hypersensitivity 205.55 13.71 152 134611 453938 110000598
Pyrexia 205.03 13.71 1826 132937 896439 109558097
Breast cancer recurrent 204.66 13.71 98 134665 3748 110450788
Breast cancer metastatic 204.52 13.71 142 134621 11039 110443497
Wound 202.49 13.71 24 134739 234413 110220123
Alopecia areata 198.24 13.71 81 134682 2106 110452430
Drug abuse 192.52 13.71 5 134758 177406 110277130
Helicobacter infection 190.62 13.71 7 134756 181870 110272666
Erythema 189.49 13.71 780 133983 290667 110163869
Confusional state 186.19 13.71 178 134585 468502 109986034
Colitis 185.42 13.71 395 134368 101928 110352608
Injury 181.81 13.71 8 134755 177257 110277279
Madarosis 177.49 13.71 86 134677 3377 110451159
Abdominal discomfort 176.72 13.71 133 134630 393725 110060811
Mobility decreased 174.42 13.71 38 134725 237384 110217152
Nail toxicity 173.90 13.71 49 134714 381 110454155
Acute myeloid leukaemia 173.44 13.71 223 134540 37887 110416649
Condition aggravated 171.61 13.71 403 134360 734433 109720103
Maternal exposure during pregnancy 169.53 13.71 50 134713 254833 110199703
Hair texture abnormal 166.69 13.71 86 134677 3868 110450668
Capillary leak syndrome 165.47 13.71 92 134671 4816 110449720
Left ventricular dysfunction 165.12 13.71 172 134591 23321 110431215
Hepatic enzyme increased 164.80 13.71 93 134670 320799 110133737
Dehydration 163.85 13.71 725 134038 278786 110175750
Blood cholesterol increased 161.86 13.71 18 134745 184767 110269769
Metastases to skin 161.33 13.71 71 134692 2228 110452308
Irritable bowel syndrome 160.28 13.71 10 134753 164205 110290331
Contusion 158.48 13.71 44 134719 233317 110221219
Hair colour changes 158.16 13.71 88 134675 4613 110449923
Paronychia 157.88 13.71 121 134642 10960 110443576
Osteoarthritis 156.94 13.71 19 134744 182604 110271932
Muscle injury 156.55 13.71 3 134760 140804 110313732
Duodenal ulcer perforation 156.43 13.71 17 134746 177683 110276853
Pericarditis 155.12 13.71 38 134725 219076 110235460
Gastrointestinal toxicity 155.05 13.71 120 134643 11028 110443508
Glossodynia 152.37 13.71 41 134722 221963 110232573
Second primary malignancy 152.27 13.71 146 134617 17922 110436614
Injection site pain 151.70 13.71 19 134744 177903 110276633
Wheezing 149.26 13.71 62 134701 255168 110199368
Type 2 diabetes mellitus 148.53 13.71 20 134743 177212 110277324
Lymphoedema 145.86 13.71 131 134632 14798 110439738
Bursitis 139.69 13.71 4 134759 129914 110324622
C-reactive protein abnormal 139.43 13.71 4 134759 129691 110324845
Asthma 138.19 13.71 66 134697 250225 110204311
Inappropriate schedule of product administration 137.14 13.71 39 134724 203598 110250938
Radiation skin injury 136.27 13.71 57 134706 1575 110452961
Impaired healing 131.88 13.71 38 134725 196679 110257857
Product use issue 131.32 13.71 112 134651 311583 110142953
Stomatitis 129.97 13.71 662 134101 269580 110184956
Fatigue 123.01 13.71 2121 132642 1213837 109240699
Migraine 122.99 13.71 29 134734 171623 110282913
Metastases to meninges 122.65 13.71 77 134686 5051 110449485
Depression 121.92 13.71 124 134639 317211 110137325
Intentional product use issue 121.41 13.71 76 134687 247830 110206706
Pulmonary toxicity 121.27 13.71 128 134635 17618 110436918
Hormone-refractory prostate cancer 119.07 13.71 44 134719 866 110453670
Dermatitis 117.53 13.71 157 134606 27680 110426856
Joint range of motion decreased 117.17 13.71 8 134755 121824 110332712
Headache 115.22 13.71 619 134144 881758 109572778
Somnolence 114.53 13.71 116 134647 297333 110157203
Metastases to pleura 114.15 13.71 54 134709 2009 110452527
Therapy partial responder 114.12 13.71 180 134583 36881 110417655
Overdose 114.03 13.71 72 134691 233722 110220814
Road traffic accident 112.98 13.71 4 134759 107394 110347142
Hypokalaemia 112.77 13.71 481 134282 181967 110272569
Thrombocytopenia 112.34 13.71 769 133994 348116 110106420
Nasopharyngitis 111.80 13.71 193 134570 394168 110060368
Swelling 111.68 13.71 159 134604 350882 110103654
Drug ineffective 111.47 13.71 1252 133511 1519288 108935248
Lacrimation increased 110.44 13.71 161 134602 30789 110423747
Biopsy lung abnormal 110.42 13.71 28 134735 137 110454399
Pain 109.73 13.71 698 134065 954257 109500279
Dermatitis acneiform 107.77 13.71 103 134660 12592 110441944
Lymphangiosis carcinomatosa 107.57 13.71 55 134708 2427 110452109
Septic shock 107.35 13.71 428 134335 157100 110297436
Drug interaction 106.74 13.71 287 134476 499896 109954640
Arthritis 105.84 13.71 36 134727 167550 110286986
Vascular device infection 105.62 13.71 115 134648 16397 110438139
Dysgeusia 105.33 13.71 251 134512 69734 110384802
Prostate cancer metastatic 105.29 13.71 69 134694 4874 110449662
Exposure during pregnancy 100.59 13.71 39 134724 167385 110287151
Metastases to spine 100.41 13.71 69 134694 5274 110449262
Gastrointestinal necrosis 100.11 13.71 75 134688 6565 110447971
Nail dystrophy 99.56 13.71 42 134721 1186 110453350
Folliculitis 99.17 13.71 40 134723 167613 110286923
Urticaria 98.89 13.71 147 134616 318710 110135826
Congestive cardiomyopathy 97.95 13.71 103 134660 14116 110440420
Sleep disorder 97.11 13.71 61 134702 198583 110255953
Alopecia 96.33 13.71 767 133996 363986 110090550
Loss of personal independence in daily activities 95.13 13.71 32 134731 149988 110304548
Portal venous gas 93.43 13.71 32 134731 500 110454036
Suicide attempt 93.30 13.71 9 134754 103385 110351151
Discomfort 90.58 13.71 77 134686 214630 110239906
Gait inability 90.19 13.71 27 134736 136349 110318187
Night sweats 89.57 13.71 26 134737 133957 110320579
Systemic scleroderma 89.26 13.71 45 134718 1927 110452609
Intestinal ischaemia 88.69 13.71 104 134659 16075 110438461
Epistaxis 88.64 13.71 354 134409 130018 110324518
Metastases to peritoneum 88.24 13.71 65 134698 5545 110448991
Medication error 88.01 13.71 12 134751 105354 110349182
Arthralgia 87.86 13.71 573 134190 779059 109675477
Bone lesion 87.23 13.71 71 134692 7016 110447520
Prescribed overdose 86.46 13.71 5 134758 87576 110366960
Injection site reaction 85.21 13.71 6 134757 89064 110365472
Acute promyelocytic leukaemia 85.04 13.71 43 134720 1853 110452683
Drug intolerance 84.63 13.71 236 134527 406276 110048260
Anxiety 83.81 13.71 185 134578 344893 110109643
Febrile bone marrow aplasia 82.30 13.71 104 134659 17361 110437175
Organising pneumonia 82.18 13.71 94 134669 14149 110440387
Neutropenic infection 80.82 13.71 50 134713 3195 110451341
Hypertension 79.81 13.71 335 134428 509749 109944787
Hepatic function abnormal 79.78 13.71 265 134498 89030 110365506
Sepsis 79.76 13.71 676 134087 326670 110127866
Hospitalisation 79.51 13.71 37 134726 142456 110312080
Back pain 79.04 13.71 744 134019 370252 110084284
Grip strength decreased 77.87 13.71 5 134758 80169 110374367
Retinitis pigmentosa 77.73 13.71 21 134742 137 110454399
Asthenia 76.78 13.71 1222 133541 687777 109766759
Peripheral venous disease 76.75 13.71 7 134756 84110 110370426
Hypocalcaemia 75.24 13.71 212 134551 65154 110389382
Myocardial infarction 74.95 13.71 74 134689 192009 110262527
Metastatic neoplasm 74.74 13.71 60 134703 5813 110448723
Multifocal micronodular pneumocyte hyperplasia 73.72 13.71 18 134745 73 110454463
Blood pressure systolic increased 72.87 13.71 8 134755 82983 110371553
Peripheral swelling 72.46 13.71 251 134512 403783 110050753
Bronchial polyp 72.22 13.71 18 134745 81 110454455
Hypercholesterolaemia 72.07 13.71 12 134751 90825 110363711
Sedation 71.91 13.71 3 134760 69680 110384856
Live birth 71.68 13.71 3 134760 69481 110385055
Metastases to chest wall 71.56 13.71 28 134735 648 110453888
Dacryostenosis acquired 71.24 13.71 28 134735 656 110453880
Cerebrovascular accident 70.55 13.71 70 134693 181214 110273322
Large intestine perforation 70.52 13.71 94 134669 16535 110438001
Delusion of grandeur 69.79 13.71 40 134723 2220 110452316
Pseudocirrhosis 69.64 13.71 30 134733 893 110453643
Drug reaction with eosinophilia and systemic symptoms 69.40 13.71 9 134754 82086 110372450
Hallucination 69.06 13.71 19 134744 101413 110353123
Hot flush 68.17 13.71 206 134557 65830 110388706
Mastitis 67.77 13.71 41 134722 2517 110452019
Insomnia 67.39 13.71 220 134543 360370 110094166
Treatment failure 66.99 13.71 149 134614 277085 110177451
Granulocyte count decreased 66.95 13.71 48 134715 3926 110450610
Myositis 66.90 13.71 129 134634 30987 110423549
Periarticular thenar erythema with onycholysis 66.74 13.71 16 134747 59 110454477
Performance status decreased 65.59 13.71 61 134702 7205 110447331
Prostate cancer 65.50 13.71 143 134620 37498 110417038
Sciatica 65.41 13.71 16 134747 92383 110362153
Dyspnoea 64.95 13.71 1786 132977 1105086 109349450
Chest discomfort 64.95 13.71 398 134365 173450 110281086
Illness 64.87 13.71 11 134752 82160 110372376
Dermatomyositis 64.72 13.71 49 134714 4357 110450179
Neurotoxicity 64.18 13.71 152 134611 42055 110412481
Nasal congestion 64.01 13.71 20 134743 98262 110356274
Pneumothorax 63.63 13.71 136 134627 35149 110419387
Adverse drug reaction 62.72 13.71 25 134738 105534 110349002
Blood lactate dehydrogenase increased 62.43 13.71 155 134608 44179 110410357
Psoriasis 61.78 13.71 48 134715 139945 110314591
Feeling abnormal 61.33 13.71 78 134685 180633 110273903
Ill-defined disorder 60.53 13.71 61 134702 156792 110297744
Invasive ductal breast carcinoma 60.39 13.71 56 134707 6590 110447946
Cardiomyopathy 60.21 13.71 129 134634 33396 110421140
Skin exfoliation 59.56 13.71 238 134525 87413 110367123
Blister 59.31 13.71 117 134646 227259 110227277
Muscle spasms 58.97 13.71 160 134603 277997 110176539
Device related thrombosis 58.75 13.71 42 134721 3420 110451116
Erysipelas 58.30 13.71 76 134687 13082 110441454
Autoimmune disorder 58.29 13.71 6 134757 65477 110389059
Obesity 57.92 13.71 33 134730 113318 110341218
Colitis ulcerative 57.56 13.71 12 134751 77351 110377185
Oesophageal fistula 57.39 13.71 22 134741 481 110454055
Odynophagia 57.19 13.71 78 134685 14023 110440513
Memory impairment 57.03 13.71 95 134668 196849 110257687
Nail discolouration 56.91 13.71 42 134721 3593 110450943
Serotonin syndrome 56.53 13.71 4 134759 59149 110395387
Mucosal infection 56.35 13.71 22 134741 506 110454030
Tremor 56.32 13.71 100 134663 202132 110252404
Stress 56.27 13.71 29 134734 105319 110349217
Suicidal ideation 56.22 13.71 22 134741 93915 110360621
Neck pain 55.90 13.71 41 134722 123089 110331447
Prostate cancer recurrent 55.75 13.71 26 134737 936 110453600
Enterocolitis 55.54 13.71 90 134673 18859 110435677
Nail bed inflammation 54.97 13.71 33 134730 1997 110452539
Injection site erythema 54.82 13.71 23 134740 94153 110360383
Cystoid macular oedema 54.61 13.71 37 134726 2763 110451773
Blepharospasm 54.55 13.71 3 134760 54848 110399688
Lymphocyte count abnormal 54.46 13.71 35 134728 2391 110452145
Intentional product misuse 54.42 13.71 49 134714 132855 110321681
Cytokine release syndrome 54.22 13.71 10 134753 70296 110384240
Cardiac dysfunction 53.79 13.71 51 134712 6172 110448364
Adverse event 53.74 13.71 33 134730 108776 110345760
Pruritus 53.65 13.71 452 134311 581108 109873428
Frequent bowel movements 53.27 13.71 11 134752 71379 110383157
Myalgia 52.95 13.71 457 134306 221924 110232612
Dry mouth 52.91 13.71 102 134661 199846 110254690
Device related infection 52.34 13.71 135 134628 39384 110415152
Lymphadenopathy 52.24 13.71 184 134579 63651 110390885
Alopecia totalis 51.93 13.71 20 134743 443 110454093
Cellulitis 51.23 13.71 295 134468 125721 110328815
Hepatic lesion 50.61 13.71 57 134706 8436 110446100
Pleural disorder 50.39 13.71 25 134738 1034 110453502
Pregnancy 50.15 13.71 3 134760 51064 110403472
Product quality issue 49.85 13.71 16 134747 77283 110377253
COVID-19 49.69 13.71 144 134619 244916 110209620
Carotidynia 49.62 13.71 15 134748 153 110454383
Myelodysplastic syndrome 49.60 13.71 128 134635 37356 110417180
Breast pain 49.44 13.71 61 134702 9939 110444597
Injection site swelling 49.38 13.71 8 134755 61782 110392754
Gait disturbance 49.06 13.71 174 134589 278034 110176502
Angioedema 48.47 13.71 30 134733 98470 110356066
Acute interstitial pneumonitis 48.46 13.71 27 134736 1419 110453117
Ear infection 48.21 13.71 9 134754 62723 110391813
Wound infection 47.99 13.71 29 134734 96436 110358100
Nephrolithiasis 47.78 13.71 11 134752 66201 110388335
Pericardial effusion 47.75 13.71 166 134597 57051 110397485
Metastases to the mediastinum 47.72 13.71 22 134741 771 110453765
Tonsillar disorder 47.72 13.71 27 134736 1462 110453074
Drug resistance 47.44 13.71 164 134599 56210 110398326
Neoplasm recurrence 47.38 13.71 44 134719 5188 110449348
Musculoskeletal pain 47.02 13.71 95 134668 182928 110271608
Influenza 46.74 13.71 84 134679 169017 110285519
Adenocarcinoma 46.71 13.71 40 134723 4240 110450296
Aggression 46.57 13.71 8 134755 59202 110395334
Delirium 46.11 13.71 58 134705 134967 110319569
Generalised oedema 46.06 13.71 110 134653 30594 110423942
Liver injury 45.96 13.71 70 134693 150343 110304193
Onychalgia 45.84 13.71 24 134739 1113 110453423
Red blood cell sedimentation rate increased 45.78 13.71 19 134744 78283 110376253
Amnesia 45.43 13.71 37 134726 105371 110349165
Full blood count abnormal 45.37 13.71 7 134756 56045 110398491
Injection site pruritus 44.85 13.71 5 134758 51253 110403283
Agitation 44.73 13.71 43 134720 113008 110341528
Mastectomy 44.68 13.71 26 134737 1485 110453051
Osteonecrosis 44.42 13.71 115 134648 33626 110420910
Plasma cell myeloma 44.35 13.71 11 134752 62925 110391611
Foot deformity 44.32 13.71 4 134759 48476 110406060
Blood pressure fluctuation 44.00 13.71 18 134745 74806 110379730
Ventricular hypokinesia 43.93 13.71 61 134702 11153 110443383
Treatment noncompliance 43.83 13.71 17 134746 72973 110381563
Swollen tongue 43.62 13.71 10 134753 60352 110394184
Ascites 43.60 13.71 226 134537 92582 110361954
Left ventricular dilatation 43.46 13.71 25 134738 1397 110453139
Basal cell carcinoma 43.44 13.71 3 134760 45267 110409269
Chemotherapy 43.39 13.71 29 134734 2117 110452419
Toxic erythema of chemotherapy 43.38 13.71 17 134746 395 110454141
Dysphagia 43.25 13.71 328 134435 153272 110301264
Blood alkaline phosphatase increased 43.01 13.71 186 134577 70749 110383787
Respiratory failure 42.93 13.71 426 134337 214906 110239630
Dizziness 42.55 13.71 597 134166 697596 109756940
Oesophagobronchial fistula 42.41 13.71 15 134748 259 110454277
Blood creatinine decreased 42.41 13.71 54 134709 9083 110445453
International normalised ratio increased 41.90 13.71 27 134736 86745 110367791
Nasal mucosal disorder 41.86 13.71 27 134736 1856 110452680
PIK3CA-activated mutation 41.53 13.71 19 134744 654 110453882
No adverse event 41.45 13.71 19 134744 73820 110380716
Bradycardia 41.43 13.71 79 134684 155438 110299098
Electrocardiogram QT prolonged 41.33 13.71 43 134720 108917 110345619
Laryngeal oedema 40.92 13.71 55 134708 9752 110444784
Therapy interrupted 40.84 13.71 6 134757 49816 110404720
Lung lobectomy 40.80 13.71 14 134749 220 110454316
Metastases to adrenals 40.69 13.71 25 134738 1578 110452958
Metastases to soft tissue 40.33 13.71 19 134744 700 110453836
Product prescribing error 40.23 13.71 7 134756 51324 110403212
Enterocolitis infectious 39.25 13.71 33 134730 3411 110451125
Constipation 39.15 13.71 633 134130 357153 110097383
Pneumatosis intestinalis 38.94 13.71 50 134713 8479 110446057
Spinal pain 38.87 13.71 76 134687 18439 110436097
Computerised tomogram thorax abnormal 38.68 13.71 30 134733 2765 110451771
Accidental overdose 38.65 13.71 8 134755 51826 110402710
Non-small cell lung cancer 38.58 13.71 48 134715 7887 110446649
Neutrophil count increased 38.52 13.71 111 134652 34541 110419995
Exposed bone in jaw 38.33 13.71 34 134729 3777 110450759
Lupus-like syndrome 38.29 13.71 3 134760 40789 110413747
Disseminated intravascular coagulation 38.19 13.71 124 134639 41162 110413374
EGFR gene mutation 38.06 13.71 17 134746 553 110453983
Papilloedema 37.93 13.71 46 134717 7363 110447173
Sleep apnoea syndrome 37.90 13.71 3 134760 40444 110414092
Infection 37.81 13.71 272 134491 361928 110092608
Rhabdomyolysis 37.79 13.71 55 134708 120346 110334190
Peritonitis 37.76 13.71 106 134657 32501 110422035
Pancreatitis 37.68 13.71 35 134728 93498 110361038
Inflammation 37.40 13.71 116 134647 193122 110261414
Streptococcal sepsis 37.20 13.71 38 134725 5034 110449502
Osteoporosis 37.05 13.71 31 134732 87121 110367415
Polyneuropathy in malignant disease 36.87 13.71 16 134747 485 110454051
Oesophageal-pulmonary fistula 36.76 13.71 9 134754 37 110454499
Platelet count decreased 36.72 13.71 436 134327 230007 110224529
Lumbosacral radiculoplexus neuropathy 36.40 13.71 11 134752 112 110454424
Drug level increased 36.34 13.71 7 134756 47712 110406824
Infusion site vesicles 36.30 13.71 17 134746 618 110453918
Malignant pleural effusion 36.25 13.71 34 134729 4059 110450477
Nightmare 36.09 13.71 3 134760 38860 110415676
Lactic acidosis 35.91 13.71 36 134727 92775 110361761
Cystitis haemorrhagic 35.80 13.71 58 134705 12151 110442385
Pulmonary mass 35.38 13.71 113 134650 37188 110417348
Hydrothorax 34.96 13.71 23 134740 1635 110452901
Bone erosion 34.90 13.71 7 134756 46364 110408172
Hiccups 34.87 13.71 59 134704 12810 110441726
Tongue coated 34.49 13.71 24 134739 1872 110452664
Metastases to bone marrow 34.16 13.71 19 134744 995 110453541
Acoustic stimulation tests abnormal 33.92 13.71 8 134755 27 110454509
Metastases to abdominal cavity 33.88 13.71 18 134745 860 110453676
Sclerema 33.68 13.71 9 134754 56 110454480
Rhinalgia 33.58 13.71 32 134731 3897 110450639
Intestinal perforation 33.56 13.71 77 134686 20867 110433669
Osteosclerosis 33.43 13.71 34 134729 4481 110450055
Acute respiratory distress syndrome 33.41 13.71 141 134622 53057 110401479
Breast neoplasm 33.41 13.71 19 134744 1039 110453497
Neuromuscular toxicity 32.80 13.71 14 134749 407 110454129
Muscle spasticity 32.73 13.71 3 134760 35912 110418624
Unintentional medical device removal 32.68 13.71 47 134716 8876 110445660
Central vision loss 32.52 13.71 9 134754 65 110454471
Oral pain 32.44 13.71 110 134653 37334 110417202
Joint injury 32.36 13.71 5 134758 39989 110414547
Arteritis 32.26 13.71 19 134744 1110 110453426
Coma 32.17 13.71 59 134704 117810 110336726
Limb injury 32.11 13.71 4 134759 37632 110416904
Breast inflammation 32.11 13.71 11 134752 172 110454364
Metastases to bladder 32.10 13.71 13 134750 330 110454206
Skin fissures 31.82 13.71 83 134680 24375 110430161
Coeliac disease 31.51 13.71 7 134756 43180 110411356
Radiation pneumonitis 31.49 13.71 33 134730 4503 110450033
Therapy non-responder 31.46 13.71 93 134670 157214 110297322
Granulocytopenia 31.45 13.71 56 134707 12659 110441877
Throat tightness 31.35 13.71 101 134662 33388 110421148
Pain in extremity 31.27 13.71 412 134351 486706 109967830
Barotrauma 31.26 13.71 11 134752 187 110454349
Hypophagia 31.14 13.71 137 134626 52489 110402047
Carbohydrate antigen 15-3 increased 31.02 13.71 21 134742 1566 110452970
Leukocytosis 31.00 13.71 139 134624 53689 110400847
Gastric perforation 30.95 13.71 34 134729 4895 110449641
Hypoglycaemia 30.90 13.71 59 134704 116045 110338491
Eastern Cooperative Oncology Group performance status worsened 30.89 13.71 27 134736 2942 110451594
Bronchiectasis 30.84 13.71 4 134759 36489 110418047
Joint dislocation 30.78 13.71 3 134760 34187 110420349
White blood cell count abnormal 30.76 13.71 40 134723 6869 110447667
Vasogenic cerebral oedema 30.73 13.71 24 134739 2234 110452302
Blood pressure increased 30.49 13.71 187 134576 258186 110196350
Gastrointestinal anastomotic leak 30.38 13.71 16 134747 751 110453785
Gastrointestinal disorder 30.20 13.71 172 134591 241780 110212756
Excessive eye blinking 30.16 13.71 22 134741 1848 110452688
Obstructive shock 30.07 13.71 10 134753 142 110454394
Microvascular coronary artery disease 30.05 13.71 13 134750 391 110454145
Nail disorder 29.98 13.71 145 134618 57790 110396746
Axillary pain 29.93 13.71 25 134738 2561 110451975
Procedural pain 29.81 13.71 4 134759 35561 110418975
Bacterial translocation 29.78 13.71 20 134743 1472 110453064
Blood uric acid decreased 29.77 13.71 20 134743 1473 110453063
Meibomian gland dysfunction 29.58 13.71 12 134751 306 110454230
Hepatotoxicity 29.51 13.71 154 134609 63246 110391290
Dysaesthesia 29.49 13.71 39 134724 6808 110447728
Asthenopia 29.41 13.71 27 134736 3137 110451399
Chills 29.23 13.71 358 134405 190222 110264314
Metastases to heart 29.21 13.71 13 134750 419 110454117
Invasive lobular breast carcinoma 29.12 13.71 16 134747 818 110453718
Nervousness 28.94 13.71 5 134758 36846 110417690
Hyperpyrexia 28.82 13.71 42 134721 8027 110446509
Skin reaction 28.80 13.71 73 134690 21071 110433465
Eosinophil percentage increased 28.72 13.71 20 134743 1562 110452974
Bone marrow oedema syndrome 28.64 13.71 8 134755 60 110454476
Gout 28.63 13.71 5 134758 36561 110417975
Karnofsky scale worsened 28.56 13.71 5 134758 0 110454536
Bronchitis 28.49 13.71 97 134666 156935 110297601
Soft tissue infection 28.28 13.71 33 134730 5074 110449462
Lower limb fracture 28.27 13.71 30 134733 75318 110379218
Lung disorder 28.26 13.71 118 134645 179929 110274607
Blood glucose increased 28.22 13.71 76 134687 132420 110322116
Aplasia 28.15 13.71 41 134722 7832 110446704
Portal hypertension 28.05 13.71 43 134720 8594 110445942
Subclavian vein thrombosis 27.96 13.71 25 134738 2807 110451729
Prescribed underdose 27.93 13.71 23 134740 65151 110389385
Gamma-glutamyltransferase increased 27.90 13.71 148 134615 61161 110393375
Palmar erythema 27.89 13.71 23 134740 2315 110452221
Periorbital disorder 27.87 13.71 8 134755 67 110454469
Unevaluable event 27.83 13.71 19 134744 59208 110395328
Paraparesis 27.81 13.71 31 134732 4535 110450001
Underdose 27.77 13.71 22 134741 63532 110391004
Cardiac failure 27.72 13.71 350 134413 187276 110267260
Hyperchlorhydria 27.26 13.71 22 134741 2147 110452389
Breast cancer 27.26 13.71 106 134657 38436 110416100
Oesophagitis 27.24 13.71 87 134676 28628 110425908
Abdominal pain 27.23 13.71 818 133945 512171 109942365
Cystitis noninfective 27.23 13.71 20 134743 1698 110452838
Administration site extravasation 27.12 13.71 20 134743 1709 110452827
Infusion site plaque 27.06 13.71 6 134757 14 110454522
Coating in mouth 26.96 13.71 11 134752 285 110454251
Mucosal disorder 26.93 13.71 30 134733 4387 110450149
Laboratory test abnormal 26.91 13.71 10 134753 44069 110410467
Vessel puncture site bruise 26.86 13.71 13 134750 509 110454027
Eosinophilia 26.67 13.71 19 134744 57917 110396619
Vulvovaginal candidiasis 26.65 13.71 26 134737 3259 110451277
Acquired gene mutation 26.57 13.71 24 134739 2730 110451806
Menopausal disorder 26.55 13.71 7 134756 41 110454495
Gastric stenosis 26.55 13.71 10 134753 208 110454328
Vascular fragility 26.50 13.71 10 134753 209 110454327
Toxicity to various agents 26.44 13.71 419 134344 480136 109974400
Gastrointestinal ischaemia 26.42 13.71 13 134750 528 110454008
Superior mesenteric artery syndrome 26.33 13.71 10 134753 213 110454323
Dyskinesia 26.25 13.71 15 134748 51431 110403105
Laryngeal tremor 26.21 13.71 5 134758 3 110454533
Cytomegalovirus infection 26.21 13.71 17 134746 54427 110400109
Candida infection 26.18 13.71 122 134641 47887 110406649
Impaired quality of life 26.08 13.71 3 134760 30014 110424522
Mouth ulceration 26.01 13.71 122 134641 48016 110406520
Ultrasound foetal abnormal 25.84 13.71 8 134755 89 110454447
Ischaemic enteritis 25.80 13.71 9 134754 149 110454387
Nicotinic acid deficiency 25.78 13.71 10 134753 226 110454310
Incorrect route of product administration 25.77 13.71 24 134739 64037 110390499
Pharyngeal abscess 25.76 13.71 15 134748 858 110453678
Bone disorder 25.63 13.71 70 134693 21122 110433414
Nephritis bacterial 25.61 13.71 7 134756 48 110454488
Nail ridging 25.61 13.71 13 134750 565 110453971
Haemolytic uraemic syndrome 25.60 13.71 31 134732 4954 110449582
Incorrect dose administered 25.59 13.71 55 134708 103586 110350950
Pulmonary fibrosis 25.33 13.71 54 134709 101988 110352548
Gas gangrene 25.24 13.71 11 134752 337 110454199
Ejection fraction 25.13 13.71 24 134739 2931 110451605
Troponin I increased 24.95 13.71 32 134731 5420 110449116
Injection site haemorrhage 24.82 13.71 5 134758 33023 110421513
Metastases to breast 24.45 13.71 11 134752 364 110454172
Diabetes mellitus 24.33 13.71 53 134710 99328 110355208
Colony stimulating factor therapy 24.32 13.71 13 134750 629 110453907
Perforation 24.12 13.71 19 134744 1791 110452745
Pancytopenia 24.09 13.71 374 134389 209239 110245297
HER2 positive breast cancer 23.96 13.71 11 134752 382 110454154
Tumour embolism 23.95 13.71 10 134753 275 110454261
Joint neoplasm 23.94 13.71 7 134756 63 110454473
Upper respiratory tract infection 23.90 13.71 81 134682 131247 110323289
Distichiasis 23.89 13.71 6 134757 28 110454508
Joint stiffness 23.89 13.71 28 134735 67215 110387321
Oral candidiasis 23.86 13.71 113 134650 44647 110409889
Retinal detachment 23.83 13.71 46 134717 11054 110443482
Hemianopia 23.83 13.71 23 134740 2845 110451691
Biliary sepsis 23.82 13.71 19 134744 1824 110452712
Ear pain 23.80 13.71 18 134745 53208 110401328
Hypovolaemic shock 23.79 13.71 54 134709 14529 110440007
Metastases to ovary 23.77 13.71 11 134752 389 110454147
Metastases to pituitary gland 23.72 13.71 6 134757 29 110454507
Viral infection 23.72 13.71 18 134745 53121 110401415
Sarcoma 23.64 13.71 15 134748 1002 110453534
Pulmonary embolism 23.64 13.71 380 134383 214094 110240442
Metastases to spleen 23.58 13.71 14 134749 830 110453706
Liver function test increased 23.56 13.71 45 134718 88503 110366033
Product administration error 23.48 13.71 8 134755 37209 110417327
Immunodeficiency 23.39 13.71 9 134754 38829 110415707
Osteitis condensans 23.39 13.71 6 134757 31 110454505
Retinal toxicity 23.38 13.71 18 134745 1641 110452895
Haematochezia 23.32 13.71 68 134695 115456 110339080
Adverse reaction 23.27 13.71 4 134759 29590 110424946
Balance disorder 23.24 13.71 69 134694 116491 110338045
Bone marrow infiltration 23.22 13.71 14 134749 854 110453682
Hip fracture 23.16 13.71 7 134756 35144 110419392
Tracheo-oesophageal fistula 23.11 13.71 13 134750 696 110453840
Cytopenia 23.10 13.71 85 134678 30031 110424505
Liver disorder 23.08 13.71 92 134671 142151 110312385
Therapy cessation 23.00 13.71 13 134750 44844 110409692
Hepatic failure 22.95 13.71 153 134610 68586 110385950
Nasal disorder 22.85 13.71 27 134736 4207 110450329
Eubacterium infection 22.85 13.71 4 134759 0 110454536
Sopor 22.81 13.71 8 134755 36538 110417998
Hydronephrosis 22.78 13.71 66 134697 20599 110433937
Osteoradionecrosis 22.68 13.71 8 134755 137 110454399
Nail infection 22.68 13.71 21 134742 2467 110452069
Vein discolouration 22.60 13.71 11 134752 436 110454100
Feeling hot 22.60 13.71 189 134574 90917 110363619
Respiratory tract congestion 22.52 13.71 5 134758 30852 110423684
Therapy responder 22.49 13.71 11 134752 441 110454095
Abdominal pain upper 22.48 13.71 295 134468 348816 110105720
Scleroderma renal crisis 22.43 13.71 14 134749 909 110453627
Hypoalbuminaemia 22.41 13.71 82 134681 28892 110425644
Axillary vein thrombosis 22.17 13.71 13 134750 753 110453783
Necrotising fasciitis 22.17 13.71 36 134727 7555 110446981
Recurrent cancer 22.17 13.71 24 134739 3399 110451137
Disease recurrence 21.95 13.71 138 134625 60646 110393890
Embolism 21.94 13.71 56 134707 16233 110438303
Colitis ischaemic 21.84 13.71 59 134704 17691 110436845
Necrotising retinitis 21.80 13.71 17 134746 1579 110452957
Device adhesion issue 21.75 13.71 40 134723 9270 110445266
Vascular pain 21.69 13.71 15 134748 1158 110453378
Macroenzyme creatine kinase 21.64 13.71 5 134758 15 110454521
Irritability 21.59 13.71 16 134747 47793 110406743
Cytomegalovirus oesophagitis 21.58 13.71 14 134749 972 110453564
Osteolysis 21.57 13.71 30 134733 5493 110449043
Blood creatine phosphokinase increased 21.38 13.71 35 134728 73042 110381494
Cardiac arrest 21.37 13.71 146 134617 196607 110257929
Gastrooesophageal reflux disease 21.36 13.71 130 134633 179846 110274690
Tumour pain 21.34 13.71 22 134741 2945 110451591
Iron deficiency anaemia 21.32 13.71 6 134757 31553 110422983
Oestradiol abnormal 21.25 13.71 6 134757 47 110454489
Lipidosis 21.25 13.71 6 134757 47 110454489
Scleroderma 21.20 13.71 32 134731 6309 110448227
Lipoprotein increased 21.17 13.71 5 134758 17 110454519
Arnold-Chiari malformation 21.14 13.71 9 134754 260 110454276
Nail bed tenderness 21.09 13.71 10 134753 374 110454162
Leukonychia 21.08 13.71 7 134756 99 110454437
Vulvovaginal dryness 20.91 13.71 21 134742 2726 110451810
Radiation necrosis 20.87 13.71 13 134750 841 110453695
Nail bed bleeding 20.84 13.71 13 134750 843 110453693
Soft tissue neoplasm 20.82 13.71 7 134756 103 110454433
Metastases to gastrointestinal tract 20.82 13.71 8 134755 176 110454360
Post-traumatic pain 20.81 13.71 11 134752 520 110454016
Eye pruritus 20.75 13.71 7 134756 32768 110421768
Ocular hyperaemia 20.70 13.71 11 134752 39275 110415261
Acute motor-sensory axonal neuropathy 20.68 13.71 11 134752 527 110454009
Poisoning 20.68 13.71 5 134758 29100 110425436
Salmonellosis 20.66 13.71 19 134744 2212 110452324
Chronic myelomonocytic leukaemia 20.62 13.71 14 134749 1049 110453487
Face oedema 20.47 13.71 88 134675 33381 110421155
Carcinoembryonic antigen increased 20.43 13.71 21 134742 2803 110451733
Heart rate decreased 20.36 13.71 44 134719 82712 110371824
Vulvitis 20.34 13.71 9 134754 286 110454250
Solid organ transplant rejection 20.32 13.71 6 134757 56 110454480
VIth nerve paralysis 20.28 13.71 17 134746 1750 110452786
Emotional distress 20.26 13.71 15 134748 44832 110409704
Folate deficiency 20.24 13.71 26 134737 4412 110450124
Staphylococcal impetigo 20.15 13.71 5 134758 22 110454514
Trigeminal nerve paresis 20.08 13.71 4 134759 4 110454532
Retinal fovea disorder 20.08 13.71 4 134759 4 110454532
Tympanic membrane disorder 20.06 13.71 8 134755 195 110454341
Toxic optic neuropathy 20.02 13.71 15 134748 1313 110453223
Monocyte count decreased 19.86 13.71 24 134739 3827 110450709
Pancreatitis viral 19.80 13.71 5 134758 24 110454512
Salmonella sepsis 19.77 13.71 10 134753 431 110454105
Tumour haemorrhage 19.76 13.71 28 134735 5217 110449319
Circulatory collapse 19.71 13.71 104 134659 42889 110411647
Catheter site bruise 19.71 13.71 11 134752 580 110453956
Gastric disorder 19.65 13.71 8 134755 33349 110421187
Lymphocyte count decreased 19.47 13.71 128 134635 57115 110397421
Inflammatory carcinoma of the breast 19.47 13.71 5 134758 26 110454510
Necrosis 19.47 13.71 43 134720 11363 110443173
Mucocutaneous disorder 19.40 13.71 8 134755 213 110454323
Eye swelling 19.35 13.71 8 134755 33040 110421496
Blood triglycerides increased 19.34 13.71 3 134760 23923 110430613
Malaise 19.28 13.71 648 134115 671171 109783365
Ovarian failure 19.28 13.71 13 134750 963 110453573
Hepatic cirrhosis 19.22 13.71 33 134730 67593 110386943
Overflow diarrhoea 19.19 13.71 8 134755 219 110454317
Blood creatine increased 19.17 13.71 43 134720 11478 110443058
Oesophageal perforation 19.12 13.71 16 134747 1643 110452893
Varicose vein 19.04 13.71 32 134731 6908 110447628
Tumour marker increased 19.04 13.71 27 134736 5033 110449503
Pseudomonal sepsis 18.83 13.71 37 134726 9009 110445527
Gastritis 18.83 13.71 121 134642 53578 110400958
Affective disorder 18.76 13.71 42 134721 11199 110443337
Bone sequestrum 18.75 13.71 14 134749 1219 110453317
Hydrocephalus 18.72 13.71 40 134723 10335 110444201
Arteriospasm coronary 18.68 13.71 37 134726 9063 110445473
Drug dependence 18.67 13.71 20 134743 50000 110404536
Clostridium bacteraemia 18.63 13.71 10 134753 488 110454048
Depressed level of consciousness 18.61 13.71 72 134691 112206 110342330
Clostridial infection 18.56 13.71 30 134733 6272 110448264
Transaminases 18.53 13.71 6 134757 78 110454458
Large intestine infection 18.45 13.71 25 134738 4467 110450069
Product use in unapproved indication 18.41 13.71 410 134353 446967 110007569
Death 18.39 13.71 1034 133729 697835 109756701
Gastrointestinal haemorrhage 18.39 13.71 122 134641 165396 110289140
Obstruction gastric 18.38 13.71 17 134746 1994 110452542
Metastases to uterus 18.32 13.71 6 134757 81 110454455
Necrotising colitis 18.26 13.71 16 134747 1749 110452787
Hypersensitivity pneumonitis 18.22 13.71 27 134736 5238 110449298
Lip swelling 18.10 13.71 21 134742 50646 110403890
Polyneuropathy chronic 18.08 13.71 5 134758 36 110454500
Cannabinoid hyperemesis syndrome 18.06 13.71 6 134757 85 110454451
Metastases to muscle 18.06 13.71 9 134754 376 110454160
Pneumocystis jirovecii pneumonia 17.99 13.71 101 134662 42634 110411902
Neuroendocrine carcinoma of prostate 17.96 13.71 5 134758 37 110454499
Hepatic encephalopathy 17.95 13.71 6 134757 28250 110426286
Hereditary optic atrophy 17.93 13.71 6 134757 87 110454449
Impaired work ability 17.89 13.71 5 134758 26414 110428122
Gastrointestinal candidiasis 17.87 13.71 10 134753 530 110454006
Ulcer haemorrhage 17.86 13.71 3 134760 22568 110431968
Vaginal prolapse 17.86 13.71 9 134754 385 110454151
Obstructive airways disorder 17.74 13.71 18 134745 46131 110408405
Dysuria 17.72 13.71 130 134633 60101 110394435
Aorto-oesophageal fistula 17.56 13.71 6 134757 93 110454443
Ovarian necrosis 17.51 13.71 5 134758 41 110454495
Skin hyperpigmentation 17.42 13.71 35 134728 8661 110445875
Mydriasis 17.41 13.71 3 134760 22154 110432382
Gastrointestinal perforation 17.38 13.71 32 134731 7424 110447112
Metastases to thorax 17.31 13.71 8 134755 282 110454254
Chylothorax 17.30 13.71 13 134750 1143 110453393
Enteritis 17.23 13.71 57 134706 19099 110435437
Leukoencephalopathy 17.23 13.71 36 134727 9159 110445377
Appendiceal abscess 17.22 13.71 9 134754 416 110454120
Therapeutic product effect incomplete 17.15 13.71 182 134581 223623 110230913
Multiple sclerosis 17.15 13.71 5 134758 25693 110428843
Labia enlarged 17.13 13.71 3 134760 0 110454536
Therapeutic response unexpected 17.13 13.71 4 134759 23839 110430697
Mediastinitis 17.11 13.71 14 134749 1394 110453142
Aortic wall hypertrophy 17.10 13.71 5 134758 45 110454491
Tooth socket haemorrhage 17.09 13.71 7 134756 183 110454353
Spinal cord compression 17.08 13.71 32 134731 7520 110447016
Blood pressure systolic inspiratory decreased 17.07 13.71 4 134759 13 110454523
Pseudomembranous colitis 16.92 13.71 29 134734 6362 110448174
Lung infiltration 16.83 13.71 67 134696 24561 110429975
Malignant neoplasm of pleura 16.82 13.71 7 134756 191 110454345
Cachexia 16.78 13.71 44 134719 12961 110441575
Taste disorder 16.73 13.71 34 134729 65353 110389183
Dysarthria 16.62 13.71 50 134713 84071 110370465
Hypertransaminasaemia 16.58 13.71 66 134697 24189 110430347
Entropion 16.58 13.71 6 134757 111 110454425
Traumatic lung injury 16.57 13.71 18 134745 2559 110451977
Dandy-Walker syndrome 16.45 13.71 5 134758 52 110454484
Uterine leiomyosarcoma 16.43 13.71 4 134759 16 110454520
Cardiac tamponade 16.41 13.71 40 134723 11267 110443269
Herpes zoster 16.40 13.71 72 134691 108307 110346229
Drug ineffective for unapproved indication 16.38 13.71 67 134696 102771 110351765
Aspartate aminotransferase increased 16.37 13.71 280 134483 159656 110294880
Pituitary tumour 16.37 13.71 13 134750 1240 110453296
Metastatic lymphoma 16.26 13.71 10 134753 632 110453904
Naevus haemorrhage 16.19 13.71 6 134757 119 110454417
Urinary tract disorder 16.11 13.71 27 134736 5817 110448719
Alanine aminotransferase increased 16.11 13.71 314 134449 183459 110271077
Abortion spontaneous 16.10 13.71 11 134752 34271 110420265
Joint effusion 16.06 13.71 3 134760 20902 110433634
Cardiac murmur 16.05 13.71 5 134758 24623 110429913
Upper limb fracture 16.04 13.71 3 134760 20885 110433651
Onychomycosis 16.02 13.71 14 134749 38517 110416019
Abdominal infection 16.00 13.71 24 134739 4707 110449829
Transaminases increased 15.98 13.71 132 134631 63258 110391278
Cranial nerve disorder 15.98 13.71 13 134750 1284 110453252
Amaurosis fugax 15.91 13.71 17 134746 2373 110452163
Herpes simplex sepsis 15.88 13.71 5 134758 59 110454477
Breast oedema 15.81 13.71 5 134758 60 110454476
Sensory disturbance 15.80 13.71 52 134711 17377 110437159
Toxic skin eruption 15.80 13.71 71 134692 27444 110427092
Systolic dysfunction 15.80 13.71 23 134740 4392 110450144
Merycism 15.77 13.71 8 134755 347 110454189
Lymphangitis 15.76 13.71 14 134749 1558 110452978
Cancer pain 15.70 13.71 29 134734 6743 110447793
Purtscher retinopathy 15.66 13.71 7 134756 228 110454308
Skin laceration 15.63 13.71 11 134752 33742 110420794
Paranoia 15.59 13.71 4 134759 22370 110432166
Noninfective conjunctivitis 15.58 13.71 5 134758 63 110454473
Urogenital prolapse 15.54 13.71 4 134759 21 110454515
Type IV hypersensitivity reaction 15.48 13.71 27 134736 6006 110448530
Subdural haematoma 15.45 13.71 13 134750 36441 110418095
Chromosomal mutation 15.44 13.71 5 134758 65 110454471
Hepatitis 15.41 13.71 57 134706 89997 110364539
Leukaemia cutis 15.38 13.71 7 134756 238 110454298
Sneezing 15.38 13.71 10 134753 31974 110422562
Eye irritation 15.36 13.71 11 134752 33441 110421095
Kidney infection 15.31 13.71 6 134757 25593 110428943
Apical granuloma 15.30 13.71 5 134758 67 110454469
Vaginitis gardnerella 15.30 13.71 5 134758 67 110454469
Glossopharyngeal nerve paralysis 15.23 13.71 5 134758 68 110454468
Acute febrile neutrophilic dermatosis 15.23 13.71 24 134739 4912 110449624
Respiratory arrest 15.19 13.71 30 134733 58269 110396267
Delusion 15.17 13.71 5 134758 23750 110430786
Renal disorder 15.13 13.71 23 134740 49456 110405080
Liver function test abnormal 15.10 13.71 39 134724 68911 110385625
Normal newborn 15.09 13.71 4 134759 21892 110432644
Lower respiratory tract infection 15.07 13.71 207 134556 242899 110211637
Hyperchromasia 15.06 13.71 3 134760 3 110454533
Sarcomatosis 15.06 13.71 3 134760 3 110454533
Coordination abnormal 14.94 13.71 6 134757 25222 110429314
Epidermolysis 14.92 13.71 12 134751 1166 110453370
Uveitis 14.90 13.71 4 134759 21706 110432830
Non-pitting oedema 14.87 13.71 6 134757 151 110454385
Amenorrhoea 14.86 13.71 34 134729 9197 110445339
Hypomagnesaemia 14.84 13.71 125 134638 60245 110394291
Injection site rash 14.83 13.71 5 134758 23414 110431122
Pancreatic atrophy 14.71 13.71 10 134753 751 110453785
Hormone receptor positive breast cancer 14.65 13.71 9 134754 568 110453968
Breast angiosarcoma 14.60 13.71 3 134760 4 110454532
Hernia 14.56 13.71 3 134760 19497 110435039
Phlebitis 14.48 13.71 35 134728 9806 110444730
Sinus bradycardia 14.47 13.71 9 134754 29474 110425062
Visual impairment 14.47 13.71 100 134663 134328 110320208
Abdominal rigidity 14.39 13.71 20 134743 3660 110450876
Cough 14.35 13.71 694 134069 460947 109993589
Onychoclasis 14.34 13.71 29 134734 7208 110447328
Pneumonia salmonella 14.32 13.71 5 134758 83 110454453
Osmotic demyelination syndrome 14.31 13.71 15 134748 2048 110452488
Meibomianitis 14.26 13.71 5 134758 84 110454452
Maculopathy 14.22 13.71 18 134745 3009 110451527
Allodynia 14.19 13.71 15 134748 2068 110452468
Extravasation 14.18 13.71 23 134740 4822 110449714
Hyperfibrinogenaemia 14.17 13.71 6 134757 171 110454365
Acne 14.15 13.71 12 134751 33508 110421028
Abnormal behaviour 14.14 13.71 16 134747 39023 110415513
Spinal stenosis 14.08 13.71 3 134760 19053 110435483
Rash 14.06 13.71 838 133925 820126 109634410
SARS-CoV-2 test positive 14.01 13.71 49 134714 16886 110437650
Arachnoid cyst 13.99 13.71 8 134755 442 110454094
Chronic obstructive pulmonary disease 13.94 13.71 77 134686 109081 110345455
Glaucoma 13.93 13.71 5 134758 22512 110432024
Metastases to nervous system 13.90 13.71 7 134756 299 110454237
Gingival swelling 13.86 13.71 24 134739 5306 110449230
Tooth extraction 13.85 13.71 41 134722 12950 110441586
ALK gene rearrangement positive 13.85 13.71 3 134760 6 110454530
Graft versus host disease 13.82 13.71 3 134760 18803 110435733
Cataract 13.81 13.71 50 134713 79435 110375101
Congenital haematological disorder 13.78 13.71 4 134759 35 110454501

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
MeSH PA D000970 Antineoplastic Agents
MeSH PA D050256 Antimitotic Agents
MeSH PA D050257 Tubulin Modulators
CHEBI has role CHEBI:35610 antineoplastic agent
CHEBI has role CHEBI:38068 antimalarial
CHEBI has role CHEBI:47868 photosensitizing agent
FDA EPC N0000175592 Microtubule Inhibitor
CHEBI has role CHEBI:22587 antiviral agent
CHEBI has role CHEBI:50919 antiemetic

Related Drugs by ATC class:

L01CD Taxanes 2 drugs
cabazitaxelpaclitaxel

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
80MG/4ML (20MG/ML) BEIZRAY ZHUHAI N218711 Oct. 23, 2024 RX SOLUTION INTRAVENOUS 11419842 May 16, 2036 TREATMENT OF BREAST CANCER
80MG/4ML (20MG/ML) BEIZRAY ZHUHAI N218711 Oct. 23, 2024 RX SOLUTION INTRAVENOUS 11419842 May 16, 2036 TREATMENT OF GASTRIC ADENOCARCINOMA
80MG/4ML (20MG/ML) BEIZRAY ZHUHAI N218711 Oct. 23, 2024 RX SOLUTION INTRAVENOUS 11419842 May 16, 2036 TREATMENT OF HEAD AND NECK CANCER
80MG/4ML (20MG/ML) BEIZRAY ZHUHAI N218711 Oct. 23, 2024 RX SOLUTION INTRAVENOUS 11419842 May 16, 2036 TREATMENT OF NON-SMALL CELL LUNG CANCER
80MG/4ML (20MG/ML) BEIZRAY ZHUHAI N218711 Oct. 23, 2024 RX SOLUTION INTRAVENOUS 11419842 May 16, 2036 TREATMENT OF PROSTATE CANCER
80MG/4ML (20MG/ML) BEIZRAY ZHUHAI N218711 Oct. 23, 2024 RX SOLUTION INTRAVENOUS 12090134 May 16, 2036 TREATMENT OF BREAST CANCER
80MG/4ML (20MG/ML) BEIZRAY ZHUHAI N218711 Oct. 23, 2024 RX SOLUTION INTRAVENOUS 12090134 May 16, 2036 TREATMENT OF GASTRIC ADENOCARCINOMA
80MG/4ML (20MG/ML) BEIZRAY ZHUHAI N218711 Oct. 23, 2024 RX SOLUTION INTRAVENOUS 12090134 May 16, 2036 TREATMENT OF HEAD AND NECK CANCER
80MG/4ML (20MG/ML) BEIZRAY ZHUHAI N218711 Oct. 23, 2024 RX SOLUTION INTRAVENOUS 12090134 May 16, 2036 TREATMENT OF NON-SMALL CELL LUNG CANCER
80MG/4ML (20MG/ML) BEIZRAY ZHUHAI N218711 Oct. 23, 2024 RX SOLUTION INTRAVENOUS 12090134 May 16, 2036 TREATMENT OF PROSTATE CANCER

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

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

External reference:

IDSource
4020968 VUID
N0000148441 NUI
D02165 KEGG_DRUG
148408-66-6 SECONDARY_CAS_RN
1299922 RXNORM
4020968 VANDF
C0246415 UMLSCUI
CHEBI:4672 CHEBI
TXL PDB_CHEM_ID
CHEMBL3545252 ChEMBL_ID
CHEMBL92 ChEMBL_ID
D000077143 MESH_DESCRIPTOR_UI
DB01248 DRUGBANK_ID
6809 IUPHAR_LIGAND_ID
15H5577CQD UNII
148124 PUBCHEM_CID
178776 MMSL
180476 MMSL
4626 MMSL
5984 MMSL
d04009 MMSL
005187 NDDF
005188 NDDF
108806006 SNOMEDCT_US
386918005 SNOMEDCT_US
6621 INN_ID

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Docetaxel HUMAN PRESCRIPTION DRUG LABEL 1 0143-9204 INJECTION, SOLUTION, CONCENTRATE 20 mg INTRAVENOUS ANDA 30 sections
Docetaxel HUMAN PRESCRIPTION DRUG LABEL 1 0143-9205 INJECTION, SOLUTION, CONCENTRATE 20 mg INTRAVENOUS ANDA 30 sections
Docetaxel HUMAN PRESCRIPTION DRUG LABEL 1 0409-0016 INJECTION, SOLUTION 10 mg INTRAVENOUS NDA 32 sections
Docetaxel HUMAN PRESCRIPTION DRUG LABEL 1 0409-0016 INJECTION, SOLUTION 10 mg INTRAVENOUS NDA 32 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 32 sections
Docetaxel HUMAN PRESCRIPTION DRUG LABEL 1 0409-0366 INJECTION, SOLUTION 20 mg INTRAVENOUS NDA 32 sections
Docetaxel HUMAN PRESCRIPTION DRUG LABEL 1 0409-0367 INJECTION, SOLUTION 20 mg INTRAVENOUS NDA 32 sections
Docetaxel HUMAN PRESCRIPTION DRUG LABEL 1 0409-0368 INJECTION, SOLUTION 20 mg INTRAVENOUS NDA 32 sections
Docetaxel HUMAN PRESCRIPTION DRUG LABEL 1 0409-1732 INJECTION, SOLUTION 10 mg INTRAVENOUS NDA 32 sections
Docetaxel HUMAN PRESCRIPTION DRUG LABEL 1 0409-2026 INJECTION, SOLUTION 10 mg INTRAVENOUS NDA 32 sections
Docetaxel HUMAN PRESCRIPTION DRUG LABEL 1 0409-2026 INJECTION, SOLUTION 10 mg INTRAVENOUS NDA 32 sections
Docetaxel HUMAN PRESCRIPTION DRUG LABEL 1 0409-4235 INJECTION, SOLUTION 20 mg INTRAVENOUS NDA 32 sections
Docetaxel HUMAN PRESCRIPTION DRUG LABEL 1 0409-5068 INJECTION, SOLUTION 20 mg INTRAVENOUS NDA 32 sections
Docetaxel HUMAN PRESCRIPTION DRUG LABEL 1 0409-7870 INJECTION, SOLUTION 10 mg INTRAVENOUS NDA 32 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 29 sections
DOCETAXEL HUMAN PRESCRIPTION DRUG LABEL 1 16729-267 INJECTION, SOLUTION, CONCENTRATE 20 mg INTRAVENOUS NDA 29 sections
Docetaxel HUMAN PRESCRIPTION DRUG LABEL 1 23155-903 INJECTION 20 mg INTRAVENOUS ANDA 20 sections
Docetaxel HUMAN PRESCRIPTION DRUG LABEL 1 23155-904 INJECTION 80 mg INTRAVENOUS ANDA 20 sections
Docetaxel HUMAN PRESCRIPTION DRUG LABEL 1 23155-905 INJECTION 160 mg INTRAVENOUS ANDA 20 sections
Docetaxel HUMAN PRESCRIPTION DRUG LABEL 1 25021-245 INJECTION, SOLUTION 20 mg INTRAVENOUS ANDA 28 sections
Docetaxel HUMAN PRESCRIPTION DRUG LABEL 1 25021-254 INJECTION 10 mg INTRAVENOUS ANDA 30 sections
Docetaxel HUMAN PRESCRIPTION DRUG LABEL 1 43066-001 INJECTION, SOLUTION 10 mg INTRAVENOUS NDA 27 sections
Docetaxel HUMAN PRESCRIPTION DRUG LABEL 1 43066-006 INJECTION, SOLUTION 10 mg INTRAVENOUS NDA 27 sections
Docetaxel HUMAN PRESCRIPTION DRUG LABEL 1 43066-010 INJECTION, SOLUTION 10 mg INTRAVENOUS NDA 27 sections
Docetaxel HUMAN PRESCRIPTION DRUG LABEL 1 43066-044 INJECTION 10 mg INTRAVENOUS ANDA 28 sections
Docetaxel HUMAN PRESCRIPTION DRUG LABEL 1 43066-046 INJECTION 10 mg INTRAVENOUS ANDA 28 sections