paclitaxel Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
antineoplastics, taxane derivatives 2044 33069-62-4

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • paclitaxel
  • (-)-Paclitaxel
  • abraxane
  • capxol
  • cyclopax
  • ebetaxel
  • genaxol
  • mitotax
  • padexol
  • plaxicel
  • taxol
  • Taxol A
  • Tocosol Paclitaxel
  • nabpaclitaxel
  • ABI-007
  • nab-paclitaxel
A cyclodecane isolated from the bark of the Pacific yew tree, TAXUS BREVIFOLIA. It stabilizes MICROTUBULES in their polymerized form leading to cell death.
  • Molecular weight: 853.92
  • Formula: C47H51NO14
  • CLOGP: 4.73
  • LIPINSKI: 2
  • HAC: 15
  • HDO: 4
  • TPSA: 221.29
  • ALOGS: -5.19
  • ROTB: 14

  • 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
EoM (Fraction excreted unchanged in urine) 5 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 5.54 ┬ÁM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 6.50 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 3 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 6.40 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.12 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 11 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
May 10, 2019 EMA TEVA BV
Sept. 20, 2019 PMDA Taiho Pharmaceutical Co., Ltd.
Dec. 29, 1992 FDA HQ SPCLT PHARMA

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
Malignant neoplasm progression 1710.54 12.35 1481 145274 70060 53132251
Neutropenia 1612.80 12.35 2083 144672 157102 53045209
Neuropathy peripheral 1465.38 12.35 1605 145150 101582 53100729
Disease progression 1201.24 12.35 1440 145315 100480 53101831
Metastases to liver 1087.97 12.35 699 146056 20797 53181514
Metastases to bone 979.35 12.35 629 146126 18699 53183612
Erythema 946.69 12.35 1611 145144 155358 53046953
Febrile neutropenia 940.93 12.35 1295 145460 103641 53098670
Flushing 794.46 12.35 975 145780 69625 53132686
Rheumatoid arthritis 783.88 12.35 17 146738 314514 52887797
Breast cancer metastatic 774.44 12.35 498 146257 14830 53187481
Drug ineffective 758.66 12.35 684 146071 816561 52385750
Anaemia 661.81 12.35 1962 144793 274756 52927555
Palmar-plantar erythrodysaesthesia syndrome 650.70 12.35 512 146243 21094 53181217
Metastases to lung 630.44 12.35 396 146359 11308 53191003
Neutrophil count decreased 616.14 12.35 717 146038 48381 53153930
Dyspnoea 568.32 12.35 3133 143622 583099 52619212
Polyneuropathy 510.89 12.35 364 146391 12869 53189442
Metastases to central nervous system 505.89 12.35 349 146406 11708 53190603
Peripheral sensory neuropathy 504.96 12.35 288 146467 6860 53195451
Myelosuppression 472.66 12.35 343 146412 12485 53189826
Neoplasm progression 452.80 12.35 482 146273 29437 53172874
Joint swelling 444.09 12.35 60 146695 234578 52967733
Mucosal inflammation 424.09 12.35 555 146200 42229 53160082
Acute myeloid leukaemia 421.06 12.35 359 146396 16573 53185738
Ejection fraction decreased 410.28 12.35 379 146376 19469 53182842
Leukopenia 409.33 12.35 729 146026 72734 53129577
Neurotoxicity 405.51 12.35 337 146418 15012 53187299
Thrombocytopenia 405.07 12.35 1059 145696 137668 53064643
Metastases to lymph nodes 401.33 12.35 252 146503 7188 53195123
Product dose omission issue 392.65 12.35 37 146718 191583 53010728
Pneumonitis 367.33 12.35 439 146316 30449 53171862
Breast cancer 358.57 12.35 552 146203 48806 53153505
Ascites 353.43 12.35 489 146266 39246 53163065
Fall 351.46 12.35 283 146472 358157 52844154
Haematotoxicity 351.23 12.35 237 146518 7660 53194651
Completed suicide 349.75 12.35 6 146749 138195 53064116
Chest discomfort 346.82 12.35 814 145941 98881 53103430
Bone marrow failure 320.91 12.35 405 146350 29710 53172601
Contraindicated product administered 320.30 12.35 12 146743 135617 53066694
Death 299.31 12.35 1840 144915 355392 52846919
Arthropathy 287.87 12.35 28 146727 141425 53060886
Sinusitis 279.52 12.35 61 146694 168503 53033808
Headache 278.65 12.35 671 146084 536150 52666161
Weight increased 277.17 12.35 108 146647 204459 52997852
Anaphylactic shock 264.96 12.35 314 146441 21579 53180732
Therapeutic product effect decreased 263.42 12.35 22 146733 125633 53076678
Pleural effusion 263.23 12.35 681 146074 87898 53114413
Systemic lupus erythematosus 262.80 12.35 22 146733 125392 53076919
Condition aggravated 261.78 12.35 259 146496 296875 52905436
Proteinuria 257.40 12.35 282 146473 17786 53184525
Synovitis 256.62 12.35 9 146746 107884 53094427
Pseudocirrhosis 249.44 12.35 88 146667 619 53201692
Feeling hot 249.13 12.35 426 146329 41118 53161193
Abdominal discomfort 247.47 12.35 151 146604 220911 52981400
Onycholysis 246.99 12.35 105 146650 1281 53201030
Metastases to peritoneum 246.35 12.35 134 146621 2901 53199410
Cystoid macular oedema 239.70 12.35 107 146648 1480 53200831
Gastrointestinal perforation 236.77 12.35 136 146619 3283 53199028
Pain 236.39 12.35 830 145925 587568 52614743
Epistaxis 233.38 12.35 556 146199 68154 53134157
General physical health deterioration 232.74 12.35 909 145846 146033 53056278
Interstitial lung disease 232.00 12.35 504 146251 58118 53144193
Second primary malignancy 227.65 12.35 175 146580 6957 53195354
Glossodynia 226.50 12.35 12 146743 100279 53102032
Skin toxicity 219.15 12.35 138 146617 3955 53198356
Hypertension 217.46 12.35 1206 145549 224225 52978086
Myelodysplastic syndrome 209.99 12.35 244 146511 16416 53185895
Injection site pain 207.32 12.35 32 146723 113359 53088952
Bronchospasm 200.74 12.35 238 146517 16360 53185951
Ovarian cancer recurrent 197 12.35 85 146670 1078 53201233
Swelling 195.73 12.35 144 146611 190961 53011350
Peripheral swelling 189.15 12.35 173 146582 205935 52996376
Product use issue 188.46 12.35 74 146681 139510 53062801
Musculoskeletal stiffness 188.24 12.35 53 146702 123315 53078996
Psoriasis 185.99 12.35 14 146741 87075 53115236
Bone pain 184.84 12.35 422 146333 50300 53152011
Ovarian cancer 178.14 12.35 143 146612 6059 53196252
Vomiting 174.05 12.35 2109 144646 495030 52707281
Drug intolerance 168.60 12.35 190 146565 205303 52997008
Pyrexia 167.00 12.35 1768 144987 401425 52800886
Drug hypersensitivity 166.33 12.35 297 146458 264945 52937366
Somnolence 164.59 12.35 132 146623 167602 53034709
Back pain 162.54 12.35 1152 145603 233095 52969216
Drug abuse 161.13 12.35 4 146751 65522 53136789
White blood cell count decreased 158.03 12.35 720 146035 123755 53078556
Nail disorder 157.26 12.35 163 146592 9642 53192669
Overdose 155.82 12.35 51 146704 107685 53094626
Breast cancer recurrent 154.84 12.35 112 146643 4053 53198258
Osteonecrosis of jaw 154.80 12.35 321 146434 35825 53166486
Hypertransaminasaemia 153.89 12.35 110 146645 3906 53198405
Nasopharyngitis 152.14 12.35 183 146572 192112 53010199
Cardiac dysfunction 151.25 12.35 82 146673 1763 53200548
Embolism 150.63 12.35 141 146614 7362 53194949
Platelet count decreased 149.10 12.35 641 146114 107458 53094853
Metastasis 148.62 12.35 115 146640 4616 53197695
Cardiotoxicity 146.21 12.35 137 146618 7162 53195149
Suicide attempt 145.17 12.35 3 146752 58165 53144146
Hospitalisation 144.56 12.35 14 146741 70998 53131313
Lymphangiosis carcinomatosa 144.08 12.35 70 146685 1186 53201125
Injection site erythema 143.02 12.35 21 146734 77228 53125083
Treatment failure 141.77 12.35 89 146666 128314 53073997
Drug interaction 140.71 12.35 242 146513 219087 52983224
Sense of oppression 140.14 12.35 66 146689 1040 53201271
Nausea 139.15 12.35 2879 143876 753212 52449099
Diarrhoea 138.94 12.35 2452 144303 623094 52579217
Arthralgia 136.11 12.35 685 146070 439098 52763213
Depression 133.65 12.35 185 146570 182867 53019444
Pancreatic carcinoma metastatic 133.30 12.35 84 146671 2410 53199901
Abdominal pain 133.23 12.35 1178 145577 254725 52947586
PIK3CA-activated mutation 130.71 12.35 57 146698 743 53201568
Influenza 127.99 12.35 51 146704 95328 53106983
Maternal exposure during pregnancy 127.51 12.35 144 146611 155495 53046816
Exposure during pregnancy 126.59 12.35 95 146660 124765 53077546
Paraesthesia 125.28 12.35 686 146069 126829 53075482
Asthma 125.25 12.35 72 146683 108900 53093411
Nail discolouration 124.65 12.35 80 146675 2371 53199940
Migraine 123.66 12.35 34 146721 80383 53121928
Contusion 123.28 12.35 76 146679 110656 53091655
Arthritis 121.60 12.35 44 146711 87254 53115057
Peripheral motor neuropathy 120.19 12.35 67 146688 1524 53200787
Dehydration 119.48 12.35 833 145922 167577 53034734
Metastases to meninges 119.25 12.35 74 146681 2065 53200246
Large intestine perforation 119.23 12.35 128 146627 7886 53194425
Inappropriate schedule of product administration 118.29 12.35 30 146725 74848 53127463
Wound 117.96 12.35 52 146703 91505 53110806
Toxicity to various agents 117.04 12.35 270 146485 219328 52982983
Loss of personal independence in daily activities 116.17 12.35 25 146730 69790 53132521
Pulmonary embolism 116.01 12.35 621 146134 113821 53088490
Tachycardia 114.36 12.35 594 146161 107618 53094693
Therapy partial responder 112.68 12.35 110 146645 6053 53196258
Gastrointestinal toxicity 112.34 12.35 98 146657 4664 53197647
Blood cholesterol increased 111.77 12.35 9 146746 52980 53149331
Oxygen saturation decreased 111.22 12.35 462 146293 76263 53126048
Mobility decreased 110.46 12.35 36 146719 76235 53126076
Hepatic atrophy 109.75 12.35 38 146717 251 53202060
Insomnia 109.67 12.35 218 146537 186854 53015457
Left ventricular dysfunction 108.53 12.35 144 146611 11093 53191218
Fibromyalgia 107.19 12.35 3 146752 44072 53158239
Dysaesthesia 107.01 12.35 89 146666 3966 53198345
Hypokalaemia 107.00 12.35 537 146218 95980 53106331
Nail toxicity 103.20 12.35 39 146716 341 53201970
Ileus 102.61 12.35 163 146592 14792 53187519
Cyanosis 101.53 12.35 172 146583 16467 53185844
Hypersensitivity 100.04 12.35 951 145804 209714 52992597
Hepatic enzyme increased 99.85 12.35 120 146635 126075 53076236
Disease recurrence 99.20 12.35 194 146561 20752 53181559
Irritable bowel syndrome 99.18 12.35 5 146750 43627 53158684
Asthenia 99.08 12.35 1408 145347 342182 52860129
Urogenital fistula 98.40 12.35 29 146726 103 53202208
Feeling abnormal 97.46 12.35 138 146617 135163 53067148
Decreased appetite 96.95 12.35 960 145795 214014 52988297
Metastases to skin 96.16 12.35 56 146699 1388 53200923
Metastases to spine 94.62 12.35 73 146682 2917 53199394
Incorrect dose administered 94.19 12.35 14 146741 51031 53151280
Injection site pruritus 93.79 12.35 5 146750 41584 53160727
Plasma cell myeloma 93.44 12.35 11 146744 47863 53154448
Hypoxia 92.54 12.35 350 146405 55330 53146981
Lower respiratory tract infection 92.48 12.35 69 146686 90912 53111399
Injection site reaction 92.22 12.35 15 146740 51151 53151160
Intestinal perforation 92.19 12.35 134 146621 11246 53191065
Memory impairment 91.82 12.35 60 146695 84697 53117614
Biliary tract infection 91.76 12.35 38 146717 432 53201879
Injection site swelling 90.58 12.35 7 146748 42621 53159690
Helicobacter infection 90.35 12.35 4 146751 39065 53163246
Intentional product misuse 90.10 12.35 14 146741 49378 53152933
Gait disturbance 89.76 12.35 189 146566 158653 53043658
Hepatic failure 88.06 12.35 257 146498 35549 53166762
Recall phenomenon 88.04 12.35 40 146715 578 53201733
Neutropenic sepsis 87.49 12.35 150 146605 14499 53187812
Muscle spasms 87.04 12.35 148 146607 134647 53067664
Suicidal ideation 86.85 12.35 29 146726 60482 53141829
Pancreatic carcinoma 86.21 12.35 101 146654 6853 53195458
Throat tightness 85.55 12.35 189 146566 22027 53180284
Cardiomyopathy 85.50 12.35 162 146593 16926 53185385
Hydronephrosis 84.46 12.35 115 146640 9081 53193230
Tumour necrosis 84.26 12.35 42 146713 754 53201557
Discomfort 84.13 12.35 83 146672 95389 53106922
Malignant pleural effusion 83.92 12.35 64 146691 2513 53199798
Abortion spontaneous 83.32 12.35 14 146741 46621 53155690
Pneumocystis jirovecii pneumonia 82.85 12.35 156 146599 16222 53186089
Small intestinal obstruction 82.64 12.35 160 146595 16987 53185324
Infusion related reaction 82.61 12.35 721 146034 155236 53047075
Laryngospasm 82.56 12.35 67 146688 2883 53199428
Cholangitis 81.58 12.35 84 146671 4929 53197382
Posterior reversible encephalopathy syndrome 80.60 12.35 153 146602 16007 53186304
Subileus 79.54 12.35 68 146687 3148 53199163
Metastatic neoplasm 78.97 12.35 74 146681 3868 53198443
Osteoarthritis 77.57 12.35 49 146706 70437 53131874
Acute promyelocytic leukaemia 77.38 12.35 42 146713 905 53201406
Pericarditis 76.23 12.35 41 146714 64365 53137946
Metastases to the mediastinum 76.11 12.35 34 146721 471 53201840
Duodenal ulcer perforation 74.13 12.35 6 146749 35177 53167134
Metastases to pleura 73.83 12.35 46 146709 1293 53201018
Pancytopenia 73.62 12.35 465 146290 90463 53111848
Carbohydrate antigen 15-3 increased 73.40 12.35 44 146711 1152 53201159
Hypoglycaemia 72.17 12.35 36 146719 58977 53143334
Therapeutic product effect incomplete 71.82 12.35 88 146667 91696 53110615
Tumour marker increased 71.23 12.35 70 146685 3883 53198428
Tumour haemorrhage 71.08 12.35 47 146708 1467 53200844
Bronchitis 70.28 12.35 125 146630 111774 53090537
Injury 68.78 12.35 27 146728 50944 53151367
Confusional state 68.51 12.35 288 146467 193933 53008378
Triple negative breast cancer 68.37 12.35 24 146731 166 53202145
Pneumothorax 67.89 12.35 139 146616 15368 53186943
Chronic obstructive pulmonary disease 66.46 12.35 43 146712 61030 53141281
Invasive ductal breast carcinoma 66.39 12.35 87 146668 6620 53195691
Stomatitis 66.31 12.35 480 146275 97678 53104633
Fluid retention 65.31 12.35 34 146721 54367 53147944
Anaphylactoid reaction 65.25 12.35 65 146690 3666 53198645
Anxiety 63.18 12.35 302 146453 196402 53005909
Unevaluable event 62.35 12.35 29 146726 49469 53152842
Hallucination 61.23 12.35 36 146719 53802 53148509
Paronychia 61.14 12.35 72 146683 4912 53197399
Macular oedema 61.04 12.35 66 146689 4099 53198212
Bronchostenosis 60.99 12.35 28 146727 415 53201896
Drug reaction with eosinophilia and systemic symptoms 60.50 12.35 9 146746 32791 53169520
Lymphoedema 60.50 12.35 101 146654 9552 53192759
Pain in extremity 60.33 12.35 498 146257 284552 52917759
Metastases to retroperitoneum 60.10 12.35 21 146734 143 53202168
Portal hypertension 59.82 12.35 62 146693 3666 53198645
Sleep apnoea syndrome 59.03 12.35 3 146752 25999 53176312
Carbohydrate antigen 125 increased 58.87 12.35 52 146703 2516 53199795
Osteoporosis 58.86 12.35 27 146728 46433 53155878
Cardiac failure 58.68 12.35 421 146334 85423 53116888
Fistula 58.55 12.35 95 146660 8775 53193536
Red blood cell sedimentation rate increased 58.52 12.35 5 146750 28052 53174259
Alveolitis 58.18 12.35 53 146702 2671 53199640
Secondary cerebellar degeneration 57.89 12.35 16 146739 42 53202269
Urticaria 56.71 12.35 188 146567 135697 53066614
Wrong technique in product usage process 56.65 12.35 49 146706 59983 53142328
Blood pressure fluctuation 56.42 12.35 14 146741 35456 53166855
Gastric disorder 56.29 12.35 8 146747 30157 53172154
Surgery 56.21 12.35 10 146745 31954 53170357
Multiple sclerosis 56.19 12.35 5 146750 27148 53175163
Pulmonary arterial hypertension 56.11 12.35 5 146750 27117 53175194
Disseminated intravascular coagulation 54.83 12.35 148 146607 19571 53182740
Performance status decreased 54.78 12.35 57 146698 3386 53198925
Small intestinal perforation 54.53 12.35 39 146716 1386 53200925
Bile duct stenosis 54.18 12.35 36 146719 1133 53201178
Recurrent cancer 54.03 12.35 43 146712 1799 53200512
Metastases to kidney 53.81 12.35 21 146734 202 53202109
Irritability 53.75 12.35 10 146745 30943 53171368
Device related infection 53.59 12.35 161 146594 22625 53179686
Bone lesion 53.58 12.35 72 146683 5614 53196697
Neoplasm recurrence 52.91 12.35 48 146707 2406 53199905
Urinary tract obstruction 52.83 12.35 43 146712 1858 53200453
Dizziness 52.16 12.35 716 146039 371543 52830768
Nasal congestion 52.12 12.35 42 146713 53245 53149066
Nephrolithiasis 52.05 12.35 18 146737 36729 53165582
Hyperaemia 51.88 12.35 46 146709 2237 53200074
Osteonecrosis 51.77 12.35 176 146579 26399 53175912
Carcinoembryonic antigen increased 51.43 12.35 39 146716 1518 53200793
Cataract 51.23 12.35 37 146718 49583 53152728
Pericardial effusion 50.83 12.35 178 146577 27100 53175211
Pregnancy 50.81 12.35 12 146743 31429 53170882
Lactic acidosis 49.82 12.35 20 146735 37233 53165078
Coronary artery disease 49.80 12.35 15 146740 33422 53168889
Radiation pneumonitis 49.73 12.35 36 146719 1304 53201007
Serotonin syndrome 49.28 12.35 7 146748 26399 53175912
Atelectasis 48.96 12.35 143 146612 19783 53182528
Anaphylactic reaction 48.89 12.35 301 146454 58025 53144286
Joint injury 48.78 12.35 3 146752 22097 53180214
Nasal septum perforation 48.59 12.35 29 146726 753 53201558
Blister 48.52 12.35 89 146666 78664 53123647
Fluid overload 48.31 12.35 9 146746 27822 53174489
Swollen tongue 48.03 12.35 13 146742 31067 53171244
Oesophagitis 47.88 12.35 117 146638 14560 53187751
Palmar erythema 47.82 12.35 38 146717 1586 53200725
Subclavian vein thrombosis 47.72 12.35 41 146714 1911 53200400
Coma 47.53 12.35 60 146695 61723 53140588
Diabetes mellitus 47.31 12.35 47 146708 53852 53148459
Hepatic lesion 46.73 12.35 58 146697 4179 53198132
Sleep disorder 46.52 12.35 56 146699 58814 53143497
Cholangitis sclerosing 46.50 12.35 33 146722 1158 53201153
Tremor 46.47 12.35 183 146572 125553 53076758
Cerebrovascular accident 46.33 12.35 142 146613 105032 53097279
Computerised tomogram thorax abnormal 46.10 12.35 35 146720 1365 53200946
Pleural neoplasm 46.04 12.35 19 146736 214 53202097
Nervousness 45.93 12.35 13 146742 30165 53172146
Metastases to chest wall 45.91 12.35 24 146731 478 53201833
Extravasation 45.83 12.35 43 146712 2251 53200060
Ear infection 45.77 12.35 8 146747 25892 53176419
Superior vena cava syndrome 45.58 12.35 26 146729 619 53201692
Eczema asteatotic 45.10 12.35 20 146735 272 53202039
Medication error 44.74 12.35 22 146733 36343 53165968
Myocardial infarction 44.58 12.35 133 146622 99221 53103090
Gastrooesophageal reflux disease 44.48 12.35 101 146654 82562 53119749
Dyskinesia 44.39 12.35 16 146739 31817 53170494
Drug dependence 44.31 12.35 4 146751 21468 53180843
Intestinal obstruction 43.94 12.35 176 146579 28565 53173746
Metastases to pelvis 43.64 12.35 21 146734 348 53201963
Adenocarcinoma 43.54 12.35 44 146711 2525 53199786
Metastases to breast 43.11 12.35 20 146735 304 53202007
Malignant ascites 42.64 12.35 29 146726 949 53201362
Stress 42.30 12.35 57 146698 57027 53145284
Type I hypersensitivity 42.30 12.35 44 146711 2613 53199698
No adverse event 42.23 12.35 28 146727 39237 53163074
Pharyngeal fistula 42.08 12.35 10 146745 10 53202301
Hepatic function abnormal 42.06 12.35 207 146548 36692 53165619
Oesophagobronchial fistula 42.00 12.35 12 146743 37 53202274
Constipation 42.00 12.35 773 145982 197639 53004672
Product quality issue 41.75 12.35 25 146730 36998 53165313
Rhabdomyolysis 41.26 12.35 36 146719 43887 53158424
Rash pruritic 41.21 12.35 46 146709 49964 53152347
Tumour lysis syndrome 41.07 12.35 76 146679 7798 53194513
Product prescribing error 40.95 12.35 7 146748 23024 53179287
Capillary leak syndrome 40.88 12.35 38 146717 1966 53200345
Endocarditis noninfective 40.85 12.35 12 146743 42 53202269
Sepsis 40.83 12.35 597 146158 145832 53056479
Blood uric acid decreased 40.82 12.35 25 146730 681 53201630
Malignant peritoneal neoplasm 40.68 12.35 26 146729 765 53201546
Biliary sepsis 40.65 12.35 28 146727 936 53201375
Adverse event 40.62 12.35 32 146723 41029 53161282
Acute myelomonocytic leukaemia 40.61 12.35 17 146738 199 53202112
Device related thrombosis 40.59 12.35 32 146723 1320 53200991
Toxic erythema of chemotherapy 40.53 12.35 15 146740 123 53202188
Hypocalcaemia 40.42 12.35 174 146581 29163 53173148
Lymphadenopathy mediastinal 40.26 12.35 43 146712 2633 53199678
Psychotic disorder 40.01 12.35 9 146746 24376 53177935
Acute interstitial pneumonitis 39.99 12.35 25 146730 707 53201604
Aortitis 39.96 12.35 26 146729 789 53201522
Basal cell carcinoma 39.87 12.35 8 146747 23461 53178850
Gastrointestinal necrosis 39.83 12.35 45 146710 2935 53199376
Cervix carcinoma 39.68 12.35 44 146711 2811 53199500
Hypomagnesaemia 39.60 12.35 154 146601 24657 53177654
Periodontitis 39.54 12.35 48 146707 3381 53198930
Pseudomembranous colitis 39.47 12.35 47 146708 3244 53199067
Limb injury 39.20 12.35 6 146749 21404 53180907
Crying 39.07 12.35 7 146748 22255 53180056
Bradycardia 38.90 12.35 86 146669 70970 53131341
Hip arthroplasty 38.86 12.35 14 146741 27848 53174463
Deep vein thrombosis 38.62 12.35 373 146382 82540 53119771
Injection site haemorrhage 38.55 12.35 7 146748 22044 53180267
Female genital tract fistula 37.65 12.35 51 146704 4007 53198304
Hormone receptor positive breast cancer 37.62 12.35 21 146734 479 53201832
COVID-19 37.44 12.35 28 146727 36860 53165451
Osteolysis 37.13 12.35 42 146713 2743 53199568
Bronchial fistula 37.11 12.35 10 146745 23 53202288
Metastases to soft tissue 37.07 12.35 15 146740 160 53202151
Radiation skin injury 36.80 12.35 26 146729 906 53201405
Capillary permeability increased 36.53 12.35 10 146745 25 53202286
Anastomotic leak 36.47 12.35 20 146735 440 53201871
Colitis 36.45 12.35 217 146538 41335 53160976
International normalised ratio increased 36.09 12.35 47 146708 47714 53154597
Metastases to stomach 35.73 12.35 15 146740 177 53202134
Eye pain 35.71 12.35 20 146735 30705 53171606
Suffocation feeling 35.68 12.35 30 146725 1357 53200954
Ovarian cancer metastatic 35.46 12.35 25 146730 868 53201443
Eosinophil percentage increased 35.34 12.35 26 146729 966 53201345
Administration site extravasation 35.15 12.35 23 146732 705 53201606
Metastases to abdominal wall 35.08 12.35 12 146743 76 53202235
Cachexia 35.03 12.35 56 146699 5108 53197203
Treatment noncompliance 34.94 12.35 24 146731 33011 53169300
Wheezing 34.92 12.35 80 146675 65195 53137116
Nightmare 34.83 12.35 4 146751 17747 53184564
Radiation necrosis 34.77 12.35 18 146737 351 53201960
Eosinophilia 34.76 12.35 8 146747 21327 53180984
Metabolic acidosis 34.64 12.35 39 146716 42203 53160108
Laboratory test abnormal 34.49 12.35 12 146743 24397 53177914
Adverse drug reaction 34.47 12.35 59 146696 53566 53148745
Hypoalbuminaemia 34.43 12.35 86 146669 10850 53191461
Therapy interrupted 34.35 12.35 6 146749 19430 53182881
Thrombotic microangiopathy 34.34 12.35 78 146677 9259 53193052
Dermatitis acneiform 33.85 12.35 51 146704 4419 53197892
Dysgeusia 33.76 12.35 218 146537 42713 53159598
Lymphocele 33.65 12.35 24 146731 849 53201462
Hypertensive crisis 33.64 12.35 102 146653 14404 53187907
Hyperpyrexia 33.55 12.35 44 146711 3350 53198961
Gallbladder disorder 33.47 12.35 5 146750 18160 53184151
Joint stiffness 33.38 12.35 21 146734 30262 53172049
Hypersensitivity pneumonitis 32.98 12.35 38 146717 2532 53199779
Therapy cessation 32.92 12.35 18 146737 28007 53174304
Device dislocation 32.66 12.35 12 146743 23585 53178726
Hot flush 32.62 12.35 232 146523 46928 53155383
Infusion related hypersensitivity reaction 32.62 12.35 10 146745 42 53202269
Renal disorder 32.40 12.35 20 146735 29119 53173192
Road traffic accident 32.30 12.35 15 146740 25616 53176695
Folliculitis 32.27 12.35 24 146731 31685 53170626
Scleroderma-like reaction 32.25 12.35 11 146744 69 53202242
Fear 32.03 12.35 4 146751 16637 53185674
Enterocolitis infectious 31.98 12.35 30 146725 1570 53200741
Electrocardiogram QT prolonged 31.92 12.35 67 146688 56336 53145975
Flatulence 31.89 12.35 24 146731 31493 53170818
Injection site rash 31.88 12.35 4 146751 16575 53185736
Onychalgia 31.66 12.35 23 146732 838 53201473
Acne 31.57 12.35 10 146745 21576 53180735
Product administration error 31.45 12.35 10 146745 21521 53180790
Kidney infection 31.36 12.35 7 146748 19060 53183251
Panic attack 31.19 12.35 10 146745 21408 53180903
Neutropenic colitis 31.05 12.35 37 146718 2556 53199755
Amnesia 30.82 12.35 48 146707 45240 53157071
Glaucoma 30.60 12.35 5 146750 16998 53185313
Primary cardiac lymphoma 30.53 12.35 9 146746 32 53202279
Herpes zoster 30.46 12.35 103 146652 73916 53128395
Hyperhidrosis 30.35 12.35 403 146352 96390 53105921
Scleroderma 30.35 12.35 52 146703 5023 53197288
Transaminases increased 30.14 12.35 163 146592 29969 53172342
Respiratory distress 29.89 12.35 177 146578 33650 53168661
Chills 29.82 12.35 429 146326 104419 53097892
Gait inability 29.68 12.35 37 146718 38274 53164037
Mental disorder 29.60 12.35 15 146740 24361 53177950
Vocal cord paralysis 29.57 12.35 31 146724 1858 53200453
Drug resistance 29.52 12.35 121 146634 19841 53182470
Tumour embolism 29.33 12.35 12 146743 132 53202179
Pneumonitis chemical 29.30 12.35 13 146742 177 53202134
Non-small cell lung cancer 29.19 12.35 42 146713 3491 53198820
Duodenal perforation 29.15 12.35 22 146733 850 53201461
Therapeutic response unexpected 29.10 12.35 6 146749 17264 53185047
Drug level increased 28.92 12.35 10 146745 20411 53181900
Cardiac cirrhosis 28.78 12.35 12 146743 139 53202172
Dyspnoea at rest 28.77 12.35 44 146711 3863 53198448
Cytomegalovirus infection 28.67 12.35 9 146746 19530 53182781
Pulse absent 28.67 12.35 52 146703 5254 53197057
Type 2 diabetes mellitus 28.50 12.35 27 146728 31643 53170668
Invasive lobular breast carcinoma 28.50 12.35 21 146734 782 53201529
Lymphadenopathy 28.45 12.35 184 146571 36071 53166240
Neuromuscular toxicity 28.40 12.35 12 146743 144 53202167
Nail dystrophy 28.35 12.35 20 146735 695 53201616
Wound dehiscence 28.30 12.35 48 146707 4598 53197713
Upper limb fracture 28.23 12.35 6 146749 16901 53185410
Underdose 28.06 12.35 12 146743 21510 53180801
Choking sensation 28.03 12.35 41 146714 3460 53198851
Pulmonary tumour thrombotic microangiopathy 27.92 12.35 9 146746 46 53202265
Night sweats 27.86 12.35 33 146722 34914 53167397
Upper respiratory tract infection 27.85 12.35 97 146658 69000 53133311
Oropharyngeal pain 27.70 12.35 122 146633 81146 53121165
Blood glucose increased 27.68 12.35 114 146641 77247 53125064
Mood swings 27.62 12.35 7 146748 17479 53184832
Poisoning 27.48 12.35 3 146752 13847 53188464
Lung infiltration 27.42 12.35 96 146659 14611 53187700
Radiation oesophagitis 27.23 12.35 14 146741 269 53202042
Procedural pain 27.23 12.35 4 146751 14713 53187598
Intestinal metastasis 27.13 12.35 11 146744 118 53202193
Head injury 27.01 12.35 19 146736 25814 53176497
Duodenitis haemorrhagic 26.98 12.35 7 146748 13 53202298
Congestive cardiomyopathy 26.84 12.35 55 146700 6083 53196228
Foot deformity 26.46 12.35 9 146746 18559 53183752
Lymphopenia 26.43 12.35 104 146651 16739 53185572
Accidental overdose 26.41 12.35 13 146742 21466 53180845
Carpal tunnel syndrome 26.40 12.35 8 146747 17759 53184552
Metastases to eye 26.34 12.35 11 146744 128 53202183
Emotional distress 26.32 12.35 30 146725 32287 53170024
Drug ineffective for unapproved indication 26.31 12.35 12 146743 20708 53181603
HER2 positive breast cancer 26.30 12.35 15 146740 357 53201954
Incorrect route of product administration 26.28 12.35 10 146745 19234 53183077
Porokeratosis 26.26 12.35 11 146744 129 53202182
Full blood count decreased 26.02 12.35 17 146738 24012 53178299
Pancreatitis 25.95 12.35 55 146700 46087 53156224
Thyroid dermatopathy 25.71 12.35 7 146748 17 53202294
Eastern Cooperative Oncology Group performance status worsened 25.71 12.35 18 146737 618 53201693
Impaired work ability 25.68 12.35 4 146751 14086 53188225
Venous thrombosis 25.66 12.35 48 146707 4966 53197345
Hypotension 25.62 12.35 896 145859 253180 52949131
Peritoneal disorder 25.56 12.35 17 146738 536 53201775
Eye disorder 25.47 12.35 11 146744 19603 53182708
Blood bilirubin increased 25.43 12.35 177 146578 35553 53166758
Dystonia 25.38 12.35 3 146752 13018 53189293
Hallucination, visual 25.36 12.35 10 146745 18822 53183489
Ankle fracture 25.34 12.35 7 146748 16508 53185803
Double hit lymphoma 25.25 12.35 6 146749 6 53202305
Prescribed overdose 25.11 12.35 4 146751 13855 53188456
Acute lymphocytic leukaemia 25.06 12.35 35 146720 2830 53199481
Femur fracture 25.04 12.35 44 146711 39541 53162770
Sinus disorder 24.97 12.35 10 146745 18644 53183667
Dermatomyositis 24.91 12.35 32 146723 2387 53199924
Jugular vein thrombosis 24.87 12.35 35 146720 2851 53199460
Aggression 24.75 12.35 17 146738 23386 53178925
Inflammation 24.54 12.35 78 146677 57058 53145253
Vena cava thrombosis 24.51 12.35 31 146724 2277 53200034
Abnormal behaviour 24.33 12.35 15 146740 21851 53180460
Right ventricular failure 24.29 12.35 8 146747 16835 53185476
Bursitis 24.24 12.35 16 146739 22476 53179835
Weight decreased 24.21 12.35 478 146277 234470 52967841
Transient ischaemic attack 24.18 12.35 38 146717 35687 53166624
Gastroenteritis radiation 24.18 12.35 16 146739 500 53201811
Viral infection 24.18 12.35 32 146723 32263 53170048
Ocular hyperaemia 24.17 12.35 15 146740 21776 53180535
Tumour pain 24.14 12.35 24 146731 1350 53200961
Skin laceration 24.13 12.35 12 146743 19699 53182612
Neutrophil count abnormal 24.09 12.35 33 146722 2621 53199690
Disability 24.07 12.35 3 146752 12495 53189816
Onychomadesis 24.06 12.35 39 146716 3599 53198712
Colitis ulcerative 24.06 12.35 14 146741 21047 53181264
Musculoskeletal disorder 24.05 12.35 9 146746 17490 53184821
Foot fracture 24.01 12.35 14 146741 21025 53181286
Device malfunction 23.94 12.35 7 146748 15901 53186410
Blood count abnormal 23.93 12.35 13 146742 20302 53182009
Mastitis 23.91 12.35 32 146723 2485 53199826
Tonsillar disorder 23.90 12.35 21 146734 1009 53201302
Device issue 23.90 12.35 15 146740 21643 53180668
Neck pain 23.69 12.35 85 146670 59931 53142380
Joint dislocation 23.68 12.35 3 146752 12342 53189969
Pelvic abscess 23.67 12.35 25 146730 1511 53200800
Rectal perforation 23.66 12.35 15 146740 435 53201876
Gastrointestinal fistula 23.57 12.35 15 146740 438 53201873
Embryonal rhabdomyosarcoma 23.53 12.35 6 146749 10 53202301
Wrist fracture 23.46 12.35 3 146752 12252 53190059
Metastases to bladder 23.43 12.35 11 146744 172 53202139
Pulmonary toxicity 23.21 12.35 48 146707 5343 53196968
Lymphatic disorder 23.20 12.35 14 146741 371 53201940
Chest pain 23.15 12.35 686 146069 189499 53012812
Pneumonia 23.14 12.35 901 145854 406268 52796043
Haemoglobin 23.09 12.35 11 146744 178 53202133
Emotional disorder 23.08 12.35 4 146751 13026 53189285
Metastases to adrenals 22.99 12.35 18 146737 735 53201576
Portal vein thrombosis 22.92 12.35 32 146723 2587 53199724
Venous thrombosis limb 22.89 12.35 34 146721 2909 53199402
Tooth erosion 22.89 12.35 15 146740 461 53201850
Sopor 22.72 12.35 15 146740 21069 53181242
Cancer fatigue 22.72 12.35 7 146748 30 53202281
Cytopenia 22.71 12.35 66 146689 9104 53193207
Cerebral ischaemia 22.67 12.35 54 146701 6611 53195700
Laryngeal necrosis 22.51 12.35 6 146749 13 53202298
Blast cells present 22.39 12.35 14 146741 396 53201915
Peritoneal fibrosis 22.15 12.35 5 146750 3 53202308
Vessel puncture site bruise 22.08 12.35 13 146742 329 53201982
Organising pneumonia 22.06 12.35 46 146709 5150 53197161
Alanine aminotransferase increased 22.05 12.35 376 146379 94719 53107592
Eye pruritus 22.04 12.35 5 146750 13464 53188847
Bladder perforation 22.04 12.35 10 146745 144 53202167
Haemolytic uraemic syndrome 21.98 12.35 31 146724 2530 53199781
Balance disorder 21.98 12.35 115 146640 73092 53129219
Cancer pain 21.96 12.35 33 146722 2853 53199458
Neoplasm 21.95 12.35 52 146703 6344 53195967
Joint range of motion decreased 21.88 12.35 11 146744 17945 53184366
Tumour ulceration 21.79 12.35 10 146745 148 53202163
Prescribed underdose 21.63 12.35 8 146747 15659 53186652
Gout 21.54 12.35 4 146751 12395 53189916
Accidental exposure to product 21.52 12.35 20 146735 23654 53178657
Hypersomnia 21.51 12.35 9 146746 16346 53185965
Enterocutaneous fistula 21.49 12.35 22 146733 1282 53201029
Peritonitis 21.47 12.35 117 146638 21570 53180741
Intracranial tumour haemorrhage 21.44 12.35 10 146745 154 53202157
Hepatitis B reactivation 21.37 12.35 27 146728 1981 53200330
Angioedema 21.36 12.35 53 146702 42023 53160288
Neutropenic infection 21.35 12.35 21 146734 1166 53201145
Emphysematous cystitis 21.26 12.35 10 146745 157 53202154
Vesical fistula 21.26 12.35 8 146747 69 53202242
Vulvovaginal inflammation 21.21 12.35 16 146739 618 53201693
Xerophthalmia 21.20 12.35 13 146742 355 53201956
Mediastinitis 21.18 12.35 11 146744 216 53202095
Delirium 21.18 12.35 52 146703 41377 53160934
Pruritus 21.15 12.35 631 146124 293201 52909110
Angiosarcoma 21.14 12.35 12 146743 283 53202028
Gelastic seizure 21.04 12.35 5 146750 5 53202306
Hydrothorax 20.90 12.35 17 146738 734 53201577
Immune-mediated hepatitis 20.89 12.35 18 146737 842 53201469
Anaemia of malignant disease 20.89 12.35 14 146741 447 53201864
BRAF gene mutation 20.79 12.35 7 146748 42 53202269
Bone erosion 20.71 12.35 3 146752 11149 53191162
Diverticulitis 20.70 12.35 42 146713 35759 53166552
Productive cough 20.67 12.35 83 146672 56646 53145665
Transfusion 20.64 12.35 6 146749 13681 53188630
Stress cardiomyopathy 20.61 12.35 61 146694 8501 53193810
Blood pressure immeasurable 20.59 12.35 21 146734 1218 53201093
Blood pressure systolic increased 20.57 12.35 41 146714 35136 53167175
Blood glucose decreased 20.56 12.35 15 146740 20001 53182310
Poor quality sleep 20.53 12.35 11 146744 17312 53184999
Splenic artery thrombosis 20.51 12.35 7 146748 44 53202267
Pulmonary vein stenosis 20.32 12.35 8 146747 79 53202232
Septic shock 20.30 12.35 261 146494 61968 53140343
Protein urine 20.17 12.35 16 146739 666 53201645
Thyroid disorder 20.14 12.35 6 146749 13467 53188844
Brachiocephalic vein thrombosis 20.14 12.35 8 146747 81 53202230
Spinal stenosis 20.12 12.35 7 146748 14234 53188077
Eye irritation 20.05 12.35 13 146742 18436 53183875
Seizure 19.95 12.35 244 146511 129265 53073046
Endometrial cancer metastatic 19.94 12.35 9 146746 128 53202183
Transaminases 19.88 12.35 8 146747 84 53202227
Hepatic vein thrombosis 19.87 12.35 9 146746 129 53202182
Seroma 19.77 12.35 27 146728 2138 53200173
Adenocarcinoma pancreas 19.68 12.35 20 146735 1155 53201156
Ear pain 19.67 12.35 32 146723 29641 53172670
Hydroureter 19.62 12.35 12 146743 326 53201985
Retroperitoneal lymphadenopathy 19.59 12.35 14 146741 497 53201814
Ill-defined disorder 19.53 12.35 70 146685 49374 53152937
Respiratory tract congestion 19.48 12.35 8 146747 14691 53187620
Hyperkalaemia 19.38 12.35 80 146675 54176 53148135
Mood altered 19.36 12.35 7 146748 13894 53188417
Oesophageal stenosis 19.28 12.35 32 146723 3012 53199299
Myeloid leukaemia 19.27 12.35 12 146743 337 53201974
Product complaint 19.18 12.35 5 146750 12252 53190059
Diabetic ketoacidosis 19.10 12.35 16 146739 19899 53182412
Debridement 19.06 12.35 22 146733 1469 53200842
Vaginal fistula 19.05 12.35 13 146742 428 53201883
Laryngeal cancer stage III 19.03 12.35 5 146750 10 53202301
Nail ridging 19.02 12.35 11 146744 269 53202042
Cholelithiasis 18.97 12.35 54 146701 40910 53161401
Cholangitis infective 18.96 12.35 10 146745 203 53202108
Sciatica 18.94 12.35 19 146736 21674 53180637
Restless legs syndrome 18.90 12.35 12 146743 17211 53185100
Blood potassium increased 18.81 12.35 13 146742 17828 53184483
Tooth extraction 18.81 12.35 68 146687 10514 53191797
Agitation 18.79 12.35 90 146665 58536 53143775
Schizophrenia 18.55 12.35 3 146752 10276 53192035
Faeces discoloured 18.50 12.35 13 146742 17673 53184638
Metastases to thorax 18.48 12.35 10 146745 214 53202097
Carbohydrate antigen 19-9 increased 18.44 12.35 9 146746 154 53202157
Cardiac murmur 18.37 12.35 5 146750 11908 53190403
Abdominal infection 18.37 12.35 24 146731 1821 53200490
Breast ulceration 18.35 12.35 7 146748 63 53202248
Ovarian failure 18.27 12.35 19 146736 1128 53201183
Loss of consciousness 18.24 12.35 427 146328 113785 53088526
Foetal exposure during pregnancy 18.20 12.35 43 146712 34672 53167639
Aorto-oesophageal fistula 18.12 12.35 5 146750 13 53202298
Scintillating scotoma 18.08 12.35 9 146746 161 53202150
Gastroenteritis viral 17.99 12.35 16 146739 19329 53182982
Dementia 17.94 12.35 12 146743 16738 53185573
Pelvic infection 17.79 12.35 11 146744 305 53202006
Disturbance in attention 17.70 12.35 43 146712 34340 53167971
Seasonal allergy 17.69 12.35 10 146745 15275 53187036
Fungal infection 17.66 12.35 39 146716 32207 53170104
Product storage error 17.64 12.35 7 146748 13123 53189188
Duodenal obstruction 17.61 12.35 10 146745 236 53202075
Sinus congestion 17.57 12.35 9 146746 14529 53187782
Hypopituitarism 17.56 12.35 17 146738 926 53201385
Subdural haematoma 17.54 12.35 8 146747 13805 53188506
Postoperative adhesion 17.53 12.35 10 146745 238 53202073
Brain cancer metastatic 17.52 12.35 7 146748 72 53202239
Influenza like illness 17.49 12.35 97 146658 60762 53141549
Hepatotoxicity 17.48 12.35 134 146621 27746 53174565
Metastases to pancreas 17.46 12.35 10 146745 240 53202071
Abdominal lymphadenopathy 17.42 12.35 15 146740 701 53201610
Sensory disturbance 17.42 12.35 76 146679 12810 53189501
Limb discomfort 17.41 12.35 27 146728 25495 53176816
Cholecystectomy 17.41 12.35 3 146752 9812 53192499
Cardiac failure congestive 17.40 12.35 167 146588 92590 53109721
Vaginal perforation 17.36 12.35 5 146750 16 53202295
Myoclonus 17.28 12.35 11 146744 15753 53186558
Respiratory depth decreased 17.15 12.35 6 146749 41 53202270
Sputum discoloured 17.15 12.35 9 146746 14330 53187981
Tumour fistulisation 17.13 12.35 5 146750 17 53202294
Cough 17.04 12.35 867 145888 256026 52946285
Cholecystitis chronic 17.02 12.35 4 146751 10514 53191797
Photophobia 16.94 12.35 12 146743 16246 53186065
Orbital myositis 16.91 12.35 5 146750 18 53202293
Metastases to ovary 16.90 12.35 11 146744 334 53201977
Bone sequestrum 16.89 12.35 22 146733 1664 53200647
Bone disorder 16.86 12.35 106 146649 20577 53181734
Endometrial cancer stage IV 16.83 12.35 4 146751 4 53202307
Aortic dissection rupture 16.83 12.35 4 146751 4 53202307
Delusion 16.80 12.35 6 146749 12003 53190308
Electrolyte imbalance 16.80 12.35 99 146656 18785 53183526
Thrombophlebitis migrans 16.79 12.35 7 146748 81 53202230
Gastric perforation 16.77 12.35 21 146734 1527 53200784
Movement disorder 16.72 12.35 16 146739 18665 53183646
Guillain-Barre syndrome 16.71 12.35 34 146721 3741 53198570
Product supply issue 16.71 12.35 19 146736 1248 53201063
Lymphatic obstruction 16.70 12.35 5 146750 19 53202292
Heavy menstrual bleeding 16.61 12.35 14 146741 17362 53184949
Keratitis 16.61 12.35 28 146727 2669 53199642
Tumour invasion 16.60 12.35 8 146747 133 53202178
Metastases to muscle 16.60 12.35 8 146747 133 53202178
Joint effusion 16.54 12.35 8 146747 13344 53188967
Breast cellulitis 16.48 12.35 13 146742 537 53201774
Liver scan abnormal 16.45 12.35 6 146749 47 53202264
Tuberculosis 16.42 12.35 5 146750 11066 53191245
Acquired gene mutation 16.37 12.35 15 146740 762 53201549
Product dispensing error 16.36 12.35 4 146751 10236 53192075
Febrile infection 16.30 12.35 19 146736 1282 53201029
Blood magnesium decreased 16.21 12.35 70 146685 11744 53190567
Gingival bleeding 16.19 12.35 72 146683 12236 53190075
Lymphangitis 16.18 12.35 16 146739 894 53201417
Intestinal prolapse 16.18 12.35 8 146747 141 53202170
Extrapyramidal disorder 16.03 12.35 7 146748 12395 53189916
Anger 16.01 12.35 7 146748 12383 53189928
Urinary retention 15.95 12.35 34 146721 28432 53173879
Post procedural fistula 15.93 12.35 10 146745 285 53202026
Bacterial diarrhoea 15.82 12.35 6 146749 53 53202258
Intestinal ischaemia 15.78 12.35 51 146704 7451 53194860
Localised infection 15.74 12.35 31 146724 26685 53175626
Angiodermatitis 15.73 12.35 7 146748 96 53202215
Eye swelling 15.73 12.35 22 146733 21672 53180639
Ototoxicity 15.71 12.35 18 146737 1192 53201119
Acute respiratory distress syndrome 15.68 12.35 114 146641 23218 53179093
Infected lymphocele 15.68 12.35 9 146746 217 53202094
Mediastinal disorder 15.60 12.35 11 146744 382 53201929
Maternal death affecting foetus 15.57 12.35 4 146751 7 53202304
Vaginal cuff dehiscence 15.57 12.35 4 146751 7 53202304
Pharyngitis streptococcal 15.56 12.35 3 146752 9052 53193259
Blood creatinine decreased 15.55 12.35 40 146715 5138 53197173
Abdominal abscess 15.51 12.35 36 146719 4334 53197977
Toxic neuropathy 15.35 12.35 11 146744 392 53201919
Bone marrow infiltration 15.29 12.35 12 146743 492 53201819
Tongue disorder 15.29 12.35 3 146752 8938 53193373
Myeloproliferative neoplasm 15.24 12.35 12 146743 494 53201817
Application site recall reaction 15.22 12.35 4 146751 8 53202303
Arterioenteric fistula 15.22 12.35 4 146751 8 53202303
Immediate post-injection reaction 15.21 12.35 11 146744 398 53201913
Hypophosphataemia 15.16 12.35 56 146699 8749 53193562
Median nerve injury 15.14 12.35 5 146750 28 53202283
Thinking abnormal 15.14 12.35 5 146750 10503 53191808
Ileal perforation 15.11 12.35 11 146744 402 53201909
Enteritis 15.11 12.35 50 146705 7396 53194915
Bronchopleural fistula 15.07 12.35 9 146746 234 53202077
Renal failure 15.07 12.35 232 146523 118220 53084091
Ovarian cyst 14.97 12.35 12 146743 15257 53187054
Enterocolitis 14.89 12.35 48 146707 7004 53195307
Gene mutation 14.86 12.35 18 146737 1265 53201046
Obstructive shock 14.85 12.35 5 146750 30 53202281
Metastatic gastric cancer 14.75 12.35 8 146747 172 53202139
BRCA2 gene mutation 14.75 12.35 6 146749 65 53202246
Chest wall necrosis 14.70 12.35 3 146752 0 53202311
Granulocyte count 14.70 12.35 3 146752 0 53202311
Ankyloglossia acquired 14.70 12.35 3 146752 0 53202311
Myiasis 14.70 12.35 3 146752 0 53202311
Hallucination, auditory 14.67 12.35 7 146748 11766 53190545
Breast neoplasm 14.63 12.35 19 146736 1433 53200878
Carcinoid tumour pulmonary 14.62 12.35 11 146744 423 53201888
Clonal haematopoiesis 14.61 12.35 4 146751 10 53202301
Hernia 14.57 12.35 5 146750 10255 53192056
Blood alkaline phosphatase increased 14.57 12.35 176 146579 41186 53161125
Cystitis haemorrhagic 14.56 12.35 33 146722 3911 53198400
Ureteric stenosis 14.54 12.35 13 146742 639 53201672
Rotator cuff syndrome 14.52 12.35 8 146747 12397 53189914
Speech disorder 14.48 12.35 57 146698 39124 53163187
Lividity 14.48 12.35 9 146746 252 53202059
Cervix carcinoma recurrent 14.44 12.35 5 146750 33 53202278
Glycosylated haemoglobin increased 14.41 12.35 7 146748 11648 53190663
Blood lactate dehydrogenase increased 14.40 12.35 106 146649 21675 53180636
Hysterectomy 14.37 12.35 3 146752 8558 53193753
Biliary obstruction 14.36 12.35 26 146729 2623 53199688
Torsade de pointes 14.36 12.35 9 146746 12996 53189315
Affect lability 14.34 12.35 4 146751 9371 53192940
Purulent discharge 14.33 12.35 38 146717 4972 53197339
Nail infection 14.28 12.35 23 146732 2111 53200200
Hereditary motor and sensory neuropathy 14.28 12.35 6 146749 71 53202240
Clonal evolution 14.28 12.35 6 146749 71 53202240
Pulmonary congestion 14.27 12.35 14 146741 16142 53186169
Mechanical ileus 14.27 12.35 10 146745 344 53201967
Failure to thrive 14.23 12.35 47 146708 6945 53195366
Rash papular 14.22 12.35 10 146745 13592 53188719
Metastases to abdominal cavity 14.10 12.35 11 146744 447 53201864
Obesity 14.08 12.35 15 146740 16647 53185664
Adrenocorticotropic hormone deficiency 14.07 12.35 9 146746 265 53202046
Exposed bone in jaw 14.07 12.35 29 146726 3221 53199090
Pulmonary artery stenosis 14.04 12.35 8 146747 190 53202121
Periodontal disease 14.02 12.35 20 146735 1650 53200661
Upper-airway cough syndrome 13.99 12.35 4 146751 9223 53193088
Polymicrogyria 13.98 12.35 6 146749 75 53202236
Aspartate aminotransferase increased 13.98 12.35 316 146439 83713 53118598
Oesophageal squamous cell carcinoma 13.98 12.35 7 146748 127 53202184
Glomerular vascular disorder 13.95 12.35 5 146750 37 53202274
Respiratory depression 13.95 12.35 9 146746 12797 53189514
Paranoia 13.92 12.35 7 146748 11417 53190894
Exostosis 13.92 12.35 7 146748 11417 53190894
Swelling face 13.89 12.35 96 146659 57072 53145239
Nail pigmentation 13.89 12.35 8 146747 194 53202117
Hepatic cirrhosis 13.85 12.35 91 146664 17931 53184380
Ovarian clear cell carcinoma 13.84 12.35 4 146751 13 53202298
Acute pulmonary oedema 13.79 12.35 52 146703 8203 53194108
Apathy 13.77 12.35 3 146752 8309 53194002
Thyroiditis 13.75 12.35 21 146734 1841 53200470
Hepatic cancer metastatic 13.75 12.35 10 146745 365 53201946
Respiratory failure 13.73 12.35 368 146387 100144 53102167
Cholangitis acute 13.72 12.35 11 146744 465 53201846
Vision blurred 13.67 12.35 160 146595 85444 53116867
Muscle twitching 13.65 12.35 15 146740 16411 53185900
Tendonitis 13.62 12.35 16 146739 16990 53185321
Status epilepticus 13.60 12.35 13 146742 15171 53187140
Pulpitis dental 13.59 12.35 14 146741 822 53201489
Distal intestinal obstruction syndrome 13.52 12.35 11 146744 475 53201836
Cervix cancer metastatic 13.51 12.35 5 146750 41 53202270
Papilloedema 13.47 12.35 31 146724 3712 53198599
Hyperferritinaemia 13.45 12.35 7 146748 138 53202173
Peripheral paralysis 13.44 12.35 6 146749 83 53202228
Peritoneal carcinoma metastatic 13.40 12.35 4 146751 15 53202296
Transaminases abnormal 13.39 12.35 12 146743 592 53201719
Pelvic pain 13.38 12.35 68 146687 12205 53190106
Laryngeal oedema 13.38 12.35 40 146715 5605 53196706
Nail avulsion 13.36 12.35 7 146748 140 53202171
Pneumothorax spontaneous 13.32 12.35 12 146743 596 53201715
Hip fracture 13.27 12.35 37 146718 28220 53174091
Embolism venous 13.26 12.35 27 146728 2972 53199339
Mucosal dryness 13.25 12.35 25 146730 2603 53199708
Aplasia 13.23 12.35 33 146722 4159 53198152
Blood triglycerides increased 13.20 12.35 9 146746 12432 53189879
Hypergeusia 13.20 12.35 4 146751 16 53202295
Toxic cardiomyopathy 13.19 12.35 7 146748 144 53202167
Granulocyte count decreased 13.15 12.35 14 146741 854 53201457
Laryngeal discomfort 13.11 12.35 9 146746 299 53202012
Uterine adhesions 13.10 12.35 5 146750 45 53202266
Hypokinesia 13.07 12.35 10 146745 13017 53189294
Fistula of small intestine 13.04 12.35 9 146746 302 53202009
Corneal disorder 13.03 12.35 20 146735 1761 53200550
Tumour associated fever 13.03 12.35 8 146747 219 53202092
Hypermetabolism 13.02 12.35 7 146748 148 53202163
Hypothalamo-pituitary disorder 13.01 12.35 13 146742 736 53201575
Metastases to vagina 13.01 12.35 4 146751 17 53202294
Endometrial cancer recurrent 13.01 12.35 4 146751 17 53202294
Hyperlipidaemia 12.98 12.35 21 146734 19494 53182817
Nail bed bleeding 12.96 12.35 9 146746 305 53202006
Haemolytic anaemia 12.93 12.35 60 146695 10379 53191932
Gastrointestinal haemorrhage 12.88 12.35 150 146605 80180 53122131
Odynophagia 12.87 12.35 46 146709 7073 53195238
Respiratory fatigue 12.83 12.35 6 146749 93 53202218
Ovarian epithelial cancer recurrent 12.83 12.35 4 146751 18 53202293
Dermatitis 12.78 12.35 79 146676 15247 53187064
Dandy-Walker syndrome 12.77 12.35 6 146749 94 53202217
Catheter site thrombosis 12.77 12.35 7 146748 154 53202157
Shock 12.76 12.35 108 146647 23031 53179280
Clostridium difficile infection 12.75 12.35 37 146718 27856 53174455
Opsoclonus myoclonus 12.69 12.35 7 146748 156 53202155
Peritoneal fluid analysis abnormal 12.65 12.35 4 146751 19 53202292
Severe acute respiratory syndrome 12.65 12.35 4 146751 19 53202292
Tumour cavitation 12.63 12.35 3 146752 3 53202308
Breast prosthesis removal 12.63 12.35 3 146752 3 53202308
Portal vein occlusion 12.63 12.35 3 146752 3 53202308
Ovarian cancer stage IV 12.60 12.35 6 146749 97 53202214
Lichenoid keratosis 12.60 12.35 18 146737 1487 53200824
Immune-mediated lung disease 12.58 12.35 9 146746 320 53201991
Progressive multifocal leukoencephalopathy 12.57 12.35 9 146746 12120 53190191
Calcium ionised increased 12.57 12.35 7 146748 159 53202152
Lymphorrhoea 12.55 12.35 5 146750 51 53202260
Abscess drainage 12.55 12.35 11 146744 527 53201784
Hepatic infection 12.53 12.35 10 146745 420 53201891
EGFR gene mutation 12.53 12.35 8 146747 235 53202076
Activated PI3 kinase delta syndrome 12.48 12.35 4 146751 20 53202291
Ovarian epithelial cancer 12.48 12.35 9 146746 324 53201987
Scar 12.42 12.35 10 146745 12683 53189628
Anal sphincter atony 12.41 12.35 8 146747 239 53202072
Cerebral infarction 12.39 12.35 112 146643 24332 53177979
Bone marrow disorder 12.38 12.35 21 146734 2012 53200299
Anhedonia 12.36 12.35 7 146748 10680 53191631

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
Febrile neutropenia 603.23 15.08 819 48346 118747 32345614
Neutropenia 569.81 15.08 873 48292 141302 32323059
Malignant neoplasm progression 532.89 15.08 624 48541 77872 32386489
Interstitial lung disease 410.01 15.08 498 48667 64503 32399858
Pancreatic carcinoma metastatic 361.02 15.08 149 49016 3180 32461181
Pancreatic carcinoma 301.47 15.08 176 48989 8130 32456231
Neuropathy peripheral 263.87 15.08 441 48724 76541 32387820
Disease progression 246.49 15.08 458 48707 86404 32377957
Pneumonitis 237.08 15.08 259 48906 29875 32434486
Leukopenia 229.85 15.08 362 48803 59760 32404601
Neutrophil count decreased 210.21 15.08 305 48860 46834 32417527
Thrombocytopenia 208.32 15.08 592 48573 147707 32316654
Anaemia 203.70 15.08 770 48395 222854 32241507
Alopecia 183.97 15.08 190 48975 20540 32443821
Non-small cell lung cancer 179.74 15.08 97 49068 3840 32460521
Mucosal inflammation 176.98 15.08 235 48930 33199 32431162
Dehydration 160.17 15.08 493 48672 128465 32335896
Death 147.79 15.08 1035 48130 381482 32082879
Cholangitis 138.59 15.08 109 49056 8249 32456112
Radiation pneumonitis 132.23 15.08 67 49098 2325 32462036
Flushing 122.41 15.08 190 48975 30937 32433424
Bone marrow failure 118.74 15.08 185 48980 30219 32434142
Haemoptysis 118.61 15.08 195 48970 33330 32431031
Completed suicide 118.43 15.08 5 49160 92512 32371849
Drug ineffective 118.13 15.08 253 48912 383224 32081137
Product dose omission issue 117.91 15.08 10 49155 102565 32361796
Metastases to central nervous system 113.95 15.08 94 49071 7614 32456747
Radiation oesophagitis 113.19 15.08 37 49128 393 32463968
Haematotoxicity 107.26 15.08 86 49079 6690 32457671
Myelosuppression 105.33 15.08 108 49057 11568 32452793
Cystoid macular oedema 103.57 15.08 40 49125 712 32463649
General physical health deterioration 99.70 15.08 391 48774 114868 32349493
Overdose 98.68 15.08 9 49156 87068 32377293
Pyrexia 97.06 15.08 819 48346 319149 32145212
Neoplasm progression 94.62 15.08 132 49033 19526 32444835
Decreased appetite 91.53 15.08 482 48683 160331 32304030
Dyspnoea 90.66 15.08 889 48276 361156 32103205
Polyneuropathy 87.60 15.08 104 49061 13111 32451250
White blood cell count decreased 86.76 15.08 319 48846 90879 32373482
Pneumothorax 86.08 15.08 119 49046 17451 32446910
Drug interaction 82.10 15.08 127 49038 218058 32246303
Erythema 81.84 15.08 294 48871 82811 32381550
Fall 80.93 15.08 107 49058 196094 32268267
Oesophagitis 80.89 15.08 99 49066 12882 32451479
Neurotoxicity 79.80 15.08 106 49059 14964 32449397
Peripheral sensory neuropathy 77.16 15.08 70 49095 6444 32457917
Depression 72.53 15.08 28 49137 97032 32367329
Immune-mediated hepatitis 72.43 15.08 38 49127 1419 32462942
Biliary tract infection 71.35 15.08 28 49137 521 32463840
Plasma cell myeloma 70.87 15.08 4 49161 57610 32406751
Headache 69.29 15.08 119 49046 196078 32268283
Sepsis 66.96 15.08 440 48725 158394 32305967
Pneumonia 63.98 15.08 818 48347 354434 32109927
Tumour haemorrhage 63.96 15.08 44 49121 2707 32461654
Pancytopenia 63.64 15.08 290 48875 90945 32373416
Metastases to lung 62.09 15.08 70 49095 8347 32456014
Nausea 60.82 15.08 746 48419 320103 32144258
Gastrointestinal perforation 60.78 15.08 49 49116 3841 32460520
Somnolence 59.72 15.08 42 49123 103755 32360606
Vomiting 59.49 15.08 580 48585 234977 32229384
Anaphylactic shock 59.39 15.08 92 49073 14942 32449419
Insomnia 58.54 15.08 40 49125 100308 32364053
Nasopharyngitis 57.47 15.08 13 49152 63774 32400587
Onycholysis 56.44 15.08 23 49142 474 32463887
Metastases to meninges 56.08 15.08 31 49134 1287 32463074
Metastases to liver 55.14 15.08 82 49083 12850 32451511
Toxicity to various agents 54.96 15.08 117 49048 177924 32286437
Infusion related reaction 54.28 15.08 172 48993 45427 32418934
Kounis syndrome 54.25 15.08 35 49130 1933 32462428
Dysphagia 53.42 15.08 209 48956 61267 32403094
Platelet count decreased 52.92 15.08 325 48840 114266 32350095
Joint swelling 52.04 15.08 8 49157 51727 32412634
Weight increased 52.01 15.08 31 49134 83632 32380729
Coronary artery disease 51.59 15.08 7 49158 49699 32414662
Hypersensitivity 51.52 15.08 198 48967 57560 32406801
Thrombotic microangiopathy 50.67 15.08 67 49098 9415 32454946
Anxiety 49.96 15.08 43 49122 95962 32368399
Therapy partial responder 48.86 15.08 48 49117 4882 32459479
Liver abscess 48.76 15.08 42 49123 3609 32460752
Hospitalisation 48.29 15.08 8 49157 48963 32415398
Psoriasis 46.69 15.08 7 49158 46116 32418245
Suicidal ideation 45.75 15.08 3 49162 38080 32426281
Suicide attempt 43.18 15.08 4 49161 38240 32426121
Colitis 43.12 15.08 131 49034 33820 32430541
Rheumatoid arthritis 42.35 15.08 8 49157 44536 32419825
Aggression 42.20 15.08 5 49160 39384 32424977
Tracheo-oesophageal fistula 41.56 15.08 18 49147 434 32463927
Bronchial fistula 41.36 15.08 14 49151 167 32464194
Disseminated intravascular coagulation 41.00 15.08 101 49064 23075 32441286
Pulmonary radiation injury 40.83 15.08 11 49154 55 32464306
Tremor 40.37 15.08 38 49127 81239 32383122
Electrocardiogram QT prolonged 40.16 15.08 6 49159 39635 32424726
Recall phenomenon 40.10 15.08 19 49146 568 32463793
Intentional product misuse 40.09 15.08 4 49161 36047 32428314
Oxygen saturation decreased 39.75 15.08 161 49004 47938 32416423
Hallucination 39.58 15.08 15 49150 52604 32411757
Cardiac failure congestive 39.48 15.08 42 49123 84810 32379551
Diarrhoea 39.26 15.08 771 48394 364031 32100330
Scleroderma-like reaction 38.93 15.08 10 49155 40 32464321
Bradycardia 38.52 15.08 31 49134 71531 32392830
Immune-mediated lung disease 37.90 15.08 19 49146 644 32463717
Skin toxicity 37.62 15.08 37 49128 3769 32460592
Embolism 37.49 15.08 51 49114 7363 32456998
Metastases to bone 37.45 15.08 62 49103 10648 32453713
Tracheal fistula 36.98 15.08 11 49154 83 32464278
Haemolytic uraemic syndrome 36.56 15.08 28 49137 2036 32462325
Device failure 36.54 15.08 29 49136 2222 32462139
Gastrointestinal toxicity 35.33 15.08 28 49137 2141 32462220
Cardiac disorder 34.88 15.08 10 49155 41856 32422505
Intestinal perforation 34.62 15.08 54 49111 8821 32455540
Pleural effusion 34.53 15.08 221 48944 78771 32385590
Acute respiratory distress syndrome 34.50 15.08 100 49065 25153 32439208
Tumour necrosis 34.28 15.08 22 49143 1204 32463157
Bronchospasm 33.81 15.08 60 49105 10895 32453466
Stomatitis 33.51 15.08 135 49030 40094 32424267
Injection site pain 33.50 15.08 5 49160 33053 32431308
Musculoskeletal stiffness 33.42 15.08 9 49156 39255 32425106
Pulmonary embolism 32.92 15.08 228 48937 83431 32380930
Hypoglycaemia 32.61 15.08 21 49144 54361 32410000
Teratoma benign 31.98 15.08 8 49157 28 32464333
Performance status decreased 31.80 15.08 35 49130 4063 32460298
Gastritis bacterial 31.52 15.08 12 49153 205 32464156
Memory impairment 31.36 15.08 11 49154 40468 32423893
Hypertransaminasaemia 31.27 15.08 35 49130 4139 32460222
Tidal volume decreased 31.14 15.08 8 49157 32 32464329
Asthma 30.82 15.08 14 49151 44051 32420310
Condition aggravated 30.76 15.08 126 49039 155535 32308826
Therapeutic product effect decreased 30.73 15.08 5 49160 31012 32433349
Nephrolithiasis 30.51 15.08 3 49162 27351 32437010
Peripheral swelling 30.50 15.08 35 49130 68310 32396051
Nail dystrophy 30.33 15.08 11 49154 163 32464198
Lung adenocarcinoma 30.06 15.08 36 49129 4578 32459783
Wrong technique in product usage process 29.91 15.08 8 49157 35051 32429310
Neutropenic sepsis 29.89 15.08 62 49103 12637 32451724
Hypophagia 29.85 15.08 91 49074 23532 32440829
Ductal adenocarcinoma of pancreas 29.53 15.08 8 49157 41 32464320
Septic shock 29.52 15.08 192 48973 68797 32395564
Hypoxia 29.37 15.08 156 49009 51976 32412385
Agitation 29.32 15.08 26 49139 57210 32407151
Metastatic gastric cancer 29.05 15.08 11 49154 185 32464176
Brain teratoma 28.80 15.08 7 49158 21 32464340
Influenza 28.65 15.08 17 49148 45997 32418364
Inappropriate schedule of product administration 28.43 15.08 17 49148 45808 32418553
Immune-mediated enterocolitis 28.09 15.08 22 49143 1653 32462708
Incorrect dose administered 28.04 15.08 9 49156 35019 32429342
Radiation skin injury 27.79 15.08 16 49149 719 32463642
Enterocolitis 27.71 15.08 44 49121 7296 32457065
Periarticular thenar erythema with onycholysis 27.48 15.08 5 49160 0 32464361
Oesophagopleural fistula 27.42 15.08 8 49157 56 32464305
Muscle spasms 27.36 15.08 40 49125 70378 32393983
Anaphylactic reaction 27.35 15.08 104 49061 30068 32434293
Rhabdomyolysis 27.34 15.08 37 49128 67228 32397133
Off label use 27.25 15.08 630 48535 305690 32158671
Myocardial infarction 27.22 15.08 98 49067 125578 32338783
Neutropenic colitis 27.18 15.08 26 49139 2559 32461802
Fluid retention 26.94 15.08 4 49161 26546 32437815
Hyperkalaemia 26.73 15.08 40 49125 69710 32394651
Complication associated with device 26.60 15.08 39 49126 6033 32458328
Prostate cancer 25.88 15.08 5 49160 27401 32436960
Cytomegalovirus infection 25.46 15.08 4 49161 25460 32438901
International normalised ratio increased 25.45 15.08 22 49143 49013 32415348
Dermatitis acneiform 25.29 15.08 38 49127 6007 32458354
Coma 24.81 15.08 17 49148 42595 32421766
Ileus 24.76 15.08 67 49098 16198 32448163
Macular oedema 24.76 15.08 26 49139 2862 32461499
Abnormal behaviour 24.63 15.08 5 49160 26461 32437900
Lactic acidosis 24.49 15.08 10 49155 33526 32430835
Pneumatosis intestinalis 24.47 15.08 28 49137 3392 32460969
Irritability 24.36 15.08 4 49161 24650 32439711
Supraventricular tachycardia 24.19 15.08 52 49113 10864 32453497
Arthralgia 24.11 15.08 129 49036 148319 32316042
Urticaria 24.02 15.08 33 49132 59581 32404780
Oesophageal pain 23.91 15.08 15 49150 789 32463572
Pneumoperitoneum 23.88 15.08 21 49144 1855 32462506
Oesophagobronchial fistula 23.74 15.08 9 49156 152 32464209
Chronic kidney disease 23.20 15.08 16 49149 39959 32424402
Angioedema 23.17 15.08 13 49152 36276 32428085
Disturbance in attention 23.15 15.08 4 49161 23749 32440612
Tachycardia 23.02 15.08 201 48964 78887 32385474
Lung squamous cell carcinoma metastatic 22.96 15.08 7 49158 58 32464303
Blood creatine phosphokinase increased 22.88 15.08 21 49144 45455 32418906
Stress cardiomyopathy 22.75 15.08 20 49145 1766 32462595
Gastric perforation 22.61 15.08 22 49143 2211 32462150
Blood glucose increased 22.58 15.08 40 49125 65201 32399160
Adrenocorticotropic hormone deficiency 22.58 15.08 13 49152 584 32463777
Blood pressure increased 22.13 15.08 55 49110 79299 32385062
Adrenal insufficiency 22.06 15.08 53 49112 11915 32452446
Enterocolitis infectious 22.02 15.08 17 49148 1251 32463110
Feeling abnormal 21.87 15.08 36 49129 60387 32403974
Metastases to skin 21.70 15.08 11 49154 382 32463979
Sense of oppression 21.49 15.08 12 49153 508 32463853
Metabolic acidosis 21.43 15.08 18 49147 40681 32423680
Taeniasis 21.28 15.08 7 49158 76 32464285
Dysarthria 21.05 15.08 12 49153 33189 32431172
Coronary artery aneurysm 20.80 15.08 7 49158 82 32464279
Eosinophilia 20.72 15.08 6 49159 24952 32439409
Lung neoplasm malignant 20.64 15.08 62 49103 15901 32448460
Dizziness 20.63 15.08 210 48955 209408 32254953
Seizure 20.54 15.08 84 49081 103770 32360591
Subdural haematoma 20.25 15.08 3 49162 19950 32444411
Confusional state 20.23 15.08 130 49035 142985 32321376
Psychotic disorder 20.12 15.08 5 49160 23015 32441346
Respiratory failure 20.07 15.08 249 48916 106933 32357428
Herpes zoster 20.06 15.08 12 49153 32329 32432032
Chills 19.97 15.08 193 48972 77891 32386470
Gait disturbance 19.97 15.08 59 49106 80349 32384012
Pericardial effusion 19.79 15.08 78 49087 22924 32441437
Infectious pleural effusion 19.50 15.08 20 49145 2141 32462220
Sinusitis 19.46 15.08 16 49149 36544 32427817
Tumour lysis syndrome 19.28 15.08 57 49108 14490 32449871
Portal venous gas 19.27 15.08 10 49155 365 32463996
Lung abscess 19.06 15.08 22 49143 2690 32461671
Paronychia 19.06 15.08 24 49141 3213 32461148
Metastases to lymph nodes 18.76 15.08 28 49137 4400 32459961
Asthenia 18.74 15.08 478 48687 235466 32228895
Nasal congestion 18.62 15.08 4 49161 20347 32444014
Hiccups 18.43 15.08 44 49121 9851 32454510
Transient ischaemic attack 18.34 15.08 8 49157 25786 32438575
Lung disorder 18.32 15.08 100 49065 33654 32430707
Cachexia 18.27 15.08 36 49129 7073 32457288
Myocardial oedema 18.26 15.08 7 49158 122 32464239
Loss of personal independence in daily activities 18.03 15.08 9 49156 26824 32437537
Hypomagnesaemia 18.02 15.08 66 49099 18739 32445622
Adenocarcinoma pancreas 18.01 15.08 16 49149 1432 32462929
Depressed mood 18.01 15.08 3 49162 18297 32446064
Hyponatraemia 17.99 15.08 182 48983 74331 32390030
Metastases to peritoneum 17.98 15.08 17 49148 1649 32462712
Tumour marker increased 17.91 15.08 11 49154 557 32463804
Extravasation 17.88 15.08 18 49147 1885 32462476
Arthritis 17.87 15.08 9 49156 26683 32437678
Anaphylactoid shock 17.85 15.08 10 49155 426 32463935
Product use issue 17.69 15.08 33 49132 52744 32411617
Feeling hot 17.67 15.08 61 49104 16825 32447536
Second primary malignancy 17.66 15.08 35 49130 6906 32457455
Lymphopenia 17.62 15.08 55 49110 14401 32449960
Metastases to the mediastinum 17.50 15.08 8 49157 220 32464141
Eastern Cooperative Oncology Group performance status worsened 17.47 15.08 11 49154 582 32463779
Failure to thrive 17.35 15.08 39 49126 8396 32455965
Dyskinesia 17.30 15.08 7 49158 23596 32440765
Vascular pseudoaneurysm ruptured 17.19 15.08 6 49159 79 32464282
Product quality issue 17.15 15.08 4 49161 19229 32445132
Blister 17.11 15.08 6 49159 22085 32442276
Gastric cancer 17.06 15.08 30 49135 5407 32458954
Treatment noncompliance 17.00 15.08 10 49155 27192 32437169
Upper respiratory tract infection 16.83 15.08 12 49153 29461 32434900
Acute kidney injury 16.75 15.08 328 48837 293140 32171221
Arterial rupture 16.64 15.08 10 49155 487 32463874
Thrombocytosis 16.62 15.08 24 49141 3661 32460700
Blood thyroid stimulating hormone abnormal 16.53 15.08 8 49157 251 32464110
Pollakiuria 16.52 15.08 4 49161 18740 32445621
Upper gastrointestinal perforation 16.49 15.08 3 49162 0 32464361
Pulmonary cavitation 16.44 15.08 12 49153 811 32463550
Diabetes mellitus 16.26 15.08 27 49138 45146 32419215
Infusion related hypersensitivity reaction 16.24 15.08 5 49160 43 32464318
Contusion 16.20 15.08 16 49149 33452 32430909
Blastic plasmacytoid dendritic cell neoplasia 15.73 15.08 6 49159 103 32464258
Balance disorder 15.73 15.08 22 49143 39437 32424924
Enteritis 15.42 15.08 34 49131 7227 32457134
Drug hypersensitivity 15.38 15.08 58 49107 73342 32391019
Oesophageal fistula 15.16 15.08 7 49158 197 32464164
Pulmonary hypoplasia 15.13 15.08 9 49156 430 32463931
Metastases to kidney 15.12 15.08 8 49157 304 32464057
Pulmonary toxicity 15.12 15.08 27 49138 4926 32459435

Pharmacologic Action:

SourceCodeDescription
ATC L01CD01 ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
ANTINEOPLASTIC AGENTS
PLANT ALKALOIDS AND OTHER NATURAL PRODUCTS
Taxanes
FDA PE N0000175085 Microtubule Inhibition
FDA EPC N0000175592 Microtubule Inhibitor
MeSH PA D000970 Antineoplastic Agents
CHEBI has role CHEBI:25212 metabolites
CHEBI has role CHEBI:35610 cytostatic
CHEBI has role CHEBI:61950 microtubule-stabilizing agent
CHEBI has role CHEBI:77746 H. sapiens metabolites
MeSH PA D050256 Antimitotic Agents
MeSH PA D000972 Antineoplastic Agents, Phytogenic
MeSH PA D050257 Tubulin Modulators

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Ocular hypertension indication 4210003 DOID:9282
Hypertensive disorder indication 38341003 DOID:10763
Open-angle glaucoma indication 84494001 DOID:1067
Secondary malignant neoplasm of pancreas indication 94459006
Kaposi's sarcoma indication 109385007
Non-small cell lung cancer indication 254637007 DOID:3908
Carcinoma of breast indication 254838004 DOID:3459
Carcinoma of fallopian tube indication 276870001 DOID:1963
Malignant tumor of ovary indication 363443007 DOID:2394
Malignant tumor of peritoneum indication 363492001
Metastatic Breast Carcinoma indication
Malignant glaucoma off-label use 10100008
Aphakic glaucoma off-label use 15374009
Secondary glaucoma off-label use 95717004
Neoplasm of esophagus off-label use 126817006 DOID:5041
Small cell carcinoma of lung off-label use 254632001 DOID:5409
Endometrial carcinoma off-label use 254878006 DOID:2871
Malignant tumor of head and/or neck off-label use 255056009
Malignant tumor of cervix off-label use 363354003 DOID:4362
Malignant tumor of testis off-label use 363449006 DOID:2998
Malignant tumor of urinary bladder off-label use 399326009 DOID:11054
Bronchospasm contraindication 4386001
Psoriasis contraindication 9014002 DOID:8893
Hyperbilirubinemia contraindication 14783006 DOID:2741
Myocardial infarction contraindication 22298006 DOID:5844
Complete atrioventricular block contraindication 27885002
Acute cerebrovascular insufficiency contraindication 29322000
Depressive disorder contraindication 35489007
Anaphylaxis contraindication 39579001
Conduction disorder of the heart contraindication 44808001
Low blood pressure contraindication 45007003
Chronic heart failure contraindication 48447003
Bradycardia contraindication 48867003
Sinus bradycardia contraindication 49710005
Acute nephropathy contraindication 58574008
Acute infectious disease contraindication 63171007
Diabetes mellitus contraindication 73211009 DOID:9351
Pulmonary emphysema contraindication 87433001
Cardiogenic shock contraindication 89138009
Kidney disease contraindication 90708001 DOID:557
Myasthenia gravis contraindication 91637004 DOID:437
Liver function tests abnormal contraindication 166603001
Second degree atrioventricular block contraindication 195042002
Decompensated cardiac failure contraindication 195111005
Asthma contraindication 195967001 DOID:2841
Heart block contraindication 233916004
Disease of liver contraindication 235856003 DOID:409
Hypoglycemic disorder contraindication 237630007
Raynaud's phenomenon contraindication 266261006
Anemia contraindication 271737000 DOID:2355
Pregnancy, function contraindication 289908002
Thrombocytopenic disorder contraindication 302215000 DOID:1588
Peripheral nerve disease contraindication 302226006
Pheochromocytoma contraindication 302835009
Neutropenic disorder contraindication 303011007 DOID:1227
Bone marrow depression contraindication 307762000
Breastfeeding (mother) contraindication 413712001
Acute exacerbation of asthma contraindication 708038006

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 11.47 acidic
pKa2 12.08 acidic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
100MG/VIAL ABRAXANE ABRAXIS BIOSCIENCE N021660 Jan. 7, 2005 RX POWDER INTRAVENOUS 7923536 Dec. 9, 2023 TREATMENT OF BREAST CANCER
100MG/VIAL ABRAXANE ABRAXIS BIOSCIENCE N021660 Jan. 7, 2005 RX POWDER INTRAVENOUS 7923536 Dec. 9, 2023 TREATMENT OF LUNG CANCER
100MG/VIAL ABRAXANE ABRAXIS BIOSCIENCE N021660 Jan. 7, 2005 RX POWDER INTRAVENOUS 7923536 Dec. 9, 2023 TREATMENT OF PANCREATIC CANCER
100MG/VIAL ABRAXANE ABRAXIS BIOSCIENCE N021660 Jan. 7, 2005 RX POWDER INTRAVENOUS 8138229 Dec. 9, 2023 TREATMENT OF BREAST CANCER
100MG/VIAL ABRAXANE ABRAXIS BIOSCIENCE N021660 Jan. 7, 2005 RX POWDER INTRAVENOUS 8138229 Dec. 9, 2023 TREATMENT OF LUNG CANCER
100MG/VIAL ABRAXANE ABRAXIS BIOSCIENCE N021660 Jan. 7, 2005 RX POWDER INTRAVENOUS 8138229 Dec. 9, 2023 TREATMENT OF PANCREATIC CANCER
100MG/VIAL ABRAXANE ABRAXIS BIOSCIENCE N021660 Jan. 7, 2005 RX POWDER INTRAVENOUS 8314156 Dec. 9, 2023 TREATMENT OF LUNG CANCER
100MG/VIAL ABRAXANE ABRAXIS BIOSCIENCE N021660 Jan. 7, 2005 RX POWDER INTRAVENOUS 8314156 Dec. 9, 2023 TREATMENT OF PANCREATIC CANCER
100MG/VIAL ABRAXANE ABRAXIS BIOSCIENCE N021660 Jan. 7, 2005 RX POWDER INTRAVENOUS 7820788 Oct. 27, 2024 TREATMENT OF BREAST CANCER
100MG/VIAL ABRAXANE ABRAXIS BIOSCIENCE N021660 Jan. 7, 2005 RX POWDER INTRAVENOUS 7820788 Oct. 27, 2024 TREATMENT OF LUNG CANCER
100MG/VIAL ABRAXANE ABRAXIS BIOSCIENCE N021660 Jan. 7, 2005 RX POWDER INTRAVENOUS 7820788 Oct. 27, 2024 TREATMENT OF PANCREATIC CANCER
100MG/VIAL ABRAXANE ABRAXIS BIOSCIENCE N021660 Jan. 7, 2005 RX POWDER INTRAVENOUS 7758891 Feb. 21, 2026 TREATMENT OF PANCREATIC CANCER
100MG/VIAL ABRAXANE ABRAXIS BIOSCIENCE N021660 Jan. 7, 2005 RX POWDER INTRAVENOUS 8268348 Feb. 21, 2026 TREATMENT OF LUNG CANCER
100MG/VIAL ABRAXANE ABRAXIS BIOSCIENCE N021660 Jan. 7, 2005 RX POWDER INTRAVENOUS 9101543 Feb. 21, 2026 TREATMENT OF PANCREATIC CANCER
100MG/VIAL ABRAXANE ABRAXIS BIOSCIENCE N021660 Jan. 7, 2005 RX POWDER INTRAVENOUS 8034375 Aug. 13, 2026 TREATMENT OF LUNG CANCER
100MG/VIAL ABRAXANE ABRAXIS BIOSCIENCE N021660 Jan. 7, 2005 RX POWDER INTRAVENOUS 9393318 March 4, 2032 TREATMENT OF LUNG CANCER
100MG/VIAL ABRAXANE ABRAXIS BIOSCIENCE N021660 Jan. 7, 2005 RX POWDER INTRAVENOUS 9597409 March 4, 2032 TREATMENT OF LUNG CANCER
100MG/VIAL ABRAXANE ABRAXIS BIOSCIENCE N021660 Jan. 7, 2005 RX POWDER INTRAVENOUS 9511046 Jan. 12, 2034 TREATMENT OF PANCREATIC CANCER

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
100MG/VIAL ABRAXANE ABRAXIS BIOSCIENCE N021660 Jan. 7, 2005 RX POWDER INTRAVENOUS Dec. 6, 2022 ADDITIONAL CLINICAL TRIAL INFORMATION ADDED TO PEDIATRIC USE SUBSECTION
100MG/VIAL ABRAXANE ABRAXIS BIOSCIENCE N021660 Jan. 7, 2005 RX POWDER INTRAVENOUS June 6, 2023 PEDIATRIC EXCLUSIVITY

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Tubulin beta Tumour-associated antigen INHIBITOR EC50 8.05 IUPHAR SCIENTIFIC LITERATURE
Nuclear receptor subfamily 1 group I member 2 Nuclear hormone receptor AGONIST EC50 5.30 IUPHAR
Delta-type opioid receptor GPCR Ki 5.83 DRUG MATRIX
Bile salt export pump Transporter WOMBAT-PK
Multidrug resistance-associated protein 7 Transporter WOMBAT-PK
Tubulin beta chain Structural INHIBITOR EC50 8.05 IUPHAR
Tyrosine-protein kinase Fyn Kinase IC50 4.62 DRUG MATRIX
Receptor tyrosine-protein kinase erbB-2 Kinase IC50 4.95 DRUG MATRIX
Multidrug resistance protein 1 Transporter IC50 5.59 CHEMBL
Substance-K receptor GPCR Ki 5.69 DRUG MATRIX
Melanocortin receptor 5 GPCR Ki 4.79 DRUG MATRIX
Tyrosine-protein kinase Mer Kinase IC50 5.31 CHEMBL
Tubulin beta-3 chain Structural IC50 8.11 CHEMBL
Nucleotide-binding oligomerization domain-containing protein 2 Cytosolic other IC50 5.10 CHEMBL
Cholecystokinin receptor type A GPCR Ki 5.64 DRUG MATRIX
Botulinum neurotoxin type A Enzyme IC50 5.28 CHEMBL

External reference:

IDSource
4020736 VUID
N0000148314 NUI
D00491 KEGG_DRUG
4020736 VANDF
C0144576 UMLSCUI
CHEBI:45863 CHEBI
TA1 PDB_CHEM_ID
CHEMBL428647 ChEMBL_ID
D017239 MESH_DESCRIPTOR_UI
DB01229 DRUGBANK_ID
2770 IUPHAR_LIGAND_ID
7052 INN_ID
P88XT4IS4D UNII
36314 PUBCHEM_CID
196466 RXNORM
2296 MMSL
42243 MMSL
5224 MMSL
64289 MMSL
d01376 MMSL
004116 NDDF
387374002 SNOMEDCT_US
67735003 SNOMEDCT_US
D000068196 MESH_DESCRIPTOR_UI

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Paclitaxel HUMAN PRESCRIPTION DRUG LABEL 1 0703-3213 INJECTION, SOLUTION, CONCENTRATE 6 mg INTRAVENOUS ANDA 16 sections
Paclitaxel HUMAN PRESCRIPTION DRUG LABEL 1 0703-3213 INJECTION, SOLUTION, CONCENTRATE 6 mg INTRAVENOUS ANDA 16 sections
Paclitaxel HUMAN PRESCRIPTION DRUG LABEL 1 0703-3216 INJECTION, SOLUTION, CONCENTRATE 6 mg INTRAVENOUS ANDA 16 sections
Paclitaxel HUMAN PRESCRIPTION DRUG LABEL 1 0703-3216 INJECTION, SOLUTION, CONCENTRATE 6 mg INTRAVENOUS ANDA 16 sections
Paclitaxel HUMAN PRESCRIPTION DRUG LABEL 1 0703-3217 INJECTION, SOLUTION, CONCENTRATE 6 mg INTRAVENOUS ANDA 16 sections
Paclitaxel HUMAN PRESCRIPTION DRUG LABEL 1 0703-3218 INJECTION, SOLUTION, CONCENTRATE 6 mg INTRAVENOUS ANDA 16 sections
Paclitaxel HUMAN PRESCRIPTION DRUG LABEL 1 0703-3218 INJECTION, SOLUTION, CONCENTRATE 6 mg INTRAVENOUS ANDA 16 sections
Paclitaxel HUMAN PRESCRIPTION DRUG LABEL 1 0703-4764 INJECTION, SOLUTION, CONCENTRATE 6 mg INTRAVENOUS ANDA 16 sections
Paclitaxel HUMAN PRESCRIPTION DRUG LABEL 1 0703-4768 INJECTION, SOLUTION, CONCENTRATE 6 mg INTRAVENOUS ANDA 16 sections
Paclitaxel Human Prescription Drug Label 1 16714-137 INJECTION, SOLUTION 6 mg INTRAVENOUS ANDA 21 sections
Paclitaxel HUMAN PRESCRIPTION DRUG LABEL 1 44567-504 INJECTION 6 mg INTRAVENOUS NDA 22 sections
Paclitaxel HUMAN PRESCRIPTION DRUG LABEL 1 44567-505 INJECTION 6 mg INTRAVENOUS NDA 22 sections
Paclitaxel HUMAN PRESCRIPTION DRUG LABEL 1 44567-506 INJECTION 6 mg INTRAVENOUS NDA 22 sections
Paclitaxel HUMAN PRESCRIPTION DRUG LABEL 1 45963-613 INJECTION, SOLUTION 6 mg INTRAVENOUS ANDA 16 sections
Paclitaxel HUMAN PRESCRIPTION DRUG LABEL 1 47781-593 INJECTION, SOLUTION 30 mg INTRAVENOUS ANDA 24 sections
Paclitaxel HUMAN PRESCRIPTION DRUG LABEL 1 47781-594 INJECTION, SOLUTION 100 mg INTRAVENOUS ANDA 24 sections
Paclitaxel HUMAN PRESCRIPTION DRUG LABEL 1 47781-595 INJECTION, SOLUTION 300 mg INTRAVENOUS ANDA 24 sections
Paclitaxel HUMAN PRESCRIPTION DRUG LABEL 1 61703-342 INJECTION, SOLUTION 6 mg INTRAVENOUS ANDA 16 sections
Paclitaxel Human Prescription Drug Label 1 63323-763 INJECTION, SOLUTION 6 mg INTRAVENOUS ANDA 21 sections
Paclitaxel HUMAN PRESCRIPTION DRUG LABEL 1 68001-516 INJECTION, SOLUTION 6 mg INTRAVENOUS ANDA 21 sections
PACLITAXELPACLITAXEL Human Prescription Drug Label 1 68083-178 INJECTION, SOLUTION 6 mg INTRAVENOUS ANDA 19 sections
PACLITAXELPACLITAXEL Human Prescription Drug Label 1 68083-179 INJECTION, SOLUTION 6 mg INTRAVENOUS ANDA 19 sections
PACLITAXELPACLITAXEL Human Prescription Drug Label 1 68083-180 INJECTION, SOLUTION 6 mg INTRAVENOUS ANDA 19 sections
ABRAXANE HUMAN PRESCRIPTION DRUG LABEL 1 68817-134 INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION 100 mg INTRAVENOUS NDA 32 sections
Paclitaxel Human Prescription Drug Label 1 69539-157 INJECTION, SOLUTION 6 mg INTRAVENOUS ANDA 21 sections
Paclitaxel Human Prescription Drug Label 1 69539-158 INJECTION, SOLUTION 6 mg INTRAVENOUS ANDA 21 sections
Paclitaxel Human Prescription Drug Label 1 69539-159 INJECTION, SOLUTION 6 mg INTRAVENOUS ANDA 21 sections
Paclitaxel HUMAN PRESCRIPTION DRUG LABEL 1 70860-200 INJECTION, SOLUTION 6 mg INTRAVENOUS ANDA 24 sections
Paclitaxel HUMAN PRESCRIPTION DRUG LABEL 1 70860-215 INJECTION, SOLUTION 6 mg INTRAVENOUS ANDA 24 sections
Paclitaxel Human Prescription Drug Label 1 72205-061 INJECTION, SOLUTION 6 mg INTRAVENOUS ANDA 21 sections