paclitaxel ๐Ÿถ Veterinary Use | 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: 3.88
  • 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 ยตM/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 1910.19 12.84 1556 144032 72031 56074448
Neutropenia 1706.59 12.84 2071 143517 156096 55990383
Neuropathy peripheral 1648.03 12.84 1658 143930 101235 56045244
Disease progression 1223.19 12.84 1432 144156 103741 56042738
Metastases to liver 1107.20 12.84 692 144896 20894 56125585
Erythema 1039.61 12.84 1619 143969 154320 55992159
Metastases to bone 1034.97 12.84 639 144949 18869 56127610
Febrile neutropenia 1018.16 12.84 1308 144280 104237 56042242
Rheumatoid arthritis 894.74 12.84 20 145568 382584 55763895
Flushing 879.25 12.84 993 144595 69107 56077372
Breast cancer metastatic 857.05 12.84 521 145067 14948 56131531
Anaemia 826.17 12.84 2005 143583 265506 55880973
Myelosuppression 709.97 12.84 484 145104 16971 56129508
Drug ineffective 697.96 12.84 815 144773 918174 55228305
Metastases to lung 665.41 12.84 401 145187 11317 56135162
Neutrophil count decreased 662.71 12.84 728 144860 49094 56097385
Palmar-plantar erythrodysaesthesia syndrome 656.90 12.84 497 145091 20568 56125911
Dyspnoea 651.63 12.84 3137 142451 589440 55557039
Polyneuropathy 566.94 12.84 377 145211 12673 56133806
Neoplasm progression 557.96 12.84 541 145047 31475 56115004
Joint swelling 549.90 12.84 56 145532 289744 55856735
Peripheral sensory neuropathy 531.68 12.84 289 145299 6667 56139812
Acute myeloid leukaemia 495.30 12.84 385 145203 16587 56129892
Metastases to central nervous system 487.52 12.84 334 145254 11802 56134677
Thrombocytopenia 477.21 12.84 1074 144514 135150 56011329
Leukopenia 446.10 12.84 718 144870 70222 56076257
Metastases to lymph nodes 444.76 12.84 263 145325 7160 56139319
Neurotoxicity 442.98 12.84 350 145238 15445 56131034
Mucosal inflammation 441.38 12.84 549 145039 42261 56104218
Contraindicated product administered 412.06 12.84 16 145572 186270 55960209
Ejection fraction decreased 404.72 12.84 366 145222 19475 56127004
Arthropathy 403.33 12.84 30 145558 200245 55946234
Chest discomfort 395.91 12.84 823 144765 98034 56048445
Death 395.58 12.84 1838 143750 339588 55806891
Pneumonitis 393.43 12.84 446 145142 31118 56115361
Product dose omission issue 381.93 12.84 42 145546 204711 55941768
Systemic lupus erythematosus 380.34 12.84 21 145567 180057 55966422
Haematotoxicity 378.23 12.84 248 145340 8135 56138344
Synovitis 374.23 12.84 9 145579 161296 55985183
Ascites 364.04 12.84 467 145121 37077 56109402
Therapeutic product effect decreased 348.06 12.84 23 145565 169429 55977050
Glossodynia 344.44 12.84 11 145577 152447 55994032
Fall 338.84 12.84 258 145330 357252 55789227
Bone marrow failure 331.17 12.84 387 145201 27899 56118580
Abdominal discomfort 325.77 12.84 155 145433 277119 55869360
Sinusitis 325.34 12.84 59 145529 197522 55948957
Completed suicide 324.69 12.84 4 145584 133829 56012650
Anaphylactic shock 308.72 12.84 329 145259 21411 56125068
Pain 307.96 12.84 800 144788 662384 55484095
Swelling 302.25 12.84 121 145467 239650 55906829
Condition aggravated 299.48 12.84 271 145317 344627 55801852
Proteinuria 293.15 12.84 290 145298 17280 56129199
Breast cancer 288.94 12.84 481 145107 48352 56098127
Second primary malignancy 286.18 12.84 199 145389 7203 56139276
Weight increased 284.52 12.84 119 145469 229584 55916895
Pseudocirrhosis 283.21 12.84 93 145495 548 56145931
Metastases to peritoneum 281.34 12.84 143 145445 2861 56143618
Feeling hot 277.80 12.84 434 145154 41353 56105126
Epistaxis 276.45 12.84 565 145023 66458 56080021
Cystoid macular oedema 272.33 12.84 114 145474 1427 56145052
Myelodysplastic syndrome 272.26 12.84 270 145318 16136 56130343
Headache 267.26 12.84 664 144924 558380 55588099
Musculoskeletal stiffness 260.22 12.84 45 145543 155962 55990517
Bronchospasm 256.56 12.84 256 145332 15413 56131066
Pleural effusion 255.61 12.84 634 144954 84846 56061633
Product use issue 254.61 12.84 82 145506 185959 55960520
Interstitial lung disease 252.03 12.84 495 145093 56568 56089911
Drug intolerance 234.62 12.84 204 145384 264614 55881865
Onycholysis 233.28 12.84 99 145489 1285 56145194
Skin toxicity 230.26 12.84 140 145448 4013 56142466
Hypertension 226.52 12.84 1236 144352 243042 55903437
Gastrointestinal perforation 222.73 12.84 125 145463 3074 56143405
Wound 216.77 12.84 47 145541 138757 56007722
Ovarian cancer recurrent 215.03 12.84 88 145500 1036 56145443
Back pain 213.83 12.84 1191 144397 235979 55910500
General physical health deterioration 211.72 12.84 936 144652 169074 55977405
Peripheral swelling 211.32 12.84 178 145410 234548 55911931
Treatment failure 204.98 12.84 92 145496 170300 55976179
Vomiting 204.79 12.84 2076 143512 496152 55650327
Arthralgia 197.56 12.84 653 144935 501016 55645463
Diarrhoea 191.43 12.84 2502 143086 636005 55510474
Psoriasis 189.02 12.84 13 145575 92679 56053800
Injection site pain 188.35 12.84 37 145551 117081 56029398
Bone pain 184.78 12.84 404 145184 49781 56096698
Hypertransaminasaemia 183.02 12.84 127 145461 4580 56141899
Nausea 182.08 12.84 2876 142712 761302 55385177
Pericarditis 180.32 12.84 32 145556 108891 56037588
Nasopharyngitis 174.96 12.84 188 145400 220771 55925708
Cardiotoxicity 171.68 12.84 149 145439 7501 56138978
Helicobacter infection 170.18 12.84 4 145584 73264 56073215
Platelet count decreased 169.99 12.84 633 144955 105750 56040729
Embolism 166.41 12.84 144 145444 7220 56139259
Ovarian cancer 165.85 12.84 134 145454 6104 56140375
Cardiac dysfunction 164.99 12.84 87 145501 1883 56144596
Abdominal pain 162.13 12.84 1185 144403 257620 55888859
Sense of oppression 161.74 12.84 69 145519 908 56145571
Pyrexia 160.95 12.84 1722 143866 417051 55729428
Metastasis 160.52 12.84 118 145470 4666 56141813
Hepatic enzyme increased 160.37 12.84 125 145463 171259 55975220
Breast cancer recurrent 158.57 12.84 110 145478 3965 56142514
PIK3CA-activated mutation 156.42 12.84 67 145521 891 56145588
Drug abuse 155.85 12.84 4 145584 67606 56078873
Pancreatic carcinoma metastatic 154.70 12.84 87 145501 2148 56144331
Blood cholesterol increased 154.58 12.84 8 145580 72571 56073908
Irritable bowel syndrome 154.32 12.84 5 145583 68453 56078026
White blood cell count decreased 153.99 12.84 690 144898 125300 56021179
Therapy partial responder 151.67 12.84 140 145448 7645 56138834
Osteonecrosis of jaw 151.66 12.84 293 145295 33065 56113414
Mobility decreased 151.54 12.84 35 145553 98956 56047523
Duodenal ulcer perforation 150.56 12.84 6 145582 68336 56078143
Maternal exposure during pregnancy 150.34 12.84 161 145427 189392 55957087
Discomfort 147.70 12.84 92 145496 141669 56004810
Hospitalisation 145.95 12.84 13 145575 74987 56071492
Arthritis 143.81 12.84 40 145548 99812 56046667
Migraine 142.57 12.84 26 145562 86771 56059708
Lymphangiosis carcinomatosa 142.44 12.84 68 145520 1181 56145298
Hypokalaemia 141.85 12.84 551 145037 93886 56052593
Contusion 141.37 12.84 78 145510 128352 56018127
Hypoxia 140.68 12.84 380 145208 53517 56092962
Overdose 140.59 12.84 49 145539 105781 56040698
Drug hypersensitivity 139.71 12.84 316 145272 274889 55871590
Tachycardia 139.39 12.84 593 144995 105283 56041196
Loss of personal independence in daily activities 136.65 12.84 23 145565 81346 56065133
Somnolence 136.15 12.84 133 145455 163280 55983199
Suicide attempt 134.93 12.84 3 145585 57833 56088646
Injection site erythema 134.33 12.84 20 145568 77428 56069051
Paraesthesia 132.81 12.84 678 144910 129836 56016643
Fibromyalgia 132.09 12.84 5 145583 59598 56086881
Depression 130.94 12.84 164 145424 179953 55966526
Exposure during pregnancy 129.36 12.84 98 145490 136244 56010235
Asthma 129.26 12.84 65 145523 112705 56033774
Metastases to meninges 127.07 12.84 77 145511 2193 56144286
Pulmonary embolism 125.88 12.84 580 145008 106544 56039935
Oxygen saturation decreased 125.04 12.84 469 145119 78598 56067881
Nail disorder 123.02 12.84 150 145438 11301 56135178
Neutropenic sepsis 122.85 12.84 173 145415 15012 56131467
Hepatic failure 122.59 12.84 269 145319 33217 56113262
Left ventricular dysfunction 121.60 12.84 147 145441 10976 56135503
Disease recurrence 121.46 12.84 220 145368 23640 56122839
Dehydration 119.43 12.84 761 144827 158064 55988415
Influenza 116.77 12.84 50 145538 95211 56051268
Lower respiratory tract infection 116.14 12.84 77 145511 114717 56031762
Nail discolouration 115.41 12.84 75 145513 2421 56144058
Large intestine perforation 115.32 12.84 121 145467 7730 56138749
Throat tightness 112.02 12.84 205 145383 22202 56124277
Peripheral motor neuropathy 111.89 12.84 62 145526 1486 56144993
Asthenia 109.45 12.84 1361 144227 341612 55804867
Cyanosis 108.93 12.84 167 145421 15643 56130836
Biliary tract infection 108.89 12.84 45 145543 544 56145935
Decreased appetite 108.85 12.84 952 144636 218279 55928200
Pneumocystis jirovecii pneumonia 106.99 12.84 165 145423 15536 56130943
Nail toxicity 105.35 12.84 38 145550 308 56146171
Blister 104.91 12.84 77 145511 108810 56037669
Intestinal perforation 104.10 12.84 135 145453 10824 56135655
Ileus 101.85 12.84 151 145437 13731 56132748
Hepatic atrophy 101.58 12.84 35 145553 244 56146235
Confusional state 101.56 12.84 244 145344 207911 55938568
Injection site reaction 101.54 12.84 10 145578 53237 56093242
Gastrointestinal toxicity 101.54 12.84 101 145487 6055 56140424
Cholangitis 100.31 12.84 91 145497 4858 56141621
Inappropriate schedule of product administration 98.69 12.84 46 145542 83341 56063138
Toxicity to various agents 98.28 12.84 278 145310 224286 55922193
Memory impairment 97.53 12.84 51 145537 86506 56059973
Metastases to skin 96.18 12.84 55 145533 1403 56145076
Pancytopenia 95.95 12.84 469 145119 88246 56058233
Osteoarthritis 95.48 12.84 44 145544 80252 56066227
Urogenital fistula 95.07 12.84 31 145557 178 56146301
Injury 93.93 12.84 20 145568 59831 56086648
Feeling abnormal 93.60 12.84 125 145463 133477 56013002
Injection site swelling 92.17 12.84 5 145583 43573 56102906
Insomnia 91.93 12.84 227 145361 191633 55954846
Gait disturbance 91.65 12.84 177 145411 163144 55983335
Injection site pruritus 88.10 12.84 5 145583 41926 56104553
Cardiomyopathy 88.01 12.84 154 145434 16104 56130375
Pancreatic carcinoma 87.95 12.84 101 145487 7140 56139339
Intentional product misuse 87.71 12.84 14 145574 51490 56094989
Tumour necrosis 86.40 12.84 41 145547 702 56145777
Incorrect dose administered 85.72 12.84 16 145572 52531 56093948
Metastases to pleura 85.50 12.84 50 145538 1332 56145147
Laryngospasm 85.37 12.84 66 145522 2818 56143661
Dysaesthesia 84.05 12.84 76 145512 4040 56142439
Drug interaction 83.66 12.84 271 145317 209484 55936995
Plasma cell myeloma 83.34 12.84 11 145577 46635 56099844
Folliculitis 83.01 12.84 20 145568 54959 56091520
Small intestinal obstruction 82.93 12.84 153 145435 16672 56129807
Posterior reversible encephalopathy syndrome 82.30 12.84 148 145440 15812 56130667
Subileus 82.01 12.84 65 145523 2879 56143600
C-reactive protein abnormal 81.86 12.84 3 145585 36806 56109673
Non-small cell lung cancer 81.58 12.84 71 145517 3587 56142892
Muscle spasms 80.49 12.84 145 145443 137226 56009253
Recall phenomenon 79.91 12.84 36 145552 544 56145935
Metastatic neoplasm 79.41 12.84 72 145516 3841 56142638
Tumour marker increased 79.39 12.84 75 145513 4218 56142261
Metastases to spine 79.02 12.84 64 145524 2925 56143554
Hydronephrosis 78.81 12.84 108 145480 9134 56137345
Red blood cell sedimentation rate increased 78.09 12.84 4 145584 36619 56109860
Suicidal ideation 77.94 12.84 26 145562 57716 56088763
Tumour haemorrhage 77.70 12.84 48 145540 1416 56145063
Malignant pleural effusion 77.49 12.84 58 145530 2358 56144121
Triple negative breast cancer 76.73 12.84 27 145561 202 56146277
Acute promyelocytic leukaemia 74.70 12.84 40 145548 894 56145585
Osteoporosis 74.65 12.84 21 145567 52031 56094448
Cardiac failure 74.25 12.84 413 145175 81680 56064799
Anaphylactoid reaction 74.09 12.84 66 145522 3440 56143039
Hepatic function abnormal 72.17 12.84 225 145363 34333 56112146
Portal hypertension 71.55 12.84 65 145523 3476 56143003
Anaphylactic reaction 71.17 12.84 322 145266 58673 56087806
Computerised tomogram thorax abnormal 69.87 12.84 45 145543 1430 56145049
Radiation pneumonitis 69.48 12.84 45 145543 1444 56145035
Invasive ductal breast carcinoma 69.43 12.84 87 145501 6739 56139740
Hypoglycaemia 68.86 12.84 29 145559 55786 56090693
Fluid retention 68.50 12.84 27 145561 54051 56092428
Carbohydrate antigen 15-3 increased 68.29 12.84 42 145546 1229 56145250
Alveolitis 68.07 12.84 56 145532 2617 56143862
Illness 67.08 12.84 6 145582 34505 56111974
Bronchitis 65.38 12.84 119 145469 112192 56034287
Adverse event 64.82 12.84 31 145557 55345 56091134
Metastases to kidney 64.69 12.84 23 145565 178 56146301
Pain in extremity 64.59 12.84 477 145111 296954 55849525
Metastases to the mediastinum 63.80 12.84 29 145559 448 56146031
Pneumothorax 63.22 12.84 127 145461 14740 56131739
Bronchostenosis 63.13 12.84 28 145560 407 56146072
Abortion spontaneous 62.10 12.84 18 145570 43735 56102744
Therapeutic product effect incomplete 62.03 12.84 112 145476 105919 56040560
Secondary cerebellar degeneration 61.91 12.84 17 145571 47 56146432
Metastases to retroperitoneum 61.37 12.84 21 145567 143 56146336
Sleep disorder 61.17 12.84 51 145537 67612 56078867
Tumour lysis syndrome 60.75 12.84 88 145500 7835 56138644
Urticaria 60.41 12.84 183 145405 144493 56001986
Superior vena cava syndrome 60.32 12.84 31 145557 635 56145844
Hypertensive crisis 59.80 12.84 120 145468 13916 56132563
Performance status decreased 59.44 12.84 57 145531 3266 56143213
Anxiety 59.40 12.84 277 145311 192895 55953584
Palmar erythema 58.84 12.84 42 145546 1585 56144894
Paronychia 58.72 12.84 68 145520 4850 56141629
Lymphoedema 58.63 12.84 101 145487 10429 56136050
Blood pressure fluctuation 58.40 12.84 16 145572 40344 56106135
COVID-19 58.06 12.84 65 145523 74993 56071486
Colitis 57.95 12.84 238 145350 41573 56104906
Atelectasis 57.42 12.84 143 145445 19165 56127314
Thrombotic microangiopathy 57.37 12.84 94 145494 9317 56137162
Surgery 57.23 12.84 8 145580 32478 56114001
Carbohydrate antigen 125 increased 57.10 12.84 50 145538 2547 56143932
Ear infection 56.82 12.84 7 145581 31288 56115191
Small intestinal perforation 56.70 12.84 38 145550 1293 56145186
Macular oedema 56.66 12.84 59 145529 3735 56142744
Cataract 56.54 12.84 31 145557 51216 56095263
Multiple sclerosis 56.36 12.84 4 145584 27798 56118681
Pulmonary arterial hypertension 56.17 12.84 3 145585 26500 56119979
Urinary tract obstruction 55.70 12.84 43 145545 1832 56144647
Hyperaemia 55.18 12.84 45 145543 2077 56144402
Acute interstitial pneumonitis 54.65 12.84 29 145559 636 56145843
Recurrent cancer 54.47 12.84 42 145546 1786 56144693
Hot flush 54.10 12.84 252 145336 46474 56100005
Unevaluable event 53.85 12.84 28 145560 47659 56098820
Sepsis 53.42 12.84 575 145013 139265 56007214
Infusion related reaction 53.32 12.84 797 144791 208134 55938345
Neoplasm recurrence 53.29 12.84 47 145541 2417 56144062
Coronary artery disease 53.28 12.84 8 145580 30788 56115691
Hepatic lesion 52.77 12.84 60 145528 4195 56142284
Carcinoembryonic antigen increased 52.37 12.84 39 145549 1573 56144906
Gastric disorder 52.30 12.84 11 145577 33199 56113280
Pericardial effusion 52.25 12.84 172 145416 27003 56119476
Type 2 diabetes mellitus 52.20 12.84 28 145560 46834 56099645
Malignant ascites 52.11 12.84 31 145557 853 56145626
Hepatitis B reactivation 51.95 12.84 46 145542 2378 56144101
Adverse drug reaction 51.93 12.84 55 145533 65077 56081402
Pregnancy 51.90 12.84 11 145577 33022 56113457
Nephrolithiasis 51.82 12.84 16 145572 37319 56109160
Hypersensitivity 51.71 12.84 941 144647 255467 55891012
Bile duct stenosis 51.17 12.84 34 145554 1140 56145339
Dizziness 51.05 12.84 676 144912 375464 55771015
Device related infection 50.91 12.84 148 145440 21732 56124747
Drug reaction with eosinophilia and systemic symptoms 49.91 12.84 9 145579 30295 56116184
Wheezing 49.73 12.84 73 145515 74953 56071526
Metastases to chest wall 49.55 12.84 25 145563 492 56145987
Cholangitis sclerosing 49.49 12.84 36 145552 1400 56145079
Nasal congestion 49.11 12.84 44 145544 56326 56090153
Medication error 49.09 12.84 24 145564 42311 56104168
Bone lesion 48.65 12.84 65 145523 5365 56141114
Constipation 48.32 12.84 762 144826 201181 55945298
Hallucination 48.31 12.84 34 145554 49115 56097364
Coma 47.98 12.84 50 145538 59605 56086874
Basal cell carcinoma 47.40 12.84 5 145583 25216 56121263
Eczema asteatotic 47.30 12.84 20 145568 257 56146222
Tumour associated fever 47.30 12.84 20 145568 257 56146222
Hypomagnesaemia 46.91 12.84 157 145431 24858 56121621
Biliary sepsis 46.66 12.84 29 145559 865 56145614
Extravasation 46.53 12.84 41 145547 2106 56144373
Metastases to pelvis 46.50 12.84 22 145566 374 56146105
Drug dependence 46.39 12.84 3 145585 22530 56123949
Irritability 46.19 12.84 10 145578 29578 56116901
Hip arthroplasty 46.16 12.84 21 145567 38602 56107877
Enterocolitis infectious 46.16 12.84 36 145552 1557 56144922
Drug resistance 45.93 12.84 137 145451 20405 56126074
Subclavian vein thrombosis 45.86 12.84 38 145550 1794 56144685
Device related thrombosis 45.76 12.84 36 145552 1577 56144902
Serotonin syndrome 45.56 12.84 7 145581 26483 56119996
Capillary leak syndrome 45.55 12.84 39 145549 1927 56144552
Aortitis 45.42 12.84 30 145558 996 56145483
Toxic erythema of chemotherapy 44.65 12.84 16 145572 127 56146352
Respiratory distress 44.47 12.84 181 145407 31486 56114993
Intestinal obstruction 44.25 12.84 166 145422 27805 56118674
Suffocation feeling 44.23 12.84 32 145556 1234 56145245
Chronic obstructive pulmonary disease 44.10 12.84 50 145538 57365 56089114
Hormone receptor positive breast cancer 43.98 12.84 23 145565 489 56145990
Swollen tongue 43.92 12.84 12 145576 30312 56116167
Malignant peritoneal neoplasm 43.88 12.84 26 145562 710 56145769
Hyperpyrexia 43.82 12.84 48 145540 3220 56143259
Type I hypersensitivity 43.37 12.84 42 145546 2436 56144043
Wrong technique in product usage process 43.23 12.84 52 145536 58116 56088363
Nervousness 42.93 12.84 11 145577 29004 56117475
Dysgeusia 42.57 12.84 214 145374 40701 56105778
Oesophagobronchial fistula 42.50 12.84 12 145576 38 56146441
Road traffic accident 42.47 12.84 10 145578 27917 56118562
Transaminases increased 42.45 12.84 167 145421 28603 56117876
Gait inability 42.34 12.84 28 145560 41790 56104689
Febrile infection 41.80 12.84 32 145556 1346 56145133
Pleural neoplasm 41.65 12.84 20 145568 352 56146127
Periodontitis 41.62 12.84 46 145542 3117 56143362
Stress 41.35 12.84 55 145533 58855 56087624
Endocarditis noninfective 40.94 12.84 12 145576 45 56146434
Joint range of motion decreased 40.78 12.84 8 145580 25357 56121122
Administration site extravasation 40.55 12.84 25 145563 735 56145744
Prescribed overdose 40.45 12.84 5 145583 22291 56124188
Acute myelomonocytic leukaemia 40.39 12.84 16 145572 172 56146307
Rash pruritic 40.18 12.84 46 145542 52548 56093931
Muscle spasticity 40.10 12.84 3 145585 19957 56126522
Metastases to abdominal wall 39.75 12.84 14 145574 105 56146374
Hypoalbuminaemia 39.75 12.84 86 145502 10513 56135966
Disseminated intravascular coagulation 39.72 12.84 119 145469 17766 56128713
Cerebrovascular accident 39.71 12.84 128 145460 99142 56047337
Joint stiffness 39.70 12.84 21 145567 35404 56111075
Lactic acidosis 39.54 12.84 21 145567 35325 56111154
Dyskinesia 39.46 12.84 13 145575 29095 56117384
Inflammation 39.46 12.84 74 145514 68997 56077482
Lymphadenopathy mediastinal 39.42 12.84 41 145547 2592 56143887
Metastases to breast 39.37 12.84 18 145570 282 56146197
Lymphocele 39.28 12.84 25 145563 778 56145701
Adenocarcinoma 39.26 12.84 42 145546 2743 56143736
Immune-mediated enterocolitis 39.17 12.84 31 145557 1370 56145109
Deep vein thrombosis 39.01 12.84 336 145252 76641 56069838
Rhabdomyolysis 38.82 12.84 29 145559 40629 56105850
Psychotic disorder 38.79 12.84 7 145581 23551 56122928
Gastrooesophageal reflux disease 38.67 12.84 100 145488 83157 56063322
Blood uric acid decreased 38.31 12.84 24 145564 726 56145753
Limb injury 38.04 12.84 6 145582 22264 56124215
Product prescribing error 37.94 12.84 7 145581 23179 56123300
Pseudomembranous colitis 37.82 12.84 42 145546 2861 56143618
Ill-defined disorder 37.79 12.84 75 145513 68468 56078011
Hypocalcaemia 37.73 12.84 161 145427 28599 56117880
Myocardial infarction 37.67 12.84 119 145469 92751 56053728
Capillary permeability increased 37.43 12.84 10 145578 24 56146455
Hypervolaemia 37.33 12.84 11 145577 26447 56120032
Peritonitis 37.12 12.84 109 145479 16093 56130386
Amnesia 37.06 12.84 39 145549 46283 56100196
Impaired healing 36.84 12.84 109 145479 86732 56059747
Cachexia 36.60 12.84 54 145534 4888 56141591
Hypersensitivity pneumonitis 36.58 12.84 38 145550 2399 56144080
Metastases to stomach 36.54 12.84 15 145573 178 56146301
Stomatitis 36.50 12.84 475 145113 120335 56026144
Diabetes mellitus 36.24 12.84 50 145538 52685 56093794
Female genital tract fistula 36.07 12.84 51 145537 4441 56142038
Chills 36.02 12.84 415 145173 102189 56044290
Lymphadenopathy 35.82 12.84 183 145405 35025 56111454
Metastases to soft tissue 35.71 12.84 14 145574 146 56146333
Fistula 35.70 12.84 74 145514 8781 56137698
Onychalgia 35.59 12.84 24 145564 825 56145654
Hyperhidrosis 35.50 12.84 386 145202 93702 56052777
Nail dystrophy 35.41 12.84 25 145563 927 56145552
Foot deformity 35.31 12.84 9 145579 23816 56122663
Anastomotic leak 35.11 12.84 19 145569 434 56146045
Eye pain 34.99 12.84 18 145570 30829 56115650
Radiation necrosis 34.93 12.84 18 145570 371 56146108
Mental disorder 34.83 12.84 9 145579 23595 56122884
Herpes zoster 34.60 12.84 92 145496 75797 56070682
Oesophagitis 34.56 12.84 97 145491 13960 56132519
Hypotension 34.51 12.84 870 144718 249638 55896841
Cervix carcinoma 34.41 12.84 40 145548 2865 56143614
Tumour embolism 34.28 12.84 13 145575 123 56146356
International normalised ratio increased 34.21 12.84 38 145550 44003 56102476
Treatment noncompliance 34.18 12.84 21 145567 32602 56113877
Ovarian cancer metastatic 34.04 12.84 24 145564 888 56145591
Renal disorder 34.00 12.84 17 145571 29588 56116891
Crying 33.97 12.84 7 145581 21433 56125046
Therapy interrupted 33.78 12.84 12 145576 25613 56120866
Bradycardia 33.77 12.84 78 145510 67426 56079053
Computerised tomogram thorax 33.76 12.84 15 145573 219 56146260
Night sweats 33.76 12.84 34 145554 41179 56105300
Gallbladder disorder 33.72 12.84 3 145585 17331 56129148
Injection site haemorrhage 33.66 12.84 8 145580 22193 56124286
Acute erythroid leukaemia 33.61 12.84 11 145577 64 56146415
Pruritus 33.39 12.84 597 144991 316026 55830453
Acne 33.29 12.84 7 145581 21129 56125350
Bronchial fistula 33.28 12.84 9 145579 23 56146456
Scleroderma-like reaction 33.19 12.84 11 145577 67 56146412
Dyspnoea at rest 33.18 12.84 45 145543 3768 56142711
Bursitis 32.96 12.84 15 145573 27567 56118912
Dermatitis acneiform 32.94 12.84 48 145540 4296 56142183
Neutropenic colitis 32.87 12.84 38 145550 2705 56143774
Product administration error 32.82 12.84 7 145581 20922 56125557
Congestive cardiomyopathy 32.64 12.84 56 145532 5763 56140716
Radiation skin injury 32.50 12.84 23 145565 856 56145623
Kidney infection 32.36 12.84 7 145581 20718 56125761
Wound dehiscence 32.14 12.84 49 145539 4566 56141913
Blood glucose increased 32.11 12.84 94 145494 75057 56071422
Peritoneal disorder 32.02 12.84 18 145570 444 56146035
Eosinophil percentage increased 31.97 12.84 24 145564 980 56145499
Rectal perforation 31.91 12.84 17 145571 376 56146103
Infusion related hypersensitivity reaction 31.77 12.84 13 145575 153 56146326
Incorrect route of product administration 31.72 12.84 8 145580 21321 56125158
Stress cardiomyopathy 31.68 12.84 68 145520 8268 56138211
Invasive lobular breast carcinoma 31.37 12.84 22 145566 807 56145672
Primary cardiac lymphoma 31.08 12.84 9 145579 32 56146447
No adverse event 30.96 12.84 29 145559 36345 56110134
Vaginal fistula 30.96 12.84 17 145571 400 56146079
Head injury 30.95 12.84 13 145575 25053 56121426
Pulse absent 30.80 12.84 50 145538 4917 56141562
Immune-mediated hepatitis 30.79 12.84 24 145564 1037 56145442
Full blood count abnormal 30.68 12.84 15 145573 26447 56120032
Cardiac cirrhosis 30.46 12.84 12 145576 127 56146352
Neutrophil count abnormal 30.35 12.84 36 145552 2634 56143845
Blood bilirubin increased 30.27 12.84 168 145420 33186 56113293
Choking sensation 30.22 12.84 40 145548 3271 56143208
Tonsillar disorder 30.22 12.84 24 145564 1066 56145413
Loss of consciousness 30.18 12.84 423 145165 108926 56037553
Metastases to bladder 30.01 12.84 13 145575 178 56146301
Disability 29.99 12.84 3 145585 15777 56130702
Nightmare 29.98 12.84 4 145584 16822 56129657
Joint dislocation 29.97 12.84 3 145585 15770 56130709
Metastases to eye 29.96 12.84 12 145576 133 56146346
Pneumonitis chemical 29.81 12.84 13 145575 181 56146298
Panic attack 29.78 12.84 8 145580 20439 56126040
Neuromuscular toxicity 29.57 12.84 12 145576 138 56146341
Oropharyngeal pain 29.51 12.84 114 145474 83674 56062805
Alanine aminotransferase increased 29.45 12.84 371 145217 93291 56053188
Duodenitis haemorrhagic 29.41 12.84 7 145581 8 56146471
Gastrointestinal necrosis 29.18 12.84 35 145553 2591 56143888
Device dislocation 29.10 12.84 11 145577 22595 56123884
Flatulence 29.00 12.84 23 145565 31265 56115214
Eosinophilia 28.97 12.84 8 145580 20069 56126410
Glaucoma 28.86 12.84 5 145583 17324 56129155
Vena cava thrombosis 28.81 12.84 31 145557 2038 56144441
Neoplasm 28.81 12.84 56 145532 6345 56140134
HER2 positive breast cancer 28.74 12.84 16 145572 387 56146092
Tumour pain 28.67 12.84 25 145563 1266 56145213
Mastitis 28.60 12.84 34 145554 2494 56143985
Upper limb fracture 28.46 12.84 5 145583 17150 56129329
Pulmonary tumour thrombotic microangiopathy 28.31 12.84 9 145579 47 56146432
Venous thrombosis 28.26 12.84 46 145542 4534 56141945
Therapeutic response unexpected 28.20 12.84 5 145583 17039 56129440
Metabolic acidosis 28.16 12.84 38 145550 40416 56106063
Aggression 27.84 12.84 11 145577 21995 56124484
Tremor 27.78 12.84 191 145397 120898 56025581
Cough 27.75 12.84 874 144714 259087 55887392
Cytopenia 27.70 12.84 71 145517 9684 56136795
Gastrointestinal fistula 27.67 12.84 16 145572 417 56146062
Guillain-Barre syndrome 27.45 12.84 40 145548 3580 56142899
Skin laceration 27.33 12.84 9 145579 20147 56126332
Cytomegalovirus infection 27.27 12.84 8 145580 19288 56127191
Hypopituitarism 27.15 12.84 22 145566 1006 56145473
Nasal septum perforation 27.14 12.84 19 145569 695 56145784
Porokeratosis 26.99 12.84 11 145577 128 56146351
Musculoskeletal disorder 26.94 12.84 8 145580 19139 56127340
Bone marrow infiltration 26.88 12.84 17 145571 523 56145956
Sinus disorder 26.84 12.84 10 145578 20724 56125755
Prescribed underdose 26.59 12.84 10 145578 20607 56125872
Acute megakaryocytic leukaemia 26.50 12.84 8 145580 34 56146445
Protein urine 26.38 12.84 18 145570 631 56145848
Neck pain 26.29 12.84 77 145511 61478 56085001
Adrenocorticotropic hormone deficiency 26.22 12.84 14 145574 311 56146168
Thyroid dermatopathy 26.14 12.84 7 145581 17 56146462
Enterocolitis 25.91 12.84 57 145531 7047 56139432
Immune-mediated myocarditis 25.90 12.84 11 145577 143 56146336
Pelvic abscess 25.86 12.84 25 145563 1447 56145032
Foot fracture 25.84 12.84 12 145576 21797 56124682
Blood pressure systolic increased 25.83 12.84 41 145547 40795 56105684
Scintillating scotoma 25.77 12.84 11 145577 145 56146334
Laboratory test abnormal 25.73 12.84 16 145572 24679 56121800
Bone erosion 25.65 12.84 4 145584 14970 56131509
Double hit lymphoma 25.62 12.84 6 145582 6 56146473
Fear 25.50 12.84 4 145584 14904 56131575
Mood swings 25.46 12.84 6 145582 16741 56129738
Viral infection 25.44 12.84 27 145561 31919 56114560
Underdose 25.30 12.84 15 145573 23742 56122737
Duodenal perforation 25.22 12.84 19 145569 780 56145699
Vocal cord paralysis 25.20 12.84 28 145560 1909 56144570
Drug level increased 25.19 12.84 11 145577 20714 56125765
Upper respiratory tract infection 25.10 12.84 97 145491 71191 56075288
Cervix carcinoma recurrent 24.97 12.84 8 145580 43 56146436
Chest pain 24.90 12.84 655 144933 189142 55957337
Portal vein thrombosis 24.83 12.84 31 145557 2392 56144087
Carpal tunnel syndrome 24.78 12.84 8 145580 18136 56128343
Impaired work ability 24.72 12.84 4 145584 14568 56131911
Transfusion 24.60 12.84 3 145585 13517 56132962
Osteolysis 24.52 12.84 32 145556 2581 56143898
Tooth erosion 24.48 12.84 15 145573 436 56146043
Acute pulmonary oedema 24.44 12.84 58 145530 7539 56138940
Haemoglobin 24.43 12.84 11 145577 166 56146313
Procedural pain 24.40 12.84 6 145582 16265 56130214
Intestinal metastasis 24.34 12.84 10 145578 119 56146360
Laryngeal discomfort 24.30 12.84 13 145575 290 56146189
Gastroenteritis radiation 24.30 12.84 15 145573 442 56146037
Accidental exposure to product 24.28 12.84 17 145571 24630 56121849
Jugular vein thrombosis 24.27 12.84 33 145555 2770 56143709
Sciatica 24.26 12.84 19 145569 25991 56120488
Infection 24.20 12.84 368 145220 199838 55946641
Device malfunction 24.10 12.84 6 145582 16130 56130349
Oligoastrocytoma 23.93 12.84 7 145581 26 56146453
Embryonal rhabdomyosarcoma 23.90 12.84 6 145582 10 56146469
Hepatotoxicity 23.81 12.84 150 145438 31003 56115476
Colitis ulcerative 23.80 12.84 17 145571 24374 56122105
Adenocarcinoma pancreas 23.79 12.84 21 145567 1081 56145398
Intracranial tumour haemorrhage 23.68 12.84 11 145577 179 56146300
Blast cells present 23.57 12.84 14 145574 384 56146095
Cholangitis infective 23.56 12.84 12 145576 241 56146238
Spinal stenosis 23.43 12.84 4 145584 14010 56132469
Exostosis 23.43 12.84 5 145583 14938 56131541
Eastern Cooperative Oncology Group performance status worsened 23.35 12.84 19 145569 874 56145605
Acute lymphocytic leukaemia 23.29 12.84 32 145556 2712 56143767
Sinus congestion 23.19 12.84 6 145582 15718 56130761
Emphysematous cystitis 23.14 12.84 10 145578 136 56146343
Poisoning 22.94 12.84 3 145585 12810 56133669
Product quality issue 22.92 12.84 29 145559 31707 56114772
Blood potassium increased 22.89 12.84 8 145580 17253 56129226
Lymphopenia 22.86 12.84 95 145493 16679 56129800
Ankle fracture 22.82 12.84 7 145581 16396 56130083
Obesity 22.76 12.84 15 145573 22433 56124046
Right ventricular failure 22.76 12.84 7 145581 16372 56130107
Pelvic pain 22.71 12.84 75 145513 11792 56134687
Hypersomnia 22.68 12.84 7 145581 16334 56130145
Cancer pain 22.65 12.84 33 145555 2953 56143526
Laryngeal necrosis 22.57 12.84 6 145582 14 56146465
Peritoneal fibrosis 22.46 12.84 5 145583 3 56146476
Drug ineffective for unapproved indication 22.44 12.84 20 145568 25673 56120806
Vesical fistula 22.38 12.84 8 145580 63 56146416
Granulocyte count decreased 22.20 12.84 19 145569 938 56145541
Balance disorder 22.17 12.84 112 145476 76408 56070071
Infected lymphocele 22.15 12.84 11 145577 209 56146270
Respiratory failure 22.06 12.84 357 145231 94705 56051774
Angiosarcoma 22.02 12.84 12 145576 278 56146201
Dystonia 22.01 12.84 3 145585 12418 56134061
Organising pneumonia 22.00 12.84 45 145543 5290 56141189
Transient ischaemic attack 21.92 12.84 33 145555 33544 56112935
Cystitis noninfective 21.91 12.84 19 145569 955 56145524
Bladder perforation 21.85 12.84 10 145578 157 56146322
Haemolytic uraemic syndrome 21.84 12.84 29 145559 2379 56144100
Hypermetabolism 21.80 12.84 10 145578 158 56146321
Eye pruritus 21.77 12.84 5 145583 14201 56132278
Accidental overdose 21.67 12.84 13 145575 20448 56126031
Eye disorder 21.66 12.84 13 145575 20439 56126040
Scleroderma 21.60 12.84 43 145545 4958 56141521
Lymphatic disorder 21.59 12.84 13 145575 366 56146113
Macular degeneration 21.50 12.84 11 145577 18897 56127582
Arterioenteric fistula 21.49 12.84 6 145582 18 56146461
Electrocardiogram QT prolonged 21.40 12.84 71 145517 54517 56091962
Joint effusion 21.38 12.84 6 145582 14892 56131587
Retroperitoneal neoplasm metastatic 21.35 12.84 7 145581 41 56146438
Gelastic seizure 21.35 12.84 5 145583 5 56146474
Abnormal behaviour 21.31 12.84 13 145575 20259 56126220
Xerophthalmia 21.21 12.84 14 145574 464 56146015
Metastases to ovary 21.21 12.84 13 145575 378 56146101
Breast cellulitis 21.13 12.84 15 145573 561 56145918
Wrist fracture 21.09 12.84 3 145585 12023 56134456
Pancreatitis 21.04 12.84 54 145534 45026 56101453
Ovarian cancer stage IV 21.03 12.84 11 145577 234 56146245
Enteritis 20.95 12.84 54 145534 7389 56139090
Cerebral ischaemia 20.93 12.84 48 145540 6102 56140377
Seasonal allergy 20.92 12.84 9 145579 17099 56129380
Septic shock 20.87 12.84 245 145343 60590 56085889
Diverticulitis 20.84 12.84 38 145550 35814 56110665
Femur fracture 20.81 12.84 44 145544 39251 56107228
Pulmonary vein stenosis 20.71 12.84 8 145580 80 56146399
Full blood count decreased 20.61 12.84 18 145570 23331 56123148
Ocular hyperaemia 20.57 12.84 16 145572 21963 56124516
Seroma 20.47 12.84 25 145563 1886 56144593
BRAF gene mutation 20.42 12.84 7 145581 48 56146431
Transaminases 20.36 12.84 8 145580 84 56146395
Hepatic vein thrombosis 20.34 12.84 9 145579 130 56146349
Blood iron decreased 20.26 12.84 4 145584 12623 56133856
Lymphangitis 20.25 12.84 17 145571 817 56145662
Blood alkaline phosphatase increased 20.25 12.84 171 145417 38774 56107705
Vessel puncture site bruise 20.19 12.84 13 145575 413 56146066
Splenic artery thrombosis 20.17 12.84 7 145581 50 56146429
Hallucination, visual 20.10 12.84 10 145578 17458 56129021
Type 1 lepra reaction 20.04 12.84 5 145583 8 56146471
Abdominal infection 20.01 12.84 24 145564 1777 56144702
Pulmonary toxicity 19.97 12.84 55 145533 7828 56138651
Enterocutaneous fistula 19.88 12.84 20 145568 1215 56145264
Sopor 19.87 12.84 15 145573 20907 56125572
Bacterial parotitis 19.84 12.84 4 145584 0 56146479
Venous thrombosis limb 19.81 12.84 30 145558 2779 56143700
Brachiocephalic vein thrombosis 19.71 12.84 8 145580 92 56146387
Tumour ulceration 19.69 12.84 9 145579 141 56146338
Emotional disorder 19.51 12.84 4 145584 12291 56134188
Retroperitoneal lymphadenopathy 19.51 12.84 14 145574 533 56145946
Radiation oesophagitis 19.47 12.84 11 145577 274 56146205
TP53 gene mutation 19.43 12.84 6 145582 28 56146451
Pneumonia 19.40 12.84 858 144730 406240 55740239
Respiratory tract congestion 19.39 12.84 8 145580 15583 56130896
Immune-mediated hepatic disorder 19.33 12.84 11 145577 278 56146201
Respiratory depth decreased 19.25 12.84 6 145582 29 56146450
Duodenal obstruction 19.23 12.84 10 145578 210 56146269
Poor quality sleep 19.21 12.84 11 145577 17744 56128735
Intestinal ischaemia 19.11 12.84 50 145538 6905 56139574
Dermatomyositis 19.10 12.84 29 145559 2693 56143786
Neuroendocrine breast tumour 19.09 12.84 6 145582 30 56146449
Rash 19.06 12.84 1062 144526 491985 55654494
Delirium 19.03 12.84 52 145536 42465 56104014
Blood glucose decreased 19.02 12.84 13 145575 19074 56127405
Influenza like illness 18.99 12.84 87 145501 60901 56085578
Breast ulceration 18.96 12.84 7 145581 61 56146418
Device issue 18.96 12.84 16 145572 21090 56125389
Eye irritation 18.91 12.84 13 145575 19015 56127464
Pelvic infection 18.91 12.84 11 145577 290 56146189
Metastases to thorax 18.90 12.84 10 145578 218 56146261
Erythema multiforme 18.84 12.84 61 145527 9493 56136986
Emotional distress 18.72 12.84 30 145558 29733 56116746
Endometrial cancer recurrent 18.71 12.84 5 145583 12 56146467
Post procedural fistula 18.65 12.84 10 145578 224 56146255
Ear pain 18.62 12.84 32 145556 30858 56115621
Cholangitis acute 18.61 12.84 13 145575 474 56146005
Myoclonus 18.59 12.84 8 145580 15195 56131284
Electrolyte imbalance 18.53 12.84 94 145494 17939 56128540
Hydrothorax 18.52 12.84 16 145572 800 56145679
Clonal haematopoiesis 18.43 12.84 5 145583 13 56146466
Ovarian clear cell carcinoma 18.43 12.84 5 145583 13 56146466
Laryngeal cancer stage III 18.43 12.84 5 145583 13 56146466
Cardiovascular disorder 18.38 12.84 66 145522 10823 56135656
Metastases to pancreas 18.38 12.84 10 145578 231 56146248
Abdominal lymphadenopathy 18.34 12.84 15 145573 695 56145784
Fungal infection 18.27 12.84 36 145552 32957 56113522
Eye swelling 18.24 12.84 17 145571 21359 56125120
Aorto-oesophageal fistula 18.16 12.84 5 145583 14 56146465
Breast neoplasm 18.09 12.84 20 145568 1356 56145123
Metastases to adrenals 18.09 12.84 15 145573 709 56145770
Dementia 18.04 12.84 11 145577 17147 56129332
Aplasia 18.03 12.84 35 145553 3961 56142518
Ovarian epithelial cancer 18.00 12.84 11 145577 318 56146161
Blood pressure diastolic abnormal 17.94 12.84 4 145584 11594 56134885
Thrombophlebitis migrans 17.87 12.84 8 145580 119 56146360
Neutropenic infection 17.85 12.84 18 145570 1097 56145382
Cancer fatigue 17.77 12.84 7 145581 74 56146405
Angiodermatitis 17.77 12.84 7 145581 74 56146405
Glomerular vascular disorder 17.77 12.84 6 145582 39 56146440
Gastroenteritis viral 17.72 12.84 16 145572 20408 56126071
Cranial nerve disorder 17.70 12.84 13 145575 513 56145966
Vaginal perforation 17.67 12.84 5 145583 16 56146463
Liver scan abnormal 17.64 12.84 6 145582 40 56146439
Therapy cessation 17.60 12.84 27 145561 27237 56119242
Blood pressure immeasurable 17.58 12.84 18 145570 1117 56145362
Blood magnesium decreased 17.57 12.84 69 145519 11805 56134674
Hyponatraemia 17.54 12.84 366 145222 101773 56044706
Acute monocytic leukaemia 17.52 12.84 8 145580 125 56146354
Cardiac murmur 17.50 12.84 4 145584 11397 56135082
Gastric perforation 17.48 12.84 21 145567 1557 56144922
Live birth 17.44 12.84 15 145573 19590 56126889
Vulvovaginal inflammation 17.40 12.84 15 145573 748 56145731
Gout 17.39 12.84 5 145583 12216 56134263
Acquired gene mutation 17.37 12.84 16 145572 871 56145608
Endometrial cancer metastatic 17.29 12.84 8 145580 129 56146350
Photophobia 17.28 12.84 10 145578 16040 56130439
Intestinal prolapse 17.24 12.84 8 145580 130 56146349
Blood creatinine decreased 17.23 12.84 40 145548 5126 56141353
Mediastinitis 17.14 12.84 9 145579 193 56146286
Nail ridging 17.09 12.84 11 145577 349 56146130
Breast sarcoma 17.08 12.84 4 145584 4 56146475
Tumour cavitation 17.08 12.84 4 145584 4 56146475
Aortic dissection rupture 17.08 12.84 4 145584 4 56146475
Maternal death affecting foetus 17.08 12.84 4 145584 4 56146475
Sensory disturbance 17.06 12.84 71 145517 12472 56134007
Lymphatic obstruction 17.01 12.84 5 145583 19 56146460
Metastases to muscle 16.96 12.84 8 145580 135 56146344
Anaemia of malignant disease 16.90 12.84 12 145576 449 56146030
Mediastinal disorder 16.87 12.84 11 145577 357 56146122
Tumour invasion 16.86 12.84 8 145580 137 56146342
Uterine atrophy 16.81 12.84 6 145582 47 56146432
Pancreatic failure 16.80 12.84 16 145572 909 56145570
Exposed bone in jaw 16.76 12.84 28 145560 2820 56143659
Oesophageal varices haemorrhage 16.75 12.84 17 145571 1044 56145435
Carbohydrate antigen 19-9 increased 16.69 12.84 9 145579 204 56146275
Ovarian failure 16.68 12.84 18 145570 1187 56145292
Subdural haematoma 16.67 12.84 7 145581 13492 56132987
Gingival bleeding 16.63 12.84 67 145521 11599 56134880
Nail avulsion 16.60 12.84 8 145580 142 56146337
Myeloproliferative neoplasm 16.56 12.84 12 145576 464 56146015
Endometrial adenocarcinoma 16.52 12.84 18 145570 1200 56145279
Toxic neuropathy 16.50 12.84 11 145577 371 56146108
Laryngeal oedema 16.50 12.84 40 145548 5270 56141209
Tongue disorder 16.49 12.84 3 145585 10033 56136446
Median nerve injury 16.43 12.84 5 145583 22 56146457
Mood altered 16.37 12.84 7 145581 13348 56133131
Restless legs syndrome 16.29 12.84 12 145576 16935 56129544
Weight decreased 16.28 12.84 486 145102 240228 55906251
Tumour fistulisation 16.25 12.84 5 145583 23 56146456
Distal intestinal obstruction syndrome 16.24 12.84 11 145577 381 56146098
Bronchopleural fistula 16.23 12.84 9 145579 216 56146263
Angioedema 16.19 12.84 54 145534 41399 56105080
Product storage error 16.08 12.84 7 145581 13206 56133273
Lupus-like syndrome 16.07 12.84 6 145582 12421 56134058
Thyroiditis 16.04 12.84 23 145565 2029 56144450
Labelled drug-drug interaction medication error 16.01 12.84 5 145583 11581 56134898
Thyroid disorder 16.01 12.84 8 145580 13930 56132549
Immediate post-injection reaction 15.99 12.84 11 145577 391 56146088
Localised infection 15.98 12.84 29 145559 27383 56119096
Immune-mediated pancreatitis 15.95 12.84 7 145581 99 56146380
Keratitis 15.92 12.84 28 145560 2939 56143540
Aspartate aminotransferase increased 15.86 12.84 301 145287 82301 56064178
Vaginal cuff dehiscence 15.81 12.84 4 145584 7 56146472
Ileal perforation 15.77 12.84 11 145577 400 56146079
Pulmonary artery stenosis 15.74 12.84 8 145580 160 56146319
Urosepsis 15.70 12.84 85 145503 16631 56129848
Cholecystectomy 15.68 12.84 3 145585 9681 56136798
Gene mutation 15.59 12.84 19 145569 1430 56145049
Artificial menopause 15.59 12.84 5 145583 27 56146452
Cardiac pseudoaneurysm 15.59 12.84 5 145583 27 56146452
Lividity 15.55 12.84 9 145579 235 56146244
Application site recall reaction 15.47 12.84 4 145584 8 56146471
Blood lactate dehydrogenase increased 15.46 12.84 99 145489 20576 56125903
Embolism venous 15.44 12.84 27 145561 2821 56143658
Myeloid leukaemia 15.44 12.84 10 145578 321 56146158
Ototoxicity 15.42 12.84 17 145571 1149 56145330
Chemotherapy 15.32 12.84 19 145569 1456 56145023
Carcinoid tumour pulmonary 15.30 12.84 11 145577 420 56146059
Mucosal dryness 15.29 12.84 25 145563 2473 56144006
Biliary obstruction 15.27 12.84 25 145563 2476 56144003
Sputum discoloured 15.25 12.84 9 145579 14283 56132196
Speech disorder 15.22 12.84 48 145540 37445 56109034
Hiatus hernia 15.21 12.84 17 145571 19635 56126844
Orbital myositis 15.15 12.84 5 145583 30 56146449
Onychomadesis 15.14 12.84 36 145552 4685 56141794
Faeces discoloured 15.12 12.84 13 145575 16983 56129496
Glycosylated haemoglobin increased 15.11 12.84 5 145583 11160 56135319
BRCA2 gene mutation 15.10 12.84 6 145582 65 56146414
Pain in jaw 15.06 12.84 53 145535 39983 56106496
Cholelithiasis 15.01 12.84 52 145536 39412 56107067
Product supply issue 15.01 12.84 19 145569 1487 56144992
Gamma-glutamyltransferase increased 15.00 12.84 134 145454 30871 56115608
Ovarian cyst 14.98 12.84 10 145578 14856 56131623
Nail pigmentation 14.89 12.84 8 145580 180 56146299
Granulocyte count 14.88 12.84 3 145585 0 56146479
Porocarcinoma 14.88 12.84 3 145585 0 56146479
Ankyloglossia acquired 14.88 12.84 3 145585 0 56146479
Myiasis 14.88 12.84 3 145585 0 56146479
Therapeutic response decreased 14.84 12.84 78 145510 52680 56093799
Tuberculosis 14.82 12.84 5 145583 11024 56135455
Limb discomfort 14.78 12.84 29 145559 26593 56119886
Hyperbilirubinaemia 14.76 12.84 59 145529 10176 56136303
Pulmonary congestion 14.74 12.84 12 145576 16103 56130376
Nasal disorder 14.68 12.84 25 145563 2557 56143922
Affect lability 14.67 12.84 4 145584 10121 56136358
Obstructive shock 14.62 12.84 5 145583 34 56146445
Ovarian endometrioid carcinoma 14.62 12.84 5 145583 34 56146445
Anger 14.50 12.84 6 145582 11666 56134813
Scar 14.49 12.84 7 145581 12426 56134053
Hypothalamo-pituitary disorder 14.44 12.84 13 145575 687 56145792
Cardiac failure congestive 14.42 12.84 151 145437 87569 56058910
Ureteric stenosis 14.42 12.84 12 145576 570 56145909
Bone marrow disorder 14.41 12.84 22 145566 2052 56144427
Bacterial diarrhoea 14.41 12.84 6 145582 74 56146405
Lung infiltration 14.39 12.84 72 145516 13666 56132813
Hepatic cancer metastatic 14.38 12.84 10 145578 362 56146117
Polymicrogyria 14.34 12.84 6 145582 75 56146404
Extrapyramidal disorder 14.33 12.84 7 145581 12349 56134130
Toxic cardiomyopathy 14.29 12.84 7 145581 129 56146350
Thinking abnormal 14.27 12.84 4 145584 9937 56136542
Productive cough 14.26 12.84 86 145502 56146 56090333
Lichenoid keratosis 14.23 12.84 18 145570 1407 56145072
Transaminases abnormal 14.22 12.84 12 145576 581 56145898
Anhedonia 14.21 12.84 4 145584 9910 56136569
Clonal evolution 14.20 12.84 6 145582 77 56146402
Status epilepticus 14.20 12.84 11 145577 15130 56131349
Hernia 14.17 12.84 5 145583 10718 56135761
Hypercalcaemia of malignancy 14.10 12.84 8 145580 201 56146278
Oesophageal squamous cell carcinoma 14.10 12.84 7 145581 133 56146346
Seizure 14.09 12.84 233 145355 124886 56021593
Peritoneal lesion 14.09 12.84 4 145584 13 56146466
Mechanical ileus 14.07 12.84 10 145578 375 56146104
Panniculitis 14.05 12.84 4 145584 9838 56136641
Pulpitis dental 13.98 12.84 14 145574 846 56145633
Dysuria 13.95 12.84 131 145457 30598 56115881
Failure to thrive 13.92 12.84 43 145545 6527 56139952
Cannabinoid hyperemesis syndrome 13.92 12.84 5 145583 40 56146439
Rotator cuff syndrome 13.90 12.84 7 145581 12136 56134343
Meibomian gland dysfunction 13.86 12.84 7 145581 138 56146341
Cholecystitis chronic 13.85 12.84 4 145584 9744 56136735
Liver function test abnormal 13.71 12.84 66 145522 45605 56100874
Cystitis haemorrhagic 13.70 12.84 31 145557 3906 56142573
Nail infection 13.67 12.84 23 145565 2330 56144149
Delusion 13.55 12.84 6 145582 11209 56135270
Carbohydrate antigen 15-3 13.48 12.84 6 145582 88 56146391
Hypergeusia 13.44 12.84 4 145584 16 56146463
Uterine adhesions 13.40 12.84 5 145583 45 56146434
Movement disorder 13.39 12.84 18 145570 19180 56127299
Cardiac disorder 13.38 12.84 67 145521 45820 56100659
Morphoea 13.36 12.84 9 145579 309 56146170
Extremity necrosis 13.34 12.84 18 145570 1500 56144979
Hyperphosphataemia 13.32 12.84 21 145567 2014 56144465
Aortic dissection 13.32 12.84 20 145568 1839 56144640
Pharyngitis streptococcal 13.31 12.84 4 145584 9494 56136985
Metastatic gastric cancer 13.30 12.84 7 145581 151 56146328
Hyperferritinaemia 13.25 12.84 7 145581 152 56146327
Metastases to vagina 13.25 12.84 4 145584 17 56146462
Carcinoembryonic antigen 13.24 12.84 6 145582 92 56146387
Dandy-Walker syndrome 13.24 12.84 6 145582 92 56146387
Anal sphincter atony 13.23 12.84 8 145580 227 56146252
Systolic dysfunction 13.23 12.84 18 145570 1512 56144967
Deformity 13.18 12.84 5 145583 10250 56136229
Upper-airway cough syndrome 13.18 12.84 4 145584 9434 56137045
Blood pressure diastolic increased 13.15 12.84 3 145585 8558 56137921
Opsoclonus myoclonus 13.13 12.84 7 145581 155 56146324
Cognitive disorder 13.07 12.84 74 145514 49059 56097420
Foetal malnutrition 13.07 12.84 6 145582 95 56146384
Torsade de pointes 13.04 12.84 8 145580 12432 56134047
Respiratory depression 13.03 12.84 8 145580 12427 56134052
Impaired quality of life 12.95 12.84 3 145585 8471 56138008
Ulcer 12.92 12.84 24 145564 22461 56124018
Empyema 12.90 12.84 20 145568 1891 56144588
Peritoneal fluid analysis abnormal 12.89 12.84 4 145584 19 56146460
Transformation to acute myeloid leukaemia 12.89 12.84 8 145580 238 56146241
Walking aid user 12.88 12.84 3 145585 8440 56138039
Dermatitis 12.87 12.84 75 145513 15082 56131397
Lymphorrhoea 12.85 12.84 5 145583 51 56146428
Hereditary motor and sensory neuropathy 12.84 12.84 6 145582 99 56146380

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 693.15 15.65 723 47912 78275 31570434
Febrile neutropenia 599.89 15.65 831 47804 121018 31527691
Neutropenia 585.74 15.65 885 47750 139479 31509230
Interstitial lung disease 394.03 15.65 478 48157 60925 31587784
Pancreatic carcinoma metastatic 369.66 15.65 147 48488 2797 31645912
Neuropathy peripheral 359.60 15.65 508 48127 75141 31573568
Pancreatic carcinoma 314.35 15.65 184 48451 8416 31640293
Disease progression 308.43 15.65 521 48114 89943 31558766
Neutrophil count decreased 265.15 15.65 341 48294 46053 31602656
Leukopenia 257.98 15.65 377 48258 57451 31591258
Anaemia 255.07 15.65 812 47823 212710 31435999
Thrombocytopenia 243.73 15.65 618 48017 142129 31506580
Pneumonitis 240.69 15.65 265 48370 30387 31618322
Non-small cell lung cancer 228.26 15.65 116 48519 3993 31644716
Alopecia 200.11 15.65 200 48435 20495 31628214
Death 177.31 15.65 1048 47587 359521 31289188
Myelosuppression 176.13 15.65 161 48474 14759 31633950
Cholangitis 168.46 15.65 121 48514 7865 31640844
Radiation pneumonitis 144.55 15.65 72 48563 2372 31646337
Mucosal inflammation 144.13 15.65 218 48417 34209 31614500
Cystoid macular oedema 135.15 15.65 48 48587 657 31648052
Product dose omission issue 130.19 15.65 8 48627 105578 31543131
Completed suicide 122.37 15.65 4 48631 91510 31557199
Metastases to central nervous system 119.82 15.65 97 48538 7539 31641170
Bone marrow failure 118.13 15.65 178 48457 27830 31620879
Haemoptysis 114.23 15.65 189 48446 32000 31616709
Neoplasm progression 114.11 15.65 148 48487 20124 31628585
Haematotoxicity 108.49 15.65 89 48546 7048 31641661
Flushing 107.04 15.65 177 48458 29951 31618758
Polyneuropathy 104.60 15.65 114 48521 12908 31635801
General physical health deterioration 104.10 15.65 396 48239 113039 31535670
Peripheral sensory neuropathy 102.87 15.65 82 48553 6233 31642476
Overdose 97.03 15.65 9 48626 84655 31564054
Immune-mediated hepatitis 96.01 15.65 49 48586 1701 31647008
Neurotoxicity 93.72 15.65 120 48515 16106 31632603
Pyrexia 89.20 15.65 781 47854 303059 31345650
Radiation oesophagitis 88.59 15.65 31 48604 405 31648304
Pneumothorax 88.29 15.65 119 48516 16791 31631918
Depression 84.66 15.65 18 48617 90797 31557912
Fall 84.17 15.65 97 48538 185992 31462717
White blood cell count decreased 82.52 15.65 308 48327 87090 31561619
Therapy partial responder 81.73 15.65 73 48562 6489 31642220
Immune-mediated lung disease 81.26 15.65 38 48597 1086 31647623
Dehydration 80.59 15.65 379 48256 118732 31529977
Biliary tract infection 78.70 15.65 31 48604 574 31648135
Decreased appetite 78.40 15.65 451 48184 152766 31495943
Plasma cell myeloma 73.72 15.65 3 48632 56528 31592181
Thrombotic microangiopathy 71.87 15.65 80 48555 9271 31639438
Drug ineffective 71.84 15.65 338 48297 395235 31253474
Drug interaction 71.46 15.65 132 48503 208411 31440298
Erythema 70.66 15.65 277 48358 80128 31568581
Anaphylactic shock 69.99 15.65 97 48538 14048 31634661
Pancytopenia 69.73 15.65 292 48343 87024 31561685
Sepsis 68.65 15.65 433 48202 151496 31497213
Headache 67.68 15.65 111 48524 183541 31465168
Metastases to liver 67.10 15.65 90 48545 12637 31636072
Anxiety 66.81 15.65 28 48607 91005 31557704
Metastases to lung 66.36 15.65 73 48562 8349 31640360
Liver abscess 64.10 15.65 49 48586 3502 31645207
Infusion related reaction 63.72 15.65 190 48445 47865 31600844
Gastrointestinal perforation 63.12 15.65 49 48586 3583 31645126
Dyspnoea 62.54 15.65 802 47833 342677 31306032
Platelet count decreased 61.02 15.65 332 48303 110103 31538606
Tumour haemorrhage 60.47 15.65 42 48593 2586 31646123
Nasopharyngitis 60.03 15.65 12 48623 63233 31585476
Pneumonia 58.96 15.65 778 47857 334534 31314175
Pulmonary toxicity 57.61 15.65 55 48580 5322 31643387
Colitis 56.83 15.65 146 48489 33741 31614968
Toxicity to various agents 56.04 15.65 122 48513 181365 31467344
Joint swelling 55.42 15.65 8 48627 53423 31595286
Adrenal insufficiency 54.13 15.65 81 48554 12578 31636131
Insomnia 53.97 15.65 40 48595 94796 31553913
Immune-mediated enterocolitis 52.93 15.65 36 48599 2142 31646567
Hypersensitivity 52.19 15.65 196 48439 55547 31593162
Kounis syndrome 51.96 15.65 35 48600 2049 31646660
Onycholysis 51.04 15.65 23 48612 602 31648107
Nausea 48.97 15.65 702 47933 307245 31341464
Weight increased 48.48 15.65 34 48601 82913 31565796
Rheumatoid arthritis 47.67 15.65 8 48627 47801 31600908
Coronary artery disease 47.57 15.65 7 48628 46080 31602629
Cardiac failure congestive 47.12 15.65 32 48603 79355 31569354
Diarrhoea 45.99 15.65 777 47858 351632 31297077
Somnolence 45.80 15.65 51 48584 99394 31549315
Vomiting 45.40 15.65 534 48101 223439 31425270
Metastases to meninges 45.37 15.65 27 48608 1272 31647437
Suicidal ideation 44.12 15.65 3 48632 36403 31612306
Psoriasis 44.05 15.65 9 48626 46710 31601999
Tremor 43.78 15.65 32 48603 76388 31572321
Pneumatosis intestinalis 43.69 15.65 40 48595 3671 31645038
Electrocardiogram QT prolonged 43.60 15.65 4 48631 37983 31610726
Intentional product misuse 43.55 15.65 4 48631 37947 31610762
Stomatitis 43.18 15.65 146 48489 39292 31609417
Aggression 42.61 15.65 4 48631 37287 31611422
Injection site pain 41.54 15.65 3 48632 34631 31614078
Bronchial fistula 41.32 15.65 14 48621 165 31648544
Bradycardia 41.06 15.65 28 48607 69299 31579410
Tracheal fistula 40.83 15.65 12 48623 85 31648624
Pulmonary radiation injury 40.67 15.65 11 48624 55 31648654
Pancreatic enzyme abnormality 40.67 15.65 11 48624 55 31648654
Hospitalisation 40.44 15.65 13 48622 49794 31598915
Cardiac disorder 40.37 15.65 6 48629 39208 31609501
Pleural effusion 39.84 15.65 223 48412 74697 31574012
Neutropenic sepsis 39.03 15.65 69 48566 12310 31636399
Metastases to bone 38.86 15.65 64 48571 10784 31637925
Scleroderma-like reaction 38.78 15.65 10 48625 40 31648669
Arthralgia 38.76 15.65 112 48523 151312 31497397
Hypoglycaemia 38.45 15.65 15 48620 50931 31597778
Performance status decreased 38.42 15.65 38 48597 3840 31644869
Tracheo-oesophageal fistula 38.41 15.65 17 48618 426 31648283
Prostate cancer 38.14 15.65 6 48629 37595 31611114
Embolism 37.78 15.65 51 48584 7202 31641507
Musculoskeletal stiffness 36.87 15.65 9 48626 41316 31607393
Immune-mediated hepatic disorder 36.70 15.65 18 48617 573 31648136
Oesophagitis 36.33 15.65 67 48568 12349 31636360
Immune-mediated dermatitis 36.27 15.65 13 48622 183 31648526
Skin toxicity 36.19 15.65 38 48597 4121 31644588
Hallucination 36.14 15.65 13 48622 46397 31602312
Enterocolitis infectious 35.46 15.65 24 48611 1416 31647293
Right ventricular ejection fraction decreased 34.90 15.65 9 48626 36 31648673
Agitation 34.67 15.65 20 48615 54149 31594560
Enterocolitis 34.67 15.65 49 48586 7225 31641484
Septic shock 34.56 15.65 196 48439 65962 31582747
Therapeutic product effect decreased 34.56 15.65 4 48631 31618 31617091
Recall phenomenon 34.49 15.65 17 48618 547 31648162
Hypertransaminasaemia 33.37 15.65 37 48598 4267 31644442
Pulmonary embolism 33.32 15.65 227 48408 81419 31567290
Blood glucose increased 33.17 15.65 27 48608 61056 31587653
Asthma 33.07 15.65 12 48623 42599 31606110
Gastritis bacterial 31.96 15.65 12 48623 194 31648515
Teratoma benign 31.86 15.65 8 48627 28 31648681
Gastrointestinal toxicity 31.74 15.65 27 48608 2247 31646462
Dysphagia 31.54 15.65 173 48462 57503 31591206
Tidal volume decreased 31.02 15.65 8 48627 32 31648677
Memory impairment 30.86 15.65 10 48625 38120 31610589
Oxygen saturation decreased 30.77 15.65 153 48482 48962 31599747
Intestinal perforation 30.74 15.65 50 48585 8339 31640370
Brain teratoma 30.70 15.65 7 48628 14 31648695
Bronchospasm 30.69 15.65 55 48580 9917 31638792
Angioedema 30.62 15.65 7 48628 33611 31615098
Adrenocorticotropic hormone deficiency 30.40 15.65 17 48618 711 31647998
Blood pressure increased 30.34 15.65 47 48588 79586 31569123
Confusional state 30.32 15.65 104 48531 133230 31515479
Condition aggravated 30.28 15.65 139 48496 163870 31484839
Metastases to peritoneum 30.16 15.65 23 48612 1637 31647072
Haemolytic uraemic syndrome 29.72 15.65 25 48610 2049 31646660
Coma 29.62 15.65 13 48622 41137 31607572
Ductal adenocarcinoma of pancreas 29.41 15.65 8 48627 41 31648668
Metastatic gastric cancer 29.34 15.65 11 48624 177 31648532
Nail dystrophy 29.17 15.65 11 48624 180 31648529
Disseminated intravascular coagulation 28.92 15.65 83 48552 20454 31628255
Dizziness 28.90 15.65 183 48452 198964 31449745
Unmasking of previously unidentified disease 28.64 15.65 17 48618 797 31647912
Pulmonary hypoplasia 28.59 15.65 14 48621 444 31648265
Anaphylactic reaction 28.55 15.65 105 48530 29448 31619261
International normalised ratio increased 28.51 15.65 17 48618 45206 31603503
Wrong technique in product usage process 28.34 15.65 8 48627 33335 31615374
Feeling abnormal 27.61 15.65 28 48607 56974 31591735
Myocardial infarction 27.52 15.65 86 48549 113368 31535341
Fluid retention 27.45 15.65 3 48632 24799 31623910
Periarticular thenar erythema with onycholysis 27.41 15.65 5 48630 0 31648709
Tumour necrosis 27.38 15.65 19 48616 1168 31647541
Lung adenocarcinoma 27.34 15.65 34 48601 4428 31644281
Oesophagopleural fistula 27.30 15.65 8 48627 56 31648653
Off label use 26.97 15.65 710 47925 346564 31302145
Muscle spasms 26.33 15.65 40 48595 68278 31580431
Hypoxia 26.23 15.65 149 48486 50164 31598545
Macular oedema 26.16 15.65 26 48609 2642 31646067
Influenza 26.11 15.65 18 48617 44307 31604402
Abnormal behaviour 26.07 15.65 3 48632 23825 31624884
Discontinued product administered 25.99 15.65 6 48629 13 31648696
Neutropenic colitis 25.97 15.65 26 48609 2666 31646043
Peripheral swelling 25.90 15.65 40 48595 67825 31580884
Heart rate decreased 25.52 15.65 6 48629 28260 31620449
Acute respiratory distress syndrome 25.24 15.65 89 48546 24451 31624258
Cytomegalovirus infection 24.93 15.65 4 48631 24703 31624006
Urticaria 24.85 15.65 31 48604 57486 31591223
Eastern Cooperative Oncology Group performance status worsened 24.81 15.65 16 48619 870 31647839
Dermatitis acneiform 24.79 15.65 37 48598 5730 31642979
Irritability 24.75 15.65 3 48632 22886 31625823
Inappropriate schedule of product administration 24.57 15.65 25 48610 50798 31597911
Lung abscess 24.25 15.65 24 48611 2427 31646282
Erythema multiforme 24.18 15.65 44 48591 8027 31640682
Pneumoperitoneum 23.95 15.65 20 48615 1623 31647086
Taeniasis 23.53 15.65 7 48628 52 31648657
Infectious pleural effusion 23.52 15.65 22 48613 2075 31646634
Oligohydramnios 23.12 15.65 11 48624 327 31648382
Pancreatic carcinoma recurrent 23.07 15.65 7 48628 56 31648653
Ileus 23.02 15.65 63 48572 15106 31633603
Chronic kidney disease 22.93 15.65 15 48620 37960 31610749
Lymphangiosis carcinomatosa 22.88 15.65 15 48620 839 31647870
Lung squamous cell carcinoma metastatic 22.86 15.65 7 48628 58 31648651
Stress cardiomyopathy 22.46 15.65 20 48615 1770 31646939
Feeling hot 22.27 15.65 65 48570 16168 31632541
Metastases to lymph nodes 22.21 15.65 30 48605 4238 31644471
Aortic injury 21.93 15.65 5 48630 10 31648699
Loss of personal independence in daily activities 21.89 15.65 8 48627 28280 31620429
Disturbance in attention 21.84 15.65 4 48631 22446 31626263
Sinusitis 21.48 15.65 15 48620 36681 31612028
Sense of oppression 21.33 15.65 12 48623 508 31648201
Non-small cell lung cancer stage IV 20.89 15.65 9 48626 211 31648498
Metabolic acidosis 20.86 15.65 18 48617 39559 31609150
Second primary malignancy 20.64 15.65 38 48597 6994 31641715
Radiation skin injury 20.56 15.65 13 48622 683 31648026
Metastases to skin 20.52 15.65 11 48624 423 31648286
Tumour pseudoprogression 20.52 15.65 11 48624 423 31648286
Lactic acidosis 20.13 15.65 12 48623 31925 31616784
Proteinuria 20.08 15.65 64 48571 16699 31632010
Seizure 19.94 15.65 82 48553 99686 31549023
Blood creatine phosphokinase increased 19.89 15.65 21 48614 41953 31606756
Pain 19.84 15.65 187 48448 186572 31462137
Cataract 19.70 15.65 6 48629 23801 31624908
Pulmonary artery occlusion 19.69 15.65 4 48631 3 31648706
Oesophagobronchial fistula 19.56 15.65 8 48627 164 31648545
Gastric perforation 19.54 15.65 21 48614 2338 31646371
Cachexia 19.49 15.65 36 48599 6643 31642066
Rhabdomyolysis 19.36 15.65 43 48592 63538 31585171
Subdural haematoma 19.30 15.65 3 48632 18968 31629741
Hyperkalaemia 19.20 15.65 44 48591 64307 31584402
Abdominal discomfort 19.10 15.65 31 48604 51536 31597173
Lung disorder 19.07 15.65 99 48536 32213 31616496
Adenocarcinoma pancreas 19.06 15.65 16 48619 1308 31647401
Nasal congestion 19.05 15.65 4 48631 20377 31628332
Eosinophilia 18.99 15.65 6 48629 23247 31625462
Paronychia 18.89 15.65 24 48611 3194 31645515
Herpes zoster 18.83 15.65 13 48622 31980 31616729
Hypopituitarism 18.70 15.65 19 48616 1982 31646727
Lymphopenia 18.36 15.65 56 48579 14273 31634436
Miller Fisher syndrome 18.33 15.65 6 48629 63 31648646
Transient ischaemic attack 18.28 15.65 7 48628 24049 31624660
Abdominal pain 18.26 15.65 320 48315 145632 31503077
Hepatic function abnormal 18.25 15.65 117 48518 41105 31607604
Pulmonary cavitation 18.13 15.65 13 48622 842 31647867
Metastases to kidney 18.08 15.65 9 48626 296 31648413
Pneumonia bacterial 17.91 15.65 45 48590 10251 31638458
Pericardial effusion 17.87 15.65 75 48560 22348 31626361
Pain in extremity 17.76 15.65 105 48530 116098 31532611
Arthritis 17.67 15.65 10 48625 27375 31621334
Hiccups 17.66 15.65 42 48593 9245 31639464
Immune-mediated pancreatitis 17.61 15.65 6 48629 72 31648637
Product use issue 17.60 15.65 38 48597 56721 31591988
Tumour marker increased 17.59 15.65 11 48624 567 31648142
Contusion 17.43 15.65 15 48620 33013 31615696
Balance disorder 17.42 15.65 19 48616 37403 31611306
Upper respiratory tract infection 17.26 15.65 12 48623 29410 31619299
Vascular pseudoaneurysm ruptured 17.17 15.65 6 48629 78 31648631
Treatment noncompliance 17.13 15.65 9 48626 25675 31623034
Hypophagia 17.00 15.65 73 48562 21969 31626740
Rhinorrhoea 16.99 15.65 7 48628 23005 31625704
Blood thyroid stimulating hormone abnormal 16.88 15.65 9 48626 342 31648367
Supraventricular tachycardia 16.85 15.65 44 48591 10263 31638446
Multiple-drug resistance 16.82 15.65 27 48608 4453 31644256
Metastases to the mediastinum 16.81 15.65 8 48627 238 31648471
Portal venous gas 16.79 15.65 9 48626 346 31648363
Immune-mediated nephritis 16.75 15.65 8 48627 240 31648469
Sleep apnoea syndrome 16.72 15.65 4 48631 18621 31630088
Hypothyroidism 16.69 15.65 63 48572 17884 31630825
Coronary artery aneurysm 16.64 15.65 6 48629 86 31648623
Upper gastrointestinal perforation 16.44 15.65 3 48632 0 31648709
Anaphylactoid shock 16.44 15.65 9 48626 361 31648348
Dysarthria 16.34 15.65 15 48620 32002 31616707
Respiratory failure 16.30 15.65 232 48403 101217 31547492
Hypophysitis 16.18 15.65 18 48617 2084 31646625
Thrombocytosis 16.17 15.65 24 48611 3699 31645010
Haemorrhage 16.12 15.65 30 48605 47304 31601405
Tumour lysis syndrome 15.99 15.65 56 48579 15329 31633380
Gastrooesophageal reflux disease 15.99 15.65 17 48618 33854 31614855
Palmar-plantar erythrodysaesthesia syndrome 15.79 15.65 56 48579 15427 31633282
Incorrect dose administered 15.72 15.65 19 48616 35733 31612976
Dry mouth 15.69 15.65 9 48626 24449 31624260
Colitis ischaemic 15.66 15.65 31 48604 6021 31642688

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
Neuropathy peripheral 1829.65 12.14 1837 162556 125059 70638992
Malignant neoplasm progression 1701.23 12.14 1733 162660 120006 70644045
Neutropenia 1669.93 12.14 2485 161908 254671 70509380
Febrile neutropenia 1153.04 12.14 1852 162541 202466 70561585
Erythema 1032.89 12.14 1740 162653 197823 70566228
Flushing 1004.46 12.14 1090 163303 81082 70682969
Disease progression 924.37 12.14 1450 162943 155222 70608829
Anaemia 842.37 12.14 2440 161953 400983 70363068
Metastases to liver 833.42 12.14 596 163797 25282 70738769
Neutrophil count decreased 770.64 12.14 959 163434 82597 70681454
Metastases to bone 766.10 12.14 535 163858 21841 70742210
Myelosuppression 733.06 12.14 587 163806 29558 70734493
Dyspnoea 631.27 12.14 3471 160922 766589 69997462
Breast cancer metastatic 597.41 12.14 342 164051 9804 70754247
Rheumatoid arthritis 583.72 12.14 21 164372 291784 70472267
Metastases to lung 578.00 12.14 400 163993 16084 70747967
Leukopenia 531.65 12.14 915 163478 105645 70658406
Polyneuropathy 531.27 12.14 422 163971 20993 70743058
Interstitial lung disease 528.98 12.14 904 163489 103781 70660270
Thrombocytopenia 528.62 12.14 1478 162915 237632 70526419
Neoplasm progression 502.38 12.14 571 163822 44657 70719394
Completed suicide 498.98 12.14 5 164388 227130 70536921
Pneumonitis 492.56 12.14 620 163773 53977 70710074
Peripheral sensory neuropathy 479.82 12.14 317 164076 11793 70752258
Palmar-plantar erythrodysaesthesia syndrome 470.30 12.14 457 163936 29790 70734261
Pancreatic carcinoma metastatic 447.09 12.14 205 164188 3635 70760416
Drug ineffective 432.86 12.14 964 163429 938788 69825263
Joint swelling 417.09 12.14 49 164344 253162 70510889
Metastases to central nervous system 415.82 12.14 316 164077 14718 70749333
Cystoid macular oedema 411.55 12.14 159 164234 1793 70762258
Mucosal inflammation 402.27 12.14 630 163763 67220 70696831
Fall 376.16 12.14 288 164105 443808 70320243
Haematotoxicity 366.29 12.14 282 164111 13392 70750659
Neurotoxicity 362.90 12.14 395 163998 29431 70734620
Product dose omission issue 360.81 12.14 41 164352 217427 70546624
Anaphylactic shock 340.26 12.14 398 163995 32092 70731959
Acute myeloid leukaemia 339.10 12.14 388 164005 30552 70733499
Bone marrow failure 338.84 12.14 489 163904 48521 70715530
Metastases to lymph nodes 332.86 12.14 228 164165 9010 70755041
Chest discomfort 332.66 12.14 826 163567 123555 70640496
Drug abuse 319.86 12.14 4 164389 147252 70616799
Feeling hot 316.78 12.14 472 163921 48198 70715853
Bronchospasm 293.37 12.14 311 164082 22481 70741570
Pancreatic carcinoma 291.93 12.14 241 164152 12663 70751388
Onycholysis 263.82 12.14 113 164280 1690 70762361
Pseudocirrhosis 263.23 12.14 86 164307 565 70763486
General physical health deterioration 261.60 12.14 1162 163231 234869 70529182
Synovitis 259.23 12.14 9 164384 129219 70634832
Therapeutic product effect decreased 252.83 12.14 21 164372 142997 70621054
Contraindicated product administered 251.74 12.14 15 164378 134597 70629454
Weight increased 249.42 12.14 125 164268 242206 70521845
Nausea 248.79 12.14 3038 161355 849050 69915001
Condition aggravated 247.98 12.14 380 164013 427255 70336796
Headache 247.36 12.14 619 163774 579786 70184265
Arthropathy 242.15 12.14 31 164362 150026 70614025
Breast cancer 239.59 12.14 340 164053 33209 70730842
Metastases to peritoneum 236.30 12.14 133 164260 3686 70760365
Musculoskeletal stiffness 234.91 12.14 32 164361 147728 70616323
Overdose 234.53 12.14 53 164340 169692 70594359
Gastrointestinal perforation 230.60 12.14 151 164242 5530 70758521
Toxicity to various agents 224.02 12.14 337 164056 381835 70382216
Second primary malignancy 221.46 12.14 207 164186 12844 70751207
Cholangitis 221.08 12.14 196 164197 11353 70752698
Back pain 220.80 12.14 1223 163170 269929 70494122
Sinusitis 219.85 12.14 60 164333 169135 70594916
Vomiting 216.07 12.14 2210 162183 590901 70173150
White blood cell count decreased 214.24 12.14 871 163522 169270 70594781
Proteinuria 210.21 12.14 298 164095 29076 70734975
Diarrhoea 205.87 12.14 2740 161653 780601 69983450
Ejection fraction decreased 205.42 12.14 302 164091 30460 70733591
Therapy partial responder 204.30 12.14 194 164199 12280 70751771
Skin toxicity 202.80 12.14 153 164240 7045 70757006
Ascites 201.34 12.14 468 163925 67079 70696972
Platelet count decreased 198.53 12.14 879 163514 177343 70586708
Arthralgia 198.28 12.14 558 163835 502832 70261219
Pyrexia 196.10 12.14 2208 162185 604744 70159307
Myelodysplastic syndrome 189.70 12.14 286 164107 29499 70734552
Pleural effusion 189.03 12.14 707 163686 132157 70631894
Pain 185.62 12.14 789 163604 628027 70136024
Hypertransaminasaemia 183.70 12.14 158 164235 8785 70755266
Glossodynia 180.91 12.14 4 164389 86483 70677568
Depression 174.64 12.14 124 164269 198850 70565201
Infusion related reaction 174.27 12.14 911 163482 196623 70567428
Pemphigus 173.07 12.14 4 164389 83032 70681019
Biliary tract infection 172.82 12.14 75 164318 1160 70762891
Drug interaction 172.38 12.14 394 163999 381047 70383004
Injection site pain 172.23 12.14 32 164361 117587 70646464
Abdominal discomfort 171.67 12.14 147 164246 214511 70549540
Radiation pneumonitis 169.33 12.14 106 164287 3587 70760464
Product use issue 168.91 12.14 104 164289 179833 70584218
Hypertension 167.43 12.14 1217 163176 294816 70469235
Swelling 166.12 12.14 117 164276 188422 70575629
Peripheral swelling 165.99 12.14 182 164211 236381 70527670
Sense of oppression 165.51 12.14 77 164316 1413 70762638
Suicide attempt 165.06 12.14 4 164389 79506 70684545
Epistaxis 164.60 12.14 568 163825 102059 70661992
Nasopharyngitis 162.58 12.14 165 164228 222041 70542010
Systemic lupus erythematosus 159.75 12.14 23 164370 101879 70662172
Drug intolerance 159.04 12.14 173 164220 225514 70538537
Psoriasis 154.81 12.14 22 164371 98411 70665640
Somnolence 152.22 12.14 165 164228 215441 70548610
Embolism 149.29 12.14 167 164226 12821 70751230
Paraesthesia 148.03 12.14 699 163694 144838 70619213
Mobility decreased 146.63 12.14 30 164363 102969 70661082
Lymphangiosis carcinomatosa 144.85 12.14 76 164317 1825 70762226
Hypersensitivity 141.69 12.14 965 163428 228847 70535204
Cardiac dysfunction 141.09 12.14 93 164300 3444 70760607
Oxygen saturation decreased 137.79 12.14 585 163808 115844 70648207
Ovarian cancer recurrent 137.39 12.14 50 164343 471 70763580
Confusional state 137.31 12.14 283 164110 284115 70479936
Metastases to meninges 136.25 12.14 87 164306 3049 70761002
Non-small cell lung cancer 136.22 12.14 115 164278 6232 70757819
Intentional product misuse 134.47 12.14 14 164379 79581 70684470
Abdominal pain 133.43 12.14 1294 163099 340833 70423218
Hospitalisation 133.31 12.14 17 164376 82551 70681500
Neutropenic sepsis 129.97 12.14 218 164175 24612 70739439
Blood cholesterol increased 127.80 12.14 5 164388 64599 70699452
Throat tightness 124.78 12.14 215 164178 24807 70739244
Insomnia 124.63 12.14 195 164198 217611 70546440
Contusion 124.36 12.14 71 164322 127965 70636086
Dehydration 123.93 12.14 923 163470 225219 70538832
Ovarian cancer 123.62 12.14 91 164302 4034 70760017
Decreased appetite 122.88 12.14 1161 163232 303619 70460432
Hypoxia 122.28 12.14 484 163909 92860 70671191
Plasma cell myeloma 120.81 12.14 14 164379 73187 70690864
Asthma 120.19 12.14 65 164328 120728 70643323
Nail toxicity 119.52 12.14 41 164352 319 70763732
Arthritis 119.49 12.14 39 164354 97941 70666110
Pulmonary embolism 118.09 12.14 690 163703 155177 70608874
Pancytopenia 117.78 12.14 674 163719 150433 70613618
Influenza 116.35 12.14 59 164334 113641 70650410
Migraine 116.31 12.14 15 164378 72223 70691828
Loss of personal independence in daily activities 116.26 12.14 27 164366 84883 70679168
Cyanosis 115.20 12.14 199 164194 23007 70741044
Helicobacter infection 114.76 12.14 3 164390 55653 70708398
Pneumothorax 114.65 12.14 211 164182 25635 70738416
Hypoglycaemia 114.30 12.14 38 164355 94326 70669725
Hepatic enzyme increased 114.30 12.14 117 164276 156873 70607178
Gastrointestinal toxicity 113.33 12.14 104 164289 6301 70757750
Wound 112.39 12.14 44 164349 98688 70665363
Recall phenomenon 112.30 12.14 53 164340 1006 70763045
Tumour haemorrhage 111.30 12.14 82 164311 3640 70760411
Osteonecrosis of jaw 110.22 12.14 273 164120 40729 70723322
Metastases to skin 108.98 12.14 59 164334 1512 70762539
Thrombotic microangiopathy 108.87 12.14 168 164225 17680 70746371
Tachycardia 107.52 12.14 682 163711 157864 70606187
Bone pain 105.95 12.14 308 164085 50514 70713537
Breast cancer recurrent 105.53 12.14 71 164322 2722 70761329
Injection site erythema 104.29 12.14 21 164372 72903 70691148
Immune-mediated hepatitis 103.87 12.14 71 164322 2795 70761256
Blood pressure fluctuation 103.33 12.14 9 164384 59003 70705048
Nail disorder 103.00 12.14 124 164269 10300 70753751
Treatment failure 98.74 12.14 113 164280 144029 70620022
Coronary artery disease 98.69 12.14 14 164379 62722 70701329
Drug reaction with eosinophilia and systemic symptoms 98.52 12.14 10 164383 58003 70706048
Inappropriate schedule of product administration 98.37 12.14 64 164329 107491 70656560
Duodenal ulcer perforation 97.68 12.14 5 164388 51107 70712944
Pericarditis 97.65 12.14 37 164356 84668 70679383
Irritable bowel syndrome 97.10 12.14 5 164388 50845 70713206
Alopecia 96.45 12.14 788 163605 197702 70566349
Gait disturbance 94.63 12.14 178 164215 184928 70579123
Fibromyalgia 93.70 12.14 4 164389 47870 70716181
Anaphylactic reaction 92.80 12.14 382 164011 74592 70689459
Cardiotoxicity 92.35 12.14 121 164272 10949 70753102
Intestinal perforation 92.28 12.14 147 164246 15897 70748154
Memory impairment 91.94 12.14 50 164343 92591 70671460
Feeling abnormal 91.73 12.14 117 164276 142202 70621849
Colitis 91.03 12.14 340 164053 63474 70700577
Nail discolouration 90.94 12.14 64 164329 2642 70761409
Bradycardia 90.55 12.14 93 164300 124522 70639529
Ileus 90.53 12.14 184 164209 24053 70739998
Hallucination 90.13 12.14 32 164361 76228 70687823
Suicidal ideation 89.75 12.14 25 164368 69571 70694480
Peripheral motor neuropathy 89.17 12.14 67 164326 3065 70760986
Blister 89.00 12.14 62 164331 100464 70663587
Asthenia 88.19 12.14 1520 162873 456146 70307905
Injection site swelling 86.53 12.14 3 164390 43154 70720897
Triple negative breast cancer 86.31 12.14 27 164366 151 70763900
Drug hypersensitivity 86.27 12.14 315 164078 262144 70501907
Myocardial infarction 85.16 12.14 168 164225 171477 70592574
Performance status decreased 83.99 12.14 83 164310 5518 70758533
Injection site reaction 83.61 12.14 9 164384 49843 70714208
Hypokalaemia 82.62 12.14 554 163839 130634 70633417
Coma 82.17 12.14 56 164337 91788 70672263
Immune-mediated enterocolitis 82.06 12.14 67 164326 3464 70760587
Exposure during pregnancy 81.85 12.14 51 164342 87666 70676385
Dysaesthesia 81.33 12.14 80 164313 5288 70758763
Radiation oesophagitis 81.17 12.14 36 164357 588 70763463
Anxiety 80.18 12.14 253 164140 220077 70543974
Metastasis 79.68 12.14 84 164309 6030 70758021
Injury 79.49 12.14 26 164367 65219 70698832
Tumour necrosis 79.21 12.14 50 164343 1717 70762334
Incorrect dose administered 78.84 12.14 28 164365 66691 70697360
Electrocardiogram QT prolonged 78.70 12.14 48 164345 83469 70680582
Sepsis 78.25 12.14 889 163504 243656 70520395
Fluid retention 77.68 12.14 25 164368 63360 70700691
Injection site pruritus 77.67 12.14 3 164390 39207 70724844
Dizziness 77.58 12.14 695 163698 463446 70300605
PIK3CA-activated mutation 77.52 12.14 34 164359 540 70763511
Hepatic atrophy 76.42 12.14 31 164362 401 70763650
C-reactive protein abnormal 76.25 12.14 3 164390 38576 70725475
Rhabdomyolysis 75.98 12.14 66 164327 95694 70668357
Tumour marker increased 75.84 12.14 66 164327 3728 70760323
Metastatic neoplasm 75.56 12.14 72 164321 4576 70759475
Urogenital fistula 74.53 12.14 23 164370 122 70763929
Acute promyelocytic leukaemia 73.65 12.14 45 164348 1457 70762594
Invasive ductal breast carcinoma 72.50 12.14 78 164315 5731 70758320
Metastases to kidney 72.41 12.14 31 164362 463 70763588
Serotonin syndrome 72.19 12.14 7 164386 42107 70721944
Osteoarthritis 72.15 12.14 41 164352 74106 70689945
Discomfort 71.82 12.14 83 164310 105353 70658698
Lactic acidosis 70.73 12.14 31 164362 64993 70699058
Pneumocystis jirovecii pneumonia 70.24 12.14 190 164203 29892 70734159
International normalised ratio increased 69.87 12.14 51 164342 80675 70683376
Muscle spasms 69.54 12.14 159 164234 153887 70610164
Pain in extremity 69.47 12.14 460 163933 327622 70436429
Nasal congestion 68.80 12.14 33 164360 65639 70698412
Subileus 68.45 12.14 72 164321 5155 70758896
Posterior reversible encephalopathy syndrome 68.26 12.14 165 164228 24237 70739814
Large intestine perforation 67.92 12.14 115 164278 13080 70750971
Alveolitis 67.66 12.14 62 164331 3749 70760302
Aggression 67.12 12.14 15 164378 48431 70715620
Nephrolithiasis 66.89 12.14 14 164379 47309 70716742
Stomatitis 66.10 12.14 517 163876 127994 70636057
Lower respiratory tract infection 66.08 12.14 98 164295 111815 70652236
Macular oedema 65.64 12.14 70 164323 5092 70758959
Malignant pleural effusion 65.57 12.14 56 164337 3083 70760968
Metastases to spine 65.47 12.14 61 164332 3768 70760283
Cataract 64.65 12.14 24 164369 55621 70708430
Enterocolitis infectious 64.47 12.14 52 164341 2642 70761409
Scleroderma-like reaction 64.36 12.14 20 164373 109 70763942
Nail dystrophy 64.09 12.14 35 164358 913 70763138
Pulmonary arterial hypertension 63.46 12.14 3 164390 32852 70731199
Cardiac failure congestive 63.44 12.14 137 164256 135320 70628731
Metastases to the mediastinum 63.19 12.14 29 164364 515 70763536
Urticaria 63.05 12.14 182 164211 162867 70601184
Bronchial fistula 62.85 12.14 22 164371 183 70763868
Computerised tomogram thorax abnormal 62.23 12.14 46 164347 2052 70761999
Anaphylactoid reaction 62.08 12.14 67 164326 4940 70759111
Haemoptysis 61.19 12.14 259 164134 51193 70712858
Illness 61.10 12.14 3 164390 31788 70732263
COVID-19 61.09 12.14 94 164299 105663 70658388
Cholangitis sclerosing 60.95 12.14 47 164346 2236 70761815
Metabolic acidosis 60.50 12.14 50 164343 74296 70689755
Hyperaemia 59.84 12.14 51 164342 2800 70761251
Accidental overdose 59.77 12.14 6 164387 35115 70728936
Bronchitis 59.66 12.14 113 164280 117130 70646921
Basal cell carcinoma 59.38 12.14 5 164388 33693 70730358
Hypertensive crisis 59.05 12.14 135 164258 19127 70744924
Irritability 59.03 12.14 9 164384 38216 70725835
Cardiomyopathy 59.02 12.14 164 164229 26209 70737842
Oesophagitis 58.95 12.14 149 164244 22503 70741548
Acute interstitial pneumonitis 58.94 12.14 35 164358 1075 70762976
Osteoporosis 58.68 12.14 20 164373 48887 70715164
Metastases to pleura 58.34 12.14 37 164356 1281 70762770
Pulmonary toxicity 58.10 12.14 96 164297 10702 70753349
Immune-mediated lung disease 57.58 12.14 40 164353 1617 70762434
Sleep apnoea syndrome 57.24 12.14 5 164388 32708 70731343
Prostate cancer 56.67 12.14 4 164389 31159 70732892
Bronchostenosis 56.33 12.14 28 164365 598 70763453
Product prescribing error 56.14 12.14 11 164382 38941 70725110
Hepatic failure 55.79 12.14 273 164120 57352 70706699
Lymphoedema 55.72 12.14 96 164297 11073 70752978
Secondary cerebellar degeneration 55.35 12.14 15 164378 45 70764006
Stress 54.94 12.14 46 164347 67920 70696131
Eosinophilia 54.83 12.14 13 164380 40306 70723745
Maternal exposure during pregnancy 54.56 12.14 116 164277 115229 70648822
Suffocation feeling 54.05 12.14 38 164355 1566 70762485
Malignant ascites 54.03 12.14 33 164360 1068 70762983
Acute myelomonocytic leukaemia 54.00 12.14 22 164371 288 70763763
Disseminated intravascular coagulation 53.86 12.14 186 164207 33412 70730639
Cytomegalovirus infection 53.71 12.14 13 164380 39745 70724306
Paronychia 52.43 12.14 73 164320 7001 70757050
Palmar erythema 52.29 12.14 39 164354 1764 70762287
Medication error 51.84 12.14 34 164359 56878 70707173
Biliary sepsis 51.67 12.14 36 164357 1462 70762589
Drug level increased 51.11 12.14 11 164382 36458 70727593
Treatment noncompliance 50.98 12.14 22 164371 46552 70717499
Left ventricular dysfunction 50.84 12.14 122 164271 17835 70746216
Carbohydrate antigen 125 increased 50.67 12.14 40 164353 1970 70762081
Swollen tongue 50.27 12.14 12 164381 37034 70727017
Hot flush 50.24 12.14 238 164155 49346 70714705
Wrong technique in product usage process 50.20 12.14 51 164342 68647 70695404
Atelectasis 49.66 12.14 164 164229 28798 70735253
Road traffic accident 49.56 12.14 10 164383 34672 70729379
Oesophagobronchial fistula 48.96 12.14 19 164374 217 70763834
Unevaluable event 48.94 12.14 30 164363 52033 70712018
Dyskinesia 48.93 12.14 17 164376 41057 70722994
Hepatic function abnormal 48.86 12.14 297 164096 67699 70696352
Pericardial effusion 48.67 12.14 209 164184 41567 70722484
Carbohydrate antigen 15-3 increased 47.58 12.14 30 164363 1028 70763023
Laryngospasm 47.38 12.14 50 164343 3593 70760458
Device related infection 47.15 12.14 173 164220 32012 70732039
Tumour lysis syndrome 46.98 12.14 132 164261 21228 70742823
Wheezing 46.83 12.14 92 164301 94078 70669973
Gastric disorder 46.80 12.14 10 164383 33312 70730739
Febrile infection 46.48 12.14 46 164347 3063 70760988
Blood glucose increased 45.89 12.14 107 164286 102875 70661176
Small intestinal perforation 45.88 12.14 45 164348 2964 70761087
Haemolytic uraemic syndrome 45.58 12.14 52 164341 4078 70759973
Adrenocorticotropic hormone deficiency 45.35 12.14 29 164364 1019 70763032
Superior vena cava syndrome 45.34 12.14 30 164363 1118 70762933
Folliculitis 45.19 12.14 21 164372 42549 70721502
Immune-mediated hepatic disorder 44.92 12.14 28 164365 940 70763111
Limb injury 44.88 12.14 4 164389 25748 70738303
Liver abscess 44.85 12.14 60 164333 5539 70758512
Extravasation 44.85 12.14 47 164346 3350 70760701
Stress cardiomyopathy 44.35 12.14 81 164312 9781 70754270
Respiratory distress 44.00 12.14 246 164147 54404 70709647
Choking sensation 43.73 12.14 48 164345 3607 70760444
Immune-mediated dermatitis 43.25 12.14 19 164374 303 70763748
Ear infection 43.01 12.14 7 164386 28329 70735722
Type I hypersensitivity 42.91 12.14 48 164345 3684 70760367
Neutropenic colitis 42.82 12.14 56 164337 5058 70758993
Subdural haematoma 42.81 12.14 8 164385 29290 70734761
Tumour associated fever 42.75 12.14 25 164368 746 70763305
Psychotic disorder 42.57 12.14 17 164376 37684 70726367
Tremor 42.24 12.14 201 164192 155423 70608628
Full blood count abnormal 42.15 12.14 13 164380 33865 70730186
Surgery 42.12 12.14 9 164384 29980 70734071
Death 42.08 12.14 1510 162883 508551 70255500
Abnormal behaviour 41.98 12.14 14 164379 34695 70729356
Carcinoembryonic antigen increased 41.96 12.14 36 164357 1994 70762057
Cachexia 41.63 12.14 79 164314 9821 70754230
Angioedema 41.62 12.14 56 164337 66554 70697497
Gastrooesophageal reflux disease 41.59 12.14 93 164300 90746 70673305
Rash pruritic 41.38 12.14 51 164342 62940 70701111
Oropharyngeal pain 41.38 12.14 102 164291 96208 70667843
Hypersensitivity pneumonitis 41.05 12.14 45 164348 3377 70760674
Rectal perforation 41.01 12.14 25 164368 806 70763245
Head injury 40.89 12.14 14 164379 34127 70729924
Blood creatine phosphokinase increased 40.88 12.14 49 164344 61214 70702837
Poisoning 40.86 12.14 3 164390 22619 70741432
Mental disorder 40.65 12.14 8 164385 28232 70735819
Joint range of motion decreased 40.48 12.14 6 164387 26020 70738031
Adenocarcinoma pancreas 40.12 12.14 35 164358 1983 70762068
Hypomagnesaemia 40.09 12.14 194 164199 40570 70723481
Recurrent cancer 40.04 12.14 38 164355 2403 70761648
Drug withdrawal syndrome 39.91 12.14 13 164380 32702 70731349
Transient ischaemic attack 39.78 12.14 29 164364 45915 70718136
Adverse drug reaction 39.66 12.14 39 164354 53305 70710746
Portal hypertension 39.44 12.14 61 164332 6431 70757620
Hydronephrosis 39.39 12.14 100 164293 15142 70748909
Female genital tract fistula 39.31 12.14 42 164351 3061 70760990
Product administration error 39.21 12.14 10 164383 29513 70734538
Cardiac disorder 39.14 12.14 48 164345 59367 70704684
Labelled drug-drug interaction medication error 38.86 12.14 5 164388 24122 70739929
Adenocarcinoma 38.64 12.14 45 164348 3608 70760443
Nervousness 38.62 12.14 12 164381 31108 70732943
Agitation 38.49 12.14 101 164292 93274 70670777
Herpes zoster 38.43 12.14 88 164305 85147 70678904
Eastern Cooperative Oncology Group performance status worsened 38.40 12.14 31 164362 1577 70762474
Joint stiffness 37.89 12.14 17 164376 35159 70728892
Eye pain 37.49 12.14 16 164377 34086 70729965
Infusion related hypersensitivity reaction 37.31 12.14 16 164377 240 70763811
Metastases to retroperitoneum 37.24 12.14 18 164375 361 70763690
Capillary permeability increased 37.15 12.14 10 164383 29 70764022
Nightmare 37.15 12.14 4 164389 22152 70741899
Sleep disorder 36.73 12.14 66 164327 69806 70694245
Haemorrhage 36.61 12.14 88 164305 83727 70680324
Hypopituitarism 36.40 12.14 40 164353 3010 70761041
Cervix carcinoma 36.28 12.14 34 164359 2116 70761935
Acne 36.13 12.14 7 164386 24982 70739069
Skin laceration 35.87 12.14 8 164385 25870 70738181
Pulmonary radiation injury 35.86 12.14 11 164382 57 70763994
Bone lesion 35.79 12.14 53 164340 5377 70758674
Tracheal fistula 35.67 12.14 13 164380 123 70763928
Acute myocardial infarction 35.56 12.14 72 164321 72815 70691236
Capillary leak syndrome 35.55 12.14 42 164351 3420 70760631
Type 2 diabetes mellitus 35.42 12.14 30 164363 44050 70720001
Aortitis 35.40 12.14 28 164365 1383 70762668
Computerised tomogram thorax 35.28 12.14 15 164378 220 70763831
Injection site haemorrhage 35.17 12.14 8 164385 25519 70738532
Hyperhidrosis 34.93 12.14 462 163931 131124 70632927
Blood pressure systolic increased 34.91 12.14 49 164344 57210 70706841
Acute kidney injury 34.80 12.14 836 163557 473788 70290263
Dysgeusia 34.79 12.14 215 164178 49287 70714764
Chills 34.64 12.14 499 163894 144287 70619764
Prescribed overdose 34.60 12.14 10 164383 27171 70736880
Dystonia 34.51 12.14 3 164390 19703 70744348
Gait inability 34.49 12.14 35 164358 47140 70716911
Blood triglycerides increased 34.42 12.14 3 164390 19661 70744390
Toxic erythema of chemotherapy 34.27 12.14 15 164378 237 70763814
Hyperkalaemia 34.27 12.14 129 164264 106462 70657589
Gout 34.22 12.14 6 164387 23000 70741051
Emotional distress 34.16 12.14 22 164371 37166 70726885
Radiation skin injury 34.09 12.14 27 164366 1336 70762715
Enterocolitis 34.06 12.14 86 164307 12980 70751071
Heart rate decreased 34.04 12.14 57 164336 61958 70702093
Pneumatosis intestinalis 33.93 12.14 54 164339 5833 70758218
Metastases to stomach 33.93 12.14 15 164378 243 70763808
Pseudomembranous colitis 33.85 12.14 50 164343 5061 70758990
Drug ineffective for unapproved indication 33.79 12.14 24 164369 38514 70725537
Amnesia 33.46 12.14 43 164350 52112 70711939
Lymphadenopathy mediastinal 33.41 12.14 44 164349 4001 70760050
Constipation 33.34 12.14 793 163600 251645 70512406
Diabetes mellitus 33.32 12.14 73 164320 71751 70692300
Incorrect route of product administration 33.26 12.14 10 164383 26482 70737569
Device related thrombosis 33.23 12.14 34 164359 2356 70761695
Small intestinal obstruction 33.20 12.14 129 164264 24526 70739525
Eczema asteatotic 32.82 12.14 19 164374 556 70763495
Cancer pain 32.74 12.14 48 164345 4826 70759225
Crying 32.71 12.14 5 164388 21194 70742857
Tonsillar disorder 32.48 12.14 24 164369 1070 70762981
Upper respiratory tract infection 32.48 12.14 86 164307 79188 70684863
Primary cardiac lymphoma 32.05 12.14 9 164384 32 70764019
Obesity 32.03 12.14 11 164382 26760 70737291
Bile duct stenosis 31.94 12.14 30 164363 1872 70762179
Fear 31.91 12.14 5 164388 20806 70743245
Hypersomnia 31.81 12.14 5 164388 20759 70743292
Scleroderma 31.80 12.14 48 164345 4953 70759098
Metastases to chest wall 31.78 12.14 17 164376 425 70763626
Metastases to eye 31.77 12.14 14 164379 225 70763826
Pleural neoplasm 31.72 12.14 16 164377 353 70763698
Pregnancy 31.68 12.14 8 164385 23773 70740278
Immune-mediated pancreatitis 31.58 12.14 13 164380 175 70763876
Neck pain 31.54 12.14 67 164326 66590 70697461
Anastomotic leak 31.51 12.14 23 164370 1006 70763045
Retroperitoneal lymphadenopathy 31.49 12.14 23 164370 1007 70763044
Malignant peritoneal neoplasm 31.47 12.14 20 164373 695 70763356
Administration site extravasation 31.32 12.14 24 164369 1131 70762920
Erythema multiforme 31.31 12.14 97 164296 16467 70747584
Myoclonus 31.23 12.14 11 164382 26344 70737707
Dermatitis acneiform 31.16 12.14 66 164327 8879 70755172
Kounis syndrome 31.15 12.14 39 164354 3372 70760679
Inflammation 30.98 12.14 87 164306 78578 70685473
Adrenal insufficiency 30.86 12.14 128 164265 25067 70738984
Hypoalbuminaemia 30.76 12.14 106 164287 19016 70745035
Disease recurrence 30.76 12.14 170 164223 37433 70726618
Hypervolaemia 30.72 12.14 28 164365 39678 70724373
Flatulence 30.66 12.14 26 164367 38155 70725896
Right ventricular failure 30.64 12.14 7 164386 22267 70741784
Hyperpyrexia 30.57 12.14 49 164344 5325 70758726
Endocarditis noninfective 30.56 12.14 13 164380 191 70763860
Blood uric acid decreased 30.51 12.14 24 164369 1176 70762875
Balance disorder 30.34 12.14 107 164286 90021 70674030
Musculoskeletal disorder 30.17 12.14 5 164388 19966 70744085
Metastases to pelvis 30.16 12.14 18 164375 558 70763493
Duodenal perforation 30.16 12.14 30 164363 2010 70762041
Bursitis 30.16 12.14 12 164381 26661 70737390
Periarticular thenar erythema with onycholysis 30.03 12.14 8 164385 22 70764029
Transaminases increased 29.84 12.14 199 164194 46819 70717232
Right ventricular ejection fraction decreased 29.77 12.14 9 164384 44 70764007
Pancreatic enzyme abnormality 29.64 12.14 11 164382 110 70763941
Tumour pain 29.45 12.14 30 164363 2068 70761983
Mood swings 28.95 12.14 4 164389 18282 70745769
Deep vein thrombosis 28.70 12.14 388 164005 110654 70653397
Angiosarcoma 28.60 12.14 17 164376 523 70763528
Cerebrovascular accident 28.42 12.14 205 164188 143265 70620786
Panic attack 28.41 12.14 8 164385 22111 70741940
Urinary tract obstruction 28.41 12.14 42 164351 4255 70759796
Laryngeal necrosis 28.37 12.14 8 164385 29 70764022
Neoplasm recurrence 28.21 12.14 40 164353 3901 70760150
Pulse absent 28.17 12.14 65 164328 9265 70754786
Subclavian vein thrombosis 28.10 12.14 31 164362 2343 70761708
Accidental exposure to product 28.02 12.14 15 164378 28036 70736015
Metastases to bladder 27.97 12.14 13 164380 238 70763813
Oligohydramnios 27.94 12.14 36 164357 3204 70760847
Hepatotoxicity 27.81 12.14 186 164207 43800 70720251
Diabetes mellitus inadequate control 27.62 12.14 9 164384 22636 70741415
Respiratory tract congestion 27.62 12.14 4 164389 17649 70746402
Delirium 27.59 12.14 85 164308 74529 70689522
Peritonitis 27.55 12.14 127 164266 26032 70738019
Ovarian failure 27.53 12.14 17 164376 561 70763490
Foot deformity 27.42 12.14 7 164386 20648 70743403
Neuromuscular toxicity 27.39 12.14 12 164381 190 70763861
Ovarian cancer metastatic 27.32 12.14 17 164376 569 70763482
Tumour embolism 27.28 12.14 11 164382 140 70763911
Hepatic lesion 27.20 12.14 50 164343 6067 70757984
Venous thrombosis limb 27.18 12.14 40 164353 4035 70760016
Kidney infection 26.99 12.14 6 164387 19449 70744602
Drug resistance 26.92 12.14 166 164227 38024 70726027
Blood potassium increased 26.74 12.14 15 164378 27311 70736740
Sopor 26.73 12.14 20 164373 31247 70732804
Limb discomfort 26.71 12.14 18 164375 29687 70734364
Abortion spontaneous 26.69 12.14 14 164379 26465 70737586
Eosinophil percentage increased 26.54 12.14 24 164369 1426 70762625
Viral infection 26.37 12.14 30 164363 38361 70725690
Melaena 26.37 12.14 57 164336 56298 70707753
Gastric perforation 26.25 12.14 38 164355 3777 70760274
Cardiac cirrhosis 26.21 12.14 12 164381 212 70763839
Status epilepticus 26.19 12.14 12 164381 24514 70739537
Procedural pain 26.13 12.14 5 164388 18004 70746047
Bone marrow infiltration 26.13 12.14 16 164377 520 70763531
Seizure 26.04 12.14 275 164118 177687 70586364
Lymphopenia 26.04 12.14 129 164264 27230 70736821
Night sweats 26.02 12.14 38 164355 43646 70720405
Enteritis 26 12.14 77 164316 12754 70751297
Mastitis 25.90 12.14 28 164365 2068 70761983
Dysphagia 25.85 12.14 386 164007 112448 70651603
Septic shock 25.70 12.14 384 164009 111874 70652177
Gallbladder disorder 25.53 12.14 5 164388 17707 70746344
Blood pressure diastolic abnormal 25.49 12.14 3 164390 15501 70748550
Wound dehiscence 25.44 12.14 49 164344 6159 70757892
Thyroid dermatopathy 25.35 12.14 7 164386 23 70764028
Foot fracture 25.34 12.14 7 164386 19593 70744458
Metastatic gastric cancer 25.23 12.14 14 164379 377 70763674
Therapy interrupted 25.17 12.14 13 164380 24789 70739262
Tooth erosion 25.07 12.14 14 164379 382 70763669
Chest pain 25.06 12.14 761 163632 250499 70513552
Vocal cord paralysis 25.04 12.14 29 164364 2312 70761739
Duodenitis haemorrhagic 25.03 12.14 10 164383 124 70763927
Colitis ulcerative 24.99 12.14 25 164368 33898 70730153
Gastritis bacterial 24.97 12.14 13 164380 307 70763744
Acute megakaryocytic leukaemia 24.96 12.14 8 164385 49 70764002
Tumour pseudoprogression 24.87 12.14 16 164377 568 70763483
Therapeutic product effect incomplete 24.86 12.14 169 164224 119713 70644338
Adverse event 24.86 12.14 48 164345 49413 70714638
Sinus congestion 24.84 12.14 5 164388 17368 70746683
Oesophagopleural fistula 24.82 12.14 8 164385 50 70764001
Hepatic infection 24.78 12.14 19 164374 896 70763155
Aplasia 24.68 12.14 53 164340 7198 70756853
Paranoia 24.67 12.14 5 164388 17283 70746768
Liver function test abnormal 24.54 12.14 67 164326 61079 70702972
Sinus bradycardia 24.54 12.14 12 164381 23611 70740440
Haemoglobin 24.52 12.14 9 164384 87 70763964
Congestive cardiomyopathy 24.50 12.14 68 164325 10858 70753193
Oligoastrocytoma 24.49 12.14 7 164386 27 70764024
Pulmonary tumour thrombotic microangiopathy 24.43 12.14 9 164384 88 70763963
Glaucoma 24.27 12.14 6 164387 18086 70745965
Vena cava thrombosis 24.09 12.14 30 164363 2580 70761471
Sinus disorder 24.09 12.14 7 164386 18952 70745099
Eye disorder 24.08 12.14 9 164384 20776 70743275
Device dislocation 24.05 12.14 11 164382 22496 70741555
Movement disorder 23.96 12.14 13 164380 24116 70739935
Lung abscess 23.90 12.14 36 164357 3708 70760343
Weight decreased 23.80 12.14 543 163850 309945 70454106
Localised infection 23.79 12.14 25 164368 33133 70730918
Spinal stenosis 23.69 12.14 3 164390 14650 70749401
Orthostatic hypotension 23.66 12.14 53 164340 51690 70712361
Metastases to breast 23.66 12.14 12 164381 268 70763783
Anaemia of malignant disease 23.65 12.14 17 164376 726 70763325
Scintillating scotoma 23.64 12.14 11 164382 202 70763849
Joint dislocation 23.43 12.14 3 164390 14528 70749523
Intestinal metastasis 23.14 12.14 12 164381 281 70763770
Tracheo-oesophageal fistula 23.11 12.14 15 164378 541 70763510
Pruritus 23.05 12.14 617 163776 344943 70419108
Eye swelling 23.05 12.14 13 164380 23601 70740450
Exostosis 23.03 12.14 3 164390 14342 70749709
Mood altered 23.02 12.14 5 164388 16470 70747581
Uterine atrophy 22.94 12.14 6 164387 15 70764036
Chromaturia 22.90 12.14 13 164380 23515 70740536
Gastrointestinal haemorrhage 22.77 12.14 206 164187 137202 70626849
Anhedonia 22.76 12.14 3 164390 14210 70749841
Infected lymphocele 22.56 12.14 11 164382 225 70763826
Pyogenic granuloma 22.43 12.14 14 164379 471 70763580
Underdose 22.40 12.14 21 164372 29362 70734689
Ovarian epithelial cancer recurrent 22.39 12.14 6 164387 17 70764034
Extrapyramidal disorder 22.39 12.14 10 164383 20740 70743311
Hallucination, visual 22.33 12.14 21 164372 29316 70734735
Pulmonary cavitation 22.32 12.14 22 164371 1458 70762593
No adverse event 22.22 12.14 25 164368 32128 70731923
Teratoma benign 22.21 12.14 8 164385 73 70763978
Metastases to soft tissue 22.11 12.14 13 164380 392 70763659
Immune-mediated myocarditis 22.08 12.14 16 164377 692 70763359
Gelastic seizure 21.89 12.14 5 164388 5 70764046
Ductal adenocarcinoma of pancreas 21.87 12.14 10 164383 176 70763875
Xerophthalmia 21.84 12.14 15 164378 595 70763456
Faeces discoloured 21.84 12.14 18 164375 26791 70737260
Hormone receptor positive breast cancer 21.70 12.14 12 164381 321 70763730
Vaginal fistula 21.67 12.14 11 164382 246 70763805
Poor quality sleep 21.66 12.14 10 164383 20339 70743712
Dysarthria 21.63 12.14 73 164320 62240 70701811
Dermatomyositis 21.60 12.14 33 164360 3442 70760609
Intestinal obstruction 21.51 12.14 159 164234 38666 70725385
Urinary retention 21.49 12.14 57 164336 52463 70711588
Eye pruritus 21.40 12.14 4 164389 14643 70749408
Ventricular tachycardia 21.39 12.14 32 164361 36391 70727660
Speech disorder 21.38 12.14 54 164339 50526 70713525
Therapy cessation 21.36 12.14 28 164365 33648 70730403
Periodontitis 21.33 12.14 37 164356 4291 70759760
Bronchopulmonary aspergillosis 21.32 12.14 11 164382 20991 70743060
Nasal septum perforation 21.27 12.14 16 164377 733 70763318
Thrombophlebitis migrans 21.27 12.14 12 164381 334 70763717
Bronchopleural fistula 21.23 12.14 15 164378 623 70763428
Arterioenteric fistula 21.23 12.14 6 164387 22 70764029
Glycosylated haemoglobin increased 21.06 12.14 7 164386 17384 70746667
Metastases to abdominal cavity 21.03 12.14 14 164379 527 70763524
Device issue 21.01 12.14 15 164378 24010 70740041
Cystitis noninfective 20.99 12.14 20 164373 1271 70762780
Therapeutic response unexpected 20.94 12.14 8 164385 18223 70745828
Rash papular 20.90 12.14 8 164385 18202 70745849
Endometrial adenocarcinoma 20.87 12.14 18 164375 1004 70763047
Acquired gene mutation 20.80 12.14 25 164368 2073 70761978
Acute erythroid leukaemia 20.78 12.14 11 164382 269 70763782
Ocular hyperaemia 20.75 12.14 16 164377 24623 70739428
Muscle twitching 20.71 12.14 10 164383 19817 70744234
Tongue disorder 20.69 12.14 3 164390 13224 70750827
Taeniasis 20.69 12.14 7 164386 52 70763999
Gastrointestinal necrosis 20.49 12.14 40 164353 5078 70758973
Transfusion 20.45 12.14 9 164384 18827 70745224
Pulmonary congestion 20.36 12.14 17 164376 25137 70738914
Hip arthroplasty 20.27 12.14 21 164372 28019 70736032
Splenic artery thrombosis 20.24 12.14 7 164386 56 70763995
Hypocalcaemia 20.10 12.14 175 164218 44684 70719367
Chronic obstructive pulmonary disease 20.06 12.14 102 164291 77539 70686512
Fungal infection 20.04 12.14 35 164358 37432 70726619
Pancreatic failure 19.97 12.14 21 164372 1503 70762548
Immune-mediated nephritis 19.96 12.14 12 164381 377 70763674
Respiratory depth decreased 19.90 12.14 6 164387 29 70764022
Vessel puncture site bruise 19.90 12.14 13 164380 474 70763577
Aortic injury 19.88 12.14 5 164388 10 70764041
Blood urine present 19.85 12.14 10 164383 19343 70744708
Pancreatic carcinoma recurrent 19.81 12.14 9 164384 156 70763895
Neuroendocrine breast tumour 19.74 12.14 6 164387 30 70764021
Nail avulsion 19.69 12.14 8 164385 104 70763947
Impaired healing 19.62 12.14 97 164296 74277 70689774
Ovarian epithelial cancer 19.61 12.14 10 164383 226 70763825
Cough 19.59 12.14 932 163461 324445 70439606
Upper gastrointestinal perforation 19.56 12.14 5 164388 11 70764040
Radiation necrosis 19.55 12.14 12 164381 392 70763659
Post thrombotic syndrome 19.49 12.14 14 164379 597 70763454
Oesophageal stenosis 19.43 12.14 34 164359 3970 70760081
Pulmonary artery stenosis 19.41 12.14 8 164385 108 70763943
Lung adenocarcinoma 19.40 12.14 50 164343 7640 70756411
Device malfunction 19.37 12.14 10 164383 19074 70744977
Infectious pleural effusion 19.31 12.14 30 164363 3174 70760877
Gastroenteritis viral 19.29 12.14 13 164380 21442 70742609
Biliary obstruction 19.29 12.14 34 164359 3993 70760058
Renal failure 19.27 12.14 315 164078 188755 70575296
Cholangitis infective 19.24 12.14 13 164380 502 70763549
Carbohydrate antigen 19-9 increased 19.20 12.14 12 164381 405 70763646
Dysstasia 19.19 12.14 18 164375 25161 70738890
Joint effusion 19.15 12.14 6 164387 15471 70748580
Hypermetabolism 19.12 12.14 11 164382 318 70763733
Guillain-Barre syndrome 18.99 12.14 51 164342 7989 70756062
Immediate post-injection reaction 18.97 12.14 11 164382 323 70763728
Dyspnoea at rest 18.95 12.14 46 164347 6773 70757278
Lymphatic disorder 18.94 12.14 11 164382 324 70763727
Cholelithiasis 18.90 12.14 52 164341 47288 70716763
Musculoskeletal pain 18.90 12.14 127 164266 90200 70673851
Haematochezia 18.89 12.14 96 164297 72985 70691066
Disturbance in attention 18.76 12.14 45 164348 42849 70721202
Carpal tunnel syndrome 18.76 12.14 8 164385 17049 70747002
Emphysematous cystitis 18.69 12.14 10 164383 250 70763801
Angiodermatitis 18.69 12.14 7 164386 72 70763979
Swelling face 18.68 12.14 79 164314 63085 70700966
Photophobia 18.59 12.14 10 164383 18640 70745411
Muscle rigidity 18.59 12.14 10 164383 18640 70745411
Cardiac murmur 18.52 12.14 3 164390 12183 70751868
Pain in jaw 18.47 12.14 45 164348 42624 70721427
Epstein-Barr virus infection 18.45 12.14 4 164389 13194 70750857
Ill-defined disorder 18.41 12.14 65 164328 54676 70709375
Tumour ulceration 18.38 12.14 9 164384 186 70763865
Transaminases 18.35 12.14 7 164386 76 70763975
Depressed level of consciousness 18.25 12.14 123 164270 87308 70676743
Dementia 18.24 12.14 15 164378 22350 70741701
HER2 positive breast cancer 18.18 12.14 11 164382 350 70763701
Laryngeal discomfort 18.11 12.14 13 164380 554 70763497
Pneumonitis chemical 18.09 12.14 11 164382 353 70763698
Immune-mediated encephalitis 18.06 12.14 11 164382 354 70763697
Scar 18.06 12.14 5 164388 13976 70750075
Immune reconstitution inflammatory syndrome 18.04 12.14 4 164389 12986 70751065
Gastroenteritis radiation 18.03 12.14 14 164379 673 70763378
Thyroiditis 17.96 12.14 33 164360 4003 70760048
Hypothalamo-pituitary disorder 17.87 12.14 17 164376 1078 70762973
Loss of consciousness 17.83 12.14 480 163913 155236 70608815
Torsade de pointes 17.64 12.14 10 164383 18106 70745945
Lung adenocarcinoma stage IV 17.60 12.14 11 164382 371 70763680
Venous thrombosis 17.58 12.14 44 164349 6605 70757446
Blood glucose decreased 17.57 12.14 18 164375 24141 70739910
Empyema 17.57 12.14 32 164361 3855 70760196
Sputum discoloured 17.52 12.14 11 164382 18840 70745211
Breast sarcoma 17.52 12.14 4 164389 4 70764047
Maternal death affecting foetus 17.52 12.14 4 164389 4 70764047
Gene mutation 17.51 12.14 24 164369 2267 70761784
Product supply issue 17.46 12.14 20 164373 1575 70762476
Atrioventricular block first degree 17.46 12.14 3 164390 11670 70752381
Liver scan abnormal 17.46 12.14 6 164387 47 70764004
Vulvovaginal inflammation 17.38 12.14 12 164381 480 70763571
Taste disorder 17.36 12.14 62 164331 11323 70752728
Product storage error 17.35 12.14 6 164387 14535 70749516
Blood pressure immeasurable 17.32 12.14 22 164371 1930 70762121
Haematoma 17.30 12.14 56 164337 48362 70715689
Chemotherapy 17.25 12.14 20 164373 1596 70762455
Lymphadenopathy 17.23 12.14 181 164212 48610 70715441
Sciatica 17.18 12.14 19 164374 24608 70739443
Blast cells present 17.15 12.14 15 164378 853 70763198
Hypophysitis 17.07 12.14 31 164362 3727 70760324
Hypophagia 17.01 12.14 159 164234 41411 70722640
Non-small cell lung cancer stage IV 16.99 12.14 10 164383 302 70763749
Tumour cavitation 16.97 12.14 5 164388 22 70764029
Breast ulceration 16.93 12.14 6 164387 52 70763999
Portal vein thrombosis 16.90 12.14 38 164355 5324 70758727
Neutrophil count abnormal 16.87 12.14 28 164365 3133 70760918
Product quality issue 16.85 12.14 28 164365 30533 70733518
Glomerular vascular disorder 16.85 12.14 8 164385 154 70763897
Pulmonary hypoplasia 16.83 12.14 6 164387 53 70763998
Plethoric face 16.79 12.14 5 164388 23 70764028
Ulcer 16.76 12.14 21 164372 25733 70738318
Non-small cell lung cancer recurrent 16.76 12.14 7 164386 98 70763953
Choriocarcinoma 16.71 12.14 8 164385 157 70763894
Pulmonary vein stenosis 16.71 12.14 8 164385 157 70763894
Obstruction gastric 16.71 12.14 19 164374 1485 70762566
Schizophrenia 16.70 12.14 9 164384 16759 70747292
Hepatic vein thrombosis 16.61 12.14 9 164384 231 70763820
Respiratory failure 16.53 12.14 510 163883 168225 70595826
End stage renal disease 16.35 12.14 3 164390 11130 70752921
Double hit lymphoma 16.35 12.14 6 164387 58 70763993
Hernia 16.29 12.14 7 164386 14853 70749198
Obstructive airways disorder 16.26 12.14 22 164371 26091 70737960
Angiosarcoma metastatic 16.26 12.14 6 164387 59 70763992
Hypercholesterolaemia 16.26 12.14 11 164382 18106 70745945
Lung squamous cell carcinoma metastatic 16.26 12.14 6 164387 59 70763992
Vaginal cuff dehiscence 16.25 12.14 4 164389 7 70764044
Influenza like illness 16.22 12.14 87 164306 65244 70698807
Discontinued product administered 16.17 12.14 6 164387 60 70763991
Protein urine 16.13 12.14 18 164375 1378 70762673
Bladder cancer 16.11 12.14 10 164383 17232 70746819
Dermatitis 16.02 12.14 88 164305 19329 70744722
Mania 15.99 12.14 10 164383 17164 70746887
Acute respiratory distress syndrome 15.99 12.14 156 164237 41098 70722953
Apathy 15.88 12.14 4 164389 11904 70752147
Lymphoma 15.84 12.14 8 164385 15454 70748597
TP53 gene mutation 15.83 12.14 5 164388 29 70764022
Brachydactyly 15.83 12.14 5 164388 29 70764022
Keratitis 15.82 12.14 30 164363 3727 70760324
Pancreatitis 15.81 12.14 83 164310 62585 70701466
Cognitive disorder 15.79 12.14 80 164313 60876 70703175
Arteriosclerosis coronary artery 15.72 12.14 9 164384 16206 70747845
Renal cancer 15.65 12.14 4 164389 11792 70752259
Onychalgia 15.62 12.14 14 164379 822 70763229
Blood magnesium decreased 15.59 12.14 72 164321 14769 70749282
Campylobacter test positive 15.58 12.14 6 164387 67 70763984
Median nerve injury 15.55 12.14 5 164388 31 70764020
Progressive multifocal leukoencephalopathy 15.53 12.14 13 164380 19201 70744850
Arrhythmia 15.52 12.14 72 164321 56071 70707980
Immune-mediated hypothyroidism 15.52 12.14 10 164383 356 70763695
Prescribed underdose 15.48 12.14 16 164377 21369 70742682
Miller Fisher syndrome 15.44 12.14 8 164385 187 70763864
Depressed mood 15.44 12.14 51 164342 43769 70720282
Tidal volume decreased 15.42 12.14 6 164387 69 70763982
Laryngeal cancer stage III 15.41 12.14 5 164388 32 70764019
Dysentery 15.41 12.14 15 164378 979 70763072
Intestinal ischaemia 15.34 12.14 62 164331 12002 70752049
Bone erosion 15.32 12.14 8 164385 15165 70748886
Ecchymosis 15.32 12.14 7 164386 14325 70749726
Coagulopathy 15.25 12.14 34 164359 33215 70730836
Radiation pericarditis 15.21 12.14 3 164390 0 70764051
Ankyloglossia acquired 15.21 12.14 3 164390 0 70764051
Therapy non-responder 15.17 12.14 110 164283 76805 70687246
Adenocarcinoma of appendix 15.12 12.14 6 164387 73 70763978
Immune-mediated cholangitis 15.07 12.14 7 164386 128 70763923
Clonal haematopoiesis 15.03 12.14 5 164388 35 70764016
Blood pressure diastolic increased 14.98 12.14 5 164388 12386 70751665
Fatigue 14.95 12.14 2153 162240 822166 69941885
Pneumothorax spontaneous 14.87 12.14 17 164376 1336 70762715
Metastases to ovary 14.83 12.14 9 164384 288 70763763
Duodenal obstruction 14.82 12.14 10 164383 385 70763666
Blood creatinine decreased 14.79 12.14 44 164349 7305 70756746
Pneumoperitoneum 14.76 12.14 25 164368 2844 70761207
Pollakiuria 14.71 12.14 35 164358 33426 70730625
Fistula 14.70 12.14 57 164336 10824 70753227
Osteolysis 14.69 12.14 28 164365 3491 70760560
Uterine adhesions 14.68 12.14 5 164388 38 70764013
Hypotension 14.61 12.14 1107 163286 403274 70360777
Brachiocephalic vein thrombosis 14.60 12.14 8 164385 210 70763841
Hypercalcaemia of malignancy 14.53 12.14 10 164383 398 70763653
Invasive lobular breast carcinoma 14.51 12.14 12 164381 632 70763419
Glomerular filtration rate decreased 14.50 12.14 16 164377 20740 70743311
Metastases to abdominal wall 14.45 12.14 7 164386 141 70763910
Diverticulitis 14.41 12.14 49 164344 41685 70722366
Endometrial cancer metastatic 14.35 12.14 5 164388 41 70764010
Cannabinoid hyperemesis syndrome 14.35 12.14 5 164388 41 70764010
Thinking abnormal 14.33 12.14 5 164388 12046 70752005
Secretion discharge 14.33 12.14 6 164387 12927 70751124
Odynophagia 14.32 12.14 54 164339 10121 70753930
Metastatic malignant melanoma 14.24 12.14 26 164367 3138 70760913
Ankle fracture 14.20 12.14 9 164384 15335 70748716
Diverticulum 14.16 12.14 7 164386 13686 70750365
Carbohydrate antigen 15-3 14.11 12.14 6 164387 88 70763963
Superinfection bacterial 14.09 12.14 16 164377 1248 70762803
Frequent bowel movements 14.02 12.14 17 164376 21136 70742915
Intentional product use issue 14.01 12.14 195 164198 119947 70644104
Lung infiltration 14.00 12.14 92 164301 21532 70742519
Peritoneal disorder 14.00 12.14 12 164381 664 70763387
Meibomian gland dysfunction 13.98 12.14 7 164386 152 70763899
Needle issue 13.92 12.14 4 164389 10911 70753140
Ovarian cancer stage III 13.92 12.14 8 164385 231 70763820
Breast cellulitis 13.90 12.14 9 164384 323 70763728
Pseudocyst 13.90 12.14 9 164384 323 70763728
Steatorrhoea 13.90 12.14 13 164380 807 70763244
Pulmonary hypertension 13.88 12.14 58 164335 46478 70717573
Hypergeusia 13.88 12.14 4 164389 16 70764035
Skin cancer 13.87 12.14 7 164386 13529 70750522
Carcinoembryonic antigen 13.87 12.14 6 164387 92 70763959
Coronary artery occlusion 13.85 12.14 8 164385 14337 70749714
Post procedural fistula 13.85 12.14 8 164385 233 70763818
Vascular pseudoaneurysm ruptured 13.81 12.14 7 164386 156 70763895
Vision blurred 13.80 12.14 147 164246 94837 70669214
Haemodialysis 13.73 12.14 12 164381 17354 70746697
Lymphocele 13.72 12.14 18 164375 1631 70762420
Subclavian artery occlusion 13.69 12.14 7 164386 159 70763892
Metastases to vagina 13.68 12.14 4 164389 17 70764034
Ear pain 13.68 12.14 27 164366 27572 70736479
Electrocardiogram QRS complex prolonged 13.65 12.14 3 164390 9803 70754248
Dandy-Walker syndrome 13.65 12.14 5 164388 48 70764003
Pulmonary artery occlusion 13.65 12.14 5 164388 48 70764003
Xeroderma 13.58 12.14 8 164385 242 70763809
Renal disorder 13.56 12.14 44 164349 37965 70726086
Rhinorrhoea 13.54 12.14 94 164299 66277 70697774
Tumour hyperprogression 13.54 12.14 7 164386 163 70763888
Upper-airway cough syndrome 13.50 12.14 3 164390 9728 70754323
Vitamin D deficiency 13.50 12.14 6 164387 12481 70751570
Bladder necrosis 13.50 12.14 4 164389 18 70764033
Aortic dissection rupture 13.50 12.14 4 164389 18 70764033
Porokeratosis 13.43 12.14 8 164385 247 70763804
Mucosal infection 13.39 12.14 10 164383 453 70763598
Increased tendency to bruise 13.39 12.14 3 164390 9672 70754379
Laryngeal oedema 13.35 12.14 43 164350 7452 70756599
Uveitis 13.34 12.14 9 164384 14836 70749215
Lupus-like syndrome 13.32 12.14 5 164388 11510 70752541
Abnormal dreams 13.31 12.14 4 164389 10599 70753452
Systemic toxicity 13.31 12.14 6 164387 102 70763949
Acute pulmonary oedema 13.31 12.14 64 164329 13348 70750703
Cardiac failure 13.30 12.14 431 163962 143110 70620941
Eye irritation 13.23 12.14 13 164380 17775 70746276
Productive cough 13.16 12.14 117 164276 78220 70685831
Acquired amegakaryocytic thrombocytopenia 13.16 12.14 4 164389 20 70764031
Blood glucose abnormal 13.15 12.14 3 164390 9554 70754497
Toxic neuropathy 13.14 12.14 13 164380 865 70763186
Neoplasm 13.14 12.14 44 164349 7780 70756271
Vaginal perforation 13.14 12.14 3 164390 3 70764048
Ulcerated haemangioma 13.14 12.14 3 164390 3 70764048
Peritoneal lesion 13.14 12.14 3 164390 3 70764048
Breast prosthesis removal 13.14 12.14 3 164390 3 70764048
Type 1 lepra reaction 13.13 12.14 5 164388 54 70763997
Tumour perforation 13.10 12.14 9 164384 357 70763694
Restless legs syndrome 13.10 12.14 14 164379 18414 70745637
Diabetic ketoacidosis 13.05 12.14 34 164359 31478 70732573
Tumour invasion 13.04 12.14 9 164384 360 70763691
Ototoxicity 13.03 12.14 24 164369 2917 70761134
Generalised tonic-clonic seizure 13.01 12.14 51 164342 41610 70722441
Portal venous gas 12.97 12.14 9 164384 363 70763688
Obstructive shock 12.97 12.14 5 164388 56 70763995
Immune-mediated renal disorder 12.85 12.14 6 164387 111 70763940
Mediastinal fibrosis 12.84 12.14 4 164389 22 70764029
Pulpitis dental 12.83 12.14 14 164379 1045 70763006
Cholecystitis chronic 12.79 12.14 3 164390 9373 70754678
CSF white blood cell count decreased 12.69 12.14 4 164389 23 70764028
Blood loss anaemia 12.65 12.14 9 164384 14432 70749619
Metastases to adrenals 12.64 12.14 15 164378 1227 70762824
Infusion site hypersensitivity 12.55 12.14 4 164389 24 70764027
Haemolytic anaemia 12.47 12.14 74 164319 16720 70747331
Thrombotic thrombocytopenic purpura 12.45 12.14 37 164356 6140 70757911
Thrombocytosis 12.39 12.14 43 164350 7741 70756310
Injection site induration 12.38 12.14 3 164390 9165 70754886
Stent malfunction 12.30 12.14 5 164388 65 70763986
Larynx irritation 12.29 12.14 6 164387 123 70763928
Hereditary motor and sensory neuropathy 12.29 12.14 6 164387 123 70763928
Radiation dysphagia 12.28 12.14 3 164390 5 70764046
Organising pneumonia 12.26 12.14 51 164342 9999 70754052
Poor venous access 12.26 12.14 10 164383 14961 70749090
Nasal disorder 12.19 12.14 25 164368 3289 70760762
Blood alkaline phosphatase increased 12.17 12.14 197 164196 58324 70705727
Jugular vein thrombosis 12.17 12.14 28 164365 3982 70760069
Metastases to uterus 12.17 12.14 5 164388 67 70763984
Lung squamous cell carcinoma stage III 12.15 12.14 4 164389 27 70764024

FDA Adverse Event Reporting System (Pediatric)

None

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 antineoplastic agents
CHEBI has role CHEBI:61950 microtubule stabilizing role
CHEBI has role CHEBI:77746 Homo sapiens metabolite
MeSH PA D050256 Antimitotic Agents
MeSH PA D000972 Antineoplastic Agents, Phytogenic
MeSH PA D050257 Tubulin Modulators

Drug Use | Suggest Off label Use Form| |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




๐Ÿถ Veterinary Drug Use

None

๐Ÿถ Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 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 16729-098 INJECTION, SOLUTION 6 mg INTRAVENOUS ANDA 16 sections
Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound) HUMAN PRESCRIPTION DRUG LABEL 1 24979-710 INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION 100 mg INTRAVENOUS NDA authorized generic 32 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 47781-593 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 47781-594 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 47781-595 INJECTION, SOLUTION 300 mg INTRAVENOUS ANDA 24 sections
Paclitaxel protein-bound particles for injectable suspension (albumin-bound) HUMAN PRESCRIPTION DRUG LABEL 1 60505-6230 INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION 100 mg INTRAVENOUS NDA authorized generic 32 sections
Paclitaxel HUMAN PRESCRIPTION DRUG LABEL 1 61703-342 INJECTION, SOLUTION 6 mg INTRAVENOUS ANDA 16 sections
Paclitaxel Human Prescription Drug Label 1 62332-620 INJECTION 6 mg INTRAVENOUS ANDA 21 sections
Paclitaxel Human Prescription Drug Label 1 62332-621 INJECTION 6 mg INTRAVENOUS ANDA 21 sections
Paclitaxel Human Prescription Drug Label 1 62332-622 INJECTION 6 mg INTRAVENOUS ANDA 21 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