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 2157.01 13.12 1723 156790 80398 63250111
Neutropenia 1944.61 13.12 2286 156227 172719 63157790
Neuropathy peripheral 1866.56 13.12 1827 156686 111840 63218669
Disease progression 1523.36 13.12 1699 156814 121059 63209450
Metastases to liver 1186.72 13.12 738 157775 22901 63307608
Myelosuppression 1157.16 13.12 727 157786 22976 63307533
Febrile neutropenia 1139.32 13.12 1440 157073 117009 63213500
Metastases to bone 1131.10 13.12 686 157827 20333 63310176
Erythema 1024.51 13.12 1684 156829 174067 63156442
Flushing 976.68 13.12 1066 157447 74021 63256488
Anaemia 961.91 13.12 2203 156310 291227 63039282
Neutrophil count decreased 827.68 13.12 854 157659 55552 63274957
Metastases to lung 719.14 13.12 429 158084 12321 63318188
Palmar-plantar erythrodysaesthesia syndrome 676.94 13.12 517 157996 22498 63308011
Dyspnoea 675.50 13.12 3343 155170 657970 62672539
Neoplasm progression 661.87 13.12 620 157893 35808 63294701
Drug ineffective 622.80 13.12 1037 157476 1043728 62286781
Polyneuropathy 614.60 13.12 408 158105 14181 63316328
Joint swelling 605.77 13.12 59 158454 327607 63002902
Metastases to central nervous system 570.26 13.12 374 158139 12731 63317778
Peripheral sensory neuropathy 566.95 13.12 305 158208 7146 63323363
Thrombocytopenia 553.80 13.12 1188 157325 149969 63180540
Rheumatoid arthritis 545.78 13.12 20 158493 253799 63076710
Acute myeloid leukaemia 543.80 13.12 403 158110 16744 63313765
Neurotoxicity 506.96 13.12 385 158128 16605 63313904
Leukopenia 490.98 13.12 771 157742 76519 63253990
Contraindicated product administered 468.38 13.12 17 158496 217631 63112878
Arthropathy 465.05 13.12 31 158482 234761 63095748
Mucosal inflammation 460.72 13.12 577 157936 46351 63284158
Metastases to lymph nodes 450.96 13.12 271 158242 7887 63322622
Chest discomfort 433.63 13.12 891 157622 109078 63221431
Systemic lupus erythematosus 430.75 13.12 22 158491 208896 63121613
Pneumonitis 429.87 13.12 484 158029 34738 63295771
Ejection fraction decreased 426.67 13.12 391 158122 21941 63308568
Haematotoxicity 426.11 13.12 275 158238 9101 63321408
Synovitis 422.80 13.12 9 158504 186909 63143600
Product dose omission issue 417.90 13.12 48 158465 234265 63096244
Death 414.52 13.12 1940 156573 372441 62958068
Ascites 404.95 13.12 504 158009 40224 63290285
Glossodynia 395.46 13.12 11 158502 178865 63151644
Therapeutic product effect decreased 390.01 13.12 23 158490 193164 63137345
Anaphylactic shock 375.96 13.12 374 158139 23259 63307250
Abdominal discomfort 373.56 13.12 167 158346 320718 63009791
Fall 368.40 13.12 266 158247 392068 62938441
Swelling 355.60 13.12 122 158391 275256 63055253
Bone marrow failure 343.00 13.12 394 158119 28896 63301613
Completed suicide 342.07 13.12 4 158509 145669 63184840
Pain 338.53 13.12 854 157659 739774 62590735
Sinusitis 336.06 13.12 77 158436 226576 63103933
Breast cancer metastatic 333.76 13.12 261 158252 11757 63318752
Condition aggravated 326.68 13.12 314 158199 401903 62928606
Myelodysplastic syndrome 319.37 13.12 293 158220 16461 63314048
Epistaxis 306.51 13.12 606 157907 72119 63258390
Proteinuria 306.41 13.12 304 158209 18841 63311668
Pseudocirrhosis 301.46 13.12 99 158414 608 63329901
Headache 301.02 13.12 715 157798 632526 62697983
Second primary malignancy 300.56 13.12 208 158305 7745 63322764
Weight increased 290.65 13.12 144 158369 260648 63069861
Interstitial lung disease 284.31 13.12 535 157978 61373 63269136
Musculoskeletal stiffness 281.16 13.12 59 158454 184559 63145950
Cystoid macular oedema 280.56 13.12 116 158397 1459 63329050
Bronchospasm 277.68 13.12 275 158238 17005 63313504
Metastases to peritoneum 276.21 13.12 146 158367 3296 63327213
Pleural effusion 271.82 13.12 670 157843 92540 63237969
Feeling hot 269.30 13.12 465 158048 49889 63280620
Drug intolerance 252.72 13.12 239 158274 308422 63022087
Peripheral swelling 245.87 13.12 183 158330 265759 63064750
Wound 244.86 13.12 54 158459 163209 63167300
Product use issue 242.30 13.12 124 158389 220396 63110113
Skin toxicity 241.06 13.12 149 158364 4565 63325944
Treatment failure 240.35 13.12 98 158415 198945 63131564
Onycholysis 236.78 13.12 104 158409 1532 63328977
Gastrointestinal perforation 235.49 13.12 132 158381 3359 63327150
Arthralgia 234.95 13.12 690 157823 569020 62761489
Back pain 230.21 13.12 1281 157232 262864 63067645
Pericarditis 222.27 13.12 32 158481 131547 63198962
Platelet count decreased 220.00 13.12 714 157799 115408 63215101
Therapy partial responder 218.09 13.12 194 158319 10464 63320045
Diarrhoea 215.93 13.12 2727 155786 712639 62617870
Hypertension 214.50 13.12 1310 157203 277993 63052516
Helicobacter infection 211.58 13.12 4 158509 92781 63237728
Ovarian cancer recurrent 208.98 13.12 83 158430 934 63329575
Nasopharyngitis 207.90 13.12 197 158316 254060 63076449
Bone pain 201.50 13.12 431 158082 54210 63276299
White blood cell count decreased 201.44 13.12 783 157730 138321 63192188
Blood cholesterol increased 199.90 13.12 8 158505 94024 63236485
Hypertransaminasaemia 197.64 13.12 150 158363 6459 63324050
General physical health deterioration 197.36 13.12 1009 157504 200393 63130116
Nausea 196.36 13.12 3104 155409 851367 62479142
Hepatic enzyme increased 193.77 13.12 134 158379 202194 63128315
Vomiting 191.65 13.12 2186 156327 557431 62773078
Cardiotoxicity 191.63 13.12 163 158350 8275 63322234
Mobility decreased 187.98 13.12 37 158476 121122 63209387
Duodenal ulcer perforation 186.81 13.12 7 158506 87202 63243307
PIK3CA-activated mutation 185.27 13.12 77 158436 982 63329527
Cardiac dysfunction 185.20 13.12 98 158415 2217 63328292
Pyrexia 183.26 13.12 1886 156627 468592 62861917
Irritable bowel syndrome 182.30 13.12 5 158508 82407 63248102
Metastasis 178.01 13.12 128 158385 5069 63325440
Fibromyalgia 177.44 13.12 5 158508 80415 63250094
Injection site pain 177.16 13.12 52 158461 129748 63200761
Discomfort 176.64 13.12 99 158414 167275 63163234
Maternal exposure during pregnancy 175.81 13.12 174 158339 219888 63110621
Hypokalaemia 175.15 13.12 614 157899 103190 63227319
Embolism 174.00 13.12 150 158363 7756 63322753
Contusion 172.93 13.12 79 158434 149965 63180544
Migraine 170.25 13.12 27 158486 103319 63227190
Hypoxia 169.18 13.12 425 158088 59367 63271142
Psoriasis 164.86 13.12 14 158499 86943 63243566
Sense of oppression 164.79 13.12 70 158443 946 63329563
Loss of personal independence in daily activities 163.51 13.12 24 158489 97266 63233243
Metastases to meninges 161.03 13.12 93 158420 2509 63328000
Abdominal pain 158.88 13.12 1264 157249 292192 63038317
Osteonecrosis of jaw 156.82 13.12 300 158213 34823 63295686
Drug abuse 154.71 13.12 6 158507 72512 63257997
Breast cancer recurrent 153.47 13.12 109 158404 4232 63326277
Tachycardia 151.83 13.12 641 157872 117515 63212994
Lymphangiosis carcinomatosa 150.16 13.12 73 158440 1372 63329137
Hospitalisation 150.11 13.12 18 158495 85063 63245446
Overdose 148.33 13.12 51 158462 115027 63215482
Hepatic failure 147.59 13.12 295 158218 35361 63295148
Depression 143.95 13.12 167 158346 196325 63134184
Oxygen saturation decreased 143.44 13.12 517 157996 88068 63242441
Arthritis 143.26 13.12 55 158458 115866 63214643
Neutropenic sepsis 142.28 13.12 190 158323 16248 63314261
Asthma 141.11 13.12 71 158442 127490 63203019
Pulmonary embolism 139.18 13.12 619 157894 116065 63214444
Suicide attempt 137.39 13.12 3 158510 60915 63269594
Exposure during pregnancy 137.33 13.12 112 158401 155435 63175074
Left ventricular dysfunction 136.52 13.12 159 158354 11829 63318680
Influenza 135.33 13.12 51 158462 108671 63221838
Disease recurrence 132.07 13.12 245 158268 27785 63302724
Blister 130.98 13.12 81 158432 129733 63200776
Somnolence 130.74 13.12 152 158361 178533 63151976
Cyanosis 130.41 13.12 185 158328 16750 63313759
Dehydration 130.29 13.12 809 157704 172545 63157964
Drug hypersensitivity 127.91 13.12 376 158137 310311 63020198
Pancytopenia 126.17 13.12 528 157985 96405 63234104
Injection site erythema 125.68 13.12 27 158486 83147 63247362
Lower respiratory tract infection 122.19 13.12 91 158422 132216 63198293
Cholangitis 121.35 13.12 105 158408 5456 63325053
Nail disorder 121.27 13.12 156 158357 12859 63317650
Decreased appetite 121.16 13.12 1054 157459 249998 63080511
Asthenia 120.55 13.12 1475 157038 382129 62948380
Throat tightness 120.36 13.12 220 158293 24667 63305842
Large intestine perforation 119.92 13.12 126 158387 8356 63322153
Osteoarthritis 119.88 13.12 44 158469 95299 63235210
Confusional state 117.39 13.12 260 158253 236120 63094389
Nail discolouration 116.01 13.12 77 158436 2673 63327836
Biliary tract infection 115.96 13.12 49 158464 653 63329856
Metastases to skin 115.22 13.12 64 158449 1599 63328910
Pneumocystis jirovecii pneumonia 114.66 13.12 174 158339 16740 63313769
Injury 114.37 13.12 22 158491 73225 63257284
Intestinal perforation 112.43 13.12 144 158369 11819 63318690
Peripheral motor neuropathy 111.86 13.12 63 158450 1618 63328891
Memory impairment 110.92 13.12 61 158452 104197 63226312
Hepatic function abnormal 110.31 13.12 269 158244 36873 63293636
Injection site reaction 109.36 13.12 10 158503 58514 63271995
Paraesthesia 108.96 13.12 718 157795 156248 63174261
Ileus 107.73 13.12 157 158356 14568 63315941
Nail toxicity 106.34 13.12 38 158475 311 63330198
Gait disturbance 106.05 13.12 184 158329 182994 63147515
Folliculitis 103.88 13.12 24 158489 70293 63260216
Feeling abnormal 102.44 13.12 132 158381 148260 63182249
Hepatic atrophy 102.30 13.12 35 158478 248 63330261
C-reactive protein abnormal 101.19 13.12 3 158510 46093 63284416
Cardiomyopathy 100.07 13.12 167 158346 17417 63313092
Metastases to spine 99.94 13.12 75 158438 3174 63327335
Metastases to pleura 99.01 13.12 57 158456 1528 63328981
Toxicity to various agents 99.00 13.12 303 158210 246947 63083562
Gastrointestinal toxicity 98.91 13.12 109 158404 7632 63322877
Hydronephrosis 98.09 13.12 127 158386 10535 63319974
Injection site swelling 97.98 13.12 5 158508 47567 63282942
Muscle spasms 97.73 13.12 149 158364 156001 63174508
Computerised tomogram thorax abnormal 95.96 13.12 58 158455 1705 63328804
Laryngospasm 95.60 13.12 71 158442 2957 63327552
Intentional product misuse 93.63 13.12 19 158494 60898 63269611
Metastatic neoplasm 93.52 13.12 81 158432 4214 63326295
Urogenital fistula 93.23 13.12 31 158482 199 63330310
Tumour necrosis 93.08 13.12 44 158469 775 63329734
Red blood cell sedimentation rate increased 92.60 13.12 4 158509 43978 63286531
Insomnia 92.57 13.12 255 158258 214997 63115512
Injection site pruritus 92.10 13.12 5 158508 45111 63285398
Tumour marker increased 89.87 13.12 84 158429 4831 63325678
Cardiac failure 87.44 13.12 447 158066 88695 63241814
Small intestinal obstruction 87.28 13.12 161 158352 18176 63312333
Anaphylactic reaction 85.16 13.12 359 158154 65741 63264768
Illness 85.01 13.12 11 158502 49048 63281461
Hepatitis B reactivation 84.66 13.12 67 158446 3070 63327439
Malignant pleural effusion 84.29 13.12 62 158451 2544 63327965
COVID-19 84.00 13.12 95 158418 113008 63217501
Subileus 83.87 13.12 67 158446 3112 63327397
Suicidal ideation 83.34 13.12 26 158487 62395 63268114
Drug interaction 82.61 13.12 294 158219 228837 63101672
Thrombotic microangiopathy 82.24 13.12 116 158397 10445 63320064
Type 2 diabetes mellitus 81.08 13.12 29 158484 63839 63266670
Posterior reversible encephalopathy syndrome 80.94 13.12 151 158362 17194 63313315
Colitis 80.89 13.12 286 158227 48242 63282267
Dysaesthesia 80.85 13.12 76 158437 4402 63326107
Incorrect dose administered 80.02 13.12 25 158488 59943 63270566
Osteoporosis 80.00 13.12 22 158491 57316 63273193
Tumour haemorrhage 79.47 13.12 50 158463 1581 63328928
Acute promyelocytic leukaemia 79.17 13.12 41 158472 886 63329623
Wheezing 78.10 13.12 74 158439 95521 63234988
Sleep disorder 78.04 13.12 54 158459 81512 63248997
Recall phenomenon 77.20 13.12 36 158477 614 63329895
Anaphylactoid reaction 76.63 13.12 68 158445 3655 63326854
Bronchitis 76.46 13.12 121 158392 124814 63205695
Alveolitis 75.98 13.12 61 158452 2854 63327655
Pain in extremity 75.48 13.12 501 158012 330985 62999524
Macular oedema 74.26 13.12 68 158445 3809 63326700
Paronychia 73.95 13.12 80 158433 5485 63325024
Radiation pneumonitis 73.32 13.12 47 158466 1536 63328973
Fluid retention 72.60 13.12 29 158484 59657 63270852
Urticaria 72.32 13.12 195 158318 165607 63164902
Immune-mediated hepatic disorder 72.15 13.12 32 158481 483 63330026
Atelectasis 71.85 13.12 163 158350 21320 63309189
Portal hypertension 71.24 13.12 66 158447 3753 63326756
Secondary cerebellar degeneration 70.26 13.12 19 158494 51 63330458
Sepsis 70.22 13.12 636 157877 152487 63178022
Therapeutic product effect incomplete 70.20 13.12 128 158385 124928 63205581
Ear infection 70.15 13.12 7 158506 38206 63292303
Carbohydrate antigen 15-3 increased 69.58 13.12 44 158469 1404 63329105
Adverse drug reaction 68.35 13.12 59 158454 79655 63250854
Blood pressure fluctuation 68.03 13.12 16 158497 46301 63284208
Pneumothorax 67.83 13.12 135 158378 16126 63314383
Metastases to the mediastinum 67.33 13.12 30 158483 458 63330051
Computerised tomogram thorax 66.46 13.12 29 158484 420 63330089
Abortion spontaneous 66.04 13.12 18 158495 47177 63283332
Hypomagnesaemia 65.86 13.12 189 158324 28548 63301961
Device related infection 64.81 13.12 165 158348 23227 63307282
Dizziness 64.68 13.12 724 157789 429201 62901308
Neoplasm recurrence 64.11 13.12 53 158460 2585 63327924
Lymphoedema 63.82 13.12 109 158404 11583 63318926
Recurrent cancer 63.65 13.12 47 158466 1940 63328569
Metastases to kidney 63.55 13.12 23 158490 196 63330313
Anxiety 63.48 13.12 303 158210 217238 63113271
Type I hypersensitivity 63.08 13.12 55 158458 2887 63327622
Small intestinal perforation 62.89 13.12 42 158471 1473 63329036
Superior vena cava syndrome 62.83 13.12 32 158481 667 63329842
Neutropenic colitis 62.65 13.12 56 158457 3039 63327470
Cholangitis sclerosing 62.19 13.12 43 158470 1598 63328911
Metastases to retroperitoneum 62.10 13.12 21 158492 143 63330366
Palmar erythema 61.61 13.12 44 158469 1723 63328786
Pericardial effusion 61.58 13.12 190 158323 29868 63300641
Capillary leak syndrome 61.55 13.12 48 158465 2152 63328357
Bronchostenosis 61.55 13.12 28 158485 450 63330059
Cataract 61.22 13.12 33 158480 57020 63273489
Prescribed overdose 60.79 13.12 7 158506 34146 63296363
Hot flush 60.64 13.12 271 158242 50888 63279621
Hyperaemia 60.43 13.12 48 158465 2211 63328298
Tumour lysis syndrome 60.25 13.12 92 158421 8898 63321611
Medication error 59.47 13.12 28 158485 52256 63278253
Gait inability 59.26 13.12 29 158484 52930 63277579
Urinary tract obstruction 59.24 13.12 47 158466 2161 63328348
Constipation 59.23 13.12 838 157675 224105 63106404
Disseminated intravascular coagulation 58.73 13.12 140 158373 18911 63311598
Hypoglycaemia 58.48 13.12 39 158474 60026 63270483
Nasal congestion 58.26 13.12 47 158466 65613 63264896
Performance status decreased 58.09 13.12 58 158455 3620 63326889
Surgery 57.75 13.12 10 158503 35902 63294607
Plasma cell myeloma 57.73 13.12 10 158503 35895 63294614
Pregnancy 57.63 13.12 11 158502 36825 63293684
Road traffic accident 57.18 13.12 11 158502 36621 63293888
Nephrolithiasis 56.92 13.12 17 158496 41967 63288542
Hypertensive crisis 56.81 13.12 121 158392 15165 63315344
Gastric disorder 56.71 13.12 12 158501 37357 63293152
Unevaluable event 56.20 13.12 29 158484 51357 63279152
Drug reaction with eosinophilia and systemic symptoms 55.34 13.12 9 158504 33827 63296682
Carbohydrate antigen 125 increased 55.12 13.12 50 158463 2766 63327743
Malignant ascites 55.05 13.12 32 158481 874 63329635
Immune-mediated enterocolitis 54.65 13.12 44 158469 2067 63328442
Joint range of motion decreased 54.46 13.12 8 158505 32420 63298089
Device related thrombosis 54.45 13.12 41 158472 1744 63328765
Hallucination 54.17 13.12 35 158478 54782 63275727
Acute interstitial pneumonitis 54.06 13.12 29 158484 675 63329834
Impaired healing 54.01 13.12 109 158404 102433 63228076
Hepatic lesion 53.28 13.12 63 158450 4762 63325747
Hyperpyrexia 53.22 13.12 55 158458 3577 63326932
Infusion related hypersensitivity reaction 51.97 13.12 21 158492 248 63330261
Basal cell carcinoma 51.71 13.12 5 158508 27986 63302523
Respiratory distress 51.43 13.12 194 158319 33757 63296752
Swollen tongue 51.15 13.12 12 158501 34788 63295721
Carcinoembryonic antigen increased 50.45 13.12 39 158474 1726 63328783
Bile duct stenosis 50.18 13.12 34 158479 1222 63329287
Extravasation 50.17 13.12 44 158469 2328 63328181
Gastrooesophageal reflux disease 50.08 13.12 102 158411 95537 63234972
Eczema asteatotic 50.03 13.12 21 158492 275 63330234
Adverse event 49.87 13.12 57 158456 67502 63263007
Drug resistance 49.83 13.12 148 158365 22785 63307724
Aortitis 49.67 13.12 32 158481 1055 63329454
Metastases to pelvis 49.56 13.12 24 158489 447 63330062
Breast cancer 49.10 13.12 245 158268 48138 63282371
Drug dependence 49.09 13.12 3 158510 24480 63306029
Transaminases increased 48.98 13.12 181 158332 31186 63299323
Bursitis 48.43 13.12 16 158497 37025 63293484
Serotonin syndrome 48.35 13.12 7 158506 28675 63301834
Joint stiffness 48.27 13.12 22 158491 41847 63288662
Enterocolitis infectious 48.19 13.12 37 158476 1621 63328888
Subclavian vein thrombosis 48.09 13.12 39 158474 1851 63328658
Amnesia 47.82 13.12 41 158472 55544 63274965
Hip arthroplasty 47.66 13.12 30 158483 47616 63282893
Stress cardiomyopathy 47.55 13.12 85 158428 9365 63321144
Hypersensitivity 47.22 13.12 1008 157505 291677 63038832
Metastases to chest wall 47.14 13.12 25 158488 568 63329941
Biliary sepsis 46.52 13.12 29 158484 902 63329607
Bone lesion 46.39 13.12 65 158448 5816 63324693
Inappropriate schedule of product administration 46.28 13.12 121 158392 103844 63226665
Stress 46.06 13.12 60 158453 67107 63263402
Multiple sclerosis 45.97 13.12 4 158509 24368 63306141
Coronary artery disease 45.96 13.12 12 158501 32365 63298144
Coma 45.70 13.12 56 158457 64308 63266201
Hypoalbuminaemia 45.67 13.12 95 158418 11710 63318799
Suffocation feeling 45.66 13.12 33 158480 1317 63329192
Intestinal obstruction 45.52 13.12 175 158338 30724 63299785
Chronic obstructive pulmonary disease 45.08 13.12 54 158459 62632 63267877
Toxic erythema of chemotherapy 44.98 13.12 16 158497 129 63330380
Pulmonary arterial hypertension 44.58 13.12 3 158510 22574 63307935
Pruritus 44.13 13.12 636 157877 360817 62969692
Infusion related reaction 44.03 13.12 859 157654 244662 63085847
Tumour associated fever 43.93 13.12 20 158493 322 63330187
Lymphadenopathy mediastinal 43.83 13.12 44 158469 2764 63327745
Bone marrow infiltration 43.80 13.12 25 158488 659 63329850
Inflammation 43.71 13.12 87 158426 82186 63248323
Lymphopenia 43.42 13.12 122 158391 18205 63312304
Night sweats 43.23 13.12 35 158478 48779 63281730
Nervousness 43.00 13.12 12 158501 30967 63299542
Product prescribing error 42.98 13.12 7 158506 26282 63304227
Dysgeusia 42.87 13.12 230 158283 46480 63284029
Muscle spasticity 42.73 13.12 3 158510 21791 63308718
Oesophagobronchial fistula 42.68 13.12 12 158501 39 63330470
Rash pruritic 42.49 13.12 52 158461 59747 63270762
Wrong technique in product usage process 42.43 13.12 56 158457 62284 63268225
Pleural neoplasm 42.37 13.12 20 158493 351 63330158
Foot deformity 42.15 13.12 9 158504 27844 63302665
Deep vein thrombosis 41.98 13.12 355 158158 83445 63247064
Psychotic disorder 41.69 13.12 7 158506 25705 63304804
Dyskinesia 41.53 13.12 14 158499 31988 63298521
Febrile infection 41.47 13.12 33 158480 1524 63328985
Cerebrovascular accident 41.33 13.12 135 158378 107889 63222620
Periodontitis 41.32 13.12 46 158467 3257 63327252
Incorrect route of product administration 41.28 13.12 9 158504 27443 63303066
Endocarditis noninfective 41.15 13.12 12 158501 46 63330463
Neutrophil count abnormal 40.95 13.12 43 158470 2849 63327660
Hypotension 40.84 13.12 929 157584 271675 63058834
Therapy interrupted 40.74 13.12 15 158498 32440 63298069
Acute myelomonocytic leukaemia 40.53 13.12 16 158497 177 63330332
Ill-defined disorder 40.46 13.12 90 158423 81665 63248844
Anastomotic leak 40.46 13.12 21 158492 456 63330053
Prescribed underdose 40.29 13.12 12 158501 29677 63300832
Myocardial infarction 40.22 13.12 122 158391 99771 63230738
Alanine aminotransferase increased 40.15 13.12 416 158097 103354 63227155
Scleroderma-like reaction 40.12 13.12 13 158500 76 63330433
Guillain-Barre syndrome 39.99 13.12 49 158464 3844 63326665
Autoimmune nephritis 39.93 13.12 20 158493 402 63330107
Lymphocele 39.69 13.12 25 158488 792 63329717
Oesophagitis 39.65 13.12 104 158409 14904 63315605
Lichenoid keratosis 39.58 13.12 34 158479 1749 63328760
Metastases to breast 39.53 13.12 18 158495 290 63330219
Peritonitis 39.48 13.12 113 158400 17041 63313468
Treatment noncompliance 39.45 13.12 22 158491 37303 63293206
Metastases to abdominal wall 39.24 13.12 14 158499 114 63330395
Immune-mediated hepatitis 38.55 13.12 30 158483 1341 63329168
Lactic acidosis 38.44 13.12 24 158489 38263 63292246
Hypocalcaemia 38.34 13.12 169 158344 31544 63298965
Administration site extravasation 38.26 13.12 26 158487 939 63329570
Onychalgia 38.11 13.12 26 158487 945 63329564
Sciatica 38.09 13.12 19 158494 34305 63296204
Capillary permeability increased 37.78 13.12 10 158503 24 63330485
Metastases to stomach 37.68 13.12 16 158497 216 63330293
Blood uric acid decreased 37.64 13.12 24 158489 777 63329732
Tumour embolism 37.53 13.12 14 158499 131 63330378
Pneumonitis chemical 37.42 13.12 16 158497 220 63330289
Bradycardia 36.74 13.12 80 158433 73147 63257362
Pseudomembranous colitis 36.65 13.12 42 158471 3070 63327439
Cytopenia 36.57 13.12 86 158427 11515 63318994
Radiation skin injury 36.42 13.12 25 158488 918 63329591
Lymphadenopathy 36.40 13.12 191 158322 38267 63292242
Full blood count abnormal 36.04 13.12 17 158496 31700 63298809
Hypervolaemia 35.89 13.12 13 158500 28400 63302109
Gallbladder disorder 35.79 13.12 3 158510 18839 63311670
Obesity 35.70 13.12 15 158498 29937 63300572
Joint dislocation 35.69 13.12 3 158510 18797 63311712
Chills 35.47 13.12 436 158077 112942 63217567
Hormone receptor positive breast cancer 35.15 13.12 20 158493 524 63329985
Limb injury 35.12 13.12 10 158503 25467 63305042
Primary cardiac lymphoma 35.12 13.12 9 158504 18 63330491
Hypersensitivity pneumonitis 35.05 13.12 38 158475 2612 63327897
Fistula 34.91 13.12 79 158434 10314 63320195
Jugular vein thrombosis 34.91 13.12 41 158472 3077 63327432
Radiation necrosis 34.88 13.12 18 158495 386 63330123
Rhabdomyolysis 34.76 13.12 35 158478 43916 63286593
Disability 34.64 13.12 3 158510 18344 63312165
Injection site haemorrhage 34.53 13.12 9 158504 24305 63306204
Herpes zoster 34.43 13.12 99 158414 82363 63248146
Eye pain 34.29 13.12 21 158492 33833 63296676
Nail dystrophy 34.15 13.12 25 158488 1018 63329491
Nightmare 34.00 13.12 4 158509 19190 63311319
Metastases to soft tissue 33.93 13.12 14 158499 175 63330334
Acute erythroid leukaemia 33.85 13.12 11 158502 65 63330444
Head injury 33.82 13.12 13 158500 27383 63303126
Immune-mediated myocarditis 33.74 13.12 16 158497 284 63330225
Duodenal perforation 33.52 13.12 23 158490 844 63329665
Cachexia 33.41 13.12 55 158458 5671 63324838
Periarticular thenar erythema with onycholysis 33.38 13.12 10 158503 43 63330466
Acute megakaryocytic leukaemia 33.20 13.12 10 158503 44 63330465
Sinus disorder 33.18 13.12 10 158503 24543 63305966
Congestive cardiomyopathy 32.91 13.12 57 158456 6125 63324384
Vaginal fistula 32.83 13.12 18 158495 438 63330071
Cough 32.82 13.12 960 157553 291783 63038726
Ovarian cancer metastatic 32.81 13.12 23 158490 874 63329635
No adverse event 32.71 13.12 33 158480 41372 63289137
Wound dehiscence 32.61 13.12 50 158463 4853 63325656
Intestinal metastasis 32.60 13.12 13 158500 148 63330361
Enterocolitis 32.49 13.12 65 158448 7793 63322716
Acne 32.37 13.12 9 158504 23284 63307225
Metastases to eye 32.36 13.12 13 158500 151 63330358
International normalised ratio increased 32.32 13.12 41 158472 46384 63284125
Diabetes mellitus 32.32 13.12 56 158457 55754 63274755
Panic attack 32.23 13.12 8 158505 22323 63308186
Eosinophil percentage increased 32.20 13.12 24 158489 1005 63329504
Blood bilirubin increased 32.14 13.12 180 158333 36960 63293549
Gastrointestinal fistula 32.07 13.12 18 158495 459 63330050
Dyspnoea at rest 32.05 13.12 45 158468 4034 63326475
Tonsillar disorder 31.92 13.12 25 158488 1128 63329381
Dermatitis acneiform 31.90 13.12 50 158463 4946 63325563
Bronchial fistula 31.84 13.12 9 158504 30 63330479
Metastases to bladder 31.76 13.12 14 158499 208 63330301
Gastrointestinal necrosis 31.67 13.12 37 158476 2761 63327748
Oropharyngeal pain 31.56 13.12 125 158388 94362 63236147
Eosinophilia 31.24 13.12 9 158504 22747 63307762
Peritoneal disorder 31.22 13.12 18 158495 484 63330025
Skin laceration 31.14 13.12 9 158504 22699 63307810
Upper limb fracture 31.12 13.12 5 158508 18963 63311546
Macular degeneration 31.05 13.12 11 158502 24365 63306144
Mental disorder 30.86 13.12 13 158500 25906 63304603
Therapeutic response unexpected 30.66 13.12 5 158508 18754 63311755
Choking sensation 30.63 13.12 41 158472 3513 63326996
Bone erosion 30.63 13.12 4 158509 17713 63312796
Loss of consciousness 30.62 13.12 439 158074 117682 63212827
Cardiac cirrhosis 30.62 13.12 12 158501 130 63330379
Procedural pain 30.60 13.12 8 158505 21561 63308948
Flatulence 30.58 13.12 25 158488 34677 63295832
Pulse absent 30.52 13.12 51 158462 5323 63325186
Rectal perforation 30.49 13.12 17 158496 428 63330081
Product administration error 30.49 13.12 9 158504 22388 63308121
Kidney infection 30.32 13.12 10 158503 23166 63307343
Irritability 30.28 13.12 21 158492 31673 63298836
Impaired work ability 30.08 13.12 4 158509 17471 63313038
Cervix carcinoma recurrent 29.90 13.12 12 158501 139 63330370
Duodenitis haemorrhagic 29.65 13.12 7 158506 8 63330501
Stomatitis 29.64 13.12 499 158014 138226 63192283
Neuromuscular toxicity 29.60 13.12 12 158501 143 63330366
Dermatomyositis 29.50 13.12 36 158477 2812 63327697
Hypermetabolism 29.32 13.12 13 158500 196 63330313
Septic shock 29.12 13.12 274 158239 66355 63264154
Tumour pain 29.08 13.12 26 158487 1411 63329098
Upper respiratory tract infection 29.04 13.12 106 158407 81941 63248568
Serous cystadenocarcinoma ovary 28.93 13.12 8 158505 24 63330485
Glaucoma 28.83 13.12 6 158507 18899 63311610
Renal disorder 28.75 13.12 24 158489 32950 63297559
Infection 28.72 13.12 401 158112 228772 63101737
Adrenocorticotropic hormone deficiency 28.69 13.12 16 158497 403 63330106
Exostosis 28.66 13.12 5 158508 17857 63312652
Viral infection 28.66 13.12 28 158485 35635 63294874
Musculoskeletal disorder 28.64 13.12 8 158505 20636 63309873
Adenocarcinoma 28.49 13.12 36 158477 2914 63327595
Hepatotoxicity 28.48 13.12 174 158339 36867 63293642
Tremor 28.48 13.12 203 158310 132036 63198473
Foot fracture 28.46 13.12 12 158501 23902 63306607
Mastitis 28.46 13.12 34 158479 2598 63327911
Hyperhidrosis 28.44 13.12 402 158111 107434 63223075
Eye pruritus 28.32 13.12 6 158507 18665 63311844
Vena cava thrombosis 28.29 13.12 31 158482 2156 63328353
Cerebral ischaemia 28.23 13.12 56 158457 6672 63323837
Infected lymphocele 28.13 13.12 13 158500 217 63330292
Cancer fatigue 28.07 13.12 10 158503 81 63330428
BRAF gene mutation 28.01 13.12 9 158504 51 63330458
Blood pressure systolic increased 27.95 13.12 47 158466 47350 63283159
Cholangitis infective 27.89 13.12 15 158498 351 63330158
Pulmonary tumour thrombotic microangiopathy 27.87 13.12 9 158504 52 63330457
Product quality issue 27.86 13.12 29 158484 35836 63294673
Underdose 27.85 13.12 17 158496 27439 63303070
Blood glucose increased 27.84 13.12 111 158402 83645 63246864
Hypopituitarism 27.77 13.12 23 158490 1125 63329384
Drug level increased 27.72 13.12 11 158502 22725 63307784
Aggression 27.63 13.12 12 158501 23486 63307023
Hydrothorax 27.55 13.12 21 158492 910 63329599
Mood swings 27.40 13.12 6 158507 18242 63312267
Immune-mediated dermatitis 27.37 13.12 12 158501 176 63330333
Endometrial cancer recurrent 27.31 13.12 7 158506 14 63330495
Intentional product use issue 27.21 13.12 197 158316 127695 63202814
Immune-mediated pancreatitis 27.21 13.12 11 158502 130 63330379
Venous thrombosis 27.15 13.12 46 158467 4856 63325653
Gastroenteritis radiation 26.91 13.12 16 158497 456 63330053
Nasal septum perforation 26.76 13.12 19 158494 737 63329772
Product substitution issue 26.74 13.12 4 158509 15992 63314517
Transient ischaemic attack 26.64 13.12 33 158480 37720 63292789
Porokeratosis 26.56 13.12 11 158502 139 63330370
Protein urine 26.41 13.12 19 158494 753 63329756
Accidental exposure to product 26.39 13.12 18 158495 27387 63303122
Acute lymphocytic leukaemia 26.38 13.12 32 158481 2484 63328025
Aplasia 26.33 13.12 42 158471 4217 63326292
Metabolic acidosis 26.30 13.12 45 158468 45024 63285485
Granulocyte count decreased 26.22 13.12 23 158490 1217 63329292
Cancer pain 26.14 13.12 36 158477 3169 63327340
Scintillating scotoma 26.14 13.12 11 158502 145 63330364
Female genital tract fistula 26.00 13.12 58 158455 7501 63323008
Pneumonia 25.88 13.12 907 157606 455860 62874649
Thyroid dermatopathy 25.83 13.12 7 158506 19 63330490
Double hit lymphoma 25.83 13.12 6 158507 6 63330503
Live birth 25.82 13.12 16 158497 25614 63304895
Accidental overdose 25.72 13.12 13 158500 23296 63307213
Aspartate aminotransferase increased 25.62 13.12 341 158172 89936 63240573
TP53 gene mutation 25.57 13.12 8 158505 41 63330468
Laboratory test abnormal 25.49 13.12 18 158495 26894 63303615
Oligoastrocytoma 25.32 13.12 7 158506 21 63330488
Thyroiditis 25.27 13.12 31 158482 2435 63328074
Sinus congestion 25.19 13.12 7 158506 18116 63312393
Hypersomnia 25.05 13.12 7 158506 18048 63312461
Neck pain 24.90 13.12 89 158424 69229 63261280
Haemolytic uraemic syndrome 24.90 13.12 31 158482 2472 63328037
Neoplasm 24.86 13.12 56 158457 7289 63323220
Joint effusion 24.84 13.12 6 158507 17054 63313455
Pelvic infection 24.74 13.12 14 158499 363 63330146
Ankle fracture 24.62 13.12 7 158506 17848 63312661
Device dislocation 24.60 13.12 17 158496 25688 63304821
Osteolysis 24.53 13.12 33 158480 2841 63327668
Electrocardiogram QT prolonged 24.46 13.12 72 158441 59458 63271051
Haemoglobin 24.39 13.12 11 158502 173 63330336
Tooth erosion 24.31 13.12 15 158498 458 63330051
Acute monocytic leukaemia 24.24 13.12 10 158503 125 63330384
Embryonal rhabdomyosarcoma 24.11 13.12 6 158507 10 63330499
Blast cells present 24.11 13.12 15 158498 465 63330044
Eastern Cooperative Oncology Group performance status worsened 24.03 13.12 22 158491 1232 63329277
Poisoning 23.91 13.12 3 158510 13697 63316812
Delirium 23.90 13.12 57 158456 50484 63280025
Laryngeal discomfort 23.87 13.12 13 158500 312 63330197
Respiratory failure 23.84 13.12 372 158141 101486 63229023
Gastric perforation 23.84 13.12 25 158488 1654 63328855
Blood potassium increased 23.77 13.12 8 158505 18301 63312208
Portal vein thrombosis 23.68 13.12 31 158482 2599 63327910
Pelvic pain 23.67 13.12 81 158432 13438 63317071
Blood alkaline phosphatase increased 23.66 13.12 186 158327 42781 63287728
Pelvic abscess 23.60 13.12 25 158488 1673 63328836
Cardiac murmur 23.51 13.12 4 158509 14548 63315961
Blood pressure diastolic abnormal 23.49 13.12 4 158509 14538 63315971
Erythema multiforme 23.41 13.12 67 158446 10102 63320407
Autoimmune cholangitis 23.41 13.12 6 158507 12 63330497
Glomerular vascular disorder 23.35 13.12 8 158505 57 63330452
Chest pain 23.31 13.12 705 157808 215254 63115255
Right ventricular failure 23.22 13.12 7 158506 17181 63313328
Vocal cord paralysis 23.09 13.12 28 158485 2173 63328336
Eye disorder 23.08 13.12 14 158499 22671 63307838
Acute pulmonary oedema 23.07 13.12 58 158455 8100 63322409
Blood magnesium decreased 23.04 13.12 79 158434 13119 63317390
Ovarian cancer 23.01 13.12 48 158465 5928 63324581
Immune-mediated hyperthyroidism 23.00 13.12 9 158504 97 63330412
Intracranial tumour haemorrhage 22.91 13.12 11 158502 201 63330308
Respiratory depth decreased 22.85 13.12 7 158506 33 63330476
Adrenal insufficiency 22.83 13.12 97 158416 17818 63312691
Clonal haematopoiesis 22.78 13.12 6 158507 14 63330495
Peritoneal fibrosis 22.63 13.12 5 158508 3 63330506
Influenza like illness 22.57 13.12 88 158425 66736 63263773
Hallucination, visual 22.46 13.12 10 158503 19288 63311221
Invasive ductal breast carcinoma 22.39 13.12 52 158461 6906 63323603
Toxic cardiomyopathy 22.37 13.12 10 158503 154 63330355
Hypothalamo-pituitary disorder 22.31 13.12 17 158496 736 63329773
Femur fracture 22.31 13.12 44 158469 41712 63288797
Sensory disturbance 22.28 13.12 80 158433 13592 63316917
Gastroenteritis viral 22.25 13.12 16 158497 23684 63306825
Spinal stenosis 22.22 13.12 5 158508 14920 63315589
Metastases to ovary 22.21 13.12 14 158499 444 63330065
Metastases to pancreas 22.19 13.12 12 158501 284 63330225
Poor quality sleep 22.17 13.12 11 158502 19924 63310585
Bladder perforation 22.13 13.12 10 158503 158 63330351
Balance disorder 22.09 13.12 122 158391 84300 63246209
Cystitis noninfective 22.01 13.12 19 158494 984 63329525
Emphysematous cystitis 21.96 13.12 10 158503 161 63330348
Chronic sinusitis 21.96 13.12 3 158510 12840 63317669
Laryngeal necrosis 21.95 13.12 6 158507 17 63330492
Lymphatic disorder 21.95 13.12 13 158500 368 63330141
Impaired quality of life 21.81 13.12 4 158509 13779 63316730
Diverticulitis 21.73 13.12 41 158472 39516 63290993
Arterioenteric fistula 21.70 13.12 6 158507 18 63330491
Hepatic cytolysis 21.67 13.12 86 158427 15321 63315188
Retroperitoneal neoplasm metastatic 21.59 13.12 7 158506 41 63330468
Gelastic seizure 21.52 13.12 5 158508 5 63330504
Pulmonary toxicity 21.48 13.12 62 158451 9393 63321116
Autoimmune disorder 21.46 13.12 8 158505 17169 63313340
Immune-mediated gastritis 21.45 13.12 7 158506 42 63330467
Retroperitoneal lymphadenopathy 21.40 13.12 15 158498 570 63329939
Radiotherapy 21.39 13.12 13 158500 386 63330123
Emotional distress 21.38 13.12 30 158483 32519 63297990
Wrist fracture 21.37 13.12 4 158509 13583 63316926
Eye swelling 21.36 13.12 17 158496 23901 63306608
Fungal infection 21.35 13.12 37 158476 36837 63293672
Seasonal allergy 21.21 13.12 13 158500 20937 63309572
Respiratory tract congestion 21.14 13.12 9 158504 17823 63312686
Lupus-like syndrome 21.09 13.12 6 158507 15289 63315220
Metastases to spinal cord 21.03 13.12 9 158504 124 63330385
Pulmonary vein stenosis 20.98 13.12 8 158505 80 63330429
Carpal tunnel syndrome 20.96 13.12 13 158500 20804 63309705
Emotional disorder 20.92 13.12 4 158509 13375 63317134
Hyponatraemia 20.87 13.12 394 158119 111506 63219003
Malignant peritoneal neoplasm 20.84 13.12 16 158497 701 63329808
Gingival bleeding 20.81 13.12 74 158439 12513 63317996
Sopor 20.76 13.12 15 158498 22149 63308360
Abnormal behaviour 20.73 13.12 14 158499 21412 63309097
Transaminases 20.63 13.12 8 158505 84 63330425
Organising pneumonia 20.63 13.12 45 158468 5731 63324778
Abdominal infection 20.59 13.12 25 158488 1943 63328566
Hypercholesterolaemia 20.56 13.12 14 158499 21320 63309189
Microangiopathic haemolytic anaemia 20.55 13.12 15 158498 608 63329901
Breast cellulitis 20.49 13.12 15 158498 611 63329898
Thrombophlebitis migrans 20.46 13.12 9 158504 133 63330376
Enteritis 20.46 13.12 56 158457 8230 63322279
Xerophthalmia 20.45 13.12 14 158499 512 63329997
Splenic artery thrombosis 20.41 13.12 7 158506 50 63330459
Eye irritation 20.41 13.12 15 158498 21956 63308553
Acquired gene mutation 20.32 13.12 18 158495 965 63329544
Abdominal lymphadenopathy 20.29 13.12 16 158497 729 63329780
Type 1 lepra reaction 20.22 13.12 5 158508 8 63330501
Radiation oesophagitis 20.15 13.12 12 158501 343 63330166
Myeloproliferative neoplasm 20.09 13.12 14 158499 527 63329982
Therapy cessation 20.08 13.12 28 158485 30429 63300080
Immune-mediated lung disease 20.06 13.12 15 158498 631 63329878
Scleroderma 20.02 13.12 43 158470 5419 63325090
Bacterial parotitis 19.98 13.12 4 158509 0 63330509
Vessel puncture site bruise 19.95 13.12 13 158500 437 63330072
Immune-mediated thyroiditis 19.93 13.12 9 158504 142 63330367
Brachiocephalic vein thrombosis 19.91 13.12 8 158505 93 63330416
Drug ineffective for unapproved indication 19.88 13.12 34 158479 34029 63296480
Blood glucose decreased 19.86 13.12 14 158499 20938 63309571
Dystonia 19.85 13.12 5 158508 13814 63316695
Hepatic vein thrombosis 19.82 13.12 9 158504 144 63330365
Breast neoplasm 19.76 13.12 21 158492 1411 63329098
Vesical fistula 19.68 13.12 8 158505 96 63330413
Gamma-glutamyltransferase increased 19.67 13.12 149 158364 33882 63296627
Cannabinoid hyperemesis syndrome 19.62 13.12 7 158506 57 63330452
Lymphangitis 19.54 13.12 17 158496 890 63329619
Rash 19.53 13.12 1174 157339 559697 62770812
Neuroendocrine breast tumour 19.30 13.12 6 158507 30 63330479
Photophobia 19.21 13.12 10 158503 17625 63312884
Electrolyte imbalance 19.20 13.12 100 158413 19976 63310533
Crying 19.14 13.12 18 158495 23325 63307184
Breast ulceration 19.11 13.12 7 158506 62 63330447
Venous thrombosis limb 19.06 13.12 30 158483 2978 63327531
Seroma 19.01 13.12 25 158488 2106 63328403
Pancreatitis 18.97 13.12 61 158452 48994 63281515
Myoclonus 18.82 13.12 8 158505 15860 63314649
Ocular hyperaemia 18.79 13.12 21 158492 25123 63305386
Device issue 18.73 13.12 19 158494 23762 63306747
Localised infection 18.71 13.12 29 158484 30181 63300328
Duodenal obstruction 18.71 13.12 10 158503 231 63330278
Gout 18.68 13.12 5 158508 13266 63317243
Oesophageal varices haemorrhage 18.65 13.12 19 158494 1215 63329294
Laryngeal cancer stage III 18.60 13.12 5 158508 13 63330496
Dementia 18.56 13.12 12 158501 18782 63311727
Metastases to thorax 18.52 13.12 10 158503 236 63330273
Enterocutaneous fistula 18.42 13.12 20 158493 1377 63329132
Systemic scleroderma 18.39 13.12 17 158496 964 63329545
Lymphocyte count decreased 18.36 13.12 134 158379 30123 63300386
Hyperthyroidism 18.35 13.12 79 158434 14594 63315915
Cardiovascular disorder 18.30 13.12 68 158445 11744 63318765
Musculoskeletal pain 18.27 13.12 145 158368 92132 63238377
Immune-mediated adrenal insuficiency 18.27 13.12 7 158506 71 63330438
Sputum discoloured 18.21 13.12 9 158504 16338 63314171
Mood altered 18.19 13.12 7 158506 14736 63315773
Failure to thrive 18.12 13.12 49 158464 7149 63323360
Cholangitis acute 18.07 13.12 13 158500 515 63329994
Angiodermatitis 18.01 13.12 7 158506 74 63330435
Intestinal ischaemia 17.97 13.12 50 158463 7418 63323091
Immune-mediated arthritis 17.85 13.12 7 158506 76 63330433
Vaginal perforation 17.84 13.12 5 158508 16 63330493
Metastases to adrenals 17.83 13.12 15 158498 750 63329759
Catheter site injury 17.75 13.12 10 158503 257 63330252
Liver scan abnormal 17.72 13.12 6 158507 41 63330468
Post procedural fistula 17.68 13.12 10 158503 259 63330250
Ear pain 17.67 13.12 40 158473 36078 63294431
Nail avulsion 17.65 13.12 9 158504 188 63330321
Pain in jaw 17.59 13.12 53 158460 43443 63287066
Pulmonary sarcoidosis 17.50 13.12 17 158496 1026 63329483
Cranial nerve disorder 17.49 13.12 13 158500 542 63329967
Frequent bowel movements 17.45 13.12 19 158494 23003 63307506
Ileal perforation 17.45 13.12 12 158501 442 63330067
Septic pulmonary embolism 17.45 13.12 7 158506 81 63330428
Hyperbilirubinaemia 17.42 13.12 65 158448 11249 63319260
Subdural haematoma 17.36 13.12 7 158506 14321 63316188
Maternal death affecting foetus 17.22 13.12 4 158509 4 63330505
Breast sarcoma 17.22 13.12 4 158509 4 63330505
Hernia 17.21 13.12 5 158508 12569 63317940
Walking aid user 17.19 13.12 3 158510 10714 63319795
Tumour ulceration 17.19 13.12 9 158504 199 63330310
Lymphatic obstruction 17.18 13.12 5 158508 19 63330490
Gene mutation 17.17 13.12 21 158492 1644 63328865
Troponin increased 17.16 13.12 60 158453 10061 63320448
Mediastinal disorder 17.15 13.12 11 158502 360 63330149
Fear 17.09 13.12 9 158504 15757 63314752
Hypophysitis 17.04 13.12 22 158491 1819 63328690
Neutropenic infection 17.03 13.12 19 158494 1348 63329161
Mediastinitis 17.03 13.12 9 158504 203 63330306
Uterine atrophy 17.02 13.12 6 158507 47 63330462
Hypothyroidism 17.00 13.12 172 158341 42460 63288049
Metastases to muscle 16.97 13.12 8 158505 140 63330369
Exposed bone in jaw 16.94 13.12 28 158485 2897 63327612
Cystitis haemorrhagic 16.92 13.12 34 158479 4089 63326420
Tumour pseudoprogression 16.92 13.12 10 158503 282 63330227
Tongue disorder 16.89 13.12 3 158510 10577 63319932
Blood pressure immeasurable 16.88 13.12 18 158495 1214 63329295
Intestinal prolapse 16.87 13.12 8 158505 142 63330367
Immune-mediated nephritis 16.87 13.12 8 158505 142 63330367
Device malfunction 16.84 13.12 12 158501 17845 63312664
Restless legs syndrome 16.77 13.12 13 158500 18518 63311991
Tumour invasion 16.77 13.12 8 158505 144 63330365
Embolism venous 16.68 13.12 29 158484 3125 63327384
Vascular device infection 16.66 13.12 48 158465 7264 63323245
Upper-airway cough syndrome 16.65 13.12 4 158509 11414 63319095
Vulvovaginal inflammation 16.63 13.12 15 158498 824 63329685
Food allergy 16.62 13.12 4 158509 11397 63319112
Median nerve injury 16.60 13.12 5 158508 22 63330487
Panniculitis 16.58 13.12 4 158509 11381 63319128
Hypercalcaemia of malignancy 16.57 13.12 9 158504 215 63330294
Blood iron decreased 16.56 13.12 8 158505 14713 63315796
Laryngeal oedema 16.53 13.12 41 158472 5677 63324832
Bronchopleural fistula 16.53 13.12 9 158504 216 63330293
Breast cancer stage III 16.46 13.12 3 158510 10383 63320126
Immune-mediated hypothyroidism 16.42 13.12 10 158503 298 63330211
Aorto-oesophageal fistula 16.42 13.12 5 158508 23 63330486
Tumour fistulisation 16.42 13.12 5 158508 23 63330486
Facet joint syndrome 16.30 13.12 5 158508 12133 63318376
Blood creatinine decreased 16.29 13.12 40 158473 5505 63325004
Pyogenic granuloma 16.24 13.12 10 158503 304 63330205
Keratitis 16.23 13.12 30 158483 3392 63327117
Pancreatic failure 16.18 13.12 16 158497 987 63329522
Nail ridging 16.12 13.12 11 158502 400 63330109
Affect lability 16.08 13.12 4 158509 11147 63319362
Speech disorder 16.08 13.12 50 158463 40579 63289930
Immediate post-injection reaction 16.05 13.12 11 158502 403 63330106
Cholelithiasis 16.04 13.12 56 158457 43869 63286640
Onychomadesis 15.97 13.12 41 158472 5799 63324710
Ovarian failure 15.97 13.12 18 158495 1292 63329217
Aortic dissection rupture 15.95 13.12 4 158509 7 63330502
Distal intestinal obstruction syndrome 15.95 13.12 11 158502 407 63330102
Lung infiltration 15.93 13.12 75 158438 14388 63316121
Swelling face 15.92 13.12 93 158420 63382 63267127
Brachydactyly 15.82 13.12 7 158506 105 63330404
Cardiac pseudoaneurysm 15.76 13.12 5 158508 27 63330482
Artificial menopause 15.76 13.12 5 158508 27 63330482
Pleural disorder 15.73 13.12 13 158500 634 63329875
Toxic neuropathy 15.72 13.12 11 158502 417 63330092
Rotator cuff syndrome 15.71 13.12 7 158506 13495 63317014
Anhedonia 15.70 13.12 4 158509 10970 63319539
Anaemia of malignant disease 15.68 13.12 12 158501 523 63329986
Productive cough 15.65 13.12 93 158420 63115 63267394
Biliary obstruction 15.64 13.12 27 158486 2894 63327615
Application site recall reaction 15.61 13.12 4 158509 8 63330501
Blood lactate dehydrogenase increased 15.56 13.12 105 158408 23011 63307498
Duodenal stenosis 15.54 13.12 12 158501 530 63329979
Product storage error 15.54 13.12 9 158504 14947 63315562
Urosepsis 15.51 13.12 89 158424 18435 63312074
Ototoxicity 15.40 13.12 18 158495 1344 63329165
Dysuria 15.37 13.12 140 158373 33598 63296911
Deformity 15.36 13.12 5 158508 11679 63318830
Dyspepsia 15.34 13.12 172 158341 102024 63228485
Hand-foot-and-mouth disease 15.32 13.12 8 158505 176 63330333
Ulcer 15.29 13.12 26 158487 26081 63304428
Extrapyramidal disorder 15.28 13.12 7 158506 13277 63317232
Cardiac disorder 15.25 13.12 70 158443 50746 63279763
Left ventricular enlargement 15.23 13.12 6 158507 66 63330443
Carbohydrate antigen 19-9 increased 15.22 13.12 9 158504 254 63330255
Movement disorder 15.21 13.12 19 158494 21642 63308867
Full blood count decreased 15.17 13.12 26 158487 25998 63304511
Infusion site swelling 15.11 13.12 3 158510 9767 63320742
Hiatus hernia 15.10 13.12 19 158494 21575 63308934
Cholecystectomy 15.07 13.12 4 158509 10673 63319836
Pharyngitis streptococcal 15.06 13.12 4 158509 10668 63319841
Angioedema 15.05 13.12 65 158448 47900 63282609
Thinking abnormal 15 13.12 4 158509 10639 63319870
Lividity 15.00 13.12 9 158504 261 63330248
Nail pigmentation 15.00 13.12 8 158505 184 63330325
Myiasis 14.99 13.12 3 158510 0 63330509
Granulocyte count 14.99 13.12 3 158510 0 63330509
Ankyloglossia acquired 14.99 13.12 3 158510 0 63330509
Metastases to bone marrow 14.96 13.12 11 158502 451 63330058
Respiratory disorder 14.83 13.12 49 158464 39033 63291476
Facial pain 14.83 13.12 4 158509 10557 63319952
Chemotherapy 14.82 13.12 19 158494 1560 63328949
Secretion discharge 14.78 13.12 6 158507 12225 63318284
Haematochezia 14.77 13.12 76 158437 53468 63277041
Scar 14.74 13.12 8 158505 13774 63316735
Pulmonary artery stenosis 14.73 13.12 8 158505 191 63330318
Immune-mediated neurological disorder 14.72 13.12 4 158509 11 63330498
Vaginal cuff dehiscence 14.72 13.12 4 158509 11 63330498
Nasal disorder 14.72 13.12 26 158487 2838 63327671
Carcinoid tumour pulmonary 14.63 13.12 11 158502 467 63330042
Respiratory depression 14.61 13.12 8 158505 13707 63316802
HER2 positive breast cancer 14.60 13.12 10 158503 366 63330143
Ventricular tachycardia 14.59 13.12 17 158496 19962 63310547
Synovial cyst 14.56 13.12 4 158509 10429 63320080
Dermatitis 14.55 13.12 82 158431 16876 63313633
Polymicrogyria 14.54 13.12 6 158507 75 63330434
Hysterectomy 14.52 13.12 3 158510 9496 63321013
Cardiac failure congestive 14.50 13.12 154 158359 92279 63238230
Limb discomfort 14.46 13.12 33 158480 29683 63300826
Needle issue 14.44 13.12 4 158509 10372 63320137
Orbital myositis 14.43 13.12 5 158508 37 63330472
Dysstasia 14.41 13.12 19 158494 21147 63309362
Cholecystitis chronic 14.40 13.12 4 158509 10357 63320152
Clonal evolution 14.40 13.12 6 158507 77 63330432
Delusion 14.35 13.12 6 158507 12011 63318498
Faeces discoloured 14.34 13.12 15 158498 18494 63312015
Product dispensing error 14.29 13.12 4 158509 10301 63320208
Catheter site inflammation 14.27 13.12 14 158499 855 63329654
Arteriospasm coronary 14.27 13.12 31 158482 3937 63326572
Oesophageal squamous cell carcinoma 14.24 13.12 7 158506 135 63330374
Tumour cavitation 14.23 13.12 4 158509 13 63330496
Peritoneal lesion 14.23 13.12 4 158509 13 63330496
Mucosal dryness 14.21 13.12 25 158488 2719 63327790
Neutrophil count 14.21 13.12 9 158504 288 63330221
Hypertriglyceridaemia 14.18 13.12 41 158472 6218 63324291
Myeloid leukaemia 14.17 13.12 10 158503 384 63330125
Hepatic cancer metastatic 14.17 13.12 10 158503 384 63330125
Pneumocystis jirovecii infection 14.16 13.12 18 158495 1466 63329043
Cytomegalovirus infection 14.07 13.12 19 158494 20933 63309576
Immunodeficiency 13.98 13.12 18 158495 20236 63310273
Therapeutic response decreased 13.95 13.12 93 158420 61432 63269077
Ureteric stenosis 13.94 13.12 12 158501 619 63329890
Torsade de pointes 13.92 13.12 8 158505 13343 63317166
Hyperlipidaemia 13.92 13.12 17 158496 19554 63310955
Triple negative breast cancer 13.87 13.12 7 158506 143 63330366
Bacterial diarrhoea 13.87 13.12 6 158507 85 63330424
Poor venous access 13.86 13.12 10 158503 14775 63315734
Skin haemorrhage 13.84 13.12 4 158509 10090 63320419
Bone marrow disorder 13.83 13.12 23 158490 2391 63328118
Aortic embolus 13.78 13.12 5 158508 43 63330466
Obstructive shock 13.67 13.12 5 158508 44 63330465
Anger 13.66 13.12 7 158506 12449 63318060
Sudden death 13.64 13.12 57 158456 10392 63320117
Pulmonary congestion 13.62 13.12 14 158499 17404 63313105
Carbohydrate antigen 15-3 13.62 13.12 6 158507 89 63330420
Hypergeusia 13.58 13.12 4 158509 16 63330493
Opsoclonus myoclonus 13.57 13.12 7 158506 150 63330359
Non-small cell lung cancer recurrent 13.56 13.12 6 158507 90 63330419
Pulpitis dental 13.50 13.12 14 158499 914 63329595
Uterine adhesions 13.48 13.12 5 158508 46 63330463
Necrosis 13.46 13.12 37 158476 5450 63325059
Carcinoembryonic antigen 13.44 13.12 6 158507 92 63330417
BRCA2 gene mutation 13.44 13.12 6 158507 92 63330417
Ovarian cyst 13.42 13.12 12 158501 15933 63314576
Metastases to vagina 13.39 13.12 4 158509 17 63330492
Status epilepticus 13.39 13.12 11 158502 15222 63315287
Transaminases abnormal 13.38 13.12 12 158501 654 63329855
Onychoclasis 13.37 13.12 40 158473 6182 63324327
Bladder disorder 13.31 13.12 3 158510 8943 63321566
Unresponsive to stimuli 13.28 13.12 136 158377 33680 63296829
Foetal malnutrition 13.27 13.12 6 158507 95 63330414
Product supply issue 13.26 13.12 19 158494 1736 63328773
Diabetes mellitus inadequate control 13.20 13.12 11 158502 15115 63315394
Essential thrombocythaemia 13.16 13.12 7 158506 160 63330349
Weight decreased 13.15 13.12 561 157952 276237 63054272

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 763.86 15.78 798 52417 87248 34816468
Febrile neutropenia 661.07 15.78 921 52294 135928 34767788
Neutropenia 629.67 15.78 967 52248 155811 34747905
Interstitial lung disease 449.93 15.78 525 52690 64757 34838959
Neuropathy peripheral 414.04 15.78 569 52646 82694 34821022
Disease progression 400.15 15.78 643 52572 107434 34796282
Leukopenia 294.97 15.78 418 52797 62438 34841278
Anaemia 291.00 15.78 896 52319 232439 34671277
Neutrophil count decreased 288.72 15.78 372 52843 50732 34852984
Thrombocytopenia 254.15 15.78 661 52554 155586 34748130
Pneumonitis 250.87 15.78 283 52932 33595 34870121
Myelosuppression 246.96 15.78 217 52998 19048 34884668
Alopecia 205.58 15.78 218 52997 24137 34879579
Cholangitis 189.65 15.78 134 53081 8555 34895161
Death 174.60 15.78 1117 52098 396932 34506784
Mucosal inflammation 168.10 15.78 248 52967 38374 34865342
Radiation pneumonitis 166.35 15.78 81 53134 2559 34901157
Neoplasm progression 151.30 15.78 182 53033 23118 34880598
Product dose omission issue 149.52 15.78 8 53207 119703 34784013
Cystoid macular oedema 142.48 15.78 50 53165 665 34903051
Completed suicide 131.16 15.78 4 53211 98164 34805552
Metastases to central nervous system 128.99 15.78 104 53111 8101 34895615
Bone marrow failure 128.94 15.78 189 53026 29064 34874652
Haemoptysis 122.01 15.78 203 53012 34803 34868913
Immune-mediated lung disease 119.20 15.78 55 53160 1536 34902180
Therapy partial responder 114.63 15.78 104 53111 9512 34894204
Haematotoxicity 114.50 15.78 97 53118 8097 34895619
Immune-mediated hepatitis 113.26 15.78 59 53156 2156 34901560
Neurotoxicity 109.33 15.78 136 53079 17874 34885842
General physical health deterioration 109.24 15.78 435 52780 127834 34775882
Peripheral sensory neuropathy 109.06 15.78 87 53128 6673 34897043
Flushing 107.66 15.78 184 53031 32236 34871480
Polyneuropathy 106.06 15.78 122 53093 14774 34888942
Thrombotic microangiopathy 94.75 15.78 98 53117 10532 34893184
Pyrexia 94.25 15.78 844 52371 332169 34571547
Decreased appetite 93.89 15.78 500 52715 165892 34737824
White blood cell count decreased 93.01 15.78 338 52877 95107 34808609
Depression 92.07 15.78 18 53197 97080 34806636
Fall 92.05 15.78 104 53111 202781 34700935
Radiation oesophagitis 88.49 15.78 31 53184 410 34903306
Anaphylactic shock 88.26 15.78 115 53100 15826 34887890
Pneumothorax 85.05 15.78 124 53091 18968 34884748
Biliary tract infection 83.49 15.78 33 53182 622 34903094
Immune-mediated enterocolitis 82.37 15.78 52 53163 2747 34900969
Pulmonary toxicity 82.27 15.78 71 53144 6076 34897640
Headache 80.42 15.78 113 53102 200522 34703194
Anxiety 76.25 15.78 28 53187 99400 34804316
Metastases to liver 74.76 15.78 98 53117 13565 34890151
Adrenal insufficiency 74.16 15.78 99 53116 13948 34889768
Sepsis 74.06 15.78 470 52745 166091 34737625
Pancytopenia 71.74 15.78 311 52904 94846 34808870
Infusion related reaction 71.59 15.78 210 53005 52847 34850869
Platelet count decreased 70.37 15.78 364 52851 119353 34784363
Dehydration 68.82 15.78 384 52831 129585 34774131
Nasopharyngitis 68.40 15.78 12 53203 69956 34833760
Drug interaction 67.36 15.78 153 53062 225793 34677923
Gastrointestinal perforation 67.24 15.78 52 53163 3811 34899905
Immune-mediated hepatic disorder 66.30 15.78 32 53183 991 34902725
Erythema 66.03 15.78 289 52926 88491 34815225
Toxicity to various agents 65.30 15.78 129 53086 200233 34703483
Metastases to lung 64.11 15.78 75 53140 9245 34894471
Joint swelling 63.77 15.78 8 53207 59882 34843834
Tumour haemorrhage 63.05 15.78 45 53170 2917 34900799
Overdose 62.81 15.78 30 53185 91029 34812687
Liver abscess 62.55 15.78 50 53165 3845 34899871
Pneumonia 61.26 15.78 830 52385 361797 34541919
Right ventricular ejection fraction decreased 60.89 15.78 15 53200 48 34903668
Insomnia 60.61 15.78 42 53173 103865 34799851
Pancreatic carcinoma metastatic 58.78 15.78 43 53172 2897 34900819
Dyspnoea 58.25 15.78 849 52366 375933 34527783
Drug ineffective 57.89 15.78 433 52782 456318 34447398
Somnolence 57.14 15.78 51 53164 111065 34792651
Colitis 55.36 15.78 154 53061 37596 34866120
Weight increased 53.73 15.78 38 53177 92995 34810721
Pancreatic enzyme abnormality 52.38 15.78 14 53201 67 34903649
Stomatitis 52.37 15.78 163 53052 42351 34861365
Plasma cell myeloma 51.85 15.78 3 53212 42034 34861682
Pancreatic carcinoma 50.50 15.78 65 53150 8836 34894880
Metastases to meninges 50.42 15.78 30 53185 1424 34902292
Pneumatosis intestinalis 49.86 15.78 44 53171 3879 34899837
Onycholysis 49.58 15.78 24 53191 748 34902968
Immune-mediated dermatitis 49.50 15.78 19 53196 330 34903386
Suicidal ideation 49.45 15.78 3 53212 40385 34863331
Nausea 49.39 15.78 758 52457 339150 34564566
Cardiac failure congestive 48.10 15.78 34 53181 83236 34820480
Macular oedema 48.06 15.78 38 53177 2876 34900840
Coronary artery disease 47.83 15.78 8 53207 48297 34855419
Injection site pain 47.45 15.78 3 53212 39002 34864714
Hypertransaminasaemia 46.95 15.78 50 53165 5556 34898160
Kounis syndrome 46.25 15.78 35 53180 2483 34901233
Enterocolitis infectious 46.19 15.78 30 53185 1665 34902051
Hypersensitivity 45.59 15.78 199 53016 60836 34842880
Neutropenic sepsis 45.50 15.78 78 53137 13689 34890027
Electrocardiogram QT prolonged 44.76 15.78 5 53210 40947 34862769
Haemolytic uraemic syndrome 44.72 15.78 33 53182 2253 34901463
Bradycardia 44.61 15.78 30 53185 75388 34828328
Bronchial fistula 44.60 15.78 15 53200 174 34903542
Aggression 44.56 15.78 4 53211 38960 34864756
Arthralgia 44.51 15.78 123 53092 169918 34733798
Intentional product misuse 44.18 15.78 8 53207 45603 34858113
Metastases to bone 43.81 15.78 71 53144 11899 34891817
Diarrhoea 43.75 15.78 834 52381 389078 34514638
Musculoskeletal stiffness 43.50 15.78 9 53206 46671 34857045
Hypoglycaemia 42.53 15.78 15 53200 54625 34849091
Tremor 42.33 15.78 38 53177 82549 34821167
Performance status decreased 42.12 15.78 41 53174 4096 34899620
Hallucination 42.08 15.78 13 53202 51485 34852231
Oligohydramnios 41.58 15.78 17 53198 351 34903365
Enterocolitis 41.49 15.78 56 53159 7970 34895746
Cardiac disorder 40.84 15.78 8 53207 43118 34860598
Pulmonary radiation injury 40.76 15.78 11 53204 55 34903661
Prostate cancer 40.53 15.78 6 53209 39643 34864073
Oesophagitis 39.77 15.78 72 53143 13189 34890527
Vomiting 39.33 15.78 561 52654 247060 34656656
Scleroderma-like reaction 38.66 15.78 10 53205 41 34903675
Therapeutic product effect decreased 38.58 15.78 4 53211 34739 34868977
Embolism 38.02 15.78 53 53162 7776 34895940
Tracheo-oesophageal fistula 37.44 15.78 17 53198 457 34903259
Pleural effusion 37.33 15.78 232 52983 81314 34822402
Tracheal fistula 37.28 15.78 12 53203 120 34903596
Skin toxicity 37.14 15.78 41 53174 4743 34898973
Memory impairment 37.11 15.78 10 53205 43308 34860408
Adrenocorticotropic hormone deficiency 36.70 15.78 21 53194 926 34902790
Tumour pseudoprogression 36.57 15.78 17 53198 483 34903233
Septic shock 36.48 15.78 210 53005 71624 34832092
Confusional state 36.44 15.78 106 53109 144054 34759662
Intestinal perforation 36.28 15.78 56 53159 9004 34894712
Blood glucose increased 36.27 15.78 29 53186 66689 34837027
Dysphagia 36.13 15.78 189 53026 62192 34841524
Delusion of grandeur 35.26 15.78 22 53193 1138 34902578
Unmasking of previously unidentified disease 34.70 15.78 20 53195 894 34902822
Non-small cell lung cancer 34.52 15.78 36 53179 3904 34899812
Hospitalisation 34.51 15.78 22 53193 56880 34846836
Recall phenomenon 34.42 15.78 17 53198 554 34903162
Rheumatoid arthritis 34.36 15.78 8 53207 38230 34865486
Oxygen saturation decreased 33.93 15.78 167 53048 53651 34850065
Blood pressure increased 33.87 15.78 51 53164 88051 34815665
Agitation 33.72 15.78 23 53192 57376 34846340
Dizziness 33.68 15.78 195 53020 218326 34685390
Angioedema 33.22 15.78 8 53207 37366 34866350
Coma 33.13 15.78 14 53201 45664 34858052
Disseminated intravascular coagulation 32.97 15.78 90 53125 21726 34881990
Peripheral swelling 32.75 15.78 41 53174 76500 34827216
Asthma 32.70 15.78 12 53203 42644 34861072
Pulmonary embolism 32.51 15.78 241 52974 89505 34814211
Myocardial infarction 32.10 15.78 87 53128 120998 34782718
Teratoma benign 31.92 15.78 8 53207 28 34903688
Off label use 31.79 15.78 849 52366 418675 34485041
Gastrointestinal toxicity 31.60 15.78 29 53186 2690 34901026
Feeling abnormal 31.33 15.78 30 53185 63205 34840511
Gastritis bacterial 31.12 15.78 12 53203 211 34903505
Tumour necrosis 30.76 15.78 21 53194 1267 34902449
Brain teratoma 30.76 15.78 7 53208 14 34903702
Pulmonary hypoplasia 30.56 15.78 15 53200 482 34903234
Tidal volume decreased 30.51 15.78 8 53207 35 34903681
Influenza 30.40 15.78 19 53196 49647 34854069
Hypothyroidism 30.37 15.78 85 53130 20817 34882899
Fluid retention 30.10 15.78 3 53212 26884 34876832
Heart rate decreased 29.83 15.78 6 53209 31739 34871977
Wrong technique in product usage process 29.55 15.78 9 53206 35977 34867739
Anaphylactic reaction 29.41 15.78 112 53103 32189 34871527
Urticaria 29.29 15.78 31 53184 62346 34841370
Muscle spasms 29.23 15.78 43 53172 74958 34828758
Inappropriate schedule of product administration 29.21 15.78 31 53184 62265 34841451
Sense of oppression 29.15 15.78 15 53200 534 34903182
Metastases to peritoneum 28.19 15.78 23 53192 1821 34901895
Bronchospasm 28.12 15.78 55 53160 10676 34893040
Stress cardiomyopathy 27.99 15.78 24 53191 2035 34901681
Eastern Cooperative Oncology Group performance status worsened 27.86 15.78 18 53197 990 34902726
Mobility decreased 27.68 15.78 6 53209 30122 34873594
Periarticular thenar erythema with onycholysis 27.45 15.78 5 53210 0 34903716
Abnormal behaviour 27.40 15.78 3 53212 24966 34878750
Oesophagopleural fistula 27.36 15.78 8 53207 56 34903660
Erythema multiforme 27.27 15.78 48 53167 8601 34895115
Rhinalgia 27.14 15.78 18 53197 1035 34902681
Irritability 27.01 15.78 3 53212 24687 34879029
Disturbance in attention 26.35 15.78 4 53211 25941 34877775
Neutropenic colitis 26.25 15.78 28 53187 3116 34900600
Loss of personal independence in daily activities 26 15.78 9 53206 33170 34870546
Abdominal discomfort 25.65 15.78 32 53183 59803 34843913
Nail dystrophy 25.61 15.78 11 53204 258 34903458
Proteinuria 25.32 15.78 74 53141 18568 34885148
Lymphopenia 25.29 15.78 68 53147 16267 34887449
International normalised ratio increased 25.18 15.78 21 53194 47306 34856410
Discontinued product administered 25.16 15.78 6 53209 16 34903700
Sinusitis 25.11 15.78 16 53199 41386 34862330
Chronic kidney disease 24.89 15.78 16 53199 41194 34862522
Radiation skin injury 24.87 15.78 15 53200 730 34902986
Pain 24.85 15.78 196 53019 204479 34699237
Infectious pleural effusion 24.25 15.78 24 53191 2446 34901270
Lymphangiosis carcinomatosa 24.19 15.78 16 53199 916 34902800
Immune-mediated myocarditis 24.08 15.78 15 53200 774 34902942
Hypopituitarism 23.95 15.78 23 53192 2259 34901457
Metabolic acidosis 23.72 15.78 19 53196 43661 34860055
Acute respiratory distress syndrome 23.60 15.78 90 53125 25879 34877837
Pleurocutaneous fistula 23.58 15.78 7 53208 52 34903664
Taeniasis 23.58 15.78 7 53208 52 34903664
Immune-mediated adrenal insuficiency 23.57 15.78 9 53206 154 34903562
Hypoxia 23.50 15.78 154 53061 54941 34848775
Condition aggravated 23.35 15.78 184 53031 192012 34711704
Dermatitis acneiform 23.04 15.78 37 53178 6152 34897564
Ileus 22.90 15.78 66 53149 16433 34887283
Foetal growth abnormality 22.75 15.78 6 53209 27 34903689
Hepatic function abnormal 22.71 15.78 130 53085 44233 34859483
Feeling hot 22.68 15.78 73 53142 19299 34884417
Pneumoperitoneum 22.59 15.78 20 53195 1770 34901946
Lung abscess 22.58 15.78 24 53191 2661 34901055
Blood creatine phosphokinase increased 22.54 15.78 21 53194 44836 34858880
Transient ischaemic attack 22.50 15.78 7 53208 27606 34876110
Oesophagobronchial fistula 22.42 15.78 9 53206 177 34903539
Immune-mediated nephritis 22.28 15.78 11 53204 358 34903358
Pain in extremity 22.19 15.78 108 53107 126405 34777311
Pneumonia bacterial 22.11 15.78 53 53162 11819 34891897
Arthritis 22.10 15.78 10 53205 31336 34872380
Aortic injury 21.97 15.78 5 53210 10 34903706
Metastases to lymph nodes 21.47 15.78 31 53184 4697 34899019
Rhabdomyolysis 21.20 15.78 45 53170 68118 34835598
Subdural haematoma 21.08 15.78 3 53212 20418 34883298
Palpitations 20.96 15.78 18 53197 39968 34863748
Stress 20.91 15.78 10 53205 30337 34873379
Contusion 20.79 15.78 15 53200 36349 34867367
Accidental overdose 20.69 15.78 3 53212 20137 34883579
Cytomegalovirus infection 20.63 15.78 7 53208 26128 34877588
Hyperkalaemia 20.60 15.78 47 53168 69342 34834374
Lymphocyte count abnormal 20.57 15.78 16 53199 1182 34902534
Balance disorder 20.47 15.78 19 53196 40635 34863081
Lactic acidosis 20.33 15.78 14 53201 34758 34868958
Metastases to skin 20.18 15.78 11 53204 441 34903275
Rhinorrhoea 20.05 15.78 7 53208 25661 34878055
Lung disorder 19.99 15.78 105 53110 34591 34869125
Treatment noncompliance 19.76 15.78 9 53206 28091 34875625
Upper respiratory tract infection 19.74 15.78 13 53202 33046 34870670
Pulmonary artery occlusion 19.72 15.78 4 53211 3 34903713
Eosinophilia 19.07 15.78 8 53207 26214 34877502
Cachexia 19.03 15.78 37 53178 7149 34896567
Cataract 19.02 15.78 8 53207 26178 34877538
Portal venous gas 18.86 15.78 10 53205 379 34903337
Blood thyroid stimulating hormone abnormal 18.83 15.78 10 53205 380 34903336
Lung squamous cell carcinoma metastatic 18.82 15.78 6 53209 58 34903658
Hiccups 18.76 15.78 45 53170 10037 34893679
Sleep apnoea syndrome 18.76 15.78 4 53211 20317 34883399
Herpes zoster 18.63 15.78 15 53200 34384 34869332
Psoriasis 18.54 15.78 19 53196 38793 34864923
Gastric perforation 18.54 15.78 21 53194 2499 34901217
Haemorrhage 18.54 15.78 31 53184 51339 34852377
Nasal congestion 18.51 15.78 6 53209 23051 34880665
Pancreatic carcinoma recurrent 18.21 15.78 6 53209 65 34903651
Pericardial effusion 18.08 15.78 80 53135 24582 34879134
Immune-mediated hypothyroidism 18.03 15.78 9 53206 300 34903416
Paronychia 17.97 15.78 24 53191 3381 34900335
Second primary malignancy 17.80 15.78 38 53177 7848 34895868
Hypophagia 17.67 15.78 78 53137 23944 34879772
Immune-mediated cholangitis 17.66 15.78 7 53208 133 34903583
Hypomagnesaemia 17.66 15.78 73 53142 21778 34881938
Blastic plasmacytoid dendritic cell neoplasia 17.58 15.78 6 53209 73 34903643
Metastases to kidney 17.25 15.78 9 53206 330 34903386
Pulmonary cavitation 17.24 15.78 13 53202 917 34902799
Vascular pseudoaneurysm ruptured 17.01 15.78 6 53209 81 34903635
Anastomotic ulcer 16.78 15.78 9 53206 349 34903367
Palmar-plantar erythrodysaesthesia syndrome 16.76 15.78 60 53155 16735 34886981
Hypophysitis 16.73 15.78 19 53196 2267 34901449
Product prescribing error 16.66 15.78 7 53208 22920 34880796
Dysarthria 16.65 15.78 17 53198 34765 34868951
Product use in unapproved indication 16.56 15.78 261 52954 117238 34786478
Aplasia 16.50 15.78 27 53188 4561 34899155
Amnesia 16.47 15.78 10 53205 26553 34877163
Respiratory failure 16.38 15.78 244 52971 108328 34795388
Tumour marker increased 16.35 15.78 11 53204 648 34903068
Vision blurred 16.34 15.78 28 53187 45935 34857781
Coronary artery aneurysm 16.20 15.78 6 53209 94 34903622
Renal hypoplasia 16.20 15.78 6 53209 94 34903622
Anaphylactoid shock 16.11 15.78 9 53206 379 34903337
Dyskinesia 16.04 15.78 7 53208 22406 34881310
Abdominal pain 15.91 15.78 343 52872 163275 34740441
Empyema 15.85 15.78 22 53193 3214 34900502
Hyponatraemia 15.83 15.78 194 53021 82497 34821219

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 2115.26 12.58 2069 179141 139236 79423942
Malignant neoplasm progression 1908.93 12.58 1923 179287 134067 79429111
Neutropenia 1889.80 12.58 2766 178444 284944 79278234
Febrile neutropenia 1304.47 12.58 2072 179138 228927 79334251
Disease progression 1268.86 12.58 1814 179396 182548 79380630
Myelosuppression 1163.96 12.58 862 180348 39434 79523744
Flushing 1071.85 12.58 1156 180054 87112 79476066
Erythema 1009.15 12.58 1814 179396 221476 79341702
Anaemia 1005.70 12.58 2735 178475 442280 79120898
Neutrophil count decreased 942.11 12.58 1114 180096 92845 79470333
Metastases to liver 888.62 12.58 637 180573 27677 79535501
Metastases to bone 818.50 12.58 572 180638 23855 79539323
Dyspnoea 643.14 12.58 3719 177491 853306 78709872
Neoplasm progression 611.50 12.58 668 180542 51014 79512164
Thrombocytopenia 609.27 12.58 1642 179568 263617 79299561
Interstitial lung disease 597.39 12.58 983 180227 111617 79451561
Leukopenia 596.51 12.58 1001 180209 115512 79447666
Metastases to lung 591.45 12.58 418 180792 17745 79545433
Polyneuropathy 566.95 12.58 457 180753 23694 79539484
Completed suicide 530.75 12.58 5 181205 245762 79317416
Pneumonitis 524.67 12.58 669 180541 60191 79502987
Peripheral sensory neuropathy 519.70 12.58 340 180870 12693 79550485
Palmar-plantar erythrodysaesthesia syndrome 486.75 12.58 481 180729 32653 79530525
Metastases to central nervous system 474.20 12.58 351 180859 16024 79547154
Joint swelling 473.12 12.58 52 181158 288594 79274584
Mucosal inflammation 437.88 12.58 687 180523 74893 79488285
Fall 416.60 12.58 301 180909 487328 79075850
Cystoid macular oedema 415.97 12.58 160 181050 1820 79561358
Anaphylactic shock 413.15 12.58 458 180752 35538 79527640
Neurotoxicity 410.39 12.58 435 180775 32083 79531095
Product dose omission issue 407.12 12.58 44 181166 247493 79315685
Haematotoxicity 403.67 12.58 312 180898 15207 79547971
Rheumatoid arthritis 387.85 12.58 21 181189 208449 79354729
Acute myeloid leukaemia 377.13 12.58 406 180804 30479 79532699
Chest discomfort 357.96 12.58 895 180315 137149 79426029
Bone marrow failure 356.75 12.58 507 180703 50600 79512578
Drug ineffective 355.80 12.58 1265 179945 1079648 78483530
Drug abuse 339.34 12.58 6 181204 162685 79400493
Metastases to lymph nodes 335.52 12.58 238 180972 10159 79553019
Bronchospasm 310.93 12.58 331 180879 24528 79538650
Synovitis 301.08 12.58 9 181201 150725 79412453
Feeling hot 298.56 12.58 508 180702 59226 79503952
Contraindicated product administered 292.58 12.58 16 181194 157522 79405656
Therapeutic product effect decreased 291.32 12.58 21 181189 163842 79399336
Arthropathy 289.82 12.58 32 181178 177079 79386099
Headache 286.35 12.58 667 180543 653105 78910073
White blood cell count decreased 282.00 12.58 1005 180205 187283 79375895
Pseudocirrhosis 277.39 12.58 90 181120 590 79562588
Onycholysis 269.48 12.58 119 181091 1964 79561214
Therapy partial responder 265.63 12.58 258 180952 17139 79546039
Nausea 262.75 12.58 3320 177890 953876 78609302
Weight increased 261.34 12.58 153 181057 277233 79285945
Cholangitis 260.78 12.58 223 180987 12553 79550625
Breast cancer metastatic 259.45 12.58 189 181021 8413 79554765
Condition aggravated 256.74 12.58 467 180743 500657 79062521
Platelet count decreased 254.78 12.58 995 180215 193669 79369509
General physical health deterioration 254.02 12.58 1267 179943 273971 79289207
Musculoskeletal stiffness 252.81 12.58 46 181164 174962 79388216
Toxicity to various agents 240.74 12.58 366 180844 421174 79142004
Gastrointestinal perforation 239.54 12.58 158 181052 5979 79557199
Arthralgia 234.00 12.58 604 180606 571199 78991979
Proteinuria 233.55 12.58 327 180883 32175 79531003
Metastases to peritoneum 232.46 12.58 137 181073 4235 79558943
Sinusitis 230.93 12.58 78 181132 195423 79367755
Second primary malignancy 226.99 12.58 217 180993 14133 79549045
Diarrhoea 224.98 12.58 3015 178195 877474 78685704
Myelodysplastic syndrome 223.93 12.58 309 180901 29992 79533186
Pyrexia 223.84 12.58 2440 178770 676269 78886909
Back pain 223.67 12.58 1316 179894 302864 79260314
Ejection fraction decreased 220.89 12.58 329 180881 34248 79528930
Pain 216.15 12.58 846 180364 702956 78860222
Ascites 215.05 12.58 508 180702 75054 79488124
Overdose 214.96 12.58 75 181135 184131 79379047
Glossodynia 214.68 12.58 4 181206 103333 79459845
Skin toxicity 211.54 12.58 165 181045 8149 79555029
Hypertransaminasaemia 211.13 12.58 192 181018 11732 79551446
Abdominal discomfort 207.01 12.58 160 181050 250567 79312611
Swelling 206.25 12.58 118 181092 216593 79346585
Peripheral swelling 205.45 12.58 186 181024 269431 79293747
Pemphigus 202.36 12.58 5 181205 99577 79463601
Vomiting 196.59 12.58 2343 178867 663485 78899693
Nasopharyngitis 196.01 12.58 173 181037 253708 79309470
Depression 193.84 12.58 127 181083 216663 79346515
Systemic lupus erythematosus 192.92 12.58 24 181186 121125 79442053
Pleural effusion 192.83 12.58 746 180464 144516 79418662
Radiation pneumonitis 190.32 12.58 116 181094 3817 79559361
Epistaxis 190.31 12.58 622 180588 110893 79452285
Biliary tract infection 185.08 12.58 81 181129 1307 79561871
Sense of oppression 175.71 12.58 81 181129 1485 79561693
Drug intolerance 172.19 12.58 208 181002 263911 79299267
Metastases to meninges 171.16 12.58 105 181105 3496 79559682
Drug interaction 170.84 12.58 437 180773 414746 79148432
Suicide attempt 169.14 12.58 4 181206 82928 79480250
Blood cholesterol increased 167.15 12.58 5 181205 83715 79479463
Infusion related reaction 166.46 12.58 992 180218 229245 79333933
Mobility decreased 166.22 12.58 37 181173 122138 79441040
Hypertension 165.98 12.58 1303 179907 329689 79233489
Injection site pain 163.72 12.58 46 181164 129792 79433386
Somnolence 162.45 12.58 182 181028 238799 79324379
Psoriatic arthropathy 162.09 12.58 3 181207 77996 79485182
Confusional state 158.50 12.58 301 180909 317696 79245482
Cardiac dysfunction 158.11 12.58 105 181105 4019 79559159
Decreased appetite 157.11 12.58 1321 179889 341097 79222081
Oxygen saturation decreased 157.00 12.58 645 180565 128402 79434776
Embolism 155.41 12.58 175 181035 13807 79549371
Contusion 154.92 12.58 72 181138 148704 79414474
Lymphangiosis carcinomatosa 154.03 12.58 82 181128 2072 79561106
Neutropenic sepsis 153.86 12.58 244 180966 26820 79536358
Thrombotic microangiopathy 152.52 12.58 208 181002 19961 79543217
Pancytopenia 145.70 12.58 753 180457 164992 79398186
Loss of personal independence in daily activities 143.78 12.58 29 181181 102551 79460627
Helicobacter infection 143.56 12.58 3 181207 69701 79493477
Migraine 142.59 12.58 16 181194 87477 79475701
Product use issue 142.37 12.58 160 181050 209662 79353516
Intentional product misuse 141.81 12.58 23 181187 95142 79468036
Hypoxia 140.06 12.58 534 180676 102709 79460469
Influenza 137.62 12.58 61 181149 129545 79433633
Hepatic enzyme increased 133.14 12.58 131 181079 182479 79380699
Asthma 132.19 12.58 71 181139 135024 79428154
Pericarditis 131.28 12.58 37 181173 104199 79458979
Throat tightness 131.11 12.58 231 180979 27676 79535502
Cyanosis 129.54 12.58 217 180993 24965 79538213
Treatment failure 129.33 12.58 118 181092 170368 79392810
Wound 129.28 12.58 51 181159 116128 79447050
Cardiotoxicity 128.95 12.58 149 181061 12090 79551088
Duodenal ulcer perforation 128.49 12.58 5 181205 66206 79496972
Insomnia 128.42 12.58 225 180985 244945 79318233
Fibromyalgia 127.87 12.58 4 181206 64336 79498842
Bone pain 126.48 12.58 344 180866 55398 79507780
Hospitalisation 125.27 12.58 30 181180 94206 79468972
Hypersensitivity 124.09 12.58 1019 180191 261220 79301958
Dehydration 123.73 12.58 976 180234 247211 79315967
Immune-mediated hepatitis 123.32 12.58 86 181124 3570 79559608
Immune-mediated enterocolitis 123.19 12.58 96 181114 4734 79558444
Ovarian cancer recurrent 123.13 12.58 44 181166 400 79562778
Pulmonary embolism 122.97 12.58 738 180472 170916 79392262
Abdominal pain 122.66 12.58 1389 179821 388180 79174998
Arthritis 122.08 12.58 54 181156 114826 79448352
Nail toxicity 119.98 12.58 41 181169 322 79562856
Irritable bowel syndrome 119.78 12.58 5 181205 62236 79500942
Pneumothorax 118.55 12.58 223 180987 28100 79535078
Metastases to skin 118.19 12.58 64 181146 1675 79561503
Blood pressure fluctuation 118.16 12.58 9 181201 67136 79496042
Paraesthesia 116.84 12.58 743 180467 175580 79387598
Tumour haemorrhage 115.87 12.58 87 181123 4057 79559121
Hypoglycaemia 114.02 12.58 44 181166 101550 79461628
Osteonecrosis of jaw 112.67 12.58 281 180929 42945 79520233
Psoriasis 112.45 12.58 32 181178 89555 79473623
Tachycardia 111.62 12.58 739 180471 177029 79386149
Blister 110.86 12.58 67 181143 119409 79443769
Gastrointestinal toxicity 110.39 12.58 113 181097 7996 79555182
Hypokalaemia 110.09 12.58 630 180580 143410 79419768
Recall phenomenon 109.71 12.58 53 181157 1084 79562094
Drug reaction with eosinophilia and systemic symptoms 109.23 12.58 10 181200 64234 79498944
Colitis 107.63 12.58 389 180821 72918 79490260
Memory impairment 107.45 12.58 60 181150 111674 79451504
Immune-mediated hepatic disorder 106.49 12.58 58 181152 1536 79561642
Macular oedema 104.54 12.58 92 181118 5382 79557796
Intestinal perforation 104.46 12.58 161 181049 17265 79545913
Feeling abnormal 104.08 12.58 125 181085 159074 79404104
Alopecia 103.57 12.58 888 180322 230467 79332711
Hallucination 103.32 12.58 33 181177 85712 79477466
Anaphylactic reaction 102.94 12.58 420 180790 83323 79479855
Gait disturbance 102.80 12.58 197 181013 207309 79355869
Nail disorder 101.61 12.58 130 181080 11722 79551456
Asthenia 101.37 12.58 1679 179531 510010 79053168
Breast cancer recurrent 100.35 12.58 70 181140 2907 79560271
Bradycardia 100.24 12.58 96 181114 135461 79427717
Suicidal ideation 100.11 12.58 25 181185 76315 79486863
Injury 98.53 12.58 27 181183 77469 79485709
Injection site erythema 98.02 12.58 28 181182 78169 79485009
C-reactive protein abnormal 96.14 12.58 3 181207 48364 79514814
Dizziness 95.26 12.58 753 180457 525688 79037490
Myocardial infarction 93.68 12.58 172 181038 183957 79379221
Injection site swelling 93.41 12.58 3 181207 47129 79516049
Osteoarthritis 92.82 12.58 41 181169 87268 79475910
Sepsis 92.69 12.58 978 180232 268450 79294728
Nail discolouration 92.32 12.58 67 181143 2964 79560214
Metastasis 92.07 12.58 95 181115 6785 79556393
Ileus 91.18 12.58 191 181019 26020 79537158
Red blood cell sedimentation rate increased 90.78 12.58 3 181207 45939 79517239
Coronary artery disease 90.73 12.58 19 181191 65455 79497723
Discomfort 90.52 12.58 91 181119 125526 79437652
Peripheral motor neuropathy 90.41 12.58 69 181141 3298 79559880
Immune-mediated lung disease 89.47 12.58 59 181151 2231 79560947
Injection site reaction 89.31 12.58 10 181200 54775 79508403
Anxiety 89.22 12.58 279 180931 248233 79314945
Tumour necrosis 88.70 12.58 55 181155 1867 79561311
Drug hypersensitivity 86.59 12.58 367 180843 298549 79264629
Computerised tomogram thorax abnormal 86.53 12.58 59 181151 2360 79560818
Performance status decreased 86.52 12.58 87 181123 6026 79557152
PIK3CA-activated mutation 86.32 12.58 37 181173 566 79562612
Muscle spasms 85.57 12.58 167 181043 174563 79388615
Exposure during pregnancy 85.36 12.58 63 181147 101069 79462109
Electrocardiogram QT prolonged 84.81 12.58 50 181160 90336 79472842
Coma 84.56 12.58 63 181147 100586 79462592
Fluid retention 83.87 12.58 27 181183 69782 79493396
Metastases to spine 83.24 12.58 73 181137 4251 79558927
Pain in extremity 83.00 12.58 487 180723 364051 79199127
Injection site pruritus 82.71 12.58 3 181207 42280 79520898
Acute promyelocytic leukaemia 82.64 12.58 48 181162 1443 79561735
Tumour marker increased 81.99 12.58 72 181138 4200 79558978
Radiation oesophagitis 81.48 12.58 37 181173 654 79562524
Plasma cell myeloma 79.05 12.58 13 181197 53246 79509932
Urticaria 78.32 12.58 192 181018 185009 79378169
Nasal congestion 78.20 12.58 38 181172 76514 79486664
Pulmonary toxicity 76.97 12.58 119 181091 12795 79550383
Dysaesthesia 76.91 12.58 80 181130 5768 79557410
Serotonin syndrome 76.57 12.58 7 181203 45020 79518158
Hepatic atrophy 76.39 12.58 31 181179 410 79562768
Adrenal insufficiency 76.15 12.58 187 181023 28300 79534878
COVID-19 76.08 12.58 152 181058 157522 79405656
Metastatic neoplasm 75.51 12.58 74 181136 4968 79558210
Rhabdomyolysis 75.12 12.58 74 181136 103057 79460121
Nephrolithiasis 74.80 12.58 15 181195 53276 79509902
Illness 74.55 12.58 9 181201 46502 79516676
Pneumocystis jirovecii pneumonia 74.11 12.58 201 181009 32307 79530871
Alveolitis 73.40 12.58 67 181143 4113 79559065
Hepatic function abnormal 73.34 12.58 345 180865 72762 79490416
Large intestine perforation 72.89 12.58 124 181086 14443 79548735
Urogenital fistula 71.92 12.58 23 181187 143 79563035
Wheezing 71.67 12.58 96 181114 116568 79446610
Scleroderma-like reaction 71.36 12.58 22 181188 119 79563059
Disseminated intravascular coagulation 71.35 12.58 211 180999 35631 79527547
Immune-mediated dermatitis 70.87 12.58 32 181178 558 79562620
Cholangitis sclerosing 70.72 12.58 54 181156 2583 79560595
Lactic acidosis 70.25 12.58 36 181174 70323 79492855
Metastases to kidney 70.12 12.58 31 181179 513 79562665
Bronchitis 70.09 12.58 118 181092 130526 79432652
Maternal exposure during pregnancy 69.92 12.58 127 181083 136411 79426767
Lower respiratory tract infection 69.06 12.58 117 181093 129103 79434075
Computerised tomogram thorax 69.03 12.58 29 181181 421 79562757
Subileus 68.42 12.58 74 181136 5580 79557598
Hepatic failure 68.22 12.58 298 180912 60914 79502264
Aggression 68.16 12.58 16 181194 50942 79512236
Cataract 67.90 12.58 28 181182 62092 79501086
Posterior reversible encephalopathy syndrome 67.60 12.58 170 181040 26111 79537067
Paronychia 67.50 12.58 86 181124 7722 79555456
International normalised ratio increased 66.19 12.58 57 181153 84664 79478514
Basal cell carcinoma 65.79 12.58 5 181205 37370 79525808
Cardiomyopathy 65.68 12.58 178 181032 28596 79534582
Bronchial fistula 65.56 12.58 23 181187 197 79562981
Metastases to pleura 65.53 12.58 42 181168 1512 79561666
Oesophagitis 65.52 12.58 160 181050 24129 79539049
Stress 65.38 12.58 51 181159 79561 79483617
Stress cardiomyopathy 65.30 12.58 102 181108 11064 79552114
Malignant pleural effusion 64.94 12.58 57 181153 3323 79559855
Hyperaemia 64.93 12.58 55 181155 3055 79560123
Osteoporosis 64.88 12.58 21 181189 54091 79509087
Cardiac failure congestive 64.72 12.58 142 181068 142260 79420918
Enterocolitis infectious 64.59 12.58 53 181157 2816 79560362
Neutropenic colitis 64.40 12.58 72 181138 5635 79557543
Product prescribing error 64.19 12.58 12 181198 44801 79518377
Road traffic accident 64.05 12.58 11 181199 43653 79519525
Stomatitis 63.89 12.58 560 180650 146197 79416981
Sleep apnoea syndrome 63.87 12.58 5 181205 36473 79526705
Metastases to the mediastinum 63.63 12.58 30 181180 580 79562598
Inappropriate schedule of product administration 63.45 12.58 130 181080 133498 79429680
Nail dystrophy 62.56 12.58 35 181175 978 79562200
Anaphylactoid reaction 62.20 12.58 69 181141 5353 79557825
Haemoptysis 61.93 12.58 272 180938 55727 79507451
Incorrect dose administered 61.79 12.58 50 181160 76580 79486598
Metabolic acidosis 61.52 12.58 58 181152 82471 79480707
Hypomagnesaemia 60.61 12.58 239 180971 46672 79516506
Atelectasis 60.54 12.58 186 181024 32071 79531107
Accidental overdose 60.24 12.58 9 181201 39572 79523606
Medication error 60.24 12.58 41 181169 68601 79494577
Device related infection 60.00 12.58 193 181017 34101 79529077
Lymphoedema 59.92 12.58 104 181106 12309 79550869
Prostate cancer 59.86 12.58 4 181206 33264 79529914
Swollen tongue 59.71 12.58 12 181198 42558 79520620
Secondary cerebellar degeneration 59.61 12.58 16 181194 47 79563131
Type I hypersensitivity 59.34 12.58 61 181149 4337 79558841
Left ventricular dysfunction 58.15 12.58 133 181077 19228 79543950
Treatment noncompliance 58.04 12.58 23 181187 52245 79510933
Folliculitis 57.31 12.58 27 181183 55353 79507825
Hypertensive crisis 57.28 12.58 138 181072 20632 79542546
Eosinophilia 57.26 12.58 16 181194 45329 79517849
Haemolytic uraemic syndrome 56.97 12.58 60 181150 4389 79558789
Palmar erythema 56.95 12.58 42 181168 1905 79561273
Adverse drug reaction 56.49 12.58 41 181169 66351 79496827
Acute interstitial pneumonitis 56.44 12.58 35 181175 1188 79561990
Periarticular thenar erythema with onycholysis 56.15 12.58 15 181195 43 79563135
Drug level increased 55.99 12.58 11 181199 39640 79523538
Infusion related hypersensitivity reaction 55.65 12.58 24 181186 373 79562805
Pericardial effusion 55.31 12.58 230 180980 46007 79517171
Malignant ascites 54.73 12.58 34 181176 1158 79562020
Joint range of motion decreased 54.44 12.58 6 181204 33276 79529902
Liver abscess 54.43 12.58 68 181142 5986 79557192
Ear infection 54.36 12.58 7 181203 34425 79528753
Bronchostenosis 54.24 12.58 28 181182 663 79562515
Acute myelomonocytic leukaemia 53.48 12.58 22 181188 302 79562876
Unevaluable event 53.21 12.58 30 181180 55555 79507623
Right ventricular ejection fraction decreased 53.15 12.58 15 181195 56 79563122
Laryngospasm 53.14 12.58 55 181155 3942 79559236
Sleep disorder 53.13 12.58 70 181140 85607 79477571
Dyskinesia 52.58 12.58 18 181192 44755 79518423
Adrenocorticotropic hormone deficiency 52.46 12.58 35 181175 1350 79561828
Suffocation feeling 52.34 12.58 38 181172 1682 79561496
Type 2 diabetes mellitus 51.64 12.58 33 181177 57089 79506089
Gastric disorder 51.58 12.58 11 181199 37422 79525756
Hydronephrosis 51.43 12.58 119 181091 17335 79545843
Oesophagobronchial fistula 51.33 12.58 20 181190 236 79562942
Hot flush 50.74 12.58 253 180957 54624 79508554
Gait inability 50.63 12.58 36 181174 58881 79504297
Small intestinal perforation 50.52 12.58 49 181161 3248 79559930
Wrong technique in product usage process 50.43 12.58 56 181154 73819 79489359
Death 50.02 12.58 1661 179549 564853 78998325
Febrile infection 49.91 12.58 49 181161 3297 79559881
Lymphopenia 49.90 12.58 168 181042 30389 79532789
Biliary sepsis 49.83 12.58 36 181174 1581 79561597
Full blood count abnormal 49.79 12.58 15 181195 40459 79522719
Transient ischaemic attack 49.64 12.58 29 181181 52666 79510512
Gastrooesophageal reflux disease 48.99 12.58 102 181108 104144 79459034
Hypersensitivity pneumonitis 48.90 12.58 51 181159 3688 79559490
Extravasation 48.78 12.58 51 181159 3699 79559479
Hypothyroidism 48.76 12.58 242 180968 52150 79511028
Pancreatic carcinoma metastatic 48.74 12.58 51 181159 3702 79559476
Carbohydrate antigen 125 increased 48.44 12.58 40 181170 2144 79561034
Respiratory distress 48.42 12.58 261 180949 58078 79505100
Carbohydrate antigen 15-3 increased 47.59 12.58 31 181179 1148 79562030
Obesity 47.03 12.58 11 181199 35114 79528064
Capillary leak syndrome 46.85 12.58 51 181159 3874 79559304
Incorrect route of product administration 46.65 12.58 11 181199 34918 79528260
Amnesia 46.20 12.58 45 181165 63012 79500166
Enterocolitis 46.17 12.58 102 181108 14410 79548768
Superior vena cava syndrome 45.96 12.58 31 181179 1218 79561960
Subdural haematoma 45.93 12.58 8 181202 31426 79531752
Tumour lysis syndrome 45.82 12.58 139 181071 23800 79539378
Immune-mediated myocarditis 45.76 12.58 30 181180 1123 79562055
Poisoning 45.58 12.58 3 181207 25269 79537909
Joint stiffness 45.28 12.58 18 181192 40812 79522366
Recurrent cancer 45.02 12.58 42 181168 2651 79560527
Prescribed overdose 44.89 12.58 15 181195 37868 79525310
Bursitis 44.61 12.58 13 181197 35831 79527347
Blood glucose increased 44.17 12.58 125 181085 114850 79448328
Nightmare 44.03 12.58 4 181206 25857 79537321
Head injury 43.93 12.58 15 181195 37354 79525824
Choking sensation 43.60 12.58 49 181161 3857 79559321
Oropharyngeal pain 43.41 12.58 117 181093 109236 79453942
Hyperpyrexia 43.32 12.58 61 181149 6031 79557147
Tremor 43.17 12.58 219 180991 169864 79393314
Irritability 42.67 12.58 20 181190 41124 79522054
Surgery 42.43 12.58 11 181199 32755 79530423
Angioedema 42.34 12.58 67 181143 75968 79487210
Abnormal behaviour 42.16 12.58 15 181195 36406 79526772
Limb injury 42.10 12.58 8 181202 29520 79533658
Radiation skin injury 42.09 12.58 31 181179 1403 79561775
Eastern Cooperative Oncology Group performance status worsened 42.05 12.58 36 181174 2029 79561149
Hypopituitarism 42.03 12.58 45 181165 3354 79559824
Blood creatine phosphokinase increased 42.01 12.58 53 181157 66037 79497141
Cardiac disorder 41.52 12.58 53 181157 65704 79497474
Skin laceration 40.96 12.58 8 181202 28954 79534224
Rash pruritic 40.96 12.58 62 181148 71567 79491611
Constipation 40.79 12.58 885 180325 282165 79281013
Tumour pseudoprogression 40.69 12.58 23 181187 656 79562522
Blood pressure systolic increased 40.25 12.58 56 181154 66930 79496248
Nervousness 40.00 12.58 13 181197 33402 79529776
Carcinoembryonic antigen increased 39.95 12.58 36 181174 2173 79561005
Herpes zoster 39.72 12.58 96 181114 92987 79470191
Tumour associated fever 39.71 12.58 25 181185 872 79562306
Pancreatic enzyme abnormality 39.70 12.58 14 181196 122 79563056
Rectal perforation 39.51 12.58 25 181185 880 79562298
Eye pain 39.38 12.58 18 181192 37560 79525618
Neoplasm recurrence 38.95 12.58 48 181162 4166 79559012
Upper respiratory tract infection 38.92 12.58 94 181116 91074 79472104
Cachexia 38.82 12.58 81 181129 11002 79552176
Product administration error 38.81 12.58 12 181198 31834 79531344
Bone marrow infiltration 38.67 12.58 23 181187 723 79562455
Aortitis 38.53 12.58 30 181180 1477 79561701
Disease recurrence 38.43 12.58 200 181010 43909 79519269
Immune-mediated pancreatitis 38.42 12.58 17 181193 282 79562896
Aplasia 38.38 12.58 66 181144 7754 79555424
Erythema multiforme 38.11 12.58 107 181103 17544 79545634
Mental disorder 37.79 12.58 12 181198 31290 79531888
Emotional distress 37.64 12.58 22 181188 39947 79523231
Device related thrombosis 37.63 12.58 38 181172 2645 79560533
Portal hypertension 37.55 12.58 62 181148 7046 79556132
Inflammation 37.45 12.58 100 181110 93653 79469525
Acne 37.44 12.58 8 181202 27182 79535996
Drug withdrawal syndrome 37.38 12.58 16 181194 34702 79528476
Capillary permeability increased 37.35 12.58 10 181200 29 79563149
Gout 36.82 12.58 6 181204 24743 79538435
Pneumatosis intestinalis 36.80 12.58 58 181152 6339 79556839
Injection site haemorrhage 36.78 12.58 9 181201 27861 79535317
Pregnancy 36.77 12.58 8 181202 26843 79536335
Duodenal perforation 36.55 12.58 34 181176 2138 79561040
Hyperkalaemia 36.54 12.58 135 181075 114263 79448915
Cancer pain 36.53 12.58 52 181158 5193 79557985
Metastases to retroperitoneum 36.49 12.58 18 181192 386 79562792
Labelled drug-drug interaction medication error 36.35 12.58 9 181201 27641 79535537
Heart rate decreased 36.35 12.58 65 181145 70251 79492927
Autoimmune nephritis 36.28 12.58 22 181188 717 79562461
Hypophysitis 36.19 12.58 46 181164 4120 79559058
Night sweats 36.09 12.58 39 181171 52056 79511122
Primary cardiac lymphoma 35.96 12.58 9 181201 18 79563160
Pulmonary arterial hypertension 35.83 12.58 10 181200 28356 79534822
Anastomotic leak 35.80 12.58 25 181185 1040 79562138
Lymphadenopathy mediastinal 35.78 12.58 47 181163 4349 79558829
Pulmonary radiation injury 35.76 12.58 11 181199 59 79563119
Hypersomnia 35.71 12.58 5 181205 23081 79540097
Metastases to stomach 35.59 12.58 16 181194 276 79562902
Hypoalbuminaemia 35.58 12.58 118 181092 21179 79541999
Cytomegalovirus infection 35.41 12.58 27 181183 42617 79520561
Agitation 35.01 12.58 113 181097 99602 79463576
Diabetes mellitus 34.93 12.58 79 181131 78311 79484867
Administration site extravasation 34.92 12.58 27 181183 1316 79561862
Eczema asteatotic 34.89 12.58 20 181190 586 79562592
Gastritis bacterial 34.69 12.58 17 181193 359 79562819
Bone lesion 34.51 12.58 54 181156 5865 79557313
Small intestinal obstruction 34.47 12.58 138 181072 27134 79536044
Toxic erythema of chemotherapy 34.39 12.58 15 181195 240 79562938
Breast cancer 34.29 12.58 160 181050 33621 79529557
Dysgeusia 34.22 12.58 235 180975 56942 79506236
Blood triglycerides increased 33.89 12.58 4 181206 21036 79542142
Metastases to eye 33.72 12.58 15 181195 252 79562926
Transaminases increased 33.58 12.58 217 180993 51526 79511652
Acute megakaryocytic leukaemia 33.42 12.58 10 181200 48 79563130
Immune-mediated hyperthyroidism 33.32 12.58 13 181197 154 79563024
Foot deformity 33.32 12.58 7 181203 24067 79539111
Metastases to pelvis 33.25 12.58 20 181190 642 79562536
Septic shock 32.91 12.58 425 180785 122376 79440802
Urinary tract obstruction 32.83 12.58 47 181163 4718 79558460
Pseudomembranous colitis 32.70 12.58 50 181160 5324 79557854
Myoclonus 32.69 12.58 11 181199 27649 79535529
Tracheal fistula 32.59 12.58 13 181197 164 79563014
Endocarditis noninfective 32.50 12.58 14 181196 217 79562961
Impaired healing 32.42 12.58 97 181113 87558 79475620
Immune-mediated thyroiditis 32.39 12.58 15 181195 278 79562900
Musculoskeletal disorder 32.36 12.58 5 181205 21443 79541735
Product substitution issue 32.26 12.58 4 181206 20252 79542926
Dystonia 32.26 12.58 5 181205 21394 79541784
Pleural neoplasm 32.06 12.58 16 181194 352 79562826
Tonsillar disorder 31.93 12.58 25 181185 1241 79561937
Cerebrovascular accident 31.90 12.58 214 180996 155078 79408100
Hypervolaemia 31.81 12.58 30 181180 42660 79520518
Oligohydramnios 31.76 12.58 39 181171 3373 79559805
Non-small cell lung cancer 31.64 12.58 54 181156 6306 79556872
Panic attack 31.61 12.58 8 181202 24208 79538970
Mood swings 31.48 12.58 4 181206 19876 79543302
Dermatomyositis 31.47 12.58 40 181170 3583 79559595
Procedural pain 31.36 12.58 7 181203 23077 79540101
Balance disorder 31.35 12.58 117 181093 98740 79464438
Accidental exposure to product 31.30 12.58 16 181194 31306 79531872
Tumour pain 31.22 12.58 32 181178 2267 79560911
Neck pain 31.22 12.58 79 181131 75338 79487840
Viral infection 31.16 12.58 31 181179 42985 79520193
Drug resistance 31.15 12.58 183 181027 42030 79521148
Abortion spontaneous 31.13 12.58 14 181196 29493 79533685
Pruritus 31.02 12.58 672 180538 393976 79169202
Bile duct stenosis 30.96 12.58 30 181180 1986 79561192
Hepatotoxicity 30.70 12.58 211 180999 51141 79512037
Immune-mediated hypothyroidism 30.67 12.58 19 181191 644 79562534
Kounis syndrome 30.63 12.58 43 181167 4239 79558939
Eye pruritus 30.57 12.58 5 181205 20565 79542613
Retroperitoneal lymphadenopathy 30.55 12.58 23 181187 1077 79562101
Sinus disorder 30.14 12.58 7 181203 22457 79540721
Blood pressure diastolic abnormal 30.08 12.58 4 181206 19198 79543980
Diabetes mellitus inadequate control 29.83 12.58 9 181201 24255 79538923
Psychotic disorder 29.80 12.58 30 181180 41372 79521806
Guillain-Barre syndrome 29.64 12.58 64 181146 8901 79554277
Metastases to bladder 29.58 12.58 14 181196 273 79562905
Dysphagia 29.55 12.58 415 180795 121721 79441457
Subclavian vein thrombosis 29.46 12.58 32 181178 2425 79560753
Haemorrhage 29.45 12.58 107 181103 91011 79472167
Blood uric acid decreased 29.43 12.58 24 181186 1264 79561914
Acute myocardial infarction 29.40 12.58 84 181126 76952 79486226
Respiratory tract congestion 29.32 12.58 5 181205 19949 79543229
Dermatitis acneiform 29.30 12.58 68 181142 9925 79553253
Lymphocyte count decreased 29.28 12.58 196 181014 47093 79516085
Fear 29.21 12.58 7 181203 21979 79541199
Foot fracture 29.20 12.58 7 181203 21974 79541204
Blood potassium increased 29.19 12.58 15 181195 29260 79533918
Scleroderma 29.03 12.58 48 181162 5462 79557716
Sciatica 28.94 12.58 20 181190 33202 79529976
Deep vein thrombosis 28.91 12.58 410 180800 120509 79442669
Chills 28.78 12.58 518 180692 159716 79403462
Metastases to chest wall 28.77 12.58 17 181193 528 79562650
Peritonitis 28.61 12.58 133 181077 27903 79535275
Sopor 28.58 12.58 20 181190 32990 79530188
Infected lymphocele 28.57 12.58 13 181197 231 79562947
Flatulence 28.49 12.58 33 181177 42691 79520487
Localised infection 28.48 12.58 26 181184 37549 79525629
Intestinal metastasis 28.47 12.58 15 181195 371 79562807
Bladder cancer 28.46 12.58 5 181205 19521 79543657
Paranoia 28.27 12.58 5 181205 19427 79543751
Intentional product use issue 28.15 12.58 216 180994 151896 79411282
Gallbladder disorder 28.08 12.58 5 181205 19335 79543843
Immune-mediated nephritis 28.01 12.58 17 181193 555 79562623
Laryngeal necrosis 27.91 12.58 8 181202 32 79563146
Joint dislocation 27.84 12.58 3 181207 16936 79546242
Pulse absent 27.72 12.58 67 181143 10036 79553142
Exostosis 27.67 12.58 3 181207 16855 79546323
Lung abscess 27.51 12.58 40 181170 4072 79559106
Immune-mediated gastritis 27.41 12.58 10 181200 97 79563081
Tumour embolism 27.34 12.58 12 181198 195 79562983
Hepatic infection 27.24 12.58 21 181189 1019 79562159
Movement disorder 27.13 12.58 14 181196 27245 79535933
Sinus congestion 27.10 12.58 6 181204 19890 79543288
Pyogenic granuloma 27.02 12.58 16 181194 499 79562679
Congestive cardiomyopathy 27.01 12.58 73 181137 11707 79551471
Haematochezia 26.97 12.58 105 181105 87540 79475638
Delirium 26.94 12.58 100 181110 84527 79478651
Hepatic lesion 26.92 12.58 53 181157 6906 79556272
Thyroiditis 26.83 12.58 42 181168 4563 79558615
Hallucination, visual 26.83 12.58 21 181189 32708 79530470
Drug ineffective for unapproved indication 26.81 12.58 47 181163 51191 79511987
Immune-mediated adrenal insuficiency 26.80 12.58 12 181198 205 79562973
Frequent bowel movements 26.78 12.58 17 181193 29522 79533656
Autoimmune cholangitis 26.76 12.58 7 181203 18 79563160
Ovarian cancer metastatic 26.72 12.58 17 181193 604 79562574
Invasive ductal breast carcinoma 26.68 12.58 48 181162 5844 79557334
Sinus bradycardia 26.60 12.58 12 181198 25235 79537943
Eye disorder 26.49 12.58 10 181200 23402 79539776
Venous thrombosis limb 26.46 12.58 41 181169 4416 79558762
Orthostatic hypotension 26.34 12.58 55 181155 56109 79507069
Empyema 26.32 12.58 40 181170 4236 79558942
Cardiac cirrhosis 26.28 12.58 12 181198 215 79562963
Status epilepticus 26.23 12.58 12 181198 25029 79538149
Eosinophil percentage increased 26.01 12.58 24 181186 1494 79561684
Hypermetabolism 25.94 12.58 14 181196 364 79562814
Neuromuscular toxicity 25.88 12.58 12 181198 223 79562955
Musculoskeletal pain 25.84 12.58 132 181078 102222 79460956
Therapy interrupted 25.83 12.58 20 181190 31321 79531857
Therapeutic product effect incomplete 25.80 12.58 202 181008 141443 79421735
Eye swelling 25.74 12.58 14 181196 26454 79536724
Cardiac murmur 25.51 12.58 3 181207 15821 79547357
Hyperthyroidism 25.41 12.58 109 181101 22100 79541078
Ovarian failure 25.40 12.58 17 181193 659 79562519
Prescribed underdose 25.40 12.58 18 181192 29496 79533682
Mastitis 25.34 12.58 28 181182 2163 79561015
Kidney infection 25.29 12.58 9 181201 21842 79541336
Oligoastrocytoma 25.26 12.58 7 181203 24 79563154
Wound dehiscence 25.23 12.58 50 181160 6545 79556633
Poor quality sleep 25.22 12.58 10 181200 22712 79540466
Vena cava thrombosis 25.20 12.58 32 181178 2863 79560315
Gastric perforation 25.18 12.58 38 181172 3999 79559179
Mood altered 25.09 12.58 5 181205 17842 79545336
Thyroid dermatopathy 25.04 12.58 7 181203 25 79563153
Oesophagopleural fistula 24.98 12.58 8 181202 50 79563128
Tooth erosion 24.93 12.58 14 181196 394 79562784
Acquired gene mutation 24.90 12.58 28 181182 2205 79560973
Dysarthria 24.89 12.58 75 181135 67547 79495631
Swelling face 24.78 12.58 81 181129 71131 79492047
Glomerular vascular disorder 24.72 12.58 11 181199 185 79562993
Hypothalamo-pituitary disorder 24.69 12.58 21 181189 1173 79562005
Tumour ulceration 24.68 12.58 12 181198 249 79562929
Lip dry 24.67 12.58 3 181207 15415 79547763
Chest pain 24.65 12.58 827 180383 281477 79281701
Neutrophil count abnormal 24.62 12.58 35 181175 3491 79559687
Limb discomfort 24.58 12.58 23 181187 32827 79530351
No adverse event 24.50 12.58 29 181181 37163 79526015
Chromaturia 24.49 12.58 14 181196 25732 79537446
Urinary retention 24.48 12.58 58 181152 56572 79506606
Infectious pleural effusion 24.44 12.58 36 181174 3708 79559470
Gastroenteritis viral 24.35 12.58 13 181197 24818 79538360
Ventricular tachycardia 24.26 12.58 36 181174 41899 79521279
Pulmonary tumour thrombotic microangiopathy 24.17 12.58 9 181201 93 79563085
Immune-mediated cholangitis 23.94 12.58 11 181199 200 79562978
Hyperhidrosis 23.86 12.58 480 180730 151012 79412166
Duodenitis haemorrhagic 23.75 12.58 10 181200 146 79563032
Scintillating scotoma 23.65 12.58 11 181199 206 79562972
Gastrointestinal haemorrhage 23.61 12.58 218 180992 147501 79415677
Cough 23.60 12.58 1039 180171 365750 79197428
Anhedonia 23.59 12.58 3 181207 14895 79548283
Melaena 23.52 12.58 66 181144 60824 79502354
Metastases to breast 23.52 12.58 12 181198 277 79562901
Cholelithiasis 23.52 12.58 53 181157 52611 79510567
Tumour cavitation 23.50 12.58 7 181203 33 79563145
Respiratory depth decreased 23.50 12.58 7 181203 33 79563145
Right ventricular failure 23.49 12.58 12 181198 23485 79539693
Therapeutic response unexpected 23.45 12.58 8 181202 19938 79543240
Joint effusion 23.42 12.58 6 181204 18008 79545170
Vaginal fistula 23.41 12.58 12 181198 280 79562898
Chronic obstructive pulmonary disease 23.40 12.58 107 181103 85312 79477866
Pancreatic carcinoma 23.37 12.58 76 181134 13501 79549677
Delusion of grandeur 23.30 12.58 22 181188 1410 79561768
Haemoglobin 23.27 12.58 9 181201 104 79563074
Vocal cord paralysis 23.16 12.58 29 181181 2558 79560620
Brachydactyly 23.16 12.58 7 181203 35 79563143
Spinal stenosis 23.11 12.58 4 181206 15787 79547391
Glaucoma 23.11 12.58 8 181202 19753 79543425
Uterine atrophy 23.05 12.58 6 181204 15 79563163
Fungal infection 23.04 12.58 37 181173 41711 79521467
Pneumonitis chemical 23.04 12.58 14 181196 458 79562720
Cholangitis infective 23.01 12.58 16 181194 661 79562517
Therapy cessation 22.97 12.58 31 181179 37531 79525647
Bronchopulmonary aspergillosis 22.87 12.58 11 181199 22283 79540895
Hypercholesterolaemia 22.78 12.58 12 181198 23083 79540095
Weight decreased 22.65 12.58 624 180586 354574 79208604
Autoimmune disorder 22.64 12.58 5 181205 16607 79546571
Blood urine present 22.63 12.58 10 181200 21287 79541891
Speech disorder 22.56 12.58 57 181153 54388 79508790
Dysstasia 22.49 12.58 18 181192 27728 79535450
Type 1 diabetes mellitus 22.43 12.58 49 181161 6870 79556308
Dermatitis 22.39 12.58 102 181108 21219 79541959
Teratoma benign 22.36 12.58 8 181202 73 79563105
Anaemia of malignant disease 22.36 12.58 17 181193 808 79562370
Gastrointestinal necrosis 22.28 12.58 43 181167 5522 79557656
Faeces discoloured 22.26 12.58 20 181190 29107 79534071
TP53 gene mutation 22.24 12.58 7 181203 41 79563137
Radiotherapy 22.20 12.58 15 181195 591 79562587
Tracheo-oesophageal fistula 22.20 12.58 15 181195 591 79562587
Periodontitis 22.13 12.58 38 181172 4458 79558720
Gelastic seizure 21.99 12.58 5 181205 5 79563173
Disturbance in attention 21.98 12.58 52 181158 50749 79512429
Enteritis 21.91 12.58 78 181132 14505 79548673
Jugular vein thrombosis 21.88 12.58 38 181172 4500 79558678
Pain in jaw 21.81 12.58 45 181165 46106 79517072
Tongue disorder 21.68 12.58 3 181207 13972 79549206
Nail avulsion 21.59 12.58 9 181201 128 79563050
Device issue 21.46 12.58 18 181192 27090 79536088
Hip arthroplasty 21.37 12.58 30 181180 35726 79527452
Immune-mediated neurological disorder 21.34 12.58 6 181204 22 79563156
Arterioenteric fistula 21.34 12.58 6 181204 22 79563156
Female genital tract fistula 21.31 12.58 44 181166 5931 79557247
Intestinal obstruction 21.28 12.58 169 181041 42851 79520327
Nasal septum perforation 21.22 12.58 16 181194 751 79562427
Thrombophlebitis migrans 21.16 12.58 13 181197 434 79562744
Acute erythroid leukaemia 20.95 12.58 11 181199 270 79562908
Device dislocation 20.86 12.58 17 181193 25953 79537225
Pleurocutaneous fistula 20.82 12.58 7 181203 52 79563126
Taeniasis 20.82 12.58 7 181203 52 79563126
Product quality issue 20.76 12.58 28 181182 33912 79529266
Cystitis noninfective 20.69 12.58 20 181190 1320 79561858
Bronchopleural fistula 20.66 12.58 15 181195 664 79562514
Liver function test abnormal 20.64 12.58 76 181134 64399 79498779
Carbohydrate antigen 15-3 20.64 12.58 8 181202 93 79563085
Xerophthalmia 20.62 12.58 15 181195 666 79562512
Pulmonary cavitation 20.61 12.58 22 181188 1634 79561544
Double hit lymphoma 20.55 12.58 6 181204 26 79563152
Immune-mediated arthritis 20.55 12.58 10 181200 208 79562970
Sputum discoloured 20.43 12.58 12 181198 21731 79541447
Epstein-Barr virus infection 20.35 12.58 4 181206 14412 79548766
Endometrial cancer recurrent 20.32 12.58 5 181205 9 79563169
Impaired quality of life 20.29 12.58 4 181206 14382 79548796
Pulmonary congestion 20.24 12.58 19 181191 27081 79536097
Obstructive airways disorder 20.23 12.58 25 181185 31434 79531744
Onychalgia 20.21 12.58 17 181193 935 79562243
Renal failure 20.17 12.58 328 180882 200640 79362538
Ulcer 20.15 12.58 23 181187 29949 79533229
Dementia 19.99 12.58 16 181194 24643 79538535
Aortic injury 19.98 12.58 5 181205 10 79563168
Hypocalcaemia 19.92 12.58 187 181023 49737 79513441
Acute kidney injury 19.88 12.58 971 180239 518433 79044745
Neuroendocrine breast tumour 19.85 12.58 6 181204 30 79563148
Splenic artery thrombosis 19.85 12.58 7 181203 61 79563117
Biliary obstruction 19.80 12.58 37 181173 4637 79558541
Hernia 19.79 12.58 7 181203 17052 79546126
Photophobia 19.76 12.58 11 181199 20517 79542661
Cannabinoid hyperemesis syndrome 19.75 12.58 7 181203 62 79563116
Gastroenteritis radiation 19.69 12.58 15 181195 715 79562463
Hypophagia 19.66 12.58 173 181037 45194 79517984
Blood magnesium decreased 19.64 12.58 82 181128 16430 79546748
Lichenoid keratosis 19.59 12.58 34 181176 4023 79559155
Ill-defined disorder 19.58 12.58 80 181130 65795 79497383
Cerebral ischaemia 19.57 12.58 63 181147 11132 79552046
Bone erosion 19.57 12.58 8 181202 17839 79545339
Vessel puncture site bruise 19.54 12.58 13 181197 499 79562679
Cardiac failure 19.44 12.58 475 180735 154367 79408811
Pulmonary artery stenosis 19.37 12.58 8 181202 111 79563067
Seizure 19.35 12.58 307 180903 188527 79374651
Gene mutation 19.25 12.58 27 181183 2659 79560519
Immune reconstitution inflammatory syndrome 19.21 12.58 4 181206 13837 79549341
Oesophageal stenosis 19.12 12.58 35 181175 4319 79558859
Torsade de pointes 19.10 12.58 10 181200 19302 79543876
Ovarian cancer 19.04 12.58 33 181177 3901 79559277
Glycosylated haemoglobin increased 19.01 12.58 10 181200 19250 79543928
Lymphatic disorder 18.99 12.58 11 181199 329 79562849
Influenza like illness 18.95 12.58 91 181119 71616 79491562
Post thrombotic syndrome 18.91 12.58 14 181196 639 79562539
Cytopenia 18.85 12.58 94 181116 20289 79542889
Angiodermatitis 18.82 12.58 7 181203 72 79563106
Non-small cell lung cancer recurrent 18.81 12.58 8 181202 120 79563058
Catheter site injury 18.74 12.58 10 181200 254 79562924
Immediate post-injection reaction 18.72 12.58 11 181199 338 79562840
Thrombocytosis 18.72 12.58 52 181158 8474 79554704
Metastases to abdominal cavity 18.70 12.58 14 181196 650 79562528
Radiation necrosis 18.70 12.58 12 181198 433 79562745
Septic pulmonary embolism 18.69 12.58 8 181202 122 79563056
Muscle rigidity 18.64 12.58 11 181199 19871 79543307
Ocular hyperaemia 18.58 12.58 22 181188 28184 79534994
Aortic embolus 18.57 12.58 7 181203 75 79563103
Therapy non-responder 18.55 12.58 128 181082 92177 79471001
Transaminases 18.49 12.58 7 181203 76 79563102
Fistula 18.42 12.58 68 181142 12872 79550306
Clonal haematopoiesis 18.41 12.58 6 181204 40 79563138
Blast cells present 18.40 12.58 16 181194 921 79562257
Product storage error 18.24 12.58 7 181203 16219 79546959
EGFR gene mutation 18.24 12.58 12 181198 452 79562726
Carbohydrate antigen 19-9 increased 18.22 12.58 12 181198 453 79562725
Lymphadenopathy 18.13 12.58 193 181017 53054 79510124
Adenocarcinoma 18.03 12.58 32 181178 3854 79559324
Scar 18.03 12.58 6 181204 15190 79547988
Pollakiuria 17.96 12.58 36 181174 37281 79525897
Arteriosclerosis coronary artery 17.95 12.58 9 181201 17807 79545371
Myocarditis 17.87 12.58 97 181113 21636 79541542
Loss of consciousness 17.85 12.58 504 180706 167439 79395739
Malignant peritoneal neoplasm 17.79 12.58 14 181196 700 79562478
Blood glucose decreased 17.78 12.58 20 181190 26214 79536964
Cognitive disorder 17.75 12.58 90 181120 69836 79493342
Pelvic infection 17.75 12.58 11 181199 373 79562805
Obstruction gastric 17.73 12.58 21 181189 1749 79561429
Underdose 17.72 12.58 30 181180 33121 79530057
Needle issue 17.68 12.58 4 181206 13064 79550114
Laryngeal discomfort 17.68 12.58 13 181197 587 79562591
Respiratory failure 17.61 12.58 537 180673 180374 79382804
Breast sarcoma 17.59 12.58 4 181206 4 79563174
Maternal death affecting foetus 17.59 12.58 4 181206 4 79563174
Acute respiratory distress syndrome 17.55 12.58 165 181045 43902 79519276
Metastases to soft tissue 17.51 12.58 13 181197 596 79562582
Apathy 17.50 12.58 4 181206 12973 79550205
Dyspnoea at rest 17.50 12.58 46 181164 7256 79555922
Wrist fracture 17.49 12.58 3 181207 11918 79551260
Liver scan abnormal 17.46 12.58 6 181204 48 79563130
Pancreatic failure 17.45 12.58 20 181190 1608 79561570
Upper gastrointestinal perforation 17.44 12.58 5 181205 20 79563158
Obstructive shock 17.43 12.58 7 181203 90 79563088
Crying 17.40 12.58 16 181194 23027 79540151
Lymphoma 17.33 12.58 9 181201 17451 79545727
Lupus-like syndrome 17.29 12.58 5 181205 13852 79549326
Mania 17.27 12.58 10 181200 18250 79544928
Arrhythmia 17.23 12.58 76 181134 61196 79501982
Malignant melanoma 17.18 12.58 6 181204 14735 79548443
Hepatic cytolysis 17.09 12.58 113 181097 27038 79536140
Poor venous access 17.08 12.58 10 181200 18139 79545039
Portal venous gas 17.04 12.58 11 181199 401 79562777
Hypercalcaemia of malignancy 17.04 12.58 11 181199 401 79562777
Upper-airway cough syndrome 17.03 12.58 3 181207 11690 79551488
Productive cough 17.02 12.58 124 181086 88207 79474971
Pulmonary hypoplasia 16.94 12.58 6 181204 53 79563125
Systemic scleroderma 16.87 12.58 17 181193 1180 79561998
Benign prostatic hyperplasia 16.87 12.58 3 181207 11609 79551569
Diverticulitis 16.86 12.58 51 181159 45885 79517293
Pulmonary vein stenosis 16.86 12.58 8 181202 157 79563021
Tumour perforation 16.82 12.58 11 181199 410 79562768
Keratitis 16.82 12.58 33 181177 4289 79558889
Rash papular 16.81 12.58 15 181195 21901 79541277
Adverse event 16.75 12.58 75 181135 60139 79503039
Lung infiltration 16.69 12.58 99 181111 22813 79540365
Protein urine 16.63 12.58 19 181191 1523 79561655
Atrioventricular block first degree 16.55 12.58 4 181206 12487 79550691
Vulvovaginal inflammation 16.47 12.58 12 181198 534 79562644
Ankle fracture 16.47 12.58 9 181201 16960 79546218
Ecchymosis 16.38 12.58 7 181203 15199 79547979
Cancer fatigue 16.37 12.58 8 181202 168 79563010
Blood pressure immeasurable 16.36 12.58 22 181188 2082 79561096
Laryngeal oedema 16.31 12.58 48 181162 8081 79555097
Facial pain 16.27 12.58 4 181206 12346 79550832
Pneumoperitoneum 16.27 12.58 27 181183 3081 79560097
Blood pressure increased 16.26 12.58 361 180849 210999 79352179
Facet joint syndrome 16.24 12.58 3 181207 11299 79551879
Chemotherapy 16.22 12.58 20 181190 1737 79561441
Venous thrombosis 16.22 12.58 44 181166 7072 79556106
Skin cancer 16.08 12.58 7 181203 15033 79548145
Hepatic vein thrombosis 16.07 12.58 9 181201 252 79562926
Secretion discharge 16.05 12.58 7 181203 15015 79548163
Renal cancer 16.03 12.58 4 181206 12222 79550956
End stage renal disease 16.02 12.58 4 181206 12216 79550962
Hypotensive crisis 15.99 12.58 7 181203 113 79563065
Emphysematous cystitis 15.98 12.58 10 181200 345 79562833
Thinking abnormal 15.97 12.58 5 181205 13156 79550022
Metastases to ovary 15.93 12.58 10 181200 347 79562831
Pancreatic carcinoma recurrent 15.91 12.58 8 181202 179 79562999
Triple negative breast cancer 15.88 12.58 7 181203 115 79563063
Breast ulceration 15.86 12.58 6 181204 65 79563113
Diverticulum 15.82 12.58 7 181203 14889 79548289
Plethoric face 15.79 12.58 5 181205 30 79563148
Glomerular filtration rate decreased 15.72 12.58 17 181193 22685 79540493
Campylobacter test positive 15.70 12.58 6 181204 67 79563111
Hydrothorax 15.68 12.58 18 181192 1450 79561728
Hormone receptor positive breast cancer 15.68 12.58 10 181200 357 79562821
Median nerve injury 15.65 12.58 5 181205 31 79563147
Hypotension 15.63 12.58 1182 180028 439135 79124043
Mastectomy 15.58 12.58 16 181194 1136 79562042
Tidal volume decreased 15.54 12.58 6 181204 69 79563109
Laryngeal cancer stage III 15.51 12.58 5 181205 32 79563146
Carpal tunnel syndrome 15.42 12.58 13 181197 19515 79543663
Taste disorder 15.37 12.58 74 181136 15749 79547429
Portal vein thrombosis 15.31 12.58 38 181172 5789 79557389
Electrocardiogram QRS complex prolonged 15.30 12.58 3 181207 10830 79552348
Depressed level of consciousness 15.29 12.58 143 181067 96509 79466669
Ankyloglossia acquired 15.27 12.58 3 181207 0 79563178
Radiation pericarditis 15.27 12.58 3 181207 0 79563178
Ototoxicity 15.24 12.58 27 181183 3247 79559931
Adenocarcinoma of appendix 15.24 12.58 6 181204 73 79563105
Blood pressure diastolic increased 15.18 12.58 7 181203 14535 79548643
Tumour hyperprogression 15.18 12.58 8 181202 198 79562980
Colitis microscopic 15.17 12.58 3 181207 10765 79552413
Vaginal cuff dehiscence 15.10 12.58 4 181206 11 79563167
Fatigue 15.02 12.58 2368 178842 927359 78635819
Pulmonary sarcoidosis 14.90 12.58 17 181193 1360 79561818
Eye irritation 14.87 12.58 15 181195 20666 79542512
Odynophagia 14.86 12.58 58 181152 11269 79551909
Pancreatitis 14.84 12.58 93 181117 68482 79494696
Immune-mediated encephalitis 14.82 12.58 11 181199 504 79562674
Uterine adhesions 14.77 12.58 5 181205 38 79563140
Vitamin D deficiency 14.71 12.58 7 181203 14272 79548906
Coagulopathy 14.68 12.58 38 181172 35968 79527210
Nail discomfort 14.61 12.58 6 181204 82 79563096
Muscle twitching 14.58 12.58 21 181189 24743 79538435
Haemobilia 14.57 12.58 11 181199 517 79562661
Increased tendency to bruise 14.57 12.58 3 181207 10461 79552717
Band sensation 14.56 12.58 13 181197 775 79562403
Vision blurred 14.55 12.58 162 181048 105736 79457442
Hip fracture 14.53 12.58 30 181180 30731 79532447
Hyperlipidaemia 14.52 12.58 23 181187 26070 79537108
Adrenal disorder 14.50 12.58 21 181189 2130 79561048
Abdominal infection 14.48 12.58 28 181182 3601 79559577
Haemodialysis 14.46 12.58 12 181198 18156 79545022
Abnormal dreams 14.46 12.58 4 181206 11408 79551770
Duodenal obstruction 14.34 12.58 10 181200 415 79562763
Visual impairment 14.28 12.58 137 181073 91994 79471184
Hyponatraemia 14.26 12.58 516 180694 177332 79385846
Embryonal rhabdomyosarcoma 14.24 12.58 5 181205 43 79563135
Granulocyte count decreased 14.21 12.58 19 181191 1789 79561389
Live birth 14.17 12.58 13 181197 18731 79544447
Discontinued product administered 14.17 12.58 6 181204 89 79563089
Pneumothorax spontaneous 14.15 12.58 17 181193 1437 79561741
Blood alkaline phosphatase increased 14.08 12.58 213 180997 63451 79499727
Carcinoembryonic antigen 13.99 12.58 6 181204 92 79563086
Thirst 13.97 12.58 13 181197 18606 79544572
Restless legs syndrome 13.96 12.58 15 181195 20077 79543101
Hypergeusia 13.96 12.58 4 181206 16 79563162
Blood loss anaemia 13.94 12.58 9 181201 15489 79547689
Fulminant type 1 diabetes mellitus 13.88 12.58 17 181193 1466 79561712
Product supply issue 13.82 12.58 20 181190 2028 79561150
Vascular device infection 13.80 12.58 53 181157 10223 79552955
Synovial cyst 13.78 12.58 3 181207 10062 79553116
Metastases to vagina 13.76 12.58 4 181206 17 79563161
Skin haemorrhage 13.75 12.58 5 181205 11976 79551202
Dandy-Walker syndrome 13.75 12.58 5 181205 48 79563130
Unmasking of previously unidentified disease 13.75 12.58 20 181190 2037 79561141
Lymphocele 13.72 12.58 18 181192 1663 79561515
Metastases to adrenals 13.69 12.58 16 181194 1314 79561864
Pseudocyst 13.68 12.58 9 181201 339 79562839
Metastases to pancreas 13.66 12.58 11 181199 569 79562609
Blood creatinine decreased 13.65 12.58 44 181166 7781 79555397
Coronary artery occlusion 13.63 12.58 9 181201 15306 79547872
Colitis ischaemic 13.62 12.58 70 181140 15289 79547889
Rhinorrhoea 13.61 12.58 109 181101 75965 79487213
Ureteric fistula 13.58 12.58 4 181206 18 79563160
Bladder necrosis 13.58 12.58 4 181206 18 79563160
Breast disorder 13.57 12.58 20 181190 2061 79561117
Pulmonary artery occlusion 13.57 12.58 5 181205 50 79563128
Vascular pseudoaneurysm ruptured 13.55 12.58 7 181203 166 79563012
Subclavian artery occlusion 13.51 12.58 7 181203 167 79563011
Corneal disorder 13.50 12.58 21 181189 2270 79560908
Eructation 13.49 12.58 4 181206 10905 79552273
Microangiopathic haemolytic anaemia 13.49 12.58 17 181193 1510 79561668
Cholecystitis chronic 13.47 12.58 3 181207 9903 79553275
Porokeratosis 13.38 12.58 8 181202 254 79562924
Arteriosclerosis 13.36 12.58 13 181197 18214 79544964
Peritoneal disorder 13.33 12.58 12 181198 723 79562455
Food allergy 13.33 12.58 4 181206 10820 79552358
Injection site induration 13.29 12.58 3 181207 9816 79553362
Dysentery 13.28 12.58 15 181195 1187 79561991
Angiosarcoma 13.25 12.58 10 181200 470 79562708
Renal disorder 13.24 12.58 50 181160 42055 79521123
Acquired amegakaryocytic thrombocytopenia 13.24 12.58 4 181206 20 79563158
Type 1 lepra reaction 13.23 12.58 5 181205 54 79563124
Vaginal perforation 13.20 12.58 3 181207 3 79563175
Ulcerated haemangioma 13.20 12.58 3 181207 3 79563175
Breast prosthesis removal 13.20 12.58 3 181207 3 79563175
Skin neoplasm bleeding 13.20 12.58 3 181207 3 79563175
Peritoneal lesion 13.20 12.58 3 181207 3 79563175
Dry mouth 13.17 12.58 132 181078 87887 79475291
Diabetic ketoacidosis 13.17 12.58 37 181173 34085 79529093
Ear pain 13.17 12.58 35 181175 32834 79530344
Thrombotic thrombocytopenic purpura 13.13 12.58 38 181172 6338 79556840
Pharyngitis streptococcal 13.12 12.58 4 181206 10710 79552468
Intervertebral disc degeneration 13.10 12.58 10 181200 15775 79547403
Brachiocephalic vein thrombosis 13.08 12.58 8 181202 265 79562913
Miller Fisher syndrome 13.05 12.58 8 181202 266 79562912
Respiratory depression 13.00 12.58 27 181183 27603 79535575
Respiratory disorder 13.00 12.58 55 181155 44801 79518377
Rotator cuff syndrome 12.93 12.58 8 181202 14087 79549091
Mediastinal fibrosis 12.92 12.58 4 181206 22 79563156
COVID-19 pneumonia 12.91 12.58 29 181181 28820 79534358
Brain injury 12.90 12.58 5 181205 11512 79551666
Deformity 12.87 12.58 3 181207 9602 79553576
Intestinal ischaemia 12.85 12.58 62 181148 13208 79549970
Steatorrhoea 12.84 12.58 13 181197 908 79562270
Immune-mediated renal disorder 12.83 12.58 7 181203 186 79562992
Device malfunction 12.81 12.58 18 181192 21430 79541748
Gastric fistula 12.80 12.58 7 181203 187 79562991
CSF white blood cell count decreased 12.77 12.58 4 181206 23 79563155
Metastases to abdominal wall 12.70 12.58 7 181203 190 79562988
Breast cellulitis 12.67 12.58 9 181201 385 79562793
Blood calcium decreased 12.66 12.58 34 181176 31785 79531393
Lip swelling 12.59 12.58 49 181161 40862 79522316

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
ATC L01CD51 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 cervix indication 363354003 DOID:4362
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 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 BRISTOL-MYERS N021660 Jan. 7, 2005 RX POWDER INTRAVENOUS 7923536 Dec. 9, 2023 TREATMENT OF BREAST CANCER
100MG/VIAL ABRAXANE BRISTOL-MYERS N021660 Jan. 7, 2005 RX POWDER INTRAVENOUS 7923536 Dec. 9, 2023 TREATMENT OF LUNG CANCER
100MG/VIAL ABRAXANE BRISTOL-MYERS N021660 Jan. 7, 2005 RX POWDER INTRAVENOUS 7923536 Dec. 9, 2023 TREATMENT OF PANCREATIC CANCER
100MG/VIAL ABRAXANE BRISTOL-MYERS N021660 Jan. 7, 2005 RX POWDER INTRAVENOUS 8138229 Dec. 9, 2023 TREATMENT OF BREAST CANCER
100MG/VIAL ABRAXANE BRISTOL-MYERS N021660 Jan. 7, 2005 RX POWDER INTRAVENOUS 8138229 Dec. 9, 2023 TREATMENT OF LUNG CANCER
100MG/VIAL ABRAXANE BRISTOL-MYERS N021660 Jan. 7, 2005 RX POWDER INTRAVENOUS 8138229 Dec. 9, 2023 TREATMENT OF PANCREATIC CANCER
100MG/VIAL ABRAXANE BRISTOL-MYERS N021660 Jan. 7, 2005 RX POWDER INTRAVENOUS 8314156 Dec. 9, 2023 TREATMENT OF LUNG CANCER
100MG/VIAL ABRAXANE BRISTOL-MYERS N021660 Jan. 7, 2005 RX POWDER INTRAVENOUS 8314156 Dec. 9, 2023 TREATMENT OF PANCREATIC CANCER
100MG/VIAL ABRAXANE BRISTOL-MYERS N021660 Jan. 7, 2005 RX POWDER INTRAVENOUS 7820788 Oct. 27, 2024 TREATMENT OF BREAST CANCER
100MG/VIAL ABRAXANE BRISTOL-MYERS N021660 Jan. 7, 2005 RX POWDER INTRAVENOUS 7820788 Oct. 27, 2024 TREATMENT OF LUNG CANCER
100MG/VIAL ABRAXANE BRISTOL-MYERS N021660 Jan. 7, 2005 RX POWDER INTRAVENOUS 7820788 Oct. 27, 2024 TREATMENT OF PANCREATIC CANCER
100MG/VIAL ABRAXANE BRISTOL-MYERS N021660 Jan. 7, 2005 RX POWDER INTRAVENOUS 7758891 Feb. 21, 2026 TREATMENT OF PANCREATIC CANCER
100MG/VIAL ABRAXANE BRISTOL-MYERS N021660 Jan. 7, 2005 RX POWDER INTRAVENOUS 8268348 Feb. 21, 2026 TREATMENT OF LUNG CANCER
100MG/VIAL ABRAXANE BRISTOL-MYERS N021660 Jan. 7, 2005 RX POWDER INTRAVENOUS 9101543 Feb. 21, 2026 TREATMENT OF PANCREATIC CANCER
100MG/VIAL ABRAXANE BRISTOL-MYERS N021660 Jan. 7, 2005 RX POWDER INTRAVENOUS 8034375 Aug. 13, 2026 TREATMENT OF LUNG CANCER
100MG/VIAL ABRAXANE BRISTOL-MYERS N021660 Jan. 7, 2005 RX POWDER INTRAVENOUS 9393318 March 4, 2032 TREATMENT OF LUNG CANCER
100MG/VIAL ABRAXANE BRISTOL-MYERS N021660 Jan. 7, 2005 RX POWDER INTRAVENOUS 9597409 March 4, 2032 TREATMENT OF LUNG CANCER
100MG/VIAL ABRAXANE BRISTOL-MYERS 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 BRISTOL-MYERS 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
Multidrug resistance protein 1 Transporter IC50 5.59 CHEMBL
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
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-associated protein 7 Transporter WOMBAT-PK
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:

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Paclitaxel HUMAN PRESCRIPTION DRUG LABEL 1 0517-4300 INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION 100 mg INTRAVENOUS NDA 30 sections
Paclitaxel HUMAN PRESCRIPTION DRUG LABEL 1 0703-3213 INJECTION, SOLUTION, CONCENTRATE 6 mg INTRAVENOUS ANDA 16 sections
Paclitaxel HUMAN PRESCRIPTION DRUG LABEL 1 0703-3213 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
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Paclitaxel HUMAN PRESCRIPTION DRUG LABEL 1 0703-3218 INJECTION, SOLUTION, CONCENTRATE 6 mg INTRAVENOUS ANDA 16 sections
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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
PACLITAXELPACLITAXEL Human Prescription Drug Label 1 23155-882 INJECTION, SOLUTION 6 mg INTRAVENOUS ANDA 19 sections
PACLITAXELPACLITAXEL Human Prescription Drug Label 1 23155-883 INJECTION, SOLUTION 6 mg INTRAVENOUS ANDA 19 sections
PACLITAXELPACLITAXEL Human Prescription Drug Label 1 23155-884 INJECTION, SOLUTION 6 mg INTRAVENOUS ANDA 19 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 46708-620 INJECTION 6 mg INTRAVENOUS ANDA 21 sections
Paclitaxel Human Prescription Drug Label 1 46708-621 INJECTION 6 mg INTRAVENOUS ANDA 21 sections
Paclitaxel Human Prescription Drug Label 1 46708-622 INJECTION 6 mg INTRAVENOUS ANDA 21 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