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 1703.71 12.57 1431 134195 66693 50402805
Neutropenia 1617.87 12.57 1985 133641 145980 50323518
Neuropathy peripheral 1503.03 12.57 1559 134067 95198 50374300
Disease progression 1104.70 12.57 1322 134304 94544 50374954
Metastases to liver 981.64 12.57 633 134993 19471 50450027
Erythema 979.41 12.57 1552 134074 144862 50324636
Metastases to bone 959.42 12.57 599 135027 17396 50452102
Febrile neutropenia 912.17 12.57 1213 134413 96454 50373044
Flushing 782.65 12.57 931 134695 66084 50403414
Anaemia 737.72 12.57 1894 133732 250562 50218936
Drug ineffective 690.20 12.57 712 134914 818621 49650877
Metastases to lung 618.18 12.57 379 135247 10641 50458857
Palmar-plantar erythrodysaesthesia syndrome 611.34 12.57 474 135152 19624 50449874
Dyspnoea 611.16 12.57 2986 132640 544622 49924876
Neutrophil count decreased 591.64 12.57 672 134954 45354 50424144
Polyneuropathy 540.93 12.57 361 135265 11770 50457728
Myelosuppression 524.08 12.57 369 135257 13148 50456350
Peripheral sensory neuropathy 500.59 12.57 276 135350 6315 50463183
Neoplasm progression 481.00 12.57 486 135140 28671 50440827
Metastases to central nervous system 474.98 12.57 324 135302 10958 50458540
Joint swelling 464.80 12.57 56 135570 245230 50224268
Rheumatoid arthritis 464.55 12.57 18 135608 202532 50266966
Acute myeloid leukaemia 439.97 12.57 347 135279 14727 50454771
Thrombocytopenia 428.12 12.57 1011 134615 126662 50342836
Neurotoxicity 414.56 12.57 332 135294 14408 50455090
Mucosal inflammation 404.35 12.57 518 135108 39624 50429874
Leukopenia 403.35 12.57 681 134945 66847 50402651
Metastases to lymph nodes 402.70 12.57 245 135381 6779 50462719
Pneumonitis 375.93 12.57 429 135197 29081 50440417
Ejection fraction decreased 375.80 12.57 346 135280 18174 50451324
Chest discomfort 366.34 12.57 784 134842 91938 50377560
Product dose omission issue 360.68 12.57 37 135589 183801 50285697
Ascites 352.14 12.57 457 135169 35404 50434094
Death 351.61 12.57 1761 133865 323618 50145880
Haematotoxicity 349.69 12.57 234 135392 7661 50461837
Contraindicated product administered 345.72 12.57 12 135614 148946 50320552
Fall 334.79 12.57 246 135380 334686 50134812
Completed suicide 332.00 12.57 4 135622 131885 50337613
Bone marrow failure 322.50 12.57 384 135242 27240 50442258
Arthropathy 319.74 12.57 28 135598 157878 50311620
Systemic lupus erythematosus 298.63 12.57 20 135606 140602 50328896
Synovitis 290.88 12.57 9 135617 123856 50345642
Sinusitis 288.37 12.57 54 135572 170504 50298994
Therapeutic product effect decreased 284.12 12.57 21 135605 136029 50333469
Cystoid macular oedema 272.25 12.57 112 135514 1287 50468211
Proteinuria 270.65 12.57 275 135351 16322 50453176
Anaphylactic shock 270.30 12.57 301 135325 19854 50449644
Abdominal discomfort 270.19 12.57 142 135484 231499 50237999
Weight increased 266.28 12.57 104 135522 201787 50267711
Glossodynia 262.35 12.57 11 135615 115558 50353940
Pseudocirrhosis 261.63 12.57 88 135538 542 50468956
Feeling hot 257.76 12.57 413 135213 38789 50430709
Condition aggravated 257.67 12.57 250 135376 296808 50172690
Headache 253.67 12.57 620 135006 505915 49963583
Breast cancer metastatic 252.89 12.57 215 135411 10149 50459349
Metastases to peritoneum 246.89 12.57 130 135496 2703 50466795
Hypertension 246.19 12.57 1169 134457 210034 50259464
Pain 245.03 12.57 769 134857 578134 49891364
Epistaxis 242.44 12.57 532 135094 63422 50406076
Swelling 241.90 12.57 118 135508 200754 50268744
General physical health deterioration 241.83 12.57 885 134741 141549 50327949
Second primary malignancy 238.81 12.57 176 135450 6738 50462760
Interstitial lung disease 237.35 12.57 473 135153 52703 50416795
Pleural effusion 236.72 12.57 611 135015 80843 50388655
Onycholysis 230.51 12.57 98 135528 1230 50468268
Skin toxicity 225.61 12.57 137 135489 3776 50465722
Bronchospasm 216.87 12.57 232 135394 14622 50454876
Myelodysplastic syndrome 216.82 12.57 234 135392 14898 50454600
Musculoskeletal stiffness 216.43 12.57 41 135585 128440 50341058
Gastrointestinal perforation 215.58 12.57 122 135504 2939 50466559
Product use issue 200.34 12.57 75 135551 149400 50320098
Ovarian cancer recurrent 197.11 12.57 78 135548 804 50468694
Injection site pain 196.71 12.57 31 135595 110993 50358505
Drug intolerance 189.13 12.57 185 135441 218919 50250579
Vomiting 186.54 12.57 1969 133657 458789 50010709
Back pain 185.97 12.57 1115 134511 218915 50250583
Peripheral swelling 176.44 12.57 175 135451 205761 50263737
Hypertransaminasaemia 174.42 12.57 113 135513 3498 50466000
Diarrhoea 169.39 12.57 2357 133269 586119 49883379
Cardiac dysfunction 168.26 12.57 85 135541 1616 50467882
Bone pain 163.46 12.57 379 135247 46850 50422648
Nausea 160.36 12.57 2714 132912 702684 49766814
Pyrexia 159.45 12.57 1637 133989 378566 50090932
Treatment failure 155.06 12.57 88 135538 137549 50331949
Wound 154.09 12.57 46 135580 105748 50363750
Embolism 152.75 12.57 136 135490 6832 50462666
Arthralgia 152.52 12.57 632 134994 438070 50031428
Sense of oppression 151.73 12.57 66 135560 879 50468619
Nasopharyngitis 150.74 12.57 177 135449 192750 50276748
Abdominal pain 148.89 12.57 1113 134513 235115 50234383
Platelet count decreased 148.76 12.57 599 135027 100127 50369371
Osteonecrosis of jaw 143.50 12.57 288 135338 32238 50437260
Drug abuse 141.72 12.57 4 135622 59842 50409656
Somnolence 140.58 12.57 125 135501 154860 50314638
Psoriasis 140.22 12.57 12 135614 68988 50400510
White blood cell count decreased 140.08 12.57 652 134974 116070 50353428
Lymphangiosis carcinomatosa 139.89 12.57 67 135559 1129 50468369
Injection site erythema 139.54 12.57 18 135608 74918 50394580
PIK3CA-activated mutation 138.03 12.57 59 135567 751 50468747
Hospitalisation 137.55 12.57 12 135614 67925 50401573
Breast cancer recurrent 136.18 12.57 99 135527 3709 50465789
Overdose 135.33 12.57 49 135577 99678 50369820
Metastasis 134.75 12.57 104 135522 4271 50465227
Drug hypersensitivity 134.24 12.57 296 135330 250714 50218784
Cardiotoxicity 130.46 12.57 125 135501 6902 50462596
Nail disorder 130.17 12.57 145 135481 9563 50459935
Hepatic enzyme increased 129.22 12.57 107 135519 137273 50332225
Migraine 124.67 12.57 25 135601 75255 50394243
Suicide attempt 124.21 12.57 3 135623 51729 50417769
Arthritis 123.94 12.57 39 135587 86682 50382816
Paraesthesia 122.43 12.57 641 134985 119602 50349896
Maternal exposure during pregnancy 122.21 12.57 149 135477 159629 50309869
Contusion 121.71 12.57 75 135551 112108 50357390
Mobility decreased 119.66 12.57 33 135593 79915 50389583
Depression 119.56 12.57 161 135465 165262 50304236
Tachycardia 119.48 12.57 557 135069 99206 50370292
Hypokalaemia 119.48 12.57 510 135116 87482 50382016
Pericarditis 118.67 12.57 32 135594 78657 50390841
Therapy partial responder 118.14 12.57 115 135511 6476 50463022
Blood cholesterol increased 116.71 12.57 8 135618 55207 50414291
Loss of personal independence in daily activities 116.55 12.57 23 135603 70027 50399471
Irritable bowel syndrome 116.35 12.57 5 135621 51436 50418062
Pulmonary embolism 116.09 12.57 560 135066 101144 50368354
Exposure during pregnancy 115.36 12.57 93 135533 120922 50348576
Helicobacter infection 115.25 12.57 4 135622 49698 50419800
Metastases to meninges 115.18 12.57 70 135556 1932 50467566
Oxygen saturation decreased 114.90 12.57 444 135182 72804 50396694
Large intestine perforation 114.63 12.57 120 135506 7374 50462124
Nail discolouration 114.52 12.57 74 135552 2280 50467218
Peripheral motor neuropathy 114.39 12.57 62 135564 1369 50468129
Left ventricular dysfunction 114.35 12.57 141 135485 10365 50459133
Gastrointestinal toxicity 114.04 12.57 97 135529 4580 50464918
Hypoxia 111.69 12.57 346 135280 50777 50418721
Influenza 111.68 12.57 50 135576 89488 50380010
Disease recurrence 108.65 12.57 194 135432 19887 50449611
Asthenia 107.28 12.57 1316 134310 317726 50151772
Pneumocystis jirovecii pneumonia 106.81 12.57 162 135464 14501 50454997
Dehydration 106.15 12.57 736 134890 151713 50317785
Neutropenic sepsis 105.47 12.57 158 135468 13989 50455509
Toxicity to various agents 105.22 12.57 261 135365 212238 50257260
Nail toxicity 104.68 12.57 38 135588 302 50469196
Drug interaction 101.33 12.57 242 135384 199379 50270119
Hepatic atrophy 100.73 12.57 35 135591 241 50469257
Decreased appetite 100.21 12.57 898 134728 200025 50269473
Throat tightness 99.72 12.57 191 135435 20656 50448842
Fibromyalgia 99.68 12.57 5 135621 44973 50424525
Biliary tract infection 98.63 12.57 39 135587 401 50469097
Duodenal ulcer perforation 98.21 12.57 6 135620 45605 50423893
Injection site reaction 98.19 12.57 10 135616 50022 50419476
Urogenital fistula 98.08 12.57 29 135597 108 50469390
Inappropriate schedule of product administration 97.94 12.57 35 135591 71796 50397702
Asthma 97.91 12.57 59 135567 89278 50380220
Hepatic failure 96.63 12.57 245 135381 32038 50437460
Feeling abnormal 94.91 12.57 118 135508 125374 50344124
Cyanosis 94.37 12.57 156 135470 15028 50454470
Ileus 93.32 12.57 144 135482 13085 50456413
Discomfort 92.84 12.57 92 135534 108288 50361210
Injection site swelling 91.45 12.57 5 135621 41768 50427730
Intestinal perforation 91.25 12.57 126 135500 10353 50459145
Insomnia 90.32 12.57 210 135416 174655 50294843
Lower respiratory tract infection 89.67 12.57 74 135552 95127 50374371
Metastases to skin 89.05 12.57 52 135574 1331 50468167
Memory impairment 88.96 12.57 51 135575 79309 50390189
Dysaesthesia 88.09 12.57 76 135550 3659 50465839
Injection site pruritus 87.97 12.57 5 135621 40406 50429092
Confusional state 86.18 12.57 236 135390 185692 50283806
Cardiomyopathy 86.15 12.57 152 135474 15434 50454064
Cholangitis 86.04 12.57 82 135544 4497 50465001
Laryngospasm 85.20 12.57 65 135561 2623 50466875
Incorrect dose administered 84.63 12.57 14 135612 48400 50421098
Gait disturbance 82.50 12.57 174 135452 149831 50319667
Tumour necrosis 82.46 12.57 40 135586 694 50468804
Subileus 81.53 12.57 64 135562 2695 50466803
Intentional product misuse 80.62 12.57 14 135612 46720 50422778
Recall phenomenon 80.14 12.57 36 135590 520 50468978
Osteoarthritis 79.93 12.57 42 135584 68564 50400934
Tumour haemorrhage 79.55 12.57 48 135578 1307 50468191
Posterior reversible encephalopathy syndrome 77.92 12.57 142 135484 14786 50454712
Suicidal ideation 77.20 12.57 26 135600 55359 50414139
Pancytopenia 76.74 12.57 435 135191 83595 50385903
Muscle spasms 76.53 12.57 137 135489 125416 50344082
Acute promyelocytic leukaemia 75.43 12.57 40 135586 844 50468654
Small intestinal obstruction 75.36 12.57 146 135480 15922 50453576
Injury 73.56 12.57 20 135606 48905 50420593
Hypersensitivity 73.26 12.57 890 134736 214271 50255227
Tumour marker increased 72.60 12.57 69 135557 3771 50465727
Metastases to spine 71.67 12.57 60 135566 2771 50466727
Metastases to pleura 70.89 12.57 44 135582 1262 50468236
Hypoglycaemia 69.88 12.57 28 135598 53553 50415945
Anaphylactoid reaction 69.78 12.57 64 135562 3342 50466156
Hydronephrosis 68.89 12.57 99 135527 8442 50461056
Malignant pleural effusion 68.75 12.57 54 135572 2276 50467222
Metastatic neoplasm 68.22 12.57 66 135560 3688 50465810
Blister 68.11 12.57 77 135549 85341 50384157
Cardiac failure 67.05 12.57 390 135236 75650 50393848
Carbohydrate antigen 15-3 increased 66.20 12.57 40 135586 1092 50468406
Red blood cell sedimentation rate increased 66.05 12.57 3 135623 29413 50440085
Fluid retention 65.18 12.57 27 135599 50622 50418876
Abortion spontaneous 64.86 12.57 16 135610 41756 50427742
Alveolitis 64.76 12.57 54 135572 2480 50467018
Metastases to the mediastinum 63.22 12.57 29 135597 441 50469057
Therapeutic product effect incomplete 63.14 12.57 92 135534 91423 50378075
Osteoporosis 62.67 12.57 21 135605 44858 50424640
C-reactive protein abnormal 61.91 12.57 3 135623 27806 50441692
Pneumothorax 61.57 12.57 124 135502 13910 50455588
Bronchitis 61.39 12.57 116 135510 104043 50365455
Metastases to retroperitoneum 61.02 12.57 21 135605 140 50469358
Bronchostenosis 60.17 12.57 27 135599 389 50469109
Infusion related reaction 60.15 12.57 707 134919 168850 50300648
Hypertensive crisis 59.84 12.57 118 135508 13036 50456462
Anxiety 58.94 12.57 260 135366 177346 50292152
Computerised tomogram thorax abnormal 58.86 12.57 40 135586 1343 50468155
Portal hypertension 58.58 12.57 58 135568 3334 50466164
Performance status decreased 57.73 12.57 56 135570 3139 50466359
Secondary cerebellar degeneration 57.25 12.57 16 135610 46 50469452
Metastases to kidney 57.19 12.57 21 135605 173 50469325
Hepatic function abnormal 56.96 12.57 205 135421 32476 50437022
Pain in extremity 56.93 12.57 463 135163 272402 50197096
Anaphylactic reaction 56.92 12.57 291 135335 53764 50415734
Surgery 56.84 12.57 7 135619 30198 50439300
Paronychia 55.81 12.57 65 135561 4499 50464999
Carbohydrate antigen 125 increased 55.76 12.57 49 135577 2418 50467080
Coronary artery disease 55.66 12.57 7 135619 29719 50439779
Unevaluable event 55.45 12.57 27 135599 46039 50423459
Adverse event 55.24 12.57 24 135602 43739 50425759
Hyperaemia 55.13 12.57 45 135581 2005 50467493
Irritability 54.95 12.57 6 135620 28420 50441078
Chronic obstructive pulmonary disease 54.84 12.57 38 135588 53397 50416101
Urinary tract obstruction 54.81 12.57 42 135584 1706 50467792
Stomatitis 54.63 12.57 461 135165 100883 50368615
Recurrent cancer 54.62 12.57 42 135584 1715 50467783
Folliculitis 53.65 12.57 19 135607 39206 50430292
Cataract 53.57 12.57 30 135596 47270 50422228
Illness 53.52 12.57 3 135623 24537 50444961
Macular oedema 53.20 12.57 57 135569 3597 50465901
Plasma cell myeloma 52.69 12.57 10 135616 31312 50438186
Urticaria 52.43 12.57 175 135451 129386 50340112
Palmar erythema 52.21 12.57 39 135587 1524 50467974
Small intestinal perforation 51.61 12.57 36 135590 1262 50468236
Blood pressure fluctuation 51.36 12.57 16 135610 35807 50433691
Atelectasis 50.91 12.57 135 135491 18135 50451363
Gastric disorder 50.64 12.57 9 135617 29539 50439959
Hepatic lesion 50.56 12.57 58 135568 3950 50465548
Bile duct stenosis 50.32 12.57 33 135593 1043 50468455
Drug reaction with eosinophilia and systemic symptoms 50.17 12.57 8 135618 28416 50441082
Carcinoembryonic antigen increased 49.73 12.57 37 135589 1437 50468061
Pleural neoplasm 49.30 12.57 20 135606 221 50469277
Lymphoedema 49.17 12.57 88 135538 9034 50460464
Coma 49.01 12.57 48 135578 56831 50412667
Nephrolithiasis 48.85 12.57 16 135610 34677 50434821
Device related infection 48.71 12.57 144 135482 20591 50448907
Cholangitis sclerosing 48.66 12.57 34 135592 1195 50468303
Tumour lysis syndrome 48.49 12.57 78 135548 7343 50462155
Radiation pneumonitis 48.40 12.57 35 135591 1300 50468198
Bone lesion 47.80 12.57 64 135562 5106 50464392
Dizziness 47.66 12.57 648 134978 345721 50123777
Sleep disorder 47.47 12.57 50 135576 57233 50412265
Eczema asteatotic 47.47 12.57 20 135606 245 50469253
Malignant ascites 46.96 12.57 29 135597 824 50468674
Medication error 46.86 12.57 19 135607 36085 50433413
Hallucination 46.80 12.57 34 135592 46623 50422875
Pregnancy 46.56 12.57 11 135615 29566 50439932
Ear infection 46.54 12.57 7 135619 25963 50443535
Capillary leak syndrome 45.67 12.57 39 135587 1851 50467647
Wrong technique in product usage process 45.39 12.57 49 135577 55461 50414037
Subclavian vein thrombosis 45.28 12.57 38 135588 1761 50467737
Pericardial effusion 45.01 12.57 161 135465 25428 50444070
Basal cell carcinoma 44.97 12.57 5 135621 23351 50446147
Superior vena cava syndrome 44.82 12.57 25 135601 585 50468913
Biliary sepsis 44.53 12.57 28 135598 822 50468676
Device related thrombosis 44.52 12.57 33 135593 1274 50468224
Swollen tongue 44.38 12.57 11 135615 28619 50440879
Metastases to pelvis 44.38 12.57 21 135605 344 50469154
Acute interstitial pneumonitis 44.33 12.57 25 135601 598 50468900
Nervousness 44.09 12.57 10 135616 27641 50441857
Constipation 43.74 12.57 720 134906 184988 50284510
Neoplasm recurrence 43.71 12.57 42 135584 2327 50467171
Serotonin syndrome 43.52 12.57 7 135619 24706 50444792
Type I hypersensitivity 43.47 12.57 42 135584 2343 50467155
Colitis 43.08 12.57 211 135415 38318 50431180
Nasal congestion 43.06 12.57 44 135582 51076 50418422
Crying 43.02 12.57 3 135623 20413 50449085
Pulmonary arterial hypertension 42.77 12.57 3 135623 20316 50449182
Sepsis 42.66 12.57 544 135082 132381 50337117
Intestinal obstruction 42.22 12.57 161 135465 26222 50443276
Oesophagobronchial fistula 42.07 12.57 12 135614 38 50469460
Metastases to chest wall 41.84 12.57 22 135604 456 50469042
COVID-19 41.82 12.57 38 135588 46624 50422874
Drug dependence 41.35 12.57 3 135623 19756 50449742
Myocardial infarction 41.20 12.57 113 135513 88914 50380584
Hot flush 41.19 12.57 230 135396 43939 50425559
Endocarditis noninfective 41.16 12.57 12 135614 42 50469456
Cerebrovascular accident 41.02 12.57 124 135502 94556 50374942
Toxic erythema of chemotherapy 41.02 12.57 15 135611 122 50469376
Dyskinesia 40.75 12.57 12 135614 27849 50441649
Acute myelomonocytic leukaemia 40.68 12.57 16 135610 162 50469336
Adverse drug reaction 40.61 12.57 53 135573 55169 50414329
Rash pruritic 40.51 12.57 41 135585 47805 50421693
Multiple sclerosis 40.45 12.57 4 135622 20489 50449009
Dysgeusia 39.92 12.57 208 135418 38708 50430790
Extravasation 39.81 12.57 37 135589 1965 50467533
Rhabdomyolysis 39.72 12.57 28 135598 38999 50430499
Periodontitis 39.71 12.57 45 135581 3024 50466474
Blood uric acid decreased 39.63 12.57 24 135602 658 50468840
Hip arthroplasty 39.51 12.57 16 135610 30413 50439085
Hypervolaemia 39.13 12.57 10 135616 25489 50444009
Aortitis 38.98 12.57 26 135600 846 50468652
Thrombotic microangiopathy 38.95 12.57 78 135548 8713 50460785
Gastrooesophageal reflux disease 38.45 12.57 93 135533 76335 50393163
Administration site extravasation 38.40 12.57 24 135602 697 50468801
Transaminases increased 38.29 12.57 162 135464 27662 50441836
Hyperpyrexia 38.25 12.57 44 135582 3005 50466493
Diabetes mellitus 38.22 12.57 45 135581 48988 50420510
Lymphadenopathy mediastinal 38.03 12.57 40 135586 2471 50467027
Pseudomembranous colitis 38.03 12.57 42 135584 2743 50466755
Lactic acidosis 37.99 12.57 21 135605 33334 50436164
Female genital tract fistula 37.97 12.57 48 135578 3618 50465880
Peritonitis 37.77 12.57 109 135517 15377 50454121
Fistula 37.72 12.57 74 135552 8144 50461354
International normalised ratio increased 37.66 12.57 36 135590 43116 50426382
Suffocation feeling 37.23 12.57 29 135597 1207 50468291
Cachexia 37.23 12.57 53 135573 4480 50465018
Capillary permeability increased 37.07 12.57 10 135616 24 50469474
Hypersensitivity pneumonitis 36.98 12.57 38 135588 2284 50467214
Psychotic disorder 36.61 12.57 7 135619 21805 50447693
Road traffic accident 36.52 12.57 10 135616 24342 50445156
Radiation necrosis 36.46 12.57 18 135608 325 50469173
Lymphocele 36.33 12.57 24 135602 768 50468730
Stress 36.20 12.57 55 135571 53738 50415760
Hypoalbuminaemia 36.17 12.57 81 135545 9779 50459719
Deep vein thrombosis 36.13 12.57 327 135299 72977 50396521
Metastases to stomach 36.03 12.57 15 135611 178 50469320
Anastomotic leak 35.99 12.57 19 135607 397 50469101
Hormone receptor positive breast cancer 35.93 12.57 20 135606 466 50469032
Tremor 35.84 12.57 172 135454 114731 50354767
Gait inability 35.83 12.57 28 135598 36999 50432499
Wheezing 35.76 12.57 70 135556 61977 50407521
Drug resistance 35.58 12.57 122 135504 18867 50450631
Metastases to soft tissue 35.23 12.57 14 135612 146 50469352
Bradycardia 35.16 12.57 75 135551 64351 50405147
Limb injury 35.07 12.57 6 135620 20244 50449254
Therapy interrupted 34.83 12.57 6 135620 20146 50449352
Enterocolitis infectious 34.70 12.57 30 135596 1448 50468050
Disseminated intravascular coagulation 34.69 12.57 113 135513 17022 50452476
Product prescribing error 34.61 12.57 7 135619 20954 50448544
Primary cardiac lymphoma 34.48 12.57 9 135617 18 50469480
Metastases to abdominal wall 34.37 12.57 12 135614 84 50469414
Respiratory distress 34.11 12.57 167 135459 30322 50439176
Neutropenic colitis 33.96 12.57 37 135589 2380 50467118
Laboratory test abnormal 33.93 12.57 10 135616 23198 50446300
Onychalgia 33.85 12.57 23 135603 772 50468726
Gallbladder disorder 33.76 12.57 3 135623 16739 50452759
Scleroderma-like reaction 33.67 12.57 11 135615 61 50469437
Metastases to breast 33.54 12.57 16 135610 267 50469231
Injection site haemorrhage 33.48 12.57 8 135618 21338 50448160
Blood glucose increased 33.40 12.57 90 135536 71234 50398264
Mental disorder 33.03 12.57 9 135617 21982 50447516
Hypocalcaemia 33 12.57 151 135475 26665 50442833
Bronchial fistula 32.97 12.57 9 135617 23 50469475
Hepatitis B reactivation 32.96 12.57 34 135592 2053 50467445
Hypomagnesaemia 32.78 12.57 136 135490 23020 50446478
Breast cancer 32.75 12.57 212 135414 42678 50426820
Amnesia 32.70 12.57 39 135587 42221 50427277
Herpes zoster 32.64 12.57 90 135536 70696 50398802
Eye pain 32.27 12.57 18 135608 28431 50441067
Eosinophil percentage increased 32.21 12.57 24 135602 934 50468564
Radiation skin injury 32.15 12.57 23 135603 840 50468658
Dyspnoea at rest 31.97 12.57 44 135582 3603 50465895
Peritoneal disorder 31.94 12.57 18 135608 430 50469068
Joint stiffness 31.83 12.57 21 135605 30287 50439211
Renal disorder 31.79 12.57 17 135609 27488 50442010
No adverse event 31.73 12.57 26 135600 33552 50435946
Product administration error 31.66 12.57 7 135619 19692 50449806
Chills 31.56 12.57 397 135229 96290 50373208
Treatment noncompliance 31.52 12.57 21 135605 30129 50439369
Adenocarcinoma 31.46 12.57 36 135590 2445 50467053
Acne 31.42 12.57 7 135619 19588 50449910
Metabolic acidosis 30.94 12.57 35 135591 38790 50430708
Type 2 diabetes mellitus 30.80 12.57 28 135598 34347 50435151
Head injury 30.59 12.57 13 135613 24007 50445491
Tonsillar disorder 30.58 12.57 24 135602 1010 50468488
Oesophagitis 30.54 12.57 92 135534 13291 50456207
Tumour embolism 30.47 12.57 12 135614 122 50469376
Choking sensation 30.37 12.57 40 135586 3140 50466358
Lymphadenopathy 30.28 12.57 173 135453 33326 50436172
Device dislocation 30.22 12.57 10 135616 21536 50447962
Flatulence 30.15 12.57 21 135605 29437 50440061
Cardiac cirrhosis 30.04 12.57 12 135614 127 50469371
Blood bilirubin increased 29.98 12.57 167 135459 31871 50437627
Hypotension 29.75 12.57 834 134792 234635 50234863
Nightmare 29.61 12.57 4 135622 16082 50453416
Electrocardiogram QT prolonged 29.50 12.57 59 135567 51827 50417671
Kidney infection 29.45 12.57 7 135619 18739 50450759
Pneumonitis chemical 29.43 12.57 13 135613 180 50469318
Neuromuscular toxicity 29.39 12.57 12 135614 135 50469363
Infusion related hypersensitivity reaction 29.27 12.57 10 135616 65 50469433
Full blood count abnormal 29.24 12.57 13 135613 23375 50446123
Eosinophilia 29.24 12.57 7 135619 18645 50450853
Duodenitis haemorrhagic 29.16 12.57 7 135619 8 50469490
Hyperhidrosis 29.11 12.57 367 135259 89059 50380439
Immune-mediated hepatitis 28.96 12.57 22 135604 882 50468616
Panic attack 28.90 12.57 8 135618 19334 50450164
Vena cava thrombosis 28.50 12.57 31 135595 1990 50467508
Pulmonary tumour thrombotic microangiopathy 28.48 12.57 9 135617 44 50469454
Musculoskeletal disorder 28.22 12.57 6 135620 17343 50452155
Pulse absent 28.03 12.57 48 135578 4758 50464740
Neoplasm 27.96 12.57 54 135572 5874 50463624
Venous thrombosis 27.90 12.57 46 135580 4420 50465078
Cytopenia 27.72 12.57 68 135558 8707 50460791
Aggression 27.58 12.57 11 135615 21105 50448393
Acute lymphocytic leukaemia 27.54 12.57 32 135594 2209 50467289
Neck pain 27.48 12.57 71 135555 56996 50412502
Vocal cord paralysis 27.39 12.57 28 135598 1673 50467825
Incorrect route of product administration 27.37 12.57 8 135618 18658 50450840
Device malfunction 27.27 12.57 4 135622 15117 50454381
Metastases to eye 27.16 12.57 11 135615 121 50469377
Metastases to bladder 27.11 12.57 12 135614 167 50469331
Ill-defined disorder 27.10 12.57 67 135559 54587 50414911
Pruritus 27.03 12.57 567 135059 283001 50186497
Joint range of motion decreased 27.02 12.57 8 135618 18504 50450994
Dermatitis acneiform 27.00 12.57 43 135583 4014 50465484
Tumour pain 26.94 12.57 24 135602 1206 50468292
Therapeutic response unexpected 26.94 12.57 5 135621 15910 50453588
Oropharyngeal pain 26.94 12.57 112 135514 77689 50391809
Hypopituitarism 26.92 12.57 21 135605 876 50468622
Sinus disorder 26.90 12.57 8 135618 18450 50451048
Nasal septum perforation 26.89 12.57 19 135607 680 50468818
Gastrointestinal necrosis 26.88 12.57 34 135592 2564 50466934
Upper limb fracture 26.84 12.57 5 135621 15868 50453630
Foot deformity 26.80 12.57 9 135617 19201 50450297
Porokeratosis 26.61 12.57 11 135615 128 50469370
Inflammation 26.50 12.57 72 135554 56840 50412658
Glaucoma 26.40 12.57 5 135621 15681 50453817
Pancreatitis 26.39 12.57 46 135580 42568 50426930
Duodenal perforation 26.36 12.57 19 135607 702 50468796
Wound dehiscence 26.25 12.57 44 135582 4286 50465212
Rectal perforation 26.18 12.57 15 135611 370 50469128
Eastern Cooperative Oncology Group performance status worsened 26.08 12.57 18 135608 620 50468878
Blood pressure systolic increased 26.08 12.57 34 135592 35415 50434083
Prescribed overdose 26.01 12.57 4 135622 14596 50454902
Alanine aminotransferase increased 25.99 12.57 356 135270 88003 50381495
Skin laceration 25.98 12.57 9 135617 18833 50450665
Night sweats 25.96 12.57 31 135595 33543 50435955
Thyroid dermatopathy 25.89 12.57 7 135619 17 50469481
Fear 25.89 12.57 4 135622 14545 50454953
Cytomegalovirus infection 25.79 12.57 8 135618 17954 50451544
Pelvic abscess 25.60 12.57 25 135601 1413 50468085
Accidental exposure to product 25.57 12.57 15 135611 23042 50446456
Product quality issue 25.49 12.57 27 135599 30831 50438667
Gastrointestinal fistula 25.44 12.57 15 135611 391 50469107
Double hit lymphoma 25.41 12.57 6 135620 6 50469492
Viral infection 25.04 12.57 26 135600 29960 50439538
Mood swings 24.98 12.57 6 135620 15948 50453550
Intestinal metastasis 24.77 12.57 10 135616 109 50469389
Mastitis 24.74 12.57 31 135595 2316 50467182
Xerophthalmia 24.41 12.57 14 135612 346 50469152
Organising pneumonia 24.39 12.57 45 135581 4729 50464769
Nail dystrophy 24.37 12.57 19 135607 792 50468706
Jugular vein thrombosis 24.35 12.57 33 135593 2663 50466835
Haemoglobin 24.30 12.57 11 135615 162 50469336
Gastroenteritis radiation 24.27 12.57 15 135611 427 50469071
Transfusion 24.26 12.57 3 135623 12902 50456596
Hepatotoxicity 24.21 12.57 140 135486 27086 50442412
Osteolysis 24.17 12.57 32 135594 2525 50466973
Blood potassium increased 24.09 12.57 7 135619 16391 50453107
Tooth erosion 23.99 12.57 15 135611 436 50469062
Disability 23.94 12.57 3 135623 12772 50456726
Lymphopenia 23.91 12.57 94 135532 15527 50453971
Cancer pain 23.88 12.57 32 135594 2555 50466943
Foot fracture 23.84 12.57 12 135614 20079 50449419
Febrile infection 23.77 12.57 22 135604 1162 50468336
Impaired work ability 23.71 12.57 4 135622 13636 50455862
Bursitis 23.71 12.57 15 135611 22120 50447378
Embryonal rhabdomyosarcoma 23.69 12.57 6 135620 10 50469488
Drug level increased 23.64 12.57 11 135615 19257 50450241
Emphysematous cystitis 23.63 12.57 10 135616 124 50469374
Therapy cessation 23.52 12.57 21 135605 25990 50443508
Spinal stenosis 23.50 12.57 4 135622 13546 50455952
Cancer fatigue 23.48 12.57 7 135619 27 50469471
Bone marrow infiltration 23.48 12.57 15 135611 453 50469045
Intracranial tumour haemorrhage 23.41 12.57 10 135616 127 50469371
Carpal tunnel syndrome 23.41 12.57 8 135618 16885 50452613
Upper respiratory tract infection 23.36 12.57 94 135532 65804 50403694
Guillain-Barre syndrome 23.34 12.57 37 135589 3440 50466058
Congestive cardiomyopathy 23.31 12.57 48 135578 5470 50464028
Pulmonary toxicity 23.04 12.57 48 135578 5514 50463984
Right ventricular failure 22.96 12.57 7 135619 15886 50453612
Vaginal fistula 22.89 12.57 14 135612 391 50469107
Joint dislocation 22.86 12.57 3 135623 12330 50457168
Full blood count decreased 22.78 12.57 16 135610 22330 50447168
Cough 22.73 12.57 825 134801 240439 50229059
Laryngeal necrosis 22.67 12.57 6 135620 13 50469485
Acute pulmonary oedema 22.63 12.57 56 135570 7211 50462287
Transient ischaemic attack 22.58 12.57 32 135594 32178 50437320
Ankle fracture 22.58 12.57 7 135619 15715 50453783
Eye disorder 22.52 12.57 11 135615 18728 50450770
Scintillating scotoma 22.48 12.57 10 135616 141 50469357
Vesical fistula 22.44 12.57 8 135618 60 50469438
Peritoneal fibrosis 22.28 12.57 5 135621 3 50469495
Computerised tomogram thorax 22.23 12.57 10 135616 145 50469353
Metastases to ovary 22.12 12.57 13 135613 337 50469161
Protein urine 22.09 12.57 16 135610 596 50468902
Procedural pain 22.06 12.57 5 135621 13827 50455671
Impaired healing 22.02 12.57 104 135522 69682 50399816
Lymphatic disorder 21.94 12.57 13 135613 342 50469156
Enterocolitis 21.94 12.57 52 135574 6515 50462983
Haemolytic uraemic syndrome 21.89 12.57 29 135597 2290 50467208
Dystonia 21.87 12.57 3 135623 11923 50457575
Hypermetabolism 21.86 12.57 10 135616 151 50469347
Scleroderma 21.75 12.57 43 135583 4758 50464740
Vessel puncture site bruise 21.74 12.57 13 135613 348 50469150
Stress cardiomyopathy 21.69 12.57 58 135568 7829 50461669
Hypersomnia 21.67 12.57 7 135619 15307 50454191
Abnormal behaviour 21.50 12.57 13 135613 19645 50449853
Loss of consciousness 21.45 12.57 396 135230 103957 50365541
Portal vein thrombosis 21.40 12.57 28 135598 2184 50467314
Prescribed underdose 21.34 12.57 8 135618 15941 50453557
Accidental overdose 21.25 12.57 13 135613 19520 50449978
Gelastic seizure 21.17 12.57 5 135621 5 50469493
Blood iron decreased 21.11 12.57 3 135623 11612 50457886
Tumour associated fever 21.07 12.57 10 135616 165 50469333
Blast cells present 21 12.57 13 135613 371 50469127
Ovarian cancer metastatic 20.99 12.57 17 135609 749 50468749
Brachiocephalic vein thrombosis 20.98 12.57 8 135618 74 50469424
Pelvic pain 20.97 12.57 72 135554 11141 50458357
Abdominal infection 20.88 12.57 24 135602 1638 50467860
Ovarian cancer 20.82 12.57 44 135582 5105 50464393
Wrist fracture 20.80 12.57 3 135623 11484 50458014
Retroperitoneal lymphadenopathy 20.76 12.57 14 135612 464 50469034
Pulmonary vein stenosis 20.61 12.57 8 135618 78 50469420
Hepatic vein thrombosis 20.55 12.57 9 135617 122 50469376
Seroma 20.50 12.57 25 135601 1816 50467682
Sinus congestion 20.46 12.57 6 135620 13965 50455533
BRAF gene mutation 20.17 12.57 7 135619 48 50469450
Femur fracture 20.12 12.57 44 135582 37420 50432078
Balance disorder 20.11 12.57 109 135517 70481 50399017
Transaminases 20.08 12.57 8 135618 84 50469414
Vulvovaginal inflammation 20.06 12.57 15 135611 587 50468911
Septic shock 20.05 12.57 238 135388 56937 50412561
Underdose 20.04 12.57 15 135611 20263 50449235
Enterocutaneous fistula 19.99 12.57 20 135606 1164 50468334
Lymphangitis 19.98 12.57 17 135609 803 50468695
Cerebral ischaemia 19.97 12.57 47 135579 5861 50463637
Splenic artery thrombosis 19.93 12.57 7 135619 50 50469448
Bladder perforation 19.85 12.57 9 135617 133 50469365
Cholangitis infective 19.85 12.57 10 135616 189 50469309
Fungal infection 19.81 12.57 31 135595 29934 50439564
Emotional distress 19.58 12.57 29 135597 28634 50440864
Hydrothorax 19.56 12.57 16 135610 715 50468783
Hallucination, visual 19.53 12.57 10 135616 16572 50452926
Device issue 19.45 12.57 15 135611 19957 50449541
Weight decreased 19.45 12.57 448 135178 220797 50248701
Emotional disorder 19.44 12.57 4 135622 11832 50457666
Tumour ulceration 19.38 12.57 9 135617 141 50469357
Sopor 19.27 12.57 15 135611 19864 50449634
Duodenal obstruction 19.20 12.57 10 135616 203 50469295
Laryngeal cancer stage III 19.16 12.57 5 135621 10 50469488
Venous thrombosis limb 19.14 12.57 29 135597 2593 50466905
Neutrophil count abnormal 19.10 12.57 28 135598 2431 50467067
Bone erosion 19.09 12.57 4 135622 11683 50457815
Eye pruritus 19.07 12.57 5 135621 12529 50456969
Respiratory depth decreased 19.04 12.57 6 135620 29 50469469
Ear pain 18.95 12.57 29 135597 28254 50441244
Keratitis 18.87 12.57 28 135598 2457 50467041
Breast ulceration 18.82 12.57 7 135619 60 50469438
Malignant peritoneal neoplasm 18.82 12.57 15 135611 646 50468852
Ocular hyperaemia 18.81 12.57 16 135610 20276 50449222
Enteritis 18.79 12.57 51 135575 6944 50462554
Tumour invasion 18.77 12.57 8 135618 101 50469397
Pelvic infection 18.75 12.57 11 135615 284 50469214
Metastases to thorax 18.73 12.57 10 135616 214 50469284
Thrombophlebitis migrans 18.70 12.57 8 135618 102 50469396
Colitis ulcerative 18.64 12.57 11 135615 16843 50452655
Muscle twitching 18.64 12.57 9 135617 15422 50454076
Diverticulitis 18.63 12.57 38 135588 33144 50436354
Blood glucose decreased 18.61 12.57 13 135613 18198 50451300
Gout 18.59 12.57 4 135622 11466 50458032
Nail ridging 18.51 12.57 11 135615 291 50469207
Gastroenteritis viral 18.43 12.57 14 135612 18772 50450726
Abdominal lymphadenopathy 18.42 12.57 15 135611 666 50468832
Post procedural fistula 18.40 12.57 10 135616 222 50469276
Joint effusion 18.34 12.57 6 135620 13015 50456483
Dementia 18.32 12.57 10 135616 15987 50453511
Breast neoplasm 18.27 12.57 20 135606 1293 50468205
Poor quality sleep 18.22 12.57 11 135615 16635 50452863
Metastases to adrenals 18.17 12.57 15 135611 679 50468819
Myoclonus 18.16 12.57 8 135618 14462 50455036
Metastases to pancreas 18.12 12.57 10 135616 229 50469269
Aorto-oesophageal fistula 17.99 12.57 5 135621 14 50469484
Product supply issue 17.98 12.57 19 135607 1180 50468318
Chest pain 17.93 12.57 610 135016 176272 50293226
Influenza like illness 17.91 12.57 86 135540 57373 50412125
Intestinal ischaemia 17.89 12.57 49 135577 6708 50462790
Neutropenic infection 17.69 12.57 18 135608 1069 50468429
Onychomadesis 17.65 12.57 33 135593 3503 50465995
Respiratory tract congestion 17.58 12.57 8 135618 14191 50455307
Angiodermatitis 17.53 12.57 7 135619 74 50469424
Vaginal perforation 17.49 12.57 5 135621 16 50469482
Intestinal prolapse 17.48 12.57 8 135618 121 50469377
Liver scan abnormal 17.43 12.57 6 135620 40 50469458
Rash papular 17.41 12.57 6 135620 12598 50456900
Ovarian failure 17.37 12.57 18 135608 1093 50468405
Dermatomyositis 17.35 12.57 25 135601 2136 50467362
Eye swelling 17.35 12.57 17 135609 20127 50449371
Sciatica 17.34 12.57 19 135607 21363 50448135
Blood creatinine decreased 17.28 12.57 40 135586 4936 50464562
Tumour fistulisation 17.26 12.57 5 135621 17 50469481
Pneumonia 17.16 12.57 834 134792 377567 50091931
Sensory disturbance 17.16 12.57 70 135556 11759 50457739
Drug ineffective for unapproved indication 17.16 12.57 19 135607 21262 50448236
Breast cellulitis 17.14 12.57 13 135613 520 50468978
Embolism venous 17.13 12.57 27 135599 2498 50467000
Exostosis 17.07 12.57 5 135621 11648 50457850
Gene mutation 17.06 12.57 19 135607 1252 50468246
Seasonal allergy 17.06 12.57 9 135617 14667 50454831
Adrenocorticotropic hormone deficiency 17.05 12.57 10 135616 258 50469240
Cardiac murmur 16.99 12.57 4 135622 10780 50458718
Anaemia of malignant disease 16.97 12.57 12 135614 430 50469068
Cholelithiasis 16.97 12.57 49 135577 37924 50431574
Mediastinitis 16.97 12.57 9 135617 190 50469308
Aortic dissection rupture 16.94 12.57 4 135622 4 50469494
Maternal death affecting foetus 16.94 12.57 4 135622 4 50469494
Radiation oesophagitis 16.92 12.57 10 135616 262 50469236
Lymphatic obstruction 16.83 12.57 5 135621 19 50469479
Invasive ductal breast carcinoma 16.74 12.57 44 135582 5877 50463621
Cardiac failure congestive 16.73 12.57 145 135481 84237 50385261
Bacterial diarrhoea 16.71 12.57 6 135620 46 50469452
Acute erythroid leukaemia 16.71 12.57 6 135620 46 50469452
Seizure 16.71 12.57 219 135407 117655 50351843
Respiratory failure 16.69 12.57 340 135286 90841 50378657
Metastases to muscle 16.69 12.57 8 135618 135 50469363
Mediastinal disorder 16.65 12.57 11 135615 352 50469146
Nail avulsion 16.64 12.57 8 135618 136 50469362
Distal intestinal obstruction syndrome 16.60 12.57 11 135615 354 50469144
Angioedema 16.56 12.57 49 135577 37627 50431871
Infected lymphocele 16.55 12.57 9 135617 200 50469298
Delirium 16.55 12.57 50 135576 38142 50431356
Eye irritation 16.53 12.57 13 135613 17127 50452371
Subdural haematoma 16.50 12.57 7 135619 12940 50456558
Gastric perforation 16.43 12.57 20 135606 1450 50468048
Myeloproliferative neoplasm 16.40 12.57 12 135614 454 50469044
Infection 16.40 12.57 346 135280 172608 50296890
Exposed bone in jaw 16.37 12.57 28 135598 2772 50466726
Gingival bleeding 16.32 12.57 67 135559 11286 50458212
Median nerve injury 16.25 12.57 5 135621 22 50469476
Toxic neuropathy 16.14 12.57 11 135615 371 50469127
Mood altered 16.13 12.57 7 135619 12766 50456732
Nasal disorder 16.10 12.57 25 135601 2283 50467215
Cystitis noninfective 16.10 12.57 15 135611 799 50468699
Bronchopleural fistula 16.08 12.57 9 135617 212 50469286
Photophobia 16.06 12.57 10 135616 14877 50454621
Nail infection 16.03 12.57 23 135603 1958 50467540
Ileal perforation 15.96 12.57 11 135615 378 50469120
Thyroid disorder 15.92 12.57 7 135619 12670 50456828
Aplasia 15.91 12.57 33 135593 3780 50465718
Immediate post-injection reaction 15.89 12.57 11 135615 381 50469117
Liver function test abnormal 15.87 12.57 63 135563 44276 50425222
Acquired gene mutation 15.84 12.57 15 135611 816 50468682
Mechanical ileus 15.83 12.57 10 135616 296 50469202
Lividity 15.82 12.57 9 135617 219 50469279
Blood alkaline phosphatase increased 15.81 12.57 162 135464 37364 50432134
Rash 15.81 12.57 986 134640 436485 50033013
HER2 positive breast cancer 15.68 12.57 10 135616 301 50469197
Vaginal cuff dehiscence 15.67 12.57 4 135622 7 50469491
Cholecystectomy 15.58 12.57 3 135623 9300 50460198
Blood pressure immeasurable 15.58 12.57 17 135609 1095 50468403
Pulmonary artery stenosis 15.52 12.57 8 135618 159 50469339
Carbohydrate antigen 19-9 increased 15.52 12.57 8 135618 159 50469339
Pulmonary congestion 15.43 12.57 11 135615 15236 50454262
Artificial menopause 15.41 12.57 5 135621 27 50469471
Orbital myositis 15.41 12.57 5 135621 27 50469471
Restless legs syndrome 15.40 12.57 12 135614 15885 50453613
Tongue disorder 15.38 12.57 3 135623 9213 50460285
Blood magnesium decreased 15.37 12.57 65 135561 11095 50458403
Limb discomfort 15.35 12.57 26 135600 24331 50445167
Arterioenteric fistula 15.33 12.57 4 135622 8 50469490
Application site recall reaction 15.33 12.57 4 135622 8 50469490
Mucosal dryness 15.24 12.57 25 135601 2392 50467106
Productive cough 15.21 12.57 81 135545 52613 50416885
Myeloid leukaemia 15.19 12.57 10 135616 318 50469180
Pancreatic failure 15.14 12.57 15 135611 863 50468635
Carcinoid tumour pulmonary 15.13 12.57 11 135615 412 50469086
Electrolyte imbalance 15.08 12.57 88 135538 17081 50452417
BRCA2 gene mutation 15.06 12.57 6 135620 63 50469435
Product storage error 14.96 12.57 7 135619 12217 50457281
Cholangitis acute 14.95 12.57 11 135615 420 50469078
Pain in jaw 14.79 12.57 53 135573 38375 50431123
Ankyloglossia acquired 14.77 12.57 3 135623 0 50469498
Immune-mediated renal disorder 14.77 12.57 3 135623 0 50469498
Granulocyte count 14.77 12.57 3 135623 0 50469498
Myiasis 14.77 12.57 3 135623 0 50469498
Glycosylated haemoglobin increased 14.74 12.57 5 135621 10601 50458897
Acute monocytic leukaemia 14.74 12.57 6 135620 67 50469431
Clonal haematopoiesis 14.71 12.57 4 135622 10 50469488
Hepatic cancer metastatic 14.68 12.57 10 135616 337 50469161
Anger 14.65 12.57 6 135620 11327 50458171
Nail pigmentation 14.62 12.57 8 135618 180 50469318
Faeces discoloured 14.60 12.57 13 135613 16111 50453387
Thyroiditis 14.52 12.57 21 135605 1801 50467697
Localised infection 14.47 12.57 29 135597 25456 50444042
Sputum discoloured 14.45 12.57 9 135617 13386 50456112
Obstructive shock 14.44 12.57 5 135621 34 50469464
Cholecystitis chronic 14.44 12.57 4 135622 9665 50459833
Endometrial cancer recurrent 14.44 12.57 4 135622 11 50469487
Opsoclonus myoclonus 14.40 12.57 7 135619 122 50469376
Speech disorder 14.37 12.57 48 135578 35500 50433998
Depressed level of consciousness 14.37 12.57 81 135545 51872 50417626
Oesophageal squamous cell carcinoma 14.35 12.57 7 135619 123 50469375
Postoperative adhesion 14.32 12.57 9 135617 264 50469234
Taste disorder 14.32 12.57 52 135574 8272 50461226
Meibomian gland dysfunction 14.30 12.57 7 135619 124 50469374
Ovarian cyst 14.29 12.57 10 135616 13986 50455512
Complication associated with device 14.28 12.57 11 135615 14644 50454854
Clonal evolution 14.28 12.57 6 135620 73 50469425
Hypothalamo-pituitary disorder 14.25 12.57 13 135613 674 50468824
Cystitis haemorrhagic 14.24 12.57 31 135595 3671 50465827
Thinking abnormal 14.21 12.57 4 135622 9563 50459935
Transaminases abnormal 14.15 12.57 12 135614 564 50468934
Polymicrogyria 14.13 12.57 6 135620 75 50469423
Hiatus hernia 14.11 12.57 17 135609 18327 50451171
Anhedonia 14.11 12.57 4 135622 9520 50459978
Scar 14.11 12.57 7 135619 11811 50457687
Ureteric stenosis 14.10 12.57 12 135614 567 50468931
Glomerular vascular disorder 14.08 12.57 5 135621 37 50469461
Toxic cardiomyopathy 14.05 12.57 7 135619 129 50469369
Hyperferritinaemia 14.05 12.57 7 135619 129 50469369
Lung infiltration 14.02 12.57 72 135554 13321 50456177
Extrapyramidal disorder 14.01 12.57 7 135619 11763 50457735
Live birth 13.95 12.57 14 135612 16394 50453104
Pulpitis dental 13.94 12.57 14 135612 819 50468679
Macular degeneration 13.77 12.57 11 135615 14377 50455121
Immune-mediated lung disease 13.70 12.57 10 135616 377 50469121
Ototoxicity 13.70 12.57 16 135610 1111 50468387
Tuberculosis 13.59 12.57 5 135621 10078 50459420
Hereditary motor and sensory neuropathy 13.59 12.57 6 135620 83 50469415
Morphoea 13.57 12.57 9 135617 290 50469208
Aortic dissection 13.55 12.57 19 135607 1584 50467914
Rotator cuff syndrome 13.54 12.57 7 135619 11537 50457961
Immune-mediated myocarditis 13.52 12.57 6 135620 84 50469414
Obesity 13.50 12.57 15 135611 16760 50452738
Bone marrow disorder 13.45 12.57 21 135605 1927 50467571
Catheter site thrombosis 13.45 12.57 7 135619 142 50469356
Hyponatraemia 13.40 12.57 345 135281 95794 50373704
Soft tissue necrosis 13.34 12.57 10 135616 393 50469105
Corneal disorder 13.34 12.57 19 135607 1607 50467891
Essential thrombocythaemia 13.32 12.57 7 135619 145 50469353
Hypergeusia 13.30 12.57 4 135622 16 50469482
Systolic dysfunction 13.27 12.57 18 135608 1454 50468044
Uterine adhesions 13.23 12.57 5 135621 45 50469453
Oesophageal varices haemorrhage 13.15 12.57 15 135611 1015 50468483
Dermatitis 13.14 12.57 74 135552 14177 50455321
Uterine atrophy 13.13 12.57 5 135621 46 50469452
Metastases to vagina 13.11 12.57 4 135622 17 50469481
Urinary retention 13.06 12.57 32 135594 26158 50443340
Respiratory depression 13.05 12.57 8 135618 12002 50457496
Peritoneal neoplasm 13.04 12.57 5 135621 47 50469451
Renal failure 13.04 12.57 204 135422 106429 50363069
Dandy-Walker syndrome 13.04 12.57 6 135620 92 50469406
Metastases to abdominal cavity 13.03 12.57 10 135616 407 50469091
Delusion 13.02 12.57 6 135620 10563 50458935
Anal sphincter atony 12.96 12.57 8 135618 227 50469271
Malignant neoplasm of pleura 12.95 12.57 5 135621 48 50469450
Failure to thrive 12.93 12.57 42 135584 6316 50463182
Affect lability 12.93 12.57 4 135622 8994 50460504
Foetal malnutrition 12.86 12.57 6 135620 95 50469403
Pneumothorax spontaneous 12.81 12.57 12 135614 644 50468854
Biliary obstruction 12.79 12.57 23 135603 2370 50467128
Urosepsis 12.77 12.57 78 135548 15387 50454111
Peritoneal fluid analysis abnormal 12.75 12.57 4 135622 19 50469479
Blood lactate dehydrogenase increased 12.74 12.57 93 135533 19469 50450029
Chemotherapy 12.74 12.57 17 135609 1352 50468146
Lichenoid keratosis 12.71 12.57 17 135609 1355 50468143
Tumour cavitation 12.70 12.57 3 135623 3 50469495
Breast sarcoma 12.70 12.57 3 135623 3 50469495
Breast prosthesis removal 12.70 12.57 3 135623 3 50469495
Haemolytic anaemia 12.70 12.57 54 135572 9238 50460260
Torsade de pointes 12.70 12.57 8 135618 11827 50457671
Product dispensing error 12.69 12.57 4 135622 8887 50460611
Lymphorrhoea 12.68 12.57 5 135621 51 50469447
Hyperlipidaemia 12.64 12.57 17 135609 17473 50452025
Haemodynamic instability 12.60 12.57 3 135623 8021 50461477
Activated PI3 kinase delta syndrome 12.59 12.57 4 135622 20 50469478

FDA Adverse Event Reporting System (Male)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Febrile neutropenia 586.38 15.76 779 43624 111461 29418663
Malignant neoplasm progression 576.61 15.76 629 43774 73230 29456894
Neutropenia 567.22 15.76 833 43570 130878 29399246
Interstitial lung disease 350.00 15.76 432 43971 57286 29472838
Neuropathy peripheral 308.78 15.76 452 43951 70575 29459549
Disease progression 252.72 15.76 446 43957 81470 29448654
Leukopenia 246.60 15.76 356 44047 54847 29475277
Pneumonitis 239.70 15.76 251 44152 27793 29502331
Anaemia 232.37 15.76 745 43658 200206 29329918
Thrombocytopenia 230.36 15.76 576 43827 134247 29395877
Neutrophil count decreased 219.91 15.76 298 44105 43269 29486855
Alopecia 200.28 15.76 191 44212 18893 29511231
Death 184.65 15.76 1003 43400 341081 29189043
Cholangitis 174.80 15.76 120 44283 7417 29522707
Mucosal inflammation 144.23 15.76 206 44197 31389 29498735
Cystoid macular oedema 141.01 15.76 48 44355 588 29529536
Radiation pneumonitis 128.25 15.76 64 44339 2165 29527959
Myelosuppression 125.65 15.76 121 44282 12106 29518018
Bone marrow failure 122.38 15.76 177 44226 27272 29502852
Completed suicide 117.60 15.76 4 44399 90242 29439882
Product dose omission issue 113.76 15.76 8 44395 96375 29433749
General physical health deterioration 110.90 15.76 373 44030 102484 29427640
Metastases to central nervous system 108.15 15.76 88 44315 7043 29523081
Flushing 108.06 15.76 172 44231 28820 29501304
Haemoptysis 106.73 15.76 176 44227 30374 29499750
Haematotoxicity 106.54 15.76 85 44318 6614 29523510
Neoplasm progression 97.92 15.76 130 44273 18482 29511642
Polyneuropathy 97.09 15.76 105 44298 12047 29518077
Peripheral sensory neuropathy 93.68 15.76 75 44328 5864 29524260
Overdose 93.10 15.76 7 44396 79812 29450312
Drug ineffective 91.41 15.76 263 44140 362907 29167217
Neurotoxicity 90.99 15.76 111 44292 14502 29515622
Immune-mediated hepatitis 88.31 15.76 44 44359 1483 29528641
Pyrexia 88.24 15.76 734 43669 286888 29243236
Dehydration 87.86 15.76 373 44030 114375 29415749
Radiation oesophagitis 87.51 15.76 30 44373 376 29529748
Pneumothorax 83.86 15.76 111 44292 15731 29514393
Erythema 79.49 15.76 272 44131 75334 29454790
Decreased appetite 77.68 15.76 426 43977 144916 29385208
Depression 74.69 15.76 18 44385 85129 29444995
Fall 74.57 15.76 94 44309 177084 29353040
Biliary tract infection 74.53 15.76 28 44375 464 29529660
Sepsis 68.86 15.76 407 43996 142275 29387849
Dyspnoea 68.60 15.76 770 43633 325962 29204162
White blood cell count decreased 66.10 15.76 274 44129 83088 29447036
Pneumonia 63.80 15.76 747 43656 319425 29210699
Drug interaction 63.78 15.76 125 44278 197260 29332864
Tumour haemorrhage 63.43 15.76 42 44361 2443 29527681
Pancytopenia 63.32 15.76 270 44133 82898 29447226
Liver abscess 63.24 15.76 47 44356 3291 29526833
Immune-mediated lung disease 62.48 15.76 28 44375 740 29529384
Anaphylactic shock 62.36 15.76 88 44315 13248 29516876
Therapy partial responder 62.18 15.76 56 44347 5143 29524981
Anxiety 60.81 15.76 26 44377 85339 29444785
Thrombotic microangiopathy 60.74 15.76 70 44333 8611 29521513
Pancreatic carcinoma metastatic 59.97 15.76 42 44361 2679 29527445
Metastases to lung 59.49 15.76 66 44337 7789 29522335
Headache 59.01 15.76 107 44296 173900 29356224
Pancreatic carcinoma 57.49 15.76 62 44341 7088 29523036
Gastrointestinal perforation 57.10 15.76 45 44358 3438 29526686
Kounis syndrome 56.84 15.76 35 44368 1794 29528330
Colitis 56.82 15.76 137 44266 31111 29499013
Onycholysis 56.65 15.76 23 44380 473 29529651
Nausea 54.10 15.76 667 43736 288588 29241536
Nasopharyngitis 53.53 15.76 12 44391 59653 29470471
Toxicity to various agents 51.02 15.76 116 44287 173545 29356579
Joint swelling 51.01 15.76 7 44396 49623 29480501
Hypersensitivity 50.97 15.76 185 44218 52718 29477406
Infusion related reaction 50.64 15.76 163 44240 43723 29486401
Platelet count decreased 49.42 15.76 297 44106 104375 29425749
Metastases to liver 49.27 15.76 74 44329 11782 29518342
Insomnia 48.96 15.76 37 44366 88724 29441400
Somnolence 48.29 15.76 42 44361 93913 29436211
Vomiting 47.96 15.76 508 43895 211752 29318372
Metastases to meninges 47.80 15.76 27 44376 1178 29528946
Hospitalisation 46.07 15.76 7 44396 45981 29484143
Diarrhoea 45.56 15.76 726 43677 331972 29198152
Plasma cell myeloma 43.99 15.76 3 44400 37112 29493012
Coronary artery disease 43.64 15.76 7 44396 44183 29485941
Weight increased 43.52 15.76 31 44372 76636 29453488
Cardiac failure congestive 42.13 15.76 32 44371 76549 29453575
Pleural effusion 41.20 15.76 215 44188 71693 29458431
Pulmonary radiation injury 40.91 15.76 11 44392 55 29530069
Suicidal ideation 40.59 15.76 3 44400 34713 29495411
Electrocardiogram QT prolonged 39.86 15.76 4 44399 36133 29493991
Tracheo-oesophageal fistula 39.25 15.76 17 44386 413 29529711
Scleroderma-like reaction 39.20 15.76 10 44393 39 29530085
Aggression 39.03 15.76 4 44399 35537 29494587
Tremor 38.85 15.76 32 44371 73506 29456618
Tracheal fistula 38.41 15.76 11 44392 72 29530052
Bronchial fistula 38.35 15.76 13 44390 157 29529967
Intentional product misuse 37.80 15.76 4 44399 34657 29495467
Embolism 37.54 15.76 49 44354 6847 29523277
Injection site pain 37.38 15.76 3 44400 32443 29497681
Off label use 36.93 15.76 645 43758 300155 29229969
Bradycardia 36.64 15.76 27 44376 65602 29464522
Cardiac disorder 36.58 15.76 6 44397 37257 29492867
Skin toxicity 36.26 15.76 36 44367 3735 29526389
Hypertransaminasaemia 35.75 15.76 35 44368 3571 29526553
Recall phenomenon 35.70 15.76 17 44386 518 29529606
Right ventricular ejection fraction decreased 35.10 15.76 9 44394 36 29530088
Dysphagia 34.81 15.76 169 44234 54757 29475367
Enterocolitis 34.18 15.76 46 44357 6620 29523504
Hypoglycaemia 33.97 15.76 15 44388 48331 29481793
Gastrointestinal toxicity 33.79 15.76 27 44376 2104 29528020
Septic shock 33.74 15.76 184 44219 62376 29467748
Adrenal insufficiency 33.49 15.76 60 44343 11054 29519070
Performance status decreased 32.95 15.76 34 44369 3693 29526431
Agitation 32.90 15.76 18 44385 51286 29478838
Hallucination 32.82 15.76 13 44390 44699 29485425
Oxygen saturation decreased 32.71 15.76 144 44259 44793 29485331
Musculoskeletal stiffness 32.66 15.76 8 44395 37450 29492674
Gastritis bacterial 32.21 15.76 12 44391 194 29529930
Teratoma benign 32.03 15.76 8 44395 28 29530096
Oesophagitis 31.71 15.76 61 44342 11862 29518262
Tidal volume decreased 31.20 15.76 8 44395 32 29530092
Neutropenic sepsis 31.19 15.76 60 44343 11667 29518457
Pulmonary embolism 31.03 15.76 209 44194 76325 29453799
Condition aggravated 31.01 15.76 114 44289 146181 29383943
Haemolytic uraemic syndrome 30.99 15.76 25 44378 1975 29528149
Stomatitis 30.96 15.76 124 44279 36989 29493135
Brain teratoma 30.85 15.76 7 44396 14 29530110
Immune-mediated enterocolitis 30.70 15.76 23 44380 1630 29528494
Therapeutic product effect decreased 30.62 15.76 4 44399 29447 29500677
Metastases to bone 30.55 15.76 54 44349 9844 29520280
Bronchospasm 30.41 15.76 53 44350 9556 29520568
Nail dystrophy 30.41 15.76 11 44392 163 29529961
Intestinal perforation 30.14 15.76 48 44355 8038 29522086
Arthralgia 30.12 15.76 108 44295 139509 29390615
Pneumatosis intestinalis 30.01 15.76 30 44373 3139 29526985
Blood glucose increased 29.53 15.76 27 44376 58957 29471167
Neutropenic colitis 28.89 15.76 26 44377 2385 29527739
Pulmonary toxicity 28.59 15.76 36 44367 4854 29525270
Disseminated intravascular coagulation 28.50 15.76 80 44323 19900 29510224
Tumour necrosis 28.49 15.76 19 44384 1118 29529006
Acute respiratory distress syndrome 28.10 15.76 87 44316 22848 29507276
Psoriasis 27.87 15.76 7 44396 32220 29497904
Memory impairment 27.78 15.76 10 44393 36460 29493664
Periarticular thenar erythema with onycholysis 27.52 15.76 5 44398 0 29530124
Oesophagopleural fistula 27.47 15.76 8 44395 56 29530068
Angioedema 27.47 15.76 7 44396 31908 29498216
Hypoxia 27.35 15.76 142 44261 47237 29482887
Anaphylactic reaction 27.03 15.76 97 44306 27476 29502648
Coma 26.54 15.76 13 44390 39437 29490687
Macular oedema 26.52 15.76 25 44378 2433 29527691
International normalised ratio increased 26.43 15.76 17 44386 44355 29485769
Enterocolitis infectious 26.34 15.76 19 44384 1270 29528854
Myocardial infarction 26.04 15.76 82 44321 110214 29419910
Rheumatoid arthritis 25.91 15.76 8 44395 32144 29497980
Confusional state 25.57 15.76 102 44301 127775 29402349
Peripheral swelling 25.53 15.76 35 44368 63704 29466420
Eastern Cooperative Oncology Group performance status worsened 25.34 15.76 15 44388 715 29529409
Dermatitis acneiform 25.32 15.76 36 44367 5455 29524669
Dizziness 25.20 15.76 174 44229 189510 29340614
Pneumoperitoneum 25.09 15.76 20 44383 1553 29528571
Wrong technique in product usage process 25.01 15.76 8 44395 31420 29498704
Fluid retention 24.98 15.76 3 44400 23557 29506567
Stress cardiomyopathy 24.53 15.76 20 44383 1604 29528520
Blood pressure increased 24.41 15.76 46 44357 73757 29456367
Abnormal behaviour 24.39 15.76 3 44400 23124 29507000
Muscle spasms 23.87 15.76 38 44365 65044 29465080
Feeling abnormal 23.78 15.76 28 44375 54417 29475707
Taeniasis 23.68 15.76 7 44396 52 29530072
Influenza 23.67 15.76 17 44386 41864 29488260
Incorrect dose administered 23.54 15.76 10 44393 32974 29497150
Irritability 23.05 15.76 3 44400 22149 29507975
Loss of personal independence in daily activities 23.04 15.76 5 44398 25435 29504689
Metabolic acidosis 23.02 15.76 14 44389 37648 29492476
Urticaria 22.93 15.76 29 44374 54631 29475493
Metastases to skin 22.75 15.76 11 44392 347 29529777
Dysarthria 22.66 15.76 9 44394 30902 29499222
Pancreatic enzyme abnormality 22.65 15.76 6 44397 28 29530096
Adrenocorticotropic hormone deficiency 22.56 15.76 13 44390 589 29529535
Non-small cell lung cancer 22.49 15.76 25 44378 2956 29527168
Tumour pseudoprogression 22.23 15.76 11 44392 365 29529759
Sense of oppression 22.22 15.76 12 44391 479 29529645
Cytomegalovirus infection 22.21 15.76 4 44399 23211 29506913
Discontinued product administered 21.72 15.76 5 44398 11 29530113
Asthma 21.52 15.76 12 44391 33837 29496287
Inappropriate schedule of product administration 21.50 15.76 21 44382 44451 29485673
Seizure 21.44 15.76 70 44333 93053 29437071
Hyperkalaemia 21.44 15.76 37 44366 61355 29468769
Infectious pleural effusion 21.31 15.76 20 44383 1936 29528188
Prostate cancer 21.21 15.76 6 44397 25521 29504603
Feeling hot 21.10 15.76 61 44342 15427 29514697
Metastases to lymph nodes 21.02 15.76 28 44375 3989 29526135
Paronychia 20.97 15.76 24 44379 2929 29527195
Rhabdomyolysis 20.91 15.76 37 44366 60771 29469353
Psychotic disorder 20.61 15.76 3 44400 20351 29509773
Heart rate decreased 20.43 15.76 6 44397 24906 29505218
Oesophagobronchial fistula 20.38 15.76 8 44395 150 29529974
Lung disorder 20.37 15.76 95 44308 30267 29499857
Lactic acidosis 20.30 15.76 10 44393 30237 29499887
Chronic kidney disease 20.29 15.76 15 44388 36401 29493723
Pericardial effusion 20.27 15.76 74 44329 21134 29508990
Cachexia 20.06 15.76 35 44368 6314 29523810
Immune-mediated hepatic disorder 19.96 15.76 10 44393 341 29529783
Lung abscess 19.87 15.76 21 44382 2345 29527779
Disturbance in attention 19.84 15.76 4 44399 21420 29508704
Pulmonary artery occlusion 19.78 15.76 4 44399 3 29530121
Blood thyroid stimulating hormone abnormal 19.44 15.76 9 44394 257 29529867
Gastric perforation 19.43 15.76 20 44383 2166 29527958
Metastases to peritoneum 19.42 15.76 17 44386 1503 29528621
Lymphangiosis carcinomatosa 18.99 15.76 13 44390 799 29529325
Lung squamous cell carcinoma metastatic 18.90 15.76 6 44397 58 29530066
Metastases to kidney 18.84 15.76 9 44394 276 29529848
Supraventricular tachycardia 18.67 15.76 44 44359 9840 29520284
Product use in unapproved indication 18.64 15.76 206 44197 86669 29443455
Radiation skin injury 18.59 15.76 12 44391 668 29529456
Thrombocytosis 18.52 15.76 24 44379 3329 29526795
Tumour marker increased 18.42 15.76 11 44392 533 29529591
Blastic plasmacytoid dendritic cell neoplasia 18.37 15.76 6 44397 64 29530060
Tumour lysis syndrome 18.26 15.76 54 44349 13830 29516294
Sinusitis 18.06 15.76 15 44388 34335 29495789
Ileus 17.98 15.76 55 44348 14347 29515777
Subdural haematoma 17.70 15.76 3 44400 18190 29511934
Blood creatine phosphokinase increased 17.64 15.76 21 44382 40623 29489501
Metastases to the mediastinum 17.52 15.76 8 44395 221 29529903
Hypophysitis 17.47 15.76 18 44385 1952 29528172
Second primary malignancy 17.46 15.76 34 44369 6671 29523453
Vascular pseudoaneurysm ruptured 17.37 15.76 6 44397 77 29530047
Coronary artery aneurysm 17.37 15.76 6 44397 77 29530047
Cataract 17.27 15.76 6 44397 22372 29507752
Portal venous gas 17.24 15.76 9 44394 335 29529789
Enteritis 17.15 15.76 34 44369 6757 29523367
Pulmonary cavitation 17.06 15.76 12 44391 771 29529353
Eosinophilia 17.00 15.76 6 44397 22155 29507969
Abdominal pain 16.78 15.76 291 44112 135066 29395058
Transient ischaemic attack 16.69 15.76 7 44396 23263 29506861
Anaphylactoid shock 16.62 15.76 9 44394 361 29529763
Nasal congestion 16.52 15.76 4 44399 18875 29511249
Upper gastrointestinal perforation 16.51 15.76 3 44400 0 29530124
Balance disorder 16.44 15.76 18 44385 36152 29493972
Erythema multiforme 16.41 15.76 36 44367 7681 29522443
Hiccups 16.28 15.76 39 44364 8814 29521310
Product use issue 16.20 15.76 33 44370 51411 29478713
Tachycardia 16.13 15.76 173 44230 72237 29457887
Herpes zoster 15.96 15.76 13 44390 30039 29500085
Pneumonia bacterial 15.95 15.76 40 44363 9303 29520821
Pain in extremity 15.80 15.76 99 44304 110334 29419790

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 1648.53 12.23 1687 149897 115838 64231310
Neutropenia 1598.31 12.23 2362 149222 237262 64109886
Malignant neoplasm progression 1488.94 12.23 1568 150016 111303 64235845
Febrile neutropenia 1045.49 12.23 1704 149880 185953 64161195
Erythema 1000.77 12.23 1668 149916 185402 64161746
Flushing 916.25 12.23 1024 150560 77624 64269524
Disease progression 794.46 12.23 1291 150293 140389 64206759
Anaemia 754.66 12.23 2273 149311 376407 63970741
Metastases to liver 717.93 12.23 531 151053 23410 64323738
Metastases to bone 706.09 12.23 494 151090 19941 64327207
Neutrophil count decreased 664.31 12.23 862 150722 76334 64270814
Dyspnoea 600.50 12.23 3289 148295 715385 63631763
Metastases to lung 539.01 12.23 374 151210 14890 64332258
Myelosuppression 525.54 12.23 441 151143 23389 64323759
Polyneuropathy 501.50 12.23 398 151186 19496 64327652
Completed suicide 500.02 12.23 5 151579 224409 64122739
Leukopenia 485.54 12.23 861 150723 100381 64246767
Thrombocytopenia 482.44 12.23 1383 150201 222418 64124730
Pneumonitis 478.45 12.23 591 150993 49774 64297374
Interstitial lung disease 474.94 12.23 836 150748 96896 64250252
Drug ineffective 455.56 12.23 801 150783 839446 63507702
Peripheral sensory neuropathy 449.85 12.23 299 151285 11079 64336069
Palmar-plantar erythrodysaesthesia syndrome 434.77 12.23 431 151153 28388 64318760
Neoplasm progression 428.80 12.23 505 151079 40459 64306689
Cystoid macular oedema 416.92 12.23 157 151427 1617 64345531
Metastases to central nervous system 391.25 12.23 297 151287 13615 64333533
Mucosal inflammation 378.71 12.23 591 150993 61993 64285155
Neurotoxicity 359.23 12.23 380 151204 27024 64320124
Fall 355.63 12.23 276 151308 416550 63930598
Joint swelling 345.81 12.23 48 151536 215334 64131814
Haematotoxicity 342.27 12.23 266 151318 12630 64334518
Bone marrow failure 337.45 12.23 486 151098 47466 64299682
Product dose omission issue 330.74 12.23 36 151548 194711 64152437
Chest discomfort 319.30 12.23 786 150798 115320 64231828
Acute myeloid leukaemia 313.32 12.23 354 151230 27109 64320039
Rheumatoid arthritis 310.34 12.23 19 151565 164275 64182873
Metastases to lymph nodes 308.70 12.23 214 151370 8503 64338645
Feeling hot 302.76 12.23 450 151134 45213 64301935
Anaphylactic shock 296.21 12.23 361 151223 29967 64317181
Drug abuse 290 12.23 4 151580 132370 64214778
General physical health deterioration 287.94 12.23 1094 150490 203331 64143817
Onycholysis 270.18 12.23 112 151472 1514 64345634
Bronchospasm 256.77 12.23 285 151299 21397 64325751
Pseudocirrhosis 254.78 12.23 84 151500 561 64346587
Nausea 238.90 12.23 2855 148729 782945 63564203
Weight increased 228.11 12.23 108 151476 213240 64133908
Headache 227.71 12.23 574 151010 528893 63818255
Toxicity to various agents 227.00 12.23 314 151270 363199 63983949
Overdose 222.61 12.23 51 151533 159515 64187633
Condition aggravated 219.50 12.23 335 151249 372091 63975057
Gastrointestinal perforation 217.93 12.23 144 151440 5280 64341868
Cholangitis 213.89 12.23 188 151396 10614 64336534
Contraindicated product administered 208.10 12.23 11 151573 107818 64239330
Ascites 206.84 12.23 453 151131 61548 64285600
Metastases to peritoneum 205.74 12.23 119 151465 3428 64343720
Vomiting 204.46 12.23 2084 149500 549033 63798115
Skin toxicity 201.37 12.23 148 151436 6454 64340694
Therapeutic product effect decreased 199.17 12.23 20 151564 115331 64231817
Back pain 199.16 12.23 1133 150451 249038 64098110
Musculoskeletal stiffness 196.37 12.23 28 151556 123178 64223970
Synovitis 194.77 12.23 9 151575 99081 64248067
Pyrexia 191.92 12.23 2080 149504 556564 63790584
Hypertension 190.75 12.23 1150 150434 258111 64089037
Diarrhoea 190.01 12.23 2557 149027 720147 63627001
Arthropathy 189.31 12.23 29 151555 120938 64226210
White blood cell count decreased 188.72 12.23 803 150781 157034 64190114
Ejection fraction decreased 187.53 12.23 281 151303 28426 64318722
Sinusitis 185.74 12.23 56 151528 145872 64201276
Proteinuria 184.86 12.23 274 151310 27449 64319699
Drug interaction 183.80 12.23 358 151226 361725 63985423
Pleural effusion 182.70 12.23 683 150901 125876 64221272
Breast cancer metastatic 181.86 12.23 144 151440 7025 64340123
Second primary malignancy 181.39 12.23 182 151402 12155 64334993
Hypertransaminasaemia 177.20 12.23 142 151442 7049 64340099
Injection site pain 173.67 12.23 27 151557 111381 64235767
Platelet count decreased 169.61 12.23 812 150772 166899 64180249
Infusion related reaction 169.02 12.23 800 150784 163667 64183481
Hypersensitivity 165.76 12.23 904 150680 195548 64151600
Therapy partial responder 161.47 12.23 157 151427 10091 64337057
Biliary tract infection 159.69 12.23 66 151518 885 64346263
Sense of oppression 157.34 12.23 74 151510 1373 64345775
Depression 155.17 12.23 122 151462 183169 64163979
Somnolence 153.77 12.23 151 151433 203494 64143654
Arthralgia 151.27 12.23 533 151051 441727 63905421
Suicide attempt 148.04 12.23 4 151580 71003 64276145
Cardiac dysfunction 145.92 12.23 91 151493 3015 64344133
Myelodysplastic syndrome 145.70 12.23 245 151339 27334 64319814
Paraesthesia 145.28 12.23 664 150920 133858 64213290
Abdominal discomfort 139.01 12.23 134 151450 182188 64164960
Lymphangiosis carcinomatosa 138.37 12.23 73 151511 1748 64345400
Nasopharyngitis 138.33 12.23 154 151430 195919 64151229
Embolism 138.31 12.23 157 151427 12078 64335070
Epistaxis 136.95 12.23 524 151060 97607 64249541
Peripheral swelling 136.14 12.23 175 151409 208978 64138170
Pain 136.08 12.23 755 150829 552756 63794392
Hospitalisation 135.30 12.23 11 151573 75196 64271952
Oxygen saturation decreased 134.06 12.23 553 151031 106623 64240525
Glossodynia 133.57 12.23 4 151580 64692 64282456
Product use issue 133.51 12.23 97 151487 151618 64195530
Radiation pneumonitis 132.84 12.23 88 151496 3240 64343908
Swelling 126.56 12.23 114 151470 160104 64187044
Metastases to meninges 126.04 12.23 80 151504 2735 64344413
Pemphigus 124.43 12.23 4 151580 60697 64286451
Abdominal pain 123.53 12.23 1198 150386 311177 64035971
Drug intolerance 121.61 12.23 158 151426 187834 64159314
Intentional product misuse 121.04 12.23 14 151570 72281 64274867
Gastrointestinal toxicity 120.42 12.23 100 151484 5222 64341926
Ovarian cancer recurrent 120.21 12.23 41 151543 308 64346840
Nail toxicity 119.41 12.23 41 151543 315 64346833
Dehydration 118.72 12.23 894 150690 215869 64131279
Confusional state 118.35 12.23 275 151309 260869 64086279
Alopecia 117.28 12.23 728 150856 164962 64182186
Mobility decreased 116.59 12.23 29 151555 85811 64261337
Decreased appetite 115.25 12.23 1087 150497 280202 64066946
Tumour haemorrhage 114.95 12.23 82 151502 3411 64343737
Recall phenomenon 114.19 12.23 53 151531 953 64346195
Systemic lupus erythematosus 113.95 12.23 22 151562 77590 64269558
Insomnia 113.46 12.23 181 151403 197655 64149493
Metastases to skin 112.58 12.23 59 151525 1393 64345755
Throat tightness 112.19 12.23 198 151386 22962 64324186
Nail disorder 111.94 12.23 119 151465 8505 64338643
Pulmonary embolism 111.82 12.23 656 150928 145700 64201448
Pneumothorax 110.38 12.23 202 151382 24096 64323052
Hypoglycaemia 109.90 12.23 37 151547 89855 64257293
Osteonecrosis of jaw 108.69 12.23 269 151315 39556 64307592
Psoriasis 108.12 12.23 19 151565 71684 64275464
Neutropenic sepsis 107.65 12.23 195 151389 23077 64324071
Injection site erythema 106.24 12.23 19 151565 70781 64276367
Influenza 106.21 12.23 59 151525 106472 64240676
Contusion 105.39 12.23 69 151515 113896 64233252
Cyanosis 104.22 12.23 187 151397 21968 64325180
Hypoxia 102.58 12.23 445 151139 87704 64259444
Pancytopenia 99.11 12.23 626 150958 142683 64204465
Migraine 98.09 12.23 15 151569 62662 64284486
Coronary artery disease 98 12.23 13 151571 60420 64286728
Loss of personal independence in daily activities 97.39 12.23 25 151559 72429 64274719
Tachycardia 97.08 12.23 643 150941 148936 64198212
Blood cholesterol increased 96.91 12.23 5 151579 50061 64297087
Arthritis 96.53 12.23 38 151546 83776 64263372
Immune-mediated hepatitis 94.98 12.23 64 151520 2425 64344723
Nail discolouration 94.73 12.23 64 151520 2436 64344712
Drug reaction with eosinophilia and systemic symptoms 94.61 12.23 9 151575 54208 64292940
Bone pain 94.53 12.23 286 151298 47286 64299862
Asthenia 91.61 12.23 1463 150121 426581 63920567
Electrocardiogram QT prolonged 91.53 12.23 36 151548 79412 64267736
Peripheral motor neuropathy 91.52 12.23 67 151517 2903 64344245
Myocardial infarction 90.15 12.23 157 151427 165664 64181484
Hepatic enzyme increased 89.50 12.23 104 151480 129839 64217309
Blood pressure fluctuation 89.49 12.23 9 151575 51862 64295286
Inappropriate schedule of product administration 89.30 12.23 53 151531 92233 64254915
Feeling abnormal 88.75 12.23 110 151474 133492 64213656
Incorrect dose administered 87.58 12.23 18 151566 60747 64286401
Bradycardia 86.50 12.23 90 151494 118129 64229019
Asthma 86.23 12.23 59 151525 95166 64251982
Breast cancer recurrent 85.83 12.23 61 151523 2522 64344626
Gait disturbance 85.65 12.23 172 151412 171983 64175165
Suicidal ideation 85.61 12.23 25 151559 66517 64280631
Hallucination 85.49 12.23 32 151552 72756 64274392
Dysaesthesia 85.28 12.23 80 151504 4915 64342233
Intestinal perforation 82.16 12.23 137 151447 15176 64331972
Memory impairment 81.79 12.23 50 151534 85632 64261516
Thrombotic microangiopathy 81.45 12.23 143 151441 16512 64330636
Ileus 80.21 12.23 171 151413 22795 64324353
Rhabdomyolysis 80.20 12.23 59 151525 91667 64255481
Coma 79.71 12.23 54 151530 87561 64259587
Cardiotoxicity 79.46 12.23 109 151475 10165 64336983
Anaphylactic reaction 79.39 12.23 346 151238 68318 64278830
Colitis 78.31 12.23 309 151275 58365 64288783
Drug hypersensitivity 78.22 12.23 291 151293 237524 64109624
Injection site reaction 78.20 12.23 9 151575 46655 64300493
Stomatitis 77.76 12.23 482 151102 109123 64238025
Tumour necrosis 77.59 12.23 49 151535 1660 64345488
Radiation oesophagitis 77.24 12.23 34 151550 537 64346611
Helicobacter infection 76.97 12.23 3 151581 38359 64308789
Performance status decreased 76.78 12.23 78 151506 5286 64341862
Wound 76.74 12.23 42 151542 76435 64270713
Hepatic atrophy 76.70 12.23 31 151553 391 64346757
Acute promyelocytic leukaemia 76.36 12.23 45 151539 1343 64345805
Injection site pruritus 75.76 12.23 3 151581 37823 64309325
Anxiety 74.05 12.23 237 151347 202412 64144736
Fluid retention 72.05 12.23 25 151559 59581 64287567
Exposure during pregnancy 71.84 12.23 47 151537 77628 64269520
Pneumocystis jirovecii pneumonia 70.54 12.23 182 151402 27452 64319696
International normalised ratio increased 70.42 12.23 50 151534 79117 64268031
Sepsis 70.25 12.23 839 150745 229502 64117646
Dizziness 69.08 12.23 662 150922 429501 63917647
Lactic acidosis 68.83 12.23 29 151555 61381 64285767
Irritable bowel syndrome 68.52 12.23 5 151579 37364 64309784
Tumour marker increased 68.21 12.23 60 151524 3390 64343758
Large intestine perforation 67.94 12.23 113 151471 12491 64334657
Hypokalaemia 67.91 12.23 505 151079 121398 64225750
Fibromyalgia 67.82 12.23 4 151580 35727 64311421
Treatment failure 67.76 12.23 106 151478 116710 64230438
Plasma cell myeloma 67.76 12.23 13 151571 46062 64301086
Metastases to kidney 67.29 12.23 29 151555 434 64346714
Serotonin syndrome 67.29 12.23 7 151577 39275 64307873
Subileus 66.95 12.23 70 151514 4907 64342241
Posterior reversible encephalopathy syndrome 66.89 12.23 159 151425 22787 64324361
Duodenal ulcer perforation 65.34 12.23 4 151580 34621 64312527
Cardiac failure congestive 65.33 12.23 130 151454 130450 64216698
Scleroderma-like reaction 65.19 12.23 20 151564 102 64347046
Alveolitis 64.71 12.23 60 151524 3632 64343516
Macular oedema 64.66 12.23 68 151516 4799 64342349
Irritability 64.38 12.23 6 151578 36740 64310408
Metastatic neoplasm 64.32 12.23 65 151519 4377 64342771
Metabolic acidosis 64.19 12.23 44 151540 70914 64276234
Aggression 63.98 12.23 15 151569 46217 64300931
PIK3CA-activated mutation 63.79 12.23 29 151555 496 64346652
Injury 63.47 12.23 26 151558 55966 64291182
Metastases to spine 63.45 12.23 59 151525 3584 64343564
Muscle spasms 63.42 12.23 149 151435 140874 64206274
Metastases to the mediastinum 63.32 12.23 29 151555 505 64346643
Metastasis 62.54 12.23 72 151512 5623 64341525
Hyperaemia 61.49 12.23 51 151533 2658 64344490
Anaphylactoid reaction 60.82 12.23 65 151519 4673 64342475
Nephrolithiasis 60.80 12.23 14 151570 43669 64303479
Urogenital fistula 60.51 12.23 18 151566 81 64347067
Bronchial fistula 60.42 12.23 21 151563 168 64346980
Pain in extremity 60.11 12.23 441 151143 302644 64044504
Nasal congestion 59.51 12.23 33 151551 59625 64287523
Malignant pleural effusion 59.46 12.23 52 151532 2915 64344233
Cataract 59.42 12.23 23 151561 51239 64295909
Hypertensive crisis 59.31 12.23 132 151452 18116 64329032
Pericarditis 58.94 12.23 37 151547 62479 64284669
Blister 58.82 12.23 62 151522 80905 64266243
Osteoarthritis 57.66 12.23 39 151545 63297 64283851
Accidental overdose 57.43 12.23 6 151578 33551 64313597
Cardiomyopathy 56.67 12.23 159 151425 25197 64321951
Cholangitis sclerosing 56.23 12.23 42 151542 1877 64345271
C-reactive protein abnormal 55.91 12.23 3 151581 29044 64318104
Acute myelomonocytic leukaemia 55.12 12.23 22 151562 268 64346880
Psychotic disorder 54.74 12.23 8 151576 34570 64312578
Bronchostenosis 54.60 12.23 27 151557 562 64346586
Basal cell carcinoma 54.12 12.23 5 151579 30833 64316315
Bronchitis 53.76 12.23 109 151475 108634 64238514
Paronychia 53.44 12.23 71 151513 6421 64340727
Eosinophilia 53.40 12.23 12 151572 38064 64309084
Computerised tomogram thorax abnormal 53.08 12.23 41 151543 1928 64345220
Malignant ascites 52.81 12.23 32 151552 1006 64346142
Urticaria 52.60 12.23 174 151410 147143 64200005
Medication error 52.26 12.23 26 151558 49940 64297208
Sleep apnoea syndrome 51.92 12.23 5 151579 29827 64317321
Metastases to pleura 51.85 12.23 34 151550 1230 64345918
Nail dystrophy 51.79 12.23 29 151555 784 64346364
Secondary cerebellar degeneration 51.72 12.23 14 151570 41 64347107
Enterocolitis infectious 51.02 12.23 44 151540 2420 64344728
Lymphoedema 50.99 12.23 87 151497 9818 64337330
Oesophagitis 50.68 12.23 138 151446 21492 64325656
Dyskinesia 50.29 12.23 15 151569 39373 64307775
Lower respiratory tract infection 50.11 12.23 91 151493 94523 64252625
Acute interstitial pneumonitis 50.00 12.23 31 151553 1016 64346132
Oesophagobronchial fistula 49.83 12.23 19 151565 203 64346945
Product prescribing error 49.69 12.23 11 151573 35258 64311890
Cytomegalovirus infection 49.67 12.23 13 151571 37186 64309962
Disseminated intravascular coagulation 49.49 12.23 178 151406 32170 64314978
Carbohydrate antigen 125 increased 49.49 12.23 39 151545 1889 64345259
Wrong technique in product usage process 49.19 12.23 48 151536 64926 64282222
Swollen tongue 49.05 12.23 11 151573 34943 64312205
Unevaluable event 48.83 12.23 29 151555 50460 64296688
Pancreatic carcinoma metastatic 48.73 12.23 50 151534 3428 64343720
Left ventricular dysfunction 47.82 12.23 116 151468 16838 64330310
Drug withdrawal syndrome 47.81 12.23 8 151576 31283 64315865
Hyperkalaemia 47.78 12.23 104 151480 101025 64246123
Haemoptysis 47.71 12.23 235 151349 48813 64298335
Pulmonary arterial hypertension 47.66 12.23 3 151581 25364 64321784
Tremor 47.65 12.23 183 151401 148047 64199101
Drug level increased 47.51 12.23 11 151573 34185 64312963
Suffocation feeling 47.36 12.23 35 151549 1539 64345609
Laryngospasm 47.32 12.23 49 151535 3396 64343752
Palmar erythema 46.95 12.23 36 151548 1674 64345474
Osteoporosis 46.95 12.23 20 151564 42060 64305088
Treatment noncompliance 46.42 12.23 22 151562 43460 64303688
Device related infection 46.41 12.23 168 151416 30458 64316690
Haemolytic uraemic syndrome 46.13 12.23 52 151532 3969 64343179
Pericardial effusion 45.51 12.23 198 151386 39056 64308092
Neutropenic colitis 45.47 12.23 55 151529 4526 64342622
Choking sensation 44.51 12.23 48 151536 3487 64343661
Stress 44.36 12.23 46 151538 60488 64286660
Type I hypersensitivity 44.07 12.23 48 151536 3526 64343622
Carbohydrate antigen 15-3 increased 44.06 12.23 28 151556 959 64346189
Liver abscess 43.85 12.23 58 151526 5222 64341926
Blood glucose increased 43.78 12.23 104 151480 97969 64249179
Immune-mediated lung disease 43.71 12.23 30 151554 1172 64345976
Biliary sepsis 43.52 12.23 32 151552 1396 64345752
Gastric disorder 43.44 12.23 8 151576 29189 64317959
Small intestinal perforation 43.43 12.23 41 151543 2539 64344609
Atelectasis 43.40 12.23 152 151432 27114 64320034
Hypersensitivity pneumonitis 42.66 12.23 45 151539 3187 64343961
Road traffic accident 42.49 12.23 10 151574 30735 64316413
Cachexia 42.33 12.23 77 151507 9140 64338008
Hot flush 41.79 12.23 217 151367 46018 64301130
Hepatic failure 41.42 12.23 247 151337 55147 64292001
Surgery 41.40 12.23 8 151576 28205 64318943
Blood creatine phosphokinase increased 41.24 12.23 46 151538 58512 64288636
Pulmonary toxicity 41.21 12.23 73 151511 8488 64338660
Acute kidney injury 41.13 12.23 776 150808 448464 63898684
Subdural haematoma 41.07 12.23 8 151576 28046 64319102
Angioedema 40.93 12.23 51 151533 61770 64285378
Abnormal behaviour 40.80 12.23 14 151570 33608 64313540
Limb injury 40.75 12.23 4 151580 23501 64323647
Tumour lysis syndrome 40.62 12.23 119 151465 19321 64327827
Recurrent cancer 40.50 12.23 38 151546 2335 64344813
Eastern Cooperative Oncology Group performance status worsened 40.38 12.23 29 151555 1219 64345929
Carcinoembryonic antigen increased 39.91 12.23 34 151550 1839 64345309
Extravasation 39.72 12.23 43 151541 3137 64344011
Rash pruritic 39.44 12.23 46 151538 57358 64289790
Head injury 39.30 12.23 14 151570 32828 64314320
Transient ischaemic attack 39.16 12.23 28 151556 44154 64302994
Gastrooesophageal reflux disease 38.86 12.23 86 151498 83057 64264091
COVID-19 38.83 12.23 58 151526 65082 64282066
Female genital tract fistula 38.68 12.23 39 151545 2619 64344529
Agitation 38.42 12.23 95 151489 88272 64258876
Discomfort 38.34 12.23 83 151501 80795 64266353
Nervousness 38.20 12.23 11 151573 29545 64317603
Pleural neoplasm 38.15 12.23 16 151568 223 64346925
Mental disorder 37.76 12.23 8 151576 26437 64320711
Respiratory distress 37.63 12.23 231 151353 52100 64295048
Rectal perforation 37.56 12.23 23 151561 737 64346411
Metastases to retroperitoneum 37.28 12.23 18 151566 355 64346793
Maternal exposure during pregnancy 37.23 12.23 109 151475 95775 64251373
Myoclonus 37.12 12.23 7 151577 25111 64322037
Capillary permeability increased 37.02 12.23 10 151574 29 64347119
Capillary leak syndrome 36.74 12.23 42 151542 3255 64343893
Product administration error 36.26 12.23 10 151574 27633 64319515
Eczema asteatotic 36.08 12.23 19 151565 453 64346695
Bone lesion 36.01 12.23 52 151532 5085 64342063
Cardiac disorder 35.96 12.23 47 151537 55769 64291379
Pulmonary radiation injury 35.71 12.23 11 151573 57 64347091
Primary cardiac lymphoma 35.66 12.23 9 151575 18 64347130
Wheezing 35.52 12.23 86 151498 80493 64266655
Nightmare 35.30 12.23 4 151580 20989 64326159
Toxic erythema of chemotherapy 35.27 12.23 15 151569 217 64346931
Oropharyngeal pain 35.25 12.23 100 151484 88767 64258381
Acute myocardial infarction 35.21 12.23 69 151515 69649 64277499
Full blood count abnormal 35.07 12.23 13 151571 29744 64317404
Pseudomembranous colitis 34.81 12.23 50 151534 4866 64342282
Stress cardiomyopathy 34.74 12.23 71 151513 9186 64337962
Constipation 34.63 12.23 743 150841 228594 64118554
Herpes zoster 34.53 12.23 85 151499 79102 64268046
Kounis syndrome 34.50 12.23 39 151545 2986 64344162
Emotional distress 34.42 12.23 21 151563 36017 64311131
Diabetes mellitus 34.25 12.23 65 151519 66409 64280739
Tonsillar disorder 34.10 12.23 24 151560 977 64346171
Dysgeusia 34.04 12.23 208 151376 46839 64300309
Gout 33.79 12.23 5 151579 21408 64325740
Eye pain 33.76 12.23 16 151568 31609 64315539
Metastases to stomach 33.73 12.23 15 151569 243 64346905
Skin laceration 33.63 12.23 8 151576 24409 64322739
Ear infection 33.58 12.23 7 151577 23397 64323751
Chills 33.42 12.23 480 151104 136784 64210364
Injection site haemorrhage 33.35 12.23 8 151576 24270 64322878
Tracheal fistula 33.29 12.23 12 151572 108 64347040
Blood triglycerides increased 33.27 12.23 3 151581 18863 64328285
Dystonia 33.26 12.23 3 151581 18862 64328286
Hydronephrosis 32.97 12.23 90 151494 14035 64333113
Acne 32.92 12.23 7 151577 23074 64324074
Prostate cancer 32.71 12.23 4 151580 19791 64327357
Cancer pain 32.67 12.23 45 151539 4212 64342936
Anastomotic leak 32.53 12.23 23 151561 943 64346205
Haemorrhage 32.43 12.23 88 151496 79263 64267885
Radiation skin injury 32.21 12.23 26 151558 1304 64345844
Hyperhidrosis 32.09 12.23 441 151143 124479 64222669
Aortitis 32.05 12.23 24 151560 1077 64346071
Infusion related hypersensitivity reaction 31.95 12.23 13 151571 167 64346981
Blood uric acid decreased 31.95 12.23 24 151560 1082 64346066
Bile duct stenosis 31.28 12.23 29 151555 1755 64345393
Portal hypertension 31.19 12.23 54 151530 6165 64340983
Fear 31.17 12.23 5 151579 20166 64326982
Flatulence 31.09 12.23 23 151561 35643 64311505
Device related thrombosis 31.09 12.23 31 151553 2054 64345094
Neck pain 30.98 12.23 61 151523 61472 64285676
Administration site extravasation 30.64 12.23 23 151561 1036 64346112
Adverse drug reaction 30.63 12.23 37 151547 45427 64301721
Endocarditis noninfective 30.51 12.23 13 151571 189 64346959
Hypervolaemia 30.49 12.23 27 151557 38258 64308890
Delirium 30.38 12.23 74 151510 69120 64278028
Pancreatic carcinoma 30.36 12.23 72 151512 10301 64336847
Superior vena cava syndrome 30.33 12.23 23 151561 1052 64346096
Hypersomnia 30.21 12.23 5 151579 19712 64327436
Joint stiffness 30.06 12.23 17 151567 30387 64316761
Therapeutic product effect incomplete 29.97 12.23 133 151451 103349 64243799
Periarticular thenar erythema with onycholysis 29.92 12.23 8 151576 22 64347126
Scleroderma 29.81 12.23 46 151538 4772 64342376
Duodenal perforation 29.73 12.23 29 151555 1871 64345277
Right ventricular ejection fraction decreased 29.65 12.23 9 151575 44 64347104
Right ventricular failure 29.64 12.23 7 151577 21464 64325684
Hepatic function abnormal 29.55 12.23 255 151329 64058 64283090
Blood pressure systolic increased 29.50 12.23 44 151540 49409 64297739
Enterocolitis 29.49 12.23 78 151506 11940 64335208
Hypoalbuminaemia 29.41 12.23 100 151484 17574 64329574
Tumour pain 29.30 12.23 29 151555 1904 64345244
Seizure 29.25 12.23 251 151333 166641 64180507
Metastases to eye 29.10 12.23 13 151571 213 64346935
Febrile infection 29.07 12.23 35 151549 2866 64344282
Small intestinal obstruction 28.94 12.23 121 151463 23452 64323696
Upper respiratory tract infection 28.79 12.23 82 151502 72703 64274445
Amnesia 28.74 12.23 43 151541 48226 64298922
Therapy interrupted 28.73 12.23 6 151578 20030 64327118
Musculoskeletal disorder 28.67 12.23 4 151580 17902 64329246
Urinary tract obstruction 28.65 12.23 41 151543 3976 64343172
Oligohydramnios 28.58 12.23 36 151548 3088 64344060
Death 28.51 12.23 1397 150187 481308 63865840
Metastases to pelvis 28.44 12.23 17 151567 521 64346627
Subclavian vein thrombosis 28.40 12.23 31 151553 2283 64344865
Lymphadenopathy mediastinal 28.30 12.23 40 151544 3836 64343312
Ovarian failure 28.24 12.23 17 151567 528 64346620
Retroperitoneal lymphadenopathy 28.22 12.23 21 151563 933 64346215
Immune-mediated enterocolitis 28.20 12.23 33 151551 2623 64344525
Peritonitis 28.08 12.23 125 151459 24898 64322250
Gait inability 27.99 12.23 35 151549 42333 64304815
Transaminases increased 27.87 12.23 190 151394 44404 64302744
Adrenocorticotropic hormone deficiency 27.86 12.23 20 151564 840 64346308
Cerebrovascular accident 27.80 12.23 199 151385 137384 64209764
Incorrect route of product administration 27.76 12.23 10 151574 23288 64323860
Mood swings 27.74 12.23 4 151580 17464 64329684
Ventricular tachycardia 27.49 12.23 24 151560 34241 64312907
Heart rate decreased 27.37 12.23 55 151529 55012 64292136
Balance disorder 27.35 12.23 103 151481 83823 64263325
Neuromuscular toxicity 27.35 12.23 12 151572 188 64346960
Joint range of motion decreased 27.31 12.23 6 151578 19337 64327811
Liver function test abnormal 27.30 12.23 62 151522 59339 64287809
Accidental exposure to product 27.14 12.23 14 151570 26350 64320798
Limb discomfort 27.14 12.23 15 151569 27160 64319988
Venous thrombosis limb 27.13 12.23 39 151545 3798 64343350
Deep vein thrombosis 26.88 12.23 371 151213 104811 64242337
Vocal cord paralysis 26.77 12.23 29 151555 2117 64345031
Folliculitis 26.73 12.23 19 151565 30058 64317090
Panic attack 26.71 12.23 8 151576 20945 64326203
Hyperpyrexia 26.67 12.23 45 151539 5032 64342116
Eosinophil percentage increased 26.63 12.23 24 151560 1400 64345748
Pregnancy 26.54 12.23 8 151576 20857 64326291
Blood potassium increased 26.45 12.23 14 151570 25966 64321182
Abortion spontaneous 26.41 12.23 13 151571 25130 64322018
Cardiac cirrhosis 26.25 12.23 12 151572 208 64346940
Hypomagnesaemia 26.25 12.23 164 151420 37212 64309936
Dermatitis acneiform 26.24 12.23 60 151524 8383 64338765
Dysphagia 26.19 12.23 374 151210 106438 64240710
Hepatic lesion 25.92 12.23 48 151536 5776 64341372
Disease recurrence 25.83 12.23 144 151440 31366 64315782
Hepatic infection 25.74 12.23 19 151565 834 64346314
Aplasia 25.71 12.23 53 151531 6900 64340248
Metastases to bladder 25.69 12.23 12 151572 219 64346929
Diabetes mellitus inadequate control 25.66 12.23 9 151575 21312 64325836
Hepatotoxicity 25.41 12.23 171 151413 39791 64307357
Weight decreased 25.36 12.23 496 151088 285243 64061905
Sleep disorder 25.32 12.23 65 151519 59644 64287504
Enteritis 25.30 12.23 74 151510 12003 64335145
Thyroid dermatopathy 25.26 12.23 7 151577 23 64347125
Gastric perforation 25.19 12.23 36 151548 3487 64343661
Xerophthalmia 25.06 12.23 15 151569 461 64346687
Metastases to chest wall 25.05 12.23 14 151570 377 64346771
Metastases to breast 25.02 12.23 12 151572 233 64346915
Pulse absent 25.01 12.23 61 151523 8885 64338263
Respiratory tract congestion 24.99 12.23 4 151580 16161 64330987
Duodenitis haemorrhagic 24.97 12.23 10 151574 123 64347025
Pulmonary tumour thrombotic microangiopathy 24.97 12.23 9 151575 81 64347067
Dysarthria 24.94 12.23 65 151519 59341 64287807
Tooth erosion 24.92 12.23 14 151570 381 64346767
Gastritis bacterial 24.84 12.23 13 151571 306 64346842
Hypopituitarism 24.77 12.23 31 151553 2642 64344506
Anaemia of malignant disease 24.75 12.23 17 151567 665 64346483
Sopor 24.75 12.23 20 151564 29641 64317507
Drug ineffective for unapproved indication 24.74 12.23 22 151562 31111 64316037
Oesophagopleural fistula 24.72 12.23 8 151576 50 64347098
Muscle twitching 24.68 12.23 7 151577 18991 64328157
Tumour embolism 24.68 12.23 10 151574 127 64347021
Vena cava thrombosis 24.67 12.23 30 151554 2482 64344666
Gallbladder disorder 24.63 12.23 5 151579 17025 64330123
Septic shock 24.59 12.23 366 151218 105071 64242077
Gastrointestinal haemorrhage 24.54 12.23 196 151388 132116 64215032
Haemoglobin 24.49 12.23 9 151575 86 64347062
Eye disorder 24.43 12.23 7 151577 18862 64328286
Laryngeal necrosis 24.39 12.23 7 151577 27 64347121
Lymphopenia 24.29 12.23 122 151462 25535 64321613
Kidney infection 24.26 12.23 6 151578 17832 64329316
Tumour pseudoprogression 24.18 12.23 15 151569 492 64346656
Intestinal metastasis 24.12 12.23 12 151572 253 64346895
Chronic obstructive pulmonary disease 23.94 12.23 86 151498 70962 64276186
Tracheo-oesophageal fistula 23.81 12.23 15 151569 506 64346642
Sinus bradycardia 23.80 12.23 12 151572 22881 64324267
Prescribed overdose 23.76 12.23 9 151575 20322 64326826
Breast cancer 23.76 12.23 133 151451 29015 64318133
Device dislocation 23.73 12.23 10 151574 21168 64325980
Viral infection 23.73 12.23 30 151554 36110 64311038
Melaena 23.72 12.23 57 151527 53491 64293657
Mastitis 23.67 12.23 26 151558 1928 64345220
Type 2 diabetes mellitus 23.65 12.23 27 151557 33993 64313155
Procedural pain 23.61 12.23 4 151580 15504 64331644
Neoplasm recurrence 23.56 12.23 36 151548 3703 64343445
Therapy cessation 23.45 12.23 25 151559 32464 64314684
Computerised tomogram thorax 23.43 12.23 10 151574 146 64347002
Immune-mediated hepatic disorder 23.32 12.23 15 151569 525 64346623
Paranoia 23.24 12.23 5 151579 16347 64330801
Foot fracture 23.02 12.23 7 151577 18150 64328998
Pyogenic granuloma 22.97 12.23 14 151570 445 64346703
Intestinal obstruction 22.91 12.23 155 151429 36131 64311017
Speech disorder 22.72 12.23 50 151534 48391 64298757
Spinal stenosis 22.57 12.23 3 151581 13928 64333220
Mood altered 22.48 12.23 5 151579 15974 64331174
Tumour associated fever 22.36 12.23 15 151569 564 64346584
Metastases to soft tissue 22.33 12.23 13 151571 379 64346769
Teratoma benign 22.10 12.23 8 151576 73 64347075
Anhedonia 22.09 12.23 3 151581 13703 64333445
Urinary retention 22.09 12.23 52 151532 49149 64297999
Taste disorder 21.91 12.23 60 151524 9373 64337775
Chromaturia 21.84 12.23 13 151571 22598 64324550
Metastases to abdominal cavity 21.84 12.23 14 151570 487 64346661
Gelastic seizure 21.82 12.23 5 151579 5 64347143
Bone marrow infiltration 21.81 12.23 14 151570 488 64346660
No adverse event 21.73 12.23 21 151563 28540 64318608
Pulmonary cavitation 21.67 12.23 21 151563 1344 64345804
Status epilepticus 21.58 12.23 12 151572 21651 64325497
Nasal septum perforation 21.48 12.23 16 151568 712 64346436
Vessel puncture site bruise 21.39 12.23 13 151571 411 64346737
Sinus congestion 21.38 12.23 5 151579 15434 64331714
Glaucoma 21.28 12.23 6 151578 16342 64330806
Eye swelling 21.26 12.23 13 151571 22268 64324880
Bursitis 21.26 12.23 12 151572 21473 64325675
Renal failure 21.15 12.23 300 151284 181388 64165760
Obesity 21.05 12.23 11 151573 20551 64326597
Rash papular 20.98 12.23 7 151577 17106 64330042
Transfusion 20.97 12.23 8 151576 17986 64329162
Fungal infection 20.89 12.23 30 151554 34221 64312927
Wound dehiscence 20.81 12.23 44 151540 5830 64341318
Movement disorder 20.76 12.23 13 151571 21987 64325161
Adenocarcinoma 20.74 12.23 32 151552 3319 64343829
Periodontitis 20.71 12.23 36 151548 4123 64343025
Pneumatosis intestinalis 20.69 12.23 41 151543 5188 64341960
Faeces discoloured 20.66 12.23 18 151566 25711 64321437
Hallucination, auditory 20.65 12.23 7 151577 16932 64330216
Night sweats 20.61 12.23 33 151551 36013 64311135
Taeniasis 20.59 12.23 7 151577 52 64347096
Sinus disorder 20.59 12.23 7 151577 16901 64330247
Scintillating scotoma 20.58 12.23 10 151574 200 64346948
Hallucination, visual 20.56 12.23 21 151563 27813 64319335
Dermatomyositis 20.55 12.23 29 151555 2777 64344371
Double hit lymphoma 20.54 12.23 6 151578 25 64347123
Device issue 20.54 12.23 14 151570 22634 64324514
Invasive ductal breast carcinoma 20.52 12.23 40 151544 5002 64342146
Orthostatic hypotension 20.50 12.23 50 151534 46688 64300460
Depressed level of consciousness 20.49 12.23 110 151474 81326 64265822
Device malfunction 20.29 12.23 8 151576 17625 64329523
Splenic artery thrombosis 20.14 12.23 7 151577 56 64347092
Cytokine release syndrome 20.09 12.23 12 151572 20817 64326331
Nail avulsion 20.00 12.23 8 151576 98 64347050
Localised infection 19.84 12.23 25 151559 30136 64317012
Respiratory depth decreased 19.82 12.23 6 151578 29 64347119
Progressive multifocal leukoencephalopathy 19.81 12.23 9 151575 18223 64328925
Foot deformity 19.81 12.23 7 151577 16497 64330651
Emphysematous cystitis 19.80 12.23 10 151574 218 64346930
Dyspnoea at rest 19.69 12.23 45 151539 6284 64340864
Product supply issue 19.64 12.23 20 151564 1359 64345789
Underdose 19.64 12.23 19 151565 25810 64321338
Poor quality sleep 19.61 12.23 10 151574 18941 64328207
Hypermetabolism 19.49 12.23 11 151573 302 64346846
Upper gastrointestinal perforation 19.49 12.23 5 151579 11 64347137
Inflammation 19.47 12.23 83 151501 65217 64281931
Post thrombotic syndrome 19.42 12.23 14 151570 592 64346556
Lymphatic disorder 19.39 12.23 11 151573 305 64346843
Bronchopleural fistula 19.34 12.23 14 151570 596 64346552
Pulmonary artery stenosis 19.31 12.23 8 151576 108 64347040
Osteolysis 19.11 12.23 28 151556 2775 64344373
Therapeutic response unexpected 19.09 12.23 8 151576 16993 64330155
Gene mutation 19.06 12.23 24 151560 2058 64345090
Immediate post-injection reaction 18.95 12.23 11 151573 319 64346829
Cholelithiasis 18.94 12.23 50 151534 45456 64301692
Radiation necrosis 18.89 12.23 11 151573 321 64346827
Glycosylated haemoglobin increased 18.87 12.23 7 151577 16012 64331136
Pulmonary congestion 18.82 12.23 17 151567 23863 64323285
Keratitis 18.77 12.23 30 151554 3207 64343941
Tongue disorder 18.65 12.23 3 151581 12077 64335071
Uterine atrophy 18.64 12.23 5 151579 14 64347134
Angiodermatitis 18.59 12.23 7 151577 72 64347076
Blood urine present 18.50 12.23 10 151574 18330 64328818
Muscle rigidity 18.41 12.23 9 151575 17464 64329684
Bronchopulmonary aspergillosis 18.40 12.23 11 151573 19074 64328074
Hypocalcaemia 18.37 12.23 164 151420 41589 64305559
Venous thrombosis 18.36 12.23 44 151540 6337 64340811
Adverse event 18.32 12.23 41 151543 39448 64307700
Transaminases 18.26 12.23 7 151577 76 64347072
Tumour ulceration 18.26 12.23 9 151575 186 64346962
Pancreatitis 18.24 12.23 75 151509 59532 64287616
Gastroenteritis radiation 18.24 12.23 14 151570 652 64346496
Ovarian cancer 18.21 12.23 30 151554 3289 64343859
Gastroenteritis viral 18.15 12.23 12 151572 19717 64327431
Pneumonitis chemical 18.15 12.23 11 151573 346 64346802
Brachiocephalic vein thrombosis 18.08 12.23 8 151576 128 64347020
Blood creatinine increased 18.08 12.23 218 151366 135564 64211584
Erythema multiforme 18.04 12.23 79 151505 15622 64331526
Hypophysitis 17.98 12.23 31 151553 3528 64343620
Disturbance in attention 17.97 12.23 44 151540 41030 64306118
Dermatitis 17.97 12.23 87 151497 17942 64329206
Cough 17.91 12.23 875 150709 301273 64045875
Ocular hyperaemia 17.86 12.23 16 151568 22548 64324600
Fistula 17.82 12.23 57 151527 9704 64337444
Eye pruritus 17.73 12.23 4 151580 12655 64334493
Chest pain 17.65 12.23 700 150884 235280 64111868
Oesophageal stenosis 17.57 12.23 32 151552 3802 64343346
Cardiac murmur 17.57 12.23 3 151581 11560 64335588
Pain in jaw 17.56 12.23 44 151540 40711 64306437
Carbohydrate antigen 19-9 increased 17.54 12.23 11 151573 368 64346780
Vulvovaginal inflammation 17.50 12.23 12 151572 468 64346680
Maternal death affecting foetus 17.46 12.23 4 151580 4 64347144
Epstein-Barr virus infection 17.38 12.23 4 151580 12484 64334664
Liver scan abnormal 17.37 12.23 6 151578 47 64347101
Diabetic ketoacidosis 17.37 12.23 27 151557 29818 64317330
Joint dislocation 17.36 12.23 3 151581 11462 64335686
Immune reconstitution inflammatory syndrome 17.34 12.23 4 151580 12466 64334682
Dementia 17.33 12.23 14 151570 20752 64326396
Empyema 17.32 12.23 31 151553 3634 64343514
Exostosis 17.31 12.23 3 151581 11435 64335713
Product quality issue 17.31 12.23 27 151557 29772 64317376
Scar 17.29 12.23 5 151579 13393 64333755
Ovarian cancer metastatic 17.28 12.23 12 151572 478 64346670
Adrenal insufficiency 17.27 12.23 101 151483 22386 64324762
Infectious pleural effusion 17.25 12.23 27 151557 2835 64344313
Gastrointestinal necrosis 17.23 12.23 37 151547 4955 64342193
Acute respiratory distress syndrome 17.17 12.23 153 151431 38782 64308366
Thrombophlebitis migrans 17.07 12.23 10 151574 295 64346853
Infected lymphocele 17.00 12.23 9 151575 217 64346931
Breast ulceration 16.95 12.23 6 151578 51 64347097
Haematoma 16.93 12.23 54 151530 46196 64300952
Carpal tunnel syndrome 16.91 12.23 8 151576 15820 64331328
Apathy 16.88 12.23 3 151581 11229 64335919
Hepatic vein thrombosis 16.85 12.23 9 151575 221 64346927
Immune-mediated renal disorder 16.84 12.23 6 151578 52 64347096
Pulmonary vein stenosis 16.84 12.23 8 151576 152 64346996
Torsade de pointes 16.75 12.23 10 151574 17353 64329795
Pulmonary hypoplasia 16.74 12.23 6 151578 53 64347095
Plethoric face 16.72 12.23 5 151579 23 64347125
Hormone receptor positive breast cancer 16.69 12.23 10 151574 308 64346840
Lung abscess 16.64 12.23 30 151554 3536 64343612
Photophobia 16.62 12.23 10 151574 17283 64329865
Dysstasia 16.60 12.23 18 151566 23197 64323951
Immune-mediated dermatitis 16.60 12.23 8 151576 157 64346991
Malignant peritoneal neoplasm 16.56 12.23 13 151571 626 64346522
Laryngeal cancer stage III 16.55 12.23 5 151579 24 64347124
Blood glucose decreased 16.46 12.23 18 151566 23105 64324043
Hypothalamo-pituitary disorder 16.46 12.23 16 151568 1028 64346120
Lymphadenopathy 16.43 12.23 175 151409 46511 64300637
Depressed mood 16.37 12.23 46 151538 40966 64306182
Arteriosclerosis coronary artery 16.36 12.23 8 151576 15521 64331627
Sputum discoloured 16.24 12.23 11 151573 17845 64329303
Vaginal cuff dehiscence 16.19 12.23 4 151580 7 64347141
Onychalgia 16.03 12.23 14 151570 783 64346365
Hip arthroplasty 15.90 12.23 16 151568 21335 64325813
Congestive cardiomyopathy 15.89 12.23 57 151527 10287 64336861
Atrioventricular block first degree 15.84 12.23 3 151581 10731 64336417
Metastases to ovary 15.76 12.23 9 151575 253 64346895
Pruritus 15.70 12.23 588 150996 311812 64035336
Joint effusion 15.69 12.23 6 151578 13467 64333681
Cystitis noninfective 15.68 12.23 16 151568 1090 64346058
Cholangitis infective 15.62 12.23 11 151573 448 64346700
Pneumoperitoneum 15.55 12.23 25 151559 2686 64344462
Blood creatinine decreased 15.55 12.23 44 151540 7006 64340142
Intestinal ischaemia 15.54 12.23 61 151523 11488 64335660
Drug resistance 15.51 12.23 138 151446 34964 64312184
Campylobacter test positive 15.50 12.23 6 151578 67 64347081
Median nerve injury 15.48 12.23 5 151579 31 64347117
Haematochezia 15.43 12.23 92 151492 66281 64280867
Obstruction gastric 15.41 12.23 18 151566 1428 64345720
Swelling face 15.40 12.23 79 151505 59087 64288061
Product storage error 15.39 12.23 6 151578 13312 64333836
Arrhythmia 15.35 12.23 68 151516 52876 64294272
Tidal volume decreased 15.34 12.23 6 151578 69 64347079
Blast cells present 15.31 12.23 14 151570 832 64346316
Pancreatic failure 15.27 12.23 18 151566 1442 64345706
Blood magnesium decreased 15.25 12.23 69 151515 13836 64333312
Guillain-Barre syndrome 15.25 12.23 46 151538 7589 64339559
Colitis ulcerative 15.24 12.23 19 151565 23009 64324139
Infusion site hypersensitivity 15.24 12.23 4 151580 10 64347138
Adenocarcinoma of appendix 15.19 12.23 6 151578 71 64347077
Hypophagia 15.18 12.23 151 151433 39436 64307712
Radiation pericarditis 15.17 12.23 3 151581 0 64347148
Ankyloglossia acquired 15.17 12.23 3 151581 0 64347148
Ecchymosis 15.11 12.23 7 151577 14015 64333133
Portal vein thrombosis 14.99 12.23 35 151549 4956 64342192
Lymphoma 14.96 12.23 7 151577 13934 64333214
Arterioenteric fistula 14.96 12.23 4 151580 11 64347137
Biliary obstruction 14.93 12.23 30 151554 3834 64343314
Mania 14.86 12.23 10 151574 16276 64330872
Meibomian gland dysfunction 14.83 12.23 7 151577 131 64347017
Xeroderma 14.78 12.23 8 151576 202 64346946
Immune-mediated nephritis 14.77 12.23 9 151575 286 64346862
Malignant melanoma 14.72 12.23 6 151578 12958 64334190
Clonal haematopoiesis 14.71 12.23 4 151580 12 64347136
Superinfection bacterial 14.70 12.23 16 151568 1174 64345974
Odynophagia 14.70 12.23 53 151531 9588 64337560
Influenza like illness 14.62 12.23 85 151499 61617 64285531
Cancer fatigue 14.61 12.23 6 151578 79 64347069
Uterine adhesions 14.61 12.23 5 151579 38 64347110
Hypotension 14.55 12.23 1061 150523 379913 63967235
Fatigue 14.51 12.23 1989 149595 746741 63600407
Pulmonary artery occlusion 14.50 12.23 5 151579 39 64347109
Pollakiuria 14.41 12.23 33 151551 31497 64315651
Nasal disorder 14.41 12.23 25 151559 2859 64344289
Psychomotor hyperactivity 14.40 12.23 8 151576 14443 64332705
Pancreatic enzyme abnormality 14.35 12.23 6 151578 83 64347065
Peritoneal disorder 14.28 12.23 12 151572 637 64346511
Lung infiltration 14.26 12.23 91 151493 20798 64326350
Hernia 14.18 12.23 7 151577 13511 64333637
Breast cellulitis 14.17 12.23 9 151575 308 64346840
Ulcer 14.16 12.23 20 151564 22970 64324178
Systemic toxicity 14.16 12.23 6 151578 86 64347062
Pseudocyst 14.14 12.23 9 151575 309 64346839
Coagulopathy 14.12 12.23 34 151550 31886 64315262
Angiosarcoma 14.08 12.23 10 151574 413 64346735
Toxic neuropathy 14.07 12.23 13 151571 783 64346365
Embryonal rhabdomyosarcoma 14.07 12.23 5 151579 43 64347105
Triple negative breast cancer 14.03 12.23 6 151578 88 64347060
Tumour cavitation 14.03 12.23 4 151580 15 64347133
Loss of consciousness 14.02 12.23 452 151132 147913 64199235
Tumour hyperprogression 13.97 12.23 7 151577 150 64346998
Renal disorder 13.87 12.23 40 151544 35325 64311823
Hypergeusia 13.82 12.23 4 151580 16 64347132
Laboratory test abnormal 13.79 12.23 22 151562 24041 64323107
Post procedural fistula 13.78 12.23 8 151576 232 64346916
Vascular pseudoaneurysm ruptured 13.76 12.23 7 151577 155 64346993
Neoplasm 13.71 12.23 42 151542 6989 64340159
Thinking abnormal 13.70 12.23 5 151579 11551 64335597
Porokeratosis 13.66 12.23 8 151576 236 64346912
Haemodialysis 13.65 12.23 12 151572 17065 64330083
Subclavian artery occlusion 13.64 12.23 7 151577 158 64346990
Metastases to vagina 13.63 12.23 4 151580 17 64347131
Mucosal infection 13.62 12.23 10 151574 435 64346713
Vision blurred 13.60 12.23 141 151443 90175 64256973
Diverticulum 13.60 12.23 7 151577 13191 64333957
Vaginal fistula 13.60 12.23 8 151576 238 64346910
Dandy-Walker syndrome 13.59 12.23 5 151579 48 64347100
Tumour perforation 13.52 12.23 9 151575 334 64346814
Angiosarcoma metastatic 13.50 12.23 5 151579 49 64347099
Lower gastrointestinal haemorrhage 13.48 12.23 8 151576 13931 64333217
Obstructive airways disorder 13.47 12.23 21 151563 23164 64323984
Ankle fracture 13.46 12.23 9 151575 14701 64332447
Ear pain 13.46 12.23 24 151560 25112 64322036
Aortic dissection rupture 13.45 12.23 4 151580 18 64347130
Bladder necrosis 13.45 12.23 4 151580 18 64347130
Coronary artery occlusion 13.40 12.23 8 151576 13883 64333265
Immune-mediated myocarditis 13.39 12.23 10 151574 447 64346701
Immune-mediated hypothyroidism 13.37 12.23 7 151577 165 64346983
Discontinued product administered 13.32 12.23 5 151579 51 64347097
Portal venous gas 13.31 12.23 9 151575 343 64346805
Non-small cell lung cancer 13.30 12.23 33 151551 4857 64342291
Thrombocytosis 13.26 12.23 42 151542 7114 64340034
Tumour invasion 13.24 12.23 9 151575 346 64346802
Chemotherapy 13.21 12.23 17 151567 1490 64345658
Ill-defined disorder 13.13 12.23 56 151528 43996 64303152
Abnormal dreams 13.12 12.23 4 151580 10352 64336796
Pulpitis dental 13.12 12.23 14 151570 1005 64346143
Glomerular filtration rate decreased 13.11 12.23 16 151568 19556 64327592
Breast sarcoma 13.09 12.23 3 151581 3 64347145
Ulcerated haemangioma 13.09 12.23 3 151581 3 64347145
Breast prosthesis removal 13.09 12.23 3 151581 3 64347145
Vaginal perforation 13.09 12.23 3 151581 3 64347145
Musculoskeletal pain 13.04 12.23 125 151459 81169 64265979
Renal impairment 13.00 12.23 231 151353 134786 64212362
Metastases to adrenals 13.00 12.23 15 151569 1174 64345974
KL-6 increased 12.98 12.23 5 151579 55 64347093
Hereditary motor and sensory neuropathy 12.97 12.23 6 151578 107 64347041
Generalised tonic-clonic seizure 12.93 12.23 49 151535 39808 64307340
Blood pressure immeasurable 12.92 12.23 19 151565 1889 64345259
Obstructive shock 12.90 12.23 5 151579 56 64347092
Acute pulmonary oedema 12.90 12.23 62 151522 12747 64334401
Cholecystitis chronic 12.87 12.23 3 151581 9284 64337864
Thrombotic thrombocytopenic purpura 12.86 12.23 37 151547 5947 64341201
Secretion discharge 12.85 12.23 6 151578 11958 64335190
Prescribed underdose 12.85 12.23 14 151570 18001 64329147
Metastases to uterus 12.82 12.23 5 151579 57 64347091
Ototoxicity 12.82 12.23 23 151561 2700 64344448
Increased tendency to bruise 12.81 12.23 3 151581 9252 64337896
Abdominal infection 12.79 12.23 24 151560 2916 64344232
Mediastinal fibrosis 12.79 12.23 4 151580 22 64347126
Jugular vein thrombosis 12.77 12.23 28 151556 3803 64343345
Non-small cell lung cancer recurrent 12.75 12.23 5 151579 58 64347090
Eructation 12.68 12.23 3 151581 9188 64337960
Lung squamous cell carcinoma metastatic 12.67 12.23 5 151579 59 64347089
CSF white blood cell count decreased 12.64 12.23 4 151580 23 64347125
Full blood count decreased 12.61 12.23 21 151563 22561 64324587
Bladder cancer 12.59 12.23 5 151579 10969 64336179
Duodenal obstruction 12.50 12.23 9 151575 380 64346768
Immune-mediated encephalitis 12.49 12.23 8 151576 278 64346870
Cognitive disorder 12.46 12.23 77 151507 55010 64292138
Distal intestinal obstruction syndrome 12.42 12.23 11 151573 627 64346521
Brain injury 12.35 12.23 4 151580 9961 64337187
Vitamin D deficiency 12.35 12.23 6 151578 11686 64335462
Acquired gene mutation 12.34 12.23 19 151565 1967 64345181
Transient psychosis 12.31 12.23 5 151579 64 64347084
Steatorrhoea 12.30 12.23 12 151572 774 64346374
Haemolytic anaemia 12.26 12.23 72 151512 15981 64331167
Bacterial diarrhoea 12.26 12.23 6 151578 122 64347026
Radiation dysphagia 12.24 12.23 3 151581 5 64347143
Stent malfunction 12.24 12.23 5 151579 65 64347083

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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

Drug Use (View source of the data)

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




๐Ÿถ Veterinary Drug Use

None

๐Ÿถ Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

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

Orange Book patent data (new drug applications)

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

Orange Book exclusivity data (new drug applications)

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

Bioactivity Summary:

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

External reference:

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

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Paclitaxel HUMAN PRESCRIPTION DRUG LABEL 1 0703-3213 INJECTION, SOLUTION, CONCENTRATE 6 mg INTRAVENOUS ANDA 16 sections
Paclitaxel HUMAN PRESCRIPTION DRUG LABEL 1 0703-3213 INJECTION, SOLUTION, CONCENTRATE 6 mg INTRAVENOUS ANDA 16 sections
Paclitaxel HUMAN PRESCRIPTION DRUG LABEL 1 0703-3216 INJECTION, SOLUTION, CONCENTRATE 6 mg INTRAVENOUS ANDA 16 sections
Paclitaxel HUMAN PRESCRIPTION DRUG LABEL 1 0703-3216 INJECTION, SOLUTION, CONCENTRATE 6 mg INTRAVENOUS ANDA 16 sections
Paclitaxel HUMAN PRESCRIPTION DRUG LABEL 1 0703-3217 INJECTION, SOLUTION, CONCENTRATE 6 mg INTRAVENOUS ANDA 16 sections
Paclitaxel HUMAN PRESCRIPTION DRUG LABEL 1 0703-3218 INJECTION, SOLUTION, CONCENTRATE 6 mg INTRAVENOUS ANDA 16 sections
Paclitaxel HUMAN PRESCRIPTION DRUG LABEL 1 0703-3218 INJECTION, SOLUTION, CONCENTRATE 6 mg INTRAVENOUS ANDA 16 sections
Paclitaxel HUMAN PRESCRIPTION DRUG LABEL 1 0703-4764 INJECTION, SOLUTION, CONCENTRATE 6 mg INTRAVENOUS ANDA 16 sections
Paclitaxel HUMAN PRESCRIPTION DRUG LABEL 1 0703-4768 INJECTION, SOLUTION, CONCENTRATE 6 mg INTRAVENOUS ANDA 16 sections
Paclitaxel Human Prescription Drug Label 1 16714-137 INJECTION, SOLUTION 6 mg INTRAVENOUS ANDA 21 sections
Paclitaxel HUMAN PRESCRIPTION DRUG LABEL 1 16729-098 INJECTION, SOLUTION 6 mg INTRAVENOUS ANDA 16 sections
Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound) HUMAN PRESCRIPTION DRUG LABEL 1 24979-710 INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION 100 mg INTRAVENOUS NDA authorized generic 32 sections
Paclitaxel HUMAN PRESCRIPTION DRUG LABEL 1 44567-504 INJECTION 6 mg INTRAVENOUS NDA 22 sections
Paclitaxel HUMAN PRESCRIPTION DRUG LABEL 1 44567-505 INJECTION 6 mg INTRAVENOUS NDA 22 sections
Paclitaxel HUMAN PRESCRIPTION DRUG LABEL 1 44567-506 INJECTION 6 mg INTRAVENOUS NDA 22 sections
Paclitaxel HUMAN PRESCRIPTION DRUG LABEL 1 45963-613 INJECTION, SOLUTION 6 mg INTRAVENOUS ANDA 16 sections
Paclitaxel HUMAN PRESCRIPTION DRUG LABEL 1 47781-593 INJECTION, SOLUTION 30 mg INTRAVENOUS ANDA 24 sections
Paclitaxel HUMAN PRESCRIPTION DRUG LABEL 1 47781-594 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 protein-bound particles for injectable suspension (albumin-bound) HUMAN PRESCRIPTION DRUG LABEL 1 60505-6230 INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION 100 mg INTRAVENOUS NDA authorized generic 32 sections
Paclitaxel HUMAN PRESCRIPTION DRUG LABEL 1 61703-342 INJECTION, SOLUTION 6 mg INTRAVENOUS ANDA 16 sections
Paclitaxel Human Prescription Drug Label 1 63323-763 INJECTION, SOLUTION 6 mg INTRAVENOUS ANDA 21 sections
Paclitaxel HUMAN PRESCRIPTION DRUG LABEL 1 68001-516 INJECTION, SOLUTION 6 mg INTRAVENOUS ANDA 21 sections
PACLITAXELPACLITAXEL Human Prescription Drug Label 1 68083-178 INJECTION, SOLUTION 6 mg INTRAVENOUS ANDA 19 sections
PACLITAXELPACLITAXEL Human Prescription Drug Label 1 68083-179 INJECTION, SOLUTION 6 mg INTRAVENOUS ANDA 19 sections
PACLITAXELPACLITAXEL Human Prescription Drug Label 1 68083-180 INJECTION, SOLUTION 6 mg INTRAVENOUS ANDA 19 sections
ABRAXANE HUMAN PRESCRIPTION DRUG LABEL 1 68817-134 INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION 100 mg INTRAVENOUS NDA 32 sections
Paclitaxel Human Prescription Drug Label 1 69539-157 INJECTION, SOLUTION 6 mg INTRAVENOUS ANDA 21 sections
Paclitaxel Human Prescription Drug Label 1 69539-158 INJECTION, SOLUTION 6 mg INTRAVENOUS ANDA 21 sections
Paclitaxel Human Prescription Drug Label 1 69539-159 INJECTION, SOLUTION 6 mg INTRAVENOUS ANDA 21 sections