gemcitabine ๐Ÿถ Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
nucleosides antiviral or antineoplastic agents, cytarabine or azacitidine derivatives 1283 95058-81-4

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • gemcitabine
  • gamcitabine
  • gemcitabine hydrochloride
  • gemcitabine HCl
Gemcitabine kills cells undergoing DNA synthesis and blocks the progression of cells through the G1/S-phase boundary. Gemcitabine is metabolized by nucleoside kinases to diphosphate (dFdCDP) and triphosphate (dFdCTP) nucleosides. Gemcitabine diphosphate inhibits ribonucleotide reductase, an enzyme responsible for catalyzing the reactions that generate deoxynucleoside triphosphates for DNA synthesis, resulting in reductions in deoxynucleotide concentrations, including dCTP. Gemcitabine triphosphate competes with dCTP for incorporation into DNA. The reduction in the intracellular concentration of dCTP by the action of the diphosphate enhances the incorporation of gemcitabine triphosphate into DNA (selfpotentiation). After the gemcitabine nucleotide is incorporated into DNA, only one additional nucleotide is added to the growing DNA strands, which eventually results in the initiation of apoptotic cell death.
  • Molecular weight: 263.20
  • Formula: C9H11F2N3O4
  • CLOGP: -0.41
  • LIPINSKI: 0
  • HAC: 7
  • HDO: 3
  • TPSA: 108.38
  • ALOGS: -1.07
  • ROTB: 2

  • Status: OFP

  • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

None

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 1 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 15 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 8 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 93.90 ยตM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
Vd (Volume of distribution) 1.50 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 32 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 1 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 1 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
May 15, 1996 FDA LILLY
June 18, 2019 PMDA Eli Lilly Japan K.K.

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 818.78 16.32 530 33370 67594 50503630
Thrombocytopenia 730.08 16.32 636 33264 127037 50444187
Disease progression 658.17 16.32 531 33369 95335 50475889
Neutropenia 549.02 16.32 581 33319 147384 50423840
Thrombotic microangiopathy 371.27 16.32 159 33741 8632 50562592
Neoplasm progression 362.33 16.32 232 33668 28925 50542299
Metastases to liver 303.16 16.32 181 33719 19923 50551301
Anaemia 279.49 16.32 558 33342 251898 50319326
Off label use 249.57 16.32 789 33111 473637 50097587
Myelosuppression 201.93 16.32 121 33779 13396 50557828
Metastases to lung 194.69 16.32 110 33790 10910 50560314
Haematotoxicity 184.80 16.32 95 33805 7800 50563424
Pleural effusion 179.57 16.32 246 33654 81208 50490016
Metastases to bone 170.30 16.32 121 33779 17874 50553350
Platelet count decreased 165.56 16.32 265 33635 100461 50470763
Metastases to lymph nodes 162.90 16.32 84 33816 6940 50564284
Pyrexia 162.86 16.32 591 33309 379612 50191612
Death 158.55 16.32 528 33372 324851 50246373
Pancytopenia 157.59 16.32 235 33665 83795 50487429
Diffuse large B-cell lymphoma recurrent 155.02 16.32 53 33847 1542 50569682
Leukopenia 150.39 16.32 205 33695 67323 50503901
Ascites 147.17 16.32 149 33751 35712 50535512
Recall phenomenon 138.15 16.32 38 33862 518 50570706
Febrile neutropenia 132.62 16.32 236 33664 97431 50473793
Acute myeloid leukaemia 130.40 16.32 96 33804 14978 50556246
Neutrophil count decreased 121.54 16.32 152 33748 45874 50525350
Bone marrow failure 121.12 16.32 119 33781 27505 50543719
Posterior reversible encephalopathy syndrome 117.84 16.32 90 33810 14838 50556386
Second primary malignancy 116.70 16.32 67 33833 6847 50564377
Joint swelling 116.17 16.32 14 33886 245272 50325952
Capillary leak syndrome 113.42 16.32 44 33856 1846 50569378
Arthralgia 109.17 16.32 81 33819 438621 50132603
Biliary tract infection 108.99 16.32 30 33870 410 50570814
Haemolytic uraemic syndrome 108.06 16.32 45 33855 2274 50568950
Drug ineffective 107.63 16.32 245 33655 819088 49752136
Metastases to peritoneum 102.57 16.32 46 33854 2787 50568437
Cholangitis 98.28 16.32 52 33848 4527 50566697
Neuropathy peripheral 97.31 16.32 206 33694 96551 50474673
Neurotoxicity 95.23 16.32 79 33821 14661 50556563
Fall 93.89 16.32 54 33846 334878 50236346
Mucosal inflammation 89.52 16.32 122 33778 40020 50531204
Abdominal pain 87.42 16.32 351 33549 235877 50335347
Product dose omission issue 85.77 16.32 11 33889 183827 50387397
Vomiting 83.19 16.32 560 33340 460198 50111026
Sepsis 82.41 16.32 235 33665 132690 50438534
Palmar-plantar erythrodysaesthesia syndrome 81.50 16.32 83 33817 20015 50551209
Therapy partial responder 80.69 16.32 52 33848 6539 50564685
Contraindicated product administered 79.95 16.32 5 33895 148953 50422271
Maternal exposure during pregnancy 78.43 16.32 8 33892 159770 50411454
Hypertransaminasaemia 71.87 16.32 39 33861 3572 50567652
Weight increased 71.69 16.32 23 33877 201868 50369356
Metastases to central nervous system 69.84 16.32 59 33841 11223 50560001
Hepatic failure 68.79 16.32 96 33804 32187 50539037
Cytokine release syndrome 68.02 16.32 52 33848 8582 50562642
Systemic lupus erythematosus 66.58 16.32 8 33892 140614 50430610
PIK3CA-activated mutation 63.73 16.32 23 33877 787 50570437
Pulmonary embolism 63.19 16.32 180 33720 101524 50469700
Sinusitis 63.13 16.32 18 33882 170540 50400684
Nasopharyngitis 61.71 16.32 26 33874 192901 50378323
Diffuse large B-cell lymphoma refractory 61.52 16.32 24 33876 1022 50570202
Cytopenia 60.81 16.32 49 33851 8726 50562498
Headache 60.28 16.32 159 33741 506376 50064848
Drug hypersensitivity 60.19 16.32 48 33852 250962 50320262
Abdominal discomfort 59.80 16.32 41 33859 231600 50339624
Musculoskeletal stiffness 59.15 16.32 8 33892 128473 50442751
Ovarian cancer recurrent 58.18 16.32 22 33878 860 50570364
Myositis 56.54 16.32 45 33855 7875 50563349
Swelling 55.33 16.32 33 33867 200839 50370385
Breast cancer recurrent 54.05 16.32 33 33867 3775 50567449
Pericardial effusion 52.89 16.32 75 33825 25514 50545710
Metastases to skin 51.81 16.32 23 33877 1360 50569864
Neutropenic sepsis 51.22 16.32 55 33845 14092 50557132
Myelodysplastic syndrome 49.88 16.32 56 33844 15076 50556148
Small intestinal obstruction 48.81 16.32 57 33843 16011 50555213
Thrombotic thrombocytopenic purpura 48.17 16.32 30 33870 3555 50567669
Wound 47.73 16.32 7 33893 105787 50465437
Therapeutic product effect decreased 47.39 16.32 16 33884 136034 50435190
Dehydration 47.37 16.32 215 33685 152234 50418990
Peripheral swelling 47.35 16.32 41 33859 205895 50365329
Bile duct stenosis 47.19 16.32 20 33880 1056 50570168
Product use in unapproved indication 46.72 16.32 177 33723 115642 50455582
General physical health deterioration 46.61 16.32 204 33696 142230 50428994
Hepatotoxicity 46.53 16.32 73 33827 27153 50544071
Injection site pain 46.43 16.32 9 33891 111015 50460209
Tumour lysis syndrome 46.32 16.32 39 33861 7382 50563842
Arthropathy 46.28 16.32 24 33876 157882 50413342
Haemoglobin decreased 46.12 16.32 188 33712 127028 50444196
BRCA2 gene mutation 43.82 16.32 10 33890 59 50571165
Pain 43.51 16.32 220 33680 578683 49992541
Metastases to pleura 43.47 16.32 20 33880 1286 50569938
Pancreatic carcinoma metastatic 43.29 16.32 23 33877 2019 50569205
Disease recurrence 43.20 16.32 60 33840 20021 50551203
Embolism 42.22 16.32 36 33864 6932 50564292
Pneumonitis 42.18 16.32 73 33827 29437 50541787
Interstitial lung disease 40.99 16.32 102 33798 53074 50518150
Drug interaction 40.93 16.32 44 33856 199577 50371647
Exposure during pregnancy 40.82 16.32 15 33885 121000 50450224
Erythema 40.74 16.32 200 33700 146214 50425010
Cholestasis 40.52 16.32 66 33834 25335 50545889
Asthma 40.09 16.32 6 33894 89331 50481893
Pancreatic fistula 39.84 16.32 7 33893 6 50571218
Lower respiratory tract infection 39.21 16.32 8 33892 95193 50476031
Hormone receptor positive breast cancer 38.99 16.32 14 33886 472 50570752
Capillary permeability increased 38.92 16.32 8 33892 26 50571198
White blood cell count decreased 38.80 16.32 168 33732 116554 50454670
Injection site erythema 38.78 16.32 3 33897 74933 50496291
Hypoalbuminaemia 38.66 16.32 40 33860 9820 50561404
Alopecia 38.16 16.32 66 33834 244981 50326243
Asthenia 38.14 16.32 353 33547 318689 50252535
Urinary tract obstruction 37.93 16.32 20 33880 1728 50569496
Overdose 37.86 16.32 10 33890 99717 50471507
Hepatic enzyme increased 37.21 16.32 23 33877 137357 50433867
Polyneuropathy 36.79 16.32 43 33857 12088 50559136
Arthritis 36.32 16.32 7 33893 86714 50484510
Nausea 36 16.32 667 33233 704731 49866493
Insomnia 35.34 16.32 39 33861 174826 50396398
EGFR gene mutation 34.99 16.32 11 33889 244 50570980
Product use issue 34.05 16.32 30 33870 149445 50421779
Breast cancer metastatic 33.55 16.32 38 33862 10326 50560898
Subacute cutaneous lupus erythematosus 33.51 16.32 20 33880 2195 50569029
Drug resistance 32.56 16.32 51 33849 18938 50552286
Carcinoembryonic antigen increased 32.37 16.32 17 33883 1457 50569767
Toxic erythema of chemotherapy 32.36 16.32 9 33891 128 50571096
Cardiac cirrhosis 32.24 16.32 9 33891 130 50571094
Memory impairment 32.00 16.32 7 33893 79353 50491871
Somnolence 31.94 16.32 34 33866 154951 50416273
Proteinuria 31.89 16.32 47 33853 16550 50554674
Bronchitis 31.76 16.32 15 33885 104144 50467080
Acquired gene mutation 31.71 16.32 14 33886 817 50570407
Microangiopathic haemolytic anaemia 31.14 16.32 12 33888 494 50570730
Pseudocellulitis 30.64 16.32 6 33894 14 50571210
Carbohydrate antigen 19-9 increased 30.60 16.32 9 33891 158 50571066
Metastases to meninges 30.09 16.32 18 33882 1984 50569240
Contusion 30.07 16.32 19 33881 112164 50459060
Muscle spasms 30.06 16.32 24 33876 125529 50445695
Jaundice 29.75 16.32 59 33841 26370 50544854
Condition aggravated 29.64 16.32 101 33799 296957 50274267
Thrombophlebitis migrans 29.57 16.32 8 33892 102 50571122
Metastasis 29.40 16.32 24 33876 4351 50566873
Carbohydrate antigen 125 increased 29.06 16.32 19 33881 2448 50568776
Metastases to chest wall 28.23 16.32 11 33889 467 50570757
Skin mass 28.03 16.32 25 33875 5110 50566114
Pericarditis 27.83 16.32 9 33891 78680 50492544
Sleep disorder 27.75 16.32 3 33897 57280 50513944
Epistaxis 27.66 16.32 100 33800 63854 50507370
Gait disturbance 27.59 16.32 36 33864 149969 50421255
Performance status decreased 26.84 16.32 20 33880 3175 50568049
Suicidal ideation 26.57 16.32 3 33897 55382 50515842
Feeling abnormal 26.45 16.32 27 33873 125465 50445759
Gastrointestinal toxicity 25.99 16.32 23 33877 4654 50566570
Metastases to bone marrow 25.90 16.32 9 33891 275 50570949
Haemoglobinaemia 25.79 16.32 6 33894 39 50571185
Influenza 25.64 16.32 14 33886 89524 50481700
Deep vein thrombosis 25.49 16.32 107 33793 73197 50498027
Oedema peripheral 25.39 16.32 187 33713 157774 50413450
Cerebral ischaemia 25.04 16.32 25 33875 5883 50565341
Cholangitis infective 24.89 16.32 8 33892 191 50571033
Loss of personal independence in daily activities 24.80 16.32 8 33892 70042 50501182
Device occlusion 24.64 16.32 25 33875 5998 50565226
Pulmonary toxicity 24.44 16.32 24 33876 5538 50565686
Migraine 24.27 16.32 10 33890 75270 50495954
Metastatic neoplasm 23.99 16.32 20 33880 3734 50567490
Urticaria 23.92 16.32 31 33869 129530 50441694
Catabolic state 23.69 16.32 6 33894 58 50571166
Decreased appetite 23.30 16.32 221 33679 200702 50370522
Atypical haemolytic uraemic syndrome 23.26 16.32 10 33890 547 50570677
Laryngospasm 22.97 16.32 17 33883 2671 50568553
Mediastinum neoplasm 22.83 16.32 6 33894 68 50571156
Peripheral sensory neuropathy 22.77 16.32 25 33875 6566 50564658
Granulocyte count decreased 22.70 16.32 11 33889 795 50570429
Inappropriate schedule of product administration 22.43 16.32 10 33890 71821 50499403
Gastric neoplasm 22.38 16.32 8 33892 266 50570958
Hypocalcaemia 22.32 16.32 53 33847 26763 50544461
Pancreatic carcinoma 22.21 16.32 24 33876 6190 50565034
Peritoneal disorder 21.91 16.32 9 33891 439 50570785
Leukaemic lymphoma 21.66 16.32 6 33894 84 50571140
Metastases to bladder 21.59 16.32 7 33893 172 50571052
Metastases to diaphragm 21.56 16.32 5 33895 32 50571192
Depression 21.08 16.32 50 33850 165373 50405851
Injection site reaction 21.03 16.32 4 33896 50028 50521196
Discomfort 20.98 16.32 25 33875 108355 50462869
Anxiety 20.84 16.32 56 33844 177550 50393674
Dizziness 20.42 16.32 142 33758 346227 50224997
Injury 20.37 16.32 4 33896 48921 50522303
Biliary obstruction 20.15 16.32 15 33885 2378 50568846
Vena cava thrombosis 20.06 16.32 14 33886 2007 50569217
Blood lactate dehydrogenase increased 20.04 16.32 42 33858 19520 50551704
Intestinal metastasis 20.01 16.32 6 33894 113 50571111
Neutrophil count abnormal 19.78 16.32 15 33885 2444 50568780
Generalised oedema 19.66 16.32 34 33866 13697 50557527
Metastases to spleen 19.58 16.32 6 33894 122 50571102
Chills 19.44 16.32 121 33779 96566 50474658
Lymphoedema 19.23 16.32 27 33873 9095 50562129
Bronchostenosis 19.14 16.32 8 33892 408 50570816
Left ventricular dysfunction 19.11 16.32 29 33871 10477 50560747
Colitis 19.05 16.32 63 33837 38466 50532758
Ureteric fistula 19.01 16.32 4 33896 15 50571209
Renal salt-wasting syndrome 19.00 16.32 7 33893 254 50570970
Hyperpyrexia 18.98 16.32 16 33884 3033 50568191
TP53 gene mutation 18.93 16.32 3 33897 0 50571224
Pseudosepsis 18.93 16.32 3 33897 0 50571224
Portal vein occlusion 18.93 16.32 3 33897 0 50571224
Paresis cranial nerve 18.93 16.32 3 33897 0 50571224
Gastrointestinal perforation 18.93 16.32 16 33884 3045 50568179
Dermatitis acneiform 18.75 16.32 18 33882 4039 50567185
IIIrd nerve paralysis 18.73 16.32 9 33891 638 50570586
Wrong technique in product usage process 18.51 16.32 7 33893 55503 50515721
Injection site swelling 18.29 16.32 3 33897 41770 50529454
Mobility decreased 18.25 16.32 16 33884 79932 50491292
Cardiotoxicity 18.20 16.32 23 33877 7004 50564220
Postictal state 18.18 16.32 10 33890 940 50570284
Metastases to adrenals 18.13 16.32 9 33891 685 50570539
Neoplasm recurrence 18.07 16.32 14 33886 2355 50568869
Renal vein thrombosis 17.99 16.32 7 33893 296 50570928
Osteoarthritis 17.86 16.32 12 33888 68594 50502630
Myocardial infarction 17.81 16.32 20 33880 89007 50482217
Tachycardia 17.70 16.32 121 33779 99642 50471582
Post thrombotic syndrome 17.50 16.32 8 33892 507 50570717
Metastases to stomach 17.16 16.32 6 33894 187 50571037
Impaired healing 17.13 16.32 13 33887 69773 50501451
Cardiomyopathy acute 16.92 16.32 6 33894 195 50571029
Infusion site thrombosis 16.78 16.32 5 33895 92 50571132
Folliculitis 16.77 16.32 3 33897 39222 50532002
Lymphangitis 16.72 16.32 9 33891 811 50570413
Cardiomyopathy 16.59 16.32 34 33866 15552 50555672
Haemoptysis 16.58 16.32 46 33854 25527 50545697
Ejection fraction abnormal 16.44 16.32 9 33891 838 50570386
Obstruction gastric 16.42 16.32 9 33891 840 50570384
Oroticaciduria 16.39 16.32 3 33897 4 50571220

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
Thrombocytopenia 536.83 17.94 669 29207 134154 29410497
Disease progression 481.45 17.94 498 29378 81418 29463233
Thrombotic microangiopathy 352.11 17.94 173 29703 8508 29536143
Neutropenia 285.31 17.94 491 29385 131220 29413431
Malignant neoplasm progression 239.35 17.94 332 29544 73527 29471124
Anaemia 233.24 17.94 579 29297 200372 29344279
Myelosuppression 212.52 17.94 140 29736 12087 29532564
Off label use 210.56 17.94 723 29153 300077 29244574
Neoplasm progression 210.37 17.94 164 29712 18448 29526203
Pancytopenia 184.88 17.94 314 29562 82854 29461797
Cholangitis 183.57 17.94 107 29769 7430 29537221
Pyrexia 149.30 17.94 629 29247 286993 29257658
Diffuse large B-cell lymphoma recurrent 143.13 17.94 64 29812 2533 29542118
Leukopenia 131.33 17.94 215 29661 54988 29489663
General physical health deterioration 124.78 17.94 302 29574 102555 29442096
Febrile neutropenia 121.96 17.94 316 29560 111924 29432727
Haemolytic uraemic syndrome 109.30 17.94 49 29827 1951 29542700
Pneumonitis 98.10 17.94 131 29745 27913 29516738
Haematotoxicity 98.05 17.94 69 29807 6630 29538021
Therapy partial responder 89.02 17.94 59 29817 5140 29539511
Platelet count decreased 85.56 17.94 266 29610 104406 29440245
Pseudocellulitis 85.34 17.94 17 29859 24 29544627
Interstitial lung disease 83.73 17.94 182 29694 57536 29487115
Neuropathy peripheral 82.26 17.94 205 29671 70822 29473829
Diffuse large B-cell lymphoma refractory 82.13 17.94 32 29844 890 29543761
Neutrophil count decreased 81.85 17.94 153 29723 43414 29501237
Neutropenic sepsis 80.92 17.94 78 29798 11649 29533002
Bacteraemia 75.94 17.94 88 29788 16235 29528416
Biliary tract infection 73.46 17.94 25 29851 467 29544184
Product dose omission issue 72.08 17.94 7 29869 96376 29448275
Drug interaction 70.11 17.94 58 29818 197327 29347324
Pulmonary embolism 64.81 17.94 197 29679 76337 29468314
Bone marrow failure 63.97 17.94 106 29770 27343 29517308
Capillary leak syndrome 62.82 17.94 33 29843 1866 29542785
Liver abscess 59.87 17.94 39 29837 3299 29541352
Pancreatic carcinoma metastatic 59.37 17.94 36 29840 2685 29541966
Pleural effusion 56.17 17.94 180 29696 71728 29472923
Overdose 54.24 17.94 8 29868 79811 29464840
Atypical haemolytic uraemic syndrome 52.58 17.94 15 29861 151 29544500
Product use in unapproved indication 51.89 17.94 199 29677 86676 29457975
Peripheral ischaemia 51.17 17.94 42 29834 5077 29539574
Arthralgia 50.81 17.94 40 29836 139577 29405074
Neurotoxicity 50.68 17.94 68 29808 14545 29530106
Immune-mediated hepatitis 48.99 17.94 26 29850 1501 29543150
Metastases to liver 47.09 17.94 59 29817 11797 29532854
Pancreatic carcinoma 46.41 17.94 46 29830 7104 29537547
Biliary obstruction 45.25 17.94 29 29847 2385 29542266
Ascites 44.79 17.94 108 29768 36511 29508140
Vomiting 44.50 17.94 366 29510 211894 29332757
Nausea 44.21 17.94 466 29410 288789 29255862
Myositis 43.79 17.94 53 29823 10230 29534421
Fall 41.61 17.94 72 29804 177106 29367545
Deep vein thrombosis 41.50 17.94 140 29736 57259 29487392
Metastases to lung 41.05 17.94 45 29831 7810 29536841
Sepsis 40.76 17.94 265 29611 142417 29402234
Chills 39.06 17.94 159 29717 71141 29473510
Asthenia 38.78 17.94 359 29517 214891 29329760
Seizure 38.76 17.94 23 29853 93100 29451551
Recall phenomenon 38.75 17.94 16 29860 519 29544132
Right ventricular ejection fraction decreased 38.64 17.94 9 29867 36 29544615
Nasopharyngitis 38.25 17.94 7 29869 59658 29484993
Cytokine release syndrome 37.99 17.94 56 29820 13063 29531588
Drug hypersensitivity 37.95 17.94 11 29865 68395 29476256
Headache 37.93 17.94 74 29802 173933 29370718
Pulmonary toxicity 36.54 17.94 34 29842 4856 29539795
Decreased appetite 36.19 17.94 261 29615 145081 29399570
Cytopenia 35.91 17.94 47 29829 9812 29534839
Hepatocellular injury 34.26 17.94 70 29806 21173 29523478
Feeling abnormal 33.61 17.94 7 29869 54438 29490213
Device occlusion 32.61 17.94 34 29842 5574 29539077
Disease recurrence 32.53 17.94 58 29818 15856 29528795
Abdominal pain 32.50 17.94 241 29635 135116 29409535
Hyperpyrexia 31.97 17.94 23 29853 2287 29542364
Extremity necrosis 31.90 17.94 20 29856 1583 29543068
Metastases to central nervous system 30.76 17.94 37 29839 7094 29537557
Depression 30.19 17.94 25 29851 85122 29459529
Myalgia 29.80 17.94 19 29857 74000 29470651
Skin toxicity 29.69 17.94 27 29849 3744 29540907
Mucosal inflammation 29.25 17.94 84 29792 31511 29513140
Histiocytic necrotising lymphadenitis 28.81 17.94 6 29870 12 29544639
Hospitalisation 28.20 17.94 6 29870 45982 29498669
Chronic coronary syndrome 28.00 17.94 7 29869 40 29544611
Insomnia 27.99 17.94 29 29847 88732 29455919
Anxiety 27.94 17.94 27 29849 85338 29459313
Dehydration 27.93 17.94 205 29671 114543 29430108
Dermatitis acneiform 27.90 17.94 31 29845 5460 29539191
Second primary malignancy 27.64 17.94 34 29842 6671 29537980
Muscle spasms 27.18 17.94 16 29860 65066 29479585
Vena cava thrombosis 26.23 17.94 15 29861 1003 29543648
White blood cell count decreased 25.73 17.94 158 29718 83204 29461447
Urosepsis 25.70 17.94 42 29834 10704 29533947
Embolism 25.31 17.94 33 29843 6863 29537788
Tumour lysis syndrome 25.10 17.94 48 29828 13836 29530815
Pancreatic enzyme abnormality 25.01 17.94 6 29870 28 29544623
Acute myeloid leukaemia 24.97 17.94 53 29823 16460 29528191
Biliary sepsis 24.82 17.94 12 29864 568 29544083
Erythropenia 24.78 17.94 9 29867 205 29544446
Coronary artery disease 24.70 17.94 7 29869 44183 29500468
Blood pressure increased 24.55 17.94 23 29853 73780 29470871
Weight increased 24.23 17.94 25 29851 76642 29468009
Vascular purpura 24.20 17.94 16 29860 1387 29543264
Joint swelling 24.04 17.94 10 29866 49620 29495031
Agitation 23.81 17.94 11 29865 51293 29493358
Discontinued product administered 23.69 17.94 5 29871 11 29544640
Electrocardiogram QT prolonged 23.68 17.94 4 29872 36133 29508518
Hypophosphataemia 23.19 17.94 34 29842 7890 29536761
Ill-defined disorder 23.15 17.94 42 29834 11636 29533015
Cardiac failure congestive 23.06 17.94 26 29850 76555 29468096
Hypertransaminasaemia 23.03 17.94 23 29853 3583 29541068
Tremor 22.10 17.94 25 29851 73513 29471138
Lung opacity 21.92 17.94 15 29861 1377 29543274
Oedema peripheral 21.85 17.94 179 29697 103378 29441273
Metabolic disorder 20.76 17.94 22 29854 3673 29540978
Lymphadenopathy 20.72 17.94 64 29812 24985 29519666
Toxicity to various agents 20.47 17.94 98 29778 173563 29371088
Granulocyte-colony stimulating factor level increased 20.36 17.94 4 29872 5 29544646
Toxic erythema of chemotherapy 20.08 17.94 6 29870 72 29544579
Bradycardia 20.06 17.94 22 29854 65607 29479044
Jaundice cholestatic 20.01 17.94 23 29853 4203 29540448
Vascular pseudoaneurysm ruptured 19.71 17.94 6 29870 77 29544574
Tumour necrosis 19.69 17.94 13 29863 1124 29543527
Somnolence 19.55 17.94 41 29835 93914 29450737
Fistula of small intestine 19.44 17.94 9 29867 386 29544265
Molluscum contagiosum 19.33 17.94 8 29868 261 29544390
Nephropathy toxic 19.21 17.94 37 29839 10719 29533932
Myocardial infarction 19.10 17.94 53 29823 110243 29434408
Cardiac disorder 18.88 17.94 7 29869 37256 29507395
Haemoglobin decreased 18.57 17.94 179 29697 108196 29436455
Palpitations 18.52 17.94 5 29871 32599 29512052
Muscle necrosis 18.42 17.94 11 29865 798 29543853
Injection site pain 18.39 17.94 5 29871 32441 29512210
Disseminated intravascular coagulation 18.37 17.94 53 29823 19927 29524724
Gastroenteritis radiation 18.34 17.94 8 29868 298 29544353
Hypercalcaemia of malignancy 18.33 17.94 7 29869 184 29544467
Flank pain 18.29 17.94 26 29850 5867 29538784
Carbohydrate antigen 19-9 increased 18.26 17.94 7 29869 186 29544465
Thrombophlebitis 18.24 17.94 18 29858 2765 29541886
Memory impairment 18.23 17.94 7 29869 36463 29508188
Enterocolitis infectious 18.22 17.94 13 29863 1276 29543375
Splenic infarction 18.19 17.94 15 29861 1824 29542827
Cystoid macular oedema 18.09 17.94 10 29866 626 29544025
Duodenal stenosis 18.09 17.94 7 29869 191 29544460
Transitional cell carcinoma recurrent 18.06 17.94 4 29872 12 29544639

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
Thrombocytopenia 1192.90 15.01 1174 51967 222627 64222964
Disease progression 833.94 15.01 786 52355 140894 64304697
Thrombotic microangiopathy 743.66 15.01 333 52808 16322 64429269
Malignant neoplasm progression 729.43 15.01 660 52481 112211 64333380
Neutropenia 712.28 15.01 929 52212 238695 64206896
Anaemia 469.53 15.01 990 52151 377690 64067901
Neoplasm progression 429.80 15.01 318 52823 40646 64404945
Myelosuppression 385.93 15.01 242 52899 23588 64422003
Pancytopenia 299.90 15.01 471 52670 142838 64302753
Pyrexia 289.65 15.01 1062 52079 557582 63888009
Cholangitis 263.15 15.01 143 52998 10659 64434932
Off label use 255.75 15.01 1113 52028 631693 63813898
Leukopenia 230.29 15.01 346 52795 100896 64344695
Haematotoxicity 229.19 15.01 139 53002 12757 64432834
Diffuse large B-cell lymphoma recurrent 221.33 15.01 87 53054 3059 64442532
Platelet count decreased 220.41 15.01 450 52691 167261 64278330
Metastases to liver 218.26 15.01 171 52970 23770 64421821
Febrile neutropenia 212.59 15.01 474 52667 187183 64258408
Haemolytic uraemic syndrome 207.26 15.01 89 53052 3932 64441659
Neuropathy peripheral 190.77 15.01 345 52796 117180 64328411
Neutrophil count decreased 177.16 15.01 265 52876 76931 64368660
Biliary tract infection 175.39 15.01 54 53087 897 64444694
Arthralgia 174.82 15.01 73 53068 442187 64003404
Recall phenomenon 168.23 15.01 53 53088 953 64444638
Metastases to lung 167.90 15.01 122 53019 15142 64430449
Capillary leak syndrome 163.46 15.01 71 53070 3226 64442365
General physical health deterioration 161.41 15.01 450 52691 203975 64241616
Bone marrow failure 160.87 15.01 198 52943 47754 64397837
Therapy partial responder 160.67 15.01 102 53039 10146 64435445
Pleural effusion 150.34 15.01 326 52815 126233 64319358
Ascites 139.61 15.01 211 52930 61790 64383801
Acute myeloid leukaemia 137.91 15.01 140 53001 27323 64418268
Metastases to lymph nodes 137.25 15.01 87 53054 8630 64436961
Pneumonitis 131.73 15.01 184 52957 50181 64395410
Interstitial lung disease 125.59 15.01 260 52881 97472 64348119
Neurotoxicity 123.78 15.01 132 53009 27272 64418319
Joint swelling 120.82 15.01 17 53124 215365 64230226
Diffuse large B-cell lymphoma refractory 119.15 15.01 42 53099 1082 64444509
Pulmonary embolism 117.22 15.01 324 52817 146032 64299559
Fall 115.73 15.01 104 53037 416722 64028869
Product dose omission issue 114.99 15.01 13 53128 194734 64250857
Second primary malignancy 114.33 15.01 89 53052 12248 64433343
Neutropenic sepsis 112.07 15.01 116 53025 23156 64422435
Pseudocellulitis 111.49 15.01 22 53119 40 64445551
Myositis 109.87 15.01 98 53043 16279 64429312
Cytokine release syndrome 109.75 15.01 109 53032 20720 64424871
Headache 106.70 15.01 170 52971 529297 63916294
Sepsis 100.75 15.01 416 52725 229925 64215666
Metastases to bone 100.46 15.01 103 53038 20332 64425259
Product use in unapproved indication 97.85 15.01 344 52797 176274 64269317
Nasopharyngitis 93.89 15.01 23 53118 196050 64249541
Overdose 90.88 15.01 12 53129 159554 64286037
Mucosal inflammation 90.55 15.01 175 52966 62409 64383182
Hypertransaminasaemia 89.53 15.01 62 53079 7129 64438462
Drug interaction 89.39 15.01 100 53041 361983 64083608
Musculoskeletal stiffness 88.04 15.01 3 53138 123203 64322388
Drug hypersensitivity 83.49 15.01 46 53095 237769 64207822
Weight increased 79.76 15.01 38 53103 213310 64232281
Vomiting 79.25 15.01 746 52395 550371 63895220
Abdominal pain 76.39 15.01 479 52662 311896 64133695
Liver abscess 71.62 15.01 48 53093 5232 64440359
Tumour lysis syndrome 71.26 15.01 84 53057 19356 64426235
Cytopenia 70.70 15.01 75 53066 15396 64430195
Atypical haemolytic uraemic syndrome 70.09 15.01 25 53116 667 64444924
Pancreatic carcinoma metastatic 68.32 15.01 40 53101 3438 64442153
Embolism 68.13 15.01 66 53075 12169 64433422
Posterior reversible encephalopathy syndrome 67.83 15.01 89 53052 22857 64422734
Bacteraemia 65.45 15.01 95 53046 26816 64418775
Pulmonary toxicity 65.04 15.01 55 53086 8506 64437085
Metastases to peritoneum 64.99 15.01 39 53102 3508 64442083
Metastases to central nervous system 64.56 15.01 68 53073 13844 64431747
Contraindicated product administered 64.12 15.01 7 53134 107822 64337769
Injection site pain 61.95 15.01 9 53132 111399 64334192
Peripheral swelling 61.85 15.01 49 53092 209104 64236487
Disease recurrence 60.87 15.01 100 53041 31410 64414181
Insomnia 60.21 15.01 45 53096 197791 64247800
Deep vein thrombosis 60.04 15.01 207 52934 104975 64340616
Peripheral ischaemia 59.93 15.01 52 53089 8326 64437265
Asthma 59.74 15.01 5 53136 95220 64350371
Asthenia 59.22 15.01 575 52566 427469 64018122
Bile duct stenosis 58.96 15.01 29 53112 1755 64443836
Chills 58.43 15.01 246 52895 137018 64308573
Drug ineffective 58.17 15.01 430 52711 839817 63605774
Feeling abnormal 57.78 15.01 19 53122 133583 64312008
Muscle spasms 56.02 15.01 23 53118 141000 64304591
Immune-mediated hepatitis 55.25 15.01 31 53110 2458 64443133
Maternal exposure during pregnancy 55.08 15.01 7 53134 95877 64349714
Biliary obstruction 54.51 15.01 36 53105 3828 64441763
White blood cell count decreased 53.86 15.01 265 52876 157572 64288019
Abdominal discomfort 52.30 15.01 44 53097 182278 64263313
Pericardial effusion 52.22 15.01 106 53035 39148 64406443
Sinusitis 51.51 15.01 28 53113 145900 64299691
Pain 50.88 15.01 259 52882 553252 63892339
Toxic erythema of chemotherapy 50.64 15.01 15 53126 217 64445374
Swelling 50.63 15.01 35 53106 160183 64285408
Device occlusion 50.60 15.01 51 53090 9862 64435729
Hyperpyrexia 50.04 15.01 38 53103 5039 64440552
Subacute cutaneous lupus erythematosus 49.64 15.01 31 53110 2994 64442597
Contusion 49.64 15.01 16 53125 113949 64331642
Pancreatic carcinoma 48.67 15.01 51 53090 10322 64435269
Palmar-plantar erythrodysaesthesia syndrome 47.18 15.01 85 53056 28734 64416857
Anxiety 46.70 15.01 59 53082 202590 64243001
Injection site erythema 46.46 15.01 3 53138 70797 64374794
Haemoglobin decreased 46.28 15.01 297 52844 194766 64250825
Microangiopathic haemolytic anaemia 44.59 15.01 22 53119 1340 64444251
Nausea 44.49 15.01 900 52241 784900 63660691
Arthropathy 44.49 15.01 22 53119 120945 64324646
Psoriasis 44.34 15.01 4 53137 71699 64373892
Hepatotoxicity 44.06 15.01 100 53041 39862 64405729
Therapeutic product effect decreased 43.92 15.01 20 53121 115331 64330260
Exposure during pregnancy 43.83 15.01 6 53135 77669 64367922
Systemic lupus erythematosus 43.78 15.01 6 53135 77606 64367985
Suicidal ideation 43.13 15.01 3 53138 66539 64379052
Wound 42.93 15.01 6 53135 76471 64369120
Decreased appetite 42.90 15.01 386 52755 280903 64164688
Extremity necrosis 42.32 15.01 27 53114 2707 64442884
Memory impairment 41.09 15.01 10 53131 85672 64359919
Depression 40.55 15.01 55 53086 183236 64262355
Dehydration 39.71 15.01 310 52831 216453 64229138
Colitis 39.33 15.01 122 53019 58552 64387039
Right ventricular ejection fraction decreased 39 15.01 9 53132 44 64445547
Erythropenia 38.99 15.01 14 53127 381 64445210
Hepatic failure 38.83 15.01 117 53024 55277 64390314
Cardiotoxicity 38.66 15.01 45 53096 10229 64435362
Somnolence 38.46 15.01 68 53073 203577 64242014
Hepatocellular injury 38.00 15.01 102 53039 45133 64400458
Skin toxicity 37.48 15.01 36 53105 6566 64439025
Bronchitis 36.74 15.01 22 53119 108721 64336870
Capillary permeability increased 36.17 15.01 8 53133 31 64445560
Gait disturbance 35.76 15.01 54 53087 172101 64273490
Mobility decreased 35.74 15.01 13 53128 85827 64359764
BRCA2 gene mutation 35.66 15.01 9 53132 68 64445523
Small intestinal obstruction 35.41 15.01 67 53074 23506 64422085
Oedema peripheral 35.38 15.01 295 52846 210022 64235569
Dermatitis acneiform 35.20 15.01 39 53102 8404 64437187
Biliary sepsis 35.04 15.01 19 53122 1409 64444182
Pancreatic fistula 34.78 15.01 9 53132 76 64445515
Blood lactate dehydrogenase increased 34.51 15.01 81 53060 32997 64412594
Metastases to pleura 34.34 15.01 18 53123 1246 64444345
Product use issue 34.09 15.01 45 53096 151670 64293921
Inappropriate schedule of product administration 33.60 15.01 17 53124 92269 64353322
Renal salt-wasting syndrome 33.23 15.01 13 53128 451 64445140
Cerebral ischaemia 33.17 15.01 41 53100 9921 64435670
Sleep disorder 32.78 15.01 5 53136 59704 64385887
Hypoalbuminaemia 32.67 15.01 55 53086 17619 64427972
Dizziness 32.64 15.01 214 52927 429949 64015642
Cholestasis 32.61 15.01 96 53045 44776 64400815
Drug resistance 32.40 15.01 82 53059 35020 64410571
Carbohydrate antigen 19-9 increased 32.10 15.01 12 53129 367 64445224
Hepatic enzyme increased 31.87 15.01 36 53105 129907 64315684
PIK3CA-activated mutation 31.67 15.01 13 53128 512 64445079
Pain in extremity 30.59 15.01 137 53004 302948 64142643
Condition aggravated 30.46 15.01 181 52960 372245 64073346
Influenza 30.18 15.01 26 53115 106505 64339086
Angioedema 30.06 15.01 7 53134 61814 64383777
Electrocardiogram QT prolonged 29.89 15.01 14 53127 79434 64366157
Arthritis 29.68 15.01 16 53125 83798 64361793
Blood pressure increased 29.62 15.01 61 53080 172491 64273100
Chronic coronary syndrome 29.42 15.01 7 53134 40 64445551
Tumour necrosis 29.28 15.01 18 53123 1691 64443900
Osteoarthritis 29.20 15.01 8 53133 63328 64382263
Immune effector cell-associated neurotoxicity syndrome 29.12 15.01 21 53120 2574 64443017
Metastases to spleen 28.74 15.01 12 53129 494 64445097
Cystoid macular oedema 28.66 15.01 18 53123 1756 64443835
Seizure 28.64 15.01 59 53082 166833 64278758
Urosepsis 28.60 15.01 59 53082 22035 64423556
Performance status decreased 28.12 15.01 28 53113 5336 64440255
Flank pain 28.11 15.01 49 53092 16140 64429451
Nephropathy toxic 27.83 15.01 51 53090 17463 64428128
Injection site reaction 27.81 15.01 3 53138 46661 64398930
Wheezing 27.65 15.01 16 53125 80563 64365028
Tremor 27.53 15.01 50 53091 148180 64297411
Myalgia 27.28 15.01 56 53085 158561 64287030
Stress 27.25 15.01 8 53133 60526 64385065
Hospitalisation 27.16 15.01 14 53127 75193 64370398
Myelodysplastic syndrome 27.12 15.01 66 53075 27513 64418078
Balance disorder 26.95 15.01 18 53123 83908 64361683
Breast cancer recurrent 26.94 15.01 20 53121 2563 64443028
Loss of personal independence in daily activities 26.90 15.01 13 53128 72441 64373150
Obstruction gastric 26.75 15.01 16 53125 1430 64444161
Post thrombotic syndrome 26.65 15.01 12 53129 594 64444997
Myocardial infarction 26.49 15.01 61 53080 165760 64279831
Gastrointestinal toxicity 26.47 15.01 27 53114 5295 64440296
Jaundice 26.38 15.01 94 53047 48418 64397173
Cardiac cirrhosis 26.33 15.01 9 53132 211 64445380
Disseminated intravascular coagulation 26.23 15.01 72 53069 32276 64413315
Jaundice cholestatic 26.20 15.01 34 53107 8636 64436955
Aortic thrombosis 26.07 15.01 16 53125 1498 64444093
Injury 25.95 15.01 7 53134 55985 64389606
Ovarian cancer recurrent 25.78 15.01 10 53131 339 64445252
Hepatic infection 25.63 15.01 13 53128 840 64444751
EGFR gene mutation 25.37 15.01 10 53131 354 64445237
Urticaria 25.34 15.01 52 53089 147265 64298326
Carcinoembryonic antigen increased 25.34 15.01 17 53124 1856 64443735
Aggression 25.09 15.01 4 53137 46228 64399363
Urinary tract obstruction 24.90 15.01 23 53118 3994 64441597
Thrombocytosis 24.71 15.01 30 53111 7126 64438465
Metastases to skin 24.13 15.01 15 53126 1437 64444154
Muscle necrosis 23.85 15.01 14 53127 1209 64444382
Injection site swelling 23.79 15.01 3 53138 41350 64404241
Pericarditis 23.54 15.01 11 53130 62505 64383086
Gastric perforation 23.46 15.01 21 53120 3502 64442089
Rhinorrhoea 23.45 15.01 10 53131 59959 64385632
Enterocolitis infectious 23.31 15.01 18 53123 2446 64443145
Polyneuropathy 23.29 15.01 51 53090 19843 64425748
Malignant ascites 23.23 15.01 13 53128 1025 64444566
Peripheral sensory neuropathy 23.18 15.01 37 53104 11341 64434250
Cholangitis infective 23.13 15.01 10 53131 449 64445142
Portal vein stenosis 22.90 15.01 5 53136 18 64445573
Hypercalcaemia of malignancy 22.77 15.01 9 53132 321 64445270
Histiocytic necrotising lymphadenitis 22.65 15.01 6 53135 56 64445535
Livedo reticularis 22.59 15.01 21 53120 3676 64441915
Cardio-respiratory arrest 22.28 15.01 29 53112 98364 64347227
Hydronephrosis 22.28 15.01 41 53100 14084 64431507
Malaise 22.21 15.01 214 52927 396033 64049558
Coronary artery disease 22.20 15.01 11 53130 60422 64385169
Wrong technique in product usage process 22.15 15.01 13 53128 64961 64380630
Metastases to bladder 22.10 15.01 8 53133 223 64445368
Bradycardia 21.83 15.01 40 53101 118179 64327412
Metastases to the mediastinum 21.68 15.01 10 53131 524 64445067
Fluid retention 21.67 15.01 11 53130 59595 64385996
Sedation 21.59 15.01 4 53137 41458 64404133
Metastasis 21.52 15.01 25 53116 5670 64439921
Palpitations 21.47 15.01 33 53108 104455 64341136
Disturbance in attention 21.31 15.01 4 53137 41070 64404521
Pleural mass 21.28 15.01 6 53135 72 64445519
Granulocyte-colony stimulating factor level increased 21.17 15.01 4 53137 5 64445586
Metastatic neoplasm 21.12 15.01 22 53119 4420 64441171
Intestinal metastasis 21.03 15.01 8 53133 257 64445334
Splenic infarction 20.88 15.01 19 53122 3238 64442353
Vascular pseudoaneurysm ruptured 20.85 15.01 7 53134 155 64445436
Gastrointestinal perforation 20.81 15.01 24 53117 5400 64440191
Coma 20.70 15.01 25 53116 87590 64358001
Pneumothorax 20.62 15.01 55 53086 24243 64421348
Thrombotic thrombocytopenic purpura 20.52 15.01 25 53116 5959 64439632
Pancreatic enzyme abnormality 20.50 15.01 6 53135 83 64445508
Leukaemic lymphoma 20.37 15.01 6 53135 85 64445506
Mediastinum neoplasm 20.18 15.01 6 53135 88 64445503
Haemoptysis 20.14 15.01 87 53054 48961 64396630
Stress cardiomyopathy 20.10 15.01 31 53110 9226 64436365
Gastric neoplasm 20.01 15.01 8 53133 294 64445297
Renal vein thrombosis 19.94 15.01 9 53132 448 64445143
Lymphadenopathy mediastinal 19.89 15.01 20 53121 3856 64441735
Catabolic state 19.81 15.01 6 53135 94 64445497
Infusion site thrombosis 19.65 15.01 7 53134 186 64445405
Hormone receptor positive breast cancer 19.61 15.01 8 53133 310 64445281
Heart rate increased 19.49 15.01 32 53109 98643 64346948
Migraine 19.38 15.01 14 53127 62663 64382928
Lymphadenopathy 19.32 15.01 83 53058 46603 64398988
Q fever 19.21 15.01 7 53134 199 64445392
Discomfort 19.19 15.01 23 53118 80855 64364736
Pneumocystis jirovecii pneumonia 19.02 15.01 58 53083 27576 64418015
Metastases to diaphragm 18.94 15.01 5 53136 46 64445545
Respiratory arrest 18.93 15.01 10 53131 52975 64392616
Transitional cell carcinoma recurrent 18.87 15.01 4 53137 12 64445579
Epistaxis 18.86 15.01 142 52999 97989 64347602
BRAF gene mutation 18.84 15.01 5 53136 47 64445544
Heart rate decreased 18.80 15.01 11 53130 55056 64390535
Erythema 18.74 15.01 236 52905 186834 64258757
Platelet count increased 18.65 15.01 45 53096 18651 64426940
Scleroderma-like reaction 18.64 15.01 6 53135 116 64445475
Haemolysis 18.63 15.01 33 53108 11006 64434585
Vascular purpura 18.55 15.01 16 53125 2540 64443051
Discontinued product administered 18.47 15.01 5 53136 51 64445540
Lower respiratory tract infection 18.39 15.01 31 53110 94583 64351008
Type 2 diabetes mellitus 18.33 15.01 3 53138 34017 64411574
Pseudosepsis 18.31 15.01 3 53138 0 64445591
Retroperitoneal neoplasm metastatic 18.31 15.01 3 53138 0 64445591
Impaired healing 18.06 15.01 14 53127 60459 64385132
Duodenal obstruction 18.06 15.01 8 53133 381 64445210
Ureteric fistula 17.99 15.01 4 53137 16 64445575
Lymphangitis 17.98 15.01 12 53129 1299 64444292
Hypophagia 17.65 15.01 72 53069 39515 64406076
Generalised oedema 17.49 15.01 47 53094 20806 64424785
Transaminases increased 17.48 15.01 78 53063 44516 64401075
Cognitive disorder 17.43 15.01 12 53129 55075 64390516
Unevaluable event 17.35 15.01 10 53131 50479 64395112
Lung opacity 17.33 15.01 17 53124 3182 64442409
Herpes zoster 17.26 15.01 24 53117 79163 64366428
Cardiomyopathy 17.24 15.01 53 53088 25303 64420288
Back pain 17.19 15.01 128 53013 250043 64195548
Skin mass 17.15 15.01 25 53116 7081 64438510
Delirium 17.15 15.01 19 53122 69175 64376416
Hypoaesthesia 17.14 15.01 58 53083 139050 64306541
Blood cholesterol increased 17.09 15.01 10 53131 50056 64395535
Hallucination 16.95 15.01 21 53120 72767 64372824
Peritoneal disorder 16.95 15.01 9 53132 640 64444951
Swollen tongue 16.91 15.01 4 53137 34950 64410641
Fistula of small intestine 16.87 15.01 9 53132 646 64444945
Loss of consciousness 16.86 15.01 64 53077 148301 64297290
Thrombophlebitis 16.81 15.01 22 53119 5632 64439959
Molluscum contagiosum 16.81 15.01 8 53133 450 64445141
Gait inability 16.67 15.01 7 53134 42361 64403230
Intestinal perforation 16.52 15.01 38 53103 15275 64430316
Blood bilirubin increased 16.41 15.01 92 53049 57461 64388130
Bone trimming 16.37 15.01 4 53137 26 64445565
Pancreatic abscess 16.35 15.01 5 53136 81 64445510
Laryngospasm 16.27 15.01 17 53124 3428 64442163
Blister 16.23 15.01 26 53115 80941 64364650
Biliary dilatation 16.06 15.01 14 53127 2254 64443337
Disseminated cryptococcosis 16.05 15.01 12 53129 1555 64444036
Chest discomfort 16.00 15.01 46 53095 116060 64329531
Road traffic accident 15.94 15.01 3 53138 30742 64414849
Triple negative breast cancer 15.92 15.01 5 53136 89 64445502
Treatment noncompliance 15.84 15.01 8 53133 43474 64402117
Oroticaciduria 15.77 15.01 3 53138 4 64445587
Blood creatine phosphokinase increased 15.73 15.01 15 53126 58543 64387048
Head injury 15.42 15.01 4 53137 32838 64412753
Platelet toxicity 15.37 15.01 3 53138 5 64445586
Gravitational oedema 15.35 15.01 12 53129 1660 64443931
Tumour thrombosis 15.28 15.01 5 53136 102 64445489
Influenza like illness 15.23 15.01 17 53124 61685 64383906
Therapy cessation 15.17 15.01 4 53137 32485 64413106
Neoplasm recurrence 15.12 15.01 17 53124 3722 64441869
Paraneoplastic pemphigus 15.05 15.01 5 53136 107 64445484
Toxicity to various agents 15.03 15.01 210 52931 363303 64082288
Stoma site dermatitis 15.02 15.01 3 53138 6 64445585

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC L01BC05 ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
ANTINEOPLASTIC AGENTS
ANTIMETABOLITES
Pyrimidine analogues
FDA MoA N0000000233 Nucleic Acid Synthesis Inhibitors
FDA EPC N0000175595 Nucleoside Metabolic Inhibitor
CHEBI has role CHEBI:35221 antimetabolite
CHEBI has role CHEBI:35610 antineoplastic agents
CHEBI has role CHEBI:35705 immunosuppressive agents
CHEBI has role CHEBI:36044 antiviral drugs
CHEBI has role CHEBI:74213 EC 1.17.4.1 inhibitor
CHEBI has role CHEBI:132992 radiosensitizing agents
CHEBI has role CHEBI:149553 anticoronaviral drug
CHEBI has role CHEBI:35703 Xenobiotic
CHEBI has role CHEBI:47868 photosensitising agent
CHEBI has role CHEBI:50266 Prodrugs
CHEBI has role CHEBI:59517 DNA synthesis inhibitors
CHEBI has role CHEBI:78298 environmental contaminants

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Non-small cell lung cancer indication 254637007 DOID:3908
Malignant tumor of ovary indication 363443007 DOID:2394
Adenocarcinoma of pancreas indication 700423003 DOID:4074
Metastatic Breast Carcinoma indication
Ewing's sarcoma off-label use 76909002 DOID:3369
Small cell carcinoma of lung off-label use 254632001 DOID:5409
Malignant tumor of head and/or neck off-label use 255056009
Malignant tumor of testis off-label use 363449006 DOID:2998
Malignant tumor of urinary bladder off-label use 399326009 DOID:11054
Biliary Tract Malignancy off-label use
Refractory Osteosarcoma off-label use
Infectious disease contraindication 40733004
Interstitial pneumonia contraindication 64667001
Leukopenia contraindication 84828003 DOID:615
Kidney disease contraindication 90708001 DOID:557
Hemolytic uremic syndrome contraindication 111407006 DOID:12554
Disease of liver contraindication 235856003 DOID:409
Anemia contraindication 271737000 DOID:2355
Pregnancy, function contraindication 289908002
Thrombocytopenic disorder contraindication 302215000 DOID:1588
Bone marrow depression contraindication 307762000
Breastfeeding (mother) contraindication 413712001




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 10.69 acidic
pKa2 12.86 acidic
pKa3 3.97 Basic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Ribonucleoside-diphosphate reductase large subunit Enzyme INHIBITOR WOMBAT-PK CHEMBL
Ribonucleoside-diphosphate reductase subunit M2 Enzyme INHIBITOR WOMBAT-PK CHEMBL
DNA polymerase (alpha/delta/epsilon) Enzyme INHIBITOR CHEMBL CHEMBL
Deoxycytidine kinase Kinase WOMBAT-PK
Thymidylate synthase Enzyme WOMBAT-PK
UMP-CMP kinase Kinase WOMBAT-PK

External reference:

IDSource
4024031 VUID
N0000022036 NUI
D01155 KEGG_DRUG
122111-03-9 SECONDARY_CAS_RN
4020975 VANDF
4024031 VANDF
C0045093 UMLSCUI
CHEBI:175901 CHEBI
GEO PDB_CHEM_ID
CHEMBL888 ChEMBL_ID
DB00441 DRUGBANK_ID
CHEMBL1637 ChEMBL_ID
C056507 MESH_SUPPLEMENTAL_RECORD_UI
60750 PUBCHEM_CID
4793 IUPHAR_LIGAND_ID
6515 INN_ID
B76N6SBZ8R UNII
12574 RXNORM
130312 MMSL
35333 MMSL
4777 MMSL
d04010 MMSL
005472 NDDF
005473 NDDF
108811008 SNOMEDCT_US
386920008 SNOMEDCT_US
412187004 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Gemcitabine HUMAN PRESCRIPTION DRUG LABEL 1 0143-9394 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 200 mg INTRAVENOUS ANDA 24 sections
Gemcitabine HUMAN PRESCRIPTION DRUG LABEL 1 0143-9395 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 1 g INTRAVENOUS ANDA 24 sections
Gemcitabine HUMAN PRESCRIPTION DRUG LABEL 1 0409-0181 INJECTION, SOLUTION 38 mg INTRAVENOUS NDA 27 sections
Gemcitabine HUMAN PRESCRIPTION DRUG LABEL 1 0409-0181 INJECTION, SOLUTION 38 mg INTRAVENOUS NDA 27 sections
Gemcitabine HUMAN PRESCRIPTION DRUG LABEL 1 0409-0182 INJECTION, SOLUTION 38 mg INTRAVENOUS NDA 27 sections
Gemcitabine HUMAN PRESCRIPTION DRUG LABEL 1 0409-0182 INJECTION, SOLUTION 38 mg INTRAVENOUS NDA 27 sections
Gemcitabine HUMAN PRESCRIPTION DRUG LABEL 1 0409-0183 INJECTION, SOLUTION 38 mg INTRAVENOUS NDA 27 sections
Gemcitabine HUMAN PRESCRIPTION DRUG LABEL 1 0409-0183 INJECTION, SOLUTION 38 mg INTRAVENOUS NDA 27 sections
Gemcitabine HUMAN PRESCRIPTION DRUG LABEL 1 0409-0185 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 38 mg INTRAVENOUS ANDA 27 sections
Gemcitabine HUMAN PRESCRIPTION DRUG LABEL 1 0409-0186 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 38 mg INTRAVENOUS ANDA 27 sections
GEMCITABINE HUMAN PRESCRIPTION DRUG LABEL 1 0409-0187 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 38 mg INTRAVENOUS ANDA 27 sections
GEMCITABINE HUMAN PRESCRIPTION DRUG LABEL 1 16714-909 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 200 mg INTRAVENOUS ANDA 25 sections
GEMCITABINE HUMAN PRESCRIPTION DRUG LABEL 1 16714-930 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 1 g INTRAVENOUS ANDA 25 sections
GEMCITABINE HYDROCHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 16729-092 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 200 mg INTRAVENOUS ANDA 23 sections
GEMCITABINE HYDROCHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 16729-117 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 1 g INTRAVENOUS ANDA 23 sections
GEMCITABINE HYDROCHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 16729-118 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 2 g INTRAVENOUS ANDA 23 sections
GEMCITABINE HUMAN PRESCRIPTION DRUG LABEL 1 16729-391 INJECTION, SOLUTION 100 mg INTRAVENOUS NDA 26 sections
GEMCITABINE HUMAN PRESCRIPTION DRUG LABEL 1 16729-419 INJECTION, SOLUTION 100 mg INTRAVENOUS NDA 26 sections
GEMCITABINE HUMAN PRESCRIPTION DRUG LABEL 1 16729-423 INJECTION, SOLUTION 100 mg INTRAVENOUS NDA 26 sections
GEMCITABINE HUMAN PRESCRIPTION DRUG LABEL 1 16729-426 INJECTION, SOLUTION 100 mg INTRAVENOUS NDA 26 sections
gemcitabine HUMAN PRESCRIPTION DRUG LABEL 1 25021-234 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 200 mg INTRAVENOUS ANDA 25 sections
gemcitabine HUMAN PRESCRIPTION DRUG LABEL 1 25021-235 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 1 g INTRAVENOUS ANDA 25 sections
gemcitabine HUMAN PRESCRIPTION DRUG LABEL 1 55111-686 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 200 mg INTRAVENOUS ANDA 26 sections
gemcitabine HUMAN PRESCRIPTION DRUG LABEL 1 55111-687 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 1 g INTRAVENOUS ANDA 26 sections
gemcitabine HUMAN PRESCRIPTION DRUG LABEL 1 55390-391 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 40 mg INTRAVENOUS ANDA 25 sections
INFUGEM HUMAN PRESCRIPTION DRUG LABEL 1 62756-008 INJECTION, SOLUTION 10 mg INTRAVENOUS NDA 27 sections
INFUGEM HUMAN PRESCRIPTION DRUG LABEL 1 62756-073 INJECTION, SOLUTION 10 mg INTRAVENOUS NDA 27 sections
INFUGEM HUMAN PRESCRIPTION DRUG LABEL 1 62756-102 INJECTION, SOLUTION 10 mg INTRAVENOUS NDA 27 sections
INFUGEM HUMAN PRESCRIPTION DRUG LABEL 1 62756-219 INJECTION, SOLUTION 10 mg INTRAVENOUS NDA 27 sections
INFUGEM HUMAN PRESCRIPTION DRUG LABEL 1 62756-321 INJECTION, SOLUTION 10 mg INTRAVENOUS NDA 27 sections