gemcitabine 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: -0.71
  • 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 ┬ÁM/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 1176.50 14.91 796 52222 64130 46568914
Thrombocytopenia 957.93 14.91 931 52087 125650 46507394
Disease progression 829.78 14.91 744 52274 90556 46542488
Neutropenia 749.65 14.91 866 52152 142338 46490706
Thrombotic microangiopathy 605.69 14.91 258 52760 8048 46624996
Haemolytic uraemic syndrome 400.22 14.91 138 52880 2376 46630668
Metastases to liver 399.58 14.91 259 52759 19326 46613718
Anaemia 376.94 14.91 869 52149 254910 46378134
Haematotoxicity 329.96 14.91 160 52858 6773 46626271
Pleural effusion 291.10 14.91 412 52606 82540 46550504
Neoplasm progression 289.46 14.91 241 52777 26442 46606602
Ascites 277.38 14.91 270 52748 36314 46596730
Pancreatic carcinoma metastatic 277.23 14.91 104 52914 2304 46630740
Metastases to lung 244.41 14.91 152 52866 10544 46622500
Recall phenomenon 229.81 14.91 64 52954 514 46632530
Metastases to bone 223.83 14.91 174 52844 17302 46615742
Bone marrow failure 210.08 14.91 211 52807 29458 46603586
Pseudocirrhosis 201.28 14.91 60 52958 628 46632416
Platelet count decreased 198.01 14.91 384 52634 99640 46533404
Febrile neutropenia 195.57 14.91 370 52648 94257 46538787
Capillary leak syndrome 193.46 14.91 75 52943 1822 46631222
Off label use 193.14 14.91 897 52121 378944 46254100
Drug ineffective 188.23 14.91 301 52717 677537 45955507
Cholangitis 187.32 14.91 96 52922 4578 46628466
Leukopenia 186.42 14.91 302 52716 68041 46565003
Posterior reversible encephalopathy syndrome 185.79 14.91 147 52871 14994 46618050
Pyrexia 184.13 14.91 833 52185 347969 46285075
Death 165.69 14.91 786 52232 334762 46298282
Acute myeloid leukaemia 159.73 14.91 137 52881 15641 46617403
Breast cancer metastatic 155.50 14.91 127 52891 13551 46619493
Diffuse large B-cell lymphoma recurrent 152.19 14.91 59 52959 1433 46631611
Palmar-plantar erythrodysaesthesia syndrome 147.62 14.91 147 52871 20304 46612740
Product dose omission issue 138.48 14.91 15 53003 168505 46464539
Neuropathy peripheral 137.86 14.91 313 52705 90580 46542464
Pancytopenia 136.97 14.91 300 52718 84758 46548286
Fall 133.58 14.91 107 52911 328990 46304054
Metastases to lymph nodes 133.48 14.91 87 52931 6544 46626500
Thrombotic thrombocytopenic purpura 133.07 14.91 72 52946 3838 46629206
Joint swelling 130.97 14.91 17 53001 166056 46466988
Neurotoxicity 130.57 14.91 115 52903 13602 46619442
Drug hypersensitivity 125.58 14.91 60 52958 243765 46389279
Neutrophil count decreased 125.36 14.91 197 52821 43229 46589815
Pancreatic carcinoma 124.62 14.91 83 52935 6474 46626570
Abdominal pain 120.76 14.91 549 52469 229482 46403562
Headache 117.36 14.91 229 52789 478123 46154921
Metastases to central nervous system 116.78 14.91 99 52919 11122 46621922
Metastases to peritoneum 113.73 14.91 57 52961 2591 46630453
Arthralgia 109.38 14.91 153 52865 364450 46268594
Biliary tract infection 106.84 14.91 33 52985 393 46632651
Interstitial lung disease 101.65 14.91 203 52815 53746 46579298
General physical health deterioration 98.25 14.91 322 52696 115447 46517597
Pneumonitis 97.82 14.91 140 52878 28280 46604764
Vomiting 97.65 14.91 860 52158 451934 46181110
Mucosal inflammation 93.89 14.91 163 52855 38813 46594231
Weight increased 93.39 14.91 35 52983 164438 46468606
Nasopharyngitis 88.73 14.91 32 52986 153966 46479078
Pulmonary toxicity 88.21 14.91 59 52959 4634 46628410
Second primary malignancy 87.43 14.91 67 52951 6517 46626527
Neutropenic sepsis 78.79 14.91 83 52935 12241 46620803
Metastases to skin 78.41 14.91 36 52982 1344 46631700
Myelosuppression 78.19 14.91 67 52951 7636 46625408
Maternal exposure during pregnancy 77.29 14.91 12 53006 102537 46530507
Overdose 76.71 14.91 12 53006 101967 46531077
Pericardial effusion 76.65 14.91 118 52900 25425 46607619
Sinusitis 76.40 14.91 26 52992 129742 46503302
Ovarian cancer 75.19 14.91 58 52960 5697 46627347
Carbohydrate antigen 19-9 increased 74.84 14.91 20 52998 135 46632909
Pulmonary embolism 73.99 14.91 281 52737 108304 46524740
Exposure during pregnancy 70.42 14.91 18 53000 108194 46524850
Injection site pain 69.39 14.91 18 53000 107134 46525910
Contraindicated product administered 68.56 14.91 6 53012 79941 46553103
Hypertransaminasaemia 68.33 14.91 45 52973 3443 46629601
Therapy partial responder 67.39 14.91 50 52968 4632 46628412
Biliary sepsis 67.04 14.91 25 52993 544 46632500
Pseudocellulitis 65.68 14.91 13 53005 14 46633030
Thrombocytosis 64.45 14.91 50 52968 4952 46628092
Asthma 64.01 14.91 13 53005 91529 46541515
Sepsis 63.47 14.91 314 52704 135700 46497344
White blood cell count decreased 63.37 14.91 274 52744 111957 46521087
Peripheral swelling 63.24 14.91 52 52966 158019 46475025
Musculoskeletal stiffness 62.43 14.91 17 53001 97976 46535068
Hepatic failure 62.03 14.91 125 52893 33291 46599753
Performance status decreased 61.57 14.91 41 52977 3196 46629848
Dehydration 61.25 14.91 349 52669 159191 46473853
Polyneuropathy 59.91 14.91 70 52948 11574 46621470
Ovarian cancer recurrent 59.41 14.91 27 52991 984 46632060
Drug interaction 59.01 14.91 87 52931 203007 46430037
Abdominal discomfort 58.91 14.91 51 52967 151114 46481930
PIK3CA-activated mutation 58.59 14.91 23 52995 578 46632466
Hypoalbuminaemia 57.38 14.91 64 52954 10063 46622981
Gastrointestinal toxicity 57.35 14.91 44 52974 4287 46628757
Bile duct stenosis 57.21 14.91 27 52991 1074 46631970
Somnolence 57.21 14.91 56 52962 156465 46476579
Insomnia 56.90 14.91 62 52956 164862 46468182
Breast cancer recurrent 56.82 14.91 42 52976 3869 46629175
Subacute cutaneous lupus erythematosus 56.23 14.91 32 52986 1883 46631161
Dizziness 55.11 14.91 200 52818 340214 46292830
Diffuse large B-cell lymphoma refractory 54.31 14.91 25 52993 939 46632105
Adenocarcinoma pancreas 53.17 14.91 26 52992 1120 46631924
Haemoglobin decreased 52.74 14.91 287 52731 128662 46504382
Memory impairment 52.00 14.91 12 53006 77325 46555719
Gait disturbance 51.91 14.91 53 52965 145210 46487834
Asthenia 51.67 14.91 560 52458 310515 46322529
Myositis 50.11 14.91 53 52965 7851 46625193
Pain 49.55 14.91 328 52690 476620 46156424
Migraine 48.83 14.91 10 53008 70016 46563028
Blood lactate dehydrogenase increased 48.40 14.91 85 52933 20415 46612629
Bronchitis 47.38 14.91 31 52987 105948 46527096
Embolism 47.28 14.91 49 52969 7089 46625955
Muscle spasms 46.20 14.91 43 52975 123070 46509974
Therapeutic product effect decreased 46.14 14.91 18 53000 82583 46550461
Generalised oedema 45.29 14.91 68 52950 14331 46618713
Small intestinal obstruction 44.76 14.91 72 52946 16100 46616944
Lymphoedema 44.68 14.91 52 52966 8560 46624484
Arthritis 44.61 14.91 16 53002 77300 46555744
Anxiety 44.51 14.91 87 52931 181870 46451174
BRCA2 gene mutation 44.12 14.91 11 53007 54 46632990
Suicidal ideation 43.86 14.91 6 53012 56376 46576668
Drug resistance 43.60 14.91 74 52944 17294 46615750
Portal hypertension 43.11 14.91 34 52984 3449 46629595
Microangiopathic haemolytic anaemia 42.66 14.91 17 53001 445 46632599
Metastases to the mediastinum 42.48 14.91 17 53001 450 46632594
Cytopenia 42.15 14.91 48 52970 7720 46625324
Oedema peripheral 41.55 14.91 317 52701 159389 46473655
Toxic erythema of chemotherapy 41.38 14.91 10 53008 42 46633002
Nausea 40.78 14.91 1044 51974 686410 45946634
Urinary tract obstruction 40.45 14.91 25 52993 1713 46631331
Condition aggravated 40.25 14.91 143 52875 244909 46388135
Systemic lupus erythematosus 40.22 14.91 12 53006 65168 46567876
Feeling abnormal 39.90 14.91 50 52968 125010 46508034
Capillary permeability increased 39.84 14.91 9 53009 26 46633018
Laryngospasm 39.83 14.91 30 52988 2843 46630201
Proteinuria 39.55 14.91 69 52949 16484 46616560
Biliary obstruction 39.04 14.91 28 52990 2461 46630583
Jaundice 38.95 14.91 95 52923 28750 46604294
Arthropathy 38.92 14.91 24 52994 84676 46548368
Nephrotic syndrome 38.54 14.91 37 52981 4884 46628160
Cataract 37.37 14.91 4 53014 45411 46587633
Neutrophil count abnormal 37.15 14.91 27 52991 2423 46630621
Blood alkaline phosphatase increased 37.04 14.91 114 52904 39495 46593549
Metastasis 36.79 14.91 34 52984 4278 46628766
Tumour marker increased 36.34 14.91 31 52987 3510 46629534
Pneumothorax 36.28 14.91 62 52956 14567 46618477
Metastatic neoplasm 35.95 14.91 31 52987 3562 46629482
Terminal agitation 35.63 14.91 7 53011 7 46633037
Wrong technique in product usage process 35.49 14.91 9 53009 54413 46578631
Lung infiltration 35.47 14.91 60 52958 13983 46619061
Depression 35.31 14.91 89 52929 170015 46463029
Peripheral ischaemia 35.18 14.91 34 52984 4525 46628519
Injection site reaction 35.14 14.91 6 53012 47843 46585201
Inappropriate schedule of product administration 34.96 14.91 15 53003 64998 46568046
Metastases to spine 34.86 14.91 27 52991 2667 46630377
Carcinoembryonic antigen increased 34.67 14.91 21 52997 1388 46631656
Injection site swelling 34.64 14.91 3 53015 40324 46592720
Thrombophlebitis migrans 34.25 14.91 8 53010 28 46633016
Cerebral ischaemia 34.18 14.91 39 52979 6286 46626758
Malignant ascites 33.83 14.91 18 53000 927 46632117
Contusion 33.47 14.91 30 52988 87457 46545587
Hormone receptor positive breast cancer 33.16 14.91 14 53004 426 46632618
Metastases to bone marrow 33.12 14.91 12 53006 240 46632804
Myelodysplastic syndrome 33.09 14.91 62 52956 15649 46617395
Left ventricular dysfunction 33.07 14.91 49 52969 10206 46622838
Carbohydrate antigen 125 increased 33.04 14.91 25 52993 2385 46630659
Post thrombotic syndrome 32.79 14.91 15 53003 555 46632489
Influenza 32.52 14.91 32 52986 89238 46543806
Electrocardiogram QT prolonged 32.50 14.91 9 53009 51316 46581728
Hepatotoxicity 32.32 14.91 81 52937 24928 46608116
Deep vein thrombosis 32.21 14.91 177 52841 79596 46553448
Hyperpyrexia 32.10 14.91 26 52992 2740 46630304
Cardiomyopathy 32.09 14.91 62 52956 16011 46617033
Pain in extremity 32.03 14.91 168 52850 258512 46374532
Urticaria 31.83 14.91 53 52965 117839 46515205
Glossodynia 31.64 14.91 6 53012 44367 46588677
Bradycardia 31.56 14.91 18 53000 66280 46566764
Erythema 31.46 14.91 273 52745 142547 46490497
Peripheral sensory neuropathy 31.18 14.91 38 52980 6565 46626479
Breast cancer 31.13 14.91 118 52900 45400 46587644
Bile duct cancer 31.09 14.91 15 53003 627 46632417
Loss of personal independence in daily activities 31.05 14.91 13 53005 57170 46575874
Device occlusion 31.02 14.91 36 52982 5909 46627135
Cardiac cirrhosis 30.96 14.91 10 53008 139 46632905
Liver abscess 30.87 14.91 25 52993 2634 46630410
Malaise 30.80 14.91 235 52783 330997 46302047
Fibromyalgia 30.55 14.91 3 53015 36460 46596584
Purtscher retinopathy 30.54 14.91 6 53012 6 46633038
Peritoneal disorder 30.51 14.91 14 53004 522 46632522
Desmoplastic small round cell tumour 30.26 14.91 10 53008 150 46632894
Bone marrow infiltration 30.21 14.91 13 53005 415 46632629
Choroidal effusion 30.04 14.91 13 53005 421 46632623
Nasal congestion 29.43 14.91 9 53009 48104 46584940
Stress 29.17 14.91 11 53007 51540 46581504
Suicide attempt 29.11 14.91 13 53005 55023 46578021
Ileus 29.00 14.91 55 52963 14009 46619035
Decreased appetite 28.96 14.91 342 52676 193494 46439550
Abortion spontaneous 28.88 14.91 7 53011 43639 46589405
Haemolytic anaemia 28.86 14.91 45 52973 9797 46623247
Metastases to pleura 28.69 14.91 17 53001 1079 46631965
Metastases to meninges 28.68 14.91 21 52997 1906 46631138
Atypical haemolytic uraemic syndrome 28.57 14.91 13 53005 475 46632569
Swelling 28.34 14.91 62 52956 124449 46508595
Retinopathy 28.32 14.91 23 52995 2433 46630611
Scleroderma-like reaction 28.22 14.91 8 53010 69 46632975
Blood bilirubin increased 27.98 14.91 94 52924 34090 46598954
Hallucination 27.70 14.91 11 53007 49940 46583104
Injury 27.36 14.91 8 53010 44019 46589025
Balance disorder 27.33 14.91 20 52998 64501 46568543
Intestinal obstruction 27.18 14.91 78 52940 25997 46607047
Epistaxis 26.85 14.91 144 52874 64161 46568883
Obstruction gastric 26.70 14.91 15 53003 861 46632183
Cholestasis 26.64 14.91 79 52939 26814 46606230
Gastrointestinal perforation 26.61 14.91 25 52993 3212 46629832
Lymphangitis 26.47 14.91 15 53003 875 46632169
Sleep disorder 26.46 14.91 10 53008 46785 46586259
Cholangitis acute 26.14 14.91 12 53006 448 46632596
No adverse event 25.79 14.91 4 53014 34227 46598817
Ectropion 25.47 14.91 9 53009 167 46632877
Gastropleural fistula 25.38 14.91 7 53011 54 46632990
Red blood cell schistocytes present 25.34 14.91 10 53008 255 46632789
Product quality issue 25.04 14.91 5 53013 35643 46597401
Catabolic state 24.94 14.91 7 53011 58 46632986
Coma 24.83 14.91 18 53000 58331 46574713
Extremity necrosis 24.77 14.91 18 53000 1615 46631429
Hepatic enzyme increased 24.74 14.91 34 52984 81753 46551291
Metastases to spleen 24.40 14.91 8 53010 117 46632927
Skin mass 24.30 14.91 30 52988 5250 46627794
Blood pressure fluctuation 24.25 14.91 3 53015 30445 46602599
Acute respiratory distress syndrome 24.24 14.91 67 52951 21855 46611189
Cognitive disorder 24.24 14.91 6 53012 36877 46596167
Disease recurrence 24.05 14.91 60 52958 18411 46614633
Renal salt-wasting syndrome 24.00 14.91 9 53009 199 46632845
Disseminated intravascular coagulation 23.98 14.91 61 52957 18944 46614100
Hospitalisation 23.93 14.91 22 52996 63363 46569681
Aspartate aminotransferase increased 23.78 14.91 162 52856 78538 46554506
Metastases to diaphragm 23.65 14.91 6 53012 32 46633012
Hydronephrosis 23.58 14.91 38 52980 8507 46624537
Malignant neoplasm of pleura 23.42 14.91 7 53011 74 46632970
Wheezing 23.33 14.91 16 53002 53370 46579674
Loss of consciousness 22.94 14.91 56 52962 108182 46524862
Mobility decreased 22.91 14.91 21 52997 60573 46572471
Palpitations 22.88 14.91 46 52972 95213 46537831
Osteoarthritis 22.86 14.91 22 52996 62003 46571041
Cutaneous T-cell lymphoma stage IV 22.80 14.91 5 53013 12 46633032
Unevaluable event 22.76 14.91 12 53006 46163 46586881
Metastases to chest wall 22.73 14.91 11 53007 463 46632581
Surgery 22.53 14.91 3 53015 28782 46604262
Intestinal strangulation 22.24 14.91 7 53011 89 46632955
Granulocyte count decreased 22.06 14.91 13 53005 817 46632227
Duodenitis haemorrhagic 21.99 14.91 5 53013 15 46633029
Gastric neoplasm 21.25 14.91 9 53009 276 46632768
Gastric perforation 21.24 14.91 15 53003 1287 46631757
Bone marrow disorder 21.09 14.91 17 53001 1779 46631265
Disturbance in attention 21.00 14.91 5 53013 31555 46601489
Eczema asteatotic 20.95 14.91 9 53009 286 46632758
Osteonecrosis of jaw 20.95 14.91 86 52932 34316 46598728
Chills 20.83 14.91 183 52835 95849 46537195
Erythropenia 20.76 14.91 8 53010 191 46632853
Tremor 20.65 14.91 65 52953 115574 46517470
Neutropenic infection 20.65 14.91 14 53004 1124 46631920
Haptoglobin decreased 20.56 14.91 11 53007 573 46632471
Lymphangiosis carcinomatosa 20.36 14.91 14 53004 1150 46631894
Oroticaciduria 20.36 14.91 4 53014 4 46633040
Pneumocystis jirovecii pneumonia 20.35 14.91 50 52968 15198 46617846
Therapy cessation 20.32 14.91 3 53015 26626 46606418
Malignant pleural effusion 20.23 14.91 19 52999 2439 46630605
Computerised tomogram abnormal 20.19 14.91 18 53000 2162 46630882
Cardiotoxicity 20.08 14.91 31 52987 6691 46626353
Retinal infarction 19.86 14.91 6 53012 66 46632978
Triple negative breast cancer 19.80 14.91 7 53011 130 46632914
Adverse drug reaction 19.78 14.91 13 53005 44349 46588695
Lower respiratory tract infection 19.77 14.91 20 52998 55069 46577975
Tumour lysis syndrome 19.73 14.91 32 52986 7204 46625840
Steatohepatitis 19.72 14.91 10 53008 466 46632578
Oedema 19.63 14.91 137 52881 66934 46566110
Athetosis 19.51 14.91 5 53013 28 46633016
Recurrent cancer 19.29 14.91 16 53002 1743 46631301
Heart rate decreased 19.28 14.91 6 53012 31717 46601327
Product use issue 19.25 14.91 50 52968 94594 46538450
Jaundice cholestatic 19.12 14.91 26 52992 5003 46628041
Radiation skin injury 19.12 14.91 12 53006 845 46632199
Gait inability 19.12 14.91 8 53010 35195 46597849
Metastases to pelvis 19.06 14.91 8 53010 240 46632804
Paraneoplastic pemphigus 18.94 14.91 5 53013 32 46633012
Visual impairment 18.92 14.91 29 52989 66660 46566384
Blood cholesterol increased 18.85 14.91 11 53007 40002 46593042
Amnesia 18.84 14.91 12 53006 41619 46591425
Myocardial infarction 18.72 14.91 53 52965 97475 46535569
Cholangitis infective 18.70 14.91 7 53011 154 46632890
Joint stiffness 18.63 14.91 4 53014 27104 46605940
Dry mouth 18.53 14.91 21 52997 54905 46578139
Pancreatic carcinoma recurrent 18.41 14.91 6 53012 86 46632958
Pulmonary oedema 18.40 14.91 110 52908 50995 46582049
Foetal exposure during pregnancy 18.36 14.91 6 53012 30741 46602303
Leukaemic lymphoma 18.34 14.91 6 53012 87 46632957
Pulmonary alveolar haemorrhage 18.12 14.91 23 52995 4139 46628905
Hypoglycaemia 18.10 14.91 21 52997 54328 46578716
Heart rate increased 18.06 14.91 36 52982 74755 46558289
Colitis 17.94 14.91 87 52931 37260 46595784
Respiratory arrest 17.86 14.91 8 53010 33808 46599236
Nephropathy toxic 17.71 14.91 31 52987 7423 46625621
Portal vein occlusion 17.35 14.91 3 53015 0 46633044
Erysipeloid 17.35 14.91 3 53015 0 46633044
Portal vein stenosis 17.35 14.91 3 53015 0 46633044
Pseudosepsis 17.35 14.91 3 53015 0 46633044
Tumour thrombosis 17.13 14.91 4 53014 14 46633030
Subileus 17.05 14.91 19 52999 2984 46630060
Speech disorder 16.95 14.91 10 53008 36157 46596887
Hepatic infection 16.86 14.91 8 53010 322 46632722
Malignant hypertension 16.71 14.91 12 53006 1057 46631987
Dyskinesia 16.65 14.91 6 53012 28919 46604125
Lymphadenopathy mediastinal 16.65 14.91 17 53001 2417 46630627
Sedation 16.54 14.91 3 53015 22907 46610137
Gastrointestinal scarring 16.52 14.91 7 53011 215 46632829
Portal vein thrombosis 16.46 14.91 17 53001 2450 46630594
Hypoxia 16.43 14.91 108 52910 51730 46581314
Hypocalcaemia 16.34 14.91 67 52951 26718 46606326
Metastases to adrenals 16.26 14.91 10 53008 679 46632365
Dysaesthesia 16.20 14.91 19 52999 3152 46629892
Neoplasm malignant 16.13 14.91 61 52957 23438 46609606
Cystitis haemorrhagic 16.08 14.91 20 52998 3527 46629517
Non-small cell lung cancer stage IV 16.08 14.91 7 53011 230 46632814
Burning sensation 16.08 14.91 16 53002 44395 46588649
Oropharyngeal pain 16.00 14.91 38 52980 74130 46558914
Paraneoplastic syndrome 15.88 14.91 9 53009 525 46632519
Spleen disorder 15.86 14.91 11 53007 917 46632127
Tachycardia 15.85 14.91 178 52840 99444 46533600
Cholangiectasis acquired 15.82 14.91 4 53014 21 46633023
Ovarian cancer stage IV 15.79 14.91 5 53013 65 46632979
Urinary tract infection 15.73 14.91 167 52851 220099 46412945
Blood creatine phosphokinase increased 15.54 14.91 6 53012 27718 46605326
Thrombophlebitis 15.47 14.91 22 52996 4415 46628629
Troponin increased 15.42 14.91 30 52988 7786 46625258
Soft tissue necrosis 15.40 14.91 8 53010 392 46632652
Erysipelas 15.39 14.91 28 52990 6910 46626134
Paresis cranial nerve 15.27 14.91 3 53015 3 46633041
Angiogram abnormal 15.27 14.91 3 53015 3 46633041
Stomatitis 15.25 14.91 131 52887 68166 46564878
EGFR gene mutation 15.24 14.91 6 53012 152 46632892
Neoplasm recurrence 15.20 14.91 16 53002 2357 46630687
Aortic thrombosis 15.16 14.91 11 53007 984 46632060
Product use in unapproved indication 15.14 14.91 163 52855 90110 46542934
Renal tubular necrosis 15.13 14.91 36 52982 10723 46622321
Enterocolitis 15.11 14.91 26 52992 6142 46626902
Lip swelling 15.08 14.91 5 53013 25390 46607654
Scintillating scotoma 14.92 14.91 6 53012 161 46632883

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 852.55 14.78 1074 47230 135970 29768204
Malignant neoplasm progression 626.70 14.78 673 47631 71614 29832560
Thrombotic microangiopathy 464.09 14.78 242 48062 8368 29895806
Neutropenia 439.17 14.78 761 47543 127779 29776395
Disease progression 435.81 14.78 588 47716 79286 29824888
Cholangitis 357.87 14.78 197 48107 7605 29896569
Haemolytic uraemic syndrome 346.43 14.78 128 48176 1874 29902300
Pancreatic carcinoma metastatic 345.33 14.78 146 48158 3101 29901073
Anaemia 302.44 14.78 875 47429 207117 29697057
Pancreatic carcinoma 271.80 14.78 165 48139 7672 29896502
Neoplasm progression 256.77 14.78 221 48083 17802 29886372
Interstitial lung disease 237.85 14.78 381 47923 59816 29844358
Leukopenia 219.86 14.78 354 47950 55805 29848369
Pancytopenia 212.16 14.78 441 47863 84611 29819563
Pyrexia 194.46 14.78 962 47342 293527 29610647
Pneumonitis 187.03 14.78 226 48078 27228 29876946
Pseudocellulitis 183.03 14.78 36 48268 15 29904159
Off label use 176.35 14.78 831 47473 248459 29655715
Febrile neutropenia 161.34 14.78 456 47848 106237 29797937
Haematotoxicity 157.20 14.78 107 48197 6063 29898111
Myelosuppression 154.14 14.78 113 48191 7209 29896965
Completed suicide 145.77 14.78 3 48301 99489 29804685
Platelet count decreased 144.52 14.78 437 47867 105692 29798482
Bone marrow failure 143.68 14.78 207 48097 29578 29874596
Metastases to liver 137.42 14.78 130 48174 11835 29892339
Neutropenic sepsis 125.41 14.78 121 48183 11288 29892886
Thrombocytosis 116.11 14.78 71 48233 3342 29900832
Product dose omission issue 111.04 14.78 10 48294 91621 29812553
Recall phenomenon 109.92 14.78 40 48264 559 29903615
Pleural effusion 109.33 14.78 314 47990 73752 29830422
Neuropathy peripheral 108.14 14.78 303 48001 70172 29834002
Drug interaction 106.64 14.78 99 48205 199469 29704705
Peripheral ischaemia 100.42 14.78 77 48227 5257 29898917
General physical health deterioration 99.10 14.78 370 47934 99574 29804600
Biliary tract infection 96.59 14.78 34 48270 429 29903745
Pulmonary embolism 96.34 14.78 311 47993 77824 29826350
Neutrophil count decreased 92.92 14.78 209 48095 42245 29861929
Overdose 85.92 14.78 16 48288 84321 29819853
Pulmonary toxicity 84.59 14.78 65 48239 4451 29899723
Headache 82.30 14.78 104 48200 182202 29721972
Ascites 82.16 14.78 180 48124 35741 29868433
Fall 80.81 14.78 105 48199 181767 29722407
Metastases to lung 76.16 14.78 78 48226 7817 29896357
Deep vein thrombosis 72.90 14.78 239 48065 60262 29843912
Atypical haemolytic uraemic syndrome 70.16 14.78 19 48285 90 29904084
Liver abscess 70.13 14.78 51 48253 3211 29900963
Malignant ascites 70.07 14.78 26 48278 385 29903789
Carbohydrate antigen 19-9 increased 67.23 14.78 21 48283 177 29903997
Depression 66.98 14.78 31 48273 90406 29813768
Cytopenia 66.28 14.78 74 48230 8182 29895992
Drug hypersensitivity 65.64 14.78 15 48289 68504 29835670
Neurotoxicity 65.57 14.78 93 48211 13089 29891085
Capillary leak syndrome 65.25 14.78 38 48266 1634 29902540
Arthralgia 64.92 14.78 74 48230 135717 29768457
Therapy partial responder 62.38 14.78 50 48254 3641 29900533
Diffuse large B-cell lymphoma recurrent 62.30 14.78 40 48264 2052 29902122
Aortic thrombosis 60.41 14.78 27 48277 658 29903516
Extremity necrosis 60.35 14.78 36 48268 1619 29902555
Mucosal inflammation 58.91 14.78 143 48161 30351 29873823
Myositis 58.83 14.78 78 48226 10299 29893875
Dehydration 56.72 14.78 367 47937 123172 29781002
Biliary obstruction 56.52 14.78 40 48264 2413 29901761
Metastases to central nervous system 56.27 14.78 64 48240 7220 29896954
Bacteraemia 55.29 14.78 94 48210 15466 29888708
Nasopharyngitis 54.18 14.78 14 48290 58835 29845339
Diffuse large B-cell lymphoma refractory 54.11 14.78 26 48278 751 29903423
White blood cell count decreased 53.35 14.78 272 48032 83675 29820499
Sepsis 52.15 14.78 409 47895 145986 29758188
Post thrombotic syndrome 51.53 14.78 16 48288 132 29904042
Feeling abnormal 51.31 14.78 14 48290 56742 29847432
Disseminated intravascular coagulation 50.56 14.78 111 48193 22060 29882114
Dizziness 48.60 14.78 157 48147 194752 29709422
Insomnia 47.77 14.78 48 48256 93288 29810886
Seizure 46.67 14.78 54 48250 98421 29805753
Drug ineffective 46.52 14.78 340 47964 340047 29564127
Oedema peripheral 46.49 14.78 311 47993 105521 29798653
Anxiety 46.24 14.78 46 48258 89825 29814349
Hypertransaminasaemia 46.11 14.78 43 48261 3842 29900332
Toxicity to various agents 46.08 14.78 140 48164 177043 29727131
Device occlusion 45.97 14.78 53 48251 6067 29898107
Non-small cell lung cancer 45.65 14.78 42 48262 3688 29900486
Adenocarcinoma pancreas 45.17 14.78 28 48276 1350 29902824
Decreased appetite 44.96 14.78 403 47901 149507 29754667
Jaundice cholestatic 43.96 14.78 45 48259 4506 29899668
Abdominal pain 42.91 14.78 369 47935 135285 29768889
Aggression 42.17 14.78 5 48299 36902 29867272
Lymphangiosis carcinomatosa 41.79 14.78 23 48281 886 29903288
Nausea 41.36 14.78 690 47614 296267 29607907
Electrocardiogram QT prolonged 40.58 14.78 5 48299 35830 29868344
Performance status decreased 39.81 14.78 40 48264 3917 29900257
Tumour lysis syndrome 38.28 14.78 72 48232 12813 29891361
Tremor 38.28 14.78 39 48265 75324 29828850
Histiocytic necrotising lymphadenitis 37.92 14.78 8 48296 8 29904166
Immune-mediated hepatitis 37.41 14.78 23 48281 1093 29903081
Cardiac failure congestive 37.14 14.78 49 48255 84358 29819816
Hepatocellular injury 36.56 14.78 107 48197 25364 29878810
Biliary sepsis 36.50 14.78 19 48285 653 29903521
Vomiting 36.36 14.78 526 47778 219292 29684882
Angioedema 36.13 14.78 6 48298 34378 29869796
Vena cava thrombosis 35.96 14.78 22 48282 1036 29903138
Alopecia 35.74 14.78 89 48215 19186 29884988
Blood pressure increased 35.65 14.78 38 48266 71890 29832284
Gastrointestinal toxicity 35.65 14.78 28 48276 1980 29902194
Diffuse large B-cell lymphoma 35.61 14.78 53 48251 7788 29896386
Microangiopathic haemolytic anaemia 35.45 14.78 20 48284 809 29903365
Coronary artery disease 35.32 14.78 18 48286 49694 29854480
Duodenal stenosis 34.35 14.78 13 48291 204 29903970
Agitation 33.59 14.78 23 48281 54050 29850124
Splenic infarction 33.59 14.78 26 48278 1799 29902375
Joint swelling 33.35 14.78 17 48287 46929 29857245
Bradycardia 33.17 14.78 34 48270 65492 29838682
Obstruction gastric 33.15 14.78 20 48284 918 29903256
Somnolence 32.48 14.78 67 48237 96696 29807478
Generalised oedema 32.35 14.78 64 48240 11821 29892353
Perforation bile duct 32.04 14.78 9 48295 50 29904124
Metastases to spleen 31.79 14.78 14 48290 329 29903845
Wrong technique in product usage process 31.51 14.78 6 48298 31149 29873025
Vision blurred 31.46 14.78 14 48290 41802 29862372
Myocardial infarction 31.40 14.78 101 48203 125524 29778650
Muscle spasms 31.31 14.78 35 48269 64803 29839371
Metastases to muscle 30.99 14.78 12 48292 201 29903973
Myalgia 30.28 14.78 48 48256 76619 29827555
Asthma 29.01 14.78 11 48293 36163 29868011
Hallucination 28.99 14.78 22 48282 49037 29855137
Palmar-plantar erythrodysaesthesia syndrome 28.99 14.78 70 48234 14800 29889374
Rhabdomyolysis 28.90 14.78 36 48268 63544 29840630
Neoplasm recurrence 28.84 14.78 24 48280 1843 29902331
Tracheo-oesophageal fistula 28.74 14.78 14 48290 417 29903757
Metastases to bone 28.73 14.78 54 48250 9604 29894570
Hospitalisation 28.68 14.78 18 48286 44301 29859873
Alveolitis 28.47 14.78 23 48281 1694 29902480
Brain teratoma 28.35 14.78 7 48297 21 29904153
Metastases to peritoneum 28.26 14.78 22 48282 1535 29902639
Abnormal behaviour 28.00 14.78 4 48300 25619 29878555
Cardiac disorder 27.52 14.78 15 48289 39878 29864296
Lung disorder 27.45 14.78 112 48192 31357 29872817
Inappropriate schedule of product administration 27.32 14.78 15 48289 39713 29864461
Scleroderma-like reaction 27.21 14.78 7 48297 26 29904148
Memory impairment 27.10 14.78 13 48291 37161 29867013
Dermatitis acneiform 26.62 14.78 39 48265 5650 29898524
Platelet count increased 26.15 14.78 49 48255 8693 29895481
Transitional cell carcinoma recurrent 26.02 14.78 6 48298 12 29904162
Gastroenteritis radiation 25.65 14.78 12 48292 326 29903848
Tumour necrosis 25.59 14.78 18 48286 1075 29903099
Prostate cancer 25.58 14.78 4 48300 23953 29880221
Vascular pseudoaneurysm ruptured 25.35 14.78 8 48296 70 29904104
Peripheral swelling 25.31 14.78 37 48267 61037 29843137
Chills 25.09 14.78 201 48103 72137 29832037
Blood creatine phosphokinase increased 24.24 14.78 21 48283 43827 29860347
Biliary cancer metastatic 24.23 14.78 5 48299 4 29904170
Platelet count abnormal 24.03 14.78 24 48280 2333 29901841
Metastases to retroperitoneum 23.83 14.78 10 48294 208 29903966
Chest discomfort 23.70 14.78 23 48281 45457 29858717
Ductal adenocarcinoma of pancreas 23.67 14.78 7 48297 48 29904126
Medication error 23.56 14.78 3 48301 20969 29883205
Balance disorder 23.37 14.78 15 48289 36478 29867696
Erythropenia 23.19 14.78 10 48294 223 29903951
Thrombotic thrombocytopenic purpura 22.98 14.78 28 48276 3397 29900777
Haemoglobin decreased 22.93 14.78 283 48021 113815 29790359
Nephrolithiasis 22.64 14.78 6 48298 24804 29879370
Cholangiocarcinoma 22.64 14.78 16 48288 963 29903211
Stress 22.48 14.78 3 48301 20232 29883942
Sleep disorder 22.19 14.78 6 48298 24473 29879701
Irritability 22.15 14.78 5 48299 23045 29881129
Hypoglycaemia 22 14.78 30 48274 50951 29853223
Bicytopenia 21.87 14.78 20 48284 1742 29902432
Unevaluable event 21.85 14.78 12 48292 31773 29872401
Drug dependence 21.75 14.78 4 48300 21291 29882883
Pancreatitis viral 21.68 14.78 5 48299 10 29904164
Paraneoplastic syndrome 21.67 14.78 12 48292 468 29903706
Livedo reticularis 21.66 14.78 22 48282 2182 29901992
Fistula of small intestine 21.60 14.78 11 48293 361 29903813
Bile duct stenosis 21.50 14.78 17 48287 1214 29902960
Product use in unapproved indication 21.47 14.78 197 48107 73496 29830678
Molluscum contagiosum 21.43 14.78 10 48294 270 29903904
Metastases to lymph nodes 21.18 14.78 29 48275 3948 29900226
Chronic obstructive pulmonary disease 21.08 14.78 26 48278 46100 29858074
Autoimmune neutropenia 21.06 14.78 10 48294 281 29903893
Skin toxicity 20.89 14.78 26 48278 3223 29900951
Disturbance in attention 20.87 14.78 5 48299 22124 29882050
Enteritis 20.83 14.78 38 48266 6607 29897567
Metastases to gastrointestinal tract 20.67 14.78 7 48297 78 29904096
Embolism 20.61 14.78 39 48265 6970 29897204
Asthenia 20.52 14.78 484 47820 220806 29683368
Hyperpyrexia 20.51 14.78 23 48281 2554 29901620
Cardiac arrest 20.27 14.78 79 48225 92771 29811403
Pneumocystis jirovecii pneumonia 20.02 14.78 67 48237 17053 29887121
Palpitations 19.91 14.78 15 48289 33558 29870616
Malaise 19.82 14.78 173 48131 166789 29737385
Vascular purpura 19.58 14.78 18 48286 1579 29902595
Paraneoplastic rash 19.56 14.78 7 48297 93 29904081
Blood lactate dehydrogenase increased 19.31 14.78 75 48229 20526 29883648
Hypotension 19.16 14.78 219 48085 200346 29703828
Granulocyte-colony stimulating factor level increased 19.14 14.78 5 48299 20 29904154
Bronchial fistula 19.13 14.78 8 48296 165 29904009
Mobility decreased 19.09 14.78 9 48295 25990 29878184
Colitis 18.95 14.78 99 48205 30721 29873453
Arthropathy 18.94 14.78 5 48299 20722 29883452
Respiratory arrest 18.77 14.78 12 48292 29246 29874928
Hypercalcaemia of malignancy 18.61 14.78 8 48296 177 29903997
Muscle necrosis 18.56 14.78 13 48291 771 29903403
Therapeutic product effect decreased 18.55 14.78 12 48292 29064 29875110
Contusion 18.51 14.78 14 48290 31266 29872908
Delirium 18.46 14.78 23 48281 40608 29863566
Metastases to the mediastinum 18.45 14.78 8 48296 181 29903993
Infusion site pain 18.33 14.78 22 48282 2628 29901546
Influenza 18.26 14.78 26 48278 43372 29860802
Product quality issue 18.19 14.78 4 48300 18770 29885404
Psychotic disorder 18.18 14.78 6 48298 21509 29882665
Tumour marker increased 18.17 14.78 11 48293 508 29903666
Treatment noncompliance 18.15 14.78 9 48295 25244 29878930
Unresponsive to stimuli 18.12 14.78 10 48294 26409 29877765
Cardio-respiratory arrest 18.12 14.78 41 48263 57265 29846909
Abdominal discomfort 17.92 14.78 32 48272 48759 29855415
Subacute cutaneous lupus erythematosus 17.83 14.78 12 48292 667 29903507
Cerebral infarction 17.82 14.78 87 48217 26286 29877888
Head injury 17.81 14.78 3 48301 17017 29887157
Pancreatic carcinoma recurrent 17.77 14.78 5 48299 28 29904146
Q fever 17.72 14.78 7 48297 124 29904050
Epistaxis 17.70 14.78 146 48158 52835 29851339
Cerebral ischaemia 17.62 14.78 34 48270 6166 29898008
Cardiotoxicity 17.47 14.78 28 48276 4386 29899788
Injection site pain 17.39 14.78 14 48290 30296 29873878
Metabolic disorder 17.25 14.78 25 48279 3586 29900588
Acute myeloid leukaemia 17.24 14.78 66 48238 17940 29886234
Respiratory failure 17.04 14.78 242 48062 100400 29803774
Second primary malignancy 17.02 14.78 34 48270 6322 29897852
Wheezing 16.88 14.78 15 48289 30923 29873251
Weight increased 16.83 14.78 63 48241 74850 29829324
Leiomyosarcoma metastatic 16.73 14.78 4 48300 10 29904164
Necrosis ischaemic 16.68 14.78 8 48296 230 29903944
Tumour invasion 16.66 14.78 9 48295 334 29903840
Blood alkaline phosphatase increased 16.58 14.78 97 48207 31390 29872784
Subdural haematoma 16.55 14.78 5 48299 18967 29885207
Hyperkalaemia 16.52 14.78 53 48251 65957 29838217
Cytokine release syndrome 16.49 14.78 44 48260 9889 29894285
Renal infarct 16.38 14.78 14 48290 1115 29903059
Laboratory test abnormal 16.33 14.78 4 48300 17438 29886736
Intestinal metastasis 16.32 14.78 7 48297 154 29904020
Portal vein stenosis 16.29 14.78 3 48301 0 29904174
Hypophosphataemia 16.27 14.78 39 48265 8206 29895968
Atelectasis 16.15 14.78 60 48244 16078 29888096
Hypertension 16.11 14.78 122 48182 121232 29782942
Autoimmune pancytopenia 16.04 14.78 6 48298 91 29904083
Lactic acidosis 16.01 14.78 16 48288 31197 29872977
Nasal congestion 16.00 14.78 5 48299 18561 29885613
Hiccups 15.87 14.78 42 48262 9392 29894782
Heart rate decreased 15.83 14.78 7 48297 20987 29883187
Metastases to bone marrow 15.82 14.78 10 48294 499 29903675
Sarcoma 15.77 14.78 9 48295 372 29903802
Depressed mood 15.76 14.78 4 48300 17025 29887149
Arthritis 15.66 14.78 10 48294 24391 29879783
Nephropathy toxic 15.56 14.78 45 48259 10594 29893580
Polyneuropathy 15.39 14.78 48 48256 11775 29892399
Hypoalbuminaemia 15.34 14.78 46 48258 11046 29893128
Disease recurrence 15.32 14.78 54 48250 14107 29890067
Flushing 15.26 14.78 15 48289 29477 29874697
Injury 15.24 14.78 8 48296 21723 29882451
Pericardial effusion 15.19 14.78 71 48233 21073 29883101
Peripheral sensory neuropathy 15.13 14.78 31 48273 5870 29898304
Embolism arterial 15.13 14.78 10 48294 539 29903635
Hypersensitivity pneumonitis 14.91 14.78 14 48290 1261 29902913
Venous thrombosis 14.89 14.78 22 48282 3212 29900962
Transaminases increased 14.87 14.78 76 48228 23381 29880793
Sedation 14.86 14.78 4 48300 16369 29887805
Gait disturbance 14.84 14.78 66 48238 74711 29829463
Duodenal obstruction 14.80 14.78 6 48298 114 29904060

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
MeSH PA D000890 Anti-Infective Agents
MeSH PA D000963 Antimetabolites
MeSH PA D000964 Antimetabolites, Antineoplastic
MeSH PA D000970 Antineoplastic Agents
MeSH PA D000998 Antiviral Agents
MeSH PA D004791 Enzyme Inhibitors
MeSH PA D007155 Immunologic Factors
MeSH PA D007166 Immunosuppressive Agents
MeSH PA D009676 Noxae
MeSH PA D011838 Radiation-Sensitizing Agents
CHEBI has role CHEBI:35221 antimetabolite
CHEBI has role CHEBI:35610 cytostatic
CHEBI has role CHEBI:35705 immunosuppressant
CHEBI has role CHEBI:36044 anti-virus drug
CHEBI has role CHEBI:74213 ribonucleotide diphosphate reductase inhibitor
CHEBI has role CHEBI:132992 radiosensitizers
CHEBI has role CHEBI:149553 anti-coronaviral agents
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

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
DNA polymerase (alpha/delta/epsilon) Enzyme INHIBITOR CHEMBL CHEMBL
Ribonucleoside-diphosphate reductase subunit M2 Enzyme INHIBITOR WOMBAT-PK CHEMBL
Ribonucleoside-diphosphate reductase large subunit Enzyme INHIBITOR WOMBAT-PK CHEMBL
UMP-CMP kinase Kinase WOMBAT-PK
Thymidylate synthase Enzyme WOMBAT-PK
Deoxycytidine 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
CHEMBL1637 ChEMBL_ID
DB00441 DRUGBANK_ID
C056507 MESH_SUPPLEMENTAL_RECORD_UI
4793 IUPHAR_LIGAND_ID
6515 INN_ID
B76N6SBZ8R UNII
60750 PUBCHEM_CID
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
Gemzar HUMAN PRESCRIPTION DRUG LABEL 1 0002-7501 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 200 mg INTRAVENOUS NDA 25 sections
Gemzar HUMAN PRESCRIPTION DRUG LABEL 1 0002-7502 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 1 g INTRAVENOUS NDA 25 sections
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 hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 45963-612 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 200 mg INTRAVENOUS ANDA 17 sections
gemcitabine hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 45963-619 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 1 g INTRAVENOUS ANDA 17 sections
gemcitabine hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 45963-620 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 2 g INTRAVENOUS ANDA 17 sections
GEMCITABINE HUMAN PRESCRIPTION DRUG LABEL 1 50742-496 INJECTION, SOLUTION 38 mg INTRAVENOUS ANDA 23 sections
GEMCITABINE HUMAN PRESCRIPTION DRUG LABEL 1 50742-497 INJECTION, SOLUTION 38 mg INTRAVENOUS ANDA 23 sections
GEMCITABINE HUMAN PRESCRIPTION DRUG LABEL 1 50742-498 INJECTION, SOLUTION 38 mg INTRAVENOUS ANDA 23 sections