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) 10 mg/mL Bocci G, Oprea TI, Benet LZ
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
Disease progression 1457.35 15.90 942 41038 121816 63325226
Malignant neoplasm progression 1185.04 15.90 714 41266 81407 63365635
Thrombocytopenia 1001.40 15.90 815 41165 150342 63296700
Neutropenia 725.57 15.90 725 41255 174280 63272762
Thrombotic microangiopathy 584.83 15.90 231 41749 10330 63436712
Neoplasm progression 525.10 15.90 317 41663 36111 63410931
Anaemia 386.25 15.90 693 41287 292737 63154305
Metastases to liver 362.09 15.90 214 41766 23425 63423617
Myelosuppression 353.71 15.90 211 41769 23492 63423550
Haematotoxicity 299.70 15.90 139 41841 9237 63437805
Off label use 287.40 15.90 1036 40944 673426 62773616
Pancytopenia 229.34 15.90 301 41679 96632 63350410
Metastases to lung 220.65 15.90 125 41855 12625 63434417
Metastases to bone 213.84 15.90 147 41833 20872 63426170
Leukopenia 204.87 15.90 254 41726 77036 63370006
Platelet count decreased 204.29 15.90 313 41667 115809 63331233
Diffuse large B-cell lymphoma recurrent 199.03 15.90 70 41910 2250 63444792
Metastases to lymph nodes 194.57 15.90 99 41881 8059 63438983
Febrile neutropenia 187.22 15.90 304 41676 118145 63328897
Ascites 183.47 15.90 177 41803 40551 63406491
Pleural effusion 177.82 15.90 261 41719 92949 63354093
Neutrophil count decreased 170.14 15.90 198 41782 56208 63390834
Death 165.29 15.90 583 41397 373798 63073244
Pyrexia 163.71 15.90 679 41301 469799 62977243
Joint swelling 162.09 15.90 15 41965 327651 63119391
Arthralgia 160.28 15.90 89 41891 569621 62877421
Rheumatoid arthritis 153.08 15.90 3 41977 253816 63193226
Biliary tract infection 143.21 15.90 41 41939 661 63446381
Metastases to peritoneum 141.92 15.90 61 41919 3381 63443661
Recall phenomenon 141.78 15.90 40 41940 610 63446432
Bone marrow failure 138.94 15.90 131 41849 29159 63417883
Acute myeloid leukaemia 135.72 15.90 103 41877 17044 63429998
Cholangitis 131.20 15.90 67 41913 5494 63441548
Second primary malignancy 129.64 15.90 75 41905 7878 63439164
Neuropathy peripheral 124.79 15.90 249 41731 113418 63333624
Contraindicated product administered 122.34 15.90 5 41975 217643 63229399
Neurotoxicity 121.28 15.90 96 41884 16894 63430148
Therapy partial responder 114.23 15.90 77 41903 10581 63436461
Posterior reversible encephalopathy syndrome 111.11 15.90 92 41888 17253 63429789
Capillary leak syndrome 110.91 15.90 45 41935 2155 63444887
Maternal exposure during pregnancy 108.95 15.90 10 41970 220052 63226990
Haemolytic uraemic syndrome 108.62 15.90 46 41934 2457 63444585
Cytopenia 108.32 15.90 77 41903 11524 63435518
Cytokine release syndrome 106.75 15.90 83 41897 14231 63432811
Product dose omission issue 102.84 15.90 16 41964 234297 63212745
Systemic lupus erythematosus 102.08 15.90 10 41970 208908 63238134
Hypertransaminasaemia 101.58 15.90 60 41920 6549 63440493
Sepsis 98.40 15.90 272 41708 152851 63294191
Fall 96.84 15.90 71 41909 392263 63054779
Mucosal inflammation 96.13 15.90 136 41844 46792 63400250
Swelling 92.99 15.90 33 41947 275345 63171697
Abdominal discomfort 91.68 15.90 49 41931 320836 63126206
Palmar-plantar erythrodysaesthesia syndrome 85.25 15.90 90 41890 22925 63424117
Headache 84.91 15.90 183 41797 633058 62813984
Hepatic failure 83.09 15.90 110 41870 35546 63411496
Arthropathy 82.99 15.90 26 41954 234766 63212276
Wound 81.92 15.90 7 41973 163256 63283786
Lymphoma 80.89 15.90 66 41914 12121 63434921
Weight increased 80.27 15.90 36 41944 260756 63186286
Blood lactate dehydrogenase increased 79.64 15.90 87 41893 23029 63424013
Therapeutic product effect decreased 78.65 15.90 16 41964 193171 63253871
Pulmonary embolism 78.65 15.90 211 41769 116473 63330569
Nasopharyngitis 78.40 15.90 35 41945 254222 63192820
Abdominal pain 77.46 15.90 391 41589 293065 63153977
Drug hypersensitivity 76.91 15.90 56 41924 310631 63136411
Musculoskeletal stiffness 75.76 15.90 15 41965 184603 63262439
Diffuse large B-cell lymphoma refractory 75.47 15.90 29 41951 1201 63445841
Metastases to central nervous system 74.68 15.90 65 41915 13040 63434002
Sinusitis 73.41 15.90 29 41951 226624 63220418
Pain 73.00 15.90 249 41731 740379 62706663
Vomiting 72.36 15.90 623 41357 558994 62888048
Tumour lysis syndrome 68.93 15.90 53 41927 8937 63438105
Alopecia 68.87 15.90 73 41907 337463 63109579
Polyneuropathy 68.69 15.90 65 41915 14524 63432518
PIK3CA-activated mutation 68.68 15.90 26 41954 1033 63446009
Neutropenic sepsis 67.59 15.90 68 41912 16370 63430672
Myositis 67.51 15.90 53 41927 9213 63437829
General physical health deterioration 66.83 15.90 287 41693 201115 63245927
Peripheral swelling 65.72 15.90 48 41932 265894 63181148
Myelodysplastic syndrome 64.70 15.90 67 41913 16687 63430355
Cholangitis infective 64.15 15.90 19 41961 347 63446695
Disease recurrence 63.05 15.90 85 41895 27945 63419097
Asthma 62.56 15.90 6 41974 127555 63319487
Lower respiratory tract infection 58.09 15.90 9 41971 132298 63314744
Pericarditis 57.66 15.90 9 41971 131570 63315472
Hepatotoxicity 56.97 15.90 94 41886 36947 63410095
Pericardial effusion 55.56 15.90 83 41897 29975 63417067
Breast cancer metastatic 55.54 15.90 53 41927 11965 63435077
Breast cancer recurrent 55.42 15.90 35 41945 4306 63442736
Ovarian cancer recurrent 55.41 15.90 22 41958 995 63446047
Metastases to pleura 55.35 15.90 25 41955 1560 63445482
Exposure during pregnancy 55.34 15.90 17 41963 155530 63291512
Metastasis 54.38 15.90 37 41943 5160 63441882
Microangiopathic haemolytic anaemia 54.21 15.90 19 41961 604 63446438
Drug resistance 53.81 15.90 71 41909 22862 63424180
Dehydration 52.91 15.90 241 41739 173113 63273929
Pneumonitis 52.32 15.90 88 41892 35134 63411908
Hepatic enzyme increased 50.64 15.90 36 41944 202292 63244750
Arthritis 50.63 15.90 8 41972 115913 63331129
Acquired gene mutation 49.19 15.90 20 41960 963 63446079
Metastases to skin 48.04 15.90 23 41957 1640 63445402
Product use issue 48.03 15.90 45 41935 220475 63226567
Haemoglobin decreased 47.97 15.90 207 41773 145278 63301764
Bile duct stenosis 47.67 15.90 21 41959 1235 63445807
Contusion 47.26 15.90 20 41960 150024 63297018
Hypoalbuminaemia 47.01 15.90 48 41932 11757 63435285
Thrombotic thrombocytopenic purpura 46.66 15.90 30 41950 3806 63443236
Small intestinal obstruction 46.51 15.90 59 41921 18278 63428764
Memory impairment 45.97 15.90 7 41973 104251 63342791
Overdose 45.85 15.90 10 41970 115068 63331974
White blood cell count decreased 45.16 15.90 197 41783 138907 63308135
Injection site pain 44.72 15.90 15 41965 129785 63317257
Peripheral ischaemia 44.67 15.90 32 41948 4846 63442196
Embolism 44.62 15.90 39 41941 7867 63439175
Proteinuria 44.50 15.90 59 41921 19086 63427956
Injection site erythema 43.30 15.90 3 41977 83171 63363871
Psoriatic arthropathy 43.08 15.90 5 41975 91515 63355527
Cholestasis 43.00 15.90 73 41907 29361 63417681
Discomfort 42.91 15.90 29 41951 167345 63279697
Neutropenic infection 42.84 15.90 20 41960 1347 63445695
Sleep disorder 42.30 15.90 3 41977 81563 63365479
Pancreatic carcinoma metastatic 42.17 15.90 23 41957 2155 63444887
Urinary tract obstruction 41.88 15.90 23 41957 2185 63444857
Interstitial lung disease 40.72 15.90 111 41869 61797 63385245
BRCA2 gene mutation 40.46 15.90 10 41970 88 63446954
Bronchitis 40.40 15.90 16 41964 124919 63322123
Atypical haemolytic uraemic syndrome 40.40 15.90 16 41964 719 63446323
Insomnia 40.12 15.90 50 41930 215202 63231840
Pancreatic fistula 39.93 15.90 7 41973 6 63447036
Cerebral ischaemia 39.61 15.90 34 41946 6694 63440348
Migraine 39.16 15.90 10 41970 103336 63343706
Capillary permeability increased 39.02 15.90 8 41972 26 63447016
Muscle spasms 38.78 15.90 28 41952 156122 63290920
Erythema 38.69 15.90 223 41757 175528 63271514
Dry gangrene 38.50 15.90 15 41965 645 63446397
Mobility decreased 38.39 15.90 16 41964 121143 63325899
Metastases to meninges 38.36 15.90 23 41957 2579 63444463
Urticaria 38.30 15.90 32 41948 165770 63281272
Somnolence 38.27 15.90 37 41943 178648 63268394
Product use in unapproved indication 37.98 15.90 225 41755 178855 63268187
Loss of personal independence in daily activities 37.67 15.90 9 41971 97281 63349761
Hormone receptor positive breast cancer 37.62 15.90 14 41966 530 63446512
EGFR gene mutation 37.55 15.90 12 41968 285 63446757
Jaundice 36.86 15.90 68 41912 29183 63417859
Pseudocellulitis 36.57 15.90 7 41973 14 63447028
Metastases to chest wall 36.45 15.90 14 41966 579 63446463
Blood cholesterol increased 35.82 15.90 9 41971 94023 63353019
Asthenia 35.66 15.90 399 41581 383205 63063837
Folliculitis 35.30 15.90 3 41977 70314 63376728
Hyperbilirubinaemia 34.55 15.90 40 41940 11274 63435768
Anxiety 34.17 15.90 57 41923 217484 63229558
Gait disturbance 33.66 15.90 43 41937 183135 63263907
Peripheral sensory neuropathy 32.81 15.90 32 41948 7419 63439623
Laryngospasm 32.74 15.90 22 41958 3006 63444036
Carcinoembryonic antigen increased 32.42 15.90 18 41962 1747 63445295
Muscle injury 32.22 15.90 3 41977 65342 63381700
Thrombophlebitis migrans 32.16 15.90 9 41971 133 63446909
Cardiac cirrhosis 32.16 15.90 9 41971 133 63446909
Myelitis transverse 32.12 15.90 16 41964 1244 63445798
Injury 32.10 15.90 5 41975 73242 63373800
Toxic erythema of chemotherapy 31.97 15.90 9 41971 136 63446906
Colitis 31.90 15.90 87 41893 48441 63398601
Drug interaction 31.59 15.90 65 41915 229066 63217976
Feeling abnormal 31.46 15.90 31 41949 148361 63298681
Deep vein thrombosis 31.35 15.90 124 41856 83676 63363366
Wheezing 31.30 15.90 12 41968 95583 63351459
Blister 31.30 15.90 24 41956 129790 63317252
Hypokalaemia 30.67 15.90 143 41837 103661 63343381
Subacute cutaneous lupus erythematosus 30.50 15.90 20 41960 2623 63444419
Suicidal ideation 30.43 15.90 3 41977 62418 63384624
Depression 30.38 15.90 52 41928 196440 63250602
Epistaxis 29.99 15.90 111 41869 72614 63374428
Treatment failure 29.58 15.90 54 41926 198989 63248053
Suicide attempt 29.51 15.90 3 41977 60915 63386127
Granulocyte count decreased 29.42 15.90 15 41965 1225 63445817
Device occlusion 29.35 15.90 30 41950 7357 63439685
Tumour associated fever 28.12 15.90 10 41970 332 63446710
Osteoarthritis 28.01 15.90 14 41966 95329 63351713
Adverse drug reaction 27.82 15.90 9 41971 79705 63367337
Acute erythroid leukaemia 27.61 15.90 7 41973 69 63446973
Condition aggravated 27.42 15.90 155 41825 402062 63044980
Carbohydrate antigen 125 increased 27.00 15.90 19 41961 2797 63444245
Decreased appetite 26.98 15.90 269 41711 250783 63196259
Paraneoplastic pemphigus 26.91 15.90 7 41973 77 63446965
Performance status decreased 26.71 15.90 21 41959 3657 63443385
Carbohydrate antigen 19-9 increased 26.69 15.90 9 41971 254 63446788
Gastrointestinal toxicity 26.42 15.90 29 41951 7712 63439330
Impaired healing 25.96 15.90 18 41962 102524 63344518
Metastatic neoplasm 25.88 15.90 22 41958 4273 63442769
Injection site reaction 25.63 15.90 4 41976 58520 63388522
Metastases to bone marrow 25.19 15.90 10 41970 452 63446590
Skin mass 25.15 15.90 25 41955 5930 63441112
Infusion related reaction 25.11 15.90 81 41899 245440 63201602
Influenza 25.08 15.90 21 41959 108701 63338341
Hepatic cytolysis 24.91 15.90 40 41940 15367 63431675
Hyperpyrexia 24.80 15.90 20 41960 3612 63443430
Dizziness 24.52 15.90 175 41805 429750 63017292
Nausea 24.50 15.90 738 41242 853733 62593309
Blood disorder 24.22 15.90 26 41954 6745 63440297
Generalised oedema 24.13 15.90 40 41940 15778 63431264
Pain in extremity 24.09 15.90 125 41855 331361 63115681
Catabolic state 23.77 15.90 6 41974 58 63446984
Haemoglobinaemia 23.59 15.90 6 41974 60 63446982
Intestinal perforation 23.50 15.90 34 41946 11929 63435113
Pneumocystis jirovecii pneumonia 23.46 15.90 41 41939 16873 63430169
Oedema peripheral 23.31 15.90 209 41771 189302 63257740
Extremity necrosis 23.11 15.90 14 41966 1599 63445443
Portal vein occlusion 23.05 15.90 4 41976 3 63447039
Rash 22.84 15.90 249 41731 560622 62886420
Hospitalisation 22.81 15.90 14 41966 85067 63361975
Cardiotoxicity 22.75 15.90 28 41952 8410 63438632
Mediastinum neoplasm 22.67 15.90 6 41974 71 63446971
Neoplasm 22.48 15.90 26 41954 7319 63439723
Systemic infection 22.39 15.90 21 41959 4639 63442403
Gait inability 22.35 15.90 4 41976 52955 63394087
Bacillus infection 22.24 15.90 11 41969 842 63446200
Skin toxicity 22.18 15.90 21 41959 4693 63442349
Neutrophil count abnormal 22.06 15.90 17 41963 2875 63444167
Wrong technique in product usage process 21.82 15.90 7 41973 62333 63384709
Hepatic lesion 21.77 15.90 21 41959 4804 63442238
Pulmonary toxicity 21.76 15.90 29 41951 9426 63437616
Leukaemic lymphoma 21.74 15.90 6 41974 84 63446958
Metastases to diaphragm 21.63 15.90 5 41975 32 63447010
Lymphangitis 21.60 15.90 11 41969 896 63446146
Injection site swelling 21.42 15.90 3 41977 47569 63399473
Gastrointestinal perforation 21.28 15.90 18 41962 3473 63443569
Adverse event 21.27 15.90 9 41971 67550 63379492
Gastric neoplasm 21.22 15.90 8 41972 314 63446728
IIIrd nerve paralysis 21.22 15.90 10 41970 688 63446354
Vaginal cellulitis 21.17 15.90 6 41974 93 63446949
Splenic marginal zone lymphoma 21.11 15.90 5 41975 36 63447006
Stress 21.06 15.90 9 41971 67158 63379884
Peritoneal disorder 21.03 15.90 9 41971 493 63446549
Hypocalcaemia 20.99 15.90 57 41923 31656 63415386
Immune-mediated hepatic disorder 20.81 15.90 9 41971 506 63446536
Drug ineffective 20.68 15.90 530 41450 1044235 62402807
Blood pressure fluctuation 20.67 15.90 3 41977 46314 63400728
Metastases to adrenals 20.35 15.90 10 41970 755 63446287
Metastases to bladder 20.20 15.90 7 41973 215 63446827
Hypercalcaemia of malignancy 20.14 15.90 7 41973 217 63446825
Gastrointestinal disorder 20.03 15.90 35 41945 131204 63315838
Cognitive disorder 20.02 15.90 6 41974 55809 63391233
Metastases to stomach 19.90 15.90 7 41973 225 63446817
Myocardial infarction 19.89 15.90 22 41958 99871 63347171
Tumour marker abnormal 19.80 15.90 8 41972 379 63446663
Biliary obstruction 19.76 15.90 16 41964 2905 63444137
Adenosquamous cell lung cancer stage IV 19.75 15.90 4 41976 12 63447030
Metastases to abdominal wall 19.65 15.90 6 41974 122 63446920
Hypomagnesaemia 19.36 15.90 52 41928 28685 63418357
Vena cava thrombosis 19.23 15.90 14 41966 2173 63444869
Ureteric fistula 19.07 15.90 4 41976 15 63447027
Neoplasm recurrence 19.02 15.90 15 41965 2623 63444419
Pseudosepsis 18.97 15.90 3 41977 0 63447042
Paresis cranial nerve 18.97 15.90 3 41977 0 63447042
Paraneoplastic dermatomyositis 18.86 15.90 4 41976 16 63447026
Retinopathy 18.85 15.90 16 41964 3103 63443939
Acute kidney injury 18.83 15.90 261 41719 263154 63183888
Stress cardiomyopathy 18.77 15.90 27 41953 9423 63437619
Febrile infection 18.50 15.90 12 41968 1545 63445497
Pancreatic carcinoma 18.49 15.90 24 41956 7604 63439438
Lymphoedema 18.42 15.90 30 41950 11662 63435380
Bone marrow infiltration 18.37 15.90 9 41971 675 63446367
Tumour thrombosis 18.30 15.90 4 41976 19 63447023
Intestinal metastasis 18.30 15.90 6 41974 155 63446887
Metastases to spine 18.28 15.90 16 41964 3233 63443809
Bronchostenosis 18.17 15.90 8 41972 470 63446572
Blast cells present 18.14 15.90 8 41972 472 63446570
Metastases to spleen 18.12 15.90 6 41974 160 63446882
Medication error 18.07 15.90 6 41974 52278 63394764
Heart rate decreased 18.06 15.90 4 41976 45556 63401486
Joint stiffness 18.03 15.90 3 41977 41866 63405176
Chills 17.69 15.90 132 41848 113246 63333796
Jaundice cholestatic 17.68 15.90 23 41957 7301 63439741
Disseminated intravascular coagulation 17.68 15.90 39 41941 19012 63428030
Febrile bone marrow aplasia 17.68 15.90 23 41957 7302 63439740
Postictal state 17.43 15.90 10 41970 1033 63446009
Cholangitis acute 17.40 15.90 8 41972 520 63446522
Obstruction gastric 17.40 15.90 10 41970 1037 63446005
Hepatic function abnormal 17.28 15.90 59 41921 37083 63409959
Renal salt-wasting syndrome 17.25 15.90 7 41973 335 63446707
Fluid retention 17.17 15.90 9 41971 59677 63387365
Red blood cell sedimentation rate increased 17.15 15.90 4 41976 43978 63403064
Blood pressure increased 16.88 15.90 53 41927 162009 63285033
Pulmonary alveolar haemorrhage 16.83 15.90 18 41962 4650 63442392
Purtscher retinopathy 16.80 15.90 5 41975 93 63446949
Post thrombotic syndrome 16.73 15.90 8 41972 569 63446473
Hyperphosphataemia 16.68 15.90 13 41967 2235 63444807
Urinary tract infection enterococcal 16.56 15.90 14 41966 2699 63444343
Left ventricular dysfunction 16.55 15.90 29 41951 11959 63435083
Ischaemia 16.50 15.90 18 41962 4754 63442288
Oroticaciduria 16.43 15.90 3 41977 4 63447038
Localised oedema 16.40 15.90 19 41961 5359 63441683
Malaise 16.38 15.90 186 41794 415768 63031274
Hydronephrosis 16.31 15.90 27 41953 10635 63436407
Sedation 16.23 15.90 3 41977 38806 63408236
Renal vein thrombosis 16.16 15.90 7 41973 395 63446647
Ovarian cancer metastatic 16.07 15.90 9 41971 888 63446154
Nasal congestion 16.00 15.90 12 41968 65648 63381394
Malignant ascites 15.99 15.90 9 41971 897 63446145
Rhinorrhoea 15.96 15.90 12 41968 65565 63381477

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
Disease progression 1228.38 17.28 973 36284 107104 34812570
Thrombocytopenia 640.26 17.28 808 36449 155439 34764235
Thrombotic microangiopathy 417.93 17.28 211 37046 10419 34909255
Malignant neoplasm progression 386.24 17.28 472 36785 87574 34832100
Neutropenia 362.79 17.28 620 36637 156158 34763516
Myelosuppression 308.64 17.28 214 37043 19051 34900623
Neoplasm progression 307.36 17.28 230 37027 23070 34896604
Anaemia 280.07 17.28 704 36553 232631 34687043
Off label use 273.66 17.28 1021 36236 418503 34501171
Pancytopenia 251.51 17.28 400 36857 94757 34824917
Febrile neutropenia 197.33 17.28 444 36813 136405 34783269
Cholangitis 191.72 17.28 118 37139 8571 34911103
Diffuse large B-cell lymphoma recurrent 191.13 17.28 85 37172 3143 34916531
Pyrexia 182.05 17.28 768 36489 332245 34587429
Leukopenia 171.10 17.28 268 36989 62588 34857086
Haematotoxicity 155.10 17.28 101 37156 8093 34911581
Cytokine release syndrome 136.31 17.28 144 37113 22733 34896941
Therapy partial responder 135.88 17.28 99 37158 9517 34910157
Haemolytic uraemic syndrome 125.17 17.28 57 37200 2229 34917445
Neuropathy peripheral 117.38 17.28 268 36989 82995 34836679
General physical health deterioration 117.30 17.28 351 36906 127918 34791756
Neutrophil count decreased 102.11 17.28 190 37067 50914 34868760
Pneumonitis 101.33 17.28 151 37106 33727 34885947
Diffuse large B-cell lymphoma refractory 100.34 17.28 41 37216 1225 34918449
Neutropenic sepsis 99.08 17.28 96 37161 13671 34906003
Product dose omission issue 97.63 17.28 8 37249 119703 34799971
Platelet count decreased 91.46 17.28 308 36949 119409 34800265
Bacteraemia 89.90 17.28 108 37149 19609 34900065
Biliary tract infection 83.53 17.28 30 37227 625 34919049
Interstitial lung disease 83.11 17.28 202 37055 65080 34854594
Pseudocellulitis 79.76 17.28 17 37240 37 34919637
Liver abscess 78.61 17.28 50 37207 3845 34915829
Neurotoxicity 74.60 17.28 94 37163 17916 34901758
Arthralgia 72.40 17.28 46 37211 169995 34749679
Capillary leak syndrome 72.05 17.28 39 37218 2219 34917455
Sepsis 70.37 17.28 357 36900 166204 34753470
Drug interaction 68.68 17.28 84 37173 225862 34693812
Bone marrow failure 67.69 17.28 116 37141 29137 34890537
Product use in unapproved indication 67.65 17.28 276 36981 117223 34802451
Pancreatic carcinoma metastatic 65.02 17.28 40 37217 2900 34916774
Metastases to liver 62.54 17.28 75 37182 13588 34906086
Overdose 60.06 17.28 12 37245 91047 34828627
Pulmonary embolism 57.44 17.28 218 37039 89528 34830146
Pancreatic enzyme abnormality 57.33 17.28 14 37243 67 34919607
Hypertransaminasaemia 55.94 17.28 47 37210 5559 34914115
Pleural effusion 54.61 17.28 201 37056 81345 34838329
Headache 54.44 17.28 81 37176 200554 34719120
Fall 54.00 17.28 83 37174 202802 34716872
Seizure 52.50 17.28 23 37234 104834 34814840
Nasopharyngitis 51.07 17.28 7 37250 69961 34849713
Disease recurrence 50.74 17.28 86 37171 21404 34898270
Peripheral ischaemia 49.30 17.28 44 37213 5643 34914031
Metastases to lung 49.09 17.28 55 37202 9265 34910409
Drug hypersensitivity 48.36 17.28 13 37244 80516 34839158
Biliary obstruction 47.49 17.28 32 37225 2713 34916961
Myositis 46.84 17.28 61 37196 12009 34907665
Pulmonary toxicity 46.37 17.28 44 37213 6103 34913571
Immune-mediated hepatitis 46.11 17.28 29 37228 2186 34917488
Feeling abnormal 44.59 17.28 7 37250 63228 34856446
Cytopenia 44.32 17.28 61 37196 12662 34907012
Asthenia 43.34 17.28 425 36832 244826 34674848
Hyperpyrexia 42.35 17.28 30 37227 2758 34916916
Atypical haemolytic uraemic syndrome 41.87 17.28 15 37242 310 34919364
Insomnia 41.65 17.28 30 37227 103877 34815797
Blood lactate dehydrogenase increased 41.60 17.28 82 37175 22908 34896766
Pancreatic carcinoma 40.96 17.28 49 37208 8852 34910822
Metastases to central nervous system 40.80 17.28 47 37210 8158 34911516
Anxiety 40.79 17.28 28 37229 99400 34820274
Depression 40.29 17.28 27 37230 97071 34822603
Enterocolitis infectious 39.89 17.28 24 37233 1671 34918003
Myalgia 39.71 17.28 20 37237 84090 34835584
Chills 39.40 17.28 181 37076 80862 34838812
Lymphoma 39.18 17.28 57 37200 12450 34907224
Vomiting 38.46 17.28 418 36839 247203 34672471
Ascites 37.42 17.28 122 37135 46449 34873225
Weight increased 37.10 17.28 27 37230 93006 34826668
Recall phenomenon 36.92 17.28 16 37241 555 34919119
Muscle spasms 36.67 17.28 17 37240 74984 34844690
Deep vein thrombosis 36.49 17.28 152 37105 65096 34854578
Decreased appetite 35.79 17.28 301 36956 166091 34753583
Mucosal inflammation 35.48 17.28 106 37151 38516 34881158
Unmasking of previously unidentified disease 35.48 17.28 18 37239 896 34918778
Urosepsis 35.35 17.28 55 37202 12744 34906930
Joint swelling 35.33 17.28 10 37247 59880 34859794
Right ventricular ejection fraction decreased 35.15 17.28 9 37248 54 34919620
Bicytopenia 34.71 17.28 25 37232 2359 34917315
Blood pressure increased 34.57 17.28 26 37231 88076 34831598
Lymphadenopathy 33.99 17.28 86 37171 28377 34891297
Nausea 33.93 17.28 529 36728 339379 34580295
White blood cell count decreased 33.73 17.28 195 37062 95250 34824424
Hospitalisation 32.66 17.28 10 37247 56892 34862782
Skin toxicity 31.88 17.28 32 37225 4752 34914922
Chronic myelomonocytic leukaemia 31.73 17.28 15 37242 639 34919035
Biliary sepsis 30.83 17.28 15 37242 682 34918992
Vena cava thrombosis 30.58 17.28 18 37239 1204 34918470
Coronary artery disease 30.54 17.28 7 37250 48298 34871376
Electrocardiogram QT prolonged 30.11 17.28 4 37253 40948 34878726
Device occlusion 30.07 17.28 36 37221 6509 34913165
Toxicity to various agents 30.06 17.28 111 37146 200251 34719423
Bradycardia 29.92 17.28 22 37235 75396 34844278
Microangiopathic haemolytic anaemia 29.79 17.28 16 37241 896 34918778
Agitation 29.66 17.28 12 37245 57387 34862287
Hepatocellular injury 29.59 17.28 70 37187 22141 34897533
Pancreatic carcinoma recurrent 29.36 17.28 8 37249 63 34919611
Tremor 29.16 17.28 27 37230 82560 34837114
Histiocytic necrotising lymphadenitis 28.49 17.28 6 37251 12 34919662
Embolism 27.97 17.28 38 37219 7791 34911883
Discontinued product administered 27.29 17.28 6 37251 16 34919658
Extremity necrosis 27.17 17.28 20 37237 1952 34917722
Ill-defined disorder 26.86 17.28 51 37206 13858 34905816
Dermatitis acneiform 26.74 17.28 33 37224 6156 34913518
Cardiac failure congestive 26.26 17.28 30 37227 83240 34836434
Injection site pain 26 17.28 5 37252 39000 34880674
Memory impairment 25.98 17.28 7 37250 43311 34876363
Cardiac disorder 25.81 17.28 7 37250 43119 34876555
Abdominal pain 25.71 17.28 277 36980 163341 34756333
Myocardial infarction 25.54 17.28 57 37200 121028 34798646
Somnolence 25.38 17.28 50 37207 111066 34808608
Adenoviral hepatitis 24.94 17.28 12 37245 532 34919142
Inappropriate schedule of product administration 24.93 17.28 18 37239 62278 34857396
Acute myeloid leukaemia 24.80 17.28 58 37199 18212 34901462
Metastases to chest wall 24.60 17.28 9 37248 198 34919476
Adenovirus reactivation 23.83 17.28 9 37248 217 34919457
Metabolic disorder 23.80 17.28 26 37231 4257 34915417
Second primary malignancy 23.34 17.28 35 37222 7851 34911823
Erythropenia 23.19 17.28 9 37248 234 34919440
Tumour lysis syndrome 22.98 17.28 54 37203 17005 34902669
Chest discomfort 22.83 17.28 15 37242 54515 34865159
Cardiotoxicity 22.62 17.28 29 37228 5619 34914055
Renal-limited thrombotic microangiopathy 22.54 17.28 7 37250 91 34919583
Angioedema 22.49 17.28 6 37251 37368 34882306
PIK3CA-activated mutation 22.26 17.28 7 37250 95 34919579
Metastases to peritoneum 21.65 17.28 17 37240 1827 34917847
Peritoneal lesion 21.62 17.28 7 37250 105 34919569
Jaundice cholestatic 21.42 17.28 26 37231 4768 34914906
Palpitations 21.25 17.28 8 37249 39978 34879696
Sleep disorder 21.25 17.28 4 37253 31684 34887990
Wrong technique in product usage process 21.24 17.28 6 37251 35980 34883694
Rhabdomyolysis 21.01 17.28 25 37232 68138 34851536
Thyroglobulin increased 21.01 17.28 5 37252 21 34919653
Wheezing 20.83 17.28 9 37248 41393 34878281
Colitis 20.36 17.28 87 37170 37663 34882011
Pain in extremity 20.35 17.28 68 37189 126445 34793229
Influenza 20.33 17.28 14 37243 49652 34870022
Resorption bone increased 20.33 17.28 8 37249 216 34919458
Granulocyte-colony stimulating factor level increased 20.14 17.28 4 37253 5 34919669
Incorrect dose administered 20.08 17.28 9 37248 40506 34879168
Vascular purpura 20.03 17.28 16 37241 1762 34917912
Contusion 19.79 17.28 7 37250 36357 34883317
Peripheral swelling 19.66 17.28 32 37225 76509 34843165
Metastases to muscle 19.64 17.28 8 37249 237 34919437
Malaise 19.56 17.28 117 37140 185708 34733966
Abdominal discomfort 19.47 17.28 21 37236 59814 34859860
Duodenal stenosis 19.45 17.28 8 37249 243 34919431
Diffuse large B-cell lymphoma 19.42 17.28 31 37226 7339 34912335
Pneumonia adenoviral 19.38 17.28 9 37248 368 34919306
Gastrointestinal obstruction 19.32 17.28 12 37245 885 34918789
Blood creatine phosphokinase increased 19.24 17.28 12 37245 44845 34874829
Condition aggravated 19.20 17.28 123 37134 192073 34727601
Hallucination 19.18 17.28 16 37241 51482 34868192
Cystoid macular oedema 19.13 17.28 11 37246 704 34918970
Vascular pseudoaneurysm ruptured 19.11 17.28 6 37251 81 34919593
Ilium fracture 18.92 17.28 7 37250 159 34919515
Vision blurred 18.76 17.28 13 37244 45950 34873724
Balance disorder 18.68 17.28 10 37247 40644 34879030
Pruritus 18.54 17.28 83 37174 141898 34777776
Hypophagia 18.46 17.28 62 37195 23960 34895714
Cardio-respiratory arrest 18.43 17.28 19 37238 55254 34864420
Peripheral artery occlusion 18.43 17.28 15 37242 1697 34917977
Toxic erythema of chemotherapy 18.35 17.28 6 37251 93 34919581
Chronic coronary syndrome 18.33 17.28 7 37250 174 34919500
Molluscum contagiosum 18.29 17.28 8 37249 284 34919390
Transitional cell carcinoma recurrent 17.85 17.28 4 37253 12 34919662
Testicular disorder 17.85 17.28 11 37246 800 34918874
Tumour necrosis 17.60 17.28 13 37244 1275 34918399
Portal vein stenosis 17.54 17.28 3 37254 0 34919674
Retroperitoneal neoplasm metastatic 17.54 17.28 3 37254 0 34919674
Dizziness 17.44 17.28 149 37108 218372 34701302
Tumour fistulisation 17.38 17.28 4 37253 14 34919660
Disseminated intravascular coagulation 17.38 17.28 57 37200 21759 34897915
Haemoglobin decreased 17.37 17.28 201 37056 120571 34799103
Gastroenteritis radiation 17.35 17.28 8 37249 322 34919352
Fistula of small intestine 17.28 17.28 9 37248 473 34919201

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
Disease progression 1964.74 15.29 1450 65335 182912 79494691
Thrombocytopenia 1583.88 15.29 1492 65293 263767 79413836
Thrombotic microangiopathy 1101.63 15.29 467 66318 19702 79657901
Malignant neoplasm progression 1081.07 15.29 901 65884 135089 79542514
Neutropenia 935.83 15.29 1176 65609 286534 79391069
Anaemia 624.14 15.29 1236 65549 443779 79233824
Myelosuppression 616.36 15.29 397 66388 39899 79637704
Neoplasm progression 571.97 15.29 417 66368 51265 79626338
Pancytopenia 449.96 15.29 621 66164 165124 79512479
Haematotoxicity 376.49 15.29 206 66579 15313 79662290
Febrile neutropenia 347.50 15.29 662 66123 230337 79447266
Off label use 332.80 15.29 1568 65217 905647 78771956
Leukopenia 331.79 15.29 447 66338 116066 79561537
Pyrexia 331.32 15.29 1280 65505 677429 79000174
Cholangitis 308.27 15.29 169 66616 12607 79664996
Metastases to liver 282.98 15.29 215 66570 28099 79649504
Diffuse large B-cell lymphoma recurrent 282.50 15.29 113 66672 4094 79673509
Platelet count decreased 263.64 15.29 534 66251 194130 79483473
Neuropathy peripheral 255.61 15.29 439 66346 140866 79536737
Cytokine release syndrome 253.66 15.29 223 66562 35775 79641828
Arthralgia 248.10 15.29 85 66700 571718 79105885
Therapy partial responder 247.77 15.29 164 66621 17233 79660370
Neutrophil count decreased 242.66 15.29 344 66441 93615 79583988
Haemolytic uraemic syndrome 219.70 15.29 96 66689 4353 79673250
Biliary tract infection 218.06 15.29 70 66715 1318 79676285
Metastases to lung 199.53 15.29 146 66639 18017 79659586
General physical health deterioration 183.84 15.29 577 66208 274661 79402942
Bone marrow failure 181.55 15.29 219 66566 50888 79626715
Joint swelling 177.36 15.29 18 66767 288628 79388975
Capillary leak syndrome 169.17 15.29 77 66708 3848 79673755
Recall phenomenon 169.07 15.29 55 66730 1082 79676521
Metastases to lymph nodes 160.24 15.29 103 66682 10294 79667309
Rheumatoid arthritis 159.62 15.29 3 66782 208467 79469136
Ascites 157.01 15.29 250 66535 75312 79602291
Hypertransaminasaemia 156.82 15.29 107 66678 11817 79665786
Neurotoxicity 152.46 15.29 161 66624 32357 79645246
Pleural effusion 151.56 15.29 359 66426 144903 79532700
Pneumonitis 151.45 15.29 219 66566 60641 79616962
Sepsis 148.06 15.29 529 66256 268899 79408704
Headache 146.01 15.29 201 66584 653571 79024032
Acute myeloid leukaemia 143.17 15.29 152 66633 30733 79646870
Product dose omission issue 143.17 15.29 19 66766 247518 79430085
Diffuse large B-cell lymphoma refractory 141.37 15.29 51 66734 1384 79676219
Neutropenic sepsis 139.51 15.29 141 66644 26923 79650680
Fall 133.64 15.29 127 66658 487502 79190101
Metastases to bone 132.80 15.29 131 66654 24296 79653307
Interstitial lung disease 127.01 15.29 287 66498 112313 79565290
Nasopharyngitis 126.10 15.29 29 66756 253852 79423751
Pulmonary embolism 124.88 15.29 371 66414 171283 79506320
Myositis 121.69 15.29 112 66673 19056 79658547
Second primary malignancy 119.73 15.29 98 66687 14252 79663351
Metastases to peritoneum 117.10 15.29 62 66723 4310 79673293
Pseudocellulitis 112.53 15.29 23 66762 53 79677550
Drug hypersensitivity 112.27 15.29 55 66730 298861 79378742
Musculoskeletal stiffness 109.86 15.29 10 66775 174998 79502605
Weight increased 107.30 15.29 49 66736 277337 79400266
Disease recurrence 105.77 15.29 156 66629 43953 79633650
Mucosal inflammation 105.30 15.29 210 66575 75370 79602233
Overdose 104.46 15.29 15 66770 184191 79493412
Blood lactate dehydrogenase increased 103.39 15.29 145 66640 39025 79638578
Product use in unapproved indication 101.48 15.29 447 66338 249912 79427691
Cytopenia 101.06 15.29 104 66681 20279 79657324
Contraindicated product administered 93.72 15.29 11 66774 157527 79520076
Peripheral ischaemia 92.67 15.29 71 66714 9386 79668217
Asthma 92.63 15.29 5 66780 135090 79542513
Peripheral swelling 91.94 15.29 56 66729 269561 79408042
Bacteraemia 91.87 15.29 125 66660 32699 79644904
Liver abscess 88.44 15.29 58 66727 5996 79671607
Abdominal discomfort 88.42 15.29 50 66735 250677 79426926
Tumour lysis syndrome 87.31 15.29 104 66681 23835 79653768
Maternal exposure during pregnancy 82.55 15.29 9 66776 136529 79541074
Insomnia 82.09 15.29 52 66733 245118 79432485
Metastases to central nervous system 81.99 15.29 84 66701 16291 79661312
Atypical haemolytic uraemic syndrome 80.85 15.29 31 66754 1001 79676602
Arthropathy 80.73 15.29 24 66761 177087 79500516
Pain 80.17 15.29 311 66474 703491 78974112
Swelling 79.65 15.29 41 66744 216670 79460933
Microangiopathic haemolytic anaemia 78.82 15.29 34 66751 1493 79676110
Therapeutic product effect decreased 76.91 15.29 21 66764 163842 79513761
Systemic lupus erythematosus 75.81 15.29 7 66778 121142 79556461
Muscle spasms 75.52 15.29 26 66759 174704 79502899
Feeling abnormal 75.48 15.29 20 66765 159179 79518424
Sinusitis 74.85 15.29 35 66750 195466 79482137
Wound 74.65 15.29 6 66779 116173 79561430
Drug interaction 74.46 15.29 147 66638 415036 79262567
Embolism 74.17 15.29 74 66711 13908 79663695
Contusion 73.82 15.29 17 66768 148759 79528844
Pancreatic carcinoma metastatic 72.64 15.29 43 66742 3710 79673893
Anxiety 72.43 15.29 61 66724 248451 79429152
Pulmonary toxicity 71.57 15.29 70 66715 12844 79664759
Posterior reversible encephalopathy syndrome 68.92 15.29 97 66688 26184 79651419
White blood cell count decreased 67.94 15.29 325 66460 187963 79489640
Hyperpyrexia 66.96 15.29 49 66736 6043 79671560
Vomiting 66.16 15.29 849 65936 664979 79012624
Skin toxicity 65.65 15.29 55 66730 8259 79669344
Injection site pain 64.09 15.29 15 66770 129823 79547780
Asthenia 62.98 15.29 680 66105 511009 79166594
Memory impairment 61.27 15.29 10 66775 111724 79565879
Immune-mediated hepatitis 60.78 15.29 38 66747 3618 79673985
Cardiotoxicity 59.86 15.29 62 66723 12177 79665426
Abdominal pain 59.72 15.29 542 66243 389027 79288576
Psoriasis 59.34 15.29 4 66781 89583 79588020
Biliary obstruction 59.23 15.29 41 66744 4633 79672970
Bile duct stenosis 58.02 15.29 30 66755 1986 79675617
Exposure during pregnancy 57.86 15.29 8 66777 101124 79576479
Colitis 57.63 15.29 163 66622 73144 79604459
Deep vein thrombosis 57.62 15.29 227 66558 120692 79556911
Suicide attempt 57.06 15.29 3 66782 82929 79594674
Depression 56.35 15.29 59 66726 216731 79460872
Extremity necrosis 55.45 15.29 34 66751 3127 79674476
Cholangitis infective 55.42 15.29 21 66764 656 79676947
Device occlusion 54.27 15.29 58 66727 11808 79665795
Drug resistance 53.71 15.29 113 66672 42100 79635503
Pancreatic enzyme abnormality 53.48 15.29 14 66771 122 79677481
Sleep disorder 53.47 15.29 5 66780 85672 79591931
Injection site erythema 53.27 15.29 3 66782 78194 79599409
Chills 52.40 15.29 269 66516 159965 79517638
Suicidal ideation 51.78 15.29 3 66782 76337 79601266
Pericarditis 51.53 15.29 12 66773 104224 79573379
Mobility decreased 51.38 15.29 19 66766 122156 79555447
Wheezing 51.03 15.29 17 66768 116647 79560956
Arthritis 49.79 15.29 17 66768 114863 79562740
Palmar-plantar erythrodysaesthesia syndrome 49.70 15.29 95 66690 33039 79644564
Toxic erythema of chemotherapy 48.99 15.29 15 66770 240 79677363
Pericardial effusion 48.94 15.29 115 66670 46122 79631481
Pain in extremity 48.88 15.29 150 66635 364388 79313215
Decreased appetite 48.73 15.29 469 66316 341949 79335654
Haemoglobin decreased 47.67 15.29 334 66451 221785 79455818
Hepatotoxicity 47.22 15.29 121 66664 51231 79626372
Product use issue 47.18 15.29 64 66721 209758 79467845
Hepatic failure 47.04 15.29 135 66650 61077 79616526
Somnolence 46.89 15.29 80 66705 238901 79438702
Loss of personal independence in daily activities 46.55 15.29 14 66771 102566 79575037
Nasal congestion 46.38 15.29 5 66780 76547 79601056
Blood pressure increased 45.99 15.29 66 66719 211294 79466309
Discomfort 45.78 15.29 24 66761 125593 79552010
Hepatic enzyme increased 44.92 15.29 52 66733 182558 79495045
Subacute cutaneous lupus erythematosus 44.57 15.29 31 66754 3530 79674073
Urticaria 44.20 15.29 54 66731 185147 79492456
Biliary sepsis 43.50 15.29 23 66762 1594 79676009
Bronchitis 43.30 15.29 28 66757 130616 79546987
Dizziness 43.30 15.29 261 66524 526180 79151423
Osteoarthritis 43.26 15.29 10 66775 87299 79590304
Cerebral ischaemia 43.08 15.29 50 66735 11145 79666458
Pancreatic carcinoma 43.08 15.29 55 66730 13522 79664081
Gait disturbance 42.06 15.29 68 66717 207438 79470165
Stress 41.74 15.29 8 66777 79604 79597999
Peripheral sensory neuropathy 41.68 15.29 53 66732 12980 79664623
Blood cholesterol increased 40.67 15.29 10 66775 83710 79593893
Injury 40.18 15.29 8 66777 77488 79600115
Metastasis 39.45 15.29 38 66747 6842 79670761
Myalgia 39.38 15.29 59 66726 185582 79492021
Malaise 38.64 15.29 246 66539 489623 79187980
Lower respiratory tract infection 38.51 15.29 31 66754 129189 79548414
Hypercalcaemia of malignancy 38.19 15.29 14 66771 398 79677205
Blister 37.73 15.29 27 66758 119449 79558154
Erythropenia 37.58 15.29 14 66771 417 79677186
Renal-limited thrombotic microangiopathy 37.35 15.29 11 66774 153 79677450
Urosepsis 37.34 15.29 74 66711 26421 79651182
Pancreatic fistula 37.33 15.29 10 66775 96 79677507
EGFR gene mutation 36.57 15.29 14 66771 450 79677153
PIK3CA-activated mutation 36.38 15.29 15 66770 588 79677015
Dehydration 36.30 15.29 342 66443 247845 79429758
Influenza 36.30 15.29 33 66752 129573 79548030
Right ventricular ejection fraction decreased 36.24 15.29 9 66776 62 79677541
Migraine 36.13 15.29 14 66771 87479 79590124
Myelodysplastic syndrome 36.11 15.29 79 66706 30222 79647381
Capillary permeability increased 36.04 15.29 8 66777 31 79677572
Metastases to pleura 35.95 15.29 20 66765 1534 79676069
Hospitalisation 35.85 15.29 17 66768 94219 79583384
Hypoalbuminaemia 35.62 15.29 64 66721 21233 79656370
Seizure 35.42 15.29 65 66720 188769 79488834
Dry gangrene 35.20 15.29 17 66768 972 79676631
Lymphoma 35.18 15.29 57 66728 17403 79660200
Lymphadenopathy 34.85 15.29 111 66674 53136 79624467
Injection site reaction 34.71 15.29 3 66782 54782 79622821
Hepatocellular injury 33.73 15.29 102 66683 47491 79630112
Rhinorrhoea 33.41 15.29 11 66774 76063 79601540
Jaundice cholestatic 33.14 15.29 44 66741 11240 79666363
BRCA2 gene mutation 33.00 15.29 9 66776 93 79677510
Dermatitis acneiform 32.53 15.29 41 66744 9952 79667651
Gastrointestinal toxicity 32.52 15.29 37 66748 8072 79669531
Disseminated intravascular coagulation 32.48 15.29 84 66701 35758 79641845
Small intestinal obstruction 32.38 15.29 71 66714 27201 79650402
Retroperitoneal neoplasm metastatic 31.98 15.29 7 66778 25 79677578
Performance status decreased 31.77 15.29 32 66753 6081 79671522
Pancreatic carcinoma recurrent 31.72 15.29 10 66775 177 79677426
Myocardial infarction 31.41 15.29 67 66718 184062 79493541
Nephropathy toxic 31.18 15.29 59 66726 20360 79657243
Chronic myelomonocytic leukaemia 31.17 15.29 15 66770 851 79676752
Polyneuropathy 31.12 15.29 65 66720 24086 79653517
Bicytopenia 31.03 15.29 28 66757 4642 79672961
Hypophagia 31.00 15.29 96 66689 45271 79632332
Cholestasis 30.86 15.29 105 66680 52004 79625599
Breast cancer metastatic 30.75 15.29 37 66748 8565 79669038
Jaundice 30.28 15.29 106 66679 53243 79624360
Inappropriate schedule of product administration 29.78 15.29 41 66744 133587 79544016
Tremor 29.76 15.29 61 66724 170022 79507581
Alopecia 29.71 15.29 97 66688 231258 79446345
Blood bilirubin increased 29.66 15.29 122 66663 66110 79611493
Carbohydrate antigen 19-9 increased 29.53 15.29 12 66773 453 79677150
Tumour necrosis 29.51 15.29 19 66766 1903 79675700
Heart rate decreased 29.45 15.29 11 66774 70305 79607298
Type 2 diabetes mellitus 29.40 15.29 6 66779 57116 79620487
Immune effector cell-associated neurotoxicity syndrome 29.28 15.29 30 66755 5818 79671785
Pneumocystis jirovecii pneumonia 29.26 15.29 76 66709 32432 79645171
Aggression 29.22 15.29 4 66781 50954 79626649
Fluid retention 29.11 15.29 11 66774 69798 79607805
Disturbance in attention 29.10 15.29 4 66781 50797 79626806
Condition aggravated 29.02 15.29 274 66511 500850 79176753
Gait inability 28.69 15.29 7 66778 58910 79618693
Urinary tract obstruction 28.62 15.29 27 66758 4738 79672865
Wrong technique in product usage process 28.61 15.29 13 66772 73862 79603741
Angioedema 28.49 15.29 14 66771 76021 79601582
Nausea 28.46 15.29 1023 65762 956173 78721430
Breast cancer recurrent 28.40 15.29 22 66763 2955 79674648
Illness 28.27 15.29 3 66782 46508 79631095
Folliculitis 28.12 15.29 6 66779 55374 79622229
Oedema peripheral 28.09 15.29 329 66456 251959 79425644
Palpitations 28.06 15.29 39 66746 126571 79551032
Heart rate increased 27.96 15.29 36 66749 120688 79556915
Infusion related reaction 27.89 15.29 99 66686 230138 79447465
Balance disorder 27.88 15.29 25 66760 98832 79578771
Bradycardia 27.86 15.29 44 66741 135513 79542090
Coma 27.74 15.29 26 66759 100623 79576980
Diffuse large B-cell lymphoma 27.73 15.29 42 66743 12107 79665496
Renal salt-wasting syndrome 27.59 15.29 13 66772 703 79676900
Impaired healing 27.43 15.29 20 66765 87635 79589968
Postictal state 27.35 15.29 18 66767 1871 79675732
Systemic infection 27.07 15.29 37 66748 9715 79667888
Myelitis transverse 26.86 15.29 18 66767 1929 79675674
Cystoid macular oedema 26.58 15.29 18 66767 1962 79675641
Electrocardiogram QT prolonged 26.53 15.29 22 66763 90364 79587239
Muscle necrosis 26.39 15.29 16 66769 1442 79676161
Dry mouth 26.37 15.29 21 66764 87998 79589605
Injection site swelling 26.33 15.29 4 66781 47128 79630475
Coronary artery disease 26.18 15.29 11 66774 65463 79612140
Hyperbilirubinaemia 25.96 15.29 61 66724 24457 79653146
Unmasking of previously unidentified disease 25.96 15.29 18 66767 2039 79675564
Obstruction gastric 25.96 15.29 17 66768 1753 79675850
Cardiac cirrhosis 25.91 15.29 9 66776 218 79677385
Metastases to spleen 25.77 15.29 12 66773 632 79676971
Post thrombotic syndrome 25.61 15.29 12 66773 641 79676962
Cardio-respiratory arrest 25.50 15.29 32 66753 108478 79569125
Paraneoplastic pemphigus 25.05 15.29 8 66777 148 79677455
Carcinoembryonic antigen increased 24.81 15.29 18 66767 2191 79675412
Enterocolitis infectious 24.79 15.29 20 66765 2849 79674754
Stress cardiomyopathy 24.64 15.29 38 66747 11128 79666475
Testicular disorder 24.58 15.29 9 66776 255 79677348
Cognitive disorder 24.54 15.29 14 66771 69912 79607691
Aortic thrombosis 24.18 15.29 16 66769 1679 79675924
Malignant ascites 23.97 15.29 14 66771 1178 79676425
Chest discomfort 23.73 15.29 50 66735 137994 79539609
Road traffic accident 23.73 15.29 4 66781 43660 79633943
Metastatic neoplasm 23.69 15.29 25 66760 5017 79672586
Gastrointestinal obstruction 23.53 15.29 16 66769 1756 79675847
Ovarian cancer recurrent 23.29 15.29 10 66775 434 79677169
Metastases to abdominal wall 23.22 15.29 8 66777 189 79677414
Chronic coronary syndrome 23.10 15.29 7 66778 108 79677495
Hepatic infection 23.01 15.29 13 66772 1027 79676576
Ischaemia 22.97 15.29 31 66754 8044 79669559
Swollen tongue 22.91 15.29 4 66781 42566 79635037
Portal vein stenosis 22.82 15.29 5 66780 18 79677585
Laryngospasm 22.77 15.29 22 66763 3975 79673628
Metastases to meninges 22.77 15.29 21 66764 3580 79674023
Hallucination 22.64 15.29 23 66762 85722 79591881
Gastric perforation 22.59 15.29 22 66763 4015 79673588
Intestinal perforation 22.57 15.29 47 66738 17379 79660224
Splenic infarction 22.46 15.29 21 66764 3643 79673960
Acquired gene mutation 22.39 15.29 17 66768 2216 79675387
Histiocytic necrotising lymphadenitis 22.36 15.29 6 66779 58 79677545
Thrombophlebitis 22.24 15.29 27 66758 6308 79671295
Gastrooesophageal reflux disease 22.22 15.29 33 66752 104213 79573390
Treatment noncompliance 22.19 15.29 8 66777 52260 79625343
Tumour associated fever 22.00 15.29 12 66773 885 79676718
Respiratory failure 21.97 15.29 240 66545 180671 79496932
Sedation 21.93 15.29 8 66777 51887 79625716
Lymphangitis 21.82 15.29 14 66771 1394 79676209
Hypoaesthesia 21.79 15.29 77 66708 179275 79498328
Acute kidney injury 21.73 15.29 579 66206 518825 79158778
Scleroderma-like reaction 21.69 15.29 7 66778 134 79677469
Adenoviral hepatitis 21.63 15.29 12 66773 915 79676688
Metastases to skin 21.44 15.29 15 66770 1724 79675879
Red blood cell sedimentation rate increased 21.33 15.29 6 66779 45936 79631667
Metastases to chest wall 21.33 15.29 10 66775 535 79677068
Gastrointestinal perforation 21.29 15.29 26 66759 6111 79671492
Adenovirus reactivation 21.20 15.29 9 66776 380 79677223
Neutropenic infection 21.14 15.29 17 66768 2410 79675193
Granulocyte-colony stimulating factor level increased 21.10 15.29 4 66781 5 79677598
Pruritus 21.06 15.29 220 66565 394428 79283175
Granulocyte count decreased 20.91 15.29 15 66770 1793 79675810
Delirium 20.90 15.29 24 66761 84603 79593000
Generalised oedema 20.90 15.29 55 66730 23654 79653949
Incorrect dose administered 20.87 15.29 20 66765 76610 79600993
Flank pain 20.61 15.29 49 66736 19795 79657808
Thrombotic thrombocytopenic purpura 20.50 15.29 26 66759 6350 79671253
Pleural mass 20.47 15.29 6 66779 82 79677521
Livedo reticularis 20.45 15.29 21 66764 4082 79673521
Vascular pseudoaneurysm ruptured 20.29 15.29 7 66778 166 79677437
Ilium fracture 20.28 15.29 8 66777 279 79677324
Metastases to bladder 20.28 15.29 8 66777 279 79677324
Leukaemic lymphoma 20.27 15.29 6 66779 85 79677518
Metastases to the mediastinum 20.25 15.29 10 66775 600 79677003
Thrombocytosis 20.21 15.29 30 66755 8496 79669107
Discontinued product administered 20.02 15.29 6 66779 89 79677514
Back pain 19.94 15.29 161 66624 304019 79373584
Mediastinum neoplasm 19.89 15.29 6 66779 91 79677512
Septic shock 19.85 15.29 173 66612 122628 79554975
Vaginal cellulitis 19.77 15.29 6 66779 93 79677510
Catabolic state 19.71 15.29 6 66779 94 79677509
Unevaluable event 19.69 15.29 11 66774 55574 79622029
Drug dependence 19.54 15.29 5 66780 40764 79636839
Blood creatine phosphokinase increased 19.50 15.29 16 66769 66074 79611529
Hypersensitivity 19.47 15.29 134 66651 262105 79415498
Vascular purpura 19.46 15.29 18 66767 3080 79674523
Hiccups 19.20 15.29 32 66753 9999 79667604
Bacillus infection 19.19 15.29 12 66773 1143 79676460
Febrile bone marrow aplasia 19.12 15.29 37 66748 12983 79664620
Head injury 19.07 15.29 4 66781 37365 79640238
Epistaxis 19.03 15.29 159 66626 111356 79566247
Amnesia 18.94 15.29 15 66770 63042 79614561
Burning sensation 18.84 15.29 13 66772 58619 79618984
Pneumonia adenoviral 18.83 15.29 9 66776 503 79677100
Adenosquamous cell lung cancer stage IV 18.81 15.29 4 66781 12 79677591
Transitional cell carcinoma recurrent 18.81 15.29 4 66781 12 79677591
Proteinuria 18.81 15.29 65 66720 32437 79645166
Platelet count increased 18.77 15.29 51 66734 22355 79655248
Metastases to diaphragm 18.76 15.29 5 66780 47 79677556
Drug level increased 18.75 15.29 5 66780 39646 79637957
Product quality issue 18.68 15.29 3 66782 33937 79643666
Medication error 18.60 15.29 18 66767 68624 79608979
Gastric neoplasm 18.51 15.29 8 66777 353 79677250
Erythema 18.50 15.29 276 66509 223014 79454589
Pneumothorax 18.49 15.29 59 66726 28264 79649339
Transaminases increased 18.40 15.29 89 66696 51654 79625949
Hormone receptor positive breast cancer 18.38 15.29 8 66777 359 79677244
Febrile infection 18.28 15.29 18 66767 3328 79674275
Pseudosepsis 18.26 15.29 3 66782 0 79677603
Neoplasm recurrence 18.23 15.29 20 66765 4194 79673409
Dacryostenosis acquired 18.18 15.29 9 66776 543 79677060
Respiratory arrest 18.17 15.29 13 66772 57537 79620066
Blood alkaline phosphatase increased 18.16 15.29 103 66682 63561 79614042
Cardiac disorder 18.10 15.29 17 66768 65740 79611863
Haematuria 18.10 15.29 109 66676 68727 79608876
Influenza like illness 18.08 15.29 20 66765 71687 79605916
Pain in jaw 18.06 15.29 8 66777 46143 79631460
Intestinal metastasis 17.99 15.29 8 66777 378 79677225
Loss of consciousness 17.90 15.29 76 66709 167867 79509736
Renal vein thrombosis 17.89 15.29 9 66776 562 79677041
Renal failure 17.67 15.29 251 66534 200717 79476886
Infusion site thrombosis 17.62 15.29 7 66778 249 79677354
Speech disorder 17.59 15.29 12 66773 54433 79623170
Ureteric fistula 17.54 15.29 4 66781 18 79677585
Lymphadenopathy mediastinal 17.53 15.29 20 66765 4376 79673227
BRAF gene mutation 17.51 15.29 5 66780 62 79677541
Gastrointestinal disorder 17.28 15.29 49 66736 122156 79555447
Duodenal obstruction 17.26 15.29 8 66777 417 79677186
Splenic marginal zone lymphoma 17.22 15.29 5 66780 66 79677537
Ovarian cancer metastatic 17.18 15.29 9 66776 612 79676991
Q fever 17.18 15.29 7 66778 266 79677337
Emotional distress 17.17 15.29 6 66779 39963 79637640
Dyskinesia 17.15 15.29 8 66777 44765 79632838
Basal cell carcinoma 17.14 15.29 5 66780 37370 79640233
Acute erythroid leukaemia 16.98 15.29 7 66778 274 79677329
Hydronephrosis 16.95 15.29 42 66743 17412 79660191
Ureteric compression 16.94 15.29 7 66778 276 79677327
Thrombophlebitis migrans 16.87 15.29 8 66777 439 79677164
Oropharyngeal pain 16.86 15.29 42 66743 109311 79568292
Subdural haematoma 16.81 15.29 3 66782 31431 79646172
Therapeutic product effect incomplete 16.77 15.29 187 66598 141458 79536145
Metastases to stomach 16.73 15.29 7 66778 285 79677318
Tumour thrombosis 16.66 15.29 6 66779 162 79677441
Blood disorder 16.66 15.29 27 66758 8246 79669357
Herpes zoster 16.60 15.29 33 66752 93050 79584553
Dyspepsia 16.56 15.29 42 66743 108645 79568958
Necrosis 16.48 15.29 29 66756 9464 79668139
Peripheral artery occlusion 16.34 15.29 15 66770 2542 79675061
Bone trimming 16.31 15.29 4 66781 26 79677577
Haemoptysis 16.24 15.29 91 66694 55908 79621695
Thyroglobulin increased 16.22 15.29 5 66780 82 79677521
Embolism arterial 16.21 15.29 12 66773 1506 79676097
Molluscum contagiosum 16.19 15.29 8 66777 481 79677122
Musculoskeletal pain 16.02 15.29 39 66746 102315 79575288
Peritoneal disorder 15.76 15.29 9 66776 726 79676877
Oroticaciduria 15.72 15.29 3 66782 4 79677599
Tumour fistulisation 15.69 15.29 4 66781 31 79677572
Heart rate irregular 15.68 15.29 4 66781 32675 79644928
Recurrent cancer 15.68 15.29 15 66770 2678 79674925
Haemobilia 15.61 15.29 8 66777 520 79677083
Lymphoedema 15.52 15.29 33 66752 12380 79665223
Pancreatic abscess 15.48 15.29 5 66780 96 79677507
Chronic obstructive pulmonary disease 15.48 15.29 30 66755 85389 79592214
Incorrect route of product administration 15.42 15.29 5 66780 34924 79642679
Platelet toxicity 15.32 15.29 3 66782 5 79677598
Metastases to muscle 15.32 15.29 7 66778 353 79677250

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 | Suggest Off label Use Form| |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
Thymidylate synthase Enzyme WOMBAT-PK
Deoxycytidine kinase Kinase 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
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 0409-0181 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 0409-0182 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 0409-0183 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 0409-0185 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 0409-0186 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 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 16729-092 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 16729-117 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 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 16729-391 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 16729-419 INJECTION, SOLUTION 100 mg INTRAVENOUS NDA 26 sections
GEMCITABINE HUMAN PRESCRIPTION DRUG LABEL 1 16729-423 INJECTION, SOLUTION 100 mg INTRAVENOUS NDA 26 sections