gemcitabine 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | 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 µM/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
BA (Bioavailability) 10 %

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
kinase-safety-class ACVR2B,CAMK2D,CDK5,EIF2AK3,GRK2,ITK,PDK1,PDK2,PRKDC 9
kinase-selectivity-class MAP2K6 1
pfas-class PFAS structural alert (1 = True, 0 = False) 1

Approvals:

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

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 2957.66 16.85 1585 54627 155030 90417205
Malignant neoplasm progression 1744.32 16.85 984 55228 105886 90466349
Thrombocytopenia 1450.14 16.85 1127 55085 207598 90364637
Neutropenia 1127.78 16.85 1006 55206 223898 90348337
Thrombotic microangiopathy 960.36 16.85 363 55849 15380 90556855
Myelosuppression 802.01 16.85 467 55745 53124 90519111
Neoplasm progression 733.46 16.85 413 55799 44073 90528162
Anaemia 704.26 16.85 974 55238 351828 90220407
Metastases to liver 500.73 16.85 277 55935 28530 90543705
Off label use 439.66 16.85 1586 54626 1100666 89471569
Pancytopenia 416.67 16.85 440 55772 119823 90452412
Haematotoxicity 381.08 16.85 176 56036 12359 90559876
Leukopenia 335.55 16.85 361 55851 100349 90471886
Febrile neutropenia 317.58 16.85 439 55773 157910 90414325
Diffuse large B-cell lymphoma recurrent 307.66 16.85 106 56106 3420 90568815
Platelet count decreased 304.03 16.85 399 55813 136570 90435665
Myelodysplastic syndrome 301.48 16.85 178 56034 20725 90551510
Metastases to lung 297.83 16.85 161 56051 15830 90556405
Neuropathy peripheral 296.29 16.85 394 55818 136576 90435659
Neutrophil count decreased 278.86 16.85 279 55933 71253 90500982
Cholangitis 276.51 16.85 119 56093 7063 90565172
Metastases to bone 264.08 16.85 176 56036 25329 90546906
Ascites 257.19 16.85 223 55989 47517 90524718
Acute myeloid leukaemia 257.09 16.85 160 56052 20480 90551755
Joint swelling 252.43 16.85 15 56197 503285 90068950
Cytopenia 229.37 16.85 140 56072 17309 90554926
Pleural effusion 228.19 16.85 313 55899 111678 90460557
Metastases to lymph nodes 226.95 16.85 121 56091 11568 90560667
Death 212.80 16.85 694 55518 455857 90116378
Therapy partial responder 208.87 16.85 144 56068 21899 90550336
Rheumatoid arthritis 201.31 16.85 5 56207 362609 90209626
Arthralgia 192.82 16.85 123 56089 778399 89793836
Recall phenomenon 187.36 16.85 52 56160 797 90571438
Capillary leak syndrome 183.95 16.85 68 56144 2699 90569536
Contraindicated product administered 175.49 16.85 5 56207 320134 90252101
Cytokine release syndrome 174.00 16.85 142 56070 27831 90544404
Neurotoxicity 172.85 16.85 127 56085 21340 90550895
Systemic lupus erythematosus 172.02 16.85 14 56198 361882 90210353
Metastases to peritoneum 170.38 16.85 72 56140 4083 90568152
Biliary tract infection 164.92 16.85 47 56165 797 90571438
Second primary malignancy 164.54 16.85 94 56118 10284 90561951
Pyrexia 163.05 16.85 824 55388 659661 89912574
Bone marrow failure 160.50 16.85 144 56068 32077 90540158
Blood lactate dehydrogenase increased 159.96 16.85 131 56081 25801 90546434
Wound 158.18 16.85 7 56205 302973 90269262
Abdominal discomfort 154.15 16.85 52 56160 477276 90094959
Swelling 147.38 16.85 39 56173 419019 90153216
Maternal exposure during pregnancy 146.15 16.85 24 56188 360039 90212196
Weight increased 143.04 16.85 41 56171 417886 90154349
Arthropathy 143.01 16.85 27 56185 366215 90206020
Nasopharyngitis 141.07 16.85 39 56173 407065 90165170
Headache 138.30 16.85 201 56011 862545 89709690
Mucosal inflammation 135.73 16.85 173 56039 57452 90514783
Disease recurrence 134.20 16.85 140 56072 37513 90534722
Musculoskeletal stiffness 131.58 16.85 15 56197 296517 90275718
Posterior reversible encephalopathy syndrome 129.77 16.85 109 56103 22230 90550005
Pericarditis 129.59 16.85 10 56202 270141 90302094
Sepsis 129.21 16.85 320 55892 179494 90392741
Haemolytic uraemic syndrome 126.32 16.85 52 56160 2759 90569476
Asthma 125.06 16.85 6 56206 242154 90330081
Product dose omission issue 123.96 16.85 17 56195 291670 90280565
Hypertransaminasaemia 123.76 16.85 92 56120 15733 90556502
Tumour lysis syndrome 122.81 16.85 80 56132 11072 90561163
Lower respiratory tract infection 121.02 16.85 9 56203 250650 90321585
Sinusitis 118.58 16.85 33 56179 343055 90229180
Psoriatic arthropathy 116.82 16.85 6 56206 228329 90343906
Peripheral swelling 115.43 16.85 56 56156 413050 90159185
Metastases to central nervous system 115.34 16.85 92 56120 17450 90554785
Hepatic failure 114.29 16.85 132 56080 39596 90532639
Folliculitis 112.66 16.85 3 56209 204350 90367885
Palmar-plantar erythrodysaesthesia syndrome 112.27 16.85 111 56101 27912 90544323
Type 2 diabetes mellitus 111.98 16.85 3 56209 203241 90368994
Pain 111.84 16.85 287 55925 996054 89576181
Polyneuropathy 111.57 16.85 94 56118 19247 90552988
Fall 111.22 16.85 82 56130 481728 90090507
Sleep disorder 108.82 16.85 3 56209 198027 90374208
Therapeutic product effect decreased 107.18 16.85 21 56191 277550 90294685
Pulmonary embolism 106.02 16.85 244 55968 130576 90441659
Wheezing 103.24 16.85 13 56199 238067 90334168
Pneumonitis 101.48 16.85 131 56081 44039 90528196
Drug hypersensitivity 99.32 16.85 85 56127 463524 90108711
Injury 98.43 16.85 6 56206 197343 90374892
Mobility decreased 96.74 16.85 19 56193 250715 90321520
Muscle injury 95.88 16.85 3 56209 176651 90395584
Memory impairment 95.43 16.85 7 56205 197237 90374998
Metastasis 93.05 16.85 54 56158 6083 90566152
Lymphoma 90.90 16.85 72 56140 13519 90558716
Impaired healing 89.82 16.85 18 56194 234181 90338054
Blood cholesterol increased 88.64 16.85 12 56200 208000 90364235
Hepatic cytolysis 87.71 16.85 102 56110 30814 90541421
Contusion 87.08 16.85 24 56188 251192 90321043
Diffuse large B-cell lymphoma refractory 86.71 16.85 35 56177 1765 90570470
Hepatic enzyme increased 86.34 16.85 59 56153 360677 90211558
Hepatotoxicity 84.20 16.85 122 56090 45720 90526515
Migraine 83.51 16.85 10 56202 190382 90381853
Pericardial effusion 82.68 16.85 108 56104 36725 90535510
Neutropenic sepsis 82.42 16.85 77 56135 18053 90554182
Exposure during pregnancy 82.21 16.85 23 56189 238387 90333848
Blister 81.83 16.85 28 56184 254970 90317265
Thrombotic thrombocytopenic purpura 80.78 16.85 43 56169 4095 90568140
Insomnia 80.53 16.85 54 56158 333420 90238815
White blood cell count decreased 80.23 16.85 257 55955 166852 90405383
Discomfort 79.97 16.85 35 56177 274300 90297935
Urticaria 79.13 16.85 48 56164 312686 90259549
Interstitial lung disease 78.56 16.85 157 56055 76248 90495987
Alopecia 77.50 16.85 117 56095 494954 90077281
Osteoarthritis 77.26 16.85 14 56198 195716 90376519
Breast cancer metastatic 76.08 16.85 68 56144 15064 90557171
Metastases to skin 74.38 16.85 33 56179 2107 90570128
Arthritis 72.85 16.85 9 56203 167306 90404929
Muscle spasms 72.06 16.85 33 56179 251850 90320385
Breast cancer recurrent 71.92 16.85 44 56168 5459 90566776
Gait inability 71.41 16.85 5 56207 146451 90425784
Liver abscess 70.15 16.85 37 56175 3459 90568776
Cholangitis infective 69.34 16.85 21 56191 444 90571791
Bursitis 68.80 16.85 3 56209 131651 90440584
Haemoglobin decreased 68.78 16.85 239 55973 161717 90410518
Bile duct stenosis 67.50 16.85 29 56183 1713 90570522
Hyperpyrexia 67.21 16.85 40 56172 4721 90567514
PIK3CA-activated mutation 67.06 16.85 26 56186 1178 90571057
Abdominal pain 66.78 16.85 447 55765 395274 90176961
Joint range of motion decreased 65.07 16.85 5 56207 135638 90436597
Hyperbilirubinaemia 64.92 16.85 60 56152 13876 90558359
Drug resistance 64.82 16.85 87 56125 30362 90541873
Product use issue 64.12 16.85 66 56146 329853 90242382
Metastases to bone marrow 63.43 16.85 21 56191 598 90571637
Overdose 62.85 16.85 11 56201 157698 90414537
Dehydration 61.27 16.85 261 55951 194186 90378049
Embolism 60.79 16.85 49 56163 9432 90562803
Hypoalbuminaemia 60.05 16.85 61 56151 15836 90556399
Vomiting 58.71 16.85 746 55466 787547 89784688
Depression 58.56 16.85 60 56152 300541 90271694
Anxiety 57.93 16.85 64 56148 309708 90262527
Metastases to pleura 56.86 16.85 27 56185 2017 90570218
Ovarian cancer recurrent 56.81 16.85 25 56187 1565 90570670
Thrombophlebitis migrans 56.43 16.85 16 56196 266 90571969
Cholestasis 55.88 16.85 89 56123 36210 90536025
Injection site pain 55.84 16.85 19 56193 173680 90398555
Small intestinal obstruction 55.19 16.85 67 56145 21167 90551068
Gait disturbance 54.22 16.85 49 56163 260447 90311788
Microangiopathic haemolytic anaemia 53.97 16.85 20 56192 799 90571436
Deep vein thrombosis 53.47 16.85 151 56061 91469 90480766
Neoplasm recurrence 52.95 16.85 30 56182 3229 90569006
Subacute cutaneous lupus erythematosus 52.94 16.85 31 56181 3551 90568684
Biliary obstruction 52.08 16.85 30 56182 3332 90568903
Proteinuria 51.81 16.85 68 56144 23223 90549012
Urinary tract obstruction 51.46 16.85 26 56186 2223 90570012
Myositis 51.45 16.85 69 56143 24059 90548176
Loss of personal independence in daily activities 51.05 16.85 11 56201 136094 90436141
Pulmonary toxicity 50.55 16.85 48 56164 11483 90560752
Metastases to chest wall 50.23 16.85 18 56194 653 90571582
Retinal toxicity 49.65 16.85 22 56190 1400 90570835
Peripheral sensory neuropathy 49.36 16.85 43 56169 9207 90563028
Injection site erythema 49.08 16.85 3 56209 98499 90473736
Jaundice 49.06 16.85 79 56133 32438 90539797
Confusional state 48.94 16.85 104 56108 386101 90186134
Dizziness 47.00 16.85 197 56015 589087 89983148
Bronchitis 46.99 16.85 18 56194 152909 90419326
Metastases to meninges 46.61 16.85 29 56183 3706 90568529
Pain in extremity 46.41 16.85 135 56077 450394 90121841
Bacterial abdominal infection 46.36 16.85 9 56203 22 90572213
Road traffic accident 46.33 16.85 6 56206 107620 90464615
Cerebral ischaemia 45.73 16.85 37 56175 7159 90565076
Gastritis bacterial 45.35 16.85 12 56200 152 90572083
Acquired gene mutation 45.34 16.85 20 56192 1259 90570976
Myelitis transverse 45.12 16.85 21 56191 1499 90570736
Infusion related reaction 45.06 16.85 122 56090 416658 90155577
Asthenia 44.82 16.85 517 55695 533234 90039001
Immune-mediated hepatic disorder 44.79 16.85 22 56190 1770 90570465
Pancreatic fistula 44.61 16.85 8 56204 10 90572225
Neutropenic infection 44.60 16.85 22 56190 1787 90570448
Pancreatic carcinoma metastatic 44.33 16.85 24 56188 2364 90569871
Hormone receptor positive breast cancer 43.97 16.85 17 56195 764 90571471
Intentional product misuse 43.84 16.85 3 56209 89601 90482634
Dry mouth 42.81 16.85 31 56181 184028 90388207
Epistaxis 42.73 16.85 133 56079 84992 90487243
Hypercholesterolaemia 42.54 16.85 6 56206 100886 90471349
Injection site reaction 42.50 16.85 4 56208 92076 90480159
Carbohydrate antigen 19-9 increased 42.39 16.85 13 56199 287 90571948
Peripheral ischaemia 42.20 16.85 32 56180 5635 90566600
Hepatic function abnormal 41.57 16.85 90 56122 46198 90526037
Dyspepsia 41.56 16.85 37 56175 198123 90374112
Septic shock 40.87 16.85 130 56082 84030 90488205
General physical health deterioration 40.83 16.85 367 55845 354748 90217487
Drug interaction 40.67 16.85 68 56144 276385 90295850
Obesity 40.66 16.85 8 56204 105499 90466736
Liver injury 40.63 16.85 28 56184 170539 90401696
Product use in unapproved indication 40.47 16.85 351 55861 335885 90236350
EGFR gene mutation 40.42 16.85 13 56199 337 90571898
Hepatitis B core antibody positive 40.38 16.85 13 56199 338 90571897
BRCA2 gene mutation 40.31 16.85 10 56202 96 90572139
Extremity necrosis 40.08 16.85 21 56191 1936 90570299
Atypical haemolytic uraemic syndrome 40.06 16.85 17 56195 974 90571261
Dry gangrene 39.77 16.85 15 56197 630 90571605
Capillary permeability increased 39.53 16.85 8 56204 26 90572209
Immune effector cell-associated neurotoxicity syndrome 39.52 16.85 31 56181 5737 90566498
Acute kidney injury 39.36 16.85 336 55876 320051 90252184
Treatment failure 39.19 16.85 81 56131 303847 90268388
Wound infection 39.09 16.85 9 56203 106393 90465842
Adverse drug reaction 38.85 16.85 12 56200 116689 90455546
Gastrointestinal toxicity 38.84 16.85 38 56174 9429 90562806
Performance status decreased 38.29 16.85 27 56185 4253 90567982
Amnesia 38.26 16.85 10 56202 108495 90463740
Gastrointestinal disorder 37.89 16.85 63 56149 256624 90315611
Peripheral venous disease 37.81 16.85 4 56208 83917 90488318
Pseudocirrhosis 37.51 16.85 16 56196 928 90571307
Hypersensitivity 37.47 16.85 150 56062 454527 90117708
Erythema 37.43 16.85 257 55955 228989 90343246
Skin toxicity 37.16 16.85 32 56180 6747 90565488
Somnolence 37.12 16.85 45 56167 209039 90363196
Joint stiffness 37.08 16.85 3 56209 78039 90494196
Red blood cell sedimentation rate increased 37.05 16.85 4 56208 82591 90489644
Toxic erythema of chemotherapy 36.75 16.85 11 56201 223 90572012
Diffuse large B-cell lymphoma 36.03 16.85 35 56177 8610 90563625
Bone marrow infiltration 35.89 16.85 15 56197 827 90571408
Neoplasm 35.16 16.85 35 56177 8868 90563367
Nausea 35.01 16.85 918 55294 1109398 89462837
Colitis 34.84 16.85 109 56103 69833 90502402
Hospitalisation 34.76 16.85 18 56194 128082 90444153
Cardiotoxicity 34.71 16.85 39 56173 11350 90560885
Suicidal ideation 34.65 16.85 3 56209 73852 90498383
Oedema peripheral 34.62 16.85 276 55936 257639 90314596
Hypokalaemia 34.55 16.85 167 56045 130949 90441286
Acute respiratory distress syndrome 34.47 16.85 63 56149 28623 90543612
Device occlusion 33.94 16.85 35 56177 9247 90562988
Hypoaesthesia 33.92 16.85 92 56120 314118 90258117
Gastrooesophageal reflux disease 33.76 16.85 32 56180 166305 90405930
Lower limb fracture 33.71 16.85 6 56206 85007 90487228
Musculoskeletal pain 33.53 16.85 34 56178 171217 90401018
Granulocyte count decreased 33.05 16.85 20 56192 2432 90569803
Feeling abnormal 32.98 16.85 33 56179 167202 90405033
High grade B-cell lymphoma Burkitt-like lymphoma recurrent 32.71 16.85 8 56204 72 90572163
Rash 32.68 16.85 326 55886 795774 89776461
Adverse event 32.61 16.85 16 56196 117402 90454833
Pseudocellulitis 32.54 16.85 9 56203 136 90572099
Hyperphosphataemia 32.25 16.85 23 56189 3688 90568547
Pulmonary alveolar haemorrhage 32.24 16.85 28 56184 5970 90566265
Malaise 32.19 16.85 222 55990 585764 89986471
Medical device site thrombosis 32.14 16.85 8 56204 78 90572157
Decreased appetite 32.13 16.85 366 55846 376174 90196061
Laryngospasm 32.10 16.85 22 56190 3311 90568924
Bacteraemia 32.04 16.85 53 56159 22247 90549988
Intestinal perforation 31.61 16.85 41 56171 13840 90558395
Hepatic lesion 31.54 16.85 27 56185 5646 90566589
Carcinoembryonic antigen increased 31.25 16.85 19 56193 2331 90569904
Metastatic neoplasm 31.11 16.85 25 56187 4790 90567445
Metastases to diaphragm 31.11 16.85 7 56205 42 90572193
Duodenal obstruction 31.10 16.85 10 56202 259 90571976
Systemic candida 30.46 16.85 25 56187 4934 90567301
Cardiac cirrhosis 30.33 16.85 9 56203 177 90572058
Illness 29.98 16.85 7 56205 81962 90490273
Cholangitis acute 29.71 16.85 12 56200 606 90571629
Paraneoplastic pemphigus 29.63 16.85 8 56204 110 90572125
Cataract 28.78 16.85 5 56207 72087 90500148
Thrombocytosis 28.53 16.85 28 56184 6973 90565262
Cardiac failure acute 28.37 16.85 36 56176 11893 90560342
Night sweats 28.26 16.85 23 56189 128743 90443492
Renal-limited thrombotic microangiopathy 27.96 16.85 9 56203 234 90572001
Recurrent cancer 27.96 16.85 18 56194 2441 90569794
Febrile bone marrow aplasia 27.40 16.85 32 56180 9706 90562529
Hydronephrosis 27.26 16.85 36 56176 12366 90559869
Skin mass 27.13 16.85 28 56184 7402 90564833
Mediastinum neoplasm 27.03 16.85 7 56205 81 90572154
Anaphylactic shock 26.72 16.85 60 56152 31557 90540678
Pulmonary fibrosis 26.47 16.85 17 56195 107486 90464749
Biliary dilatation 26.36 16.85 18 56194 2693 90569542
Blood disorder 26.03 16.85 28 56184 7762 90564473
Fluid retention 26.02 16.85 11 56201 88080 90484155
Pruritus 26.00 16.85 213 55999 541312 90030923
Ovarian cancer metastatic 25.99 16.85 13 56199 1088 90571147
Medication error 25.94 16.85 10 56202 84642 90487593
Transfusion-associated dyspnoea 25.87 16.85 6 56206 42 90572193
Postictal state 25.86 16.85 14 56198 1379 90570856
Blood bilirubin increased 25.70 16.85 72 56140 43398 90528837
Tumour associated fever 25.67 16.85 10 56202 459 90571776
Carbohydrate antigen 125 increased 25.56 16.85 19 56193 3247 90568988
Transferrin 25.54 16.85 4 56208 0 90572235
Disseminated intravascular coagulation 25.49 16.85 47 56165 21491 90550744
Cognitive disorder 25.24 16.85 6 56206 69401 90502834
Lymphatic duct injury 25.16 16.85 6 56206 48 90572187
Nephropathy toxic 25.11 16.85 35 56177 12653 90559582
Systemic infection 25.08 16.85 22 56190 4753 90567482
Hepatic mass 24.91 16.85 16 56196 2161 90570074
Multiple organ dysfunction syndrome 24.90 16.85 96 56116 68240 90503995
Myeloid leukaemia 24.68 16.85 10 56202 509 90571726
Rhinorrhoea 24.57 16.85 12 56200 88304 90483931
Intentional product use issue 24.55 16.85 62 56150 216830 90355405
Wrong technique in product usage process 24.47 16.85 7 56205 71564 90500671
Respiratory failure 24.45 16.85 141 56071 118277 90453958
Rhabdoid tumour 24.44 16.85 6 56206 55 90572180
Immune-mediated hypothyroidism 24.39 16.85 14 56198 1544 90570691
Lymphangitis 24.30 16.85 12 56200 977 90571258
Osteoporosis 24.13 16.85 15 56197 96516 90475719
Metastases to spleen 24.09 16.85 8 56204 230 90572005
Metastases to bladder 24.02 16.85 8 56204 232 90572003
Condition aggravated 23.93 16.85 245 55967 595300 89976935
Tumour marker abnormal 23.93 16.85 9 56203 375 90571860
Hyponatraemia 23.77 16.85 153 56059 133385 90438850
Follicular lymphoma 23.75 16.85 9 56203 383 90571852
Gastric pneumatosis 23.70 16.85 5 56207 21 90572214
Carbohydrate antigen 15-3 increased 23.58 16.85 15 56197 1992 90570243
Inflammation 23.51 16.85 47 56165 178545 90393690
Haemobilia 23.34 16.85 7 56205 143 90572092
Portal vein occlusion 23.33 16.85 5 56207 23 90572212
Underdose 23.27 16.85 3 56209 54014 90518221
Metastases to spine 23.27 16.85 19 56193 3724 90568511
Hypercalcaemia of malignancy 23.16 16.85 8 56204 260 90571975
Blood alkaline phosphatase increased 23.09 16.85 74 56138 48005 90524230
Abdominal pain upper 23.03 16.85 117 56095 332557 90239678
Pneumocystis jirovecii pneumonia 22.91 16.85 45 56167 21571 90550664
Gastrointestinal perforation 22.84 16.85 20 56192 4312 90567923
Alanine aminotransferase increased 22.56 16.85 138 56074 118200 90454035
Acute erythroid leukaemia 22.43 16.85 7 56205 164 90572071
Blood pressure fluctuation 22.37 16.85 3 56209 52410 90519825
Renal salt-wasting syndrome 22.37 16.85 9 56203 450 90571785
Nasal congestion 22.22 16.85 12 56200 83402 90488833
Nephrotic syndrome 22.14 16.85 25 56187 7314 90564921
Leukaemic lymphoma 22.12 16.85 6 56206 84 90572151
Retinopathy 22.10 16.85 18 56194 3516 90568719
Hypocalcaemia 22.00 16.85 67 56145 42301 90529934
Hepatic cancer recurrent 21.89 16.85 7 56205 178 90572057
Jaundice cholestatic 21.84 16.85 29 56183 10014 90562221
Generalised oedema 21.83 16.85 41 56171 19012 90553223
Bacillus infection 21.69 16.85 11 56201 948 90571287
Lymphadenopathy 21.58 16.85 70 56142 45705 90526530
Bile duct cancer recurrent 21.50 16.85 4 56208 7 90572228
Renal failure 21.44 16.85 147 56065 130860 90441375
Laryngitis 21.43 16.85 3 56209 50750 90521485
Biliary sepsis 21.40 16.85 11 56201 975 90571260
Vaginal cellulitis 21.26 16.85 6 56206 98 90572137
Stress 21.26 16.85 12 56200 81383 90490852
Ischaemia 21.25 16.85 21 56191 5274 90566961
Tumour necrosis 21.24 16.85 11 56201 990 90571245
Gastric neoplasm 21.21 16.85 8 56204 336 90571899
Metastases to heart 20.92 16.85 7 56205 206 90572029
Haemoglobinaemia 20.77 16.85 6 56206 107 90572128
Heart rate decreased 20.73 16.85 4 56208 53501 90518734
Influenza 20.70 16.85 34 56178 139230 90433005
Intestinal metastasis 20.61 16.85 7 56205 216 90572019
Immune-mediated hepatitis 20.56 16.85 16 56196 2928 90569307
Anisocytosis 20.52 16.85 10 56202 791 90571444
Escherichia infection 20.49 16.85 36 56176 15859 90556376
Chills 20.37 16.85 146 56066 131835 90440400
Vena cava thrombosis 20.32 16.85 15 56197 2537 90569698
IIIrd nerve paralysis 20.16 16.85 10 56202 822 90571413
Liver scan abnormal 20.16 16.85 5 56207 48 90572187
Catabolic state 20.16 16.85 5 56207 48 90572187
Adenosquamous cell lung cancer stage IV 20.01 16.85 4 56208 12 90572223
Sedation 19.99 16.85 3 56209 48168 90524067
Suicide attempt 19.86 16.85 11 56201 75388 90496847
Haemolytic anaemia 19.85 16.85 30 56182 11667 90560568
Cardiac failure 19.82 16.85 126 56086 109370 90462865
Metastases to stomach 19.80 16.85 7 56205 244 90571991
Blepharospasm 19.76 16.85 5 56207 55440 90516795
Splenic marginal zone lymphoma 19.71 16.85 5 56207 53 90572182
Ectropion 19.69 16.85 7 56205 248 90571987
Neutrophil count abnormal 19.67 16.85 18 56194 4110 90568125
Tumour marker increased 19.63 16.85 21 56191 5786 90566449
Intestinal obstruction 19.55 16.85 59 56153 37072 90535163
Pancreatic carcinoma 19.48 16.85 25 56187 8352 90563883
Peritoneal disorder 19.42 16.85 9 56203 636 90571599
Nephritis 19.40 16.85 16 56196 3179 90569056
Pneumothorax 19.23 16.85 39 56173 19128 90553107
Scleroderma-like reaction 19.21 16.85 6 56206 141 90572094
Paresis cranial nerve 19.16 16.85 3 56209 0 90572235
Pseudosepsis 19.16 16.85 3 56209 0 90572235
Purtscher retinopathy 19.09 16.85 6 56206 144 90572091
Enterocutaneous fistula 19.08 16.85 12 56200 1562 90570673
Disease susceptibility 19.05 16.85 7 56205 273 90571962
Gastrointestinal ulcer haemorrhage 19.03 16.85 10 56202 928 90571307
Cardiomyopathy 18.96 16.85 40 56172 20166 90552069
Blood pressure increased 18.91 16.85 61 56151 197156 90375079
Renal impairment 18.89 16.85 121 56091 105300 90466935
Hypophagia 18.82 16.85 57 56155 35880 90536355
Pelvic venous thrombosis 18.78 16.85 13 56199 1988 90570247
Onychomadesis 18.78 16.85 3 56209 45995 90526240
Swollen tongue 18.76 16.85 3 56209 45953 90526282
Gastric perforation 18.72 16.85 13 56199 1998 90570237
Neck pain 18.70 16.85 26 56186 113937 90458298
Malignant ascites 18.69 16.85 10 56202 962 90571273
Metastases to adrenals 18.63 16.85 10 56202 968 90571267
Osteonecrosis of jaw 18.61 16.85 60 56152 39043 90533192
Acute monocytic leukaemia 18.57 16.85 6 56206 158 90572077
Lymphangiosis carcinomatosa 18.42 16.85 12 56200 1660 90570575
Febrile infection 18.39 16.85 13 56199 2056 90570179
Hallucination 18.29 16.85 9 56203 65950 90506285
Organising pneumonia 18.18 16.85 23 56189 7574 90564661
Post transplant lymphoproliferative disorder 18.18 16.85 22 56190 6927 90565308
Mixed liver injury 18.12 16.85 23 56189 7600 90564635
Urinary tract infection enterococcal 18.10 16.85 15 56197 3001 90569234
Ejection fraction decreased 18.06 16.85 46 56166 26207 90546028
Nail disorder 18.06 16.85 7 56205 59060 90513175
Neoplasm malignant 17.99 16.85 54 56158 33826 90538409
Metastases to abdominal wall 17.92 16.85 6 56206 177 90572058
Ureteric fistula 17.92 16.85 4 56208 23 90572212
Intussusception 17.83 16.85 10 56202 1055 90571180
Metastases to pancreas 17.75 16.85 7 56205 332 90571903
Respiratory disorder 17.74 16.85 9 56203 64807 90507428
Aspartate aminotransferase increased 17.74 16.85 117 56095 102820 90469415
Neutropenic colitis 17.69 16.85 17 56195 4126 90568109
Bronchostenosis 17.68 16.85 8 56204 535 90571700
Blast cells present 17.55 16.85 8 56204 544 90571691
Lymphoedema 17.54 16.85 31 56181 13722 90558513
Left ventricular dysfunction 17.35 16.85 32 56180 14637 90557598
Hypomagnesaemia 17.30 16.85 55 56157 35533 90536702
Hypothyroidism 17.24 16.85 72 56140 53055 90519180
Pseudomonal sepsis 17.15 16.85 17 56195 4285 90567950
Foetal exposure during pregnancy 17.11 16.85 3 56209 42972 90529263
COVID-19 pneumonia 17.08 16.85 36 56176 18141 90554094
Colitis ulcerative 17.05 16.85 8 56204 60258 90511977
Water intoxication 17.03 16.85 8 56204 583 90571652
Rash maculo-papular 17.00 16.85 60 56152 40873 90531362
Hyperthyroidism 16.90 16.85 36 56176 18274 90553961

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 2447.71 16.52 1740 50433 141916 42427246
Thrombocytopenia 968.05 16.52 1175 50998 189104 42380058
Myelosuppression 693.62 16.52 494 51679 39967 42529195
Malignant neoplasm progression 674.96 16.52 744 51429 107656 42461506
Neutropenia 542.42 16.52 915 51258 198516 42370646
Neoplasm progression 496.60 16.52 354 51819 28646 42540516
Thrombotic microangiopathy 464.97 16.52 265 51908 14517 42554645
Cholangitis 427.82 16.52 225 51948 10502 42558660
Off label use 392.16 16.52 1676 50497 636659 41932503
Pancytopenia 391.86 16.52 593 51580 117150 42452012
Anaemia 359.07 16.52 945 51228 279333 42289829
Haematotoxicity 345.61 16.52 197 51976 10788 42558374
Therapy partial responder 289.90 16.52 221 51952 19800 42549362
Diffuse large B-cell lymphoma recurrent 288.78 16.52 134 52039 4752 42564410
Leukopenia 249.09 16.52 377 51796 74369 42494793
Febrile neutropenia 222.86 16.52 612 51561 185091 42384071
Neuropathy peripheral 211.96 16.52 417 51756 101436 42467726
Cytokine release syndrome 172.08 16.52 241 51932 44286 42524876
Pyrexia 171.56 16.52 940 51233 393102 42176060
Neutrophil count decreased 170.27 16.52 290 51883 63125 42506037
Neutropenic sepsis 163.44 16.52 144 52029 15802 42553360
Pneumonitis 155.58 16.52 222 51951 41496 42527666
Product dose omission issue 141.46 16.52 13 52160 154352 42414810
Platelet count decreased 141.18 16.52 431 51742 138150 42431012
Interstitial lung disease 136.99 16.52 299 51874 78163 42490999
Haemolytic uraemic syndrome 125.12 16.52 61 52112 2418 42566744
Liver abscess 112.04 16.52 72 52101 4898 42564264
Cytopenia 111.77 16.52 122 52051 17375 42551787
General physical health deterioration 106.43 16.52 416 51757 150830 42418332
Diffuse large B-cell lymphoma refractory 106.40 16.52 51 52122 1946 42567216
Biliary tract infection 104.84 16.52 39 52134 779 42568383
Metastases to liver 101.10 16.52 112 52061 16214 42552948
Arthralgia 100.05 16.52 64 52109 205174 42363988
Capillary leak syndrome 97.27 16.52 53 52120 2654 42566508
Hypertransaminasaemia 93.89 16.52 83 52090 9144 42560018
Drug interaction 91.10 16.52 116 52057 266883 42302279
Blood lactate dehydrogenase increased 90.24 16.52 134 52039 25947 42543215
Sepsis 84.59 16.52 473 51700 198861 42370301
Bacteraemia 84.27 16.52 127 52046 24913 42544249
Metastases to lung 84.25 16.52 86 52087 11338 42557824
Pancreatic carcinoma metastatic 81.76 16.52 50 52123 3116 42566046
Headache 81.63 16.52 104 52069 239265 42329897
Neurotoxicity 81.08 16.52 121 52052 23530 42545632
Fall 79.86 16.52 102 52071 234418 42334744
Overdose 77.54 16.52 17 52156 105247 42463915
Drug hypersensitivity 77.50 16.52 14 52159 99375 42469787
Disease recurrence 77.32 16.52 134 52039 29544 42539618
Hyperpyrexia 76.64 16.52 50 52123 3490 42565672
Metastases to central nervous system 74.63 16.52 77 52096 10278 42558884
Nasopharyngitis 74.48 16.52 8 52165 83988 42485174
Pancreatic abscess 72.94 16.52 21 52152 177 42568985
Myositis 70.52 16.52 89 52084 14777 42554385
Pseudocellulitis 69.68 16.52 22 52151 261 42568901
Anxiety 69.56 16.52 29 52144 118531 42450631
Biliary obstruction 68.42 16.52 45 52128 3184 42565978
Lymphoma 68.35 16.52 86 52087 14235 42554927
Pulmonary toxicity 67.20 16.52 67 52106 8588 42560574
Insomnia 66.11 16.52 31 52142 118222 42450940
Asthma 60.54 16.52 4 52169 62310 42506852
Seizure 58.14 16.52 38 52135 120523 42448639
Bone marrow failure 57.56 16.52 126 52047 32967 42536195
Product use in unapproved indication 57.14 16.52 404 51769 184052 42385110
Acute myeloid leukaemia 56.03 16.52 99 52074 22157 42547005
Muscle spasms 55.60 16.52 18 52155 86026 42483136
Weight increased 54.89 16.52 32 52141 107951 42461211
Depression 53.83 16.52 35 52138 111328 42457834
Hospitalisation 52.75 16.52 13 52160 74317 42494845
Injection site pain 52.54 16.52 5 52168 57793 42511369
Myalgia 52.45 16.52 26 52147 96054 42473108
Somnolence 51.56 16.52 58 52115 141047 42428115
Deep vein thrombosis 51.08 16.52 208 51965 76749 42492413
Pancreatic enzyme abnormality 50.54 16.52 14 52159 101 42569061
Bicytopenia 50.18 16.52 37 52136 3147 42566015
Renal-limited thrombotic microangiopathy 50.07 16.52 17 52156 257 42568905
Drug ineffective 48.77 16.52 1059 51114 629138 41940024
Joint swelling 48.07 16.52 12 52161 68010 42501152
Feeling abnormal 48.00 16.52 13 52160 69773 42499389
White blood cell count decreased 47.42 16.52 263 51910 110133 42459029
Suicidal ideation 47.05 16.52 3 52170 48158 42521004
Vena cava thrombosis 46.42 16.52 27 52146 1534 42567628
Plasma cell myeloma 46.37 16.52 3 52170 47575 42521587
Blood pressure increased 45.36 16.52 35 52138 101893 42467269
Atypical haemolytic uraemic syndrome 44.84 16.52 19 52154 540 42568622
Tremor 44.79 16.52 32 52141 96897 42472265
Psoriasis 44.73 16.52 4 52169 48600 42520562
Sleep disorder 44.15 16.52 4 52169 48091 42521071
Second primary malignancy 43.32 16.52 56 52117 9519 42559643
Coronary artery disease 43.11 16.52 7 52166 53713 42515449
Enterocolitis infectious 42.90 16.52 28 52145 1955 42567207
Pancreatic carcinoma recurrent 42.80 16.52 12 52161 91 42569071
Peripheral ischaemia 42.77 16.52 46 52127 6439 42562723
Ascites 42.32 16.52 159 52014 56519 42512643
Asthenia 42.27 16.52 527 51646 280266 42288896
Carbohydrate antigen 19-9 increased 42.08 16.52 15 52158 264 42568898
Decreased appetite 41.35 16.52 389 51784 192748 42376414
Bradycardia 41.12 16.52 27 52146 85457 42483705
Diffuse large B-cell lymphoma 40.77 16.52 54 52119 9400 42559762
Agitation 40.59 16.52 14 52159 64300 42504862
Immune-mediated hepatitis 40.50 16.52 35 52138 3739 42565423
Tumour lysis syndrome 40.20 16.52 86 52087 22145 42547017
Pleural effusion 40.07 16.52 229 51944 96937 42472225
Pulmonary embolism 39.97 16.52 267 51906 119345 42449817
Condition aggravated 39.22 16.52 175 51998 260579 42308583
Wheezing 38.06 16.52 10 52163 54771 42514391
Cardiac disorder 37.90 16.52 7 52166 48925 42520237
Lymphadenopathy 36.94 16.52 107 52066 33258 42535904
Incorrect dose administered 36.18 16.52 10 52163 52964 42516198
Pancreatic carcinoma 36.01 16.52 51 52122 9455 42559707
Abdominal discomfort 35.88 16.52 24 52149 75231 42493931
Biliary sepsis 35.74 16.52 19 52154 905 42568257
Ill-defined disorder 35.36 16.52 68 52105 16228 42552934
Memory impairment 35.21 16.52 9 52164 50213 42518949
Influenza 35.19 16.52 16 52157 62159 42507003
Toxicity to various agents 34.91 16.52 153 52020 228983 42340179
Cardiac failure congestive 34.88 16.52 32 52141 85570 42483592
Mucosal inflammation 34.79 16.52 136 52037 49238 42519924
Loss of personal independence in daily activities 34.79 16.52 9 52164 49807 42519355
Electrocardiogram QT prolonged 34.77 16.52 8 52165 47937 42521225
Thrombophlebitis migrans 34.49 16.52 14 52159 356 42568806
Rhabdomyolysis 34.44 16.52 27 52146 77992 42491170
Pain in extremity 34.42 16.52 84 52089 150520 42418642
Peripheral swelling 34.18 16.52 36 52137 90234 42478928
Right ventricular ejection fraction decreased 33.92 16.52 9 52164 54 42569108
Recall phenomenon 33.63 16.52 16 52157 600 42568562
Angioedema 33.06 16.52 6 52167 42471 42526691
Metastatic lymphoma 33.00 16.52 14 52159 399 42568763
Inappropriate schedule of product administration 32.28 16.52 42 52131 95860 42473302
Palpitations 32.15 16.52 11 52162 50786 42518376
Azotaemia 32.10 16.52 38 52135 5906 42563256
Myocardial infarction 31.74 16.52 65 52108 123944 42445218
Cholangitis infective 31.72 16.52 13 52160 339 42568823
Nausea 31.55 16.52 670 51503 396129 42173033
Metastases to peritoneum 31.03 16.52 25 52148 2424 42566738
Chronic myelomonocytic leukaemia 30.39 16.52 16 52157 747 42568415
Gastrointestinal toxicity 29.42 16.52 30 52143 3949 42565213
Urosepsis 29.37 16.52 60 52113 14960 42554202
Parasitic gastroenteritis 29.34 16.52 10 52163 153 42569009
Hallucination 29.27 16.52 17 52156 57490 42511672
Wrong technique in product usage process 29.21 16.52 8 52165 42627 42526535
Chills 29.05 16.52 206 51967 93860 42475302
Balance disorder 29.00 16.52 11 52162 47634 42521528
Device occlusion 28.62 16.52 43 52130 8407 42560755
Hepatocellular injury 28.22 16.52 78 52095 23600 42545562
Unmasking of previously unidentified disease 28.18 16.52 18 52155 1211 42567951
Colitis 27.87 16.52 122 52051 46450 42522712
Histiocytic necrotising lymphadenitis 27.66 16.52 6 52167 12 42569150
Urticaria 27.50 16.52 30 52143 74006 42495156
Immune-mediated myocarditis 27.49 16.52 22 52151 2112 42567050
PIK3CA-activated mutation 27.48 16.52 9 52164 121 42569041
Retinopathy haemorrhagic 27.42 16.52 8 52165 71 42569091
Jaundice cholestatic 27.41 16.52 33 52140 5220 42563942
Vision blurred 27.15 16.52 16 52157 53683 42515479
Pneumocystis jirovecii pneumonia 27.15 16.52 80 52093 25101 42544061
Coma 27.01 16.52 16 52157 53538 42515624
Exposure to radiation 26.94 16.52 8 52165 76 42569086
Dizziness 26.70 16.52 187 51986 249067 42320095
Vomiting 26.59 16.52 500 51673 289223 42279939
Pruritus 26.40 16.52 130 52043 188641 42380521
Hyperhidrosis 26.21 16.52 44 52129 90468 42478694
Skin toxicity 26.10 16.52 36 52137 6513 42562649
Peripheral sensory neuropathy 26.07 16.52 42 52131 8720 42560442
Embolism 26.06 16.52 42 52131 8721 42560441
Haemoglobin decreased 25.95 16.52 262 51911 132209 42436953
Discontinued product administered 25.95 16.52 6 52167 18 42569144
Extremity necrosis 25.89 16.52 22 52151 2297 42566865
Malaise 25.86 16.52 153 52020 212003 42357159
Metastases to lymph nodes 25.46 16.52 34 52139 5964 42563198
Gait disturbance 25.39 16.52 51 52122 97949 42471213
Hypertension 25.23 16.52 112 52061 167092 42402070
Pain 24.63 16.52 187 51986 244661 42324501
Dry mouth 24.61 16.52 9 52164 39870 42529292
Prostate cancer 24.47 16.52 12 52161 44631 42524531
Microangiopathic haemolytic anaemia 24.34 16.52 16 52157 1131 42568031
Visceral venous thrombosis 24.23 16.52 6 52167 26 42569136
Disseminated intravascular coagulation 24.13 16.52 76 52097 24718 42544444
Irritability 24.12 16.52 3 52170 28125 42541037
Metastases to chest wall 23.97 16.52 10 52163 273 42568889
Disturbance in attention 23.72 16.52 4 52169 29862 42539300
Bile duct necrosis 23.52 16.52 7 52166 67 42569095
Arthropathy 23.43 16.52 4 52169 29593 42539569
Nasal congestion 23.32 16.52 4 52169 29497 42539665
Tumour pseudoprogression 23.14 16.52 15 52158 1035 42568127
Adenoviral hepatitis 23.06 16.52 12 52161 547 42568615
Drug dependence 22.88 16.52 4 52169 29090 42540072
Necrotic angiodermatitis 22.83 16.52 4 52169 0 42569162
Therapy non-responder 22.80 16.52 127 52046 53232 42515930
Nephropathy toxic 22.63 16.52 58 52115 16780 42552382
Cardiotoxicity 22.58 16.52 36 52137 7409 42561753
Sedation 22.27 16.52 5 52168 30470 42538692
Dry skin 22.26 16.52 16 52157 48322 42520840
Hypotension 22.19 16.52 205 51968 257426 42311736
Peritoneal lesion 21.97 16.52 8 52165 150 42569012
Erythropenia 21.91 16.52 9 52164 236 42568926
Biliary abscess 21.82 16.52 6 52167 42 42569120
Flushing 21.79 16.52 9 52164 37019 42532143
Malignant ascites 21.57 16.52 12 52161 626 42568536
Cardio-respiratory arrest 21.51 16.52 24 52149 58612 42510550
Unresponsive to stimuli 21.31 16.52 6 52167 31397 42537765
Heart rate decreased 21.30 16.52 9 52164 36523 42532639
Septic shock 21.28 16.52 188 51985 91484 42477678
Macular oedema 21.26 16.52 24 52149 3545 42565617
Immune effector cell-associated neurotoxicity syndrome 21.17 16.52 40 52133 9421 42559741
Migraine 21.10 16.52 3 52170 25411 42543751
Adenovirus reactivation 20.78 16.52 10 52163 385 42568777
Unevaluable event 20.72 16.52 8 52165 34280 42534882
Erectile dysfunction 20.55 16.52 3 52170 24910 42544252
Contusion 20.54 16.52 13 52160 41972 42527190
Heart rate increased 20.42 16.52 21 52152 53234 42515928
Hyperfibrinogenaemia 20.25 16.52 7 52166 112 42569050
Chest discomfort 20.25 16.52 29 52144 63587 42505575
Vibrio vulnificus infection 20.06 16.52 4 52169 4 42569158
Influenza like illness 19.97 16.52 7 52166 31833 42537329
Ototoxicity 19.92 16.52 19 52154 2306 42566856
Biloma 19.92 16.52 7 52166 118 42569044
Chronic obstructive pulmonary disease 19.87 16.52 29 52144 63085 42506077
Ureteric compression 19.85 16.52 9 52164 302 42568860
Myeloblast count increased 19.77 16.52 5 52168 24 42569138
Peripheral artery occlusion 19.73 16.52 17 52156 1809 42567353
Thyroglobulin increased 19.61 16.52 5 52168 25 42569137
Granulocyte-colony stimulating factor level increased 19.59 16.52 4 52169 5 42569157
Norovirus infection 19.52 16.52 12 52161 755 42568407
Immune-mediated enterocolitis 19.39 16.52 29 52144 5648 42563514
Treatment noncompliance 19.36 16.52 11 52162 37661 42531501
Arthritis 19.27 16.52 14 52159 42051 42527111
Metabolic acidosis 19.27 16.52 21 52152 51837 42517325
Loss of consciousness 19.19 16.52 54 52119 92300 42476862
Hypoalbuminaemia 19.18 16.52 52 52121 15558 42553604
Cardiac arrest 19.16 16.52 69 52104 109251 42459911
Psychotic disorder 19.05 16.52 6 52167 29202 42539960
Hepatorenal failure 18.96 16.52 11 52162 622 42568540
Dermatitis acneiform 18.93 16.52 34 52139 7705 42561457
Sinusitis 18.88 16.52 18 52155 47274 42521888
Molluscum contagiosum 18.66 16.52 9 52164 348 42568814
Metabolic disorder 18.60 16.52 26 52147 4762 42564400
Subdural haematoma 18.59 16.52 3 52170 23135 42546027
Duodenal stenosis 18.59 16.52 9 52164 351 42568811
Pneumonia acinetobacter 18.57 16.52 8 52165 237 42568925
Drug ineffective for unapproved indication 18.49 16.52 108 52065 46055 42523107
Muscle necrosis 18.42 16.52 13 52160 1032 42568130
Illness 18.40 16.52 4 52169 24926 42544236
Obstructive airways disorder 18.21 16.52 4 52169 24755 42544407
Ilium fracture 18.06 16.52 7 52166 157 42569005
Toxic erythema of chemotherapy 17.98 16.52 7 52166 159 42569003
Pneumonia adenoviral 17.84 16.52 9 52164 384 42568778
Drug level increased 17.79 16.52 5 52168 26195 42542967
Eastern Cooperative Oncology Group performance status worsened 17.70 16.52 14 52159 1322 42567840
Product prescribing error 17.70 16.52 5 52168 26107 42543055
Blood bilirubin increased 17.67 16.52 100 52073 42152 42527010
Radiation hepatitis 17.49 16.52 5 52168 41 42569121
Metastasis 17.46 16.52 25 52148 4680 42564482
Mobility decreased 17.18 16.52 11 52162 35295 42533867
Testicular disorder 17.15 16.52 12 52161 940 42568222
Portal vein stenosis 17.12 16.52 3 52170 0 42569162
Pancreatitis viral 17.06 16.52 4 52169 13 42569149
Necrotising oesophagitis 16.94 16.52 12 52161 959 42568203
Blood glucose increased 16.91 16.52 41 52132 73658 42495504
Autoimmune hypothyroidism 16.89 16.52 7 52166 188 42568974
Metastases to bone 16.88 16.52 48 52125 14761 42554401
Resorption bone increased 16.87 16.52 8 52165 298 42568864
Ventricular fibrillation 16.66 16.52 8 52165 30115 42539047
Gastroenteritis radiation 16.62 16.52 8 52165 308 42568854
Transaminases increased 16.61 16.52 82 52091 32803 42536359

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 4226.37 16.24 2611 91931 241423 110253334
Thrombocytopenia 2411.39 16.24 2149 92393 346736 110148021
Malignant neoplasm progression 1855.80 16.24 1384 93158 173183 110321574
Myelosuppression 1844.68 16.24 1094 93448 93246 110401511
Neutropenia 1534.27 16.24 1739 92803 372881 110121876
Thrombotic microangiopathy 1513.22 16.24 655 93887 28494 110466263
Anaemia 1037.02 16.24 1751 92791 545335 109949422
Neoplasm progression 953.31 16.24 627 93915 63968 110430789
Pancytopenia 815.26 16.24 949 93593 208664 110286093
Cholangitis 721.81 16.24 328 94214 16007 110478750
Haematotoxicity 650.91 16.24 331 94211 20751 110474006
Off label use 601.04 16.24 2697 91845 1497488 108997269
Neuropathy peripheral 548.88 16.24 720 93822 178557 110316200
Leukopenia 535.67 16.24 648 93894 148143 110346614
Febrile neutropenia 518.10 16.24 952 93590 315815 110178942
Therapy partial responder 466.08 16.24 326 94216 36735 110458022
Diffuse large B-cell lymphoma recurrent 446.72 16.24 177 94365 6122 110488635
Platelet count decreased 444.57 16.24 745 93797 229698 110265059
Neutrophil count decreased 438.93 16.24 529 94013 120412 110374345
Metastases to liver 418.91 16.24 300 94242 35086 110459671
Cytokine release syndrome 370.37 16.24 374 94168 69932 110424825
Pyrexia 349.86 16.24 1605 92937 896660 109598097
Arthralgia 314.25 16.24 137 94405 779495 109715262
Joint swelling 300.45 16.24 20 94522 442825 110051932
Metastases to lung 297.26 16.24 206 94336 22857 110471900
Cytopenia 284.39 16.24 223 94319 29893 110464864
Acute myeloid leukaemia 276.08 16.24 242 94300 37868 110456889
Pneumonitis 274.67 16.24 333 94209 76198 110418559
Capillary leak syndrome 266.70 16.24 114 94428 4794 110489963
Biliary tract infection 261.17 16.24 85 94457 1639 110493118
Interstitial lung disease 248.08 16.24 435 94107 138899 110355858
Headache 239.75 16.24 241 94301 882136 109612621
Haemolytic uraemic syndrome 235.77 16.24 105 94437 4880 110489877
Nasopharyngitis 225.62 16.24 34 94508 394327 110100430
Ascites 224.33 16.24 333 94209 92475 110402282
Rheumatoid arthritis 220.73 16.24 8 94534 299605 110195152
Disease recurrence 218.94 16.24 265 94277 60519 110434238
Hypertransaminasaemia 217.00 16.24 174 94368 24081 110470676
Neutropenic sepsis 210.28 16.24 189 94353 30557 110464200
Neurotoxicity 206.78 16.24 216 94326 41991 110452766
Metastases to lymph nodes 204.90 16.24 139 94403 14893 110479864
Recall phenomenon 204.08 16.24 67 94475 1329 110493428
Musculoskeletal stiffness 197.75 16.24 10 94532 279812 110214945
Myelodysplastic syndrome 196.60 16.24 199 94343 37285 110457472
Weight increased 195.54 16.24 58 94484 419586 110075171
Sepsis 192.09 16.24 666 93876 326680 110168077
Product dose omission issue 188.08 16.24 26 94516 321756 110173001
Blood lactate dehydrogenase increased 187.61 16.24 210 94332 44124 110450633
Bone marrow failure 187.17 16.24 239 94303 57609 110437148
Abdominal discomfort 182.47 16.24 55 94487 393803 110100954
Liver abscess 180.95 16.24 101 94441 7638 110487119
Asthma 179.91 16.24 8 94534 250283 110244474
Second primary malignancy 179.73 16.24 138 94404 17930 110476827
Pleural effusion 178.13 16.24 438 94104 177271 110317486
Fall 176.42 16.24 154 94388 603328 109891429
Systemic lupus erythematosus 173.83 16.24 11 94531 254327 110240430
Drug hypersensitivity 173.07 16.24 86 94456 454004 110040753
Wound 170.14 16.24 7 94535 234430 110260327
Contraindicated product administered 168.90 16.24 11 94531 248256 110246501
Peripheral swelling 167.30 16.24 68 94474 403966 110090791
Metastases to bone 165.34 16.24 167 94375 31205 110463552
Arthropathy 161.65 16.24 26 94516 287496 110207261
Pain 161.09 16.24 362 94180 954593 109540164
Swelling 155.53 16.24 53 94489 350988 110143769
Metastases to central nervous system 155.51 16.24 140 94402 22677 110472080
Insomnia 155.39 16.24 57 94485 360533 110134224
Wheezing 153.03 16.24 19 94523 255211 110239546
Metastases to peritoneum 152.79 16.24 81 94461 5529 110489228
Tumour lysis syndrome 151.53 16.24 158 94384 30643 110464114
Pemphigus 150.54 16.24 8 94534 214562 110280195
Diffuse large B-cell lymphoma refractory 148.45 16.24 62 94480 2459 110492298
Hyperpyrexia 148.11 16.24 90 94452 7979 110486778
Sleep disorder 147.34 16.24 5 94537 198639 110296118
Pulmonary embolism 145.03 16.24 458 94084 214016 110280741
Maternal exposure during pregnancy 143.38 16.24 23 94519 254860 110239897
Sinusitis 141.86 16.24 39 94503 296649 110198108
Muscle spasms 141.84 16.24 32 94510 278125 110216632
Myositis 134.41 16.24 149 94393 30967 110463790
Duodenal ulcer perforation 133.48 16.24 4 94538 177696 110317061
Bacteraemia 132.20 16.24 172 94370 42218 110452539
Mucosal inflammation 131.14 16.24 268 94274 95873 110398884
Mobility decreased 130.06 16.24 23 94519 237399 110257358
White blood cell count decreased 129.52 16.24 461 94081 228929 110265828
Overdose 129.49 16.24 22 94520 233772 110260985
Anxiety 128.97 16.24 67 94475 345011 110149746
Contusion 126.98 16.24 23 94519 233338 110261419
Memory impairment 124.80 16.24 12 94530 196932 110297825
General physical health deterioration 124.06 16.24 702 93840 424593 110070164
Pulmonary toxicity 123.14 16.24 110 94432 17636 110477121
Biliary obstruction 123.08 16.24 70 94472 5488 110489269
Therapeutic product effect decreased 122.78 16.24 29 94513 244287 110250470
Pericarditis 118.35 16.24 22 94520 219092 110275665
Injury 117.24 16.24 9 94533 177256 110317501
Type 2 diabetes mellitus 117.21 16.24 9 94533 177223 110317534
Osteoarthritis 113.44 16.24 12 94530 182611 110312146
Blood cholesterol increased 112.62 16.24 13 94529 184772 110309985
Lower respiratory tract infection 110.64 16.24 35 94507 243071 110251686
Depression 108.04 16.24 69 94473 317266 110177491
Urticaria 104.95 16.24 72 94470 318785 110175972
Drug ineffective 104.03 16.24 1849 92693 1518691 108976066
Folliculitis 101.65 16.24 12 94530 167641 110327116
Impaired healing 101.54 16.24 22 94520 196695 110298062
Pseudocellulitis 101.42 16.24 30 94512 415 110494342
Migraine 99.94 16.24 14 94528 171638 110323119
Deep vein thrombosis 99.39 16.24 304 94238 139583 110355174
Discomfort 99.34 16.24 30 94512 214677 110280080
Exposure during pregnancy 99.04 16.24 13 94529 167411 110327346
Pancreatic carcinoma metastatic 96.42 16.24 54 94488 4110 110490647
Intentional product misuse 96.30 16.24 4 94538 132900 110361857
Blister 96.13 16.24 37 94505 227339 110267418
Dry mouth 96.08 16.24 26 94516 199922 110294835
Psoriasis 95.79 16.24 6 94536 139987 110354770
Drug interaction 94.81 16.24 177 94365 500006 109994751
Injection site pain 93.68 16.24 19 94523 177903 110316854
C-reactive protein abnormal 93.65 16.24 4 94538 129691 110365066
Product use in unapproved indication 91.95 16.24 676 93866 446701 110048056
Hepatic cytolysis 90.38 16.24 166 94376 54887 110439870
Gait inability 89.96 16.24 7 94535 136369 110358388
Extremity necrosis 89.93 16.24 50 94492 3752 110491005
Pain in extremity 88.30 16.24 177 94365 486941 110007816
Embolism 88.19 16.24 88 94454 16201 110478556
Posterior reversible encephalopathy syndrome 86.85 16.24 125 94417 33736 110461021
Arthritis 85.97 16.24 19 94523 167567 110327190
Peripheral ischaemia 85.69 16.24 73 94469 10985 110483772
Hepatic enzyme increased 85.32 16.24 89 94453 320803 110173954
Atypical haemolytic uraemic syndrome 84.43 16.24 36 94506 1504 110493253
Joint range of motion decreased 84.02 16.24 5 94537 121827 110372930
Cholangitis infective 82.73 16.24 30 94512 809 110493948
Dizziness 80.33 16.24 316 94226 697877 109796880
Renal-limited thrombotic microangiopathy 78.90 16.24 26 94516 522 110494235
Feeling abnormal 78.75 16.24 28 94514 180683 110314074
Metastasis 75.41 16.24 60 94482 8207 110486550
Haemoglobin decreased 75.36 16.24 415 94127 248312 110246445
Loss of personal independence in daily activities 74.97 16.24 18 94524 150002 110344755
Bile duct stenosis 73.90 16.24 39 94503 2637 110492120
Septic shock 73.50 16.24 298 94244 157230 110337527
Microangiopathic haemolytic anaemia 73.34 16.24 35 94507 1908 110492849
Immune effector cell-associated neurotoxicity syndrome 73.01 16.24 76 94466 14706 110480051
Lip dry 72.54 16.24 3 94539 100080 110394677
Peripheral sensory neuropathy 72.25 16.24 80 94462 16600 110478157
Skin toxicity 71.95 16.24 68 94474 11715 110483042
Gait disturbance 70.81 16.24 80 94462 278128 110216629
Hepatotoxicity 70.74 16.24 163 94379 63237 110431520
Immune-mediated hepatitis 70.59 16.24 53 94489 6658 110488099
Pancreatic abscess 70.58 16.24 19 94523 182 110494575
Palmar-plantar erythrodysaesthesia syndrome 70.26 16.24 126 94416 40899 110453858
Road traffic accident 69.49 16.24 6 94536 107392 110387365
Malaise 68.69 16.24 318 94224 671501 109823256
Asthenia 68.53 16.24 894 93648 688105 109806652
Hepatic failure 68.35 16.24 169 94373 68570 110426187
Cardiotoxicity 68.06 16.24 78 94464 16803 110477954
Colitis 67.72 16.24 217 94325 102106 110392651
Injection site erythema 67.67 16.24 3 94539 94173 110400584
Product use issue 67.63 16.24 101 94441 311594 110183163
Sciatica 66.21 16.24 3 94539 92396 110402361
Pericardial effusion 65.94 16.24 149 94393 57068 110437689
Somnolence 65.89 16.24 95 94447 297354 110197403
Nasal congestion 64.95 16.24 5 94537 98277 110396480
Injection site reaction 63.47 16.24 3 94539 89067 110405690
Hypoalbuminaemia 62.96 16.24 99 94443 28875 110465882
Thrombophlebitis migrans 62.85 16.24 24 94518 750 110494007
Carbohydrate antigen 19-9 increased 62.84 16.24 22 94520 534 110494223
Infusion related reaction 62.81 16.24 146 94396 381016 110113741
Decreased appetite 62.69 16.24 652 93890 475194 110019563
Bicytopenia 61.76 16.24 49 94493 6675 110488082
Suicidal ideation 61.45 16.24 5 94537 93932 110400825
Device occlusion 60.95 16.24 70 94472 15115 110479642
Hospitalisation 60.53 16.24 23 94519 142470 110352287
Drug resistance 59.69 16.24 142 94400 56232 110438525
Peripheral venous disease 59.41 16.24 3 94539 84114 110410643
Hypercholesterolaemia 58.97 16.24 5 94537 90832 110403925
Subacute cutaneous lupus erythematosus 58.30 16.24 42 94500 4952 110489805
Musculoskeletal pain 57.99 16.24 43 94499 182980 110311777
Neoplasm recurrence 56.55 16.24 42 94500 5190 110489567
Prescribed overdose 56.37 16.24 5 94537 87576 110407181
Gastrointestinal toxicity 56.29 16.24 58 94484 11090 110483667
Gastrooesophageal reflux disease 56.11 16.24 43 94499 179933 110314824
Stress 55.97 16.24 11 94531 105337 110389420
Blood pressure increased 55.77 16.24 84 94458 258289 110236468
Bronchitis 55.00 16.24 33 94509 156999 110337758
Suicide attempt 54.50 16.24 11 94531 103383 110391374
Polyneuropathy 54.41 16.24 98 94444 31914 110462843
Biliary sepsis 54.15 16.24 28 94514 1815 110492942
Rhinorrhoea 53.96 16.24 11 94531 102655 110392102
Obesity 53.95 16.24 15 94527 113336 110381421
Product quality issue 53.83 16.24 3 94539 77296 110417461
Toxic erythema of chemotherapy 53.16 16.24 18 94524 394 110494363
Dyspepsia 52.98 16.24 51 94491 190914 110303843
Abdominal pain upper 52.61 16.24 140 94402 348971 110145786
Lymphadenopathy 51.31 16.24 145 94397 63690 110431067
Hypoaesthesia 51.24 16.24 121 94421 314102 110180655
Acute kidney injury 50.93 16.24 794 93748 634636 109860121
Disseminated intravascular coagulation 50.37 16.24 110 94432 41176 110453581
Chills 49.27 16.24 305 94237 190275 110304482
Confusional state 48.95 16.24 220 94322 468460 110026297
Thrombocytosis 48.56 16.24 52 94490 10392 110484365
Hypersensitivity 48.22 16.24 180 94362 403818 110090939
Lymphoma 48.16 16.24 72 94470 20099 110474658
Pancreatic enzyme abnormality 47.92 16.24 14 94528 185 110494572
Pancreatic carcinoma recurrent 47.37 16.24 14 94528 193 110494564
Illness 47.13 16.24 7 94535 82164 110412593
Immune-mediated myocarditis 46.85 16.24 32 94510 3466 110491291
Immune-mediated hepatic disorder 46.48 16.24 35 94507 4415 110490342
Alopecia 45.86 16.24 159 94383 364594 110130163
Metastases to skin 45.71 16.24 27 94515 2272 110492485
Hepatocellular injury 45.66 16.24 120 94422 50522 110444235
Pneumocystis jirovecii pneumonia 45.62 16.24 108 94434 42627 110452130
Cerebral ischaemia 45.58 16.24 54 94488 12050 110482707
Gastrointestinal disorder 45.45 16.24 86 94456 241866 110252891
Retinal toxicity 45.31 16.24 24 94518 1635 110493122
Jaundice cholestatic 45.11 16.24 59 94483 14549 110480208
Blood bilirubin increased 44.82 16.24 155 94387 75817 110418940
Hyperbilirubinaemia 44.79 16.24 88 94454 30583 110464174
Amnesia 44.79 16.24 17 94525 105391 110389366
Urosepsis 44.78 16.24 88 94454 30587 110464170
Pancreatic fistula 44.30 16.24 12 94530 118 110494639
Diffuse large B-cell lymphoma 44.19 16.24 61 94481 15837 110478920
Red blood cell sedimentation rate increased 44.15 16.24 7 94535 78295 110416462
Influenza 43.69 16.24 48 94494 169053 110325704
Wound infection 43.67 16.24 14 94528 96451 110398306
Metastases to bone marrow 43.64 16.24 20 94522 994 110493763
Vomiting 43.62 16.24 1052 93490 909623 109585134
Angioedema 43.35 16.24 15 94527 98485 110396272
Jaundice 43.24 16.24 130 94412 59106 110435651
Condition aggravated 43.08 16.24 411 94131 734425 109760332
Cholestasis 42.84 16.24 137 94405 64381 110430376
Pancreatic carcinoma 42.75 16.24 58 94484 14814 110479943
Performance status decreased 42.59 16.24 41 94501 7225 110487532
Breast cancer metastatic 42.30 16.24 50 94492 11131 110483626
Plasma cell myeloma 42.16 16.24 3 94539 62933 110431824
Breast cancer recurrent 41.85 16.24 31 94511 3815 110490942
Medication error 41.54 16.24 19 94523 105347 110389410
Thrombotic thrombocytopenic purpura 41.45 16.24 40 94502 7071 110487686
Injection site swelling 41.23 16.24 3 94539 61787 110432970
PIK3CA-activated mutation 41.14 16.24 17 94525 656 110494101
Acute respiratory distress syndrome 40.97 16.24 119 94423 53079 110441678
Hepatic function abnormal 40.90 16.24 168 94374 89127 110405630
Hypercalcaemia of malignancy 40.57 16.24 16 94526 546 110494211
Respiratory failure 40.57 16.24 319 94223 215013 110279744
Metastases to pleura 40.42 16.24 24 94518 2039 110492718
EGFR gene mutation 40.35 16.24 16 94526 554 110494203
Myalgia 40.07 16.24 81 94461 222300 110272457
Palpitations 39.18 16.24 47 94495 159165 110335592
Nephropathy toxic 39.11 16.24 78 94464 27400 110467357
Disturbance in attention 38.68 16.24 4 94538 61991 110432766
Bacterial abdominal infection 38.50 16.24 9 94533 45 110494712
Tremor 37.87 16.24 72 94470 202160 110292597
Heart rate decreased 37.48 16.24 12 94530 82744 110412013
Incorrect dose administered 37.39 16.24 21 94521 103620 110391137
Swollen tongue 37.39 16.24 4 94538 60358 110434399
Wrong technique in product usage process 37.26 16.24 14 94528 87334 110407423
Cholangitis acute 36.82 16.24 22 94520 1891 110492866
Abdominal pain 36.60 16.24 629 93913 512360 109982397
Visceral venous thrombosis 36.52 16.24 8 94534 28 110494729
Aggression 36.48 16.24 4 94538 59206 110435551
Right ventricular ejection fraction decreased 36.05 16.24 9 94533 62 110494695
Metastases to meninges 36.00 16.24 32 94510 5096 110489661
Pseudocirrhosis 35.98 16.24 17 94525 906 110493851
Pruritus 35.90 16.24 321 94221 581239 109913518
Duodenal obstruction 35.80 16.24 14 94528 467 110494290
Organising pneumonia 35.68 16.24 52 94490 14191 110480566
Blepharospasm 35.65 16.24 3 94539 54848 110439909
Erythropenia 35.63 16.24 14 94528 473 110494284
Sedation 35.52 16.24 8 94534 69675 110425082
Incorrect route of product administration 35.51 16.24 6 94536 64055 110430702
Immune-mediated hypothyroidism 35.45 16.24 25 94517 2850 110491907
Proteinuria 35.24 16.24 94 94448 39924 110454833
Inappropriate schedule of product administration 35.15 16.24 76 94466 203561 110291196
Death 35.15 16.24 813 93729 698056 109796701
Renal impairment 34.85 16.24 278 94264 188167 110306590
Nausea 34.77 16.24 1337 93205 1234353 109260404
Myelitis transverse 34.63 16.24 23 94519 2378 110492379
Malignant ascites 34.60 16.24 19 94523 1391 110493366
Granulocyte count decreased 34.46 16.24 28 94514 3946 110490811
Tumour necrosis 34.33 16.24 23 94519 2413 110492344
Hypophagia 34.26 16.24 111 94431 52515 110442242
Small intestinal obstruction 33.94 16.24 81 94461 32132 110462625
Seizure 33.83 16.24 88 94454 221097 110273660
Urinary tract obstruction 33.77 16.24 31 94511 5146 110489611
Dry gangrene 33.69 16.24 17 94525 1047 110493710
Inflammation 33.45 16.24 72 94470 193166 110301591
Hepatic infection 33.25 16.24 18 94524 1281 110493476
Vena cava thrombosis 33.25 16.24 26 94516 3468 110491289
Bradycardia 33.12 16.24 51 94491 155466 110339291
Dehydration 33.05 16.24 375 94167 279136 110215621
Underdose 33.00 16.24 7 94535 63547 110431210
Macular oedema 32.95 16.24 35 94507 6931 110487826
Muscle necrosis 32.87 16.24 20 94522 1777 110492980
Cognitive disorder 32.64 16.24 17 94525 87494 110407263
Intentional product use issue 32.55 16.24 106 94436 247800 110246957
Oedema peripheral 32.38 16.24 426 94116 328234 110166523
Metastatic neoplasm 32.29 16.24 32 94510 5841 110488916
Transaminases increased 32.04 16.24 123 94419 63267 110431490
Hallucination 31.91 16.24 24 94518 101408 110393349
Metastatic lymphoma 31.90 16.24 14 94528 628 110494129
Postictal state 31.87 16.24 22 94520 2424 110492333
Aortic thrombosis 31.70 16.24 21 94521 2162 110492595
BRCA2 gene mutation 31.67 16.24 9 94533 107 110494650
Haemobilia 31.67 16.24 14 94528 639 110494118
Electrocardiogram QT prolonged 31.52 16.24 28 94514 108932 110385825
Coronary artery disease 31.41 16.24 11 94531 71679 110423078
Carcinoembryonic antigen increased 31.26 16.24 23 94519 2801 110491956
Metastases to chest wall 31.20 16.24 14 94528 662 110494095
Capillary permeability increased 31 16.24 8 94534 64 110494693
Systemic infection 30.85 16.24 40 94502 9779 110484978
Chronic myelomonocytic leukaemia 30.80 16.24 16 94526 1047 110493710
Neck pain 30.66 16.24 36 94506 123094 110371663
Renal salt-wasting syndrome 30.51 16.24 15 94527 873 110493884
Adverse event 30.24 16.24 29 94513 108780 110385977
Epistaxis 30.22 16.24 203 94339 130169 110364588
Fluid retention 30.07 16.24 22 94520 94285 110400472
Coma 29.85 16.24 34 94508 117835 110376922
Blood alkaline phosphatase increased 29.80 16.24 130 94412 70805 110423952
High grade B-cell lymphoma Burkitt-like lymphoma recurrent 29.50 16.24 8 94534 79 110494678
Tumour associated fever 29.48 16.24 16 94526 1145 110493612
Pelvic venous thrombosis 29.45 16.24 22 94520 2742 110492015
Back pain 29.38 16.24 191 94351 370805 110123952
Balance disorder 29.11 16.24 34 94508 116526 110378231
Therapeutic product effect incomplete 29.09 16.24 306 94236 223499 110271258
Parasitic gastroenteritis 28.79 16.24 10 94532 237 110494520
Cardiac failure 28.50 16.24 265 94277 187361 110307396
Azotaemia 28.49 16.24 39 94503 10046 110484711
Dermatitis acneiform 28.45 16.24 44 94498 12651 110482106
Biliary abscess 28.33 16.24 7 94535 46 110494711
Metastases to spleen 28.24 16.24 14 94528 830 110493927
Osteoporosis 28.22 16.24 20 94522 87132 110407625
Drug ineffective for unapproved indication 28.10 16.24 167 94375 102671 110392086
Eastern Cooperative Oncology Group performance status worsened 28.05 16.24 22 94520 2947 110491810
Heart rate increased 28.00 16.24 50 94492 143784 110350973
Retinopathy haemorrhagic 27.57 16.24 8 94534 103 110494654
Tumour pseudoprogression 27.05 16.24 17 94525 1599 110493158
Drug dependence 27.04 16.24 5 94537 50015 110444742
Accidental exposure to product 27.03 16.24 5 94537 50003 110444754
Paraneoplastic pemphigus 27.02 16.24 9 94533 187 110494570
Gastritis bacterial 26.81 16.24 12 94530 564 110494193
Gastrointestinal obstruction 26.52 16.24 19 94523 2221 110492536
Burning sensation 26.48 16.24 13 94529 69199 110425558
Medical device site thrombosis 26.45 16.24 8 94534 120 110494637
Biliary dilatation 26.20 16.24 23 94519 3602 110491155
Metastases to diaphragm 26.20 16.24 7 94535 65 110494692
Haematuria 26.12 16.24 140 94402 82865 110411892
Ovarian cancer metastatic 26.11 16.24 13 94529 778 110493979
Treatment noncompliance 26.03 16.24 15 94527 72975 110421782
Myocardial infarction 26.00 16.24 81 94461 192002 110302755
Obstruction gastric 25.99 16.24 18 94524 1993 110492764
Hepatic lesion 25.76 16.24 34 94508 8459 110486298
Scleroderma-like reaction 25.69 16.24 9 94533 219 110494538
Vascular purpura 25.42 16.24 23 94519 3748 110491009
Recurrent cancer 25.31 16.24 22 94520 3401 110491356
Ovarian cancer recurrent 25.13 16.24 12 94530 655 110494102
Adverse drug reaction 25.08 16.24 32 94510 105527 110389230
Frequent bowel movements 24.99 16.24 15 94527 71375 110423382
Lymphangitis 24.98 16.24 16 94526 1556 110493201
Bile duct necrosis 24.81 16.24 7 94535 81 110494676
Testicular disorder 24.62 16.24 10 94532 369 110494388
Rash maculo-papular 24.60 16.24 127 94415 74095 110420662
Oropharyngeal pain 24.59 16.24 49 94493 135227 110359530
Gastrointestinal perforation 24.41 16.24 31 94511 7425 110487332
Pneumothorax 24.40 16.24 76 94466 35209 110459548
Splenic infarction 24.36 16.24 24 94518 4350 110490407
Transferrin 24.26 16.24 4 94538 0 110494757
Epilepsy 24.21 16.24 30 94512 100179 110394578
Febrile bone marrow aplasia 24.17 16.24 49 94493 17416 110477341
Hypersensitivity pneumonitis 24.10 16.24 26 94516 5239 110489518
Swelling face 24.07 16.24 26 94516 92295 110402462
Hydronephrosis 24.01 16.24 54 94488 20611 110474146
Gastric pneumatosis 23.95 16.24 6 94536 42 110494715
Retroperitoneal neoplasm metastatic 23.71 16.24 6 94536 44 110494713
Hypothyroidism 23.65 16.24 124 94418 72775 110421982
Hormone receptor positive breast cancer 23.64 16.24 11 94531 566 110494191
Cardiac cirrhosis 23.58 16.24 9 94533 281 110494476
Laryngitis 23.45 16.24 4 94538 42407 110452350
Necrosis 23.44 16.24 38 94504 11368 110483389
Drug level increased 23.30 16.24 6 94536 47713 110447044
Loss of consciousness 23.05 16.24 88 94454 196218 110298539
Lymphatic duct injury 23.03 16.24 6 94536 50 110494707
Influenza like illness 22.94 16.24 25 94517 88387 110406370
Speech disorder 22.90 16.24 12 94530 61557 110433200
Ureteric compression 22.88 16.24 9 94533 305 110494452
Cystoid macular oedema 22.76 16.24 19 94523 2781 110491976
Hiccups 22.64 16.24 40 94502 12829 110481928
Rash 22.60 16.24 532 94010 820432 109674325
Ischaemia 22.52 16.24 33 94509 9050 110485707
Mediastinum neoplasm 22.49 16.24 7 94535 116 110494641
Metastases to abdominal wall 22.48 16.24 8 94534 204 110494553
Immune-mediated enterocolitis 22.40 16.24 35 94507 10150 110484607
Night sweats 22.30 16.24 51 94491 133932 110360825
Post thrombotic syndrome 22.16 16.24 11 94531 654 110494103
Thrombophlebitis 22.15 16.24 30 94512 7649 110487108
Metastases to bladder 22.11 16.24 9 94533 334 110494423
Cardiomyopathy 22.08 16.24 71 94471 33454 110461303
Generalised oedema 22.04 16.24 67 94475 30637 110464120
Necrotic angiodermatitis 22.03 16.24 4 94538 3 110494754
Nail disorder 21.99 16.24 11 94531 57924 110436833
Gastric perforation 21.97 16.24 24 94518 4905 110489852
Head injury 21.80 16.24 5 94537 43012 110451745
Myeloid leukaemia 21.67 16.24 12 94530 893 110493864
Cardiac disorder 21.58 16.24 20 94522 76260 110418497
Vibrio vulnificus infection 21.49 16.24 4 94538 4 110494753
Unevaluable event 21.36 16.24 12 94530 59215 110435542
Laryngospasm 21.28 16.24 23 94519 4645 110490112
Bronchostenosis 21.27 16.24 12 94530 926 110493831
Enterocolitis infectious 21.26 16.24 20 94522 3424 110491333
Portal vein stenosis 21.23 16.24 5 94537 26 110494731
COVID-19 pneumonia 21.23 16.24 75 94467 37068 110457689
Histiocytic necrotising lymphadenitis 21.22 16.24 6 94536 70 110494687
Renal failure 21.19 16.24 291 94251 226283 110268474
Anisocytosis 21.08 16.24 13 94529 1183 110493574
Colitis ulcerative 21.06 16.24 21 94521 77342 110417415
Granulocyte-colony stimulating factor level increased 21.02 16.24 4 94538 5 110494752
Abnormal behaviour 20.89 16.24 4 94538 39035 110455722
Duodenal stenosis 20.82 16.24 12 94530 965 110493792
Hypertension 20.72 16.24 309 94233 509775 109984982
Dyskinesia 20.71 16.24 9 94533 51437 110443320
Agranulocytosis 20.69 16.24 106 94436 61654 110433103
Vascular pseudoaneurysm ruptured 20.60 16.24 10 94532 566 110494191
Nephrotic syndrome 20.58 16.24 40 94502 13791 110480966
Pain in jaw 20.53 16.24 9 94533 51168 110443589
Bone erosion 20.51 16.24 7 94535 46364 110448393
Transfusion-associated dyspnoea 20.49 16.24 6 94536 80 110494677
Adenoviral hepatitis 20.42 16.24 12 94530 1000 110493757
Metastases to spine 20.39 16.24 24 94518 5319 110489438
Unmasking of previously unidentified disease 20.34 16.24 18 94524 2850 110491907
Neutropenic infection 20.33 16.24 19 94523 3226 110491531
Haemolytic anaemia 20.33 16.24 51 94491 20869 110473888
Metastases to the mediastinum 20.33 16.24 11 94531 782 110493975
Chronic obstructive pulmonary disease 20.31 16.24 39 94503 109119 110385638
Intestinal perforation 20.30 16.24 51 94491 20893 110473864
Leukaemic lymphoma 20.15 16.24 6 94536 85 110494672
Chest pain 20.14 16.24 215 94327 376160 110118597
Ilium fracture 20.07 16.24 8 94534 281 110494476
Hyperfibrinogenaemia 19.99 16.24 7 94535 170 110494587
Gravitational oedema 19.98 16.24 15 94527 1883 110492874
Irritability 19.83 16.24 8 94534 47801 110446956
Bacillus infection 19.82 16.24 14 94528 1600 110493157
Eye pain 19.80 16.24 9 94533 50090 110444667
Basal cell carcinoma 19.74 16.24 7 94535 45263 110449494
Delirium 19.68 16.24 55 94487 134970 110359787
Portal vein occlusion 19.59 16.24 6 94536 94 110494663
Immune-mediated dermatitis 19.57 16.24 16 94526 2274 110492483
Platelet count increased 19.41 16.24 58 94484 26276 110468481
Bone marrow infiltration 19.40 16.24 11 94531 857 110493900
Vaginal cellulitis 19.36 16.24 6 94536 98 110494659
Abdominal infection 19.31 16.24 22 94520 4709 110490048
Liver injury 19.26 16.24 65 94477 150348 110344409
Product prescribing error 19.10 16.24 10 94532 51321 110443436
Pleural mass 19.08 16.24 6 94536 103 110494654
Lymphocyte count decreased 19.01 16.24 98 94444 57145 110437612
Acquired gene mutation 18.96 16.24 17 94525 2737 110492020
Subdural haematoma 18.96 16.24 4 94538 36450 110458307
Ear pain 18.89 16.24 11 94531 53215 110441542
Eye irritation 18.84 16.24 3 94539 33449 110461308
Adenosquamous cell lung cancer stage IV 18.73 16.24 4 94538 12 110494745
Bile duct cancer recurrent 18.73 16.24 4 94538 12 110494745
Obstructive airways disorder 18.69 16.24 8 94534 46141 110448616
Surgery 18.67 16.24 6 94536 41277 110453480
Discontinued product administered 18.62 16.24 6 94536 112 110494645
Escherichia bacteraemia 18.41 16.24 32 94510 10132 110484625
Gastric neoplasm 18.35 16.24 8 94534 353 110494404
Lupus-like syndrome 18.32 16.24 6 94536 40786 110453971
Cholangiocarcinoma 18.29 16.24 17 94525 2868 110491889
Adenovirus reactivation 18.24 16.24 10 94532 730 110494027
Pseudosepsis 18.20 16.24 3 94539 0 110494757
Peripheral artery occlusion 18.19 16.24 17 94525 2888 110491869
Therapy interrupted 18.11 16.24 10 94532 49812 110444945
Respiratory arrest 18.07 16.24 14 94528 58285 110436472
Rectal haemorrhage 18.07 16.24 48 94494 119785 110374972
Intestinal metastasis 18.05 16.24 9 94533 540 110494217
Follicular lymphoma 18.05 16.24 10 94532 745 110494012
Agitation 18.04 16.24 44 94498 113007 110381750
Myeloblast count increased 17.95 16.24 5 94537 55 110494702
Skin mass 17.90 16.24 31 94511 9785 110484972
Paraneoplastic dermatomyositis 17.89 16.24 7 94535 234 110494523
Limb injury 17.87 16.24 5 94537 37631 110457126
Oroticaciduria 17.84 16.24 4 94538 16 110494741
Emotional distress 17.81 16.24 8 94534 44839 110449918
Cardio-respiratory arrest 17.77 16.24 46 94496 115790 110378967
Carbohydrate antigen 15-3 increased 17.74 16.24 13 94529 1574 110493183
Respiratory depression 17.73 16.24 3 94539 31998 110462759
Sneezing 17.72 16.24 3 94539 31981 110462776
Pneumonia acinetobacter 17.70 16.24 8 94534 385 110494372
Platelet toxicity 17.64 16.24 4 94538 17 110494740
Biloma 17.58 16.24 7 94535 245 110494512
Hallucination, visual 17.48 16.24 6 94536 39599 110455158
Drug reaction with eosinophilia and systemic symptoms 17.40 16.24 27 94515 82068 110412689
Heart rate irregular 17.34 16.24 4 94538 34270 110460487
BRAF gene mutation 17.33 16.24 5 94537 63 110494694
Gastroenteritis viral 17.14 16.24 3 94539 31223 110463534
Dry skin 17.10 16.24 42 94500 107611 110387146
Metastases to heart 16.97 16.24 8 94534 424 110494333
Rib fracture 16.97 16.24 4 94538 33766 110460991
Transitional cell carcinoma recurrent 16.95 16.24 4 94538 21 110494736
Liver scan abnormal 16.91 16.24 5 94537 69 110494688
Molluscum contagiosum 16.86 16.24 9 94533 623 110494134
Onycholysis 16.80 16.24 16 94526 2783 110491974
Pneumonia adenoviral 16.75 16.24 9 94533 631 110494126
Lymphadenopathy mediastinal 16.70 16.24 22 94520 5462 110489295
Respiratory disorder 16.59 16.24 22 94520 71360 110423397
Immune-mediated cholangitis 16.58 16.24 10 94532 874 110493883
Chronic coronary syndrome 16.47 16.24 7 94535 290 110494467
Haemoptysis 16.46 16.24 111 94431 71243 110423514
Lymphangiosis carcinomatosa 16.46 16.24 15 94527 2467 110492290
Eye swelling 16.44 16.24 4 94538 33044 110461713
Myoclonus 16.40 16.24 4 94538 32994 110461763
Diabetes mellitus 16.40 16.24 38 94504 99343 110395414
Pancreatitis viral 16.36 16.24 4 94538 25 110494732
Systemic candida 16.27 16.24 30 94512 9944 110484813
Q fever 16.25 16.24 7 94535 300 110494457

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
MeSH PA D000963 Antimetabolites
MeSH PA D000964 Antimetabolites, Antineoplastic
MeSH PA D000970 Antineoplastic Agents
FDA EPC N0000175595 Nucleoside Metabolic Inhibitor
CHEBI has role CHEBI:35221 antimetabolite
CHEBI has role CHEBI:35610 antineoplastic agent
CHEBI has role CHEBI:35705 immunosuppressive agent
CHEBI has role CHEBI:36044 antiviral drug
CHEBI has role CHEBI:74213 EC 1.17.4.1 (ribonucleoside-diphosphate reductase) inhibitor
CHEBI has role CHEBI:132992 radiosensitizing agent
CHEBI has role CHEBI:149553 anticoronaviral agent
CHEBI has role CHEBI:35474 anxiolytic drug
CHEBI has role CHEBI:35703 xenobiotic
CHEBI has role CHEBI:47868 photosensitizing agent
CHEBI has role CHEBI:50266 prodrug
CHEBI has role CHEBI:59517 DNA synthesis inhibitor
CHEBI has role CHEBI:78298 environmental contaminant

Related Drugs by ATC class:

L01BC Pyrimidine analogues 9 drugs
azacitidinecapecitabinecarmofurcytarabinedecitabinefloxuridinefluorouraciltegafurtrifluridine

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




🐶 Veterinary Drug Use

None

🐶 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)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
EQ 225MG BASE INLEXZO JANSSEN BIOTECH N219683 Sept. 9, 2025 RX SYSTEM INTRAVESICAL 12636300 Nov. 7, 2038 TREATMENT OF BCG-UNRESPONSIVE, NON-MUSCLE INVASIVE BLADDER CANCER BY INTRAVESICAL ADMINISTRATION OF EQ. 225 MG GEMCITIBINE EVERY 3 WEEKS FOR 6 MONTHS FOLLOWED BY EVERY 12 WEEKS FOR UP TO 18 MONTHS

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
EQ 225MG BASE INLEXZO JANSSEN BIOTECH N219683 Sept. 9, 2025 RX SYSTEM INTRAVESICAL Sept. 9, 2028 NEW PRODUCT

Bioactivity Summary:

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

External reference:

IDSource
4024031 VUID
N0000022036 NUI
D01155 KEGG_DRUG
122111-03-9 SECONDARY_CAS_RN
4020975 VANDF
4024031 VANDF
C0045093 UMLSCUI
CHEBI:175901 CHEBI
GEO PDB_CHEM_ID
CHEMBL888 ChEMBL_ID
DB00441 DRUGBANK_ID
CHEMBL1637 ChEMBL_ID
D000093542 MESH_DESCRIPTOR_UI
60750 PUBCHEM_CID
4793 IUPHAR_LIGAND_ID
6515 INN_ID
B76N6SBZ8R UNII
12574 RXNORM
130312 MMSL
35333 MMSL
4777 MMSL
d04010 MMSL
005472 NDDF
005473 NDDF
108811008 SNOMEDCT_US
386920008 SNOMEDCT_US
412187004 SNOMEDCT_US
B76N6SBZ8R INXIGHT DRUGS

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Gemcitabine HUMAN PRESCRIPTION DRUG LABEL 1 0143-9340 INJECTION, SOLUTION 38 mg INTRAVENOUS ANDA 25 sections
Gemcitabine HUMAN PRESCRIPTION DRUG LABEL 1 0143-9341 INJECTION, SOLUTION 38 mg INTRAVENOUS ANDA 25 sections
Gemcitabine HUMAN PRESCRIPTION DRUG LABEL 1 0143-9342 INJECTION, SOLUTION 38 mg INTRAVENOUS ANDA 25 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 29 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 HUMAN PRESCRIPTION DRUG LABEL 1 25021-234 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 200 mg INTRAVENOUS ANDA 25 sections
gemcitabine HUMAN PRESCRIPTION DRUG LABEL 1 25021-235 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 1 g INTRAVENOUS ANDA 25 sections
Gemcitabine HUMAN PRESCRIPTION DRUG LABEL 1 25021-239 INJECTION, SOLUTION 38 mg INTRAVENOUS ANDA 25 sections
gemcitabine HUMAN PRESCRIPTION DRUG LABEL 1 55111-686 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 200 mg INTRAVENOUS ANDA 26 sections
gemcitabine HUMAN PRESCRIPTION DRUG LABEL 1 55111-687 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 1 g INTRAVENOUS ANDA 26 sections
gemcitabine HUMAN PRESCRIPTION DRUG LABEL 1 55390-391 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 40 mg INTRAVENOUS ANDA 25 sections
INLEXZO HUMAN PRESCRIPTION DRUG LABEL 1 57894-225 SYSTEM 225 mg INTRAVESICAL NDA 29 sections
GEMCITABINE HUMAN PRESCRIPTION DRUG LABEL 1 63323-102 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 200 mg INTRAVENOUS ANDA 25 sections
GEMCITABINE HUMAN PRESCRIPTION DRUG LABEL 1 63323-102 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 200 mg INTRAVENOUS ANDA 25 sections
GEMCITABINE HUMAN PRESCRIPTION DRUG LABEL 1 63323-125 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 1 g INTRAVENOUS ANDA 25 sections
GEMCITABINE HUMAN PRESCRIPTION DRUG LABEL 1 63323-125 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 1 g INTRAVENOUS ANDA 25 sections
GEMCITABINE HUMAN PRESCRIPTION DRUG LABEL 1 63323-126 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 2 g INTRAVENOUS ANDA 25 sections
Gemcitabine HUMAN PRESCRIPTION DRUG LABEL 1 67457-616 INJECTION, SOLUTION 200 mg INTRAVENOUS ANDA 27 sections
Gemcitabine HUMAN PRESCRIPTION DRUG LABEL 1 67457-617 INJECTION, SOLUTION 1 g INTRAVENOUS ANDA 27 sections
Gemcitabine HUMAN PRESCRIPTION DRUG LABEL 1 67457-618 INJECTION, SOLUTION 2 g INTRAVENOUS ANDA 27 sections
GEMCITABINE HUMAN PRESCRIPTION DRUG LABEL 1 68001-342 INJECTION, SOLUTION 100 mg INTRAVENOUS NDA 26 sections