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

Stem definitionDrug idCAS RN
antineoplastics, topoisomerase I inhibitors 1482 97682-44-5

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • irinotecan liposome injection
  • onivyde
  • irinotecan liposome
  • irinotecan
  • irinotecan hydrochloride
  • irinotecan hydrochloride hydrate
  • irinotecan hydrochloride trihydrate
  • irinotecan HCl
Irinotecan is a derivative of camptothecin. Camptothecins act as specific inhibitors of the enzyme DNA topoisomerase I. Irinotecan and its active metabolite SN-38 bind reversibly to the topoisomerase I-DNA complex and induce single-strand DNA lesions which block the DNA replication fork and are responsible for the cytotoxicity. Irinotecan is metabolized by carboxylesterase to SN-38. SN-38 is approximately 1000 times as potent as irinotecan as an inhibitor of topoisomerase I purified from human and rodent tumour cell lines.
  • Molecular weight: 586.69
  • Formula: C33H38N4O6
  • CLOGP: 3.07
  • LIPINSKI: 1
  • HAC: 10
  • HDO: 1
  • TPSA: 112.51
  • ALOGS: -3.74
  • ROTB: 5

  • 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 Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 16.70 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 0.75 ยตM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 8 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 3.50 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 7 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.51 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 9 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
June 14, 1996 FDA PFIZER INC
March 25, 2020 PMDA Nihon Servier Co., Ltd

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
Neutropenia 859.66 22.08 702 30718 174303 63283299
Diarrhoea 790.39 22.08 1323 30097 714043 62743559
Disease progression 762.04 22.08 566 30854 122192 63335410
Neuropathy peripheral 478.70 22.08 418 31002 113249 63344353
Myelosuppression 334.71 22.08 184 31236 23519 63434083
Malignant neoplasm progression 331.43 22.08 295 31125 81826 63375776
Febrile neutropenia 308.77 22.08 335 31085 118114 63339488
Mucosal inflammation 287.28 22.08 215 31205 46713 63410889
Neurotoxicity 270.91 22.08 143 31277 16847 63440755
Vomiting 262.72 22.08 735 30685 558882 62898720
Thrombocytopenia 243.13 22.08 335 31085 150822 63306780
Dysarthria 237.89 22.08 185 31235 42526 63415076
Dermatitis acneiform 236.11 22.08 90 31330 4906 63452696
Palmar-plantar erythrodysaesthesia syndrome 222.90 22.08 140 31280 22875 63434727
Bone marrow failure 220.01 22.08 152 31268 29138 63428464
Nausea 219.63 22.08 917 30503 853554 62604048
Leukopenia 216.06 22.08 227 31193 77063 63380539
Metastases to liver 212.04 22.08 137 31283 23502 63434100
Neoplasm progression 192.51 22.08 153 31267 36275 63421327
Abdominal pain 187.68 22.08 434 30986 293022 63164580
Neutrophil count decreased 174.50 22.08 175 31245 56231 63401371
Off label use 172.84 22.08 724 30696 673738 62783864
Skin toxicity 170.50 22.08 70 31350 4644 63452958
Decreased appetite 158.98 22.08 370 31050 250682 63206920
Ascites 149.79 22.08 139 31281 40589 63417013
Arthralgia 141.20 22.08 53 31367 569657 62887945
Joint swelling 140.16 22.08 5 31415 327661 63129941
Polyneuropathy 139.37 22.08 88 31332 14501 63443101
Proteinuria 138.23 22.08 97 31323 19048 63438554
Haematotoxicity 135.65 22.08 74 31346 9302 63448300
Metastases to peritoneum 130.94 22.08 53 31367 3389 63454213
Anaemia 127.79 22.08 376 31044 293054 63164548
Paronychia 124.61 22.08 59 31361 5506 63452096
Stomatitis 122.03 22.08 234 31186 138491 63319111
Death 120.83 22.08 433 30987 373948 63083654
Asthenia 115.65 22.08 434 30986 383170 63074432
Gastrointestinal toxicity 108.96 22.08 60 31360 7681 63449921
Peripheral sensory neuropathy 108.32 22.08 59 31361 7392 63450210
Dehydration 105.77 22.08 252 31168 173102 63284500
Cholinergic syndrome 103.68 22.08 28 31392 490 63457112
Peripheral swelling 101.45 22.08 8 31412 265934 63191668
Colorectal cancer metastatic 99.02 22.08 28 31392 585 63457017
Metastases to lung 95.31 22.08 66 31354 12684 63444918
Product dose omission issue 92.38 22.08 6 31414 234307 63223295
Cholangitis 92.01 22.08 48 31372 5513 63452089
Contraindicated product administered 90.71 22.08 4 31416 217644 63239958
Swelling 90.66 22.08 14 31406 275364 63182238
Sinusitis 85.93 22.08 7 31413 226646 63230956
Pain 78.85 22.08 155 31265 740473 62717129
Intestinal obstruction 76.17 22.08 85 31335 30814 63426788
Therapeutic product effect decreased 75.98 22.08 5 31415 193182 63264420
Ileus 75.94 22.08 61 31359 14664 63442938
Maternal exposure during pregnancy 75.18 22.08 10 31410 220052 63237550
Pulmonary embolism 73.68 22.08 172 31248 116512 63341090
Mucosal toxicity 73.58 22.08 20 31400 359 63457243
Hypokalaemia 73.33 22.08 160 31260 103644 63353958
Therapy partial responder 72.30 22.08 52 31368 10606 63446996
Weight increased 68.32 22.08 22 31398 260770 63196832
Metastases to lymph nodes 67.56 22.08 45 31375 8113 63449489
Speech disorder 66.58 22.08 91 31329 40538 63417064
Trichomegaly 66.55 22.08 14 31406 76 63457526
Musculoskeletal stiffness 66.50 22.08 7 31413 184611 63272991
Tongue oedema 65.79 22.08 36 31384 4550 63453052
Abdominal discomfort 62.51 22.08 41 31379 320844 63136758
Nasopharyngitis 62.23 22.08 24 31396 254233 63203369
Hyperammonaemia 61.36 22.08 36 31384 5196 63452406
Pain in extremity 61.07 22.08 45 31375 331441 63126161
Hypertransaminasaemia 58.49 22.08 38 31382 6571 63451031
Laryngospasm 58.43 22.08 29 31391 2999 63454603
Drug hypersensitivity 56.16 22.08 43 31377 310644 63146958
Exposure during pregnancy 55.75 22.08 6 31414 155541 63302061
Headache 55.55 22.08 147 31273 633094 62824508
Product use in unapproved indication 54.91 22.08 204 31216 178876 63278726
Enterocutaneous fistula 54.82 22.08 22 31398 1375 63456227
Wound 54.38 22.08 8 31412 163255 63294347
Lower respiratory tract infection 53.29 22.08 3 31417 132304 63325298
Carcinoembryonic antigen increased 53.11 22.08 23 31397 1742 63455860
Neutropenic colitis 52.02 22.08 27 31393 3068 63454534
Fall 51.98 22.08 71 31349 392263 63065339
Protein urine 51.73 22.08 18 31402 754 63456848
Asthma 51.05 22.08 3 31417 127558 63330044
Metastases to meninges 50.45 22.08 25 31395 2577 63455025
General physical health deterioration 50.17 22.08 215 31205 201187 63256415
Epistaxis 50.10 22.08 111 31309 72614 63384988
Pericarditis 50.02 22.08 4 31416 131575 63326027
Sepsis 49.95 22.08 178 31242 152945 63304657
Splenic artery thrombosis 48.74 22.08 10 31410 47 63457555
Drug ineffective 48.12 22.08 312 31108 1044453 62413149
Hypomagnesaemia 48.04 22.08 65 31355 28672 63428930
Skin fissures 48.02 22.08 42 31378 11346 63446256
Neuromyotonia 47.58 22.08 10 31410 54 63457548
Steatohepatitis 47.05 22.08 16 31404 625 63456977
Hypertension 46.62 22.08 266 31154 279037 63178565
Colitis 46.51 22.08 85 31335 48443 63409159
Hepatic enzyme increased 46.43 22.08 21 31399 202307 63255295
Gastrointestinal perforation 46.23 22.08 26 31394 3465 63454137
Arthritis 45.56 22.08 3 31417 115918 63341684
Cystitis radiation 45.36 22.08 10 31410 70 63457532
Venous pressure jugular decreased 45.24 22.08 9 31411 35 63457567
Bladder tamponade 45.24 22.08 10 31410 71 63457531
Hypertensive crisis 44.62 22.08 46 31374 15240 63442362
Enteritis 44.16 22.08 35 31385 8251 63449351
Drug intolerance 43.81 22.08 53 31367 308608 63148994
Large intestine perforation 43.44 22.08 35 31385 8447 63449155
Posterior reversible encephalopathy syndrome 43.23 22.08 48 31372 17297 63440305
White blood cell count decreased 42.23 22.08 158 31262 138946 63318656
Rash pustular 41.50 22.08 32 31388 7250 63450352
Nasal septum perforation 40.75 22.08 15 31405 741 63456861
Intestinal perforation 40.46 22.08 39 31381 11924 63445678
Metastases to ovary 39.87 22.08 13 31407 445 63457157
Ganglioneuroma 39.65 22.08 10 31410 132 63457470
Condition aggravated 39.42 22.08 88 31332 402129 63055473
Blister 37.60 22.08 9 31411 129805 63327797
Discomfort 37.42 22.08 18 31402 167356 63290246
Pyrexia 37.37 22.08 376 31044 470102 62987500
Proctalgia 37.35 22.08 28 31392 6082 63451520
Cough 36.74 22.08 55 31365 292688 63164914
Trismus 36.01 22.08 23 31397 3862 63453740
Device related infection 34.75 22.08 50 31370 23342 63434260
Mobility decreased 33.93 22.08 9 31411 121150 63336452
Paraesthesia 33.40 22.08 160 31260 156806 63300796
Osteonecrosis of jaw 32.99 22.08 61 31359 35062 63422540
COVID-19 32.45 22.08 8 31412 113095 63344507
Myalgia 32.39 22.08 16 31404 146513 63311089
Product use issue 32.20 22.08 37 31383 220483 63237119
Depression 32.03 22.08 30 31390 196462 63261140
Ileal perforation 32.03 22.08 11 31409 443 63457159
Jaw operation 32.00 22.08 13 31407 839 63456763
Bronchitis 31.88 22.08 11 31409 124924 63332678
Insomnia 31.55 22.08 36 31384 215216 63242386
Tumour ulceration 31.34 22.08 9 31411 199 63457403
Influenza 30.59 22.08 8 31412 108714 63348888
Metastasis 29.97 22.08 23 31397 5174 63452428
Systemic infection 29.93 22.08 22 31398 4638 63452964
Dizziness 29.71 22.08 111 31309 429814 63027788
Stomatitis haemorrhagic 29.28 22.08 6 31414 28 63457574
Dysaesthesia pharynx 29.10 22.08 8 31412 150 63457452
Aortitis 28.95 22.08 13 31407 1074 63456528
Anorectal disorder 28.66 22.08 15 31405 1734 63455868
Arteriospasm coronary 28.39 22.08 20 31400 3948 63453654
Aortic intramural haematoma 27.85 22.08 7 31413 91 63457511
Immune thrombocytopenia 27.67 22.08 30 31390 10526 63447076
Feeling abnormal 27.47 22.08 20 31400 148372 63309230
Superior vena cava syndrome 27.40 22.08 11 31409 688 63456914
Contusion 26.78 22.08 21 31399 150023 63307579
Depilation 26.66 22.08 5 31415 13 63457589
Tumour perforation 26.45 22.08 7 31413 113 63457489
Loss of personal independence in daily activities 25.82 22.08 8 31412 97282 63360320
Vena cava thrombosis 25.52 22.08 15 31405 2172 63455430
Dyschezia 24.86 22.08 15 31405 2279 63455323
Large intestinal obstruction 24.71 22.08 15 31405 2304 63455298
Cutaneous tuberculosis 24.54 22.08 7 31413 151 63457451
Treatment failure 24.37 22.08 38 31382 199005 63258597
Drug resistance 24.32 22.08 42 31378 22891 63434711
Granulocyte count decreased 24.29 22.08 12 31408 1228 63456374
Dysentery 24.03 22.08 11 31409 950 63456652
Cardiac failure congestive 23.82 22.08 8 31412 92425 63365177
Xerosis 23.80 22.08 11 31409 971 63456631
Catheter site bruise 23.75 22.08 9 31411 482 63457120
Skin disorder 23.74 22.08 48 31372 29459 63428143
Anxiety 23.47 22.08 45 31375 217496 63240106
Oropharyngeal discomfort 23.39 22.08 20 31400 5240 63452362
Brachiocephalic vein thrombosis 22.78 22.08 6 31414 95 63457507
Venoocclusive liver disease 22.77 22.08 19 31401 4816 63452786
Renal tubular disorder 22.70 22.08 15 31405 2667 63454935
Hyperbilirubinaemia 22.68 22.08 28 31392 11286 63446316
Aphasia 22.30 22.08 50 31370 32950 63424652
Cardiotoxicity 22.15 22.08 24 31396 8414 63449188

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
Diarrhoea 1217.47 18.10 1892 40826 388020 34526193
Disease progression 889.61 18.10 860 41858 107217 34806996
Neutropenia 798.78 18.10 968 41750 155810 34758403
Skin toxicity 426.01 18.10 175 42543 4609 34909604
Dermatitis acneiform 395.28 18.10 179 42539 6010 34908203
Myelosuppression 379.09 18.10 256 42462 19009 34895204
Neuropathy peripheral 355.63 18.10 472 42246 82791 34831422
Palmar-plantar erythrodysaesthesia syndrome 354.12 18.10 233 42485 16562 34897651
Stomatitis 349.77 18.10 339 42379 42175 34872038
Neoplasm progression 300.60 18.10 240 42478 23060 34891153
Metastases to liver 279.40 18.10 186 42532 13477 34900736
Decreased appetite 247.92 18.10 594 42124 165798 34748415
Malignant neoplasm progression 243.14 18.10 407 42311 87639 34826574
Gastrointestinal toxicity 240.47 18.10 99 42619 2620 34911593
Nausea 239.74 18.10 932 41786 338976 34575237
Vomiting 232.97 18.10 747 41971 246874 34667339
Alopecia 230.46 18.10 210 42508 24145 34890068
Mucosal inflammation 211.13 18.10 248 42470 38374 34875839
Proteinuria 200.78 18.10 173 42545 18469 34895744
Neutrophil count decreased 166.64 18.10 255 42463 50849 34863364
Bone marrow failure 165.11 18.10 191 42527 29062 34885151
Off label use 159.82 18.10 964 41754 418560 34495653
Haematotoxicity 156.60 18.10 107 42611 8087 34906126
Metastases to lung 155.52 18.10 112 42606 9208 34905005
Cholinergic syndrome 154.51 18.10 48 42670 539 34913674
Leukopenia 153.01 18.10 275 42443 62581 34851632
Neurotoxicity 150.56 18.10 145 42573 17865 34896348
Paronychia 149 18.10 76 42642 3329 34910884
Febrile neutropenia 139.42 18.10 425 42293 136424 34777789
Peripheral sensory neuropathy 135.68 18.10 91 42627 6669 34907544
Thrombocytopenia 121.53 18.10 443 42275 155804 34758409
Interstitial lung disease 121.46 18.10 255 42463 65027 34849186
Drug interaction 114.75 18.10 67 42651 225879 34688334
General physical health deterioration 110.30 18.10 376 42342 127893 34786320
Intestinal obstruction 107.51 18.10 136 42582 22686 34891527
Skin reaction 106.39 18.10 71 42647 5159 34909054
Ileus 105.50 18.10 115 42603 16384 34897829
Completed suicide 99.23 18.10 5 42713 98163 34816050
Product dose omission issue 97.33 18.10 15 42703 119696 34794517
Therapy partial responder 96.99 18.10 86 42632 9530 34904683
Fall 93.65 18.10 67 42651 202818 34711395
Polyneuropathy 90.35 18.10 101 42617 14795 34899418
Colorectal cancer metastatic 86.62 18.10 33 42685 707 34913506
Carcinoembryonic antigen increased 84.55 18.10 32 42686 673 34913540
Arthralgia 82.66 18.10 53 42665 169988 34744225
Necrotising fasciitis 81.72 18.10 53 42665 3669 34910544
Abdominal pain 80.60 18.10 404 42314 163214 34750999
Hiccups 80.17 18.10 79 42639 10003 34904210
Epistaxis 74.90 18.10 197 42521 58054 34856159
Cholangitis 74.57 18.10 71 42647 8618 34905595
Metastases to peritoneum 74.46 18.10 39 42679 1805 34912408
Pulmonary embolism 74.37 18.10 260 42458 89486 34824727
Dehydration 72.72 18.10 333 42385 129636 34784577
Metastases to lymph nodes 65.87 18.10 51 42667 4677 34909536
Hypomagnesaemia 65.54 18.10 105 42613 21746 34892467
Myocardial infarction 64.12 18.10 34 42684 121051 34793162
Asthenia 61.89 18.10 511 42207 244740 34669473
Pneumonia 58.32 18.10 237 42481 362390 34551823
Headache 57.57 18.10 98 42620 200537 34713676
Rhabdomyolysis 56.62 18.10 8 42710 68155 34846058
Cardiac failure congestive 56.24 18.10 16 42702 83254 34830959
Bradycardia 55.77 18.10 12 42706 75406 34838807
Ileal perforation 54.80 18.10 24 42694 742 34913471
Gastrointestinal perforation 54.54 18.10 42 42676 3821 34910392
Enteritis 54.23 18.10 58 42660 8084 34906129
Myalgia 53.51 18.10 18 42700 84092 34830121
Tumour necrosis 51.32 18.10 27 42691 1261 34912952
Rash pustular 49.88 18.10 46 42672 5362 34908851
Joint swelling 49.81 18.10 7 42711 59883 34854330
Stoma site haemorrhage 48.28 18.10 23 42695 867 34913346
Colitis microscopic 48.19 18.10 32 42686 2305 34911908
Weight increased 47.96 18.10 27 42691 93006 34821207
Small intestinal perforation 47.87 18.10 31 42687 2140 34912073
Toxicity to various agents 47.85 18.10 109 42609 200253 34713960
Blood alkaline phosphatase abnormal 47.44 18.10 19 42699 467 34913746
Fatigue 47.01 18.10 673 42045 369980 34544233
Proteus infection 46.40 18.10 24 42694 1082 34913131
Nicotinic acid deficiency 45.89 18.10 13 42705 103 34914110
Agitation 44.82 18.10 8 42710 57391 34856822
Anxiety 44.29 18.10 34 42684 99394 34814819
Anastomotic complication 43.62 18.10 17 42701 388 34913825
Rectal tenesmus 43.13 18.10 21 42697 831 34913382
Blood glucose increased 42.92 18.10 14 42704 66704 34847509
Enterocolitis 42.91 18.10 51 42667 7975 34906238
Dyspnoea 42.56 18.10 278 42440 376504 34537709
Mouth ulceration 42.43 18.10 62 42656 11848 34902365
Hospitalisation 42.18 18.10 9 42709 56893 34857320
Hypertension 41.98 18.10 298 42420 136145 34778068
Tumour marker increased 41.87 18.10 19 42699 640 34913573
Pain in extremity 41.85 18.10 56 42662 126457 34787756
Coronary artery disease 41.72 18.10 5 42713 48300 34865913
Carbohydrate antigen 19-9 increased 41.61 18.10 14 42704 206 34914007
Conjunctivitis 41.26 18.10 55 42663 9650 34904563
Intestinal perforation 41.09 18.10 53 42665 9007 34905206
Portal hypertension 40.30 18.10 36 42682 4026 34910187
Hypokalaemia 40.11 18.10 159 42559 58055 34856158
Acral peeling skin syndrome 39.91 18.10 10 42708 46 34914167
Depression 39.80 18.10 36 42682 97062 34817151
Feeling abnormal 39.41 18.10 14 42704 63221 34850992
Cardiac arrest 39.00 18.10 36 42682 96123 34818090
Drug ineffective 38.57 18.10 365 42353 456386 34457827
Anal haemorrhage 38.53 18.10 29 42689 2549 34911664
Confusional state 38.10 18.10 74 42644 144086 34770127
Failure to anastomose 37.99 18.10 13 42705 202 34914011
Suicidal ideation 37.98 18.10 3 42715 40385 34873828
Somnolence 37.96 18.10 48 42670 111068 34803145
Asthma 37.88 18.10 4 42714 42652 34871561
Anaemia of malignant disease 37.68 18.10 16 42702 458 34913755
Induration 37.61 18.10 20 42698 955 34913258
Hyperammonaemia 36.61 18.10 42 42676 6325 34907888
Peritonitis 36.48 18.10 69 42649 16296 34897917
Wheezing 36.47 18.10 4 42714 41398 34872815
Transdifferentiation of neoplasm 36.25 18.10 10 42708 71 34914142
Subclavian vein thrombosis 36.22 18.10 19 42699 882 34913331
Sciatic nerve palsy 35.99 18.10 9 42709 41 34914172
Arteriospasm coronary 35.61 18.10 31 42687 3351 34910862
Pneumatosis intestinalis 35.47 18.10 33 42685 3890 34910323
Anaemia 35.42 18.10 438 42280 232897 34681316
Perforation bile duct 35.12 18.10 8 42710 22 34914191
Colon cancer metastatic 35.05 18.10 23 42695 1624 34912589
Prothrombin level decreased 34.88 18.10 20 42698 1108 34913105
Peripheral swelling 34.30 18.10 26 42692 76515 34837698
Cellulitis 34.25 18.10 11 42707 52940 34861273
Dysphonia 34.11 18.10 83 42635 23300 34890913
Right ventricular ejection fraction decreased 33.93 18.10 9 42709 54 34914159
Acute abdomen 33.77 18.10 24 42694 1931 34912282
Incorrect dose administered 33.07 18.10 5 42713 40510 34873703
Hyperbilirubinaemia 32.69 18.10 67 42651 16776 34897437
Hypoferritinaemia 32.63 18.10 7 42711 13 34914200
Venoocclusive liver disease 32.12 18.10 44 42674 7922 34906291
International normalised ratio increased 32.12 18.10 9 42709 47318 34866895
Oesophagobronchial fistula 31.90 18.10 11 42707 175 34914038
Pyrexia 31.75 18.10 577 42141 332436 34581777
Vascular pseudoaneurysm 31.55 18.10 24 42694 2143 34912070
Large intestine perforation 31.36 18.10 45 42673 8458 34905755
Hallucination 31.08 18.10 12 42706 51486 34862727
Influenza 30.93 18.10 11 42707 49655 34864558
Gene mutation 30.79 18.10 20 42698 1388 34912825
Pulmonary artery thrombosis 30.72 18.10 16 42702 732 34913481
Portal vein thrombosis 30.70 18.10 30 42688 3758 34910455
Dizziness 30.11 18.10 151 42567 218370 34695843
Leukoencephalopathy 29.80 18.10 31 42687 4184 34910029
Stoma site pain 29.15 18.10 15 42703 669 34913544
Unevaluable event 29.08 18.10 3 42715 32587 34881626
Paraesthesia 28.42 18.10 154 42564 64018 34850195
Pancreatic carcinoma recurrent 28.28 18.10 8 42710 63 34914150
Heart rate increased 27.63 18.10 11 42707 46332 34867881
Atrial fibrillation 27.26 18.10 69 42649 122324 34791889
Chills 27.26 18.10 181 42537 80862 34833351
Balance disorder 27.09 18.10 8 42710 40646 34873567
Tremor 26.84 18.10 37 42681 82550 34831663
Nodular regenerative hyperplasia 26.78 18.10 16 42702 957 34913256
White blood cell count decreased 26.78 18.10 204 42514 95241 34818972
Stomal varices 26.58 18.10 8 42710 80 34914133
Small intestinal obstruction 26.36 18.10 57 42661 14809 34899404
Perioral dermatitis 26.35 18.10 9 42709 139 34914074
Metastases to pelvis 26.20 18.10 11 42707 306 34913907
Sinusitis 26.08 18.10 9 42709 41393 34872820
Vena cava thrombosis 25.84 18.10 17 42701 1205 34913008
Tumour perforation 25.80 18.10 11 42707 318 34913895
Dysgeusia 25.68 18.10 81 42637 26416 34887797
Toxic erythema of chemotherapy 25.65 18.10 8 42710 91 34914122
Growth of eyelashes 25.34 18.10 8 42710 95 34914118
Acne 25.09 18.10 47 42671 11019 34903194
Protein urine 24.93 18.10 15 42703 909 34913304
Fistula of small intestine 24.76 18.10 12 42706 470 34913743
Cough 24.74 18.10 97 42621 150043 34764170
Therapeutic product effect decreased 24.73 18.10 6 42712 34737 34879476
Paraesthesia oral 24.66 18.10 28 42690 4169 34910044
Large intestinal obstruction 24.58 18.10 18 42700 1517 34912696
Chronic kidney disease 24.21 18.10 10 42708 41200 34873013
Catheter site thrombosis 24.14 18.10 8 42710 112 34914101
Wrong technique in product usage process 24.13 18.10 7 42711 35979 34878234
Skin disorder 24.07 18.10 52 42666 13503 34900710
Peritoneal haematoma 24.02 18.10 7 42711 62 34914151
Electrocardiogram QT prolonged 23.96 18.10 10 42708 40942 34873271
Colon cancer recurrent 23.95 18.10 8 42710 115 34914098
Perihepatic abscess 23.76 18.10 8 42710 118 34914095
Toxic leukoencephalopathy 23.58 18.10 11 42707 395 34913818
Intestinal strangulation 23.54 18.10 6 42712 30 34914183
Diaphragmatic operation 23.54 18.10 6 42712 30 34914183
Subileus 23.44 18.10 24 42694 3179 34911034
Hypersensitivity 23.43 18.10 141 42577 60894 34853319
Epidermal naevus syndrome 23.41 18.10 5 42713 9 34914204
Deep vein thrombosis 23.33 18.10 148 42570 65100 34849113
Abdominal pain upper 23.04 18.10 158 42560 71332 34842881
COVID-19 23.01 18.10 37 42681 77513 34836700
Adenocarcinoma 22.92 18.10 19 42699 1921 34912292
Chronic obstructive pulmonary disease 22.71 18.10 16 42702 48902 34865311
Clostridial infection 22.69 18.10 25 42693 3602 34910611
Skin fissures 22.66 18.10 30 42688 5229 34908984
Acute cutaneous lupus erythematosus 22.50 18.10 7 42711 79 34914134
Acute kidney injury 22.25 18.10 252 42466 304736 34609477
Insomnia 22.05 18.10 60 42658 103847 34810366
Colitis 22.00 18.10 98 42620 37652 34876561
Device related thrombosis 21.87 18.10 15 42703 1140 34913073
Memory impairment 21.70 18.10 13 42705 43305 34870908
Abdominal pain lower 21.64 18.10 43 42675 10528 34903685
Dysentery 21.55 18.10 10 42708 355 34913858
Hypoglycaemia 21.50 18.10 21 42697 54619 34859594
Ascites 21.46 18.10 113 42605 46458 34867755
Pruritus 21.36 18.10 95 42623 141886 34772327
Overdose 21.32 18.10 50 42668 91009 34823204
Haematoma 21.27 18.10 3 42715 25602 34888611
Obstruction gastric 21.20 18.10 14 42704 999 34913214
Onychoclasis 21.19 18.10 18 42700 1882 34912331
Unresponsive to stimuli 21.18 18.10 4 42714 27565 34886648
Contusion 21.08 18.10 9 42709 36355 34877858
Colony stimulating factor therapy 21.06 18.10 8 42710 170 34914043
Change of bowel habit 20.83 18.10 14 42704 1029 34913184
Oxygen saturation decreased 20.82 18.10 21 42697 53797 34860416
Cachexia 20.82 18.10 34 42684 7152 34907061
Rhabdomyosarcoma recurrent 20.74 18.10 7 42711 104 34914109
Acute myocardial infarction 20.73 18.10 21 42697 53698 34860515
Proctalgia 20.69 18.10 30 42688 5693 34908520
Abnormal behaviour 20.56 18.10 3 42715 24966 34889247
VIth nerve disorder 20.52 18.10 5 42713 20 34914193
Seizure 20.46 18.10 63 42655 104794 34809419
Fluid retention 20.44 18.10 4 42714 26883 34887330
Proctectomy 20.38 18.10 7 42711 110 34914103
Ventricular tachycardia 20.11 18.10 4 42714 26575 34887638
Coma 19.85 18.10 16 42702 45662 34868551
Constipation 19.82 18.10 255 42463 136727 34777486
Nail disorder 19.79 18.10 18 42700 2061 34912152
Volvulus of small bowel 19.76 18.10 6 42712 62 34914151
Treatment noncompliance 19.72 18.10 5 42713 28095 34886118
Hypertransaminasaemia 19.70 18.10 29 42689 5577 34908636
Loss of consciousness 19.67 18.10 45 42673 82622 34831591
Malignant ascites 19.56 18.10 10 42708 440 34913773
Medulloblastoma 19.42 18.10 6 42712 66 34914147
Steatohepatitis 19.30 18.10 9 42709 323 34913890
Septic shock 19.28 18.10 152 42566 71682 34842531
Adverse drug reaction 19.14 18.10 6 42712 29336 34884877
Bronchitis 19.12 18.10 14 42704 41949 34872264
Klebsiella infection 19.05 18.10 36 42682 8495 34905718
Superior vena cava syndrome 19.01 18.10 11 42707 620 34913593
Restlessness 18.94 18.10 4 42714 25478 34888735
Enterocutaneous fistula 18.56 18.10 13 42705 1022 34913191
Hypovolaemic shock 18.50 18.10 32 42686 7053 34907160
White blood cell count increased 18.40 18.10 14 42704 41137 34873076
Nasopharyngitis 18.39 18.10 36 42682 69932 34844281
Blood pressure systolic increased 18.35 18.10 3 42715 22949 34891264
Musculoskeletal stiffness 18.30 18.10 18 42700 46662 34867551
Mobility decreased 18.21 18.10 7 42711 30121 34884092
Heart rate decreased 18.17 18.10 8 42710 31737 34882476
Cardiotoxicity 18.12 18.10 28 42690 5620 34908593

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
Diarrhoea 1822.25 17.51 2900 64551 877589 78799348
Neutropenia 1664.60 17.51 1597 65854 286113 79390824
Disease progression 1454.10 17.51 1220 66231 183142 79493795
Neuropathy peripheral 882.34 17.51 820 66631 140485 79536452
Myelosuppression 632.51 17.51 405 67046 39891 79637046
Dermatitis acneiform 609.03 17.51 251 67200 9742 79667195
Palmar-plantar erythrodysaesthesia syndrome 532.33 17.51 338 67113 32796 79644141
Skin toxicity 507.23 17.51 209 67242 8105 79668832
Neoplasm progression 503.72 17.51 388 67063 51294 79625643
Mucosal inflammation 466.02 17.51 436 67015 75144 79601793
Malignant neoplasm progression 465.28 17.51 574 66877 135416 79541521
Metastases to liver 445.27 17.51 285 67166 28029 79648908
Febrile neutropenia 431.03 17.51 731 66720 230268 79446669
Vomiting 382.25 17.51 1332 66119 664496 79012441
Neurotoxicity 379.22 17.51 272 67179 32246 79644691
Proteinuria 374.76 17.51 270 67181 32232 79644705
Thrombocytopenia 370.64 17.51 741 66710 264518 79412419
Decreased appetite 366.92 17.51 859 66592 341559 79335378
Bone marrow failure 358.38 17.51 317 67134 50790 79626147
Stomatitis 354.51 17.51 523 66928 146234 79530703
Leukopenia 352.87 17.51 463 66988 116050 79560887
Neutrophil count decreased 339.70 17.51 408 67043 93551 79583386
Nausea 336.05 17.51 1645 65806 955551 78721386
Gastrointestinal toxicity 329.07 17.51 153 67298 7956 79668981
Metastases to lung 263.86 17.51 174 67277 17989 79658948
Arthralgia 250.31 17.51 86 67365 571717 79105220
Peripheral sensory neuropathy 247.54 17.51 148 67303 12885 79664052
Cholinergic syndrome 242.93 17.51 72 67379 1015 79675922
Paronychia 240.49 17.51 122 67329 7686 79669251
Haematotoxicity 233.55 17.51 152 67299 15367 79661570
Therapy partial responder 206.17 17.51 147 67304 17250 79659687
Joint swelling 199.45 17.51 11 67440 288635 79388302
Intestinal obstruction 198.23 17.51 212 67239 42808 79634129
Off label use 195.34 17.51 1372 66079 905843 78771094
Polyneuropathy 194.03 17.51 162 67289 23989 79652948
Abdominal pain 188.64 17.51 739 66712 388830 79288107
Metastases to peritoneum 188.35 17.51 86 67365 4286 79672651
Completed suicide 184.55 17.51 5 67446 245762 79431175
Dehydration 175.27 17.51 534 66917 247653 79429284
Dysarthria 173.26 17.51 248 67203 67374 79609563
Asthenia 164.68 17.51 860 66591 510829 79166108
Colorectal cancer metastatic 163.94 17.51 55 67396 1183 79675754
General physical health deterioration 159.87 17.51 554 66897 274684 79402253
Ileus 159.07 17.51 150 67301 26061 79650876
Product dose omission issue 155.12 17.51 15 67436 247522 79429415
Cholangitis 151.49 17.51 108 67343 12668 79664269
Interstitial lung disease 151.43 17.51 310 67141 112290 79564647
Fall 148.69 17.51 117 67334 487512 79189425
Pulmonary embolism 145.98 17.51 395 67056 171259 79505678
Anaemia 145.89 17.51 752 66699 444263 79232674
Headache 144.47 17.51 206 67245 653566 79023371
Peripheral swelling 143.74 17.51 27 67424 269590 79407347
Epistaxis 140.59 17.51 299 67152 111216 79565721
Metastases to lymph nodes 130.49 17.51 91 67360 10306 79666631
Weight increased 129.57 17.51 37 67414 277349 79399588
Drug abuse 123.27 17.51 3 67448 162688 79514249
Sinusitis 122.06 17.51 12 67439 195489 79481448
Pain 119.10 17.51 262 67189 703540 78973397
Ascites 117.28 17.51 221 67230 75341 79601596
Swelling 117 17.51 21 67430 216690 79460247
Pain in extremity 116.79 17.51 83 67368 364455 79312482
Hypomagnesaemia 115.70 17.51 169 67282 46742 79630195
Arthropathy 110.23 17.51 11 67440 177100 79499837
Drug interaction 107.10 17.51 116 67335 415067 79261870
Therapeutic product effect decreased 105.12 17.51 9 67442 163854 79513083
Carcinoembryonic antigen increased 103.25 17.51 46 67405 2163 79674774
Contraindicated product administered 100.11 17.51 9 67442 157529 79519408
Enteritis 99.26 17.51 89 67362 14494 79662443
Hypokalaemia 91.50 17.51 299 67152 143741 79533196
Asthma 90.68 17.51 6 67445 135089 79541848
Hyperammonaemia 90.31 17.51 75 67376 11018 79665919
Hiccups 88.35 17.51 71 67380 9960 79666977
Hypertension 86.77 17.51 527 66924 330465 79346472
Abdominal discomfort 85.77 17.51 53 67398 250674 79426263
Rash pustular 84.94 17.51 73 67378 11238 79665699
Nasopharyngitis 83.66 17.51 56 67395 253825 79423112
Maternal exposure during pregnancy 83.61 17.51 9 67442 136529 79540408
White blood cell count decreased 81.98 17.51 346 67105 187942 79488995
Musculoskeletal stiffness 80.48 17.51 24 67427 174984 79501953
Arthritis 80.47 17.51 4 67447 114876 79562061
Gastrointestinal perforation 80.03 17.51 55 67396 6082 79670855
Drug hypersensitivity 79.85 17.51 81 67370 298835 79378102
Cough 79.43 17.51 117 67334 366672 79310265
Myalgia 77.49 17.51 30 67421 185611 79491326
Ileal perforation 77.19 17.51 30 67421 995 79675942
Intestinal perforation 76.96 17.51 84 67367 17342 79659595
Glossodynia 74.34 17.51 3 67448 103334 79573603
Hypertransaminasaemia 71.88 17.51 68 67383 11856 79665081
Pericarditis 68.87 17.51 5 67446 104231 79572706
Hyperbilirubinaemia 68.84 17.51 94 67357 24424 79652513
Drug intolerance 67.81 17.51 74 67377 264045 79412892
Large intestine perforation 67.45 17.51 72 67379 14495 79662442
Pyrexia 67.26 17.51 872 66579 677837 78999100
Mobility decreased 65.57 17.51 12 67439 122163 79554774
Contusion 65.55 17.51 22 67429 148754 79528183
Necrotising fasciitis 64.58 17.51 48 67403 6002 79670935
Intentional product misuse 64.53 17.51 4 67447 95161 79581776
Dizziness 63.68 17.51 230 67221 526211 79150726
Exposure during pregnancy 63.65 17.51 6 67445 101126 79575811
Anastomotic complication 62.71 17.51 21 67430 449 79676488
Lower respiratory tract infection 62.62 17.51 16 67435 129204 79547733
Depression 62.26 17.51 55 67396 216735 79460202
Tumour necrosis 62.02 17.51 31 67420 1891 79675046
Hepatic enzyme increased 61.88 17.51 39 67412 182571 79494366
Skin reaction 61.66 17.51 72 67379 15996 79660941
Colitis 61.54 17.51 168 67283 73139 79603798
Venoocclusive liver disease 61.37 17.51 62 67389 11709 79665228
Anxiety 61.20 17.51 72 67379 248440 79428497
Cardiac failure congestive 61.12 17.51 22 67429 142380 79534557
Steatohepatitis 60.75 17.51 25 67426 965 79675972
Gene mutation 60.27 17.51 34 67417 2652 79674285
Skin fissures 59.45 17.51 64 67387 13009 79663928
Influenza 59.17 17.51 18 67433 129588 79547349
Enterocutaneous fistula 58.52 17.51 30 67421 1931 79675006
Arteriospasm coronary 58.01 17.51 47 67404 6669 79670268
Rhabdomyolysis 57.84 17.51 9 67442 103122 79573815
Wheezing 57.39 17.51 14 67437 116650 79560287
Bradycardia 56.40 17.51 22 67429 135535 79541402
Blister 55.62 17.51 16 67435 119460 79557477
Feeling abnormal 55.33 17.51 33 67418 159166 79517771
Myocardial infarction 54.97 17.51 45 67406 184084 79492853
Condition aggravated 54.78 17.51 228 67223 500896 79176041
Trichomegaly 53.75 17.51 14 67437 118 79676819
Product use issue 53.60 17.51 59 67392 209763 79467174
Proctalgia 52.73 17.51 53 67398 9948 79666989
Dyspnoea 52.62 17.51 468 66983 856557 78820380
Suicidal ideation 52.39 17.51 3 67448 76337 79600600
Deep vein thrombosis 51.66 17.51 221 67230 120698 79556239
Small intestinal perforation 51.34 17.51 33 67418 3264 79673673
Speech disorder 51.01 17.51 130 67321 54315 79622622
Confusional state 50.68 17.51 122 67329 317875 79359062
Stoma site haemorrhage 50.58 17.51 27 67424 1889 79675048
Osteoarthritis 50.39 17.51 7 67444 87302 79589635
Vena cava thrombosis 50.15 17.51 31 67420 2864 79674073
Protein urine 50.14 17.51 25 67426 1517 79675420
Heart rate increased 49.56 17.51 20 67431 120704 79556233
Subclavian vein thrombosis 49.52 17.51 29 67422 2428 79674509
Paraesthesia 49.50 17.51 286 67165 176037 79500900
Device related infection 49.14 17.51 97 67354 34197 79642740
Hospitalisation 48.99 17.51 10 67441 94226 79582711
Bronchitis 48.40 17.51 25 67426 130619 79546318
Pneumonia 47.64 17.51 345 67106 659901 79017036
Insomnia 47.58 17.51 84 67367 245086 79431851
Tongue oedema 47.57 17.51 43 67408 7074 79669863
Pneumatosis intestinalis 47.45 17.51 41 67410 6356 79670581
Peritonitis 47.25 17.51 85 67366 27951 79648986
Incorrect dose administered 47.03 17.51 5 67446 76625 79600312
Drug ineffective 46.94 17.51 639 66812 1080274 78596663
Mucosal toxicity 46.75 17.51 18 67433 582 79676355
Portal vein thrombosis 46.61 17.51 39 67412 5788 79671149
Large intestinal obstruction 46.44 17.51 31 67420 3268 79673669
Metastases to meninges 46.31 17.51 32 67419 3569 79673368
Superior vena cava syndrome 45.85 17.51 22 67429 1227 79675710
Laryngospasm 45.57 17.51 33 67418 3964 79672973
Rectal tenesmus 45.33 17.51 24 67427 1651 79675286
Blood pressure fluctuation 44.99 17.51 3 67448 67142 79609795
Wound 44.91 17.51 21 67430 116158 79560779
Colon cancer metastatic 44.64 17.51 26 67425 2155 79674782
Somnolence 44.48 17.51 84 67367 238897 79438040
Nicotinic acid deficiency 44.14 17.51 13 67438 179 79676758
Blood glucose increased 44.11 17.51 21 67430 114954 79561983
Pruritus 44.07 17.51 178 67273 394470 79282467
Dysentery 43.61 17.51 21 67430 1181 79675756
Acral peeling skin syndrome 43.57 17.51 10 67441 46 79676891
Posterior reversible encephalopathy syndrome 43.43 17.51 79 67372 26202 79650735
Dysphonia 42.52 17.51 125 67326 56747 79620190
Dysgeusia 42.11 17.51 125 67326 57052 79619885
Migraine 42.07 17.51 11 67440 87482 79589455
Portal hypertension 41.82 17.51 40 67411 7068 79669869
COVID-19 41.76 17.51 43 67408 157631 79519306
Anal haemorrhage 41.67 17.51 32 67419 4202 79672735
Splenic artery thrombosis 41.64 17.51 10 67441 58 79676879
Duodenal ulcer perforation 41.47 17.51 4 67447 66207 79610730
Nodular regenerative hyperplasia 41.13 17.51 21 67430 1340 79675597
Metastasis 41.02 17.51 39 67412 6841 79670096
Cardiotoxicity 40.69 17.51 51 67400 12188 79664749
Skin disorder 40.43 17.51 89 67362 33854 79643083
Blood alkaline phosphatase abnormal 40.05 17.51 18 67433 864 79676073
Discomfort 39.64 17.51 29 67422 125588 79551349
Growth of eyelashes 39.43 17.51 12 67439 186 79676751
Loss of personal independence in daily activities 38.94 17.51 19 67432 102561 79574376
Chills 38.69 17.51 250 67201 159984 79516953
Coronary artery disease 38.38 17.51 5 67446 65469 79611468
Anorectal disorder 38.32 17.51 24 67427 2269 79674668
Acute abdomen 38.30 17.51 27 67424 3110 79673827
Enterocolitis 38.29 17.51 54 67397 14458 79662479
Pulmonary artery thrombosis 37.83 17.51 20 67431 1372 79675565
Rectal haemorrhage 37.78 17.51 146 67305 76154 79600783
Proteus infection 37.50 17.51 23 67428 2095 79674842
Failure to anastomose 37.36 17.51 12 67439 224 79676713
Transdifferentiation of neoplasm 37.05 17.51 10 67441 98 79676839
Neuromyotonia 36.78 17.51 10 67441 101 79676836
International normalised ratio increased 36.50 17.51 13 67438 84708 79592229
Leukoencephalopathy 36.37 17.51 39 67412 7890 79669047
Septic shock 36.30 17.51 202 67249 122599 79554338
Right ventricular ejection fraction decreased 36.15 17.51 9 67442 62 79676875
Wrong technique in product usage process 36.07 17.51 9 67442 73866 79603071
Nasal septum perforation 35.94 17.51 16 67435 751 79676186
Gait inability 35.76 17.51 4 67447 58913 79618024
Intestinal metastasis 35.22 17.51 13 67438 373 79676564
Hypoferritinaemia 35.20 17.51 7 67444 13 79676924
Injection site reaction 35.14 17.51 3 67448 54782 79622155
Balance disorder 35.04 17.51 20 67431 98837 79578100
Memory impairment 34.99 17.51 26 67425 111708 79565229
Pelvic fluid collection 34.93 17.51 16 67435 803 79676134
Sciatic nerve palsy 34.44 17.51 9 67442 77 79676860
Therapeutic product effect incomplete 34.20 17.51 221 67230 141424 79535513
Tumour perforation 34.13 17.51 13 67438 408 79676529
Venous pressure jugular decreased 33.93 17.51 9 67442 82 79676855
Subileus 33.61 17.51 32 67419 5622 79671315
Heart rate decreased 33.50 17.51 9 67442 70307 79606630
Death 33.36 17.51 668 66783 565846 79111091
Hepatic lesion 33.29 17.51 35 67416 6924 79670013
Disease recurrence 33.02 17.51 97 67354 44012 79632925
Blood pressure systolic increased 33.02 17.51 8 67443 66978 79609959
Colitis microscopic 32.86 17.51 43 67408 10725 79666212
Influenza like illness 32.65 17.51 10 67441 71697 79605240
Hypertensive crisis 32.51 17.51 61 67390 20709 79656228
Conjunctivitis 32.43 17.51 69 67382 25646 79651291
Oesophagobronchial fistula 32.42 17.51 11 67440 245 79676692
Chronic obstructive pulmonary disease 32.15 17.51 16 67435 85403 79591534
Aggression 32.12 17.51 3 67448 50955 79625982
Prothrombin level decreased 32.07 17.51 19 67432 1625 79675312
Metastases to central nervous system 31.99 17.51 53 67398 16322 79660615
Liver abscess 31.76 17.51 32 67419 6022 79670915
Alopecia 31.71 17.51 317 67134 231038 79445899
Fistula of small intestine 31.68 17.51 15 67436 812 79676125
Pancreatic carcinoma recurrent 31.63 17.51 10 67441 177 79676760
Induration 31.54 17.51 20 67431 1932 79675005
Agitation 31.49 17.51 23 67428 99692 79577245
Cataract 31.45 17.51 7 67444 62113 79614824
Vascular pseudoaneurysm 31.24 17.51 25 67426 3485 79673452
Oxygen saturation decreased 31.09 17.51 38 67413 129009 79547928
Cystitis radiation 31.01 17.51 10 67441 189 79676748
Aortitis 30.94 17.51 18 67433 1489 79675448
Treatment noncompliance 30.61 17.51 4 67447 52264 79624673
Haematoma 30.56 17.51 4 67447 52191 79624746
Gait disturbance 30.42 17.51 83 67368 207423 79469514
Granulocyte count decreased 30.41 17.51 19 67432 1789 79675148
Dysaesthesia pharynx 30.16 17.51 10 67441 207 79676730
Perforation bile duct 30.02 17.51 7 67444 35 79676902
Venous thrombosis limb 29.93 17.51 27 67424 4430 79672507
Disseminated intravascular coagulation 29.93 17.51 82 67369 35760 79641177
Cardiac arrest 29.85 17.51 63 67388 172033 79504904
Productive cough 29.72 17.51 19 67432 88312 79588625
Neutropenic colitis 29.64 17.51 30 67421 5677 79671260
Klebsiella infection 29.53 17.51 50 67401 15670 79661267
Paraesthesia oral 29.44 17.51 58 67393 20413 79656524
Ganglioneuroma 29.42 17.51 9 67442 142 79676795
Carbohydrate antigen 19-9 increased 29.41 17.51 12 67439 453 79676484
Constipation 29.31 17.51 367 67084 282683 79394254
Trismus 28.87 17.51 29 67422 5438 79671499
Anaemia of malignant disease 28.68 17.51 14 67437 811 79676126
Hepatic failure 28.58 17.51 115 67336 61097 79615840
Adenocarcinoma of colon 28.55 17.51 29 67422 5512 79671425
Stomal varices 28.48 17.51 8 67443 92 79676845
Tumour ulceration 28.35 17.51 10 67441 251 79676686
Tremor 28.07 17.51 64 67387 170019 79506918
Performance status decreased 27.92 17.51 30 67421 6083 79670854
Limbic encephalitis 27.90 17.51 14 67437 861 79676076
Hypoalbuminaemia 27.85 17.51 58 67393 21239 79655698
Small intestinal obstruction 27.52 17.51 67 67384 27205 79649732
Diaphragmatic paralysis 27.48 17.51 15 67436 1097 79675840
K-ras gene mutation 27.42 17.51 7 67444 54 79676883
Fatigue 27.03 17.51 1000 66451 928727 78748210
Biliary tract infection 26.97 17.51 16 67435 1372 79675565
Palpitations 26.76 17.51 41 67410 126569 79550368
Dry skin 26.54 17.51 121 67330 67874 79609063
Cellulitis 26.40 17.51 32 67419 109028 79567909
Gastrointestinal stoma complication 26.10 17.51 20 67431 2617 79674320
Electrocardiogram QT prolonged 25.85 17.51 23 67428 90363 79586574
Venous thrombosis 25.84 17.51 31 67420 7085 79669852
Diaphragmatic operation 25.73 17.51 6 67445 30 79676907
Jaw operation 25.66 17.51 13 67438 816 79676121
Adverse drug reaction 25.65 17.51 12 67439 66380 79610557
Metastases to ovary 25.30 17.51 10 67441 347 79676590
Anastomotic fistula 25.28 17.51 8 67443 142 79676795
Metastatic neoplasm 25.27 17.51 26 67425 5016 79671921
Lactic acidosis 25.27 17.51 14 67437 70345 79606592
Epidermal naevus syndrome 25.24 17.51 5 67446 9 79676928
Acute myeloid leukaemia 25.13 17.51 70 67381 30815 79646122
Nasal congestion 25.03 17.51 17 67434 76535 79600402
Toxic erythema of chemotherapy 24.80 17.51 9 67442 246 79676691
Gastrooesophageal reflux disease 24.79 17.51 31 67420 104215 79572722
Toxic epidermal necrolysis 24.74 17.51 4 67447 44577 79632360
Overdose 24.58 17.51 77 67374 184129 79492808
Product use in unapproved indication 24.38 17.51 321 67130 250038 79426899
Hypovolaemic shock 24.34 17.51 40 67411 12236 79664701
Medication error 24.16 17.51 14 67437 68628 79608309
Toxicity to various agents 24.11 17.51 234 67217 421306 79255631
Depilation 23.99 17.51 5 67446 13 79676924
Perihepatic abscess 23.93 17.51 8 67443 170 79676767
Malignant ascites 23.84 17.51 14 67437 1178 79675759
Osteoporosis 23.83 17.51 8 67443 54104 79622833
Viral infection 23.56 17.51 4 67447 43012 79633925
Hydronephrosis 23.37 17.51 48 67403 17406 79659531
Hypervolaemia 23.32 17.51 4 67447 42686 79634251
Xeroderma 23.03 17.51 9 67442 303 79676634
Optic glioma 22.99 17.51 6 67445 51 79676886
Nephrotic syndrome 22.95 17.51 37 67414 11137 79665800
Intestinal strangulation 22.59 17.51 6 67445 55 79676882
Hypoglycaemia 22.34 17.51 32 67419 101562 79575375
Pelvic venous thrombosis 22.30 17.51 17 67434 2208 79674729
Rhabdomyosarcoma recurrent 22.13 17.51 7 67444 124 79676813
Lip swelling 21.98 17.51 4 67447 40907 79636030
Febrile infection 21.94 17.51 20 67431 3326 79673611
Colon cancer recurrent 21.93 17.51 7 67444 128 79676809
Drug resistance 21.90 17.51 82 67369 42131 79634806
Rectal perforation 21.79 17.51 12 67439 893 79676044
Neutropenic sepsis 21.69 17.51 61 67390 27003 79649934
Unresponsive to stimuli 21.68 17.51 10 67441 55778 79621159
Colony stimulating factor therapy 21.61 17.51 10 67441 514 79676423
Intentional product use issue 21.43 17.51 62 67389 152050 79524887
Ileus paralytic 21.34 17.51 33 67418 9587 79667350
Renal hydrocele 21.28 17.51 5 67446 26 79676911
Emotional distress 21.28 17.51 4 67447 39965 79636972
Perioral dermatitis 21.27 17.51 9 67442 373 79676564
Rectal cancer 21.11 17.51 20 67431 3493 79673444
Obstruction gastric 21.07 17.51 15 67436 1755 79675182
Hypothyroidism 20.98 17.51 9 67442 52383 79624554
VIth nerve disorder 20.97 17.51 5 67446 28 79676909
Abnormal behaviour 20.83 17.51 3 67448 36418 79640519
Osteonecrosis of jaw 20.81 17.51 82 67369 43144 79633793
Aortic intramural haematoma 20.71 17.51 7 67444 154 79676783
Stevens-Johnson syndrome 20.68 17.51 4 67447 39162 79637775
Swelling face 20.51 17.51 18 67433 71194 79605743
Bladder tamponade 20.44 17.51 10 67441 582 79676355
Psychotic disorder 20.29 17.51 5 67446 41397 79635540
Prostatic calcification 20.28 17.51 6 67445 84 79676853
Necrotising colitis 20.24 17.51 12 67439 1028 79675909
Sepsis 20.14 17.51 330 67121 269098 79407839
Jaundice 20.13 17.51 94 67357 53255 79623682
Neutrophilia 20.11 17.51 29 67422 7922 79669015
Enteral nutrition 20.09 17.51 6 67445 87 79676850
Febrile bone marrow aplasia 20.08 17.51 38 67413 12982 79663955
Anal fistula 20.06 17.51 27 67424 6917 79670020
Road traffic accident 20.04 17.51 6 67445 43658 79633279
Chronic kidney disease 19.94 17.51 16 67435 66138 79610799
Hallucination 19.87 17.51 26 67425 85719 79591218
Administration site extravasation 19.82 17.51 13 67438 1330 79675607
Gastrointestinal inflammation 19.79 17.51 28 67423 7516 79669421
Food protein-induced enterocolitis syndrome 19.77 17.51 5 67446 37 79676900
Tumour marker increased 19.57 17.51 21 67430 4251 79672686
Platelet count decreased 19.53 17.51 251 67200 194413 79482524
Abdominal abscess 19.52 17.51 27 67424 7100 79669837
Device related thrombosis 19.50 17.51 17 67434 2666 79674271
Pancreatic fistula 19.31 17.51 6 67445 100 79676837
Clostridial infection 19.30 17.51 24 67427 5690 79671247
Colonic fistula 19.24 17.51 10 67441 662 79676275
Tumour lysis syndrome 19.23 17.51 54 67397 23885 79653052
Stomatitis haemorrhagic 19.20 17.51 6 67445 102 79676835
Burning sensation 19.20 17.51 13 67438 58619 79618318
Cachexia 19.18 17.51 34 67417 11049 79665888
Tumour embolism 18.99 17.51 7 67444 200 79676737
Cell-mediated cytotoxicity 18.91 17.51 5 67446 45 79676892
Proctectomy 18.90 17.51 7 67444 203 79676734
Peritoneal haematoma 18.86 17.51 7 67444 204 79676733
Unevaluable event 18.64 17.51 12 67439 55573 79621364
Xerosis 18.60 17.51 12 67439 1194 79675743
Loss of consciousness 18.55 17.51 76 67375 167867 79509070
Jugular vein thrombosis 18.53 17.51 21 67430 4517 79672420
Oedema peripheral 18.52 17.51 131 67320 252157 79424780
Pelvic abscess 18.48 17.51 15 67436 2134 79674803
Treatment failure 18.30 17.51 78 67373 170408 79506529
Immune thrombocytopenia 18.24 17.51 44 67407 17761 79659176
Administration site recall reaction 18.23 17.51 3 67448 0 79676937
Cutaneous tuberculosis 18.19 17.51 7 67444 226 79676711
Pancreatic carcinoma metastatic 18.17 17.51 19 67432 3734 79673203
Peripheral sensorimotor neuropathy 17.83 17.51 17 67434 2993 79673944
Duodenal varices 17.69 17.51 4 67447 17 79676920
Portal vein embolisation 17.69 17.51 4 67447 17 79676920
Sedation 17.68 17.51 11 67440 51884 79625053
Adverse event 17.61 17.51 15 67436 60199 79616738
Incorrect route of product administration 17.55 17.51 4 67447 34925 79642012

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC L01CE02 ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
ANTINEOPLASTIC AGENTS
PLANT ALKALOIDS AND OTHER NATURAL PRODUCTS
Topoisomerase 1 (TOP1) inhibitors
FDA MoA N0000000176 Topoisomerase Inhibitors
MeSH PA D000970 Antineoplastic Agents
MeSH PA D004791 Enzyme Inhibitors
MeSH PA D059004 Topoisomerase I Inhibitors
MeSH PA D059003 Topoisomerase Inhibitors
CHEBI has role CHEBI:35610 antineoplastic agents
CHEBI has role CHEBI:50266 Prodrugs
CHEBI has role CHEBI:50276 topoisomerase I inhibitors
CHEBI has role CHEBI:68495 Type I cell-death inducers
FDA EPC N0000175609 Topoisomerase Inhibitor

Drug Use | Suggest Off label Use Form| |View source of the data|

DiseaseRelationSNOMED_IDDOID
Secondary malignant neoplasm of pancreas indication 94459006
Metastasis from malignant tumor of colon indication 314998002
Adenocarcinoma of pancreas indication 700423003 DOID:4074
Astrocytoma, anaplastic off-label use 55353007 DOID:3078
Ewing's sarcoma off-label use 76909002 DOID:3369
Small cell carcinoma of lung off-label use 254632001 DOID:5409
Non-small cell lung cancer off-label use 254637007 DOID:3908
Glioblastoma multiforme of brain off-label use 276828006 DOID:3073
Hyperbilirubinemia contraindication 14783006 DOID:2741
Dehydration contraindication 34095006
Diarrhea contraindication 62315008
Interstitial pneumonia contraindication 64667001
Intestinal obstruction contraindication 81060008 DOID:8437
Kidney disease contraindication 90708001 DOID:557
Acute pancreatitis contraindication 197456007 DOID:2913
Disease of liver contraindication 235856003 DOID:409
Sepsis syndrome contraindication 238150007
Renal dialysis contraindication 265764009
Anemia contraindication 271737000 DOID:2355
Pregnancy, function contraindication 289908002
Thrombocytopenic disorder contraindication 302215000 DOID:1588
Neutropenic disorder contraindication 303011007 DOID:1227
Bone marrow depression contraindication 307762000
Thromboembolic disorder contraindication 371039008
Breastfeeding (mother) contraindication 413712001
Chronic lung disease contraindication 413839001
UGT1A1*28 polymorphism contraindication 430235005




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 10.46 acidic
pKa2 9.25 Basic
pKa3 2.69 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
EQ 43MG BASE/10ML (EQ 4.3MG BASE/ML) ONIVYDE IPSEN INC N207793 Oct. 22, 2015 RX INJECTABLE, LIPOSOMAL INTRAVENOUS 8703181 May 2, 2025 TREATMENT OF PANCREATIC CANCER
EQ 43MG BASE/10ML (EQ 4.3MG BASE/ML) ONIVYDE IPSEN INC N207793 Oct. 22, 2015 RX INJECTABLE, LIPOSOMAL INTRAVENOUS 9730891 May 2, 2025 TREATMENT OF METASTATIC ADENOCARCINOMA OF THE PANCREAS THAT HAS PROGRESSED ON GEMCITABINE-BASED THERAPY, IN COMBINATION WITH 5-FLUOROURACIL AND LEUCOVORIN
EQ 43MG BASE/10ML (EQ 4.3MG BASE/ML) ONIVYDE IPSEN INC N207793 Oct. 22, 2015 RX INJECTABLE, LIPOSOMAL INTRAVENOUS 10980795 June 12, 2033 TREATMENT OF METASTATIC ADENOCARCINOMA OF THE PANCREAS THAT HAS PROGRESSED ON GEMCITABINE-BASED THERAPY, IN COMBINATION WITH 5-FLUOROURACIL AND LEUCOVORIN
EQ 43MG BASE/10ML (EQ 4.3MG BASE/ML) ONIVYDE IPSEN INC N207793 Oct. 22, 2015 RX INJECTABLE, LIPOSOMAL INTRAVENOUS 11369597 June 12, 2033 TREATMENT OF METASTATIC ADENOCARCINOMA OF THE PANCREAS THAT HAS PROGRESSED ON GEMCITABINE-BASED THERAPY, IN COMBINATION WITH 5-FLUOROURACIL AND LEUCOVORIN
EQ 43MG BASE/10ML (EQ 4.3MG BASE/ML) ONIVYDE IPSEN INC N207793 Oct. 22, 2015 RX INJECTABLE, LIPOSOMAL INTRAVENOUS 9339497 June 12, 2033 TREATMENT OF METASTATIC ADENOCARCINOMA OF THE PANCREAS THAT HAS PROGRESSED ON GEMCITABINE-BASED THERAPY, IN COMBINATION WITH 5-FLUOROURACIL AND LEUCOVORIN
EQ 43MG BASE/10ML (EQ 4.3MG BASE/ML) ONIVYDE IPSEN INC N207793 Oct. 22, 2015 RX INJECTABLE, LIPOSOMAL INTRAVENOUS 9364473 June 12, 2033 TREATMENT OF METASTATIC ADENOCARCINOMA OF THE PANCREAS THAT HAS PROGRESSED ON GEMCITABINE-BASED THERAPY, IN COMBINATION WITH 5-FLUOROURACIL AND LEUCOVORIN, IN A PATIENT HOMOZYGOUS FOR THE UGT1A1*28 ALLELE
EQ 43MG BASE/10ML (EQ 4.3MG BASE/ML) ONIVYDE IPSEN INC N207793 Oct. 22, 2015 RX INJECTABLE, LIPOSOMAL INTRAVENOUS 9452162 June 12, 2033 TREATMENT OF PANCREATIC CANCER THAT HAS PROGRESSED ON GEMCITABINE-BASED THERAPY, IN COMBINATION WITH 5-FLUOROURACIL AND LEUCOVORIN
EQ 43MG BASE/10ML (EQ 4.3MG BASE/ML) ONIVYDE IPSEN INC N207793 Oct. 22, 2015 RX INJECTABLE, LIPOSOMAL INTRAVENOUS 9492442 June 12, 2033 TREATMENT OF EXOCRINE PANCREATIC CANCER THAT HAS PROGRESSED ON GEMCITABINE-BASED THERAPY, IN COMBINATION WITH 5-FLUOROURACIL AND LEUCOVORIN
EQ 43MG BASE/10ML (EQ 4.3MG BASE/ML) ONIVYDE IPSEN INC N207793 Oct. 22, 2015 RX INJECTABLE, LIPOSOMAL INTRAVENOUS 9492442 June 12, 2033 TREATMENT OF METASTATIC ADENOCARCINOMA OF THE PANCREAS THAT HAS PROGRESSED ON GEMCITABINE-BASED THERAPY, IN COMBINATION WITH 5-FLUOROURACIL AND LEUCOVORIN
EQ 43MG BASE/10ML (EQ 4.3MG BASE/ML) ONIVYDE IPSEN INC N207793 Oct. 22, 2015 RX INJECTABLE, LIPOSOMAL INTRAVENOUS 9492442 June 12, 2033 TREATMENT OF PANCREATIC CANCER THAT HAS PROGRESSED ON GEMCITABINE-BASED THERAPY, IN COMBINATION WITH 5-FLUOROURACIL AND LEUCOVORIN
EQ 43MG BASE/10ML (EQ 4.3MG BASE/ML) ONIVYDE IPSEN INC N207793 Oct. 22, 2015 RX INJECTABLE, LIPOSOMAL INTRAVENOUS 9717724 June 12, 2033 TREATMENT OF METASTATIC ADENOCARCINOMA OF THE PANCREAS THAT HAS PROGRESSED ON GEMCITABINE-BASED THERAPY, IN COMBINATION WITH 5-FLUOROURACIL AND LEUCOVORIN
EQ 43MG BASE/10ML (EQ 4.3MG BASE/ML) ONIVYDE IPSEN INC N207793 Oct. 22, 2015 RX INJECTABLE, LIPOSOMAL INTRAVENOUS 9717724 June 12, 2033 TREATMENT OF METASTATIC ADENOCARCINOMA OF THE PANCREAS THAT HAS PROGRESSED ON GEMCITABINE-BASED THERAPY, IN COMBINATION WITH 5-FLUOROURACIL AND LEUCOVORIN, IN A PATIENT NOT HOMOZYGOUS FOR THE UGT1A1*28 ALLELE

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
DNA topoisomerase 1 Enzyme INHIBITOR DRUGBANK CHEMBL
Muscarinic acetylcholine receptor M4 GPCR Ki 6.66 DRUG MATRIX
Canalicular multispecific organic anion transporter 1 Transporter WOMBAT-PK
Alpha-2C adrenergic receptor GPCR Ki 6.34 DRUG MATRIX
Multidrug resistance-associated protein 1 Transporter WOMBAT-PK
ATP-binding cassette sub-family G member 2 Transporter WOMBAT-PK
Multidrug resistance-associated protein 4 Transporter WOMBAT-PK
Acetylcholinesterase Enzyme Ki 7.30 CHEMBL
Interstitial collagenase Enzyme IC50 5.22 DRUG MATRIX
Solute carrier family 22 member 1 Transporter IC50 4.68 CHEMBL
Solute carrier family 22 member 2 Transporter IC50 5.57 CHEMBL
Multidrug and toxin extrusion protein 1 Transporter IC50 5.68 CHEMBL
Multidrug and toxin extrusion protein 2 Transporter IC50 5.10 CHEMBL
Multidrug resistance protein 1 Transporter WOMBAT-PK
Solute carrier family 22 member 3 Transporter IC50 4.13 CHEMBL
Acetylcholinesterase Enzyme Ki 7.58 CHEMBL

External reference:

IDSource
4024027 VUID
N0000022032 NUI
D01061 KEGG_DRUG
136572-09-3 SECONDARY_CAS_RN
4020969 VANDF
4024027 VANDF
C0123931 UMLSCUI
CHEBI:80630 CHEBI
CP0 PDB_CHEM_ID
CHEMBL541887 ChEMBL_ID
CHEMBL481 ChEMBL_ID
CHEMBL3989514 ChEMBL_ID
D000077146 MESH_DESCRIPTOR_UI
DB00762 DRUGBANK_ID
6823 IUPHAR_LIGAND_ID
6694 INN_ID
7673326042 UNII
60838 PUBCHEM_CID
153329 RXNORM
12129 MMSL
236647 MMSL
4918 MMSL
81265 MMSL
d04026 MMSL
d08389 MMSL
005262 NDDF
005263 NDDF
108783005 SNOMEDCT_US
372538008 SNOMEDCT_US
386912006 SNOMEDCT_US
715213000 SNOMEDCT_US
725861003 SNOMEDCT_US
CHEMBL1200512 ChEMBL_ID

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Camptosar HUMAN PRESCRIPTION DRUG LABEL 1 0009-7529 INJECTION, SOLUTION 20 mg INTRAVENOUS NDA 35 sections
Camptosar HUMAN PRESCRIPTION DRUG LABEL 1 0009-7529 INJECTION, SOLUTION 20 mg INTRAVENOUS NDA 35 sections
Camptosar HUMAN PRESCRIPTION DRUG LABEL 1 0009-7529 INJECTION, SOLUTION 20 mg INTRAVENOUS NDA 35 sections
Irinotecan Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0143-9583 INJECTION 20 mg INTRAVENOUS ANDA 28 sections
Irinotecan Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0143-9583 INJECTION 20 mg INTRAVENOUS ANDA 28 sections
Irinotecan Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0143-9701 INJECTION 20 mg INTRAVENOUS ANDA 28 sections
Irinotecan Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0143-9701 INJECTION 20 mg INTRAVENOUS ANDA 28 sections
Irinotecan Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0143-9702 INJECTION 20 mg INTRAVENOUS ANDA 28 sections
Irinotecan Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0143-9702 INJECTION 20 mg INTRAVENOUS ANDA 28 sections
Onivyde HUMAN PRESCRIPTION DRUG LABEL 1 15054-0043 INJECTION, POWDER, FOR SOLUTION 4.30 mg INTRAVENOUS NDA 31 sections
Onivyde HUMAN PRESCRIPTION DRUG LABEL 1 15054-0043 INJECTION, POWDER, FOR SOLUTION 4.30 mg INTRAVENOUS NDA 31 sections
Irinotecan hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 16714-027 INJECTION 20 mg INTRAVENOUS ANDA 30 sections
Irinotecan hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 16714-027 INJECTION 20 mg INTRAVENOUS ANDA 30 sections
Irinotecan hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 16714-131 INJECTION 20 mg INTRAVENOUS ANDA 30 sections
Irinotecan hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 16714-131 INJECTION 20 mg INTRAVENOUS ANDA 30 sections
Irinotecan Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 25021-230 INJECTION, SOLUTION 20 mg INTRAVENOUS ANDA 32 sections
Irinotecan Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 25021-230 INJECTION, SOLUTION 20 mg INTRAVENOUS ANDA 32 sections
Irinotecan hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 45963-614 INJECTION, SOLUTION 20 mg INTRAVENOUS ANDA 20 sections
Irinotecan hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 45963-614 INJECTION, SOLUTION 20 mg INTRAVENOUS ANDA 20 sections
Irinotecan hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 45963-614 INJECTION, SOLUTION 20 mg INTRAVENOUS ANDA 20 sections
Irinotecan hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 45963-614 INJECTION, SOLUTION 20 mg INTRAVENOUS ANDA 20 sections
Irinotecan hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 45963-614 INJECTION, SOLUTION 20 mg INTRAVENOUS ANDA 20 sections
Irinotecan hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 45963-614 INJECTION, SOLUTION 20 mg INTRAVENOUS ANDA 20 sections
Irinotecan Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 50742-401 INJECTION 40 mg INTRAVENOUS ANDA 27 sections
Irinotecan Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 50742-401 INJECTION 40 mg INTRAVENOUS ANDA 27 sections
Irinotecan Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 50742-401 INJECTION 40 mg INTRAVENOUS ANDA 27 sections
Irinotecan Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 50742-402 INJECTION 100 mg INTRAVENOUS ANDA 27 sections
Irinotecan Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 50742-402 INJECTION 100 mg INTRAVENOUS ANDA 27 sections
Irinotecan Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 50742-402 INJECTION 100 mg INTRAVENOUS ANDA 27 sections
IRINOTECAN HYDROCHLORIDE Human Prescription Drug Label 1 55150-352 INJECTION, SOLUTION 20 mg INTRAVENOUS ANDA 30 sections