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 743.01 20.78 623 26646 147342 50430513
Diarrhoea 716.50 20.78 1191 26078 587285 49990570
Disease progression 585.21 20.78 453 26816 95413 50482442
Neuropathy peripheral 349.30 20.78 339 26930 96418 50481437
Mucosal inflammation 234.18 20.78 185 27084 39957 50537898
Febrile neutropenia 233.26 20.78 275 26994 97392 50480463
Malignant neoplasm progression 231.30 20.78 231 27038 67893 50509962
Vomiting 222.95 20.78 646 26623 460112 50117743
Dysarthria 217.36 20.78 172 27097 37231 50540624
Bone marrow failure 214.08 20.78 151 27118 27473 50550382
Dermatitis acneiform 192.43 20.78 75 27194 3982 50573873
Palmar-plantar erythrodysaesthesia syndrome 191.82 20.78 125 27144 19973 50557882
Thrombocytopenia 186.88 20.78 283 26986 127390 50450465
Off label use 180.24 20.78 612 26657 473814 50104041
Leukopenia 179.41 20.78 201 27068 67327 50510528
Myelosuppression 177.31 20.78 103 27166 13414 50564441
Neurotoxicity 176.78 20.78 106 27163 14634 50563221
Abdominal pain 160.77 20.78 377 26892 235851 50342004
Nausea 155.80 20.78 769 26500 704629 49873226
Neutrophil count decreased 154.15 20.78 155 27114 45871 50531984
Metastases to liver 149.06 20.78 107 27162 19997 50557858
Skin toxicity 146.43 20.78 61 27208 3852 50574003
Decreased appetite 140.27 20.78 324 26945 200599 50377256
Haematotoxicity 136.01 20.78 72 27197 7823 50570032
Proteinuria 131.51 20.78 92 27177 16505 50561350
Stomatitis 130.62 20.78 212 27057 101132 50476723
Neoplasm progression 123.86 20.78 112 27157 29045 50548810
Polyneuropathy 117.07 20.78 76 27193 12055 50565800
Joint swelling 111.10 20.78 5 27264 245281 50332574
Arthralgia 110.94 20.78 49 27220 438653 50139202
Ascites 107.82 20.78 114 27155 35747 50542108
Peripheral sensory neuropathy 102.05 20.78 56 27213 6535 50571320
Death 97.98 20.78 390 26879 324989 50252866
Gastrointestinal toxicity 96.01 20.78 48 27221 4629 50573226
Metastases to lung 94.16 20.78 64 27205 10956 50566899
Paronychia 94.16 20.78 47 27222 4517 50573338
Asthenia 85.47 20.78 369 26900 318673 50259182
Dehydration 85.24 20.78 226 27043 152223 50425632
Anaemia 84.43 20.78 313 26956 252143 50325712
Metastases to peritoneum 82.50 20.78 37 27232 2796 50575059
Peripheral swelling 82.13 20.78 8 27261 205928 50371927
Cholinergic syndrome 80.99 20.78 22 27247 360 50577495
Colorectal cancer metastatic 78.89 20.78 23 27246 492 50577363
Product dose omission issue 76.40 20.78 6 27263 183832 50394023
Intestinal obstruction 75.99 20.78 82 27187 26301 50551554
Mucosal toxicity 70.40 20.78 19 27250 303 50577552
Maternal exposure during pregnancy 69.95 20.78 4 27265 159774 50418081
Drug ineffective 69.88 20.78 219 27050 819114 49758741
Ileus 68.67 20.78 57 27212 13172 50564683
Cholangitis 68.40 20.78 38 27231 4541 50573314
Sinusitis 67.02 20.78 7 27262 170551 50407304
Swelling 65.77 20.78 14 27255 200858 50376997
Speech disorder 65.42 20.78 88 27181 35460 50542395
Hypertension 64.90 20.78 255 27014 210948 50366907
Contraindicated product administered 64.38 20.78 4 27265 148954 50428901
Pulmonary embolism 62.18 20.78 156 27113 101548 50476307
Pain 61.14 20.78 139 27130 578764 49999091
Weight increased 60.39 20.78 17 27252 201874 50375981
Enterocutaneous fistula 56.54 20.78 22 27247 1162 50576693
Therapeutic product effect decreased 54.97 20.78 5 27264 136045 50441810
Protein urine 54.33 20.78 18 27251 594 50577261
Drug hypersensitivity 53.13 20.78 35 27234 250975 50326880
Carcinoembryonic antigen increased 51.87 20.78 22 27247 1452 50576403
Steatohepatitis 50.23 20.78 16 27253 465 50577390
Pain in extremity 50.15 20.78 44 27225 272821 50305034
Exposure during pregnancy 50.11 20.78 4 27265 121011 50456844
Epistaxis 48.79 20.78 107 27162 63847 50514008
Metastases to meninges 48.46 20.78 23 27246 1979 50575876
Splenic artery thrombosis 47.89 20.78 10 27259 47 50577808
Gastrointestinal perforation 47.36 20.78 26 27243 3035 50574820
Neuromyotonia 47.21 20.78 10 27259 51 50577804
Metastases to lymph nodes 46.65 20.78 35 27234 6989 50570866
Nasopharyngitis 46.39 20.78 23 27246 192904 50384951
Musculoskeletal stiffness 46.26 20.78 7 27262 128474 50449381
Posterior reversible encephalopathy syndrome 45.81 20.78 48 27221 14880 50562975
Hypokalaemia 45.66 20.78 127 27142 87865 50489990
Cystitis radiation 45.56 20.78 10 27259 62 50577793
Fall 45.37 20.78 69 27200 334863 50242992
General physical health deterioration 45.34 20.78 174 27095 142260 50435595
Hypomagnesaemia 45.18 20.78 59 27210 23097 50554758
Large intestine perforation 44.64 20.78 35 27234 7459 50570396
Venous pressure jugular decreased 44.48 20.78 9 27260 35 50577820
Bladder tamponade 44.39 20.78 10 27259 71 50577784
Drug intolerance 43.13 20.78 33 27236 219071 50358784
Abdominal discomfort 42.97 20.78 37 27232 231604 50346251
Tongue oedema 41.89 20.78 26 27243 3813 50574042
Nasal septum perforation 40.65 20.78 15 27254 684 50577171
Proctalgia 40.24 20.78 28 27241 4975 50572880
Lower respiratory tract infection 39.83 20.78 3 27266 95198 50482657
Headache 39.81 20.78 140 27129 506395 50071460
Laryngospasm 39.31 20.78 22 27247 2666 50575189
Ganglioneuroma 38.81 20.78 10 27259 132 50577723
Cough 38.47 20.78 44 27225 241220 50336635
Trichomegaly 38.24 20.78 8 27261 38 50577817
Intestinal perforation 38.22 20.78 37 27232 10442 50567413
Enteritis 38.10 20.78 31 27238 6964 50570891
Therapy partial responder 37.58 20.78 30 27239 6561 50571294
Product use in unapproved indication 37.27 20.78 142 27127 115677 50462178
Hyperammonaemia 36.97 20.78 26 27243 4698 50573157
Asthma 36.85 20.78 3 27266 89334 50488521
Hypertensive crisis 36.33 20.78 40 27229 13114 50564741
Insomnia 36.15 20.78 25 27244 174840 50403015
White blood cell count decreased 35.83 20.78 141 27128 116581 50461274
Arthritis 35.53 20.78 3 27266 86718 50491137
Wound 35.37 20.78 7 27262 105787 50472068
Trismus 34.83 20.78 22 27247 3326 50574529
Tumour ulceration 33.50 20.78 9 27260 141 50577714
Sepsis 33.36 20.78 151 27118 132774 50445081
Ileal perforation 32.78 20.78 11 27258 378 50577477
Condition aggravated 32.32 20.78 70 27199 296988 50280867
Jaw operation 32.04 20.78 13 27256 767 50577088
Hypertransaminasaemia 30.91 20.78 21 27248 3590 50574265
Skin fissures 30.48 20.78 30 27239 8638 50569217
Device related infection 30.29 20.78 46 27223 20689 50557166
Aortic intramural haematoma 29.81 20.78 7 27262 61 50577794
Myalgia 29.59 20.78 15 27254 124304 50453551
Immune thrombocytopenia 29.48 20.78 30 27239 8987 50568868
Hepatic enzyme increased 29.24 20.78 19 27250 137361 50440494
Pericarditis 28.99 20.78 4 27265 78685 50499170
Dysaesthesia pharynx 28.95 20.78 8 27261 140 50577715
Stomatitis haemorrhagic 28.77 20.78 6 27263 28 50577827
Feeling abnormal 28.61 20.78 16 27253 125476 50452379
Pyrexia 28.27 20.78 321 26948 379882 50197973
Paraesthesia 28.25 20.78 134 27135 120109 50457746
Depression 27.64 20.78 29 27240 165394 50412461
Product use issue 27.55 20.78 24 27245 149451 50428404
Aortitis 27.35 20.78 12 27257 860 50576995
Bronchitis 27.24 20.78 11 27258 104148 50473707
Catheter site bruise 26.61 20.78 9 27260 317 50577538
Tumour perforation 26.40 20.78 7 27262 104 50577751
Depilation 26.24 20.78 5 27264 13 50577842
Influenza 25.90 20.78 8 27261 89530 50488325
Colitis 25.54 20.78 61 27208 38468 50539387
Osteonecrosis of jaw 25.45 20.78 55 27214 32471 50545384
Vena cava thrombosis 25.43 20.78 15 27254 2006 50575849
Dyschezia 24.32 20.78 14 27255 1790 50576065
Drug interaction 24.31 20.78 44 27225 199577 50378278
Cutaneous tuberculosis 24.00 20.78 7 27262 150 50577705
Female genital tract fistula 23.75 20.78 18 27251 3648 50574207
Cardiac failure congestive 23.60 20.78 8 27261 84374 50493481
Discomfort 23.05 20.78 15 27254 108365 50469490
Renal tubular disorder 22.85 20.78 15 27254 2422 50575433
Blister 22.37 20.78 9 27260 85409 50492446
Cardiotoxicity 22.29 20.78 23 27246 7004 50570851
Hypocapnia 22.19 20.78 8 27261 341 50577514
Liver abscess 22.00 20.78 15 27254 2578 50575277
Dizziness 21.95 20.78 104 27165 346265 50231590
Diaphragmatic paralysis 21.78 20.78 9 27260 556 50577299
Enteral nutrition 21.67 20.78 5 27264 40 50577815
Cardiac myxoma 21.67 20.78 7 27262 213 50577642
Anorectal disorder 21.40 20.78 12 27257 1460 50576395
Superior vena cava syndrome 21.12 20.78 9 27260 601 50577254
Gastrointestinal stoma complication 21.11 20.78 12 27257 1498 50576357
Metastasis 20.95 20.78 18 27251 4357 50573498
Multiple-drug resistance 20.87 20.78 16 27253 3298 50574557

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 1071.23 17.93 1675 36021 331023 29205808
Neutropenia 729.20 17.93 866 36830 130845 29405986
Disease progression 687.93 17.93 672 37024 81244 29455587
Stomatitis 322.90 17.93 311 37385 36802 29500029
Palmar-plantar erythrodysaesthesia syndrome 320.79 17.93 212 37484 14547 29522284
Neuropathy peripheral 308.81 17.93 415 37281 70612 29466219
Dermatitis acneiform 304.78 17.93 146 37550 5345 29531486
Skin toxicity 284.03 17.93 124 37572 3647 29533184
Myelosuppression 271.45 17.93 178 37518 12049 29524782
Alopecia 258.86 17.93 206 37490 18878 29517953
Decreased appetite 253.34 17.93 566 37130 144776 29392055
Nausea 217.55 17.93 833 36863 288422 29248409
Mucosal inflammation 215.02 17.93 232 37464 31363 29505468
Vomiting 213.02 17.93 673 37023 211587 29325244
Metastases to liver 211.93 17.93 151 37545 11705 29525126
Neoplasm progression 192.76 17.93 172 37524 18440 29518391
Proteinuria 191.97 17.93 160 37536 15644 29521187
Gastrointestinal toxicity 186.68 17.93 78 37618 2053 29534778
Off label use 171.92 17.93 797 36899 300003 29236828
Bone marrow failure 165.10 17.93 189 37507 27260 29509571
Neutrophil count decreased 158.54 17.93 234 37462 43333 29493498
Leukopenia 154.62 17.93 263 37433 54940 29481891
Cholinergic syndrome 148.50 17.93 45 37651 441 29536390
Malignant neoplasm progression 135.48 17.93 294 37402 73565 29463266
Interstitial lung disease 127.35 17.93 248 37448 57470 29479361
Paronychia 126.85 17.93 66 37630 2887 29533944
Metastases to lung 126.62 17.93 94 37602 7761 29529070
General physical health deterioration 118.58 17.93 343 37353 102514 29434317
Febrile neutropenia 114.06 17.93 358 37338 111882 29424949
Drug interaction 111.96 17.93 56 37640 197329 29339502
Intestinal obstruction 111.30 17.93 130 37566 19147 29517684
Neurotoxicity 111.27 17.93 114 37582 14499 29522332
Haematotoxicity 107.60 17.93 80 37616 6619 29530212
Ileus 105.42 17.93 110 37586 14292 29522539
Peripheral sensory neuropathy 102.34 17.93 74 37622 5865 29530966
Completed suicide 94.51 17.93 5 37691 90241 29446590
Thrombocytopenia 90.02 17.93 375 37321 134448 29402383
Skin reaction 87.64 17.93 60 37636 4357 29532474
Abdominal pain 85.34 17.93 370 37326 134987 29401844
Carcinoembryonic antigen increased 83.36 17.93 31 37665 593 29536238
Necrotising fasciitis 82.07 17.93 52 37644 3313 29533518
Fall 81.48 17.93 64 37632 177114 29359717
Hiccups 80.30 17.93 76 37620 8777 29528054
Epistaxis 77.29 17.93 190 37506 51514 29485317
Product dose omission issue 76.46 17.93 15 37681 96368 29440463
Colorectal cancer metastatic 75.42 17.93 28 37668 533 29536298
Pulmonary embolism 65.06 17.93 230 37466 76304 29460527
Cholangitis 63.25 17.93 62 37634 7475 29529356
Drug ineffective 62.02 17.93 246 37450 362924 29173907
Arthralgia 60.97 17.93 53 37643 139564 29397267
Myocardial infarction 59.91 17.93 33 37663 110263 29426568
Polyneuropathy 58.84 17.93 75 37621 12077 29524754
Gastrointestinal perforation 56.84 17.93 42 37654 3441 29533390
Metastases to lymph nodes 55.79 17.93 44 37652 3973 29532858
Dehydration 55.73 17.93 291 37405 114457 29422374
Headache 55.52 17.93 85 37611 173922 29362909
Ileal perforation 55.52 17.93 24 37672 688 29536143
Cardiac failure congestive 54.61 17.93 15 37681 76566 29460265
Rhabdomyolysis 53.74 17.93 7 37689 60801 29476030
Myalgia 53.72 17.93 14 37682 74005 29462826
Tumour necrosis 53.43 17.93 27 37669 1110 29535721
Colitis microscopic 52.61 17.93 31 37665 1732 29535099
Small intestinal perforation 52.15 17.93 30 37666 1602 29535229
Therapy partial responder 51.72 17.93 47 37649 5152 29531679
Proteus infection 50.78 17.93 24 37672 851 29535980
Blood alkaline phosphatase abnormal 50.63 17.93 19 37677 373 29536458
Nicotinic acid deficiency 49.81 17.93 13 37683 69 29536762
Pneumonia 49.58 17.93 225 37471 319947 29216884
Stoma site haemorrhage 48.90 17.93 22 37674 695 29536136
Hypertension 48.76 17.93 284 37412 116330 29420501
Metastases to peritoneum 48.73 17.93 28 37668 1492 29535339
Bradycardia 48.42 17.93 12 37684 65617 29471214
Enteritis 48.13 17.93 51 37645 6740 29530091
Fatigue 46.85 17.93 612 37084 316209 29220622
Anastomotic complication 45.38 17.93 17 37679 332 29536499
Toxicity to various agents 45.36 17.93 96 37600 173565 29363266
Anal haemorrhage 44.58 17.93 29 37667 1933 29534898
Asthenia 42.08 17.93 439 37257 214811 29322020
Dysphonia 41.68 17.93 82 37614 19114 29517717
Blood glucose increased 41.22 17.93 12 37684 58972 29477859
Joint swelling 40.89 17.93 7 37689 49623 29487208
Agitation 40.63 17.93 8 37688 51296 29485535
Cardiac arrest 40.45 17.93 30 37666 85561 29451270
Portal hypertension 39.64 17.93 34 37662 3452 29533379
Mouth ulceration 39.61 17.93 57 37639 10298 29526533
Hypomagnesaemia 39.61 17.93 76 37620 17392 29519439
Acral peeling skin syndrome 39.50 17.93 10 37686 46 29536785
Coronary artery disease 39.25 17.93 5 37691 44185 29492646
Hospitalisation 38.98 17.93 6 37690 45982 29490849
Pyrexia 38.93 17.93 547 37149 287075 29249756
Induration 38.83 17.93 20 37676 856 29535975
Tumour marker increased 38.09 17.93 17 37679 527 29536304
Peritonitis 38.01 17.93 68 37628 14756 29522075
Anxiety 37.72 17.93 32 37664 85333 29451498
Intestinal perforation 37.72 17.93 49 37647 8037 29528794
Confusional state 37.45 17.93 66 37630 127811 29409020
Failure to anastomose 37.45 17.93 13 37683 202 29536629
Weight increased 37.37 17.93 26 37670 76641 29460190
Subclavian vein thrombosis 36.83 17.93 19 37677 816 29536015
Right ventricular ejection fraction decreased 36.56 17.93 9 37687 36 29536795
Anaemia of malignant disease 36.38 17.93 15 37681 381 29536450
Transdifferentiation of neoplasm 36.21 17.93 10 37686 68 29536763
Sciatic nerve palsy 36.17 17.93 9 37687 38 29536793
Acute abdomen 35.29 17.93 24 37672 1723 29535108
Prothrombin level decreased 35.29 17.93 20 37676 1038 29535793
Carbohydrate antigen 19-9 increased 34.90 17.93 12 37684 181 29536650
Perforation bile duct 34.79 17.93 8 37688 22 29536809
Feeling abnormal 34.67 17.93 13 37683 54432 29482399
Dyspnoea 34.30 17.93 260 37436 326472 29210359
Pain in extremity 34.17 17.93 55 37641 110378 29426453
Hyperammonaemia 34.02 17.93 39 37657 5624 29531207
Somnolence 33.83 17.93 42 37654 93913 29442918
Conjunctivitis 33.53 17.93 46 37650 7952 29528879
Suicidal ideation 33.20 17.93 3 37693 34713 29502118
Depression 32.87 17.93 36 37660 85111 29451720
Rash pustular 32.84 17.93 35 37661 4656 29532175
Stoma site pain 32.48 17.93 15 37681 504 29536327
Catheter site thrombosis 32.11 17.93 8 37688 34 29536797
Rectal tenesmus 32.02 17.93 16 37680 642 29536189
International normalised ratio increased 31.05 17.93 9 37687 44363 29492468
Venoocclusive liver disease 30.85 17.93 41 37655 6876 29529955
Chills 30.64 17.93 175 37521 71125 29465706
Pulmonary artery thrombosis 30.06 17.93 15 37681 600 29536231
Hypokalaemia 29.84 17.93 135 37561 50068 29486763
Asthma 29.65 17.93 4 37692 33845 29502986
Paraesthesia 29.22 17.93 141 37555 53704 29483127
Arteriospasm coronary 29.13 17.93 25 37671 2540 29534291
Cellulitis 29.09 17.93 11 37685 45829 29491002
Wheezing 28.95 17.93 4 37692 33236 29503595
Small intestinal obstruction 28.60 17.93 56 37640 13005 29523826
Nodular regenerative hyperplasia 28.57 17.93 15 37681 668 29536163
Vascular pseudoaneurysm 28.47 17.93 22 37674 1927 29534904
Vena cava thrombosis 28.04 17.93 17 37679 1001 29535830
Leukoencephalopathy 27.96 17.93 29 37667 3738 29533093
Hyperbilirubinaemia 27.94 17.93 60 37636 14874 29521957
Perioral dermatitis 27.68 17.93 9 37687 113 29536718
Unevaluable event 27.44 17.93 3 37693 29848 29506983
Metastases to pelvis 27.26 17.93 11 37685 264 29536567
Toxic erythema of chemotherapy 27.20 17.93 8 37688 70 29536761
Influenza 26.66 17.93 10 37686 41871 29494960
Colon cancer metastatic 26.65 17.93 19 37677 1472 29535359
Anaemia 26.64 17.93 381 37315 200570 29336261
Fistula of small intestine 26.56 17.93 12 37684 383 29536448
Incorrect dose administered 26.41 17.93 5 37691 32979 29503852
Abdominal pain upper 26.40 17.93 150 37546 60843 29475988
Hallucination 26.32 17.93 12 37684 44700 29492131
White blood cell count decreased 26.19 17.93 189 37507 83173 29453658
Enterocolitis 25.94 17.93 37 37659 6629 29530202
Perihepatic abscess 25.73 17.93 8 37688 86 29536745
Peripheral swelling 25.66 17.93 26 37670 63713 29473118
Portal vein thrombosis 25.51 17.93 26 37670 3283 29533548
Tremor 25.30 17.93 34 37662 73504 29463327
Abdominal pain lower 25.26 17.93 42 37654 8596 29528235
Ascites 25.24 17.93 103 37593 36516 29500315
Dizziness 24.88 17.93 141 37555 189543 29347288
Loss of consciousness 24.72 17.93 35 37661 74021 29462810
Device related thrombosis 24.29 17.93 15 37681 913 29535918
Balance disorder 24.11 17.93 8 37688 36162 29500669
Hypoglycaemia 24.08 17.93 16 37680 48330 29488501
Paraesthesia oral 24.07 17.93 26 37670 3511 29533320
Peritoneal haematoma 24.03 17.93 7 37689 59 29536772
Pruritus 23.96 17.93 73 37623 116776 29420055
Atrial fibrillation 23.87 17.93 63 37633 105583 29431248
Clostridial infection 23.68 17.93 25 37671 3290 29533541
Large intestinal obstruction 23.62 17.93 17 37679 1337 29535494
Intestinal strangulation 23.29 17.93 6 37690 30 29536801
Skin disorder 23.27 17.93 48 37648 11570 29525261
Acne 23.26 17.93 42 37654 9178 29527653
Epidermal naevus syndrome 23.20 17.93 5 37691 9 29536822
Wrong technique in product usage process 22.68 17.93 6 37690 31422 29505409
Obstruction gastric 22.61 17.93 14 37682 856 29535975
Acute cutaneous lupus erythematosus 22.21 17.93 7 37689 79 29536752
Deep vein thrombosis 22.16 17.93 137 37559 57262 29479569
Septic shock 22.11 17.93 146 37550 62414 29474417
Heart rate increased 22.08 17.93 11 37685 38927 29497904
Klebsiella infection 21.84 17.93 36 37660 7313 29529518
Large intestine perforation 21.82 17.93 36 37660 7320 29529511
Onychoclasis 21.79 17.93 18 37678 1735 29535096
Oesophagobronchial fistula 21.66 17.93 8 37688 150 29536681
Cachexia 21.49 17.93 33 37663 6316 29530515
Colony stimulating factor therapy 21.18 17.93 8 37688 160 29536671
Hypovolaemic shock 21.17 17.93 32 37664 6040 29530791
Medulloblastoma 21.10 17.93 6 37690 46 29536785
Chronic kidney disease 21.08 17.93 10 37686 36406 29500425
Protein urine 21.08 17.93 13 37683 789 29536042
Tumour perforation 21.01 17.93 9 37687 252 29536579
Change of bowel habit 20.90 17.93 14 37682 980 29535851
Stomal varices 20.88 17.93 6 37690 48 29536783
Colon cancer recurrent 20.83 17.93 7 37689 98 29536733
Electrocardiogram QT prolonged 20.80 17.93 10 37686 36127 29500704
Fistula 20.70 17.93 29 37667 5110 29531721
Adverse drug reaction 20.66 17.93 3 37693 24017 29512814
Pelvic fluid collection 20.58 17.93 7 37689 102 29536729
Sinusitis 20.56 17.93 9 37687 34341 29502490
Therapeutic product effect decreased 20.55 17.93 6 37690 29445 29507386
Acute myocardial infarction 20.37 17.93 19 37677 48419 29488412
VIth nerve disorder 20.31 17.93 5 37691 20 29536811
Superior vena cava syndrome 20.16 17.93 11 37685 530 29536301
Constipation 20.00 17.93 228 37468 113932 29422899
Anal fissure 19.74 17.93 21 37675 2787 29534044
Haematoma 19.73 17.93 3 37693 23209 29513622
Unresponsive to stimuli 19.72 17.93 4 37692 25122 29511709
Oxygen saturation decreased 19.65 17.93 17 37679 44920 29491911
Steatohepatitis 19.64 17.93 9 37687 297 29536534
Abnormal behaviour 19.63 17.93 3 37693 23124 29513707
Subileus 19.48 17.93 21 37675 2829 29534002
White blood cell count increased 19.25 17.93 12 37684 37504 29499327
Nail disorder 19.15 17.93 17 37679 1807 29535024
Dysgeusia 19.11 17.93 68 37628 22606 29514225
Acute kidney injury 18.88 17.93 232 37464 265035 29271796
Disseminated intravascular coagulation 18.65 17.93 62 37634 19918 29516913
Hypertransaminasaemia 18.64 17.93 23 37673 3583 29533248
Colonic fistula 18.41 17.93 9 37687 344 29536487
Biliary tract infection 18.32 17.93 10 37686 482 29536349
Chest pain 18.26 17.93 77 37619 111896 29424935
Venous thrombosis 18.14 17.93 21 37675 3061 29533770
Fluid retention 17.98 17.93 4 37692 23556 29513275
Cardiotoxicity 17.98 17.93 26 37670 4718 29532113
Limbic encephalitis 17.97 17.93 9 37687 363 29536468

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 1620.33 16.87 2571 56225 720133 63719803
Neutropenia 1468.96 16.87 1420 57376 238204 64201732
Disease progression 1066.57 16.87 943 57853 140737 64299199
Neuropathy peripheral 701.50 16.87 688 58108 116837 64323099
Palmar-plantar erythrodysaesthesia syndrome 469.75 16.87 305 58491 28514 64411422
Dermatitis acneiform 449.76 16.87 197 58599 8246 64431690
Mucosal inflammation 413.81 16.87 388 58408 62196 64377740
Myelosuppression 382.94 16.87 250 58546 23580 64416356
Neoplasm progression 375.62 16.87 306 58490 40658 64399278
Stomatitis 365.08 16.87 474 58322 109131 64330805
Decreased appetite 357.78 16.87 790 58006 280499 64159437
Malignant neoplasm progression 357.19 16.87 476 58320 112395 64327541
Proteinuria 355.55 16.87 253 58543 27470 64412466
Bone marrow failure 353.43 16.87 316 58480 47636 64392300
Skin toxicity 348.26 16.87 153 58643 6449 64433487
Febrile neutropenia 337.00 16.87 609 58187 187048 64252888
Vomiting 327.04 16.87 1172 57624 549945 63889991
Leukopenia 317.27 16.87 425 58371 100817 64339119
Neutrophil count decreased 310.25 16.87 367 58429 76829 64363107
Metastases to liver 305.87 16.87 218 58578 23723 64416213
Gastrointestinal toxicity 279.62 16.87 123 58673 5199 64434737
Thrombocytopenia 273.53 16.87 619 58177 223182 64216754
Neurotoxicity 264.50 16.87 211 58585 27193 64412743
Nausea 262.60 16.87 1406 57390 784394 63655542
Metastases to lung 220.73 16.87 150 58646 15114 64424822
Cholinergic syndrome 215.41 16.87 63 58733 780 64439156
Off label use 213.39 16.87 1136 57660 631670 63808266
Peripheral sensory neuropathy 204.14 16.87 128 58668 11250 64428686
Haematotoxicity 201.54 16.87 133 58663 12763 64427173
Intestinal obstruction 196.82 16.87 202 58594 36084 64403852
Paronychia 191.54 16.87 101 58695 6391 64433545
Arthralgia 191.45 16.87 82 58714 442178 63997758
Completed suicide 181.35 16.87 5 58791 224409 64215527
Abdominal pain 174.04 16.87 652 58144 311723 64128213
General physical health deterioration 163.15 16.87 482 58314 203943 64235993
Joint swelling 153.93 16.87 11 58785 215371 64224565
Interstitial lung disease 153.71 16.87 300 58496 97432 64342504
Dysarthria 149.87 16.87 225 58571 59181 64380755
Ileus 148.99 16.87 141 58655 22825 64417111
Epistaxis 138.53 16.87 288 58508 97843 64342093
Dehydration 136.36 16.87 471 58325 216292 64223644
Polyneuropathy 134.54 16.87 125 58671 19769 64420167
Colorectal cancer metastatic 133.19 16.87 45 58751 915 64439021
Fall 130.55 16.87 113 58683 416713 64023223
Product dose omission issue 125.69 16.87 15 58781 194732 64245204
Cholangitis 123.49 16.87 92 58704 10710 64429226
Pulmonary embolism 121.38 16.87 350 58446 146006 64293930
Headache 120.05 16.87 186 58610 529281 63910655
Drug interaction 118.48 16.87 94 58702 361989 64077947
Asthenia 117.19 16.87 728 58068 427316 64012620
Hypertension 116.93 16.87 507 58289 258754 64181182
Metastases to peritoneum 115.60 16.87 59 58737 3488 64436448
Peripheral swelling 111.11 16.87 27 58769 209126 64230810
Weight increased 106.79 16.87 31 58765 213317 64226619
Carcinoembryonic antigen increased 100.69 16.87 44 58752 1829 64438107
Ascites 95.82 16.87 189 58607 61812 64378124
Pain in extremity 95.00 16.87 82 58714 303003 64136933
Anaemia 94.30 16.87 629 58167 378051 64061885
Sinusitis 92.28 16.87 12 58784 145916 64294020
Swelling 90.51 16.87 18 58778 160200 64279736
Metastases to lymph nodes 88.12 16.87 69 58727 8648 64431288
Drug ineffective 88.09 16.87 431 58365 839816 63600120
Hypomagnesaemia 87.80 16.87 137 58659 37239 64402697
Pain 86.83 16.87 240 58556 553271 63886665
Hiccups 86.18 16.87 67 58729 8309 64431627
Enteritis 85.77 16.87 78 58718 11999 64427937
Gastrointestinal perforation 82.47 16.87 55 58741 5369 64434567
Ileal perforation 78.93 16.87 30 58766 866 64439070
Therapy partial responder 76.35 16.87 68 58728 10180 64429756
Myalgia 75.84 16.87 25 58771 158592 64281344
Contraindicated product administered 75.59 16.87 6 58790 107823 64332113
White blood cell count decreased 75.18 16.87 314 58482 157523 64282413
Maternal exposure during pregnancy 74.35 16.87 3 58793 95881 64344055
Therapeutic product effect decreased 74.11 16.87 9 58787 115342 64324594
Arthropathy 74 16.87 11 58785 120956 64318980
Drug hypersensitivity 72.49 16.87 66 58730 237749 64202187
Intestinal perforation 70.20 16.87 78 58718 15235 64424701
Cough 69.42 16.87 105 58691 302043 64137893
Hyperammonaemia 66.51 16.87 62 58734 9842 64430094
Pyrexia 66.37 16.87 789 58007 557855 63882081
Asthma 64.83 16.87 6 58790 95219 64344717
Necrotising fasciitis 64.57 16.87 47 58749 5279 64434657
Anastomotic complication 64.44 16.87 21 58775 380 64439556
Steatohepatitis 63.77 16.87 25 58771 786 64439150
Tumour necrosis 63.28 16.87 31 58765 1678 64438258
Cardiac failure congestive 61.68 16.87 21 58775 130559 64309377
Hypokalaemia 60.77 16.87 246 58550 121657 64318279
Arthritis 60.65 16.87 4 58792 83810 64356126
Abdominal discomfort 59.96 16.87 47 58749 182275 64257661
Nasopharyngitis 59.05 16.87 55 58741 196018 64243918
Enterocutaneous fistula 56.92 16.87 28 58768 1529 64438407
Rhabdomyolysis 56.89 16.87 8 58788 91718 64348218
Large intestine perforation 55.72 16.87 63 58733 12541 64427395
Exposure during pregnancy 55.35 16.87 4 58792 77671 64362265
Alopecia 55.05 16.87 297 58499 165393 64274543
Small intestinal perforation 53.90 16.87 32 58764 2548 64437388
Skin reaction 53.35 16.87 61 58735 12291 64427645
Myocardial infarction 52.96 16.87 44 58752 165777 64274159
Feeling abnormal 52.70 16.87 28 58768 133574 64306362
Influenza 52.32 16.87 16 58780 106515 64333421
Depression 52.20 16.87 54 58742 183237 64256699
Vena cava thrombosis 52.07 16.87 31 58765 2481 64437455
Musculoskeletal stiffness 51.34 16.87 24 58772 123182 64316754
Bradycardia 50.87 16.87 22 58774 118197 64321739
Intentional product misuse 50.73 16.87 4 58792 72291 64367645
Dysphonia 50.68 16.87 123 58673 46259 64393677
Stoma site haemorrhage 50.16 16.87 26 58770 1587 64438349
Pruritus 49.95 16.87 134 58662 312266 64127670
Drug intolerance 49.57 16.87 59 58737 187933 64252003
Speech disorder 49.28 16.87 125 58671 48316 64391620
Dizziness 48.80 16.87 214 58582 429949 64009987
Paraesthesia 48.72 16.87 247 58549 134275 64305661
Suicidal ideation 48.67 16.87 3 58793 66539 64373397
Peritonitis 48.34 16.87 84 58712 24939 64414997
Hypertransaminasaemia 48.26 16.87 45 58751 7146 64432790
Contusion 47.80 16.87 22 58774 113943 64325993
Product use issue 47.53 16.87 41 58755 151674 64288262
Somnolence 47.48 16.87 70 58726 203575 64236361
Glossodynia 47.07 16.87 3 58793 64693 64375243
Anxiety 46.92 16.87 70 58726 202579 64237357
Nicotinic acid deficiency 46.87 16.87 13 58783 131 64439805
Protein urine 46.50 16.87 23 58773 1271 64438665
Anal haemorrhage 46.33 16.87 32 58764 3308 64436628
Hospitalisation 45.62 16.87 7 58789 75200 64364736
Nodular regenerative hyperplasia 45.35 16.87 20 58776 850 64439086
Deep vein thrombosis 45.25 16.87 203 58593 104979 64334957
Mucosal toxicity 45.25 16.87 17 58779 475 64439461
Lower respiratory tract infection 45.05 16.87 15 58781 94599 64345337
Proctalgia 44.48 16.87 44 58752 7515 64432421
Mobility decreased 43.79 16.87 12 58784 85828 64354108
Hyperbilirubinaemia 43.36 16.87 73 58723 21132 64418804
Dyspnoea 43.25 16.87 433 58363 718241 63721695
Posterior reversible encephalopathy syndrome 43.00 16.87 76 58720 22870 64417066
Acral peeling skin syndrome 42.83 16.87 10 58786 46 64439890
Insomnia 42.33 16.87 72 58724 197764 64242172
Chills 42.21 16.87 241 58555 137023 64302913
Splenic artery thrombosis 41.66 16.87 10 58786 53 64439883
Metastases to meninges 41.49 16.87 28 58768 2787 64437149
Heart rate increased 41.45 16.87 19 58777 98656 64341280
Colitis microscopic 41.41 16.87 42 58754 7390 64432546
Proteus infection 41.33 16.87 23 58773 1620 64438316
Superior vena cava syndrome 41.30 16.87 20 58776 1055 64438881
Blood alkaline phosphatase abnormal 41.06 16.87 18 58778 754 64439182
Blood glucose increased 41.02 16.87 19 58777 98054 64341882
Portal vein thrombosis 40.97 16.87 35 58761 4956 64434980
Venoocclusive liver disease 40.81 16.87 48 58748 9967 64429969
Confusional state 40.25 16.87 114 58682 261030 64178906
Portal hypertension 39.98 16.87 38 58758 6181 64433755
Pericarditis 39.85 16.87 5 58791 62511 64377425
Cardiotoxicity 39.82 16.87 48 58748 10226 64429710
Bronchitis 39.74 16.87 25 58771 108718 64331218
Hepatic enzyme increased 39.64 16.87 36 58760 129907 64310029
Acute abdomen 39.04 16.87 27 58769 2797 64437139
Subclavian vein thrombosis 38.93 16.87 25 58771 2289 64437647
Pneumonia 38.89 16.87 325 58471 559251 63880685
Incorrect dose administered 38.39 16.87 5 58791 60760 64379176
Rectal tenesmus 38.35 16.87 19 58777 1054 64438882
Coronary artery disease 38.11 16.87 5 58791 60428 64379508
Right ventricular ejection fraction decreased 38.09 16.87 9 58787 44 64439892
Cardiac arrest 37.85 16.87 51 58745 154013 64285923
Neuromyotonia 37.79 16.87 10 58786 83 64439853
Device related infection 37.58 16.87 85 58711 30541 64409395
Pelvic fluid collection 37.38 16.87 16 58780 632 64439304
International normalised ratio increased 36.92 16.87 13 58783 79154 64360782
Rectal haemorrhage 36.76 16.87 132 58664 61685 64378251
Transdifferentiation of neoplasm 36.68 16.87 10 58786 94 64439842
Failure to anastomose 36.47 16.87 12 58784 224 64439712
Wheezing 36.28 16.87 14 58782 80565 64359371
Pulmonary artery thrombosis 36.25 16.87 19 58777 1187 64438749
Blood pressure fluctuation 36.03 16.87 3 58793 51868 64388068
Condition aggravated 36.00 16.87 196 58600 372230 64067706
Osteoarthritis 35.99 16.87 7 58789 63329 64376607
Septic shock 35.67 16.87 190 58606 105247 64334689
Colitis 35.50 16.87 126 58670 58548 64381388
Wrong technique in product usage process 35.24 16.87 8 58788 64966 64374970
Intestinal metastasis 35.11 16.87 12 58784 253 64439683
Cystitis radiation 35.02 16.87 10 58786 113 64439823
Blister 34.94 16.87 15 58781 80952 64358984
Skin disorder 34.16 16.87 77 58719 27603 64412333
Sciatic nerve palsy 34.09 16.87 9 58787 74 64439862
Fistula of small intestine 33.96 16.87 15 58781 640 64439296
Paraesthesia oral 33.46 16.87 50 58746 13081 64426855
Liver abscess 33.44 16.87 32 58764 5248 64434688
Venous pressure jugular decreased 33.26 16.87 9 58787 82 64439854
Metastasis 33.23 16.87 33 58763 5662 64434274
Rash pustular 33.22 16.87 43 58753 9842 64430094
Induration 33.10 16.87 20 58776 1644 64438292
Colon cancer metastatic 32.90 16.87 21 58775 1902 64438034
Leukoencephalopathy 32.82 16.87 36 58760 6931 64433005
Fatigue 32.71 16.87 903 57893 747827 63692109
Influenza like illness 32.66 16.87 8 58788 61694 64378242
Prothrombin level decreased 32.54 16.87 19 58777 1467 64438469
Nasal septum perforation 32.44 16.87 15 58781 713 64439223
Electrocardiogram QT prolonged 32.29 16.87 16 58780 79432 64360504
Aortitis 32.11 16.87 17 58779 1084 64438852
Venous thrombosis limb 31.68 16.87 27 58769 3810 64436126
Aggression 31.23 16.87 3 58793 46229 64393707
Balance disorder 31.07 16.87 19 58777 83907 64356029
Tremor 30.74 16.87 55 58741 148175 64291761
Tumour ulceration 30.48 16.87 10 58786 185 64439751
Limbic encephalitis 30.44 16.87 14 58782 657 64439279
Anaemia of malignant disease 30.22 16.87 14 58782 668 64439268
Laryngospasm 30.01 16.87 25 58771 3420 64436516
Dysaesthesia pharynx 29.94 16.87 10 58786 196 64439740
Constipation 29.82 16.87 330 58466 229007 64210929
Migraine 29.73 16.87 10 58786 62667 64377269
Small intestinal obstruction 29.57 16.87 66 58730 23507 64416429
Enterocolitis 29.54 16.87 45 58751 11973 64427963
Perforation bile duct 29.50 16.87 7 58789 35 64439901
Disseminated intravascular coagulation 29.35 16.87 80 58716 32268 64407668
Subileus 29.34 16.87 29 58767 4948 64434988
Trichomegaly 28.99 16.87 8 58788 79 64439857
Oxygen saturation decreased 28.92 16.87 33 58763 107143 64332793
Klebsiella infection 28.87 16.87 47 58749 13234 64426702
Ganglioneuroma 28.76 16.87 9 58787 142 64439794
Agitation 28.75 16.87 23 58773 88344 64351592
Haematoma 28.75 16.87 4 58792 46246 64393690
Large intestinal obstruction 28.64 16.87 22 58774 2680 64437256
Biliary tract infection 28.63 16.87 15 58781 936 64439000
Hepatic failure 28.55 16.87 113 58683 55281 64384655
Tumour perforation 28.48 16.87 11 58785 332 64439604
Therapeutic product effect incomplete 28.15 16.87 176 58620 103306 64336630
K-ras gene mutation 28.15 16.87 7 58789 44 64439892
Vascular pseudoaneurysm 27.90 16.87 23 58773 3101 64436835
Anorectal disorder 27.89 16.87 19 58777 1920 64438016
Trismus 27.86 16.87 28 58768 4873 64435063
Gastrointestinal stoma complication 27.79 16.87 20 58776 2206 64437730
Toxicity to various agents 27.58 16.87 206 58590 363307 64076629
Dysgeusia 27.58 16.87 100 58696 46947 64392989
Hypovolaemic shock 27.47 16.87 40 58756 10226 64429710
Diaphragmatic paralysis 27.45 16.87 15 58781 1019 64438917
COVID-19 26.65 16.87 13 58783 65127 64374809
Gastrointestinal disorder 26.58 16.87 156 58640 89553 64350383
Treatment noncompliance 26.47 16.87 4 58792 43478 64396458
Cataract 26.45 16.87 7 58789 51255 64388681
Chronic obstructive pulmonary disease 26.42 16.87 16 58780 71032 64368904
Pneumatosis intestinalis 26.35 16.87 28 58768 5201 64434735
Wound 26.04 16.87 19 58777 76458 64363478
Loss of personal independence in daily activities 26.00 16.87 17 58779 72437 64367499
Gait disturbance 25.88 16.87 76 58720 172079 64267857
Jaw operation 25.83 16.87 13 58783 746 64439190
Performance status decreased 25.76 16.87 28 58768 5336 64434600
Heart rate decreased 25.74 16.87 9 58787 55058 64384878
Gait inability 25.56 16.87 4 58792 42364 64397572
Productive cough 25.17 16.87 18 58778 73185 64366751
Perihepatic abscess 25.12 16.87 8 58788 134 64439802
Venous thrombosis 25.04 16.87 30 58766 6351 64433585
Hypoglycaemia 24.99 16.87 27 58769 89865 64350071
Toxic erythema of chemotherapy 24.97 16.87 9 58787 223 64439713
Epidermal naevus syndrome 24.87 16.87 5 58791 9 64439927
Metastatic neoplasm 24.56 16.87 25 58771 4417 64435519
Skin fissures 24.50 16.87 38 58758 10268 64429668
Anal fistula 24.49 16.87 27 58769 5226 64434710
Acute myeloid leukaemia 24.01 16.87 67 58729 27396 64412540
Carbohydrate antigen 19-9 increased 24 16.87 10 58786 369 64439567
Optic glioma 23.82 16.87 6 58790 40 64439896
Depilation 23.61 16.87 5 58791 13 64439923
Perioral dermatitis 23.54 16.87 9 58787 264 64439672
Memory impairment 23.53 16.87 26 58770 85656 64354280
Blood pressure systolic increased 23.26 16.87 8 58788 49445 64390491
Tongue oedema 23.24 16.87 28 58768 5962 64433974
Febrile infection 23.11 16.87 20 58776 2881 64437055
Cellulitis 23.00 16.87 31 58765 93626 64346310
Rectal perforation 22.92 16.87 12 58784 748 64439188
Obstruction gastric 22.80 16.87 15 58781 1431 64438505
Viral infection 22.76 16.87 3 58793 36137 64403799
Stomal varices 22.76 16.87 6 58790 49 64439887
Lactic acidosis 22.59 16.87 14 58782 61396 64378540
Gastrointestinal inflammation 22.48 16.87 28 58768 6167 64433769
Nephrotic syndrome 22.36 16.87 35 58761 9532 64430404
Palpitations 22.36 16.87 38 58758 104450 64335486
Neutrophilia 22.31 16.87 29 58767 6665 64433271
Hypervolaemia 22.24 16.87 4 58792 38281 64401655
Intestinal strangulation 22.24 16.87 6 58790 54 64439882
Hepatic lesion 22.23 16.87 27 58769 5797 64434139
Device related thrombosis 22.15 16.87 17 58779 2068 64437868
Malignant ascites 22.01 16.87 13 58783 1025 64438911
Disease recurrence 21.99 16.87 71 58725 31439 64408497
Aortic intramural haematoma 21.94 16.87 7 58789 118 64439818
Loss of consciousness 21.94 16.87 66 58730 148299 64291637
Hepatotoxicity 21.80 16.87 83 58713 39879 64400057
Hydronephrosis 21.73 16.87 43 58753 14082 64425854
Oesophagobronchial fistula 21.62 16.87 8 58788 214 64439722
Duodenal ulcer perforation 21.51 16.87 3 58793 34622 64405314
Dry skin 21.43 16.87 98 58698 51063 64388873
Prostatic calcification 21.41 16.87 6 58790 63 64439873
Multiple-drug resistance 21.41 16.87 28 58768 6474 64433462
Toxic epidermal necrolysis 21.34 16.87 4 58792 37162 64402774
Tumour embolism 21.31 16.87 7 58789 130 64439806
Conjunctivitis 21.19 16.87 53 58743 20301 64419635
Colony stimulating factor therapy 21.06 16.87 10 58786 505 64439431
Metastases to central nervous system 20.98 16.87 42 58754 13870 64426066
Immune thrombocytopenia 20.97 16.87 44 58752 15022 64424914
Renal hydrocele 20.91 16.87 5 58791 26 64439910
Bladder tamponade 20.84 16.87 10 58786 517 64439419
Overdose 20.82 16.87 75 58721 159491 64280445
Adenocarcinoma of colon 20.79 16.87 24 58772 4884 64435052
VIth nerve disorder 20.75 16.87 5 58791 27 64439909
Unresponsive to stimuli 20.70 16.87 10 58786 50383 64389553
Abnormal behaviour 20.68 16.87 3 58793 33619 64406317
Discomfort 20.65 16.87 26 58770 80852 64359084
Cachexia 20.55 16.87 33 58763 9184 64430752
Hypoalbuminaemia 20.52 16.87 48 58748 17626 64422310
Emotional distress 20.44 16.87 4 58792 36034 64403902
Colonic fistula 20.35 16.87 10 58786 545 64439391
Arteriospasm coronary 20.31 16.87 25 58771 5440 64434496
Chronic kidney disease 20.23 16.87 14 58782 57905 64382031
Jugular vein thrombosis 20.17 16.87 21 58775 3810 64436126
Clostridial infection 19.97 16.87 24 58772 5095 64434841
Chest pain 19.70 16.87 130 58666 235850 64204086
Tumour lysis syndrome 19.59 16.87 50 58746 19390 64420546
Peritoneal haematoma 19.59 16.87 7 58789 169 64439767
Pneumoretroperitoneum 19.52 16.87 6 58790 89 64439847
Hypertensive crisis 19.51 16.87 48 58748 18200 64421736
Psychotic disorder 19.27 16.87 4 58792 34574 64405362
Anastomotic fistula 19.10 16.87 6 58790 96 64439840
Hypotension 19.08 16.87 239 58557 380735 64059201
Rhabdomyosarcoma recurrent 19.04 16.87 6 58790 97 64439839
Stomatitis haemorrhagic 19.04 16.87 6 58790 97 64439839
Stevens-Johnson syndrome 19.01 16.87 4 58792 34245 64405691
Gastrooesophageal reflux disease 18.95 16.87 29 58767 83114 64356822
Catheter site thrombosis 18.82 16.87 7 58789 190 64439746
Adverse drug reaction 18.71 16.87 9 58787 45455 64394481
Female genital tract fistula 18.54 16.87 17 58779 2641 64437295
Cell-mediated cytotoxicity 18.53 16.87 5 58791 45 64439891
Swelling face 18.50 16.87 16 58780 59150 64380786
Product use in unapproved indication 18.50 16.87 244 58552 176374 64263562
Respiratory arrest 18.25 16.87 13 58783 52972 64386964
Enteral nutrition 18.25 16.87 5 58791 48 64439888
Lymphadenopathy mediastinal 18.21 16.87 20 58776 3856 64436080
Pancreatic carcinoma metastatic 18.19 16.87 19 58777 3459 64436477
Cutaneous tuberculosis 18.16 16.87 7 58789 210 64439726
Reproductive toxicity 18.00 16.87 3 58793 0 64439936
Administration site recall reaction 18.00 16.87 3 58793 0 64439936
Gene mutation 17.91 16.87 15 58781 2067 64437869
Unevaluable event 17.90 16.87 12 58784 50477 64389459
Necrotising colitis 17.89 16.87 11 58785 933 64439003
Osteoporosis 17.83 16.87 8 58788 42072 64397864
Rectal cancer 17.76 16.87 17 58779 2789 64437147
Nasal congestion 17.63 16.87 17 58779 59641 64380295
Duodenal varices 17.58 16.87 4 58792 16 64439920
Product quality issue 17.56 16.87 3 58793 29796 64410140
Abdominal abscess 17.51 16.87 25 58771 6279 64433657
Anal fissure 17.42 16.87 22 58774 4914 64435022
Iatrogenic infection 17.39 16.87 5 58791 58 64439878
Portal vein embolisation 17.39 16.87 4 58792 17 64439919
Pelvic abscess 17.35 16.87 14 58782 1831 64438105
Burning sensation 17.35 16.87 12 58784 49652 64390284
Platelet count decreased 17.28 16.87 231 58565 167480 64272456
Recall phenomenon 17.25 16.87 11 58785 995 64438941
Ileus paralytic 17.24 16.87 29 58767 8386 64431550
Fingerprint loss 17.24 16.87 5 58791 60 64439876
Dysaesthesia 17.21 16.87 22 58774 4973 64434963
Irritability 17.19 16.87 6 58790 36740 64403196
Lip swelling 17.16 16.87 4 58792 31903 64408033
Allodynia 17.11 16.87 12 58784 1271 64438665
Sepsis 17.08 16.87 300 58496 230041 64209895
Peripheral sensorimotor neuropathy 17.01 16.87 16 58780 2569 64437367
Death 16.91 16.87 567 58229 482138 63957798
Type 2 diabetes mellitus 16.89 16.87 5 58791 34015 64405921

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
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 (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 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)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
EQ 43MG BASE/10ML (EQ 4.3MG BASE/ML) ONIVYDE IPSEN INC N207793 Oct. 22, 2015 RX INJECTABLE, LIPOSOMAL INTRAVENOUS Oct. 22, 2022 FOR USE IN COMBINATION WITH 5-FLUOROURACIL AND LEUCOVORIN, FOR THE TREATMENT OF PATIENTS WITH METASTATIC ADENOCARCINOMA OF THE PANCREAS THAT HAS PROGRESSED FOLLOWING GEMCITABINE-BASED THERAPY

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
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 0143-9702 INJECTION 20 mg INTRAVENOUS ANDA 28 sections
Onivyde HUMAN PRESCRIPTION DRUG LABEL 1 15054-0043 INJECTION, POWDER, FOR SOLUTION 4.30 mg INTRAVENOUS NDA 29 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 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 55150-352 INJECTION, SOLUTION 20 mg INTRAVENOUS ANDA 30 sections
IRINOTECAN HYDROCHLORIDE Human Prescription Drug Label 1 55150-352 INJECTION, SOLUTION 20 mg INTRAVENOUS ANDA 30 sections
IRINOTECAN HYDROCHLORIDE Human Prescription Drug Label 1 55150-353 INJECTION, SOLUTION 20 mg INTRAVENOUS ANDA 30 sections
IRINOTECAN HYDROCHLORIDE Human Prescription Drug Label 1 55150-353 INJECTION, SOLUTION 20 mg INTRAVENOUS ANDA 30 sections
IRINOTECAN HYDROCHLORIDE Human Prescription Drug Label 1 55150-354 INJECTION, SOLUTION 20 mg INTRAVENOUS ANDA 30 sections
IRINOTECAN HYDROCHLORIDE Human Prescription Drug Label 1 55150-354 INJECTION, SOLUTION 20 mg INTRAVENOUS ANDA 30 sections
IRINOTECAN HYDROCHLORIDE Human Prescription Drug Label 1 55150-355 INJECTION, SOLUTION 20 mg INTRAVENOUS ANDA 30 sections
Irinotecan Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 59923-702 INJECTION 20 mg INTRAVENOUS ANDA 26 sections
Irinotecan Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 59923-714 INJECTION 20 mg INTRAVENOUS ANDA 31 sections
Irinotecan Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 59923-715 INJECTION 20 mg INTRAVENOUS ANDA 31 sections