irinotecan 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | 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 µM/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

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
kinase-safety-class AAK1,ACVR2B,ACVRL1,ALK,AURKA,AXL,BRAF,CAMK2B,CAMK2D,CDK4,CDK5,CDK9,CLK4,CSF1R,DDR1,DYRK1B,EGFR,EIF2AK3,EPHB4,ERBB2,FGFR1,FLT3,GAK,GRK2,GSK3B,INSR,IRAK1,IRAK3,ITK,JAK2,KDR,KIT,LCK,MAP3K11,MAP3K21,MAP3K7,MAP4K1,MAP4K3,MAP4K5,MAPK10,MAPK7,MAPK9,MARK4,MELK,MET,NTRK1,NTRK2,PDK1,PDK2,PDK4,PIK3CA,PIK3CB,PIK3CD,PIK3CG,PIM3,PRKCD,PRKDC,SIK2,SIK3,SRC,STK17A,STK33,SYK,TEK,TGFBR1,TNIK,TTK,ULK1 68
kinase-selectivity-class AXL,BRAF,CAMK2A,CAMK2D,CDK4,CDK9,CLK2,CLK4,EIF2AK3,EPHB4,FLT3,IRAK1,IRAK3,MAP2K6,MAP3K14,MAP3K7,MAP4K1,MAP4K5,MAPK12,MARK4,MET,PDK1,PRKDC,PTK2,SIK2,SIK3,STK33,SYK,TEK,TTK,TYRO3,ULK1,ZAP70 33
mdck-mdr1-bcrp-efflux MDCK-MDR1-BCRP efflux ratio 13.740 High 1
pfas-class PFAS structural alert (1 = True, 0 = False) 0
rat-kpuu-brain Rat brain Kpuu 0.029 % High 1

Approvals:

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

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Disease progression 1176.55 22.61 775 39057 155840 90432775
Neutropenia 1159.40 22.61 884 38948 224020 90364595
Diarrhoea 1127.31 22.61 1691 38141 937499 89651116
Neuropathy peripheral 745.59 22.61 557 39275 136413 90452202
Febrile neutropenia 587.85 22.61 515 39317 157834 90430781
Myelosuppression 563.23 22.61 329 39503 53262 90535353
Malignant neoplasm progression 471.24 22.61 384 39448 106486 90482129
Neurotoxicity 331.29 22.61 170 39662 21297 90567318
Dermatitis acneiform 330.47 22.61 119 39713 6235 90582380
Thrombocytopenia 325.92 22.61 429 39403 208296 90380319
Mucosal inflammation 325.61 22.61 240 39592 57385 90531230
Dysarthria 319.35 22.61 232 39600 54250 90534365
Vomiting 302.77 22.61 893 38939 787400 89801215
Metastases to liver 300.22 22.61 176 39656 28631 90559984
Leukopenia 296.38 22.61 288 39544 100422 90488193
Bone marrow failure 271.95 22.61 172 39660 32049 90556566
Palmar-plantar erythrodysaesthesia syndrome 268.02 22.61 162 39670 27861 90560754
Neoplasm progression 255.16 22.61 187 39645 44299 90544316
Nausea 249.71 22.61 1054 38778 1109262 89479353
Skin toxicity 240.46 22.61 96 39736 6683 90581932
Off label use 239.03 22.61 1035 38797 1101217 89487398
Abdominal pain 212.93 22.61 509 39323 395212 90193403
Neutrophil count decreased 205.57 22.61 202 39630 71330 90517285
Anaemia 195.35 22.61 459 39373 352343 90236272
Joint swelling 187.22 22.61 8 39824 503292 90085323
Polyneuropathy 177.71 22.61 109 39723 19232 90569383
Ascites 176.17 22.61 155 39677 47585 90541030
Arthralgia 163.63 22.61 69 39763 778453 89810162
Metastases to lung 151.73 22.61 92 39740 15899 90572716
Haematotoxicity 150.44 22.61 84 39748 12451 90576164
Proteinuria 147.46 22.61 104 39728 23187 90565428
Hypokalaemia 144.96 22.61 229 39603 130887 90457728
Metastases to peritoneum 144.44 22.61 58 39774 4097 90584518
Gastrointestinal toxicity 143.22 22.61 74 39758 9393 90579222
Dehydration 143.02 22.61 284 39548 194163 90394452
Decreased appetite 142.19 22.61 425 39407 376115 90212500
Therapy partial responder 140.89 22.61 99 39733 21944 90566671
Cholinergic syndrome 140.75 22.61 37 39795 659 90587956
Death 140.29 22.61 480 39352 456071 90132544
Asthenia 138.49 22.61 531 39301 533220 90055395
Cholangitis 134.82 22.61 65 39767 7117 90581498
Swelling 134.47 22.61 14 39818 419044 90169571
Paronychia 125.22 22.61 64 39768 7942 90580673
Contraindicated product administered 122.70 22.61 4 39828 320135 90268480
Sinusitis 119.56 22.61 8 39824 343080 90245535
Glossodynia 116.70 22.61 6 39826 321773 90266842
Peripheral sensory neuropathy 116.52 22.61 64 39768 9186 90579429
Colorectal cancer metastatic 115.30 22.61 33 39799 816 90587799
Peripheral swelling 113.45 22.61 22 39810 413084 90175531
Myelodysplastic syndrome 113.37 22.61 85 39747 20818 90567797
Enteritis 109.98 22.61 64 39768 10257 90578358
Pulmonary embolism 109.58 22.61 202 39630 130618 90457997
Weight increased 107.16 22.61 26 39806 417901 90170714
Maternal exposure during pregnancy 105.84 22.61 16 39816 360047 90228568
Nasopharyngitis 105.02 22.61 25 39807 407079 90181536
Pain 104.19 22.61 174 39658 996167 89592448
Intestinal obstruction 103.18 22.61 103 39729 37028 90551587
Musculoskeletal stiffness 103.05 22.61 7 39825 296525 90292090
Pericarditis 101.34 22.61 4 39828 270147 90318468
Therapeutic product effect decreased 101.19 22.61 5 39827 277566 90311049
Wound 100.11 22.61 9 39823 302971 90285644
Speech disorder 97.47 22.61 110 39722 45475 90543140
Lower respiratory tract infection 96.50 22.61 3 39829 250656 90337959
Abdominal discomfort 91.32 22.61 48 39784 477280 90111335
Product dose omission issue 90.36 22.61 11 39821 291676 90296939
Steatohepatitis 90.04 22.61 27 39805 789 90587826
Colitis 88.32 22.61 130 39702 69812 90518803
Ileus 86.89 22.61 66 39766 16480 90572135
Asthma 86.27 22.61 5 39827 242155 90346460
Exposure during pregnancy 81.75 22.61 6 39826 238404 90350211
Hepatic enzyme increased 80.49 22.61 29 39803 360707 90227908
Headache 80.01 22.61 162 39670 862584 89726031
Hypomagnesaemia 79.72 22.61 88 39744 35500 90553115
Mucosal toxicity 79.52 22.61 21 39811 381 90588234
Mobility decreased 78.78 22.61 9 39823 250725 90337890
Drug hypersensitivity 78.33 22.61 54 39778 463555 90125060
Metastases to lymph nodes 75.85 22.61 53 39779 11636 90576979
Blister 75.67 22.61 11 39821 254987 90333628
Arteriospasm coronary 75.02 22.61 39 39793 5011 90583604
Epistaxis 71.95 22.61 132 39700 84993 90503622
Sepsis 71.56 22.61 207 39625 179607 90409008
Large intestine perforation 70.04 22.61 47 39785 9665 90578950
Trismus 68.11 22.61 36 39796 4785 90583830
Pain in extremity 67.82 22.61 59 39773 450470 90138145
Trichomegaly 67.31 22.61 14 39818 82 90588533
Wheezing 66.76 22.61 12 39820 238068 90350547
Hyperammonaemia 65.95 22.61 39 39793 6436 90582179
Rash pustular 65.47 22.61 42 39790 8007 90580608
Carcinoembryonic antigen increased 65.44 22.61 28 39804 2322 90586293
Discomfort 64.77 22.61 20 39812 274315 90314300
Neutropenic colitis 64.44 22.61 33 39799 4110 90584505
Acute myeloid leukaemia 64.36 22.61 61 39771 20579 90568036
Tongue oedema 63.95 22.61 36 39796 5418 90583197
Injection site pain 63.70 22.61 3 39829 173696 90414919
Stomatitis 62.75 22.61 263 39569 274435 90314180
Laryngospasm 62.06 22.61 30 39802 3303 90585312
Arthritis 61.00 22.61 3 39829 167312 90421303
Folliculitis 60.19 22.61 9 39823 204344 90384271
Product use in unapproved indication 59.78 22.61 299 39533 335937 90252678
White blood cell count decreased 59.51 22.61 185 39647 166924 90421691
Metastases to meninges 58.82 22.61 30 39802 3705 90584910
Posterior reversible encephalopathy syndrome 56.65 22.61 59 39773 22280 90566335
Device related infection 56.44 22.61 63 39769 25723 90562892
Hypertensive crisis 56.29 22.61 53 39779 17731 90570884
Fall 55.09 22.61 79 39753 481731 90106884
Metastasis 54.87 22.61 34 39798 6103 90582512
Enterocutaneous fistula 54.81 22.61 22 39810 1552 90587063
Drug intolerance 54.59 22.61 70 39762 447521 90141094
Depression 53.46 22.61 33 39799 300568 90288047
Enterocolitis 53.22 22.61 41 39791 10449 90578166
Protein urine 52.93 22.61 18 39814 794 90587821
Insomnia 52.21 22.61 42 39790 333432 90255183
Venous pressure jugular decreased 51.43 22.61 10 39822 39 90588576
Sleep disorder 51.33 22.61 12 39820 198018 90390597
Hyperbilirubinaemia 50.89 22.61 45 39787 13891 90574724
Skin fissures 49.29 22.61 53 39779 20756 90567859
Gastrointestinal perforation 49.18 22.61 28 39804 4304 90584311
Splenic artery thrombosis 48.77 22.61 10 39822 54 90588561
Impaired healing 48.64 22.61 21 39811 234178 90354437
Migraine 48.44 22.61 12 39820 190380 90398235
Contusion 48.37 22.61 25 39807 251191 90337424
Neuromyotonia 47.73 22.61 10 39822 61 90588554
Type 2 diabetes mellitus 47.63 22.61 15 39817 203229 90385386
Intestinal perforation 47.09 22.61 43 39789 13838 90574777
Inflammation 45.93 22.61 11 39821 178581 90410034
Anisometropia 45.59 22.61 10 39822 78 90588537
Cystitis radiation 45.26 22.61 10 39822 81 90588534
Deep vein thrombosis 44.97 22.61 114 39718 91506 90497109
Gait inability 44.17 22.61 6 39826 146450 90442165
Cholestasis 43.70 22.61 66 39766 36233 90552382
Metastases to ovary 43.66 22.61 14 39818 513 90588102
Depilation 43.28 22.61 8 39824 22 90588593
Nasal septum perforation 42.31 22.61 15 39817 750 90587865
General physical health deterioration 42.29 22.61 284 39548 354831 90233784
Pleuroparenchymal fibroelastosis 41.68 22.61 11 39821 199 90588416
Ganglioneuroma 40.90 22.61 10 39822 131 90588484
Peritoneal disorder 40.88 22.61 14 39818 631 90587984
Treatment failure 40.82 22.61 44 39788 303884 90284731
Hypertransaminasaemia 40.49 22.61 42 39790 15783 90572832
Hypocalcaemia 40.03 22.61 69 39763 42299 90546316
Bladder tamponade 39.90 22.61 10 39822 146 90588469
Tumour ulceration 39.74 22.61 11 39821 240 90588375
Non-cirrhotic portal hypertension 39.46 22.61 12 39820 368 90588247
Proctalgia 39.33 22.61 31 39801 8167 90580448
Azotaemia 38.85 22.61 26 39806 5322 90583293
Larynx irritation 38.70 22.61 10 39822 166 90588449
Metastases to central nervous system 38.63 22.61 43 39789 17499 90571116
Condition aggravated 38.24 22.61 134 39698 595411 89993204
Liver abscess 38.10 22.61 22 39810 3474 90585141
Dizziness 36.89 22.61 134 39698 589150 89999465
Confusional state 36.11 22.61 72 39760 386133 90202482
Osteonecrosis of jaw 36.05 22.61 63 39769 39040 90549575
Platelet count decreased 35.93 22.61 137 39695 136832 90451783
Myalgia 35.88 22.61 16 39816 175109 90413506
Pyrexia 35.70 22.61 445 39387 660040 89928575
Superior vena cava syndrome 35.39 22.61 13 39819 720 90587895
Disease recurrence 35.15 22.61 61 39771 37592 90551023
Influenza 34.99 22.61 9 39823 139255 90449360
Pneumonia 34.33 22.61 154 39678 637905 89950710
Anxiety 34.19 22.61 52 39780 309720 90278895
Systemic infection 34.17 22.61 23 39809 4752 90583863
Aortitis 34.05 22.61 15 39817 1335 90587280
COVID-19 33.70 22.61 16 39816 168827 90419788
Sciatica 33.49 22.61 3 39829 101379 90487236
Cough 33.46 22.61 70 39762 368892 90219723
Road traffic accident 33.45 22.61 4 39828 107622 90480993
Drug resistance 33.35 22.61 53 39779 30396 90558219
Product use issue 33.04 22.61 59 39773 329860 90258755
Upper respiratory tract infection 32.80 22.61 8 39824 128310 90460305
Oesophagitis 32.47 22.61 39 39793 17210 90571405
Dysaesthesia pharynx 32.40 22.61 9 39823 199 90588416
Interstitial lung disease 32.35 22.61 90 39742 76315 90512300
Large intestinal obstruction 32.05 22.61 18 39814 2696 90585919
Loss of personal independence in daily activities 31.96 22.61 10 39822 136095 90452520
Ileal perforation 31.68 22.61 11 39821 517 90588098
Hypoalbuminaemia 31.67 22.61 37 39795 15860 90572755
Nephrotic syndrome 31.49 22.61 26 39806 7313 90581302
Pulmonary fibrosis 31.04 22.61 5 39827 107498 90481117
Renal-limited thrombotic microangiopathy 31.01 22.61 9 39823 234 90588381
Cardiotoxicity 30.54 22.61 31 39801 11358 90577257
Hypovolaemic shock 30.17 22.61 25 39807 7069 90581546
Colon cancer metastatic 30.16 22.61 14 39818 1407 90587208
Liver injury 29.93 22.61 19 39813 170548 90418067
Immune thrombocytopenia 29.92 22.61 33 39799 13293 90575322
Bronchitis 29.75 22.61 15 39817 152912 90435703
Jaw operation 29.73 22.61 12 39820 859 90587756
Memory impairment 29.43 22.61 26 39806 197218 90391397
Pruritus 28.93 22.61 131 39701 541394 90047221
Intentional product misuse 28.67 22.61 3 39829 89601 90499014
Gait disturbance 28.48 22.61 44 39788 260452 90328163
Granulocyte count decreased 28.25 22.61 16 39816 2436 90586179
Anorectal disorder 28.22 22.61 15 39817 2016 90586599
Toxic cardiomyopathy 27.93 22.61 9 39823 335 90588280
Gastroenteritis aeromonas 27.80 22.61 6 39826 43 90588572
Vena cava thrombosis 27.65 22.61 16 39816 2536 90586079
Eustachian tube dysfunction 27.61 22.61 11 39821 761 90587854
Musculoskeletal pain 27.50 22.61 21 39811 171230 90417385
Neutrophil count abnormal 27.44 22.61 19 39813 4109 90584506
Pancytopenia 27.30 22.61 115 39717 120148 90468467
Aphasia 27.26 22.61 59 39773 42753 90545862
Gastrooesophageal reflux disease 27.22 22.61 20 39812 166317 90422298
Septic shock 27.05 22.61 90 39742 84070 90504545
Anorectal varices haemorrhage 26.98 22.61 5 39827 14 90588601
Aortic intramural haematoma 26.77 22.61 7 39825 122 90588493
Paraesthesia oral 26.62 22.61 49 39783 31610 90557005
Recall phenomenon 26.60 22.61 11 39821 838 90587777
Stress cardiomyopathy 26.47 22.61 31 39801 13324 90575291
Tongue disorder 26.32 22.61 28 39804 10832 90577783
Night sweats 26.01 22.61 12 39820 128754 90459861
Dysphagia 25.98 22.61 108 39724 112170 90476445
Tumour perforation 25.59 22.61 7 39825 146 90588469
Venoocclusive liver disease 25.24 22.61 21 39811 5972 90582643
Paraesthesia 25.02 22.61 192 39640 250134 90338481
Dry skin 24.68 22.61 90 39742 87983 90500632
Urticaria 24.60 22.61 64 39768 312670 90275945
Hepatic failure 24.45 22.61 54 39778 39674 90548941
Bacterial translocation 24.38 22.61 10 39822 746 90587869
Dry mouth 24.30 22.61 27 39805 184032 90404583
Dysentery 24.03 22.61 11 39821 1071 90587544
Second primary malignancy 23.82 22.61 26 39806 10352 90578263
Cutaneous tuberculosis 23.73 22.61 7 39825 193 90588422
Hepatic cytolysis 23.70 22.61 46 39786 30870 90557745
Constipation 23.68 22.61 207 39625 280188 90308427
Intestinal ischaemia 23.49 22.61 24 39808 8859 90579756
Dyschezia 23.43 22.61 15 39817 2850 90585765
Febrile bone marrow aplasia 23.41 22.61 25 39807 9713 90578902
Intentional product use issue 23.35 22.61 37 39795 216855 90371760
Catheter site bruise 23.27 22.61 9 39823 575 90588040
Stomatitis haemorrhagic 23.25 22.61 6 39826 99 90588516
Brachiocephalic vein thrombosis 22.87 22.61 6 39826 106 90588509
Skin disorder 22.71 22.61 50 39782 36656 90551959
Feeling abnormal 22.67 22.61 24 39808 167211 90421404
Growth of eyelashes 22.65 22.61 7 39825 227 90588388

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 1473.79 17.86 2294 51180 458555 42109306
Disease progression 1155.41 17.86 1142 52332 142514 42425347
Neutropenia 983.18 17.86 1227 52247 198204 42369657
Neuropathy peripheral 617.94 17.86 698 52776 101155 42466706
Myelosuppression 610.63 17.86 462 53012 39999 42527862
Skin toxicity 538.36 17.86 228 53246 6321 42561540
Dermatitis acneiform 427.24 17.86 204 53270 7535 42560326
Palmar-plantar erythrodysaesthesia syndrome 418.60 17.86 282 53192 20300 42547561
Stomatitis 391.56 17.86 394 53080 49935 42517926
Metastases to liver 388.94 17.86 247 53227 16079 42551782
Neoplasm progression 365.71 17.86 298 53176 28702 42539159
Malignant neoplasm progression 290.84 17.86 502 52972 107898 42459963
Nausea 289.62 17.86 1120 52354 395679 42172182
Gastrointestinal toxicity 279.46 17.86 124 53350 3855 42564006
Decreased appetite 276.26 17.86 690 52784 192447 42375414
Vomiting 260.51 17.86 876 52598 288847 42279014
Febrile neutropenia 240.24 17.86 639 52835 185064 42382797
Alopecia 236.40 17.86 234 53240 29042 42538819
Therapy partial responder 223.88 17.86 192 53282 19829 42548032
Metastases to lung 209.70 17.86 147 53327 11277 42556584
Proteinuria 206.82 17.86 195 53279 22788 42545073
Haematotoxicity 200.81 17.86 141 53333 10844 42557017
Mucosal inflammation 194.28 17.86 273 53201 49101 42518760
Leukopenia 176.98 17.86 328 53146 74418 42493443
Neutrophil count decreased 174.21 17.86 297 53177 63118 42504743
Paronychia 172.48 17.86 91 53383 4164 42563697
Neurotoxicity 167.20 17.86 176 53298 23475 42544386
Cholinergic syndrome 159.17 17.86 51 53423 620 42567241
Peripheral sensory neuropathy 159.07 17.86 112 53362 8650 42559211
Off label use 156.53 17.86 1346 52128 636989 41930872
Thrombocytopenia 156.30 17.86 559 52915 189720 42378141
Colorectal cancer metastatic 141.21 17.86 51 53423 910 42566951
Bone marrow failure 140.69 17.86 190 53284 32903 42534958
Intestinal obstruction 134.28 17.86 168 53306 26990 42540871
Interstitial lung disease 133.12 17.86 300 53174 78162 42489699
Product dose omission issue 130.84 17.86 19 53455 154346 42413515
Polyneuropathy 126.81 17.86 136 53338 18525 42549336
Drug interaction 125.95 17.86 91 53383 266908 42300953
Fall 119.94 17.86 73 53401 234447 42333414
Ileus 113.68 17.86 130 53344 19009 42548852
Hiccups 112.79 17.86 105 53369 12066 42555795
Metastases to peritoneum 112.57 17.86 57 53417 2392 42565469
General physical health deterioration 111.24 17.86 429 53045 150817 42417044
Enteritis 109.39 17.86 98 53376 10718 42557143
Carcinoembryonic antigen increased 107.51 17.86 41 53433 857 42567004
Hypomagnesaemia 102.45 17.86 151 53323 28337 42539524
Abdominal pain 102.14 17.86 491 52983 189980 42377881
Completed suicide 100.22 17.86 5 53469 96460 42471401
Arthralgia 96.65 17.86 70 53404 205168 42362693
Skin reaction 89.80 17.86 73 53401 6994 42560867
Rash pustular 89.27 17.86 69 53405 6146 42561715
Asthenia 84.57 17.86 622 52852 280171 42287690
Intestinal perforation 84.19 17.86 85 53389 10789 42557072
Headache 82.21 17.86 108 53366 239261 42328600
Cholangitis 79.69 17.86 82 53392 10645 42557216
Pneumonia 73.70 17.86 277 53197 421872 42145989
Fatigue 71.44 17.86 847 52627 434794 42133067
Rhabdomyolysis 69.93 17.86 8 53466 78011 42489850
Necrotising fasciitis 68.65 17.86 52 53422 4494 42563367
Dehydration 67.11 17.86 353 53121 141414 42426447
Epistaxis 66.81 17.86 210 53264 66616 42501245
Enterocolitis 66.81 17.86 72 53402 9857 42558004
Myalgia 66.54 17.86 19 53455 96061 42471800
Rectal tenesmus 65.59 17.86 31 53443 1117 42566744
Metastases to lymph nodes 63.94 17.86 56 53418 5942 42561919
Myocardial infarction 62.75 17.86 39 53435 123970 42443891
Pneumatosis intestinalis 62.31 17.86 50 53424 4702 42563159
Cardiac failure congestive 61.01 17.86 16 53458 85586 42482275
Joint swelling 60.90 17.86 7 53467 68015 42499846
Weight increased 60.35 17.86 30 53444 107953 42459908
Arteriospasm coronary 60.32 17.86 49 53425 4689 42563172
Bradycardia 59.01 17.86 17 53457 85467 42482394
Somnolence 57.88 17.86 55 53419 141050 42426811
Hypokalaemia 57.24 17.86 209 53265 71512 42496349
Stoma site haemorrhage 57.21 17.86 28 53446 1091 42566770
Conjunctivitis 56.05 17.86 75 53399 12864 42554997
Pulmonary embolism 56.02 17.86 297 53177 119315 42448546
Asthma 54.34 17.86 7 53467 62307 42505554
Blood glucose increased 54.02 17.86 13 53461 73686 42494175
Tumour marker increased 51.96 17.86 24 53450 820 42567041
Anxiety 51.26 17.86 44 53430 118516 42449345
Mouth ulceration 50.48 17.86 77 53397 14886 42552975
Gastrointestinal perforation 50.08 17.86 43 53431 4443 42563418
Coronary artery disease 49.43 17.86 5 53469 53715 42514146
Hospitalisation 49.11 17.86 16 53458 74314 42493547
Colon cancer metastatic 48.64 17.86 29 53445 1683 42566178
Incorrect dose administered 48.56 17.86 5 53469 52969 42514892
Depression 48.54 17.86 41 53433 111322 42456539
Suicidal ideation 48.45 17.86 3 53471 48158 42519703
Cardiotoxicity 48.36 17.86 53 53421 7392 42560469
Wheezing 48.14 17.86 6 53468 54775 42513086
Agitation 47.82 17.86 11 53463 64303 42503558
Pain in extremity 47.61 17.86 72 53402 150532 42417329
Tumour necrosis 47.10 17.86 28 53446 1616 42566245
Ileal perforation 46.53 17.86 24 53450 1047 42566814
Hyperammonaemia 45.97 17.86 53 53421 7813 42560048
Carbohydrate antigen 19-9 increased 45.51 17.86 16 53458 263 42567598
Colitis 45.29 17.86 145 53329 46427 42521434
Small intestinal perforation 45.21 17.86 34 53440 2907 42564954
Anastomotic complication 44.73 17.86 18 53456 436 42567425
Dyspnoea 44.62 17.86 349 53125 442272 42125589
Nicotinic acid deficiency 43.89 17.86 13 53461 119 42567742
Stoma site pain 43.79 17.86 21 53453 782 42567079
Aggression 43.69 17.86 3 53471 44160 42523701
Peripheral swelling 43.47 17.86 30 53444 90240 42477621
Hepatic venous pressure gradient abnormal 43.25 17.86 10 53464 29 42567832
Stomal varices 43.22 17.86 13 53461 126 42567735
Pruritus 42.63 17.86 110 53364 188661 42379200
Pancreatic carcinoma recurrent 42.50 17.86 12 53462 91 42567770
Confusional state 42.36 17.86 92 53382 167505 42400356
Blood alkaline phosphatase abnormal 41.86 17.86 19 53455 623 42567238
Anal haemorrhage 41.49 17.86 32 53442 2841 42565020
Toxicity to various agents 41.40 17.86 148 53326 228988 42338873
Failure to anastomose 41.18 17.86 14 53460 207 42567654
Colitis microscopic 41.15 17.86 33 53441 3100 42564761
Transdifferentiation of neoplasm 40.90 17.86 11 53463 68 42567793
Proteus infection 40.67 17.86 24 53450 1366 42566495
Anaemia 40.63 17.86 533 52941 279745 42288116
Hypertension 40.16 17.86 352 53122 166852 42401009
Influenza 40.00 17.86 14 53460 62161 42505700
Portal hypertension 39.98 17.86 39 53435 4748 42563113
Acral peeling skin syndrome 39.65 17.86 10 53464 46 42567815
Feeling abnormal 39.57 17.86 19 53455 69767 42498094
Peritonitis 39.39 17.86 78 53396 18555 42549306
Metastases to central nervous system 38.83 17.86 56 53418 10299 42557562
Pyrexia 38.58 17.86 701 52773 393341 42174520
Cough 38.53 17.86 106 53368 177997 42389864
Neutropenic colitis 38.43 17.86 37 53437 4433 42563428
UGT1A1 gene mutation 36.69 17.86 8 53466 16 42567845
Condition aggravated 36.31 17.86 186 53288 260568 42307293
Chronic obstructive pulmonary disease 36.07 17.86 17 53457 63097 42504764
Sciatic nerve palsy 35.76 17.86 9 53465 41 42567820
Balance disorder 35.71 17.86 8 53466 47637 42520224
Anaemia of malignant disease 35.24 17.86 16 53458 525 42567336
Hallucination 35.23 17.86 14 53460 57493 42510368
Pharyngeal inflammation 34.91 17.86 17 53457 655 42567206
Paraesthesia 34.76 17.86 183 53291 73276 42494585
Induration 34.69 17.86 20 53454 1090 42566771
Change of bowel habit 34.37 17.86 20 53454 1109 42566752
Subclavian vein thrombosis 33.96 17.86 19 53455 977 42566884
Right ventricular ejection fraction decreased 33.70 17.86 9 53465 54 42567807
Sinusitis 33.38 17.86 9 53465 47283 42520578
Peritoneal disorder 32.49 17.86 13 53461 310 42567551
Hypoferritinaemia 32.44 17.86 7 53467 13 42567848
COVID-19 32.40 17.86 60 53414 115888 42451973
Venoocclusive liver disease 31.94 17.86 51 53423 10251 42557610
Tremor 31.93 17.86 45 53429 96884 42470977
Lewis-Sumner syndrome 31.79 17.86 9 53465 69 42567792
Chronic kidney disease 31.50 17.86 10 53464 47231 42520630
Insomnia 31.47 17.86 63 53411 118190 42449671
Chills 31.46 17.86 214 53260 93852 42474009
Rectal cancer metastatic 31.24 17.86 12 53462 256 42567605
Heart rate increased 30.96 17.86 14 53460 53241 42514620
Oesophagobronchial fistula 30.89 17.86 11 53463 188 42567673
Prothrombin level decreased 30.88 17.86 19 53455 1167 42566694
Small intestinal obstruction 30.88 17.86 67 53407 16994 42550867
Portal vein thrombosis 30.62 17.86 33 53441 4516 42563345
Pulmonary artery thrombosis 30.55 17.86 17 53457 865 42566996
Therapeutic product effect decreased 30.52 17.86 6 53468 39144 42528717
Electrocardiogram QT prolonged 30.49 17.86 11 53463 47934 42519927
Wrong technique in product usage process 30.31 17.86 8 53466 42627 42525234
Vascular pseudoaneurysm 30.28 17.86 26 53448 2686 42565175
Cellulitis 30.27 17.86 20 53454 61565 42506296
Rhabdomyosarcoma recurrent 30.18 17.86 10 53464 136 42567725
Unevaluable event 29.53 17.86 4 53470 34284 42533577
Device related infection 29.41 17.86 73 53401 20206 42547655
Productive cough 29.29 17.86 14 53460 51553 42516308
Large intestine perforation 29.28 17.86 47 53427 9489 42558372
Dizziness 29.20 17.86 188 53286 249066 42318795
Multiple organ dysfunction syndrome 29.12 17.86 48 53426 96987 42470874
Loss of personal independence in daily activities 29.11 17.86 13 53461 49803 42518058
Treatment noncompliance 28.90 17.86 6 53468 37666 42530195
Atrial fibrillation 28.77 17.86 85 53389 139508 42428353
Large intestinal obstruction 28.70 17.86 21 53453 1721 42566140
Nasopharyngitis 28.67 17.86 38 53436 83958 42483903
Metastatic neoplasm 28.53 17.86 28 53446 3433 42564428
White blood cell count decreased 28.36 17.86 236 53238 110160 42457701
Gene mutation 28.29 17.86 21 53453 1760 42566101
Musculoskeletal stiffness 28.06 17.86 19 53455 57746 42510115
Acute myeloid leukaemia 28.04 17.86 76 53398 22180 42545681
Dysphonia 28.04 17.86 89 53385 28361 42539500
Nodular regenerative hyperplasia 27.83 17.86 17 53457 1031 42566830
Contusion 27.79 17.86 9 53465 41976 42525885
Acne 27.50 17.86 56 53418 13588 42554273
International normalised ratio increased 27.48 17.86 13 53461 48155 42519706
Perforation bile duct 27.33 17.86 8 53466 70 42567791
Cytomegalovirus infection 27.28 17.86 4 53470 32302 42535559
Colony stimulating factor therapy 27.01 17.86 10 53464 192 42567669
Cardiomyopathy acute 26.93 17.86 8 53466 74 42567787
Portal venous gas 26.81 17.86 13 53461 496 42567365
Cardiac arrest 26.79 17.86 61 53413 109259 42458602
Colorectal cancer recurrent 26.74 17.86 8 53466 76 42567785
Swelling 26.73 17.86 18 53456 54867 42512994
Skin disorder 26.72 17.86 63 53411 16881 42550980
Leukoencephalopathy 26.66 17.86 32 53442 4922 42562939
Tumour perforation 26.57 17.86 13 53461 506 42567355
Fluid retention 26.51 17.86 4 53470 31615 42536246
Adenocarcinoma metastatic 26.29 17.86 8 53466 81 42567780
Unresponsive to stimuli 26.26 17.86 4 53470 31399 42536462
Vena cava thrombosis 26.13 17.86 19 53455 1542 42566319
Hypoglycaemia 26.11 17.86 22 53452 59832 42508029
Protein urine 25.93 17.86 16 53458 988 42566873
Acute abdomen 25.79 17.86 21 53453 2016 42565845
Growth of eyelashes 25.77 17.86 8 53466 87 42567774
Paraesthesia oral 25.60 17.86 32 53442 5131 42562730
Hyperbilirubinaemia 25.53 17.86 70 53404 20565 42547296
Cytokine release syndrome 25.43 17.86 12 53462 44515 42523346
Sedation 25.22 17.86 4 53470 30471 42537390
Toxic leukoencephalopathy 25.15 17.86 14 53460 713 42567148
Device related thrombosis 25.13 17.86 18 53456 1427 42566434
Bronchitis 25.05 17.86 14 53460 47187 42520674
Azotaemia 25.05 17.86 34 53440 5910 42561951
Liver abscess 24.96 17.86 31 53443 4939 42562922
Inappropriate schedule of product administration 24.74 17.86 52 53422 95850 42472011
Nephrotic syndrome 24.12 17.86 41 53433 8677 42559184
Heart rate decreased 23.88 17.86 8 53466 36524 42531337
Colon cancer recurrent 23.87 17.86 8 53466 113 42567748
Restlessness 23.84 17.86 4 53470 29245 42538616
Overflow diarrhoea 23.84 17.86 7 53467 62 42567799
Memory impairment 23.76 17.86 17 53457 50205 42517656
Perihepatic abscess 23.68 17.86 8 53466 116 42567745
Hepatic cytolysis 23.43 17.86 3 53471 26841 42541020
Intestinal strangulation 23.38 17.86 6 53468 30 42567831
Epidermal naevus syndrome 23.27 17.86 5 53469 9 42567852
Venous thrombosis 23.27 17.86 27 53447 4008 42563853
Adenocarcinoma 23.14 17.86 20 53454 2084 42565777
Abdominal pain upper 23.06 17.86 180 53294 82429 42485432
Septic shock 23.02 17.86 195 53279 91477 42476384
Coma 22.98 17.86 20 53454 53534 42514327
Diaphragmatic operation 22.90 17.86 6 53468 33 42567828
Accidental overdose 22.82 17.86 4 53470 28326 42539535
Tumour pseudoprogression 22.81 17.86 15 53459 1035 42566826
Metastases to pelvis 22.76 17.86 11 53463 417 42567444
Subileus 22.75 17.86 25 53449 3496 42564365
Haematoma 22.47 17.86 4 53470 28019 42539842
Clostridial infection 22.47 17.86 26 53448 3848 42564013
Blood pressure systolic increased 22.41 17.86 4 53470 27964 42539897
Acute cutaneous lupus erythematosus 22.32 17.86 7 53467 79 42567782
Loss of consciousness 22.25 17.86 52 53422 92302 42475559
Perioral dermatitis 22.03 17.86 9 53465 227 42567634
Faecaluria 22.02 17.86 5 53469 13 42567848
Petit mal epilepsy 22.02 17.86 25 53449 3625 42564236
Oedema peripheral 21.90 17.86 92 53382 135984 42431877
Terminal ileitis 21.80 17.86 12 53462 598 42567263
Fistula 21.61 17.86 37 53437 7875 42559986
Nail disorder 21.41 17.86 20 53454 2307 42565554
Toxic erythema of chemotherapy 21.40 17.86 8 53466 158 42567703
Abdominal pain lower 21.33 17.86 47 53427 12045 42555816
Fistula of small intestine 21.29 17.86 12 53462 626 42567235
Peritoneal haematoma 21.28 17.86 7 53467 93 42567768
Catheter site thrombosis 21.26 17.86 8 53466 161 42567700
Dysgeusia 21.12 17.86 92 53382 34097 42533764
Toxic epidermal necrolysis 21.06 17.86 4 53470 26746 42541115
Mobility decreased 20.97 17.86 9 53465 35297 42532564
Adenocarcinoma of colon 20.95 17.86 25 53449 3822 42564039
Disease recurrence 20.79 17.86 83 53391 29595 42538266
Abnormal behaviour 20.73 17.86 4 53470 26447 42541414
Deep vein thrombosis 20.55 17.86 166 53308 76791 42491070
Full blood count abnormal 20.50 17.86 6 53468 29870 42537991
Disturbance in attention 20.49 17.86 6 53468 29860 42538001
Pelvic abscess 20.47 17.86 14 53460 1031 42566830
Medication error 20.42 17.86 8 53466 33146 42534715
White blood cell count increased 20.38 17.86 16 53458 45071 42522790
Anal inflammation 20.20 17.86 19 53455 2210 42565651
Obstruction gastric 20.19 17.86 14 53460 1054 42566807
Abdominal discomfort 20.09 17.86 40 53434 75215 42492646
Superior vena cava syndrome 20.02 17.86 12 53462 703 42567158
Adverse drug reaction 20.01 17.86 11 53463 37423 42530438
Hypersensitivity 19.81 17.86 157 53317 72213 42495648
Acute kidney injury 19.81 17.86 333 53141 367004 42200857
Ascites 19.57 17.86 130 53344 56548 42511313
Dysentery 19.52 17.86 10 53464 430 42567431
Granulocyte count decreased 19.49 17.86 16 53458 1554 42566307
Pleural fistula 19.48 17.86 5 53469 25 42567836
Rectal cancer 19.42 17.86 19 53455 2321 42565540
Hepatic lesion 19.38 17.86 26 53448 4468 42563393
Laboratory test abnormal 19.05 17.86 3 53471 22975 42544886
VIth nerve disorder 19.01 17.86 5 53469 28 42567833
Therapeutic product effect incomplete 18.93 17.86 153 53321 70786 42497075
Medulloblastoma 18.72 17.86 6 53468 73 42567788
Malignant ascites 18.63 17.86 11 53463 627 42567234
Gout 18.59 17.86 6 53468 28049 42539812
Colonic fistula 18.53 17.86 10 53464 479 42567382
Viral infection 18.49 17.86 3 53471 22480 42545381
Metastasis 18.46 17.86 26 53448 4679 42563182
Cachexia 18.44 17.86 35 53439 8069 42559792
Incorrect route of product administration 18.38 17.86 4 53470 24301 42543560
Proctectomy 18.28 17.86 7 53467 148 42567713
Pulmonary oedema 18.27 17.86 24 53450 53248 42514613
Nasal septum perforation 18.23 17.86 8 53466 242 42567619
Acute myocardial infarction 18.17 17.86 28 53446 58137 42509724
Hypovolaemic shock 18.00 17.86 36 53438 8623 42559238
Pancreatic carcinoma metastatic 17.94 17.86 21 53453 3145 42564716
Emotional disorder 17.87 17.86 30 53444 6284 42561577

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 2465.56 18.04 3667 82562 1135838 109367232
Neutropenia 2225.15 18.04 2035 84194 372585 110130485
Disease progression 2204.37 18.04 1690 84539 242344 110260726
Neuropathy peripheral 1457.54 18.04 1168 85061 178109 110324961
Myelosuppression 1145.32 18.04 783 85446 93557 110409513
Febrile neutropenia 813.95 18.04 1113 85116 315654 110187416
Dermatitis acneiform 747.49 18.04 304 85925 12391 110490679
Skin toxicity 669.30 18.04 275 85954 11508 110491562
Metastases to liver 668.68 18.04 389 85840 34997 110468073
Palmar-plantar erythrodysaesthesia syndrome 668.64 18.04 410 85819 40615 110462455
Neoplasm progression 662.64 18.04 484 85745 64111 110438959
Malignant neoplasm progression 657.99 18.04 744 85485 173823 110329247
Thrombocytopenia 503.94 18.04 943 85286 347942 110155128
Mucosal inflammation 498.38 18.04 486 85743 95655 110407415
Neurotoxicity 471.12 18.04 333 85896 41874 110461196
Leukopenia 465.83 18.04 577 85652 148214 110354856
Vomiting 430.29 18.04 1619 84610 909056 109594014
Therapy partial responder 428.99 18.04 299 85930 36762 110466308
Gastrointestinal toxicity 414.24 18.04 193 86036 10955 110492115
Nausea 409.90 18.04 1972 84257 1233718 109269352
Proteinuria 403.82 18.04 297 85932 39721 110463349
Neutrophil count decreased 384.90 18.04 473 85756 120468 110382602
Bone marrow failure 384.32 18.04 336 85893 57512 110445558
Decreased appetite 378.90 18.04 1014 85215 474832 110028238
Metastases to lung 366.80 18.04 227 86002 22836 110480234
Polyneuropathy 312.67 18.04 233 85996 31779 110471291
Haematotoxicity 301.46 18.04 194 86035 20888 110482182
Arthralgia 297.86 18.04 118 86111 779514 109723556
Peripheral sensory neuropathy 295.66 18.04 176 86053 16504 110486566
Joint swelling 287.06 18.04 14 86215 442831 110060239
Cholinergic syndrome 286.09 18.04 84 86145 1248 110501822
Paronychia 278.35 18.04 147 86082 10934 110492136
Off label use 276.21 18.04 2053 84176 1498132 109004938
Intestinal obstruction 260.70 18.04 261 85968 52966 110450104
Stomatitis 252.19 18.04 612 85617 269630 110233440
Metastases to peritoneum 245.94 18.04 109 86120 5501 110497569
Colorectal cancer metastatic 238.12 18.04 76 86153 1513 110501557
Abdominal pain 231.31 18.04 900 85329 512089 109990981
Enteritis 229.75 18.04 158 86071 18998 110484072
Dysarthria 228.13 18.04 304 85925 83817 110419253
Anaemia 226.83 18.04 935 85294 546151 109956919
Dehydration 210.36 18.04 584 85645 278927 110224143
Asthenia 210.30 18.04 1076 85153 687923 109815147
Headache 208.32 18.04 229 86000 882148 109620922
Hypomagnesaemia 201.51 18.04 242 85987 60128 110442942
Weight increased 197.41 18.04 43 86186 419601 110083469
Interstitial lung disease 194.92 18.04 372 85857 138962 110364108
Swelling 194.12 18.04 23 86206 351018 110152052
Cholangitis 189.48 18.04 132 86097 16203 110486867
Ileus 185.23 18.04 169 86060 30560 110472510
Peripheral swelling 182.89 18.04 45 86184 403989 110099081
Sinusitis 181.19 18.04 13 86216 296675 110206395
Hypokalaemia 179.58 18.04 422 85807 182026 110321044
Pulmonary embolism 177.26 18.04 464 85765 214010 110289060
Fall 176.59 18.04 128 86101 603354 109899716
Product dose omission issue 175.66 18.04 22 86207 321760 110181310
Completed suicide 166.03 18.04 5 86224 242376 110260694
Arthropathy 158.54 18.04 19 86210 287503 110215567
Glossodynia 158.10 18.04 3 86226 222001 110281069
Rash pustular 156.64 18.04 107 86122 12722 110490348
Epistaxis 155.84 18.04 326 85903 130046 110373024
Asthma 155.64 18.04 10 86219 250281 110252789
Pain 153.71 18.04 322 85907 954633 109548437
Nasopharyngitis 151.45 18.04 59 86170 394302 110108768
Contraindicated product administered 151.23 18.04 11 86218 248256 110254814
Therapeutic product effect decreased 151.22 18.04 10 86219 244306 110258764
Pericarditis 148.35 18.04 5 86224 219109 110283961
Maternal exposure during pregnancy 145.18 18.04 15 86214 254868 110248202
Hiccups 142.30 18.04 101 86128 12768 110490302
Wheezing 140.38 18.04 17 86212 255213 110247857
Musculoskeletal stiffness 139.24 18.04 25 86204 279797 110223273
General physical health deterioration 137.77 18.04 676 85553 424619 110078451
Carcinoembryonic antigen increased 137.22 18.04 59 86170 2765 110500305
Mobility decreased 135.15 18.04 14 86215 237408 110265662
Intestinal perforation 133.74 18.04 119 86110 20825 110482245
Abdominal discomfort 132.45 18.04 71 86158 393787 110109283
Ascites 131.24 18.04 249 85980 92559 110410511
Pain in extremity 130.24 18.04 113 86116 487005 110016065
Lower respiratory tract infection 129.35 18.04 18 86211 243088 110259982
Metastases to lymph nodes 128.30 18.04 101 86128 14931 110488139
Arteriospasm coronary 125.80 18.04 82 86147 9018 110494052
Drug abuse 123.95 18.04 3 86226 177408 110325662
Colitis 123.59 18.04 257 85972 102066 110401004
Duodenal ulcer perforation 120.48 18.04 4 86225 177696 110325374
Blister 116.00 18.04 19 86210 227357 110275713
Drug hypersensitivity 115.82 18.04 110 86119 453980 110049090
Osteoarthritis 114.41 18.04 7 86222 182616 110320454
Wound 114.37 18.04 22 86207 234415 110268655
Hepatic enzyme increased 113.63 18.04 54 86175 320838 110182232
Contusion 113.63 18.04 22 86207 233339 110269731
Arthritis 112.82 18.04 4 86225 167582 110335488
Hyperammonaemia 110.22 18.04 89 86140 13643 110489427
Exposure during pregnancy 106.16 18.04 6 86223 167418 110335652
White blood cell count decreased 105.16 18.04 405 85824 228985 110274085
Enterocolitis 100.35 18.04 97 86132 18852 110484218
Depression 98.45 18.04 63 86166 317272 110185798
Migraine 95.44 18.04 11 86218 171641 110331429
Drug intolerance 94.02 18.04 107 86122 406405 110096665
Gait inability 89.28 18.04 4 86225 136372 110366698
Myalgia 89.14 18.04 31 86198 222350 110280720
Neutropenic colitis 88.49 18.04 63 86166 8002 110495068
Type 2 diabetes mellitus 87.78 18.04 16 86213 177216 110325854
Confusional state 87.62 18.04 144 86085 468536 110034534
Steatohepatitis 86.84 18.04 34 86195 1251 110501819
Intentional product misuse 86.67 18.04 4 86225 132900 110370170
Large intestine perforation 85.95 18.04 84 86145 16545 110486525
Insomnia 85.48 18.04 93 86136 360497 110142573
Cough 85.22 18.04 143 86086 461498 110041572
Drug interaction 83.36 18.04 165 86064 500018 110003052
Pyrexia 83.35 18.04 1067 85162 897198 109605872
Hyperbilirubinaemia 81.82 18.04 110 86119 30561 110472509
Anxiety 81.79 18.04 89 86140 344989 110158081
Gastrointestinal perforation 81.24 18.04 58 86171 7398 110495672
Cardiotoxicity 81.20 18.04 82 86147 16799 110486271
Condition aggravated 79.94 18.04 299 85930 734537 109768533
Pruritus 78.34 18.04 215 86014 581345 109921725
Device related infection 78.12 18.04 123 86106 39396 110463674
Acute myeloid leukaemia 77.26 18.04 120 86109 37990 110465080
Metastases to central nervous system 76.99 18.04 92 86137 22725 110480345
Deep vein thrombosis 76.81 18.04 262 85967 139625 110363445
Discomfort 76.18 18.04 36 86193 214671 110288399
Metastasis 73.70 18.04 57 86172 8210 110494860
Dizziness 72.77 18.04 289 85940 697904 109805166
Joint range of motion decreased 72.47 18.04 6 86223 121826 110381244
Rectal tenesmus 71.35 18.04 35 86194 2227 110500843
Influenza 70.53 18.04 22 86207 169079 110333991
Ileal perforation 70.50 18.04 30 86199 1370 110501700
Stoma site haemorrhage 69.41 18.04 35 86194 2363 110500707
Obesity 69.06 18.04 5 86224 113346 110389724
Speech disorder 68.96 18.04 150 86079 61419 110441651
Pneumonia 68.63 18.04 402 85827 876312 109626758
Colon cancer metastatic 68.02 18.04 35 86194 2466 110500604
Venoocclusive liver disease 67.95 18.04 71 86158 15136 110487934
Trichomegaly 67.88 18.04 17 86212 132 110502938
Azotaemia 65.77 18.04 58 86171 10027 110493043
Night sweats 64.43 18.04 13 86216 133970 110369100
Septic shock 64.04 18.04 268 85961 157260 110345810
Rhabdomyolysis 63.82 18.04 9 86220 120392 110382678
Disease recurrence 63.48 18.04 144 86085 60640 110442430
Skin reaction 62.87 18.04 80 86149 21064 110482006
Anastomotic complication 62.79 18.04 22 86207 589 110502481
Hospitalisation 62.24 18.04 17 86212 142476 110360594
Road traffic accident 61.96 18.04 6 86223 107392 110395678
Liver abscess 61.77 18.04 50 86179 7689 110495381
Pneumatosis intestinalis 61.61 18.04 52 86177 8477 110494593
Skin fissures 61.13 18.04 85 86144 24373 110478697
Sleep disorder 60.81 18.04 40 86189 198604 110304466
Suicidal ideation 60.69 18.04 3 86226 93934 110409136
Loss of personal independence in daily activities 59.96 18.04 21 86208 149999 110353071
Memory impairment 59.83 18.04 40 86189 196904 110306166
Impaired healing 59.70 18.04 40 86189 196677 110306393
Intentional product use issue 58.65 18.04 64 86165 247842 110255228
Large intestinal obstruction 58.43 18.04 37 86192 3871 110499199
Hypercholesterolaemia 58.37 18.04 3 86226 90834 110412236
Posterior reversible encephalopathy syndrome 58.28 18.04 99 86130 33762 110469308
Gene mutation 57.70 18.04 35 86194 3394 110499676
Tumour necrosis 57.47 18.04 31 86198 2405 110500665
Chills 57.39 18.04 297 85932 190283 110312787
Cardiac failure congestive 57.23 18.04 23 86206 150977 110352093
Vena cava thrombosis 57.09 18.04 35 86194 3459 110499611
Injection site reaction 57.05 18.04 3 86226 89067 110414003
Peritonitis 57.00 18.04 96 86133 32511 110470559
Lip dry 56.68 18.04 6 86223 100077 110402993
Folliculitis 56.63 18.04 30 86199 167623 110335447
Depilation 56.56 18.04 12 86217 39 110503031
Necrotising fasciitis 56.31 18.04 47 86182 7544 110495526
Metastases to meninges 56.13 18.04 40 86189 5088 110497982
Enterocutaneous fistula 56.03 18.04 30 86199 2293 110500777
Myelodysplastic syndrome 56.00 18.04 103 86126 37381 110465689
Protein urine 54.90 18.04 26 86203 1530 110501540
Tongue oedema 54.88 18.04 48 86181 8208 110494862
Conjunctivitis 54.50 18.04 96 86133 33696 110469374
Sciatica 53.73 18.04 5 86224 92394 110410676
Trismus 53.46 18.04 43 86186 6553 110496517
Pancreatic carcinoma recurrent 53.14 18.04 15 86214 192 110502878
Superior vena cava syndrome 52.25 18.04 24 86205 1317 110501753
Small intestinal perforation 52.24 18.04 36 86193 4340 110498730
Incorrect dose administered 52.09 18.04 9 86220 103632 110399438
Drug reaction with eosinophilia and systemic symptoms 51.85 18.04 3 86226 82092 110420978
Bronchitis 51.72 18.04 29 86200 157003 110346067
UGT1A1 gene mutation 51.66 18.04 10 86219 17 110503053
Portal vein thrombosis 50.91 18.04 43 86186 7015 110496055
Bradycardia 50.82 18.04 29 86200 155488 110347582
Proctalgia 50.79 18.04 57 86172 13165 110489905
Hypertransaminasaemia 50.04 18.04 77 86152 24178 110478892
Sepsis 49.70 18.04 430 85799 326916 110176154
Carbohydrate antigen 19-9 increased 49.51 18.04 18 86211 538 110502532
Dysgeusia 49.38 18.04 143 86086 69842 110433228
Fatigue 49.35 18.04 1268 84961 1214690 109288380
Growth of eyelashes 49.33 18.04 14 86215 183 110502887
Portal hypertension 49.13 18.04 46 86183 8591 110494479
Urticaria 49.03 18.04 110 86119 318747 110184323
Mucosal toxicity 48.84 18.04 19 86210 687 110502383
Nephrotic syndrome 48.70 18.04 57 86172 13774 110489296
Feeling abnormal 48.12 18.04 42 86187 180669 110322401
Subclavian vein thrombosis 47.89 18.04 29 86200 2803 110500267
Stomal varices 47.85 18.04 13 86216 143 110502927
Nodular regenerative hyperplasia 47.78 18.04 24 86205 1607 110501463
Gastrooesophageal reflux disease 47.72 18.04 42 86187 179934 110323136
Blood glucose increased 47.32 18.04 22 86207 132474 110370596
Nasal septum perforation 47.19 18.04 20 86209 904 110502166
COVID-19 46.96 18.04 74 86155 244986 110258084
Product use issue 46.74 18.04 109 86120 311586 110191484
Blood pressure fluctuation 46.46 18.04 3 86226 74821 110428249
Hypoalbuminaemia 46.32 18.04 82 86147 28892 110474178
Death 46.08 18.04 783 85446 698086 109804984
Anal haemorrhage 46.02 18.04 35 86194 4917 110498153
Anorectal disorder 46.01 18.04 28 86201 2731 110500339
Musculoskeletal pain 45.83 18.04 45 86184 182978 110320092
Laryngospasm 45.62 18.04 34 86195 4634 110498436
Heart rate increased 45.34 18.04 28 86201 143806 110359264
Hepatic failure 45.21 18.04 137 86092 68602 110434468
Skin disorder 45.18 18.04 102 86127 42811 110460259
Dysphonia 45.03 18.04 146 86083 75783 110427287
Metastatic neoplasm 44.89 18.04 37 86192 5836 110497234
Acral peeling skin syndrome 44.38 18.04 10 86219 46 110503024
Hypertension 43.43 18.04 597 85632 509487 109993583
Medication error 43.41 18.04 14 86215 105352 110397718
Adenocarcinoma of colon 43.31 18.04 37 86192 6131 110496939
Hypovolaemic shock 43.08 18.04 55 86174 14528 110488542
Osteoporosis 42.86 18.04 8 86221 87144 110415926
Dysentery 42.61 18.04 21 86208 1350 110501720
Device related thrombosis 42.56 18.04 29 86200 3433 110499637
Nicotinic acid deficiency 42.54 18.04 13 86216 223 110502847
Transdifferentiation of neoplasm 42.38 18.04 11 86218 100 110502970
Pulmonary artery thrombosis 42.36 18.04 22 86207 1580 110501490
Failure to anastomose 42.21 18.04 13 86216 229 110502841
Dyspnoea 41.75 18.04 610 85619 1106262 109396808
Tumour lysis syndrome 41.51 18.04 81 86148 30720 110472350
Somnolence 41.47 18.04 108 86121 297341 110205729
Granulocyte count decreased 41.21 18.04 30 86199 3944 110499126
Platelet count decreased 41.06 18.04 314 85915 230129 110272941
Chronic obstructive pulmonary disease 40.76 18.04 17 86212 109141 110393929
Ileus paralytic 40.71 18.04 48 86181 11689 110491381
Balance disorder 40.64 18.04 20 86209 116540 110386530
Hepatic lesion 40.38 18.04 41 86188 8452 110494618
Subileus 39.95 18.04 36 86193 6401 110496669
Myocardial infarction 39.73 18.04 55 86174 192028 110311042
Splenic artery thrombosis 39.66 18.04 10 86219 80 110502990
Prescribed underdose 39.34 18.04 3 86226 65171 110437899
Venous pressure jugular decreased 39.13 18.04 10 86219 85 110502985
Hypertensive crisis 38.99 18.04 69 86160 24303 110478767
Anisometropia 38.92 18.04 10 86219 87 110502983
Amnesia 38.43 18.04 17 86212 105391 110397679
Rhabdomyosarcoma recurrent 38.26 18.04 11 86218 151 110502919
Gait disturbance 38.04 18.04 102 86127 278106 110224964
Blood pressure systolic increased 37.97 18.04 9 86220 82982 110420088
Small intestinal obstruction 37.81 18.04 80 86149 32133 110470937
Productive cough 37.80 18.04 21 86208 114284 110388786
Non-cirrhotic portal hypertension 37.72 18.04 16 86213 725 110502345
Treatment failure 37.63 18.04 102 86127 277132 110225938
Neuromyotonia 37.32 18.04 10 86219 104 110502966
Wrong technique in product usage process 37.07 18.04 11 86218 87337 110415733
Pancytopenia 37.00 18.04 285 85944 209328 110293742
Right ventricular ejection fraction decreased 36.88 18.04 9 86220 62 110503008
Coronary artery disease 36.52 18.04 6 86223 71684 110431386
Tumour perforation 36.44 18.04 15 86214 630 110502440
Neck pain 36.07 18.04 26 86203 123104 110379966
Leukoencephalopathy 35.94 18.04 40 86189 9155 110493915
Hypoferritinaemia 35.76 18.04 7 86222 13 110503057
Illness 35.51 18.04 10 86219 82161 110420909
Adverse drug reaction 35.48 18.04 19 86210 105540 110397530
Lewis-Sumner syndrome 35.37 18.04 9 86220 75 110502995
Intestinal metastasis 35.26 18.04 14 86215 535 110502535
Sciatic nerve palsy 35.16 18.04 9 86220 77 110502993
Plasma cell myeloma 35.06 18.04 4 86225 62932 110440138
Blood alkaline phosphatase abnormal 34.97 18.04 18 86211 1269 110501801
Drug resistance 34.88 18.04 110 86119 56264 110446806
Tumour ulceration 34.80 18.04 12 86217 306 110502764
Liver function test increased 34.35 18.04 13 86216 88535 110414535
Paraesthesia oral 34.30 18.04 79 86150 33592 110469478
Influenza like illness 34.27 18.04 13 86216 88399 110414671
Agranulocytosis 34.16 18.04 116 86113 61644 110441426
Heart rate decreased 34.08 18.04 11 86218 82745 110420325
Acute abdomen 34.01 18.04 25 86204 3336 110499734
Toxic cardiomyopathy 33.52 18.04 15 86214 774 110502296
Incorrect route of product administration 33.45 18.04 5 86224 64056 110439014
Vascular pseudoaneurysm 33.29 18.04 27 86202 4163 110498907
Treatment noncompliance 33.23 18.04 8 86221 72982 110430088
Proteus infection 33.14 18.04 23 86206 2805 110500265
Dysaesthesia pharynx 32.65 18.04 11 86218 261 110502809
Pelvic fluid collection 32.63 18.04 16 86213 1017 110502053
Nasal congestion 32.58 18.04 18 86211 98264 110404806
Oesophagobronchial fistula 32.57 18.04 11 86218 263 110502807
Aortitis 32.45 18.04 20 86209 1995 110501075
Product quality issue 32.32 18.04 10 86219 77289 110425781
Adenocarcinoma metastatic 32.11 18.04 12 86217 388 110502682
Cataract 31.97 18.04 11 86218 79474 110423596
Dry skin 31.86 18.04 167 86062 107486 110395584
Venous thrombosis 31.54 18.04 36 86193 8469 110494601
Larynx irritation 31.38 18.04 10 86219 198 110502872
Rectal cancer 31.35 18.04 25 86204 3764 110499306
Colitis microscopic 31.18 18.04 45 86184 13349 110489721
Neutropenic sepsis 31.17 18.04 72 86157 30674 110472396
Hydronephrosis 31.14 18.04 57 86172 20608 110482462
Upper respiratory tract infection 30.94 18.04 34 86195 131294 110371776
Therapeutic product effect incomplete 30.87 18.04 288 85941 223517 110279553
Recall phenomenon 30.81 18.04 17 86212 1379 110501691
Electrocardiogram QT prolonged 30.64 18.04 24 86205 108936 110394134
Toxic epidermal necrolysis 30.63 18.04 4 86225 56723 110446347
Adverse event 30.56 18.04 24 86205 108785 110394285
Stoma site pain 30.39 18.04 19 86210 1944 110501126
Constipation 30.11 18.04 418 85811 357368 110145702
Ganglioneuroma 30.09 18.04 9 86220 143 110502927
Peritoneal disorder 29.75 18.04 14 86215 812 110502258
Haematoma 29.55 18.04 5 86224 58471 110444599
Pleuroparenchymal fibroelastosis 29.54 18.04 11 86218 352 110502718
Induration 29.34 18.04 20 86209 2369 110500701
Cystitis radiation 29.26 18.04 10 86219 248 110502822
Prothrombin level decreased 29.24 18.04 18 86211 1792 110501278
Paraesthesia 29.20 18.04 337 85892 276184 110226886
Fistula of small intestine 29.11 18.04 15 86214 1060 110502010
Disseminated intravascular coagulation 28.77 18.04 84 86145 41202 110461868
Metastases to ovary 28.51 18.04 11 86218 389 110502681
Venous thrombosis limb 27.97 18.04 27 86202 5238 110497832
Terminal ileitis 27.85 18.04 17 86212 1667 110501403
Rectal adenocarcinoma 27.80 18.04 17 86212 1672 110501398
Hip arthroplasty 27.71 18.04 5 86224 55808 110447262
Pharyngeal inflammation 27.57 18.04 17 86212 1697 110501373
Biliary tract infection 27.48 18.04 17 86212 1707 110501363
Klebsiella infection 27.43 18.04 53 86176 19956 110483114
Febrile bone marrow aplasia 27.37 18.04 49 86180 17416 110485654
Anaemia of malignant disease 27.26 18.04 14 86215 982 110502088
Pancreatic carcinoma metastatic 27.26 18.04 24 86205 4140 110498930
Foot deformity 27.21 18.04 3 86226 48477 110454593
Rectal cancer recurrent 27.13 18.04 7 86222 62 110503008
Bacterial translocation 27.11 18.04 16 86213 1476 110501594
Limbic encephalitis 26.98 18.04 13 86216 795 110502275
Tumour marker increased 26.97 18.04 26 86203 5034 110498036
Agitation 26.93 18.04 29 86200 113022 110390048
Cytomegalovirus infection 26.77 18.04 5 86224 54439 110448631
Drug level increased 26.66 18.04 3 86226 47716 110455354
K-ras gene mutation 26.65 18.04 7 86222 67 110503003
Hepatotoxicity 26.64 18.04 109 86120 63291 110439779
Colony stimulating factor therapy 26.62 18.04 12 86217 630 110502440
Diaphragmatic paralysis 26.50 18.04 15 86214 1279 110501791
Rectal haemorrhage 26.43 18.04 172 86057 119661 110383409
Swelling face 26.39 18.04 20 86209 92301 110410769
Hypocalcaemia 26.39 18.04 111 86118 65255 110437815
Mouth ulceration 26.26 18.04 90 86139 48048 110455022
Colitis ulcerative 25.89 18.04 14 86215 77349 110425721
Joint stiffness 25.87 18.04 10 86219 67233 110435837
Viral infection 25.87 18.04 5 86224 53134 110449936
International normalised ratio increased 25.84 18.04 18 86211 86754 110416316
Sedation 25.78 18.04 11 86218 69672 110433398
Diaphragmatic operation 25.74 18.04 6 86223 33 110503037
Gastrointestinal stoma complication 25.72 18.04 21 86208 3268 110499802
Anastomotic fistula 25.71 18.04 8 86221 146 110502924
Performance status decreased 25.67 18.04 30 86199 7236 110495834
Epidermal naevus syndrome 25.65 18.04 5 86224 9 110503061
Pulmonary toxicity 25.55 18.04 48 86181 17698 110485372
Inflammation 25.54 18.04 72 86157 193166 110309904
Electrolyte imbalance 25.48 18.04 75 86154 36953 110466117
Immune thrombocytopenia 25.41 18.04 55 86174 22439 110480631
Malignant ascites 25.30 18.04 15 86214 1395 110501675
Renal-limited thrombotic microangiopathy 25.16 18.04 11 86218 537 110502533
Perforation bile duct 25.14 18.04 7 86222 85 110502985
Oxygen saturation decreased 25.07 18.04 53 86176 156929 110346141
Oedema 25.06 18.04 82 86147 209894 110293176
Enterocolitis infectious 24.88 18.04 21 86208 3423 110499647
Tongue disorder 24.86 18.04 42 86187 14256 110488814
Perihepatic abscess 24.62 18.04 8 86221 169 110502901
Neoplasm recurrence 24.41 18.04 25 86204 5207 110497863
Haematochezia 24.38 18.04 164 86065 115360 110387710
Femur fracture 24.34 18.04 3 86226 44466 110458604
Retroperitoneal neoplasm metastatic 24.26 18.04 6 86223 44 110503026
Gastroenteritis aeromonas 24.02 18.04 6 86223 46 110503024
Ear pain 23.91 18.04 6 86223 53220 110449850
Osteonecrosis of jaw 23.81 18.04 87 86142 47930 110455140
Large intestine infection 23.79 18.04 23 86206 4469 110498601
Second primary malignancy 23.72 18.04 47 86182 18021 110485049
Rash pruritic 23.53 18.04 25 86204 98044 110405026
Jaw operation 23.50 18.04 12 86217 832 110502238
Overdose 22.90 18.04 99 86130 233695 110269375
Systemic infection 22.87 18.04 33 86196 9786 110493284
Onychomadesis 22.87 18.04 4 86225 45659 110457411
Tremor 22.76 18.04 81 86148 202151 110300919
Faecaluria 22.76 18.04 5 86224 20 110503050
Pancreatic fistula 22.75 18.04 7 86222 123 110502947
Jaundice 22.68 18.04 99 86130 59137 110443933
Overflow diarrhoea 22.67 18.04 8 86221 219 110502851
Inappropriate schedule of product administration 22.63 18.04 82 86147 203555 110299515
Ill-defined disorder 22.58 18.04 56 86173 156797 110346273
Anorectal varices haemorrhage 22.56 18.04 5 86224 21 110503049
Oesophagitis 22.54 18.04 61 86168 28654 110474416
Eustachian tube dysfunction 22.49 18.04 11 86218 695 110502375
Chronic kidney disease 22.49 18.04 16 86213 76275 110426795
Intestinal strangulation 22.43 18.04 6 86223 62 110503008
Hypertriglyceridaemia 22.40 18.04 43 86186 16111 110486959
Pelvic venous thrombosis 22.36 18.04 18 86211 2746 110500324
Respiratory disorder 22.35 18.04 14 86215 71368 110431702
Hypoglycaemia 22.29 18.04 35 86194 116069 110387001
Necrotising colitis 22.21 18.04 15 86214 1750 110501320
Portal vein embolisation 22.19 18.04 5 86224 23 110503047
Unresponsive to stimuli 22.15 18.04 11 86218 63779 110439291
Neuroblastoma recurrent 22.10 18.04 10 86219 530 110502540
Rectal cancer metastatic 21.90 18.04 10 86219 541 110502529
Lymphangiosis carcinomatosa 21.88 18.04 17 86212 2465 110500605
Colonic fistula 21.81 18.04 11 86218 743 110502327
Peripheral motor neuropathy 21.79 18.04 21 86208 4065 110499005
Optic glioma 21.77 18.04 6 86223 70 110503000
Lung disorder 21.70 18.04 70 86159 179977 110323093
Lymphadenopathy mediastinal 21.68 18.04 24 86205 5460 110497610
Wound infection 21.61 18.04 26 86203 96439 110406631
Muscular weakness 21.52 18.04 110 86119 248358 110254712
Product use in unapproved indication 21.51 18.04 478 85751 446899 110056171
Aphasia 21.38 18.04 97 86132 58900 110444170
Toxic erythema of chemotherapy 21.32 18.04 9 86220 403 110502667
Transposition of the great vessels 21.24 18.04 6 86223 77 110502993
Rectal perforation 21.18 18.04 12 86217 1025 110502045
Accidental overdose 21.15 18.04 7 86222 51827 110451243
Abdominal abscess 21.07 18.04 30 86199 8789 110494281
Cachexia 21.04 18.04 37 86192 12968 110490102
Toxic leukoencephalopathy 20.96 18.04 14 86215 1603 110501467
Oedema peripheral 20.95 18.04 160 86069 328500 110174570
VIth nerve disorder 20.94 18.04 5 86224 31 110503039
Embolism 20.94 18.04 42 86187 16247 110486823
Diarrhoea haemorrhagic 20.92 18.04 41 86188 15598 110487472
Hallucination, visual 20.89 18.04 3 86226 39602 110463468
Aggression 20.88 18.04 10 86219 59200 110443870
Gastrointestinal inflammation 20.87 18.04 31 86198 9438 110493632
Tumour haemorrhage 20.81 18.04 23 86206 5222 110497848
Xeroderma 20.73 18.04 10 86219 613 110502457
Clostridial infection 20.59 18.04 25 86204 6277 110496793
Anal fistula 20.51 18.04 29 86200 8444 110494626
Therapy non-responder 20.50 18.04 59 86170 157248 110345822
Obstruction gastric 20.44 18.04 15 86214 1996 110501074
Acne 20.36 18.04 65 86164 33455 110469615
Acquired gene mutation 20.32 18.04 17 86212 2737 110500333
Febrile infection 20.29 18.04 21 86208 4427 110498643
Emotional distress 20.25 18.04 5 86224 44842 110458228
Food protein-induced enterocolitis syndrome 20.18 18.04 5 86224 37 110503033
Oesophageal varices haemorrhage 20.17 18.04 22 86207 4923 110498147
Hyperammonaemic encephalopathy 20.15 18.04 23 86206 5411 110497659
Administration site extravasation 20.11 18.04 14 86215 1715 110501355
Eosinophilia 20.10 18.04 10 86219 57926 110445144
Back injury 20.06 18.04 6 86223 47393 110455677
Aortic intramural haematoma 19.99 18.04 7 86222 187 110502883
Congestive cardiomyopathy 19.90 18.04 38 86191 14181 110488889
Cellulitis 19.74 18.04 43 86186 125973 110377097
Frequent bowel movements 19.73 18.04 16 86213 71374 110431696
Anal inflammation 19.66 18.04 16 86213 2480 110500590
Hepatectomy 19.57 18.04 8 86221 330 110502740
Pneumonitis 19.49 18.04 114 86115 76417 110426653
Brachiocephalic vein thrombosis 19.48 18.04 8 86221 334 110502736
Renal hydrocele 19.41 18.04 5 86224 44 110503026
Pulmonary fibrosis 19.36 18.04 31 86198 102011 110401059
Eastern Cooperative Oncology Group performance status worsened 19.21 18.04 17 86212 2952 110500118
Malignant gastrointestinal obstruction 19.21 18.04 5 86224 46 110503024
Bladder tamponade 19.15 18.04 10 86219 726 110502344
Palpitations 19.12 18.04 62 86167 159150 110343920
Gallbladder rupture 19.10 18.04 12 86217 1238 110501832
Prostatic calcification 19.01 18.04 6 86223 115 110502955
Neuroblastoma 18.95 18.04 8 86221 358 110502712
Blood alkaline phosphatase increased 18.93 18.04 107 86122 70828 110432242
Pelvic abscess 18.84 18.04 16 86213 2630 110500440
Jugular vein thrombosis 18.77 18.04 22 86207 5323 110497747
Bile duct stenosis 18.68 18.04 16 86213 2660 110500410
Petit mal epilepsy 18.52 18.04 26 86203 7521 110495549
Gastric perforation 18.51 18.04 21 86208 4908 110498162
Administration site recall reaction 18.47 18.04 3 86226 0 110503070
Abnormal behaviour 18.33 18.04 4 86225 39035 110464035
Cardiomyopathy acute 18.15 18.04 8 86221 398 110502672
Colon cancer recurrent 18.15 18.04 6 86223 134 110502936

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
FDA EPC N0000175609 Topoisomerase Inhibitor
CHEBI has role CHEBI:35610 antineoplastic agent
CHEBI has role CHEBI:50266 prodrug
CHEBI has role CHEBI:50276 EC 5.99.1.2 (DNA topoisomerase) inhibitor
CHEBI has role CHEBI:68495 apoptosis inducer

Related Drugs by ATC class:

L01CE Topoisomerase 1 (TOP1) inhibitors 2 drugs
belotecantopotecan

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




🐶 Veterinary Drug Use

None

🐶 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 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 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 N207793 Oct. 22, 2015 RX INJECTABLE, LIPOSOMAL INTRAVENOUS 12364691 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 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 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 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 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 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 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 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 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
EQ 43MG BASE/10ML (EQ 4.3MG BASE/ML) ONIVYDE IPSEN N207793 Oct. 22, 2015 RX INJECTABLE, LIPOSOMAL INTRAVENOUS 11344552 Aug. 19, 2036 TREATMENT OF METASTATIC PANCREATIC ADENOCARCINOMA IN COMBINATION WITH OXALIPLATIN, FLUOROURACIL, AND LEUCOVORIN

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 N207793 Oct. 22, 2015 RX INJECTABLE, LIPOSOMAL INTRAVENOUS Feb. 13, 2027 IN COMBINATION WITH OXALIPLATIN, FLUOROURACIL AND LEUCOVORIN, FOR THE FIRST-LINE TREATMENT OF ADULT PATIENTS WITH METASTATIC PANCREATIC ADENOCARCINOMA
EQ 43MG BASE/10ML (EQ 4.3MG BASE/ML) ONIVYDE IPSEN N207793 Oct. 22, 2015 RX INJECTABLE, LIPOSOMAL INTRAVENOUS Feb. 13, 2031 FOR FIRST-LINE TREATMENT OF ADULT PATIENTS WITH METASTATIC PANCREATIC ADENOCARCINOMA

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
CHEMBL481 ChEMBL_ID
CHEMBL3989514 ChEMBL_ID
CHEMBL1200512 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

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Camptosar HUMAN PRESCRIPTION DRUG LABEL 1 0009-0082 INJECTION, SOLUTION 20 mg INTRAVENOUS NDA 34 sections
Camptosar HUMAN PRESCRIPTION DRUG LABEL 1 0009-0112 INJECTION, SOLUTION 20 mg INTRAVENOUS NDA 34 sections
Camptosar HUMAN PRESCRIPTION DRUG LABEL 1 0009-7529 INJECTION, SOLUTION 20 mg INTRAVENOUS NDA 34 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 32 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 25021-230 INJECTION, SOLUTION 20 mg INTRAVENOUS ANDA 31 sections
Irinotecan hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 45963-614 INJECTION, SOLUTION 20 mg INTRAVENOUS ANDA 19 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 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 55150-354 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 59751-087 INJECTION 20 mg INTRAVENOUS ANDA 28 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
Irinotecan Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 59923-716 INJECTION 20 mg INTRAVENOUS ANDA 31 sections
Irinotecan Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 60505-6128 INJECTION, SOLUTION 20 mg INTRAVENOUS ANDA 30 sections
Irinotecan Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 60505-6272 INJECTION, SOLUTION 20 mg INTRAVENOUS ANDA 29 sections
Irinotecan Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 61703-349 INJECTION, SOLUTION 20 mg INTRAVENOUS ANDA 35 sections
Irinotecan Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 61703-349 INJECTION, SOLUTION 20 mg INTRAVENOUS ANDA 35 sections
Irinotecan Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 63323-193 INJECTION, SOLUTION 20 mg INTRAVENOUS ANDA 31 sections
Irinotecan Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 67184-0511 INJECTION, SOLUTION 20 mg INTRAVENOUS ANDA 29 sections
Irinotecan Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 67184-0512 INJECTION, SOLUTION 20 mg INTRAVENOUS ANDA 29 sections
Irinotecan Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 67184-0513 INJECTION, SOLUTION 20 mg INTRAVENOUS ANDA 29 sections
Irinotecan hydrochloide HUMAN PRESCRIPTION DRUG LABEL 1 68001-480 INJECTION 20 mg INTRAVENOUS ANDA 30 sections