irinotecan 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| antineoplastics, topoisomerase I inhibitors | 1482 | 97682-44-5 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
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.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
None
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| 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 |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| June 14, 1996 | FDA | PFIZER INC | |
| March 25, 2020 | PMDA | Nihon Servier Co., Ltd |
FDA Adverse Event Reporting System (Female)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Neutropenia | 859.66 | 22.08 | 702 | 30718 | 174303 | 63283299 |
| Diarrhoea | 790.39 | 22.08 | 1323 | 30097 | 714043 | 62743559 |
| Disease progression | 762.04 | 22.08 | 566 | 30854 | 122192 | 63335410 |
| Neuropathy peripheral | 478.70 | 22.08 | 418 | 31002 | 113249 | 63344353 |
| Myelosuppression | 334.71 | 22.08 | 184 | 31236 | 23519 | 63434083 |
| Malignant neoplasm progression | 331.43 | 22.08 | 295 | 31125 | 81826 | 63375776 |
| Febrile neutropenia | 308.77 | 22.08 | 335 | 31085 | 118114 | 63339488 |
| Mucosal inflammation | 287.28 | 22.08 | 215 | 31205 | 46713 | 63410889 |
| Neurotoxicity | 270.91 | 22.08 | 143 | 31277 | 16847 | 63440755 |
| Vomiting | 262.72 | 22.08 | 735 | 30685 | 558882 | 62898720 |
| Thrombocytopenia | 243.13 | 22.08 | 335 | 31085 | 150822 | 63306780 |
| Dysarthria | 237.89 | 22.08 | 185 | 31235 | 42526 | 63415076 |
| Dermatitis acneiform | 236.11 | 22.08 | 90 | 31330 | 4906 | 63452696 |
| Palmar-plantar erythrodysaesthesia syndrome | 222.90 | 22.08 | 140 | 31280 | 22875 | 63434727 |
| Bone marrow failure | 220.01 | 22.08 | 152 | 31268 | 29138 | 63428464 |
| Nausea | 219.63 | 22.08 | 917 | 30503 | 853554 | 62604048 |
| Leukopenia | 216.06 | 22.08 | 227 | 31193 | 77063 | 63380539 |
| Metastases to liver | 212.04 | 22.08 | 137 | 31283 | 23502 | 63434100 |
| Neoplasm progression | 192.51 | 22.08 | 153 | 31267 | 36275 | 63421327 |
| Abdominal pain | 187.68 | 22.08 | 434 | 30986 | 293022 | 63164580 |
| Neutrophil count decreased | 174.50 | 22.08 | 175 | 31245 | 56231 | 63401371 |
| Off label use | 172.84 | 22.08 | 724 | 30696 | 673738 | 62783864 |
| Skin toxicity | 170.50 | 22.08 | 70 | 31350 | 4644 | 63452958 |
| Decreased appetite | 158.98 | 22.08 | 370 | 31050 | 250682 | 63206920 |
| Ascites | 149.79 | 22.08 | 139 | 31281 | 40589 | 63417013 |
| Arthralgia | 141.20 | 22.08 | 53 | 31367 | 569657 | 62887945 |
| Joint swelling | 140.16 | 22.08 | 5 | 31415 | 327661 | 63129941 |
| Polyneuropathy | 139.37 | 22.08 | 88 | 31332 | 14501 | 63443101 |
| Proteinuria | 138.23 | 22.08 | 97 | 31323 | 19048 | 63438554 |
| Haematotoxicity | 135.65 | 22.08 | 74 | 31346 | 9302 | 63448300 |
| Metastases to peritoneum | 130.94 | 22.08 | 53 | 31367 | 3389 | 63454213 |
| Anaemia | 127.79 | 22.08 | 376 | 31044 | 293054 | 63164548 |
| Paronychia | 124.61 | 22.08 | 59 | 31361 | 5506 | 63452096 |
| Stomatitis | 122.03 | 22.08 | 234 | 31186 | 138491 | 63319111 |
| Death | 120.83 | 22.08 | 433 | 30987 | 373948 | 63083654 |
| Asthenia | 115.65 | 22.08 | 434 | 30986 | 383170 | 63074432 |
| Gastrointestinal toxicity | 108.96 | 22.08 | 60 | 31360 | 7681 | 63449921 |
| Peripheral sensory neuropathy | 108.32 | 22.08 | 59 | 31361 | 7392 | 63450210 |
| Dehydration | 105.77 | 22.08 | 252 | 31168 | 173102 | 63284500 |
| Cholinergic syndrome | 103.68 | 22.08 | 28 | 31392 | 490 | 63457112 |
| Peripheral swelling | 101.45 | 22.08 | 8 | 31412 | 265934 | 63191668 |
| Colorectal cancer metastatic | 99.02 | 22.08 | 28 | 31392 | 585 | 63457017 |
| Metastases to lung | 95.31 | 22.08 | 66 | 31354 | 12684 | 63444918 |
| Product dose omission issue | 92.38 | 22.08 | 6 | 31414 | 234307 | 63223295 |
| Cholangitis | 92.01 | 22.08 | 48 | 31372 | 5513 | 63452089 |
| Contraindicated product administered | 90.71 | 22.08 | 4 | 31416 | 217644 | 63239958 |
| Swelling | 90.66 | 22.08 | 14 | 31406 | 275364 | 63182238 |
| Sinusitis | 85.93 | 22.08 | 7 | 31413 | 226646 | 63230956 |
| Pain | 78.85 | 22.08 | 155 | 31265 | 740473 | 62717129 |
| Intestinal obstruction | 76.17 | 22.08 | 85 | 31335 | 30814 | 63426788 |
| Therapeutic product effect decreased | 75.98 | 22.08 | 5 | 31415 | 193182 | 63264420 |
| Ileus | 75.94 | 22.08 | 61 | 31359 | 14664 | 63442938 |
| Maternal exposure during pregnancy | 75.18 | 22.08 | 10 | 31410 | 220052 | 63237550 |
| Pulmonary embolism | 73.68 | 22.08 | 172 | 31248 | 116512 | 63341090 |
| Mucosal toxicity | 73.58 | 22.08 | 20 | 31400 | 359 | 63457243 |
| Hypokalaemia | 73.33 | 22.08 | 160 | 31260 | 103644 | 63353958 |
| Therapy partial responder | 72.30 | 22.08 | 52 | 31368 | 10606 | 63446996 |
| Weight increased | 68.32 | 22.08 | 22 | 31398 | 260770 | 63196832 |
| Metastases to lymph nodes | 67.56 | 22.08 | 45 | 31375 | 8113 | 63449489 |
| Speech disorder | 66.58 | 22.08 | 91 | 31329 | 40538 | 63417064 |
| Trichomegaly | 66.55 | 22.08 | 14 | 31406 | 76 | 63457526 |
| Musculoskeletal stiffness | 66.50 | 22.08 | 7 | 31413 | 184611 | 63272991 |
| Tongue oedema | 65.79 | 22.08 | 36 | 31384 | 4550 | 63453052 |
| Abdominal discomfort | 62.51 | 22.08 | 41 | 31379 | 320844 | 63136758 |
| Nasopharyngitis | 62.23 | 22.08 | 24 | 31396 | 254233 | 63203369 |
| Hyperammonaemia | 61.36 | 22.08 | 36 | 31384 | 5196 | 63452406 |
| Pain in extremity | 61.07 | 22.08 | 45 | 31375 | 331441 | 63126161 |
| Hypertransaminasaemia | 58.49 | 22.08 | 38 | 31382 | 6571 | 63451031 |
| Laryngospasm | 58.43 | 22.08 | 29 | 31391 | 2999 | 63454603 |
| Drug hypersensitivity | 56.16 | 22.08 | 43 | 31377 | 310644 | 63146958 |
| Exposure during pregnancy | 55.75 | 22.08 | 6 | 31414 | 155541 | 63302061 |
| Headache | 55.55 | 22.08 | 147 | 31273 | 633094 | 62824508 |
| Product use in unapproved indication | 54.91 | 22.08 | 204 | 31216 | 178876 | 63278726 |
| Enterocutaneous fistula | 54.82 | 22.08 | 22 | 31398 | 1375 | 63456227 |
| Wound | 54.38 | 22.08 | 8 | 31412 | 163255 | 63294347 |
| Lower respiratory tract infection | 53.29 | 22.08 | 3 | 31417 | 132304 | 63325298 |
| Carcinoembryonic antigen increased | 53.11 | 22.08 | 23 | 31397 | 1742 | 63455860 |
| Neutropenic colitis | 52.02 | 22.08 | 27 | 31393 | 3068 | 63454534 |
| Fall | 51.98 | 22.08 | 71 | 31349 | 392263 | 63065339 |
| Protein urine | 51.73 | 22.08 | 18 | 31402 | 754 | 63456848 |
| Asthma | 51.05 | 22.08 | 3 | 31417 | 127558 | 63330044 |
| Metastases to meninges | 50.45 | 22.08 | 25 | 31395 | 2577 | 63455025 |
| General physical health deterioration | 50.17 | 22.08 | 215 | 31205 | 201187 | 63256415 |
| Epistaxis | 50.10 | 22.08 | 111 | 31309 | 72614 | 63384988 |
| Pericarditis | 50.02 | 22.08 | 4 | 31416 | 131575 | 63326027 |
| Sepsis | 49.95 | 22.08 | 178 | 31242 | 152945 | 63304657 |
| Splenic artery thrombosis | 48.74 | 22.08 | 10 | 31410 | 47 | 63457555 |
| Drug ineffective | 48.12 | 22.08 | 312 | 31108 | 1044453 | 62413149 |
| Hypomagnesaemia | 48.04 | 22.08 | 65 | 31355 | 28672 | 63428930 |
| Skin fissures | 48.02 | 22.08 | 42 | 31378 | 11346 | 63446256 |
| Neuromyotonia | 47.58 | 22.08 | 10 | 31410 | 54 | 63457548 |
| Steatohepatitis | 47.05 | 22.08 | 16 | 31404 | 625 | 63456977 |
| Hypertension | 46.62 | 22.08 | 266 | 31154 | 279037 | 63178565 |
| Colitis | 46.51 | 22.08 | 85 | 31335 | 48443 | 63409159 |
| Hepatic enzyme increased | 46.43 | 22.08 | 21 | 31399 | 202307 | 63255295 |
| Gastrointestinal perforation | 46.23 | 22.08 | 26 | 31394 | 3465 | 63454137 |
| Arthritis | 45.56 | 22.08 | 3 | 31417 | 115918 | 63341684 |
| Cystitis radiation | 45.36 | 22.08 | 10 | 31410 | 70 | 63457532 |
| Venous pressure jugular decreased | 45.24 | 22.08 | 9 | 31411 | 35 | 63457567 |
| Bladder tamponade | 45.24 | 22.08 | 10 | 31410 | 71 | 63457531 |
| Hypertensive crisis | 44.62 | 22.08 | 46 | 31374 | 15240 | 63442362 |
| Enteritis | 44.16 | 22.08 | 35 | 31385 | 8251 | 63449351 |
| Drug intolerance | 43.81 | 22.08 | 53 | 31367 | 308608 | 63148994 |
| Large intestine perforation | 43.44 | 22.08 | 35 | 31385 | 8447 | 63449155 |
| Posterior reversible encephalopathy syndrome | 43.23 | 22.08 | 48 | 31372 | 17297 | 63440305 |
| White blood cell count decreased | 42.23 | 22.08 | 158 | 31262 | 138946 | 63318656 |
| Rash pustular | 41.50 | 22.08 | 32 | 31388 | 7250 | 63450352 |
| Nasal septum perforation | 40.75 | 22.08 | 15 | 31405 | 741 | 63456861 |
| Intestinal perforation | 40.46 | 22.08 | 39 | 31381 | 11924 | 63445678 |
| Metastases to ovary | 39.87 | 22.08 | 13 | 31407 | 445 | 63457157 |
| Ganglioneuroma | 39.65 | 22.08 | 10 | 31410 | 132 | 63457470 |
| Condition aggravated | 39.42 | 22.08 | 88 | 31332 | 402129 | 63055473 |
| Blister | 37.60 | 22.08 | 9 | 31411 | 129805 | 63327797 |
| Discomfort | 37.42 | 22.08 | 18 | 31402 | 167356 | 63290246 |
| Pyrexia | 37.37 | 22.08 | 376 | 31044 | 470102 | 62987500 |
| Proctalgia | 37.35 | 22.08 | 28 | 31392 | 6082 | 63451520 |
| Cough | 36.74 | 22.08 | 55 | 31365 | 292688 | 63164914 |
| Trismus | 36.01 | 22.08 | 23 | 31397 | 3862 | 63453740 |
| Device related infection | 34.75 | 22.08 | 50 | 31370 | 23342 | 63434260 |
| Mobility decreased | 33.93 | 22.08 | 9 | 31411 | 121150 | 63336452 |
| Paraesthesia | 33.40 | 22.08 | 160 | 31260 | 156806 | 63300796 |
| Osteonecrosis of jaw | 32.99 | 22.08 | 61 | 31359 | 35062 | 63422540 |
| COVID-19 | 32.45 | 22.08 | 8 | 31412 | 113095 | 63344507 |
| Myalgia | 32.39 | 22.08 | 16 | 31404 | 146513 | 63311089 |
| Product use issue | 32.20 | 22.08 | 37 | 31383 | 220483 | 63237119 |
| Depression | 32.03 | 22.08 | 30 | 31390 | 196462 | 63261140 |
| Ileal perforation | 32.03 | 22.08 | 11 | 31409 | 443 | 63457159 |
| Jaw operation | 32.00 | 22.08 | 13 | 31407 | 839 | 63456763 |
| Bronchitis | 31.88 | 22.08 | 11 | 31409 | 124924 | 63332678 |
| Insomnia | 31.55 | 22.08 | 36 | 31384 | 215216 | 63242386 |
| Tumour ulceration | 31.34 | 22.08 | 9 | 31411 | 199 | 63457403 |
| Influenza | 30.59 | 22.08 | 8 | 31412 | 108714 | 63348888 |
| Metastasis | 29.97 | 22.08 | 23 | 31397 | 5174 | 63452428 |
| Systemic infection | 29.93 | 22.08 | 22 | 31398 | 4638 | 63452964 |
| Dizziness | 29.71 | 22.08 | 111 | 31309 | 429814 | 63027788 |
| Stomatitis haemorrhagic | 29.28 | 22.08 | 6 | 31414 | 28 | 63457574 |
| Dysaesthesia pharynx | 29.10 | 22.08 | 8 | 31412 | 150 | 63457452 |
| Aortitis | 28.95 | 22.08 | 13 | 31407 | 1074 | 63456528 |
| Anorectal disorder | 28.66 | 22.08 | 15 | 31405 | 1734 | 63455868 |
| Arteriospasm coronary | 28.39 | 22.08 | 20 | 31400 | 3948 | 63453654 |
| Aortic intramural haematoma | 27.85 | 22.08 | 7 | 31413 | 91 | 63457511 |
| Immune thrombocytopenia | 27.67 | 22.08 | 30 | 31390 | 10526 | 63447076 |
| Feeling abnormal | 27.47 | 22.08 | 20 | 31400 | 148372 | 63309230 |
| Superior vena cava syndrome | 27.40 | 22.08 | 11 | 31409 | 688 | 63456914 |
| Contusion | 26.78 | 22.08 | 21 | 31399 | 150023 | 63307579 |
| Depilation | 26.66 | 22.08 | 5 | 31415 | 13 | 63457589 |
| Tumour perforation | 26.45 | 22.08 | 7 | 31413 | 113 | 63457489 |
| Loss of personal independence in daily activities | 25.82 | 22.08 | 8 | 31412 | 97282 | 63360320 |
| Vena cava thrombosis | 25.52 | 22.08 | 15 | 31405 | 2172 | 63455430 |
| Dyschezia | 24.86 | 22.08 | 15 | 31405 | 2279 | 63455323 |
| Large intestinal obstruction | 24.71 | 22.08 | 15 | 31405 | 2304 | 63455298 |
| Cutaneous tuberculosis | 24.54 | 22.08 | 7 | 31413 | 151 | 63457451 |
| Treatment failure | 24.37 | 22.08 | 38 | 31382 | 199005 | 63258597 |
| Drug resistance | 24.32 | 22.08 | 42 | 31378 | 22891 | 63434711 |
| Granulocyte count decreased | 24.29 | 22.08 | 12 | 31408 | 1228 | 63456374 |
| Dysentery | 24.03 | 22.08 | 11 | 31409 | 950 | 63456652 |
| Cardiac failure congestive | 23.82 | 22.08 | 8 | 31412 | 92425 | 63365177 |
| Xerosis | 23.80 | 22.08 | 11 | 31409 | 971 | 63456631 |
| Catheter site bruise | 23.75 | 22.08 | 9 | 31411 | 482 | 63457120 |
| Skin disorder | 23.74 | 22.08 | 48 | 31372 | 29459 | 63428143 |
| Anxiety | 23.47 | 22.08 | 45 | 31375 | 217496 | 63240106 |
| Oropharyngeal discomfort | 23.39 | 22.08 | 20 | 31400 | 5240 | 63452362 |
| Brachiocephalic vein thrombosis | 22.78 | 22.08 | 6 | 31414 | 95 | 63457507 |
| Venoocclusive liver disease | 22.77 | 22.08 | 19 | 31401 | 4816 | 63452786 |
| Renal tubular disorder | 22.70 | 22.08 | 15 | 31405 | 2667 | 63454935 |
| Hyperbilirubinaemia | 22.68 | 22.08 | 28 | 31392 | 11286 | 63446316 |
| Aphasia | 22.30 | 22.08 | 50 | 31370 | 32950 | 63424652 |
| Cardiotoxicity | 22.15 | 22.08 | 24 | 31396 | 8414 | 63449188 |
FDA Adverse Event Reporting System (Male)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Diarrhoea | 1217.47 | 18.10 | 1892 | 40826 | 388020 | 34526193 |
| Disease progression | 889.61 | 18.10 | 860 | 41858 | 107217 | 34806996 |
| Neutropenia | 798.78 | 18.10 | 968 | 41750 | 155810 | 34758403 |
| Skin toxicity | 426.01 | 18.10 | 175 | 42543 | 4609 | 34909604 |
| Dermatitis acneiform | 395.28 | 18.10 | 179 | 42539 | 6010 | 34908203 |
| Myelosuppression | 379.09 | 18.10 | 256 | 42462 | 19009 | 34895204 |
| Neuropathy peripheral | 355.63 | 18.10 | 472 | 42246 | 82791 | 34831422 |
| Palmar-plantar erythrodysaesthesia syndrome | 354.12 | 18.10 | 233 | 42485 | 16562 | 34897651 |
| Stomatitis | 349.77 | 18.10 | 339 | 42379 | 42175 | 34872038 |
| Neoplasm progression | 300.60 | 18.10 | 240 | 42478 | 23060 | 34891153 |
| Metastases to liver | 279.40 | 18.10 | 186 | 42532 | 13477 | 34900736 |
| Decreased appetite | 247.92 | 18.10 | 594 | 42124 | 165798 | 34748415 |
| Malignant neoplasm progression | 243.14 | 18.10 | 407 | 42311 | 87639 | 34826574 |
| Gastrointestinal toxicity | 240.47 | 18.10 | 99 | 42619 | 2620 | 34911593 |
| Nausea | 239.74 | 18.10 | 932 | 41786 | 338976 | 34575237 |
| Vomiting | 232.97 | 18.10 | 747 | 41971 | 246874 | 34667339 |
| Alopecia | 230.46 | 18.10 | 210 | 42508 | 24145 | 34890068 |
| Mucosal inflammation | 211.13 | 18.10 | 248 | 42470 | 38374 | 34875839 |
| Proteinuria | 200.78 | 18.10 | 173 | 42545 | 18469 | 34895744 |
| Neutrophil count decreased | 166.64 | 18.10 | 255 | 42463 | 50849 | 34863364 |
| Bone marrow failure | 165.11 | 18.10 | 191 | 42527 | 29062 | 34885151 |
| Off label use | 159.82 | 18.10 | 964 | 41754 | 418560 | 34495653 |
| Haematotoxicity | 156.60 | 18.10 | 107 | 42611 | 8087 | 34906126 |
| Metastases to lung | 155.52 | 18.10 | 112 | 42606 | 9208 | 34905005 |
| Cholinergic syndrome | 154.51 | 18.10 | 48 | 42670 | 539 | 34913674 |
| Leukopenia | 153.01 | 18.10 | 275 | 42443 | 62581 | 34851632 |
| Neurotoxicity | 150.56 | 18.10 | 145 | 42573 | 17865 | 34896348 |
| Paronychia | 149 | 18.10 | 76 | 42642 | 3329 | 34910884 |
| Febrile neutropenia | 139.42 | 18.10 | 425 | 42293 | 136424 | 34777789 |
| Peripheral sensory neuropathy | 135.68 | 18.10 | 91 | 42627 | 6669 | 34907544 |
| Thrombocytopenia | 121.53 | 18.10 | 443 | 42275 | 155804 | 34758409 |
| Interstitial lung disease | 121.46 | 18.10 | 255 | 42463 | 65027 | 34849186 |
| Drug interaction | 114.75 | 18.10 | 67 | 42651 | 225879 | 34688334 |
| General physical health deterioration | 110.30 | 18.10 | 376 | 42342 | 127893 | 34786320 |
| Intestinal obstruction | 107.51 | 18.10 | 136 | 42582 | 22686 | 34891527 |
| Skin reaction | 106.39 | 18.10 | 71 | 42647 | 5159 | 34909054 |
| Ileus | 105.50 | 18.10 | 115 | 42603 | 16384 | 34897829 |
| Completed suicide | 99.23 | 18.10 | 5 | 42713 | 98163 | 34816050 |
| Product dose omission issue | 97.33 | 18.10 | 15 | 42703 | 119696 | 34794517 |
| Therapy partial responder | 96.99 | 18.10 | 86 | 42632 | 9530 | 34904683 |
| Fall | 93.65 | 18.10 | 67 | 42651 | 202818 | 34711395 |
| Polyneuropathy | 90.35 | 18.10 | 101 | 42617 | 14795 | 34899418 |
| Colorectal cancer metastatic | 86.62 | 18.10 | 33 | 42685 | 707 | 34913506 |
| Carcinoembryonic antigen increased | 84.55 | 18.10 | 32 | 42686 | 673 | 34913540 |
| Arthralgia | 82.66 | 18.10 | 53 | 42665 | 169988 | 34744225 |
| Necrotising fasciitis | 81.72 | 18.10 | 53 | 42665 | 3669 | 34910544 |
| Abdominal pain | 80.60 | 18.10 | 404 | 42314 | 163214 | 34750999 |
| Hiccups | 80.17 | 18.10 | 79 | 42639 | 10003 | 34904210 |
| Epistaxis | 74.90 | 18.10 | 197 | 42521 | 58054 | 34856159 |
| Cholangitis | 74.57 | 18.10 | 71 | 42647 | 8618 | 34905595 |
| Metastases to peritoneum | 74.46 | 18.10 | 39 | 42679 | 1805 | 34912408 |
| Pulmonary embolism | 74.37 | 18.10 | 260 | 42458 | 89486 | 34824727 |
| Dehydration | 72.72 | 18.10 | 333 | 42385 | 129636 | 34784577 |
| Metastases to lymph nodes | 65.87 | 18.10 | 51 | 42667 | 4677 | 34909536 |
| Hypomagnesaemia | 65.54 | 18.10 | 105 | 42613 | 21746 | 34892467 |
| Myocardial infarction | 64.12 | 18.10 | 34 | 42684 | 121051 | 34793162 |
| Asthenia | 61.89 | 18.10 | 511 | 42207 | 244740 | 34669473 |
| Pneumonia | 58.32 | 18.10 | 237 | 42481 | 362390 | 34551823 |
| Headache | 57.57 | 18.10 | 98 | 42620 | 200537 | 34713676 |
| Rhabdomyolysis | 56.62 | 18.10 | 8 | 42710 | 68155 | 34846058 |
| Cardiac failure congestive | 56.24 | 18.10 | 16 | 42702 | 83254 | 34830959 |
| Bradycardia | 55.77 | 18.10 | 12 | 42706 | 75406 | 34838807 |
| Ileal perforation | 54.80 | 18.10 | 24 | 42694 | 742 | 34913471 |
| Gastrointestinal perforation | 54.54 | 18.10 | 42 | 42676 | 3821 | 34910392 |
| Enteritis | 54.23 | 18.10 | 58 | 42660 | 8084 | 34906129 |
| Myalgia | 53.51 | 18.10 | 18 | 42700 | 84092 | 34830121 |
| Tumour necrosis | 51.32 | 18.10 | 27 | 42691 | 1261 | 34912952 |
| Rash pustular | 49.88 | 18.10 | 46 | 42672 | 5362 | 34908851 |
| Joint swelling | 49.81 | 18.10 | 7 | 42711 | 59883 | 34854330 |
| Stoma site haemorrhage | 48.28 | 18.10 | 23 | 42695 | 867 | 34913346 |
| Colitis microscopic | 48.19 | 18.10 | 32 | 42686 | 2305 | 34911908 |
| Weight increased | 47.96 | 18.10 | 27 | 42691 | 93006 | 34821207 |
| Small intestinal perforation | 47.87 | 18.10 | 31 | 42687 | 2140 | 34912073 |
| Toxicity to various agents | 47.85 | 18.10 | 109 | 42609 | 200253 | 34713960 |
| Blood alkaline phosphatase abnormal | 47.44 | 18.10 | 19 | 42699 | 467 | 34913746 |
| Fatigue | 47.01 | 18.10 | 673 | 42045 | 369980 | 34544233 |
| Proteus infection | 46.40 | 18.10 | 24 | 42694 | 1082 | 34913131 |
| Nicotinic acid deficiency | 45.89 | 18.10 | 13 | 42705 | 103 | 34914110 |
| Agitation | 44.82 | 18.10 | 8 | 42710 | 57391 | 34856822 |
| Anxiety | 44.29 | 18.10 | 34 | 42684 | 99394 | 34814819 |
| Anastomotic complication | 43.62 | 18.10 | 17 | 42701 | 388 | 34913825 |
| Rectal tenesmus | 43.13 | 18.10 | 21 | 42697 | 831 | 34913382 |
| Blood glucose increased | 42.92 | 18.10 | 14 | 42704 | 66704 | 34847509 |
| Enterocolitis | 42.91 | 18.10 | 51 | 42667 | 7975 | 34906238 |
| Dyspnoea | 42.56 | 18.10 | 278 | 42440 | 376504 | 34537709 |
| Mouth ulceration | 42.43 | 18.10 | 62 | 42656 | 11848 | 34902365 |
| Hospitalisation | 42.18 | 18.10 | 9 | 42709 | 56893 | 34857320 |
| Hypertension | 41.98 | 18.10 | 298 | 42420 | 136145 | 34778068 |
| Tumour marker increased | 41.87 | 18.10 | 19 | 42699 | 640 | 34913573 |
| Pain in extremity | 41.85 | 18.10 | 56 | 42662 | 126457 | 34787756 |
| Coronary artery disease | 41.72 | 18.10 | 5 | 42713 | 48300 | 34865913 |
| Carbohydrate antigen 19-9 increased | 41.61 | 18.10 | 14 | 42704 | 206 | 34914007 |
| Conjunctivitis | 41.26 | 18.10 | 55 | 42663 | 9650 | 34904563 |
| Intestinal perforation | 41.09 | 18.10 | 53 | 42665 | 9007 | 34905206 |
| Portal hypertension | 40.30 | 18.10 | 36 | 42682 | 4026 | 34910187 |
| Hypokalaemia | 40.11 | 18.10 | 159 | 42559 | 58055 | 34856158 |
| Acral peeling skin syndrome | 39.91 | 18.10 | 10 | 42708 | 46 | 34914167 |
| Depression | 39.80 | 18.10 | 36 | 42682 | 97062 | 34817151 |
| Feeling abnormal | 39.41 | 18.10 | 14 | 42704 | 63221 | 34850992 |
| Cardiac arrest | 39.00 | 18.10 | 36 | 42682 | 96123 | 34818090 |
| Drug ineffective | 38.57 | 18.10 | 365 | 42353 | 456386 | 34457827 |
| Anal haemorrhage | 38.53 | 18.10 | 29 | 42689 | 2549 | 34911664 |
| Confusional state | 38.10 | 18.10 | 74 | 42644 | 144086 | 34770127 |
| Failure to anastomose | 37.99 | 18.10 | 13 | 42705 | 202 | 34914011 |
| Suicidal ideation | 37.98 | 18.10 | 3 | 42715 | 40385 | 34873828 |
| Somnolence | 37.96 | 18.10 | 48 | 42670 | 111068 | 34803145 |
| Asthma | 37.88 | 18.10 | 4 | 42714 | 42652 | 34871561 |
| Anaemia of malignant disease | 37.68 | 18.10 | 16 | 42702 | 458 | 34913755 |
| Induration | 37.61 | 18.10 | 20 | 42698 | 955 | 34913258 |
| Hyperammonaemia | 36.61 | 18.10 | 42 | 42676 | 6325 | 34907888 |
| Peritonitis | 36.48 | 18.10 | 69 | 42649 | 16296 | 34897917 |
| Wheezing | 36.47 | 18.10 | 4 | 42714 | 41398 | 34872815 |
| Transdifferentiation of neoplasm | 36.25 | 18.10 | 10 | 42708 | 71 | 34914142 |
| Subclavian vein thrombosis | 36.22 | 18.10 | 19 | 42699 | 882 | 34913331 |
| Sciatic nerve palsy | 35.99 | 18.10 | 9 | 42709 | 41 | 34914172 |
| Arteriospasm coronary | 35.61 | 18.10 | 31 | 42687 | 3351 | 34910862 |
| Pneumatosis intestinalis | 35.47 | 18.10 | 33 | 42685 | 3890 | 34910323 |
| Anaemia | 35.42 | 18.10 | 438 | 42280 | 232897 | 34681316 |
| Perforation bile duct | 35.12 | 18.10 | 8 | 42710 | 22 | 34914191 |
| Colon cancer metastatic | 35.05 | 18.10 | 23 | 42695 | 1624 | 34912589 |
| Prothrombin level decreased | 34.88 | 18.10 | 20 | 42698 | 1108 | 34913105 |
| Peripheral swelling | 34.30 | 18.10 | 26 | 42692 | 76515 | 34837698 |
| Cellulitis | 34.25 | 18.10 | 11 | 42707 | 52940 | 34861273 |
| Dysphonia | 34.11 | 18.10 | 83 | 42635 | 23300 | 34890913 |
| Right ventricular ejection fraction decreased | 33.93 | 18.10 | 9 | 42709 | 54 | 34914159 |
| Acute abdomen | 33.77 | 18.10 | 24 | 42694 | 1931 | 34912282 |
| Incorrect dose administered | 33.07 | 18.10 | 5 | 42713 | 40510 | 34873703 |
| Hyperbilirubinaemia | 32.69 | 18.10 | 67 | 42651 | 16776 | 34897437 |
| Hypoferritinaemia | 32.63 | 18.10 | 7 | 42711 | 13 | 34914200 |
| Venoocclusive liver disease | 32.12 | 18.10 | 44 | 42674 | 7922 | 34906291 |
| International normalised ratio increased | 32.12 | 18.10 | 9 | 42709 | 47318 | 34866895 |
| Oesophagobronchial fistula | 31.90 | 18.10 | 11 | 42707 | 175 | 34914038 |
| Pyrexia | 31.75 | 18.10 | 577 | 42141 | 332436 | 34581777 |
| Vascular pseudoaneurysm | 31.55 | 18.10 | 24 | 42694 | 2143 | 34912070 |
| Large intestine perforation | 31.36 | 18.10 | 45 | 42673 | 8458 | 34905755 |
| Hallucination | 31.08 | 18.10 | 12 | 42706 | 51486 | 34862727 |
| Influenza | 30.93 | 18.10 | 11 | 42707 | 49655 | 34864558 |
| Gene mutation | 30.79 | 18.10 | 20 | 42698 | 1388 | 34912825 |
| Pulmonary artery thrombosis | 30.72 | 18.10 | 16 | 42702 | 732 | 34913481 |
| Portal vein thrombosis | 30.70 | 18.10 | 30 | 42688 | 3758 | 34910455 |
| Dizziness | 30.11 | 18.10 | 151 | 42567 | 218370 | 34695843 |
| Leukoencephalopathy | 29.80 | 18.10 | 31 | 42687 | 4184 | 34910029 |
| Stoma site pain | 29.15 | 18.10 | 15 | 42703 | 669 | 34913544 |
| Unevaluable event | 29.08 | 18.10 | 3 | 42715 | 32587 | 34881626 |
| Paraesthesia | 28.42 | 18.10 | 154 | 42564 | 64018 | 34850195 |
| Pancreatic carcinoma recurrent | 28.28 | 18.10 | 8 | 42710 | 63 | 34914150 |
| Heart rate increased | 27.63 | 18.10 | 11 | 42707 | 46332 | 34867881 |
| Atrial fibrillation | 27.26 | 18.10 | 69 | 42649 | 122324 | 34791889 |
| Chills | 27.26 | 18.10 | 181 | 42537 | 80862 | 34833351 |
| Balance disorder | 27.09 | 18.10 | 8 | 42710 | 40646 | 34873567 |
| Tremor | 26.84 | 18.10 | 37 | 42681 | 82550 | 34831663 |
| Nodular regenerative hyperplasia | 26.78 | 18.10 | 16 | 42702 | 957 | 34913256 |
| White blood cell count decreased | 26.78 | 18.10 | 204 | 42514 | 95241 | 34818972 |
| Stomal varices | 26.58 | 18.10 | 8 | 42710 | 80 | 34914133 |
| Small intestinal obstruction | 26.36 | 18.10 | 57 | 42661 | 14809 | 34899404 |
| Perioral dermatitis | 26.35 | 18.10 | 9 | 42709 | 139 | 34914074 |
| Metastases to pelvis | 26.20 | 18.10 | 11 | 42707 | 306 | 34913907 |
| Sinusitis | 26.08 | 18.10 | 9 | 42709 | 41393 | 34872820 |
| Vena cava thrombosis | 25.84 | 18.10 | 17 | 42701 | 1205 | 34913008 |
| Tumour perforation | 25.80 | 18.10 | 11 | 42707 | 318 | 34913895 |
| Dysgeusia | 25.68 | 18.10 | 81 | 42637 | 26416 | 34887797 |
| Toxic erythema of chemotherapy | 25.65 | 18.10 | 8 | 42710 | 91 | 34914122 |
| Growth of eyelashes | 25.34 | 18.10 | 8 | 42710 | 95 | 34914118 |
| Acne | 25.09 | 18.10 | 47 | 42671 | 11019 | 34903194 |
| Protein urine | 24.93 | 18.10 | 15 | 42703 | 909 | 34913304 |
| Fistula of small intestine | 24.76 | 18.10 | 12 | 42706 | 470 | 34913743 |
| Cough | 24.74 | 18.10 | 97 | 42621 | 150043 | 34764170 |
| Therapeutic product effect decreased | 24.73 | 18.10 | 6 | 42712 | 34737 | 34879476 |
| Paraesthesia oral | 24.66 | 18.10 | 28 | 42690 | 4169 | 34910044 |
| Large intestinal obstruction | 24.58 | 18.10 | 18 | 42700 | 1517 | 34912696 |
| Chronic kidney disease | 24.21 | 18.10 | 10 | 42708 | 41200 | 34873013 |
| Catheter site thrombosis | 24.14 | 18.10 | 8 | 42710 | 112 | 34914101 |
| Wrong technique in product usage process | 24.13 | 18.10 | 7 | 42711 | 35979 | 34878234 |
| Skin disorder | 24.07 | 18.10 | 52 | 42666 | 13503 | 34900710 |
| Peritoneal haematoma | 24.02 | 18.10 | 7 | 42711 | 62 | 34914151 |
| Electrocardiogram QT prolonged | 23.96 | 18.10 | 10 | 42708 | 40942 | 34873271 |
| Colon cancer recurrent | 23.95 | 18.10 | 8 | 42710 | 115 | 34914098 |
| Perihepatic abscess | 23.76 | 18.10 | 8 | 42710 | 118 | 34914095 |
| Toxic leukoencephalopathy | 23.58 | 18.10 | 11 | 42707 | 395 | 34913818 |
| Intestinal strangulation | 23.54 | 18.10 | 6 | 42712 | 30 | 34914183 |
| Diaphragmatic operation | 23.54 | 18.10 | 6 | 42712 | 30 | 34914183 |
| Subileus | 23.44 | 18.10 | 24 | 42694 | 3179 | 34911034 |
| Hypersensitivity | 23.43 | 18.10 | 141 | 42577 | 60894 | 34853319 |
| Epidermal naevus syndrome | 23.41 | 18.10 | 5 | 42713 | 9 | 34914204 |
| Deep vein thrombosis | 23.33 | 18.10 | 148 | 42570 | 65100 | 34849113 |
| Abdominal pain upper | 23.04 | 18.10 | 158 | 42560 | 71332 | 34842881 |
| COVID-19 | 23.01 | 18.10 | 37 | 42681 | 77513 | 34836700 |
| Adenocarcinoma | 22.92 | 18.10 | 19 | 42699 | 1921 | 34912292 |
| Chronic obstructive pulmonary disease | 22.71 | 18.10 | 16 | 42702 | 48902 | 34865311 |
| Clostridial infection | 22.69 | 18.10 | 25 | 42693 | 3602 | 34910611 |
| Skin fissures | 22.66 | 18.10 | 30 | 42688 | 5229 | 34908984 |
| Acute cutaneous lupus erythematosus | 22.50 | 18.10 | 7 | 42711 | 79 | 34914134 |
| Acute kidney injury | 22.25 | 18.10 | 252 | 42466 | 304736 | 34609477 |
| Insomnia | 22.05 | 18.10 | 60 | 42658 | 103847 | 34810366 |
| Colitis | 22.00 | 18.10 | 98 | 42620 | 37652 | 34876561 |
| Device related thrombosis | 21.87 | 18.10 | 15 | 42703 | 1140 | 34913073 |
| Memory impairment | 21.70 | 18.10 | 13 | 42705 | 43305 | 34870908 |
| Abdominal pain lower | 21.64 | 18.10 | 43 | 42675 | 10528 | 34903685 |
| Dysentery | 21.55 | 18.10 | 10 | 42708 | 355 | 34913858 |
| Hypoglycaemia | 21.50 | 18.10 | 21 | 42697 | 54619 | 34859594 |
| Ascites | 21.46 | 18.10 | 113 | 42605 | 46458 | 34867755 |
| Pruritus | 21.36 | 18.10 | 95 | 42623 | 141886 | 34772327 |
| Overdose | 21.32 | 18.10 | 50 | 42668 | 91009 | 34823204 |
| Haematoma | 21.27 | 18.10 | 3 | 42715 | 25602 | 34888611 |
| Obstruction gastric | 21.20 | 18.10 | 14 | 42704 | 999 | 34913214 |
| Onychoclasis | 21.19 | 18.10 | 18 | 42700 | 1882 | 34912331 |
| Unresponsive to stimuli | 21.18 | 18.10 | 4 | 42714 | 27565 | 34886648 |
| Contusion | 21.08 | 18.10 | 9 | 42709 | 36355 | 34877858 |
| Colony stimulating factor therapy | 21.06 | 18.10 | 8 | 42710 | 170 | 34914043 |
| Change of bowel habit | 20.83 | 18.10 | 14 | 42704 | 1029 | 34913184 |
| Oxygen saturation decreased | 20.82 | 18.10 | 21 | 42697 | 53797 | 34860416 |
| Cachexia | 20.82 | 18.10 | 34 | 42684 | 7152 | 34907061 |
| Rhabdomyosarcoma recurrent | 20.74 | 18.10 | 7 | 42711 | 104 | 34914109 |
| Acute myocardial infarction | 20.73 | 18.10 | 21 | 42697 | 53698 | 34860515 |
| Proctalgia | 20.69 | 18.10 | 30 | 42688 | 5693 | 34908520 |
| Abnormal behaviour | 20.56 | 18.10 | 3 | 42715 | 24966 | 34889247 |
| VIth nerve disorder | 20.52 | 18.10 | 5 | 42713 | 20 | 34914193 |
| Seizure | 20.46 | 18.10 | 63 | 42655 | 104794 | 34809419 |
| Fluid retention | 20.44 | 18.10 | 4 | 42714 | 26883 | 34887330 |
| Proctectomy | 20.38 | 18.10 | 7 | 42711 | 110 | 34914103 |
| Ventricular tachycardia | 20.11 | 18.10 | 4 | 42714 | 26575 | 34887638 |
| Coma | 19.85 | 18.10 | 16 | 42702 | 45662 | 34868551 |
| Constipation | 19.82 | 18.10 | 255 | 42463 | 136727 | 34777486 |
| Nail disorder | 19.79 | 18.10 | 18 | 42700 | 2061 | 34912152 |
| Volvulus of small bowel | 19.76 | 18.10 | 6 | 42712 | 62 | 34914151 |
| Treatment noncompliance | 19.72 | 18.10 | 5 | 42713 | 28095 | 34886118 |
| Hypertransaminasaemia | 19.70 | 18.10 | 29 | 42689 | 5577 | 34908636 |
| Loss of consciousness | 19.67 | 18.10 | 45 | 42673 | 82622 | 34831591 |
| Malignant ascites | 19.56 | 18.10 | 10 | 42708 | 440 | 34913773 |
| Medulloblastoma | 19.42 | 18.10 | 6 | 42712 | 66 | 34914147 |
| Steatohepatitis | 19.30 | 18.10 | 9 | 42709 | 323 | 34913890 |
| Septic shock | 19.28 | 18.10 | 152 | 42566 | 71682 | 34842531 |
| Adverse drug reaction | 19.14 | 18.10 | 6 | 42712 | 29336 | 34884877 |
| Bronchitis | 19.12 | 18.10 | 14 | 42704 | 41949 | 34872264 |
| Klebsiella infection | 19.05 | 18.10 | 36 | 42682 | 8495 | 34905718 |
| Superior vena cava syndrome | 19.01 | 18.10 | 11 | 42707 | 620 | 34913593 |
| Restlessness | 18.94 | 18.10 | 4 | 42714 | 25478 | 34888735 |
| Enterocutaneous fistula | 18.56 | 18.10 | 13 | 42705 | 1022 | 34913191 |
| Hypovolaemic shock | 18.50 | 18.10 | 32 | 42686 | 7053 | 34907160 |
| White blood cell count increased | 18.40 | 18.10 | 14 | 42704 | 41137 | 34873076 |
| Nasopharyngitis | 18.39 | 18.10 | 36 | 42682 | 69932 | 34844281 |
| Blood pressure systolic increased | 18.35 | 18.10 | 3 | 42715 | 22949 | 34891264 |
| Musculoskeletal stiffness | 18.30 | 18.10 | 18 | 42700 | 46662 | 34867551 |
| Mobility decreased | 18.21 | 18.10 | 7 | 42711 | 30121 | 34884092 |
| Heart rate decreased | 18.17 | 18.10 | 8 | 42710 | 31737 | 34882476 |
| Cardiotoxicity | 18.12 | 18.10 | 28 | 42690 | 5620 | 34908593 |
FDA Adverse Event Reporting System (Geriatric)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Diarrhoea | 1822.25 | 17.51 | 2900 | 64551 | 877589 | 78799348 |
| Neutropenia | 1664.60 | 17.51 | 1597 | 65854 | 286113 | 79390824 |
| Disease progression | 1454.10 | 17.51 | 1220 | 66231 | 183142 | 79493795 |
| Neuropathy peripheral | 882.34 | 17.51 | 820 | 66631 | 140485 | 79536452 |
| Myelosuppression | 632.51 | 17.51 | 405 | 67046 | 39891 | 79637046 |
| Dermatitis acneiform | 609.03 | 17.51 | 251 | 67200 | 9742 | 79667195 |
| Palmar-plantar erythrodysaesthesia syndrome | 532.33 | 17.51 | 338 | 67113 | 32796 | 79644141 |
| Skin toxicity | 507.23 | 17.51 | 209 | 67242 | 8105 | 79668832 |
| Neoplasm progression | 503.72 | 17.51 | 388 | 67063 | 51294 | 79625643 |
| Mucosal inflammation | 466.02 | 17.51 | 436 | 67015 | 75144 | 79601793 |
| Malignant neoplasm progression | 465.28 | 17.51 | 574 | 66877 | 135416 | 79541521 |
| Metastases to liver | 445.27 | 17.51 | 285 | 67166 | 28029 | 79648908 |
| Febrile neutropenia | 431.03 | 17.51 | 731 | 66720 | 230268 | 79446669 |
| Vomiting | 382.25 | 17.51 | 1332 | 66119 | 664496 | 79012441 |
| Neurotoxicity | 379.22 | 17.51 | 272 | 67179 | 32246 | 79644691 |
| Proteinuria | 374.76 | 17.51 | 270 | 67181 | 32232 | 79644705 |
| Thrombocytopenia | 370.64 | 17.51 | 741 | 66710 | 264518 | 79412419 |
| Decreased appetite | 366.92 | 17.51 | 859 | 66592 | 341559 | 79335378 |
| Bone marrow failure | 358.38 | 17.51 | 317 | 67134 | 50790 | 79626147 |
| Stomatitis | 354.51 | 17.51 | 523 | 66928 | 146234 | 79530703 |
| Leukopenia | 352.87 | 17.51 | 463 | 66988 | 116050 | 79560887 |
| Neutrophil count decreased | 339.70 | 17.51 | 408 | 67043 | 93551 | 79583386 |
| Nausea | 336.05 | 17.51 | 1645 | 65806 | 955551 | 78721386 |
| Gastrointestinal toxicity | 329.07 | 17.51 | 153 | 67298 | 7956 | 79668981 |
| Metastases to lung | 263.86 | 17.51 | 174 | 67277 | 17989 | 79658948 |
| Arthralgia | 250.31 | 17.51 | 86 | 67365 | 571717 | 79105220 |
| Peripheral sensory neuropathy | 247.54 | 17.51 | 148 | 67303 | 12885 | 79664052 |
| Cholinergic syndrome | 242.93 | 17.51 | 72 | 67379 | 1015 | 79675922 |
| Paronychia | 240.49 | 17.51 | 122 | 67329 | 7686 | 79669251 |
| Haematotoxicity | 233.55 | 17.51 | 152 | 67299 | 15367 | 79661570 |
| Therapy partial responder | 206.17 | 17.51 | 147 | 67304 | 17250 | 79659687 |
| Joint swelling | 199.45 | 17.51 | 11 | 67440 | 288635 | 79388302 |
| Intestinal obstruction | 198.23 | 17.51 | 212 | 67239 | 42808 | 79634129 |
| Off label use | 195.34 | 17.51 | 1372 | 66079 | 905843 | 78771094 |
| Polyneuropathy | 194.03 | 17.51 | 162 | 67289 | 23989 | 79652948 |
| Abdominal pain | 188.64 | 17.51 | 739 | 66712 | 388830 | 79288107 |
| Metastases to peritoneum | 188.35 | 17.51 | 86 | 67365 | 4286 | 79672651 |
| Completed suicide | 184.55 | 17.51 | 5 | 67446 | 245762 | 79431175 |
| Dehydration | 175.27 | 17.51 | 534 | 66917 | 247653 | 79429284 |
| Dysarthria | 173.26 | 17.51 | 248 | 67203 | 67374 | 79609563 |
| Asthenia | 164.68 | 17.51 | 860 | 66591 | 510829 | 79166108 |
| Colorectal cancer metastatic | 163.94 | 17.51 | 55 | 67396 | 1183 | 79675754 |
| General physical health deterioration | 159.87 | 17.51 | 554 | 66897 | 274684 | 79402253 |
| Ileus | 159.07 | 17.51 | 150 | 67301 | 26061 | 79650876 |
| Product dose omission issue | 155.12 | 17.51 | 15 | 67436 | 247522 | 79429415 |
| Cholangitis | 151.49 | 17.51 | 108 | 67343 | 12668 | 79664269 |
| Interstitial lung disease | 151.43 | 17.51 | 310 | 67141 | 112290 | 79564647 |
| Fall | 148.69 | 17.51 | 117 | 67334 | 487512 | 79189425 |
| Pulmonary embolism | 145.98 | 17.51 | 395 | 67056 | 171259 | 79505678 |
| Anaemia | 145.89 | 17.51 | 752 | 66699 | 444263 | 79232674 |
| Headache | 144.47 | 17.51 | 206 | 67245 | 653566 | 79023371 |
| Peripheral swelling | 143.74 | 17.51 | 27 | 67424 | 269590 | 79407347 |
| Epistaxis | 140.59 | 17.51 | 299 | 67152 | 111216 | 79565721 |
| Metastases to lymph nodes | 130.49 | 17.51 | 91 | 67360 | 10306 | 79666631 |
| Weight increased | 129.57 | 17.51 | 37 | 67414 | 277349 | 79399588 |
| Drug abuse | 123.27 | 17.51 | 3 | 67448 | 162688 | 79514249 |
| Sinusitis | 122.06 | 17.51 | 12 | 67439 | 195489 | 79481448 |
| Pain | 119.10 | 17.51 | 262 | 67189 | 703540 | 78973397 |
| Ascites | 117.28 | 17.51 | 221 | 67230 | 75341 | 79601596 |
| Swelling | 117 | 17.51 | 21 | 67430 | 216690 | 79460247 |
| Pain in extremity | 116.79 | 17.51 | 83 | 67368 | 364455 | 79312482 |
| Hypomagnesaemia | 115.70 | 17.51 | 169 | 67282 | 46742 | 79630195 |
| Arthropathy | 110.23 | 17.51 | 11 | 67440 | 177100 | 79499837 |
| Drug interaction | 107.10 | 17.51 | 116 | 67335 | 415067 | 79261870 |
| Therapeutic product effect decreased | 105.12 | 17.51 | 9 | 67442 | 163854 | 79513083 |
| Carcinoembryonic antigen increased | 103.25 | 17.51 | 46 | 67405 | 2163 | 79674774 |
| Contraindicated product administered | 100.11 | 17.51 | 9 | 67442 | 157529 | 79519408 |
| Enteritis | 99.26 | 17.51 | 89 | 67362 | 14494 | 79662443 |
| Hypokalaemia | 91.50 | 17.51 | 299 | 67152 | 143741 | 79533196 |
| Asthma | 90.68 | 17.51 | 6 | 67445 | 135089 | 79541848 |
| Hyperammonaemia | 90.31 | 17.51 | 75 | 67376 | 11018 | 79665919 |
| Hiccups | 88.35 | 17.51 | 71 | 67380 | 9960 | 79666977 |
| Hypertension | 86.77 | 17.51 | 527 | 66924 | 330465 | 79346472 |
| Abdominal discomfort | 85.77 | 17.51 | 53 | 67398 | 250674 | 79426263 |
| Rash pustular | 84.94 | 17.51 | 73 | 67378 | 11238 | 79665699 |
| Nasopharyngitis | 83.66 | 17.51 | 56 | 67395 | 253825 | 79423112 |
| Maternal exposure during pregnancy | 83.61 | 17.51 | 9 | 67442 | 136529 | 79540408 |
| White blood cell count decreased | 81.98 | 17.51 | 346 | 67105 | 187942 | 79488995 |
| Musculoskeletal stiffness | 80.48 | 17.51 | 24 | 67427 | 174984 | 79501953 |
| Arthritis | 80.47 | 17.51 | 4 | 67447 | 114876 | 79562061 |
| Gastrointestinal perforation | 80.03 | 17.51 | 55 | 67396 | 6082 | 79670855 |
| Drug hypersensitivity | 79.85 | 17.51 | 81 | 67370 | 298835 | 79378102 |
| Cough | 79.43 | 17.51 | 117 | 67334 | 366672 | 79310265 |
| Myalgia | 77.49 | 17.51 | 30 | 67421 | 185611 | 79491326 |
| Ileal perforation | 77.19 | 17.51 | 30 | 67421 | 995 | 79675942 |
| Intestinal perforation | 76.96 | 17.51 | 84 | 67367 | 17342 | 79659595 |
| Glossodynia | 74.34 | 17.51 | 3 | 67448 | 103334 | 79573603 |
| Hypertransaminasaemia | 71.88 | 17.51 | 68 | 67383 | 11856 | 79665081 |
| Pericarditis | 68.87 | 17.51 | 5 | 67446 | 104231 | 79572706 |
| Hyperbilirubinaemia | 68.84 | 17.51 | 94 | 67357 | 24424 | 79652513 |
| Drug intolerance | 67.81 | 17.51 | 74 | 67377 | 264045 | 79412892 |
| Large intestine perforation | 67.45 | 17.51 | 72 | 67379 | 14495 | 79662442 |
| Pyrexia | 67.26 | 17.51 | 872 | 66579 | 677837 | 78999100 |
| Mobility decreased | 65.57 | 17.51 | 12 | 67439 | 122163 | 79554774 |
| Contusion | 65.55 | 17.51 | 22 | 67429 | 148754 | 79528183 |
| Necrotising fasciitis | 64.58 | 17.51 | 48 | 67403 | 6002 | 79670935 |
| Intentional product misuse | 64.53 | 17.51 | 4 | 67447 | 95161 | 79581776 |
| Dizziness | 63.68 | 17.51 | 230 | 67221 | 526211 | 79150726 |
| Exposure during pregnancy | 63.65 | 17.51 | 6 | 67445 | 101126 | 79575811 |
| Anastomotic complication | 62.71 | 17.51 | 21 | 67430 | 449 | 79676488 |
| Lower respiratory tract infection | 62.62 | 17.51 | 16 | 67435 | 129204 | 79547733 |
| Depression | 62.26 | 17.51 | 55 | 67396 | 216735 | 79460202 |
| Tumour necrosis | 62.02 | 17.51 | 31 | 67420 | 1891 | 79675046 |
| Hepatic enzyme increased | 61.88 | 17.51 | 39 | 67412 | 182571 | 79494366 |
| Skin reaction | 61.66 | 17.51 | 72 | 67379 | 15996 | 79660941 |
| Colitis | 61.54 | 17.51 | 168 | 67283 | 73139 | 79603798 |
| Venoocclusive liver disease | 61.37 | 17.51 | 62 | 67389 | 11709 | 79665228 |
| Anxiety | 61.20 | 17.51 | 72 | 67379 | 248440 | 79428497 |
| Cardiac failure congestive | 61.12 | 17.51 | 22 | 67429 | 142380 | 79534557 |
| Steatohepatitis | 60.75 | 17.51 | 25 | 67426 | 965 | 79675972 |
| Gene mutation | 60.27 | 17.51 | 34 | 67417 | 2652 | 79674285 |
| Skin fissures | 59.45 | 17.51 | 64 | 67387 | 13009 | 79663928 |
| Influenza | 59.17 | 17.51 | 18 | 67433 | 129588 | 79547349 |
| Enterocutaneous fistula | 58.52 | 17.51 | 30 | 67421 | 1931 | 79675006 |
| Arteriospasm coronary | 58.01 | 17.51 | 47 | 67404 | 6669 | 79670268 |
| Rhabdomyolysis | 57.84 | 17.51 | 9 | 67442 | 103122 | 79573815 |
| Wheezing | 57.39 | 17.51 | 14 | 67437 | 116650 | 79560287 |
| Bradycardia | 56.40 | 17.51 | 22 | 67429 | 135535 | 79541402 |
| Blister | 55.62 | 17.51 | 16 | 67435 | 119460 | 79557477 |
| Feeling abnormal | 55.33 | 17.51 | 33 | 67418 | 159166 | 79517771 |
| Myocardial infarction | 54.97 | 17.51 | 45 | 67406 | 184084 | 79492853 |
| Condition aggravated | 54.78 | 17.51 | 228 | 67223 | 500896 | 79176041 |
| Trichomegaly | 53.75 | 17.51 | 14 | 67437 | 118 | 79676819 |
| Product use issue | 53.60 | 17.51 | 59 | 67392 | 209763 | 79467174 |
| Proctalgia | 52.73 | 17.51 | 53 | 67398 | 9948 | 79666989 |
| Dyspnoea | 52.62 | 17.51 | 468 | 66983 | 856557 | 78820380 |
| Suicidal ideation | 52.39 | 17.51 | 3 | 67448 | 76337 | 79600600 |
| Deep vein thrombosis | 51.66 | 17.51 | 221 | 67230 | 120698 | 79556239 |
| Small intestinal perforation | 51.34 | 17.51 | 33 | 67418 | 3264 | 79673673 |
| Speech disorder | 51.01 | 17.51 | 130 | 67321 | 54315 | 79622622 |
| Confusional state | 50.68 | 17.51 | 122 | 67329 | 317875 | 79359062 |
| Stoma site haemorrhage | 50.58 | 17.51 | 27 | 67424 | 1889 | 79675048 |
| Osteoarthritis | 50.39 | 17.51 | 7 | 67444 | 87302 | 79589635 |
| Vena cava thrombosis | 50.15 | 17.51 | 31 | 67420 | 2864 | 79674073 |
| Protein urine | 50.14 | 17.51 | 25 | 67426 | 1517 | 79675420 |
| Heart rate increased | 49.56 | 17.51 | 20 | 67431 | 120704 | 79556233 |
| Subclavian vein thrombosis | 49.52 | 17.51 | 29 | 67422 | 2428 | 79674509 |
| Paraesthesia | 49.50 | 17.51 | 286 | 67165 | 176037 | 79500900 |
| Device related infection | 49.14 | 17.51 | 97 | 67354 | 34197 | 79642740 |
| Hospitalisation | 48.99 | 17.51 | 10 | 67441 | 94226 | 79582711 |
| Bronchitis | 48.40 | 17.51 | 25 | 67426 | 130619 | 79546318 |
| Pneumonia | 47.64 | 17.51 | 345 | 67106 | 659901 | 79017036 |
| Insomnia | 47.58 | 17.51 | 84 | 67367 | 245086 | 79431851 |
| Tongue oedema | 47.57 | 17.51 | 43 | 67408 | 7074 | 79669863 |
| Pneumatosis intestinalis | 47.45 | 17.51 | 41 | 67410 | 6356 | 79670581 |
| Peritonitis | 47.25 | 17.51 | 85 | 67366 | 27951 | 79648986 |
| Incorrect dose administered | 47.03 | 17.51 | 5 | 67446 | 76625 | 79600312 |
| Drug ineffective | 46.94 | 17.51 | 639 | 66812 | 1080274 | 78596663 |
| Mucosal toxicity | 46.75 | 17.51 | 18 | 67433 | 582 | 79676355 |
| Portal vein thrombosis | 46.61 | 17.51 | 39 | 67412 | 5788 | 79671149 |
| Large intestinal obstruction | 46.44 | 17.51 | 31 | 67420 | 3268 | 79673669 |
| Metastases to meninges | 46.31 | 17.51 | 32 | 67419 | 3569 | 79673368 |
| Superior vena cava syndrome | 45.85 | 17.51 | 22 | 67429 | 1227 | 79675710 |
| Laryngospasm | 45.57 | 17.51 | 33 | 67418 | 3964 | 79672973 |
| Rectal tenesmus | 45.33 | 17.51 | 24 | 67427 | 1651 | 79675286 |
| Blood pressure fluctuation | 44.99 | 17.51 | 3 | 67448 | 67142 | 79609795 |
| Wound | 44.91 | 17.51 | 21 | 67430 | 116158 | 79560779 |
| Colon cancer metastatic | 44.64 | 17.51 | 26 | 67425 | 2155 | 79674782 |
| Somnolence | 44.48 | 17.51 | 84 | 67367 | 238897 | 79438040 |
| Nicotinic acid deficiency | 44.14 | 17.51 | 13 | 67438 | 179 | 79676758 |
| Blood glucose increased | 44.11 | 17.51 | 21 | 67430 | 114954 | 79561983 |
| Pruritus | 44.07 | 17.51 | 178 | 67273 | 394470 | 79282467 |
| Dysentery | 43.61 | 17.51 | 21 | 67430 | 1181 | 79675756 |
| Acral peeling skin syndrome | 43.57 | 17.51 | 10 | 67441 | 46 | 79676891 |
| Posterior reversible encephalopathy syndrome | 43.43 | 17.51 | 79 | 67372 | 26202 | 79650735 |
| Dysphonia | 42.52 | 17.51 | 125 | 67326 | 56747 | 79620190 |
| Dysgeusia | 42.11 | 17.51 | 125 | 67326 | 57052 | 79619885 |
| Migraine | 42.07 | 17.51 | 11 | 67440 | 87482 | 79589455 |
| Portal hypertension | 41.82 | 17.51 | 40 | 67411 | 7068 | 79669869 |
| COVID-19 | 41.76 | 17.51 | 43 | 67408 | 157631 | 79519306 |
| Anal haemorrhage | 41.67 | 17.51 | 32 | 67419 | 4202 | 79672735 |
| Splenic artery thrombosis | 41.64 | 17.51 | 10 | 67441 | 58 | 79676879 |
| Duodenal ulcer perforation | 41.47 | 17.51 | 4 | 67447 | 66207 | 79610730 |
| Nodular regenerative hyperplasia | 41.13 | 17.51 | 21 | 67430 | 1340 | 79675597 |
| Metastasis | 41.02 | 17.51 | 39 | 67412 | 6841 | 79670096 |
| Cardiotoxicity | 40.69 | 17.51 | 51 | 67400 | 12188 | 79664749 |
| Skin disorder | 40.43 | 17.51 | 89 | 67362 | 33854 | 79643083 |
| Blood alkaline phosphatase abnormal | 40.05 | 17.51 | 18 | 67433 | 864 | 79676073 |
| Discomfort | 39.64 | 17.51 | 29 | 67422 | 125588 | 79551349 |
| Growth of eyelashes | 39.43 | 17.51 | 12 | 67439 | 186 | 79676751 |
| Loss of personal independence in daily activities | 38.94 | 17.51 | 19 | 67432 | 102561 | 79574376 |
| Chills | 38.69 | 17.51 | 250 | 67201 | 159984 | 79516953 |
| Coronary artery disease | 38.38 | 17.51 | 5 | 67446 | 65469 | 79611468 |
| Anorectal disorder | 38.32 | 17.51 | 24 | 67427 | 2269 | 79674668 |
| Acute abdomen | 38.30 | 17.51 | 27 | 67424 | 3110 | 79673827 |
| Enterocolitis | 38.29 | 17.51 | 54 | 67397 | 14458 | 79662479 |
| Pulmonary artery thrombosis | 37.83 | 17.51 | 20 | 67431 | 1372 | 79675565 |
| Rectal haemorrhage | 37.78 | 17.51 | 146 | 67305 | 76154 | 79600783 |
| Proteus infection | 37.50 | 17.51 | 23 | 67428 | 2095 | 79674842 |
| Failure to anastomose | 37.36 | 17.51 | 12 | 67439 | 224 | 79676713 |
| Transdifferentiation of neoplasm | 37.05 | 17.51 | 10 | 67441 | 98 | 79676839 |
| Neuromyotonia | 36.78 | 17.51 | 10 | 67441 | 101 | 79676836 |
| International normalised ratio increased | 36.50 | 17.51 | 13 | 67438 | 84708 | 79592229 |
| Leukoencephalopathy | 36.37 | 17.51 | 39 | 67412 | 7890 | 79669047 |
| Septic shock | 36.30 | 17.51 | 202 | 67249 | 122599 | 79554338 |
| Right ventricular ejection fraction decreased | 36.15 | 17.51 | 9 | 67442 | 62 | 79676875 |
| Wrong technique in product usage process | 36.07 | 17.51 | 9 | 67442 | 73866 | 79603071 |
| Nasal septum perforation | 35.94 | 17.51 | 16 | 67435 | 751 | 79676186 |
| Gait inability | 35.76 | 17.51 | 4 | 67447 | 58913 | 79618024 |
| Intestinal metastasis | 35.22 | 17.51 | 13 | 67438 | 373 | 79676564 |
| Hypoferritinaemia | 35.20 | 17.51 | 7 | 67444 | 13 | 79676924 |
| Injection site reaction | 35.14 | 17.51 | 3 | 67448 | 54782 | 79622155 |
| Balance disorder | 35.04 | 17.51 | 20 | 67431 | 98837 | 79578100 |
| Memory impairment | 34.99 | 17.51 | 26 | 67425 | 111708 | 79565229 |
| Pelvic fluid collection | 34.93 | 17.51 | 16 | 67435 | 803 | 79676134 |
| Sciatic nerve palsy | 34.44 | 17.51 | 9 | 67442 | 77 | 79676860 |
| Therapeutic product effect incomplete | 34.20 | 17.51 | 221 | 67230 | 141424 | 79535513 |
| Tumour perforation | 34.13 | 17.51 | 13 | 67438 | 408 | 79676529 |
| Venous pressure jugular decreased | 33.93 | 17.51 | 9 | 67442 | 82 | 79676855 |
| Subileus | 33.61 | 17.51 | 32 | 67419 | 5622 | 79671315 |
| Heart rate decreased | 33.50 | 17.51 | 9 | 67442 | 70307 | 79606630 |
| Death | 33.36 | 17.51 | 668 | 66783 | 565846 | 79111091 |
| Hepatic lesion | 33.29 | 17.51 | 35 | 67416 | 6924 | 79670013 |
| Disease recurrence | 33.02 | 17.51 | 97 | 67354 | 44012 | 79632925 |
| Blood pressure systolic increased | 33.02 | 17.51 | 8 | 67443 | 66978 | 79609959 |
| Colitis microscopic | 32.86 | 17.51 | 43 | 67408 | 10725 | 79666212 |
| Influenza like illness | 32.65 | 17.51 | 10 | 67441 | 71697 | 79605240 |
| Hypertensive crisis | 32.51 | 17.51 | 61 | 67390 | 20709 | 79656228 |
| Conjunctivitis | 32.43 | 17.51 | 69 | 67382 | 25646 | 79651291 |
| Oesophagobronchial fistula | 32.42 | 17.51 | 11 | 67440 | 245 | 79676692 |
| Chronic obstructive pulmonary disease | 32.15 | 17.51 | 16 | 67435 | 85403 | 79591534 |
| Aggression | 32.12 | 17.51 | 3 | 67448 | 50955 | 79625982 |
| Prothrombin level decreased | 32.07 | 17.51 | 19 | 67432 | 1625 | 79675312 |
| Metastases to central nervous system | 31.99 | 17.51 | 53 | 67398 | 16322 | 79660615 |
| Liver abscess | 31.76 | 17.51 | 32 | 67419 | 6022 | 79670915 |
| Alopecia | 31.71 | 17.51 | 317 | 67134 | 231038 | 79445899 |
| Fistula of small intestine | 31.68 | 17.51 | 15 | 67436 | 812 | 79676125 |
| Pancreatic carcinoma recurrent | 31.63 | 17.51 | 10 | 67441 | 177 | 79676760 |
| Induration | 31.54 | 17.51 | 20 | 67431 | 1932 | 79675005 |
| Agitation | 31.49 | 17.51 | 23 | 67428 | 99692 | 79577245 |
| Cataract | 31.45 | 17.51 | 7 | 67444 | 62113 | 79614824 |
| Vascular pseudoaneurysm | 31.24 | 17.51 | 25 | 67426 | 3485 | 79673452 |
| Oxygen saturation decreased | 31.09 | 17.51 | 38 | 67413 | 129009 | 79547928 |
| Cystitis radiation | 31.01 | 17.51 | 10 | 67441 | 189 | 79676748 |
| Aortitis | 30.94 | 17.51 | 18 | 67433 | 1489 | 79675448 |
| Treatment noncompliance | 30.61 | 17.51 | 4 | 67447 | 52264 | 79624673 |
| Haematoma | 30.56 | 17.51 | 4 | 67447 | 52191 | 79624746 |
| Gait disturbance | 30.42 | 17.51 | 83 | 67368 | 207423 | 79469514 |
| Granulocyte count decreased | 30.41 | 17.51 | 19 | 67432 | 1789 | 79675148 |
| Dysaesthesia pharynx | 30.16 | 17.51 | 10 | 67441 | 207 | 79676730 |
| Perforation bile duct | 30.02 | 17.51 | 7 | 67444 | 35 | 79676902 |
| Venous thrombosis limb | 29.93 | 17.51 | 27 | 67424 | 4430 | 79672507 |
| Disseminated intravascular coagulation | 29.93 | 17.51 | 82 | 67369 | 35760 | 79641177 |
| Cardiac arrest | 29.85 | 17.51 | 63 | 67388 | 172033 | 79504904 |
| Productive cough | 29.72 | 17.51 | 19 | 67432 | 88312 | 79588625 |
| Neutropenic colitis | 29.64 | 17.51 | 30 | 67421 | 5677 | 79671260 |
| Klebsiella infection | 29.53 | 17.51 | 50 | 67401 | 15670 | 79661267 |
| Paraesthesia oral | 29.44 | 17.51 | 58 | 67393 | 20413 | 79656524 |
| Ganglioneuroma | 29.42 | 17.51 | 9 | 67442 | 142 | 79676795 |
| Carbohydrate antigen 19-9 increased | 29.41 | 17.51 | 12 | 67439 | 453 | 79676484 |
| Constipation | 29.31 | 17.51 | 367 | 67084 | 282683 | 79394254 |
| Trismus | 28.87 | 17.51 | 29 | 67422 | 5438 | 79671499 |
| Anaemia of malignant disease | 28.68 | 17.51 | 14 | 67437 | 811 | 79676126 |
| Hepatic failure | 28.58 | 17.51 | 115 | 67336 | 61097 | 79615840 |
| Adenocarcinoma of colon | 28.55 | 17.51 | 29 | 67422 | 5512 | 79671425 |
| Stomal varices | 28.48 | 17.51 | 8 | 67443 | 92 | 79676845 |
| Tumour ulceration | 28.35 | 17.51 | 10 | 67441 | 251 | 79676686 |
| Tremor | 28.07 | 17.51 | 64 | 67387 | 170019 | 79506918 |
| Performance status decreased | 27.92 | 17.51 | 30 | 67421 | 6083 | 79670854 |
| Limbic encephalitis | 27.90 | 17.51 | 14 | 67437 | 861 | 79676076 |
| Hypoalbuminaemia | 27.85 | 17.51 | 58 | 67393 | 21239 | 79655698 |
| Small intestinal obstruction | 27.52 | 17.51 | 67 | 67384 | 27205 | 79649732 |
| Diaphragmatic paralysis | 27.48 | 17.51 | 15 | 67436 | 1097 | 79675840 |
| K-ras gene mutation | 27.42 | 17.51 | 7 | 67444 | 54 | 79676883 |
| Fatigue | 27.03 | 17.51 | 1000 | 66451 | 928727 | 78748210 |
| Biliary tract infection | 26.97 | 17.51 | 16 | 67435 | 1372 | 79675565 |
| Palpitations | 26.76 | 17.51 | 41 | 67410 | 126569 | 79550368 |
| Dry skin | 26.54 | 17.51 | 121 | 67330 | 67874 | 79609063 |
| Cellulitis | 26.40 | 17.51 | 32 | 67419 | 109028 | 79567909 |
| Gastrointestinal stoma complication | 26.10 | 17.51 | 20 | 67431 | 2617 | 79674320 |
| Electrocardiogram QT prolonged | 25.85 | 17.51 | 23 | 67428 | 90363 | 79586574 |
| Venous thrombosis | 25.84 | 17.51 | 31 | 67420 | 7085 | 79669852 |
| Diaphragmatic operation | 25.73 | 17.51 | 6 | 67445 | 30 | 79676907 |
| Jaw operation | 25.66 | 17.51 | 13 | 67438 | 816 | 79676121 |
| Adverse drug reaction | 25.65 | 17.51 | 12 | 67439 | 66380 | 79610557 |
| Metastases to ovary | 25.30 | 17.51 | 10 | 67441 | 347 | 79676590 |
| Anastomotic fistula | 25.28 | 17.51 | 8 | 67443 | 142 | 79676795 |
| Metastatic neoplasm | 25.27 | 17.51 | 26 | 67425 | 5016 | 79671921 |
| Lactic acidosis | 25.27 | 17.51 | 14 | 67437 | 70345 | 79606592 |
| Epidermal naevus syndrome | 25.24 | 17.51 | 5 | 67446 | 9 | 79676928 |
| Acute myeloid leukaemia | 25.13 | 17.51 | 70 | 67381 | 30815 | 79646122 |
| Nasal congestion | 25.03 | 17.51 | 17 | 67434 | 76535 | 79600402 |
| Toxic erythema of chemotherapy | 24.80 | 17.51 | 9 | 67442 | 246 | 79676691 |
| Gastrooesophageal reflux disease | 24.79 | 17.51 | 31 | 67420 | 104215 | 79572722 |
| Toxic epidermal necrolysis | 24.74 | 17.51 | 4 | 67447 | 44577 | 79632360 |
| Overdose | 24.58 | 17.51 | 77 | 67374 | 184129 | 79492808 |
| Product use in unapproved indication | 24.38 | 17.51 | 321 | 67130 | 250038 | 79426899 |
| Hypovolaemic shock | 24.34 | 17.51 | 40 | 67411 | 12236 | 79664701 |
| Medication error | 24.16 | 17.51 | 14 | 67437 | 68628 | 79608309 |
| Toxicity to various agents | 24.11 | 17.51 | 234 | 67217 | 421306 | 79255631 |
| Depilation | 23.99 | 17.51 | 5 | 67446 | 13 | 79676924 |
| Perihepatic abscess | 23.93 | 17.51 | 8 | 67443 | 170 | 79676767 |
| Malignant ascites | 23.84 | 17.51 | 14 | 67437 | 1178 | 79675759 |
| Osteoporosis | 23.83 | 17.51 | 8 | 67443 | 54104 | 79622833 |
| Viral infection | 23.56 | 17.51 | 4 | 67447 | 43012 | 79633925 |
| Hydronephrosis | 23.37 | 17.51 | 48 | 67403 | 17406 | 79659531 |
| Hypervolaemia | 23.32 | 17.51 | 4 | 67447 | 42686 | 79634251 |
| Xeroderma | 23.03 | 17.51 | 9 | 67442 | 303 | 79676634 |
| Optic glioma | 22.99 | 17.51 | 6 | 67445 | 51 | 79676886 |
| Nephrotic syndrome | 22.95 | 17.51 | 37 | 67414 | 11137 | 79665800 |
| Intestinal strangulation | 22.59 | 17.51 | 6 | 67445 | 55 | 79676882 |
| Hypoglycaemia | 22.34 | 17.51 | 32 | 67419 | 101562 | 79575375 |
| Pelvic venous thrombosis | 22.30 | 17.51 | 17 | 67434 | 2208 | 79674729 |
| Rhabdomyosarcoma recurrent | 22.13 | 17.51 | 7 | 67444 | 124 | 79676813 |
| Lip swelling | 21.98 | 17.51 | 4 | 67447 | 40907 | 79636030 |
| Febrile infection | 21.94 | 17.51 | 20 | 67431 | 3326 | 79673611 |
| Colon cancer recurrent | 21.93 | 17.51 | 7 | 67444 | 128 | 79676809 |
| Drug resistance | 21.90 | 17.51 | 82 | 67369 | 42131 | 79634806 |
| Rectal perforation | 21.79 | 17.51 | 12 | 67439 | 893 | 79676044 |
| Neutropenic sepsis | 21.69 | 17.51 | 61 | 67390 | 27003 | 79649934 |
| Unresponsive to stimuli | 21.68 | 17.51 | 10 | 67441 | 55778 | 79621159 |
| Colony stimulating factor therapy | 21.61 | 17.51 | 10 | 67441 | 514 | 79676423 |
| Intentional product use issue | 21.43 | 17.51 | 62 | 67389 | 152050 | 79524887 |
| Ileus paralytic | 21.34 | 17.51 | 33 | 67418 | 9587 | 79667350 |
| Renal hydrocele | 21.28 | 17.51 | 5 | 67446 | 26 | 79676911 |
| Emotional distress | 21.28 | 17.51 | 4 | 67447 | 39965 | 79636972 |
| Perioral dermatitis | 21.27 | 17.51 | 9 | 67442 | 373 | 79676564 |
| Rectal cancer | 21.11 | 17.51 | 20 | 67431 | 3493 | 79673444 |
| Obstruction gastric | 21.07 | 17.51 | 15 | 67436 | 1755 | 79675182 |
| Hypothyroidism | 20.98 | 17.51 | 9 | 67442 | 52383 | 79624554 |
| VIth nerve disorder | 20.97 | 17.51 | 5 | 67446 | 28 | 79676909 |
| Abnormal behaviour | 20.83 | 17.51 | 3 | 67448 | 36418 | 79640519 |
| Osteonecrosis of jaw | 20.81 | 17.51 | 82 | 67369 | 43144 | 79633793 |
| Aortic intramural haematoma | 20.71 | 17.51 | 7 | 67444 | 154 | 79676783 |
| Stevens-Johnson syndrome | 20.68 | 17.51 | 4 | 67447 | 39162 | 79637775 |
| Swelling face | 20.51 | 17.51 | 18 | 67433 | 71194 | 79605743 |
| Bladder tamponade | 20.44 | 17.51 | 10 | 67441 | 582 | 79676355 |
| Psychotic disorder | 20.29 | 17.51 | 5 | 67446 | 41397 | 79635540 |
| Prostatic calcification | 20.28 | 17.51 | 6 | 67445 | 84 | 79676853 |
| Necrotising colitis | 20.24 | 17.51 | 12 | 67439 | 1028 | 79675909 |
| Sepsis | 20.14 | 17.51 | 330 | 67121 | 269098 | 79407839 |
| Jaundice | 20.13 | 17.51 | 94 | 67357 | 53255 | 79623682 |
| Neutrophilia | 20.11 | 17.51 | 29 | 67422 | 7922 | 79669015 |
| Enteral nutrition | 20.09 | 17.51 | 6 | 67445 | 87 | 79676850 |
| Febrile bone marrow aplasia | 20.08 | 17.51 | 38 | 67413 | 12982 | 79663955 |
| Anal fistula | 20.06 | 17.51 | 27 | 67424 | 6917 | 79670020 |
| Road traffic accident | 20.04 | 17.51 | 6 | 67445 | 43658 | 79633279 |
| Chronic kidney disease | 19.94 | 17.51 | 16 | 67435 | 66138 | 79610799 |
| Hallucination | 19.87 | 17.51 | 26 | 67425 | 85719 | 79591218 |
| Administration site extravasation | 19.82 | 17.51 | 13 | 67438 | 1330 | 79675607 |
| Gastrointestinal inflammation | 19.79 | 17.51 | 28 | 67423 | 7516 | 79669421 |
| Food protein-induced enterocolitis syndrome | 19.77 | 17.51 | 5 | 67446 | 37 | 79676900 |
| Tumour marker increased | 19.57 | 17.51 | 21 | 67430 | 4251 | 79672686 |
| Platelet count decreased | 19.53 | 17.51 | 251 | 67200 | 194413 | 79482524 |
| Abdominal abscess | 19.52 | 17.51 | 27 | 67424 | 7100 | 79669837 |
| Device related thrombosis | 19.50 | 17.51 | 17 | 67434 | 2666 | 79674271 |
| Pancreatic fistula | 19.31 | 17.51 | 6 | 67445 | 100 | 79676837 |
| Clostridial infection | 19.30 | 17.51 | 24 | 67427 | 5690 | 79671247 |
| Colonic fistula | 19.24 | 17.51 | 10 | 67441 | 662 | 79676275 |
| Tumour lysis syndrome | 19.23 | 17.51 | 54 | 67397 | 23885 | 79653052 |
| Stomatitis haemorrhagic | 19.20 | 17.51 | 6 | 67445 | 102 | 79676835 |
| Burning sensation | 19.20 | 17.51 | 13 | 67438 | 58619 | 79618318 |
| Cachexia | 19.18 | 17.51 | 34 | 67417 | 11049 | 79665888 |
| Tumour embolism | 18.99 | 17.51 | 7 | 67444 | 200 | 79676737 |
| Cell-mediated cytotoxicity | 18.91 | 17.51 | 5 | 67446 | 45 | 79676892 |
| Proctectomy | 18.90 | 17.51 | 7 | 67444 | 203 | 79676734 |
| Peritoneal haematoma | 18.86 | 17.51 | 7 | 67444 | 204 | 79676733 |
| Unevaluable event | 18.64 | 17.51 | 12 | 67439 | 55573 | 79621364 |
| Xerosis | 18.60 | 17.51 | 12 | 67439 | 1194 | 79675743 |
| Loss of consciousness | 18.55 | 17.51 | 76 | 67375 | 167867 | 79509070 |
| Jugular vein thrombosis | 18.53 | 17.51 | 21 | 67430 | 4517 | 79672420 |
| Oedema peripheral | 18.52 | 17.51 | 131 | 67320 | 252157 | 79424780 |
| Pelvic abscess | 18.48 | 17.51 | 15 | 67436 | 2134 | 79674803 |
| Treatment failure | 18.30 | 17.51 | 78 | 67373 | 170408 | 79506529 |
| Immune thrombocytopenia | 18.24 | 17.51 | 44 | 67407 | 17761 | 79659176 |
| Administration site recall reaction | 18.23 | 17.51 | 3 | 67448 | 0 | 79676937 |
| Cutaneous tuberculosis | 18.19 | 17.51 | 7 | 67444 | 226 | 79676711 |
| Pancreatic carcinoma metastatic | 18.17 | 17.51 | 19 | 67432 | 3734 | 79673203 |
| Peripheral sensorimotor neuropathy | 17.83 | 17.51 | 17 | 67434 | 2993 | 79673944 |
| Duodenal varices | 17.69 | 17.51 | 4 | 67447 | 17 | 79676920 |
| Portal vein embolisation | 17.69 | 17.51 | 4 | 67447 | 17 | 79676920 |
| Sedation | 17.68 | 17.51 | 11 | 67440 | 51884 | 79625053 |
| Adverse event | 17.61 | 17.51 | 15 | 67436 | 60199 | 79616738 |
| Incorrect route of product administration | 17.55 | 17.51 | 4 | 67447 | 34925 | 79642012 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | L01CE02 | ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS ANTINEOPLASTIC AGENTS PLANT ALKALOIDS AND OTHER NATURAL PRODUCTS Topoisomerase 1 (TOP1) inhibitors |
| FDA MoA | N0000000176 | Topoisomerase Inhibitors |
| MeSH PA | D000970 | Antineoplastic Agents |
| MeSH PA | D004791 | Enzyme Inhibitors |
| MeSH PA | D059004 | Topoisomerase I Inhibitors |
| MeSH PA | D059003 | Topoisomerase Inhibitors |
| CHEBI has role | CHEBI:35610 | antineoplastic agents |
| CHEBI has role | CHEBI:50266 | Prodrugs |
| CHEBI has role | CHEBI:50276 | topoisomerase I inhibitors |
| CHEBI has role | CHEBI:68495 | Type I cell-death inducers |
| FDA EPC | N0000175609 | Topoisomerase Inhibitor |
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| 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 level | Dissociation constant | Type (acidic/basic) |
|---|---|---|
| pKa1 | 10.46 | acidic |
| pKa2 | 9.25 | Basic |
| pKa3 | 2.69 | Basic |
Orange Book patent data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent use |
|---|---|---|---|---|---|---|---|---|---|---|
| EQ 43MG BASE/10ML (EQ 4.3MG BASE/ML) | ONIVYDE | IPSEN INC | N207793 | Oct. 22, 2015 | RX | INJECTABLE, LIPOSOMAL | INTRAVENOUS | 8703181 | May 2, 2025 | TREATMENT OF PANCREATIC CANCER |
| EQ 43MG BASE/10ML (EQ 4.3MG BASE/ML) | ONIVYDE | IPSEN INC | N207793 | Oct. 22, 2015 | RX | INJECTABLE, LIPOSOMAL | INTRAVENOUS | 9730891 | May 2, 2025 | TREATMENT OF METASTATIC ADENOCARCINOMA OF THE PANCREAS THAT HAS PROGRESSED ON GEMCITABINE-BASED THERAPY, IN COMBINATION WITH 5-FLUOROURACIL AND LEUCOVORIN |
| EQ 43MG BASE/10ML (EQ 4.3MG BASE/ML) | ONIVYDE | IPSEN INC | N207793 | Oct. 22, 2015 | RX | INJECTABLE, LIPOSOMAL | INTRAVENOUS | 10980795 | June 12, 2033 | TREATMENT OF METASTATIC ADENOCARCINOMA OF THE PANCREAS THAT HAS PROGRESSED ON GEMCITABINE-BASED THERAPY, IN COMBINATION WITH 5-FLUOROURACIL AND LEUCOVORIN |
| EQ 43MG BASE/10ML (EQ 4.3MG BASE/ML) | ONIVYDE | IPSEN INC | N207793 | Oct. 22, 2015 | RX | INJECTABLE, LIPOSOMAL | INTRAVENOUS | 11369597 | June 12, 2033 | TREATMENT OF METASTATIC ADENOCARCINOMA OF THE PANCREAS THAT HAS PROGRESSED ON GEMCITABINE-BASED THERAPY, IN COMBINATION WITH 5-FLUOROURACIL AND LEUCOVORIN |
| EQ 43MG BASE/10ML (EQ 4.3MG BASE/ML) | ONIVYDE | IPSEN INC | N207793 | Oct. 22, 2015 | RX | INJECTABLE, LIPOSOMAL | INTRAVENOUS | 9339497 | June 12, 2033 | TREATMENT OF METASTATIC ADENOCARCINOMA OF THE PANCREAS THAT HAS PROGRESSED ON GEMCITABINE-BASED THERAPY, IN COMBINATION WITH 5-FLUOROURACIL AND LEUCOVORIN |
| EQ 43MG BASE/10ML (EQ 4.3MG BASE/ML) | ONIVYDE | IPSEN INC | N207793 | Oct. 22, 2015 | RX | INJECTABLE, LIPOSOMAL | INTRAVENOUS | 9364473 | June 12, 2033 | TREATMENT OF METASTATIC ADENOCARCINOMA OF THE PANCREAS THAT HAS PROGRESSED ON GEMCITABINE-BASED THERAPY, IN COMBINATION WITH 5-FLUOROURACIL AND LEUCOVORIN, IN A PATIENT HOMOZYGOUS FOR THE UGT1A1*28 ALLELE |
| EQ 43MG BASE/10ML (EQ 4.3MG BASE/ML) | ONIVYDE | IPSEN INC | N207793 | Oct. 22, 2015 | RX | INJECTABLE, LIPOSOMAL | INTRAVENOUS | 9452162 | June 12, 2033 | TREATMENT OF PANCREATIC CANCER THAT HAS PROGRESSED ON GEMCITABINE-BASED THERAPY, IN COMBINATION WITH 5-FLUOROURACIL AND LEUCOVORIN |
| EQ 43MG BASE/10ML (EQ 4.3MG BASE/ML) | ONIVYDE | IPSEN INC | N207793 | Oct. 22, 2015 | RX | INJECTABLE, LIPOSOMAL | INTRAVENOUS | 9492442 | June 12, 2033 | TREATMENT OF EXOCRINE PANCREATIC CANCER THAT HAS PROGRESSED ON GEMCITABINE-BASED THERAPY, IN COMBINATION WITH 5-FLUOROURACIL AND LEUCOVORIN |
| EQ 43MG BASE/10ML (EQ 4.3MG BASE/ML) | ONIVYDE | IPSEN INC | N207793 | Oct. 22, 2015 | RX | INJECTABLE, LIPOSOMAL | INTRAVENOUS | 9492442 | June 12, 2033 | TREATMENT OF METASTATIC ADENOCARCINOMA OF THE PANCREAS THAT HAS PROGRESSED ON GEMCITABINE-BASED THERAPY, IN COMBINATION WITH 5-FLUOROURACIL AND LEUCOVORIN |
| EQ 43MG BASE/10ML (EQ 4.3MG BASE/ML) | ONIVYDE | IPSEN INC | N207793 | Oct. 22, 2015 | RX | INJECTABLE, LIPOSOMAL | INTRAVENOUS | 9492442 | June 12, 2033 | TREATMENT OF PANCREATIC CANCER THAT HAS PROGRESSED ON GEMCITABINE-BASED THERAPY, IN COMBINATION WITH 5-FLUOROURACIL AND LEUCOVORIN |
| EQ 43MG BASE/10ML (EQ 4.3MG BASE/ML) | ONIVYDE | IPSEN INC | N207793 | Oct. 22, 2015 | RX | INJECTABLE, LIPOSOMAL | INTRAVENOUS | 9717724 | June 12, 2033 | TREATMENT OF METASTATIC ADENOCARCINOMA OF THE PANCREAS THAT HAS PROGRESSED ON GEMCITABINE-BASED THERAPY, IN COMBINATION WITH 5-FLUOROURACIL AND LEUCOVORIN |
| EQ 43MG BASE/10ML (EQ 4.3MG BASE/ML) | ONIVYDE | IPSEN INC | N207793 | Oct. 22, 2015 | RX | INJECTABLE, LIPOSOMAL | INTRAVENOUS | 9717724 | June 12, 2033 | TREATMENT OF METASTATIC ADENOCARCINOMA OF THE PANCREAS THAT HAS PROGRESSED ON GEMCITABINE-BASED THERAPY, IN COMBINATION WITH 5-FLUOROURACIL AND LEUCOVORIN, IN A PATIENT NOT HOMOZYGOUS FOR THE UGT1A1*28 ALLELE |
Orange Book exclusivity data (new drug applications)
None
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA 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:
| ID | Source |
|---|---|
| 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:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| Camptosar | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0009-7529 | INJECTION, SOLUTION | 20 mg | INTRAVENOUS | NDA | 35 sections |
| Camptosar | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0009-7529 | INJECTION, SOLUTION | 20 mg | INTRAVENOUS | NDA | 35 sections |
| Camptosar | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0009-7529 | INJECTION, SOLUTION | 20 mg | INTRAVENOUS | NDA | 35 sections |
| Irinotecan Hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0143-9583 | INJECTION | 20 mg | INTRAVENOUS | ANDA | 28 sections |
| Irinotecan Hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0143-9583 | INJECTION | 20 mg | INTRAVENOUS | ANDA | 28 sections |
| Irinotecan Hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0143-9701 | INJECTION | 20 mg | INTRAVENOUS | ANDA | 28 sections |
| Irinotecan Hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0143-9701 | INJECTION | 20 mg | INTRAVENOUS | ANDA | 28 sections |
| Irinotecan Hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0143-9702 | INJECTION | 20 mg | INTRAVENOUS | ANDA | 28 sections |
| Irinotecan Hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0143-9702 | INJECTION | 20 mg | INTRAVENOUS | ANDA | 28 sections |
| Onivyde | HUMAN PRESCRIPTION DRUG LABEL | 1 | 15054-0043 | INJECTION, POWDER, FOR SOLUTION | 4.30 mg | INTRAVENOUS | NDA | 31 sections |
| Onivyde | HUMAN PRESCRIPTION DRUG LABEL | 1 | 15054-0043 | INJECTION, POWDER, FOR SOLUTION | 4.30 mg | INTRAVENOUS | NDA | 31 sections |
| Irinotecan hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 16714-027 | INJECTION | 20 mg | INTRAVENOUS | ANDA | 30 sections |
| Irinotecan hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 16714-027 | INJECTION | 20 mg | INTRAVENOUS | ANDA | 30 sections |
| Irinotecan hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 16714-131 | INJECTION | 20 mg | INTRAVENOUS | ANDA | 30 sections |
| Irinotecan hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 16714-131 | INJECTION | 20 mg | INTRAVENOUS | ANDA | 30 sections |
| Irinotecan Hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 25021-230 | INJECTION, SOLUTION | 20 mg | INTRAVENOUS | ANDA | 32 sections |
| Irinotecan Hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 25021-230 | INJECTION, SOLUTION | 20 mg | INTRAVENOUS | ANDA | 32 sections |
| Irinotecan hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 45963-614 | INJECTION, SOLUTION | 20 mg | INTRAVENOUS | ANDA | 20 sections |
| Irinotecan hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 45963-614 | INJECTION, SOLUTION | 20 mg | INTRAVENOUS | ANDA | 20 sections |
| Irinotecan hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 45963-614 | INJECTION, SOLUTION | 20 mg | INTRAVENOUS | ANDA | 20 sections |
| Irinotecan hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 45963-614 | INJECTION, SOLUTION | 20 mg | INTRAVENOUS | ANDA | 20 sections |
| Irinotecan hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 45963-614 | INJECTION, SOLUTION | 20 mg | INTRAVENOUS | ANDA | 20 sections |
| Irinotecan hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 45963-614 | INJECTION, SOLUTION | 20 mg | INTRAVENOUS | ANDA | 20 sections |
| Irinotecan Hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 50742-401 | INJECTION | 40 mg | INTRAVENOUS | ANDA | 27 sections |
| Irinotecan Hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 50742-401 | INJECTION | 40 mg | INTRAVENOUS | ANDA | 27 sections |
| Irinotecan Hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 50742-401 | INJECTION | 40 mg | INTRAVENOUS | ANDA | 27 sections |
| Irinotecan Hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 50742-402 | INJECTION | 100 mg | INTRAVENOUS | ANDA | 27 sections |
| Irinotecan Hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 50742-402 | INJECTION | 100 mg | INTRAVENOUS | ANDA | 27 sections |
| Irinotecan Hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 50742-402 | INJECTION | 100 mg | INTRAVENOUS | ANDA | 27 sections |
| IRINOTECAN HYDROCHLORIDE | Human Prescription Drug Label | 1 | 55150-352 | INJECTION, SOLUTION | 20 mg | INTRAVENOUS | ANDA | 30 sections |