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
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

Molecule

Description

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:

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	800.96	20.96	657	28375	157510	56105525
Diarrhoea	748.01	20.96	1240	27792	637267	55625768
Disease progression	646.00	20.96	490	28542	104683	56158352
Neuropathy peripheral	405.29	20.96	371	28661	102522	56160513
Myelosuppression	284.14	20.96	151	28881	17304	56245731
Mucosal inflammation	272.25	20.96	204	28828	42606	56220429
Malignant neoplasm progression	254.36	20.96	247	28785	73340	56189695
Febrile neutropenia	243.84	20.96	286	28746	105259	56157776
Vomiting	241.85	20.96	680	28352	497548	55765487
Thrombocytopenia	222.92	20.96	311	28721	135913	56127122
Dysarthria	221.95	20.96	175	28857	39375	56223660
Bone marrow failure	216.81	20.96	151	28881	28135	56234900
Palmar-plantar erythrodysaesthesia syndrome	216.31	20.96	135	28897	20930	56242105
Leukopenia	195.82	20.96	211	28821	70729	56192306
Dermatitis acneiform	190.65	20.96	75	28957	4269	56258766
Neurotoxicity	184.65	20.96	110	28922	15685	56247350
Metastases to liver	181.43	20.96	122	28910	21464	56241571
Nausea	180.33	20.96	823	28209	763355	55499680
Colorectal cancer metastatic	178.39	20.96	48	28984	793	56262242
Off label use	175.88	20.96	656	28376	555524	55707511
Abdominal pain	174.84	20.96	401	28631	258404	56004631
Neutrophil count decreased	164.16	20.96	163	28869	49659	56213376
Decreased appetite	152.75	20.96	344	28688	218887	56044148
Skin toxicity	152.24	20.96	63	28969	4090	56258945
Neoplasm progression	144.74	20.96	125	28907	31891	56231144
Proteinuria	137.42	20.96	95	28937	17475	56245560
Haematotoxicity	134.91	20.96	72	28960	8311	56254724
Arthralgia	128.96	20.96	49	28983	501620	55761415
Joint swelling	127.83	20.96	5	29027	289795	55973240
Polyneuropathy	124.85	20.96	80	28952	12970	56250065
Stomatitis	121.55	20.96	221	28811	120589	56142446
Death	113.56	20.96	410	28622	341016	55922019
Ascites	112.99	20.96	117	28915	37427	56225608
Paronychia	104.63	20.96	51	28981	4867	56258168
Peripheral sensory neuropathy	104.28	20.96	57	28975	6899	56256136
Metastases to lung	102.71	20.96	68	28964	11650	56251385
Anaemia	100.83	20.96	335	28697	267176	55995859
Colon cancer	99.95	20.96	62	28970	9499	56253536
Gastrointestinal toxicity	99.41	20.96	53	28979	6103	56256932
Asthenia	97.63	20.96	392	28640	342581	55920454
Metastases to peritoneum	94.88	20.96	41	28991	2963	56260072
Dehydration	93.94	20.96	234	28798	158591	56104444
Peripheral swelling	91.54	20.96	8	29024	234718	56028317
Cholinergic syndrome	89.33	20.96	24	29008	394	56262641
Product dose omission issue	82.56	20.96	6	29026	204747	56058288
Contraindicated product administered	79.51	20.96	4	29028	186282	56076753
Swelling	79.37	20.96	14	29018	239757	56023278
Maternal exposure during pregnancy	78.04	20.96	5	29027	189548	56073487
Sinusitis	76.31	20.96	7	29025	197574	56065461
Intestinal obstruction	75.00	20.96	82	28950	27889	56235146
Ileus	74.76	20.96	60	28972	13822	56249213
Mucosal toxicity	73.51	20.96	20	29012	345	56262690
Cholangitis	72.65	20.96	40	28992	4909	56258126
Weight increased	68.64	20.96	17	29015	229686	56033349
Therapeutic product effect decreased	68.21	20.96	5	29027	169447	56093588
Pain	68.20	20.96	151	28881	663033	55600002
Speech disorder	64.77	20.96	88	28944	37405	56225630
Drug ineffective	63.63	20.96	252	28780	918737	55344298
Pulmonary embolism	63.45	20.96	158	28874	106966	56156069
Enterocutaneous fistula	56.57	20.96	22	29010	1213	56261822
Musculoskeletal stiffness	56.46	20.96	7	29025	156000	56107035
Laryngospasm	55.69	20.96	28	29004	2856	56260179
Exposure during pregnancy	54.93	20.96	4	29028	136338	56126697
Pain in extremity	54.66	20.96	44	28988	297387	55965648
Desmoplastic small round cell tumour	54.65	20.96	14	29018	189	56262846
Protein urine	54.07	20.96	18	29014	631	56262404
Abdominal discomfort	53.52	20.96	39	28993	277235	55985800
Metastases to meninges	52.71	20.96	25	29007	2245	56260790
Nasopharyngitis	52.71	20.96	24	29008	220935	56042100
Hypertension	52.50	20.96	257	28775	244021	56019014
Therapy partial responder	51.44	20.96	38	28994	7747	56255288
Drug intolerance	51.43	20.96	37	28995	264781	55998254
Nephroblastoma	51.37	20.96	12	29020	107	56262928
Carcinoembryonic antigen increased	50.91	20.96	22	29010	1590	56261445
Steatohepatitis	50.66	20.96	16	29016	473	56262562
Adenocarcinoma of colon	50.51	20.96	25	29007	2465	56260570
Drug hypersensitivity	48.96	20.96	42	28990	275163	55987872
Epistaxis	48.56	20.96	107	28925	66916	56196119
Metastases to lymph nodes	48.53	20.96	36	28996	7387	56255648
Wound	48.38	20.96	7	29025	138797	56124238
Splenic artery thrombosis	48.33	20.96	10	29022	47	56262988
Gastrointestinal perforation	47.35	20.96	26	29006	3173	56259862
Lower respiratory tract infection	47.31	20.96	3	29029	114791	56148244
Neuromyotonia	47.17	20.96	10	29022	54	56262981
Colon cancer metastatic	46.98	20.96	19	29013	1162	56261873
Fall	46.81	20.96	70	28962	357440	55905595
Hypertensive crisis	46.33	20.96	46	28986	13990	56249045
Asthma	46.32	20.96	3	29029	112767	56150268
Cystitis radiation	46.00	20.96	10	29022	62	56262973
Posterior reversible encephalopathy syndrome	44.90	20.96	48	28984	15912	56247123
Venous pressure jugular decreased	44.87	20.96	9	29023	35	56263000
Bladder tamponade	44.82	20.96	10	29022	71	56262964
Headache	44.71	20.96	144	28888	558900	55704135
Tongue oedema	44.56	20.96	27	29005	3965	56259070
Large intestine perforation	44.56	20.96	35	28997	7816	56255219
Hypokalaemia	44.49	20.96	128	28904	94309	56168726
General physical health deterioration	44.02	20.96	189	28843	169821	56093214
Hypomagnesaemia	43.63	20.96	59	28973	24956	56238079
Hyperammonaemia	41.68	20.96	28	29004	4912	56258123
Pericarditis	41.65	20.96	4	29028	108919	56154116
Nasal septum perforation	40.98	20.96	15	29017	699	56262336
Cough	40.08	20.96	45	28987	259916	56003119
Arthritis	40.01	20.96	3	29029	99849	56163186
Ganglioneuroma	39.24	20.96	10	29022	132	56262903
White blood cell count decreased	38.93	20.96	148	28884	125842	56137193
Proctalgia	38.92	20.96	28	29004	5481	56257554
Hepatic enzyme increased	38.75	20.96	20	29012	171364	56091671
Trichomegaly	38.59	20.96	8	29024	38	56262997
Intestinal perforation	38.19	20.96	37	28995	10922	56252113
Enteritis	37.61	20.96	31	29001	7412	56255623
Neutropenic colitis	37.07	20.96	21	29011	2722	56260313
Product use in unapproved indication	35.25	20.96	155	28877	140667	56122368
Paraesthesia	35.24	20.96	147	28885	130367	56132668
Trismus	34.49	20.96	22	29010	3536	56259499
Sepsis	34.30	20.96	153	28879	139687	56123348
Device related infection	34.26	20.96	49	28983	21831	56241204
Tumour ulceration	33.89	20.96	9	29023	141	56262894
Hypertransaminasaemia	33.42	20.96	24	29008	4683	56258352
Insomnia	33.23	20.96	30	29002	191830	56071205
Discomfort	32.86	20.96	16	29016	141745	56121290
Ileal perforation	32.66	20.96	11	29021	400	56262635
Condition aggravated	32.54	20.96	82	28950	344816	55918219
Jaw operation	31.58	20.96	13	29019	832	56262203
Pyrexia	30.99	20.96	341	28691	418432	55844603
Blister	30.72	20.96	9	29023	108878	56154157
Myalgia	30.45	20.96	15	29017	132010	56131025
Aortic intramural haematoma	30.11	20.96	7	29025	61	56262974
Product use issue	30.00	20.96	31	29001	186010	56077025
Feeling abnormal	29.59	20.96	16	29016	133586	56129449
Colitis	29.43	20.96	66	28966	41745	56221290
Dysaesthesia pharynx	29.24	20.96	8	29024	141	56262894
Aortitis	29.15	20.96	13	29019	1013	56262022
Skin fissures	29.08	20.96	30	29002	9543	56253492
Depression	29.05	20.96	30	29002	180087	56082948
Stomatitis haemorrhagic	29.03	20.96	6	29026	28	56263007
Immune thrombocytopenia	28.94	20.96	30	29002	9595	56253440
Bronchitis	28.69	20.96	11	29021	112300	56150735
Osteonecrosis of jaw	28.51	20.96	57	28975	33301	56229734
Rectal cancer recurrent	28.37	20.96	6	29026	32	56263003
Catheter site bruise	26.78	20.96	9	29023	325	56262710
Tumour perforation	26.70	20.96	7	29025	104	56262931
Influenza	26.64	20.96	8	29024	95253	56167782
Rectal cancer	26.58	20.96	15	29017	1930	56261105
Mobility decreased	26.46	20.96	9	29023	98982	56164053
Depilation	26.46	20.96	5	29027	13	56263022
Metastasis	26.44	20.96	21	29011	4763	56258272
Skin disorder	26.23	20.96	48	28984	26261	56236774
Dyschezia	25.76	20.96	15	29017	2048	56260987
Vena cava thrombosis	25.72	20.96	15	29017	2054	56260981
Cutaneous tuberculosis	24.26	20.96	7	29025	151	56262884
Dizziness	24.06	20.96	106	28926	376034	55887001
Cardiac failure congestive	23.40	20.96	8	29024	87712	56175323
Oropharyngeal discomfort	23.39	20.96	19	29013	4449	56258586
Cardiotoxicity	23.28	20.96	24	29008	7626	56255409
Renal tubular disorder	23.07	20.96	15	29017	2491	56260544
Brachiocephalic vein thrombosis	22.59	20.96	6	29026	94	56262941
Loss of personal independence in daily activities	22.45	20.96	7	29025	81362	56181673
Drug resistance	22.44	20.96	39	28993	20503	56242532
Hypocapnia	22.21	20.96	8	29024	356	56262679
Liver abscess	21.92	20.96	15	29017	2711	56260324
Enteral nutrition	21.89	20.96	5	29027	40	56262995
Cardiac myxoma	21.88	20.96	7	29025	216	56262819
Metastases to ovary	21.65	20.96	8	29024	383	56262652
Adenocarcinoma	21.63	20.96	15	29017	2770	56260265
Diaphragmatic paralysis	21.53	20.96	9	29023	599	56262436
Oesophagitis	21.30	20.96	31	29001	14026	56249009
Female genital tract fistula	21.23	20.96	18	29014	4474	56258561
Hydronephrosis	21.21	20.96	25	29007	9217	56253818
Contusion	21.15	20.96	21	29011	128409	56134626
Gastrointestinal stoma complication	21.13	20.96	12	29020	1563	56261472
Anorectal disorder	21.13	20.96	12	29020	1563	56261472
Constipation	21.11	20.96	177	28855	201766	56061269

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	1135.55	18.55	1764	38178	350645	31306757
Neutropenia	765.92	18.55	911	39031	139453	31517949
Disease progression	759.34	18.55	738	39204	89726	31567676
Neuropathy peripheral	353.12	18.55	455	39487	75194	31582208
Stomatitis	351.14	18.55	333	39609	39105	31618297
Skin toxicity	335.29	18.55	143	39799	4016	31653386
Dermatitis acneiform	326.85	18.55	155	39787	5612	31651790
Palmar-plantar erythrodysaesthesia syndrome	320.93	18.55	215	39727	15268	31642134
Myelosuppression	316.03	18.55	210	39732	14710	31642692
Colorectal cancer metastatic	279.23	18.55	90	39852	1112	31656290
Metastases to liver	261.98	18.55	176	39766	12551	31644851
Alopecia	252.48	18.55	209	39733	20486	31636916
Decreased appetite	248.52	18.55	576	39366	152641	31504761
Nausea	222.59	18.55	869	39073	307078	31350324
Vomiting	221.21	18.55	701	39241	223272	31434130
Mucosal inflammation	212.70	18.55	239	39703	34188	31623214
Neoplasm progression	209.14	18.55	186	39756	20086	31637316
Gastrointestinal toxicity	202.71	18.55	84	39858	2190	31655212
Proteinuria	199.68	18.55	167	39775	16596	31640806
Bone marrow failure	163.74	18.55	189	39753	27819	31629583
Off label use	162.28	18.55	862	39080	346412	31310990
Neutrophil count decreased	162.09	18.55	243	39699	46151	31611251
Malignant neoplasm progression	155.00	18.55	321	39621	78677	31578725
Leukopenia	150.46	18.55	265	39677	57563	31599839
Cholinergic syndrome	147.74	18.55	45	39897	455	31656947
Metastases to lung	146.38	18.55	105	39837	8317	31649085
Paronychia	145.02	18.55	74	39868	3144	31654258
Haematotoxicity	126.38	18.55	90	39852	7047	31650355
Febrile neutropenia	124.99	18.55	387	39555	121462	31535940
Interstitial lung disease	124.50	18.55	253	39689	61150	31596252
Drug interaction	119.21	18.55	57	39885	208486	31448916
Neurotoxicity	116.49	18.55	122	39820	16104	31641298
Peripheral sensory neuropathy	112.66	18.55	80	39862	6235	31651167
Ileus	110.60	18.55	115	39827	15054	31642348
Intestinal obstruction	110.35	18.55	133	39809	20477	31636925
General physical health deterioration	106.01	18.55	349	39593	113086	31544316
Completed suicide	94.78	18.55	5	39937	91509	31565893
Skin reaction	93.87	18.55	64	39878	4670	31652732
Thrombocytopenia	93.03	18.55	391	39551	142356	31515046
Fall	86.46	18.55	65	39877	186024	31471378
Carcinoembryonic antigen increased	86.22	18.55	32	39910	616	31656786
Product dose omission issue	85.48	18.55	15	39927	105571	31551831
Abdominal pain	84.60	18.55	386	39556	145566	31511836
Necrotising fasciitis	83.41	18.55	53	39889	3433	31653969
Hiccups	79.82	18.55	77	39865	9210	31648192
Epistaxis	79.24	18.55	195	39747	53512	31603890
Metastases to peritoneum	71.41	18.55	37	39905	1623	31655779
Colon cancer	71.38	18.55	70	39872	8543	31648859
Arthralgia	70.16	18.55	53	39889	151371	31506031
Cholangitis	70.12	18.55	67	39875	7919	31649483
Pulmonary embolism	68.12	18.55	242	39700	81404	31575998
Therapy partial responder	65.24	18.55	59	39883	6503	31650899
Colon cancer metastatic	63.20	18.55	34	39908	1611	31655791
Polyneuropathy	63.20	18.55	80	39862	12942	31644460
Dehydration	62.37	18.55	306	39636	118805	31538597
Rectal cancer	61.65	18.55	37	39905	2164	31655238
Myocardial infarction	60.28	18.55	34	39908	113420	31543982
Plasma cell myeloma	58.79	18.55	3	39939	56528	31600874
Cardiac failure congestive	56.66	18.55	15	39927	79372	31578030
Rhabdomyolysis	56.12	18.55	7	39935	63574	31593828
Ileal perforation	55.72	18.55	24	39918	690	31656712
Gastrointestinal perforation	55.70	18.55	42	39900	3590	31653812
Drug ineffective	55.28	18.55	284	39658	395289	31262113
Myalgia	54.38	18.55	15	39927	77243	31580159
Colitis microscopic	54.26	18.55	33	39909	1977	31655425
Metastases to lymph nodes	53.88	18.55	44	39898	4224	31653178
Pneumonia	53.73	18.55	229	39713	335083	31322319
Colorectal cancer	53.15	18.55	46	39896	4783	31652619
Tumour necrosis	52.62	18.55	27	39915	1160	31656242
Bradycardia	51.61	18.55	12	39930	69315	31588087
Blood alkaline phosphatase abnormal	50.75	18.55	19	39923	375	31657027
Headache	50.30	18.55	97	39845	183555	31473847
Enteritis	50.26	18.55	53	39889	7046	31650356
Asthenia	50.20	18.55	467	39475	224288	31433114
Proteus infection	49.40	18.55	24	39918	916	31656486
Fatigue	48.51	18.55	639	39303	334567	31322835
Stoma site haemorrhage	47.59	18.55	22	39920	750	31656652
Nicotinic acid deficiency	46.53	18.55	13	39929	94	31657308
Small intestinal perforation	46.40	18.55	30	39912	2002	31655400
Hypomagnesaemia	45.24	18.55	84	39858	18974	31638428
Joint swelling	44.53	18.55	7	39935	53424	31603978
Hypertension	44.52	18.55	295	39647	127805	31529597
Anastomotic complication	44.38	18.55	17	39925	358	31657044
Agitation	43.15	18.55	8	39934	54161	31603241
Blood glucose increased	42.72	18.55	12	39930	61071	31596331
Weight increased	42.43	18.55	26	39916	82921	31574481
Carbohydrate antigen 19-9 increased	42.29	18.55	14	39928	189	31657213
Toxicity to various agents	42.15	18.55	105	39837	181382	31476020
Cardiac arrest	41.43	18.55	31	39911	89031	31568371
Coronary artery disease	40.85	18.55	5	39937	46082	31611320
Anxiety	40.68	18.55	33	39909	91000	31566402
Hospitalisation	40.45	18.55	7	39935	49800	31607602
Acral peeling skin syndrome	39.61	18.55	10	39932	46	31657356
Mouth ulceration	39.52	18.55	58	39884	10790	31646612
Dysphonia	39.50	18.55	83	39859	20508	31636894
Anal haemorrhage	39.40	18.55	29	39913	2389	31655013
Asthma	39.34	18.55	4	39938	42607	31614795
Dyspnoea	38.67	18.55	264	39678	343215	31314187
Confusional state	38.63	18.55	68	39874	133266	31524136
Rectal tenesmus	38.40	18.55	19	39923	755	31656647
Intestinal perforation	38.29	18.55	50	39892	8339	31649063
Induration	38.20	18.55	20	39922	896	31656506
Portal hypertension	38.03	18.55	34	39908	3691	31653711
Anaemia of malignant disease	37.97	18.55	16	39926	435	31656967
Pain in extremity	37.68	18.55	55	39887	116148	31541254
Adenocarcinoma of colon	37.64	18.55	32	39910	3248	31654154
Failure to anastomose	37.59	18.55	13	39929	202	31657200
Tumour marker increased	37.29	18.55	17	39925	561	31656841
Conjunctivitis	37.21	18.55	50	39892	8573	31648829
Peritonitis	36.94	18.55	68	39874	15259	31642143
Depression	36.88	18.55	36	39906	90779	31566623
Right ventricular ejection fraction decreased	36.66	18.55	9	39933	36	31657366
Subclavian vein thrombosis	36.36	18.55	19	39923	848	31656554
Transdifferentiation of neoplasm	36.32	18.55	10	39932	68	31657334
Pyrexia	36.20	18.55	560	39382	303280	31354122
Enterocolitis	35.78	18.55	45	39897	7229	31650173
Sciatic nerve palsy	35.72	18.55	9	39933	41	31657361
Somnolence	35.34	18.55	44	39898	99401	31558001
Prothrombin level decreased	35.07	18.55	20	39922	1063	31656339
Feeling abnormal	34.98	18.55	14	39928	56988	31600414
Acute abdomen	34.88	18.55	24	39918	1777	31655625
Perforation bile duct	34.88	18.55	8	39934	22	31657380
Suicidal ideation	34.72	18.55	3	39939	36403	31620999
Hypokalaemia	34.20	18.55	146	39796	53428	31603974
Hyperammonaemia	33.45	18.55	39	39903	5794	31651608
Portal vein thrombosis	31.89	18.55	30	39912	3477	31653925
Wheezing	31.66	18.55	4	39938	35982	31621420
Rash pustular	31.62	18.55	35	39907	4914	31652488
International normalised ratio increased	31.40	18.55	9	39933	45214	31612188
Stoma site pain	31.08	18.55	15	39927	564	31656838
Cellulitis	30.79	18.55	11	39931	48007	31609395
Pneumatosis intestinalis	30.45	18.55	30	39912	3681	31653721
COVID-19	29.71	18.55	16	39926	54805	31602597
Vascular pseudoaneurysm	29.65	18.55	23	39919	2050	31655352
Chills	29.60	18.55	177	39765	73973	31583429
Large intestine perforation	29.53	18.55	42	39900	7594	31649808
Paraesthesia	29.25	18.55	144	39798	55927	31601475
Pulmonary artery thrombosis	29.22	18.55	15	39927	645	31656757
Incorrect dose administered	29.08	18.55	5	39937	35747	31621655
Small intestinal obstruction	29.04	18.55	57	39885	13415	31643987
Venoocclusive liver disease	29.00	18.55	41	39901	7371	31650031
Catheter site thrombosis	28.98	18.55	8	39934	55	31657347
Influenza	28.68	18.55	10	39932	44315	31613087
Peripheral swelling	28.61	18.55	26	39916	67839	31589563
Oesophagobronchial fistula	28.53	18.55	10	39932	162	31657240
Anaemia	28.29	18.55	401	39541	213121	31444281
Unevaluable event	27.89	18.55	3	39939	30572	31626830
White blood cell count decreased	27.79	18.55	197	39745	87201	31570201
Perioral dermatitis	27.78	18.55	9	39933	113	31657289
Abdominal pain upper	27.64	18.55	156	39786	63846	31593556
Hallucination	27.50	18.55	12	39930	46398	31611004
Vena cava thrombosis	27.39	18.55	17	39925	1056	31656346
Leukoencephalopathy	27.39	18.55	29	39913	3873	31653529
Hyperbilirubinaemia	27.36	18.55	61	39881	15689	31641713
Pruritus	27.06	18.55	75	39867	125092	31532310
Tumour perforation	27.04	18.55	11	39931	273	31657129
Tremor	26.95	18.55	34	39908	76386	31581016
Metastases to pelvis	26.82	18.55	11	39931	279	31657123
Paraesthesia oral	26.81	18.55	28	39914	3680	31653722
Arteriospasm coronary	26.80	18.55	25	39917	2866	31654536
Nodular regenerative hyperplasia	26.65	18.55	16	39926	936	31656466
Dizziness	26.55	18.55	145	39797	199002	31458400
Fistula of small intestine	25.99	18.55	12	39930	408	31656994
Perihepatic abscess	25.82	18.55	8	39934	86	31657316
Atrial fibrillation	25.48	18.55	67	39875	113716	31543686
Toxic erythema of chemotherapy	25.41	18.55	8	39934	91	31657311
Skin disorder	25.31	18.55	51	39891	12230	31645172
Balance disorder	24.98	18.55	8	39934	37414	31619988
Deep vein thrombosis	24.89	18.55	146	39796	60590	31596812
Abdominal pain lower	24.71	18.55	43	39899	9233	31648169
Pancreatic carcinoma recurrent	24.44	18.55	7	39935	56	31657346
Wrong technique in product usage process	24.35	18.55	6	39936	33337	31624065
Peritoneal haematoma	24.11	18.55	7	39935	59	31657343
Ascites	24.07	18.55	109	39833	40904	31616498
Heart rate increased	23.78	18.55	11	39931	41099	31616303
Device related thrombosis	23.48	18.55	15	39927	980	31656422
Intestinal strangulation	23.36	18.55	6	39936	30	31657372
Clostridial infection	23.30	18.55	25	39917	3390	31654012
Epidermal naevus syndrome	23.25	18.55	5	39937	9	31657393
Protein urine	22.82	18.55	14	39928	852	31656550
Loss of consciousness	22.79	18.55	39	39903	77316	31580086
Large intestinal obstruction	22.68	18.55	17	39925	1440	31655962
Sinusitis	22.53	18.55	9	39933	36687	31620715
Therapeutic product effect decreased	22.50	18.55	6	39936	31616	31625786
Obstruction gastric	22.44	18.55	14	39928	878	31656524
Acute cutaneous lupus erythematosus	22.29	18.55	7	39935	79	31657323
Electrocardiogram QT prolonged	22.23	18.55	10	39932	37977	31619425
Chronic kidney disease	22.22	18.55	10	39932	37965	31619437
Acute myocardial infarction	21.98	18.55	19	39923	50804	31606598
Acne	21.91	18.55	43	39899	10117	31647285
Cachexia	21.90	18.55	34	39908	6645	31650757
Adverse drug reaction	21.69	18.55	3	39939	25198	31632204
Onychoclasis	21.60	18.55	18	39924	1777	31655625
Acute kidney injury	21.57	18.55	237	39705	279477	31377925
Gene mutation	21.18	18.55	15	39927	1163	31656239
Septic shock	20.95	18.55	149	39793	66009	31591393
Hypersensitivity	20.93	18.55	131	39811	55612	31601790
Change of bowel habit	20.83	18.55	14	39928	997	31656405
Nail disorder	20.75	18.55	18	39924	1877	31655525
Chronic obstructive pulmonary disease	20.63	18.55	16	39926	45150	31612252
Klebsiella infection	20.56	18.55	36	39906	7767	31649635
Colony stimulating factor therapy	20.56	18.55	8	39934	176	31657226
Therapeutic product effect incomplete	20.53	18.55	109	39833	43587	31613815
Haematoma	20.48	18.55	3	39939	24136	31633266
Oxygen saturation decreased	20.48	18.55	19	39923	49096	31608306
Chest pain	20.45	18.55	77	39865	116880	31540522
VIth nerve disorder	20.37	18.55	5	39937	20	31657382
Stomal varices	20.32	18.55	6	39936	54	31657348
White blood cell count increased	20.24	18.55	12	39930	38988	31618414
Unresponsive to stimuli	20.14	18.55	4	39938	25796	31631606
Abnormal behaviour	20.13	18.55	3	39939	23825	31633577
Superior vena cava syndrome	19.99	18.55	11	39931	545	31656857
Hypovolaemic shock	19.95	18.55	32	39910	6430	31650972
Seizure	19.94	18.55	62	39880	99706	31557696
Dysgeusia	19.91	18.55	70	39872	23396	31634006
Hypoglycaemia	19.76	18.55	21	39921	50925	31606477
Volvulus of small bowel	19.58	18.55	6	39936	62	31657340
Steatohepatitis	19.54	18.55	9	39933	304	31657098
Colon cancer recurrent	19.50	18.55	7	39935	122	31657280
Cough	19.16	18.55	96	39846	134718	31522684
Pancreatic carcinoma metastatic	19.12	18.55	21	39921	2923	31654479
Fluid retention	19.04	18.55	4	39938	24798	31632604
Subileus	18.85	18.55	21	39921	2969	31654433
Contusion	18.85	18.55	9	39933	33019	31624383
Medulloblastoma	18.85	18.55	6	39936	71	31657331
Overdose	18.83	18.55	50	39892	84614	31572788
Pelvic fluid collection	18.70	18.55	7	39935	138	31657264
Fistula	18.58	18.55	29	39913	5692	31651710

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	1694.06	16.98	2693	59871	780648	70085232
Neutropenia	1573.45	16.98	1500	61064	255656	70610224
Disease progression	1209.88	16.98	1043	61521	155629	70710251
Neuropathy peripheral	803.34	16.98	756	61808	126140	70739740
Myelosuppression	518.38	16.98	326	62238	29819	70836061
Palmar-plantar erythrodysaesthesia syndrome	494.93	16.98	317	62247	29930	70835950
Dermatitis acneiform	474.23	16.98	206	62358	8739	70857141
Mucosal inflammation	449.49	16.98	415	62149	67435	70798445
Neoplasm progression	420.57	16.98	336	62228	44892	70820988
Colorectal cancer metastatic	404.46	16.98	121	62443	1688	70864192
Malignant neoplasm progression	396.40	16.98	512	62052	121227	70744653
Skin toxicity	395.43	16.98	170	62394	7028	70858852
Metastases to liver	386.08	16.98	256	62308	25622	70840258
Proteinuria	370.55	16.98	262	62302	29112	70836768
Stomatitis	364.07	16.98	505	62059	128006	70737874
Decreased appetite	362.38	16.98	817	61747	303963	70561917
Febrile neutropenia	361.94	16.98	647	61917	203671	70662209
Bone marrow failure	356.41	16.98	316	62248	48694	70817186
Vomiting	351.30	16.98	1233	61331	591878	70274002
Leukopenia	329.48	16.98	437	62127	106123	70759757
Neutrophil count decreased	325.96	16.98	385	62179	83171	70782709
Thrombocytopenia	314.69	16.98	668	61896	238442	70627438
Gastrointestinal toxicity	286.59	16.98	131	62433	6274	70859606
Nausea	286.37	16.98	1491	61073	850597	70015283
Neurotoxicity	271.71	16.98	219	62345	29607	70836273
Metastases to lung	248.08	16.98	164	62400	16320	70849560
Arthralgia	224.57	16.98	82	62482	503308	70362572
Cholinergic syndrome	223.17	16.98	65	62499	821	70865059
Paronychia	220.63	16.98	113	62451	6961	70858919
Peripheral sensory neuropathy	218.26	16.98	135	62429	11975	70853905
Off label use	208.79	16.98	1240	61324	741820	70124060
Haematotoxicity	208.09	16.98	137	62427	13537	70852343
Intestinal obstruction	198.11	16.98	206	62358	38619	70827261
Abdominal pain	184.45	16.98	691	61873	341436	70524444
Joint swelling	179.59	16.98	11	62553	253200	70612680
Completed suicide	177.20	16.98	5	62559	227130	70638750
Ileus	161.80	16.98	149	62415	24088	70841792
Dysarthria	157.31	16.98	232	62332	62081	70803799
Dehydration	152.34	16.98	492	62072	225650	70640230
Interstitial lung disease	152.13	16.98	305	62259	104380	70761500
Metastases to peritoneum	151.88	16.98	72	62492	3747	70862133
General physical health deterioration	148.71	16.98	502	62062	235529	70630351
Polyneuropathy	145.58	16.98	133	62431	21282	70844598
Epistaxis	142.00	16.98	293	62271	102334	70763546
Product dose omission issue	138.85	16.98	15	62549	217453	70648427
Fall	137.63	16.98	114	62450	443982	70421898
Asthenia	134.61	16.98	774	61790	456892	70408988
Colon cancer	134.42	16.98	107	62457	14199	70851681
Cholangitis	134.11	16.98	98	62466	11451	70854429
Pulmonary embolism	127.32	16.98	363	62201	155504	70710376
Peripheral swelling	126.72	16.98	27	62537	236536	70629344
Weight increased	123.17	16.98	31	62533	242300	70623580
Headache	122.88	16.98	202	62362	580203	70285677
Drug interaction	109.61	16.98	105	62459	381336	70484544
Anaemia	109.33	16.98	668	61896	402755	70463125
Swelling	108.46	16.98	18	62546	188521	70677359
Sinusitis	107.15	16.98	12	62552	169183	70696697
Pain in extremity	104.33	16.98	82	62482	328000	70537880
Therapy partial responder	103.94	16.98	87	62477	12387	70853493
Pain	102.23	16.98	255	62309	628561	70237319
Carcinoembryonic antigen increased	101.89	16.98	45	62519	1985	70863895
Ascites	97.12	16.98	196	62368	67351	70798529
Hypertension	97.10	16.98	516	62048	295517	70570363
Arthropathy	94.12	16.98	11	62553	150046	70715834
Therapeutic product effect decreased	93.50	16.98	9	62555	143009	70722871
Hypomagnesaemia	91.85	16.98	144	62420	40620	70825260
Metastases to lymph nodes	88.73	16.98	70	62494	9168	70856712
Hiccups	87.82	16.98	69	62495	8983	70856897
Enteritis	87.81	16.98	80	62484	12751	70853129
Contraindicated product administered	86.62	16.98	9	62555	134603	70731277
Maternal exposure during pregnancy	84.87	16.98	4	62560	115341	70750539
Asthma	83.37	16.98	6	62558	120787	70745093
Gastrointestinal perforation	81.79	16.98	55	62509	5626	70860254
Colon cancer metastatic	80.86	16.98	39	62525	2109	70863771
White blood cell count decreased	79.57	16.98	329	62235	169812	70696068
Ileal perforation	78.93	16.98	30	62534	896	70864984
Rectal cancer	78.74	16.98	44	62520	3230	70862650
Myalgia	76.98	16.98	26	62538	167866	70698014
Drug ineffective	75.52	16.98	503	62061	939249	69926631
Cough	73.71	16.98	108	62456	325269	70540611
Abdominal discomfort	72.92	16.98	50	62514	214608	70651272
Adenocarcinoma of colon	72.40	16.98	50	62514	5342	70860538
Intestinal perforation	71.03	16.98	79	62485	15965	70849915
Arthritis	70.19	16.98	4	62560	97976	70767904
Hyperammonaemia	70.09	16.98	64	62500	10229	70855651
Nasopharyngitis	70.00	16.98	56	62508	222150	70643730
Drug hypersensitivity	69.94	16.98	77	62487	262382	70603498
Necrotising fasciitis	66.68	16.98	48	62516	5478	70860402
Pyrexia	66.06	16.98	821	61743	606131	70259749
Musculoskeletal stiffness	65.82	16.98	24	62540	147736	70718144
Large intestine perforation	65.47	16.98	69	62495	13126	70852754
Steatohepatitis	64.33	16.98	25	62539	794	70865086
Glossodynia	63.62	16.98	3	62561	86484	70779396
Tumour necrosis	63.26	16.98	31	62533	1736	70864144
Hypokalaemia	63.15	16.98	256	62308	130932	70734948
Anastomotic complication	62.69	16.98	21	62543	430	70865450
Cardiac failure congestive	62.05	16.98	21	62543	135436	70730444
Exposure during pregnancy	61.57	16.98	4	62560	87713	70778167
Drug intolerance	61.46	16.98	65	62499	225622	70640258
Enterocutaneous fistula	58.44	16.98	29	62535	1669	70864211
Desmoplastic small round cell tumour	58.06	16.98	17	62547	219	70865661
Rhabdomyolysis	57.66	16.98	8	62556	95752	70770128
Depression	56.81	16.98	55	62509	198919	70666961
Pericarditis	56.23	16.98	5	62559	84700	70781180
Skin reaction	55.14	16.98	65	62499	13984	70851896
Contusion	55.02	16.98	22	62542	128014	70737866
Influenza	54.98	16.98	16	62548	113684	70752196
Intentional product misuse	54.78	16.98	4	62560	79591	70786289
Mobility decreased	54.61	16.98	12	62552	102987	70762893
Colorectal cancer	54.45	16.98	51	62513	8419	70857461
Paraesthesia	54.14	16.98	263	62301	145274	70720606
Feeling abnormal	54.12	16.98	29	62535	142290	70723590
Pruritus	53.79	16.98	143	62421	345417	70520463
Dizziness	53.68	16.98	219	62345	463922	70401958
Lower respiratory tract infection	53.66	16.98	16	62548	111897	70753983
Hepatic enzyme increased	52.73	16.98	37	62527	156953	70708927
Bradycardia	52.59	16.98	22	62542	124593	70741287
Plasma cell myeloma	52.39	16.98	3	62561	73198	70792682
Anxiety	51.97	16.98	71	62493	220259	70645621
Vena cava thrombosis	51.91	16.98	31	62533	2579	70863301
Myocardial infarction	51.90	16.98	45	62519	171600	70694280
Deep vein thrombosis	51.31	16.98	214	62350	110828	70755052
COVID-19	50.92	16.98	15	62549	105742	70760138
Small intestinal perforation	50.33	16.98	32	62532	2977	70862903
Product use issue	49.91	16.98	51	62513	179886	70685994
Stoma site haemorrhage	49.55	16.98	26	62538	1683	70864197
Suicidal ideation	49.36	16.98	3	62561	69593	70796287
Subclavian vein thrombosis	49.32	16.98	29	62535	2345	70863535
Dysphonia	49.22	16.98	125	62439	49975	70815905
Dyspnoea	48.66	16.98	440	62124	769620	70096260
Protein urine	48.51	16.98	24	62540	1372	70864508
Speech disorder	48.45	16.98	125	62439	50455	70815425
Hypertransaminasaemia	48.40	16.98	49	62515	8894	70856986
Device related infection	48.17	16.98	95	62469	32090	70833790
Portal vein thrombosis	48.02	16.98	39	62525	5323	70860557
Nephroblastoma	47.94	16.98	13	62551	124	70865756
Peritonitis	47.64	16.98	84	62480	26075	70839805
Proctalgia	47.33	16.98	47	62517	8336	70857544
Hospitalisation	47.20	16.98	8	62556	82560	70783320
Blister	47.06	16.98	15	62549	100511	70765369
Metastases to meninges	46.69	16.98	31	62533	3105	70862775
Somnolence	46.44	16.98	74	62490	215532	70650348
Mucosal toxicity	46.13	16.98	18	62546	578	70865302
Confusional state	45.53	16.98	116	62448	284282	70581598
Pneumatosis intestinalis	44.84	16.98	39	62525	5848	70860032
Venoocclusive liver disease	44.58	16.98	51	62513	10627	70855253
Nicotinic acid deficiency	44.57	16.98	13	62551	165	70865715
Heart rate increased	44.37	16.98	19	62545	106129	70759751
Wheezing	44.18	16.98	14	62550	94156	70771724
Posterior reversible encephalopathy syndrome	43.98	16.98	78	62486	24324	70841556
Insomnia	43.92	16.98	78	62486	217728	70648152
Skin disorder	43.51	16.98	88	62476	30269	70835611
Anal haemorrhage	43.29	16.98	32	62532	3804	70862076
Acral peeling skin syndrome	43.16	16.98	10	62554	46	70865834
Rectal tenesmus	43.11	16.98	22	62542	1344	70864536
Hyperbilirubinaemia	43.09	16.98	74	62490	22494	70843386
Chills	43.09	16.98	246	62318	144540	70721340
Bronchitis	42.97	16.98	25	62539	117218	70748662
Osteoarthritis	42.79	16.98	7	62557	74140	70791740
Condition aggravated	42.69	16.98	213	62351	427422	70438458
Laryngospasm	42.49	16.98	31	62533	3612	70862268
Blood glucose increased	42.15	16.98	19	62545	102963	70762917
Arteriospasm coronary	42.08	16.98	38	62526	5986	70859894
Splenic artery thrombosis	41.98	16.98	10	62554	53	70865827
Pneumonia	41.96	16.98	331	62233	595901	70269979
Incorrect dose administered	41.55	16.98	5	62559	66714	70799166
Proteus infection	41.49	16.98	23	62541	1662	70864218
Cardiotoxicity	41.44	16.98	50	62514	11020	70854860
Nodular regenerative hyperplasia	41.32	16.98	21	62543	1272	70864608
Blood alkaline phosphatase abnormal	41.01	16.98	18	62546	782	70865098
Rash pustular	40.97	16.98	48	62516	10260	70855620
Superior vena cava syndrome	40.68	16.98	20	62544	1128	70864752
Blood pressure fluctuation	40.51	16.98	3	62561	59009	70806871
Colitis	40.31	16.98	136	62428	63678	70802202
Portal hypertension	39.65	16.98	38	62526	6454	70859426
Alopecia	39.51	16.98	305	62259	198185	70667695
Colitis microscopic	39.28	16.98	44	62520	8961	70856919
Acute abdomen	39.24	16.98	27	62537	2867	70863013
Wound	39.20	16.98	19	62545	98713	70767167
Pancreatic carcinoma metastatic	38.83	16.98	30	62534	3810	70862070
Rectal haemorrhage	38.71	16.98	137	62427	65694	70800186
Right ventricular ejection fraction decreased	38.39	16.98	9	62555	44	70865836
Coronary artery disease	38.34	16.98	5	62559	62731	70803149
Paraesthesia oral	38.30	16.98	57	62507	15360	70850520
Metastasis	37.74	16.98	36	62528	6078	70859802
Septic shock	37.61	16.98	197	62367	112061	70753819
Transdifferentiation of neoplasm	37.01	16.98	10	62554	94	70865786
Failure to anastomose	36.86	16.98	12	62552	224	70865656
Wrong technique in product usage process	36.42	16.98	8	62556	68690	70797190
Neuromyotonia	36.36	16.98	10	62554	101	70865779
Cardiac arrest	36.19	16.98	53	62511	159781	70706099
International normalised ratio increased	36.13	16.98	13	62551	80713	70785167
Pulmonary artery thrombosis	36.01	16.98	19	62545	1244	70864636
Pelvic fluid collection	35.93	16.98	16	62548	720	70865160
Nasal septum perforation	35.66	16.98	16	62548	733	70865147
Tumour perforation	35.37	16.98	13	62551	353	70865527
Gene mutation	34.96	16.98	23	62541	2268	70863612
Cystitis radiation	34.50	16.98	10	62554	124	70865756
Intestinal metastasis	34.32	16.98	12	62552	281	70865599
Leukoencephalopathy	34.17	16.98	37	62527	7257	70858623
Sciatic nerve palsy	34.06	16.98	9	62555	77	70865803
Hypertensive crisis	33.98	16.98	61	62503	19201	70846679
Duodenal ulcer perforation	33.97	16.98	3	62561	51109	70814771
Therapeutic product effect incomplete	33.92	16.98	201	62363	119681	70746199
Influenza like illness	33.85	16.98	8	62556	65323	70800557
Venous pressure jugular decreased	33.56	16.98	9	62555	82	70865798
Migraine	33.42	16.98	11	62553	72227	70793653
Electrocardiogram QT prolonged	33.26	16.98	16	62548	83501	70782379
Fistula of small intestine	33.21	16.98	15	62549	698	70865182
Liver abscess	32.74	16.98	32	62532	5567	70860313
Discomfort	32.64	16.98	27	62537	105409	70760471
Induration	32.51	16.98	20	62544	1756	70864124
Prothrombin level decreased	32.50	16.98	19	62545	1520	70864360
Large intestinal obstruction	31.96	16.98	24	62540	2922	70862958
Balance disorder	31.93	16.98	20	62544	90108	70775772
Aggression	31.78	16.98	3	62561	48443	70817437
Aortitis	31.34	16.98	18	62546	1393	70864487
Tremor	31.11	16.98	56	62508	155568	70710312
Venous thrombosis limb	31.04	16.98	27	62537	4048	70861832
Fatigue	30.99	16.98	948	61616	823371	70042509
Tumour ulceration	30.80	16.98	10	62554	185	70865695
Enterocolitis	30.60	16.98	47	62517	13019	70852861
Conjunctivitis	30.53	16.98	64	62500	22572	70843308
Hepatic lesion	30.37	16.98	32	62532	6085	70859795
Dysaesthesia pharynx	30.21	16.98	10	62554	197	70865683
Carbohydrate antigen 19-9 increased	30.19	16.98	12	62552	405	70865475
Small intestinal obstruction	30.15	16.98	67	62497	24588	70841292
Agitation	30.05	16.98	23	62541	93352	70772528
Loss of personal independence in daily activities	29.86	16.98	19	62545	84891	70780989
Perforation bile duct	29.73	16.98	7	62557	35	70865845
Vascular pseudoaneurysm	29.54	16.98	24	62540	3277	70862603
Anaemia of malignant disease	29.52	16.98	14	62550	729	70865151
Heart rate decreased	29.48	16.98	9	62555	62006	70803874
Haematoma	29.25	16.98	4	62560	48414	70817466
Chronic obstructive pulmonary disease	29.24	16.98	16	62548	77625	70788255
Disseminated intravascular coagulation	29.10	16.98	80	62484	33518	70832362
Ganglioneuroma	29.05	16.98	9	62555	142	70865738
Oxygen saturation decreased	29.00	16.98	36	62528	116393	70749487
Trichomegaly	28.98	16.98	8	62556	82	70865798
Subileus	28.95	16.98	29	62535	5198	70860682
Oesophagobronchial fistula	28.93	16.98	10	62554	226	70865654
Constipation	28.85	16.98	345	62219	252093	70613787
Klebsiella infection	28.79	16.98	48	62516	14244	70851636
Limbic encephalitis	28.77	16.98	14	62550	772	70865108
Cataract	28.46	16.98	7	62557	55638	70810242
Gait disturbance	28.46	16.98	77	62487	185029	70680851
K-ras gene mutation	28.38	16.98	7	62557	44	70865836
Metastases to central nervous system	28.31	16.98	49	62515	14985	70850895
Pancreatic carcinoma recurrent	28.27	16.98	9	62555	156	70865724
Gait inability	28.26	16.98	4	62560	47171	70818709
Dysgeusia	28.23	16.98	102	62462	49400	70816480
Hepatic failure	28.14	16.98	113	62451	57512	70808368
Death	28.00	16.98	617	61947	509444	70356436
Blood pressure systolic increased	27.78	16.98	8	62556	57251	70808629
Treatment noncompliance	27.78	16.98	4	62560	46570	70819310
Trismus	27.74	16.98	28	62536	5063	70860817
Gastrointestinal stoma complication	27.64	16.98	20	62544	2300	70863580
Diaphragmatic paralysis	27.34	16.98	15	62549	1062	70864818
Disease recurrence	27.24	16.98	84	62480	37519	70828361
Anorectal disorder	27.00	16.98	19	62545	2092	70863788
Productive cough	26.91	16.98	18	62546	78319	70787561
Hypovolaemic shock	26.82	16.98	40	62524	10797	70855083
Memory impairment	25.97	16.98	26	62538	92615	70773265
Performance status decreased	25.52	16.98	28	62536	5573	70860307
Adenocarcinoma	25.43	16.98	23	62541	3630	70862250
Biliary tract infection	25.43	16.98	15	62549	1220	70864660
Perihepatic abscess	25.38	16.98	8	62556	134	70865746
Jaw operation	25.30	16.98	13	62551	806	70865074
Epidermal naevus syndrome	25.03	16.98	5	62559	9	70865871
Venous thrombosis	24.84	16.98	30	62534	6619	70859261
Tongue oedema	24.63	16.98	29	62535	6230	70859650
Toxic erythema of chemotherapy	24.53	16.98	9	62555	243	70865637
Rectal cancer recurrent	24.42	16.98	6	62558	37	70865843
Malignant ascites	24.33	16.98	14	62550	1087	70864793
Metastatic neoplasm	24.30	16.98	25	62539	4623	70861257
Optic glioma	24.28	16.98	7	62557	85	70865795
Pancreatic carcinoma	24.23	16.98	42	62522	12862	70853018
Neutropenic colitis	24.06	16.98	26	62538	5088	70860792
Depilation	23.78	16.98	5	62559	13	70865867
Dry skin	23.67	16.98	105	62459	55826	70810054
Type 2 diabetes mellitus	23.64	16.98	5	62559	44075	70821805
Lactic acidosis	23.63	16.98	14	62550	65010	70800870
Cellulitis	23.18	16.98	32	62532	98896	70766984
Adverse drug reaction	23.18	16.98	9	62555	53335	70812545
Skin fissures	22.90	16.98	38	62526	11232	70854648
Toxicity to various agents	22.90	16.98	221	62343	381951	70483929
Perioral dermatitis	22.75	16.98	9	62555	300	70865580
Enteral nutrition	22.74	16.98	6	62558	51	70865829
Obstruction gastric	22.71	16.98	15	62549	1489	70864391
Gastrointestinal disorder	22.65	16.98	165	62399	105262	70760618
Febrile infection	22.48	16.98	20	62544	3089	70862791
Hypervolaemia	22.35	16.98	4	62560	39702	70826178
Intestinal strangulation	22.34	16.98	6	62558	55	70865825
Stomal varices	22.34	16.98	6	62558	55	70865825
Acute myeloid leukaemia	22.31	16.98	69	62495	30871	70835009
Rectal perforation	22.28	16.98	12	62552	819	70865061
Toxic epidermal necrolysis	22.24	16.98	4	62560	39553	70826327
Aortic intramural haematoma	22.17	16.98	7	62557	118	70865762
Anal fistula	22.11	16.98	27	62537	6023	70859857
Gastrooesophageal reflux disease	21.67	16.98	29	62535	90810	70775070
Osteoporosis	21.67	16.98	8	62556	48899	70816981
Hydronephrosis	21.62	16.98	44	62520	15198	70850682
Overdose	21.56	16.98	77	62487	169668	70696212
Prostatic calcification	21.52	16.98	6	62558	64	70865816
Gastrointestinal inflammation	21.39	16.98	28	62536	6695	70859185
Neutrophilia	21.33	16.98	29	62535	7192	70858688
Viral infection	21.33	16.98	4	62560	38387	70827493
Chest pain	21.29	16.98	132	62432	251128	70614752
Palpitations	21.12	16.98	41	62523	110712	70755168
Renal hydrocele	21.07	16.98	5	62559	26	70865854
Rectal adenocarcinoma	21.05	16.98	14	62550	1406	70864474
Chronic kidney disease	21.01	16.98	14	62550	61043	70804837
Granulocyte count decreased	20.90	16.98	14	62550	1423	70864457
Tumour embolism	20.87	16.98	7	62557	144	70865736
Bladder tamponade	20.80	16.98	10	62554	537	70865343
Psychotic disorder	20.79	16.98	4	62560	37697	70828183
Colony stimulating factor therapy	20.76	16.98	10	62554	539	70865341
VIth nerve disorder	20.76	16.98	5	62559	28	70865852
Hypoglycaemia	20.67	16.98	32	62532	94332	70771548
Abnormal behaviour	20.65	16.98	3	62561	34706	70831174
Unresponsive to stimuli	20.60	16.98	10	62554	51921	70813959
Device related thrombosis	20.60	16.98	17	62547	2373	70863507
Nephrotic syndrome	20.46	16.98	35	62529	10605	70855275
Emotional distress	20.39	16.98	4	62560	37184	70828696
Necrotising colitis	20.26	16.98	12	62552	983	70864897
Loss of consciousness	20.21	16.98	70	62494	155646	70710234
Colonic fistula	20.16	16.98	10	62554	575	70865305
Hypoalbuminaemia	20.13	16.98	49	62515	19073	70846807
Nasal congestion	20.10	16.98	17	62547	65655	70800225
Platelet count decreased	20.09	16.98	243	62321	177979	70687901
Jugular vein thrombosis	19.95	16.98	21	62543	3989	70861891
Clostridial infection	19.83	16.98	24	62540	5305	70860575
Pancreatic fistula	19.71	16.98	6	62558	89	70865791
Jaundice	19.66	16.98	92	62472	50016	70815864
Cachexia	19.61	16.98	33	62531	9867	70856013
Peritoneal haematoma	19.59	16.98	7	62557	175	70865705
Food protein-induced enterocolitis syndrome	19.56	16.98	5	62559	37	70865843
Immune thrombocytopenia	19.56	16.98	44	62520	16280	70849600
Multiple-drug resistance	19.44	16.98	28	62536	7327	70858553
Stevens-Johnson syndrome	19.40	16.98	4	62560	35903	70829977
Product use in unapproved indication	19.26	16.98	273	62291	207205	70658675
Stomatitis haemorrhagic	19.23	16.98	6	62558	97	70865783
Pulmonary arterial hypertension	19.18	16.98	3	62561	32852	70833028
Hepatotoxicity	18.93	16.98	83	62481	43903	70821977
Rhabdomyosarcoma recurrent	18.74	16.98	6	62558	106	70865774
Cell-mediated cytotoxicity	18.70	16.98	5	62559	45	70865835
Administration site extravasation	18.62	16.98	12	62552	1143	70864737
Swelling face	18.55	16.98	17	62547	63147	70802733
Neuroblastoma recurrent	18.43	16.98	6	62558	112	70865768
Cutaneous tuberculosis	18.36	16.98	7	62557	211	70865669
Medication error	18.33	16.98	14	62550	56898	70808982
Osteonecrosis of jaw	18.13	16.98	78	62486	40924	70824956
Administration site recall reaction	18.10	16.98	3	62561	0	70865880
Rectal cancer metastatic	18.07	16.98	9	62555	522	70865358
Lymphadenopathy mediastinal	18.05	16.98	20	62544	4025	70861855
Anastomotic fistula	18.00	16.98	6	62558	121	70865759
Lip swelling	17.98	16.98	4	62560	34050	70831830
Colitis ulcerative	17.88	16.98	4	62560	33919	70831961
Catheter site thrombosis	17.87	16.98	7	62557	227	70865653
Hypothyroidism	17.86	16.98	9	62555	45746	70820134
Unevaluable event	17.83	16.98	12	62552	52051	70813829
Colon cancer recurrent	17.77	16.98	6	62558	126	70865754
Duodenal varices	17.71	16.98	4	62560	16	70865864
Tumour lysis syndrome	17.65	16.98	50	62514	21310	70844570
Portal vein embolisation	17.52	16.98	4	62560	17	70865863
Pelvic abscess	17.51	16.98	14	62550	1869	70864011
Cardiac disorder	17.44	16.98	16	62548	59399	70806481
Product quality issue	17.38	16.98	3	62561	30558	70835322
Tumour marker increased	17.34	16.98	19	62545	3775	70862105
Abdominal abscess	17.32	16.98	25	62539	6553	70859327
Fingerprint loss	17.25	16.98	5	62559	62	70865818
Neck pain	17.24	16.98	20	62544	66637	70799243
Dyschezia	17.23	16.98	16	62548	2611	70863269
Ileus paralytic	17.08	16.98	29	62535	8732	70857148
Diabetes mellitus	17.06	16.98	23	62541	71801	70794079
Recall phenomenon	17.06	16.98	11	62553	1048	70864832
Burning sensation	17.04	16.98	13	62551	52857	70813023

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
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)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Exclusivity date	Description
EQ 43MG BASE/10ML (EQ 4.3MG BASE/ML)	ONIVYDE	IPSEN INC	N207793	Oct. 22, 2015	RX	INJECTABLE, LIPOSOMAL	INTRAVENOUS	Oct. 22, 2022	FOR USE IN COMBINATION WITH 5-FLUOROURACIL AND LEUCOVORIN, FOR THE TREATMENT OF PATIENTS WITH METASTATIC ADENOCARCINOMA OF THE PANCREAS THAT HAS PROGRESSED FOLLOWING GEMCITABINE-BASED THERAPY

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
DNA topoisomerase 1	Enzyme	P11387	TOP1_HUMAN	INHIBITOR			DRUGBANK	CHEMBL
Muscarinic acetylcholine receptor M4	GPCR	P08173	ACM4_HUMAN		Ki	6.66	DRUG MATRIX
Canalicular multispecific organic anion transporter 1	Transporter	Q92887	MRP2_HUMAN				WOMBAT-PK
Alpha-2C adrenergic receptor	GPCR	P18825	ADA2C_HUMAN		Ki	6.34	DRUG MATRIX
Multidrug resistance-associated protein 1	Transporter	P33527	MRP1_HUMAN				WOMBAT-PK
ATP-binding cassette sub-family G member 2	Transporter	Q9UNQ0	ABCG2_HUMAN				WOMBAT-PK
Multidrug resistance-associated protein 4	Transporter	O15439	MRP4_HUMAN				WOMBAT-PK
Acetylcholinesterase	Enzyme	P22303	ACES_HUMAN		Ki	7.30	CHEMBL
Interstitial collagenase	Enzyme	P03956	MMP1_HUMAN		IC50	5.22	DRUG MATRIX
Solute carrier family 22 member 1	Transporter	O15245	S22A1_HUMAN		IC50	4.68	CHEMBL
Solute carrier family 22 member 2	Transporter	O15244	S22A2_HUMAN		IC50	5.57	CHEMBL
Multidrug and toxin extrusion protein 1	Transporter	Q96FL8	S47A1_HUMAN		IC50	5.68	CHEMBL
Multidrug and toxin extrusion protein 2	Transporter	Q86VL8	S47A2_HUMAN		IC50	5.10	CHEMBL
Multidrug resistance protein 1	Transporter	P08183	MDR1_HUMAN				WOMBAT-PK
Solute carrier family 22 member 3	Transporter	O75751	S22A3_HUMAN		IC50	4.13	CHEMBL
Acetylcholinesterase	Enzyme		ACES_TORCA		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
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	29 sections
Irinotecan hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	16714-027	INJECTION	20 mg	INTRAVENOUS	ANDA	30 sections
Irinotecan hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	16714-027	INJECTION	20 mg	INTRAVENOUS	ANDA	30 sections
Irinotecan hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	16714-131	INJECTION	20 mg	INTRAVENOUS	ANDA	30 sections
Irinotecan hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	16714-131	INJECTION	20 mg	INTRAVENOUS	ANDA	30 sections
Irinotecan Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	25021-230	INJECTION, SOLUTION	20 mg	INTRAVENOUS	ANDA	32 sections
Irinotecan Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	25021-230	INJECTION, SOLUTION	20 mg	INTRAVENOUS	ANDA	32 sections
Irinotecan hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	45963-614	INJECTION, SOLUTION	20 mg	INTRAVENOUS	ANDA	20 sections
Irinotecan hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	45963-614	INJECTION, SOLUTION	20 mg	INTRAVENOUS	ANDA	20 sections
Irinotecan hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	45963-614	INJECTION, SOLUTION	20 mg	INTRAVENOUS	ANDA	20 sections
Irinotecan hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	45963-614	INJECTION, SOLUTION	20 mg	INTRAVENOUS	ANDA	20 sections
Irinotecan hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	45963-614	INJECTION, SOLUTION	20 mg	INTRAVENOUS	ANDA	20 sections
Irinotecan Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	50742-401	INJECTION	40 mg	INTRAVENOUS	ANDA	27 sections
Irinotecan Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	50742-401	INJECTION	40 mg	INTRAVENOUS	ANDA	27 sections
Irinotecan Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	50742-402	INJECTION	100 mg	INTRAVENOUS	ANDA	27 sections
Irinotecan Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	50742-402	INJECTION	100 mg	INTRAVENOUS	ANDA	27 sections
IRINOTECAN HYDROCHLORIDE	Human Prescription Drug Label	1	55150-352	INJECTION, SOLUTION	20 mg	INTRAVENOUS	ANDA	30 sections
IRINOTECAN HYDROCHLORIDE	Human Prescription Drug Label	1	55150-352	INJECTION, SOLUTION	20 mg	INTRAVENOUS	ANDA	30 sections
IRINOTECAN HYDROCHLORIDE	Human Prescription Drug Label	1	55150-353	INJECTION, SOLUTION	20 mg	INTRAVENOUS	ANDA	30 sections
IRINOTECAN HYDROCHLORIDE	Human Prescription Drug Label	1	55150-353	INJECTION, SOLUTION	20 mg	INTRAVENOUS	ANDA	30 sections
IRINOTECAN HYDROCHLORIDE	Human Prescription Drug Label	1	55150-354	INJECTION, SOLUTION	20 mg	INTRAVENOUS	ANDA	30 sections
IRINOTECAN HYDROCHLORIDE	Human Prescription Drug Label	1	55150-354	INJECTION, SOLUTION	20 mg	INTRAVENOUS	ANDA	30 sections