All FDA-approved EMA-approved PMDA-approved
Target Card Uniprot Example: P23975

oxaliplatin 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
antineoplastic agents, platinum derivatives	4210	61825-94-3

Description:

Molecule

Description

Synonyms: oxaliplatin oxalatoplatin oxalatoplatinum

An organoplatinum complex in which the platinum atom is complexed with 1,2-diaminocyclohexane, and with an oxalate ligand which is displaced to yield active oxaliplatin derivatives. These derivatives form inter- and intra-strand DNA crosslinks that inhibit DNA replication and transcription. Oxaliplatin is an antineoplastic agent that is often administered with FLUOROURACIL and FOLINIC ACID in the treatment of metastatic COLORECTAL NEOPLASMS. Molecular weight: 397.29 Formula: C8H14N2O4Pt CLOGP: LIPINSKI: None HAC: None HDO: None TPSA: ALOGS: ROTB: None

Drug dosage:

None

ADMET properties:

Property	Value	Reference
BDDCS (Biopharmaceutical Drug Disposition Classification System)	1	Benet LZ, Broccatelli F, Oprea TI
S (Water solubility)	6 mg/mL	Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose)	8.13 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
Vd (Volume of distribution)	0.50 L/kg	Lombardo F, Berellini G, Obach RS
CL (Clearance)	0.10 mL/min/kg	Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma)	0.13 %	Lombardo F, Berellini G, Obach RS
t_half (Half-life)	58.92 hours	Lombardo F, Berellini G, Obach RS

Approvals:

Date	Agency	Company	Orphan
Aug. 9, 2002	FDA
March 18, 2005	PMDA	Yakult Honsha

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
Neuropathy peripheral	1132.01	17.02	909	58826	101984	56130348
Neutropenia	985.52	17.02	1015	58720	157152	56075180
Laryngospasm	983.73	17.02	279	59456	2605	56229727
Thrombocytopenia	734.21	17.02	810	58925	135414	56096918
Disease progression	718.33	17.02	710	59025	104463	56127869
Neurotoxicity	697.99	17.02	339	59396	15456	56216876
Diarrhoea	586.32	17.02	1738	57997	636769	55595563
Mucosal inflammation	499.25	17.02	392	59343	42418	56189914
Palmar-plantar erythrodysaesthesia syndrome	440.60	17.02	276	59459	20789	56211543
Paraesthesia	434.76	17.02	610	59125	129904	56102428
Vomiting	406.10	17.02	1303	58432	496925	55735407
Myelosuppression	330.95	17.02	215	59520	17240	56215092
Bone marrow failure	329.63	17.02	259	59476	28027	56204305
Dysarthria	322.77	17.02	295	59440	39255	56193077
Stridor	322.11	17.02	124	59611	3171	56229161
Peripheral sensory neuropathy	315.34	17.02	152	59583	6804	56225528
Dermatitis acneiform	308.86	17.02	130	59605	4214	56228118
Polyneuropathy	293.18	17.02	179	59556	12871	56219461
Drug ineffective	286.80	17.02	334	59401	918655	55313677
Throat tightness	284.70	17.02	216	59519	22191	56210141
Arthralgia	284.03	17.02	90	59645	501579	55730753
Bronchospasm	282.42	17.02	187	59548	15482	56216850
Arteriospasm coronary	265.51	17.02	111	59624	3536	56228796
Skin toxicity	264.61	17.02	115	59620	4038	56228294
Dysaesthesia pharynx	249.56	17.02	52	59683	97	56232235
Colorectal cancer metastatic	249.45	17.02	73	59662	768	56231564
Metastases to liver	243.62	17.02	194	59541	21392	56210940
Joint swelling	242.01	17.02	17	59718	289783	55942549
Nausea	241.95	17.02	1507	58228	762671	55469661
Febrile neutropenia	210.49	17.02	391	59344	105154	56127178
Haematotoxicity	206.45	17.02	122	59613	8261	56224071
Gastrointestinal toxicity	204.41	17.02	109	59626	6047	56226285
Pain	197.79	17.02	249	59486	662935	55569397
Arthropathy	193.00	17.02	4	59731	200271	56032061
Leukopenia	190.48	17.02	300	59435	70640	56161692
Gastrointestinal perforation	185.77	17.02	83	59652	3116	56229216
Malignant neoplasm progression	184.99	17.02	302	59433	73285	56159047
Headache	180.39	17.02	197	59538	558847	55673485
Swelling	179.03	17.02	22	59713	239749	55992583
Enteritis	177.24	17.02	106	59629	7337	56224995
Product dose omission issue	176.85	17.02	10	59725	204743	56027589
Sinusitis	175.88	17.02	8	59727	197573	56034759
Neutrophil count decreased	174.73	17.02	239	59496	49583	56182749
Posterior reversible encephalopathy syndrome	172.77	17.02	140	59595	15820	56216512
Systemic lupus erythematosus	168.17	17.02	5	59730	180073	56052259
Contraindicated product administered	167.60	17.02	7	59728	186279	56046053
Non-cirrhotic portal hypertension	163.34	17.02	38	59697	142	56232190
Portal hypertension	162.37	17.02	78	59657	3463	56228869
Erythema	156.41	17.02	440	59295	155499	56076833
Dyspnoea	156.21	17.02	1118	58617	591459	55640873
Nasopharyngitis	156.14	17.02	24	59711	220935	56011397
Weight increased	153.40	17.02	29	59706	229674	56002658
Pemphigus	152.00	17.02	3	59732	157209	56075123
Dehydration	146.59	17.02	435	59300	158390	56073942
Maternal exposure during pregnancy	142.43	17.02	17	59718	189536	56042796
Glossodynia	139.61	17.02	5	59730	152453	56079879
Anaphylactic shock	139.25	17.02	142	59593	21598	56210734
Abdominal discomfort	134.58	17.02	63	59672	277211	55955121
Therapeutic product effect decreased	132.90	17.02	13	59722	169439	56062893
Chills	132.08	17.02	318	59417	102286	56130046
Abdominal pain	129.02	17.02	580	59155	258225	55974107
Peripheral swelling	125.73	17.02	46	59689	234680	55997652
Wound	125.55	17.02	5	59730	138799	56093533
Venoocclusive liver disease	123.92	17.02	70	59665	4351	56227981
Ascites	122.50	17.02	174	59561	37370	56194962
Fall	120.67	17.02	121	59614	357389	55874943
Paronychia	119.59	17.02	71	59664	4847	56227485
Laryngeal oedema	117.11	17.02	72	59663	5238	56227094
Product use issue	116.95	17.02	27	59708	186014	56046318
Hyperammonaemia	114.12	17.02	69	59666	4871	56227461
Depression	111.52	17.02	27	59708	180090	56052242
Anaemia	109.82	17.02	567	59168	266944	55965388
Dysphonia	109.23	17.02	175	59560	41772	56190560
Splenomegaly	107.53	17.02	88	59647	10080	56222252
Insomnia	107.21	17.02	35	59700	191825	56040507
Immune thrombocytopenia	105.37	17.02	85	59650	9540	56222792
Dysaesthesia	104.23	17.02	61	59674	4055	56228277
Hypomagnesaemia	103.17	17.02	130	59605	24885	56207447
Asthma	102.19	17.02	4	59731	112766	56119566
Paraesthesia oral	101.04	17.02	99	59636	14350	56217982
Lower respiratory tract infection	100.96	17.02	5	59730	114789	56117543
Cardiotoxicity	99.91	17.02	75	59660	7575	56224757
Intestinal perforation	99.75	17.02	87	59648	10872	56221460
Drug intolerance	99.59	17.02	81	59654	264737	55967595
Asthenia	96.94	17.02	659	59076	342314	55890018
Speech disorder	95.68	17.02	155	59580	37338	56194994
Focal nodular hyperplasia	94.39	17.02	31	59704	490	56231842
Tongue oedema	92.83	17.02	56	59679	3936	56228396
Metastases to lung	92.79	17.02	86	59649	11632	56220700
Bronchitis	92.44	17.02	7	59728	112304	56120028
Therapy partial responder	92.18	17.02	72	59663	7713	56224619
Intestinal obstruction	90.30	17.02	129	59606	27842	56204490
Hypokalaemia	90.23	17.02	262	59473	94175	56138157
Pericarditis	89.06	17.02	7	59728	108916	56123416
Decreased appetite	87.36	17.02	461	59274	218770	56013562
Large intestine perforation	87.36	17.02	70	59665	7781	56224551
Anastomotic leak	86.30	17.02	28	59707	425	56231907
Dysphagia	84.77	17.02	234	59501	81713	56150619
Enterocolitis	84.76	17.02	66	59669	7038	56225294
Hepatic enzyme increased	82.99	17.02	39	59696	171345	56060987
Musculoskeletal stiffness	82.77	17.02	31	59704	155976	56076356
Neuromyotonia	82.51	17.02	18	59717	46	56232286
Stress cardiomyopathy	81.61	17.02	69	59666	8267	56224065
Flushing	80.41	17.02	208	59527	69892	56162440
Metastases to peritoneum	79.99	17.02	46	59689	2958	56229374
Influenza	78.22	17.02	6	59729	95255	56137077
Pain in extremity	77.97	17.02	122	59613	297309	55935023
Exposure during pregnancy	77.69	17.02	24	59711	136318	56096014
Hyperthermia	75.87	17.02	66	59669	8219	56224113
Stomatitis	75.15	17.02	290	59445	120520	56111812
Hyperhidrosis	74.95	17.02	245	59490	93843	56138489
Alopecia	74.45	17.02	123	59612	293335	55938997
Nodular regenerative hyperplasia	73.79	17.02	25	59710	437	56231895
Treatment failure	73.38	17.02	45	59690	170347	56061985
Contusion	72.47	17.02	23	59712	128407	56103925
Arthritis	72.43	17.02	10	59725	99842	56132490
Ileus	71.83	17.02	81	59654	13801	56218531
Injection site pain	71.60	17.02	18	59717	117100	56115232
Colon cancer	71.54	17.02	68	59667	9493	56222839
Condition aggravated	71.50	17.02	163	59572	344735	55887597
Laryngeal discomfort	71.29	17.02	22	59713	281	56232051
General physical health deterioration	70.09	17.02	361	59374	169649	56062683
Platelet count decreased	69.98	17.02	260	59475	106123	56126209
Oxygen saturation decreased	69.48	17.02	213	59522	78854	56153478
Neoplasm progression	69.29	17.02	123	59612	31893	56200439
Hyperammonaemic encephalopathy	67.82	17.02	37	59698	2148	56230184
Pyrexia	67.67	17.02	710	59025	418063	55814269
Hospitalisation	66.80	17.02	3	59732	74997	56157335
Haemolytic anaemia	65.19	17.02	65	59670	9620	56222712
Helicobacter infection	65.03	17.02	3	59732	73265	56159067
Drug hypersensitivity	62.92	17.02	123	59612	275082	55957250
Injection site erythema	60.53	17.02	6	59729	77442	56154890
Colon cancer metastatic	60.24	17.02	28	59707	1153	56231179
Interstitial lung disease	60.04	17.02	164	59571	56899	56175433
Duodenal ulcer perforation	60.01	17.02	3	59732	68339	56163993
Peritonitis	58.70	17.02	79	59656	16123	56216209
Adenocarcinoma of colon	58.08	17.02	35	59700	2455	56229877
Hypertensive crisis	57.95	17.02	73	59662	13963	56218369
Tumour perforation	57.82	17.02	15	59720	96	56232236
Anaphylactic reaction	57.60	17.02	165	59570	58830	56173502
Discomfort	57.55	17.02	40	59695	141721	56090611
Acute coronary syndrome	57.50	17.02	61	59674	9707	56222625
Feeling hot	57.50	17.02	133	59602	41654	56190678
Cardiac failure congestive	56.56	17.02	12	59723	87708	56144624
Drug abuse	56.24	17.02	4	59731	67606	56164726
Hypertension	56.08	17.02	447	59288	243831	55988501
Enterocutaneous fistula	56.00	17.02	27	59708	1208	56231124
Metastases to meninges	55.79	17.02	33	59702	2237	56230095
Chemical peritonitis	53.78	17.02	14	59721	91	56232241
Neutropenic colitis	52.49	17.02	34	59701	2709	56229623
Extravasation	52.21	17.02	31	59704	2116	56230216
Hydronephrosis	51.39	17.02	56	59679	9186	56223146
Injury	51.38	17.02	3	59732	59848	56172484
Tachycardia	50.90	17.02	235	59500	105641	56126691
Colitis	49.94	17.02	126	59609	41685	56190647
Disseminated intravascular coagulation	49.84	17.02	77	59658	17808	56214524
Suicide attempt	49.35	17.02	3	59732	57833	56174499
Suicidal ideation	49.25	17.02	3	59732	57739	56174593
Cholinergic syndrome	49.11	17.02	18	59717	400	56231932
Somnolence	48.78	17.02	61	59674	163352	56068980
Varices oesophageal	48.21	17.02	33	59702	2883	56229449
Blister	47.92	17.02	28	59707	108859	56123473
Upper respiratory tract infection	47.53	17.02	9	59726	71279	56161053
Diffuse large B-cell lymphoma recurrent	47.04	17.02	27	59708	1730	56230602
Dihydropyrimidine dehydrogenase deficiency	46.92	17.02	12	59723	72	56232260
Gastric varices haemorrhage	46.84	17.02	13	59722	111	56232221
Choking sensation	46.69	17.02	34	59701	3277	56229055
Proteinuria	46.68	17.02	74	59661	17496	56214836
Metastases to ovary	46.54	17.02	17	59718	374	56231958
Rectal perforation	46.45	17.02	17	59718	376	56231956
Diffuse large B-cell lymphoma refractory	46.11	17.02	23	59712	1109	56231223
Blood lactate dehydrogenase abnormal	45.97	17.02	15	59720	232	56232100
Mobility decreased	45.67	17.02	24	59711	98967	56133365
Cough	45.27	17.02	134	59601	259827	55972505
Stress	44.91	17.02	5	59730	58905	56173427
Evans syndrome	44.86	17.02	14	59721	186	56232146
Band sensation	44.85	17.02	20	59715	747	56231585
Sensation of foreign body	44.26	17.02	36	59699	4086	56228246
Mucosal toxicity	43.93	17.02	16	59719	349	56231983
Pneumonia	43.90	17.02	253	59482	406845	55825487
Laryngeal dyspnoea	43.89	17.02	13	59722	143	56232189
Suffocation feeling	43.67	17.02	23	59712	1243	56231089
Off label use	43.00	17.02	828	58907	555352	55676980
Intentional product misuse	42.97	17.02	3	59732	51501	56180831
Steatohepatitis	42.84	17.02	17	59718	472	56231860
Overdose	42.76	17.02	30	59705	105800	56126532
Cataract	42.71	17.02	3	59732	51244	56181088
Leukoencephalopathy	42.47	17.02	35	59700	4047	56228285
Hepatic failure	42.19	17.02	103	59632	33383	56198949
Pancytopenia	41.96	17.02	196	59539	88519	56143813
Injection site reaction	41.94	17.02	4	59731	53243	56179089
Drug interaction	41.90	17.02	101	59634	209654	56022678
Anxiety	41.85	17.02	89	59646	193083	56039249
Gait disturbance	41.78	17.02	68	59667	163253	56069079
Neutrophil count abnormal	41.29	17.02	29	59706	2641	56229691
Cold dysaesthesia	41.26	17.02	8	59727	8	56232324
Splenic artery thrombosis	41.14	17.02	10	59725	47	56232285
Carcinoembryonic antigen increased	41.10	17.02	24	59711	1588	56230744
White blood cell count decreased	40.91	17.02	251	59484	125739	56106593
Cytokine release syndrome	40.89	17.02	54	59681	10821	56221511
Osteoporosis	40.76	17.02	4	59731	52048	56180284
Factor VII deficiency	40.71	17.02	9	59726	25	56232307
Breast cancer	40.29	17.02	3	59732	48830	56183502
Migraine	40.10	17.02	21	59714	86776	56145556
Metastases to spleen	39.88	17.02	12	59723	140	56232192
Tremor	39.80	17.02	242	59493	120847	56111485
Acute polyneuropathy	39.15	17.02	13	59722	213	56232119
Infusion related hypersensitivity reaction	38.83	17.02	12	59723	154	56232178
Cystitis radiation	38.82	17.02	10	59725	62	56232270
Large intestinal obstruction	38.75	17.02	25	59710	1978	56230354
Type 2 diabetes mellitus	38.32	17.02	3	59732	46859	56185473
Pharyngeal dyskinesia	38.20	17.02	9	59726	36	56232296
Hypertrichosis	38.20	17.02	20	59715	1068	56231264
Multiple organ dysfunction syndrome	38.10	17.02	133	59602	52637	56179695
Oropharyngeal discomfort	37.73	17.02	34	59701	4434	56227898
Fatigue	37.68	17.02	600	59135	787952	55444380
Bladder tamponade	37.65	17.02	10	59725	71	56232261
Pharyngeal paraesthesia	37.52	17.02	23	59712	1664	56230668
Thrombocytopenic purpura	37.17	17.02	21	59714	1305	56231027
Cardiac ventricular thrombosis	37.12	17.02	16	59719	550	56231782
Short-bowel syndrome	36.96	17.02	15	59720	442	56231890
Chronic obstructive pulmonary disease	36.71	17.02	8	59727	57407	56174925
Folliculitis	36.52	17.02	7	59728	54972	56177360
Infection	36.45	17.02	101	59634	200105	56032227
Hypertransaminasaemia	36.21	17.02	34	59701	4673	56227659
Paralysis	35.75	17.02	46	59689	8986	56223346
Memory impairment	35.68	17.02	24	59711	86533	56145799
Muscle rigidity	35.59	17.02	50	59685	10621	56221711
Atypical haemolytic uraemic syndrome	35.38	17.02	16	59719	618	56231714
Formication	35.09	17.02	31	59704	3939	56228393
Ileal perforation	35.00	17.02	14	59721	397	56231935
COVID-19	34.91	17.02	18	59717	75040	56157292
Incorrect dose administered	34.26	17.02	7	59728	52540	56179792
Metastasis	33.86	17.02	33	59702	4751	56227581
ECG signs of myocardial ischaemia	33.75	17.02	9	59726	65	56232267
Injection site pruritus	33.42	17.02	3	59732	41928	56190404
Sleep disorder	33.34	17.02	15	59720	67648	56164684
Inappropriate schedule of product administration	33.21	17.02	24	59711	83363	56148969
Hypoalbuminaemia	32.91	17.02	48	59687	10551	56221781
Myalgia	32.81	17.02	56	59679	131969	56100363
Abortion spontaneous	32.64	17.02	4	59731	43749	56188583
Muscle spasms	32.36	17.02	253	59482	137118	56095214
Anastomotic fistula	32.34	17.02	7	59728	17	56232315
Respiratory distress	32.30	17.02	90	59645	31577	56200755
Female genital tract fistula	31.82	17.02	31	59704	4461	56227871
Type I hypersensitivity	31.70	17.02	24	59711	2454	56229878
Peripheral motor neuropathy	31.63	17.02	20	59715	1528	56230804
Tumour ulceration	31.56	17.02	10	59725	140	56232192
Ocular toxicity	31.47	17.02	15	59720	654	56231678
Gastric perforation	31.28	17.02	20	59715	1558	56230774
Haemolysis	31.17	17.02	36	59699	6292	56226040
Motion sickness	31.11	17.02	16	59719	823	56231509
Catheter site bruise	30.62	17.02	12	59723	322	56232010
Vascular pain	30.58	17.02	15	59720	697	56231635
Perforation	30.50	17.02	17	59718	1029	56231303
Nicotinic acid deficiency	30.35	17.02	8	59727	55	56232277
Tumour necrosis	29.98	17.02	15	59720	728	56231604
Hyperpyrexia	29.85	17.02	26	59709	3242	56229090
Rectal cancer	29.79	17.02	21	59714	1924	56230408
Metastases to lymph nodes	29.68	17.02	38	59697	7385	56224947
Dysgeusia	29.43	17.02	103	59632	40812	56191520
Blood pressure fluctuation	29.36	17.02	4	59731	40356	56191976
Paraphilia	29.25	17.02	5	59730	0	56232332
Rectal cancer recurrent	29.14	17.02	7	59728	31	56232301
Hemiparesis	29.12	17.02	68	59667	21422	56210910
Pulmonary embolism	29.04	17.02	204	59531	106920	56125412
Hemiparaesthesia	28.75	17.02	8	59727	69	56232263
Inflammation	28.67	17.02	19	59716	69052	56163280
Wrong technique in product usage process	28.50	17.02	13	59722	58155	56174177
Congestive cardiomyopathy	28.49	17.02	33	59702	5786	56226546
Hypophagia	28.40	17.02	81	59654	28795	56203537
Cyanosis	28.29	17.02	56	59679	15754	56216578
Anaphylactoid reaction	28.28	17.02	26	59709	3480	56228852
Subileus	28.06	17.02	24	59711	2920	56229412
Mucosal necrosis	27.96	17.02	7	59728	38	56232294
Trismus	27.95	17.02	26	59709	3532	56228800
Haemolytic uraemic syndrome	27.92	17.02	22	59713	2386	56229946
Tonic clonic movements	27.44	17.02	17	59718	1253	56231079
K-ras gene mutation	27.32	17.02	6	59729	16	56232316
Left ventricular failure	27.30	17.02	30	59705	4966	56227366
Inferior vena cava stenosis	27.05	17.02	6	59729	17	56232315
Feeling abnormal	26.92	17.02	64	59671	133538	56098794
Medical device site extravasation	26.90	17.02	5	59730	3	56232329
Administration site extravasation	26.77	17.02	14	59721	746	56231586
White blood cell count abnormal	26.62	17.02	32	59703	5835	56226497
Hepatic function abnormal	26.61	17.02	89	59646	34469	56197863
Cardiospasm	26.55	17.02	6	59729	19	56232313
Lip oedema	26.52	17.02	25	59710	3453	56228879
Skin fissures	26.37	17.02	41	59694	9532	56222800
Impaired healing	26.34	17.02	32	59703	86809	56145523
Herpes zoster	26.31	17.02	25	59710	75864	56156468
Palmar erythema	25.93	17.02	18	59717	1609	56230723
Cholangitis	25.81	17.02	29	59706	4920	56227412
Schistosomiasis	25.79	17.02	5	59730	5	56232327
Haematemesis	25.73	17.02	78	59657	28680	56203652
Autoimmune haemolytic anaemia	25.70	17.02	27	59708	4249	56228083
Catabolic state	25.52	17.02	7	59728	57	56232275
Thrombotic microangiopathy	25.50	17.02	40	59695	9371	56222961
Hypotension	25.44	17.02	390	59345	250118	55982214
Confusional state	25.37	17.02	124	59611	208031	56024301
Rhabdomyolysis	25.32	17.02	6	59729	40652	56191680
Aortic intramural haematoma	25.10	17.02	7	59728	61	56232271
Influenza like illness	25.01	17.02	17	59718	60971	56171361
Hepatocellular injury	24.75	17.02	73	59662	26441	56205891
Small intestinal obstruction	24.75	17.02	55	59680	16770	56215562
Adverse event	24.70	17.02	14	59721	55362	56176970
Loss of personal independence in daily activities	24.66	17.02	30	59705	81339	56150993
Gastrointestinal anastomotic leak	24.64	17.02	9	59726	198	56232134
Urinary tract infection	24.54	17.02	152	59583	240361	55991971
Chest discomfort	24.35	17.02	184	59551	98673	56133659
Ileus paralytic	24.34	17.02	26	59709	4169	56228163
Monoparesis	24.29	17.02	17	59718	1539	56230793
Treatment noncompliance	24.29	17.02	3	59732	32620	56199712
Metastases to diaphragm	24.22	17.02	6	59729	31	56232301
Gastrointestinal stoma complication	24.11	17.02	17	59718	1558	56230774
Sedation	24.10	17.02	4	59731	34850	56197482
Biliary tract infection	24.09	17.02	12	59723	577	56231755
Metastases to bone marrow	24.08	17.02	10	59725	313	56232019
Soft tissue necrosis	23.99	17.02	11	59724	439	56231893
Productive cough	23.98	17.02	15	59720	56217	56176115
Type II hypersensitivity	23.77	17.02	5	59730	10	56232322
Granulocyte count decreased	23.75	17.02	14	59721	943	56231389
Tachypnoea	23.33	17.02	51	59684	15379	56216953
Myopathy toxic	23.26	17.02	11	59724	471	56231861
Adverse drug reaction	23.12	17.02	21	59714	65111	56167221
Renal tubular disorder	23.02	17.02	20	59715	2486	56229846
Hypocapnia	22.93	17.02	10	59725	354	56231978
Nasal congestion	22.73	17.02	16	59719	56354	56175978
Portal shunt	22.59	17.02	5	59730	14	56232318
Implant site dehiscence	22.59	17.02	5	59730	14	56232318
Disease recurrence	22.57	17.02	66	59669	23794	56208538
Cardiogenic shock	22.49	17.02	52	59683	16273	56216059
Oesophageal varices haemorrhage	22.41	17.02	14	59721	1047	56231285
Balance disorder	22.36	17.02	29	59706	76491	56155841
Colitis ischaemic	22.33	17.02	39	59696	9981	56222351
Septic shock	22.18	17.02	125	59610	60710	56171622
Subacute cutaneous lupus erythematosus	22.09	17.02	19	59716	2330	56230002
Rhinorrhoea	21.95	17.02	17	59718	57020	56175312
Retching	21.93	17.02	46	59689	13484	56218848
Skin reaction	21.86	17.02	45	59690	13018	56219314
Blood phosphorus decreased	21.84	17.02	24	59711	3973	56228359
Emotional distress	21.53	17.02	3	59732	29760	56202572
Heart rate decreased	21.47	17.02	8	59727	40419	56191913
Dizziness	21.45	17.02	276	59459	375864	55856468
Blood glucose increased	21.43	17.02	29	59706	75122	56157210
Diabetes mellitus	21.23	17.02	15	59720	52720	56179612
Lacrimation disorder	21.16	17.02	4	59731	3	56232329
Hyperventilation	21.16	17.02	28	59707	5620	56226712
Hypoaesthesia oral	21.07	17.02	41	59694	11390	56220942
Gastrooesophageal reflux disease	20.97	17.02	35	59700	83222	56149110
Eyelid ptosis	20.94	17.02	30	59705	6489	56225843
Dry eye	20.85	17.02	6	59729	35710	56196622
Hepatic encephalopathy	20.79	17.02	38	59697	10072	56222260
Respiratory failure	20.70	17.02	172	59563	94890	56137442
Respiratory fatigue	20.68	17.02	7	59728	122	56232210
Post embolisation syndrome	20.63	17.02	4	59731	4	56232328
Dyslalia	20.58	17.02	10	59725	455	56231877
Coronary artery disease	20.29	17.02	4	59731	30792	56201540
Encapsulating peritoneal sclerosis	20.21	17.02	9	59726	335	56231997
Portal vein dilatation	20.15	17.02	5	59730	26	56232306
Pelvic fluid collection	20.08	17.02	12	59723	829	56231503
Toxic encephalopathy	20.07	17.02	28	59707	5910	56226422
Jaw operation	20.03	17.02	12	59723	833	56231499
Reticulocytosis	19.93	17.02	7	59728	137	56232195
Xerosis	19.86	17.02	11	59724	658	56231674
Drug reaction with eosinophilia and systemic symptoms	19.83	17.02	4	59731	30300	56202032
Road traffic accident	19.77	17.02	3	59732	27924	56204408
Encephalopathy	19.69	17.02	82	59653	35243	56197089
Subclavian vein thrombosis	19.67	17.02	16	59719	1816	56230516
Colorectal cancer	19.45	17.02	21	59714	3408	56228924
Bursitis	19.44	17.02	3	59732	27579	56204753
Oral dysaesthesia	19.42	17.02	6	59729	77	56232255
Viral infection	19.34	17.02	5	59730	31941	56200391
Hepatic vein stenosis	19.14	17.02	5	59730	33	56232299
Sputum abnormal	19.13	17.02	10	59725	532	56231800
Hyperlipasaemia	19.08	17.02	10	59725	535	56231797
Temperature intolerance	18.84	17.02	32	59703	8008	56224324
Red cell fragmentation syndrome	18.77	17.02	5	59730	36	56232296
Peripheral nerve injury	18.70	17.02	9	59726	401	56231931
Colorectal cancer recurrent	18.69	17.02	4	59731	9	56232323
Rectal cancer metastatic	18.67	17.02	8	59727	271	56232061
Unevaluable event	18.63	17.02	14	59721	47673	56184659
Stoma site haemorrhage	18.41	17.02	12	59723	966	56231366
Full blood count abnormal	18.38	17.02	3	59732	26459	56205873
Hypervolaemia	18.37	17.02	3	59732	26455	56205877
Tongue discomfort	18.34	17.02	16	59719	2000	56230332
Trichomegaly	18.20	17.02	5	59730	41	56232291
Pigmentation disorder	18.19	17.02	22	59713	4037	56228295
Embolism	18.18	17.02	30	59705	7334	56224998
Diaphragmatic paralysis	18.05	17.02	10	59725	598	56231734
Hereditary motor and sensory neuropathy	18.03	17.02	6	59729	99	56232233
Hyperbilirubinaemia	18.01	17.02	36	59699	10199	56222133
Aortic thrombosis	17.98	17.02	12	59723	1005	56231327
Aortitis	17.89	17.02	12	59723	1014	56231318
Endometrial dysplasia	17.87	17.02	4	59731	12	56232320
Gastrointestinal inflammation	17.61	17.02	24	59711	4954	56227378
Appendicitis noninfective	17.55	17.02	3	59732	0	56232332
Multiple sclerosis	17.52	17.02	4	59731	27798	56204534
Cold sweat	17.50	17.02	37	59698	10906	56221426
Femoral artery embolism	17.49	17.02	5	59730	48	56232284
Duodenal ulcer	17.46	17.02	29	59706	7126	56225206
Protein urine	17.45	17.02	10	59725	639	56231693
Femur fracture	17.43	17.02	10	59725	39285	56193047
Aortic dissection	17.40	17.02	15	59720	1844	56230488
Acute respiratory distress syndrome	17.35	17.02	57	59678	21869	56210463
Pulmonary artery thrombosis	17.30	17.02	10	59725	649	56231683
Hallucination	17.26	17.02	16	59719	49133	56183199
Cognitive disorder	17.25	17.02	16	59719	49117	56183215
Metastatic neoplasm	17.19	17.02	21	59714	3892	56228440
Gastrointestinal stoma output increased	17.04	17.02	7	59728	213	56232119

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
Neuropathy peripheral	1344.16	15.73	1295	81530	74354	31540165
Disease progression	790.83	15.73	1073	81752	89391	31525128
Neurotoxicity	675.37	15.73	458	82367	15768	31598751
Diarrhoea	645.14	15.73	2198	80627	350211	31264308
Neutropenia	628.43	15.73	1229	81596	139135	31475384
Dermatitis acneiform	574.26	15.73	287	82538	5480	31609039
Palmar-plantar erythrodysaesthesia syndrome	569.24	15.73	405	82420	15078	31599441
Skin toxicity	554.57	15.73	253	82572	3906	31610613
Arteriospasm coronary	479.48	15.73	205	82620	2686	31611833
Thrombocytopenia	461.50	15.73	1096	81729	141651	31472868
Metastases to liver	404.61	15.73	305	82520	12422	31602097
Paronychia	386.20	15.73	182	82643	3036	31611483
Vomiting	333.99	15.73	1310	81515	222663	31391856
Erythema	332.47	15.73	682	82143	79723	31534796
Interstitial lung disease	307.70	15.73	565	82260	60838	31553681
Peripheral sensory neuropathy	305.74	15.73	196	82629	6119	31608400
Polyneuropathy	303.06	15.73	260	82565	12762	31601757
Paraesthesia	286.05	15.73	520	82305	55551	31558968
Myelosuppression	278.34	15.73	263	82562	14657	31599862
Nausea	272.89	15.73	1548	81277	306399	31308120
Venoocclusive liver disease	263.40	15.73	190	82635	7222	31607297
Chills	259.46	15.73	588	82237	73562	31540957
Mucosal inflammation	255.10	15.73	378	82447	34049	31580470
Portal hypertension	248.44	15.73	142	82683	3583	31610936
Haematotoxicity	237.87	15.73	176	82649	6961	31607558
Product dose omission issue	236.52	15.73	9	82816	105577	31508942
Gastrointestinal perforation	235.67	15.73	136	82689	3496	31611023
Hypersensitivity	229.25	15.73	472	82353	55271	31559248
Bone marrow failure	228.62	15.73	322	82503	27686	31586833
Completed suicide	223.33	15.73	3	82822	91511	31523008
Colorectal cancer metastatic	218.53	15.73	91	82734	1111	31613408
Drug ineffective	214.02	15.73	447	82378	395126	31219393
Arthralgia	208.57	15.73	68	82757	151356	31463163
Gastrointestinal toxicity	202.55	15.73	105	82720	2169	31612350
Stomatitis	191.26	15.73	358	82467	39080	31575439
Enteritis	190.60	15.73	154	82671	6945	31607574
Metastases to lung	189.54	15.73	165	82660	8257	31606262
Drug interaction	182.48	15.73	166	82659	208377	31406142
Laryngospasm	168.96	15.73	78	82747	1238	31613281
Fall	167.73	15.73	144	82681	185945	31428574
Flushing	159.36	15.73	284	82541	29844	31584675
Bronchospasm	156.55	15.73	160	82665	9812	31604707
Focal nodular hyperplasia	155.87	15.73	43	82782	120	31614399
Cardiotoxicity	154.26	15.73	118	82707	4909	31609610
Headache	150.35	15.73	155	82670	183497	31431022
Overdose	146.40	15.73	23	82802	84641	31529878
Pneumonia	142.76	15.73	428	82397	334884	31279635
Hypomagnesaemia	142.17	15.73	210	82615	18848	31595671
Abdominal pain	139.42	15.73	750	82075	145202	31469317
Decreased appetite	138.10	15.73	775	82050	152442	31462077
Hyperammonaemic encephalopathy	135.56	15.73	80	82745	2146	31612373
Carcinoembryonic antigen increased	127.79	15.73	52	82773	596	31613923
Hyperammonaemia	126.68	15.73	112	82713	5721	31608798
Dysaesthesia pharynx	122.55	15.73	29	82796	31	31614488
Skin reaction	121.41	15.73	100	82725	4634	31609885
Feeling hot	121.26	15.73	179	82646	16054	31598465
Proteinuria	119.72	15.73	181	82644	16582	31597937
Cardiac failure congestive	112.13	15.73	34	82791	79353	31535166
Oxygen saturation decreased	109.30	15.73	329	82496	48786	31565733
Therapy partial responder	107.95	15.73	108	82717	6454	31608065
Neutrophil count decreased	107.25	15.73	315	82510	46079	31568440
Anastomotic leak	106.36	15.73	45	82780	573	31613946
Dehydration	106.23	15.73	601	82224	118510	31496009
Pyrexia	106.23	15.73	1236	81589	302604	31311915
Leukopenia	105.64	15.73	362	82463	57466	31557053
Colon cancer metastatic	105.13	15.73	61	82764	1584	31612935
Infusion related reaction	104.21	15.73	319	82506	47736	31566783
Depression	103.56	15.73	54	82771	90761	31523758
Ascites	102.10	15.73	286	82539	40727	31573792
Intravascular haemolysis	102.09	15.73	39	82786	373	31614146
Insomnia	100.11	15.73	62	82763	94774	31519745
Enterocolitis	95.23	15.73	106	82719	7168	31607351
Hospitalisation	94.57	15.73	10	82815	49797	31564722
Intestinal obstruction	93.58	15.73	182	82643	20428	31594091
Varices oesophageal	92.43	15.73	74	82751	3292	31611227
Anxiety	90.03	15.73	64	82761	90969	31523550
Metastases to peritoneum	89.05	15.73	55	82770	1605	31612914
Joint swelling	89.05	15.73	16	82809	53415	31561104
Somnolence	86.99	15.73	79	82746	99366	31515153
Myalgia	86.52	15.73	47	82778	77211	31537308
Weight increased	86.47	15.73	55	82770	82892	31531627
Peripheral swelling	85.66	15.73	35	82790	67830	31546689
Anastomotic complication	84.04	15.73	33	82792	342	31614177
Tumour perforation	81.73	15.73	30	82795	254	31614265
Ileus	81.47	15.73	144	82681	15025	31599494
Anaphylactic shock	80.82	15.73	138	82687	14007	31600512
Aggression	80.72	15.73	4	82821	37287	31577232
Malignant neoplasm progression	80.11	15.73	413	82412	78585	31535934
Laryngeal discomfort	79.90	15.73	27	82798	174	31614345
Diffuse large B-cell lymphoma recurrent	78.71	15.73	64	82761	2911	31611608
Rhabdomyolysis	78.30	15.73	34	82791	63547	31550972
Toxic leukoencephalopathy	75.49	15.73	29	82796	282	31614237
Type I hypersensitivity	75.21	15.73	43	82782	1085	31613434
Influenza	74.45	15.73	13	82812	44312	31570207
Neoplasm progression	73.26	15.73	163	82662	20109	31594410
Foetal exposure during pregnancy	73.18	15.73	10	82815	40866	31573653
Inappropriate schedule of product administration	73.15	15.73	21	82804	50802	31563717
Stomal varices	72.31	15.73	19	82806	41	31614478
Confusional state	71.39	15.73	151	82674	133183	31481336
Injection site pain	71.06	15.73	5	82820	34629	31579890
Incorrect dose administered	70.99	15.73	6	82819	35746	31578773
Tumour necrosis	70.55	15.73	42	82783	1145	31613374
Asthma	70.48	15.73	13	82812	42598	31571921
Extravasation	69.64	15.73	48	82777	1694	31612825
Vascular pain	69.12	15.73	22	82803	114	31614405
Large intestine perforation	68.60	15.73	92	82733	7544	31606975
Portal shunt	68.05	15.73	17	82808	27	31614492
Dihydropyrimidine dehydrogenase deficiency	67.13	15.73	19	82806	60	31614459
Hallucination	67.11	15.73	19	82806	46391	31568128
Contusion	67.10	15.73	5	82820	33023	31581496
Peritonitis	66.73	15.73	133	82692	15194	31599325
Pneumatosis intestinalis	66.49	15.73	64	82761	3647	31610872
Pain in extremity	66.13	15.73	127	82698	116076	31498443
Death	65.48	15.73	615	82210	359954	31254565
Myocardial infarction	65.43	15.73	123	82702	113331	31501188
Disseminated intravascular coagulation	65.27	15.73	157	82668	20380	31594139
Non-cirrhotic portal hypertension	65.27	15.73	25	82800	241	31614278
Rectal perforation	65.01	15.73	29	82796	423	31614096
Blood glucose increased	64.34	15.73	40	82785	61043	31553476
Electrocardiogram QT prolonged	64.11	15.73	11	82814	37976	31576543
Hepatic atrophy	63.19	15.73	22	82803	157	31614362
Product use issue	62.85	15.73	35	82790	56724	31557795
Suicidal ideation	62.65	15.73	10	82815	36396	31578123
Hyperhidrosis	61.94	15.73	343	82482	67050	31547469
Adenocarcinoma of colon	61.49	15.73	58	82767	3222	31611297
Metastases to lymph nodes	60.75	15.73	65	82760	4203	31610316
Memory impairment	60.20	15.73	13	82812	38117	31576402
Electrocardiogram ST segment elevation	59.55	15.73	67	82758	4584	31609935
Tumour lysis syndrome	59.33	15.73	127	82698	15258	31599261
Paraesthesia oral	59.11	15.73	60	82765	3648	31610871
Hypertransaminasaemia	58.55	15.73	64	82761	4240	31610279
Coronary artery disease	57.77	15.73	24	82801	46063	31568456
Palmar erythema	56.72	15.73	23	82802	261	31614258
Necrotising fasciitis	56.65	15.73	57	82768	3429	31611090
Rash pustular	56.17	15.73	67	82758	4882	31609637
Cholinergic syndrome	56.08	15.73	27	82798	473	31614046
Dysphonia	55.61	15.73	148	82677	20443	31594076
Febrile neutropenia	55.21	15.73	523	82302	121326	31493193
Feeling abnormal	55.13	15.73	41	82784	56961	31557558
Hyperthermia	55.05	15.73	96	82729	9908	31604611
Agitation	54.97	15.73	37	82788	54132	31560387
Intestinal perforation	54.88	15.73	87	82738	8302	31606217
Splenomegaly	54.76	15.73	115	82710	13634	31600885
Cholangitis	53.87	15.73	84	82741	7902	31606617
Arthritis	53.28	15.73	5	82820	27380	31587139
Nodular regenerative hyperplasia	52.24	15.73	32	82793	920	31613599
Therapeutic product effect decreased	51.54	15.73	10	82815	31612	31582907
Hiccups	50.95	15.73	89	82736	9198	31605321
Administration site extravasation	50.41	15.73	26	82799	531	31613988
Temperature intolerance	49.95	15.73	50	82775	2989	31611530
Nasopharyngitis	49.82	15.73	55	82770	63190	31551329
Pain	49.43	15.73	286	82539	186473	31428046
Rectal cancer	49.27	15.73	43	82782	2158	31612361
Toxicity to various agents	49.07	15.73	276	82549	181211	31433308
Pulmonary embolism	48.89	15.73	373	82452	81273	31533246
Rectal cancer metastatic	48.78	15.73	20	82805	234	31614285
Drug reaction with eosinophilia and systemic symptoms	47.87	15.73	10	82815	30008	31584511
Irritability	47.85	15.73	3	82822	22886	31591633
Colon cancer	47.85	15.73	83	82742	8530	31605989
Stoma site haemorrhage	47.68	15.73	28	82797	744	31613775
Gastrointestinal anastomotic leak	47.60	15.73	22	82803	350	31614169
General physical health deterioration	47.52	15.73	479	82346	112956	31501563
Recall phenomenon	47.25	15.73	25	82800	539	31613980
Asthenia	47.23	15.73	837	81988	223918	31390601
Cellulitis	47.13	15.73	34	82791	47984	31566535
Unevaluable event	47.11	15.73	11	82814	30564	31583955
Drug dependence	47.08	15.73	3	82822	22576	31591943
Chronic obstructive pulmonary disease	46.98	15.73	30	82795	45136	31569383
Treatment noncompliance	46.65	15.73	6	82819	25678	31588841
Malignant ascites	45.72	15.73	22	82803	385	31614134
Transdifferentiation of neoplasm	45.42	15.73	14	82811	64	31614455
Mucosal toxicity	45.33	15.73	19	82806	236	31614283
Septic shock	44.03	15.73	310	82515	65848	31548671
Musculoskeletal stiffness	43.60	15.73	27	82798	41298	31573221
Prinzmetal angina	43.52	15.73	28	82797	879	31613640
Hypokalaemia	42.93	15.73	263	82562	53311	31561208
Dizziness	42.62	15.73	325	82500	198822	31415697
Splenorenal shunt	42.59	15.73	10	82815	10	31614509
Periportal sinus dilatation	42.10	15.73	11	82814	23	31614496
Neutropenic sepsis	41.90	15.73	97	82728	12282	31602237
Sinusitis	41.53	15.73	22	82803	36674	31577845
Throat tightness	41.43	15.73	73	82752	7596	31606923
Condition aggravated	41.35	15.73	255	82570	163754	31450765
Perforation	41.30	15.73	17	82808	201	31614318
Drug level increased	41.16	15.73	3	82822	20183	31594336
Immune thrombocytopenia	40.97	15.73	77	82748	8421	31606098
Evans syndrome	40.76	15.73	18	82807	256	31614263
Abnormal behaviour	39.98	15.73	7	82818	23821	31590698
Wound dehiscence	39.82	15.73	45	82780	3093	31611426
Cyanosis	39.77	15.73	92	82733	11643	31602876
Blood pressure fluctuation	39.67	15.73	6	82819	22730	31591789
Small intestinal obstruction	39.63	15.73	100	82725	13372	31601147
Noninfective epididymitis	39.60	15.73	8	82817	0	31614519
Oxygen saturation normal	39.60	15.73	8	82817	0	31614519
Influenza like illness	39.49	15.73	9	82816	25428	31589091
Diabetes mellitus	39.38	15.73	32	82793	42524	31571995
Intestinal ischaemia	39.28	15.73	68	82757	6977	31607542
Anastomotic fistula	39.26	15.73	13	82812	78	31614441
Enterovesical fistula	39.14	15.73	24	82801	691	31613828
Acute coronary syndrome	38.75	15.73	96	82729	12693	31601826
Psychotic disorder	38.63	15.73	6	82819	22287	31592232
Colorectal cancer	38.60	15.73	55	82770	4774	31609745
Chronic kidney disease	38.44	15.73	26	82799	37949	31576570
Off label use	38.35	15.73	1182	81643	346092	31268427
Cardiac disorder	38.17	15.73	28	82797	39186	31575333
Subileus	38.15	15.73	43	82782	2947	31611572
Large intestinal obstruction	37.82	15.73	31	82794	1426	31613093
Wrong technique in product usage process	37.72	15.73	20	82805	33323	31581196
Prostate cancer	37.72	15.73	26	82799	37575	31576944
Hypercreatinaemia	37.65	15.73	15	82810	162	31614357
Seizure	37.61	15.73	134	82691	99634	31514885
Blood pressure immeasurable	37.51	15.73	25	82800	834	31613685
Abdominal discomfort	37.25	15.73	48	82777	51519	31563000
Nicotinic acid deficiency	37.19	15.73	13	82812	94	31614425
Dysaesthesia	36.94	15.73	36	82789	2083	31612436
COVID-19	36.61	15.73	54	82771	54767	31559752
Fluid retention	36.14	15.73	10	82815	24792	31589727
International normalised ratio increased	35.97	15.73	39	82786	45184	31569335
Bronchitis	35.96	15.73	29	82796	38688	31575831
Premature baby	35.95	15.73	3	82822	18063	31596456
Cytomegalovirus infection	35.93	15.73	10	82815	24697	31589822
Tumour marker increased	35.79	15.73	21	82804	557	31613962
Gastric perforation	35.48	15.73	37	82788	2322	31612197
Type II hypersensitivity	35.47	15.73	10	82815	31	31614488
Hypertensive crisis	35.22	15.73	71	82754	8176	31606343
Pseudocirrhosis	35.05	15.73	9	82816	17	31614502
Herpes zoster	35.02	15.73	20	82805	31973	31582546
Contraindicated product administered	35.00	15.73	5	82820	19767	31594752
Liver function test abnormal	34.80	15.73	17	82808	29675	31584844
Hepatic infarction	34.77	15.73	15	82810	201	31614318
Blood creatine phosphokinase increased	34.74	15.73	35	82790	41939	31572580
Anaphylactic reaction	34.56	15.73	161	82664	29392	31585127
Hypoglycaemia	34.20	15.73	50	82775	50896	31563623
Acute abdomen	34.05	15.73	32	82793	1769	31612750
Stridor	33.85	15.73	36	82789	2311	31612208
Amaurosis fugax	33.54	15.73	20	82805	547	31613972
Portal venous gas	33.37	15.73	17	82808	338	31614181
Metastasis	33.07	15.73	44	82781	3580	31610939
Folliculitis	32.80	15.73	47	82778	4101	31610418
Portal vein thrombosis	32.65	15.73	43	82782	3464	31611055
Carbohydrate antigen 19-9 increased	32.36	15.73	14	82811	189	31614330
Performance status decreased	32.23	15.73	45	82780	3833	31610686
Cerebrovascular accident	31.82	15.73	104	82721	79380	31535139
Pelvic abscess	31.69	15.73	23	82802	882	31613637
Device related infection	31.46	15.73	104	82721	16195	31598324
Hypervolaemia	31.42	15.73	5	82820	18246	31596273
Haematoma	31.18	15.73	12	82813	24127	31590392
Dyspnoea	31.00	15.73	1142	81683	342337	31272182
Ocular toxicity	30.91	15.73	14	82811	212	31614307
Lymphangiosis carcinomatosa	30.58	15.73	22	82803	832	31613687
Leukoencephalopathy	30.54	15.73	44	82781	3858	31610661
Hypoalbuminaemia	30.52	15.73	80	82745	10948	31603571
Delirium	30.49	15.73	38	82787	41383	31573136
Hypovolaemic shock	30.47	15.73	58	82767	6404	31608115
Encapsulating peritoneal sclerosis	30.26	15.73	19	82806	571	31613948
Right ventricular ejection fraction decreased	30.16	15.73	9	82816	36	31614483
Pulmonary toxicity	30.11	15.73	52	82773	5325	31609194
Biliary fistula	29.77	15.73	9	82816	38	31614481
Oesophageal haemorrhage	29.63	15.73	25	82800	1198	31613321
ECG signs of myocardial ischaemia	29.56	15.73	13	82812	183	31614336
Accidental overdose	29.49	15.73	6	82819	18344	31596175
Hepatectomy	29.39	15.73	10	82815	66	31614453
Sciatic nerve palsy	29.22	15.73	9	82816	41	31614478
Localised infection	29.13	15.73	3	82822	15262	31599257
Perforation bile duct	29.08	15.73	8	82817	22	31614497
Blood alkaline phosphatase abnormal	28.93	15.73	16	82809	378	31614141
Sedation	28.87	15.73	7	82818	18958	31595561
Hyperkalaemia	28.77	15.73	80	82745	64271	31550248
Haemorrhage intracranial	28.71	15.73	3	82822	15085	31599434
Failure to anastomose	28.40	15.73	13	82812	202	31614317
Medication error	28.30	15.73	12	82813	22760	31591759
Nasal congestion	28.27	15.73	9	82816	20372	31594147
Blood cholesterol increased	28.26	15.73	5	82820	16888	31597631
Blood pressure systolic increased	28.09	15.73	8	82817	19462	31595057
Oesophageal varices haemorrhage	28.08	15.73	36	82789	2824	31611695
Haemolytic anaemia	28.07	15.73	72	82753	9724	31604795
Anaphylactoid reaction	28.06	15.73	31	82794	2078	31612441
Hyperaemia	27.99	15.73	23	82802	1062	31613457
Swelling	27.78	15.73	34	82791	37324	31577195
Head injury	27.72	15.73	5	82820	16653	31597866
Haemoglobinuria	27.67	15.73	18	82807	576	31613943
Mobility decreased	27.54	15.73	19	82806	27450	31587069
Alopecia	27.40	15.73	117	82708	20578	31593941
Upper respiratory tract infection	27.37	15.73	22	82803	29400	31585119
Muscular weakness	27.34	15.73	84	82741	65364	31549155
Hyperbilirubinaemia	27.34	15.73	97	82728	15653	31598866
Anal sphincter atony	27.31	15.73	10	82815	84	31614435
Small intestinal perforation	27.26	15.73	30	82795	2002	31612517
Necrotising oesophagitis	27.08	15.73	17	82808	511	31614008
Full blood count abnormal	27.00	15.73	5	82820	16342	31598177
Brain teratoma	27.00	15.73	7	82818	14	31614505
Emotional distress	26.94	15.73	3	82822	14353	31600166
Cachexia	26.75	15.73	56	82769	6623	31607896
Acute respiratory distress syndrome	26.74	15.73	131	82694	24409	31590110
Pulmonary fibrosis	26.72	15.73	100	82725	16560	31597959
Vocal cord paralysis	26.42	15.73	21	82804	924	31613595
Erectile dysfunction	25.79	15.73	9	82816	19226	31595293
Circulatory collapse	25.66	15.73	111	82714	19633	31594886
Productive cough	25.50	15.73	30	82795	33510	31581009
Skin fissures	25.37	15.73	43	82782	4337	31610182
Basal cell carcinoma	25.26	15.73	8	82817	18171	31596348
Osteomyelitis	25.24	15.73	4	82821	14639	31599880
Subdural haematoma	25.23	15.73	9	82816	18962	31595557
Pruritus	25.10	15.73	463	82362	124704	31489815
Road traffic accident	25.02	15.73	6	82819	16375	31598144
Hot flush	24.97	15.73	96	82729	16100	31598419
Biliary tract infection	24.96	15.73	17	82808	588	31613931
Gait disturbance	24.81	15.73	111	82714	77384	31537135
Toxic epidermal necrolysis	24.73	15.73	10	82815	19514	31595005
Embolism	24.73	15.73	57	82768	7196	31607323
Ileal perforation	24.67	15.73	18	82807	696	31613823
Adverse drug reaction	24.52	15.73	18	82807	25183	31589336
Renal disorder	24.18	15.73	16	82809	23629	31590890
Aortitis	24.14	15.73	14	82811	363	31614156
Koebner phenomenon	23.88	15.73	8	82817	50	31614469
Peripheral sensorimotor neuropathy	23.85	15.73	24	82801	1444	31613075
Oesophagitis	23.76	15.73	79	82746	12337	31602182
Perihepatic abscess	23.66	15.73	9	82816	85	31614434
Cardiac ventricular disorder	23.63	15.73	12	82813	237	31614282
Pulmonary artery thrombosis	23.63	15.73	17	82808	643	31613876
Nephrolithiasis	23.54	15.73	22	82803	27317	31587202
Eosinophilia	23.42	15.73	16	82809	23237	31591282
Laryngeal oedema	23.33	15.73	35	82790	3182	31611337
Pulmonary oedema	23.28	15.73	51	82774	44451	31570068
Adenocarcinoma	23.27	15.73	26	82799	1765	31612754
Throat irritation	23.20	15.73	65	82760	9249	31605270
Fistula of small intestine	22.74	15.73	14	82811	406	31614113
Cold sweat	22.68	15.73	64	82761	9145	31605374
Blood creatinine increased	22.67	15.73	138	82687	88940	31525579
Xerosis	22.36	15.73	15	82810	506	31614013
Interventricular septum rupture	22.22	15.73	6	82819	15	31614504
Hepatic failure	22.19	15.73	154	82671	32548	31581971
Cerebral vasoconstriction	22.19	15.73	11	82814	206	31614313
Onycholysis	22.15	15.73	16	82809	609	31613910
Muscle contractions involuntary	22.12	15.73	25	82800	1719	31612800
Liver abscess	22.09	15.73	36	82789	3515	31611004
Papilloedema	22.03	15.73	30	82795	2496	31612023
Oropharyngeal pain	22.02	15.73	30	82795	31453	31583066
Intestinal dilatation	21.97	15.73	20	82805	1061	31613458
Diffuse large B-cell lymphoma refractory	21.94	15.73	20	82805	1063	31613456
Gout	21.92	15.73	10	82815	18164	31596355
Cataract	21.90	15.73	18	82807	23789	31590730
Product prescribing error	21.90	15.73	12	82813	19630	31594889
Fingerprint loss	21.88	15.73	7	82818	37	31614482
Metastases to muscle	21.86	15.73	11	82814	213	31614306
Labelled drug-drug interaction medication error	21.79	15.73	4	82821	13159	31601360
Sleep disorder	21.76	15.73	22	82803	26326	31588193
Metastases to retroperitoneum	21.72	15.73	11	82814	216	31614303
Astringent therapy	21.68	15.73	6	82819	17	31614502
Hyperpyrexia	21.67	15.73	29	82796	2372	31612147
Pachymeningitis	21.67	15.73	9	82816	109	31614410
Gastric dilatation	21.65	15.73	16	82809	631	31613888
Wheezing	21.62	15.73	38	82787	35948	31578571
Neck pain	21.47	15.73	17	82808	22893	31591626
Rectosigmoid cancer	21.47	15.73	10	82815	162	31614357
Oesophagobronchial fistula	21.47	15.73	10	82815	162	31614357
Hyperfibrinolysis	21.19	15.73	6	82819	19	31614500
Obstruction gastric	21.13	15.73	18	82807	874	31613645
Tachycardia	20.92	15.73	297	82528	75910	31538609
Colon cancer recurrent	20.90	15.73	9	82816	120	31614399
Monocytopenia	20.90	15.73	8	82817	77	31614442
Portal vein dilatation	20.82	15.73	5	82820	6	31614513
Injection site erythema	20.75	15.73	6	82819	14456	31600063
Induration	20.71	15.73	18	82807	898	31613621
Nephrotic syndrome	20.62	15.73	52	82773	6951	31607568
Gene mutation	20.51	15.73	20	82805	1158	31613361
Haemoglobin abnormal	20.41	15.73	34	82791	3381	31611138
Oedema peripheral	20.39	15.73	186	82639	109653	31504866
Conjunctivitis	20.33	15.73	59	82766	8564	31605955
Aortic thrombosis	20.33	15.73	16	82809	694	31613825
Feeling cold	20.29	15.73	63	82762	9491	31605028
Laboratory test abnormal	20.25	15.73	12	82813	18802	31595717
Acral peeling skin syndrome	20.22	15.73	7	82818	49	31614470
Jaundice	20.18	15.73	142	82683	30145	31584374
Sarcoidosis	20.15	15.73	30	82795	2709	31611810
Trismus	20.12	15.73	28	82797	2377	31612142
Full blood count decreased	20.11	15.73	9	82816	16531	31597988
Wound infection	20.03	15.73	49	82776	6426	31608093
Catheter site extravasation	20.03	15.73	8	82817	87	31614432
Allodynia	20.03	15.73	15	82810	604	31613915
Mucocutaneous rash	19.91	15.73	6	82819	25	31614494
Pulmonary hypertension	19.91	15.73	14	82811	20027	31594492
Pelvic fluid collection	19.89	15.73	9	82816	136	31614383
Thrombotic thrombocytopenic purpura	19.82	15.73	33	82792	3280	31611239
Pneumonitis chemical	19.71	15.73	9	82816	139	31614380
Lower respiratory tract infection	19.65	15.73	27	82798	28210	31586309
Drug intolerance	19.52	15.73	70	82755	51963	31562556
Respiratory arrest	19.41	15.73	24	82801	26233	31588286
Diffuse large B-cell lymphoma	19.31	15.73	58	82767	8583	31605936
Hand-foot-genital syndrome	19.28	15.73	5	82820	10	31614509
Ischiorectal hernia	19.28	15.73	5	82820	10	31614509
Malaise	19.15	15.73	576	82249	167935	31446584
Hypersplenism	19.13	15.73	12	82813	360	31614159
Peritoneal haematoma	19.10	15.73	7	82818	59	31614460
Perineal disorder	18.89	15.73	7	82818	61	31614458
Angioedema	18.87	15.73	37	82788	33581	31580938
Cholestasis	18.76	15.73	121	82704	24954	31589565
Peritoneal lesion	18.76	15.73	8	82817	104	31614415
Oropharyngeal spasm	18.73	15.73	9	82816	157	31614362
Heart rate decreased	18.71	15.73	28	82797	28238	31586281
Shock	18.65	15.73	112	82713	22533	31591986
Obstructive airways disorder	18.65	15.73	5	82820	12659	31601860
Underdose	18.52	15.73	5	82820	12602	31601917
Disease susceptibility	18.50	15.73	7	82818	65	31614454
Band sensation	18.49	15.73	8	82817	108	31614411
Peripheral ischaemia	18.45	15.73	42	82783	5258	31609261
Blood triglycerides increased	18.43	15.73	6	82819	13391	31601128
Blood pressure increased	18.42	15.73	127	82698	79506	31535013
Gastrointestinal stoma complication	18.39	15.73	19	82806	1179	31613340
Appendicitis noninfective	18.38	15.73	5	82820	13	31614506
Pulmonary infarction	18.29	15.73	19	82806	1187	31613332
Choking sensation	18.23	15.73	18	82807	1058	31613461
Gastrointestinal mucosal necrosis	18.08	15.73	9	82816	170	31614349
Nephritis allergic	18.01	15.73	12	82813	400	31614119
Balance disorder	17.88	15.73	45	82780	37377	31577142
Chemical peritonitis	17.79	15.73	8	82817	119	31614400
Abdominal sepsis	17.76	15.73	17	82808	962	31613557
Metastases to spleen	17.72	15.73	12	82813	411	31614108
Blindness transient	17.66	15.73	24	82801	1993	31612526
Metastases to bone marrow	17.63	15.73	13	82812	511	31614008
Microangiopathic haemolytic anaemia	17.54	15.73	16	82809	851	31613668
Product administration error	17.46	15.73	9	82816	15238	31599281
Neurosarcoidosis	17.44	15.73	9	82816	184	31614335
Perineal ulceration	17.39	15.73	5	82820	17	31614502
Blood bilirubin decreased	17.30	15.73	11	82814	338	31614181
Vascular injury	17.29	15.73	10	82815	258	31614261
Hypothyroidism	17.22	15.73	13	82812	17934	31596585
Acute motor-sensory axonal neuropathy	17.16	15.73	8	82817	130	31614389
Gastrointestinal necrosis	17.14	15.73	30	82795	3104	31611415
Hypersomnia	17.13	15.73	4	82821	11115	31603404
Peripheral motor neuropathy	17.10	15.73	22	82803	1732	31612787
Intrahepatic portal hepatic venous fistula	17.04	15.73	4	82821	4	31614515
Biliary cancer metastatic	17.04	15.73	4	82821	4	31614515
Peritoneal disorder	16.88	15.73	10	82815	270	31614249
Loss of personal independence in daily activities	16.88	15.73	30	82795	28258	31586261
Hypoaesthesia	16.87	15.73	222	82603	55800	31558719
Colon cancer stage III	16.81	15.73	9	82816	199	31614320
Oral dysaesthesia	16.77	15.73	7	82818	86	31614433
Duodenal stenosis	16.77	15.73	9	82816	200	31614319
VIth nerve disorder	16.76	15.73	5	82820	20	31614499
Axonal and demyelinating polyneuropathy	16.56	15.73	5	82820	21	31614498
Metastases to pelvis	16.56	15.73	10	82815	280	31614239
Proteus infection	16.44	15.73	16	82809	924	31613595
Blood glucose decreased	16.44	15.73	6	82819	12465	31602054
Fistula	16.34	15.73	42	82783	5679	31608840
Type III immune complex mediated reaction	16.34	15.73	10	82815	287	31614232
Pancreatitis	16.33	15.73	44	82781	35727	31578792
Bacterial colitis	16.33	15.73	6	82819	51	31614468
Hyperlipidaemia	16.25	15.73	7	82818	13153	31601366
Hypotension	16.18	15.73	671	82154	203947	31410572
Stevens-Johnson syndrome	16.14	15.73	13	82812	17359	31597160
Tunnel vision	16.13	15.73	12	82813	478	31614041
Vascular access site occlusion	16.03	15.73	6	82819	54	31614465
Rhinorrhoea	16.02	15.73	22	82803	22990	31591529
Hepatic cancer recurrent	16.00	15.73	10	82815	298	31614221
Faeces discoloured	15.99	15.73	8	82817	13778	31600741
Respiratory depression	15.98	15.73	9	82816	14501	31600018
Electromyogram abnormal	15.93	15.73	6	82819	55	31614464
Retroperitoneal abscess	15.89	15.73	8	82817	155	31614364
Ichthyosis	15.89	15.73	7	82818	99	31614420
Pancreatic carcinoma metastatic	15.87	15.73	28	82797	2916	31611603
Eczema impetiginous	15.86	15.73	5	82820	25	31614494
Radiation interaction	15.86	15.73	5	82820	25	31614494
Skin laceration	15.85	15.73	5	82820	11386	31603133
Platelet count decreased	15.80	15.73	389	82436	110046	31504473
Hyperthyroidism	15.79	15.73	3	82822	9628	31604891
Haematemesis	15.78	15.73	118	82707	25535	31588984
Rectal obstruction	15.77	15.73	4	82821	7	31614512
Nail disorder	15.76	15.73	22	82803	1873	31612646
Prostatic calcification	15.76	15.73	7	82818	101	31614418

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
Neuropathy peripheral	2642.68	15.28	2026	125262	124870	70676286
Neutropenia	1522.12	15.28	2079	125209	255077	70546079
Disease progression	1514.08	15.28	1625	125663	155047	70646109
Neurotoxicity	1317.21	15.28	762	126526	29064	70772092
Thrombocytopenia	1147.34	15.28	1751	125537	237359	70563797
Diarrhoea	1004.77	15.28	3378	123910	779963	70021193
Laryngospasm	928.07	15.28	319	126969	3324	70797832
Palmar-plantar erythrodysaesthesia syndrome	918.84	15.28	609	126679	29638	70771518
Dermatitis acneiform	851.70	15.28	384	126904	8561	70792595
Skin toxicity	755.93	15.28	331	126957	6867	70794289
Arteriospasm coronary	724.78	15.28	305	126983	5719	70795437
Paraesthesia	695.61	15.28	1065	126223	144472	70656684
Mucosal inflammation	602.28	15.28	674	126614	67176	70733980
Myelosuppression	590.09	15.28	465	126823	29680	70771476
Peripheral sensory neuropathy	576.22	15.28	325	126963	11785	70789371
Metastases to liver	547.46	15.28	418	126870	25460	70775696
Polyneuropathy	536.48	15.28	383	126905	21032	70780124
Vomiting	528.64	15.28	2282	125006	590829	70210327
Bone marrow failure	521.47	15.28	536	126752	48474	70752682
Arthralgia	519.85	15.28	132	127156	503258	70297898
Venoocclusive liver disease	468.99	15.28	272	127016	10406	70790750
Paronychia	449.16	15.28	230	127058	6844	70794312
Erythema	447.03	15.28	1057	126231	198506	70602650
Bronchospasm	410.73	15.28	335	126953	22457	70778699
Colorectal cancer metastatic	409.21	15.28	145	127143	1664	70799492
Chills	404.43	15.28	838	126450	143948	70657208
Portal hypertension	369.05	15.28	196	127092	6296	70794860
Headache	367.86	15.28	302	126986	580103	70221053
Nausea	365.64	15.28	2693	124595	849395	69951761
Interstitial lung disease	365.63	15.28	666	126622	104019	70697137
Haematotoxicity	359.69	15.28	252	127036	13422	70787734
Drug ineffective	351.38	15.28	727	126561	939025	69862131
Enteritis	341.09	15.28	238	127050	12593	70788563
Joint swelling	340.88	15.28	31	127257	253180	70547976
Gastrointestinal toxicity	340.64	15.28	185	127103	6220	70794936
Product dose omission issue	330.24	15.28	14	127274	217454	70583702
Gastrointestinal perforation	327.13	15.28	173	127115	5508	70795648
Dysaesthesia pharynx	297.10	15.28	70	127218	137	70801019
Neoplasm progression	289.66	15.28	381	126907	44847	70756309
Fall	278.69	15.28	233	127055	443863	70357293
Cardiotoxicity	270.36	15.28	195	127093	10875	70790281
Pain	268.43	15.28	448	126840	628368	70172788
Metastases to lung	267.35	15.28	228	127060	16256	70784900
Throat tightness	264.86	15.28	273	127015	24749	70776407
Stridor	262.69	15.28	144	127144	4932	70796224
Neutrophil count decreased	256.22	15.28	503	126785	83053	70718103
Arthropathy	248.73	15.28	4	127284	150053	70651103
Drug abuse	243.77	15.28	4	127284	147252	70653904
Leukopenia	241.04	15.28	567	126721	105993	70695163
Malignant neoplasm progression	240.59	15.28	615	126673	121124	70680032
Type I hypersensitivity	238.83	15.28	122	127166	3610	70797546
Peripheral swelling	230.67	15.28	69	127219	236494	70564662
Weight increased	230.34	15.28	74	127214	242257	70558899
Focal nodular hyperplasia	225.97	15.28	73	127215	616	70800540
Dysarthria	218.14	15.28	397	126891	61916	70739240
Flushing	218.04	15.28	466	126822	81706	70719450
Hyperammonaemia	214.86	15.28	165	127123	10128	70791028
Sinusitis	214.04	15.28	26	127262	169169	70631987
Non-cirrhotic portal hypertension	213.21	15.28	62	127226	351	70800805
Decreased appetite	209.05	15.28	1089	126199	303691	70497465
Febrile neutropenia	207.45	15.28	820	126468	203498	70597658
Therapy partial responder	205.29	15.28	174	127114	12300	70788856
Nasopharyngitis	203.95	15.28	72	127216	222134	70579022
Contraindicated product administered	199.94	15.28	10	127278	134602	70666554
Hypomagnesaemia	199.55	15.28	302	126986	40462	70760694
Swelling	198.91	15.28	47	127241	188492	70612664
Stomatitis	197.23	15.28	592	126696	127919	70673237
Anaphylactic shock	194.69	15.28	265	127023	32225	70768931
Hyperammonaemic encephalopathy	194.61	15.28	113	127175	4330	70796826
Depression	194.02	15.28	58	127230	198916	70602240
Ascites	191.94	15.28	394	126894	67153	70734003
Drug interaction	190.63	15.28	243	127045	381198	70419958
Insomnia	185.94	15.28	79	127209	217727	70583429
Therapeutic product effect decreased	183.31	15.28	21	127267	142997	70658159
Abdominal pain	183.03	15.28	1144	126144	340983	70460173
Product use issue	181.82	15.28	49	127239	179888	70621268
Splenomegaly	180.34	15.28	195	127093	18675	70782481
Systemic lupus erythematosus	167.67	15.28	3	127285	101899	70699257
Dysphonia	166.29	15.28	312	126976	49788	70751368
Enterocolitis	165.05	15.28	157	127131	12909	70788247
Proteinuria	164.63	15.28	232	127056	29142	70772014
Asthma	164.58	15.28	14	127274	120779	70680377
Overdose	164.53	15.28	50	127238	169695	70631461
Psoriasis	161.54	15.28	3	127285	98430	70702726
Contusion	161.12	15.28	20	127268	128016	70673140
Feeling hot	160.18	15.28	302	126986	48368	70752788
Abdominal discomfort	158.97	15.28	94	127194	214564	70586592
Maternal exposure during pregnancy	158.17	15.28	13	127275	115332	70685824
Anastomotic leak	157.71	15.28	62	127226	967	70800189
Hyperhidrosis	157.52	15.28	557	126731	131029	70670127
Pyrexia	157.06	15.28	1721	125567	605231	70195925
Pain in extremity	156.73	15.28	216	127072	327866	70473290
Intestinal obstruction	152.20	15.28	260	127028	38565	70762591
Oxygen saturation decreased	149.95	15.28	505	126783	115924	70685232
Dyspnoea	144.94	15.28	2057	125231	768003	70033153
Influenza	144.94	15.28	17	127271	113683	70687473
Laryngeal discomfort	141.87	15.28	49	127239	518	70800638
Injection site pain	141.76	15.28	21	127267	117598	70683558
Nodular regenerative hyperplasia	140.75	15.28	61	127227	1232	70799924
Hypersensitivity	139.10	15.28	794	126494	229018	70572138
Cardiac failure congestive	134.73	15.28	38	127250	135419	70665737
Arthritis	134.45	15.28	11	127277	97969	70703187
Varices oesophageal	133.59	15.28	96	127192	5321	70795835
Asthenia	132.46	15.28	1328	125960	456338	70344818
Cytokine release syndrome	132.25	15.28	198	127090	26269	70774887
Pneumonia	132.10	15.28	586	126702	595646	70205510
Hyperthermia	131.60	15.28	156	127132	16515	70784641
Paraesthesia oral	131.28	15.28	150	127138	15267	70785889
Pemphigus	130.63	15.28	4	127284	83032	70718124
Dehydration	130.15	15.28	771	126517	225371	70575785
Dysaesthesia	129.80	15.28	94	127194	5274	70795882
Musculoskeletal stiffness	128.63	15.28	52	127236	147708	70653448
Intentional product misuse	128.33	15.28	3	127285	79592	70721564
Bronchitis	128.10	15.28	27	127261	117216	70683940
Anxiety	126.74	15.28	125	127163	220205	70580951
Carcinoembryonic antigen increased	125.96	15.28	65	127223	1965	70799191
Colon cancer metastatic	125.33	15.28	66	127222	2082	70799074
Tumour perforation	125.03	15.28	40	127248	326	70800830
Suicide attempt	124.47	15.28	4	127284	79506	70721650
Somnolence	124.39	15.28	122	127166	215484	70585672
Metastases to peritoneum	123.46	15.28	80	127208	3739	70797417
Large intestine perforation	121.98	15.28	134	127154	13061	70788095
Skin reaction	121.85	15.28	138	127150	13911	70787245
Glossodynia	120.67	15.28	9	127279	86478	70714678
Immune thrombocytopenia	119.46	15.28	147	127141	16177	70784979
Osteoarthritis	118.75	15.28	3	127285	74144	70727012
Drug intolerance	117.64	15.28	139	127149	225548	70575608
Lower respiratory tract infection	115.83	15.28	29	127259	111884	70689272
Hospitalisation	114.04	15.28	9	127279	82559	70718597
Intravascular haemolysis	112.53	15.28	44	127244	676	70800480
Condition aggravated	111.30	15.28	394	126894	427241	70373915
Posterior reversible encephalopathy syndrome	111.29	15.28	175	127113	24227	70776929
Myalgia	110.19	15.28	84	127204	167808	70633348
Wound	109.38	15.28	22	127266	98710	70702446
Laryngeal oedema	108.12	15.28	97	127191	7398	70793758
Ileus	108.03	15.28	172	127116	24065	70777091
Extravasation	106.97	15.28	70	127218	3327	70797829
Stress	104.36	15.28	4	127284	67962	70733194
Adenocarcinoma of colon	100.80	15.28	81	127207	5311	70795845
Exposure during pregnancy	100.46	15.28	18	127270	87699	70713457
Disseminated intravascular coagulation	100.19	15.28	200	127088	33398	70767758
Peritonitis	99.65	15.28	173	127115	25986	70775170
Intestinal perforation	99.36	15.28	133	127155	15911	70785245
Hepatic enzyme increased	98.68	15.28	82	127206	156908	70644248
Administration site extravasation	98.67	15.28	46	127242	1109	70800047
Blood cholesterol increased	98.52	15.28	4	127284	64600	70736556
Hypertransaminasaemia	97.20	15.28	99	127189	8844	70792312
Acute coronary syndrome	95.76	15.28	147	127141	19932	70781224
Injection site erythema	95.21	15.28	10	127278	72914	70728242
Hypertensive crisis	94.66	15.28	143	127145	19119	70782037
Colon cancer	93.85	15.28	122	127166	14184	70786972
Confusional state	92.64	15.28	236	127052	284162	70516994
Tumour necrosis	91.08	15.28	50	127238	1717	70799439
Cholinergic syndrome	90.60	15.28	40	127248	846	70800310
Portal shunt	90.26	15.28	22	127266	53	70801103
Haemolytic anaemia	88.74	15.28	129	127159	16665	70784491
Suicidal ideation	87.22	15.28	11	127277	69585	70731571
Inappropriate schedule of product administration	87.05	15.28	42	127246	107513	70693643
Dihydropyrimidine dehydrogenase deficiency	86.72	15.28	24	127264	110	70801046
Memory impairment	86.69	15.28	29	127259	92612	70708544
Pneumatosis intestinalis	86.53	15.28	77	127211	5810	70795346
General physical health deterioration	85.89	15.28	720	126568	235311	70565845
Mucosal toxicity	84.68	15.28	34	127254	562	70800594
Rhabdomyolysis	84.47	15.28	33	127255	95727	70705429
Mobility decreased	83.70	15.28	40	127248	102959	70698197
Hypokalaemia	83.07	15.28	459	126829	130729	70670427
Toxic leukoencephalopathy	82.87	15.28	39	127249	961	70800195
Incorrect dose administered	82.52	15.28	11	127277	66708	70734448
Platelet count decreased	80.61	15.28	572	126716	177650	70623506
Tongue oedema	80.56	15.28	76	127212	6183	70794973
Electrocardiogram QT prolonged	80.17	15.28	25	127263	83492	70717664
Tumour lysis syndrome	79.72	15.28	140	127148	21220	70779936
Fluid retention	79.48	15.28	10	127278	63375	70737781
Stomal varices	79.09	15.28	19	127269	42	70801114
Diffuse large B-cell lymphoma recurrent	77.58	15.28	58	127230	3418	70797738
Helicobacter infection	77.04	15.28	6	127282	55650	70745506
Off label use	76.47	15.28	1807	125481	741253	70059903
Drug hypersensitivity	76.37	15.28	230	127058	262229	70538927
Anaphylactic reaction	76.02	15.28	301	126987	74673	70726483
Treatment failure	75.91	15.28	88	127200	144054	70657102
Anastomotic complication	75.60	15.28	29	127259	422	70800734
Pericarditis	75.03	15.28	29	127259	84676	70716480
Osteoporosis	74.67	15.28	3	127285	48904	70752252
Migraine	74.20	15.28	19	127269	72219	70728937
Aggression	73.87	15.28	3	127285	48443	70752713
Rectal perforation	73.80	15.28	34	127254	797	70800359
Chronic obstructive pulmonary disease	73.18	15.28	24	127264	77617	70723539
Blood pressure fluctuation	72.34	15.28	10	127278	59002	70742154
Upper respiratory tract infection	72.13	15.28	26	127262	79248	70721908
Pulmonary embolism	70.91	15.28	501	126787	155366	70645790
Stress cardiomyopathy	70.86	15.28	88	127200	9774	70791382
Leukoencephalopathy	70.78	15.28	76	127212	7218	70793938
Cholangitis	70.39	15.28	95	127193	11454	70789702
Injection site reaction	70.07	15.28	5	127283	49847	70751309
Electrocardiogram ST segment elevation	69.90	15.28	77	127211	7527	70793629
Anastomotic fistula	69.72	15.28	20	127268	107	70801049
Feeling abnormal	68.56	15.28	93	127195	142226	70658930
Myocardial infarction	67.75	15.28	128	127160	171517	70629639
Blister	67.61	15.28	49	127239	100477	70700679
Nicotinic acid deficiency	67.22	15.28	21	127267	157	70800999
Anaemia	67.03	15.28	1056	126232	402367	70398789
Cyanosis	66.63	15.28	136	127152	23070	70778086
Vascular pain	66.49	15.28	32	127256	830	70800326
Rash pustular	66.21	15.28	87	127201	10221	70790935
Metastases to lymph nodes	65.68	15.28	82	127206	9156	70792000
Coronary artery disease	65.40	15.28	16	127272	62720	70738436
Hiccups	65.40	15.28	81	127207	8971	70792185
Rectal cancer	65.10	15.28	51	127237	3223	70797933
Rectal cancer metastatic	64.25	15.28	27	127261	504	70800652
Neuromyotonia	63.27	15.28	18	127270	93	70801063
Blood glucose increased	63.22	15.28	55	127233	102927	70698229
Hallucination	62.90	15.28	29	127259	76231	70724925
Evans syndrome	62.50	15.28	25	127263	409	70800747
Sedation	62.06	15.28	6	127282	46725	70754431
Drug reaction with eosinophilia and systemic symptoms	62.05	15.28	14	127274	57999	70743157
Hypoalbuminaemia	60.85	15.28	117	127171	19005	70782151
Subileus	60.73	15.28	60	127228	5167	70795989
Gastric perforation	60.29	15.28	52	127236	3763	70797393
Choking sensation	60.17	15.28	51	127237	3604	70797552
Metastasis	59.85	15.28	64	127224	6050	70795106
Infusion related reaction	59.76	15.28	579	126709	196955	70604201
Band sensation	59.72	15.28	28	127260	684	70800472
Duodenal ulcer perforation	59.59	15.28	10	127278	51102	70750054
Herpes zoster	59.36	15.28	40	127248	85195	70715961
Cellulitis	59.33	15.28	54	127234	98874	70702282
Dizziness	59.25	15.28	540	126748	463601	70337555
Periportal sinus dilatation	58.89	15.28	14	127274	29	70801127
Influenza like illness	58.47	15.28	22	127266	65309	70735847
Tachycardia	58.35	15.28	485	126803	158061	70643095
Stoma site haemorrhage	58.21	15.28	37	127251	1672	70799484
Injection site pruritus	57.92	15.28	3	127285	39207	70761949
Septic shock	57.73	15.28	372	126916	111886	70689270
Gastrointestinal anastomotic leak	57.21	15.28	24	127264	446	70800710
Discomfort	56.99	15.28	63	127225	105373	70695783
Sleep disorder	56.97	15.28	27	127261	69845	70731311
Speech disorder	56.97	15.28	210	127078	50370	70750786
Treatment noncompliance	56.83	15.28	8	127280	46566	70754590
Chemical peritonitis	56.82	15.28	21	127267	274	70800882
Diffuse large B-cell lymphoma refractory	56.79	15.28	33	127255	1266	70799890
Large intestinal obstruction	56.66	15.28	45	127243	2901	70798255
Palmar erythema	56.40	15.28	37	127251	1766	70799390
COVID-19	56.28	15.28	64	127224	105693	70695463
Gait disturbance	56.16	15.28	159	127129	184947	70616209
ECG signs of myocardial ischaemia	56.14	15.28	22	127266	340	70800816
Hepatic atrophy	55.75	15.28	23	127265	409	70800747
Nasal congestion	55.70	15.28	24	127264	65648	70735508
Cough	55.51	15.28	349	126939	325028	70476128
Encapsulating peritoneal sclerosis	55.42	15.28	28	127260	809	70800347
Wrong technique in product usage process	55.32	15.28	27	127261	68671	70732485
Ocular toxicity	55.29	15.28	28	127260	813	70800343
Hyperbilirubinaemia	55.28	15.28	124	127164	22444	70778712
Drug dependence	54.68	15.28	3	127285	37318	70763838
Oesophageal varices haemorrhage	54.42	15.28	49	127239	3754	70797402
Necrotising fasciitis	54.37	15.28	58	127230	5468	70795688
International normalised ratio increased	53.44	15.28	40	127248	80686	70720470
Drug level increased	53.22	15.28	3	127285	36466	70764690
Hepatic failure	52.60	15.28	224	127064	57401	70743755
Psychotic disorder	52.36	15.28	4	127284	37697	70763459
Recall phenomenon	51.93	15.28	29	127259	1030	70800126
Emotional distress	51.50	15.28	4	127284	37184	70763972
Dysphagia	51.48	15.28	363	126925	112471	70688685
Enterocutaneous fistula	51.06	15.28	34	127254	1664	70799492
Hypervolaemia	50.43	15.28	6	127282	39700	70761456
Hypertension	50.29	15.28	778	126510	295255	70505901
Prinzmetal angina	50.23	15.28	33	127255	1579	70799577
Splenorenal shunt	50.02	15.28	11	127277	13	70801143
Urinary tract infection	49.91	15.28	253	127035	248516	70552640
Diabetes mellitus	49.62	15.28	34	127254	71790	70729366
Metastases to spleen	49.58	15.28	23	127265	548	70800608
Colorectal cancer	49.09	15.28	68	127220	8402	70792754
Anaphylactoid reaction	48.29	15.28	52	127236	4955	70796201
Breast cancer	48.22	15.28	3	127285	33546	70767610
Productive cough	47.88	15.28	42	127246	78295	70722861
Biliary tract infection	47.79	15.28	29	127259	1206	70799950
Ileal perforation	47.17	15.28	26	127262	900	70800256
Acute abdomen	46.86	15.28	40	127248	2854	70798302
Transdifferentiation of neoplasm	46.63	15.28	14	127274	90	70801066
Medication error	46.38	15.28	22	127266	56890	70744266
Hypercreatinaemia	46.18	15.28	18	127270	274	70800882
Cataract	46.14	15.28	21	127267	55624	70745532
Enterovesical fistula	45.99	15.28	27	127261	1056	70800100
Viral infection	45.91	15.28	7	127281	38384	70762772
Malignant ascites	45.58	15.28	27	127261	1074	70800082
Portal venous gas	45.29	15.28	19	127269	353	70800803
Hyperpyrexia	45.27	15.28	52	127236	5322	70795834
Metastases to bone marrow	44.97	15.28	23	127265	682	70800474
Liver function test abnormal	44.90	15.28	27	127261	61119	70740037
Infusion related hypersensitivity reaction	44.85	15.28	17	127271	239	70800917
Steatohepatitis	44.50	15.28	24	127264	795	70800361
Formication	44.27	15.28	48	127240	4609	70796547
White blood cell count decreased	43.97	15.28	483	126805	169658	70631498
Head injury	43.75	15.28	5	127283	34136	70767020
Skin fissures	43.53	15.28	75	127213	11195	70789961
Small intestinal perforation	43.51	15.28	39	127249	2970	70798186
Haemoglobinuria	43.43	15.28	23	127265	734	70800422
Cold sweat	43.37	15.28	95	127193	16921	70784235
Pulmonary toxicity	43.21	15.28	73	127215	10725	70790431
Type II hypersensitivity	42.90	15.28	11	127277	35	70801121
Oxygen saturation normal	42.60	15.28	8	127280	0	70801156
Hyperkalaemia	42.48	15.28	79	127209	106512	70694644
Wound dehiscence	42.38	15.28	54	127234	6154	70795002
Metastases to meninges	42.13	15.28	39	127249	3097	70798059
Heart rate decreased	41.99	15.28	30	127258	61985	70739171
Performance status decreased	41.89	15.28	51	127237	5550	70795606
Oropharyngeal discomfort	41.69	15.28	53	127235	6026	70795130
Type 2 diabetes mellitus	40.88	15.28	14	127274	44066	70757090
Colitis	40.85	15.28	224	127064	63590	70737566
Laryngeal dyspnoea	40.56	15.28	16	127272	252	70800904
Oropharyngeal pain	40.52	15.28	69	127219	96241	70704915
Amaurosis fugax	40.51	15.28	23	127265	844	70800312
Peripheral motor neuropathy	40.25	15.28	38	127250	3094	70798062
Cardiac disorder	39.89	15.28	29	127259	59386	70741770
Hypoglycaemia	39.34	15.28	68	127220	94296	70706860
Neck pain	39.23	15.28	37	127251	66620	70734536
Trismus	39.12	15.28	47	127241	5044	70796112
Temperature intolerance	39.00	15.28	62	127226	8661	70792495
Rhinorrhoea	38.88	15.28	37	127251	66334	70734822
Nervousness	38.79	15.28	5	127283	31115	70770041
Basal cell carcinoma	38.39	15.28	7	127281	33691	70767465
Blood pressure systolic increased	38.37	15.28	28	127260	57231	70743925
Unevaluable event	38.21	15.28	23	127265	52040	70749116
Acute respiratory distress syndrome	38.14	15.28	161	127127	41093	70760063
Road traffic accident	37.84	15.28	8	127280	34674	70766482
Hypovolaemic shock	37.84	15.28	69	127219	10768	70790388
Loss of personal independence in daily activities	37.43	15.28	59	127229	84851	70716305
Hepatocellular injury	37.40	15.28	173	127115	45918	70755238
Small intestinal obstruction	37.22	15.28	113	127175	24542	70776614
Portal vein thrombosis	37.17	15.28	47	127241	5315	70795841
Aortitis	37.09	15.28	26	127262	1385	70799771
Cold dysaesthesia	37.07	15.28	8	127280	8	70801148
K-ras gene mutation	37.03	15.28	10	127278	41	70801115
Neutropenic sepsis	36.73	15.28	113	127175	24717	70776439
Colitis ulcerative	36.65	15.28	8	127280	33915	70767241
Balance disorder	36.62	15.28	66	127222	90062	70711094
Hypertrichosis	36.50	15.28	24	127264	1150	70800006
Hydronephrosis	36.50	15.28	83	127205	15159	70785997
Portal vein dilatation	36.28	15.28	10	127278	45	70801111
Haematoma	36.09	15.28	21	127267	48397	70752759
Factor VII deficiency	36.01	15.28	9	127279	25	70801131
Underdose	35.96	15.28	5	127283	29378	70771778
Abnormal behaviour	35.89	15.28	9	127279	34700	70766456
Hallucination, visual	35.89	15.28	5	127283	29332	70771824
Irritability	35.69	15.28	12	127276	38213	70762943
Lip oedema	35.67	15.28	47	127241	5536	70795620
Gastrooesophageal reflux disease	35.60	15.28	68	127220	90771	70710385
Splenic artery thrombosis	34.94	15.28	10	127278	53	70801103
Jaundice	34.88	15.28	180	127108	49928	70751228
Perforation	34.87	15.28	24	127264	1241	70799915
Embolism	34.81	15.28	74	127214	12914	70788242
Full blood count abnormal	34.62	15.28	9	127279	33869	70767287
Pharyngeal paraesthesia	34.41	15.28	30	127258	2202	70798954
Neutropenic colitis	34.15	15.28	44	127244	5070	70796086
Obesity	34.11	15.28	4	127284	26767	70774389
Blood pressure immeasurable	33.71	15.28	28	127260	1924	70799232
Abortion spontaneous	33.63	15.28	4	127284	26475	70774681
Hypotension	33.40	15.28	956	126332	403425	70397731
Product prescribing error	33.40	15.28	14	127274	38938	70762218
Sensation of foreign body	33.14	15.28	42	127246	4760	70796396
Peripheral sensorimotor neuropathy	33.04	15.28	32	127256	2690	70798466
Guillain-Barre syndrome	33.03	15.28	55	127233	7985	70793171
Accidental overdose	32.84	15.28	11	127277	35110	70766046
Toxic epidermal necrolysis	32.68	15.28	15	127273	39542	70761614
Muscle contractions involuntary	32.66	15.28	35	127253	3316	70797840
Aortic thrombosis	32.49	15.28	25	127263	1538	70799618
Respiratory distress	32.44	15.28	188	127100	54462	70746694
Oedema peripheral	32.34	15.28	258	127030	227833	70573323
Metastases to ovary	32.29	15.28	14	127274	283	70800873
Granulocyte count decreased	32.12	15.28	24	127264	1413	70799743
Right ventricular ejection fraction decreased	32.05	15.28	9	127279	44	70801112
Noninfective epididymitis	31.95	15.28	6	127282	0	70801156
Biliary fistula	31.75	15.28	10	127278	77	70801079
Intentional product use issue	31.62	15.28	110	127178	120032	70681124
Haemolytic uraemic syndrome	31.53	15.28	38	127250	4092	70797064
Trichomegaly	31.42	15.28	10	127278	80	70801076
Cystitis radiation	31.29	15.28	11	127277	123	70801033
Oesophageal haemorrhage	31.23	15.28	25	127263	1630	70799526
Haemolysis	31.17	15.28	66	127222	11485	70789671
Dysgeusia	31.17	15.28	173	127115	49329	70751827
Liver abscess	31.03	15.28	44	127244	5555	70795601
Short-bowel syndrome	31.02	15.28	16	127272	483	70800673
Femur fracture	30.96	15.28	13	127275	36119	70765037
Retching	30.76	15.28	80	127208	15899	70785257
Eosinophilia	30.75	15.28	17	127271	40302	70760854
Pancreatic carcinoma metastatic	30.41	15.28	36	127252	3804	70797352
Intestinal ischaemia	30.35	15.28	67	127221	11997	70789159
Pulmonary artery thrombosis	30.27	15.28	22	127266	1241	70799915
Thrombotic microangiopathy	30.00	15.28	85	127203	17763	70783393
Hepatic function abnormal	29.98	15.28	217	127071	67779	70733377
Cytomegalovirus infection	29.98	15.28	17	127271	39741	70761415
Adverse drug reaction	29.79	15.28	31	127257	53313	70747843
Suffocation feeling	29.78	15.28	24	127264	1580	70799576
Haematemesis	29.71	15.28	169	127119	48628	70752528
Thrombocytopenic purpura	29.70	15.28	28	127260	2276	70798880
Adverse event	29.64	15.28	27	127261	49434	70751722
Cytopenia	29.61	15.28	83	127205	17240	70783916
Hypophagia	29.40	15.28	150	127138	41420	70759736
Perforation bile duct	29.39	15.28	8	127280	34	70801122
Nephrolithiasis	29.37	15.28	25	127263	47298	70753858
Appendicitis noninfective	29.29	15.28	7	127281	15	70801141
Osteomyelitis	29.22	15.28	9	127279	30309	70770847
Hypersplenism	29.11	15.28	15	127273	452	70800704
Ear pain	28.84	15.28	7	127281	27592	70773564
Alopecia	28.84	15.28	223	127065	198267	70602889
Toxicity to various agents	28.60	15.28	498	126790	381674	70419482
Failure to anastomose	28.55	15.28	12	127276	224	70800932
Adenocarcinoma	28.52	15.28	34	127254	3619	70797537
Fatigue	28.52	15.28	1200	126088	823119	69978037
Pelvic abscess	28.41	15.28	25	127263	1858	70799298
Heart rate irregular	28.36	15.28	9	127279	29734	70771422
Localised infection	28.30	15.28	12	127276	33146	70768010
Hyperaemia	28.18	15.28	30	127258	2821	70798335
Autoimmune haemolytic anaemia	27.91	15.28	50	127238	7696	70793460
Oral dysaesthesia	27.90	15.28	11	127277	173	70800983
Congestive cardiomyopathy	27.85	15.28	61	127227	10865	70790291
Medical device site extravasation	27.80	15.28	6	127282	6	70801150
Pelvic fluid collection	27.76	15.28	17	127271	719	70800437
Carbohydrate antigen 19-9 increased	27.75	15.28	14	127274	403	70800753
Sciatic nerve palsy	27.75	15.28	9	127279	77	70801079
Blood glucose decreased	27.56	15.28	5	127283	24154	70777002
Hepatectomy	27.55	15.28	11	127277	179	70800977
Hypothyroidism	27.39	15.28	25	127263	45730	70755426
Device issue	27.35	15.28	5	127283	24020	70777136
Tumour ulceration	27.28	15.28	11	127277	184	70800972
Multiple sclerosis	27.24	15.28	6	127282	25279	70775877
Tooth disorder	27.21	15.28	5	127283	23933	70777223
Musculoskeletal pain	27.07	15.28	78	127210	90249	70710907
Gastric varices haemorrhage	26.98	15.28	13	127275	338	70800818
Koebner phenomenon	26.98	15.28	8	127280	49	70801107
Perineal disorder	26.90	15.28	7	127281	24	70801132
Blood creatine phosphokinase increased	26.59	15.28	43	127245	61220	70739936
Tendonitis	26.53	15.28	4	127284	22118	70779038
Hyperfibrinolysis	26.47	15.28	7	127281	26	70801130
Hypoacusis	26.46	15.28	8	127280	27261	70773895
Impaired healing	26.33	15.28	59	127229	74315	70726841
Oesophagitis	26.30	15.28	95	127193	22557	70778599
Device related infection	26.26	15.28	121	127167	32064	70769092
Hypoaesthesia oral	26.21	15.28	64	127224	12236	70788920
Skin laceration	26.20	15.28	7	127281	25871	70775285
Endothelial dysfunction	26.09	15.28	11	127277	207	70800949
Blood pressure diastolic decreased	26.05	15.28	7	127281	25773	70775383
Poor quality sleep	26.03	15.28	3	127285	20346	70780810
Chest discomfort	25.93	15.28	339	126949	124042	70677114
Death	25.92	15.28	707	126581	509354	70291802
Hepatic encephalopathy	25.89	15.28	93	127195	22025	70779131
Pharyngeal dyskinesia	25.82	15.28	8	127280	58	70801098
Necrotising oesophagitis	25.70	15.28	16	127272	697	70800459
Fistula of small intestine	25.70	15.28	16	127272	697	70800459
Gait inability	25.69	15.28	28	127260	47147	70754009
Dry eye	25.52	15.28	13	127275	32269	70768887
Cholestasis	25.43	15.28	160	127128	47712	70753444
Mucosal disorder	25.36	15.28	30	127258	3168	70797988
Premature delivery	25.21	15.28	4	127284	21300	70779856
Gastrointestinal necrosis	25.15	15.28	38	127250	5080	70796076
Full blood count decreased	25.12	15.28	6	127282	23912	70777244
Pulmonary hypertension	24.93	15.28	28	127260	46508	70754648
Tonic clonic movements	24.92	15.28	24	127264	2003	70799153
Night sweats	24.83	15.28	25	127263	43659	70757497
Sinus bradycardia	24.67	15.28	6	127282	23617	70777539
Rectal cancer recurrent	24.63	15.28	7	127281	36	70801120
Haemorrhage intracranial	24.53	15.28	7	127281	24770	70776386
Pseudocirrhosis	24.46	15.28	15	127273	636	70800520
Oropharyngeal spasm	24.43	15.28	12	127276	326	70800830
Drug ineffective for unapproved indication	24.36	15.28	20	127268	38518	70762638
Abdominal wall oedema	24.28	15.28	5	127283	3	70801153
Acute polyneuropathy	24.26	15.28	13	127275	425	70800731
Gene mutation	24.24	15.28	25	127263	2266	70798890
Limb injury	24.19	15.28	8	127280	25744	70775412
Diffuse large B-cell lymphoma	23.99	15.28	65	127223	13237	70787919
Gastrointestinal stoma complication	23.98	15.28	25	127263	2295	70798861
Pulmonary fibrosis	23.70	15.28	123	127165	34187	70766969
Loss of consciousness	23.69	15.28	402	126886	155314	70645842
Post embolisation syndrome	23.65	15.28	8	127280	79	70801077
Subacute cutaneous lupus erythematosus	23.61	15.28	29	127259	3184	70797972
Platelet count increased	23.56	15.28	4	127284	20269	70780887
Intervertebral disc protrusion	23.38	15.28	5	127283	21498	70779658
Nephrotic syndrome	23.35	15.28	56	127232	10584	70790572
Atypical haemolytic uraemic syndrome	23.34	15.28	16	127272	822	70800334
Perihepatic abscess	23.33	15.28	9	127279	133	70801023
Vasospasm	23.28	15.28	17	127271	966	70800190
Respiratory arrest	23.27	15.28	38	127250	53895	70747261
Abdominal abscess	23.11	15.28	42	127246	6536	70794620
Retroperitoneal abscess	23.07	15.28	12	127276	369	70800787
Product substitution issue	23.01	15.28	3	127285	18510	70782646
Mixed adenoneuroendocrine carcinoma	22.96	15.28	6	127282	21	70801135
Acral peeling skin syndrome	22.81	15.28	7	127281	49	70801107
Therapy interrupted	22.79	15.28	8	127280	24794	70776362
Livedo reticularis	22.78	15.28	31	127257	3767	70797389
Obstruction gastric	22.76	15.28	20	127268	1484	70799672
Hallucination, auditory	22.71	15.28	3	127285	18325	70782831
Hepatic lesion	22.70	15.28	40	127248	6077	70795079
Catheter site extravasation	22.69	15.28	12	127276	382	70800774
Seizure	22.66	15.28	207	127081	177755	70623401
Interventricular septum rupture	22.54	15.28	6	127282	23	70801133
Pain in jaw	22.50	15.28	26	127262	42643	70758513
Cardiomegaly	22.41	15.28	8	127280	24537	70776619
Infection	22.38	15.28	256	127032	210529	70590627
Surgery	22.36	15.28	13	127275	29976	70771180
Hypersomnia	22.22	15.28	5	127283	20759	70780397
Adenocarcinoma gastric	22.19	15.28	21	127267	1715	70799441
Organising pneumonia	22.17	15.28	53	127235	9997	70791159
Renal hydrocele	22.14	15.28	6	127282	25	70801131
Hyperlipasaemia	22.14	15.28	17	127271	1043	70800113
Disease recurrence	22.08	15.28	129	127159	37474	70763682
Allodynia	22.04	15.28	19	127269	1374	70799782
Protein urine	22.00	15.28	19	127269	1377	70799779
Pancreatic neuroendocrine tumour metastatic	21.97	15.28	9	127279	157	70800999
Epistaxis	21.93	15.28	281	127007	102346	70698810
Limbic encephalitis	21.87	15.28	15	127273	771	70800385
Gout	21.87	15.28	7	127281	22999	70778157
Venoocclusive disease	21.81	15.28	32	127256	4168	70796988
Labelled drug-drug interaction medication error	21.79	15.28	8	127280	24119	70777037
Pigmentation disorder	21.79	15.28	35	127253	4931	70796225
Microangiopathic haemolytic anaemia	21.77	15.28	19	127269	1397	70799759
Metastases to muscle	21.76	15.28	11	127277	318	70800838
Rectal adenocarcinoma	21.72	15.28	19	127269	1401	70799755
Gallbladder disorder	21.71	15.28	3	127285	17709	70783447
Blood alkaline phosphatase abnormal	21.63	15.28	15	127273	785	70800371
Blood potassium increased	21.60	15.28	11	127277	27315	70773841
Eczema impetiginous	21.59	15.28	6	127282	28	70801128
Astringent therapy	21.59	15.28	6	127282	28	70801128
Cardiospasm	21.59	15.28	6	127282	28	70801128
Fingerprint loss	21.57	15.28	7	127281	60	70801096
Peripheral nerve injury	21.51	15.28	14	127274	659	70800497
Hepatic vein stenosis	21.37	15.28	7	127281	62	70801094
Proctitis	21.27	15.28	29	127259	3529	70797627
Prostatic calcification	21.27	15.28	7	127281	63	70801093
Tremor	21.27	15.28	395	126893	155229	70645927
Female genital tract fistula	21.20	15.28	27	127261	3076	70798080
No adverse event	21.19	15.28	16	127272	32137	70769019
Cardiac ventricular disorder	21.15	15.28	11	127277	338	70800818
Ischiorectal hernia	21.15	15.28	5	127283	10	70801146
Hand-foot-genital syndrome	21.15	15.28	5	127283	10	70801146
Axonal and demyelinating polyneuropathy	21.15	15.28	5	127283	10	70801146
Venous thrombosis limb	21.09	15.28	31	127257	4044	70797112
Skin disorder	21.09	15.28	109	127179	30248	70770908
Musculoskeletal disorder	21.00	15.28	5	127283	19966	70781190
Oedema	20.94	15.28	105	127183	103476	70697680
Sciatica	20.88	15.28	9	127279	24618	70776538
Hiatus hernia	20.87	15.28	6	127282	21128	70780028
Liver function test increased	20.86	15.28	18	127270	33829	70767327
Toothache	20.63	15.28	4	127284	18426	70782730
Hemiparaesthesia	20.57	15.28	8	127280	121	70801035
Cachexia	20.55	15.28	51	127237	9849	70791307
Skin discolouration	20.50	15.28	22	127266	37303	70763853
Amnesia	20.47	15.28	39	127249	52116	70749040
Hypocapnia	20.36	15.28	13	127275	592	70800564
Therapeutic response unexpected	20.31	15.28	4	127284	18227	70782929
Vocal cord paralysis	20.31	15.28	23	127265	2318	70798838
Oesophageal fistula	20.30	15.28	11	127277	368	70800788
Tumour haemorrhage	20.26	15.28	29	127259	3693	70797463
Hepatic infarction	20.26	15.28	15	127273	871	70800285
Gastric disorder	20.20	15.28	18	127270	33304	70767852
Swelling face	20.08	15.28	53	127235	63111	70738045
Induration	19.92	15.28	20	127268	1756	70799400
Thrombotic thrombocytopenic purpura	19.90	15.28	38	127250	6139	70795017
Delirium	19.84	15.28	68	127220	74546	70726610
Drug eruption	19.84	15.28	25	127263	39471	70761685
Gastrointestinal mucosal necrosis	19.81	15.28	9	127279	204	70800952
Diaphragmatic paralysis	19.75	15.28	16	127272	1061	70800095
Musculoskeletal discomfort	19.69	15.28	4	127284	17828	70783328
Catheter site bruise	19.51	15.28	10	127278	298	70800858
Impaired work ability	19.49	15.28	3	127285	16337	70784819
Dry skin	19.44	15.28	169	127119	55762	70745394
Tachypnoea	19.32	15.28	102	127186	28536	70772620
Immunodeficiency	19.25	15.28	4	127284	17551	70783605
Therapy non-responder	19.19	15.28	72	127216	76843	70724313
Implant site dehiscence	19.19	15.28	6	127282	45	70801111
Anger	19.15	15.28	3	127285	16129	70785027
Peripheral ischaemia	19.12	15.28	46	127242	8712	70792444
Metastases to diaphragm	19.07	15.28	6	127282	46	70801110
Macroglossia	19.07	15.28	16	127272	1115	70800041
Product administration error	19.06	15.28	15	127273	29508	70771648
Heart rate increased	19.03	15.28	112	127176	106036	70695120
Anal sphincter atony	19.00	15.28	10	127278	315	70800841
Oesophagobronchial fistula	18.93	15.28	9	127279	227	70800929
Monocytopenia	18.86	15.28	8	127280	153	70801003
Eye pain	18.84	15.28	20	127268	34082	70767074
Catabolic state	18.83	15.28	7	127281	93	70801063
Infusion site hypoaesthesia	18.82	15.28	5	127283	19	70801137
Chemotherapy cardiotoxicity attenuation	18.82	15.28	5	127283	19	70801137
Lymphangiosis carcinomatosa	18.78	15.28	20	127268	1881	70799275
Mental impairment	18.78	15.28	4	127284	17251	70783905
Mucocutaneous rash	18.64	15.28	6	127282	50	70801106
Restless legs syndrome	18.63	15.28	5	127283	18423	70782733
Pulmonary congestion	18.62	15.28	11	127277	25143	70776013
Impaired quality of life	18.58	15.28	46	127242	8870	70792286
Bradycardia	18.56	15.28	139	127149	124476	70676680
Extrapyramidal disorder	18.54	15.28	7	127281	20743	70780413
Intrahepatic portal hepatic venous fistula	18.53	15.28	4	127284	4	70801152
Neonatal asphyxia	18.53	15.28	4	127284	4	70801152
Inferior vena cava stenosis	18.53	15.28	6	127282	51	70801105
Eczema	18.45	15.28	20	127268	33761	70767395
Pruritus	18.45	15.28	777	126511	344783	70456373
Hypercholesterolaemia	18.16	15.28	5	127283	18112	70783044
Inflammation	18.13	15.28	76	127212	78589	70722567
Pneumoperitoneum	18.09	15.28	24	127264	2845	70798311
Cholelithiasis	18.06	15.28	36	127252	47304	70753852
Cognitive disorder	18.00	15.28	53	127235	60903	70740253
Aplastic anaemia	17.94	15.28	4	127284	16712	70784444
Bursitis	17.93	15.28	13	127275	26660	70774496
Osteopenia	17.91	15.28	4	127284	16693	70784463
Endometrial dysplasia	17.71	15.28	5	127283	25	70801131
Malaise	17.70	15.28	948	126340	431984	70369172
Radiation interaction	17.67	15.28	6	127282	60	70801096
Tetany	17.63	15.28	21	127267	2233	70798923
Metastases to retroperitoneum	17.56	15.28	10	127278	369	70800787
Fistula	17.49	15.28	51	127237	10830	70790326
Pneumonitis	17.46	15.28	162	127126	54435	70746721
Soft tissue necrosis	17.45	15.28	13	127275	762	70800394
Mental disorder	17.42	15.28	15	127273	28225	70772931
Mucosal necrosis	17.42	15.28	7	127281	116	70801040
Cerebrovascular accident	17.35	15.28	169	127119	143301	70657855
Splenic abscess	17.35	15.28	11	127277	495	70800661
Disability	17.31	15.28	3	127285	14980	70786176
Aortic intramural haematoma	17.31	15.28	7	127281	118	70801038
Pachymeningitis	17.26	15.28	9	127279	278	70800878
Therapy cessation	17.24	15.28	21	127267	33655	70767501
Tumour fistulisation	17.24	15.28	5	127283	28	70801128
VIth nerve disorder	17.24	15.28	5	127283	28	70801128
Palpitations	17.24	15.28	122	127166	110631	70690525
Feeling cold	17.20	15.28	91	127197	25479	70775677
Renal disorder	17.14	15.28	26	127262	37983	70763173
Nephritis allergic	17.09	15.28	12	127276	641	70800515
Gastrointestinal obstruction	17.03	15.28	17	127271	1482	70799674
Fear	17.02	15.28	8	127280	20803	70780353
Acute promyelocytic leukaemia	17.00	15.28	17	127271	1485	70799671
Depressed mood	16.99	15.28	33	127255	43787	70757369
Blood triglycerides increased	16.97	15.28	7	127281	19657	70781499
Colon cancer recurrent	16.94	15.28	7	127281	125	70801031
Motion sickness	16.85	15.28	13	127275	803	70800353
Aplasia	16.82	15.28	39	127249	7212	70793944
Laboratory test abnormal	16.82	15.28	13	127275	25810	70775346
Jaw operation	16.81	15.28	13	127275	806	70800350
Metastatic neoplasm	16.74	15.28	30	127258	4618	70796538
Cerebral vasoconstriction	16.73	15.28	16	127272	1324	70799832
Aortic dissection	16.73	15.28	27	127261	3820	70797336
Coombs test positive	16.71	15.28	8	127280	205	70800951
Lacrimation disorder	16.60	15.28	4	127284	9	70801147
Biliary cancer metastatic	16.60	15.28	4	127284	9	70801147
Blindness transient	16.45	15.28	29	127259	4407	70796749
Abdominal sepsis	16.45	15.28	19	127269	1956	70799200
Ichthyosis	16.40	15.28	7	127281	136	70801020
Vascular access site occlusion	16.32	15.28	6	127282	77	70801079
Venous injury	16.31	15.28	12	127276	690	70800466
Neutrophil count abnormal	16.29	15.28	24	127264	3137	70798019
Chronic myeloid leukaemia	16.28	15.28	28	127260	4173	70796983
Myoclonus	16.26	15.28	14	127274	26341	70774815
Neoplasm recurrence	16.24	15.28	27	127261	3914	70797242
Dementia	16.24	15.28	10	127278	22355	70778801
Xerosis	16.22	15.28	14	127274	1014	70800142
Colorectal cancer recurrent	16.19	15.28	6	127282	79	70801077
Onycholysis	16.13	15.28	18	127270	1785	70799371
Gastritis	16.09	15.28	35	127253	44556	70756600
Hyperthyroidism	16.01	15.28	8	127280	20083	70781073
Hepatic fibrosis	15.98	15.28	35	127253	6232	70794924
Neuronal neuropathy	15.97	15.28	3	127285	0	70801156
Tunnel vision	15.94	15.28	15	127273	1216	70799940
Ventricular fibrillation	15.91	15.28	93	127195	27018	70774138
Movement disorder	15.91	15.28	12	127276	24117	70777039
Colonic fistula	15.89	15.28	11	127277	574	70800582
Hypertriglyceridaemia	15.87	15.28	52	127236	11759	70789397
Back pain	15.85	15.28	368	126920	270784	70530372
Ankle fracture	15.82	15.28	4	127284	15340	70785816
Sputum discoloured	15.81	15.28	7	127281	18844	70782312
Lymphadenopathy mediastinal	15.73	15.28	27	127261	4018	70797138
Sepsis	15.67	15.28	561	126727	243984	70557172
Gastric dilatation	15.66	15.28	15	127273	1243	70799913
Red blood cell count decreased	15.66	15.28	45	127243	52116	70749040
C-reactive protein increased	15.65	15.28	125	127163	110392	70690764
Tumour marker increased	15.65	15.28	26	127262	3768	70797388
Gastric varices	15.59	15.28	11	127277	592	70800564
Gastrointestinal stoma output increased	15.53	15.28	8	127280	241	70800915
Live birth	15.40	15.28	3	127285	13776	70787380
Pallor	15.40	15.28	126	127162	40848	70760308
Chronic kidney disease	15.33	15.28	57	127231	61000	70740156
Coombs positive haemolytic anaemia	15.32	15.28	13	127275	920	70800236
Sense of oppression	15.30	15.28	16	127272	1474	70799682

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	L01XA03	ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS ANTINEOPLASTIC AGENTS OTHER ANTINEOPLASTIC AGENTS Platinum compounds
FDA EXT	N0000175073	Platinum-containing Compounds
FDA EPC	N0000175413	Platinum-based Drug
MeSH PA	D000970	Antineoplastic Agents
CHEBI has role	CHEBI:25435	mutagens
CHEBI has role	CHEBI:35610	antineoplastic agents

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

Disease	Relation	SNOMED_ID	DOID
Metastasis from malignant tumor of colon	indication	314998002
Small intestine cancer	indication	363509000	DOID:10154
Lymph Node Positive Colorectal Carcinoma	indication
Malignant tumor of colon	off-label use	363406005	DOID:219
Malignant tumor of testis	off-label use	363449006	DOID:2998
Adenocarcinoma of pancreas	off-label use	700423003	DOID:4074
Fibrosis of lung	contraindication	51615001	DOID:3770
Interstitial pneumonia	contraindication	64667001
Kidney disease	contraindication	90708001	DOID:557
Liver function tests abnormal	contraindication	166603001
Disease of liver	contraindication	235856003	DOID:409
Pregnancy, function	contraindication	289908002
Peripheral nerve disease	contraindication	302226006
Breastfeeding (mother)	contraindication	413712001

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

None

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

None

External reference:

ID	Source
4021355	VUID
N0000148774	NUI
D01790	KEGG_DRUG
4021355	VANDF
C0069717	UMLSCUI
CHEBI:31941	CHEBI
1PT	PDB_CHEM_ID
CHEMBL414804	ChEMBL_ID
D000077150	MESH_DESCRIPTOR_UI
DB00526	DRUGBANK_ID
7433	IUPHAR_LIGAND_ID
6012	INN_ID
04ZR38536J	UNII
9887053	PUBCHEM_CID
32592	RXNORM
165344	MMSL
16916	MMSL
d04811	MMSL
007166	NDDF
327032007	SNOMEDCT_US
395814003	SNOMEDCT_US

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Oxaliplatin	HUMAN PRESCRIPTION DRUG LABEL	1	0703-3985	INJECTION, SOLUTION, CONCENTRATE	50 mg	INTRAVENOUS	NDA	28 sections
Oxaliplatin	HUMAN PRESCRIPTION DRUG LABEL	1	0703-3985	INJECTION, SOLUTION, CONCENTRATE	50 mg	INTRAVENOUS	NDA	28 sections
Oxaliplatin	HUMAN PRESCRIPTION DRUG LABEL	1	0703-3986	INJECTION, SOLUTION, CONCENTRATE	100 mg	INTRAVENOUS	NDA	28 sections
Oxaliplatin	HUMAN PRESCRIPTION DRUG LABEL	1	0703-3986	INJECTION, SOLUTION, CONCENTRATE	100 mg	INTRAVENOUS	NDA	28 sections
Oxaliplatin	HUMAN PRESCRIPTION DRUG LABEL	1	0781-3315	INJECTION, SOLUTION	5 mg	INTRAVENOUS	ANDA	29 sections
Oxaliplatin	HUMAN PRESCRIPTION DRUG LABEL	1	0781-3317	INJECTION, SOLUTION	5 mg	INTRAVENOUS	ANDA	29 sections
Oxaliplatin	HUMAN PRESCRIPTION DRUG LABEL	1	0781-9315	INJECTION, SOLUTION	5 mg	INTRAVENOUS	ANDA	28 sections
Oxaliplatin	HUMAN PRESCRIPTION DRUG LABEL	1	0781-9317	INJECTION, SOLUTION	5 mg	INTRAVENOUS	ANDA	28 sections
OXALIPLATIN	HUMAN PRESCRIPTION DRUG LABEL	1	0955-1725	INJECTION, SOLUTION, CONCENTRATE	5 mg	INTRAVENOUS	NDA AUTHORIZED GENERIC	33 sections
OXALIPLATIN	HUMAN PRESCRIPTION DRUG LABEL	1	0955-1727	INJECTION, SOLUTION, CONCENTRATE	5 mg	INTRAVENOUS	NDA AUTHORIZED GENERIC	33 sections
OXALIPLATIN	HUMAN PRESCRIPTION DRUG LABEL	1	0955-1731	INJECTION, SOLUTION, CONCENTRATE	5 mg	INTRAVENOUS	NDA AUTHORIZED GENERIC	33 sections
OXALIPLATIN	HUMAN PRESCRIPTION DRUG LABEL	1	0955-1733	INJECTION, SOLUTION, CONCENTRATE	5 mg	INTRAVENOUS	NDA AUTHORIZED GENERIC	33 sections
oxaliplatin	HUMAN PRESCRIPTION DRUG LABEL	1	16714-727	INJECTION	5 mg	INTRAVENOUS	ANDA	27 sections
oxaliplatin	HUMAN PRESCRIPTION DRUG LABEL	1	16714-728	INJECTION	5 mg	INTRAVENOUS	ANDA	27 sections
oxaliplatin	HUMAN PRESCRIPTION DRUG LABEL	1	16729-332	INJECTION, SOLUTION, CONCENTRATE	5 mg	INTRAVENOUS	ANDA	30 sections
oxaliplatin	HUMAN PRESCRIPTION DRUG LABEL	1	25021-233	INJECTION, SOLUTION	5 mg	INTRAVENOUS	ANDA	28 sections
Oxaliplatin	HUMAN PRESCRIPTION DRUG LABEL	1	43066-014	INJECTION, SOLUTION	5 mg	INTRAVENOUS	ANDA	28 sections
Oxaliplatin	HUMAN PRESCRIPTION DRUG LABEL	1	43066-018	INJECTION, SOLUTION	5 mg	INTRAVENOUS	ANDA	28 sections
Oxaliplatin	HUMAN PRESCRIPTION DRUG LABEL	1	45963-611	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	5 mg	INTRAVENOUS	ANDA	20 sections
Oxaliplatin	HUMAN PRESCRIPTION DRUG LABEL	1	45963-611	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	5 mg	INTRAVENOUS	ANDA	20 sections
Oxaliplatin	Human Prescription Drug Label	1	47335-046	INJECTION, SOLUTION, CONCENTRATE	50 mg	INTRAVENOUS	ANDA	27 sections
Oxaliplatin	Human Prescription Drug Label	1	47335-047	INJECTION, SOLUTION, CONCENTRATE	100 mg	INTRAVENOUS	ANDA	27 sections
Oxaliplatin	Human Prescription Drug Label	1	47335-176	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	50 mg	INTRAVENOUS	ANDA	28 sections
Oxaliplatin	Human Prescription Drug Label	1	47335-178	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	100 mg	INTRAVENOUS	ANDA	28 sections
Oxaliplatin	HUMAN PRESCRIPTION DRUG LABEL	1	50742-405	INJECTION, SOLUTION	50 mg	INTRAVENOUS	ANDA	26 sections
Oxaliplatin	HUMAN PRESCRIPTION DRUG LABEL	1	50742-406	INJECTION, SOLUTION	100 mg	INTRAVENOUS	ANDA	26 sections
Oxaliplatin	Human Prescription Drug Label	1	55150-331	INJECTION, SOLUTION	5 mg	INTRAVENOUS	ANDA	29 sections
Oxaliplatin	Human Prescription Drug Label	1	55150-332	INJECTION, SOLUTION	5 mg	INTRAVENOUS	ANDA	29 sections
Oxaliplatin	HUMAN PRESCRIPTION DRUG LABEL	1	57277-001	INJECTION, SOLUTION	5 mg	INTRAVENOUS	ANDA	26 sections
Oxaliplatin	HUMAN PRESCRIPTION DRUG LABEL	1	57277-002	INJECTION, SOLUTION	5 mg	INTRAVENOUS	ANDA	26 sections