cisplatin Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
antineoplastic agents, platinum derivatives	4392	15663-27-1

Description:

Molecule

Description

Synonyms: cisplatin platinum diamminodichloride cis-Platinum

An inorganic and water-soluble platinum complex. After undergoing hydrolysis, it reacts with DNA to produce both intra and interstrand crosslinks. These crosslinks appear to impair replication and transcription of DNA. The cytotoxicity of cisplatin correlates with cellular arrest in the G2 phase of the cell cycle. Molecular weight: 300.05 Formula: Cl2H6N2Pt 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)	2.53 mg/mL	Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine)	2.30 %	Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose)	4.75 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD

Approvals:

Date	Agency	Company	Orphan
Dec. 19, 1978	FDA	HQ SPCLT PHARMA

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
Febrile neutropenia	923.86	15.53	770	47306	93857	46544129
Neutropenia	832.47	15.53	873	47203	142331	46495655
Thrombocytopenia	508.27	15.53	638	47438	125943	46512043
Malignant neoplasm progression	438.55	15.53	430	47646	64496	46573490
Bone marrow failure	435.04	15.53	308	47768	29361	46608625
Haematotoxicity	418.09	15.53	183	47893	6750	46631236
Mucosal inflammation	397.83	15.53	326	47750	38650	46599336
Vomiting	350.23	15.53	1140	46936	451654	46186332
Disease progression	329.67	15.53	437	47639	90863	46547123
Ototoxicity	311.93	15.53	91	47985	978	46637008
Pancytopenia	272.05	15.53	384	47692	84674	46553312
Anaemia	257.53	15.53	708	47368	255071	46382915
Dehydration	237.83	15.53	514	47562	159026	46478960
Acute myeloid leukaemia	236.27	15.53	166	47910	15612	46622374
Posterior reversible encephalopathy syndrome	235.38	15.53	163	47913	14978	46623008
Second primary malignancy	223.15	15.53	117	47959	6467	46631519
Nausea	217.52	15.53	1325	46751	686129	45951857
Leukopenia	211.75	15.53	304	47772	68039	46569947
Hypomagnesaemia	202.19	15.53	174	47902	22036	46615950
Renal salt-wasting syndrome	185.22	15.53	43	48033	165	46637821
Arthralgia	183.86	15.53	73	48003	364530	46273456
Off label use	183.82	15.53	825	47251	379016	46258970
Ovarian germ cell teratoma	164.85	15.53	35	48041	78	46637908
Diffuse large B-cell lymphoma recurrent	161.47	15.53	60	48016	1432	46636554
Teratoma	160.20	15.53	37	48039	138	46637848
Deafness	158.80	15.53	132	47944	15936	46622050
Hypokalaemia	157.42	15.53	306	47770	87718	46550268
Fall	154.56	15.53	73	48003	329024	46308962
Myelosuppression	153.88	15.53	97	47979	7606	46630380
Neutrophil count decreased	144.55	15.53	200	47876	43226	46594760
Myelodysplastic syndrome	138.76	15.53	121	47955	15590	46622396
Neutropenic sepsis	136.04	15.53	108	47968	12216	46625770
Aortic thrombosis	133.86	15.53	47	48029	948	46637038
Metastases to central nervous system	127.44	15.53	100	47976	11121	46626865
Joint swelling	127.40	15.53	12	48064	166061	46471925
Gastrointestinal toxicity	127.24	15.53	70	48006	4261	46633725
Product dose omission issue	122.07	15.53	15	48061	168505	46469481
Drug ineffective	116.27	15.53	338	47738	677500	45960486
Nephropathy toxic	112.91	15.53	79	47997	7375	46630611
Diffuse large B-cell lymphoma refractory	112.57	15.53	41	48035	923	46637063
Drug hypersensitivity	111.46	15.53	56	48020	243769	46394217
Urogenital fistula	111.33	15.53	26	48050	103	46637883
Pyrexia	105.40	15.53	666	47410	348136	46289850
Neoplasm progression	104.33	15.53	133	47943	26550	46611436
Metastases to lung	103.88	15.53	87	47989	10609	46627377
Product use in unapproved indication	103.78	15.53	263	47813	90010	46547976
Platelet count decreased	101.34	15.53	278	47798	99746	46538240
Drug resistance	100.59	15.53	106	47970	17262	46620724
Peripheral swelling	94.97	15.53	23	48053	158048	46479938
Pain	92.83	15.53	223	47853	476725	46161261
Cardiotoxicity	92.05	15.53	67	48009	6655	46631331
Sepsis	89.83	15.53	326	47750	135688	46502298
Neurotoxicity	89.00	15.53	89	47987	13628	46624358
Weight increased	87.65	15.53	30	48046	164443	46473543
Oesophagitis	87.52	15.53	88	47988	13563	46624423
Headache	83.62	15.53	236	47840	478116	46159870
Pain in extremity	83.49	15.53	86	47990	258594	46379392
Hyponatraemia	82.89	15.53	261	47815	101071	46536915
Hypocalcaemia	81.18	15.53	118	47958	26667	46611319
Musculoskeletal stiffness	80.98	15.53	5	48071	97988	46539998
Hydronephrosis	79.88	15.53	68	48008	8477	46629509
Acute kidney injury	75.24	15.53	457	47619	235398	46402588
Tumour lysis syndrome	74.73	15.53	61	48015	7175	46630811
Hypophagia	74.53	15.53	119	47957	29187	46608799
Pulmonary embolism	74.00	15.53	263	47813	108322	46529664
Septic shock	71.06	15.53	173	47903	57720	46580266
Teratoma benign	70.74	15.53	16	48060	53	46637933
White blood cell count decreased	70.71	15.53	265	47811	111966	46526020
Injection site pain	69.64	15.53	13	48063	107139	46530847
Febrile bone marrow aplasia	69.09	15.53	57	48019	6805	46631181
Metastases to lymph nodes	68.69	15.53	56	48020	6575	46631411
Abdominal discomfort	68.59	15.53	35	48041	151130	46486856
Renal failure	67.28	15.53	263	47813	113331	46524655
Arthritis	66.84	15.53	3	48073	77313	46560673
Asthma	66.61	15.53	8	48068	91534	46546452
Neuropathy peripheral	66.12	15.53	225	47851	90668	46547318
Condition aggravated	63.82	15.53	96	47980	244956	46393030
Nasopharyngitis	63.63	15.53	40	48036	153958	46484028
Insomnia	62.61	15.53	47	48029	164877	46473109
Pruritus	61.14	15.53	97	47979	242255	46395731
Metastases to skin	59.89	15.53	29	48047	1351	46636635
Leukoencephalopathy	59.62	15.53	42	48034	3962	46634024
Electrolyte imbalance	58.28	15.53	80	47996	17146	46620840
Therapeutic product effect decreased	58.21	15.53	8	48068	82593	46555393
Arthropathy	57.84	15.53	9	48067	84691	46553295
Metastases to liver	57.49	15.53	85	47991	19500	46618486
Muscle spasms	56.59	15.53	28	48048	123085	46514901
Migraine	56.59	15.53	4	48072	70022	46567964
Metastases to breast	56.27	15.53	18	48058	269	46637717
Ascites	55.61	15.53	119	47957	36465	46601521
Cardiomyopathy	54.91	15.53	75	48001	15998	46621988
Depression	53.20	15.53	58	48018	170046	46467940
Gastrointestinal perforation	53.01	15.53	36	48040	3201	46634785
Diarrhoea	52.02	15.53	836	47240	558766	46079220
Oesophageal fistula	52.00	15.53	14	48062	109	46637877
Overdose	50.29	15.53	21	48055	101958	46536028
Polyneuropathy	50.25	15.53	61	48015	11583	46626403
Rash	49.70	15.53	194	47882	356318	46281668
Therapy partial responder	49.47	15.53	40	48036	4642	46633344
Contraindicated product administered	49.24	15.53	11	48065	79936	46558050
Palmar-plantar erythrodysaesthesia syndrome	49.21	15.53	81	47995	20370	46617616
Contusion	48.26	15.53	15	48061	87472	46550514
Abdominal pain	47.78	15.53	402	47674	229629	46408357
Myasthenia gravis crisis	47.55	15.53	17	48059	362	46637624
Large intestine perforation	47.01	15.53	48	48028	7532	46630454
Stomatitis	46.98	15.53	166	47910	68131	46569855
Renal tubular disorder	46.64	15.53	30	48046	2435	46635551
Swelling	46.58	15.53	36	48040	124475	46513511
Radiation skin injury	46.45	15.53	21	48055	836	46637150
Injection site erythema	46.32	15.53	10	48066	74417	46563569
Suicidal ideation	46.20	15.53	3	48073	56379	46581607
Ovarian cancer recurrent	46.16	15.53	22	48054	989	46636997
Renal tubular necrosis	45.84	15.53	56	48020	10703	46627283
Decreased appetite	45.83	15.53	349	47727	193487	46444499
Tinnitus	45.54	15.53	93	47983	27580	46610406
Feeling abnormal	44.49	15.53	38	48038	125022	46512964
Pleural effusion	44.26	15.53	186	47890	82766	46555220
Urticaria	44.21	15.53	34	48042	117858	46520128
Bronchitis	43.11	15.53	28	48048	105951	46532035
Gait disturbance	42.74	15.53	52	48024	145211	46492775
Deafness bilateral	41.79	15.53	22	48054	1225	46636761
Osteoarthritis	41.43	15.53	7	48069	62018	46575968
Mesenteric abscess	41.28	15.53	11	48065	82	46637904
Somnolence	41.02	15.53	61	48015	156460	46481526
Disease recurrence	40.26	15.53	70	48006	18401	46619585
Chemical peritonitis	39.96	15.53	11	48065	94	46637892
Blood creatinine increased	39.74	15.53	170	47906	76233	46561753
Sinusitis	39.73	15.53	45	48031	129723	46508263
Haemoglobin decreased	39.22	15.53	247	47829	128702	46509284
Large intestinal ulcer perforation	38.45	15.53	10	48066	67	46637919
Gastric perforation	38.12	15.53	21	48055	1281	46636705
Anastomotic leak	38.08	15.53	15	48061	421	46637565
Metastases to abdominal wall	37.95	15.53	10	48066	71	46637915
Loss of personal independence in daily activities	37.01	15.53	7	48069	57176	46580810
Inappropriate antidiuretic hormone secretion	36.86	15.53	58	48018	14044	46623942
Cystitis haemorrhagic	36.83	15.53	30	48046	3517	46634469
Embryonal rhabdomyosarcoma	36.83	15.53	7	48069	6	46637980
Nephritis bacterial	36.76	15.53	8	48068	21	46637965
Ureteric rupture	36.31	15.53	7	48069	7	46637979
Bicytopenia	35.87	15.53	22	48054	1642	46636344
Dizziness	35.79	15.53	205	47871	340209	46297777
Nasal abscess	35.65	15.53	11	48065	145	46637841
Encephalopathy	35.61	15.53	95	47981	33494	46604492
Metastases to peritoneum	35.36	15.53	26	48050	2622	46635364
Malignant transformation	35.31	15.53	13	48063	302	46637684
Performance status decreased	34.93	15.53	28	48048	3209	46634777
Melanoderma	34.92	15.53	11	48065	156	46637830
Neutropenic colitis	34.60	15.53	24	48052	2208	46635778
Wernicke's encephalopathy	34.19	15.53	8	48068	32	46637954
Metastases to bone	33.95	15.53	63	48013	17413	46620573
Dermatitis	33.81	15.53	56	48020	14152	46623834
Unevaluable event	33.67	15.53	4	48072	46171	46591815
Varicella zoster virus infection	33.55	15.53	24	48052	2319	46635667
Gastrointestinal fungal infection	33.46	15.53	12	48064	258	46637728
Haemophagocytic lymphohistiocytosis	33.26	15.53	42	48034	8300	46629686
Radiation injury	33.25	15.53	14	48062	468	46637518
Chloroma	33.13	15.53	11	48065	186	46637800
Hospitalisation	32.98	15.53	12	48064	63373	46574613
Cataract	32.95	15.53	4	48072	45411	46592575
Hypophosphataemia	32.45	15.53	39	48037	7328	46630658
Intentional product misuse	32.19	15.53	5	48071	47123	46590863
Cervix neoplasm	32.19	15.53	11	48065	204	46637782
Osteosarcoma	31.86	15.53	10	48066	140	46637846
Ovarian cancer	31.33	15.53	34	48042	5721	46632265
Abortion spontaneous	31.29	15.53	4	48072	43642	46594344
Nasal congestion	30.90	15.53	6	48070	48107	46589879
Injection site reaction	30.66	15.53	6	48070	47843	46590143
Anxiety	30.03	15.53	92	47984	181865	46456121
Axillary vein thrombosis	29.53	15.53	12	48064	366	46637620
Memory impairment	29.37	15.53	22	48054	77315	46560671
Respiratory symptom	29.18	15.53	21	48055	2049	46635937
Balance disorder	29.15	15.53	15	48061	64506	46573480
White blood cell count abnormal	29.14	15.53	31	48045	5101	46632885
Vesical fistula	28.99	15.53	8	48068	69	46637917
Ileus	28.97	15.53	52	48024	14012	46623974
Enteritis	28.52	15.53	35	48041	6720	46631266
Metastases to adrenals	28.46	15.53	14	48062	675	46637311
Herpes simplex encephalitis	28.43	15.53	11	48065	294	46637692
Cervix carcinoma	28.33	15.53	23	48053	2684	46635302
Influenza like illness	28.14	15.53	12	48064	57558	46580428
Stress	28.13	15.53	9	48067	51542	46586444
Radiation pneumonitis	28.08	15.53	17	48059	1240	46636746
Cervix cancer metastatic	28.02	15.53	7	48069	39	46637947
Sinus polyp	27.99	15.53	11	48065	307	46637679
Bladder perforation	27.92	15.53	9	48067	138	46637848
Malnutrition	27.86	15.53	51	48025	13952	46624034
Enterocolitis infectious	27.61	15.53	18	48058	1495	46636491
Cardiac tamponade	27.25	15.53	28	48048	4426	46633560
Injury	27.22	15.53	6	48070	44021	46593965
Wrong technique in product usage process	27.15	15.53	11	48065	54411	46583575
Fibromyalgia	26.98	15.53	3	48073	36460	46601526
Chronic obstructive pulmonary disease	26.63	15.53	13	48063	57620	46580366
Exposure during pregnancy	26.60	15.53	44	48032	108168	46529818
Venoocclusive liver disease	26.51	15.53	27	48049	4224	46633762
Thymus enlargement	26.47	15.53	8	48068	98	46637888
Alveolar soft part sarcoma	26.39	15.53	8	48068	99	46637887
Ovarian vein thrombosis	26.29	15.53	7	48069	52	46637934
Product quality issue	26.21	15.53	3	48073	35645	46602341
Renal impairment	26.14	15.53	148	47928	74224	46563762
Suicide attempt	26.07	15.53	12	48064	55024	46582962
Mobility decreased	26.04	15.53	15	48061	60579	46577407
Gastrooesophageal reflux disease	25.93	15.53	23	48053	74321	46563665
Metastases to meninges	25.91	15.53	19	48057	1908	46636078
Asthenia	25.91	15.53	457	47619	310618	46327368
Pericardial effusion	25.83	15.53	71	48005	25472	46612514
Osteosarcoma metastatic	25.65	15.53	6	48070	24	46637962
Haemolytic uraemic syndrome	25.55	15.53	21	48055	2493	46635493
Clostridium bacteraemia	25.34	15.53	9	48067	188	46637798
Malaise	25.21	15.53	219	47857	331013	46306973
Metastases to abdominal cavity	25.11	15.53	11	48065	406	46637580
Drug clearance decreased	25.09	15.53	15	48061	1069	46636917
Acoustic stimulation tests abnormal	24.92	15.53	8	48068	121	46637865
Cervix carcinoma recurrent	24.90	15.53	6	48070	28	46637958
Cardiac failure congestive	24.76	15.53	35	48041	91715	46546271
Aortic embolus	24.73	15.53	6	48070	29	46637957
Recall phenomenon	24.64	15.53	12	48064	566	46637420
Amputation stump pain	24.39	15.53	6	48070	31	46637955
Deep vein thrombosis	24.35	15.53	153	47923	79620	46558366
Myalgia	24.25	15.53	57	48019	123031	46514955
Hypoalbuminaemia	24.21	15.53	40	48036	10087	46627899
Neutrophil count abnormal	23.93	15.53	20	48056	2430	46635556
Burning sensation	23.80	15.53	8	48068	44403	46593583
Plasma cell leukaemia	23.76	15.53	15	48061	1178	46636808
Adverse drug reaction	23.76	15.53	8	48068	44354	46593632
Hiccups	23.62	15.53	15	48061	1191	46636795
Hepatic enzyme increased	23.29	15.53	30	48046	81757	46556229
Femur fracture	22.96	15.53	5	48071	36992	46600994
Vision blurred	22.94	15.53	29	48047	79679	46558307
Fluid retention	22.86	15.53	12	48064	51034	46586952
Stem cell transplant	22.82	15.53	17	48059	1749	46636237
Metastasis	22.65	15.53	25	48051	4287	46633699
Bacteraemia	22.56	15.53	47	48029	14132	46623854
Malignant peritoneal neoplasm	22.49	15.53	12	48064	687	46637299
Disseminated intravascular coagulation	22.46	15.53	56	48020	18949	46619037
Drug intolerance	22.41	15.53	77	47999	146972	46491014
Anti-Muellerian hormone level decreased	22.37	15.53	7	48069	97	46637889
Osteoporosis	22.32	15.53	7	48069	40601	46597385
Diffuse large B-cell lymphoma	22.26	15.53	29	48047	5909	46632077
Influenza	22.21	15.53	36	48040	89234	46548752
Enterococcal sepsis	22.17	15.53	15	48061	1325	46636661
Adrenocortical carcinoma	22.14	15.53	6	48070	48	46637938
Chronic kidney disease	22.06	15.53	92	47984	40779	46597207
Fistula of small intestine	21.74	15.53	9	48067	288	46637698
Vena cava thrombosis	21.73	15.53	18	48058	2161	46635825
Inappropriate schedule of product administration	21.62	15.53	21	48055	64992	46572994
Proctitis	21.54	15.53	16	48060	1639	46636347
Tumour haemorrhage	21.43	15.53	15	48061	1400	46636586
Vascular compression	21.38	15.53	7	48069	113	46637873
Oesophageal stenosis	21.33	15.53	20	48056	2829	46635157
Muscular weakness	21.06	15.53	39	48037	91805	46546181
Acquired gene mutation	21.02	15.53	11	48065	605	46637381
Acute myelomonocytic leukaemia	20.99	15.53	8	48068	205	46637781
Female genital tract fistula	20.98	15.53	21	48055	3218	46634768
Blood glucose increased	20.93	15.53	26	48050	71987	46565999
Pulmonary toxicity	20.92	15.53	25	48051	4668	46633318
Arteriospasm coronary	20.78	15.53	22	48054	3599	46634387
Oroticaciduria	20.75	15.53	4	48072	4	46637982
Diabetes mellitus	20.66	15.53	13	48063	50052	46587934
Neck pain	20.66	15.53	16	48060	55290	46582696
Blood magnesium decreased	20.57	15.53	39	48037	10953	46627033
Peripheral artery thrombosis	20.27	15.53	16	48060	1793	46636193
Salivary gland cancer	20.13	15.53	7	48069	137	46637849
Fatigue	20.04	15.53	476	47600	608221	46029765
Median nerve injury	19.99	15.53	5	48071	28	46637958
Incorrect dose administered	19.97	15.53	11	48065	45539	46592447
Peripheral sensory neuropathy	19.87	15.53	29	48047	6574	46631412
Peripheral ischaemia	19.86	15.53	24	48052	4535	46633451
Gastroenteritis radiation	19.85	15.53	10	48066	508	46637478
Metastases to pelvis	19.81	15.53	8	48068	240	46637746
Intestinal perforation	19.69	15.53	38	48038	10813	46627173
Failure to thrive	19.66	15.53	29	48047	6635	46631351
Maternal death affecting foetus	19.48	15.53	4	48072	7	46637979
VIth nerve paresis	19.45	15.53	6	48070	79	46637907
Medulloblastoma recurrent	19.32	15.53	6	48070	81	46637905
Purulent pericarditis	19.29	15.53	5	48071	33	46637953
Blister	19.24	15.53	11	48065	44620	46593366
Wheezing	19.24	15.53	16	48060	53370	46584616
Radiation oesophagitis	19.21	15.53	8	48068	260	46637726
Urogenital disorder	19.04	15.53	5	48071	35	46637951
Cytopenia	19.00	15.53	31	48045	7737	46630249
Leukaemic lymphoma	18.92	15.53	6	48070	87	46637899
Pain in jaw	18.75	15.53	8	48068	38364	46599622
Hypoglycaemia	18.73	15.53	17	48059	54332	46583654
Blood sodium decreased	18.69	15.53	57	48019	21669	46616317
Drug clearance increased	18.67	15.53	6	48070	91	46637895
Adverse event	18.60	15.53	6	48070	34178	46603808
Low cardiac output syndrome	18.47	15.53	8	48068	287	46637699
Refeeding syndrome	18.34	15.53	5	48071	41	46637945
Agitation	18.31	15.53	18	48058	55397	46582589
Radiation mucositis	18.13	15.53	5	48071	43	46637943
Gestational trophoblastic tumour	18.03	15.53	5	48071	44	46637942
Cerebral venous thrombosis	18.01	15.53	16	48060	2111	46635875
Central obesity	17.87	15.53	11	48065	826	46637160
Gastrointestinal necrosis	17.75	15.53	18	48058	2800	46635186
Pulmonary vascular disorder	17.75	15.53	8	48068	316	46637670
Transdifferentiation of neoplasm	17.74	15.53	4	48072	13	46637973
Emphysematous cholecystitis	17.64	15.53	3	48073	0	46637986
Tumour thrombosis	17.52	15.53	4	48072	14	46637972
Aorto-oesophageal fistula	17.52	15.53	4	48072	14	46637972
Sweat gland tumour	17.47	15.53	6	48070	113	46637873
Pelvic fluid collection	17.41	15.53	11	48065	865	46637121
Roseolovirus test positive	17.20	15.53	5	48071	53	46637933
Ovarian failure	17.15	15.53	12	48064	1120	46636866
Melanosis	17.10	15.53	4	48072	16	46637970
Myasthenic syndrome	17.09	15.53	7	48069	218	46637768
Therapy responder	17.05	15.53	8	48068	347	46637639
Mucosal erosion	17.05	15.53	13	48063	1385	46636601
Ovarian disorder	17.03	15.53	10	48066	689	46637297
Myocardial infarction	17.02	15.53	48	48028	97480	46540506
Lymphopenia	16.97	15.53	44	48032	15249	46622737
Multiple organ dysfunction syndrome	16.93	15.53	101	47975	51609	46586377
Eye pain	16.89	15.53	4	48072	27936	46610050
Hypoglossal nerve paresis	16.86	15.53	6	48070	126	46637860
Hallucination	16.77	15.53	16	48060	49935	46588051
Tumour invasion	16.73	15.53	6	48070	129	46637857
Aortitis	16.72	15.53	10	48066	713	46637273
Lip swelling	16.66	15.53	3	48073	25392	46612594
Tremor	16.65	15.53	62	48014	115577	46522409
Stent malfunction	16.64	15.53	5	48071	60	46637926
Marchiafava-Bignami disease	16.54	15.53	4	48072	19	46637967
Palpitations	16.54	15.53	47	48029	95212	46542774
Neoplasm recurrence	16.51	15.53	16	48060	2357	46635629
Wound	16.48	15.53	12	48064	42790	46595196
Drug interaction	16.46	15.53	132	47944	202962	46435024
Hypoaesthesia	16.30	15.53	65	48011	118804	46519182
Necrotising colitis	16.25	15.53	9	48067	555	46637431
Pregnancy	16.18	15.53	4	48072	27133	46610853
Multiple sclerosis	16.11	15.53	3	48073	24788	46613198
Sarcomatoid carcinoma	16.05	15.53	4	48072	22	46637964
Small fibre neuropathy	16.00	15.53	6	48070	147	46637839
Small cell lung cancer	15.87	15.53	13	48063	1536	46636450
Throat irritation	15.85	15.53	5	48071	28896	46609090
Genital abscess	15.81	15.53	6	48070	152	46637834
Gastric disorder	15.79	15.53	4	48072	26701	46611285
Radiation proctitis	15.56	15.53	3	48073	3	46637983
Osteoradionecrosis	15.56	15.53	6	48070	159	46637827
Malignant neoplasm of pleura	15.55	15.53	5	48071	76	46637910

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
Febrile neutropenia	1347.76	13.11	1434	67773	105259	29778012
Neutropenia	818.36	13.11	1228	67979	127312	29755959
Mucosal inflammation	736.23	13.11	590	68617	29904	29853367
Thrombocytopenia	485.18	13.11	1013	68194	136031	29747240
Dehydration	360.89	13.11	846	68361	122693	29760578
Malignant neoplasm progression	340.82	13.11	604	68603	71683	29811588
Bone marrow failure	331.99	13.11	376	68831	29409	29853862
Leukopenia	316.12	13.11	508	68699	55651	29827620
Pancytopenia	305.33	13.11	633	68574	84419	29798852
Vomiting	278.73	13.11	1123	68084	218695	29664576
Stomatitis	266.32	13.11	377	68830	36902	29846369
Neutropenic sepsis	264.95	13.11	216	68991	11193	29872078
Nausea	241.46	13.11	1333	67874	295624	29587647
Haematotoxicity	241.29	13.11	160	69047	6010	29877261
Dysphagia	223.56	13.11	439	68768	56259	29827012
Disease progression	215.60	13.11	531	68676	79343	29803928
Acute myeloid leukaemia	205.13	13.11	230	68977	17776	29865495
Second primary malignancy	197.27	13.11	143	69064	6213	29877058
Off label use	189.66	13.11	1100	68107	248190	29635081
Neoplasm progression	183.08	13.11	217	68990	17806	29865465
Anaemia	183.04	13.11	955	68252	207037	29676234
Pulmonary embolism	175.50	13.11	485	68722	77650	29805621
Neutrophil count decreased	170.05	13.11	331	68876	42123	29841148
Product dose omission issue	157.29	13.11	15	69192	91616	29791655
Fall	156.88	13.11	115	69092	181757	29701514
Aortic thrombosis	156.09	13.11	59	69148	626	29882645
Arthralgia	136.20	13.11	72	69135	135719	29747552
Nephropathy toxic	135.25	13.11	144	69063	10495	29872776
Renal salt-wasting syndrome	132.23	13.11	36	69171	111	29883160
Myelodysplastic syndrome	119.62	13.11	180	69027	18598	29864673
Hyponatraemia	118.44	13.11	383	68824	66819	29816452
Tumour lysis syndrome	116.02	13.11	146	69061	12739	29870532
Pyrexia	115.99	13.11	1112	68095	293377	29589894
Oesophagitis	112.60	13.11	134	69073	11037	29872234
Headache	110.78	13.11	156	69051	182150	29701121
Decreased appetite	110.66	13.11	657	68550	149253	29734018
Myelosuppression	109.18	13.11	108	69099	7214	29876057
Diffuse large B-cell lymphoma refractory	108.26	13.11	47	69160	730	29882541
Drug interaction	107.71	13.11	185	69022	199383	29683888
Anastomotic leak	107.66	13.11	44	69163	583	29882688
Septic shock	107.13	13.11	357	68850	63250	29820021
Cardiotoxicity	103.36	13.11	84	69123	4330	29878941
Therapy partial responder	103.20	13.11	78	69129	3613	29879658
Cardiac failure congestive	100.09	13.11	35	69172	84372	29798899
Overdose	99.96	13.11	35	69172	84302	29798969
Hypomagnesaemia	98.54	13.11	154	69053	16444	29866827
Arterial thrombosis	95.46	13.11	52	69155	1354	29881917
White blood cell count decreased	92.69	13.11	412	68795	83535	29799736
Odynophagia	91.22	13.11	79	69128	4448	29878823
Depression	90.54	13.11	48	69159	90389	29792882
Aorto-oesophageal fistula	89.23	13.11	21	69186	27	29883244
Rhabdomyolysis	89.16	13.11	19	69188	63561	29819710
Gastric perforation	88.77	13.11	57	69150	2024	29881247
Product use in unapproved indication	87.72	13.11	370	68837	73323	29809948
Febrile bone marrow aplasia	86.38	13.11	100	69107	7997	29875274
Radiation skin injury	84.11	13.11	38	69169	652	29882619
Hypophagia	83.71	13.11	169	69038	22067	29861204
Tinnitus	82.90	13.11	140	69067	15948	29867323
Diffuse large B-cell lymphoma recurrent	81.17	13.11	54	69153	2038	29881233
Vena cava thrombosis	79.90	13.11	42	69165	1016	29882255
Weight increased	77.61	13.11	38	69169	74875	29808396
Metastases to lung	76.77	13.11	93	69114	7802	29875469
Inappropriate antidiuretic hormone secretion	76.34	13.11	112	69095	11310	29871961
Deafness	75.99	13.11	106	69101	10219	29873052
Rheumatoid arthritis	75.52	13.11	5	69202	41192	29842079
Acute kidney injury	75.00	13.11	963	68244	272879	29610392
Peripheral swelling	74.70	13.11	24	69183	61050	29822221
Ototoxicity	74.21	13.11	44	69163	1352	29881919
Peripheral artery thrombosis	73.34	13.11	52	69155	2180	29881091
Osteoradionecrosis	71.54	13.11	20	69187	70	29883201
Anxiety	69.66	13.11	63	69144	89808	29793463
Neutropenic colitis	68.79	13.11	50	69157	2180	29881091
Suicide attempt	68.62	13.11	4	69203	36693	29846578
Muscle spasms	68.52	13.11	32	69175	64806	29818465
Splenic infarction	68.15	13.11	46	69161	1779	29881492
Intentional product misuse	67.29	13.11	3	69204	34664	29848607
Death	66.80	13.11	518	68689	356765	29526506
Metastases to central nervous system	66.30	13.11	83	69124	7201	29876070
Platelet count decreased	65.70	13.11	445	68762	105684	29777587
Peripheral ischaemia	65.68	13.11	71	69136	5263	29878008
Bacterial translocation	64.84	13.11	24	69183	239	29883032
Hospitalisation	64.73	13.11	12	69195	44307	29838964
Sepsis	64.53	13.11	567	68640	145828	29737443
Suicidal ideation	64.41	13.11	5	69202	36109	29847162
Insomnia	63.73	13.11	73	69134	93263	29790008
Asthma	61.82	13.11	6	69201	36168	29847103
Myalgia	61.52	13.11	52	69155	76615	29806656
Hypokalaemia	60.46	13.11	253	68954	49939	29833332
Joint swelling	60.03	13.11	17	69190	46929	29836342
Oesophageal fistula	59.20	13.11	21	69186	183	29883088
Drug ineffective	58.79	13.11	504	68703	339883	29543388
Cytomegalovirus oesophagitis	58.74	13.11	22	69185	227	29883044
Musculoskeletal stiffness	58.64	13.11	7	69200	35874	29847397
General physical health deterioration	58.26	13.11	413	68794	99531	29783740
Nasopharyngitis	57.76	13.11	32	69175	58817	29824454
Dermatitis	56.09	13.11	81	69126	8061	29875210
Pain in extremity	55.92	13.11	106	69101	110115	29773156
Acute respiratory distress syndrome	55.89	13.11	149	69058	23323	29859948
Hypoglycaemia	55.68	13.11	24	69183	50957	29832314
Gastrointestinal toxicity	55.18	13.11	42	69165	1966	29881305
Blood pressure increased	55.04	13.11	51	69156	71877	29811394
Portal venous gas	53.39	13.11	22	69185	298	29882973
Hypocalcaemia	53.24	13.11	138	69069	21238	29862033
Hiccups	52.50	13.11	85	69122	9349	29873922
Pneumonitis	52.46	13.11	161	69046	27293	29855978
Osteosarcoma	52.45	13.11	19	69188	177	29883094
Aplasia	51.93	13.11	55	69152	3982	29879289
Cardiac disorder	51.83	13.11	14	69193	39879	29843392
Diarrhoea	51.61	13.11	1069	68138	333034	29550237
Renal failure	50.97	13.11	488	68719	128478	29754793
Pulmonary vascular disorder	50.37	13.11	22	69185	347	29882924
B-cell lymphoma recurrent	49.91	13.11	26	69181	617	29882654
Oesophagobronchial fistula	49.64	13.11	17	69190	132	29883139
Blood creatine phosphokinase increased	48.91	13.11	20	69187	43828	29839443
Electrolyte imbalance	48.86	13.11	92	69115	11408	29871863
Ameloblastoma	48.74	13.11	15	69192	79	29883192
Hepatitis B	48.71	13.11	65	69142	6007	29877264
Hypertension	48.36	13.11	133	69074	121221	29762050
Dizziness	48.34	13.11	259	68948	194650	29688621
Pruritus	48.26	13.11	128	69079	118076	29765195
Tremor	48.20	13.11	62	69145	75301	29807970
Aggression	47.86	13.11	13	69194	36894	29846377
Oesophageal stenosis	47.71	13.11	35	69172	1548	29881723
Hallucination	47.67	13.11	27	69180	49032	29834239
Metastases to liver	47.50	13.11	93	69114	11872	29871399
Malignant transformation	47.38	13.11	26	69181	687	29882584
Tumour necrosis	46.77	13.11	30	69177	1063	29882208
Vision blurred	46.76	13.11	19	69188	41797	29841474
Radiation pneumonitis	46.76	13.11	38	69169	1958	29881313
Inappropriate schedule of product administration	46.17	13.11	17	69190	39711	29843560
Renal infarct	45.89	13.11	30	69177	1099	29882172
Condition aggravated	45.84	13.11	164	69043	137702	29745569
Colitis	45.77	13.11	166	69041	30654	29852617
Intestinal ischaemia	45.18	13.11	67	69140	6830	29876441
Injection site pain	44.71	13.11	8	69199	30302	29852969
Deafness neurosensory	44.69	13.11	40	69167	2353	29880918
Coronary artery disease	44.64	13.11	30	69177	49682	29833589
Salivary gland cancer	44.63	13.11	18	69189	230	29883041
Azoospermia	44.44	13.11	21	69186	401	29882870
Deep vein thrombosis	43.75	13.11	264	68943	60237	29823034
Gait disturbance	43.34	13.11	66	69141	74711	29808560
Feeling abnormal	42.53	13.11	41	69166	56715	29826556
Atypical haemolytic uraemic syndrome	42.51	13.11	14	69193	95	29883176
Somnolence	42.43	13.11	101	69106	96662	29786609
Disease recurrence	42.26	13.11	98	69109	14063	29869208
Metastases to lymph nodes	42.22	13.11	49	69158	3928	29879343
Radiation mucositis	42.13	13.11	14	69193	98	29883173
Myocardial infarction	40.73	13.11	151	69056	125474	29757797
Influenza	40.59	13.11	25	69182	43373	29839898
Carotid artery thrombosis	40.59	13.11	19	69188	355	29882916
Bacteraemia	40.35	13.11	102	69105	15458	29867813
Urticaria	40.27	13.11	40	69167	54566	29828705
Mobility decreased	40.27	13.11	6	69201	25993	29857278
Wheezing	39.92	13.11	11	69196	30927	29852344
Chemotherapy	39.54	13.11	21	69186	519	29882752
Angioedema	39.47	13.11	15	69192	34369	29848902
Pneumatosis intestinalis	38.85	13.11	39	69168	2651	29880620
Embolism	38.79	13.11	63	69144	6946	29876325
Neoplasm recurrence	38.46	13.11	33	69174	1834	29881437
Blood stem cell transplant failure	38.27	13.11	19	69188	406	29882865
Therapeutic product effect decreased	38.16	13.11	10	69197	29066	29854205
Palmar-plantar erythrodysaesthesia syndrome	38.06	13.11	97	69110	14773	29868498
Neuropathy peripheral	38.03	13.11	286	68921	70189	29813082
Tracheo-oesophageal fistula	38.02	13.11	19	69188	412	29882859
Nephrolithiasis	37.80	13.11	6	69201	24804	29858467
Foetal exposure during pregnancy	37.72	13.11	19	69188	36852	29846419
Chloroma	37.41	13.11	19	69188	427	29882844
Radiation oesophagitis	37.38	13.11	18	69189	359	29882912
Large intestine perforation	37.33	13.11	65	69142	7586	29875685
Heart rate decreased	37.17	13.11	3	69204	20991	29862280
Tumour haemorrhage	37.15	13.11	37	69170	2491	29880780
Wrong technique in product usage process	36.76	13.11	13	69194	31142	29852129
Adverse drug reaction	36.65	13.11	5	69202	23140	29860131
Drug hypersensitivity	36.42	13.11	64	69143	68455	29814816
Tumour perforation	35.81	13.11	16	69191	267	29883004
Enteritis	35.79	13.11	59	69148	6586	29876685
Neurosensory hypoacusis	35.51	13.11	7	69200	0	29883271
Memory impairment	35.34	13.11	21	69186	37153	29846118
Arthritis	34.79	13.11	7	69200	24394	29858877
Renal tubular disorder	34.77	13.11	50	69157	4956	29878315
Abdominal discomfort	34.55	13.11	37	69170	48754	29834517
Pulmonary arteriopathy	34.55	13.11	11	69196	66	29883205
Electrocardiogram QT prolonged	34.41	13.11	20	69187	35815	29847456
Testicular germ cell cancer metastatic	34.41	13.11	11	69196	67	29883204
Alopecia	34.03	13.11	110	69097	19165	29864106
Renal impairment	33.43	13.11	319	68888	83865	29799406
Influenza like illness	33.23	13.11	9	69198	25596	29857675
Rash	32.61	13.11	285	68922	191604	29691667
Confusional state	32.38	13.11	181	69026	134653	29748618
Recall phenomenon	32.16	13.11	19	69188	580	29882691
Arterial occlusive disease	32.02	13.11	43	69164	3997	29879274
Lymphopenia	31.77	13.11	84	69123	13079	29870192
Dyskinesia	31.69	13.11	6	69201	21828	29861443
Empyema	31.68	13.11	36	69171	2820	29880451
Unevaluable event	31.59	13.11	17	69190	31768	29851503
Injury	31.48	13.11	6	69201	21725	29861546
Balance disorder	31.47	13.11	23	69184	36470	29846801
Cerebral venous sinus thrombosis	31.39	13.11	15	69192	294	29882977
Erectile dysfunction	30.93	13.11	3	69204	18099	29865172
International normalised ratio increased	30.79	13.11	39	69168	47700	29835571
Oesophageal perforation	30.75	13.11	17	69190	456	29882815
Osteosarcoma recurrent	30.33	13.11	8	69199	21	29883250
Blood sodium decreased	30.29	13.11	93	69114	15763	29867508
Hypophosphataemia	30.23	13.11	62	69145	8183	29875088
Liver function test abnormal	30.11	13.11	17	69190	30933	29852338
Respiratory failure	29.99	13.11	360	68847	100282	29782989
Mantle cell lymphoma recurrent	29.71	13.11	16	69191	407	29882864
Cataract	29.64	13.11	7	69200	21828	29861443
Blood glucose increased	29.60	13.11	61	69146	61469	29821802
Thrombotic microangiopathy	29.53	13.11	63	69144	8547	29874724
Chronic obstructive pulmonary disease	29.42	13.11	38	69169	46088	29837183
Primitive neuroectodermal tumour	29.38	13.11	10	69197	76	29883195
Leukoencephalopathy	29.32	13.11	41	69166	3961	29879310
Malaise	29.24	13.11	246	68961	166716	29716555
Bronchial fistula	29.22	13.11	12	69195	161	29883110
Acquired gene mutation	29.11	13.11	23	69184	1138	29882133
Osteoarthritis	28.96	13.11	4	69203	18345	29864926
Pancreatitis	28.95	13.11	25	69182	36465	29846806
Depressed mood	28.64	13.11	3	69204	17026	29866245
Interstitial lung disease	28.47	13.11	237	68970	59960	29823311
Metastatic gastric cancer	28.38	13.11	12	69195	174	29883097
Muscular weakness	28.23	13.11	66	69141	63579	29819692
Bicytopenia	28.16	13.11	27	69180	1735	29881536
Cerebral ischaemia	28.09	13.11	51	69156	6149	29877122
Hypoacusis	28.02	13.11	84	69123	14055	29869216
Product prescribing error	28.00	13.11	3	69204	16730	29866541
Angina pectoris	27.60	13.11	17	69190	29501	29853770
Metastasis	27.52	13.11	36	69171	3262	29880009
Incorrect dose administered	27.28	13.11	20	69187	31666	29851605
Blood pressure fluctuation	27.20	13.11	4	69203	17499	29865772
Toxicity to various agents	26.73	13.11	271	68936	176912	29706359
Prostate cancer	26.59	13.11	11	69196	23946	29859325
Enterocolitis	26.57	13.11	52	69155	6635	29876636
Abnormal behaviour	26.51	13.11	13	69194	25610	29857661
Disseminated intravascular coagulation	26.09	13.11	111	69096	22060	29861211
Papillary thyroid cancer	26.00	13.11	17	69190	623	29882648
Emotional distress	25.94	13.11	3	69204	15762	29867509
Serotonin syndrome	25.79	13.11	5	69202	17886	29865385
Product quality issue	25.52	13.11	6	69201	18768	29864503
Extravasation	25.48	13.11	26	69181	1802	29881469
Hepatic candidiasis	25.41	13.11	8	69199	46	29883225
Blindness cortical	25.36	13.11	13	69194	298	29882973
Oesophageal carcinoma	25.27	13.11	34	69173	3167	29880104
Refractory cancer	25.13	13.11	10	69197	123	29883148
Nasal congestion	25.11	13.11	6	69201	18560	29864711
Retinal toxicity	25.01	13.11	14	69193	385	29882886
Gout	24.62	13.11	5	69202	17310	29865961
Road traffic accident	24.13	13.11	5	69202	17066	29866205
Arteriospasm coronary	24.09	13.11	30	69177	2588	29880683
Necrosis	23.98	13.11	43	69164	5136	29878135
Fluid retention	23.93	13.11	14	69193	24984	29858287
Morphoea	23.91	13.11	10	69197	141	29883130
Oedema peripheral	23.83	13.11	145	69062	105687	29777584
Gait inability	23.75	13.11	7	69200	18834	29864437
Soft tissue disorder	23.70	13.11	16	69191	619	29882652
Chest discomfort	23.69	13.11	43	69164	45437	29837834
Flagellate dermatitis	23.55	13.11	6	69201	13	29883258
Dermatitis acneiform	23.53	13.11	45	69162	5644	29877627
Irritability	23.39	13.11	12	69195	23038	29860233
Teratoma	23.24	13.11	6	69201	14	29883257
Blood HIV RNULL increased	23.20	13.11	22	69185	1394	29881877
Bradycardia	23.06	13.11	76	69131	65450	29817821
Adenocarcinoma gastric	23.01	13.11	20	69187	1131	29882140
Pneumothorax	23.01	13.11	86	69121	16107	29867164
Cerebral infarction	22.96	13.11	121	69086	26252	29857019
Contusion	22.96	13.11	23	69184	31257	29852014
Pulmonary toxicity	22.86	13.11	39	69168	4477	29878794
Refeeding syndrome	22.73	13.11	7	69200	37	29883234
Sedation	22.72	13.11	5	69202	16368	29866903
Accidental overdose	22.66	13.11	7	69200	18268	29865003
Necrosis ischaemic	22.51	13.11	11	69196	227	29883044
Plasma cell leukaemia	22.49	13.11	18	69189	907	29882364
Superior mesenteric artery syndrome	22.33	13.11	8	69199	72	29883199
Therapy cessation	22.31	13.11	4	69203	15133	29868138
Radiation injury	22.16	13.11	14	69193	483	29882788
Pain	22.10	13.11	274	68933	172367	29710904
Extremity necrosis	22.09	13.11	23	69184	1632	29881639
Herpes zoster	22.00	13.11	22	69185	29921	29853350
Blood cholesterol increased	21.96	13.11	6	69201	16964	29866307
Sleep disorder	21.66	13.11	15	69192	24464	29858807
Carotid artery dissection	21.57	13.11	9	69198	126	29883145
Procedural vomiting	21.51	13.11	9	69198	127	29883144
Blood creatinine increased	21.44	13.11	313	68894	91062	29792209
Metastases to peritoneum	21.44	13.11	22	69185	1535	29881736
Diabetes mellitus	21.43	13.11	40	69167	41825	29841446
Hypochloraemia	21.34	13.11	15	69192	620	29882651
Gastrooesophageal reflux disease	21.16	13.11	26	69181	32229	29851042
Drug clearance decreased	21.15	13.11	20	69187	1263	29882008
Embolism arterial	20.89	13.11	14	69193	535	29882736
Haematoma	20.77	13.11	15	69192	23938	29859333
Product administration error	20.76	13.11	4	69203	14373	29868898
Iliac artery occlusion	20.72	13.11	9	69198	140	29883131
Lactic acidosis	20.65	13.11	25	69182	31188	29852083
Vascular injury	20.52	13.11	11	69196	277	29882994
Gastrointestinal ischaemia	20.48	13.11	10	69197	206	29883065
Granulocyte count decreased	20.44	13.11	15	69192	664	29882607
Neurotoxicity	20.41	13.11	72	69135	13110	29870161
Back pain	20.35	13.11	146	69061	102450	29780821
Oral candidiasis	20.28	13.11	64	69143	11007	29872264
Cell-mediated immune deficiency	20.27	13.11	6	69201	27	29883244
Metastases to skin	20.26	13.11	12	69195	368	29882903
Blood glucose decreased	20.24	13.11	3	69204	13050	29870221
Coronary artery thrombosis	20.24	13.11	25	69182	2139	29881132
Drug intolerance	20.05	13.11	47	69160	45244	29838027
Non-small cell lung cancer	19.93	13.11	33	69174	3697	29879574
Campylobacter test positive	19.92	13.11	6	69201	29	29883242
Adrenocortical carcinoma	19.92	13.11	6	69201	29	29883242
Cholelithiasis	19.83	13.11	11	69196	20214	29863057
Small cell lung cancer	19.68	13.11	23	69184	1857	29881414
Cerebral venous thrombosis	19.62	13.11	14	69193	593	29882678
Full blood count decreased	19.52	13.11	6	69201	15711	29867560
Seminoma	19.48	13.11	10	69197	230	29883041
Localised infection	19.46	13.11	4	69203	13733	29869538
Drug resistance	19.37	13.11	95	69112	20038	29863233
Hypoalbuminaemia	19.30	13.11	63	69144	11029	29872242
Progressive multifocal leukoencephalopathy	19.25	13.11	55	69152	8958	29874313
Venous thrombosis	19.18	13.11	30	69177	3204	29880067
Transient ischaemic attack	19.11	13.11	18	69189	25182	29858089
Haematochezia	19.06	13.11	31	69176	34191	29849080
Transitional cell carcinoma recurrent	18.99	13.11	5	69202	13	29883258
Laryngeal pain	18.99	13.11	28	69179	2839	29880432
Oesophageal pain	18.90	13.11	15	69192	747	29882524
Wound	18.89	13.11	3	69204	12399	29870872
Medulloblastoma recurrent	18.89	13.11	7	69200	70	29883201
Pharyngeal inflammation	18.88	13.11	11	69196	327	29882944
Transformation to acute myeloid leukaemia	18.83	13.11	14	69193	632	29882639
Agitation	18.83	13.11	63	69144	54010	29829261
Eczema	18.72	13.11	4	69203	13365	29869906
Dropped head syndrome	18.62	13.11	7	69200	73	29883198
Myoclonus	18.60	13.11	4	69203	13308	29869963
COVID-19	18.60	13.11	9	69198	17869	29865402
Visceral venous thrombosis	18.47	13.11	5	69202	15	29883256
Pleural mesothelioma malignant	18.46	13.11	7	69200	75	29883196
Procedural nausea	18.46	13.11	7	69200	75	29883196
Haemoptysis	18.40	13.11	129	69078	30949	29852322
Intestinal infarction	18.35	13.11	13	69194	544	29882727
Mucosal toxicity	18.10	13.11	9	69198	193	29883078
Speech disorder	18.01	13.11	18	69189	24494	29858777
Pleural effusion	17.88	13.11	255	68952	73811	29809460
Sinusitis	17.84	13.11	31	69176	33314	29849957
Hyperlipidaemia	17.84	13.11	5	69202	13902	29869369
Chromaturia	17.75	13.11	5	69202	13860	29869411
Ureteric dilatation	17.72	13.11	8	69199	137	29883134
Trigeminal nerve paresis	17.53	13.11	4	69203	4	29883267
Dermatitis diaper	17.51	13.11	10	69197	286	29882985
Fanconi syndrome	17.40	13.11	21	69186	1754	29881517
Granulocyte-colony stimulating factor level increased	17.36	13.11	5	69202	20	29883251
Human chorionic gonadotropin increased	17.36	13.11	5	69202	20	29883251
Type 2 diabetes mellitus	17.28	13.11	5	69202	13617	29869654
Blood creatinine	17.26	13.11	6	69201	49	29883222
Palpitations	17.25	13.11	32	69175	33541	29849730
Performance status decreased	17.24	13.11	32	69175	3925	29879346
Chemotherapeutic drug level increased	17.11	13.11	9	69198	218	29883053
Cerebrovascular accident	16.94	13.11	118	69089	83359	29799912
Blood lactate dehydrogenase increased	16.90	13.11	93	69114	20508	29862763
Peritonitis bacterial	16.78	13.11	3	69204	11375	29871896
Sleep apnoea syndrome	16.77	13.11	9	69198	16848	29866423
Psychotic disorder	16.75	13.11	15	69192	21500	29861771
Gingivitis ulcerative	16.75	13.11	6	69201	54	29883217
Gastrointestinal perforation	16.71	13.11	30	69177	3586	29879685
Loss of consciousness	16.70	13.11	111	69096	79264	29804007
Thrombocytosis	16.65	13.11	29	69178	3384	29879887
Eosinophilia	16.60	13.11	16	69191	22144	29861127
Lymphangiosis carcinomatosa	16.59	13.11	15	69192	894	29882377
Withdrawal syndrome	16.52	13.11	3	69204	11247	29872024
Tumour thrombosis	16.46	13.11	6	69201	57	29883214
Lung adenocarcinoma	16.44	13.11	32	69175	4067	29879204
Blood magnesium decreased	16.41	13.11	38	69169	5445	29877826
Swelling face	16.25	13.11	15	69192	21189	29862082
Deafness bilateral	16.20	13.11	16	69191	1066	29882205
Monocyte count decreased	16.17	13.11	14	69193	788	29882483
Upper respiratory tract infection	16.15	13.11	24	69183	27452	29855819
Hepatitis B reactivation	16.11	13.11	26	69181	2851	29880420
Burning sensation	16.09	13.11	9	69198	16465	29866806
Metastases to bone	16.04	13.11	54	69153	9604	29873667
Urinary tract infection	16.01	13.11	102	69105	73557	29809714
Delusion	15.97	13.11	4	69203	11985	29871286
Ganglioneuroma	15.91	13.11	4	69203	8	29883263
Laryngeal cancer stage IV	15.91	13.11	4	69203	8	29883263
Hot flush	15.88	13.11	7	69200	14673	29868598
Gastrointestinal anastomotic leak	15.75	13.11	10	69197	348	29882923
Peripheral sensory neuropathy	15.63	13.11	39	69168	5862	29877409
Loss of personal independence in daily activities	15.61	13.11	16	69191	21519	29861752
Wound evisceration	15.60	13.11	7	69200	118	29883153
Testicular cancer metastatic	15.60	13.11	6	69201	67	29883204
Osteosarcoma metastatic	15.60	13.11	4	69203	9	29883262
Oesophageal squamous cell carcinoma	15.57	13.11	10	69197	355	29882916
Rib fracture	15.54	13.11	5	69202	12715	29870556
Bronchitis	15.47	13.11	43	69164	39082	29844189
Disturbance in attention	15.42	13.11	17	69190	22112	29861159
Subcutaneous emphysema	15.41	13.11	15	69192	982	29882289
Fistula of small intestine	15.40	13.11	10	69197	362	29882909
Swelling	15.39	13.11	38	69169	35937	29847334
Myelitis transverse	15.37	13.11	15	69192	985	29882286
Choriocarcinoma	15.30	13.11	5	69202	33	29883238
Diabetic ketoacidosis	15.23	13.11	9	69198	15977	29867294
Pharyngeal stenosis	15.22	13.11	3	69204	0	29883271
Testicular malignant teratoma	15.22	13.11	3	69204	0	29883271
Hyperammonaemic encephalopathy	15.19	13.11	20	69187	1824	29881447
Sarcoma	15.18	13.11	10	69197	371	29882900
Hyperhidrosis	15.04	13.11	92	69115	66998	29816273
Dementia	15.04	13.11	5	69202	12456	29870815
Traumatic lung injury	15.03	13.11	16	69191	1165	29882106
Laboratory test abnormal	15.02	13.11	11	69196	17431	29865840
Dysstasia	15.00	13.11	3	69204	10502	29872769
Diffuse large B-cell lymphoma	14.99	13.11	46	69161	7795	29875476
No adverse event	14.99	13.11	11	69196	17408	29865863
Fatigue	14.92	13.11	598	68609	320075	29563196
Visual impairment	14.78	13.11	30	69177	30408	29852863
Neutrophil count abnormal	14.69	13.11	17	69190	1358	29881913
Blood triglycerides increased	14.67	13.11	7	69200	14010	29869261
Hypersomnia	14.64	13.11	4	69203	11312	29871959
Peritonitis	14.63	13.11	92	69115	21283	29861988
Hepatic enzyme increased	14.63	13.11	35	69172	33459	29849812
Hypoaesthesia	14.57	13.11	70	69137	54160	29829111
Plasmacytoma	14.44	13.11	27	69180	3329	29879942
Candida infection	14.43	13.11	72	69135	15290	29867981
Injection site erythema	14.34	13.11	7	69200	13827	29869444
Blister	14.29	13.11	16	69191	20667	29862604
Enterococcal bacteraemia	14.29	13.11	17	69190	1399	29881872
Hip fracture	14.27	13.11	4	69203	11120	29872151
Anastomotic complication	14.26	13.11	9	69198	310	29882961
Accidental exposure to product	14.22	13.11	3	69204	10112	29873159
Nasopharyngeal cancer	14.21	13.11	7	69200	147	29883124
Hemianopia	14.19	13.11	12	69195	654	29882617
Candida sepsis	14.18	13.11	15	69192	1084	29882187
Blastic plasmacytoid dendritic cell neoplasia	14.07	13.11	6	69201	89	29883182
Basal cell carcinoma	14.01	13.11	10	69197	16058	29867213
Focal nodular hyperplasia	14.00	13.11	7	69200	152	29883119
Treatment noncompliance	13.95	13.11	23	69184	25230	29858041
Gene mutation	13.92	13.11	13	69194	808	29882463
Suture related complication	13.88	13.11	7	69200	155	29883116
Hyperglycaemic hyperosmolar nonketotic syndrome	13.84	13.11	14	69193	960	29882311
Human herpesvirus 8 infection	13.83	13.11	12	69195	677	29882594
Bone sarcoma	13.83	13.11	6	69201	93	29883178
Haemoperitoneum	13.82	13.11	17	69190	1448	29881823
Eye pain	13.77	13.11	5	69202	11784	29871487
Short stature	13.76	13.11	5	69202	47	29883224
Movement disorder	13.75	13.11	3	69204	9880	29873391
Fistula	13.72	13.11	34	69173	5088	29878183
Blood pressure systolic increased	13.72	13.11	9	69198	15101	29868170
Penile vein thrombosis	13.70	13.11	4	69203	17	29883254
Therapeutic embolisation	13.69	13.11	9	69198	333	29882938
Gastrointestinal haemorrhage	13.67	13.11	125	69082	83321	29799950
Platelet transfusion	13.56	13.11	14	69193	984	29882287
Blood culture positive	13.54	13.11	33	69174	4886	29878385
Cholestasis	13.52	13.11	23	69184	24927	29858344
Decorticate posture	13.51	13.11	4	69203	18	29883253
Scleroderma	13.50	13.11	16	69191	1311	29881960
Cellulitis	13.39	13.11	59	69148	46725	29836546
Anaplastic lymphoma kinase gene mutation	13.33	13.11	6	69201	102	29883169
Tracheal stenosis	13.29	13.11	7	69200	170	29883101
Pulmonary necrosis	13.27	13.11	9	69198	351	29882920
Oral pain	13.21	13.11	50	69157	9419	29873852
Ventricular extrasystoles	13.17	13.11	5	69202	11469	29871802
Torulopsis infection	13.17	13.11	4	69203	20	29883251
Diaphragmatic rupture	13.17	13.11	4	69203	20	29883251
Presbyacusis	13.15	13.11	3	69204	3	29883268
Haemorrhagic tumour necrosis	13.15	13.11	3	69204	3	29883268
Mastoid effusion	13.15	13.11	3	69204	3	29883268
Gastropleural fistula	13.15	13.11	3	69204	3	29883268
Thymic cancer metastatic	13.15	13.11	3	69204	3	29883268

Pharmacologic Action:

Source	Code	Description
ATC	L01XA01	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
MeSH PA	D003432	Cross-Linking Reagents
MeSH PA	D007202	Indicators and Reagents
MeSH PA	D011838	Radiation-Sensitizing Agents
CHEBI has role	CHEBI:25435	mutagens
CHEBI has role	CHEBI:35610	cytostatic
CHEBI has role	CHEBI:47868	photosensitising agent
CHEBI has role	CHEBI:50684	cross-linking reagents
CHEBI has role	CHEBI:50902	genotoxic agent
CHEBI has role	CHEBI:61015	nephrotoxins

Drug Use (View source of the data)

Disease	Relation	SNOMED_ID	DOID
Malignant tumor of ovary	indication	363443007	DOID:2394
Ovarian Germ Cell Tumor Carcinoma	indication
Testicular Germ Cell Tumor	indication
Invasive Bladder Malignancy	indication

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:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
Epidermal growth factor receptor	Kinase	P00533	EGFR_HUMAN		IC50	5.58		DRUG MATRIX
Tyrosine-protein kinase Lck	Kinase	P06239	LCK_HUMAN		IC50	4.64		DRUG MATRIX
Tyrosine-protein kinase Fyn	Kinase	P06241	FYN_HUMAN		IC50	5.32		DRUG MATRIX
C-X-C chemokine receptor type 2	GPCR	P25025	CXCR2_HUMAN		Ki	5.02		DRUG MATRIX
Thromboxane-A synthase	Enzyme	P24557	THAS_HUMAN		IC50	5.03		DRUG MATRIX
C-C chemokine receptor type 2	GPCR	P41597	CCR2_HUMAN		Ki	5.15		DRUG MATRIX
Mitogen-activated protein kinase 3	Kinase	P27361	MK03_HUMAN		IC50	5.33		DRUG MATRIX
Melanocortin receptor 5	GPCR	P33032	MC5R_HUMAN		Ki	5.22		DRUG MATRIX
Multidrug resistance-associated protein 5	Transporter	O15440	MRP5_HUMAN					WOMBAT-PK
Multidrug resistance-associated protein 6	Transporter	O95255	MRP6_HUMAN					WOMBAT-PK
Canalicular multispecific organic anion transporter 1	Transporter	Q92887	MRP2_HUMAN					WOMBAT-PK
D(3) dopamine receptor	GPCR	P35462	DRD3_HUMAN		Ki	5.95		CHEMBL
Adenosine receptor A3	GPCR	P0DMS8	AA3R_HUMAN		Ki	5.62		DRUG MATRIX
Muscarinic acetylcholine receptor M5	GPCR	P08912	ACM5_HUMAN		Ki	5.37		CHEMBL
DNA	DNA			OTHER				CHEMBL	CHEMBL
Sodium/potassium-transporting ATPase subunit alpha-2	Ion channel		AT1A2_PIG		IC50	5.03		DRUG MATRIX

External reference:

ID	Source
D00275	KEGG_DRUG
4018139	VUID
N0000146476	NUI
4018139	VANDF
C0008838	UMLSCUI
CHEBI:27899	CHEBI
CPT	PDB_CHEM_ID
CHEMBL11359	ChEMBL_ID
CHEMBL1386	ChEMBL_ID
CHEMBL2068237	ChEMBL_ID
DB00515	DRUGBANK_ID
D002945	MESH_DESCRIPTOR_UI
5702198	PUBCHEM_CID
5343	IUPHAR_LIGAND_ID
4426	INN_ID
Q20Q21Q62J	UNII
2555	RXNORM
31747	MMSL
4456	MMSL
d00195	MMSL
002641	NDDF
387318005	SNOMEDCT_US
57066004	SNOMEDCT_US

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
CISplatin	HUMAN PRESCRIPTION DRUG LABEL	1	0143-9504	INJECTION	1 mg	INTRAVENOUS	ANDA	19 sections
CISplatin	HUMAN PRESCRIPTION DRUG LABEL	1	0143-9505	INJECTION	1 mg	INTRAVENOUS	ANDA	19 sections
Cisplatin	HUMAN PRESCRIPTION DRUG LABEL	1	0703-5747	INJECTION, SOLUTION	50 mg	INTRAVENOUS	ANDA	21 sections
Cisplatin	HUMAN PRESCRIPTION DRUG LABEL	1	0703-5748	INJECTION, SOLUTION	100 mg	INTRAVENOUS	ANDA	21 sections
Cisplatin	HUMAN PRESCRIPTION DRUG LABEL	1	16729-288	INJECTION	1 mg	INTRAVENOUS	ANDA	26 sections
CISplatin	HUMAN PRESCRIPTION DRUG LABEL	1	44567-509	INJECTION, SOLUTION	1 mg	INTRAVENOUS	NDA	19 sections
CISplatin	HUMAN PRESCRIPTION DRUG LABEL	1	44567-510	INJECTION, SOLUTION	1 mg	INTRAVENOUS	NDA	19 sections
CISplatin	HUMAN PRESCRIPTION DRUG LABEL	1	44567-511	INJECTION, SOLUTION	1 mg	INTRAVENOUS	NDA	19 sections
Cisplatin	HUMAN PRESCRIPTION DRUG LABEL	1	44567-530	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	1 mg	INTRAVENOUS	NDA	26 sections
Cisplatin	HUMAN PRESCRIPTION DRUG LABEL	1	63323-103	INJECTION, SOLUTION	1 mg	INTRAVENOUS	ANDA	13 sections
Cisplatin	HUMAN PRESCRIPTION DRUG LABEL	1	68001-283	INJECTION	1 mg	INTRAVENOUS	ANDA	26 sections
CISPLATIN	Human Prescription Drug Label	1	68083-162	INJECTION, SOLUTION	1 mg	INTRAVENOUS	ANDA	13 sections
CISPLATIN	Human Prescription Drug Label	1	68083-163	INJECTION, SOLUTION	1 mg	INTRAVENOUS	ANDA	13 sections
Cisplatin	HUMAN PRESCRIPTION DRUG LABEL	1	70860-206	INJECTION, SOLUTION	1 mg	INTRAVENOUS	ANDA	21 sections