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

cisplatin 🐶 Veterinary Use | 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	1070.56	15.52	853	51678	96814	50455779
Neutropenia	975.81	15.52	969	51562	146996	50405597
Thrombocytopenia	677.41	15.52	745	51786	126928	50425665
Malignant neoplasm progression	536.74	15.52	493	52038	67631	50484962
Bone marrow failure	476.59	15.52	318	52213	27306	50525287
Disease progression	471.26	15.52	538	51993	95328	50457265
Haematotoxicity	466.77	15.52	206	52325	7689	50544904
Mucosal inflammation	458.92	15.52	360	52171	39782	50512811
Vomiting	414.58	15.52	1229	51302	459529	50093064
Ototoxicity	404.75	15.52	113	52418	1014	50551579
Anaemia	368.99	15.52	810	51721	251646	50300947
Pancytopenia	328.41	15.52	420	52111	83610	50468983
Myelosuppression	291.04	15.52	179	52352	13338	50539255
Acute myeloid leukaemia	268.27	15.52	177	52354	14897	50537696
Nausea	266.83	15.52	1434	51097	703964	49848629
Dehydration	259.32	15.52	521	52010	151928	50400665
Leukopenia	255.09	15.52	332	52199	67196	50485397
Posterior reversible encephalopathy syndrome	248.13	15.52	168	52363	14760	50537833
Arthralgia	239.37	15.52	79	52452	438623	50113970
Second primary malignancy	233.78	15.52	123	52408	6791	50545802
Hypomagnesaemia	218.87	15.52	186	52345	22970	50529623
Off label use	214.15	15.52	1015	51516	473411	50079182
Joint swelling	194.89	15.52	16	52515	245270	50307323
Renal salt-wasting syndrome	185.36	15.52	45	52486	216	50552377
Hypokalaemia	179.36	15.52	325	52206	87667	50464926
Neutrophil count decreased	173.28	15.52	226	52305	45800	50506793
Deafness	171.17	15.52	137	52394	15554	50537039
Myelodysplastic syndrome	166.95	15.52	133	52398	14999	50537594
Diffuse large B-cell lymphoma recurrent	153.51	15.52	59	52472	1536	50551057
Gastrointestinal toxicity	151.88	15.52	81	52450	4596	50547997
Pain	150.40	15.52	231	52300	578672	49973921
Aortic thrombosis	149.23	15.52	51	52480	938	50551655
Neutropenic sepsis	142.68	15.52	118	52413	14029	50538564
Fall	138.04	15.52	89	52442	334843	50217750
Product dose omission issue	137.98	15.52	15	52516	183823	50368770
Metastases to lung	134.88	15.52	103	52428	10917	50541676
Abdominal discomfort	134.60	15.52	37	52494	231604	50320989
Platelet count decreased	134.06	15.52	312	52219	100414	50452179
Peripheral swelling	131.24	15.52	27	52504	205909	50346684
Metastases to central nervous system	130.56	15.52	102	52429	11180	50541413
Drug resistance	129.42	15.52	127	52404	18862	50533731
Arthropathy	129.03	15.52	9	52522	157897	50394696
Teratoma	125.36	15.52	29	52502	108	50552485
Neoplasm progression	123.71	15.52	152	52379	29005	50523588
Nephropathy toxic	120.78	15.52	85	52446	7944	50544649
Ovarian germ cell teratoma	118.40	15.52	25	52506	53	50552540
Drug ineffective	115.60	15.52	450	52081	818883	49733710
Contraindicated product administered	114.75	15.52	11	52520	148947	50403646
Pyrexia	114.07	15.52	729	51802	379474	50173119
Weight increased	114.03	15.52	34	52497	201857	50350736
Sepsis	113.26	15.52	349	52182	132576	50420017
Musculoskeletal stiffness	112.11	15.52	5	52526	128476	50424117
Acute kidney injury	110.48	15.52	499	52032	227559	50325034
Therapeutic product effect decreased	110.43	15.52	8	52523	136042	50416551
Urogenital fistula	109.57	15.52	26	52505	111	50552482
Pulmonary embolism	106.91	15.52	288	52243	101416	50451177
Hyponatraemia	105.88	15.52	277	52254	95862	50456731
Drug hypersensitivity	104.29	15.52	66	52465	250944	50301649
Product use in unapproved indication	104.20	15.52	310	52221	115509	50437084
Swelling	102.74	15.52	40	52491	200832	50351761
Diffuse large B-cell lymphoma refractory	101.77	15.52	39	52492	1007	50551586
Cardiotoxicity	100.18	15.52	72	52459	6955	50545638
Oesophagitis	99.68	15.52	94	52437	13289	50539304
Neurotoxicity	95.66	15.52	96	52435	14644	50537949
Pain in extremity	91.58	15.52	89	52442	272776	50279817
Nasopharyngitis	91.35	15.52	43	52488	192884	50359709
Headache	90.67	15.52	250	52281	506285	50046308
Hydronephrosis	87.70	15.52	72	52459	8469	50544124
Cardiomyopathy	87.64	15.52	94	52437	15492	50537101
Septic shock	85.97	15.52	186	52345	56989	50495604
Rash	85.87	15.52	206	52325	437265	50115328
Pruritus	85.68	15.52	101	52430	283467	50269126
Tumour lysis syndrome	85.66	15.52	67	52464	7354	50545239
Hypocalcaemia	84.72	15.52	121	52410	26695	50525898
White blood cell count decreased	80.19	15.52	285	52246	116437	50436156
Hypophagia	80.19	15.52	120	52411	27608	50524985
Renal failure	79.91	15.52	268	52263	106365	50446228
Disease recurrence	79.28	15.52	101	52430	19980	50532613
Metastases to lymph nodes	78.03	15.52	62	52469	6962	50545631
Arthritis	76.89	15.52	3	52528	86718	50465875
Condition aggravated	76.40	15.52	119	52412	296939	50255654
Neuropathy peripheral	75.00	15.52	246	52285	96511	50456082
Injection site pain	73.98	15.52	13	52518	111011	50441582
Insomnia	73.94	15.52	45	52486	174820	50377773
Metastases to liver	71.43	15.52	96	52435	20008	50532585
Wound	71.34	15.52	12	52519	105782	50446811
Renal tubular disorder	70.23	15.52	39	52492	2398	50550195
Teratoma benign	69.72	15.52	16	52515	57	50552536
Sinusitis	69.22	15.52	46	52485	170512	50382081
Contusion	68.79	15.52	16	52515	112167	50440426
Febrile bone marrow aplasia	68.60	15.52	55	52476	6256	50546337
Tinnitus	67.82	15.52	112	52419	28020	50524573
Ascites	64.93	15.52	126	52405	35735	50516858
Therapy partial responder	64.42	15.52	54	52477	6537	50546056
Asthma	62.81	15.52	9	52522	89328	50463265
Metastases to skin	62.63	15.52	30	52501	1353	50551240
Electrolyte imbalance	62.55	15.52	83	52448	17086	50535507
Migraine	62.31	15.52	4	52527	75276	50477317
Leukoencephalopathy	60.48	15.52	42	52489	3841	50548752
Renal tubular necrosis	60.13	15.52	63	52468	10105	50542488
Abdominal pain	59.90	15.52	435	52096	235793	50316800
Palmar-plantar erythrodysaesthesia syndrome	59.57	15.52	88	52443	20010	50532583
Gastrointestinal perforation	59.49	15.52	38	52493	3023	50549570
Muscle spasms	59.37	15.52	28	52503	125525	50427068
Radiation skin injury	59.12	15.52	25	52506	838	50551755
Drug intolerance	58.98	15.52	85	52446	219019	50333574
Hepatic enzyme increased	57.16	15.52	36	52495	137344	50415249
Diarrhoea	56.94	15.52	891	51640	587585	49965008
Pleural effusion	56.87	15.52	200	52331	81254	50471339
Deafness bilateral	56.76	15.52	27	52504	1199	50551394
Metastases to breast	56.37	15.52	18	52513	265	50552328
Decreased appetite	56.21	15.52	379	52152	200544	50352049
Oesophageal fistula	55.80	15.52	15	52516	115	50552478
Blister	54.77	15.52	11	52520	85407	50467186
Pericarditis	52.88	15.52	9	52522	78680	50473913
Ovarian cancer recurrent	52.07	15.52	23	52508	859	50551734
Polyneuropathy	51.05	15.52	63	52468	12068	50540525
Large intestine perforation	50.83	15.52	50	52481	7444	50545149
Myasthenia gravis crisis	50.80	15.52	18	52513	370	50552223
Metastases to bone	50.77	15.52	77	52454	17918	50534675
Blood creatinine increased	48.92	15.52	182	52349	75978	50476615
Urticaria	48.55	15.52	38	52493	129523	50423070
Osteoarthritis	48.02	15.52	7	52524	68599	50483994
Overdose	47.51	15.52	22	52509	99705	50452888
Injection site erythema	47.32	15.52	10	52521	74926	50477667
Loss of personal independence in daily activities	47.10	15.52	8	52523	70042	50482551
Gait disturbance	46.78	15.52	52	52479	149953	50402640
Renal impairment	46.27	15.52	178	52353	75483	50477110
Peripheral artery thrombosis	46	15.52	26	52505	1654	50550939
Suicidal ideation	45.66	15.52	3	52528	55382	50497211
Feeling abnormal	45.53	15.52	38	52493	125454	50427139
Infusion related reaction	45.39	15.52	66	52465	169491	50383102
Deep vein thrombosis	44.45	15.52	172	52359	73132	50479461
Depression	43.68	15.52	65	52466	165358	50387235
Fatigue	43.14	15.52	499	52032	707102	49845491
Haemoglobin decreased	43.04	15.52	252	52279	126964	50425629
Metastases to peritoneum	42.62	15.52	30	52501	2803	50549790
Mobility decreased	42.37	15.52	15	52516	79933	50472660
Bronchitis	42.35	15.52	28	52503	104131	50448462
Encephalopathy	42.16	15.52	102	52429	33609	50518984
Discomfort	41.61	15.52	31	52500	108349	50444244
Mesenteric abscess	41.19	15.52	11	52520	82	50552511
Inappropriate antidiuretic hormone secretion	41.06	15.52	59	52472	13084	50539509
Alopecia	40.72	15.52	125	52406	244922	50307671
Chemical peritonitis	40.29	15.52	11	52520	90	50552503
Somnolence	39.86	15.52	62	52469	154923	50397670
Cystitis haemorrhagic	39.68	15.52	32	52499	3670	50548923
Anastomotic leak	38.65	15.52	15	52516	401	50552192
Large intestinal ulcer perforation	38.37	15.52	10	52521	67	50552526
Ileus	37.88	15.52	57	52474	13172	50539421
Recall phenomenon	37.74	15.52	16	52515	540	50552053
Bicytopenia	37.54	15.52	24	52507	1912	50550681
Hospitalisation	37.30	15.52	12	52519	67925	50484668
Malignant transformation	37.26	15.52	14	52517	342	50552251
Performance status decreased	37.21	15.52	29	52502	3166	50549427
Wernicke's encephalopathy	36.97	15.52	8	52523	20	50552573
Ureteric rupture	36.26	15.52	7	52524	7	50552586
Nasal abscess	36.21	15.52	11	52520	136	50552457
Metastases to abdominal wall	36.19	15.52	10	52521	86	50552507
Cervix neoplasm	36.10	15.52	12	52519	202	50552391
Dermatitis	36.06	15.52	58	52473	14193	50538400
Gastric perforation	35.59	15.52	21	52510	1449	50551144
Fibromyalgia	35.47	15.52	3	52528	44975	50507618
Embryonal rhabdomyosarcoma	35.32	15.52	7	52524	9	50552584
Dizziness	35.24	15.52	213	52318	346156	50206437
Nephritis bacterial	35.19	15.52	8	52523	27	50552566
Cataract	35.09	15.52	4	52527	47296	50505297
Neutropenic colitis	34.99	15.52	25	52506	2392	50550201
Melanoderma	34.83	15.52	11	52520	156	50552437
Radiation injury	34.75	15.52	14	52517	414	50552179
Balance disorder	34.52	15.52	15	52516	70575	50482018
Unevaluable event	33.91	15.52	4	52527	46062	50506531
Asthenia	33.77	15.52	491	52040	318551	50234042
Exposure during pregnancy	33.47	15.52	46	52485	120969	50431624
Gastrointestinal fungal infection	33.45	15.52	12	52519	256	50552337
Haemophagocytic lymphohistiocytosis	33.41	15.52	43	52488	8590	50544003
Cerebral venous thrombosis	33.35	15.52	22	52509	1849	50550744
Injection site reaction	33.01	15.52	6	52525	50026	50502567
Malnutrition	32.44	15.52	53	52478	13136	50539457
Bladder perforation	32.32	15.52	10	52521	132	50552461
Chloroma	32.30	15.52	11	52520	200	50552393
Intentional product misuse	32.17	15.52	5	52526	46729	50505864
Varicella zoster virus infection	32.08	15.52	24	52507	2465	50550128
Cardiac tamponade	32.03	15.52	30	52501	4202	50548391
Injury	31.99	15.52	6	52525	48919	50503674
Nasal congestion	31.91	15.52	7	52524	51113	50501480
Adverse drug reaction	31.68	15.52	9	52522	55213	50497380
Metastases to adrenals	31.26	15.52	15	52516	679	50551914
Axillary vein thrombosis	30.67	15.52	12	52519	328	50552265
Maternal exposure during pregnancy	30.63	15.52	76	52455	159702	50392891
Enteritis	30.52	15.52	37	52494	6958	50545635
Pericardial effusion	30.48	15.52	76	52455	25513	50527080
Stress	30.43	15.52	9	52522	53784	50498809
Memory impairment	30.07	15.52	23	52508	79337	50473256
Vesical fistula	29.91	15.52	8	52523	60	50552533
Abortion spontaneous	29.84	15.52	4	52527	41768	50510825
Lower respiratory tract infection	29.67	15.52	33	52498	95168	50457425
Hypophosphataemia	29.61	15.52	40	52491	8374	50544219
White blood cell count abnormal	29.16	15.52	32	52499	5408	50547185
Haemolytic uraemic syndrome	29.09	15.52	22	52509	2297	50550296
Peripheral sensory neuropathy	28.98	15.52	35	52496	6556	50546037
Wrong technique in product usage process	28.43	15.52	11	52520	55499	50497094
Herpes simplex encephalitis	28.10	15.52	11	52520	301	50552292
Venoocclusive liver disease	28.10	15.52	28	52503	4233	50548360
Sinus polyp	27.90	15.52	11	52520	307	50552286
Enterocolitis infectious	27.86	15.52	18	52513	1460	50551133
Vena cava thrombosis	27.20	15.52	20	52511	2001	50550592
Acoustic stimulation tests abnormal	27.18	15.52	8	52523	88	50552505
Disseminated intravascular coagulation	27.18	15.52	57	52474	17078	50535515
Anxiety	27.12	15.52	94	52437	177512	50375081
Radiation pneumonitis	27.01	15.52	17	52514	1318	50551275
Thymus enlargement	26.86	15.52	8	52523	92	50552501
Tumour haemorrhage	26.77	15.52	17	52514	1338	50551255
Treatment failure	26.74	15.52	65	52466	137572	50415021
Alveolar soft part sarcoma	26.33	15.52	8	52523	99	50552494
Peripheral ischaemia	26.19	15.52	27	52504	4249	50548344
Respiratory symptom	26.15	15.52	21	52510	2393	50550200
Acquired gene mutation	25.88	15.52	14	52517	817	50551776
Female genital tract fistula	25.87	15.52	25	52506	3641	50548952
Intestinal perforation	25.63	15.52	42	52489	10437	50542156
Clostridium bacteraemia	25.54	15.52	9	52522	182	50552411
Gastrooesophageal reflux disease	25.49	15.52	25	52506	76403	50476190
Cytopenia	25.39	15.52	38	52493	8737	50543856
Adverse event	25.35	15.52	7	52524	43756	50508837
Fistula of small intestine	25.27	15.52	10	52521	282	50552311
Metastases to meninges	25.13	15.52	19	52512	1983	50550610
Blood cholesterol increased	25.05	15.52	13	52518	55202	50497391
Aortic embolus	25.03	15.52	6	52525	27	50552566
Metastases to abdominal cavity	25.02	15.52	11	52520	406	50552187
Respiratory failure	24.85	15.52	171	52360	91010	50461583
Wheezing	24.79	15.52	17	52514	62030	50490563
Hypoalbuminaemia	24.77	15.52	40	52491	9820	50542773
Chronic kidney disease	24.66	15.52	94	52437	39677	50512916
Dysphagia	24.56	15.52	151	52380	77367	50475226
Inappropriate schedule of product administration	24.54	15.52	23	52508	71808	50480785
Osteoporosis	24.51	15.52	8	52523	44871	50507722
Neoplasm recurrence	24.38	15.52	20	52511	2349	50550244
Amputation stump pain	24.35	15.52	6	52525	31	50552562
Impaired healing	24.25	15.52	22	52509	69764	50482829
Cerebellar haemangioma	24.21	15.52	7	52524	72	50552521
Drug clearance decreased	24.17	15.52	15	52516	1134	50551459
Influenza like illness	23.96	15.52	15	52516	57444	50495149
Metastasis	23.91	15.52	26	52505	4349	50548244
Jaw operation	23.90	15.52	13	52518	767	50551826
Suicide attempt	23.74	15.52	12	52519	51720	50500873
Neutrophil count abnormal	23.73	15.52	20	52511	2439	50550154
Arteriospasm coronary	23.63	15.52	23	52508	3379	50549214
Chronic obstructive pulmonary disease	23.62	15.52	13	52518	53422	50499171
Stem cell transplant	23.57	15.52	17	52514	1651	50550942
Multiple organ dysfunction syndrome	23.43	15.52	109	52422	50228	50502365
Oesophageal stenosis	23.07	15.52	21	52510	2837	50549756
Malignant peritoneal neoplasm	23.03	15.52	12	52519	649	50551944
Malaise	22.99	15.52	230	52301	335302	50217291
Bacteraemia	22.88	15.52	48	52483	14385	50538208
Embolism	22.83	15.52	32	52499	6936	50545657
Enterococcal sepsis	22.74	15.52	15	52516	1260	50551333
Radiation oesophagitis	22.44	15.52	9	52522	263	50552330
Ovarian vein thrombosis	22.44	15.52	6	52525	45	50552548
Acute myelomonocytic leukaemia	22.33	15.52	8	52523	170	50552423
Anti-Muellerian hormone level decreased	22.31	15.52	7	52524	97	50552496
Influenza	21.90	15.52	37	52494	89501	50463092
Femur fracture	21.69	15.52	6	52525	37458	50515135
Burning sensation	21.68	15.52	10	52521	45436	50507157
Fluid retention	21.43	15.52	13	52518	50636	50501957
Folliculitis	21.40	15.52	7	52524	39218	50513375
Proctitis	21.37	15.52	17	52514	1911	50550682
Oroticaciduria	21.25	15.52	4	52527	3	50552590
Blood magnesium decreased	21.16	15.52	40	52491	11120	50541473
Osteosarcoma metastatic	21.14	15.52	5	52526	21	50552572
Vascular compression	21.10	15.52	7	52524	117	50552476
Incorrect dose administered	21.08	15.52	12	52519	48402	50504191
Neck pain	21.03	15.52	17	52514	57050	50495543
Median nerve injury	20.95	15.52	5	52526	22	50552571
Blood glucose increased	20.85	15.52	26	52505	71298	50481295
Osteosarcoma	20.83	15.52	7	52524	122	50552471
Muscular weakness	20.80	15.52	42	52489	94971	50457622
Cervix carcinoma recurrent	20.77	15.52	5	52526	23	50552570
Hiccups	20.72	15.52	16	52515	1723	50550870
Maternal death affecting foetus	20.72	15.52	4	52527	4	50552589
Vision blurred	20.65	15.52	31	52500	78616	50473977
Failure to thrive	20.53	15.52	29	52502	6329	50546264
Therapy responder	20.50	15.52	9	52522	331	50552262
Ill-defined disorder	20.50	15.52	16	52515	54638	50497955
Pulmonary toxicity	20.43	15.52	27	52504	5535	50547058
Medulloblastoma recurrent	20.39	15.52	6	52525	66	50552527
Lymphopenia	20.32	15.52	48	52483	15573	50537020
Myalgia	20.21	15.52	64	52467	124255	50428338
Diabetes mellitus	20.17	15.52	13	52518	49020	50503573
Pulmonary vascular disorder	20.13	15.52	9	52522	346	50552247
Odynophagia	19.93	15.52	29	52502	6503	50546090
Tachycardia	19.90	15.52	174	52357	99589	50453004
Radiation proctitis	19.83	15.52	4	52527	6	50552587
Product quality issue	19.72	15.52	4	52527	30854	50521739
Superior sagittal sinus thrombosis	19.52	15.52	11	52520	696	50551897
Renal-limited thrombotic microangiopathy	19.45	15.52	4	52527	7	50552586
VIth nerve paresis	19.41	15.52	6	52525	79	50552514
Refeeding syndrome	19.38	15.52	5	52526	32	50552561
Blood sodium decreased	19.35	15.52	57	52474	21090	50531503
Radiation mucositis	19.25	15.52	5	52526	33	50552560
Leukaemic lymphoma	19.07	15.52	6	52525	84	50552509
Pain in jaw	19.05	15.52	8	52523	38420	50514173
Hypoaesthesia	18.98	15.52	68	52463	127189	50425404
Drug clearance increased	18.94	15.52	6	52525	86	50552507
Gastrointestinal necrosis	18.87	15.52	18	52513	2580	50550013
Salivary gland cancer	18.86	15.52	7	52524	165	50552428
Low cardiac output syndrome	18.84	15.52	8	52523	271	50552322
Stomatitis	18.80	15.52	174	52357	101170	50451423
Marchiafava-Bignami disease	18.78	15.52	4	52527	9	50552584
Purulent pericarditis	18.76	15.52	5	52526	37	50552556
Cardiac failure congestive	18.73	15.52	37	52494	84345	50468248
Pregnancy	18.56	15.52	4	52527	29573	50523020
Gastric disorder	18.53	15.52	4	52527	29544	50523049
Blood pressure fluctuation	18.51	15.52	7	52524	35816	50516777
Hypoglycaemia	18.48	15.52	17	52514	53564	50499029
Pelvic fluid collection	18.47	15.52	11	52520	772	50551821
Adrenocortical carcinoma	18.41	15.52	5	52526	40	50552553
Cerebral salt-wasting syndrome	18.30	15.52	5	52526	41	50552552
Hypoacusis	18.28	15.52	55	52476	20592	50532001
Gastroenteritis radiation	18.25	15.52	9	52522	433	50552160
Central obesity	18.17	15.52	12	52519	1010	50551583
Sinus tachycardia	18.08	15.52	56	52475	21298	50531295
Respiratory distress	18.03	15.52	71	52460	30418	50522175
Sweat gland tumour	17.99	15.52	6	52525	102	50552491
Tumour invasion	17.94	15.52	6	52525	103	50552490
Mucosal erosion	17.92	15.52	13	52518	1274	50551319
Hypoglossal nerve paresis	17.78	15.52	6	52525	106	50552487
Myasthenic syndrome	17.77	15.52	7	52524	195	50552398
Emphysematous cholecystitis	17.61	15.52	3	52528	0	50552593
Urinary tract toxicity	17.61	15.52	3	52528	0	50552593
Hypersensitivity	17.56	15.52	141	52390	215020	50337573
Acute respiratory distress syndrome	17.55	15.52	55	52476	21044	50531549
Transdifferentiation of neoplasm	17.48	15.52	4	52527	14	50552579
Tumour thrombosis	17.48	15.52	4	52527	14	50552579
Necrosis	17.41	15.52	23	52508	4713	50547880
Product use issue	17.30	15.52	88	52443	149387	50403206
Osteoradionecrosis	17.28	15.52	6	52525	116	50552477
Aorto-oesophageal fistula	17.27	15.52	4	52527	15	50552578
Ovarian failure	17.26	15.52	12	52519	1099	50551494
Ovarian disorder	17.19	15.52	10	52521	672	50551921
Hepatic lesion	17.16	15.52	21	52510	3987	50548606
Urogenital disorder	17.16	15.52	5	52526	53	50552540
Roseolovirus test positive	17.16	15.52	5	52526	53	50552540
Dry eye	17.04	15.52	6	52525	32089	50520504
Fanconi syndrome	17.02	15.52	12	52519	1124	50551469
Cytomegalovirus infection	17.00	15.52	49	52482	17913	50534680
Neurosensory hypoacusis	16.98	15.52	7	52524	220	50552373
Necrotising colitis	16.95	15.52	9	52522	506	50552087
Metastases to pelvis	16.78	15.52	8	52523	357	50552236
Cardiopulmonary failure	16.64	15.52	19	52512	3354	50549239
Sleep disorder	16.62	15.52	21	52510	57262	50495331
Melanosis	16.51	15.52	4	52527	19	50552574
Abdominal compartment syndrome	16.45	15.52	9	52522	537	50552056
Lip swelling	16.24	15.52	3	52528	24733	50527860
Blood pressure increased	16.20	15.52	77	52454	133055	50419538
Agitation	16.09	15.52	19	52512	53365	50499228
Stent malfunction	16.02	15.52	5	52526	68	50552525
Blood culture positive	15.96	15.52	21	52510	4287	50548306
Limb discomfort	15.89	15.52	3	52528	24354	50528239
Road traffic accident	15.89	15.52	3	52528	24349	50528244
Plasma cell leukaemia	15.86	15.52	11	52520	1004	50551589
Hypoxia	15.82	15.52	99	52432	51024	50501569
Eye pain	15.66	15.52	5	52526	28444	50524149
Granulocytopenia	15.63	15.52	23	52508	5208	50547385
VIth nerve disorder	15.54	15.52	3	52528	3	50552590
Metastases to pleura	15.52	15.52	12	52519	1294	50551299

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	1391.34	13.00	1567	74025	110673	29388262
Neutropenia	890.94	13.00	1366	74226	130345	29368590
Mucosal inflammation	759.36	13.00	636	74956	30959	29467976
Thrombocytopenia	534.54	13.00	1108	74484	133715	29365220
Malignant neoplasm progression	418.44	13.00	708	74884	73151	29425784
Pancytopenia	365.32	13.00	714	74878	82454	29416481
Dehydration	362.75	13.00	862	74730	113886	29385049
Bone marrow failure	342.98	13.00	386	75206	27063	29471872
Leukopenia	332.30	13.00	544	75048	54659	29444276
Disease progression	325.96	13.00	675	74917	81241	29417694
Vomiting	305.27	13.00	1209	74383	211051	29287884
Stomatitis	275.44	13.00	403	75189	36710	29462225
Myelosuppression	260.59	13.00	230	75362	11997	29486938
Neutropenic sepsis	258.77	13.00	225	75367	11502	29487433
Haematotoxicity	258.41	13.00	179	75413	6520	29492415
Nausea	249.88	13.00	1421	74171	287834	29211101
Acute myeloid leukaemia	240.78	13.00	252	75340	16261	29482674
Dysphagia	231.78	13.00	464	75128	54462	29444473
Neoplasm progression	217.65	13.00	253	75339	18359	29480576
Second primary malignancy	205.80	13.00	156	75436	6549	29492386
Anaemia	204.92	13.00	1034	74558	199917	29299018
Neutrophil count decreased	201.97	13.00	383	75209	43184	29455751
Product dose omission issue	189.73	13.00	15	75577	96368	29402567
Drug abuse	188.79	13.00	3	75589	79880	29419055
Pulmonary embolism	182.74	13.00	518	75074	76016	29422919
Off label use	171.53	13.00	1333	74259	299467	29199468
Aortic thrombosis	168.46	13.00	64	75528	617	29498318
Fall	166.38	13.00	126	75466	177052	29321883
Arthralgia	165.40	13.00	75	75517	139542	29359393
Nephropathy toxic	161.91	13.00	167	75425	10589	29488346
Renal salt-wasting syndrome	157.62	13.00	44	75548	134	29498801
Myelodysplastic syndrome	143.33	13.00	201	75391	17593	29481342
Pyrexia	139.86	13.00	1230	74362	286392	29212543
Drug interaction	129.62	13.00	190	75402	197195	29301740
Therapy partial responder	127.46	13.00	106	75486	5093	29493842
Decreased appetite	122.15	13.00	710	74882	144632	29354303
Hyponatraemia	116.46	13.00	409	75183	67224	29431711
Cardiotoxicity	114.80	13.00	96	75496	4648	29494287
Headache	111.77	13.00	170	75422	173837	29325098
Septic shock	110.03	13.00	381	75211	62179	29436756
Ototoxicity	109.22	13.00	61	75531	1504	29497431
Hypomagnesaemia	108.81	13.00	175	75417	17293	29481642
Overdose	107.51	13.00	35	75557	79784	29419151
Anastomotic leak	105.52	13.00	44	75548	552	29498383
Diffuse large B-cell lymphoma refractory	105.11	13.00	50	75542	872	29498063
Tumour lysis syndrome	104.69	13.00	152	75440	13732	29485203
Oesophagitis	102.50	13.00	139	75453	11784	29487151
White blood cell count decreased	101.38	13.00	452	75140	82910	29416025
Acute kidney injury	96.76	13.00	1069	74523	264198	29234737
Cardiac failure congestive	95.62	13.00	38	75554	76543	29422392
Arterial thrombosis	95.16	13.00	54	75538	1374	29497561
Weight increased	92.56	13.00	40	75552	76627	29422308
Rhabdomyolysis	92.51	13.00	21	75571	60787	29438148
Radiation skin injury	90.34	13.00	41	75551	639	29498296
Aorto-oesophageal fistula	90.12	13.00	22	75570	31	29498904
Hypophagia	89.93	13.00	178	75414	20694	29478241
Tinnitus	88.59	13.00	150	75442	15464	29483471
Febrile bone marrow aplasia	87.70	13.00	101	75491	7250	29491685
Depression	85.79	13.00	56	75536	85091	29413844
Odynophagia	84.16	13.00	80	75512	4590	29494345
Peripheral swelling	83.98	13.00	29	75563	63710	29435225
Gastric perforation	83.32	13.00	58	75534	2128	29496807
Muscle spasms	81.72	13.00	32	75560	65050	29433885
Inappropriate antidiuretic hormone secretion	81.43	13.00	119	75473	10813	29488122
Deafness	80.09	13.00	113	75479	9942	29488993
Sepsis	79.56	13.00	630	74962	142052	29356883
Vena cava thrombosis	77.43	13.00	42	75550	976	29497959
Peripheral ischaemia	76.16	13.00	79	75513	5040	29493895
Hospitalisation	75.99	13.00	13	75579	45975	29452960
Joint swelling	75.77	13.00	17	75575	49613	29449322
Anxiety	73.43	13.00	66	75526	85299	29413636
Peripheral artery thrombosis	73.25	13.00	53	75539	2069	29496866
Platelet count decreased	73.17	13.00	488	75104	104184	29394751
Metastases to lung	72.77	13.00	95	75497	7760	29491175
Product use in unapproved indication	72.58	13.00	424	75168	86451	29412484
Intentional product misuse	72.25	13.00	4	75588	34657	29464278
Metastases to central nervous system	71.98	13.00	90	75502	7041	29491894
Osteoradionecrosis	71.62	13.00	20	75572	61	29498874
Suicide attempt	70.90	13.00	4	75588	34106	29464829
Suicidal ideation	69.40	13.00	5	75587	34711	29464224
Nasopharyngitis	69.09	13.00	33	75559	59632	29439303
Insomnia	69.01	13.00	75	75517	88686	29410249
Myalgia	68.87	13.00	53	75539	73966	29424969
Musculoskeletal stiffness	67.94	13.00	8	75584	37450	29461485
Neutropenic colitis	67.22	13.00	53	75539	2358	29496577
Bacterial translocation	67.09	13.00	24	75568	192	29498743
Aplasia	66.46	13.00	66	75526	3997	29494938
Pain in extremity	66.01	13.00	113	75479	110320	29388615
Hypokalaemia	65.39	13.00	278	75314	49925	29449010
Death	65.06	13.00	561	75031	341523	29157412
Blood pressure increased	64.75	13.00	56	75536	73747	29425188
Splenic infarction	63.64	13.00	46	75546	1793	29497142
General physical health deterioration	62.77	13.00	464	75128	102393	29396542
Dermatitis	62.65	13.00	88	75504	7710	29491225
Gastrointestinal toxicity	61.92	13.00	48	75544	2083	29496852
Oesophageal fistula	61.60	13.00	22	75570	175	29498760
Psoriasis	60.69	13.00	6	75586	32221	29466714
Rheumatoid arthritis	57.98	13.00	7	75585	32145	29466790
Renal failure	57.70	13.00	508	75084	118091	29380844
Atypical haemolytic uraemic syndrome	57.49	13.00	20	75572	146	29498789
Portal venous gas	56.24	13.00	24	75568	320	29498615
Radiation pneumonitis	55.79	13.00	46	75546	2183	29496752
Pneumonitis	55.66	13.00	178	75414	27866	29471069
Inappropriate schedule of product administration	55.60	13.00	22	75570	44450	29454485
Asthma	54.98	13.00	10	75582	33839	29465096
Cardiac disorder	54.44	13.00	14	75578	37249	29461686
Condition aggravated	54.17	13.00	192	75400	146103	29352832
Thrombotic microangiopathy	54.09	13.00	87	75505	8594	29490341
Injection site pain	53.98	13.00	9	75583	32437	29466498
Acute respiratory distress syndrome	53.42	13.00	154	75438	22781	29476154
Hypocalcaemia	53.30	13.00	144	75448	20521	29478414
Tremor	52.99	13.00	66	75526	73472	29425463
Hiccups	52.82	13.00	87	75505	8766	29490169
Aggression	52.61	13.00	13	75579	35528	29463407
Electrolyte imbalance	52.03	13.00	99	75493	11175	29487760
Dizziness	51.94	13.00	279	75313	189405	29309530
Hepatitis B	51.73	13.00	67	75525	5430	29493505
Diffuse large B-cell lymphoma recurrent	51.64	13.00	47	75545	2550	29496385
Malignant transformation	51.47	13.00	30	75562	804	29498131
Oesophagobronchial fistula	50.75	13.00	18	75574	140	29498795
Neuropathy peripheral	50.71	13.00	333	75259	70694	29428241
Tumour necrosis	50.09	13.00	33	75559	1104	29497831
Pulmonary vascular disorder	50.09	13.00	26	75566	551	29498384
Deafness neurosensory	49.99	13.00	46	75546	2532	29496403
Gait disturbance	49.60	13.00	69	75523	73280	29425655
Wheezing	49.51	13.00	12	75580	33228	29465707
Radiation oesophagitis	49.31	13.00	23	75569	383	29498552
Metastases to liver	48.54	13.00	99	75493	11757	29487178
Vision blurred	48.40	13.00	21	75571	40155	29458780
Hallucination	48.38	13.00	27	75565	44685	29454250
Drug ineffective	47.88	13.00	648	74944	362522	29136413
Blood creatine phosphokinase increased	47.78	13.00	22	75570	40622	29458313
Bacteraemia	47.49	13.00	119	75473	16204	29482731
Ameloblastoma	47.25	13.00	15	75577	79	29498856
Deep vein thrombosis	47.15	13.00	279	75313	57120	29441815
Feeling abnormal	46.91	13.00	42	75550	54403	29444532
Hypertension	46.60	13.00	148	75444	116466	29382469
Pruritus	46.20	13.00	149	75443	116700	29382235
Heart rate decreased	45.98	13.00	5	75587	24907	29474028
Somnolence	45.96	13.00	108	75484	93847	29405088
Cytomegalovirus oesophagitis	45.72	13.00	22	75570	394	29498541
Mobility decreased	45.54	13.00	6	75586	25774	29473161
Oesophageal stenosis	45.52	13.00	35	75557	1500	29497435
Leukoencephalopathy	45.34	13.00	52	75540	3715	29495220
Renal infarct	44.80	13.00	31	75561	1126	29497809
Influenza	44.30	13.00	26	75566	41855	29457080
Wrong technique in product usage process	43.68	13.00	13	75579	31415	29467520
Azoospermia	43.25	13.00	21	75571	384	29498551
Coronary artery disease	43.22	13.00	30	75562	44160	29454775
Therapeutic product effect decreased	43.15	13.00	11	75581	29440	29469495
Renal impairment	43	13.00	355	75237	80978	29417957
Colitis	42.99	13.00	176	75416	31072	29467863
Osteosarcoma	42.84	13.00	17	75575	186	29498749
B-cell lymphoma recurrent	42.70	13.00	24	75568	599	29498336
Metastases to lymph nodes	42.64	13.00	52	75540	3965	29494970
Drug hypersensitivity	41.76	13.00	69	75523	68337	29430598
Intestinal ischaemia	41.60	13.00	67	75525	6625	29492310
COVID-19	41.55	13.00	20	75572	35994	29462941
Salivary gland cancer	41.40	13.00	18	75574	252	29498683
Radiation mucositis	41.09	13.00	15	75577	128	29498807
Memory impairment	40.95	13.00	21	75571	36449	29462486
Renal tubular disorder	40.88	13.00	53	75539	4299	29494636
Lymphopenia	40.78	13.00	100	75492	13433	29485502
Diarrhoea	40.73	13.00	1125	74467	331573	29167362
Alopecia	40.51	13.00	124	75468	18960	29479975
Urticaria	40.48	13.00	48	75544	54612	29444323
Carotid artery thrombosis	40.32	13.00	19	75573	324	29498611
Disease recurrence	40.14	13.00	110	75482	15804	29483131
Anastomotic complication	40.01	13.00	19	75573	330	29498605
Pulmonary arteriopathy	39.82	13.00	13	75579	76	29498859
Angioedema	39.54	13.00	16	75576	31899	29467036
Arthritis	39.34	13.00	8	75584	25011	29473924
Electrocardiogram QT prolonged	38.84	13.00	22	75570	36115	29462820
Foetal exposure during pregnancy	38.78	13.00	19	75573	33848	29465087
Pneumatosis intestinalis	38.57	13.00	44	75548	3125	29495810
Interstitial lung disease	38.42	13.00	266	75326	57452	29441483
Enteritis	38.20	13.00	65	75527	6726	29492209
Balance disorder	37.49	13.00	23	75569	36147	29462788
Embolism	37.47	13.00	65	75527	6831	29492104
Hypoglycaemia	37.38	13.00	41	75551	48305	29450630
Adverse drug reaction	37.11	13.00	8	75584	24012	29474923
Chemotherapy	37.05	13.00	21	75571	533	29498402
Blood stem cell transplant failure	36.76	13.00	19	75573	399	29498536
Blood pressure fluctuation	36.69	13.00	4	75588	19890	29479045
Prostate cancer	36.51	13.00	10	75582	25517	29473418
Tracheo-oesophageal fistula	36.25	13.00	19	75573	411	29498524
Influenza like illness	36.12	13.00	9	75583	24461	29474474
Large intestine perforation	35.69	13.00	66	75526	7290	29491645
Hypoacusis	35.69	13.00	99	75493	14324	29484611
Incorrect dose administered	35.56	13.00	20	75572	32964	29465971
Tumour perforation	35.51	13.00	16	75576	245	29498690
Blood sodium decreased	35.20	13.00	100	75492	14667	29484268
Bronchial fistula	35.05	13.00	14	75578	156	29498779
Neurosensory hypoacusis	34.80	13.00	7	75585	0	29498935
Teratoma	34.58	13.00	9	75583	19	29498916
Tumour haemorrhage	34.56	13.00	37	75555	2448	29496487
Empyema	34.53	13.00	39	75553	2740	29496195
Confusional state	34.45	13.00	189	75403	127688	29371247
Nephrolithiasis	34.27	13.00	11	75581	25323	29473612
Palmar-plantar erythrodysaesthesia syndrome	34.27	13.00	99	75493	14660	29484275
Metastasis	34.16	13.00	43	75549	3386	29495549
Respiratory failure	34.09	13.00	389	75203	96742	29402193
Chloroma	34.07	13.00	19	75573	467	29498468
Neoplasm recurrence	33.98	13.00	33	75559	1944	29496991
International normalised ratio increased	33.90	13.00	38	75554	44334	29454601
Unevaluable event	33.80	13.00	17	75575	29834	29469101
Progressive multifocal leukoencephalopathy	33.57	13.00	71	75521	8648	29490287
Cataract	33.48	13.00	8	75584	22370	29476565
Flagellate dermatitis	33.39	13.00	9	75583	23	29498912
Myocardial infarction	32.53	13.00	158	75434	110138	29388797
Osteoarthritis	32.49	13.00	4	75588	18099	29480836
Dyskinesia	32.42	13.00	6	75586	20055	29478880
Recall phenomenon	32.37	13.00	19	75573	516	29498419
Muscular weakness	32.23	13.00	69	75523	61983	29436952
Product prescribing error	32.19	13.00	4	75588	17972	29480963
Acquired gene mutation	31.56	13.00	26	75566	1232	29497703
Malaise	31.43	13.00	259	75333	159343	29339592
Rash	31.35	13.00	322	75270	189497	29309438
Depressed mood	31.13	13.00	3	75589	16445	29482490
Papillary thyroid cancer	30.89	13.00	19	75573	563	29498372
Pancreatitis	30.48	13.00	26	75566	34488	29464447
Abdominal discomfort	30.48	13.00	47	75545	47856	29451079
Blood glucose increased	30.29	13.00	66	75526	58918	29440017
Nasal congestion	29.76	13.00	6	75586	18873	29480062
Arterial occlusive disease	29.55	13.00	43	75549	3891	29495044
Osteosarcoma recurrent	29.53	13.00	8	75584	21	29498914
Liver function test abnormal	29.12	13.00	19	75573	28899	29470036
Pulmonary toxicity	29.10	13.00	48	75544	4842	29494093
Oedema peripheral	29.02	13.00	151	75441	103406	29395529
Toxicity to various agents	28.91	13.00	294	75298	173367	29325568
Serotonin syndrome	28.81	13.00	5	75587	17507	29481428
Hypophosphataemia	28.76	13.00	63	75529	7861	29491074
Bicytopenia	28.63	13.00	29	75563	1798	29497137
Pain	28.63	13.00	290	75302	171142	29327793
Sedation	28.57	13.00	5	75587	17400	29481535
Peritonitis	28.42	13.00	93	75499	14731	29484204
Chest discomfort	28.42	13.00	46	75546	45937	29452998
Mantle cell lymphoma recurrent	28.34	13.00	17	75575	481	29498454
Chronic obstructive pulmonary disease	28.20	13.00	38	75554	40917	29458018
Injury	28.12	13.00	7	75585	19039	29479896
Contusion	27.98	13.00	23	75569	31072	29467863
Erectile dysfunction	27.82	13.00	6	75586	18003	29480932
Drug resistance	27.81	13.00	119	75473	21421	29477514
Hepatic candidiasis	27.80	13.00	9	75583	51	29498884
Blood HIV RNA increased	27.46	13.00	22	75570	1002	29497933
Gout	27.45	13.00	5	75587	16906	29482029
Bradycardia	27.11	13.00	82	75510	65547	29433388
Extravasation	27.05	13.00	27	75565	1645	29497290
Gait inability	26.65	13.00	7	75585	18368	29480567
Back pain	26.54	13.00	153	75439	102131	29396804
Abnormal behaviour	26.44	13.00	13	75579	23114	29475821
Primitive neuroectodermal tumour	26.32	13.00	9	75583	62	29498873
Disseminated intravascular coagulation	26.27	13.00	111	75481	19869	29479066
Cerebral venous sinus thrombosis	26.24	13.00	15	75577	387	29498548
Cerebral ischaemia	26.22	13.00	50	75542	5653	29493282
Herpes zoster	26.10	13.00	23	75569	30029	29468906
Irritability	26.02	13.00	12	75580	22140	29476795
Blood creatinine increased	25.57	13.00	331	75261	84771	29414164
Enterocolitis	25.34	13.00	54	75538	6612	29492323
Arteriospasm coronary	25.29	13.00	32	75560	2533	29496402
Loss of personal independence in daily activities	25.23	13.00	17	75575	25423	29473512
Emotional distress	25.11	13.00	3	75589	13892	29485043
Dermatitis acneiform	25.07	13.00	48	75544	5443	29493492
Accidental overdose	24.96	13.00	7	75585	17586	29481349
Pneumothorax	24.84	13.00	93	75499	15749	29483186
Sleep disorder	24.59	13.00	16	75576	24370	29474565
Angina pectoris	24.57	13.00	21	75571	27829	29471106
Lymphadenopathy mediastinal	24.53	13.00	29	75563	2140	29496795
Radiation injury	24.49	13.00	15	75577	441	29498494
Fluid retention	24.38	13.00	15	75577	23545	29475390
Cerebral infarction	24.29	13.00	126	75466	24549	29474386
Refeeding syndrome	24.23	13.00	7	75585	25	29498910
Oesophageal perforation	24.13	13.00	18	75574	737	29498198
Lactic acidosis	24.11	13.00	25	75567	30222	29468713
Therapy cessation	24.08	13.00	4	75588	14458	29484477
Testicular malignant teratoma	23.97	13.00	6	75586	10	29498925
Refractory cancer	23.87	13.00	10	75582	127	29498808
Product administration error	23.73	13.00	4	75588	14306	29484629
Pharyngeal inflammation	23.55	13.00	13	75579	313	29498622
Diabetes mellitus	23.54	13.00	41	75551	39790	29459145
Retinal toxicity	23.53	13.00	14	75578	390	29498545
Sinusitis	23.52	13.00	32	75560	34318	29464617
Diaphragm muscle weakness	23.32	13.00	10	75582	135	29498800
Necrosis	23.00	13.00	44	75548	4986	29493949
Gastrooesophageal reflux disease	22.95	13.00	28	75564	31468	29467467
Blindness cortical	22.86	13.00	13	75579	332	29498603
Localised infection	22.61	13.00	4	75588	13812	29485123
Blood cholesterol increased	22.51	13.00	6	75586	15589	29483346
Granulocyte count decreased	22.49	13.00	16	75576	608	29498327
Road traffic accident	22.43	13.00	6	75586	15555	29483380
Haematoma	22.37	13.00	16	75576	23196	29475739
Oral candidiasis	22.13	13.00	69	75523	10653	29488282
Cholelithiasis	22.11	13.00	10	75582	18662	29480273
Hypochloraemia	22.09	13.00	15	75577	528	29498407
Agitation	21.98	13.00	63	75529	51241	29447694
Granulocyte-colony stimulating factor level increased	21.93	13.00	5	75587	4	29498931
Morphoea	21.80	13.00	10	75582	160	29498775
Gastrointestinal ischaemia	21.80	13.00	10	75582	160	29498775
Superior mesenteric artery syndrome	21.74	13.00	8	75584	70	29498865
Pleural effusion	21.73	13.00	280	75312	71628	29427307
Sleep apnoea syndrome	21.51	13.00	9	75583	17590	29481345
Myoclonus	21.46	13.00	4	75588	13305	29485630
Necrosis ischaemic	21.45	13.00	11	75581	227	29498708
Soft tissue disorder	21.43	13.00	16	75576	656	29498279
Performance status decreased	21.39	13.00	36	75556	3691	29495244
Coronary artery thrombosis	21.35	13.00	26	75566	1979	29496956
Labelled drug-drug interaction medication error	21.07	13.00	3	75589	12156	29486779
Blood glucose decreased	20.86	13.00	3	75589	12066	29486869
Wound	20.85	13.00	3	75589	12060	29486875
Extremity necrosis	20.78	13.00	23	75569	1580	29497355
Embolism arterial	20.67	13.00	14	75578	491	29498444
Choriocarcinoma	20.50	13.00	5	75587	7	29498928
Underdose	20.40	13.00	3	75589	11866	29487069
Vascular injury	20.34	13.00	11	75581	254	29498681
Neutrophil count abnormal	20.09	13.00	22	75570	1493	29497442
Hypoalbuminaemia	20.07	13.00	65	75527	10240	29488695
Metastases to peritoneum	20.03	13.00	22	75570	1498	29497437
Blood pressure systolic increased	19.98	13.00	9	75583	16836	29482099
Hyperammonaemic encephalopathy	19.90	13.00	25	75567	1965	29496970
Neurotoxicity	19.85	13.00	82	75510	14531	29484404
Full blood count decreased	19.83	13.00	8	75584	15984	29482951
Deafness bilateral	19.83	13.00	18	75574	973	29497962
Metastases to skin	19.80	13.00	12	75580	346	29498589
Palpitations	19.78	13.00	33	75559	32571	29466364
Iliac artery occlusion	19.67	13.00	9	75583	143	29498792
Product quality issue	19.63	13.00	8	75584	15887	29483048
Blood lactate dehydrogenase increased	19.54	13.00	99	75493	19110	29479825
Carotid artery dissection	19.51	13.00	9	75583	146	29498789
Adrenocortical carcinoma	19.50	13.00	6	75586	28	29498907
Mitral valve incompetence	19.40	13.00	5	75587	13288	29485647
Procedural vomiting	19.39	13.00	9	75583	148	29498787
Campylobacter test positive	19.32	13.00	6	75586	29	29498906
Hyperhidrosis	19.28	13.00	92	75500	64448	29434487
Failure to thrive	19.26	13.00	53	75539	7631	29491304
Speech disorder	19.24	13.00	19	75573	23497	29475438
Hot flush	19.17	13.00	7	75585	14863	29484072
Cell-mediated immune deficiency	19.16	13.00	6	75586	30	29498905
Transitional cell carcinoma recurrent	19.07	13.00	5	75587	11	29498924
Laryngeal pain	18.85	13.00	28	75564	2580	29496355
Medulloblastoma recurrent	18.85	13.00	7	75585	63	29498872
Transient ischaemic attack	18.81	13.00	19	75573	23251	29475684
Transformation to acute myeloid leukaemia	18.78	13.00	15	75577	680	29498255
EGFR gene mutation	18.66	13.00	8	75584	108	29498827
Loss of consciousness	18.55	13.00	112	75480	73944	29424991
Swelling	18.51	13.00	39	75553	35244	29463691
Haematochezia	18.48	13.00	42	75550	36941	29461994
Procedural nausea	18.47	13.00	7	75585	67	29498868
Psychotic disorder	18.38	13.00	15	75577	20339	29478596
Urinary tract infection	18.35	13.00	109	75483	72245	29426690
Chromaturia	18.33	13.00	5	75587	12797	29486138
Hepatitis B reactivation	18.28	13.00	31	75561	3198	29495737
Intestinal infarction	18.27	13.00	13	75579	494	29498441
Upper respiratory tract infection	18.20	13.00	26	75566	27323	29471612
Peripheral sensory neuropathy	18.01	13.00	44	75548	5895	29493040
Venous thrombosis	18.00	13.00	30	75562	3052	29495883
Meningitis tuberculous	17.99	13.00	14	75578	611	29498324
Visceral venous thrombosis	17.97	13.00	5	75587	15	29498920
Hypoaesthesia	17.91	13.00	73	75519	53394	29445541
Disturbance in attention	17.88	13.00	17	75575	21407	29477528
Hyperlipidaemia	17.88	13.00	5	75587	12585	29486350
Gastrointestinal perforation	17.85	13.00	32	75560	3451	29495484
Accidental exposure to product	17.84	13.00	3	75589	10750	29488185
Cerebral venous thrombosis	17.73	13.00	14	75578	624	29498311
Ureteric dilatation	17.67	13.00	8	75584	124	29498811
Drug clearance decreased	17.65	13.00	20	75572	1410	29497525
Oesophageal pain	17.64	13.00	15	75577	743	29498192
Haemoptysis	17.57	13.00	136	75456	30414	29468521
Dermatitis diaper	17.53	13.00	10	75582	257	29498678
Drug intolerance	17.53	13.00	64	75528	48315	29450620
Bronchitis	17.51	13.00	43	75549	36825	29462110
Fanconi syndrome	17.47	13.00	21	75571	1577	29497358
Mucosal toxicity	17.37	13.00	9	75583	190	29498745
Injection site erythema	17.28	13.00	7	75585	13949	29484986
Blood creatinine	17.22	13.00	6	75586	44	29498891
Dysstasia	17.21	13.00	3	75589	10471	29488464
Gastrointestinal anastomotic leak	17.19	13.00	11	75581	350	29498585
Visual impairment	17.18	13.00	31	75561	29677	29469258
Traumatic lung injury	17.17	13.00	18	75574	1162	29497773
Trigeminal nerve paresis	17.13	13.00	4	75588	4	29498931
Metastases to bone	17.12	13.00	60	75532	9838	29489097
B-cell lymphoma refractory	17	13.00	8	75584	136	29498799
Gingivitis ulcerative	16.99	13.00	6	75586	46	29498889
Chemotherapeutic drug level increased	16.91	13.00	9	75583	201	29498734
Human chorionic gonadotropin increased	16.86	13.00	5	75587	20	29498915
Metastases to meninges	16.86	13.00	18	75574	1187	29497748
Delusion	16.79	13.00	4	75588	11212	29487723
Lymphangiosis carcinomatosa	16.75	13.00	15	75577	797	29498138
Burning sensation	16.70	13.00	10	75582	15928	29483007
Movement disorder	16.67	13.00	3	75589	10234	29488701
Type 2 diabetes mellitus	16.51	13.00	7	75585	13574	29485361
Myelitis transverse	16.38	13.00	16	75576	949	29497986
Blister	16.38	13.00	16	75576	19890	29479045
Withdrawal syndrome	16.30	13.00	4	75588	10988	29487947
Thrombocytosis	16.16	13.00	30	75562	3323	29495612
Subcutaneous emphysema	16.01	13.00	16	75576	976	29497959
Swelling face	16.01	13.00	17	75575	20333	29478602
Wound evisceration	15.97	13.00	7	75585	100	29498835
Small cell lung cancer	15.93	13.00	21	75571	1731	29497204
Dementia	15.88	13.00	5	75587	11653	29487282
Rectal haemorrhage	15.87	13.00	41	75551	34508	29464427
Hypersomnia	15.78	13.00	4	75588	10750	29488185
Tumour thrombosis	15.78	13.00	6	75586	58	29498877
Eye pain	15.74	13.00	5	75587	11590	29487345
Hepatic enzyme increased	15.60	13.00	40	75552	33759	29465176
Testicular cancer metastatic	15.60	13.00	6	75586	60	29498875
Testicular germ cell cancer metastatic	15.60	13.00	6	75586	60	29498875
Ganglioneuroma	15.51	13.00	4	75588	8	29498927
Gene mutation	15.37	13.00	16	75576	1025	29497910
Blood magnesium decreased	15.35	13.00	39	75553	5355	29493580
Blastic plasmacytoid dendritic cell neoplasia	15.26	13.00	6	75586	64	29498871
Osteosarcoma metastatic	15.20	13.00	4	75588	9	29498926
Plasma cell leukaemia	15.02	13.00	14	75578	783	29498152
Immune-mediated hepatic disorder	15.01	13.00	10	75582	341	29498594
Hyperglycaemic hyperosmolar nonketotic syndrome	15	13.00	16	75576	1054	29497881
Blood triglycerides increased	15.00	13.00	7	75585	12827	29486108
Enterococcal bacteraemia	14.92	13.00	19	75573	1514	29497421
Carotid artery perforation	14.92	13.00	3	75589	0	29498935
Pharyngeal stenosis	14.92	13.00	3	75589	0	29498935
Plasma cell myeloma	14.87	13.00	47	75545	37068	29461867
Respiratory depression	14.86	13.00	8	75584	13515	29485420
Viral load increased	14.82	13.00	22	75570	2027	29496908
Eosinophilia	14.81	13.00	21	75571	22140	29476795
Hepatic steatosis	14.80	13.00	10	75582	14936	29483999
Dyspnoea exertional	14.77	13.00	46	75546	36444	29462491
Rib fracture	14.76	13.00	7	75585	12711	29486224
Cerebral haemorrhage	14.66	13.00	37	75555	31389	29467546
JC virus infection	14.63	13.00	21	75571	1876	29497059
Basal cell carcinoma	14.61	13.00	13	75579	16897	29482038
Thrombotic thrombocytopenic purpura	14.60	13.00	28	75564	3178	29495757
Laboratory test abnormal	14.52	13.00	15	75577	18170	29480765
Haemoperitoneum	14.44	13.00	19	75573	1563	29497372
Apparent mineralocorticoid excess	14.43	13.00	5	75587	36	29498899
Frequent bowel movements	14.43	13.00	3	75589	9236	29489699
White blood cell disorder	14.42	13.00	18	75574	1405	29497530
Infected neoplasm	14.41	13.00	6	75586	75	29498860
Metapneumovirus bronchiolitis	14.37	13.00	4	75588	12	29498923
Head injury	14.33	13.00	12	75580	16069	29482866
Diabetic ketoacidosis	14.32	13.00	12	75580	16061	29482874
Dropped head syndrome	14.27	13.00	7	75585	131	29498804
Treatment noncompliance	14.26	13.00	25	75567	24202	29474733
Sarcoma	14.24	13.00	10	75582	372	29498563
Penile vein thrombosis	14.13	13.00	4	75588	13	29498922
Cerebrovascular accident	14.13	13.00	127	75465	76784	29422151
Polyneuropathy	14.07	13.00	65	75527	12087	29486848
Malocclusion	14.06	13.00	6	75586	80	29498855
Eczema	14.03	13.00	9	75583	13817	29485118
Fistula of small intestine	13.94	13.00	10	75582	385	29498550
Laryngeal cancer stage IV	13.91	13.00	4	75588	14	29498921
Gastrointestinal haemorrhage	13.89	13.00	133	75459	79400	29419535
Paranoia	13.88	13.00	4	75588	9873	29489062
Therapeutic embolisation	13.85	13.00	9	75583	294	29498641
Osteomyelitis	13.81	13.00	9	75583	13700	29485235
Candida infection	13.80	13.00	76	75516	15149	29483786
Thrombophlebitis migrans	13.73	13.00	6	75586	85	29498850
Metastatic gastric cancer	13.59	13.00	7	75585	146	29498789
Focal nodular hyperplasia	13.50	13.00	7	75585	148	29498787
Torulopsis infection	13.49	13.00	4	75588	16	29498919
Optic atrophy	13.45	13.00	13	75579	761	29498174
Subdural haematoma	13.44	13.00	16	75576	18177	29480758
Fistula	13.44	13.00	36	75556	5103	29493832
Hip fracture	13.42	13.00	5	75587	10487	29488448
Chondrosarcoma	13.37	13.00	5	75587	46	29498889
Hemianopia	13.34	13.00	12	75580	641	29498294
Cellulitis	13.30	13.00	66	75526	45774	29453161
Oral pain	13.25	13.00	53	75539	9254	29489681
Tetany	13.20	13.00	12	75580	650	29498285
Abdominal wound dehiscence	13.19	13.00	6	75586	94	29498841
Tracheal stenosis	13.17	13.00	7	75585	156	29498779
Tooth disorder	13.13	13.00	4	75588	9525	29489410
Cytopenia	13.13	13.00	55	75537	9804	29489131
Laryngeal inflammation	13.12	13.00	4	75588	18	29498917
Decorticate posture	13.12	13.00	4	75588	18	29498917
Retinal ischaemia	13.00	13.00	9	75583	327	29498608

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
Febrile neutropenia	2189.66	12.76	2112	109007	185545	64202068
Neutropenia	1587.98	12.76	2005	109114	237619	64149994
Thrombocytopenia	1116.79	12.76	1633	109486	222168	64165445
Mucosal inflammation	1038.22	12.76	861	110258	61723	64325890
Malignant neoplasm progression	901.53	12.76	1040	110079	111831	64275782
Bone marrow failure	742.01	12.76	634	110485	47318	64340295
Pancytopenia	725.60	12.76	1054	110065	142255	64245358
Haematotoxicity	637.67	12.76	350	110769	12546	64375067
Disease progression	630.16	12.76	981	110138	140699	64246914
Leukopenia	509.66	12.76	743	110376	100499	64287114
Myelosuppression	509.40	12.76	381	110738	23449	64364164
Acute myeloid leukaemia	506.02	12.76	402	110717	27061	64360552
Anaemia	490.94	12.76	1599	109520	377081	64010532
Dehydration	470.70	12.76	1106	110013	215657	64171956
Vomiting	468.13	12.76	2031	109088	549086	63838527
Arthralgia	421.99	12.76	120	110999	442140	63945473
Second primary malignancy	402.59	12.76	256	110863	12081	64375532
Nausea	352.98	12.76	2434	108685	783366	63604247
Neutropenic sepsis	344.17	12.76	300	110819	22972	64364641
Off label use	324.96	12.76	2028	109091	630778	63756835
Aortic thrombosis	319.30	12.76	114	111005	1400	64386213
Renal salt-wasting syndrome	317.16	12.76	86	111033	378	64387235
Neutrophil count decreased	313.18	12.76	513	110606	76683	64310930
Fall	301.65	12.76	172	110947	416654	63970959
Ototoxicity	293.37	12.76	126	110993	2597	64385016
Neoplasm progression	273.39	12.76	345	110774	40619	64346994
Joint swelling	263.63	12.76	31	111088	215351	64172262
Hypomagnesaemia	262.59	12.76	323	110796	37053	64350560
Myelodysplastic syndrome	253.83	12.76	274	110845	27305	64360308
Rheumatoid arthritis	250.49	12.76	7	111112	164287	64223326
Pulmonary embolism	243.62	12.76	676	110443	145680	64241933
Product dose omission issue	243.45	12.76	26	111093	194721	64192892
Nephropathy toxic	241.46	12.76	217	110902	17297	64370316
Pyrexia	230.92	12.76	1698	109421	556946	63830667
Acute kidney injury	226.29	12.76	1434	109685	447806	63939807
Drug abuse	208.11	12.76	4	111115	132370	64255243
Peripheral swelling	208.10	12.76	52	111067	209101	64178512
Headache	202.47	12.76	378	110741	529089	63858524
Deafness	195.09	12.76	197	110922	18162	64369451
Weight increased	193.86	12.76	63	111056	213285	64174328
Cardiotoxicity	192.63	12.76	152	110967	10122	64377491
Pain	187.21	12.76	424	110695	553087	63834526
Tumour lysis syndrome	185.68	12.76	197	110922	19243	64368370
Platelet count decreased	183.96	12.76	671	110448	167040	64220573
Dysphagia	180.26	12.76	496	110623	106316	64281297
Sepsis	180.15	12.76	830	110289	229511	64158102
Posterior reversible encephalopathy syndrome	178.70	12.76	209	110910	22737	64364876
Decreased appetite	175.73	12.76	951	110168	280338	64107275
Stomatitis	175.17	12.76	499	110620	109106	64278507
Septic shock	174.36	12.76	486	110633	104951	64282662
Therapy partial responder	173.85	12.76	143	110976	10105	64377508
Metastases to lung	173.67	12.76	170	110949	15094	64372519
Musculoskeletal stiffness	171.89	12.76	10	111109	123196	64264417
Metastases to central nervous system	171.62	12.76	162	110957	13750	64373863
Anastomotic leak	171.25	12.76	64	111055	902	64386711
Arthropathy	168.21	12.76	10	111109	120957	64266656
Nasopharyngitis	162.74	12.76	67	111052	196006	64191607
Product use in unapproved indication	162.15	12.76	668	110451	175950	64211663
Drug hypersensitivity	160.81	12.76	106	111013	237709	64149904
Pain in extremity	158.60	12.76	173	110946	302912	64084701
Hypokalaemia	158.28	12.76	516	110603	121387	64266226
White blood cell count decreased	157.72	12.76	613	110506	157224	64230389
Tinnitus	155.09	12.76	239	110880	33894	64353719
Hyponatraemia	154.69	12.76	584	110535	147755	64239858
Diffuse large B-cell lymphoma recurrent	148.93	12.76	83	111036	3063	64384550
Oesophagitis	148.79	12.76	185	110934	21445	64366168
Overdose	145.12	12.76	47	111072	159519	64228094
Abdominal discomfort	140.80	12.76	69	111050	182253	64205360
Injection site pain	138.84	12.76	15	111104	111393	64276220
Radiation skin injury	134.96	12.76	59	111060	1271	64386342
Therapeutic product effect decreased	132.95	12.76	20	111099	115331	64272282
Renal failure	131.96	12.76	641	110478	181047	64206566
Teratoma	131.94	12.76	34	111085	117	64387496
Neuropathy peripheral	131.14	12.76	473	110646	117052	64270561
Drug resistance	129.91	12.76	224	110895	34878	64352735
Gastrointestinal toxicity	129.35	12.76	92	111027	5230	64382383
Insomnia	126.03	12.76	94	111025	197742	64189871
Condition aggravated	123.49	12.76	288	110831	372138	64015475
Pruritus	121.85	12.76	220	110899	312180	64075433
Hypophagia	120.36	12.76	232	110887	39355	64348258
Inappropriate antidiuretic hormone secretion	119.91	12.76	169	110950	22120	64365493
Peripheral artery thrombosis	119.89	12.76	71	111048	2944	64384669
Muscle spasms	117.29	12.76	48	111071	140975	64246638
Febrile bone marrow aplasia	116.34	12.76	119	111000	11136	64376477
Oesophageal fistula	116.01	12.76	36	111083	275	64387338
Swelling	115.79	12.76	66	111053	160152	64227461
Systemic lupus erythematosus	115.75	12.76	4	111115	77608	64310005
Metastases to lymph nodes	112.31	12.76	104	111015	8613	64379000
Aorto-oesophageal fistula	111.03	12.76	26	111093	52	64387561
Asthma	110.91	12.76	16	111103	95209	64292404
Hypocalcaemia	108.22	12.76	229	110890	41524	64346089
Diffuse large B-cell lymphoma refractory	108.04	12.76	48	111071	1076	64386537
Arthritis	107.78	12.76	10	111109	83804	64303809
Gastric perforation	107.25	12.76	70	111049	3453	64384160
Contusion	106.41	12.76	32	111087	113933	64273680
Ovarian germ cell teratoma	105.79	12.76	25	111094	53	64387560
Drug ineffective	105.53	12.76	934	110185	839313	63548300
Disease recurrence	104.91	12.76	192	110927	31318	64356295
Depression	102.16	12.76	99	111020	183192	64204421
Leukoencephalopathy	101.34	12.76	89	111030	6878	64380735
Intentional product misuse	100.42	12.76	6	111113	72289	64315324
Palmar-plantar erythrodysaesthesia syndrome	100.27	12.76	179	110940	28640	64358973
Deep vein thrombosis	99.74	12.76	402	110717	104780	64282833
Metastases to liver	99.57	12.76	161	110958	23780	64363833
Renal tubular disorder	98.34	12.76	82	111037	5905	64381708
Venoocclusive liver disease	96.53	12.76	102	111017	9913	64377700
Psoriasis	96.50	12.76	7	111112	71696	64315917
Contraindicated product administered	94.14	12.76	34	111085	107795	64279818
Drug interaction	93.32	12.76	316	110803	361767	64025846
Odynophagia	92.59	12.76	98	111021	9543	64378070
Wound	91.07	12.76	12	111107	76465	64311148
Peripheral ischaemia	91.02	12.76	91	111028	8287	64379326
Suicidal ideation	90.99	12.76	6	111113	66536	64321077
Pemphigus	90.97	12.76	3	111116	60698	64326915
Arterial thrombosis	90.85	12.76	55	111064	2375	64385238
Hypoacusis	90.43	12.76	161	110958	25706	64361907
Mobility decreased	89.97	12.76	19	111100	85821	64301792
Sinusitis	89.52	12.76	72	111047	145856	64241757
Hiccups	89.20	12.76	90	111029	8286	64379327
Dermatitis	88.65	12.76	131	110988	17898	64369715
Renal impairment	88.56	12.76	463	110656	134554	64253059
Gait disturbance	88.05	12.76	100	111019	172055	64215558
Neurotoxicity	87.49	12.76	164	110955	27240	64360373
Electrolyte imbalance	86.81	12.76	156	110963	25087	64362526
Radiation pneumonitis	86.63	12.76	60	111059	3268	64384345
Anxiety	86.06	12.76	135	110984	202514	64185099
Dizziness	85.94	12.76	415	110704	429748	63957865
Malignant transformation	85.52	12.76	41	111078	1100	64386513
Urogenital fistula	85.09	12.76	22	111097	77	64387536
Rash	83.91	12.76	456	110663	458093	63929520
Urticaria	83.91	12.76	78	111041	147239	64240374
Osteoarthritis	82.94	12.76	7	111112	63329	64324284
Teratoma benign	79.44	12.76	20	111099	61	64387552
Migraine	79.21	12.76	8	111111	62669	64324944
Bacteraemia	78.49	12.76	155	110964	26756	64360857
Feeling abnormal	78.16	12.76	69	111050	133533	64254080
Hospitalisation	78.10	12.76	17	111102	75190	64312423
Suicide attempt	78.04	12.76	14	111105	70993	64316620
Recall phenomenon	78.00	12.76	37	111082	969	64386644
Blood pressure increased	77.08	12.76	111	111008	172441	64215172
Blister	76.92	12.76	22	111097	80945	64306668
Somnolence	76.15	12.76	147	110972	203498	64184115
Cardiac failure congestive	75.72	12.76	68	111051	130512	64257101
Injection site erythema	75.59	12.76	15	111104	70785	64316828
Acute respiratory distress syndrome	74.97	12.76	190	110929	38745	64348868
Myalgia	74.91	12.76	98	111021	158519	64229094
Diarrhoea	74.19	12.76	1696	109423	721008	63666605
Osteoradionecrosis	73.55	12.76	20	111099	89	64387524
Stress	73.28	12.76	9	111110	60525	64327088
Bronchitis	72.72	12.76	49	111070	108694	64278919
Balance disorder	72.34	12.76	27	111092	83899	64303714
Nasal congestion	71.90	12.76	9	111110	59649	64327964
Enteritis	71.62	12.76	96	111023	11981	64375632
Hepatic enzyme increased	71.44	12.76	71	111048	129872	64257741
Wheezing	71.02	12.76	25	111094	80554	64307059
Pneumonitis	70.60	12.76	219	110900	50146	64337467
Drug intolerance	69.16	12.76	137	110982	187855	64199758
Deafness bilateral	68.95	12.76	42	111077	1834	64385779
Rhabdomyolysis	68.84	12.76	36	111083	91690	64295923
Pulmonary vascular disorder	68.47	12.76	33	111086	896	64386717
Large intestine perforation	68.43	12.76	96	111023	12508	64375105
Osteosarcoma	68.17	12.76	24	111095	282	64387331
Aplasia	67.34	12.76	71	111048	6882	64380731
Wrong technique in product usage process	66.83	12.76	15	111104	64959	64322654
Radiation oesophagitis	66.75	12.76	28	111091	543	64387070
Bicytopenia	66.63	12.76	53	111066	3569	64384044
Thrombotic microangiopathy	66.54	12.76	110	111009	16545	64371068
Injury	66.15	12.76	9	111110	55983	64331630
Hepatitis B	66.13	12.76	74	111045	7671	64379942
Blood creatinine increased	65.88	12.76	430	110689	135352	64252261
Cytomegalovirus oesophagitis	64.97	12.76	28	111091	582	64387031
Loss of personal independence in daily activities	64.68	12.76	22	111097	72432	64315181
Chloroma	64.23	12.76	29	111090	676	64386937
Hypophosphataemia	63.96	12.76	101	111018	14619	64372994
Inappropriate schedule of product administration	63.86	12.76	40	111079	92246	64295367
Neutropenic colitis	63.60	12.76	57	111062	4524	64383089
Bacterial translocation	63.55	12.76	25	111094	408	64387205
Pleural effusion	63.36	12.76	404	110715	126155	64261458
Influenza	62.33	12.76	55	111064	106476	64281137
Influenza like illness	61.97	12.76	15	111104	61687	64325926
Atypical haemolytic uraemic syndrome	61.58	12.76	28	111091	664	64386949
Portal venous gas	61.23	12.76	23	111096	329	64387284
Colitis	60.25	12.76	230	110889	58444	64329169
Electrocardiogram QT prolonged	59.89	12.76	31	111088	79417	64308196
Oesophageal stenosis	59.86	12.76	51	111068	3783	64383830
Metastases to skin	59.85	12.76	35	111084	1417	64386196
Discomfort	58.86	12.76	33	111086	80845	64306768
Injection site swelling	58.76	12.76	3	111116	41350	64346263
Bronchial fistula	58.59	12.76	19	111100	170	64387443
Metastases to breast	57.59	12.76	20	111099	225	64387388
Blood pressure fluctuation	57.49	12.76	10	111109	51861	64335752
Infusion related reaction	56.99	12.76	124	110995	164343	64223270
Renal tubular necrosis	56.98	12.76	121	110998	21989	64365624
Radiation injury	56.92	12.76	27	111092	707	64386906
Acquired gene mutation	56.91	12.76	38	111081	1948	64385665
Deafness neurosensory	56.31	12.76	62	111057	6312	64381301
Osteosarcoma metastatic	55.78	12.76	14	111105	42	64387571
Oesophagobronchial fistula	55.59	12.76	19	111100	203	64387410
Hypoglycaemia	55.55	12.76	44	111075	89848	64297765
Vena cava thrombosis	55.52	12.76	41	111078	2471	64385142
Pulmonary arteriopathy	55.46	12.76	16	111103	92	64387521
Memory impairment	55.44	12.76	40	111079	85642	64301971
Salivary gland cancer	54.94	12.76	22	111097	377	64387236
Metastasis	54.88	12.76	58	111061	5637	64381976
Exposure during pregnancy	54.67	12.76	33	111086	77642	64309971
Embolism	54.62	12.76	85	111034	12150	64375463
Disseminated intravascular coagulation	53.30	12.76	149	110970	32199	64355414
Ameloblastoma	53.09	12.76	15	111104	79	64387534
Renal infarct	52.50	12.76	39	111080	2372	64385241
Cataract	52.39	12.76	12	111107	51250	64336363
Vision blurred	52.39	12.76	47	111072	90269	64297344
Heart rate decreased	52.23	12.76	15	111104	55052	64332561
Tumour necrosis	52.13	12.76	34	111085	1675	64385938
Empyema	51.67	12.76	46	111073	3619	64383994
Anastomotic complication	51.39	12.76	21	111098	380	64387233
Malaise	50.56	12.76	438	110681	395809	63991804
Metastases to bone	50.55	12.76	110	111009	20325	64367288
Tremor	50.33	12.76	113	111006	148117	64239496
General physical health deterioration	50.25	12.76	556	110563	203869	64183744
Splenic infarction	50.18	12.76	43	111076	3214	64384399
Cardiomyopathy	50.13	12.76	125	110994	25231	64362382
Serotonin syndrome	49.67	12.76	5	111114	39277	64348336
Interstitial lung disease	49.53	12.76	313	110806	97419	64290194
Fibromyalgia	49.51	12.76	3	111116	35728	64351885
Osteoporosis	49.15	12.76	7	111112	42073	64345540
Arteriospasm coronary	48.01	12.76	53	111066	5412	64382201
Respiratory failure	48.01	12.76	456	110663	160727	64226886
Pulmonary toxicity	47.66	12.76	66	111053	8495	64379118
Tumour haemorrhage	47.58	12.76	43	111076	3450	64384163
Lymphopenia	47.11	12.76	123	110996	25534	64362079
Performance status decreased	47.08	12.76	52	111067	5312	64382301
Gastrointestinal perforation	46.61	12.76	52	111067	5372	64382241
Cerebral infarction	46.41	12.76	166	110953	40878	64346735
Gastrooesophageal reflux disease	46.18	12.76	45	111074	83098	64304515
Blood creatine phosphokinase increased	45.41	12.76	22	111097	58536	64329077
Fluid retention	45.31	12.76	23	111096	59583	64328030
Maternal exposure during pregnancy	44.48	12.76	60	111059	95824	64291789
Mantle cell lymphoma recurrent	44.15	12.76	20	111099	470	64387143
Radiation mucositis	43.91	12.76	15	111104	160	64387453
Sedation	43.81	12.76	9	111110	41453	64346160
Chronic obstructive pulmonary disease	43.62	12.76	35	111084	71013	64316600
Fatigue	43.61	12.76	971	110148	747759	63639854
Polyneuropathy	43.54	12.76	102	111017	19792	64367821
Blood cholesterol increased	43.32	12.76	16	111103	50050	64337563
Muscular weakness	43.29	12.76	97	111022	127241	64260372
Aggression	43.10	12.76	13	111106	46219	64341394
Blood sodium decreased	42.99	12.76	130	110989	29352	64358261
Peritonitis	42.95	12.76	117	111002	24906	64362707
Necrosis	42.53	12.76	61	111058	8110	64379503
Blood stem cell transplant failure	42.47	12.76	20	111099	515	64387098
B-cell lymphoma recurrent	42.27	12.76	23	111096	809	64386804
Drug withdrawal syndrome	42.25	12.76	3	111116	31288	64356325
Adverse drug reaction	42.00	12.76	13	111106	45451	64342162
Type 2 diabetes mellitus	41.32	12.76	5	111114	34015	64353598
Cerebral venous thrombosis	41.27	12.76	34	111085	2407	64385206
Drug clearance decreased	41.22	12.76	35	111084	2584	64385029
Palpitations	41.18	12.76	73	111046	104415	64283198
Burning sensation	41.11	12.76	17	111102	49647	64337966
Dermatitis acneiform	41.00	12.76	61	111058	8382	64379231
Hallucination	40.88	12.76	39	111080	72749	64314864
Cystitis haemorrhagic	40.84	12.76	59	111060	7897	64379716
Coronary artery disease	40.70	12.76	27	111092	60406	64327207
Tumour perforation	40.70	12.76	17	111102	326	64387287
Intestinal ischaemia	40.51	12.76	72	111047	11477	64376136
Hypoalbuminaemia	40.19	12.76	92	111027	17582	64370031
Pneumatosis intestinalis	39.66	12.76	47	111072	5182	64382431
Oedema peripheral	39.56	12.76	207	110912	210110	64177503
Nervousness	39.44	12.76	3	111116	29553	64358060
Red blood cell sedimentation rate increased	39.43	12.76	4	111115	31231	64356382
Pneumothorax	39.13	12.76	111	111008	24187	64363426
Cardiac disorder	38.87	12.76	24	111095	55792	64331821
Hypoaesthesia	38.83	12.76	117	111002	138991	64248622
Refeeding syndrome	38.61	12.76	11	111108	60	64387553
Incorrect dose administered	38.49	12.76	29	111090	60736	64326877
Hydronephrosis	38.37	12.76	79	111040	14046	64373567
Back pain	38.22	12.76	263	110856	249908	64137705
Adrenocortical carcinoma	38.02	12.76	11	111108	64	64387549
Lactic acidosis	38.01	12.76	30	111089	61380	64326233
Gastrointestinal anastomotic leak	37.70	12.76	17	111102	395	64387218
Neoplasm recurrence	37.68	12.76	39	111080	3700	64383913
Injection site reaction	37.00	12.76	17	111102	46647	64340966
Confusional state	36.77	12.76	281	110838	260863	64126750
Toxicity to various agents	36.68	12.76	425	110694	363088	64024525
Unevaluable event	36.16	12.76	21	111098	50468	64337145
Angioedema	36.05	12.76	32	111087	61789	64325824
Sleep disorder	35.92	12.76	30	111089	59679	64327934
Metastases to peritoneum	35.75	12.76	37	111082	3510	64384103
Myasthenia gravis crisis	35.63	12.76	21	111098	863	64386750
Gastrointestinal fungal infection	35.48	12.76	16	111103	372	64387241
Osteosarcoma recurrent	35.38	12.76	9	111110	29	64387584
Heart rate increased	35.33	12.76	73	111046	98602	64289011
Peripheral sensory neuropathy	34.96	12.76	67	111052	11311	64376302
Product prescribing error	34.59	12.76	9	111110	35260	64352353
Fanconi syndrome	34.49	12.76	31	111088	2470	64385143
Cholelithiasis	33.93	12.76	18	111101	45488	64342125
Road traffic accident	33.91	12.76	6	111113	30739	64356874
Blood pressure systolic increased	33.43	12.76	22	111097	49431	64338182
Large intestinal ulcer perforation	33.36	12.76	10	111109	67	64387546
Melanoderma	33.25	12.76	15	111104	349	64387264
Neurosensory hypoacusis	33.11	12.76	13	111106	211	64387402
Localised infection	33.02	12.76	6	111113	30155	64357458
Small cell lung cancer	32.84	12.76	31	111088	2630	64384983
Ureteric rupture	32.72	12.76	7	111112	7	64387606
Coronary artery thrombosis	32.72	12.76	32	111087	2837	64384776
Refractory cancer	32.45	12.76	13	111106	223	64387390
Abortion spontaneous	32.31	12.76	3	111116	25140	64362473
Mesenteric abscess	32.14	12.76	11	111108	118	64387495
Extremity necrosis	32.13	12.76	31	111088	2703	64384910
Haematoma	32.05	12.76	20	111099	46230	64341383
Blindness cortical	31.95	12.76	19	111100	794	64386819
Acoustic stimulation tests abnormal	31.88	12.76	8	111111	24	64387589
Wernicke's encephalopathy	31.88	12.76	8	111111	24	64387589
Cervix neoplasm	31.55	12.76	12	111107	178	64387435
Malnutrition	31.41	12.76	88	111031	19037	64368576
Irritability	31.36	12.76	12	111107	36734	64350879
Metastases to meninges	31.36	12.76	31	111088	2784	64384829
Plasma cell leukaemia	31.33	12.76	24	111095	1529	64386084
Eye pain	31.15	12.76	8	111111	31617	64355996
Ascites	31.05	12.76	198	110921	61803	64325810
Injection site haemorrhage	30.93	12.76	3	111116	24275	64363338
Throat irritation	30.86	12.76	9	111110	32702	64354911
Blood glucose increased	30.71	12.76	78	111041	97995	64289618
Cytopenia	30.30	12.76	76	111043	15395	64372218
Dyskinesia	30.23	12.76	15	111104	39373	64348240
Chemical peritonitis	30.13	12.76	13	111106	271	64387342
Nasal abscess	29.96	12.76	11	111108	147	64387466
Extravasation	29.96	12.76	32	111087	3148	64384465
Flagellate dermatitis	29.84	12.76	12	111107	208	64387405
Gait inability	29.81	12.76	18	111101	42350	64345263
Cerebral ischaemia	29.80	12.76	58	111061	9904	64377709
Myoclonus	29.76	12.76	4	111115	25114	64362499
Plasmacytoma	29.71	12.76	35	111084	3835	64383778
International normalised ratio increased	29.69	12.76	57	111062	79110	64308503
Visceral venous thrombosis	29.57	12.76	7	111112	15	64387598
Swelling face	29.54	12.76	35	111084	59131	64328482
Nephritis bacterial	29.53	12.76	8	111111	35	64387578
Gastric disorder	29.51	12.76	7	111112	29190	64358423
Accidental exposure to product	29.40	12.76	5	111114	26359	64361254
Product administration error	29.20	12.76	6	111113	27637	64359976
Progressive multifocal leukoencephalopathy	29.07	12.76	83	111036	18149	64369464
COVID-19	28.97	12.76	42	111077	65098	64322515
Emotional distress	28.77	12.76	13	111106	36025	64351588
Blood lactate dehydrogenase increased	28.64	12.76	123	110996	32955	64354658
Underdose	28.58	12.76	5	111114	25824	64361789
Limb discomfort	28.50	12.76	6	111113	27169	64360444
Musculoskeletal pain	28.38	12.76	61	111058	81233	64306380
Basal cell carcinoma	28.16	12.76	9	111110	30829	64356784
Hepatic candidiasis	28.11	12.76	9	111110	77	64387536
Myocardial infarction	28.02	12.76	169	110950	165652	64221961
Lymphadenopathy mediastinal	28.02	12.76	34	111085	3842	64383771
Blood magnesium decreased	27.96	12.76	69	111050	13836	64373777
Lip swelling	27.94	12.76	10	111109	31897	64355716
Femur fracture	27.75	12.76	12	111107	34123	64353490
Urinary tract infection	27.73	12.76	260	110859	231336	64156277
Oesophageal perforation	27.64	12.76	19	111100	1022	64386591
Metastases to adrenals	27.62	12.76	20	111099	1169	64386444
Cerebral venous sinus thrombosis	27.59	12.76	24	111095	1831	64385782
Joint stiffness	27.54	12.76	9	111110	30395	64357218
Labelled drug-drug interaction medication error	27.40	12.76	3	111116	22059	64365554
Swollen tongue	27.30	12.76	13	111106	34941	64352672
Limb injury	27.24	12.76	4	111115	23501	64364112
Agitation	27.11	12.76	71	111048	88296	64299317
Poisoning	27.11	12.76	3	111116	21876	64365737
Therapy cessation	27.09	12.76	11	111108	32478	64355135
EGFR gene mutation	27.04	12.76	13	111106	351	64387262
Pancreatitis	26.93	12.76	38	111081	59569	64328044
Papillary thyroid cancer	26.90	12.76	26	111093	2272	64385341
Failure to thrive	26.88	12.76	57	111062	10347	64377266
Enterocolitis	26.71	12.76	62	111057	11956	64375657
Hepatic steatosis	26.67	12.76	10	111109	30997	64356616
Blood glucose decreased	26.65	12.76	4	111115	23119	64364494
Cholangitis	26.55	12.76	58	111061	10744	64376869
Right ventricular failure	26.46	12.76	3	111116	21468	64366145
Testicular malignant teratoma	26.33	12.76	6	111113	10	64387603
Tracheal stenosis	26.26	12.76	12	111107	288	64387325
Nephrolithiasis	26.21	12.76	22	111097	43661	64343952
Tumour thrombosis	26.18	12.76	9	111110	98	64387515
Pericarditis	26.17	12.76	42	111077	62474	64325139
Erythropenia	26.03	12.76	13	111106	382	64387231
Device issue	25.91	12.76	4	111115	22644	64364969
Impaired healing	25.91	12.76	40	111079	60433	64327180
Blood HIV RNA increased	25.78	12.76	21	111098	1463	64386150
Hyperhidrosis	25.75	12.76	119	111000	124801	64262812
Diabetes mellitus	25.68	12.76	47	111072	66427	64321186
Superior mesenteric artery syndrome	25.66	12.76	10	111109	159	64387454
Dry eye	25.57	12.76	9	111110	29010	64358603
Pregnancy	25.50	12.76	3	111116	20862	64366751
Medulloblastoma recurrent	25.47	12.76	9	111110	107	64387506
Lower respiratory tract infection	25.39	12.76	81	111038	94533	64293080
Diaphragm muscle weakness	25.37	12.76	10	111109	164	64387449
Tracheo-oesophageal fistula	25.36	12.76	14	111105	507	64387106
Neutrophil count abnormal	25.29	12.76	28	111091	2868	64384745
Traumatic lung injury	25.24	12.76	25	111094	2251	64385362
Pain in jaw	25.11	12.76	20	111099	40735	64346878
Ovarian vein thrombosis	25.08	12.76	7	111112	35	64387578
Candida infection	25.06	12.76	114	111005	31305	64356308
Sleep apnoea syndrome	25.03	12.76	10	111109	29822	64357791
Liver function test abnormal	24.78	12.76	40	111079	59361	64328252
Hypersensitivity	24.62	12.76	218	110901	196234	64191379
Dysstasia	24.60	12.76	5	111114	23210	64364403
Hip fracture	24.58	12.76	8	111111	27091	64360522
Wound evisceration	24.53	12.76	9	111110	120	64387493
Necrotising colitis	24.52	12.76	17	111102	927	64386686
Death	24.43	12.76	639	110480	482066	63905547
Product use issue	24.40	12.76	157	110962	151558	64236055
Upper respiratory tract infection	24.27	12.76	56	111063	72729	64314884
Haemoptysis	24.17	12.76	156	110963	48892	64338721
Gout	24.01	12.76	4	111115	21409	64366204
Accidental overdose	23.97	12.76	14	111105	33543	64354070
Duodenal ulcer perforation	23.95	12.76	15	111104	34610	64353003
Granulocyte-colony stimulating factor level increased	23.90	12.76	5	111114	4	64387609
Melanosis	23.87	12.76	7	111112	43	64387570
Rib fracture	23.83	12.76	6	111113	24032	64363581
Intestinal perforation	23.73	12.76	69	111050	15244	64372369
Hepatic cirrhosis	23.44	12.76	8	111111	26290	64361323
Nightmare	23.36	12.76	4	111115	20989	64366624
Myeloid leukaemia	23.35	12.76	14	111105	594	64387019
Alpha 1 foetoprotein increased	23.25	12.76	15	111104	725	64386888
Blood pressure diastolic decreased	23.23	12.76	5	111114	22296	64365317
Sopor	23.21	12.76	11	111108	29650	64357963
Chest discomfort	23.11	12.76	112	111007	115994	64271619
Metastatic neoplasm	22.88	12.76	33	111086	4409	64383204
Device related infection	22.86	12.76	109	111010	30517	64357096
Stem cell transplant	22.70	12.76	29	111090	3452	64384161
Obesity	22.70	12.76	4	111115	20558	64367055
Herpes simplex encephalitis	22.66	12.76	14	111105	627	64386986
Encephalopathy	22.52	12.76	176	110943	58643	64328970
Multiple sclerosis	22.48	12.76	3	111116	18938	64368675
Dyspnoea	22.48	12.76	1011	110108	717663	63669950
Acne	22.42	12.76	6	111113	23075	64364538
Fistula of small intestine	22.38	12.76	14	111105	641	64386972
Haemophagocytic lymphohistiocytosis	22.33	12.76	74	111045	17535	64370078
Purulent pericarditis	22.28	12.76	7	111112	56	64387557
Sciatica	22.25	12.76	4	111115	20260	64367353
Fanconi syndrome acquired	22.17	12.76	24	111095	2397	64385216
Myelitis transverse	22.15	12.76	20	111099	1603	64386010
Lymphangiosis carcinomatosa	22.06	12.76	21	111098	1800	64385813
Crying	21.98	12.76	4	111115	20086	64367527
Product quality issue	21.90	12.76	12	111107	29787	64357826
Depressed mood	21.85	12.76	23	111096	40989	64346624
Haemoglobin decreased	21.82	12.76	464	110655	194599	64193014
Aortic embolus	21.75	12.76	7	111112	61	64387552
Chromaturia	21.74	12.76	6	111113	22605	64365008
Viral load increased	21.64	12.76	24	111095	2463	64385150
Tooth disorder	21.43	12.76	6	111113	22396	64365217
Gingivitis ulcerative	21.40	12.76	10	111109	253	64387360
Abnormal behaviour	21.35	12.76	16	111103	33606	64354007
Iliac artery occlusion	21.15	12.76	10	111109	260	64387353
Angina pectoris	21.11	12.76	28	111091	45053	64342560
Asthenia	21.09	12.76	920	110199	427124	63960489
Ear infection	21.07	12.76	7	111112	23397	64364216
Transitional cell carcinoma recurrent	21.03	12.76	5	111114	11	64387602
Prescribed underdose	21.03	12.76	3	111116	18012	64369601
Multiple organ dysfunction syndrome	20.99	12.76	267	110852	101146	64286467
Movement disorder	20.85	12.76	6	111113	21994	64365619
Acute promyelocytic leukaemia	20.73	12.76	18	111101	1370	64386243
Cerebellar haemangioma	20.72	12.76	7	111112	72	64387541
Iron deficiency anaemia	20.69	12.76	6	111113	21883	64365730
Mucosal toxicity	20.65	12.76	12	111107	480	64387133
Jaw operation	20.50	12.76	14	111105	745	64386868
Hyperlipidaemia	20.46	12.76	7	111112	22969	64364644
Metastases to abdominal cavity	20.45	12.76	12	111107	489	64387124
Amputation stump pain	20.44	12.76	6	111113	37	64387576
Carotid artery thrombosis	20.43	12.76	20	111099	1775	64385838
Blood culture positive	20.20	12.76	43	111076	7825	64379788
Varicella zoster virus infection	20.20	12.76	29	111090	3859	64383754
Apparent mineralocorticoid excess	20.17	12.76	6	111113	39	64387574
Transient ischaemic attack	20.13	12.76	28	111091	44154	64343459
Enterocolitis infectious	20.11	12.76	23	111096	2441	64385172
Rhinorrhoea	20.11	12.76	46	111073	59923	64327690
Conductive deafness	20.06	12.76	7	111112	80	64387533
Gastrointestinal necrosis	19.98	12.76	33	111086	4959	64382654
Granulocyte count decreased	19.97	12.76	17	111102	1259	64386354
Oral candidiasis	19.85	12.76	86	111033	23126	64364487
Surgery	19.83	12.76	12	111107	28201	64359412
Embryonal rhabdomyosarcoma	19.79	12.76	6	111113	42	64387571
Azoospermia	19.77	12.76	8	111111	141	64387472
Bradycardia	19.69	12.76	121	110998	118098	64269515
Subclavian vein thrombosis	19.57	12.76	22	111097	2292	64385321
Chemotherapy	19.45	12.76	18	111101	1489	64386124
Pharyngeal stenosis	19.45	12.76	5	111114	17	64387596
Hypersomnia	19.39	12.76	5	111114	19712	64367901
Hallucination, auditory	19.36	12.76	3	111116	16936	64370677
Frequent bowel movements	19.28	12.76	4	111115	18301	64369312
Renal tubular injury	19.27	12.76	16	111103	1145	64386468
Neoplasm malignant	19.26	12.76	89	111030	24599	64363014
Abdominal pain	19.26	12.76	688	110431	311687	64075926
Small intestinal perforation	19.25	12.76	23	111096	2557	64385056
Oroticaciduria	19.23	12.76	4	111115	3	64387610
Oesophageal squamous cell carcinoma metastatic	19.23	12.76	4	111115	3	64387610
Extrapyramidal disorder	19.15	12.76	5	111114	19547	64368066
Hepatitis B reactivation	19.14	12.76	32	111087	4857	64382756
Carotid artery dissection	19.13	12.76	10	111109	324	64387289
Renal tubular dysfunction	19.12	12.76	13	111106	687	64386926
Alveolar soft part sarcoma	19.10	12.76	7	111112	93	64387520
Dropped head syndrome	18.96	12.76	9	111110	236	64387377
Anti-Muellerian hormone level decreased	18.84	12.76	7	111112	97	64387516
Sinus polyp	18.82	12.76	11	111108	445	64387168
Thrombocytopenia neonatal	18.82	12.76	5	111114	20	64387593
Ileus	18.81	12.76	84	111035	22882	64364731
Retinal ischaemia	18.79	12.76	13	111106	707	64386906
Trigeminal nerve paresis	18.70	12.76	4	111115	4	64387609
Maternal death affecting foetus	18.70	12.76	4	111115	4	64387609
Chemotherapeutic drug level increased	18.63	12.76	10	111109	342	64387271
Liver abscess	18.62	12.76	33	111086	5247	64382366
Haemoperitoneum	18.60	12.76	28	111091	3887	64383726
Cystitis	18.50	12.76	28	111091	42647	64344966
Ureteric dilatation	18.49	12.76	8	111111	168	64387445
Agranulocytosis	18.47	12.76	121	110998	38108	64349505
Subcutaneous emphysema	18.45	12.76	18	111101	1591	64386022
Prescribed overdose	18.44	12.76	6	111113	20325	64367288
Herpes zoster	18.43	12.76	72	111047	79115	64308498
Testicular cancer metastatic	18.28	12.76	6	111113	56	64387557
Unresponsive to stimuli	18.27	12.76	37	111082	50356	64337257
Axillary vein thrombosis	18.19	12.76	12	111107	603	64387010
Dystonia	18.15	12.76	5	111114	18860	64368753
Pneumonia	18.12	12.76	1156	109963	558420	63829193
Metastases to pleura	18.09	12.76	16	111103	1248	64386365
Clostridium colitis	18.01	12.76	22	111097	2503	64385110
Testicular germ cell cancer metastatic	18.00	12.76	6	111113	59	64387554
Choriocarcinoma	17.91	12.76	6	111113	60	64387553
Amnesia	17.88	12.76	35	111084	48234	64339379
Pharyngeal inflammation	17.83	12.76	14	111105	925	64386688
Cervix carcinoma recurrent	17.81	12.76	4	111115	6	64387607
Disturbance in attention	17.76	12.76	27	111092	41047	64346566
Sweat gland tumour	17.70	12.76	11	111108	498	64387115
Osteomyelitis	17.68	12.76	13	111106	27574	64360039
Bone marrow disorder	17.59	12.76	23	111096	2802	64384811
Gastroenteritis viral	17.59	12.76	6	111113	19723	64367890
Mental disorder	17.56	12.76	12	111107	26433	64361180
Clostridium bacteraemia	17.52	12.76	9	111110	281	64387332
Acute myelomonocytic leukaemia	17.52	12.76	9	111110	281	64387332
Lymphadenopathy	17.49	12.76	139	110980	46547	64341066
Metastases to abdominal wall	17.48	12.76	7	111112	120	64387493
Gastrointestinal ischaemia	17.46	12.76	10	111109	389	64387224
Heart rate irregular	17.46	12.76	13	111106	27400	64360213
Recurrent cancer	17.45	12.76	21	111098	2352	64385261
Staphylococcal infection	17.43	12.76	148	110971	50530	64337083
Portal vein thrombosis	17.36	12.76	31	111088	4960	64382653
Retinopathy	17.34	12.76	25	111094	3340	64384273
Campylobacter test positive	17.32	12.76	6	111113	67	64387546
Morphoea	17.30	12.76	10	111109	396	64387217
Night sweats	17.28	12.76	22	111097	36024	64351589
Sarcomatoid carcinoma	17.15	12.76	5	111114	30	64387583
Immune-mediated hepatic disorder	17.10	12.76	11	111108	529	64387084
Breast cancer	17.10	12.76	15	111104	29133	64358480
Thrombophlebitis migrans	17.09	12.76	9	111110	296	64387317
Medication error	17.02	12.76	38	111081	49928	64337685
Median nerve injury	17.01	12.76	5	111114	31	64387582
Neck pain	16.98	12.76	52	111067	61481	64326132
Hypovolaemia	16.97	12.76	62	111057	15424	64372189
Laryngeal pain	16.95	12.76	33	111086	5635	64381978
Vertigo	16.91	12.76	49	111070	58962	64328651
Delusion	16.91	12.76	5	111114	18009	64369604
Primitive neuroectodermal tumour	16.88	12.76	5	111114	32	64387581
Muscle spasticity	16.84	12.76	4	111115	16665	64370948
Jugular vein occlusion	16.76	12.76	4	111115	9	64387604
Respiratory arrest	16.69	12.76	42	111077	52943	64334670
Eczema	16.60	12.76	16	111103	29704	64357909
Embolism venous	16.55	12.76	25	111094	3482	64384131
Venous thrombosis	16.53	12.76	35	111084	6346	64381267
Poor quality sleep	16.49	12.76	6	111113	18945	64368668
Vascular injury	16.47	12.76	14	111105	1035	64386578
Staphylococcal bacteraemia	16.37	12.76	47	111072	10308	64377305
Glaucoma	16.36	12.76	4	111115	16344	64371269
Device malfunction	16.36	12.76	5	111114	17628	64369985
Ganglioneuroma	16.31	12.76	7	111112	144	64387469
Embolism arterial	16.27	12.76	15	111104	1235	64386378
Gene mutation	16.26	12.76	19	111100	2063	64385550
Organising pneumonia	16.20	12.76	43	111076	9012	64378601
Oesophageal squamous cell carcinoma recurrent	16.10	12.76	3	111116	0	64387613
Mixed deafness	16.10	12.76	3	111116	0	64387613
Emphysematous cholecystitis	16.10	12.76	3	111116	0	64387613
Sepsis pasteurella	16.10	12.76	3	111116	0	64387613
Gastrointestinal haemorrhage	16.06	12.76	148	110971	132164	64255449
Delirium	16.05	12.76	63	111056	69131	64318482
Leukaemic lymphoma	16.03	12.76	6	111113	85	64387528
Paraneoplastic dermatomyositis	16.02	12.76	5	111114	39	64387574
Toxic leukoencephalopathy	16.01	12.76	13	111106	902	64386711
Oesophageal squamous cell carcinoma	15.97	12.76	10	111109	459	64387154
Ischaemic stroke	15.97	12.76	95	111024	28940	64358673
Ovarian cancer recurrent	15.96	12.76	9	111110	340	64387273
Metapneumovirus bronchiolitis	15.94	12.76	4	111115	12	64387601
Marchiafava-Bignami disease	15.94	12.76	4	111115	12	64387601
Hot flush	15.88	12.76	35	111084	46200	64341413
Staphylococcus test positive	15.84	12.76	32	111087	5613	64382000
Liver function test increased	15.80	12.76	18	111101	30952	64356661
Dementia	15.80	12.76	8	111111	20758	64366855
Meningitis tuberculous	15.77	12.76	14	111105	1097	64386516
Lung cancer metastatic	15.70	12.76	23	111096	3117	64384496
Laryngeal cancer stage IV	15.70	12.76	4	111115	13	64387600
Eye irritation	15.63	12.76	4	111115	15852	64371761
Restless legs syndrome	15.62	12.76	5	111114	17111	64370502
Abdominal pain upper	15.60	12.76	210	110909	174820	64212793
Proctitis	15.59	12.76	23	111096	3136	64384477
Rash pruritic	15.50	12.76	49	111070	57355	64330258
Retinal toxicity	15.48	12.76	15	111104	1315	64386298
Cytokine release syndrome	15.45	12.76	74	111045	20755	64366858
Metastases to retroperitoneum	15.40	12.76	9	111110	364	64387249
Skin ulcer	15.34	12.76	33	111086	43941	64343672
Myasthenic syndrome	15.33	12.76	11	111108	634	64386979
Pericardial effusion	15.33	12.76	118	111001	39136	64348477
Dyspnoea exertional	15.33	12.76	70	111049	73660	64313953
Sinus disorder	15.32	12.76	5	111114	16903	64370710
Pelvic fluid collection	15.28	12.76	11	111108	637	64386976
Uterine atrophy	15.26	12.76	4	111115	15	64387598
BRAF gene mutation	15.20	12.76	5	111114	47	64387566
Cell-mediated immune deficiency	15.19	12.76	6	111113	99	64387514
Necrosis ischaemic	15.19	12.76	13	111106	970	64386643
Granulocytopenia	15.19	12.76	46	111073	10394	64377219
Fistula	15.14	12.76	44	111075	9717	64377896
Metastases to thorax	15.09	12.76	7	111112	174	64387439
Vascular compression	15.06	12.76	8	111111	268	64387345
Noctiphobia	15.05	12.76	4	111115	16	64387597
Myositis	15.03	12.76	62	111057	16315	64371298
Sinus congestion	15.02	12.76	4	111115	15435	64372178
Cellulitis	15.01	12.76	97	111022	93560	64294053
Hypoxia	14.95	12.76	224	110895	87925	64299688
Muscle twitching	14.94	12.76	7	111112	18991	64368622
Kidney infection	14.93	12.76	6	111113	17832	64369781
Thrombocytosis	14.91	12.76	36	111083	7120	64380493
Procedural vomiting	14.90	12.76	11	111108	663	64386950
Endothelial dysfunction	14.84	12.76	7	111112	181	64387432
Blood loss anaemia	14.71	12.76	3	111116	13889	64373724
Renal-limited thrombotic microangiopathy	14.67	12.76	4	111115	18	64387595
Hypoglossal nerve paresis	14.66	12.76	6	111113	109	64387504
Eosinophilia	14.64	12.76	27	111092	38049	64349564
Fracture	14.61	12.76	7	111112	18748	64368865
Ovarian failure	14.60	12.76	10	111109	535	64387078
Diabetic ketoacidosis	14.53	12.76	18	111101	29827	64357786
Cerebral salt-wasting syndrome	14.51	12.76	6	111113	112	64387501
Dysphonia	14.43	12.76	37	111082	46345	64341268
Synovial sarcoma	14.34	12.76	5	111114	57	64387556
Depressed level of consciousness	14.28	12.76	82	111037	81354	64306259
Thymus enlargement	14.27	12.76	6	111113	117	64387496
Anaplastic lymphoma kinase gene mutation	14.23	12.76	6	111113	118	64387495
Upper limb fracture	14.19	12.76	4	111115	14862	64372751
Hernia	14.14	12.76	3	111116	13515	64374098
Pericardial fibrosis	14.03	12.76	5	111114	61	64387552
Carotid artery perforation	14.02	12.76	3	111116	3	64387610
Full blood count decreased	14.01	12.76	11	111108	22571	64365042
Mood altered	14.00	12.76	5	111114	15974	64371639
Intestinal infarction	13.98	12.76	14	111105	1277	64386336
Hyperglycaemic hyperosmolar nonketotic syndrome	13.95	12.76	16	111103	1703	64385910
Hyperammonaemic encephalopathy	13.85	12.76	25	111094	4033	64383580
Skin exfoliation	13.81	12.76	36	111083	44849	64342764
Haematochezia	13.81	12.76	63	111056	66310	64321303
Malignant pleural effusion	13.79	12.76	21	111098	2946	64384667
Stent malfunction	13.74	12.76	5	111114	65	64387548
Diabetes mellitus inadequate control	13.73	12.76	10	111109	21311	64366302
Fear	13.60	12.76	9	111110	20162	64367451
Enterococcal sepsis	13.54	12.76	19	111100	2475	64385138
Skin toxicity	13.53	12.76	33	111086	6569	64381044
Obstructive airways disorder	13.52	12.76	12	111107	23173	64364440
Retroperitoneal lymphadenopathy	13.50	12.76	12	111107	942	64386671
Thrombophlebitis	13.49	12.76	30	111089	5624	64381989
Enterococcal bacteraemia	13.48	12.76	19	111100	2486	64385127
Metastases to bladder	13.47	12.76	7	111112	224	64387389
VIth nerve paresis	13.44	12.76	6	111113	136	64387477
Culture urine positive	13.44	12.76	25	111094	4126	64383487
Thrombotic thrombocytopenic purpura	13.44	12.76	31	111088	5953	64381660
Coma	13.41	12.76	92	111027	87523	64300090
Procedural pain	13.34	12.76	5	111114	15503	64372110
Retroperitoneal neoplasm	13.32	12.76	4	111115	27	64387586
Body temperature decreased	13.31	12.76	15	111104	25913	64361700
Oral fungal infection	13.29	12.76	21	111098	3040	64384573
Epiphyses premature fusion	13.28	12.76	5	111114	72	64387541
Adenocarcinoma gastric	13.21	12.76	15	111104	1580	64386033
Hypothermia	13.19	12.76	9	111110	19847	64367766
Malignant peritoneal neoplasm	13.17	12.76	10	111109	629	64386984
Mydriasis	13.07	12.76	5	111114	15307	64372306
Gastroenteritis sapovirus	13.05	12.76	6	111113	146	64387467
Blood chloride decreased	13.05	12.76	35	111084	7381	64380232
Blastic plasmacytoid dendritic cell neoplasia	12.97	12.76	5	111114	77	64387536
Ecchymosis	12.97	12.76	4	111115	14018	64373595
Pulmonary artery thrombosis	12.92	12.76	13	111106	1193	64386420
Paranoia	12.89	12.76	6	111113	16346	64371267
Eye pruritus	12.86	12.76	3	111116	12656	64374957
Peritoneal sarcoma	12.81	12.76	3	111116	6	64387607
Stoma site dermatitis	12.81	12.76	3	111116	6	64387607
Mania	12.81	12.76	6	111113	16280	64371333

FDA Adverse Event Reporting System (Pediatric)

None

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	antineoplastic agents
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
CHEBI has role	CHEBI:68495	Type I cell-death inducers
CHEBI has role	CHEBI:173085	ferroptosis inducers

Drug Use | Suggest Off label Use Form| |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

🐶 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:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
D(3) dopamine receptor	GPCR	P35462	DRD3_HUMAN		Ki	5.95		CHEMBL
Muscarinic acetylcholine receptor M5	GPCR	P08912	ACM5_HUMAN		Ki	5.37		CHEMBL
Canalicular multispecific organic anion transporter 1	Transporter	Q92887	MRP2_HUMAN					WOMBAT-PK
Adenosine receptor A3	GPCR	P0DMS8	AA3R_HUMAN		Ki	5.62		DRUG MATRIX
Multidrug resistance-associated protein 6	Transporter	O95255	MRP6_HUMAN					WOMBAT-PK
Multidrug resistance-associated protein 5	Transporter	O15440	MRP5_HUMAN					WOMBAT-PK
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	5.34		DRUG MATRIX
Melanocortin receptor 5	GPCR	P33032	MC5R_HUMAN		Ki	5.22		DRUG MATRIX
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
CHEMBL1386	ChEMBL_ID
CHEMBL11359	ChEMBL_ID
CHEMBL2068237	ChEMBL_ID
DB00515	DRUGBANK_ID
5343	IUPHAR_LIGAND_ID
4426	INN_ID
Q20Q21Q62J	UNII
5702198	PUBCHEM_CID
2555	RXNORM
31747	MMSL
4456	MMSL
d00195	MMSL
002641	NDDF
387318005	SNOMEDCT_US
57066004	SNOMEDCT_US
D002945	MESH_DESCRIPTOR_UI

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