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

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

Stem definition	Drug id	CAS RN
human origin	4958	477202-00-9

Description:

Molecule	Description
Synonyms: ipilimumab yervoy MDX-010 MDX-CTLA-4 ipilimumab (genetical recombination)	An anti-CTLA-4 ANTIGEN monoclonal antibody initially indicated for the treatment of certain types of metastatic MELANOMA. Its mode of actions may include blocking of CTLA-4 mediated inhibition of CYTOTOXIC T LYMPHOCYTES, allowing for more efficient destruction of target tumor cells. Molecular weight: Formula: CLOGP: LIPINSKI: None HAC: None HDO: None TPSA: ALOGS: ROTB: None

Drug dosage:

None

ADMET properties:

None

Approvals:

Date	Agency	Company	Orphan
July 13, 2011	EMA
March 25, 2011	FDA	BRISTOL MYERS SQUIBB
July 3, 2015	PMDA	BRISTOL-MYERS SQUIBB K.K

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
Malignant neoplasm progression	2079.43	21.88	864	22470	81257	63384431
Hypophysitis	1313.35	21.88	264	23070	1577	63464111
Colitis	1159.46	21.88	491	22843	48037	63417651
Immune-mediated enterocolitis	829.22	21.88	185	23149	1926	63463762
Adrenal insufficiency	517.65	21.88	208	23126	17707	63447981
Immune-mediated hepatitis	445.70	21.88	103	23231	1268	63464420
Death	431.79	21.88	604	22730	373777	63091911
Hypopituitarism	414.80	21.88	94	23240	1054	63464634
Intentional product use issue	403.70	21.88	351	22983	127541	63338147
Pneumonitis	400.14	21.88	214	23120	35008	63430680
Autoimmune colitis	375.11	21.88	76	23258	473	63465215
Hypothyroidism	315.56	21.88	196	23138	42436	63423252
Hyperthyroidism	299.05	21.88	133	23201	14540	63451148
Immune-mediated hepatic disorder	274.31	21.88	58	23276	457	63465231
Autoimmune hepatitis	270.81	21.88	106	23228	8404	63457284
Thyroiditis	261.64	21.88	76	23258	2390	63463298
Fulminant type 1 diabetes mellitus	244.46	21.88	52	23282	423	63465265
Myocarditis	241.02	21.88	103	23231	10222	63455466
Lymphocytic hypophysitis	230.21	21.88	44	23290	192	63465496
Immune-mediated lung disease	223.15	21.88	51	23283	595	63465093
Type 1 diabetes mellitus	213.56	21.88	72	23262	3718	63461970
Hepatic function abnormal	206.93	21.88	143	23191	36999	63428689
Diarrhoea	190.87	21.88	635	22699	714731	62750957
Enterocolitis	188.73	21.88	80	23254	7778	63457910
Adrenocorticotropic hormone deficiency	188.15	21.88	41	23293	378	63465310
Hepatitis	175.55	21.88	133	23201	39655	63426033
Immune-mediated thyroiditis	171.51	21.88	32	23302	119	63465569
Pyrexia	158.87	21.88	454	22880	470024	62995664
Secondary adrenocortical insufficiency	155.88	21.88	45	23289	1383	63464305
Liver disorder	142.71	21.88	134	23200	53553	63412135
Immune-mediated dermatitis	140.21	21.88	28	23306	160	63465528
Diabetic ketoacidosis	138.41	21.88	89	23245	20416	63445272
Vitiligo	130.64	21.88	39	23295	1350	63464338
Myositis	121.39	21.88	62	23272	9204	63456484
Hypothalamo-pituitary disorder	120.31	21.88	32	23302	721	63464967
Drug ineffective	113.49	21.88	131	23203	1044634	62421054
Meningitis aseptic	112.16	21.88	48	23286	4775	63460913
Immune-mediated myocarditis	110.72	21.88	25	23309	275	63465413
Metastases to central nervous system	106.45	21.88	64	23270	13041	63452647
Immune-mediated encephalitis	105.64	21.88	23	23311	211	63465477
Immune-mediated hypophysitis	104.71	21.88	19	23315	58	63465630
Immune-mediated nephritis	97.94	21.88	20	23314	130	63465558
Sepsis	95.41	21.88	188	23146	152935	63312753
Tumour pseudoprogression	95.22	21.88	22	23312	270	63465418
Drug intolerance	93.09	21.88	5	23329	308656	63157032
Joint swelling	91.01	21.88	8	23326	327658	63138030
Drug hypersensitivity	90.76	21.88	6	23328	310681	63155007
Autoimmune thyroiditis	90.48	21.88	39	23295	3947	63461741
Pain	90.21	21.88	84	23250	740544	62725144
Myasthenia gravis	85.28	21.88	39	23295	4542	63461146
Rash maculo-papular	83.55	21.88	79	23255	31817	63433871
Encephalitis	76.37	21.88	45	23289	8835	63456853
Prescribed overdose	75.31	21.88	77	23257	34076	63431612
Cytokine release syndrome	72.44	21.88	52	23282	14262	63451426
Autoimmune dermatitis	70.73	21.88	15	23319	120	63465568
Arthropathy	70.15	21.88	4	23330	234788	63230900
Haemophagocytic lymphohistiocytosis	68.93	21.88	45	23289	10582	63455106
Immune-mediated hypothyroidism	68.32	21.88	17	23317	291	63465397
Immune-mediated uveitis	67.89	21.88	12	23322	30	63465658
Autoimmune nephritis	67.74	21.88	18	23316	404	63465284
Product dose omission issue	67.03	21.88	5	23329	234308	63231380
Lipase increased	66.87	21.88	43	23291	9857	63455831
Rash	65.54	21.88	390	22944	560481	62905207
Adrenocortical insufficiency acute	64.23	21.88	24	23310	1674	63464014
Intestinal perforation	64.09	21.88	45	23289	11918	63453770
Pleural effusion	63.59	21.88	119	23215	93091	63372597
Exposure via body fluid	61.00	21.88	18	23316	598	63465090
Hyponatraemia	60.91	21.88	130	23204	111770	63353918
Drug interaction	59.93	21.88	7	23327	229124	63236564
Leukoderma	59.03	21.88	12	23322	76	63465612
Autoimmune arthritis	57.18	21.88	11	23323	50	63465638
Nasopharyngitis	56.96	21.88	12	23322	254245	63211443
Drug-induced liver injury	56.84	21.88	72	23262	40150	63425538
Synovitis	56.40	21.88	3	23331	186915	63278773
Enteritis	55.99	21.88	36	23298	8250	63457438
Aspartate aminotransferase increased	55.15	21.88	110	23224	90167	63375521
Treatment failure	54.84	21.88	5	23329	199038	63266650
Condition aggravated	54.49	21.88	41	23293	402176	63063512
Guillain-Barre syndrome	53.76	21.88	27	23307	3866	63461822
Abdominal discomfort	52.80	21.88	26	23308	320859	63144829
Swelling	52.28	21.88	18	23316	275360	63190328
Vogt-Koyanagi-Harada disease	52.03	21.88	12	23322	146	63465542
Amylase increased	51.56	21.88	31	23303	6314	63459374
Metastatic malignant melanoma	51.25	21.88	19	23315	1296	63464392
Peripheral swelling	51.15	21.88	17	23317	265925	63199763
Serous retinal detachment	51.13	21.88	14	23320	353	63465335
Uveitis	51.04	21.88	40	23294	12513	63453175
Alopecia	50.25	21.88	31	23303	337505	63128183
Sinusitis	50.14	21.88	11	23323	226642	63239046
Non-small cell lung cancer	49.84	21.88	25	23309	3570	63462118
Immune-mediated adverse reaction	49.34	21.88	13	23321	282	63465406
Thyroid disorder	48.43	21.88	42	23292	15120	63450568
Decreased appetite	48.02	21.88	201	23133	250851	63214837
Nephritis	45.51	21.88	21	23313	2495	63463193
Encephalitis autoimmune	45.47	21.88	18	23316	1468	63464220
Autoimmune pancreatitis	45.30	21.88	12	23322	266	63465422
Adrenalitis	44.98	21.88	8	23326	21	63465667
Hypersensitivity	44.79	21.88	26	23308	292659	63173029
Maternal exposure during pregnancy	44.21	21.88	13	23321	220049	63245639
Thyrotoxic crisis	42.95	21.88	15	23319	861	63464827
Immune-mediated adrenal insuficiency	42.77	21.88	9	23325	69	63465619
Immune-mediated pancreatitis	42.68	21.88	10	23324	131	63465557
Transaminases increased	42.51	21.88	55	23279	31312	63434376
Cortisol decreased	41.35	21.88	16	23318	1228	63464460
Myasthenic syndrome	41.30	21.88	11	23323	249	63465439
Neurofibrosarcoma	41.18	21.88	10	23324	154	63465534
Acute kidney injury	40.70	21.88	198	23136	263217	63202471
Autoimmune myocarditis	40.28	21.88	9	23325	94	63465594
Duodenitis	40.20	21.88	22	23312	3753	63461935
Exposure during pregnancy	40.04	21.88	5	23329	155542	63310146
Drug eruption	39.96	21.88	51	23283	28643	63437045
Hepatic failure	39.94	21.88	57	23277	35599	63430089
Blood pressure increased	39.85	21.88	6	23328	162056	63303632
Iridocyclitis	39.32	21.88	19	23315	2503	63463185
Pancreatitis	39.03	21.88	67	23267	48988	63416700
Dehydration	38.93	21.88	146	23188	173208	63292480
Large intestine perforation	38.81	21.88	29	23305	8453	63457235
Alanine aminotransferase increased	38.56	21.88	104	23230	103666	63362022
Meningitis	38.45	21.88	27	23307	7150	63458538
Pregnancy on contraceptive	38.44	21.88	15	23319	1177	63464511
Blood corticotrophin decreased	38.22	21.88	11	23323	334	63465354
Dizziness	38.21	21.88	62	23272	429863	63035825
Endocrine disorder	38.16	21.88	13	23321	692	63464996
Cholangitis	37.17	21.88	24	23310	5537	63460151
Immune-mediated arthritis	36.59	21.88	8	23326	75	63465613
Interstitial lung disease	36.08	21.88	74	23260	61834	63403854
Tumour pain	35.73	21.88	15	23319	1422	63464266
Diabetes mellitus	35.27	21.88	69	23265	55741	63409947
Musculoskeletal stiffness	35.13	21.88	12	23322	184606	63281082
Immune-mediated hyperthyroidism	34.64	21.88	8	23326	98	63465590
Fall	34.46	21.88	57	23277	392277	63073411
Erythema multiforme	34.17	21.88	29	23305	10140	63455548
Embolism	33.89	21.88	26	23308	7880	63457808
Disseminated intravascular coagulation	33.30	21.88	38	23296	19013	63446675
Feeling abnormal	33.22	21.88	7	23327	148385	63317303
Hyperglycaemia	33.07	21.88	57	23277	41810	63423878
Rheumatoid arthritis	32.91	21.88	27	23307	253792	63211896
Therapeutic product effect incomplete	32.23	21.88	4	23330	125052	63340636
Discomfort	31.63	21.88	11	23323	167363	63298325
Glucocorticoid deficiency	31.47	21.88	9	23325	267	63465421
Metastases to lung	30.40	21.88	30	23304	12720	63452968
Adrenal disorder	30.18	21.88	14	23320	1683	63464005
Pain in extremity	30.18	21.88	47	23287	331439	63134249
Propionibacterium infection	29.94	21.88	6	23328	35	63465653
Gastritis	29.74	21.88	51	23283	37252	63428436
Meningoradiculitis	29.44	21.88	7	23327	98	63465590
Demyelinating polyneuropathy	29.38	21.88	11	23323	771	63464917
Tubulointerstitial nephritis	28.70	21.88	36	23298	19867	63445821
Asthma	28.58	21.88	6	23328	127555	63338133
Cholestasis	28.57	21.88	44	23290	29390	63436298
Toxicity to various agents	27.70	21.88	30	23304	247220	63218468
Systemic inflammatory response syndrome	27.48	21.88	20	23314	5601	63460087
Pancreatic failure	26.73	21.88	11	23323	992	63464696
Overdose	26.65	21.88	5	23329	115073	63350615
Dermatitis	26.60	21.88	32	23302	16926	63448762
Mobility decreased	26.54	21.88	6	23328	121153	63344535
Weight increased	25.67	21.88	35	23299	260757	63204931
Prescribed underdose	25.54	21.88	42	23292	29647	63436041
Adverse event	25.38	21.88	68	23266	67491	63398197
Silent thyroiditis	24.85	21.88	6	23328	90	63465598
Impaired healing	24.74	21.88	4	23330	102538	63363150
Autoimmune hypothyroidism	24.70	21.88	7	23327	201	63465487
Immune-mediated renal disorder	24.55	21.88	5	23329	32	63465656
Primary hypothyroidism	24.21	21.88	6	23328	101	63465587
Autoimmune haemolytic anaemia	23.93	21.88	17	23317	4584	63461104
Immune-mediated cholangitis	23.92	21.88	5	23329	37	63465651
Blister	23.73	21.88	9	23325	129805	63335883
Adenocarcinoma	22.90	21.88	14	23320	2936	63462752
Migraine	22.87	21.88	5	23329	103341	63362347
Gastrooesophageal reflux disease	22.48	21.88	4	23330	95635	63370053
Hepatotoxicity	22.44	21.88	45	23289	36996	63428692

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
Malignant neoplasm progression	2664.78	16.87	1512	39747	86534	34829138
Hypophysitis	1689.69	16.87	417	40842	1869	34913803
Colitis	1687.95	16.87	843	40416	36907	34878765
Immune-mediated enterocolitis	1129.68	16.87	316	40943	2483	34913189
Adrenal insufficiency	943.09	16.87	416	40843	13631	34902041
Hypopituitarism	729.91	16.87	215	41044	2067	34913605
Pneumonitis	593.00	16.87	413	40846	33465	34882207
Intentional product use issue	557.55	16.87	503	40756	59313	34856359
Hypothyroidism	530.95	16.87	322	40937	20580	34895092
Autoimmune colitis	499.65	16.87	134	41125	880	34914792
Immune-mediated hepatitis	476.59	16.87	154	41105	2061	34913611
Autoimmune hepatitis	426.57	16.87	169	41090	4191	34911481
Thyroiditis	423.10	16.87	143	41116	2219	34913453
Hyperthyroidism	404.43	16.87	213	41046	10353	34905319
Adrenocorticotropic hormone deficiency	337.18	16.87	97	41162	850	34914822
Myocarditis	332.52	16.87	205	41054	13477	34902195
Immune-mediated lung disease	331.63	16.87	108	41151	1483	34914189
Diarrhoea	327.34	16.87	1104	40155	388808	34526864
Immune-mediated dermatitis	326.25	16.87	77	41182	272	34915400
Immune-mediated hepatic disorder	325.40	16.87	96	41163	927	34914745
Type 1 diabetes mellitus	314.48	16.87	135	41124	4123	34911549
Secondary adrenocortical insufficiency	311.33	16.87	101	41158	1369	34914303
Prescribed overdose	309.39	16.87	179	41080	10468	34905204
Lymphocytic hypophysitis	303.01	16.87	71	41188	241	34915431
Enterocolitis	293.56	16.87	157	41102	7869	34907803
Immune-mediated myocarditis	281.73	16.87	81	41178	708	34914964
Hepatitis	277.12	16.87	228	41031	23676	34891996
Fulminant type 1 diabetes mellitus	272.00	16.87	81	41178	810	34914862
Death	255.41	16.87	1034	40225	397015	34518657
Liver disorder	239.53	16.87	242	41017	32755	34882917
Hepatic function abnormal	229.11	16.87	272	40987	44091	34871581
Drug interaction	218.26	16.87	12	41247	225934	34689738
Myositis	198.95	16.87	142	41117	11928	34903744
Rash	196.73	16.87	643	40616	222109	34693563
Pyrexia	194.23	16.87	841	40418	332172	34583500
Diabetic ketoacidosis	186.30	16.87	161	41098	17871	34897801
Vitiligo	172.39	16.87	58	41201	886	34914786
Metastases to central nervous system	169.54	16.87	111	41148	8094	34907578
Drug ineffective	157.77	16.87	185	41074	456566	34459106
Hypothalamo-pituitary disorder	151.58	16.87	51	41208	779	34914893
Myasthenia gravis	143.66	16.87	94	41165	6846	34908826
Immune-mediated hypothyroidism	138.94	16.87	38	41221	271	34915401
Interstitial lung disease	137.35	16.87	263	40996	65019	34850653
Immune-mediated adrenal insuficiency	136.98	16.87	33	41226	130	34915542
Adverse event	132.46	16.87	136	41123	18741	34896931
Autoimmune thyroiditis	130.71	16.87	50	41209	1124	34914548
Immune-mediated hypophysitis	127.28	16.87	28	41231	65	34915607
Immune-mediated thyroiditis	126.65	16.87	30	41229	108	34915564
Toxicity to various agents	124.10	16.87	41	41218	200321	34715351
Uveitis	120.38	16.87	87	41172	7448	34908224
Lipase increased	115.77	16.87	93	41166	9323	34906349
Encephalitis	111.67	16.87	82	41177	7195	34908477
Immune-mediated nephritis	110.26	16.87	33	41226	336	34915336
Immune-mediated uveitis	103.61	16.87	22	41237	40	34915632
Completed suicide	98.55	16.87	4	41255	98164	34817508
Pulmonary toxicity	93.72	16.87	69	41190	6078	34909594
Product dose omission issue	92.85	16.87	15	41244	119696	34795976
Nephritis	92.57	16.87	49	41210	2402	34913270
Autoimmune nephritis	91.84	16.87	27	41232	257	34915415
Tubulointerstitial nephritis	87.81	16.87	116	41143	20908	34894764
Adrenocortical insufficiency acute	87.10	16.87	41	41218	1559	34914113
Leukoderma	86.48	16.87	20	41239	63	34915609
Intestinal perforation	85.76	16.87	77	41182	8983	34906689
Immune-mediated myositis	85.40	16.87	44	41215	2039	34913633
Endocrine disorder	84.49	16.87	26	41233	293	34915379
Adrenal disorder	82.33	16.87	35	41224	1042	34914630
Large intestine perforation	81.94	16.87	73	41186	8430	34907242
Overdose	81.48	16.87	7	41252	91052	34824620
Decreased appetite	80.73	16.87	399	40860	165993	34749679
Thyroid disorder	80.64	16.87	49	41210	3133	34912539
Rash maculo-papular	79.66	16.87	130	41129	28321	34887351
Immune-mediated encephalitis	78.51	16.87	23	41236	216	34915456
Dermatitis	77.11	16.87	74	41185	9394	34906278
Immune-mediated pancreatitis	76.52	16.87	20	41239	117	34915555
Erythema multiforme	75.02	16.87	70	41189	8579	34907093
Hyponatraemia	74.70	16.87	241	41018	82450	34833222
Autoimmune disorder	73.85	16.87	38	41221	1756	34913916
Non-small cell lung cancer	73.43	16.87	50	41209	3890	34911782
Hyperglycaemia	72.09	16.87	150	41109	39330	34876342
Blood thyroid stimulating hormone decreased	71.03	16.87	38	41221	1903	34913769
Autoimmune pancreatitis	70.86	16.87	23	41236	312	34915360
Immune-mediated hyperthyroidism	70.80	16.87	16	41243	44	34915628
Facial paralysis	69.32	16.87	74	41185	10660	34905012
Immune-mediated adverse reaction	69.26	16.87	26	41233	554	34915118
Blood corticotrophin decreased	67.69	16.87	20	41239	194	34915478
Prescribed underdose	67.48	16.87	67	41192	8866	34906806
Pemphigoid	67.32	16.87	66	41193	8600	34907072
Guillain-Barre syndrome	66.21	16.87	56	41203	6031	34909641
Enteritis	65.11	16.87	63	41196	8079	34907593
Cortisol decreased	64.82	16.87	30	41229	1097	34914575
Hypercalcaemia	64.05	16.87	85	41174	15383	34900289
Meningitis aseptic	62.68	16.87	42	41217	3182	34912490
Skin disorder	60.03	16.87	77	41182	13478	34902194
Condition aggravated	59.64	16.87	84	41175	192112	34723560
Blood pressure increased	58.13	16.87	16	41243	88086	34827586
Fall	57.82	16.87	94	41165	202791	34712881
Serous retinal detachment	57.33	16.87	23	41236	589	34915083
Amylase increased	57.03	16.87	51	41208	5917	34909755
Haemoglobin decreased	55.78	16.87	37	41222	120735	34794937
Autoimmune haemolytic anaemia	54.40	16.87	44	41215	4452	34911220
Drug hypersensitivity	54.31	16.87	14	41245	80515	34835157
Agitation	52.48	16.87	4	41255	57395	34858277
Hepatotoxicity	51.97	16.87	92	41167	21393	34894279
Tumour pseudoprogression	51.06	16.87	20	41239	480	34915192
Radiation pneumonitis	50.38	16.87	34	41225	2606	34913066
Dizziness	50.28	16.87	115	41144	218406	34697266
Haemophagocytic lymphohistiocytosis	50.23	16.87	69	41190	12904	34902768
Feeling abnormal	48.82	16.87	8	41251	63227	34852445
Tri-iodothyronine free decreased	48.71	16.87	12	41247	53	34915619
Pituitary enlargement	47.16	16.87	10	41249	18	34915654
Somnolence	46.18	16.87	38	41221	111078	34804594
Anxiety	45.18	16.87	31	41228	99397	34816275
Enterocolitis haemorrhagic	43.90	16.87	22	41237	961	34914711
Immune-mediated endocrinopathy	43.86	16.87	10	41249	29	34915643
Aspartate aminotransferase increased	43.67	16.87	177	41082	67606	34848066
Intracranial tumour haemorrhage	43.61	16.87	16	41243	319	34915353
Iridocyclitis	43.31	16.87	26	41233	1626	34914046
Joint swelling	43.18	16.87	9	41250	59881	34855791
Pancreatic enzymes increased	42.70	16.87	19	41240	633	34915039
Immune-mediated gastritis	41.00	16.87	10	41249	42	34915630
Autoimmune neuropathy	40.08	16.87	10	41249	47	34915625
Cardiac failure congestive	39.12	16.87	25	41234	83245	34832427
Pain in extremity	38.51	16.87	56	41203	126457	34789215
Weight increased	38.42	16.87	32	41227	93001	34822671
Immune-mediated renal disorder	38.39	16.87	12	41247	143	34915529
Cytokine release syndrome	38.38	16.87	84	41175	22793	34892879
Inappropriate schedule of product administration	38.05	16.87	13	41246	62283	34853389
Pruritus	37.92	16.87	292	40967	141689	34773983
Alanine aminotransferase increased	37.82	16.87	192	41067	80623	34835049
Drug-induced liver injury	37.64	16.87	96	41163	28736	34886936
Arthritis	37.48	16.87	101	41158	31245	34884427
Myasthenic syndrome	36.47	16.87	16	41243	515	34915157
Bradycardia	36.32	16.87	22	41237	75396	34840276
Blood glucose increased	35.73	16.87	17	41242	66701	34848971
Dehydration	35.65	16.87	269	40990	129700	34785972
Encephalitis autoimmune	35.13	16.87	17	41242	688	34914984
Aggression	34.82	16.87	3	41256	38961	34876711
Hallucination	34.62	16.87	9	41250	51489	34864183
White blood cell count decreased	34.53	16.87	37	41222	95408	34820264
Pain	33.72	16.87	126	41133	204549	34711123
Therapeutic product effect incomplete	33.66	16.87	9	41250	50532	34865140
Myocardial infarction	33.61	16.87	57	41202	121028	34794644
Drug eruption	33.30	16.87	73	41186	19825	34895847
Peripheral swelling	33.27	16.87	25	41234	76516	34839156
Immune-mediated arthritis	33.22	16.87	10	41249	104	34915568
Silent thyroiditis	33.17	16.87	9	41250	62	34915610
Coma	32.65	16.87	7	41252	45671	34870001
Meningitis	32.33	16.87	34	41225	4813	34910859
Pancreatic toxicity	32.00	16.87	8	41251	38	34915634
Sialoadenitis	31.80	16.87	15	41244	573	34915099
Autoimmune lung disease	31.66	16.87	8	41251	40	34915632
Wrong technique in product usage process	31.54	16.87	3	41256	35983	34879689
Immune-mediated cholangitis	31.20	16.87	10	41249	130	34915542
General physical health deterioration	31.07	16.87	258	41001	128011	34787661
Chronic gastritis	31.01	16.87	21	41238	1619	34914053
Vogt-Koyanagi-Harada disease	30.96	16.87	9	41250	82	34915590
Depression	30.51	16.87	42	41217	97056	34818616
Melanoma recurrent	30.39	16.87	10	41249	142	34915530
Polymyalgia rheumatica	30.14	16.87	20	41239	1490	34914182
Immune thrombocytopenia	30.03	16.87	45	41214	9107	34906565
Tremor	29.88	16.87	32	41227	82555	34833117
Immune-mediated cytopenia	29.82	16.87	7	41252	24	34915648
Autoimmune arthritis	29.63	16.87	8	41251	54	34915618
Tumour associated fever	29.61	16.87	13	41246	419	34915253
Incorrect dose administered	29.39	16.87	6	41253	40509	34875163
Chest discomfort	29.04	16.87	14	41245	54516	34861156
Iris adhesions	28.93	16.87	11	41248	243	34915429
Loss of consciousness	28.85	16.87	33	41226	82634	34833038
Hypertension	28.82	16.87	75	41184	136368	34779304
Angioedema	28.24	16.87	5	41254	37369	34878303
Chest pain	28.07	16.87	68	41191	126694	34788978
Coronary artery disease	27.94	16.87	11	41248	48294	34867378
Thrombophlebitis migrans	27.85	16.87	10	41249	187	34915485
Drug intolerance	27.82	16.87	18	41241	59552	34856120
Nasopharyngitis	27.75	16.87	25	41234	69943	34845729
Autoimmune dermatitis	27.56	16.87	6	41253	13	34915659
Duodenitis	27.21	16.87	31	41228	4797	34910875
Muscle spasms	27.20	16.87	29	41230	74972	34840700
Immune-mediated neuropathy	27.07	16.87	7	41252	39	34915633
International normalised ratio increased	27.01	16.87	11	41248	47316	34868356
Palpitations	26.86	16.87	7	41252	39979	34875693
Peripheral motor neuropathy	26.72	16.87	20	41239	1806	34913866
Immune-mediated encephalopathy	26.68	16.87	6	41253	16	34915656
Epistaxis	26.66	16.87	18	41241	58233	34857439
Prostate cancer	26.52	16.87	7	41252	39642	34876030
Treatment failure	26.41	16.87	11	41248	46686	34868986
Wheezing	26.41	16.87	8	41251	41394	34874278
Thyroid function test abnormal	26.02	16.87	14	41245	709	34914963
Hyperhidrosis	25.57	16.87	31	41228	75661	34840011
Intestinal intraepithelial lymphocytes increased	25.43	16.87	9	41250	161	34915511
Nephrolithiasis	25.38	16.87	3	41256	30330	34885342
Pleurocutaneous fistula	25.34	16.87	7	41252	52	34915620
Tachycardia	25.31	16.87	38	41221	84734	34830938
Asthma	24.20	16.87	10	41249	42646	34873026
Cortisol increased	24.18	16.87	9	41250	187	34915485
Transient acantholytic dermatosis	24.09	16.87	8	41251	117	34915555
Bile duct stenosis	24.08	16.87	16	41243	1195	34914477
Insomnia	23.59	16.87	55	41204	103852	34811820
Orbital myositis	23.55	16.87	8	41251	126	34915546
Radiation necrosis	23.32	16.87	8	41251	130	34915542
Heart rate increased	23.04	16.87	13	41246	46330	34869342
Haematocrit decreased	22.89	16.87	5	41254	32211	34883461
Disseminated intravascular coagulation	22.84	16.87	67	41192	21749	34893923
Cryptitis	22.56	16.87	9	41250	227	34915445
Heart rate decreased	22.41	16.87	5	41254	31740	34883932
Prerenal failure	22.31	16.87	19	41240	2065	34913607
Autoimmune hypothyroidism	22.03	16.87	6	41253	42	34915630
Musculoskeletal stiffness	21.94	16.87	14	41245	46666	34869006
Pleural effusion	21.89	16.87	168	41091	81378	34834294
Cytomegalovirus enterocolitis	21.89	16.87	14	41245	980	34914692
Blood corticotrophin abnormal	21.56	16.87	5	41254	16	34915656
Giant cell arteritis	21.46	16.87	13	41246	826	34914846
Adrenalitis	21.33	16.87	5	41254	17	34915655
Metastases to lymph nodes	21.15	16.87	27	41232	4701	34910971
Tumour pain	20.63	16.87	14	41245	1083	34914589
Spermatogenesis abnormal	20.51	16.87	6	41253	56	34915616
Transaminases increased	20.51	16.87	74	41185	26749	34888923
Microvillous inclusion disease	20.42	16.87	8	41251	192	34915480
Primary adrenal insufficiency	20.42	16.87	6	41253	57	34915615
Primary hypothyroidism	20.33	16.87	6	41253	58	34915614
Optic neuritis	20.23	16.87	23	41236	3551	34912121
Thyroxine free decreased	20.22	16.87	9	41250	300	34915372
Achromotrichia acquired	20.21	16.87	4	41255	4	34915668
Disease progression	20.17	16.87	63	41196	108014	34807658
Unresponsive to stimuli	20.16	16.87	4	41255	27565	34888107
Tumour haemorrhage	20.15	16.87	21	41238	2941	34912731
Metastases to skin	19.84	16.87	10	41249	442	34915230
Parvovirus infection	19.82	16.87	10	41249	443	34915229
White blood cell count increased	19.81	16.87	12	41247	41139	34874533
Hepatic failure	19.75	16.87	87	41172	34444	34881228
Haemorrhage	19.61	16.87	19	41240	51351	34864321
Opsoclonus myoclonus	19.55	16.87	6	41253	67	34915605
Embolism	19.54	16.87	34	41225	7795	34907877
Granulomatous lymphadenitis	19.54	16.87	7	41252	130	34915542
Arthropathy	19.48	16.87	4	41255	26903	34888769
Muscular weakness	19.46	16.87	150	41109	72747	34842925
Fluid retention	19.46	16.87	4	41255	26883	34888789
Probiotic therapy	19.39	16.87	7	41252	133	34915539
Metabolic acidosis	19.32	16.87	14	41245	43666	34872006
Metastases to meninges	19.24	16.87	15	41244	1439	34914233
Psychotic disorder	19.08	16.87	3	41256	24449	34891223
Brain oedema	19.06	16.87	47	41212	13774	34901898
Diabetes mellitus	18.94	16.87	107	41152	46766	34868906
Polyarthritis	18.87	16.87	25	41234	4515	34911157
Drug dependence	18.83	16.87	3	41256	24214	34891458
Myelitis	18.82	16.87	12	41247	835	34914837
Sarcoidosis	18.80	16.87	20	41239	2868	34912804
Gastrointestinal perforation	18.78	16.87	23	41236	3840	34911832
Autoimmune thyroid disorder	18.59	16.87	4	41255	8	34915664
Metastases to liver	18.35	16.87	46	41213	13617	34902055
Swelling	18.20	16.87	14	41245	42352	34873320
Red blood cell count decreased	17.88	16.87	6	41253	29084	34886588
Apoptosis	17.77	16.87	9	41250	402	34915270
Metastases to lung	17.69	16.87	36	41223	9284	34906388
Thyrotoxic crisis	17.69	16.87	9	41250	406	34915266
Blood urea increased	17.42	16.87	7	41252	30357	34885315
Acute kidney injury	17.41	16.87	477	40782	304511	34611161
Blood corticotrophin increased	17.40	16.87	6	41253	99	34915573
Cholangitis sclerosing	17.39	16.87	14	41245	1407	34914265
Product use issue	17.30	16.87	30	41229	63186	34852486
Glucocorticoid deficiency	17.30	16.87	8	41251	292	34915380
Oxygen saturation decreased	17.18	16.87	23	41236	53795	34861877
Polymyositis	17.11	16.87	14	41245	1439	34914233
Gait disturbance	17.06	16.87	48	41211	85092	34830580
Lichen planus	17.02	16.87	12	41247	987	34914685
Electrocardiogram QT prolonged	17.00	16.87	14	41245	40938	34874734
Gastrooesophageal reflux disease	16.98	16.87	12	41247	37912	34877760
Biopsy	16.97	16.87	8	41251	305	34915367
Loss of personal independence in daily activities	16.94	16.87	9	41250	33170	34882502
Treatment noncompliance	16.92	16.87	6	41253	28094	34887578

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
Malignant neoplasm progression	4440.72	17.89	2114	57404	133876	79550994
Hypophysitis	2759.84	17.89	637	58881	3529	79681341
Colitis	2463.14	17.89	1165	58353	72142	79612728
Immune-mediated enterocolitis	1756.46	17.89	456	59062	4374	79680496
Adrenal insufficiency	1398.02	17.89	591	58927	27896	79656974
Hypopituitarism	1130.36	17.89	299	59219	3100	79681770
Pneumonitis	934.88	17.89	576	58942	60284	79624586
Immune-mediated hepatitis	864.60	17.89	246	59272	3410	79681460
Autoimmune colitis	802.46	17.89	196	59322	1427	79683443
Hypothyroidism	799.79	17.89	494	59024	51898	79632972
Thyroiditis	678.06	17.89	215	59303	4390	79680480
Hyperthyroidism	671.49	17.89	329	59189	21880	79662990
Autoimmune hepatitis	612.93	17.89	255	59263	11528	79673342
Immune-mediated hepatic disorder	596.33	17.89	154	59364	1440	79683430
Intentional product use issue	587.91	17.89	643	58875	151469	79533401
Myocarditis	542.96	17.89	283	59235	21450	79663420
Immune-mediated lung disease	541.05	17.89	154	59364	2136	79682734
Type 1 diabetes mellitus	533.15	17.89	199	59319	6720	79678150
Adrenocorticotropic hormone deficiency	514.19	17.89	133	59385	1252	79683618
Fulminant type 1 diabetes mellitus	495.60	17.89	131	59387	1352	79683518
Immune-mediated dermatitis	475.80	17.89	106	59412	484	79684386
Lymphocytic hypophysitis	473.56	17.89	105	59413	467	79684403
Secondary adrenocortical insufficiency	461.49	17.89	145	59373	2869	79682001
Death	452.53	17.89	1174	58344	565340	79119530
Enterocolitis	450.65	17.89	219	59299	14293	79670577
Hepatic function abnormal	444.43	17.89	396	59122	72711	79612159
Diarrhoea	432.70	17.89	1537	57981	878952	78805918
Immune-mediated myocarditis	395.59	17.89	104	59414	1049	79683821
Liver disorder	369.89	17.89	356	59162	72061	79612809
Hepatitis	356.90	17.89	311	59207	55416	79629454
Pyrexia	356.12	17.89	1212	58306	677497	79007373
Myositis	318.56	17.89	191	59327	18977	79665893
Diabetic ketoacidosis	317.51	17.89	237	59281	33885	79650985
Immune-mediated thyroiditis	288.38	17.89	62	59456	231	79684639
Vitiligo	279.85	17.89	91	59427	2018	79682852
Hypothalamo-pituitary disorder	262.83	17.89	76	59442	1118	79683752
Metastases to central nervous system	235.99	17.89	149	59369	16226	79668644
Immune-mediated hypophysitis	234.59	17.89	48	59470	131	79684739
Drug interaction	227.75	17.89	23	59495	415160	79269710
Myasthenia gravis	224.73	17.89	123	59395	10276	79674594
Drug ineffective	217.19	17.89	295	59223	1080618	78604252
Interstitial lung disease	214.21	17.89	336	59182	112264	79572606
Immune-mediated nephritis	212.67	17.89	55	59463	517	79684353
Immune-mediated hypothyroidism	209.34	17.89	56	59462	607	79684263
Prescribed overdose	208.13	17.89	194	59324	37689	79647181
Autoimmune thyroiditis	198.06	17.89	85	59433	4148	79680722
Immune-mediated adrenal insuficiency	191.62	17.89	42	59476	175	79684695
Toxicity to various agents	184.68	17.89	44	59474	421496	79263374
Lipase increased	184.34	17.89	128	59390	16338	79668532
Rash	175.87	17.89	874	58644	577484	79107386
Encephalitis	175.31	17.89	119	59399	14641	79670229
Immune-mediated encephalitis	174.50	17.89	46	59472	469	79684401
Immune-mediated uveitis	172.56	17.89	34	59484	71	79684799
Meningitis aseptic	166.65	17.89	88	59430	6840	79678030
Joint swelling	166.28	17.89	13	59505	288633	79396237
Completed suicide	164.40	17.89	4	59514	245763	79439107
Uveitis	156.75	17.89	117	59401	16713	79668157
Rash maculo-papular	156.46	17.89	201	59317	55877	79628993
Leukoderma	155.44	17.89	34	59484	140	79684730
Drug hypersensitivity	155.21	17.89	20	59498	298896	79385974
Pain	150.31	17.89	183	59335	703619	78981251
Adrenocortical insufficiency acute	145.33	17.89	62	59456	2981	79681889
Tumour pseudoprogression	144.05	17.89	42	59476	637	79684233
Drug intolerance	141.22	17.89	16	59502	264103	79420767
Decreased appetite	138.82	17.89	564	58954	341854	79343016
Non-small cell lung cancer	136.79	17.89	75	59443	6285	79678585
Hyponatraemia	130.36	17.89	358	59160	177490	79507380
Product dose omission issue	129.85	17.89	16	59502	247521	79437349
Autoimmune nephritis	127.65	17.89	39	59479	700	79684170
Haemophagocytic lymphohistiocytosis	122.18	17.89	113	59405	21724	79663146
Large intestine perforation	121.86	17.89	95	59423	14472	79670398
Enteritis	121.77	17.89	95	59423	14488	79670382
Condition aggravated	121.61	17.89	117	59401	501007	79183863
Tubulointerstitial nephritis	119.35	17.89	145	59373	38090	79646780
Intestinal perforation	119.09	17.89	101	59417	17325	79667545
Hyperglycaemia	116.20	17.89	197	59321	70138	79614732
Cytokine release syndrome	113.15	17.89	137	59381	35861	79649009
Guillain-Barre syndrome	112.98	17.89	75	59443	8890	79675980
Immune-mediated pancreatitis	112.38	17.89	29	59489	270	79684600
Erythema multiforme	111.89	17.89	98	59420	17553	79667317
Overdose	109.78	17.89	7	59511	184199	79500671
Peripheral swelling	108.81	17.89	33	59485	269584	79415286
Adrenal disorder	106.62	17.89	45	59473	2106	79682764
Autoimmune pancreatitis	105.76	17.89	33	59485	637	79684233
Immune-mediated myositis	103.64	17.89	51	59467	3416	79681454
Serous retinal detachment	103.12	17.89	36	59482	998	79683872
Blood pressure increased	103.05	17.89	17	59501	211343	79473527
Cortisol decreased	102.88	17.89	44	59474	2128	79682742
Nephritis	102.70	17.89	54	59464	4160	79680710
Nasopharyngitis	102.58	17.89	31	59487	253850	79431020
Endocrine disorder	102.37	17.89	34	59484	807	79684063
Arthropathy	101.88	17.89	8	59510	177103	79507767
Amylase increased	100.10	17.89	76	59442	11133	79673737
Aspartate aminotransferase increased	98.50	17.89	276	59242	138365	79546505
Blood corticotrophin decreased	98.42	17.89	30	59488	534	79684336
Immune-mediated hyperthyroidism	97.14	17.89	23	59495	144	79684726
Pulmonary toxicity	94.77	17.89	78	59440	12836	79672034
Thyroid disorder	92.94	17.89	80	59438	13999	79670871
Immune-mediated adverse reaction	92.53	17.89	32	59486	862	79684008
Swelling	92.11	17.89	24	59494	216687	79468183
Pleural effusion	89.62	17.89	275	59243	144987	79539883
Synovitis	89.01	17.89	6	59512	150728	79534142
Dizziness	87.83	17.89	162	59356	526279	79158591
Dermatitis	87.15	17.89	93	59425	21228	79663642
Fall	85.91	17.89	145	59373	487484	79197386
Sepsis	85.70	17.89	413	59105	269015	79415855
Treatment failure	84.70	17.89	13	59505	170473	79514397
Dehydration	84.46	17.89	388	59130	247799	79437071
Autoimmune haemolytic anaemia	84.21	17.89	61	59457	8319	79676551
Facial paralysis	82.77	17.89	90	59428	20982	79663888
Weight increased	82.01	17.89	53	59465	277333	79407537
Alanine aminotransferase increased	80.79	17.89	286	59232	162284	79522586
Feeling abnormal	79.40	17.89	12	59506	159187	79525683
Prescribed underdose	77.95	17.89	103	59415	29411	79655459
Pemphigoid	77.56	17.89	75	59443	15240	79669630
Alopecia	75.80	17.89	39	59479	231316	79453554
Abdominal discomfort	75.36	17.89	47	59471	250680	79434190
Sinusitis	75.19	17.89	26	59492	195475	79489395
Iridocyclitis	75.05	17.89	42	59476	3662	79681208
Systemic lupus erythematosus	74.01	17.89	4	59514	121145	79563725
Autoimmune arthritis	73.80	17.89	18	59500	130	79684740
Vogt-Koyanagi-Harada disease	73.76	17.89	20	59498	229	79684641
Drug-induced liver injury	73.00	17.89	156	59362	65961	79618909
Radiation pneumonitis	72.70	17.89	42	59476	3891	79680979
Pain in extremity	72.24	17.89	100	59418	364438	79320432
Autoimmune dermatitis	71.85	17.89	18	59500	147	79684723
Therapeutic product effect incomplete	69.90	17.89	11	59507	141634	79543236
Musculoskeletal stiffness	69.53	17.89	22	59496	174986	79509884
Hypercalcaemia	69.31	17.89	112	59406	38318	79646552
Product use issue	69.28	17.89	35	59483	209787	79475083
Maternal exposure during pregnancy	68.76	17.89	10	59508	136528	79548342
Acute kidney injury	68.05	17.89	638	58880	518766	79166104
Blood thyroid stimulating hormone decreased	67.67	17.89	46	59472	5670	79679200
Hypersensitivity	67.34	17.89	58	59460	262181	79422689
Immune-mediated arthritis	66.88	17.89	18	59500	200	79684670
Duodenitis	66.73	17.89	52	59466	7915	79676955
Meningitis	66.42	17.89	56	59462	9526	79675344
Encephalitis autoimmune	66.36	17.89	33	59485	2261	79682609
Hepatotoxicity	64.75	17.89	128	59390	51224	79633646
Wound	64.74	17.89	6	59512	116173	79568697
Drug eruption	64.68	17.89	117	59401	43818	79641052
Immune-mediated renal disorder	64.25	17.89	17	59501	176	79684694
Myasthenic syndrome	64.06	17.89	24	59494	818	79684052
Skin disorder	62.68	17.89	100	59418	33843	79651027
Hepatic failure	59.21	17.89	137	59381	61075	79623795
Disseminated intravascular coagulation	58.66	17.89	100	59418	35742	79649128
Diabetes mellitus	57.56	17.89	158	59360	78232	79606638
Tri-iodothyronine free decreased	57.00	17.89	18	59500	362	79684508
Exposure during pregnancy	56.95	17.89	5	59513	101127	79583743
Pancreatitis	56.21	17.89	144	59374	68431	79616439
Enterocolitis haemorrhagic	55.99	17.89	29	59489	2165	79682705
Transaminases increased	55.86	17.89	121	59397	51622	79633248
Pituitary enlargement	55.81	17.89	13	59505	75	79684795
Wheezing	55.48	17.89	10	59508	116654	79568216
Asthma	55.44	17.89	16	59502	135079	79549791
Silent thyroiditis	54.38	17.89	15	59503	184	79684686
Haemoglobin decreased	53.60	17.89	52	59466	222067	79462803
Pemphigus	53.26	17.89	6	59512	99576	79585294
Adrenalitis	52.99	17.89	11	59507	33	79684837
Tumour pain	51.91	17.89	28	59490	2271	79682599
Immune-mediated endocrinopathy	51.37	17.89	11	59507	40	79684830
Mobility decreased	51.00	17.89	14	59504	122161	79562709
Anxiety	50.38	17.89	67	59451	248445	79436425
Immune-mediated cholangitis	48.98	17.89	14	59504	197	79684673
Metastatic malignant melanoma	48.77	17.89	29	59489	2834	79682036
Agitation	48.62	17.89	8	59510	99707	79585163
Pancreatic toxicity	48.54	17.89	11	59507	55	79684815
Immune thrombocytopenia	48.35	17.89	63	59455	17742	79667128
Osteoarthritis	47.36	17.89	5	59513	87304	79597566
Autoimmune myocarditis	47.28	17.89	16	59502	403	79684467
Intracranial tumour haemorrhage	47.17	17.89	17	59501	518	79684352
Autoimmune neuropathy	46.86	17.89	12	59506	108	79684762
Pancreatic enzymes increased	46.62	17.89	22	59496	1343	79683527
Chronic gastritis	46.41	17.89	32	59486	4036	79680834
Autoimmune lung disease	46.15	17.89	10	59508	39	79684831
Discomfort	46.10	17.89	18	59500	125599	79559271
Embolism	45.22	17.89	54	59464	13928	79670942
Inappropriate schedule of product administration	44.53	17.89	22	59496	133606	79551264
Cholangitis	44.07	17.89	51	59467	12725	79672145
Gastritis	43.78	17.89	105	59413	47888	79636982
Immune-mediated encephalopathy	43.61	17.89	9	59509	26	79684844
Palpitations	43.49	17.89	20	59498	126590	79558280
Immune-mediated gastritis	43.26	17.89	11	59507	96	79684774
Metastases to lung	42.83	17.89	60	59458	18103	79666767
Impaired healing	42.81	17.89	7	59511	87648	79597222
Bradycardia	42.69	17.89	24	59494	135533	79549337
Suicidal ideation	42.38	17.89	4	59514	76336	79608534
Meningoradiculitis	42.24	17.89	12	59506	165	79684705
Contusion	41.84	17.89	30	59488	148746	79536124
Thyrotoxic crisis	41.73	17.89	20	59498	1264	79683606
Heart rate increased	41.57	17.89	19	59499	120705	79564165
Hypertension	41.26	17.89	119	59399	330873	79353997
Muscle spasms	40.89	17.89	42	59476	174688	79510182
Tremor	40.81	17.89	40	59478	170043	79514827
Fluid retention	40.56	17.89	3	59515	69806	79615064
Migraine	40.53	17.89	8	59510	87485	79597385
Rheumatoid arthritis	40.44	17.89	58	59460	208412	79476458
Oxygen saturation decreased	40.42	17.89	23	59495	129024	79555846
Glucocorticoid deficiency	40.23	17.89	16	59502	642	79684228
General physical health deterioration	39.98	17.89	346	59172	274892	79409978
Angioedema	39.63	17.89	5	59513	76030	79608840
Tumour haemorrhage	39.01	17.89	29	59489	4115	79680755
Demyelinating polyneuropathy	38.91	17.89	21	59497	1705	79683165
Loss of personal independence in daily activities	38.81	17.89	14	59504	102566	79582304
Thrombophlebitis migrans	38.65	17.89	14	59504	433	79684437
Loss of consciousness	38.59	17.89	41	59477	167902	79516968
Neoplasm malignant	38.55	17.89	78	59440	31732	79653138
Cardiac failure congestive	38.39	17.89	30	59488	142372	79542498
Blood glucose increased	38.20	17.89	19	59499	114956	79569914
Immune-mediated cytopenia	38.20	17.89	9	59509	55	79684815
Exposure via body fluid	37.91	17.89	13	59505	341	79684529
Blister	37.84	17.89	21	59497	119455	79565415
Depression	37.60	17.89	65	59453	216725	79468145
Chest discomfort	37.31	17.89	29	59489	138015	79546855
Primary hypothyroidism	37.30	17.89	11	59507	174	79684696
Medication error	37.05	17.89	4	59514	68638	79616232
Autoimmune hypothyroidism	36.86	17.89	12	59506	267	79684603
Insomnia	36.06	17.89	81	59437	245089	79439781
Brain oedema	35.56	17.89	66	59452	25197	79659673
Chest pain	35.54	17.89	101	59417	282203	79402667
Incorrect dose administered	35.51	17.89	7	59511	76623	79608247
Gastrooesophageal reflux disease	34.98	17.89	17	59501	104229	79580641
Autoimmune disorder	34.96	17.89	52	59466	16560	79668310
Pancreatic failure	34.46	17.89	19	59499	1609	79683261
Coma	34.41	17.89	16	59502	100633	79584237
Cytomegalovirus enterocolitis	34.17	17.89	19	59499	1636	79683234
Lower respiratory tract infection	33.86	17.89	28	59490	129192	79555678
Metastases to meninges	33.45	17.89	25	59493	3576	79681294
Nasal congestion	33.43	17.89	8	59510	76544	79608326
Immune-mediated neuropathy	33.40	17.89	8	59510	53	79684817
Orbital myositis	33.07	17.89	10	59508	173	79684697
Blood corticotrophin abnormal	32.89	17.89	8	59510	57	79684813
Gastrointestinal perforation	32.86	17.89	31	59487	6106	79678764
Somnolence	32.72	17.89	82	59436	238899	79445971
Peripheral motor neuropathy	32.68	17.89	24	59494	3343	79681527
Gait disturbance	32.65	17.89	66	59452	207440	79477430
Metastases to liver	32.62	17.89	68	59450	28246	79656624
Psoriatic arthropathy	32.43	17.89	9	59509	77990	79606880
Heart rate decreased	31.40	17.89	7	59511	70309	79614561
Primary adrenal insufficiency	31.39	17.89	10	59508	207	79684663
Radiation necrosis	31.38	17.89	12	59506	433	79684437
Optic neuritis	31.17	17.89	37	59481	9483	79675387
Neurofibrosarcoma	31.08	17.89	10	59508	214	79684656
Lichenoid keratosis	30.81	17.89	25	59493	4032	79680838
Prerenal failure	30.67	17.89	24	59494	3674	79681196
Influenza	30.49	17.89	31	59487	129575	79555295
Spermatogenesis abnormal	30.30	17.89	6	59512	13	79684857
Arthralgia	30.23	17.89	277	59241	571526	79113344
Myelitis	30.12	17.89	20	59498	2371	79682499
Achromotrichia acquired	29.70	17.89	6	59512	15	79684855
Tumour associated fever	29.24	17.89	14	59504	883	79683987
Melanoma recurrent	29.18	17.89	10	59508	262	79684608
Balance disorder	29.03	17.89	19	59499	98838	79586032
Intestinal intraepithelial lymphocytes increased	28.98	17.89	9	59509	171	79684699
Pregnancy on contraceptive	28.97	17.89	14	59504	901	79683969
Pleurocutaneous fistula	28.53	17.89	7	59511	52	79684818
Memory impairment	28.31	17.89	25	59493	111709	79573161
Sarcoidosis	28.29	17.89	33	59485	8302	79676568
Unresponsive to stimuli	28.28	17.89	4	59514	55784	79629086
Bile duct stenosis	28.18	17.89	18	59500	1998	79682872
Blood corticotrophin increased	28.13	17.89	9	59509	189	79684681
Sedation	28.07	17.89	3	59515	51892	79632978
Paraesthesia	27.80	17.89	56	59462	176267	79508603
Hepatic cytolysis	27.61	17.89	62	59456	27089	79657781
Hyperhidrosis	27.58	17.89	44	59474	151448	79533422
Metastases to lymph nodes	27.01	17.89	36	59482	10361	79674509
Myocardial infarction	26.93	17.89	61	59457	184068	79500802
Skin toxicity	26.70	17.89	32	59486	8282	79676588
Polymyalgia rheumatica	26.39	17.89	24	59494	4513	79680357
Peripheral sensory neuropathy	26.29	17.89	40	59478	12993	79671877
Myelitis transverse	26.27	17.89	17	59501	1930	79682940
White blood cell count decreased	26.24	17.89	64	59454	188224	79496646
Cholangitis sclerosing	26.05	17.89	19	59499	2618	79682252
Endocrine toxicity	25.86	17.89	5	59513	9	79684861
Burning sensation	25.85	17.89	6	59512	58626	79626244
Sialoadenitis	25.84	17.89	17	59501	1984	79682886
Hallucination	25.84	17.89	16	59502	85729	79599141
Bronchitis	25.67	17.89	36	59482	130608	79554262
Blood pressure systolic increased	25.58	17.89	9	59509	66977	79617893
Immune-mediated cystitis	25.56	17.89	6	59512	36	79684834
Autoimmune retinopathy	25.52	17.89	5	59513	10	79684860
Abdominal pain upper	25.36	17.89	84	59434	223735	79461135
Respiratory arrest	25.15	17.89	6	59512	57544	79627326
Aggression	25.03	17.89	4	59514	50954	79633916
Osteoporosis	24.95	17.89	5	59513	54107	79630763
Eosinophilic fasciitis	24.92	17.89	9	59509	276	79684594
Cryptitis	24.53	17.89	9	59509	289	79684581
Nephrolithiasis	24.42	17.89	5	59513	53286	79631584
Pericardial effusion	24.37	17.89	83	59435	46154	79638716
Folliculitis	23.76	17.89	6	59512	55374	79629496
Treatment noncompliance	23.75	17.89	5	59513	52263	79632607
Polymyositis	23.67	17.89	19	59499	3017	79681853
Pulmonary sarcoidosis	23.59	17.89	14	59504	1363	79683507
Limbic encephalitis	23.59	17.89	12	59506	863	79684007
Hypoaesthesia	23.42	17.89	63	59455	179289	79505581
Encephalopathy	23.34	17.89	106	59412	67291	79617579
Capillary leak syndrome	23.30	17.89	21	59497	3904	79680966
Electrocardiogram QT prolonged	23.16	17.89	20	59498	90366	79594504
Giant cell arteritis	23.13	17.89	18	59500	2733	79682137
Oesophagitis	23.08	17.89	54	59464	24235	79660635
Microvillous inclusion disease	23.08	17.89	8	59510	217	79684653
Apoptosis	22.88	17.89	10	59508	510	79684360
Tachycardia	22.80	17.89	63	59455	177705	79507165
Epistaxis	22.64	17.89	30	59488	111485	79573385
Tumour lysis syndrome	22.51	17.89	53	59465	23886	79660984
Cortisol increased	22.43	17.89	10	59508	535	79684335
Eyelid ptosis	22.43	17.89	34	59484	11010	79673860
Cardiac tamponade	22.40	17.89	31	59487	9245	79675625
Pallor	22.32	17.89	5	59513	50057	79634813
General physical condition abnormal	22.30	17.89	26	59492	6537	79678333
Hypokalaemia	21.90	17.89	183	59335	143857	79541013
Swollen tongue	21.70	17.89	3	59515	42567	79642303
Cortisol abnormal	21.65	17.89	6	59512	75	79684795
Probiotic therapy	21.62	17.89	7	59511	153	79684717
Retinopathy	21.50	17.89	20	59498	3871	79680999
Pulmonary embolism	21.46	17.89	209	59309	171445	79513425
Thyroxine free decreased	21.35	17.89	12	59506	1055	79683815
Sudden death	21.34	17.89	50	59468	22461	79662409
Polyarthritis	21.23	17.89	35	59483	12167	79672703
Muscular weakness	21.23	17.89	198	59320	160531	79524339
Gastrointestinal toxicity	20.95	17.89	28	59490	8081	79676789
Septic shock	20.84	17.89	160	59358	122641	79562229
Sleep disorder	20.72	17.89	20	59498	85657	79599213
Haematocrit decreased	20.56	17.89	10	59508	61302	79623568
Rhinorrhoea	20.53	17.89	16	59502	76058	79608812
Pulmonary fibrosis	20.50	17.89	4	59514	44108	79640762
Diarrhoea haemorrhagic	20.44	17.89	36	59482	13198	79671672
International normalised ratio increased	20.23	17.89	20	59498	84701	79600169
Road traffic accident	20.21	17.89	4	59514	43660	79641210
Propionibacterium infection	20.16	17.89	8	59510	319	79684551
Parvovirus infection	20.14	17.89	10	59508	683	79684187
Troponin I increased	19.95	17.89	21	59497	4717	79680153
Red blood cell count decreased	19.88	17.89	9	59509	57504	79627366
Hypoalbuminaemia	19.86	17.89	47	59471	21250	79663620
Flushing	19.77	17.89	22	59496	88246	79596624
Accidental overdose	19.69	17.89	3	59515	39578	79645292
Acute motor axonal neuropathy	19.57	17.89	6	59512	109	79684761
Pneumonia bacterial	19.50	17.89	44	59474	19287	79665583
Therapeutic response decreased	19.42	17.89	13	59505	66840	79618030
Autoimmune thyroid disorder	19.33	17.89	5	59513	47	79684823
Jejunal ulcer	19.28	17.89	7	59511	218	79684652
Pericarditis	19.23	17.89	30	59488	104206	79580664
Blood bilirubin increased	19.21	17.89	99	59419	66133	79618737
Gastrointestinal disorder	19.10	17.89	39	59479	122166	79562704
Product prescribing error	18.95	17.89	5	59513	44808	79640062
Metastases to bone	18.68	17.89	50	59468	24377	79660493
Urticaria	18.66	17.89	73	59445	185128	79499742
Retinal melanoma	18.60	17.89	3	59515	0	79684870
Cholecystitis	18.56	17.89	47	59471	22165	79662705
Lip swelling	18.41	17.89	4	59514	40907	79643963
Physical deconditioning	18.40	17.89	14	59504	2056	79682814
Localised infection	18.34	17.89	3	59515	37572	79647298
Drug dependence	18.32	17.89	4	59514	40765	79644105
Psoriasis	18.29	17.89	24	59494	89563	79595307
Head injury	18.21	17.89	3	59515	37366	79647504
Radiation skin injury	18.08	17.89	12	59506	1422	79683448
Arthritis	18.02	17.89	147	59371	114733	79570137

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	L01FX04	ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS ANTINEOPLASTIC AGENTS MONOCLONAL ANTIBODIES AND ANTIBODY DRUG CONJUGATES Other monoclonal antibodies and antibody drug conjugates
MeSH PA	D000970	Antineoplastic Agents
MeSH PA	D000074322	Antineoplastic Agents, Immunological
MeSH PA	D000082082	Immune Checkpoint Inhibitors
FDA PE	N0000182157	Increased T Lymphocyte Activation
FDA MoA	N0000182634	CTLA-4-directed Antibody Interactions
FDA EPC	N0000182635	CTLA-4-directed Blocking Antibody

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

Disease	Relation	SNOMED_ID	DOID
Unresectable advanced or recurrent malignant pleural mesothelioma	indication	254645002	DOID:7474
Unresectable advanced or recurrent esophageal cancer	indication	363402007
Metastatic nonsmall cell lung cancer with no sensitising EGFR mutation or ALK translocation	indication	427038005
Metastatic malignant melanoma	indication	443493003
Renal cell carcinoma	indication	702391001	DOID:4450
Microsatellite instability-high colorectal cancer	indication	737058005
High grade squamous intraepithelial neoplasia of esophagus	indication	1197288009

🐶 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
Cytotoxic T-lymphocyte protein 4	Surface antigen	P16410	CTLA4_HUMAN	ANTIBODY BINDING				UNKNOWN	DRUG LABEL

External reference:

ID	Source
D04603	KEGG_DRUG
4030653	VUID
N0000182641	NUI
4030653	VANDF
CHEMBL1789844	ChEMBL_ID
6888	IUPHAR_LIGAND_ID
DB06186	DRUGBANK_ID
1094833	RXNORM
180596	MMSL
27014	MMSL
d07565	MMSL
013688	NDDF
697995005	SNOMEDCT_US
704649006	SNOMEDCT_US
C1367202	UMLSCUI
D000074324	MESH_DESCRIPTOR_UI
8568	INN_ID
6T8C155666	UNII

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
YERVOY	HUMAN PRESCRIPTION DRUG LABEL	1	0003-2327	INJECTION	5 mg	INTRAVENOUS	BLA	25 sections
YERVOY	HUMAN PRESCRIPTION DRUG LABEL	1	0003-2327	INJECTION	5 mg	INTRAVENOUS	BLA	25 sections
YERVOY	HUMAN PRESCRIPTION DRUG LABEL	1	0003-2327	INJECTION	5 mg	INTRAVENOUS	BLA	25 sections
YERVOY	HUMAN PRESCRIPTION DRUG LABEL	1	0003-2328	INJECTION	5 mg	INTRAVENOUS	BLA	25 sections
YERVOY	HUMAN PRESCRIPTION DRUG LABEL	1	0003-2328	INJECTION	5 mg	INTRAVENOUS	BLA	25 sections
YERVOY	HUMAN PRESCRIPTION DRUG LABEL	1	0003-2328	INJECTION	5 mg	INTRAVENOUS	BLA	25 sections