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

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

Stem definition	Drug id	CAS RN
human origin	4923	946414-94-4

Description:

Molecule

Description

Synonyms: nivolumab opdivo MDX-1106 ONO-4538 BMS-936558 nivolumab (genetical recombination)

A genetically engineered, fully humanized immunoglobulin G4 monoclonal antibody that binds to the PD-1 RECEPTOR, activating an immune response to tumor cells. It is used as monotherapy or in combination with IPILIMUMAB for the treatment of advanced malignant MELANOMA. It is also used in the treatment of advanced or recurring NON-SMALL CELL LUNG CANCER; RENAL CELL CARCINOMA; and HODGKIN'S LYMPHOMA. 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
June 19, 2015	EMA	Bristol-Myers Squibb
Dec. 22, 2014	FDA	BRISTOL MYERS SQUIBB
July 4, 2014	PMDA	Ono Pharmaceutical Co., Ltd

FDA Adverse Event Reporting System (Female)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Malignant neoplasm progression	5470.44	16.51	2141	47620	79980	63359281
Death	1511.58	16.51	1650	48111	372731	63066530
Intentional product use issue	1230.99	16.51	922	48839	126970	63312291
Immune-mediated enterocolitis	1016.81	16.51	252	49509	1859	63437402
Pneumonitis	908.99	16.51	476	49285	34746	63404515
Hypophysitis	892.89	16.51	221	49540	1620	63437641
Colitis	890.86	16.51	524	49237	48004	63391257
Hypothyroidism	731.90	16.51	441	49320	42191	63397070
Fulminant type 1 diabetes mellitus	585.16	16.51	122	49639	353	63438908
Immune-mediated hepatitis	538.16	16.51	139	49622	1232	63438029
Adrenal insufficiency	522.30	16.51	263	49498	17652	63421609
Hyperthyroidism	480.01	16.51	233	49528	14440	63424821
Myocarditis	475.79	16.51	208	49553	10117	63429144
Immune-mediated lung disease	366.48	16.51	88	49673	558	63438703
Thyroiditis	361.04	16.51	116	49645	2350	63436911
Type 1 diabetes mellitus	360.60	16.51	129	49632	3661	63435600
Hepatic function abnormal	345.54	16.51	263	49498	36879	63402382
Hypopituitarism	339.34	16.51	93	49668	1055	63438206
Immune-mediated hepatic disorder	327.79	16.51	77	49684	438	63438823
Autoimmune colitis	322.90	16.51	77	49684	472	63438789
Autoimmune hepatitis	314.51	16.51	147	49614	8363	63430898
Diabetic ketoacidosis	268.79	16.51	179	49582	20326	63418935
Drug ineffective	259.15	16.51	264	49497	1044501	62394760
Adrenocorticotropic hormone deficiency	237.29	16.51	57	49704	362	63438899
Cholangitis	233.55	16.51	105	49656	5456	63433805
Myositis	229.59	16.51	122	49639	9144	63430117
Myasthenia gravis	226.43	16.51	97	49664	4484	63434777
Pemphigoid	202.84	16.51	104	49657	7240	63432021
Tumour pseudoprogression	198.20	16.51	46	49715	246	63439015
Metastases to central nervous system	197.77	16.51	125	49636	12980	63426281
Leukoderma	195.63	16.51	37	49724	51	63439210
Hepatitis	193.90	16.51	195	49566	39593	63399668
Secondary adrenocortical insufficiency	192.08	16.51	63	49698	1365	63437896
Pyrexia	191.80	16.51	802	48959	469676	62969585
Immune-mediated myocarditis	186.45	16.51	44	49717	256	63439005
Drug intolerance	185.73	16.51	15	49746	308646	63130615
Enterocolitis	179.42	16.51	98	49663	7760	63431501
Liver disorder	169.95	16.51	210	49551	53477	63385784
Drug hypersensitivity	166.73	16.51	23	49738	310664	63128597
Immune-mediated thyroiditis	164.26	16.51	35	49726	116	63439145
Cachexia	163.70	16.51	83	49678	5643	63433618
Pleural effusion	162.99	16.51	275	49486	92935	63346326
Joint swelling	162.92	16.51	30	49731	327636	63111625
Interstitial lung disease	162.89	16.51	221	49540	61687	63377574
Pain	157.34	16.51	211	49550	740417	62698844
Vitiligo	150.16	16.51	52	49709	1337	63437924
Lichenoid keratosis	144.76	16.51	54	49707	1729	63437532
Immune-mediated dermatitis	140.34	16.51	32	49729	156	63439105
Lymphocytic hypophysitis	138.27	16.51	33	49728	203	63439058
Encephalitis	134.73	16.51	85	49676	8795	63430466
Abdominal discomfort	132.99	16.51	43	49718	320842	63118419
Sepsis	128.34	16.51	334	49427	152789	63286472
Swelling	126.98	16.51	30	49731	275348	63163913
Systemic lupus erythematosus	126.03	16.51	10	49751	208908	63230353
Immune-mediated hypothyroidism	124.64	16.51	32	49729	276	63438985
Product dose omission issue	124.12	16.51	18	49743	234295	63204966
Uveitis	123.57	16.51	92	49669	12461	63426800
Pemphigus	122.39	16.51	5	49756	183721	63255540
Glossodynia	122.16	16.51	4	49757	178872	63260389
Arthropathy	122.16	16.51	19	49742	234773	63204488
Sinusitis	121.01	16.51	17	49744	226636	63212625
Immune-mediated nephritis	119.91	16.51	27	49734	123	63439138
Autoimmune thyroiditis	117.52	16.51	59	49702	3927	63435334
Synovitis	115.43	16.51	8	49753	186910	63252351
Prescribed underdose	111.90	16.51	127	49634	29562	63409699
Alopecia	108.72	16.51	65	49696	337471	63101790
Hypothalamo-pituitary disorder	108.50	16.51	35	49726	718	63438543
Immune-mediated uveitis	108.23	16.51	20	49741	22	63439239
Immune-mediated encephalitis	107.97	16.51	27	49734	207	63439054
Wound	106.90	16.51	5	49756	163258	63276003
Drug interaction	103.58	16.51	26	49735	229105	63210156
Immune-mediated hypophysitis	101.96	16.51	21	49740	56	63439205
Relapsing fever	101.35	16.51	25	49736	180	63439081
Exposure during pregnancy	101.08	16.51	5	49756	155542	63283719
Nasopharyngitis	100.25	16.51	37	49724	254220	63185041
Non-small cell lung cancer	96.65	16.51	50	49711	3545	63435716
Myasthenic syndrome	95.45	16.51	25	49736	235	63439026
Cytokine release syndrome	94.37	16.51	83	49678	14231	63425030
Meningitis aseptic	93.40	16.51	54	49707	4769	63434492
Peripheral swelling	93.20	16.51	46	49715	265896	63173365
Rash maculo-papular	90.20	16.51	118	49643	31778	63407483
Radiation pneumonitis	89.88	16.51	37	49724	1546	63437715
Cholangitis sclerosing	88.59	16.51	37	49724	1604	63437657
Nephritis	88.45	16.51	42	49719	2474	63436787
Discomfort	88.27	16.51	13	49748	167361	63271900
Cholestasis	88.11	16.51	112	49649	29322	63409939
Respiratory failure	86.11	16.51	223	49538	101635	63337626
Autoimmune myocarditis	84.85	16.51	19	49742	84	63439177
Decreased appetite	83.84	16.51	404	49357	250648	63188613
Treatment failure	83.59	16.51	26	49735	199017	63240244
Autoimmune nephritis	83.47	16.51	25	49736	397	63438864
Tubulointerstitial nephritis	83.39	16.51	90	49671	19813	63419448
Haemophagocytic lymphohistiocytosis	83.15	16.51	68	49693	10559	63428702
Toxicity to various agents	81.85	16.51	46	49715	247204	63192057
Vogt-Koyanagi-Harada disease	81.82	16.51	20	49741	138	63439123
Erythema multiforme	81.53	16.51	66	49695	10103	63429158
Autoimmune haemolytic anaemia	79.88	16.51	48	49713	4553	63434708
Acute kidney injury	78.85	16.51	411	49350	263004	63176257
Condition aggravated	78.76	16.51	121	49640	402096	63037165
Diarrhoea	78.40	16.51	880	48881	714486	62724775
Exposure via body fluid	74.16	16.51	25	49736	591	63438670
Maternal exposure during pregnancy	72.75	16.51	41	49720	220021	63219240
Disseminated intravascular coagulation	72.64	16.51	82	49679	18969	63420292
Pericardial effusion	72.57	16.51	103	49658	29955	63409306
Hyponatraemia	72.06	16.51	222	49539	111678	63327583
Hypersensitivity	71.92	16.51	74	49687	292611	63146650
Aspartate aminotransferase increased	71.57	16.51	193	49568	90084	63349177
Dizziness	70.07	16.51	145	49616	429780	63009481
Weight increased	66.28	16.51	64	49697	260728	63178533
Autoimmune pancreatitis	66.12	16.51	19	49742	259	63439002
Overdose	65.37	16.51	7	49754	115071	63324190
Therapeutic product effect incomplete	65.27	16.51	10	49751	125046	63314215
Serous retinal detachment	65.13	16.51	20	49741	347	63438914
Eosinophilic fasciitis	65.08	16.51	17	49744	158	63439103
Pain in extremity	64.59	16.51	100	49661	331386	63107875
Autoimmune dermatitis	64.41	16.51	16	49745	119	63439142
Thyroid disorder	62.53	16.51	68	49693	15094	63424167
Lipase increased	62.46	16.51	56	49705	9844	63429417
Product use in unapproved indication	61.03	16.51	290	49471	178790	63260471
Feeling abnormal	59.45	16.51	21	49740	148371	63290890
Encephalitis autoimmune	59.04	16.51	27	49734	1459	63437802
Musculoskeletal stiffness	58.74	16.51	36	49725	184582	63254679
Pancreatitis	58.55	16.51	123	49638	48932	63390329
Febrile neutropenia	58.54	16.51	215	49546	118234	63321027
Off label use	58.34	16.51	794	48967	673668	62765593
Immune-mediated adrenal insuficiency	56.74	16.51	13	49748	65	63439196
Embolism	56.48	16.51	48	49713	7858	63431403
Blood thyroid stimulating hormone increased	56.21	16.51	46	49715	7148	63432113
Immune-mediated arthritis	55.93	16.51	13	49748	70	63439191
Tumour pain	53.63	16.51	25	49736	1412	63437849
General physical health deterioration	53.30	16.51	304	49457	201098	63238163
Immune-mediated cholangitis	52.96	16.51	11	49750	31	63439230
Loss of personal independence in daily activities	52.58	16.51	7	49754	97283	63341978
Mobility decreased	52.34	16.51	15	49746	121144	63318117
Skin toxicity	51.95	16.51	37	49724	4677	63434584
Polyarthritis	51.75	16.51	51	49710	10095	63429166
Alanine aminotransferase increased	50.14	16.51	187	49574	103583	63335678
Blood corticotrophin decreased	49.56	16.51	16	49745	329	63438932
Cardiac tamponade	49.25	16.51	36	49725	4739	63434522
Immune-mediated myositis	49.00	16.51	23	49738	1320	63437941
Osteoarthritis	48.90	16.51	8	49753	95335	63343926
Fall	48.65	16.51	152	49609	392182	63047079
Enteritis	48.62	16.51	45	49716	8241	63431020
Drug-induced liver injury	48.17	16.51	101	49660	40121	63399140
Migraine	48.09	16.51	11	49750	103335	63335926
Immune-mediated adverse reaction	47.82	16.51	15	49746	280	63438981
Adverse event	47.21	16.51	138	49623	67421	63371840
Amylase increased	46.31	16.51	39	49722	6306	63432955
Psoriatic arthropathy	46.22	16.51	8	49753	91512	63347749
Tumour lysis syndrome	45.50	16.51	45	49716	8945	63430316
Hyperglycaemia	45.41	16.51	101	49660	41766	63397495
Immune-mediated encephalopathy	44.75	16.51	8	49753	6	63439255
Asthma	44.73	16.51	22	49739	127539	63311722
Anaemia	44.64	16.51	387	49374	293043	63146218
Lymphangiosis carcinomatosa	44.40	16.51	22	49739	1423	63437838
Immune-mediated pancreatitis	44.36	16.51	12	49749	129	63439132
Silent thyroiditis	43.91	16.51	11	49750	85	63439176
Ascites	43.89	16.51	98	49663	40630	63398631
Metastases to lung	43.78	16.51	52	49709	12698	63426563
Hypokalaemia	43.60	16.51	179	49582	103625	63335636
Blood pressure increased	43.24	16.51	38	49723	162024	63277237
Headache	43.18	16.51	305	49456	632936	62806325
Primary hypothyroidism	42.73	16.51	11	49750	96	63439165
Arthralgia	42.55	16.51	267	49494	569443	62869818
Metastases to meninges	42.23	16.51	26	49735	2576	63436685
Meningitis	42.15	16.51	39	49722	7138	63432123
Tumour haemorrhage	41.88	16.51	22	49739	1609	63437652
Adrenal disorder	41.06	16.51	22	49739	1675	63437586
Intentional overdose	40.88	16.51	5	49756	74147	63365114
Glucocorticoid deficiency	40.47	16.51	13	49748	263	63438998
Duodenitis	40.16	16.51	29	49732	3746	63435515
Lichen planus	39.58	16.51	24	49737	2314	63436947
Immune thrombocytopenia	39.50	16.51	45	49716	10511	63428750
Ill-defined disorder	39.46	16.51	8	49753	81747	63357514
Dermatitis	39.30	16.51	57	49704	16901	63422360
Rheumatoid arthritis	39.28	16.51	88	49673	253731	63185530
Contusion	39.05	16.51	36	49725	150008	63289253
Transaminases increased	39.01	16.51	80	49681	31287	63407974
Hypoalbuminaemia	38.65	16.51	47	49714	11758	63427503
Encephalopathy	38.38	16.51	90	49671	38530	63400731
Stress	38.36	16.51	4	49757	67163	63372098
Capillary leak syndrome	38.31	16.51	23	49738	2177	63437084
Adrenocortical insufficiency acute	38.27	16.51	21	49740	1677	63437584
Autoimmune arthritis	38.19	16.51	9	49752	52	63439209
Wheezing	37.48	16.51	14	49747	95581	63343680
Metastatic malignant melanoma	37.40	16.51	19	49742	1296	63437965
Guillain-Barre syndrome	37.12	16.51	28	49733	3865	63435396
Keratoacanthoma	36.93	16.51	14	49747	469	63438792
Suicide attempt	36.46	16.51	3	49758	60915	63378346
Hepatic failure	36.42	16.51	84	49677	35572	63403689
Urticaria	36.25	16.51	46	49715	165756	63273505
Pregnancy on contraceptive	36.19	16.51	18	49743	1174	63438087
Adverse drug reaction	36.07	16.51	9	49752	79705	63359556
Pancreatic failure	36.04	16.51	17	49744	986	63438275
Autoimmune hypothyroidism	35.49	16.51	11	49750	197	63439064
Thrombocytopenia	35.37	16.51	221	49540	150936	63288325
Diabetes mellitus	35.22	16.51	110	49651	55700	63383561
Wrong technique in product usage process	34.87	16.51	4	49757	62336	63376925
Anxiety	34.83	16.51	74	49687	217467	63221794
Pulmonary embolism	34.78	16.51	182	49579	116502	63322759
Immune-mediated gastritis	34.75	16.51	8	49753	41	63439220
Muscle spasms	34.47	16.51	43	49718	156107	63283154
Lithiasis	33.98	16.51	8	49753	46	63439215
Hypoaesthesia	33.52	16.51	50	49711	168343	63270918
Immune-mediated hyperthyroidism	33.25	16.51	9	49752	97	63439164
Cholecystitis	33.21	16.51	50	49711	15327	63423934
Drug eruption	33.14	16.51	71	49690	28623	63410638
Depression	33.02	16.51	65	49696	196427	63242834
Eagle Barrett syndrome	32.76	16.51	6	49755	6	63439255
Hepatocellular injury	31.91	16.51	68	49693	27313	63411948
Endocrine disorder	31.81	16.51	14	49747	691	63438570
Hypercalcaemia	31.47	16.51	69	49692	28253	63411008
Immune-mediated renal disorder	31.43	16.51	7	49754	30	63439231
Radiation skin injury	30.90	16.51	15	49746	928	63438333
Heart rate increased	30.48	16.51	18	49743	94220	63345041
Limbic encephalitis	30.48	16.51	11	49750	320	63438941
Suicidal ideation	30.35	16.51	6	49755	62415	63376846
Gastrooesophageal reflux disease	29.91	16.51	19	49742	95620	63343641
Impaired healing	29.90	16.51	22	49739	102520	63336741
Cortisol decreased	29.74	16.51	16	49745	1228	63438033
Dehydration	29.72	16.51	235	49526	173119	63266142
Eosinophilia	29.44	16.51	59	49702	22697	63416564
Pericarditis	29.29	16.51	36	49725	131543	63307718
Brain oedema	29.02	16.51	45	49716	14150	63425111
Eyelid ptosis	28.94	16.51	32	49729	7235	63432026
Cerebral microangiopathy	28.88	16.51	10	49751	257	63439004
Pneumonia	28.71	16.51	510	49251	456257	62983004
Immune-mediated neuropathy	28.61	16.51	6	49755	18	63439243
Nasal congestion	28.59	16.51	8	49753	65652	63373609
Oesophagitis	28.51	16.51	46	49715	14962	63424299
Hypoxia	28.24	16.51	107	49654	59685	63379576
Large intestine perforation	28.15	16.51	34	49727	8448	63430813
Gastrointestinal disorder	28.07	16.51	37	49724	131202	63308059
Toxic skin eruption	27.97	16.51	42	49719	12843	63426418
Haemolytic anaemia	27.91	16.51	37	49724	10088	63429173
Medication error	27.69	16.51	4	49757	52280	63386981
Insomnia	27.63	16.51	82	49679	215170	63224091
Catabolic state	27.62	16.51	7	49754	57	63439204
Adrenalitis	27.48	16.51	6	49755	23	63439238
Multiple sclerosis relapse	27.39	16.51	3	49758	48475	63390786
Demyelinating polyneuropathy	27.32	16.51	13	49748	769	63438492
Blood thyroid stimulating hormone decreased	27.07	16.51	25	49736	4565	63434696
Osteoporosis	26.87	16.51	6	49755	57332	63381929
Gastritis	26.82	16.51	77	49684	37226	63402035
Palmar-plantar erythrodysaesthesia syndrome	26.64	16.51	57	49704	22958	63416303
Fluid retention	26.50	16.51	7	49754	59679	63379582
Gait disturbance	26.34	16.51	66	49695	183112	63256149
Balance disorder	26.09	16.51	17	49744	84405	63354856
Influenza	26.08	16.51	28	49733	108694	63330567
Autoimmune neuropathy	26.02	16.51	6	49755	31	63439230
Iridocyclitis	25.98	16.51	19	49742	2503	63436758
Thyrotoxic crisis	25.92	16.51	13	49748	863	63438398
Hyperhidrosis	25.62	16.51	28	49733	107808	63331453
Peripheral sensory neuropathy	24.94	16.51	30	49731	7421	63431840
Oral mucosa erosion	24.93	16.51	14	49747	1169	63438092
Memory impairment	24.85	16.51	27	49734	104231	63335030
Mucosal inflammation	24.71	16.51	87	49674	46841	63392420
Blood alkaline phosphatase increased	24.67	16.51	82	49679	42885	63396376
Tremor	24.66	16.51	41	49720	132198	63307063
Immune-mediated oesophagitis	24.61	16.51	4	49757	0	63439261
Neutropenia	24.60	16.51	227	49534	174778	63264483
Systemic inflammatory response syndrome	24.57	16.51	26	49735	5595	63433666
Cardiomyopathy	24.45	16.51	47	49714	17537	63421724
Metastasis	24.44	16.51	25	49736	5172	63434089
Thoracic cavity drainage	24.39	16.51	7	49754	95	63439166
Cardiac failure congestive	24.25	16.51	22	49739	92411	63346850
Organising pneumonia	23.98	16.51	26	49735	5750	63433511
Blister	23.52	16.51	41	49720	129773	63309488
Tumour thrombosis	23.15	16.51	5	49756	18	63439243
Paraesthesia	23.00	16.51	56	49705	156910	63282351
Lower respiratory tract infection	22.88	16.51	43	49718	132264	63306997
Nephritis allergic	22.77	16.51	8	49753	215	63439046
Graft versus host disease	22.26	16.51	27	49734	6736	63432525
Abdominal pain upper	22.15	16.51	85	49676	206359	63232902
Thrombophlebitis migrans	22.10	16.51	7	49754	135	63439126
Gait inability	22.06	16.51	7	49754	52952	63386309
Blood creatine phosphokinase increased	22.06	16.51	63	49698	30367	63408894
Amnesia	22.02	16.51	8	49753	55577	63383684
Rhinorrhoea	21.96	16.51	12	49749	65565	63373696
Blood glucose increased	21.90	16.51	20	49741	83736	63355525
Autoimmune myositis	21.77	16.51	7	49754	142	63439119
Hepatobiliary disease	21.57	16.51	9	49752	389	63438872
Incorrect dose administered	21.54	16.51	10	49751	59958	63379303
Ileus	21.27	16.51	40	49721	14685	63424576
Haemoglobin decreased	21.24	16.51	52	49709	145433	63293828
Tracheal stenosis	21.07	16.51	7	49754	158	63439103
Paraparesis	21.06	16.51	16	49745	2232	63437029
Palpitations	20.99	16.51	35	49726	112735	63326526
Bradycardia	20.97	16.51	16	49745	73211	63366050
General physical condition abnormal	20.90	16.51	21	49740	4253	63435008
Heart rate decreased	20.89	16.51	5	49756	45555	63393706
Subacute cutaneous lupus erythematosus	20.86	16.51	17	49744	2626	63436635
Loss of consciousness	20.77	16.51	38	49723	118083	63321178
Pneumonia bacterial	20.76	16.51	31	49730	9434	63429827
Sleep disorder	20.71	16.51	20	49741	81546	63357715
Hepatotoxicity	20.66	16.51	70	49691	36971	63402290
Enterocolitis infectious	20.58	16.51	14	49747	1644	63437617
Ketoacidosis	20.48	16.51	21	49740	4357	63434904
Aspiration pleural cavity	20.31	16.51	11	49750	856	63438405
VIth nerve paralysis	20.27	16.51	11	49750	859	63438402
Orbital myositis	20.15	16.51	5	49756	37	63439224
Aplasia pure red cell	20.05	16.51	21	49740	4466	63434795
Tri-iodothyronine free decreased	19.86	16.51	8	49753	316	63438945
Electrocardiogram QT prolonged	19.78	16.51	11	49750	59519	63379742
Pneumothorax	19.66	16.51	41	49720	16220	63423041
Neutrophil count decreased	19.66	16.51	92	49669	56314	63382947
Gastroenteritis eosinophilic	18.98	16.51	6	49755	115	63439146
Dermatitis psoriasiform	18.82	16.51	15	49746	2244	63437017
Upper respiratory tract infection	18.73	16.51	22	49739	82025	63357236
Achromobacter infection	18.72	16.51	5	49756	51	63439210
Multiple organ dysfunction syndrome	18.64	16.51	91	49670	56661	63382600
Autoimmune retinopathy	18.46	16.51	3	49758	0	63439261
Antiacetylcholine receptor antibody positive	18.46	16.51	3	49758	0	63439261
Thyroid stimulating hormone deficiency	18.46	16.51	3	49758	0	63439261
Hepatic enzyme increased	18.22	16.51	89	49672	202239	63237022
Agranulocytosis	18.18	16.51	52	49709	25082	63414179
Generalised oedema	18.10	16.51	39	49722	15779	63423482
Platelet count decreased	18.05	16.51	154	49607	115968	63323293
Hydronephrosis	18.00	16.51	31	49730	10631	63428630
Transfusion	17.97	16.51	38	49723	15179	63424082
Tumour embolism	17.91	16.51	6	49755	139	63439122
Oxygen saturation decreased	17.91	16.51	26	49735	88559	63350702
Ear infection	17.90	16.51	4	49757	38209	63401052
Blood lactate dehydrogenase increased	17.88	16.51	49	49712	23067	63416194
Troponin increased	17.84	16.51	30	49731	10091	63429170
Acute polyneuropathy	17.83	16.51	7	49754	258	63439003
Type 3 diabetes mellitus	17.80	16.51	4	49757	18	63439243
Primary adrenal insufficiency	17.79	16.51	6	49755	142	63439119
KL-6 increased	17.76	16.51	5	49756	63	63439198
Lethargy	17.68	16.51	11	49750	55996	63383265
Optic neuritis	17.61	16.51	27	49734	8408	63430853
Thyroiditis subacute	17.43	16.51	7	49754	274	63438987
Liver function test increased	17.42	16.51	61	49700	32750	63406511
Blood corticotrophin increased	17.34	16.51	5	49756	69	63439192
Pericardial drainage	17.34	16.51	7	49754	278	63438983
Thyroxine free abnormal	17.30	16.51	4	49757	21	63439240
Agitation	17.19	16.51	13	49748	59744	63379517
Polymyositis	17.18	16.51	13	49748	1803	63437458
Pericardial excision	17.14	16.51	4	49757	22	63439239
Immune-mediated cytopenia	16.99	16.51	4	49757	23	63439238
Gamma-glutamyltransferase increased	16.98	16.51	62	49699	33969	63405292
Road traffic accident	16.83	16.51	4	49757	36628	63402633
Therapy partial responder	16.71	16.51	30	49731	10628	63428633
Rheumatic disorder	16.71	16.51	16	49745	3056	63436205
Metastases to bone	16.70	16.51	45	49716	20974	63418287
Intestinal perforation	16.66	16.51	32	49729	11931	63427330
Joint stiffness	16.63	16.51	6	49755	41863	63397398
Troponin T increased	16.55	16.51	11	49750	1243	63438018
Dermatitis acneiform	16.53	16.51	20	49741	4976	63434285

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	8424.76	14.16	4256	88367	83790	34780518
Immune-mediated enterocolitis	1397.76	14.16	448	92175	2351	34861957
Intentional product use issue	1361.18	14.16	1184	91439	58632	34805676
Hypothyroidism	1288.55	14.16	760	91863	20142	34844166
Pneumonitis	1205.94	14.16	873	91750	33005	34831303
Death	1180.82	14.16	2971	89652	395078	34469230
Adrenal insufficiency	1160.23	14.16	619	92004	13428	34850880
Colitis	1086.99	14.16	857	91766	36893	34827415
Hypophysitis	1028.03	14.16	338	92285	1948	34862360
Fulminant type 1 diabetes mellitus	918.31	14.16	250	92373	641	34863667
Hypopituitarism	701.80	14.16	254	92369	2028	34862280
Myocarditis	673.08	14.16	431	92192	13251	34851057
Pemphigoid	648.89	14.16	358	92265	8308	34856000
Interstitial lung disease	642.27	14.16	827	91796	64455	34799853
Hyperthyroidism	582.94	14.16	358	92265	10208	34854100
Thyroiditis	562.52	14.16	218	92405	2144	34862164
Adrenocorticotropic hormone deficiency	557.80	14.16	172	92451	775	34863533
Immune-mediated hepatitis	554.52	14.16	212	92411	2003	34862305
Type 1 diabetes mellitus	542.36	14.16	252	92371	4006	34860302
Immune-mediated lung disease	526.56	14.16	187	92436	1404	34862904
Myositis	524.80	14.16	352	92271	11718	34852590
Immune-mediated hepatic disorder	475.01	14.16	155	92468	868	34863440
Secondary adrenocortical insufficiency	464.68	14.16	167	92456	1303	34863005
Immune-mediated myocarditis	459.21	14.16	142	92481	647	34863661
Autoimmune hepatitis	416.62	14.16	212	92411	4148	34860160
Drug interaction	395.38	14.16	63	92560	225883	34638425
Autoimmune colitis	369.33	14.16	128	92495	886	34863422
Hepatic function abnormal	367.20	14.16	517	92106	43846	34820462
Prescribed underdose	360.91	14.16	249	92374	8684	34855624
Enterocolitis	343.90	14.16	232	92391	7794	34856514
Drug ineffective	341.73	14.16	427	92196	456324	34407984
Myasthenia gravis	327.35	14.16	213	92410	6727	34857581
Toxicity to various agents	316.18	14.16	72	92551	200290	34664018
Immune-mediated dermatitis	309.31	14.16	87	92536	262	34864046
Metastases to central nervous system	292.75	14.16	212	92411	7993	34856315
Hepatitis	276.78	14.16	329	92294	23575	34840733
Liver disorder	275.12	14.16	386	92237	32611	34831697
Diabetic ketoacidosis	268.50	14.16	283	92340	17749	34846559
Radiation pneumonitis	248.24	14.16	127	92496	2513	34861795
Vitiligo	235.01	14.16	90	92533	854	34863454
Lymphocytic hypophysitis	219.56	14.16	65	92558	247	34864061
Hypothalamo-pituitary disorder	216.96	14.16	82	92541	748	34863560
Cachexia	212.62	14.16	166	92457	7020	34857288
Prescribed overdose	204.57	14.16	192	92431	10455	34853853
Lichen planus	202.21	14.16	82	92541	917	34863391
Product dose omission issue	198.98	14.16	38	92585	119673	34744635
Pyrexia	197.36	14.16	1531	91092	331482	34532826
Tubulointerstitial nephritis	196.49	14.16	260	92363	20764	34843544
Encephalitis	191.63	14.16	157	92466	7120	34857188
Immune-mediated hypothyroidism	189.94	14.16	58	92565	251	34864057
Completed suicide	189.11	14.16	20	92603	98148	34766160
Overdose	187.70	14.16	14	92609	91045	34773263
Decreased appetite	177.87	14.16	891	91732	165501	34698807
Thyroid disorder	173.36	14.16	107	92516	3075	34861233
Cholangitis	173.32	14.16	160	92463	8529	34855779
Immune-mediated thyroiditis	171.95	14.16	45	92578	93	34864215
Diarrhoea	168.31	14.16	1672	90951	388240	34476068
Autoimmune thyroiditis	166.84	14.16	75	92548	1099	34863209
Tumour pseudoprogression	166.32	14.16	59	92564	441	34863867
Cholangitis sclerosing	165.25	14.16	79	92544	1342	34862966
Leukoderma	163.17	14.16	39	92584	44	34864264
Lung disorder	161.44	14.16	312	92311	34384	34829924
Immune-mediated adrenal insuficiency	159.89	14.16	44	92579	119	34864189
Immune-mediated hypophysitis	158.76	14.16	39	92584	54	34864254
General physical health deterioration	151.46	14.16	707	91916	127562	34736746
Hypercalcaemia	144.07	14.16	191	92432	15277	34849031
Adverse event	137.16	14.16	207	92416	18670	34845638
Uveitis	133.59	14.16	130	92493	7405	34856903
Immune-mediated nephritis	132.14	14.16	46	92577	323	34863985
Pulmonary toxicity	132.02	14.16	118	92505	6029	34858279
Adrenal disorder	131.74	14.16	62	92561	1015	34863293
Immune-mediated myositis	128.86	14.16	76	92547	2007	34862301
Immune-mediated encephalitis	126.47	14.16	40	92583	199	34864109
Drug hypersensitivity	124.70	14.16	30	92593	80499	34783809
Dizziness	123.03	14.16	246	92377	218275	34646033
Autoimmune nephritis	119.69	14.16	40	92583	244	34864064
Immune-mediated uveitis	116.04	14.16	28	92595	34	34864274
Nephritis	115.01	14.16	75	92548	2376	34861932
Pleural effusion	114.02	14.16	473	92150	81073	34783235
Tumour haemorrhage	111.30	14.16	79	92544	2883	34861425
Blood corticotrophin decreased	109.87	14.16	35	92588	179	34864129
Immune-mediated cholangitis	106.57	14.16	31	92592	109	34864199
Haemoglobin decreased	106.30	14.16	98	92525	120674	34743634
Autoimmune pancreatitis	101.91	14.16	37	92586	298	34864010
Immune thrombocytopenia	101.03	14.16	123	92500	9029	34855279
Rash	99.92	14.16	964	91659	221788	34642520
Skin disorder	98.98	14.16	149	92474	13406	34850902
Blood pressure increased	97.67	14.16	56	92567	88046	34776262
Intentional product misuse	96.91	14.16	6	92617	45605	34818703
Polyarthritis	95.22	14.16	86	92537	4454	34859854
Immune-mediated pancreatitis	94.04	14.16	28	92595	109	34864199
Palmar-plantar erythrodysaesthesia syndrome	90.60	14.16	161	92462	16634	34847674
Relapsing fever	90.60	14.16	29	92594	151	34864157
Encephalitis autoimmune	87.51	14.16	41	92582	664	34863644
Lipase increased	87.26	14.16	116	92507	9300	34855008
Erythema multiforme	87.08	14.16	111	92512	8538	34855770
Condition aggravated	86.84	14.16	243	92380	191953	34672355
Intentional overdose	86.41	14.16	8	92615	43666	34820642
Feeling abnormal	86.05	14.16	30	92593	63205	34801103
Immune-mediated adverse reaction	85.44	14.16	38	92585	542	34863766
Enteritis	84.36	14.16	106	92517	8036	34856272
Autoimmune haemolytic anaemia	80.51	14.16	78	92545	4418	34859890
Agitation	80.25	14.16	26	92597	57373	34806935
Cortisol decreased	80.07	14.16	45	92578	1082	34863226
Dermatomyositis	79.86	14.16	47	92576	1236	34863072
Suicidal ideation	78.32	14.16	8	92615	40380	34823928
Hyperglycaemia	77.84	14.16	256	92367	39224	34825084
Suicide attempt	77.83	14.16	7	92616	39109	34825199
Pain in extremity	77.65	14.16	135	92488	126378	34737930
Cardiac failure congestive	77.56	14.16	64	92559	83206	34781102
Aggression	77.45	14.16	7	92616	38957	34825351
Immune-mediated hyperthyroidism	76.86	14.16	20	92603	40	34864268
Blood thyroid stimulating hormone increased	76.53	14.16	74	92549	4181	34860127
International normalised ratio increased	76.52	14.16	16	92607	47311	34816997
Meningitis aseptic	75.47	14.16	65	92558	3159	34861149
Incorrect dose administered	73.67	14.16	10	92613	40505	34823803
Anxiety	72.73	14.16	94	92529	99334	34764974
Therapeutic product effect decreased	72.53	14.16	5	92618	34738	34829570
Autoimmune disorder	72.42	14.16	50	92573	1744	34862564
Adrenocortical insufficiency acute	70.32	14.16	47	92576	1553	34862755
Foetal exposure during pregnancy	70.24	14.16	9	92614	38092	34826216
Unevaluable event	70.10	14.16	4	92619	32586	34831722
Myasthenic syndrome	69.39	14.16	32	92591	499	34863809
Vogt-Koyanagi-Harada disease	68.61	14.16	20	92603	71	34864237
Immune-mediated arthritis	68.38	14.16	21	92602	93	34864215
Hyperhidrosis	67.06	14.16	61	92562	75631	34788677
Blood glucose increased	66.29	14.16	48	92575	66670	34797638
Dermatitis	66.19	14.16	102	92521	9366	34854942
Tri-iodothyronine free decreased	65.86	14.16	18	92605	47	34864261
Depression	65.80	14.16	97	92526	97001	34767307
Therapeutic product effect incomplete	65.36	14.16	26	92597	50515	34813793
Immune-mediated gastritis	65.00	14.16	17	92606	35	34864273
Pericardial effusion	63.79	14.16	176	92447	24486	34839822
Lichenoid keratosis	63.71	14.16	53	92570	2455	34861853
Sialoadenitis	63.27	14.16	31	92592	557	34863751
Fall	62.89	14.16	300	92323	202585	34661723
Thyroid function test abnormal	62.85	14.16	33	92590	690	34863618
Tumour pain	62.60	14.16	38	92585	1059	34863249
Muscle spasms	62.31	14.16	64	92559	74937	34789371
Joint swelling	62.27	14.16	41	92582	59849	34804459
Weight increased	62.01	14.16	94	92529	92939	34771369
Arthritis	61.55	14.16	203	92420	31143	34833165
Stress	61.55	14.16	5	92618	30342	34833966
Polymyalgia rheumatica	60.76	14.16	42	92581	1468	34862840
Non-small cell lung cancer	60.70	14.16	63	92560	3877	34860431
Endocrine disorder	60.52	14.16	25	92598	294	34864014
Rash maculo-papular	60.17	14.16	189	92434	28262	34836046
Silent thyroiditis	59.76	14.16	17	92606	54	34864254
Serous retinal detachment	59.16	14.16	30	92593	582	34863726
Peripheral swelling	58.44	14.16	70	92553	76471	34787837
Somnolence	58.29	14.16	130	92493	110986	34753322
Electrocardiogram QT prolonged	58.22	14.16	18	92605	40934	34823374
Eosinophilic fasciitis	58.20	14.16	18	92605	82	34864226
Immune-mediated renal disorder	58.13	14.16	20	92603	135	34864173
Drug intolerance	57.70	14.16	44	92579	59526	34804782
Hyponatraemia	57.66	14.16	396	92227	82295	34782013
Autoimmune arthritis	57.43	14.16	16	92607	46	34864262
Heart rate decreased	57.32	14.16	8	92615	31737	34832571
Metastases to bone	57.31	14.16	109	92514	11861	34852447
General physical condition abnormal	57.19	14.16	60	92563	3739	34860569
Immune-mediated cystitis	57.15	14.16	14	92609	19	34864289
Prostate cancer	57.14	14.16	17	92606	39632	34824676
Autoimmune myocarditis	57.05	14.16	22	92601	213	34864095
Coma	56.65	14.16	25	92598	45653	34818655
Bradycardia	56.49	14.16	70	92553	75348	34788960
Heart rate increased	56.48	14.16	26	92597	46317	34817991
Pneumothorax	56.23	14.16	143	92480	18949	34845359
Blood thyroid stimulating hormone decreased	55.60	14.16	44	92579	1897	34862411
Immune-mediated endocrinopathy	54.83	14.16	14	92609	25	34864283
Haemophagocytic lymphohistiocytosis	54.70	14.16	112	92511	12861	34851447
Blood pressure fluctuation	54.61	14.16	3	92620	25246	34839062
Wrong technique in product usage process	54.53	14.16	14	92609	35972	34828336
Coronary artery disease	54.52	14.16	30	92593	48275	34816033
Abdominal discomfort	54.46	14.16	47	92576	59788	34804520
Organising pneumonia	54.39	14.16	73	92550	5906	34858402
Pneumonia bacterial	54.26	14.16	106	92517	11766	34852542
Loss of personal independence in daily activities	54.08	14.16	11	92612	33168	34831140
Myocardial infarction	53.95	14.16	154	92469	120931	34743377
Rheumatic disorder	53.74	14.16	28	92595	576	34863732
Tumour associated fever	53.24	14.16	25	92598	407	34863901
Immune-mediated encephalopathy	51.99	14.16	12	92611	10	34864298
Haematocrit decreased	51.85	14.16	11	92612	32205	34832103
Nephrolithiasis	51.69	14.16	9	92614	30324	34833984
Drug-induced liver injury	50.72	14.16	180	92443	28652	34835656
Angioedema	50.37	14.16	18	92605	37356	34826952
Meningitis	50.05	14.16	63	92560	4784	34859524
Loss of consciousness	49.98	14.16	89	92534	82578	34781730
Amylase increased	49.97	14.16	70	92553	5898	34858410
Hallucination	49.93	14.16	38	92585	51460	34812848
Unresponsive to stimuli	49.66	14.16	7	92616	27562	34836746
Autoimmune neuropathy	49.56	14.16	14	92609	43	34864265
Drug dependence	49.09	14.16	4	92619	24213	34840095
Musculoskeletal stiffness	48.47	14.16	32	92591	46648	34817660
Nasopharyngitis	48.27	14.16	69	92554	69899	34794409
Primary adrenal insufficiency	48.18	14.16	14	92609	49	34864259
Insomnia	47.88	14.16	130	92493	103777	34760531
Palpitations	47.85	14.16	23	92600	39963	34824345
Asthma	47.41	14.16	27	92596	42629	34821679
Pancreatic enzymes increased	46.23	14.16	26	92597	626	34863682
Enterocolitis haemorrhagic	45.93	14.16	30	92593	953	34863355
Mobility decreased	45.11	14.16	12	92611	30116	34834192
Medication error	44.87	14.16	7	92616	25558	34838750
Hypotension	44.76	14.16	374	92249	221275	34643033
Drug-device incompatibility	44.42	14.16	9	92614	0	34864308
Drug level increased	43.83	14.16	4	92619	22092	34842216
Tremor	43.81	14.16	96	92527	82491	34781817
Diabetes mellitus	43.70	14.16	242	92381	46631	34817677
Primary hypothyroidism	43.58	14.16	13	92610	51	34864257
Embolism	43.45	14.16	76	92547	7753	34856555
Intracranial tumour haemorrhage	43.19	14.16	20	92603	315	34863993
Guillain-Barre syndrome	43.14	14.16	66	92557	6021	34858287
Autoimmune dermatitis	42.97	14.16	10	92613	9	34864299
Pneumonia aspiration	42.92	14.16	222	92401	41681	34822627
Autoimmune hypothyroidism	42.69	14.16	12	92611	36	34864272
Metastases to meninges	41.73	14.16	33	92590	1421	34862887
Cancer pain	41.66	14.16	43	92580	2629	34861679
Adrenalitis	41.51	14.16	10	92613	12	34864296
Abnormal behaviour	41.28	14.16	8	92615	24961	34839347
Blood corticotrophin increased	41.14	14.16	14	92609	91	34864217
Product prescribing error	40.87	14.16	6	92617	22921	34841387
Cardiac arrest	40.86	14.16	125	92498	96034	34768274
Cytomegalovirus enterocolitis	40.82	14.16	28	92595	966	34863342
Respiratory arrest	40.45	14.16	12	92611	28031	34836277
Drug eruption	40.08	14.16	130	92493	19768	34844540
Psychotic disorder	40.07	14.16	8	92615	24444	34839864
Adverse drug reaction	39.77	14.16	14	92609	29328	34834980
Metastases to pleura	39.74	14.16	21	92602	445	34863863
Dyskinesia	39.65	14.16	6	92617	22407	34841901
Nephrotic syndrome	39.37	14.16	70	92553	7233	34857075
Red blood cell count decreased	39.22	14.16	14	92609	29076	34835232
Disseminated intravascular coagulation	39.06	14.16	137	92486	21679	34842629
Metastases to lung	38.75	14.16	80	92543	9240	34855068
Eyelid ptosis	38.74	14.16	61	92562	5705	34858603
Epistaxis	38.66	14.16	59	92564	58192	34806116
Immune-mediated neuropathy	38.65	14.16	11	92612	35	34864273
Treatment failure	38.60	14.16	40	92583	46657	34817651
Wheezing	38.31	14.16	32	92591	41370	34822938
Drug withdrawal syndrome	38.26	14.16	4	92619	19830	34844478
Taste disorder	37.83	14.16	68	92555	7087	34857221
Aspartate aminotransferase increased	37.81	14.16	308	92315	67475	34796833
Lymphangiosis carcinomatosa	37.68	14.16	26	92597	906	34863402
Headache	37.63	14.16	345	92278	200290	34664018
Aspiration pleural cavity	37.59	14.16	25	92598	819	34863489
Polymyositis	37.52	14.16	31	92592	1422	34862886
Hepatic failure	37.50	14.16	186	92437	34345	34829963
Treatment noncompliance	37.08	14.16	14	92609	28086	34836222
Cytokine release syndrome	37.01	14.16	139	92484	22738	34841570
Accidental overdose	36.54	14.16	5	92618	20135	34844173
Facial paralysis	36.52	14.16	85	92538	10649	34853659
Autoimmune thyroid disorder	36.26	14.16	8	92615	4	34864304
Thrombophlebitis migrans	35.90	14.16	15	92608	182	34864126
Pain	35.82	14.16	358	92265	204317	34659991
Balance disorder	35.71	14.16	33	92590	40621	34823687
Neutropenia	35.62	14.16	256	92367	156522	34707786
Prerenal failure	35.16	14.16	35	92588	2049	34862259
Sinusitis	34.75	14.16	35	92588	41367	34822941
Dermatitis psoriasiform	34.69	14.16	30	92593	1466	34862842
Metastases to lymph nodes	34.55	14.16	52	92571	4676	34859632
Paraesthesia	34.52	14.16	74	92549	64098	34800210
White blood cell count decreased	34.50	14.16	133	92490	95312	34768996
Iridocyclitis	34.07	14.16	31	92592	1621	34862687
Pleurodesis	33.07	14.16	9	92614	23	34864285
Gastrointestinal haemorrhage	32.82	14.16	122	92501	88355	34775953
Stomatitis	32.26	14.16	208	92415	42306	34822002
Morphoea	31.97	14.16	14	92609	192	34864116
Gait disturbance	31.84	14.16	117	92506	85023	34779285
Full blood count decreased	31.64	14.16	5	92618	18083	34846225
Injury	31.43	14.16	8	92615	20679	34843629
Superior vena cava syndrome	31.31	14.16	20	92603	611	34863697
Swelling	31.01	14.16	40	92583	42326	34821982
Hypertension	30.88	14.16	223	92400	136220	34728088
Sleep apnoea syndrome	30.60	14.16	8	92615	20313	34843995
Acquired tracheo-oesophageal fistula	30.47	14.16	11	92612	87	34864221
Inappropriate schedule of product administration	30.16	14.16	76	92547	62220	34802088
Chest discomfort	30.07	14.16	62	92561	54468	34809840
Blood urea increased	29.95	14.16	22	92601	30342	34833966
Stevens-Johnson syndrome	29.94	14.16	113	92510	18526	34845782
Glucocorticoid deficiency	29.86	14.16	15	92608	285	34864023
Confusional state	29.63	14.16	242	92381	143918	34720390
Limbic encephalitis	29.62	14.16	17	92606	426	34863882
Pituitary enlargement	29.52	14.16	8	92615	20	34864288
Tachycardia	29.45	14.16	120	92503	84652	34779656
Orthostatic hypotension	29.38	14.16	16	92607	25903	34838405
Metastases to skin	29.30	14.16	17	92606	435	34863873
Product quality issue	29.14	14.16	5	92618	17030	34847278
Cardiac tamponade	29.06	14.16	51	92572	5215	34859093
Premature baby	29.05	14.16	8	92615	19625	34844683
Intestinal perforation	28.93	14.16	70	92553	8990	34855318
Pallor	28.49	14.16	16	92607	25464	34838844
Metastases to liver	28.18	14.16	90	92533	13573	34850735
Contusion	28.01	14.16	33	92590	36331	34827977
Nasal congestion	27.99	14.16	13	92610	23044	34841264
Drug resistance	27.97	14.16	17	92606	25910	34838398
Transient acantholytic dermatosis	27.86	14.16	11	92612	114	34864194
Gastrointestinal perforation	27.54	14.16	42	92581	3821	34860487
Hypervolaemia	27.41	14.16	9	92614	19700	34844608
Blood corticotrophin abnormal	26.90	14.16	7	92616	14	34864294
Colitis microscopic	26.75	14.16	32	92591	2305	34862003
Bronchial fistula	26.62	14.16	12	92611	177	34864131
Cardiac disorder	26.44	14.16	46	92577	43080	34821228
Ill-defined disorder	26.34	14.16	3	92620	13906	34850402
White blood cell count increased	26.05	14.16	43	92580	41108	34823200
Myelitis	25.99	14.16	20	92603	827	34863481
Haematoma	25.97	14.16	18	92605	25587	34838721
Abdominal pain	25.84	14.16	293	92330	163325	34700983
Prostatic specific antigen increased	25.81	14.16	4	92619	14676	34849632
Optic neuritis	25.68	14.16	39	92584	3535	34860773
Therapy non-responder	25.63	14.16	40	92583	39106	34825202
Bile duct stenosis	25.51	14.16	23	92600	1188	34863120
Cholecystitis	25.41	14.16	74	92549	10614	34853694
Cardiomegaly	25.40	14.16	5	92618	15433	34848875
Infusion related reaction	25.35	14.16	233	92390	52824	34811484
Autoimmune lung disease	25.26	14.16	8	92615	40	34864268
Amnesia	25.23	14.16	20	92603	26543	34837765
Sleep disorder	25.23	14.16	28	92595	31660	34832648
Thrombosis	24.86	14.16	61	92562	50397	34813911
Pancytopenia	24.81	14.16	149	92474	95008	34769300
IgA nephropathy	24.68	14.16	23	92600	1240	34863068
Chest pain	24.60	14.16	216	92407	126546	34737762
Haemoptysis	24.58	14.16	168	92455	34838	34829470
Migraine	24.27	14.16	8	92615	17470	34846838
Road traffic accident	24.21	14.16	8	92615	17442	34846866
Immune-mediated cytopenia	24.20	14.16	7	92616	24	34864284
Pneumocystis jirovecii pneumonia	24.19	14.16	110	92513	19600	34844708
Memory impairment	24.09	14.16	49	92574	43269	34821039
Glomerular filtration rate decreased	24.03	14.16	3	92620	12958	34851350
Incorrect route of product administration	24.03	14.16	5	92618	14840	34849468
Skin hypopigmentation	23.88	14.16	13	92610	293	34864015
Extrapyramidal disorder	23.84	14.16	3	92620	12877	34851431
Obesity	23.83	14.16	3	92620	12875	34851433
Blood potassium decreased	23.51	14.16	9	92614	17906	34846402
Mechanical ileus	23.46	14.16	14	92609	378	34863930
Radiation necrosis	23.45	14.16	10	92613	128	34864180
Hyperlipidaemia	23.30	14.16	5	92618	14524	34849784
Iris adhesions	23.25	14.16	12	92611	242	34864066
Hypoglycaemia	23.22	14.16	71	92552	54569	34809739
Erectile dysfunction	23.02	14.16	13	92610	20624	34843684
Lip swelling	22.97	14.16	7	92616	16073	34848235
Gastrooesophageal reflux disease	22.75	14.16	41	92582	37883	34826425
Pancreatic failure	22.67	14.16	18	92605	780	34863528
Malignant pleural effusion	22.66	14.16	24	92599	1512	34862796
Melanoma recurrent	22.52	14.16	10	92613	142	34864166
Urticaria	22.48	14.16	87	92536	62290	34802018
Pericarditis	22.48	14.16	75	92548	11570	34852738
Blood triglycerides increased	22.45	14.16	5	92618	14154	34850154
Leukopenia	22.44	14.16	88	92535	62768	34801540
Dyspnoea exertional	22.37	14.16	51	92572	43228	34821080
Lactic acidosis	22.32	14.16	36	92587	34736	34829572
Large intestine perforation	22.30	14.16	61	92562	8442	34855866
Fluid retention	22.25	14.16	23	92600	26864	34837444
Infectious pleural effusion	22.22	14.16	30	92593	2440	34861868
Ventricular fibrillation	22.16	14.16	17	92606	22937	34841371
Transfusion	21.93	14.16	61	92562	8524	34855784
Syncope	21.89	14.16	147	92476	91304	34773004
Paranoia	21.88	14.16	3	92620	12065	34852243
Glomerulonephritis membranous	21.87	14.16	21	92602	1176	34863132
Gout	21.66	14.16	12	92611	19241	34845067
Hallucination, visual	21.64	14.16	10	92613	17781	34846527
Off label use	21.54	14.16	1336	91287	418188	34446120
Pancreatic toxicity	21.48	14.16	7	92616	39	34864269
Abdominal distension	21.45	14.16	81	92542	58411	34805897
Chronic gastritis	21.36	14.16	24	92599	1616	34862692
Paraneoplastic syndrome	21.36	14.16	15	92608	538	34863770
Sterile pyuria	21.33	14.16	7	92616	40	34864268
Generalised tonic-clonic seizure	21.33	14.16	15	92608	21159	34843149
Cryptitis	21.17	14.16	11	92612	225	34864083
Thyroxine free decreased	21.04	14.16	12	92611	297	34864011
Skin toxicity	21.00	14.16	42	92581	4742	34859566
Pericarditis malignant	20.77	14.16	7	92616	44	34864264
Pneumonia	20.72	14.16	1166	91457	361461	34502847
Autoimmune encephalopathy	20.63	14.16	7	92616	45	34864263
Upper respiratory tract infection	20.50	14.16	35	92588	33024	34831284
Full blood count abnormal	20.48	14.16	12	92611	18656	34845652
Intestinal metastasis	20.33	14.16	11	92612	245	34864063
Therapeutic response decreased	20.11	14.16	29	92594	29284	34835024
Cortisol increased	20.10	14.16	10	92613	186	34864122
Influenza	20.07	14.16	66	92557	49600	34814708
Coagulopathy	19.96	14.16	14	92609	19775	34844533
Burning sensation	19.93	14.16	12	92611	18382	34845926
Pleurocutaneous fistula	19.77	14.16	7	92616	52	34864256
Antinuclear antibody	19.74	14.16	4	92619	0	34864308
Optic perineuritis	19.74	14.16	4	92619	0	34864308
Blood pressure systolic increased	19.72	14.16	19	92604	22933	34841375
Physical deconditioning	19.63	14.16	21	92602	1338	34862970
Pulmonary sepsis	19.61	14.16	27	92596	2238	34862070
Thyroxine free abnormal	19.56	14.16	5	92618	9	34864299
Duodenitis	19.55	14.16	41	92582	4787	34859521
Therapy interrupted	19.50	14.16	6	92617	13691	34850617
Hepatotoxicity	19.40	14.16	110	92513	21375	34842933
Lung neoplasm malignant	19.34	14.16	11	92612	17384	34846924
Pericardial drainage	19.30	14.16	8	92615	95	34864213
Peripheral motor neuropathy	19.28	14.16	24	92599	1802	34862506
Appetite disorder	19.24	14.16	28	92595	2443	34861865
Diabetic ketoacidotic hyperglycaemic coma	19.14	14.16	9	92614	147	34864161
Osteoarthritis	19.04	14.16	16	92607	20626	34843682
Glomerulonephritis rapidly progressive	19.03	14.16	15	92608	643	34863665
Hypophonesis	18.89	14.16	5	92618	11	34864297
Flatulence	18.86	14.16	17	92606	21181	34843127
Swelling face	18.85	14.16	20	92603	23085	34841223
Hypertransaminasaemia	18.64	14.16	44	92579	5562	34858746
Cortisol abnormal	18.63	14.16	6	92617	32	34864276
Respiratory failure	18.62	14.16	397	92226	108175	34756133
Alanine aminotransferase increased	18.51	14.16	309	92314	80506	34783802
Chondritis	18.40	14.16	9	92614	161	34864147
Intestinal intraepithelial lymphocytes increased	18.40	14.16	9	92614	161	34864147
Obstructive airways disorder	18.40	14.16	9	92614	15485	34848823
Viral infection	18.40	14.16	12	92611	17611	34846697
Irritability	18.39	14.16	23	92600	24667	34839641
Muscle rigidity	18.19	14.16	3	92620	10515	34853793
Pulmonary sarcoidosis	18.13	14.16	14	92609	582	34863726
Seizure	18.06	14.16	184	92439	104673	34759635
Device malfunction	17.96	14.16	3	92620	10418	34853890
Oesophagitis	17.78	14.16	76	92547	13185	34851123
Metastasis	17.73	14.16	36	92587	4108	34860200
Renal disorder	17.72	14.16	122	92501	25358	34838950
Metastases to peritoneum	17.52	14.16	23	92600	1821	34862487
Radiation skin injury	17.40	14.16	15	92608	730	34863578
Hallucination, auditory	17.37	14.16	5	92618	11912	34852396
Hypoalbuminaemia	17.28	14.16	71	92552	12103	34852205
Coronary artery occlusion	17.12	14.16	4	92619	10958	34853350
Cerebrovascular accident	17.12	14.16	143	92480	84668	34779640
Achromotrichia acquired	16.98	14.16	4	92619	4	34864304
Autoimmune anaemia	16.98	14.16	4	92619	4	34864304
Biliary tract infection	16.97	14.16	14	92609	641	34863667
Scleroderma-like reaction	16.90	14.16	6	92617	45	34864263
Metastases to spine	16.90	14.16	27	92596	2557	34861751
Autoimmune myositis	16.83	14.16	8	92615	134	34864174
Myoclonus	16.82	14.16	9	92614	14716	34849592
Respiratory rate increased	16.72	14.16	3	92620	9891	34854417
Troponin increased	16.63	14.16	67	92556	11322	34852986
Oropharyngeal pain	16.63	14.16	44	92579	35441	34828867
Ileus	16.60	14.16	87	92536	16412	34847896
Neoplasm malignant	16.50	14.16	17	92606	19888	34844420
Pain in jaw	16.38	14.16	7	92616	13033	34851275
Blood thyroid stimulating hormone abnormal	16.05	14.16	11	92612	379	34863929
Hepatic steatosis	16.01	14.16	15	92608	18347	34845961
Sarcoidosis	15.98	14.16	28	92595	2860	34861448
Hospitalisation	15.96	14.16	87	92536	56815	34807493
Euthanasia	15.95	14.16	5	92618	24	34864284
Haemodynamic instability	15.85	14.16	3	92620	9520	34854788
Mania	15.82	14.16	3	92620	9508	34854800
Troponin T increased	15.81	14.16	25	92598	2346	34861962
Ventricular extrasystoles	15.81	14.16	6	92617	12002	34852306
Cardio-respiratory arrest	15.78	14.16	84	92539	55189	34809119
Hepatobiliary disease	15.77	14.16	11	92612	390	34863918
Chest tube insertion	15.73	14.16	7	92616	100	34864208
Lethargy	15.70	14.16	56	92567	41066	34823242
Pancreatic atrophy	15.62	14.16	12	92611	495	34863813
Muscle twitching	15.61	14.16	4	92619	10294	34854014
Skin cancer	15.61	14.16	4	92619	10293	34854015
Dysphagia	15.58	14.16	242	92381	62139	34802169
Synovitis	15.49	14.16	9	92614	14057	34850251
Pulmonary oedema	15.44	14.16	69	92554	47460	34816848
Chronic inflammatory demyelinating polyradiculoneuropathy	15.40	14.16	14	92609	731	34863577
Brain oedema	15.39	14.16	75	92548	13746	34850562
Ketosis-prone diabetes mellitus	15.37	14.16	4	92619	8	34864300
Arthropathy	15.34	14.16	30	92593	26877	34837431
Spinal cord compression	15.22	14.16	33	92590	3942	34860366
Rhinorrhoea	15.17	14.16	28	92595	25640	34838668
Serous retinopathy	15.13	14.16	7	92616	110	34864198
Limb injury	15.13	14.16	6	92617	11683	34852625
Squamous cell carcinoma of skin	15.07	14.16	5	92618	10876	34853432
Joint injury	15.03	14.16	3	92620	9170	34855138
Red blood cell sedimentation rate increased	15.01	14.16	3	92620	9159	34855149
Blood urine present	14.97	14.16	5	92618	10829	34853479
Neutrophil count increased	14.96	14.16	14	92609	17132	34847176
Disorientation	14.91	14.16	42	92581	33146	34831162
Blood pressure decreased	14.87	14.16	78	92545	51437	34812871
Dysuria	14.85	14.16	31	92592	27121	34837187
Blood pressure diastolic decreased	14.85	14.16	3	92620	9091	34855217
Renal tubular acidosis	14.85	14.16	24	92599	2295	34862013
Paraneoplastic retinopathy	14.81	14.16	3	92620	0	34864308
Myofascitis	14.81	14.16	3	92620	0	34864308
Laryngeal obstruction	14.81	14.16	3	92620	0	34864308
Glomerulonephritis	14.80	14.16	22	92601	1956	34862352
Opsoclonus myoclonus	14.80	14.16	6	92617	67	34864241
Haemorrhage	14.70	14.16	78	92545	51292	34813016
Rales	14.67	14.16	4	92619	9879	34854429
Abdominal pain upper	14.67	14.16	120	92503	71370	34792938
Diabetic hyperosmolar coma	14.66	14.16	11	92612	438	34863870
Depressed level of consciousness	14.64	14.16	61	92562	42780	34821528
Disease progression	14.62	14.16	200	92423	107877	34756431
Toxic neuropathy	14.59	14.16	12	92611	547	34863761
Hypoaesthesia	14.58	14.16	99	92524	61345	34802963
Atrioventricular block complete	14.55	14.16	56	92567	9263	34855045
Bladder cancer	14.55	14.16	13	92610	16265	34848043
Evans syndrome	14.51	14.16	9	92614	261	34864047
Neuritis	14.50	14.16	15	92608	919	34863389
Tracheal obstruction	14.49	14.16	6	92617	71	34864237
Respiratory depression	14.48	14.16	13	92610	16232	34848076
Thyroxine free increased	14.47	14.16	9	92614	262	34864046
Altered state of consciousness	14.40	14.16	107	92516	22786	34841522
Biliary obstruction	14.40	14.16	26	92597	2719	34861589
Haemodialysis	14.30	14.16	5	92618	10521	34853787
Microvillous inclusion disease	14.25	14.16	8	92615	192	34864116

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	12666.32	13.20	5550	124182	130440	79484216
Immune-mediated enterocolitis	2185.39	13.20	640	129092	4190	79610466
Pneumonitis	1910.05	13.20	1205	128527	59655	79555001
Hypothyroidism	1887.81	13.20	1133	128599	51259	79563397
Colitis	1768.89	13.20	1232	128500	72075	79542581
Hypophysitis	1753.41	13.20	522	129210	3644	79611012
Death	1668.64	13.20	3155	126577	563359	79051297
Adrenal insufficiency	1659.96	13.20	846	128886	27641	79587015
Intentional product use issue	1568.23	13.20	1561	128171	150551	79464105
Fulminant type 1 diabetes mellitus	1490.03	13.20	369	129363	1114	79613542
Myocarditis	1104.37	13.20	589	129143	21144	79593512
Hypopituitarism	1062.24	13.20	339	129393	3060	79611596
Immune-mediated hepatitis	1042.00	13.20	340	129392	3316	79611340
Hyperthyroidism	973.79	13.20	546	129186	21663	79592993
Interstitial lung disease	939.79	13.20	1033	128699	111567	79503089
Type 1 diabetes mellitus	902.66	13.20	361	129371	6558	79608098
Thyroiditis	900.60	13.20	323	129409	4282	79610374
Immune-mediated lung disease	881.91	13.20	268	129464	2022	79612634
Pemphigoid	831.75	13.20	434	129298	14881	79599775
Adrenocorticotropic hormone deficiency	822.51	13.20	227	129505	1158	79613498
Immune-mediated hepatic disorder	786.47	13.20	226	129506	1368	79613288
Myositis	753.81	13.20	439	129293	18729	79595927
Hepatic function abnormal	749.76	13.20	749	128983	72358	79542298
Autoimmune colitis	659.62	13.20	198	129534	1425	79613231
Immune-mediated myocarditis	657.23	13.20	183	129549	970	79613686
Secondary adrenocortical insufficiency	648.65	13.20	227	129505	2787	79611869
Autoimmune hepatitis	645.80	13.20	336	129396	11447	79603209
Myasthenia gravis	548.41	13.20	289	129443	10110	79604546
Enterocolitis	538.09	13.20	320	129412	14192	79600464
Diabetic ketoacidosis	518.69	13.20	436	129296	33686	79580970
Drug ineffective	496.14	13.20	621	129111	1080292	78534364
Immune-mediated dermatitis	460.43	13.20	120	129612	470	79614186
Liver disorder	440.93	13.20	566	129166	71851	79542805
Metastases to central nervous system	426.89	13.20	289	129443	16086	79598570
Prescribed underdose	425.80	13.20	366	129366	29148	79585508
Drug interaction	419.79	13.20	83	129649	415100	79199556
Cholangitis	415.36	13.20	259	129473	12517	79602139
Toxicity to various agents	414.39	13.20	90	129642	421450	79193206
Pyrexia	400.64	13.20	2164	127568	676545	78938111
Hepatitis	370.17	13.20	455	129277	55272	79559384
Cachexia	361.11	13.20	225	129507	10858	79603798
Leukoderma	360.57	13.20	78	129654	96	79614560
Hypothalamo-pituitary disorder	340.05	13.20	111	129621	1083	79613573
Tumour pseudoprogression	333.76	13.20	96	129636	583	79614073
Lymphocytic hypophysitis	331.59	13.20	92	129640	480	79614176
Vitiligo	331.52	13.20	126	129606	1983	79612673
Immune-mediated thyroiditis	325.22	13.20	79	129653	214	79614442
Completed suicide	320.48	13.20	20	129712	245747	79368909
Drug hypersensitivity	314.33	13.20	54	129678	298862	79315794
Immune-mediated hypothyroidism	313.71	13.20	91	129641	572	79614084
Radiation pneumonitis	304.64	13.20	142	129590	3791	79610865
Joint swelling	301.63	13.20	53	129679	288593	79326063
Drug intolerance	295.30	13.20	40	129692	264079	79350577
Decreased appetite	291.23	13.20	1215	128517	341203	79273453
Tubulointerstitial nephritis	289.86	13.20	334	129398	37901	79576755
Encephalitis	284.85	13.20	217	129515	14543	79600113
Pleural effusion	284.31	13.20	688	129044	144574	79470082
Immune-mediated hypophysitis	270.68	13.20	62	129670	117	79614539
Immune-mediated nephritis	263.97	13.20	77	129655	495	79614161
Product dose omission issue	255.24	13.20	47	129685	247490	79367166
Cholangitis sclerosing	254.44	13.20	111	129621	2526	79612130
Autoimmune thyroiditis	250.10	13.20	127	129605	4106	79610550
Diarrhoea	240.11	13.20	2332	127400	878157	78736499
Therapeutic product effect decreased	238.08	13.20	6	129726	163857	79450799
Uveitis	233.20	13.20	204	129528	16626	79598030
Pain	233.16	13.20	499	129233	703303	78911353
Overdose	228.57	13.20	19	129713	184187	79430469
Immune-mediated adrenal insuficiency	228.09	13.20	56	129676	161	79614495
Immune-mediated encephalitis	227.42	13.20	67	129665	448	79614208
Immune-mediated uveitis	222.82	13.20	48	129684	57	79614599
General physical health deterioration	213.32	13.20	950	128782	274288	79340368
Peripheral swelling	211.36	13.20	87	129645	269530	79345126
Abdominal discomfort	199.63	13.20	79	129653	250648	79364008
Swelling	199.47	13.20	53	129679	216658	79397998
Injection site pain	195.63	13.20	3	129729	129835	79484821
Lichen planus	195.42	13.20	94	129638	2697	79611959
Dizziness	191.55	13.20	353	129379	526088	79088568
Sinusitis	185.34	13.20	45	129687	195456	79419200
Immune-mediated myositis	184.62	13.20	97	129635	3370	79611286
Nasopharyngitis	183.27	13.20	92	129640	253789	79360867
Synovitis	183.05	13.20	17	129715	150717	79463939
Autoimmune nephritis	179.74	13.20	61	129671	678	79613978
Relapsing fever	178.93	13.20	53	129679	362	79614294
Condition aggravated	178.78	13.20	340	129392	500784	79113872
Lichenoid keratosis	175.73	13.20	99	129633	3958	79610698
Adrenal disorder	173.88	13.20	80	129652	2071	79612585
Tumour haemorrhage	173.77	13.20	99	129633	4045	79610611
Arthropathy	171.38	13.20	39	129693	177072	79437584
Thyroid disorder	168.19	13.20	157	129575	13922	79600734
Erythema multiforme	166.48	13.20	173	129559	17478	79597178
Pain in extremity	161.47	13.20	214	129518	364324	79250332
Autoimmune haemolytic anaemia	161.24	13.20	123	129609	8257	79606399
Hypercalcaemia	159.15	13.20	250	129482	38180	79576476
Meningitis aseptic	158.80	13.20	113	129619	6815	79607841
Non-small cell lung cancer	155.69	13.20	108	129624	6252	79608404
Immune-mediated cholangitis	155.45	13.20	41	129691	170	79614486
Hyperglycaemia	151.49	13.20	346	129386	69989	79544667
Musculoskeletal stiffness	151.48	13.20	48	129684	174960	79439696
Weight increased	151.33	13.20	137	129595	277249	79337407
Glossodynia	149.26	13.20	4	129728	103333	79511323
Blood pressure increased	147.47	13.20	80	129652	211280	79403376
Enteritis	146.73	13.20	148	129584	14435	79600221
Autoimmune pancreatitis	146.23	13.20	51	129681	619	79614037
Prescribed overdose	145.32	13.20	238	129494	37645	79577011
Feeling abnormal	144.46	13.20	40	129692	159159	79455497
Nephritis	143.48	13.20	88	129644	4126	79610530
Immune thrombocytopenia	142.48	13.20	160	129572	17645	79597011
Lipase increased	142.20	13.20	154	129578	16312	79598344
Exposure during pregnancy	142.16	13.20	5	129727	101127	79513529
Alopecia	141.50	13.20	102	129630	231253	79383403
Headache	140.88	13.20	567	129165	653205	78961451
Pericardial effusion	140.31	13.20	262	129470	45975	79568681
Vogt-Koyanagi-Harada disease	139.53	13.20	39	129693	210	79614446
Blood corticotrophin decreased	138.93	13.20	47	129685	517	79614139
Maternal exposure during pregnancy	136.28	13.20	28	129704	136510	79478146
Haemophagocytic lymphohistiocytosis	134.88	13.20	172	129560	21665	79592991
Cytokine release syndrome	133.83	13.20	223	129509	35775	79578881
Therapeutic product effect incomplete	133.45	13.20	33	129699	141612	79473044
Pulmonary toxicity	131.65	13.20	132	129600	12782	79601874
Myasthenic syndrome	131.25	13.20	50	129682	792	79613864
Rash maculo-papular	131.02	13.20	285	129447	55793	79558863
Treatment failure	128.78	13.20	58	129674	170428	79444228
Immune-mediated pancreatitis	128.11	13.20	38	129694	261	79614395
Lung disorder	127.03	13.20	352	129380	80205	79534451
Systemic lupus erythematosus	126.97	13.20	22	129710	121127	79493529
Intentional product misuse	126.23	13.20	7	129725	95158	79519498
Intentional overdose	125.88	13.20	13	129719	105947	79508709
Wound	124.20	13.20	20	129712	116159	79498497
Mobility decreased	124.14	13.20	24	129708	122151	79492505
Immune-mediated arthritis	121.50	13.20	34	129698	184	79614472
Serous retinal detachment	121.29	13.20	50	129682	984	79613672
Polyarthritis	121.24	13.20	123	129609	12079	79602577
Disseminated intravascular coagulation	118.77	13.20	211	129521	35631	79579025
Encephalitis autoimmune	115.98	13.20	62	129670	2232	79612424
Autoimmune myocarditis	115.48	13.20	38	129694	381	79614275
Hyponatraemia	115.12	13.20	583	129149	177265	79437391
Sepsis	114.77	13.20	791	128941	268637	79346019
Immune-mediated adverse reaction	114.35	13.20	46	129686	848	79613808
Eosinophilic fasciitis	112.50	13.20	34	129698	251	79614405
Fall	111.93	13.20	412	129320	487217	79127439
Loss of personal independence in daily activities	108.88	13.20	18	129714	102562	79512094
Discomfort	107.71	13.20	35	129697	125582	79489074
Respiratory failure	107.41	13.20	579	129153	180332	79434324
Adrenocortical insufficiency acute	107.33	13.20	65	129667	2978	79611678
Immune-mediated hyperthyroidism	106.72	13.20	29	129703	138	79614518
Hypersensitivity	106.10	13.20	164	129568	262075	79352581
Contusion	104.20	13.20	56	129676	148720	79465936
Aspartate aminotransferase increased	103.81	13.20	474	129258	138167	79476489
Dermatitis	102.92	13.20	149	129583	21172	79593484
Anxiety	102.87	13.20	153	129579	248359	79366297
Cortisol decreased	102.28	13.20	56	129676	2116	79612540
Blood thyroid stimulating hormone increased	102.23	13.20	101	129631	9607	79605049
Stress	102.15	13.20	7	129725	79605	79535051
Palmar-plantar erythrodysaesthesia syndrome	102.08	13.20	189	129543	32945	79581711
Suicide attempt	101.61	13.20	9	129723	82923	79531733
Acute kidney injury	101.10	13.20	1289	128443	518115	79096541
Tumour pain	99.30	13.20	56	129676	2243	79612413
Injury	98.89	13.20	7	129725	77489	79537167
Pneumothorax	98.07	13.20	170	129562	28153	79586503
Asthma	97.35	13.20	49	129683	135046	79479610
Immune-mediated encephalopathy	97.29	13.20	20	129712	15	79614641
Silent thyroiditis	97.21	13.20	28	129704	171	79614485
Helicobacter infection	96.07	13.20	4	129728	69700	79544956
Diabetes mellitus	95.69	13.20	313	129419	78077	79536579
Haemoglobin decreased	95.62	13.20	133	129599	221986	79392670
Blood pressure fluctuation	95.49	13.20	3	129729	67142	79547514
Immune-mediated gastritis	94.41	13.20	24	129708	83	79614573
Duodenal ulcer perforation	94.02	13.20	3	129729	66208	79548448
Migraine	93.65	13.20	15	129717	87478	79527178
Skin disorder	92.75	13.20	184	129548	33759	79580897
Pemphigus	92.25	13.20	24	129708	99558	79515098
Pneumonia bacterial	91.72	13.20	134	129598	19197	79595459
Product use issue	90.96	13.20	125	129607	209697	79404959
Embolism	90.91	13.20	113	129619	13869	79600787
Pneumonia	90.53	13.20	1542	128190	658704	78955952
Heart rate increased	89.71	13.20	42	129690	120682	79493974
Wheezing	89.17	13.20	39	129693	116625	79498031
Meningitis	88.72	13.20	93	129639	9489	79605167
General physical condition abnormal	87.81	13.20	78	129654	6485	79608171
Muscle spasms	85.28	13.20	95	129637	174635	79440021
Amylase increased	85.06	13.20	98	129634	11111	79603545
Immune-mediated renal disorder	84.75	13.20	25	129707	168	79614488
Irritable bowel syndrome	84.37	13.20	4	129728	62237	79552419
Drug-induced liver injury	84.32	13.20	268	129464	65849	79548807
Depression	82.59	13.20	141	129591	216649	79398007
Autoimmune arthritis	82.11	13.20	23	129709	125	79614531
Organising pneumonia	81.93	13.20	95	129637	10844	79603812
Palpitations	81.12	13.20	53	129679	126557	79488099
Osteoarthritis	80.95	13.20	21	129711	87288	79527368
Insomnia	80.71	13.20	174	129558	244996	79369660
Incorrect dose administered	80.10	13.20	14	129718	76616	79538040
Medication error	80.05	13.20	9	129723	68633	79546023
Suicidal ideation	79.68	13.20	14	129718	76326	79538330
Autoimmune dermatitis	79.64	13.20	23	129709	142	79614514
Ill-defined disorder	78.45	13.20	8	129724	65867	79548789
Wrong technique in product usage process	78.32	13.20	13	129719	73862	79540794
Hepatic failure	77.95	13.20	248	129484	60964	79553692
Cholestasis	77.53	13.20	223	129509	51886	79562770
Metastases to meninges	76.29	13.20	56	129676	3545	79611111
Dermatomyositis	75.98	13.20	56	129676	3567	79611089
Lymphangiosis carcinomatosa	75.95	13.20	46	129686	2108	79612548
Hyperhidrosis	75.43	13.20	81	129651	151411	79463245
Heart rate decreased	75.38	13.20	12	129720	70304	79544352
Cardiac tamponade	75.32	13.20	84	129648	9192	79605464
Agitation	75.16	13.20	34	129698	99681	79514975
Coma	74.80	13.20	35	129697	100614	79514042
Blood thyroid stimulating hormone decreased	74.62	13.20	67	129665	5649	79609007
Adverse drug reaction	74.25	13.20	10	129722	66382	79548274
Guillain-Barre syndrome	74.20	13.20	82	129650	8883	79605773
Sialoadenitis	73.83	13.20	44	129688	1957	79612699
Metastases to bone	73.58	13.20	138	129594	24289	79590367
Immune-mediated endocrinopathy	73.57	13.20	17	129715	34	79614622
Eyelid ptosis	73.00	13.20	90	129642	10954	79603702
Primary hypothyroidism	72.72	13.20	22	129710	163	79614493
Electrocardiogram QT prolonged	72.66	13.20	28	129704	90358	79524298
Tri-iodothyronine free decreased	71.84	13.20	26	129706	354	79614302
Nasal congestion	71.77	13.20	18	129714	76534	79538122
Immune-mediated cystitis	71.37	13.20	16	129716	26	79614630
Unevaluable event	70.98	13.20	5	129727	55580	79559076
Pneumonia aspiration	70.88	13.20	255	129477	66712	79547944
Endocrine disorder	70.24	13.20	32	129700	809	79613847
Metastases to lung	69.50	13.20	114	129618	18049	79596607
Cardiac failure congestive	68.85	13.20	78	129654	142324	79472332
Skin toxicity	68.73	13.20	76	129656	8238	79606418
Urticaria	68.22	13.20	123	129609	185078	79429578
Alanine aminotransferase increased	67.79	13.20	475	129257	162095	79452561
Autoimmune hypothyroidism	67.74	13.20	23	129709	256	79614400
Blood glucose increased	67.28	13.20	53	129679	114922	79499734
Paraesthesia	65.94	13.20	116	129616	176207	79438449
C-reactive protein abnormal	65.91	13.20	3	129729	48364	79566292
Immune-mediated neuropathy	65.43	13.20	16	129716	45	79614611
International normalised ratio increased	65.25	13.20	28	129704	84693	79529963
Pancreatitis	62.55	13.20	249	129483	68326	79546330
Tumour associated fever	62.16	13.20	30	129702	867	79613789
Red blood cell sedimentation rate increased	62.11	13.20	3	129729	45939	79568717
Primary adrenal insufficiency	61.09	13.20	20	129712	197	79614459
Abdominal pain upper	61.04	13.20	175	129557	223644	79391012
Anaemia	60.71	13.20	1039	128693	443976	79170680
Dermatitis psoriasiform	60.44	13.20	44	129688	2750	79611906
Multiple sclerosis relapse	59.96	13.20	4	129728	46529	79568127
Rash	59.41	13.20	1293	128439	577065	79037591
Duodenitis	59.35	13.20	69	129663	7898	79606758
Autoimmune neuropathy	59.13	13.20	17	129715	103	79614553
Polymyalgia rheumatica	58.87	13.20	53	129679	4484	79610172
Blood corticotrophin increased	58.79	13.20	19	129713	179	79614477
Impaired healing	58.48	13.20	35	129697	87620	79527036
Bradycardia	58.48	13.20	81	129651	135476	79479180
Lower respiratory tract infection	57.99	13.20	75	129657	129145	79485511
Cancer pain	57.90	13.20	56	129676	5189	79609467
Drug eruption	57.77	13.20	180	129552	43755	79570901
Thrombophlebitis migrans	57.17	13.20	23	129709	424	79614232
Loss of consciousness	57.09	13.20	117	129615	167826	79446830
Limbic encephalitis	56.84	13.20	28	129704	847	79613809
Aggression	56.22	13.20	8	129724	50950	79563706
Arthralgia	55.85	13.20	628	129104	571175	79043481
Pancreatic enzymes increased	55.60	13.20	32	129700	1333	79613323
Cholecystitis	55.45	13.20	116	129616	22096	79592560
Polymyositis	55.00	13.20	43	129689	2993	79611663
Ascites	54.79	13.20	256	129476	75306	79539350
Adrenalitis	54.70	13.20	13	129719	31	79614625
Unresponsive to stimuli	54.50	13.20	12	129720	55776	79558880
Haematocrit decreased	54.49	13.20	16	129716	61296	79553360
Drug-device incompatibility	54.23	13.20	10	129722	0	79614656
Balance disorder	53.64	13.20	49	129683	98808	79515848
Hypoaesthesia	53.60	13.20	134	129598	179218	79435438
Iridocyclitis	53.53	13.20	46	129686	3658	79610998
Rheumatic disorder	53.50	13.20	43	129689	3115	79611541
Blood pressure systolic increased	53.43	13.20	21	129711	66965	79547691
Memory impairment	53.14	13.20	62	129670	111672	79502984
Pancreatic failure	52.90	13.20	33	129699	1595	79613061
Cytomegalovirus enterocolitis	52.40	13.20	33	129699	1622	79613034
Nephrotic syndrome	52.35	13.20	77	129655	11097	79603559
Fluid retention	52.30	13.20	24	129708	69785	79544871
Oesophagitis	51.73	13.20	119	129613	24170	79590486
Drug dependence	51.11	13.20	4	129728	40765	79573891
Taste disorder	50.94	13.20	92	129640	15731	79598925
Gastrooesophageal reflux disease	50.49	13.20	57	129675	104189	79510467
Tremor	50.11	13.20	128	129604	169955	79444701
Folliculitis	50.05	13.20	14	129718	55366	79559290
Dehydration	49.86	13.20	620	129112	247567	79367089
Influenza	49.60	13.20	84	129648	129522	79485134
Respiratory arrest	49.38	13.20	16	129716	57534	79557122
Gait disturbance	49.03	13.20	173	129559	207333	79407323
Glucocorticoid deficiency	48.62	13.20	23	129709	635	79614021
Large intestine perforation	48.56	13.20	86	129646	14481	79600175
Angioedema	48.46	13.20	32	129700	76003	79538653
Somnolence	48.34	13.20	212	129520	238769	79375887
Hypertension	48.05	13.20	328	129404	330664	79283992
Blister	48.00	13.20	75	129657	119401	79495255
Metastases to lymph nodes	47.78	13.20	71	129661	10326	79604330
Red blood cell count decreased	47.60	13.20	17	129715	57496	79557160
Transaminases increased	47.28	13.20	188	129544	51555	79563101
Hypoalbuminaemia	47.20	13.20	106	129626	21191	79593465
Nephrolithiasis	47.19	13.20	14	129718	53277	79561379
Gastrointestinal perforation	47.14	13.20	54	129678	6083	79608573
Chest discomfort	47.05	13.20	96	129636	137948	79476708
Metastases to liver	46.88	13.20	126	129606	28188	79586468
Haemoptysis	46.85	13.20	198	129534	55801	79558855
Facial paralysis	46.83	13.20	105	129627	20967	79593689
Drug level increased	46.73	13.20	5	129727	39646	79575010
Intracranial tumour haemorrhage	46.72	13.20	21	129711	514	79614142
Localised infection	46.24	13.20	4	129728	37571	79577085
Hallucination	45.93	13.20	43	129689	85702	79528954
Sleep disorder	45.85	13.20	43	129689	85634	79529022
Stevens-Johnson syndrome	45.65	13.20	154	129578	39012	79575644
Metastasis	45.37	13.20	56	129676	6824	79607832
Pulmonary embolism	45.03	13.20	452	129280	171202	79443454
Oropharyngeal pain	44.55	13.20	68	129664	109285	79505371
Encephalopathy	44.30	13.20	222	129510	67175	79547481
Treatment noncompliance	44.03	13.20	15	129717	52253	79562403
Acquired tracheo-oesophageal fistula	43.99	13.20	14	129718	125	79614531
Demyelinating polyneuropathy	43.87	13.20	30	129702	1696	79612960
Amnesia	43.75	13.20	24	129708	63033	79551623
Morphoea	43.64	13.20	19	129713	430	79614226
Thyroid function test abnormal	43.43	13.20	38	129694	3096	79611560
Gastrointestinal disorder	43.36	13.20	83	129649	122122	79492534
Cardiac failure	43.19	13.20	413	129319	154429	79460227
Product prescribing error	43.05	13.20	10	129722	44803	79569853
Pain in jaw	42.97	13.20	11	129721	46140	79568516
Off label use	42.81	13.20	1843	127889	905372	78709284
Renal disorder	42.58	13.20	158	129574	41947	79572709
Rhinorrhoea	42.12	13.20	37	129695	76037	79538619
Hypervolaemia	42.07	13.20	9	129723	42681	79571975
Sopor	42.06	13.20	3	129729	33007	79581649
Drug withdrawal syndrome	41.90	13.20	4	129728	34714	79579942
Pneumocystis jirovecii pneumonia	41.65	13.20	132	129600	32376	79582280
Heart rate irregular	41.55	13.20	3	129729	32676	79581980
Ear infection	41.47	13.20	4	129728	34428	79580228
Radiation skin injury	41.45	13.20	27	129705	1407	79613249
Confusional state	41.40	13.20	325	129407	317672	79296984
Exposure via body fluid	41.12	13.20	17	129715	337	79614319
Dyskinesia	41.06	13.20	11	129721	44762	79569894
Product quality issue	40.73	13.20	4	129728	33936	79580720
Immune-mediated cytopenia	40.37	13.20	11	129721	53	79614603
Pancreatic toxicity	40.03	13.20	11	129721	55	79614601
Obesity	39.97	13.20	5	129727	35120	79579536
Nervousness	39.93	13.20	4	129728	33411	79581245
Osteoporosis	39.92	13.20	19	129713	54093	79560563
Ileus	39.79	13.20	113	129619	26098	79588558
Superior vena cava syndrome	39.78	13.20	25	129707	1224	79613432
Joint range of motion decreased	39.73	13.20	4	129728	33278	79581378
Rheumatoid arthritis	39.73	13.20	189	129543	208281	79406375
Bile duct stenosis	39.69	13.20	30	129702	1986	79612670
Incorrect route of product administration	39.68	13.20	5	129727	34924	79579732
Road traffic accident	39.53	13.20	11	129721	43653	79571003
Physical deconditioning	38.98	13.20	30	129702	2040	79612616
Upper respiratory tract infection	38.79	13.20	55	129677	91113	79523543
Brain oedema	38.43	13.20	109	129623	25154	79589502
Autoimmune lung disease	38.40	13.20	10	129722	39	79614617
Metastatic malignant melanoma	38.25	13.20	34	129698	2829	79611827
Oxygen saturation decreased	38.09	13.20	97	129635	128950	79485706
Autoimmune thyroid disorder	37.81	13.20	10	129722	42	79614614
Enterocolitis haemorrhagic	37.44	13.20	30	129702	2164	79612492
Troponin increased	37.39	13.20	91	129641	19164	79595492
Pituitary enlargement	36.90	13.20	11	129721	77	79614579
Epistaxis	36.78	13.20	79	129653	111436	79503220
Pleurodesis	36.73	13.20	10	129722	48	79614608
Febrile neutropenia	36.55	13.20	553	129179	230446	79384210
Glomerulonephritis membranous	36.21	13.20	26	129706	1590	79613066
Aspiration pleural cavity	36.20	13.20	26	129706	1591	79613065
Spinal cord compression	35.91	13.20	48	129684	6329	79608327
Accidental overdose	35.78	13.20	10	129722	39571	79575085
Pericarditis malignant	35.75	13.20	10	129722	54	79614602
Burning sensation	35.61	13.20	26	129706	58606	79556050
Blood corticotrophin abnormal	35.60	13.20	10	129722	55	79614601
Swelling face	35.52	13.20	38	129694	71174	79543482
Thyroxine free abnormal	35.43	13.20	9	129723	31	79614625
Sleep apnoea syndrome	35.32	13.20	8	129724	36470	79578186
Orthostatic hypotension	35.30	13.20	24	129708	56140	79558516
Abnormal behaviour	35.24	13.20	8	129724	36413	79578243
Psychotic disorder	34.67	13.20	12	129720	41390	79573266
Cardiac arrest	34.59	13.20	153	129579	171943	79442713
Intestinal perforation	34.52	13.20	83	129649	17343	79597313
Prerenal failure	34.43	13.20	36	129696	3662	79610994
Joint injury	34.38	13.20	5	129727	31330	79583326
Pulmonary sepsis	34.31	13.20	36	129696	3676	79610980
Sudden death	34.12	13.20	97	129635	22414	79592242
Troponin T increased	34.07	13.20	35	129697	3487	79611169
Joint stiffness	33.90	13.20	12	129720	40818	79573838
Myocardial infarction	33.88	13.20	169	129563	183960	79430696
Hepatobiliary disease	33.64	13.20	19	129713	763	79613893
Gastritis	33.62	13.20	161	129571	47832	79566824
Lactic acidosis	33.49	13.20	39	129693	70320	79544336
Malignant pleural effusion	33.44	13.20	34	129698	3346	79611310
Autoimmune myositis	33.34	13.20	14	129718	289	79614367
Glomerulonephritis	33.00	13.20	34	129698	3399	79611257
Blood pressure diastolic decreased	32.74	13.20	5	129727	30211	79584445
Dysphagia	32.69	13.20	323	129409	121813	79492843
Capillary leak syndrome	32.65	13.20	36	129696	3889	79610767
Blood alkaline phosphatase increased	32.62	13.20	196	129536	63468	79551188
Metastases to pleura	32.54	13.20	24	129708	1530	79613126
Biliary obstruction	32.37	13.20	39	129693	4635	79610021
Blood creatine phosphokinase increased	32.31	13.20	201	129531	65889	79548767
Dyspepsia	31.84	13.20	82	129650	108605	79506051
Blood potassium decreased	31.83	13.20	18	129714	46494	79568162
Full blood count abnormal	31.77	13.20	13	129719	40461	79574195
Blood glucose decreased	31.72	13.20	3	129729	26231	79588425
Coronary artery disease	31.48	13.20	36	129696	65438	79549218
Optic neuritis	31.47	13.20	56	129676	9464	79605192
Keratoacanthoma	31.00	13.20	20	129712	1025	79613631
Bursitis	30.69	13.20	10	129722	35834	79578822
Pallor	30.66	13.20	22	129710	50040	79564616
Autoimmune encephalopathy	30.59	13.20	10	129722	98	79614558
Bronchial fistula	30.51	13.20	12	129720	208	79614448
Neutrophil count decreased	30.48	13.20	259	129473	93700	79520956
Troponin I increased	30.33	13.20	38	129694	4700	79609956
Chronic gastritis	29.92	13.20	35	129697	4033	79610623
Gait inability	29.87	13.20	31	129701	58886	79555770
Psoriatic arthropathy	29.43	13.20	51	129681	77948	79536708
Gastric disorder	29.42	13.20	12	129720	37421	79577235
Pancreatic atrophy	29.26	13.20	16	129716	603	79614053
Lip swelling	29.22	13.20	15	129717	40896	79573760
Cortisol abnormal	29.15	13.20	9	129723	72	79614584
Therapy non-responder	29.12	13.20	67	129665	92238	79522418
Peripheral sensory neuropathy	29.03	13.20	65	129667	12968	79601688
Infectious pleural effusion	28.85	13.20	33	129699	3711	79610945
Blood calcium decreased	28.83	13.20	8	129724	31811	79582845
Therapeutic response decreased	28.77	13.20	40	129692	66813	79547843
Infection	28.73	13.20	253	129479	241459	79373197
Foot deformity	28.46	13.20	3	129729	24071	79590585
Chest pain	28.30	13.20	308	129424	281996	79332660
Dermatitis acneiform	28.30	13.20	55	129677	9938	79604718
Radiation necrosis	28.19	13.20	14	129718	431	79614225
Therapy interrupted	28.18	13.20	8	129724	31333	79583323
Hypokalaemia	28.11	13.20	358	129374	143682	79470974
Adverse event	28.11	13.20	181	129551	60033	79554623
Abdominal distension	28.08	13.20	100	129632	119550	79495106
Type 3 diabetes mellitus	28.04	13.20	8	129724	47	79614609
Inappropriate schedule of product administration	27.95	13.20	117	129615	133511	79481145
Full blood count decreased	27.81	13.20	5	129727	26814	79587842
IgA nephropathy	27.70	13.20	23	129709	1745	79612911
Tumour embolism	27.69	13.20	11	129721	196	79614460
Transfusion	27.68	13.20	87	129645	21243	79593413
Cerebral infarction	27.61	13.20	147	129585	45529	79569127
Malnutrition	27.58	13.20	90	129642	22412	79592244
Autoimmune disorder	27.57	13.20	74	129658	16538	79598118
Blood thyroid stimulating hormone abnormal	27.57	13.20	18	129714	942	79613714
Hepatotoxicity	27.54	13.20	160	129572	51192	79563464
Myasthenia gravis crisis	27.51	13.20	19	129713	1092	79613564
Myelitis	27.29	13.20	26	129706	2365	79612291
Thoracic cavity drainage	27.19	13.20	12	129720	281	79614375
Autoimmune retinopathy	27.05	13.20	6	129726	9	79614647
Arthritis	27.05	13.20	296	129436	114584	79500072
Swollen tongue	27.01	13.20	18	129714	42552	79572104
Tachycardia	26.85	13.20	174	129558	177594	79437062
Blood urea increased	26.68	13.20	24	129708	48766	79565890
Hepatocellular injury	26.64	13.20	150	129582	47443	79567213
Hallucination, visual	26.53	13.20	10	129722	32719	79581937
Peripheral motor neuropathy	26.50	13.20	30	129702	3337	79611319
Feeling hot	26.45	13.20	35	129697	59699	79554957
Extrapyramidal disorder	26.37	13.20	3	129729	22676	79591980
Metastases to peritoneum	26.31	13.20	34	129698	4338	79610318
Breast cancer	26.27	13.20	11	129721	33770	79580886
Panic attack	26.25	13.20	4	129728	24212	79590444
Pulmonary sarcoidosis	26.03	13.20	20	129712	1357	79613299
Hepatic cytolysis	25.89	13.20	100	129632	27051	79587605
Biliary tract infection	25.88	13.20	20	129712	1368	79613288
Meningoradiculitis	25.76	13.20	10	129722	167	79614489
Atrioventricular block complete	25.59	13.20	72	129660	16538	79598118
Inappropriate antidiuretic hormone secretion	25.17	13.20	97	129635	26216	79588440
Altered state of consciousness	25.12	13.20	139	129593	43683	79570973
Metastases to spine	25.05	13.20	33	129699	4291	79610365
Achromotrichia acquired	25.04	13.20	6	129726	15	79614641
Thyrotoxic crisis	25.04	13.20	19	129713	1265	79613391
Immunodeficiency	25.01	13.20	3	129729	21765	79592891
Hyperlipidaemia	24.72	13.20	6	129726	26087	79588569
Skin hypopigmentation	24.60	13.20	17	129715	978	79613678
Crying	24.54	13.20	4	129728	23039	79591617
Renal failure	24.42	13.20	461	129271	200507	79414149
Acute respiratory failure	24.22	13.20	173	129559	59368	79555288
Cholangitis acute	24.14	13.20	20	129712	1512	79613144
Chronic inflammatory demyelinating polyradiculoneuropathy	24.14	13.20	18	129714	1167	79613489
Acute polyneuropathy	24.09	13.20	13	129719	477	79614179
Prostate cancer	24.05	13.20	12	129720	33256	79581400
Limb injury	23.97	13.20	9	129723	29519	79585137
Polyneuropathy	23.90	13.20	90	129642	24061	79590595
Septic shock	23.87	13.20	305	129427	122496	79492160
Cryptitis	23.83	13.20	11	129721	287	79614369
Nausea	23.70	13.20	1295	128437	955901	78658755
Diabetic ketoacidotic hyperglycaemic coma	23.27	13.20	10	129722	219	79614437
Obstructive airways disorder	23.27	13.20	11	129721	31448	79583208
Pleurocutaneous fistula	23.12	13.20	7	129725	52	79614604
Hepatitis fulminant	23.09	13.20	42	129690	7220	79607436
Failure to thrive	23.02	13.20	56	129676	11788	79602868
Hypoxia	22.93	13.20	263	129469	102980	79511676
Performance status decreased	22.89	13.20	38	129694	6075	79608581
Chondritis	22.88	13.20	9	129723	156	79614500
Grip strength decreased	22.84	13.20	4	129728	21865	79592791
Device dislocation	22.67	13.20	7	129725	25963	79588693
Lower limb fracture	22.66	13.20	5	129727	23210	79591446
Hepatic enzyme increased	22.65	13.20	189	129543	182421	79432235
Hepatitis acute	22.62	13.20	66	129666	15476	79599180
Haemolytic anaemia	22.50	13.20	72	129660	17748	79596908
Respiratory rate increased	22.45	13.20	4	129728	21596	79593060
Generalised tonic-clonic seizure	22.38	13.20	23	129709	43887	79570769
Abortion spontaneous	22.32	13.20	10	129722	29497	79585159
Gamma-glutamyltransferase increased	22.32	13.20	159	129573	54521	79560135
Muscle spasticity	22.27	13.20	4	129728	21471	79593185
Acute motor axonal neuropathy	22.23	13.20	8	129724	107	79614549
Intestinal intraepithelial lymphocytes increased	22.12	13.20	9	129723	171	79614485
Toxic skin eruption	21.99	13.20	83	129649	22210	79592446
Endocrine toxicity	21.98	13.20	5	129727	9	79614647
Orbital myositis	21.98	13.20	9	129723	174	79614482
Glomerular filtration rate decreased	21.94	13.20	5	129727	22697	79591959
Myelitis transverse	21.89	13.20	21	129711	1926	79612730
Lethargy	21.82	13.20	64	129668	81228	79533428
Optic perineuritis	21.69	13.20	4	129728	0	79614656
Skin laceration	21.62	13.20	10	129722	28952	79585704
Renal tubular acidosis	21.58	13.20	28	129704	3586	79611070
White blood cell count decreased	21.53	13.20	199	129533	188089	79426567
Paraneoplastic syndrome	21.50	13.20	16	129716	1034	79613622
Viral infection	21.40	13.20	23	129709	42993	79571663
Torsade de pointes	21.38	13.20	3	129729	19309	79595347
Hallucination, auditory	21.15	13.20	4	129728	20689	79593967
Pregnancy on contraceptive	21.14	13.20	15	129717	900	79613756
Eye irritation	21.13	13.20	4	129728	20677	79593979
Intestinal metastasis	21.12	13.20	11	129721	375	79614281
Sterile pyuria	21.11	13.20	7	129725	72	79614584
Cerebral microangiopathy	21.11	13.20	10	129722	277	79614379
Mechanical ileus	21.08	13.20	15	129717	904	79613752
Muscle twitching	21.04	13.20	7	129725	24757	79589899
Tumour hyperprogression	20.95	13.20	9	129723	197	79614459
Foot fracture	20.93	13.20	5	129727	21976	79592680
Aplasia pure red cell	20.93	13.20	42	129690	7768	79606888
Pulmonary arterial hypertension	20.86	13.20	10	129722	28356	79586300
Hypersensitivity pneumonitis	20.83	13.20	28	129704	3711	79610945
Myofascitis	20.73	13.20	5	129727	13	79614643
Steroid diabetes	20.68	13.20	27	129705	3479	79611177
Non-cardiac chest pain	20.65	13.20	47	129685	9477	79605179
Tracheal stenosis	20.63	13.20	11	129721	394	79614262
Gastroenteritis eosinophilic	20.53	13.20	10	129722	295	79614361
Small intestinal perforation	20.41	13.20	26	129706	3271	79611385
Tumour lysis syndrome	20.30	13.20	85	129647	23854	79590802
Throat irritation	20.25	13.20	22	129710	40924	79573732
Cortisol increased	20.15	13.20	12	129720	533	79614123
Autoimmune uveitis	19.96	13.20	5	129727	16	79614640
Flushing	19.90	13.20	75	129657	88193	79526463
Depressed mood	19.88	13.20	30	129702	48450	79566206
Gastrointestinal toxicity	19.83	13.20	42	129690	8067	79606589
Hypophonesis	19.73	13.20	5	129727	17	79614639
Blood triglycerides increased	19.61	13.20	5	129727	21035	79593621
Transient acantholytic dermatosis	19.57	13.20	8	129724	154	79614502
Catabolic state	19.50	13.20	7	129725	93	79614563
Pericardial drainage	19.47	13.20	11	129721	442	79614214
Oesophageal prosthesis insertion	19.46	13.20	4	129728	3	79614653
Autoimmune blistering disease	19.46	13.20	4	129728	3	79614653
Gastroenteritis viral	19.45	13.20	8	129724	24823	79589833
Kidney transplant rejection	19.44	13.20	48	129684	10198	79604458
Depressed level of consciousness	19.36	13.20	86	129646	96566	79518090
Paranoia	19.35	13.20	4	129728	19428	79595228
Tumour thrombosis	19.29	13.20	8	129724	160	79614496
White blood cell count increased	19.14	13.20	60	129672	74573	79540083
Oesophageal fistula	19.12	13.20	11	129721	458	79614198
Autoimmune cholangitis	19.10	13.20	5	129727	20	79614636
Thyroxine free decreased	19.09	13.20	15	129717	1052	79613604
Cutaneous sarcoidosis	19.03	13.20	11	129721	462	79614194
Flatulence	18.95	13.20	25	129707	42699	79571957
Autoimmune anaemia	18.93	13.20	4	129728	4	79614652
Appetite disorder	18.83	13.20	40	129692	7699	79606957
Subacute cutaneous lupus erythematosus	18.83	13.20	26	129706	3535	79611121
Therapy cessation	18.78	13.20	20	129712	37542	79577114
Lymphadenopathy mediastinal	18.75	13.20	29	129703	4367	79610289
Hypertransaminasaemia	18.68	13.20	52	129680	11872	79602784
Chylothorax	18.59	13.20	13	129719	762	79613894
Melanoma recurrent	18.56	13.20	9	129723	263	79614393
Haemodynamic instability	18.55	13.20	3	129729	17379	79597277
Diabetic ketosis	18.46	13.20	11	129721	489	79614167
Lymphadenopathy	18.45	13.20	149	129583	53098	79561558
Pericarditis	18.41	13.20	97	129635	104139	79510517
Pulmonary tuberculosis	18.39	13.20	40	129692	7825	79606831
Enterocolitis infectious	18.35	13.20	23	129709	2846	79611810
Rales	18.18	13.20	5	129727	19996	79594660
Metastases to adrenals	18.18	13.20	16	129716	1314	79613342
Metastases to skin	18.14	13.20	18	129714	1721	79612935
Blood urine present	18.13	13.20	6	129726	21291	79593365
Blood bilirubin increased	18.13	13.20	176	129556	66056	79548600
Cardio-respiratory arrest	18.06	13.20	103	129629	108407	79506249
Thrombocytopenia	18.06	13.20	562	129170	264697	79349959
Haematoma	18.03	13.20	36	129696	52159	79562497
Muscle rigidity	18.01	13.20	5	129727	19877	79594779
Sarcoidosis	17.93	13.20	41	129691	8294	79606362
Pulmonary hypertension	17.63	13.20	32	129700	48048	79566608
Paraparesis	17.52	13.20	26	129706	3777	79610879
Basal cell carcinoma	17.48	13.20	21	129711	37354	79577302
Tracheal obstruction	17.39	13.20	8	129724	207	79614449
Immune-mediated oesophagitis	17.31	13.20	4	129728	8	79614648
VIth nerve paralysis	17.29	13.20	17	129715	1607	79613049
Gallbladder disorder	17.27	13.20	5	129727	19335	79595321
Dysstasia	17.25	13.20	12	129720	27734	79586922
Skin discolouration	17.21	13.20	25	129707	41009	79573647
Cytokine storm	17.21	13.20	14	129718	1032	79613624
Malignant peritoneal neoplasm	17.18	13.20	12	129720	702	79613954
Lithiasis	17.18	13.20	8	129724	213	79614443
Scleroderma-like reaction	17.16	13.20	7	129725	134	79614522
Eosinophil count increased	17.14	13.20	64	129668	17041	79597615
Seasonal allergy	17.14	13.20	3	129729	16403	79598253
Vaginal haemorrhage	17.13	13.20	7	129725	21810	79592846
Blood alkaline phosphatase abnormal	17.09	13.20	13	129719	869	79613787
Eye swelling	17.05	13.20	11	129721	26457	79588199
Microvillous inclusion disease	17.04	13.20	8	129724	217	79614439
Systemic inflammatory response syndrome	16.98	13.20	49	129683	11416	79603240
Metastases to pancreas	16.96	13.20	11	129721	569	79614087
Delusion	16.96	13.20	6	129726	20417	79594239
Mitral valve incompetence	16.92	13.20	13	129719	28552	79586104
Hypokinesia	16.89	13.20	5	129727	19055	79595601
Productive cough	16.86	13.20	80	129652	88251	79526405
Mydriasis	16.82	13.20	4	129728	17639	79597017
Creatinine renal clearance decreased	16.81	13.20	5	129727	18997	79595659
Cholelithiasis	16.79	13.20	38	129694	52626	79562030
Thrombosis	16.75	13.20	75	129657	84025	79530631
Thyroiditis subacute	16.66	13.20	9	129723	331	79614325
Sarcoid-like reaction	16.65	13.20	5	129727	36	79614620
Chest tube insertion	16.65	13.20	7	129725	145	79614511
Tendonitis	16.63	13.20	9	129723	23821	79590835
Complication associated with device	16.62	13.20	4	129728	17492	79597164
Cough	16.57	13.20	462	129270	366327	79248329
Restless legs syndrome	16.52	13.20	6	129726	20086	79594570
Gastrointestinal haemorrhage	16.51	13.20	157	129575	147562	79467094
Lymphocyte count abnormal	16.50	13.20	16	129716	1487	79613169
Tumour flare	16.34	13.20	14	129718	1109	79613547
Probiotic therapy	16.30	13.20	7	129725	153	79614503
Keratouveitis	16.27	13.20	3	129729	0	79614656
Immune-mediated cholestasis	16.27	13.20	3	129729	0	79614656
Paraneoplastic retinopathy	16.27	13.20	3	129729	0	79614656
Sciatica	16.26	13.20	18	129714	33204	79581452
Serous retinopathy	16.26	13.20	7	129725	154	79614502
Intervertebral disc degeneration	16.24	13.20	3	129729	15782	79598874
Renal vasculitis	16.21	13.20	11	129721	614	79614042
Ketoacidosis	16.20	13.20	38	129694	7816	79606840
Musculoskeletal discomfort	16.18	13.20	6	129726	19829	79594827
Neuritis	16.16	13.20	17	129715	1741	79612915
Blood pressure abnormal	16.16	13.20	4	129728	17165	79597491
Protein-losing gastroenteropathy	16.13	13.20	11	129721	619	79614037
Speech disorder	16.00	13.20	41	129691	54404	79560252
Osteopenia	15.94	13.20	5	129727	18359	79596297
Toxic neuropathy	15.88	13.20	13	129719	967	79613689
Infected neoplasm	15.79	13.20	9	129723	368	79614288
Prothrombin time prolonged	15.78	13.20	4	129728	16895	79597761
Abdominal pain	15.78	13.20	498	129234	389071	79225585
Skin ulcer	15.74	13.20	41	129691	54109	79560547
Psychomotor hyperactivity	15.71	13.20	4	129728	16845	79597811
Dermatitis bullous	15.71	13.20	55	129677	14190	79600466
Infective spondylitis	15.65	13.20	10	129722	504	79614152
Pathological fracture	15.58	13.20	45	129687	10492	79604164
Drug resistance	15.56	13.20	28	129704	42185	79572471
Apoptosis	15.55	13.20	10	129722	510	79614146
Petechiae	15.51	13.20	7	129725	20558	79594098
Spermatogenesis abnormal	15.48	13.20	4	129728	15	79614641
Sputum discoloured	15.48	13.20	8	129724	21735	79592921
Glycosylated haemoglobin increased	15.42	13.20	6	129726	19254	79595402
Cardiac disorder	15.40	13.20	55	129677	65702	79548954
Dyspnoea exertional	15.39	13.20	81	129651	86992	79527664
Paraesthesia oral	15.39	13.20	7	129725	20464	79594192
Proctitis	15.37	13.20	33	129699	6399	79608257
Pericardial excision	15.30	13.20	5	129727	49	79614607
Lung opacity	15.29	13.20	29	129703	5145	79609511
Mental disorder	15.28	13.20	17	129715	31285	79583371
Glomerulonephritis rapidly progressive	15.26	13.20	16	129716	1632	79613024
Urinary incontinence	15.20	13.20	27	129705	40882	79573774
Blood pressure decreased	15.19	13.20	97	129635	99369	79515287
Skin cancer	15.17	13.20	3	129729	15037	79599619
Coagulopathy	15.04	13.20	22	129710	35984	79578672
Cardiomyopathy	15.00	13.20	89	129643	28685	79585971
Papilloedema	14.92	13.20	32	129700	6201	79608455
Pharyngeal oedema	14.92	13.20	4	129728	16268	79598388
Tumour necrosis	14.91	13.20	17	129715	1905	79612751
Hepatic cirrhosis	14.90	13.20	21	129711	34885	79579771
Oesophageal stenosis	14.89	13.20	26	129706	4328	79610328
Blood lactate dehydrogenase increased	14.89	13.20	112	129620	39058	79575598
Hot flush	14.87	13.20	43	129689	54834	79559822
Platelet count increased	14.87	13.20	9	129723	22397	79592259
Right ventricular failure	14.82	13.20	10	129722	23487	79591169
Ear pain	14.82	13.20	19	129713	32850	79581806
Thyroiditis acute	14.77	13.20	7	129725	194	79614462
Neoplasm malignant	14.75	13.20	18	129714	31792	79582864
Oral mucosa erosion	14.73	13.20	17	129715	1930	79612726
Myoclonus	14.66	13.20	14	129718	27646	79587010
Hiatus hernia	14.60	13.20	10	129722	23302	79591354
Hypoparathyroidism	14.59	13.20	13	129719	1085	79613571
Acquired amegakaryocytic thrombocytopenia	14.56	13.20	4	129728	20	79614636
Breath sounds abnormal	14.52	13.20	4	129728	15980	79598676
Visual impairment	14.51	13.20	89	129643	92042	79522614
Evans syndrome	14.48	13.20	9	129723	432	79614224
Illness	14.47	13.20	34	129698	46477	79568179
Small intestinal haemorrhage	14.42	13.20	25	129707	4138	79610518
Giant cell arteritis	14.42	13.20	20	129712	2731	79611925
Axonal and demyelinating polyneuropathy	14.40	13.20	4	129728	21	79614635
Hypotension	14.38	13.20	578	129154	439739	79174917
Radiation associated pain	14.37	13.20	6	129726	122	79614534
Haemorrhage	14.36	13.20	88	129644	91030	79523626
Cutaneous nocardiosis	14.36	13.20	7	129725	207	79614449
Hypercholesterolaemia	14.34	13.20	10	129722	23085	79591571
Procedural pain	14.33	13.20	10	129722	23074	79591582
Aspartate aminotransferase abnormal	14.28	13.20	16	129716	1760	79612896
BRAF gene mutation	14.24	13.20	5	129727	62	79614594
Salivary duct inflammation	14.19	13.20	3	129729	3	79614653
Ocular hyperaemia	14.12	13.20	15	129717	28191	79586465
Eye pruritus	14.02	13.20	8	129724	20562	79594094
Hyperglycaemic hyperosmolar nonketotic syndrome	14.00	13.20	18	129714	2285	79612371
Hypothermia	13.92	13.20	10	129722	22736	79591920
Disease recurrence	13.92	13.20	32	129700	44077	79570579
Euthanasia	13.90	13.20	6	129726	133	79614523
Paraneoplastic neurological syndrome	13.89	13.20	5	129727	67	79614589
Pleurisy	13.84	13.20	43	129689	10432	79604224
Diabetic hyperosmolar coma	13.82	13.20	11	129721	786	79613870
Encephalomyelitis	13.79	13.20	7	129725	226	79614430
Lip dry	13.74	13.20	4	129728	15414	79599242
Bronchitis	13.70	13.20	141	129591	130503	79484153
IIIrd nerve paralysis	13.67	13.20	13	129719	1180	79613476
Thyroiditis chronic	13.54	13.20	4	129728	27	79614629
Respiratory depression	13.49	13.20	15	129717	27615	79587041
Multiple sclerosis	13.37	13.20	10	129722	22272	79592384
Metastases to abdominal cavity	13.34	13.20	10	129722	654	79614002

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	L01FF01	ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS ANTINEOPLASTIC AGENTS MONOCLONAL ANTIBODIES AND ANTIBODY DRUG CONJUGATES PD-1/PDL-1 (Programmed cell death protein 1/death ligand 1) inhibitors
ATC	L01XY03	ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS ANTINEOPLASTIC AGENTS OTHER ANTINEOPLASTIC AGENTS Combinations of antineoplastic agents
MeSH PA	D000970	Antineoplastic Agents
MeSH PA	D000074322	Antineoplastic Agents, Immunological
MeSH PA	D000082082	Immune Checkpoint Inhibitors
FDA MoA	N0000191259	Programmed Death Receptor-1-directed Antibody Interactions
FDA EPC	N0000191260	Programmed Death Receptor-1 Blocking Antibody

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

Disease	Relation	SNOMED_ID	DOID
Transitional cell carcinoma	indication	27090000	DOID:2671
Squamous cell carcinoma of lung	indication	254634000	DOID:3907
Non-small cell lung cancer	indication	254637007	DOID:3908
Unresectable advanced or recurrent malignant pleural mesothelioma	indication	254645002	DOID:7474
Head and neck cancer	indication	255055008	DOID:11934
Unresectable, advanced or recurrent gastric cancer	indication	276810009
Malignant tumor of stomach	indication	363349007	DOID:10534
Malignant tumor of esophagus	indication	363402007
Advanced melanoma with tumour cell PD-L1 expression below 1%	indication	443493003
Metastatic malignant melanoma	indication	443493003
Metastatic renal cell carcinoma	indication	702392008
Microsatellite instability-high colorectal cancer	indication	737058005
Classical Hodgkin lymphoma	indication	762690000
Postoperative adjuvant therapy for urothelial carcinoma	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
Programmed cell death protein 1	Membrane receptor	Q15116	PDCD1_HUMAN	ANTIBODY BINDING	Kd	9.14		IUPHAR	SCIENTIFIC LITERATURE

External reference:

ID	Source
31YO63LBSN	UNII
D10316	KEGG_DRUG
4034032	VUID
N0000191289	NUI
4034032	VANDF
C3657270	UMLSCUI
CHEMBL2108738	ChEMBL_ID
DB09035	DRUGBANK_ID
D000077594	MESH_DESCRIPTOR_UI
9623	INN_ID
7335	IUPHAR_LIGAND_ID
1597876	RXNORM
231573	MMSL
30781	MMSL
d08324	MMSL
015839	NDDF
704191007	SNOMEDCT_US
704192000	SNOMEDCT_US

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
OPDIVO	HUMAN PRESCRIPTION DRUG LABEL	1	0003-3734	INJECTION	10 mg	INTRAVENOUS	BLA	24 sections
OPDIVO	HUMAN PRESCRIPTION DRUG LABEL	1	0003-3734	INJECTION	10 mg	INTRAVENOUS	BLA	24 sections
OPDIVO	HUMAN PRESCRIPTION DRUG LABEL	1	0003-3734	INJECTION	10 mg	INTRAVENOUS	BLA	24 sections
OPDIVO	HUMAN PRESCRIPTION DRUG LABEL	1	0003-3734	INJECTION	10 mg	INTRAVENOUS	BLA	24 sections
OPDIVO	HUMAN PRESCRIPTION DRUG LABEL	1	0003-3756	INJECTION	10 mg	INTRAVENOUS	BLA	24 sections
OPDIVO	HUMAN PRESCRIPTION DRUG LABEL	1	0003-3756	INJECTION	10 mg	INTRAVENOUS	BLA	24 sections
OPDIVO	HUMAN PRESCRIPTION DRUG LABEL	1	0003-3756	INJECTION	10 mg	INTRAVENOUS	BLA	24 sections
OPDIVO	HUMAN PRESCRIPTION DRUG LABEL	1	0003-3756	INJECTION	10 mg	INTRAVENOUS	BLA	24 sections
OPDIVO	HUMAN PRESCRIPTION DRUG LABEL	1	0003-3772	INJECTION	10 mg	INTRAVENOUS	BLA	24 sections
OPDIVO	HUMAN PRESCRIPTION DRUG LABEL	1	0003-3772	INJECTION	10 mg	INTRAVENOUS	BLA	24 sections
OPDIVO	HUMAN PRESCRIPTION DRUG LABEL	1	0003-3772	INJECTION	10 mg	INTRAVENOUS	BLA	24 sections
OPDIVO	HUMAN PRESCRIPTION DRUG LABEL	1	0003-3772	INJECTION	10 mg	INTRAVENOUS	BLA	24 sections
OPDIVO	HUMAN PRESCRIPTION DRUG LABEL	1	0003-3774	INJECTION	10 mg	INTRAVENOUS	BLA	24 sections
OPDIVO	HUMAN PRESCRIPTION DRUG LABEL	1	0003-3774	INJECTION	10 mg	INTRAVENOUS	BLA	24 sections
OPDIVO	HUMAN PRESCRIPTION DRUG LABEL	1	0003-3774	INJECTION	10 mg	INTRAVENOUS	BLA	24 sections
OPDIVO	HUMAN PRESCRIPTION DRUG LABEL	1	0003-3774	INJECTION	10 mg	INTRAVENOUS	BLA	24 sections
OPDUALAG	HUMAN PRESCRIPTION DRUG LABEL	2	0003-7125	INJECTION	12 mg	INTRAVENOUS	BLA	27 sections