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

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

Stem definition	Drug id	CAS RN
humanized origin	4924	1374853-91-4

Description:

Molecule

Description

Synonyms: pembrolizumab keytruda lambrolizumab SCH-900475 MK-3475 pembrolizumab (genetical recombination)

A humanized monoclonal immunoglobulin (Ig) G4 antibody directed against human cell surface receptor PD-1 (programmed death-1 or programmed cell death-1) with potential immune checkpoint inhibitory and antineoplastic activities. Upon administration, pembrolizumab binds to PD-1, an inhibitory signaling receptor expressed on the surface of activated T cells, and blocks the binding to and activation of PD-1 by its ligands, which results in the activation of T-cell-mediated immune responses against tumor cells. The ligands for PD-1 include programmed cell death ligand 1 (PD-L1), overexpressed on certain cancer cells, and programmed cell death ligand 2 (PD-L2), which is primarily expressed on APCs. Activated PD-1 negatively regulates T-cell activation and plays a key role in in tumor evasion from host immunity. Molecular weight: Formula: CLOGP: LIPINSKI: None HAC: None HDO: None TPSA: ALOGS: ROTB: None

Drug dosage:

None

ADMET properties:

None

Approvals:

Date	Agency	Company	Orphan
July 17, 2015	EMA	Merck Sharp & Dohme Limited
Sept. 4, 2014	FDA	MERCK SHARP DOHME
Sept. 28, 2016	PMDA	MSD K.K.

FDA Adverse Event Reporting System (Female)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Malignant neoplasm progression	4275.60	16.51	1748	43616	80373	63363285
Hypothyroidism	1261.39	16.51	613	44751	42019	63401639
Immune-mediated hypothyroidism	617.66	16.51	117	45247	191	63443467
Product use in unapproved indication	560.49	16.51	664	44700	178416	63265242
Immune-mediated hepatic disorder	540.41	16.51	114	45250	401	63443257
Immune-mediated adverse reaction	504.22	16.51	98	45266	197	63443461
Myocarditis	501.06	16.51	210	45154	10115	63433543
Hypertension	432.58	16.51	740	44624	278563	63165095
Immune-mediated enterocolitis	428.84	16.51	125	45239	1986	63441672
Palmar-plantar erythrodysaesthesia syndrome	399.00	16.51	232	45132	22783	63420875
Proteinuria	394.16	16.51	216	45148	18929	63424729
Thyroiditis	388.44	16.51	120	45244	2346	63441312
Immune-mediated myocarditis	358.74	16.51	74	45290	226	63443432
Hyperthyroidism	356.86	16.51	185	45179	14488	63429170
Pneumonitis	356.63	16.51	253	45111	34969	63408689
Colitis	354.95	16.51	287	45077	48241	63395417
Tumour pseudoprogression	343.18	16.51	71	45293	221	63443437
Immune-mediated hepatitis	326.97	16.51	92	45272	1279	63442379
Death	326.24	16.51	781	44583	373600	63070058
Immune-mediated lung disease	322.65	16.51	78	45286	568	63443090
Adrenal insufficiency	316.90	16.51	183	45181	17732	63425926
Tubulointerstitial nephritis	283.81	16.51	177	45187	19726	63423932
Immune-mediated dermatitis	282.01	16.51	56	45308	132	63443526
Platelet count decreased	274.58	16.51	375	44989	115747	63327911
Therapy partial responder	258.06	16.51	134	45230	10524	63433134
Hypophysitis	254.13	16.51	81	45283	1760	63441898
Type 1 diabetes mellitus	242.23	16.51	94	45270	3696	63439962
Hepatitis	236.73	16.51	209	45155	39579	63404079
Immune-mediated thyroiditis	226.63	16.51	45	45319	106	63443552
Hepatic function abnormal	220.76	16.51	195	45169	36947	63406711
Myelosuppression	209.76	16.51	157	45207	23546	63420112
Adrenocorticotropic hormone deficiency	201.12	16.51	49	45315	370	63443288
Interstitial lung disease	180.71	16.51	222	45142	61686	63381972
Immune-mediated pancreatitis	169.88	16.51	35	45329	106	63443552
Immune-mediated hyperthyroidism	167.63	16.51	33	45331	73	63443585
Blood thyroid stimulating hormone increased	167.16	16.51	88	45276	7106	63436552
Lichenoid keratosis	160.96	16.51	57	45307	1726	63441932
Pyrexia	160.84	16.51	713	44651	469765	62973893
Myositis	159.45	16.51	93	45271	9173	63434485
Vitiligo	158.85	16.51	53	45311	1336	63442322
Neutropenia	152.76	16.51	366	44998	174639	63269019
Joint swelling	151.46	16.51	26	45338	327640	63116018
Thrombocytopenia	143.78	16.51	327	45037	150830	63292828
Autoimmune colitis	136.20	16.51	38	45326	511	63443147
Immune-mediated arthritis	132.23	16.51	26	45338	57	63443601
Myasthenia gravis	129.59	16.51	64	45300	4517	63439141
Fulminant type 1 diabetes mellitus	127.61	16.51	35	45329	440	63443218
Drug ineffective	127.11	16.51	358	45006	1044407	62399251
Abdominal discomfort	125.20	16.51	37	45327	320848	63122810
Hepatic cytolysis	125.17	16.51	97	45267	15310	63428348
Nephritis	124.79	16.51	52	45312	2464	63441194
Pain	123.46	16.51	213	45151	740415	62703243
Decreased appetite	119.91	16.51	423	44941	250629	63193029
Immune-mediated gastritis	119.79	16.51	22	45342	27	63443631
Swelling	118.46	16.51	26	45338	275352	63168306
Renal impairment	118.05	16.51	220	45144	88135	63355523
Immune-mediated adrenal insuficiency	115.58	16.51	23	45341	55	63443603
Sinusitis	113.91	16.51	14	45350	226639	63217019
Autoimmune hypothyroidism	113.62	16.51	27	45337	181	63443477
Thyroid disorder	113.57	16.51	91	45273	15071	63428587
Neoplasm progression	113.38	16.51	135	45229	36293	63407365
Cholangitis	112.36	16.51	62	45302	5499	63438159
Fall	110.94	16.51	72	45292	392262	63051396
Arthropathy	109.83	16.51	18	45346	234774	63208884
Dizziness	109.71	16.51	88	45276	429837	63013821
Autoimmune thyroiditis	107.76	16.51	54	45310	3932	63439726
Nasopharyngitis	107.36	16.51	25	45339	254232	63189426
Therapeutic product effect decreased	104.65	16.51	9	45355	193178	63250480
Drug hypersensitivity	103.93	16.51	46	45318	310641	63133017
Synovitis	103.21	16.51	8	45356	186910	63256748
Autoimmune hepatitis	102.30	16.51	68	45296	8442	63435216
Maternal exposure during pregnancy	100.44	16.51	18	45346	220044	63223614
Hepatotoxicity	100.33	16.51	128	45236	36913	63406745
Gastrointestinal perforation	96.46	16.51	48	45316	3443	63440215
Dysphonia	95.05	16.51	142	45222	47472	63396186
Exposure during pregnancy	93.97	16.51	4	45360	155543	63288115
Hypopituitarism	93.47	16.51	34	45330	1114	63442544
Systemic lupus erythematosus	93.39	16.51	18	45346	208900	63234758
Condition aggravated	93.33	16.51	90	45274	402127	63041531
Wound	92.99	16.51	6	45358	163257	63280401
Glossodynia	92.48	16.51	10	45354	178866	63264792
Drug intolerance	90.87	16.51	54	45310	308607	63135051
Neuropathy peripheral	88.80	16.51	228	45136	113439	63330219
Headache	85.85	16.51	205	45159	633036	62810622
Acute kidney injury	85.76	16.51	394	44970	263021	63180637
Skin toxicity	85.59	16.51	49	45315	4665	63438993
Immune-mediated encephalitis	85.52	16.51	22	45342	212	63443446
Immune-mediated myositis	84.72	16.51	33	45331	1310	63442348
Immune-mediated nephritis	84.69	16.51	20	45344	130	63443528
Diarrhoea	82.20	16.51	825	44539	714541	62729117
Tumour associated fever	81.78	16.51	23	45341	319	63443339
Hypersensitivity	80.93	16.51	55	45309	292630	63151028
Discomfort	77.87	16.51	13	45351	167361	63276297
Inappropriate schedule of product administration	76.55	16.51	204	45160	103761	63339897
Eastern Cooperative Oncology Group performance status worsened	76.24	16.51	30	45334	1224	63442434
Secondary adrenocortical insufficiency	75.86	16.51	31	45333	1397	63442261
Immune-mediated hypophysitis	74.82	16.51	16	45348	61	63443597
Tumour hyperprogression	74.64	16.51	17	45347	92	63443566
Immune-mediated renal disorder	73.84	16.51	14	45350	23	63443635
Myasthenic syndrome	73.77	16.51	20	45344	240	63443418
Weight increased	72.10	16.51	49	45315	260743	63182915
Renal tubular necrosis	71.81	16.51	63	45301	11815	63431843
Product use issue	71.11	16.51	329	45035	220191	63223467
Adverse event	70.74	16.51	152	45212	67407	63376251
Drug interaction	70.39	16.51	38	45326	229093	63214565
Radiotherapy	69.58	16.51	21	45343	378	63443280
Contusion	69.03	16.51	12	45352	150032	63293626
Diabetic ketoacidosis	68.81	16.51	79	45285	20426	63423232
Cholecystitis	66.97	16.51	68	45296	15309	63428349
Immune-mediated neuropathy	66.63	16.51	12	45352	12	63443646
Troponin increased	63.85	16.51	55	45309	10066	63433592
Neutrophil count decreased	63.81	16.51	131	45233	56275	63387383
Alopecia	63.71	16.51	89	45275	337447	63106211
Peripheral swelling	63.39	16.51	58	45306	265884	63177774
Pancytopenia	63.24	16.51	182	45182	96751	63346907
Enterocolitis	62.79	16.51	49	45315	7809	63435849
Pemphigoid	61.31	16.51	47	45317	7297	63436361
Musculoskeletal stiffness	60.63	16.51	28	45336	184590	63259068
Off label use	60.03	16.51	740	44624	673722	62769936
Autoimmune nephritis	60.03	16.51	19	45345	403	63443255
Immune-mediated cholangitis	59.93	16.51	12	45352	30	63443628
Immune-mediated endocrinopathy	59.83	16.51	10	45354	3	63443655
Bronchitis	59.69	16.51	9	45355	124926	63318732
Cholestasis	59.04	16.51	88	45276	29346	63414312
Glucocorticoid deficiency	58.96	16.51	17	45347	259	63443399
Polymyalgia rheumatica	57.28	16.51	35	45329	3756	63439902
Treatment failure	55.52	16.51	37	45327	199006	63244652
Blood corticotrophin decreased	55.22	16.51	17	45347	328	63443330
Subacute cutaneous lupus erythematosus	54.86	16.51	30	45334	2613	63441045
Insomnia	53.63	16.51	45	45319	215207	63228451
Anaemia	53.59	16.51	376	44988	293054	63150604
Cardiac failure	53.03	16.51	162	45202	88980	63354678
Depression	52.85	16.51	38	45326	196454	63247204
Lichen planus	52.61	16.51	28	45336	2310	63441348
Infusion related reaction	52.29	16.51	59	45305	245462	63198196
Malaise	52.11	16.51	489	44875	415465	63028193
Lower respiratory tract infection	51.99	16.51	15	45349	132292	63311366
Posterior reversible encephalopathy syndrome	51.86	16.51	63	45301	17282	63426376
Intentional product use issue	51.18	16.51	14	45350	127878	63315780
Asthma	50.98	16.51	14	45350	127547	63316111
Mobility decreased	50.92	16.51	12	45352	121147	63322511
Febrile neutropenia	50.86	16.51	193	45171	118256	63325402
Migraine	50.40	16.51	7	45357	103339	63340319
Osteoarthritis	50.11	16.51	5	45359	95338	63348320
Autoimmune pancreatitis	50.07	16.51	15	45349	263	63443395
Autoimmune arthritis	49.89	16.51	11	45353	50	63443608
Rheumatoid arthritis	49.81	16.51	65	45299	253754	63189904
Influenza	49.34	16.51	9	45355	108713	63334945
Lymphocytic hypophysitis	48.04	16.51	14	45350	222	63443436
Pulmonary embolism	47.55	16.51	187	45177	116497	63327161
Radiation pneumonitis	47.42	16.51	23	45341	1560	63442098
Guillain-Barre syndrome	46.53	16.51	31	45333	3862	63439796
Cytokine release syndrome	46.10	16.51	54	45310	14260	63429398
Adrenal disorder	45.90	16.51	23	45341	1674	63441984
Immune-mediated neurological disorder	44.93	16.51	8	45356	7	63443651
Pericardial effusion	44.11	16.51	78	45286	29980	63413678
Overdose	43.49	16.51	14	45350	115064	63328594
Pericarditis	43.12	16.51	20	45344	131559	63312099
Eosinophilic fasciitis	42.90	16.51	12	45352	163	63443495
Small intestinal perforation	42.36	16.51	21	45343	1494	63442164
Mucosal inflammation	41.76	16.51	99	45265	46829	63396829
Large intestine perforation	41.56	16.51	40	45324	8442	63435216
Cortisol decreased	40.08	16.51	19	45345	1225	63442433
Encephalitis	40.01	16.51	40	45324	8840	63434818
No adverse event	39.76	16.51	90	45274	41315	63402343
Urogenital fistula	39.66	16.51	12	45352	218	63443440
Autoimmune myocarditis	39.19	16.51	10	45354	93	63443565
Pneumothorax	39.07	16.51	53	45311	16208	63427450
Pleural effusion	38.47	16.51	150	45214	93060	63350598
Muscle spasms	38.44	16.51	33	45331	156117	63287541
Cholangitis sclerosing	37.91	16.51	20	45344	1621	63442037
Acquired gene mutation	37.88	16.51	17	45347	966	63442692
Immune thrombocytopenia	37.68	16.51	42	45322	10514	63433144
Adrenocortical insufficiency acute	37.27	16.51	20	45344	1678	63441980
Rash maculo-papular	37.16	16.51	75	45289	31821	63411837
Liver disorder	37.14	16.51	103	45261	53584	63390074
Amylase increased	37.05	16.51	33	45331	6312	63437346
Aspartate aminotransferase increased	37.03	16.51	145	45219	90132	63353526
Pulmonary sarcoidosis	36.91	16.51	17	45347	1026	63442632
Hepatitis toxic	36.72	16.51	25	45339	3228	63440430
Uveitis	36.56	16.51	45	45319	12508	63431150
Dermatitis bullous	35.91	16.51	37	45327	8471	63435187
Wheezing	35.47	16.51	12	45352	95583	63348075
Hypothalamo-pituitary disorder	35.46	16.51	15	45349	738	63442920
Tumour haemorrhage	35.21	16.51	19	45345	1612	63442046
Toxicity to various agents	35.00	16.51	78	45286	247172	63196486
Loss of personal independence in daily activities	34.76	16.51	13	45351	97277	63346381
Hyperamylasaemia	34.60	16.51	13	45351	467	63443191
Hospice care	34.40	16.51	35	45329	7897	63435761
Female genital tract fistula	33.96	16.51	34	45330	7525	63436133
Myelitis transverse	33.85	16.51	17	45347	1243	63442415
Adrenalitis	33.78	16.51	7	45357	22	63443636
Suicidal ideation	33.52	16.51	3	45361	62418	63381240
Blood thyroid stimulating hormone decreased	33.21	16.51	27	45337	4563	63439095
Hyponatraemia	32.42	16.51	162	45202	111738	63331920
Polyarthritis	32.21	16.51	38	45326	10108	63433550
Hypertransaminasaemia	32.06	16.51	31	45333	6578	63437080
Gastrointestinal disorder	31.98	16.51	28	45336	131211	63312447
Metastases to central nervous system	31.92	16.51	43	45321	13062	63430596
Intestinal perforation	31.84	16.51	41	45323	11922	63431736
Cytokine storm	31.31	16.51	11	45353	325	63443333
Immune-mediated cystitis	31.22	16.51	5	45359	0	63443658
Immune-mediated uveitis	31.20	16.51	7	45357	35	63443623
Melanoma recurrent	30.58	16.51	9	45355	148	63443510
Thyrotoxic crisis	30.13	16.51	14	45350	862	63442796
Blister	30.08	16.51	29	45335	129785	63313873
Toxic epidermal necrolysis	30.02	16.51	60	45304	25274	63418384
Urticaria	29.97	16.51	45	45319	165757	63277901
Polyglandular autoimmune syndrome type II	29.84	16.51	7	45357	44	63443614
Periarticular thenar erythema with onycholysis	29.58	16.51	7	45357	46	63443612
Arthralgia	29.41	16.51	263	45101	569447	62874211
Metastases to meninges	29.38	16.51	20	45344	2582	63441076
Ascites	29.02	16.51	79	45285	40649	63403009
Metastases to adrenals	28.75	16.51	13	45351	752	63442906
EGFR gene mutation	28.74	16.51	10	45354	287	63443371
Alanine aminotransferase increased	28.50	16.51	148	45216	103622	63340036
Pain in extremity	28.39	16.51	131	45233	331355	63112303
Skin disorder	28.17	16.51	64	45300	29443	63414215
Knee arthroplasty	28.07	16.51	3	45361	54203	63389455
Meningitis aseptic	27.99	16.51	25	45339	4798	63438860
Intentional product misuse	27.72	16.51	5	45359	60912	63382746
Haemophagocytic lymphohistiocytosis	27.63	16.51	36	45328	10591	63433067
Folliculitis	27.56	16.51	8	45356	70309	63373349
Metastatic malignant melanoma	27.50	16.51	15	45349	1300	63442358
Diabetes mellitus	27.38	16.51	95	45269	55715	63387943
Impaired healing	27.33	16.51	20	45344	102522	63341136
Drug effective for unapproved indication	26.93	16.51	21	45343	3343	63440315
Cutaneous sarcoidosis	26.68	16.51	10	45354	357	63443301
Amputation stump pain	26.58	16.51	6	45358	31	63443627
Nephropathy toxic	26.04	16.51	33	45331	9446	63434212
Neurofibrosarcoma	25.91	16.51	8	45356	156	63443502
Hepatocellular injury	25.71	16.51	59	45305	27322	63416336
Hepatic failure	25.25	16.51	69	45295	35587	63408071
Radiation associated pain	25.03	16.51	7	45357	95	63443563
Cardiomyopathy	24.99	16.51	45	45319	17539	63426119
Autoimmune endocrine disorder	24.98	16.51	4	45360	0	63443658
Autoimmune cholangitis	24.83	16.51	5	45359	13	63443645
Taste disorder	24.79	16.51	39	45325	13623	63430035
Upper respiratory tract infection	24.60	16.51	14	45350	82033	63361625
Mixed deafness	24.30	16.51	5	45359	15	63443643
Erythema multiforme	24.21	16.51	33	45331	10136	63433522
Gastric perforation	24.09	16.51	15	45349	1664	63441994
Gastrooesophageal reflux disease	23.79	16.51	20	45344	95619	63348039
Malignant ascites	23.69	16.51	12	45352	894	63442764
Disseminated intravascular coagulation	23.64	16.51	46	45318	19005	63424653
Tumour pain	23.61	16.51	14	45350	1423	63442235
Dyspnoea	23.56	16.51	332	45032	660981	62782677
Morphoea	23.53	16.51	9	45355	340	63443318
Cancer pain	23.50	16.51	19	45345	3186	63440472
Cardiac failure congestive	23.40	16.51	19	45345	92414	63351244
Blood pressure abnormal	23.02	16.51	40	45324	15158	63428500
Stress cardiomyopathy	23.01	16.51	31	45333	9419	63434239
KL-6 increased	22.95	16.51	6	45358	62	63443596
Hyperhidrosis	22.83	16.51	26	45338	107810	63335848
Immune-mediated cytopenia	22.81	16.51	5	45359	22	63443636
Stomatitis	22.53	16.51	173	45191	138552	63305106
Neonatal respiratory depression	22.52	16.51	6	45358	67	63443591
Transaminases increased	22.51	16.51	61	45303	31306	63412352
Blood alkaline phosphatase abnormal	22.50	16.51	10	45354	555	63443103
Sarcoid-like reaction	22.45	16.51	5	45359	24	63443634
Blood corticotrophin increased	22.44	16.51	6	45358	68	63443590
Infection	22.43	16.51	86	45278	229087	63214571
Cardiac tamponade	22.42	16.51	22	45342	4753	63438905
Thyroid hormones decreased	22.33	16.51	9	45355	391	63443267
Renal arteriosclerosis	22.21	16.51	6	45358	71	63443587
Cerebral infarction	21.90	16.51	51	45313	23842	63419816
Tumour necrosis	21.86	16.51	11	45353	808	63442850
Positron emission tomogram abnormal	21.74	16.51	8	45356	271	63443387
Cortisol increased	21.72	16.51	9	45355	420	63443238
Oligodipsia	21.52	16.51	5	45359	30	63443628
Stevens-Johnson syndrome	21.51	16.51	52	45312	24898	63418760
Hip arthroplasty	21.49	16.51	4	45360	47642	63396016
Nasal congestion	21.47	16.51	10	45354	65650	63378008
Ileus	21.33	16.51	38	45326	14687	63428971
Thyroid hormones increased	20.97	16.51	9	45355	459	63443199
Silent thyroiditis	20.90	16.51	6	45358	90	63443568
BRAF V600E mutation positive	20.85	16.51	5	45359	35	63443623
Rash morbilliform	20.83	16.51	18	45346	3307	63440351
Ophthalmoplegia	20.81	16.51	13	45351	1451	63442207
Stress	20.80	16.51	11	45353	67156	63376502
Coma	20.75	16.51	10	45354	64354	63379304
Fistula	20.73	16.51	31	45333	10362	63433296
Adverse drug reaction	20.66	16.51	16	45348	79698	63363960
Circumstance or information capable of leading to medication error	20.39	16.51	19	45345	3851	63439807
Hypoaesthesia	20.04	16.51	58	45306	168335	63275323
Troponin T increased	20.03	16.51	12	45352	1242	63442416
Joint stiffness	20.03	16.51	3	45361	41866	63401792
Palpitations	19.99	16.51	31	45333	112739	63330919
General physical health deterioration	19.99	16.51	226	45138	201176	63242482
Aortic embolus	19.95	16.51	5	45359	43	63443615
Burning sensation	19.89	16.51	7	45357	54400	63389258
Unevaluable event	19.86	16.51	6	45358	51380	63392278
Drug eruption	19.79	16.51	55	45309	28639	63415019
Meningitis	19.74	16.51	25	45339	7152	63436506
Urinary tract infection enterococcal	19.71	16.51	16	45348	2697	63440961
Fluid retention	19.66	16.51	9	45355	59677	63383981
Wrong technique in product usage process	19.62	16.51	10	45354	62330	63381328
Lung adenocarcinoma recurrent	19.44	16.51	4	45360	12	63443646
Tremor	19.29	16.51	41	45323	132198	63311460
Renal failure	19.26	16.51	147	45217	117505	63326153
Autoimmune uveitis	19.20	16.51	4	45360	13	63443645
Inflammatory marker increased	19.09	16.51	24	45340	6815	63436843
Therapeutic product effect incomplete	18.89	16.51	38	45326	125018	63318640
Pain in jaw	18.89	16.51	4	45360	43492	63400166
Autoimmune dermatitis	18.88	16.51	6	45358	129	63443529
Autoimmune pericarditis	18.73	16.51	3	45361	0	63443658
Ulcerative duodenitis	18.73	16.51	3	45361	0	63443658
International normalised ratio increased	18.72	16.51	5	45359	46420	63397238
Metastases to lung	18.59	16.51	33	45331	12717	63430941
Anxiety	18.59	16.51	86	45278	217455	63226203
Autoimmune thyroid disorder	18.55	16.51	4	45360	16	63443642
Paraneoplastic syndrome	18.51	16.51	9	45355	614	63443044
Duodenal perforation	18.44	16.51	10	45354	857	63442801
Gait disturbance	18.40	16.51	68	45296	183110	63260548
Primary adrenal insufficiency	18.34	16.51	6	45358	142	63443516
Blood thyroid stimulating hormone abnormal	18.25	16.51	10	45354	874	63442784
Encephalitis autoimmune	18.16	16.51	12	45352	1474	63442184
Malignant pleural effusion	18.16	16.51	15	45349	2591	63441067
Rectal perforation	18.12	16.51	8	45356	437	63443221
Optic neuritis	18.04	16.51	26	45338	8409	63435249
Paraesthesia	18.00	16.51	55	45309	156911	63286747
Eyelid ptosis	17.94	16.51	24	45340	7243	63436415
Nephrotic syndrome	17.89	16.51	21	45343	5555	63438103
Febrile bone marrow aplasia	17.79	16.51	24	45340	7301	63436357
Therapeutic response decreased	17.73	16.51	11	45353	61514	63382144
Renal haemorrhage	17.64	16.51	10	45354	934	63442724
Cardiac dysfunction	17.56	16.51	14	45350	2301	63441357
Peritonitis	17.26	16.51	38	45326	17116	63426542
Haemolytic anaemia	17.13	16.51	28	45336	10097	63433561
Toxic skin eruption	17.08	16.51	32	45332	12853	63430805
Pancreatic failure	17.08	16.51	10	45354	993	63442665
Aplasia	17.04	16.51	18	45346	4241	63439417
Duodenitis	17.00	16.51	17	45347	3758	63439900
Cholecystitis acute	17.00	16.51	25	45339	8235	63435423
Chest pain	16.93	16.51	88	45276	215871	63227787
Loss of consciousness	16.91	16.51	37	45327	118084	63325574
Antinuclear antibody	16.84	16.51	8	45356	518	63443140
Peripheral motor neuropathy	16.82	16.51	12	45352	1669	63441989
Sarcoidosis	16.79	16.51	23	45341	7099	63436559
Road traffic accident	16.68	16.51	3	45361	36629	63407029
Bilirubin conjugated abnormal	16.66	16.51	3	45361	3	63443655
Pericarditis malignant	16.66	16.51	3	45361	3	63443655

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	3799.06	13.75	2042	48240	86004	34820645
Immune-mediated adverse reaction	869.78	13.75	195	50087	385	34906264
Immune-mediated hepatic disorder	794.12	13.75	202	50080	821	34905828
Pneumonitis	554.32	13.75	429	49853	33449	34873200
Immune-mediated enterocolitis	546.67	13.75	190	50092	2609	34904040
Interstitial lung disease	536.06	13.75	560	49722	64722	34841927
Immune-mediated myocarditis	521.02	13.75	137	50145	652	34905997
Immune-mediated lung disease	471.56	13.75	148	50134	1443	34905206
Product use in unapproved indication	458.05	13.75	694	49588	116805	34789844
Hypothyroidism	395.76	13.75	289	49993	20613	34886036
Tumour pseudoprogression	394.30	13.75	100	50182	400	34906249
Immune-mediated hepatitis	381.65	13.75	137	50145	2078	34904571
Therapy partial responder	367.30	13.75	207	50075	9409	34897240
Adrenal insufficiency	347.60	13.75	229	50053	13818	34892831
Colitis	336.98	13.75	339	49943	37411	34869238
Immune-mediated hypothyroidism	305.00	13.75	74	50208	235	34906414
Type 1 diabetes mellitus	267.35	13.75	128	50154	4130	34902519
Immune-mediated renal disorder	259.26	13.75	57	50225	98	34906551
Myasthenia gravis	255.85	13.75	146	50136	6794	34899855
Tubulointerstitial nephritis	237.29	13.75	215	50067	20809	34885840
Death	237.24	13.75	1163	49119	396886	34509763
Immune-mediated arthritis	230.48	13.75	49	50233	65	34906584
Product use issue	229.79	13.75	362	49920	62854	34843795
Myocarditis	229.52	13.75	176	50106	13506	34893143
Immune-mediated myositis	215.90	13.75	89	50193	1994	34904655
Adrenocorticotropic hormone deficiency	203.24	13.75	69	50213	878	34905771
Adverse event	199.32	13.75	186	50096	18691	34887958
Myositis	195.33	13.75	152	50130	11918	34894731
Hypophysitis	194.80	13.75	85	50197	2201	34904448
Myelosuppression	173.60	13.75	174	50108	19091	34887558
Neoplasm progression	169.95	13.75	188	50094	23112	34883537
Autoimmune hepatitis	166.83	13.75	94	50188	4266	34902383
Immune-mediated dermatitis	162.34	13.75	46	50236	303	34906346
Hyperthyroidism	155.82	13.75	126	50156	10440	34896209
Drug interaction	152.86	13.75	67	50215	225879	34680770
Hepatitis	145.98	13.75	176	50106	23728	34882921
Hepatic function abnormal	136.77	13.75	236	50046	44127	34862522
Pemphigoid	135.59	13.75	107	50175	8559	34898090
Tumour hyperprogression	132.53	13.75	30	50252	63	34906586
Immune-mediated thyroiditis	130.86	13.75	32	50250	106	34906543
Immune-mediated pancreatitis	126.01	13.75	31	50251	106	34906543
Thyroiditis	124.40	13.75	63	50219	2299	34904350
Off label use	123.28	13.75	1025	49257	418499	34488150
Vitiligo	120.96	13.75	47	50235	897	34905752
Eastern Cooperative Oncology Group performance status worsened	114.50	13.75	46	50236	962	34905687
Nephritis	113.62	13.75	60	50222	2391	34904258
Completed suicide	110.42	13.75	8	50274	98160	34808489
Autoimmune colitis	107.37	13.75	44	50238	970	34905679
Overdose	103.63	13.75	7	50275	91052	34815597
Fall	101.18	13.75	86	50196	202799	34703850
Decreased appetite	100.35	13.75	489	49793	165903	34740746
Pulmonary toxicity	92.10	13.75	74	50208	6073	34900576
Immune-mediated adrenal insuficiency	87.33	13.75	24	50258	139	34906510
Palmar-plantar erythrodysaesthesia syndrome	87.12	13.75	114	50168	16681	34889968
Immune-mediated nephritis	83.58	13.75	28	50254	341	34906308
Secondary adrenocortical insufficiency	82.69	13.75	41	50241	1429	34905220
Immune-mediated encephalitis	82.52	13.75	25	50257	214	34906435
Lichenoid keratosis	82.46	13.75	49	50233	2459	34904190
Cholangitis sclerosing	81.02	13.75	40	50242	1381	34905268
Dizziness	80.12	13.75	119	50163	218402	34688247
Haemophagocytic lymphohistiocytosis	79.96	13.75	96	50186	12877	34893772
Inappropriate schedule of product administration	78.51	13.75	232	50050	62064	34844585
Skin toxicity	76.84	13.75	60	50222	4724	34901925
Hypertransaminasaemia	76.67	13.75	64	50218	5542	34901107
Diabetic ketoacidosis	76.39	13.75	111	50171	17921	34888728
Immune-mediated gastritis	75.32	13.75	17	50265	35	34906614
Polymyalgia rheumatica	72.94	13.75	38	50244	1472	34905177
Immune thrombocytopenia	72.21	13.75	77	50205	9075	34897574
Immune-mediated cholangitis	72.17	13.75	20	50262	120	34906529
Thyroid disorder	71.77	13.75	49	50233	3133	34903516
Toxic epidermal necrolysis	71.76	13.75	119	50163	21527	34885122
Renal impairment	71.30	13.75	297	49985	94216	34812433
Hypopituitarism	70.92	13.75	43	50239	2239	34904410
Diarrhoea	68.52	13.75	858	49424	389054	34517595
Cholangitis	66.61	13.75	72	50210	8617	34898032
Immune-mediated cytopenia	66.54	13.75	14	50268	17	34906632
Immune-mediated hypophysitis	65.50	13.75	17	50265	76	34906573
Headache	65.35	13.75	118	50164	200517	34706132
Toxicity to various agents	64.23	13.75	119	50163	200243	34706406
Adrenal disorder	63.44	13.75	31	50251	1046	34905603
Blood thyroid stimulating hormone increased	61.16	13.75	50	50232	4205	34902444
Dysphonia	58.85	13.75	114	50168	23269	34883380
Proteinuria	57.18	13.75	99	50183	18543	34888106
Autoimmune hypothyroidism	55.16	13.75	13	50269	35	34906614
Eosinophilic fasciitis	54.85	13.75	15	50267	85	34906564
Pneumonia bacterial	54.58	13.75	76	50206	11796	34894853
Pericarditis malignant	54.38	13.75	13	50269	38	34906611
Insomnia	54.26	13.75	42	50240	103865	34802784
Fulminant type 1 diabetes mellitus	53.55	13.75	26	50256	865	34905784
Hepatotoxicity	53.16	13.75	104	50178	21381	34885268
Hypothalamo-pituitary disorder	52.24	13.75	25	50257	805	34905844
Organising pneumonia	52.00	13.75	53	50229	5926	34900723
Autoimmune arthritis	51.86	13.75	13	50269	49	34906600
Eyelid ptosis	51.77	13.75	52	50230	5714	34900935
Depression	51.02	13.75	39	50243	97059	34809590
Intentional product misuse	50.46	13.75	4	50278	45607	34861042
Hypotension	50.16	13.75	158	50124	221491	34685158
Agitation	49.44	13.75	11	50271	57388	34849261
Myasthenic syndrome	49.36	13.75	21	50261	510	34906139
Bradycardia	48.35	13.75	24	50258	75394	34831255
Cardiac failure congestive	48.32	13.75	30	50252	83240	34823409
Colitis microscopic	48.05	13.75	34	50248	2303	34904346
Subacute cutaneous lupus erythematosus	47.78	13.75	25	50257	977	34905672
Immune-mediated uveitis	46.92	13.75	12	50270	50	34906599
Autoimmune nephritis	46.80	13.75	17	50265	267	34906382
Encephalitis autoimmune	46.71	13.75	22	50260	683	34905966
Autoimmune myocarditis	46.06	13.75	16	50266	219	34906430
Stevens-Johnson syndrome	45.84	13.75	90	50192	18549	34888100
Rash	45.51	13.75	505	49777	222247	34684402
Tumour haemorrhage	45.10	13.75	36	50246	2926	34903723
Blood thyroid stimulating hormone abnormal	45.00	13.75	18	50264	372	34906277
Hepatic cytolysis	44.48	13.75	77	50205	14419	34892230
Electrocardiogram QT prolonged	44.18	13.75	4	50278	40948	34865701
Autoimmune thyroiditis	44.07	13.75	25	50257	1149	34905500
Drug hypersensitivity	44.04	13.75	31	50251	80498	34826151
Pain in extremity	43.34	13.75	72	50210	126441	34780208
Plasma cell myeloma	43.03	13.75	5	50277	42032	34864617
Hypersensitivity pneumonitis	41.87	13.75	27	50255	1568	34905081
Anxiety	41.62	13.75	49	50233	99379	34807270
Injection site pain	41.57	13.75	4	50278	39001	34867648
Hospitalisation	41.44	13.75	15	50267	56887	34849762
International normalised ratio increased	40.90	13.75	9	50273	47318	34859331
Nasopharyngitis	40.88	13.75	25	50257	69943	34836706
Encephalitis	40.25	13.75	51	50231	7226	34899423
Haemoglobin decreased	40.20	13.75	70	50212	120702	34785947
Prostate cancer	39.89	13.75	5	50277	39644	34867005
Aggression	38.99	13.75	5	50277	38959	34867690
Hallucination	38.49	13.75	13	50269	51485	34855164
Muscle spasms	38.28	13.75	31	50251	74970	34831679
Radiation pneumonitis	37.90	13.75	31	50251	2609	34904040
Enteritis	37.24	13.75	52	50230	8090	34898559
Autoimmune pancreatitis	37.06	13.75	15	50267	320	34906329
Hypersensitivity	36.80	13.75	21	50261	61014	34845635
Immune-mediated endocrinopathy	36.76	13.75	9	50273	30	34906619
Drug eruption	36.18	13.75	85	50197	19813	34886836
Liver disorder	36.07	13.75	117	50165	32880	34873769
Unevaluable event	35.65	13.75	3	50279	32587	34874062
Hyperhidrosis	35.36	13.75	34	50248	75658	34830991
Tremor	35.32	13.75	40	50242	82547	34824102
Immune-mediated neuropathy	35.28	13.75	9	50273	37	34906612
Syncope	35.22	13.75	48	50234	91403	34815246
Autoimmune lung disease	34.90	13.75	9	50273	39	34906610
Joint swelling	34.16	13.75	22	50260	59868	34846781
Pleural effusion	33.89	13.75	217	50065	81329	34825320
Pericardial effusion	33.11	13.75	94	50188	24568	34882081
Seizure	32.90	13.75	63	50219	104794	34801855
Musculoskeletal stiffness	32.83	13.75	13	50269	46667	34859982
Melanoma recurrent	32.32	13.75	11	50271	141	34906508
Pain	32.32	13.75	168	50114	204507	34702142
Taste disorder	31.69	13.75	45	50237	7110	34899539
Cancer pain	31.45	13.75	28	50254	2644	34904005
Lymphocytic hypophysitis	31.21	13.75	13	50269	299	34906350
Lung disorder	30.95	13.75	115	50167	34581	34872068
Malignant pleural effusion	30.78	13.75	22	50260	1514	34905135
Paraneoplastic neurological syndrome	30.60	13.75	8	50274	37	34906612
Mucosal inflammation	30.36	13.75	123	50159	38499	34868150
Urticaria	30.34	13.75	27	50255	62350	34844299
Condition aggravated	30.20	13.75	158	50124	192038	34714611
Lymphangiosis carcinomatosa	30.09	13.75	18	50264	914	34905735
Chest discomfort	29.80	13.75	21	50261	54509	34852140
Treatment noncompliance	29.63	13.75	3	50279	28097	34878552
Drug-induced liver injury	29.52	13.75	100	50182	28732	34877917
Radiation necrosis	29.40	13.75	10	50272	128	34906521
Drug ineffective	29.25	13.75	472	49810	456279	34450370
Cardiac arrest	29.11	13.75	59	50223	96100	34810549
Lichen planus	28.94	13.75	18	50264	981	34905668
Somnolence	28.92	13.75	74	50208	111042	34795607
Blood corticotrophin decreased	28.65	13.75	11	50271	203	34906446
Coma	28.57	13.75	15	50267	45663	34860986
Immune-mediated hyperthyroidism	28.32	13.75	8	50274	52	34906597
Myocardial infarction	28.27	13.75	85	50197	121000	34785649
Primary biliary cholangitis	28.11	13.75	11	50271	214	34906435
Bacterial diarrhoea	27.94	13.75	8	50274	55	34906594
Stress	27.83	13.75	5	50277	30342	34876307
Primary hypothyroidism	27.81	13.75	8	50274	56	34906593
Immune-mediated neurological disorder	27.73	13.75	5	50277	0	34906649
Tumour associated fever	27.15	13.75	13	50269	419	34906230
Metastases to central nervous system	27.04	13.75	45	50237	8160	34898489
Radiotherapy	26.98	13.75	13	50269	425	34906224
Pancytopenia	26.86	13.75	231	50051	94926	34811723
Miller Fisher syndrome	26.61	13.75	9	50273	113	34906536
Abdominal distension	26.48	13.75	27	50255	58465	34848184
Optic neuritis	26.32	13.75	29	50253	3545	34903104
Coronary artery disease	25.87	13.75	19	50263	48286	34858363
Hypertension	25.84	13.75	305	49977	136138	34770511
Flagellate dermatitis	25.66	13.75	8	50274	76	34906573
Loss of consciousness	25.64	13.75	50	50232	82617	34824032
Heart rate decreased	25.55	13.75	7	50275	31738	34874911
Autoimmune uveitis	25.38	13.75	5	50277	3	34906646
Upper respiratory tract infection	25.31	13.75	8	50274	33051	34873598
Autoimmune myositis	25.28	13.75	9	50273	133	34906516
Neutropenia	25.24	13.75	340	49942	156438	34750211
Dermatomyositis	24.85	13.75	18	50264	1265	34905384
KL-6 increased	24.59	13.75	7	50275	47	34906602
Dermatitis psoriasiform	24.54	13.75	19	50263	1477	34905172
Product dose omission issue	24.52	13.75	89	50193	119622	34787027
Hepatocellular injury	24.49	13.75	79	50203	22132	34884517
Cryptitis	24.17	13.75	10	50272	226	34906423
Stomatitis	24.15	13.75	123	50159	42391	34864258
Autoimmune haemolytic anaemia	24.06	13.75	31	50251	4465	34902184
Limbic encephalitis	23.87	13.75	12	50270	431	34906218
Intestinal intraepithelial lymphocytes increased	23.70	13.75	9	50273	161	34906488
Guillain-Barre syndrome	23.66	13.75	36	50246	6051	34900598
Respiratory failure	23.42	13.75	249	50033	108323	34798326
Latent autoimmune diabetes in adults	23.20	13.75	7	50275	59	34906590
Thrombocytopenia	23.19	13.75	334	49948	155913	34750736
Immune-mediated cystitis	23.09	13.75	6	50276	27	34906622
Chest pain	22.94	13.75	99	50183	126663	34779986
Gastrooesophageal reflux disease	22.92	13.75	13	50269	37911	34868738
Pericardial effusion malignant	22.91	13.75	6	50276	28	34906621
Silent thyroiditis	22.70	13.75	7	50275	64	34906585
Heart rate increased	22.60	13.75	20	50262	46323	34860326
Skin disorder	22.59	13.75	56	50226	13499	34893150
Body surface area decreased	22.59	13.75	5	50277	9	34906640
Tumour necrosis	22.54	13.75	17	50265	1271	34905378
Drug effective for unapproved indication	22.51	13.75	23	50259	2579	34904070
Pyrexia	22.42	13.75	632	49650	332381	34574268
Wrong technique in product usage process	22.24	13.75	12	50270	35974	34870675
Pneumocystis test positive	22.18	13.75	4	50278	0	34906649
Blood thyroid stimulating hormone decreased	22.18	13.75	20	50262	1921	34904728
Loss of personal independence in daily activities	22.11	13.75	10	50272	33169	34873480
Glomerulonephritis rapidly progressive	22.01	13.75	13	50269	645	34906004
Rash maculo-papular	21.88	13.75	90	50192	28361	34878288
Medication error	21.81	13.75	5	50277	25560	34881089
Meningitis aseptic	21.76	13.75	25	50257	3199	34903450
Apoptosis	21.75	13.75	11	50271	400	34906249
Cardiac tamponade	21.69	13.75	32	50250	5234	34901415
Transaminases increased	21.54	13.75	86	50196	26737	34879912
Paraneoplastic syndrome	21.36	13.75	12	50270	541	34906108
Sinusitis	21.26	13.75	17	50265	41385	34865264
Contusion	21.22	13.75	13	50269	36351	34870298
Trichoglossia	21.01	13.75	10	50272	318	34906331
Swelling	21.01	13.75	18	50264	42348	34864301
Thyroid function test abnormal	20.88	13.75	13	50269	710	34905939
Therapeutic product effect decreased	20.87	13.75	12	50270	34731	34871918
Metastases to skin	20.76	13.75	11	50271	441	34906208
Confusional state	20.72	13.75	122	50160	144038	34762611
Abdominal pain upper	20.68	13.75	45	50237	71445	34835204
Blood pressure systolic increased	20.58	13.75	4	50278	22948	34883701
Abdominal discomfort	20.52	13.75	34	50248	59801	34846848
Small intestinal perforation	20.27	13.75	20	50262	2151	34904498
Influenza	20.21	13.75	25	50257	49641	34857008
Mobility decreased	20.20	13.75	9	50273	30119	34876530
Dermatitis	20.07	13.75	43	50239	9425	34897224
Cortisol decreased	20.00	13.75	15	50267	1112	34905537
Haematoma	19.95	13.75	6	50276	25599	34881050
Injury	19.88	13.75	3	50279	20684	34885965
Autoimmune neuropathy	19.84	13.75	6	50276	51	34906598
Fluid retention	19.72	13.75	7	50275	26880	34879769
Autoimmune disorder	19.55	13.75	18	50264	1776	34904873
Respiratory arrest	19.41	13.75	8	50274	28035	34878614
Duodenitis	19.40	13.75	29	50253	4799	34901850
Adrenocortical insufficiency acute	19.30	13.75	17	50265	1583	34905066
Tumour embolism	19.25	13.75	6	50276	57	34906592
Right ventricular ejection fraction decreased	19.25	13.75	6	50276	57	34906592
Abnormal behaviour	19.19	13.75	6	50276	24963	34881686
Weight increased	19.16	13.75	69	50213	92964	34813685
Cortisol increased	19.05	13.75	8	50274	188	34906461
Asthma	18.95	13.75	20	50262	42636	34864013
Mixed liver injury	18.92	13.75	22	50260	2851	34903798
Nephrolithiasis	18.91	13.75	10	50272	30323	34876326
Microvillous inclusion disease	18.89	13.75	8	50274	192	34906457
Melaena	18.84	13.75	14	50268	35366	34871283
Angina pectoris	18.60	13.75	11	50271	31352	34875297
Ventricular fibrillation	18.59	13.75	5	50277	22949	34883700
Psychotic disorder	18.57	13.75	6	50276	24446	34882203
Non-small cell lung cancer stage III	18.53	13.75	4	50278	6	34906643
Lactic acidosis	18.20	13.75	14	50268	34758	34871891
Feeling hot	18.19	13.75	3	50279	19369	34887280
Tumour pain	18.14	13.75	14	50268	1083	34905566
Pneumocystis jirovecii pneumonia	18.14	13.75	66	50216	19644	34887005
Probiotic therapy	18.04	13.75	7	50275	133	34906516
Depressed level of consciousness	18.03	13.75	21	50261	42820	34863829
Pulmonary sarcoidosis	17.93	13.75	11	50271	585	34906064
Thyroid hormones increased	17.91	13.75	6	50276	73	34906576
Intentional product use issue	17.84	13.75	37	50245	59779	34846870
Blood pressure fluctuation	17.80	13.75	7	50275	25242	34881407
Lung lobectomy	17.77	13.75	5	50277	32	34906617
Peripheral swelling	17.66	13.75	54	50228	76487	34830162
Cholecystitis	17.65	13.75	44	50238	10644	34896005
Vascular access complication	17.63	13.75	9	50273	334	34906315
Myasthenia gravis crisis	17.42	13.75	11	50271	616	34906033
General physical health deterioration	17.38	13.75	270	50012	127999	34778650
Pancreatic failure	17.31	13.75	12	50270	786	34905863
Cutaneous sarcoidosis	17.18	13.75	7	50275	152	34906497
Atrioventricular block complete	17.14	13.75	40	50242	9279	34897370
Anaemia	17.13	13.75	448	49834	232887	34673762
Therapeutic product effect incomplete	17.07	13.75	29	50253	50512	34856137
Keratoacanthoma	17.05	13.75	11	50271	639	34906010
Tinnitus	17.03	13.75	4	50278	20114	34886535
Nasal congestion	16.91	13.75	6	50276	23051	34883598
Cachexia	16.83	13.75	34	50248	7152	34899497
Drug intolerance	16.81	13.75	38	50244	59532	34847117
Serotonin syndrome	16.80	13.75	4	50278	19929	34886720
Vomiting	16.75	13.75	253	50029	247368	34659281
Wheezing	16.68	13.75	21	50261	41381	34865268
Transitional cell carcinoma recurrent	16.66	13.75	4	50278	12	34906637
Acquired tracheo-oesophageal fistula	16.65	13.75	6	50276	92	34906557
Autoimmune cholangitis	16.64	13.75	3	50279	0	34906649
Overgrowth fungal	16.64	13.75	3	50279	0	34906649
Oesophagomediastinal fistula	16.64	13.75	3	50279	0	34906649
Arthropathy	16.58	13.75	9	50273	26898	34879751
Blood pressure increased	16.43	13.75	68	50214	88034	34818615
Palpitations	16.40	13.75	20	50262	39966	34866683
Weight abnormal	16.35	13.75	11	50271	686	34905963
Transitional cell carcinoma metastatic	16.28	13.75	5	50277	45	34906604
Blood corticotrophin increased	16.24	13.75	6	50276	99	34906550
Cardiac disorder	16.23	13.75	23	50259	43103	34863546
Dyskinesia	16.16	13.75	6	50276	22407	34884242
Pulmonary hypertension	16.13	13.75	5	50277	20919	34885730
Hypoglycaemia	16.12	13.75	34	50248	54606	34852043
Granulocyte count increased	16.12	13.75	9	50273	401	34906248
Thrombosis	16.09	13.75	30	50252	50428	34856221
Autoimmune encephalopathy	16.09	13.75	5	50277	47	34906602
Dysphagia	15.83	13.75	148	50134	62233	34844416
Endocrine ophthalmopathy	15.81	13.75	5	50277	50	34906599
Metabolic acidosis	15.75	13.75	24	50258	43656	34862993
Thrombophlebitis migrans	15.73	13.75	7	50275	190	34906459
Metastatic malignant melanoma	15.70	13.75	17	50265	2038	34904611
Melanosis	15.57	13.75	4	50278	17	34906632
Gliosis	15.50	13.75	7	50275	197	34906452
Chronic kidney disease	15.49	13.75	22	50260	41188	34865461
Biopsy	15.47	13.75	8	50274	305	34906344
Ophthalmoplegia	15.44	13.75	16	50266	1824	34904825
Neutrophil count decreased	15.44	13.75	126	50156	50978	34855671
Lung opacity	15.43	13.75	18	50264	2341	34904308
Immune-mediated encephalopathy	15.39	13.75	4	50278	18	34906631
Adrenalitis	15.39	13.75	4	50278	18	34906631
Disorientation	15.38	13.75	15	50267	33173	34873476
Recurrent cancer	15.27	13.75	14	50268	1373	34905276
Haemoglobin abnormal	15.16	13.75	23	50259	3857	34902792
Anti-thyroid antibody positive	15.07	13.75	5	50277	59	34906590
Laryngopharyngitis	15.05	13.75	4	50278	20	34906629
Lymph node abscess	15.05	13.75	4	50278	20	34906629
Catheter site rash	14.96	13.75	7	50275	214	34906435
Diffuse panbronchiolitis	14.56	13.75	3	50279	3	34906646
Immune-mediated oesophagitis	14.56	13.75	3	50279	3	34906646
Seronegative arthritis	14.49	13.75	12	50270	1027	34905622
Retroperitoneal lymphadenopathy	14.34	13.75	11	50271	843	34905806
Oesophageal carcinoma recurrent	14.16	13.75	4	50278	26	34906623
Systemic scleroderma	14.15	13.75	8	50274	365	34906284
Large intestine perforation	14.04	13.75	35	50247	8468	34898181
Balance disorder	14.03	13.75	23	50259	40631	34866018
Sleep disorder	13.92	13.75	15	50267	31673	34874976
Lymphadenectomy	13.88	13.75	8	50274	379	34906270
Platelet count abnormal	13.87	13.75	19	50263	2903	34903746
Treatment failure	13.83	13.75	29	50253	46668	34859981
Leukoderma	13.79	13.75	5	50277	78	34906571
Migraine	13.79	13.75	4	50278	17474	34889175
Febrile bone marrow aplasia	13.77	13.75	34	50248	8175	34898474

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	6632.62	13.52	3099	80664	132891	79527734
Hypothyroidism	1288.05	13.52	758	83005	51634	79608991
Immune-mediated hepatic disorder	1279.51	13.52	304	83459	1290	79659335
Immune-mediated adverse reaction	1203.47	13.52	260	83503	634	79659991
Immune-mediated enterocolitis	901.02	13.52	293	83470	4537	79656088
Immune-mediated myocarditis	833.03	13.52	202	83561	951	79659674
Immune-mediated hypothyroidism	831.87	13.52	182	83581	481	79660144
Immune-mediated lung disease	726.77	13.52	209	83554	2081	79658544
Pneumonitis	705.52	13.52	553	83210	60307	79600318
Interstitial lung disease	673.90	13.52	705	83058	111895	79548730
Product use in unapproved indication	655.13	13.52	1039	82724	249320	79411305
Immune-mediated hepatitis	646.46	13.52	213	83550	3443	79657182
Tumour pseudoprogression	637.12	13.52	147	83616	532	79660093
Myocarditis	620.76	13.52	347	83416	21386	79639239
Colitis	562.91	13.52	526	83237	72781	79587844
Therapy partial responder	541.49	13.52	294	83469	17103	79643522
Adrenal insufficiency	541.30	13.52	350	83413	28137	79632488
Type 1 diabetes mellitus	483.77	13.52	204	83559	6715	79653910
Tubulointerstitial nephritis	468.13	13.52	359	83404	37876	79622749
Hyperthyroidism	405.08	13.52	266	83497	21943	79638682
Thyroiditis	401.30	13.52	159	83604	4446	79656179
Immune-mediated dermatitis	388.78	13.52	96	83667	494	79660131
Adrenocorticotropic hormone deficiency	384.72	13.52	114	83649	1271	79659354
Hypophysitis	384.68	13.52	150	83613	4016	79656609
Death	372.81	13.52	1372	82391	565142	79095483
Myasthenia gravis	343.91	13.52	183	83580	10216	79650409
Immune-mediated thyroiditis	337.53	13.52	75	83688	218	79660407
Immune-mediated renal disorder	333.50	13.52	69	83694	124	79660501
Myositis	331.24	13.52	222	83541	18946	79641679
Immune-mediated arthritis	330.84	13.52	70	83693	148	79660477
Palmar-plantar erythrodysaesthesia syndrome	318.28	13.52	270	83493	32864	79627761
Hepatitis	315.42	13.52	339	83424	55388	79605237
Myelosuppression	306.94	13.52	288	83475	40008	79620617
Hepatic function abnormal	303.39	13.52	379	83384	72728	79587897
Proteinuria	298.24	13.52	258	83505	32244	79628381
Immune-mediated myositis	282.30	13.52	114	83649	3353	79657272
Hypertension	276.38	13.52	869	82894	330123	79330502
Neoplasm progression	274.38	13.52	304	83459	51378	79609247
Immune-mediated pancreatitis	271.32	13.52	63	83700	236	79660389
Vitiligo	241.96	13.52	89	83674	2020	79658605
Completed suicide	226.28	13.52	7	83756	245760	79414865
Autoimmune hepatitis	221.86	13.52	144	83619	11639	79648986
Decreased appetite	214.23	13.52	817	82946	341601	79319024
Drug interaction	203.22	13.52	91	83672	415092	79245533
Autoimmune colitis	203.00	13.52	73	83690	1550	79659075
Lichenoid keratosis	194.95	13.52	92	83671	3965	79656660
Immune-mediated gastritis	189.25	13.52	39	83724	68	79660557
Fall	187.57	13.52	143	83620	487486	79173139
Blood thyroid stimulating hormone increased	181.20	13.52	118	83645	9590	79651035
Joint swelling	180.57	13.52	41	83722	288605	79372020
Nephritis	179.57	13.52	88	83675	4126	79656499
Dizziness	176.34	13.52	176	83587	526265	79134360
Eastern Cooperative Oncology Group performance status worsened	175.39	13.52	70	83693	1995	79658630
Immune-mediated hyperthyroidism	171.95	13.52	39	83724	128	79660497
Pemphigoid	170.49	13.52	136	83627	15179	79645446
Cholangitis	169.68	13.52	126	83637	12650	79647975
Headache	169.50	13.52	266	83497	653506	79007119
Immune-mediated adrenal insuficiency	166.94	13.52	40	83723	177	79660448
Autoimmune hypothyroidism	166.84	13.52	42	83721	237	79660388
Hepatic cytolysis	163.92	13.52	171	83592	26980	79633645
Tumour hyperprogression	163.80	13.52	39	83724	167	79660458
Pain	163.60	13.52	307	83456	703495	78957130
Off label use	160.60	13.52	1553	82210	905662	78754963
Renal impairment	157.76	13.52	442	83321	157341	79503284
Fulminant type 1 diabetes mellitus	157.00	13.52	59	83704	1424	79659201
Product use issue	152.51	13.52	526	83237	209296	79451329
Neutropenia	152.28	13.52	652	83111	287058	79373567
Contraindicated product administered	150.60	13.52	3	83760	157535	79503090
Diabetic ketoacidosis	148.08	13.52	181	83582	33941	79626684
Thrombocytopenia	148.06	13.52	611	83152	264648	79395977
Nasopharyngitis	147.35	13.52	42	83721	253839	79406786
Secondary adrenocortical insufficiency	146.83	13.52	69	83694	2945	79657680
Immune-mediated encephalitis	145.70	13.52	43	83720	472	79660153
Drug hypersensitivity	143.85	13.52	67	83696	298849	79361776
Hypopituitarism	141.91	13.52	70	83693	3329	79657296
Platelet count decreased	139.71	13.52	486	83277	194178	79466447
Immune-mediated nephritis	136.99	13.52	42	83721	530	79660095
Skin toxicity	135.77	13.52	93	83670	8221	79652404
Autoimmune thyroiditis	135.76	13.52	73	83690	4160	79656465
Overdose	135.33	13.52	17	83746	184189	79476436
Inappropriate schedule of product administration	134.20	13.52	375	83388	133253	79527372
Pyrexia	131.92	13.52	1186	82577	677523	78983102
Sinusitis	130.03	13.52	24	83739	195477	79465148
Diarrhoea	127.65	13.52	1448	82315	879041	78781584
Immune-mediated cholangitis	122.39	13.52	31	83732	180	79660445
Immune-mediated hypophysitis	122.37	13.52	30	83733	149	79660476
Dysphonia	121.51	13.52	216	83547	56656	79603969
Cholangitis sclerosing	121.20	13.52	58	83705	2579	79658046
Hypersensitivity	116.86	13.52	65	83698	262174	79398451
Abdominal discomfort	116.35	13.52	59	83704	250668	79409957
Arthropathy	115.12	13.52	23	83740	177088	79483537
Injection site pain	114.95	13.52	5	83758	129833	79530792
Swelling	114.86	13.52	42	83721	216669	79443956
Therapeutic product effect decreased	113.62	13.52	18	83745	163845	79496780
Polymyalgia rheumatica	112.25	13.52	66	83697	4471	79656154
Drug intolerance	111.29	13.52	70	83693	264049	79396576
Haemophagocytic lymphohistiocytosis	108.25	13.52	124	83639	21713	79638912
Hypertransaminasaemia	106.02	13.52	93	83670	11831	79648794
Myasthenic syndrome	105.79	13.52	38	83725	804	79659821
Synovitis	105.78	13.52	16	83747	150718	79509907
Toxicity to various agents	105.76	13.52	175	83588	421365	79239260
Hepatotoxicity	102.03	13.52	189	83574	51163	79609462
Immune thrombocytopenia	101.89	13.52	109	83654	17696	79642929
Adverse event	101.80	13.52	207	83556	60007	79600618
Pulmonary toxicity	101.57	13.52	94	83669	12820	79647805
Toxic epidermal necrolysis	100.00	13.52	173	83590	44408	79616217
Tumour associated fever	99.76	13.52	37	83726	860	79659765
Intentional overdose	97.53	13.52	3	83760	105957	79554668
Autoimmune arthritis	97.11	13.52	24	83739	124	79660501
Maternal exposure during pregnancy	96.95	13.52	14	83749	136524	79524101
Condition aggravated	96.81	13.52	242	83521	500882	79159743
Insomnia	96.55	13.52	70	83693	245100	79415525
Thyroid disorder	96.53	13.52	95	83668	13984	79646641
Pancytopenia	94.91	13.52	385	83378	165360	79495265
Depression	94.75	13.52	55	83708	216735	79443890
Musculoskeletal stiffness	94.29	13.52	33	83730	174975	79485650
Contusion	93.23	13.52	21	83742	148755	79511870
Drug ineffective	90.34	13.52	716	83047	1080197	78580428
Radiotherapy	90.10	13.52	31	83732	575	79660050
Peripheral swelling	89.11	13.52	91	83672	269526	79391099
Weight increased	89.01	13.52	96	83667	277290	79383335
Autoimmune nephritis	87.79	13.52	32	83731	707	79659918
Pemphigus	87.61	13.52	4	83759	99578	79561047
Neuropathy peripheral	83.90	13.52	332	83431	140973	79519652
Tumour haemorrhage	83.84	13.52	53	83710	4091	79656534
Subacute cutaneous lupus erythematosus	83.39	13.52	50	83713	3511	79657114
Pleural effusion	82.82	13.52	337	83426	144925	79515700
Hypothalamo-pituitary disorder	82.77	13.52	35	83728	1159	79659466
Immune-mediated cytopenia	82.69	13.52	18	83745	46	79660579
Pain in extremity	81.85	13.52	162	83601	364376	79296249
Eosinophilic fasciitis	81.52	13.52	24	83739	261	79660364
Immune-mediated endocrinopathy	80.98	13.52	17	83746	34	79660591
Acute kidney injury	79.86	13.52	865	82898	518539	79142086
Immune-mediated uveitis	78.95	13.52	19	83744	86	79660539
Adrenal disorder	77.22	13.52	40	83723	2111	79658514
Mobility decreased	77.04	13.52	17	83746	122158	79538467
Blood corticotrophin decreased	76.72	13.52	27	83736	537	79660088
Lymphocytic hypophysitis	76.35	13.52	27	83736	545	79660080
Radiation pneumonitis	76.33	13.52	49	83714	3884	79656741
Anaemia	75.89	13.52	757	83006	444258	79216367
Autoimmune pancreatitis	75.85	13.52	28	83735	642	79659983
Pericardial effusion	75.85	13.52	157	83606	46080	79614545
Wound	75.66	13.52	15	83748	116164	79544461
Muscle spasms	74.00	13.52	46	83717	174684	79485941
Discomfort	72.43	13.52	21	83742	125596	79535029
Autoimmune myocarditis	72.41	13.52	24	83739	395	79660230
Immune-mediated neurological disorder	72.35	13.52	14	83749	14	79660611
Intentional product misuse	71.81	13.52	8	83755	95157	79565468
Intentional product use issue	71.73	13.52	35	83728	152077	79508548
Blood cholesterol increased	71.62	13.52	4	83759	83716	79576909
Eyelid ptosis	71.07	13.52	72	83691	10972	79649653
Pneumonia bacterial	68.86	13.52	93	83670	19238	79641387
Asthma	68.54	13.52	28	83735	135067	79525558
Systemic lupus erythematosus	68.49	13.52	21	83742	121128	79539497
Urticaria	67.68	13.52	57	83706	185144	79475481
Troponin increased	67.62	13.52	92	83671	19163	79641462
Immune-mediated neuropathy	66.90	13.52	15	83748	46	79660579
Pericarditis malignant	66.19	13.52	15	83748	49	79660576
Glossodynia	65.92	13.52	14	83749	103323	79557302
Injury	65.39	13.52	4	83759	77492	79583133
Cholecystitis	64.58	13.52	97	83666	22115	79638510
Migraine	64.41	13.52	8	83755	87485	79573140
Suicidal ideation	64.23	13.52	4	83759	76336	79584289
Bronchitis	63.22	13.52	29	83734	130615	79530010
Neutrophil count decreased	62.54	13.52	229	83534	93730	79566895
Guillain-Barre syndrome	62.40	13.52	61	83702	8904	79651721
Liver disorder	61.92	13.52	192	83571	72225	79588400
Glucocorticoid deficiency	61.83	13.52	24	83739	634	79659991
Gastrointestinal perforation	60.94	13.52	51	83712	6086	79654539
Influenza	60.83	13.52	30	83733	129576	79531049
Rash maculo-papular	59.85	13.52	161	83602	55917	79604708
Treatment failure	58.07	13.52	56	83707	170430	79490195
Enteritis	57.89	13.52	74	83689	14509	79646116
Lichen planus	57.23	13.52	36	83727	2755	79657870
Metastases to central nervous system	57.14	13.52	78	83685	16297	79644328
Loss of personal independence in daily activities	55.82	13.52	19	83744	102561	79558064
Hypotension	55.34	13.52	256	83507	440061	79220564
Mucosal inflammation	55.27	13.52	190	83573	75390	79585235
Lower respiratory tract infection	54.73	13.52	34	83729	129186	79531439
Renal tubular necrosis	54.63	13.52	96	83667	24943	79635682
Cardiac failure congestive	54.30	13.52	42	83721	142360	79518265
Medication error	53.79	13.52	5	83758	68637	79591988
Taste disorder	53.15	13.52	74	83689	15749	79644876
Blood thyroid stimulating hormone abnormal	53.09	13.52	24	83739	936	79659689
International normalised ratio increased	52.98	13.52	12	83751	84709	79575916
Stress	52.42	13.52	10	83753	79602	79581023
Wheezing	51.80	13.52	29	83734	116635	79543990
Bradycardia	51.66	13.52	40	83723	135517	79525108
Osteoarthritis	51.43	13.52	14	83749	87295	79573330
Hepatocellular injury	51.15	13.52	137	83626	47456	79613169
Pulmonary embolism	51.12	13.52	332	83431	171322	79489303
Encephalitis	51.04	13.52	70	83693	14690	79645935
Drug eruption	50.83	13.52	130	83633	43805	79616820
Organising pneumonia	50.68	13.52	60	83703	10879	79649746
Encephalitis autoimmune	50.61	13.52	31	83732	2263	79658362
Anxiety	50.27	13.52	117	83646	248395	79412230
Agitation	50.04	13.52	21	83742	99694	79560931
Cortisol decreased	49.58	13.52	30	83733	2142	79658483
Small intestinal perforation	49.43	13.52	35	83728	3262	79657363
Upper respiratory tract infection	49.41	13.52	17	83746	91151	79569474
Coma	49.23	13.52	22	83741	100627	79559998
Tremor	49.03	13.52	64	83699	170019	79490606
Cancer pain	48.83	13.52	42	83721	5203	79655422
Stevens-Johnson syndrome	48.57	13.52	119	83644	39047	79621578
Meningitis aseptic	47.96	13.52	47	83716	6881	79653744
Hyperhidrosis	46.83	13.52	54	83709	151438	79509187
Arthralgia	46.49	13.52	381	83382	571422	79089203
Amylase increased	46.27	13.52	58	83705	11151	79649474
Respiratory failure	46.23	13.52	337	83426	180574	79480051
Infusion related reaction	46.08	13.52	109	83654	230128	79430497
Syncope	44.45	13.52	75	83688	179374	79481251
Cholestasis	44.39	13.52	138	83625	51971	79608654
Immune-mediated cystitis	44.28	13.52	10	83753	32	79660593
Nasal congestion	43.75	13.52	13	83750	76539	79584086
KL-6 increased	43.62	13.52	13	83750	148	79660477
Cardiac tamponade	43.17	13.52	51	83712	9225	79651400
Heart rate increased	43.06	13.52	38	83725	120686	79539939
Autoimmune haemolytic anaemia	42.23	13.52	48	83715	8332	79652293
Pulmonary sarcoidosis	42.08	13.52	23	83740	1354	79659271
Alopecia	42.07	13.52	115	83648	231240	79429385
Malignant pleural effusion	41.91	13.52	32	83731	3348	79657277
Blood thyroid stimulating hormone decreased	41.87	13.52	40	83723	5676	79654949
Transaminases increased	41.31	13.52	134	83629	51609	79609016
Aspartate aminotransferase increased	41.18	13.52	268	83495	138373	79522252
Unevaluable event	41.12	13.52	5	83758	55580	79605045
Silent thyroiditis	40.90	13.52	13	83750	186	79660439
Polyarthritis	40.89	13.52	57	83706	12145	79648480
Blood pressure systolic increased	40.87	13.52	10	83753	66976	79593649
Cardiac arrest	40.74	13.52	74	83689	172022	79488603
Adrenocortical insufficiency acute	40.38	13.52	30	83733	3013	79657612
Enterocolitis	40.24	13.52	62	83701	14450	79646175
Abdominal pain upper	40.14	13.52	112	83651	223707	79436918
Hallucination	40.00	13.52	20	83743	85725	79574900
Skin disorder	39.85	13.52	101	83662	33842	79626783
Lymphangiosis carcinomatosa	39.75	13.52	26	83737	2128	79658497
Metastatic malignant melanoma	39.73	13.52	29	83734	2834	79657791
Febrile bone marrow aplasia	39.49	13.52	58	83705	12962	79647663
Gastrooesophageal reflux disease	39.42	13.52	31	83732	104215	79556410
Ophthalmoplegia	39.29	13.52	29	83734	2883	79657742
Aggression	39.17	13.52	4	83759	50954	79609671
Paraneoplastic neurological syndrome	38.92	13.52	10	83753	62	79660563
Plasma cell myeloma	38.88	13.52	5	83758	53254	79607371
Chest discomfort	38.71	13.52	53	83710	137991	79522634
Folliculitis	38.56	13.52	6	83757	55374	79605251
Adrenalitis	38.49	13.52	9	83754	35	79660590
Heart rate decreased	38.30	13.52	13	83750	70303	79590322
Therapeutic product effect incomplete	38.12	13.52	56	83707	141589	79519036
Autoimmune cholangitis	37.78	13.52	8	83755	17	79660608
Tumour necrosis	37.43	13.52	24	83739	1898	79658727
Chest pain	37.31	13.52	161	83602	282143	79378482
Palpitations	37.15	13.52	47	83716	126563	79534062
Alanine aminotransferase increased	37.13	13.52	295	83468	162275	79498350
Hypersensitivity pneumonitis	36.98	13.52	31	83732	3708	79656917
Melanoma recurrent	36.92	13.52	13	83750	259	79660366
Loss of consciousness	36.47	13.52	76	83687	167867	79492758
Diabetes mellitus	36.36	13.52	171	83592	78219	79582406
Pneumothorax	36.13	13.52	87	83676	28236	79632389
Large intestine perforation	35.94	13.52	59	83704	14508	79646117
Duodenitis	35.76	13.52	43	83720	7924	79652701
Autoimmune endocrine disorder	35.16	13.52	6	83757	0	79660625
Wrong technique in product usage process	34.81	13.52	17	83746	73858	79586767
Urogenital fistula	34.77	13.52	11	83752	155	79660470
Fluid retention	34.54	13.52	15	83748	69794	79590831
Feeling hot	34.40	13.52	10	83753	59724	79600901
Respiratory arrest	34.33	13.52	9	83754	57541	79603084
Knee arthroplasty	34.29	13.52	3	83760	43245	79617380
Somnolence	34.27	13.52	132	83631	238849	79421776
Confusional state	34.19	13.52	195	83568	317802	79342823
Paraesthesia	34.07	13.52	85	83678	176238	79484387
Electrocardiogram QT prolonged	34.02	13.52	27	83736	90359	79570266
Psoriatic arthropathy	33.75	13.52	20	83743	77979	79582646
Haemoglobin decreased	33.60	13.52	120	83643	221999	79438626
Primary hypothyroidism	33.59	13.52	11	83752	174	79660451
Serotonin syndrome	33.43	13.52	4	83759	45023	79615602
Burning sensation	33.42	13.52	10	83753	58622	79602003
Autoimmune uveitis	33.34	13.52	7	83756	14	79660611
Cutaneous sarcoidosis	33.24	13.52	14	83749	459	79660166
Rash	33.13	13.52	818	82945	577540	79083085
Blood corticotrophin increased	32.86	13.52	11	83752	187	79660438
Atrioventricular block complete	32.81	13.52	61	83702	16549	79644076
Product dose omission issue	32.81	13.52	141	83622	247396	79413229
Drug-induced liver injury	32.71	13.52	147	83616	65970	79594655
Swelling face	32.63	13.52	17	83746	71195	79589430
Rheumatoid arthritis	32.63	13.52	111	83652	208359	79452266
Depressed level of consciousness	32.61	13.52	32	83731	96620	79564005
Myelitis transverse	32.31	13.52	22	83741	1925	79658700
Pain in jaw	32.13	13.52	5	83758	46146	79614479
Hospitalisation	32.02	13.52	31	83732	94205	79566420
Hypoaesthesia	31.97	13.52	90	83673	179262	79481363
Latent autoimmune diabetes in adults	31.53	13.52	9	83754	87	79660538
Treatment noncompliance	31.51	13.52	8	83755	52260	79608365
Gait disturbance	31.46	13.52	112	83651	207394	79453231
Blood pressure abnormal	31.38	13.52	61	83702	17108	79643517
Malignant ascites	31.23	13.52	18	83745	1174	79659451
Optic neuritis	31.20	13.52	44	83719	9476	79651149
Sedation	31.17	13.52	8	83755	51887	79608738
Uveitis	31.01	13.52	60	83703	16770	79643855
Myocardial infarction	30.93	13.52	95	83668	184034	79476591
Limbic encephalitis	30.63	13.52	16	83747	859	79659766
Lactic acidosis	30.50	13.52	18	83745	70341	79590284
Blister	30.45	13.52	49	83714	119427	79541198
Hepatitis toxic	30.31	13.52	32	83731	5115	79655510
Multiple sclerosis relapse	30.30	13.52	6	83757	46527	79614098
Tumour ulceration	29.89	13.52	11	83752	250	79660375
Myasthenia gravis crisis	29.71	13.52	17	83746	1094	79659531
Pericardial effusion malignant	29.66	13.52	10	83753	174	79660451
Haematoma	29.58	13.52	9	83754	52186	79608439
General physical health deterioration	29.53	13.52	429	83334	274809	79385816
Pericarditis	29.24	13.52	40	83723	104196	79556429
Lung disorder	29.18	13.52	164	83599	80393	79580232
Prescribed overdose	29.05	13.52	3	83760	37880	79622745
Tumour pain	29.02	13.52	22	83741	2277	79658348
Dermatitis	28.83	13.52	67	83696	21254	79639371
Lung opacity	28.42	13.52	31	83732	5143	79655482
Glomerulonephritis rapidly progressive	28.25	13.52	19	83744	1629	79658996
Drug effective for unapproved indication	27.94	13.52	33	83730	5968	79654657
Metastases to meninges	27.91	13.52	26	83737	3575	79657050
Hyponatraemia	27.58	13.52	297	83466	177551	79483074
Autoimmune lung disease	27.44	13.52	7	83756	42	79660583
Acquired gene mutation	27.38	13.52	21	83742	2212	79658413
Thrombophlebitis migrans	27.36	13.52	12	83751	435	79660190
Impaired healing	27.35	13.52	31	83732	87624	79573001
Morphoea	27.31	13.52	12	83751	437	79660188
Dermatitis psoriasiform	27.29	13.52	23	83740	2771	79657854
Seizure	27.26	13.52	104	83659	188730	79471895
Body surface area decreased	27.16	13.52	7	83756	44	79660581
Bursitis	27.07	13.52	3	83760	35841	79624784
Thyroid function test abnormal	26.97	13.52	24	83739	3110	79657515
Oropharyngeal pain	26.80	13.52	46	83717	109307	79551318
Erythema multiforme	26.70	13.52	58	83705	17593	79643032
Dermatitis bullous	26.51	13.52	51	83712	14194	79646431
Febrile neutropenia	26.36	13.52	364	83399	230635	79429990
Periarticular thenar erythema with onycholysis	26.27	13.52	7	83756	51	79660574
Osteoporosis	26.19	13.52	12	83751	54100	79606525
Cardiac failure	26.10	13.52	263	83500	154579	79506046
Abdominal distension	26.09	13.52	54	83709	119596	79541029
Pancreatic failure	26.08	13.52	18	83745	1610	79659015
Intestinal intraepithelial lymphocytes increased	25.96	13.52	9	83754	171	79660454
Gastrointestinal disorder	25.94	13.52	56	83707	122149	79538476
Miller Fisher syndrome	25.77	13.52	10	83753	264	79660361
Road traffic accident	25.72	13.52	7	83756	43657	79616968
Meningitis	25.26	13.52	40	83723	9542	79651083
Paraneoplastic syndrome	25.26	13.52	15	83748	1035	79659590
Product quality issue	25.23	13.52	3	83760	33937	79626688
Cryptitis	24.95	13.52	10	83753	288	79660337
Immune-mediated oesophagitis	24.93	13.52	5	83758	7	79660618
Autoimmune myositis	24.79	13.52	10	83753	293	79660332
Vision blurred	24.64	13.52	46	83717	105852	79554773
Immune-mediated encephalopathy	24.61	13.52	6	83757	29	79660596
Disease progression	24.60	13.52	299	83464	184063	79476562
Pulmonary hypertension	24.32	13.52	10	83753	48070	79612555
Hyperpyrexia	24.32	13.52	31	83732	6061	79654564
Primary adrenal insufficiency	24.31	13.52	9	83754	208	79660417
Hyperamylasaemia	24.03	13.52	15	83748	1132	79659493
Metabolic acidosis	23.83	13.52	31	83732	82498	79578127
Intestinal perforation	23.82	13.52	55	83708	17371	79643254
Tumour cavitation	23.81	13.52	6	83757	34	79660591
Psychotic disorder	23.71	13.52	7	83756	41395	79619230
Posterior reversible encephalopathy syndrome	23.69	13.52	71	83692	26210	79634415
Cerebral infarction	23.69	13.52	103	83660	45573	79615052
Sarcoid-like reaction	23.66	13.52	6	83757	35	79660590
Lipase increased	23.65	13.52	53	83710	16413	79644212
Irritability	23.48	13.52	7	83756	41137	79619488
Vascular access complication	23.48	13.52	19	83744	2163	79658462
Gastrointestinal tube removal	23.44	13.52	4	83759	0	79660625
Amputation stump pain	23.38	13.52	6	83757	37	79660588
Mixed liver injury	23.33	13.52	34	83729	7544	79653081
Product administration error	23.22	13.52	3	83760	31843	79628782
Nephropathy toxic	23.18	13.52	60	83703	20359	79640266
Dyskinesia	23.16	13.52	9	83754	44764	79615861
Pneumocystis jirovecii pneumonia	23.13	13.52	81	83682	32427	79628198
Colitis microscopic	23.12	13.52	41	83722	10727	79649898
Abnormal behaviour	23.09	13.52	5	83758	36416	79624209
Swollen tongue	22.96	13.52	8	83755	42562	79618063
Mixed deafness	22.91	13.52	5	83758	13	79660612
Joint injury	22.73	13.52	3	83760	31332	79629293
Accidental exposure to product	22.72	13.52	3	83760	31319	79629306
Apoptosis	22.58	13.52	11	83752	509	79660116
Thyroid hormones increased	22.50	13.52	11	83752	513	79660112
Hip arthroplasty	22.48	13.52	5	83758	35751	79624874
Emotional distress	22.45	13.52	7	83756	39962	79620663
Aspartate aminotransferase abnormal	22.43	13.52	17	83746	1759	79658866
Transitional cell carcinoma metastatic	22.37	13.52	6	83757	45	79660580
Joint range of motion decreased	22.29	13.52	4	83759	33278	79627347
Dermatomyositis	22.19	13.52	23	83740	3600	79657025
Melanosis	22.14	13.52	6	83757	47	79660578
Cortisol increased	22.09	13.52	11	83752	534	79660091
Autoimmune encephalopathy	21.97	13.52	7	83756	101	79660524
Stomatitis	21.79	13.52	243	83520	146514	79514111
Coronary artery disease	21.71	13.52	22	83741	65452	79595173
C-reactive protein abnormal	21.50	13.52	12	83751	48355	79612270
Bacterial diarrhoea	21.49	13.52	8	83755	188	79660437
Restlessness	21.45	13.52	11	83752	46481	79614144
Autoimmune neuropathy	21.25	13.52	7	83756	113	79660512
Gamma-glutamyltransferase abnormal	20.98	13.52	11	83752	595	79660030
Cytokine release syndrome	20.87	13.52	84	83679	35914	79624711
Radiation associated pain	20.80	13.52	7	83756	121	79660504
EGFR gene mutation	20.70	13.52	10	83753	454	79660171
Pancreatitis	20.62	13.52	133	83630	68442	79592183
Lung adenocarcinoma recurrent	20.53	13.52	5	83758	24	79660601
Dyspepsia	20.52	13.52	53	83710	108634	79551991
Drug level increased	20.46	13.52	8	83755	39643	79620982
Neurofibrosarcoma	20.45	13.52	8	83755	216	79660409
Microvillous inclusion disease	20.41	13.52	8	83755	217	79660408
Right ventricular ejection fraction decreased	20.40	13.52	6	83757	65	79660560
Serous retinal detachment	20.36	13.52	13	83750	1021	79659604
Night sweats	20.32	13.52	15	83748	52080	79608545
Blood bilirubin increased	20.25	13.52	129	83634	66103	79594522
Cytokine storm	20.22	13.52	13	83750	1033	79659592
Sciatica	20.19	13.52	5	83758	33217	79627408
No adverse event	20.16	13.52	85	83678	37107	79623518
Thyrotoxic crisis	20.11	13.52	14	83749	1270	79659355
Oedema peripheral	20.03	13.52	169	83594	252119	79408506
Obesity	20.00	13.52	6	83757	35119	79625506
Nephrolithiasis	19.95	13.52	16	83747	53275	79607350
Oligodipsia	19.74	13.52	5	83758	29	79660596
Hyperglycaemia	19.69	13.52	134	83629	70201	79590424
Orthostatic hypotension	19.64	13.52	18	83745	56146	79604479
Sarcoidosis	19.55	13.52	33	83730	8302	79652323
Polyglandular autoimmune syndrome type II	19.46	13.52	5	83758	31	79660594
Therapeutic response decreased	19.42	13.52	25	83738	66828	79593797
Laryngopharyngitis	19.41	13.52	6	83757	78	79660547
Diffuse uveal melanocytic proliferation	19.40	13.52	4	83759	7	79660618
Haemoglobin abnormal	19.37	13.52	30	83733	7024	79653601
Probiotic therapy	19.27	13.52	7	83756	153	79660472
Sleep disorder	19.25	13.52	38	83725	85639	79574986
Autoimmune dermatitis	19.06	13.52	7	83756	158	79660467
Amnesia	18.92	13.52	23	83740	63034	79597591
Flagellate dermatitis	18.92	13.52	8	83755	265	79660360
Blood lactate dehydrogenase abnormal	18.83	13.52	8	83755	268	79660357
Breast cancer	18.83	13.52	6	83757	33775	79626850
Accidental overdose	18.81	13.52	9	83754	39572	79621053
Angina pectoris	18.79	13.52	16	83747	51716	79608909
Disorientation	18.73	13.52	23	83740	62753	79597872
Female genital tract fistula	18.67	13.52	27	83736	5948	79654677
SJS-TEN overlap	18.67	13.52	11	83752	748	79659877
Viral infection	18.65	13.52	11	83752	43005	79617620
Systemic scleroderma	18.63	13.52	13	83750	1184	79659441
Cancer fatigue	18.62	13.52	7	83756	169	79660456
Cachexia	18.60	13.52	38	83725	11045	79649580
Endocrine toxicity	18.44	13.52	4	83759	10	79660615
Ureteric dilatation	18.43	13.52	7	83756	174	79660451
Allergic colitis	18.35	13.52	5	83758	40	79660585
Joint stiffness	18.33	13.52	10	83753	40820	79619805
Ascites	18.28	13.52	139	83624	75423	79585202
Autoimmune retinopathy	18.16	13.52	4	83759	11	79660614
Physical deconditioning	18.11	13.52	16	83747	2054	79658571
Incorrect route of product administration	18.10	13.52	7	83756	34922	79625703
Adverse drug reaction	18.10	13.52	26	83737	66366	79594259
Radiation necrosis	18.09	13.52	9	83754	436	79660189
Renal tubular injury	18.00	13.52	14	83749	1505	79659120
Feeling abnormal	17.98	13.52	96	83667	159103	79501522
Transitional cell carcinoma recurrent	17.91	13.52	4	83759	12	79660613
Heart rate irregular	17.87	13.52	6	83757	32673	79627952
Infection	17.83	13.52	165	83598	241547	79419078
Pulmonary granuloma	17.77	13.52	16	83747	2105	79658520
Rhinorrhoea	17.74	13.52	33	83730	76041	79584584
Haemoptysis	17.70	13.52	110	83653	55889	79604736
Cardiac disorder	17.68	13.52	26	83737	65731	79594894
Autoimmune pericarditis	17.58	13.52	3	83760	0	79660625
Oesophagomediastinal fistula	17.58	13.52	3	83760	0	79660625
Ileus	17.53	13.52	64	83699	26147	79634478
Weight abnormal	17.47	13.52	14	83749	1572	79659053
Tumour rupture	17.46	13.52	9	83754	470	79660155
BRAF V600E mutation positive	17.45	13.52	5	83758	49	79660576
Neutrophil count abnormal	17.43	13.52	20	83743	3506	79657119
Trichoglossia	17.40	13.52	10	83753	649	79659976
Cardiomyopathy	17.37	13.52	68	83695	28706	79631919
Throat tightness	17.35	13.52	4	83759	27903	79632722
Neck pain	17.33	13.52	33	83730	75384	79585241
Eye pain	17.17	13.52	9	83754	37569	79623056
Blood alkaline phosphatase abnormal	17.14	13.52	11	83752	871	79659754
Memory impairment	17.13	13.52	60	83703	111674	79548951
Bilirubin conjugated abnormal	17.02	13.52	6	83757	120	79660505
Poisoning	17.01	13.52	3	83760	25269	79635356
Ketoacidosis	16.98	13.52	30	83733	7824	79652801
Chronic kidney disease	16.98	13.52	27	83736	66127	79594498
Cytomegalovirus enterocolitis	16.95	13.52	14	83749	1641	79658984
Nervousness	16.82	13.52	7	83756	33408	79627217
Malaise	16.79	13.52	651	83112	489218	79171407
Haematocrit decreased	16.72	13.52	24	83739	61288	79599337
Platelet count abnormal	16.72	13.52	23	83740	4839	79655786
Primary biliary cholangitis	16.71	13.52	12	83751	1143	79659482
Blood pressure fluctuation	16.67	13.52	28	83735	67117	79593508
Gallbladder enlargement	16.67	13.52	14	83749	1679	79658946
Full blood count abnormal	16.65	13.52	11	83752	40463	79620162
Pneumocystis test positive	16.64	13.52	4	83759	18	79660607
Balance disorder	16.59	13.52	51	83712	98806	79561819
Blood corticotrophin abnormal	16.54	13.52	5	83758	60	79660565
Back pain	16.37	13.52	223	83540	303957	79356668
Vogt-Koyanagi-Harada disease	16.27	13.52	7	83756	242	79660383
Unmasking of previously unidentified disease	16.23	13.52	15	83748	2042	79658583
Stress cardiomyopathy	16.11	13.52	36	83727	11130	79649495
Vascular purpura	16.04	13.52	18	83745	3080	79657545
Ischaemic stroke	15.89	13.52	73	83690	33058	79627567
Visual impairment	15.84	13.52	47	83716	92084	79568541
Lymphadenectomy	15.79	13.52	12	83751	1247	79659378
Feeding disorder	15.69	13.52	45	83718	16209	79644416
Circumstance or information capable of leading to medication error	15.62	13.52	20	83743	3928	79656697
Oxygen saturation decreased	15.60	13.52	76	83687	128971	79531654
Granulocyte count increased	15.57	13.52	12	83751	1273	79659352
Paraneoplastic dermatomyositis	15.51	13.52	5	83758	75	79660550
Superior vena cava stenosis	15.50	13.52	3	83760	3	79660622
Ulcerative duodenitis	15.50	13.52	3	83760	3	79660622
Cardio-respiratory arrest	15.50	13.52	60	83703	108450	79552175
Lymphadenopathy mediastinal	15.43	13.52	21	83742	4375	79656250
Vital functions abnormal	15.41	13.52	10	83753	807	79659818
Aortic embolus	15.39	13.52	5	83758	77	79660548
Dysphagia	15.39	13.52	196	83567	121940	79538685
Cataract	15.34	13.52	26	83737	62094	79598531
Rash morbilliform	15.29	13.52	25	83738	6125	79654500
Pancreatectomy	15.28	13.52	4	83759	27	79660598
Metastases to adrenals	15.20	13.52	12	83751	1318	79659307
Urinary tract infection enterococcal	15.14	13.52	18	83745	3277	79657348
Leukoderma	15.13	13.52	6	83757	168	79660457
Autoimmune blistering disease	15.04	13.52	3	83760	4	79660621
Septic shock	15.02	13.52	196	83567	122605	79538020
Anaphylactic reaction	14.93	13.52	42	83721	83701	79576924
Skin depigmentation	14.86	13.52	11	83752	1099	79659526
Antinuclear antibody	14.82	13.52	8	83755	459	79660166
Oesophageal fistula	14.79	13.52	8	83755	461	79660164
Pulse abnormal	14.75	13.52	18	83745	3366	79657259
Hospice care	14.57	13.52	33	83730	10291	79650334
Hepatic steatosis	14.54	13.52	11	83752	37727	79622898
Acute coronary syndrome	14.47	13.52	52	83711	21081	79639544
Acute polyneuropathy	14.46	13.52	8	83755	482	79660143
Angioedema	14.41	13.52	37	83726	75998	79584627
Gliosis	14.34	13.52	8	83755	490	79660135
Influenza like illness	14.29	13.52	34	83729	71673	79588952
Basal cell carcinoma	14.27	13.52	11	83752	37364	79623261
Herpes zoster	14.26	13.52	50	83713	93033	79567592
Troponin T increased	14.18	13.52	18	83745	3504	79657121
Tachycardia	14.14	13.52	119	83644	177649	79482976
Gastroduodenal ulcer	14.11	13.52	8	83755	506	79660119
Rheumatic disorder	14.10	13.52	17	83746	3141	79657484
Vanishing bile duct syndrome	14.09	13.52	13	83750	1765	79658860
Cystitis	14.03	13.52	21	83742	52711	79607914
Hypoglycaemia	13.98	13.52	57	83706	101537	79559088
Femur fracture	13.98	13.52	12	83751	38640	79621985
Benign mediastinal neoplasm	13.89	13.52	4	83759	40	79660585
Fungal infection	13.87	13.52	14	83749	41734	79618891
Renal failure	13.87	13.52	292	83471	200676	79459949
Respiratory disorder	13.84	13.52	16	83747	44840	79615785
Immunodeficiency	13.77	13.52	3	83760	21765	79638860
Gastric perforation	13.74	13.52	19	83744	4018	79656607
Tendonitis	13.70	13.52	4	83759	23826	79636799
Cheilitis	13.67	13.52	22	83741	5319	79655306
Myoclonus	13.59	13.52	6	83757	27654	79632971
Cholestatic liver injury	13.55	13.52	21	83742	4920	79655705

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	L01FF02	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
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
Unresectable urothelial carcinoma	indication	27090000	DOID:2671
Non-small cell lung cancer	indication	254637007	DOID:3908
Endometrial carcinoma progressing after chemotherapy	indication	254878006	DOID:2871
Malignant tumor of head and/or neck	indication	255056009
Squamous cell carcinoma of esophagus	indication	276804009	DOID:3748
Advanced or recurrent cervical cancer	indication	363354003	DOID:4362
Metastatic malignant melanoma	indication	443493003
Metastatic renal cell carcinoma	indication	702392008
Triple negative breast neoplasms	indication	706970001
Microsatellite instability-high colorectal cancer	indication	737058005
Classical Hodgkin lymphoma	indication	762690000
HER2-negative breast cancer	indication	767444009

🐶 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	10		IUPHAR	DRUG LABEL

External reference:

ID	Source
D10574	KEGG_DRUG
4033703	VUID
N0000191088	NUI
4033703	VANDF
CHEMBL3137343	ChEMBL_ID
C582435	MESH_SUPPLEMENTAL_RECORD_UI
7499	IUPHAR_LIGAND_ID
DB09037	DRUGBANK_ID
1547545	RXNORM
228586	MMSL
30533	MMSL
d08287	MMSL
015666	NDDF
716125002	SNOMEDCT_US
763541003	SNOMEDCT_US
C3658706	UMLSCUI
9798	INN_ID
DPT0O3T46P	UNII

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
KEYTRUDA	HUMAN PRESCRIPTION DRUG LABEL	1	0006-3026	INJECTION, SOLUTION	25 mg	INTRAVENOUS	BLA	30 sections
KEYTRUDA	HUMAN PRESCRIPTION DRUG LABEL	1	0006-3026	INJECTION, SOLUTION	25 mg	INTRAVENOUS	BLA	30 sections
KEYTRUDA	HUMAN PRESCRIPTION DRUG LABEL	1	0006-3026	INJECTION, SOLUTION	25 mg	INTRAVENOUS	BLA	30 sections
KEYTRUDA	HUMAN PRESCRIPTION DRUG LABEL	1	0006-3026	INJECTION, SOLUTION	25 mg	INTRAVENOUS	BLA	30 sections
KEYTRUDA	HUMAN PRESCRIPTION DRUG LABEL	1	0006-3026	INJECTION, SOLUTION	25 mg	INTRAVENOUS	BLA	30 sections
KEYTRUDA	HUMAN PRESCRIPTION DRUG LABEL	1	0006-3029	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	50 mg	INTRAVENOUS	BLA	30 sections
KEYTRUDA	HUMAN PRESCRIPTION DRUG LABEL	1	0006-3029	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	50 mg	INTRAVENOUS	BLA	30 sections
KEYTRUDA	HUMAN PRESCRIPTION DRUG LABEL	1	0006-3029	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	50 mg	INTRAVENOUS	BLA	30 sections
KEYTRUDA	HUMAN PRESCRIPTION DRUG LABEL	1	0006-3029	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	50 mg	INTRAVENOUS	BLA	30 sections
KEYTRUDA	HUMAN PRESCRIPTION DRUG LABEL	1	0006-3029	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	50 mg	INTRAVENOUS	BLA	30 sections