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

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

Stem definition	Drug id	CAS RN
human origin	4966	815610-63-0

Description:

Molecule	Description
Synonyms: ustekinumab stelara CNTO 1275 CNTO-1275	A humanized monoclonal antibody that binds to IL-12 and IL-23 and is used as a DERMATOLOGIC AGENT in the treatment of patients with plaque PSORIASIS who have not responded to other therapies. Molecular weight: Formula: CLOGP: LIPINSKI: None HAC: None HDO: None TPSA: ALOGS: ROTB: None

Drug dosage:

Dose	Unit	Route
0.54	mg	P

ADMET properties:

None

Approvals:

Date	Agency	Company	Orphan
Jan. 1, 2009	EMA
Sept. 25, 2009	FDA	CENTOCOR ORTHO BIOTECH INC
March 25, 2020	PMDA	Janssen Pharmaceutical 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
Product dose omission issue	1506.01	17.84	2260	145711	232053	63108998
Product use issue	1388.32	17.84	2107	145864	218413	63122638
Rheumatoid factor positive	1188.28	17.84	1210	146761	83196	63257855
Anti-cyclic citrullinated peptide antibody positive	1093.30	17.84	1350	146621	114862	63226189
Synovitis	1066.71	17.84	1708	146263	185210	63155841
Pericarditis	986.62	17.84	1367	146604	130212	63210839
Syringe issue	897.83	17.84	313	147658	2556	63338495
Wound	856.79	17.84	1437	146534	161826	63179225
Infusion related reaction	833.26	17.84	1794	146177	243727	63097324
Hepatic enzyme increased	822.05	17.84	1593	146378	200735	63140316
Hand deformity	814.78	17.84	1387	146584	158070	63182981
Off label use	781.45	17.84	3368	144603	671094	62669957
Discomfort	762.08	17.84	1384	146587	165990	63175061
Glossodynia	735.70	17.84	1416	146555	177460	63163591
Drug ineffective	731.01	17.84	4528	143443	1040237	62300814
Treatment failure	709.07	17.84	1484	146487	197559	63143492
Pemphigus	693.47	17.84	1403	146568	182323	63158728
Systemic lupus erythematosus	672.45	17.84	1495	146476	207423	63133628
Rheumatic fever	648.30	17.84	641	147330	42470	63298581
Drug intolerance	611.65	17.84	1840	146131	306821	63034230
Arthropathy	580.21	17.84	1517	146454	233275	63107776
Helicobacter infection	568.59	17.84	877	147094	91908	63249143
Therapeutic product effect decreased	566.71	17.84	1333	146638	191854	63149197
Duodenal ulcer perforation	556.54	17.84	840	147131	86369	63254682
Swollen joint count increased	554.95	17.84	543	147428	35511	63305540
Toxicity to various agents	530.91	17.84	9	147962	247241	63093810
General physical health deterioration	512.50	17.84	1316	146655	200086	63140965
Psoriatic arthropathy	474.65	17.84	802	147169	90718	63250333
Type 2 diabetes mellitus	472.66	17.84	660	147311	63208	63277843
Alopecia	464.32	17.84	1781	146190	335755	63005296
Blood cholesterol increased	456.16	17.84	800	147171	93232	63247819
Hypotension	437.25	17.84	59	147912	272545	63068506
Acute kidney injury	434.63	17.84	52	147919	263363	63077688
Rheumatoid arthritis	425.27	17.84	1429	146542	252390	63088661
Drug interaction	412.81	17.84	32	147939	229099	63111952
Hypersensitivity	400.30	17.84	1542	146429	291143	63049908
Death	399.11	17.84	187	147784	374194	62966857
Joint swelling	389.82	17.84	1653	146318	326013	63015038
Contraindicated product administered	388.29	17.84	1252	146719	216396	63124655
Abdominal discomfort	384.20	17.84	1622	146349	319263	63021788
Anaemia	368.54	17.84	113	147858	293317	63047734
Exposure during pregnancy	361.39	17.84	983	146988	154564	63186487
Neutropenia	361.33	17.84	10	147961	174995	63166056
Swelling	357.13	17.84	1427	146544	273951	63067100
Dyspnoea	343.33	17.84	638	147333	660675	62680376
Psoriasis	339.34	17.84	674	147297	86283	63254768
Completed suicide	322.71	17.84	3	147968	145670	63195381
Blister	320.27	17.84	839	147132	128975	63212076
Fall	320.14	17.84	267	147704	392067	62948984
Musculoskeletal stiffness	317.40	17.84	1049	146922	183569	63157482
Hip arthroplasty	310.96	17.84	464	147507	47182	63293869
Needle issue	290.07	17.84	220	147751	10156	63330895
Inappropriate schedule of product administration	284.57	17.84	699	147272	103266	63237785
Intestinal resection	269.38	17.84	132	147839	2716	63338335
Somnolence	267.38	17.84	47	147924	178638	63162413
Knee arthroplasty	261.16	17.84	460	147511	53746	63287305
Mobility decreased	253.11	17.84	737	147234	120422	63220629
Adverse drug reaction	253.04	17.84	568	147403	79146	63261905
Injury	247.28	17.84	535	147436	72712	63268339
Condition aggravated	246.54	17.84	1692	146279	400525	62940526
Product storage error	244.64	17.84	233	147738	14723	63326328
Hyponatraemia	240.31	17.84	4	147967	111896	63229155
Thrombocytopenia	236.82	17.84	35	147936	151122	63189929
Constipation	230.85	17.84	118	147853	224825	63116226
Maternal exposure during pregnancy	227.09	17.84	1065	146906	218997	63122054
Disease progression	218.56	17.84	18	147953	122740	63218311
Adverse event	218.44	17.84	485	147486	67074	63273977
White blood cell count decreased	209.36	17.84	36	147935	139068	63201983
Drug tolerance decreased	207.31	17.84	229	147742	17244	63323807
Pancytopenia	202.03	17.84	5	147966	96928	63244123
Liver injury	201.92	17.84	440	147531	60080	63280971
Platelet count decreased	198.75	17.84	20	147951	116102	63224949
Hypokalaemia	197.11	17.84	11	147960	103793	63237258
Therapy non-responder	193.65	17.84	497	147474	75404	63265647
Haemoglobin decreased	193.65	17.84	50	147921	145435	63195616
Cough	193.24	17.84	239	147732	292504	63048547
Lower respiratory tract infection	190.21	17.84	709	147262	131598	63209453
Fibromyalgia	184.30	17.84	506	147465	79914	63261137
Cardiac arrest	181.48	17.84	8	147963	92537	63248514
Oxygen saturation decreased	179.37	17.84	6	147965	88579	63252472
Dehydration	176.23	17.84	92	147879	173262	63167789
Prescribed overdose	175.15	17.84	298	147673	33855	63307196
Tremor	173.05	17.84	47	147924	132192	63208859
Bone erosion	172.94	17.84	210	147761	17507	63323544
Neuropathy peripheral	171.96	17.84	29	147942	113638	63227413
Exostosis	165.13	17.84	206	147765	17656	63323395
Retinitis	163.60	17.84	127	147844	6069	63334982
C-reactive protein abnormal	162.80	17.84	343	147628	45753	63295298
Renal failure	161.30	17.84	38	147933	117614	63223437
Hepatic cirrhosis	160.07	17.84	240	147731	24494	63316557
Joint dislocation	158.32	17.84	207	147764	18593	63322458
Rash	157.22	17.84	1995	145976	558876	62782175
Back pain	149.09	17.84	241	147730	263904	63077147
Bradycardia	148.11	17.84	5	147966	73222	63267829
Atrial fibrillation	147.89	17.84	44	147927	116592	63224459
Intentional product use issue	145.22	17.84	637	147334	127255	63213796
Folliculitis	145.07	17.84	426	147545	69891	63271160
Balance disorder	143.26	17.84	15	147956	84407	63256644
Asthenia	142.08	17.84	441	147530	383163	62957888
Deep vein thrombosis postoperative	141.82	17.84	153	147818	11216	63329835
Pleural effusion	140.50	17.84	24	147947	93186	63247865
Chills	139.75	17.84	45	147926	113333	63227718
Lip dry	139.16	17.84	176	147795	15294	63325757
Enthesopathy	132.96	17.84	130	147841	8484	63332567
Colectomy	132.34	17.84	80	147891	2526	63338525
Facet joint syndrome	131.91	17.84	152	147819	11986	63329065
Respiratory failure	131.76	17.84	37	147934	101821	63239230
Depressed level of consciousness	130.12	17.84	3	147968	62075	63278976
Pyrexia	127.84	17.84	613	147358	469865	62871186
Gastrointestinal haemorrhage	126.62	17.84	19	147952	81157	63259894
Irritable bowel syndrome	124.56	17.84	449	147522	81963	63259088
Live birth	124.04	17.84	218	147753	25412	63315639
Leukopenia	123.10	17.84	17	147954	77273	63263778
X-ray abnormal	122.58	17.84	121	147850	7989	63333062
Coma	121.63	17.84	7	147964	64357	63276694
Hypoxia	121.21	17.84	4	147967	59788	63281263
Blood pressure increased	118.06	17.84	122	147849	161940	63179111
Agitation	114.47	17.84	6	147965	59751	63281300
Cardio-respiratory arrest	111.85	17.84	7	147964	59952	63281099
Lupus-like syndrome	111.46	17.84	157	147814	15138	63325913
Adjustment disorder with depressed mood	111.26	17.84	128	147843	10076	63330975
Overdose	111.22	17.84	65	147906	115013	63226038
Feeling abnormal	110.03	17.84	110	147861	148282	63192769
Peripheral venous disease	110.03	17.84	157	147814	15320	63325731
Nausea	109.95	17.84	1371	146600	853100	62487951
Syncope	109.68	17.84	69	147902	117316	63223735
Loss of consciousness	109.59	17.84	70	147901	118051	63223000
Seizure	109.47	17.84	89	147882	132545	63208506
Cardiac failure	108.76	17.84	36	147935	89106	63251945
Tachycardia	108.28	17.84	71	147900	118085	63222966
Muscle injury	108.24	17.84	367	147604	64978	63276073
Cardiac failure congestive	108.18	17.84	40	147931	92393	63248658
Anal abscess	107.46	17.84	88	147883	4544	63336507
Hypoglycaemia	106.35	17.84	9	147962	60056	63280995
Pulmonary embolism	105.74	17.84	71	147900	116613	63224438
Basal cell carcinoma	105.53	17.84	214	147757	27777	63313274
Blood pressure decreased	104.26	17.84	14	147957	65008	63276043
Hallucination	103.46	17.84	6	147965	54811	63286240
Pustular psoriasis	101.31	17.84	85	147886	4541	63336510
Sepsis	100.92	17.84	125	147846	152998	63188053
Renal impairment	100.47	17.84	40	147931	88315	63252736
Autoimmune disorder	100.37	17.84	159	147812	17018	63324033
Cognitive disorder	99.83	17.84	8	147963	55807	63285244
Therapeutic response decreased	99.67	17.84	343	147628	61182	63279869
Joint range of motion decreased	97.21	17.84	226	147745	32202	63308849
Hyperhidrosis	95.87	17.84	67	147904	107769	63233282
Mucosal inflammation	95.62	17.84	3	147968	46925	63294126
Suicide attempt	95.60	17.84	14	147957	60904	63280147
Diarrhoea	95.22	17.84	1139	146832	714227	62626824
Dyspnoea exertional	94.31	17.84	14	147957	60288	63280763
Foot deformity	93.42	17.84	203	147768	27650	63313401
Epistaxis	92.97	17.84	27	147944	72698	63268353
Red blood cell sedimentation rate increased	92.16	17.84	268	147703	43714	63297337
Weight decreased	90.92	17.84	335	147636	276463	63064588
Red blood cell sedimentation rate	89.78	17.84	81	147890	4773	63336278
Multiple organ dysfunction syndrome	89.16	17.84	13	147958	56739	63284312
Pulmonary fibrosis	88.69	17.84	248	147723	39561	63301490
Dislocation of vertebra	88.61	17.84	105	147866	8530	63332521
Anti-cyclic citrullinated peptide antibody	86.14	17.84	92	147879	6666	63334385
Deep vein thrombosis	85.81	17.84	44	147927	83756	63257295
Tongue disorder	85.23	17.84	114	147857	10466	63330585
Pulmonary oedema	85.21	17.84	13	147958	54860	63286191
Arthralgia	85.07	17.84	1828	146143	567882	62773169
Blood pressure fluctuation	84.65	17.84	6	147965	46311	63294740
Osteoarthritis	84.33	17.84	442	147529	94901	63246150
Heart rate increased	81.87	17.84	60	147911	94178	63246873
Vomiting	81.83	17.84	872	147099	558745	62782306
Productive cough	81.66	17.84	23	147948	63185	63277866
Gastrooesophageal reflux disease	81.65	17.84	62	147909	95577	63245474
Blood parathyroid hormone decreased	81.18	17.84	107	147864	9684	63331367
Heart rate decreased	80.18	17.84	7	147964	45553	63295498
Palpitations	79.75	17.84	87	147884	112683	63228368
Myalgia	79.52	17.84	137	147834	146392	63194659
Rhabdomyolysis	79.44	17.84	6	147965	43945	63297106
Drug level decreased	79.13	17.84	95	147876	7824	63333227
Hypercholesterolaemia	79.11	17.84	162	147809	21172	63319879
Haematocrit decreased	78.46	17.84	3	147968	39337	63301714
Wound infection	76.37	17.84	160	147811	21250	63319801
Interstitial lung disease	75.51	17.84	25	147946	61883	63279168
Inflammation	75.24	17.84	385	147586	81888	63259163
Fluid retention	74.76	17.84	23	147948	59663	63281388
Sleep disorder due to general medical condition, insomnia type	74.26	17.84	279	147692	51938	63289113
Pain in jaw	73.09	17.84	8	147963	43488	63297563
Panniculitis	72.98	17.84	110	147861	11275	63329776
Product use in unapproved indication	71.49	17.84	684	147287	178396	63162655
Granuloma skin	71.19	17.84	93	147878	8344	63332707
Skin haemorrhage	71.17	17.84	102	147869	9992	63331059
Accidental exposure to product	70.41	17.84	180	147791	27225	63313826
Arthritis	70.27	17.84	487	147484	115434	63225617
Grip strength decreased	69.75	17.84	158	147813	22129	63318922
Hyperglycaemia	69.60	17.84	8	147963	41859	63299192
Red blood cell count decreased	69.52	17.84	7	147964	40638	63300413
Blood glucose increased	69.34	17.84	56	147915	83700	63257351
Osteonecrosis of jaw	68.96	17.84	3	147968	35120	63305931
Tenosynovitis	68.91	17.84	119	147852	13676	63327375
Lupus vulgaris	68.41	17.84	77	147894	5917	63335134
Prescribed underdose	68.15	17.84	187	147784	29502	63311549
Encephalopathy	67.79	17.84	6	147965	38614	63302437
Breast cancer stage III	67.51	17.84	101	147870	10285	63330766
Blood bilirubin increased	67.33	17.84	5	147966	37135	63303916
Mental status changes	67.26	17.84	7	147964	39592	63301459
Suicidal ideation	66.60	17.84	31	147940	62390	63278661
Cutaneous T-cell lymphoma	66.58	17.84	41	147930	1339	63339712
Drug reaction with eosinophilia and systemic symptoms	66.07	17.84	3	147968	33833	63307218
Unresponsive to stimuli	66.03	17.84	3	147968	33813	63307238
Neurologic neglect syndrome	65.88	17.84	53	147918	2668	63338383
Chronic kidney disease	65.58	17.84	13	147958	45385	63295666
Injection site pain	65.39	17.84	127	147844	129673	63211378
Disorientation	64.44	17.84	8	147963	39444	63301607
Rectal abscess	64.16	17.84	39	147932	1244	63339807
Carotid artery thrombosis	62.56	17.84	52	147919	2742	63338309
Urinary tract infection	62.15	17.84	362	147609	264322	63076729
Liquid product physical issue	61.87	17.84	37	147934	1145	63339906
Anxiety	61.54	17.84	279	147692	217262	63123789
Dizziness	61.51	17.84	673	147298	429252	62911799
Gastric disorder	61.09	17.84	209	147762	37160	63303891
Laryngitis	60.75	17.84	127	147844	16840	63324211
Drug delivery system malfunction	60.49	17.84	36	147935	1104	63339947
Injection site erythema	60.10	17.84	63	147908	83111	63257940
No adverse event	59.51	17.84	12	147959	41393	63299658
Cardiac disorder	59.43	17.84	22	147949	50794	63290257
Product leakage	59.33	17.84	32	147939	809	63340242
Skin necrosis	59.06	17.84	112	147859	13838	63327213
Joint stiffness	58.94	17.84	223	147748	41646	63299405
Septic shock	58.41	17.84	42	147929	66587	63274464
Disturbance in attention	57.17	17.84	10	147961	38179	63302872
Skin plaque	57.09	17.84	83	147888	8237	63332814
Impaired healing	57.05	17.84	422	147549	102120	63238931
Ileostomy	56.58	17.84	38	147933	1444	63339607
Pneumonia aspiration	56.42	17.84	7	147964	34533	63306518
Restlessness	56.27	17.84	3	147968	29450	63311601
Cholestasis	56.23	17.84	3	147968	29431	63311620
C-reactive protein	56.21	17.84	63	147908	4819	63336232
Femur fracture	56.20	17.84	14	147957	41742	63299309
Urinary incontinence	56.12	17.84	5	147966	32009	63309042
Therapeutic product effect incomplete	55.63	17.84	489	147482	124567	63216484
Orthostatic hypotension	55.16	17.84	9	147962	36151	63304900
Intestinal stenosis	55.07	17.84	49	147922	2835	63338216
Serotonin syndrome	54.55	17.84	3	147968	28679	63312372
Coronary artery disease	54.29	17.84	6	147965	32371	63308680
Tinnitus	54.06	17.84	9	147962	35619	63305432
Acute respiratory failure	53.93	17.84	8	147963	34477	63306574
Anal fistula	53.70	17.84	53	147918	3498	63337553
Lethargy	53.58	17.84	32	147939	55975	63285076
Rash maculo-papular	53.25	17.84	6	147965	31890	63309161
Pulmonary hypertension	52.85	17.84	11	147960	37112	63303939
Respiratory distress	52.81	17.84	8	147963	33943	63307108
Tendonitis	52.65	17.84	131	147840	19484	63321567
Eye pain	52.61	17.84	8	147963	33846	63307205
Melaena	52.54	17.84	5	147966	30360	63310691
Urinary retention	52.40	17.84	5	147966	30296	63310755
Haematoma	52.38	17.84	9	147962	34811	63306240
Lymphocyte count decreased	52.30	17.84	5	147966	30252	63310799
Pneumonitis	51.06	17.84	10	147961	35212	63305839
Ascites	50.46	17.84	16	147955	40712	63300339
Bone pain	49.82	17.84	33	147938	54608	63286443
Blood potassium decreased	49.48	17.84	18	147953	42008	63299043
Hypophagia	49.47	17.84	7	147964	31252	63309799
Apoptotic colonopathy	49.42	17.84	12	147959	19	63341032
Body temperature increased	49.04	17.84	13	147958	37179	63303872
Intentional product misuse	48.86	17.84	42	147929	60875	63280176
Dyskinesia	48.74	17.84	8	147963	31994	63309057
Neck pain	48.42	17.84	54	147917	69264	63271787
Hypervolaemia	48.32	17.84	5	147966	28408	63312643
Oedema peripheral	47.83	17.84	253	147718	189258	63151793
Arrhythmia	47.22	17.84	15	147956	38125	63302926
Fistula	47.20	17.84	86	147885	10307	63330744
Vision blurred	47.11	17.84	89	147882	91835	63249216
Dysgeusia	47.11	17.84	25	147946	46685	63294366
Acute myocardial infarction	46.82	17.84	9	147962	32115	63308936
Plasma cell myeloma	46.49	17.84	13	147958	35892	63305159
Haemoptysis	46.49	17.84	6	147965	28720	63312331
Blood alkaline phosphatase increased	46.36	17.84	21	147950	42946	63298105
Hepatic failure	46.00	17.84	13	147958	35643	63305408
Tooth disorder	45.28	17.84	6	147965	28151	63312900
Frequent bowel movements	45.10	17.84	137	147834	22885	63318166
Device dislocation	45.09	17.84	4	147967	25701	63315350
Alanine aminotransferase abnormal	44.95	17.84	54	147917	4450	63336601
Sinus tachycardia	44.76	17.84	3	147968	24265	63316786
Blood calcium decreased	44.10	17.84	5	147966	26446	63314605
Adjustment disorder	43.60	17.84	45	147926	3133	63337918
Obesity	43.38	17.84	161	147810	29791	63311260
Abscess	43.36	17.84	110	147861	16558	63324493
Blood creatine phosphokinase increased	43.36	17.84	9	147962	30421	63310630
Haematemesis	43.32	17.84	9	147962	30403	63310648
Chest discomfort	43.06	17.84	123	147848	109846	63231205
Injection site swelling	43.01	17.84	29	147942	47543	63293508
Nasal congestion	42.82	17.84	54	147917	65606	63275445
Lower limb fracture	42.73	17.84	139	147832	24082	63316969
Thrombosis	42.49	17.84	53	147918	64702	63276349
Angioedema	42.35	17.84	30	147941	47935	63293116
Hepatic function abnormal	41.91	17.84	17	147954	37125	63303926
Ill-defined disorder	41.85	17.84	330	147641	81425	63259626
Pallor	41.62	17.84	10	147961	30558	63310493
Hypothyroidism	41.28	17.84	24	147947	42608	63298443
Sciatica	41.24	17.84	174	147797	34150	63306901
Latent tuberculosis	41.20	17.84	40	147931	2587	63338464
Erythrodermic psoriasis	41.04	17.84	27	147944	991	63340060
Jaundice	40.96	17.84	9	147962	29242	63311809
Flushing	40.90	17.84	70	147901	75017	63266034
Breast cancer	40.51	17.84	221	147750	48162	63292889
Ejection fraction decreased	40.50	17.84	3	147968	22329	63318722
Myocardial infarction	40.39	17.84	110	147861	99783	63241268
Rheumatoid nodule	40.32	17.84	109	147862	17046	63324005
Abscess intestinal	40.27	17.84	32	147939	1582	63339469
Hot flush	40.15	17.84	36	147935	51123	63289928
Dysphagia	40.14	17.84	92	147879	88493	63252558
Bursitis	40.10	17.84	182	147789	36859	63304192
Squamous cell carcinoma	39.93	17.84	72	147899	8560	63332491
Limb discomfort	39.92	17.84	10	147961	29706	63311345
Accidental overdose	39.90	17.84	4	147967	23305	63317746
Intestinal obstruction	39.77	17.84	160	147811	30739	63310312
Macular degeneration	39.67	17.84	5	147966	24371	63316680
Blood sodium decreased	39.41	17.84	5	147966	24247	63316804
Dry eye	39.40	17.84	23	147948	40738	63300313
Product packaging issue	39.18	17.84	28	147943	1178	63339873
Nervousness	38.68	17.84	12	147959	30967	63310084
Drug level increased	38.66	17.84	4	147967	22732	63318319
Atelectasis	38.63	17.84	3	147968	21480	63319571
Abnormal behaviour	38.51	17.84	3	147968	21423	63319628
Aggression	37.81	17.84	5	147966	23493	63317558
Metastases to bone	37.62	17.84	3	147968	21016	63320035
Fear of injection	37.36	17.84	63	147908	7101	63333950
Hepatocellular injury	37.20	17.84	9	147962	27372	63313679
Dysuria	37.17	17.84	16	147955	33722	63307329
Pyoderma gangrenosum	37.06	17.84	44	147927	3581	63337470
Rash erythematous	36.99	17.84	27	147944	42483	63298568
Hypoaesthesia	36.80	17.84	574	147397	167819	63173232
Generalised tonic-clonic seizure	36.66	17.84	11	147960	29005	63312046
Coagulopathy	36.58	17.84	3	147968	20541	63320510
Pain	36.55	17.84	2091	145880	738537	62602514
Eye disorder	36.09	17.84	5	147966	22680	63318371
Ulcer	35.88	17.84	138	147833	25969	63315082
Pulmonary arterial hypertension	35.86	17.84	5	147966	22572	63318479
Ear infection	35.74	17.84	180	147791	38033	63303018
Withdrawal syndrome	35.38	17.84	3	147968	19994	63321057
Ventricular tachycardia	35.34	17.84	3	147968	19976	63321075
Vertigo	35.28	17.84	53	147918	59834	63281217
Device malfunction	34.73	17.84	106	147865	17751	63323300
Hypoacusis	34.70	17.84	7	147964	24144	63316907
Walking aid user	34.68	17.84	77	147894	10640	63330411
Hypertension	34.64	17.84	874	147097	278429	63062622
Blood creatinine increased	34.57	17.84	98	147873	87746	63253305
Leukocytosis	34.31	17.84	9	147962	25926	63315125
Visual acuity reduced	34.28	17.84	5	147966	21821	63319230
Lichen myxoedematosus	34.21	17.84	9	147962	23	63341028
Feeling cold	34.17	17.84	7	147964	23881	63317170
Injection related reaction	33.94	17.84	22	147949	787	63340264
Unevaluable event	33.77	17.84	42	147929	51344	63289707
Chronic recurrent multifocal osteomyelitis	33.70	17.84	10	147961	45	63341006
Metastases to liver	33.66	17.84	7	147964	23632	63317419
Infection	33.59	17.84	734	147237	228439	63112612
Cholangitis sclerosing	33.58	17.84	29	147942	1612	63339439
Gait inability	33.56	17.84	225	147746	52734	63288317
Depression	33.31	17.84	295	147676	196197	63144854
Swelling face	32.92	17.84	61	147910	63414	63277637
Hepatotoxicity	32.92	17.84	23	147948	37018	63304033
Small intestinal resection	32.81	17.84	18	147953	471	63340580
Ileectomy	32.70	17.84	13	147958	158	63340893
Poor quality sleep	32.66	17.84	4	147967	19931	63321120
Speech disorder	32.59	17.84	28	147943	40601	63300450
Red blood cell sedimentation rate abnormal	32.33	17.84	4	147967	19778	63321273
Drug resistance	32.23	17.84	7	147964	22926	63318125
Gastritis	32.06	17.84	24	147947	37279	63303772
Pericardial effusion	31.95	17.84	15	147956	30043	63311008
Night sweats	31.91	17.84	209	147762	48605	63292446
Eosinophilia	31.87	17.84	7	147964	22749	63318302
Oropharyngeal pain	31.86	17.84	113	147858	94374	63246677
Swollen tongue	31.74	17.84	21	147950	34779	63306272
Blood potassium increased	31.71	17.84	3	147968	18306	63322745
Cerebral haemorrhage	31.65	17.84	16	147955	30713	63310338
Rib fracture	31.55	17.84	7	147964	22590	63318461
Transient ischaemic attack	31.54	17.84	25	147946	37728	63303323
Personality disorder	31.51	17.84	52	147919	5759	63335292
Sinus congestion	31.07	17.84	103	147868	18020	63323031
Disseminated intravascular coagulation	30.78	17.84	4	147967	19047	63322004
Glaucoma	30.47	17.84	4	147967	18901	63322150
Haemorrhage	30.46	17.84	60	147911	60962	63280089
Upper gastrointestinal haemorrhage	30.36	17.84	4	147967	18848	63322203
Mitral valve incompetence	29.61	17.84	5	147966	19589	63321462
Hiatus hernia	29.53	17.84	7	147964	21587	63319464
Lip swelling	29.36	17.84	18	147953	31045	63310006
Dysphonia	29.16	17.84	41	147930	47573	63293478
Spinal fracture	29.13	17.84	4	147967	18267	63322784
Road traffic accident	29.11	17.84	165	147806	36467	63304584
C-reactive protein increased	28.97	17.84	343	147628	94364	63246687
Nightmare	28.78	17.84	5	147966	19189	63321862
White blood cell count increased	28.58	17.84	43	147928	48518	63292533
Injection site pruritus	28.49	17.84	38	147933	45078	63295973
Chronic obstructive pulmonary disease	28.48	17.84	65	147906	62621	63278430
Electrolyte imbalance	28.47	17.84	6	147965	20070	63320981
Insomnia	28.35	17.84	343	147628	214909	63126142
Blood glucose decreased	28.24	17.84	7	147964	20945	63320106
Diplopia	28.21	17.84	10	147961	23718	63317333
Chest pain	28.11	17.84	345	147626	215614	63125437
Abdominal abscess	27.98	17.84	43	147928	4483	63336568
Hip fracture	27.96	17.84	17	147954	29457	63311594
Dementia	27.96	17.84	5	147966	18789	63322262
Sleep disorder	27.93	17.84	302	147669	81264	63259787
Acute respiratory distress syndrome	27.84	17.84	10	147961	23524	63317527
Dyspepsia	27.77	17.84	362	147609	101834	63239217
Neutropenic sepsis	27.67	17.84	3	147968	16435	63324616
Flank pain	27.61	17.84	3	147968	16407	63324644
Restless legs syndrome	27.41	17.84	5	147966	18526	63322525
Lymphopenia	26.99	17.84	5	147966	18322	63322729
Foot fracture	26.89	17.84	11	147960	23903	63317148
Product substitution issue	26.73	17.84	3	147968	15993	63325058
Ileal stenosis	26.71	17.84	26	147945	1687	63339364
Kidney infection	26.69	17.84	116	147855	23060	63317991
Pollakiuria	26.66	17.84	16	147955	27921	63313130
Faecal calprotectin increased	26.55	17.84	35	147936	3168	63337883
Intervertebral disc protrusion	26.51	17.84	11	147960	23698	63317353
Pneumocystis jirovecii pneumonia	26.27	17.84	4	147967	16910	63324141
Blood pressure diastolic decreased	26.26	17.84	10	147961	22696	63318355
Tubulointerstitial nephritis	26.16	17.84	7	147964	19896	63321155
Underdose	26.15	17.84	130	147841	27326	63313725
Haematuria	26.05	17.84	18	147953	29139	63311912
Vaginal haemorrhage	25.87	17.84	16	147955	27471	63313580
Head injury	25.72	17.84	16	147955	27380	63313671
Gastric ulcer	25.54	17.84	12	147959	24025	63317026
Infected dermal cyst	25.44	17.84	15	147956	452	63340599
Cerebral infarction	25.28	17.84	12	147959	23881	63317170
Transfusion	25.06	17.84	3	147968	15214	63325837
Osteonecrosis	24.92	17.84	13	147958	24517	63316534
Osteoporosis	24.85	17.84	223	147748	57115	63283936
Migraine	24.79	17.84	358	147613	102988	63238063
Bronchiectasis	24.66	17.84	4	147967	16138	63324913
Nasopharyngitis	24.62	17.84	771	147200	253486	63087565
Neuralgia	24.53	17.84	15	147956	25911	63315140
Musculoskeletal discomfort	24.22	17.84	6	147965	17961	63323090
Loss of personal independence in daily activities	24.12	17.84	339	147632	96951	63244100
Myoclonus	24.09	17.84	4	147967	15864	63325187
Product administration error	24.08	17.84	11	147960	22386	63318665
Lacrimation increased	24.01	17.84	9	147962	20622	63320429
Bone density decreased	23.77	17.84	3	147968	14609	63326442
Mastitis	23.76	17.84	30	147941	2602	63338449
Fracture	23.72	17.84	8	147963	19576	63321475
Cardiac murmur	23.64	17.84	3	147968	14549	63326502
Eye irritation	23.30	17.84	11	147960	21960	63319091
Plasmablastic lymphoma	23.19	17.84	11	147960	210	63340841
Sacroiliitis	23.09	17.84	33	147938	3224	63337827
Surgery	23.01	17.84	153	147818	35759	63305292
Bacteraemia	22.99	17.84	6	147965	17342	63323709
Small intestine operation	22.99	17.84	7	147964	35	63341016
Toothache	22.98	17.84	8	147963	19191	63321860
Premature delivery	22.94	17.84	22	147949	30259	63310792
Mental impairment	22.79	17.84	3	147968	14148	63326903
Mouth ulceration	22.70	17.84	26	147945	32958	63308093
Heart rate irregular	22.61	17.84	12	147959	22409	63318642
Oedema	22.56	17.84	336	147635	97286	63243765
Oesophagitis	22.31	17.84	4	147967	15004	63326047
Petechiae	22.25	17.84	3	147968	13894	63327157
Feeling hot	22.24	17.84	53	147918	50301	63290750
Malignant melanoma in situ	22.24	17.84	18	147953	914	63340137
Therapy cessation	22.14	17.84	134	147837	30323	63310728
Cervical dysplasia	21.96	17.84	32	147939	3182	63337869
Injection site mass	21.94	17.84	8	147963	18648	63322403
Anaphylactic shock	21.91	17.84	14	147957	23619	63317432
Body temperature decreased	21.81	17.84	10	147961	20309	63320742
Chromaturia	21.74	17.84	6	147965	16711	63324340
Immunodeficiency	21.69	17.84	10	147961	20244	63320807
Renal disorder	21.62	17.84	27	147944	32947	63308104
Nodule	21.58	17.84	11	147960	21015	63320036
Seasonal allergy	21.44	17.84	11	147960	20939	63320112
Postoperative wound infection	21.39	17.84	65	147906	10860	63330191
Disability	21.26	17.84	92	147879	18255	63322796
Pain in extremity	21.25	17.84	599	147372	330887	63010164
Intestinal operation	21.23	17.84	14	147957	516	63340535
Mood swings	21.17	17.84	8	147963	18240	63322811
Flatulence	21.14	17.84	30	147941	34672	63306379
Pelvic fracture	21.10	17.84	3	147968	13345	63327706
Premature baby	21.05	17.84	11	147960	20724	63320327
Bronchospasm	21.03	17.84	7	147964	17273	63323778
Genital cyst	21.01	17.84	7	147964	49	63341002
Skin discolouration	20.84	17.84	35	147936	37793	63303258
Supraventricular tachycardia	20.79	17.84	4	147967	14267	63326784
Ear injury	20.75	17.84	10	147961	198	63340853
Mental disorder	20.62	17.84	18	147953	25901	63315150
Adrenal insufficiency	20.54	17.84	8	147963	17907	63323144
Drug level below therapeutic	20.51	17.84	39	147932	4827	63336224
Device defective	20.37	17.84	24	147947	1938	63339113
Progressive multifocal leukoencephalopathy	20.30	17.84	3	147968	12968	63328083
Pancreatitis acute	20.27	17.84	20	147951	27146	63313905
Abdominal pain lower	20.23	17.84	18	147953	25660	63315391
Presyncope	20.12	17.84	21	147950	27764	63313287
Infected fistula	20.01	17.84	10	147961	215	63340836
Diabetes mellitus	20.00	17.84	65	147906	55745	63285306
Generalised oedema	19.98	17.84	6	147965	15812	63325239
Cardiomegaly	19.97	17.84	8	147963	17606	63323445
Anaplastic large-cell lymphoma	19.92	17.84	8	147963	100	63340951
Blindness	19.92	17.84	13	147958	21686	63319365
Fear	19.88	17.84	6	147965	15760	63325291
Drug-induced liver injury	19.83	17.84	161	147810	40061	63300990
Muscle spasms	19.73	17.84	251	147720	155899	63185152
Hemiplegia	19.71	17.84	57	147914	9266	63331785
Urticaria	19.69	17.84	516	147455	165286	63175765
Proteinuria	19.67	17.84	10	147961	19135	63321916
Tooth abscess	19.65	17.84	78	147893	14891	63326160
Enteropathic spondylitis	19.54	17.84	6	147965	31	63341020
Retching	19.53	17.84	5	147966	14640	63326411
Inflammatory bowel disease	19.49	17.84	34	147937	3939	63337112
Tonsillitis	19.46	17.84	42	147929	5693	63335358
Polyneuropathy	19.42	17.84	5	147966	14584	63326467
Dactylitis	19.31	17.84	27	147944	2585	63338466
Dysstasia	19.00	17.84	13	147958	21153	63319898
Joint effusion	18.94	17.84	8	147963	17052	63323999
Spinal osteoarthritis	18.94	17.84	7	147964	16179	63324872
Loss of therapeutic response	18.86	17.84	14	147957	625	63340426
Musculoskeletal chest pain	18.86	17.84	13	147958	21070	63319981
Throat irritation	18.80	17.84	37	147934	37610	63303441
Proctectomy	18.79	17.84	8	147963	117	63340934
Laboratory test abnormal	18.75	17.84	21	147950	26891	63314160
Insurance issue	18.71	17.84	43	147928	6078	63334973
Sleep disorder due to a general medical condition	18.66	17.84	3	147968	12185	63328866
Panic attack	18.39	17.84	15	147956	22316	63318735
Procedural pain	18.38	17.84	14	147957	21555	63319496
Hyperadrenocorticism	18.35	17.84	11	147960	342	63340709
Seronegative arthritis	18.28	17.84	33	147938	3926	63337125
Sensory loss	18.28	17.84	59	147912	10179	63330872
Stoma site ulcer	18.25	17.84	10	147961	261	63340790
Bacterial vulvovaginitis	18.21	17.84	15	147956	781	63340270
Ocular hyperaemia	18.21	17.84	19	147952	25125	63315926
Guttate psoriasis	18.08	17.84	12	147959	447	63340604
Product dispensing error	18.05	17.84	59	147912	10246	63330805
Depressed mood	17.99	17.84	42	147929	40149	63300902
Intestinal anastomosis	17.99	17.84	12	147959	451	63340600
Bone disorder	17.97	17.84	14	147957	21312	63319739
Wheezing	17.97	17.84	318	147653	95277	63245774
Blood albumin decreased	17.94	17.84	6	147965	14760	63326291
Sleep apnoea syndrome	17.93	17.84	25	147946	29108	63311943
Alanine aminotransferase increased	17.92	17.84	155	147816	103615	63237436
Myocardial ischaemia	17.92	17.84	4	147967	12855	63328196
Drug level abnormal	17.87	17.84	8	147963	133	63340918
Hypoalbuminaemia	17.87	17.84	3	147968	11802	63329249
Multiple allergies	17.86	17.84	5	147966	13797	63327254

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
Product dose omission issue	2847.33	15.30	1839	44741	117872	34792479
Drug ineffective	1316.72	15.30	2240	44340	454511	34455840
Off label use	832.18	15.30	1759	44821	417765	34492586
Product use issue	811.47	15.30	672	45908	62544	34847807
Inappropriate schedule of product administration	637.15	15.30	582	45998	61714	34848637
Syringe issue	577.69	15.30	234	46346	5430	34904921
Psoriasis	557.53	15.30	441	46139	38371	34871980
Psoriatic arthropathy	463.86	15.30	303	46277	19495	34890856
Drug eruption	411.93	15.30	282	46298	19616	34890735
Therapeutic product effect decreased	371.23	15.30	333	46247	34410	34875941
Product storage error	365.59	15.30	190	46390	7932	34902419
Needle issue	285.44	15.30	147	46433	6018	34904333
Hypersensitivity	266.71	15.30	366	46214	60669	34849682
Hepatic function abnormal	243.78	15.30	298	46282	44065	34866286
Intestinal resection	233.96	15.30	88	46492	1661	34908690
Treatment failure	233.17	15.30	299	46281	46398	34863953
Acute kidney injury	225.36	15.30	64	46516	304924	34605427
Drug interaction	225.00	15.30	21	46559	225925	34684426
Basal cell carcinoma	216.95	15.30	192	46388	19466	34890885
Synovitis	212.87	15.30	165	46415	13901	34896450
Toxicity to various agents	209.48	15.30	15	46565	200347	34710004
Latent tuberculosis	202.21	15.30	74	46506	1289	34909062
Urticaria	201.91	15.30	325	46255	62052	34848299
Hypotension	199.81	15.30	29	46551	221620	34688731
Therapeutic response decreased	189.38	15.30	214	46366	29099	34881252
Anal abscess	181.33	15.30	111	46469	6362	34903989
Lower respiratory tract infection	171.27	15.30	211	46369	31426	34878925
Tenosynovitis	163.97	15.30	92	46488	4478	34905873
Stomatitis	163.51	15.30	240	46340	42274	34868077
Arthritis	163.18	15.30	205	46375	31141	34879210
Alanine aminotransferase abnormal	151.10	15.30	88	46492	4600	34905751
Enthesopathy	147.12	15.30	86	46494	4527	34905824
Febrile neutropenia	143.64	15.30	10	46570	136839	34773512
Therapeutic product effect incomplete	142.99	15.30	248	46332	50293	34860058
Squamous cell carcinoma	136.49	15.30	117	46463	11358	34898993
C-reactive protein abnormal	135.76	15.30	104	46476	8606	34901745
Mycobacterium tuberculosis complex test positive	135.65	15.30	55	46525	1277	34909074
Muscle spasms	130.14	15.30	300	46280	74701	34835650
Vein rupture	129.60	15.30	48	46532	866	34909485
Pyrexia	125.56	15.30	156	46424	332857	34577494
Pain in extremity	125.39	15.30	412	46168	126101	34784250
Epistaxis	122.71	15.30	252	46328	57999	34852352
Neutropenia	117.21	15.30	32	46548	156746	34753605
Dyspnoea	112.60	15.30	207	46373	376575	34533776
Anaemia	112.38	15.30	88	46492	233247	34677104
Tongue disorder	111.18	15.30	76	46504	5263	34905088
Drug level decreased	109.98	15.30	88	46492	7758	34902593
Abscess	108.16	15.30	104	46476	11713	34898638
Drug abuse	107.67	15.30	6	46574	99090	34811261
Product leakage	104.31	15.30	36	46544	524	34909827
Death	100.20	15.30	241	46339	397808	34512543
Device deployment issue	100.05	15.30	27	46553	158	34910193
Completed suicide	95.25	15.30	10	46570	98158	34812193
Arthralgia	93.62	15.30	461	46119	169580	34740771
Liquid product physical issue	92.45	15.30	32	46548	470	34909881
Accidental exposure to product	92.22	15.30	99	46481	12703	34897648
Cellulitis	88.72	15.30	209	46371	52742	34857609
Fistula	88.04	15.30	73	46507	6767	34903584
Hyponatraemia	86.84	15.30	6	46574	82685	34827666
Thrombocytopenia	85.73	15.30	51	46529	156196	34754155
Asthenia	85.04	15.30	122	46458	245129	34665222
Tuberculin test positive	81.84	15.30	37	46543	1130	34909221
Therapy non-responder	80.80	15.30	168	46412	38978	34871373
Infusion related reaction	79.90	15.30	201	46379	52856	34857495
Hepatic steatosis	79.89	15.30	110	46470	18252	34892099
Device malfunction	79.34	15.30	83	46497	10338	34900013
Somnolence	78.76	15.30	25	46555	111091	34799260
Surgery	77.51	15.30	95	46485	14062	34896289
Prostate cancer	77.02	15.30	166	46414	39483	34870868
Vomiting	76.53	15.30	133	46447	247488	34662863
Hyperkalaemia	75.98	15.30	4	46576	69385	34840966
Pancytopenia	75.77	15.30	17	46563	95140	34815211
Hepatic cirrhosis	75.75	15.30	104	46476	17210	34893141
Platelet count decreased	74.70	15.30	33	46547	119684	34790667
Disease progression	73.66	15.30	26	46554	108051	34802300
Drug delivery system malfunction	68.69	15.30	24	46556	363	34909988
Tendonitis	68.16	15.30	72	46508	9068	34901283
Respiratory failure	67.62	15.30	30	46550	108542	34801809
Skin plaque	67.34	15.30	53	46527	4561	34905790
Device issue	65.87	15.30	73	46507	9704	34900647
Venous injury	65.60	15.30	22	46558	292	34910059
Headache	65.25	15.30	474	46106	200161	34710190
Bradycardia	65.25	15.30	11	46569	75407	34834944
Infection	64.58	15.30	266	46314	90649	34819702
Erythrodermic psoriasis	64.38	15.30	29	46551	878	34909473
Haemoglobin decreased	64.02	15.30	41	46539	120731	34789620
Frequent bowel movements	63.93	15.30	82	46498	12705	34897646
Rhabdomyolysis	63.47	15.30	8	46572	68155	34842196
Colectomy	62.93	15.30	36	46544	1818	34908533
Tachycardia	62.00	15.30	18	46562	84754	34825597
Confusional state	61.30	15.30	61	46519	144099	34766252
Gastrointestinal infection	60.70	15.30	55	46525	5743	34904608
Pneumonia	60.62	15.30	743	45837	361884	34548467
Skin injury	60.07	15.30	38	46542	2307	34908044
Oedema peripheral	59.09	15.30	44	46536	119768	34790583
Overdose	58.55	15.30	24	46556	91035	34819316
Tooth abscess	58.31	15.30	54	46526	5799	34904552
Renal failure	58.13	15.30	53	46527	130504	34779847
Anal fistula	58.07	15.30	52	46528	5347	34905004
Decreased appetite	57.37	15.30	83	46497	166309	34744042
Hepatic enzyme increased	56.69	15.30	146	46434	38934	34871417
Malignant melanoma	55.53	15.30	61	46519	8029	34902322
Incorrect dose administered	55.34	15.30	148	46432	40367	34869984
Clostridium difficile infection	55.05	15.30	94	46486	18804	34891547
Intestinal stenosis	54.94	15.30	35	46545	2151	34908200
Postoperative wound infection	54.94	15.30	48	46532	4778	34905573
Pneumonia lipoid	54.40	15.30	14	46566	66	34910285
Intestinal obstruction	54.35	15.30	104	46476	22718	34887633
Therapy cessation	54.22	15.30	88	46492	16885	34893466
Constipation	53.74	15.30	62	46518	136920	34773431
Pustular psoriasis	53.33	15.30	31	46549	1614	34908737
Product packaging issue	53.16	15.30	23	46557	631	34909720
Neutrophil count decreased	52.80	15.30	4	46576	51100	34859251
Agitation	52.80	15.30	7	46573	57392	34852959
White blood cell count decreased	52.52	15.30	31	46549	95414	34814937
Localised infection	51.91	15.30	88	46492	17499	34892852
Oxygen saturation decreased	50.87	15.30	6	46574	53812	34856539
Hepatic fibrosis	50.80	15.30	45	46535	4562	34905789
Dehydration	50.79	15.30	59	46521	129910	34780441
Cardiac arrest	50.46	15.30	33	46547	96126	34814225
Rectal abscess	49.94	15.30	28	46552	1360	34908991
Underdose	48.94	15.30	75	46505	13705	34896646
Injection site papule	48.68	15.30	18	46562	323	34910028
Abdominal abscess	48.48	15.30	42	46538	4133	34906218
Red blood cell sedimentation rate	48.36	15.30	26	46554	1162	34909189
Gastrointestinal haemorrhage	48.31	15.30	29	46551	88448	34821903
Hypoxia	47.73	15.30	8	46572	55087	34855264
Insurance issue	47.19	15.30	31	46549	2008	34908343
Chikungunya virus infection	47.15	15.30	11	46569	31	34910320
Granuloma skin	46.56	15.30	26	46554	1253	34909098
Neuropathy peripheral	45.87	15.30	27	46553	83236	34827115
Drug level below therapeutic	45.04	15.30	46	46534	5569	34904782
Pleural effusion	44.14	15.30	27	46553	81519	34828832
Delirium	43.91	15.30	4	46576	43987	34866364
Tremor	43.80	15.30	28	46552	82559	34827792
Arthropathy	41.60	15.30	103	46477	26804	34883547
Intentional overdose	40.95	15.30	5	46575	43669	34866682
International normalised ratio increased	40.71	15.30	7	46573	47320	34863031
Blood parathyroid hormone decreased	40.47	15.30	25	46555	1455	34908896
Anti-cyclic citrullinated peptide antibody positive	40.19	15.30	27	46553	1816	34908535
Depressed level of consciousness	39.94	15.30	5	46575	42836	34867515
Ileostomy	39.44	15.30	19	46561	672	34909679
Muscle swelling	39.36	15.30	16	46564	374	34909977
Inflammation	39.27	15.30	104	46476	28191	34882160
Hypoglycaemia	39.21	15.30	12	46568	54628	34855723
Multiple organ dysfunction syndrome	39.19	15.30	27	46553	76539	34833812
Adenocarcinoma of colon	39.15	15.30	34	46546	3357	34906994
Joint ankylosis	39.09	15.30	25	46555	1547	34908804
Bone cyst	38.68	15.30	25	46555	1575	34908776
Panniculitis	38.27	15.30	27	46553	1967	34908384
Dyspnoea exertional	38.12	15.30	6	46574	43273	34867078
Hypokalaemia	37.97	15.30	15	46565	58199	34852152
Musculoskeletal stiffness	37.48	15.30	142	46438	46538	34863813
Subcutaneous abscess	37.40	15.30	35	46545	3808	34906543
Coma	36.66	15.30	8	46572	45670	34864681
Faecal calprotectin increased	36.65	15.30	29	46551	2515	34907836
Pityriasis rubra pilaris	36.55	15.30	11	46569	100	34910251
Sporotrichosis	36.43	15.30	10	46570	63	34910288
Injection site haemorrhage	35.87	15.30	54	46526	9714	34900637
Abscess intestinal	35.62	15.30	24	46556	1622	34908729
Intestinal operation	35.49	15.30	13	46567	227	34910124
Infected fistula	35.00	15.30	12	46568	171	34910180
Pulmonary oedema	34.91	15.30	10	46570	47519	34862832
Device defective	34.68	15.30	18	46562	748	34909603
Hepatocellular carcinoma	34.19	15.30	46	46534	7463	34902888
Hallucination	34.03	15.30	13	46567	51485	34858866
Guttate psoriasis	34.00	15.30	13	46567	257	34910094
Drug intolerance	33.74	15.30	163	46417	59407	34850944
Cardio-respiratory arrest	33.26	15.30	16	46564	55257	34855094
Dizziness	33.21	15.30	164	46416	218357	34691994
Disability	32.83	15.30	36	46544	4729	34905622
Alcoholic liver disease	32.54	15.30	16	46564	592	34909759
Tuberculosis	32.33	15.30	48	46532	8529	34901822
Post procedural infection	32.27	15.30	36	46544	4820	34905531
Wheezing	31.74	15.30	8	46572	41394	34868957
Atrial fibrillation	31.50	15.30	73	46507	122320	34788031
Hidradenitis	31.44	15.30	19	46561	1063	34909288
Inflammatory bowel disease	31.16	15.30	28	46552	2892	34907459
Aggression	30.92	15.30	7	46573	38957	34871394
Dermatitis exfoliative generalised	30.89	15.30	31	46549	3676	34906675
Haematuria	30.88	15.30	14	46566	50052	34860299
Cutaneous sporotrichosis	30.53	15.30	8	46572	41	34910310
Blood creatinine increased	30.19	15.30	50	46530	94926	34815425
Loss of personal independence in daily activities	30.07	15.30	105	46475	33074	34877277
Mental status changes	29.90	15.30	7	46573	38076	34872275
Abdominal pain	29.71	15.30	341	46239	163277	34747074
Herpes zoster	29.59	15.30	107	46473	34292	34876059
Ileal stenosis	29.56	15.30	20	46560	1361	34908990
Oedema	29.47	15.30	12	46568	45729	34864622
Chills	29.32	15.30	39	46541	81004	34829347
Hand deformity	28.94	15.30	30	46550	3695	34906656
Erysipelas	28.85	15.30	34	46546	4829	34905522
Ankle fracture	28.13	15.30	31	46549	4094	34906257
Prostate infection	28.03	15.30	17	46563	957	34909394
Injection site swelling	28.02	15.30	53	46527	11474	34898877
Cutaneous T-cell lymphoma	27.62	15.30	20	46560	1518	34908833
Infected cyst	27.56	15.30	14	46566	556	34909795
Wrong schedule	27.33	15.30	10	46570	174	34910177
Rheumatoid nodule	27.08	15.30	26	46554	2921	34907430
Pneumonitis	27.05	15.30	6	46574	33872	34876479
Cardiac failure congestive	26.31	15.30	44	46536	83226	34827125
Nasopharyngitis	26.02	15.30	171	46409	69797	34840554
Acne	25.81	15.30	50	46530	11016	34899335
Nephrolithiasis	25.79	15.30	94	46486	30239	34880112
Pneumoretroperitoneum	25.64	15.30	9	46571	138	34910213
Blood pressure increased	25.63	15.30	49	46531	88053	34822298
Suicide attempt	25.63	15.30	10	46570	39106	34871245
Osteolysis	25.63	15.30	26	46554	3122	34907229
Malignant melanoma in situ	25.54	15.30	20	46560	1708	34908643
Blood creatine phosphokinase increased	25.47	15.30	14	46566	44843	34865508
Interferon gamma release assay positive	25.44	15.30	6	46574	18	34910333
Respiratory distress	25.29	15.30	8	46572	35657	34874694
Cognitive disorder	25.22	15.30	4	46576	28689	34881662
Leukopenia	25.11	15.30	28	46552	62828	34847523
Intestinal fistula	25.03	15.30	16	46564	989	34909362
Gastrointestinal inflammation	25.01	15.30	27	46553	3484	34906867
Fall	25.00	15.30	163	46417	202722	34707629
SARS-CoV-2 test positive	24.99	15.30	35	46545	5898	34904453
Dysphagia	24.69	15.30	28	46552	62353	34847998
Cholelithiasis	24.69	15.30	73	46507	21075	34889276
Intentional product use issue	24.61	15.30	26	46554	59790	34850561
Diverticulitis	24.26	15.30	70	46510	19934	34890417
Colitis ulcerative	24.23	15.30	62	46518	16458	34893893
Colon cancer	23.95	15.30	42	46538	8579	34901772
Periumbilical abscess	23.83	15.30	7	46573	58	34910293
Poor quality product administered	23.81	15.30	20	46560	1887	34908464
Loss of therapeutic response	23.77	15.30	13	46567	601	34909750
Laryngeal cancer	23.73	15.30	14	46566	749	34909602
Sacroiliitis	23.58	15.30	18	46562	1480	34908871
Energy increased	23.56	15.30	17	46563	1283	34909068
Neoplasm malignant	23.51	15.30	69	46511	19836	34890515
Coronary artery disease	23.45	15.30	18	46562	48287	34862064
Carbon dioxide abnormal	23.39	15.30	9	46571	181	34910170
Melaena	23.26	15.30	9	46571	35371	34874980
Abscess limb	23.24	15.30	26	46554	3491	34906860
Tonsil cancer	23.22	15.30	16	46564	1122	34909229
Lung neoplasm malignant	23.19	15.30	63	46517	17332	34893019
Small intestinal resection	23.05	15.30	12	46568	502	34909849
Large intestinal stenosis	22.87	15.30	18	46562	1549	34908802
Red blood cell sedimentation rate abnormal	22.81	15.30	26	46554	3563	34906788
Dry mouth	22.80	15.30	6	46574	30159	34880192
Rash maculo-papular	22.79	15.30	5	46575	28446	34881905
Cardiogenic shock	22.75	15.30	4	46576	26614	34883737
Urinary retention	22.61	15.30	10	46570	36278	34874073
Botryomycosis	22.40	15.30	6	46574	34	34910317
Renal impairment	22.25	15.30	59	46521	94454	34815897
Joint swelling	22.04	15.30	146	46434	59744	34850607
Postoperative abscess	22.04	15.30	10	46570	308	34910043
Haematemesis	21.94	15.30	5	46575	27706	34882645
Chronic kidney disease	21.80	15.30	14	46566	41196	34869155
Unresponsive to stimuli	21.78	15.30	5	46575	27564	34882787
Agranulocytosis	21.67	15.30	3	46577	23818	34886533
Kidney infection	21.51	15.30	31	46549	5363	34904988
Renal neoplasm	21.34	15.30	16	46564	1281	34909070
Dysuria	21.30	15.30	5	46575	27147	34883204
Pneumonia aspiration	21.14	15.30	15	46565	41888	34868463
Skin cancer	21.00	15.30	44	46536	10253	34900098
Polydipsia	20.98	15.30	26	46554	3889	34906462
Oral pustule	20.97	15.30	9	46571	242	34910109
Mucous stools	20.87	15.30	18	46562	1760	34908591
Abnormal behaviour	20.81	15.30	4	46576	24965	34885386
Anal fissure	20.64	15.30	27	46553	4263	34906088
Ventricular tachycardia	20.64	15.30	5	46575	26574	34883777
Blood glucose increased	20.39	15.30	36	46544	66682	34843669
Heart rate increased	20.38	15.30	19	46561	46324	34864027
Lymphocyte count decreased	20.23	15.30	3	46577	22619	34887732
Encephalopathy	20.09	15.30	11	46569	35308	34875043
Hypocalcaemia	20.01	15.30	4	46576	24285	34886066
Protein S deficiency	19.79	15.30	7	46573	110	34910241
Thyroid cancer	19.71	15.30	17	46563	1663	34908688
Intentional product misuse	19.70	15.30	19	46561	45592	34864759
Large intestine anastomosis	19.61	15.30	6	46574	58	34910293
Myocardial infarction	19.61	15.30	247	46333	120838	34789513
Skin necrosis	19.58	15.30	31	46549	5822	34904529
Fistula discharge	19.57	15.30	13	46567	858	34909493
Ulcer	19.49	15.30	39	46541	8796	34901555
Restlessness	19.39	15.30	5	46575	25477	34884874
Seizure	19.38	15.30	73	46507	104784	34805567
Contraindication to vaccination	19.35	15.30	5	46575	24	34910327
Cholestasis	19.18	15.30	6	46574	26942	34883409
Bone erosion	18.90	15.30	25	46555	3990	34906361
Guillain-Barre syndrome	18.68	15.30	31	46549	6056	34904295
Cholecystectomy	18.59	15.30	21	46559	2849	34907502
Cardiac failure	18.55	15.30	61	46519	91187	34819164
Onycholysis	18.51	15.30	12	46568	760	34909591
Condition aggravated	18.47	15.30	359	46221	191837	34718514
Circulatory collapse	18.34	15.30	3	46577	21035	34889316
Tubulointerstitial nephritis	18.32	15.30	3	46577	21021	34889330
Alopecia areata	18.14	15.30	8	46572	230	34910121
Haematochezia	18.07	15.30	115	46465	46419	34863932
Carbuncle	18.01	15.30	5	46575	33	34910318
Stoma creation	17.89	15.30	5	46575	34	34910317
Hypophagia	17.73	15.30	5	46575	24017	34886334
Meningitis listeria	17.72	15.30	10	46570	492	34909859
Chest pain	17.61	15.30	98	46482	126664	34783687
Enterocutaneous fistula	17.55	15.30	13	46567	1022	34909329
Therapy change	17.41	15.30	21	46559	3056	34907295
Medical device site fistula	17.29	15.30	5	46575	39	34910312
Accidental overdose	17.27	15.30	3	46577	20137	34890214
COVID-19	17.03	15.30	168	46412	77382	34832969
Upper respiratory tract infection	16.97	15.30	88	46492	32971	34877380
Adrenal cortex necrosis	16.96	15.30	4	46576	12	34910339
Dysarthria	16.83	15.30	13	46567	34769	34875582
Eosinophilia	16.70	15.30	7	46573	26215	34884136
Red blood cell count decreased	16.63	15.30	9	46571	29081	34881270
Cholangiocarcinoma	16.54	15.30	14	46566	1335	34909016
Blood bilirubin increased	16.49	15.30	16	46564	38280	34872071
Gastrointestinal bacterial infection	16.38	15.30	9	46571	420	34909931
Colostomy closure	16.37	15.30	5	46575	48	34910303
Gastrooesophageal reflux disease	16.15	15.30	16	46564	37908	34872443
Ejection fraction decreased	16.11	15.30	3	46577	19151	34891200
Septic shock	16.04	15.30	46	46534	71788	34838563
Anaplastic astrocytoma	15.91	15.30	6	46574	114	34910237
External ear cellulitis	15.88	15.30	4	46576	17	34910334
Proctocolectomy	15.86	15.30	6	46574	115	34910236
Skin ulcer	15.74	15.30	65	46515	22151	34888200
Pertussis	15.72	15.30	7	46573	206	34910145
Transaminases increased	15.61	15.30	74	46506	26749	34883602
Stevens-Johnson syndrome	15.50	15.30	3	46577	18636	34891715
Disorientation	15.32	15.30	13	46567	33175	34877176

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
Product dose omission issue	2915.43	14.98	2865	141700	244672	79355151
Product use issue	1949.53	14.98	2141	142424	207681	79392142
Off label use	1230.12	14.98	4012	140553	903203	78696620
Syringe issue	988.42	14.98	387	144178	5911	79593912
Synovitis	971.80	14.98	1279	143286	149455	79450368
Drug ineffective	920.02	14.98	4123	140442	1076790	78523033
Psoriatic arthropathy	812.34	14.98	847	143718	77152	79522671
Rheumatoid factor positive	804.23	14.98	747	143818	59092	79540731
Anti-cyclic citrullinated peptide antibody positive	767.53	14.98	847	143718	82296	79517527
Pericarditis	738.15	14.98	927	143638	103309	79496514
Psoriasis	727.55	14.98	854	143711	88733	79511090
Treatment failure	724.71	14.98	1189	143376	169297	79430526
Inappropriate schedule of product administration	703.72	14.98	1029	143536	132599	79467224
Hand deformity	692.94	14.98	897	143668	103022	79496801
Wound	692.11	14.98	949	143616	115230	79484593
Pemphigus	691.42	14.98	877	143688	98705	79501118
Toxicity to various agents	669.63	14.98	21	144544	421519	79178304
Systemic lupus erythematosus	668.67	14.98	954	143611	120195	79479628
Glossodynia	662.64	14.98	875	143690	102462	79497361
Infusion related reaction	651.57	14.98	1347	143218	228890	79370933
Acute kidney injury	626.61	14.98	97	144468	519307	79080516
Therapeutic product effect decreased	600.32	14.98	1070	143495	162793	79437030
Drug interaction	582.64	14.98	45	144520	415138	79184685
Arthropathy	567.84	14.98	1092	143473	176019	79423804
Hepatic enzyme increased	557.61	14.98	1103	143462	181507	79418316
Discomfort	552.39	14.98	890	143675	124727	79475096
Hypotension	545.32	14.98	76	144489	440241	79159582
Hypersensitivity	530.77	14.98	1344	143221	260895	79338928
Drug intolerance	474.60	14.98	1295	143270	262824	79336999
Duodenal ulcer perforation	465.52	14.98	587	143978	65624	79534199
Rheumatic fever	458.20	14.98	394	144171	28131	79571692
Helicobacter infection	447.82	14.98	591	143974	69113	79530710
Intestinal resection	442.69	14.98	188	144377	3569	79596254
Alopecia	441.41	14.98	1160	143405	230195	79369628
Neutropenia	412.53	14.98	28	144537	287682	79312141
Completed suicide	398.23	14.98	10	144555	245757	79354066
Needle issue	384.35	14.98	259	144306	12809	79587014
Anaemia	378.14	14.98	167	144398	444848	79154975
Death	376.01	14.98	287	144278	566227	79033596
Febrile neutropenia	364.71	14.98	12	144553	230987	79368836
Swollen joint count increased	360.76	14.98	313	144252	22614	79577209
Contraindicated product administered	355.05	14.98	842	143723	156696	79443127
Rheumatoid arthritis	353.31	14.98	1001	143564	207469	79392354
Abdominal discomfort	347.01	14.98	1121	143444	249606	79350217
Dyspnoea	343.63	14.98	646	143919	856379	78743444
Product storage error	342.74	14.98	263	144302	15963	79583860
Thrombocytopenia	327.57	14.98	46	144519	265213	79334610
Joint swelling	324.18	14.98	1204	143361	287442	79312381
Blister	319.91	14.98	684	143881	118792	79481031
Exposure during pregnancy	313.31	14.98	615	143950	100517	79499306
Type 2 diabetes mellitus	301.94	14.98	441	144124	56681	79543142
Musculoskeletal stiffness	295.12	14.98	839	143726	174169	79425654
Hyponatraemia	288.95	14.98	7	144558	177841	79421982
Drug eruption	287.50	14.98	376	144189	43559	79556264
C-reactive protein abnormal	284.54	14.98	393	144172	47974	79551849
Hip arthroplasty	281.96	14.98	336	144229	35420	79564403
Basal cell carcinoma	281.30	14.98	343	144222	37032	79562791
Swelling	276.61	14.98	943	143622	215768	79384055
Blood cholesterol increased	276.31	14.98	523	144042	83197	79516626
Drug abuse	269.84	14.98	5	144560	162686	79437137
Enthesopathy	262.53	14.98	196	144369	11412	79588411
Lower respiratory tract infection	261.65	14.98	663	143902	128557	79471266
Somnolence	253.13	14.98	61	144504	238920	79360903
General physical health deterioration	244.08	14.98	1067	143498	274171	79325652
Mobility decreased	237.15	14.98	617	143948	121558	79478265
Maternal exposure during pregnancy	236.38	14.98	661	143904	135877	79463946
Platelet count decreased	232.80	14.98	37	144528	194627	79405196
Pancytopenia	232.08	14.98	18	144547	165727	79434096
Anal abscess	229.71	14.98	166	144399	9189	79590634
Knee arthroplasty	225.79	14.98	332	144233	42916	79556907
Disease progression	222.83	14.98	34	144531	184328	79415495
Fibromyalgia	218.57	14.98	407	144158	63933	79535890
White blood cell count decreased	207.50	14.98	44	144521	188244	79411579
Therapy non-responder	206.31	14.98	492	144073	91813	79508010
Haemoglobin decreased	205.39	14.98	73	144492	222046	79377777
Tenosynovitis	200.77	14.98	190	144375	15364	79584459
Cardiac arrest	200.69	14.98	35	144530	172061	79427762
Injury	196.30	14.98	434	144131	77062	79522761
Adverse event	194.73	14.98	373	144192	59841	79539982
Bradycardia	194.72	14.98	13	144552	135544	79464279
Adverse drug reaction	193.85	14.98	394	144171	65998	79533825
Oxygen saturation decreased	192.59	14.98	10	144555	129037	79470786
Liver injury	192.14	14.98	358	144207	56256	79543567
Arthritis	191.81	14.98	549	144016	114331	79485492
Hepatic cirrhosis	189.53	14.98	273	144292	34633	79565190
Fall	189.19	14.98	374	144191	487255	79112568
Constipation	189.18	14.98	142	144423	282908	79316915
Hypokalaemia	184.90	14.98	22	144543	144018	79455805
Irritable bowel syndrome	184.85	14.98	372	144193	61869	79537954
Hyperkalaemia	183.90	14.98	5	144560	114393	79485430
Tongue disorder	182.84	14.98	172	144393	13803	79586020
Folliculitis	182.72	14.98	346	144219	55034	79544789
Renal failure	180.82	14.98	69	144496	200899	79398924
Urticaria	179.55	14.98	738	143827	184463	79415360
Alanine aminotransferase abnormal	176.98	14.98	139	144426	8728	79591095
Deep vein thrombosis postoperative	169.55	14.98	147	144418	10605	79589218
Respiratory failure	166.30	14.98	60	144505	180851	79418972
Dehydration	163.92	14.98	126	144439	248061	79351762
Lip dry	163.13	14.98	169	144396	15249	79584574
Intentional overdose	162.02	14.98	7	144558	105953	79493870
Neuropathy peripheral	159.87	14.98	31	144534	141274	79458549
Gastrointestinal haemorrhage	159.74	14.98	36	144529	147683	79452140
Colectomy	158.13	14.98	90	144475	3284	79596539
Pyrexia	157.96	14.98	664	143901	678045	78921778
Facet joint syndrome	157.33	14.98	144	144421	11158	79588665
Hypoxia	157.27	14.98	7	144558	103236	79496587
Retinitis	156.80	14.98	108	144457	5535	79594288
Tremor	155.33	14.98	57	144508	170026	79429797
Overdose	154.81	14.98	70	144495	184136	79415687
Prescribed overdose	152.28	14.98	258	144307	37625	79562198
Pleural effusion	148.13	14.98	40	144525	145222	79454601
Rhabdomyolysis	147.79	14.98	10	144555	103121	79496702
Neutrophil count decreased	147.79	14.98	5	144560	93954	79505869
Agitation	144.87	14.98	9	144556	99706	79500117
Stomatitis	144.72	14.98	588	143977	146169	79453654
Atrial fibrillation	143.16	14.98	91	144474	197795	79402028
Bone erosion	142.80	14.98	169	144396	17678	79582145
Muscle injury	142.71	14.98	289	144276	48272	79551551
Depressed level of consciousness	142.62	14.98	8	144557	96644	79503179
Coma	140.67	14.98	11	144554	100638	79499185
Arthralgia	140.64	14.98	1619	142946	570184	79029639
Exostosis	138.82	14.98	162	144403	16696	79583127
Tachycardia	138.14	14.98	75	144490	177693	79422130
Therapeutic product effect incomplete	136.88	14.98	564	144001	141081	79458742
Latent tuberculosis	134.86	14.98	81	144484	3272	79596551
Cardio-respiratory arrest	133.41	14.98	19	144546	108491	79491332
Therapeutic response decreased	133.12	14.98	341	144224	66512	79533311
International normalised ratio increased	131.54	14.98	5	144560	84716	79515107
Inflammation	130.15	14.98	420	144145	93333	79506490
Red blood cell sedimentation rate	128.15	14.98	95	144470	5470	79594353
Hypoglycaemia	126.77	14.98	17	144548	101577	79498246
Leukopenia	126.76	14.98	28	144537	116485	79483338
Accidental exposure to product	125.47	14.98	213	144352	31109	79568714
Chills	125.38	14.98	67	144498	160167	79439656
Squamous cell carcinoma	125.11	14.98	148	144417	15474	79584349
Vomiting	123.28	14.98	706	143859	665122	78934701
Drug delivery system malfunction	122.94	14.98	47	144518	670	79599153
Autoimmune disorder	122.62	14.98	151	144414	16461	79583362
Multiple organ dysfunction syndrome	120.93	14.98	34	144531	120212	79479611
Lupus-like syndrome	120.56	14.98	137	144428	13720	79586103
Asthenia	120.49	14.98	498	144067	511191	79088632
Live birth	120.39	14.98	159	144406	18585	79581238
Tendonitis	120.15	14.98	180	144385	23650	79576173
Peripheral venous disease	119.67	14.98	146	144419	15763	79584060
Infection	119.61	14.98	799	143766	240913	79358910
Blood parathyroid hormone decreased	117.84	14.98	119	144446	10417	79589406
Joint dislocation	115.51	14.98	148	144417	16791	79583032
Adjustment disorder with depressed mood	115.38	14.98	110	144455	8976	79590847
Sepsis	113.77	14.98	196	144369	269232	79330591
Joint range of motion decreased	113.57	14.98	211	144354	33071	79566752
Osteoarthritis	113.02	14.98	382	144183	86927	79512896
Renal impairment	112.14	14.98	74	144491	157709	79442114
Panniculitis	110.51	14.98	124	144441	12247	79587576
Dyspnoea exertional	110.01	14.98	14	144551	87059	79512764
Cough	109.85	14.98	322	144243	366467	79233356
Sleep disorder due to general medical condition, insomnia type	108.09	14.98	242	144323	43314	79556509
Granuloma skin	106.99	14.98	106	144459	9068	79590755
Hallucination	105.44	14.98	15	144550	85730	79514093
Cardiac failure congestive	105.03	14.98	64	144501	142338	79457485
Cardiac failure	104.25	14.98	77	144488	154765	79445058
Pustular psoriasis	103.90	14.98	79	144486	4727	79595096
Liquid product physical issue	103.70	14.98	48	144517	1126	79598697
Blood pressure increased	103.43	14.98	139	144426	211221	79388602
Hyperglycaemia	103.22	14.98	6	144559	70329	79529494
Frequent bowel movements	102.97	14.98	189	144376	29350	79570473
Drug reaction with eosinophilia and systemic symptoms	102.53	14.98	3	144562	64241	79535582
Cognitive disorder	102.51	14.98	6	144559	69920	79529903
Drug level decreased	101.63	14.98	128	144437	14274	79585549
Product leakage	99.43	14.98	44	144521	926	79598897
Balance disorder	99.31	14.98	28	144537	98829	79500994
Grip strength decreased	98.77	14.98	157	144408	21712	79578111
Pulmonary oedema	98.47	14.98	20	144545	88234	79511589
Pulmonary embolism	95.56	14.98	102	144463	171552	79428271
Ileostomy	94.65	14.98	51	144514	1669	79598154
Anti-cyclic citrullinated peptide antibody	94.28	14.98	81	144484	5771	79594052
Foot deformity	94.16	14.98	162	144403	23912	79575911
Wound infection	93.26	14.98	161	144404	23830	79575993
Respiratory arrest	90.72	14.98	3	144562	57547	79542276
Abscess	90.50	14.98	155	144410	22796	79577027
Gastric disorder	89.56	14.98	205	144360	37228	79562595
Dislocation of vertebra	88.12	14.98	89	144476	7791	79592032
Suicide attempt	88.07	14.98	21	144544	82911	79516912
Red blood cell sedimentation rate increased	88.01	14.98	231	144334	45711	79554112
Loss of consciousness	87.82	14.98	105	144460	167838	79431985
Seizure	87.59	14.98	129	144436	188705	79411118
Fistula	86.57	14.98	112	144453	12828	79586995
Cutaneous T-cell lymphoma	85.33	14.98	56	144509	2647	79597176
Nasopharyngitis	85.30	14.98	767	143798	253114	79346709
Rash	84.22	14.98	1494	143071	576864	79022959
Rectal abscess	84.16	14.98	51	144514	2094	79597729
Mental status changes	84.02	14.98	11	144554	66948	79532875
Hyperhidrosis	81.04	14.98	93	144472	151399	79448424
X-ray abnormal	80.78	14.98	74	144491	5739	79594084
Encephalopathy	80.10	14.98	13	144552	67384	79532439
Impaired healing	79.93	14.98	343	144222	87312	79512511
Skin plaque	79.83	14.98	98	144467	10647	79589176
Blood pressure fluctuation	79.69	14.98	13	144552	67132	79532691
Skin necrosis	79.15	14.98	128	144437	17959	79581864
Vein rupture	78.83	14.98	48	144517	1988	79597835
Drug tolerance decreased	78.62	14.98	107	144458	12871	79586952
Blood bilirubin increased	78.21	14.98	13	144552	66219	79533604
Syncope	78.06	14.98	128	144437	179321	79420502
Breast cancer stage III	76.88	14.98	92	144473	9734	79590089
Back pain	76.60	14.98	288	144277	303892	79295931
Intentional product misuse	75.59	14.98	39	144526	95126	79504697
Unresponsive to stimuli	75.47	14.98	7	144558	55781	79544042
Hepatic function abnormal	75.28	14.98	297	144268	72810	79527013
Intestinal stenosis	75.24	14.98	59	144506	3695	79596128
Heart rate increased	75.03	14.98	65	144500	120659	79479164
Erythrodermic psoriasis	74.70	14.98	44	144521	1714	79598109
Interstitial lung disease	74.49	14.98	57	144508	112543	79487280
Blood pressure decreased	74.32	14.98	44	144521	99422	79500401
Hypocalcaemia	74.05	14.98	4	144561	49920	79549903
Melaena	74.05	14.98	11	144554	60879	79538944
Red blood cell count decreased	73.25	14.98	9	144556	57504	79542319
Rheumatoid nodule	73.05	14.98	121	144444	17317	79582506
Aggression	72.82	14.98	5	144560	50953	79548870
Neurologic neglect syndrome	72.32	14.98	52	144513	2855	79596968
Blood creatine phosphokinase increased	71.64	14.98	16	144549	66074	79533749
Disorientation	70.50	14.98	14	144551	62762	79537061
Heart rate decreased	70.47	14.98	20	144545	70296	79529527
Carotid artery thrombosis	70.03	14.98	52	144513	3001	79596822
Skin haemorrhage	69.90	14.98	97	144468	11884	79587939
Fluid retention	69.69	14.98	20	144545	69789	79530034
Anal fistula	69.68	14.98	74	144491	6870	79592953
Laryngitis	69.49	14.98	113	144452	15926	79583897
Deep vein thrombosis	69.38	14.98	70	144495	120849	79478974
Orthostatic hypotension	68.64	14.98	10	144555	56154	79543669
Rash maculo-papular	68.50	14.98	10	144555	56068	79543755
Abscess intestinal	67.96	14.98	49	144516	2702	79597121
Chronic kidney disease	67.83	14.98	18	144547	66136	79533687
Sciatica	67.72	14.98	171	144394	33051	79566772
Pneumonitis	67.46	14.98	14	144551	60846	79538977
Urinary retention	67.12	14.98	11	144554	56619	79543204
Condition aggravated	67.12	14.98	1278	143287	499846	79099977
Cholestasis	66.74	14.98	8	144557	52101	79547722
Lymphocyte count decreased	66.54	14.98	5	144560	47284	79552539
C-reactive protein	66.51	14.98	62	144503	4917	79594906
Shock	66.16	14.98	3	144562	43545	79556278
Lower limb fracture	65.64	14.98	136	144429	23079	79576744
Osteonecrosis of jaw	65.59	14.98	3	144562	43223	79556600
Agranulocytosis	65.59	14.98	4	144561	45026	79554797
Respiratory distress	65.54	14.98	13	144552	58326	79541497
Intestinal obstruction	65.45	14.98	199	144366	42821	79557002
Dyskinesia	65.15	14.98	4	144561	44769	79555054
Coronary artery disease	64.92	14.98	19	144546	65455	79534368
Blood glucose increased	64.33	14.98	68	144497	114907	79484916
Altered state of consciousness	63.51	14.98	4	144561	43818	79556005
Restlessness	62.45	14.98	6	144559	46486	79553337
Device malfunction	62.23	14.98	127	144438	21321	79578502
Pneumonia aspiration	61.86	14.98	22	144543	66945	79532878
Septic shock	61.85	14.98	79	144486	122722	79477101
Ear infection	61.79	14.98	169	144396	34263	79565560
Postoperative wound infection	61.23	14.98	95	144470	12866	79586957
Therapy cessation	61.17	14.98	178	144387	37384	79562439
Myelosuppression	60.49	14.98	3	144562	40293	79559530
Intentional product use issue	60.29	14.98	477	144088	151635	79448188
Hepatic failure	60.26	14.98	18	144547	61194	79538629
Cardiogenic shock	60.23	14.98	4	144561	41910	79557913
Mucosal inflammation	59.99	14.98	31	144534	75549	79524274
Haematuria	59.63	14.98	25	144540	68811	79531012
Abdominal abscess	59.53	14.98	69	144496	7058	79592765
Hepatocellular injury	59.28	14.98	8	144557	47585	79552238
Hypoaesthesia	59.25	14.98	540	144025	178812	79421011
Ulcer	58.73	14.98	152	144413	29820	79570003
Product packaging issue	58.08	14.98	33	144532	1200	79598623
Productive cough	58.06	14.98	45	144520	88286	79511537
Disturbance in attention	57.74	14.98	11	144554	50790	79549033
Oedema peripheral	57.73	14.98	248	144317	252040	79347783
Bursitis	57.55	14.98	169	144396	35675	79564148
Ill-defined disorder	57.17	14.98	254	144311	65621	79534202
Ascites	57.05	14.98	33	144532	75529	79524294
Pain in jaw	56.91	14.98	8	144557	46143	79553680
Irritability	56.09	14.98	5	144560	41139	79558684
Hypervolaemia	56.07	14.98	6	144559	42684	79557139
Haemoptysis	55.98	14.98	16	144549	55983	79543840
Haematemesis	55.95	14.98	13	144552	52251	79547572
Gastrooesophageal reflux disease	55.74	14.98	64	144501	104182	79495641
Incorrect dose administered	55.24	14.98	280	144285	76350	79523473
Pain	55.15	14.98	1667	142898	702135	78897688
Full blood count abnormal	54.96	14.98	5	144560	40469	79559354
Hypercholesterolaemia	54.72	14.98	126	144439	22969	79576854
Blood urea increased	54.54	14.98	11	144554	48779	79551044
Night sweats	53.92	14.98	212	144353	51883	79547940
Intestinal operation	53.89	14.98	24	144541	513	79599310
Hypophagia	53.35	14.98	9	144556	45358	79554465
Stevens-Johnson syndrome	52.75	14.98	5	144560	39161	79560662
Weight decreased	52.73	14.98	402	144163	354796	79245027
Blood creatinine increased	52.48	14.98	128	144437	154929	79444894
Ventricular tachycardia	52.34	14.98	7	144558	41928	79557895
Blood alkaline phosphatase increased	52.20	14.98	25	144540	63639	79536184
Insurance issue	52.12	14.98	58	144507	5675	79594148
Fear of injection	52.06	14.98	66	144499	7408	79592415
Jaundice	51.95	14.98	16	144549	53333	79546490
Mycobacterium tuberculosis complex test positive	51.94	14.98	42	144523	2750	79597073
Disability	51.61	14.98	103	144462	17017	79582806
Headache	51.60	14.98	1550	143015	652222	78947601
Joint stiffness	51.37	14.98	177	144388	40653	79559170
Lupus vulgaris	51.25	14.98	45	144520	3301	79596522
Eosinophilia	51.16	14.98	10	144555	45335	79554488
Acute respiratory failure	50.97	14.98	22	144543	59519	79540304
Sleep disorder	50.92	14.98	297	144268	85380	79514443
Angioedema	50.91	14.98	38	144527	75997	79523826
Accidental overdose	50.88	14.98	6	144559	39575	79560248
Device deployment issue	50.81	14.98	44	144521	3168	79596655
Cellulitis	50.58	14.98	355	144210	108705	79491118
Circulatory collapse	50.23	14.98	5	144560	37663	79562160
Diabetic ketoacidosis	49.79	14.98	3	144562	34119	79565704
Sinus tachycardia	48.95	14.98	5	144560	36903	79562920
Suicidal ideation	48.78	14.98	40	144525	76300	79523523
Haematoma	48.46	14.98	17	144548	52178	79547645
Urinary incontinence	48.36	14.98	8	144557	40901	79558922
Dysuria	48.34	14.98	16	144549	50935	79548888
Kidney infection	48.27	14.98	116	144449	21735	79578088
Palpitations	48.18	14.98	98	144467	126512	79473311
Abnormal behaviour	48.14	14.98	5	144560	36416	79563407
Feeling abnormal	48.13	14.98	139	144426	159060	79440763
Ejection fraction decreased	47.69	14.98	4	144561	34573	79565250
Coagulopathy	47.44	14.98	5	144560	36001	79563822
Hypothyroidism	47.06	14.98	18	144547	52374	79547449
Obesity	46.60	14.98	155	144410	34970	79564853
Tubulointerstitial nephritis	46.28	14.98	7	144558	38228	79561595
Leukocytosis	46.14	14.98	11	144554	43444	79556379
Acute myocardial infarction	46.03	14.98	43	144522	76993	79522830
Muscle spasms	46.03	14.98	502	144063	174228	79425595
Toxic epidermal necrolysis	45.95	14.98	12	144553	44569	79555254
Pulmonary hypertension	45.78	14.98	15	144550	48065	79551758
Breast cancer	45.64	14.98	150	144415	33631	79566192
Drug withdrawal syndrome	45.29	14.98	5	144560	34713	79565110
Dizziness	45.17	14.98	677	143888	525764	79074059
Upper gastrointestinal haemorrhage	44.88	14.98	10	144555	41370	79558453
Tooth abscess	44.70	14.98	94	144471	16116	79583707
Sinusitis	44.50	14.98	546	144019	194955	79404868
Drug level increased	44.20	14.98	9	144556	39642	79560181
Road traffic accident	43.82	14.98	176	144389	43488	79556335
Tinnitus	43.70	14.98	13	144552	44320	79555503
Ventricular fibrillation	43.20	14.98	4	144561	31922	79567901
Arrhythmia	43.16	14.98	29	144536	61243	79538580
Eye pain	43.00	14.98	8	144557	37570	79562253
Oral pain	42.98	14.98	4	144561	31794	79568029
Adjustment disorder	42.59	14.98	44	144521	3956	79595867
Cerebral haemorrhage	42.39	14.98	26	144539	57647	79542176
No adverse event	42.38	14.98	8	144557	37184	79562639
Drug resistance	42.31	14.98	12	144553	42201	79557622
Gastrointestinal infection	42.06	14.98	75	144490	11386	79588437
Surgery	42.06	14.98	143	144422	32623	79567200
White blood cell count increased	41.90	14.98	44	144521	74589	79525234
Small intestinal resection	41.40	14.98	24	144541	907	79598916
Generalised tonic-clonic seizure	41.29	14.98	14	144551	43896	79555927
Diarrhoea	41.26	14.98	1249	143316	879240	78720583
Sacroiliitis	41.25	14.98	42	144523	3712	79596111
Sinus congestion	41.16	14.98	103	144462	19793	79580030
Inflammatory bowel disease	41.11	14.98	51	144514	5600	79594223
Blood calcium decreased	40.47	14.98	5	144560	31814	79568009
Blood sodium decreased	40.45	14.98	6	144559	33249	79566574
Acute hepatic failure	40.15	14.98	4	144561	30109	79569714
Malignant melanoma	40.09	14.98	85	144480	14656	79585167
Venous injury	39.23	14.98	22	144543	780	79599043
Intentional self-injury	39.09	14.98	6	144559	32413	79567410
Tuberculin test positive	39.04	14.98	39	144526	3369	79596454
Pallor	39.04	14.98	21	144544	50041	79549782
Dysgeusia	39.03	14.98	28	144537	57149	79542674
C-reactive protein increased	38.86	14.98	381	144184	128646	79471177
Body temperature increased	38.69	14.98	16	144549	44404	79555419
Blood potassium decreased	38.54	14.98	18	144547	46494	79553329
Ileal stenosis	38.24	14.98	33	144532	2365	79597458
Lethargy	38.19	14.98	55	144510	81237	79518586
Personality disorder	37.72	14.98	51	144514	6095	79593728
Clostridium difficile infection	37.35	14.98	165	144400	42520	79557303
Drug level below therapeutic	37.23	14.98	65	144500	9705	79590118
Ileectomy	36.72	14.98	14	144551	198	79599625
Cardiac disorder	36.66	14.98	39	144526	65718	79534105
Drug dependence	36.63	14.98	14	144551	40755	79559068
Atelectasis	36.63	14.98	7	144558	32250	79567573
Visual acuity reduced	36.59	14.98	5	144560	29464	79570359
Infected fistula	36.56	14.98	17	144548	403	79599420
Underdose	36.01	14.98	137	144428	33014	79566809
Haemorrhage	35.98	14.98	69	144496	91049	79508774
Pneumonia lipoid	35.96	14.98	13	144552	157	79599666
Plasmablastic lymphoma	35.81	14.98	18	144547	509	79599314
Nausea	35.75	14.98	1397	143168	955799	78644024
Malignant melanoma in situ	35.61	14.98	32	144533	2420	79597403
Faecal calprotectin increased	35.57	14.98	47	144518	5494	79594329
Loss of personal independence in daily activities	35.46	14.98	312	144253	102268	79497555
Lip swelling	35.20	14.98	15	144550	40896	79558927
Myalgia	35.20	14.98	195	144370	185446	79414377
Pericardial effusion	35.18	14.98	20	144545	46217	79553606
Apoptotic colonopathy	35.13	14.98	12	144553	121	79599702
Mucous stools	35.03	14.98	45	144520	5117	79594706
Postoperative abscess	34.79	14.98	20	144545	744	79599079
Injection site erythema	34.71	14.98	55	144510	78142	79521681
Diplopia	34.50	14.98	9	144556	33457	79566366
Electrolyte imbalance	34.44	14.98	7	144558	30874	79568949
Intestinal fistula	34.13	14.98	25	144540	1413	79598410
Adenocarcinoma of colon	34.04	14.98	46	144519	5495	79594328
Manufacturing product shipping issue	34.02	14.98	11	144554	92	79599731
Thrombosis	33.81	14.98	63	144502	84037	79515786
Dysphagia	33.12	14.98	112	144453	122024	79477799
Neurotoxicity	33.04	14.98	9	144556	32509	79567314
Gait inability	32.93	14.98	201	144364	58716	79541107
Mitral valve incompetence	32.86	14.98	6	144559	28559	79571264
Disseminated intravascular coagulation	32.72	14.98	12	144553	35830	79563993
Dermatitis exfoliative generalised	32.71	14.98	52	144513	7189	79592634
Neutropenic sepsis	32.65	14.98	5	144560	27059	79572764
Tumour lysis syndrome	32.39	14.98	3	144562	23936	79575887
Bone pain	32.27	14.98	32	144533	55710	79544113
Acute respiratory distress syndrome	32.20	14.98	20	144545	44047	79555776
Chikungunya virus infection	32.13	14.98	13	144552	217	79599606
Product dispensing error	32.12	14.98	73	144492	13190	79586633
Loss of therapeutic response	32.09	14.98	20	144545	864	79598959
Poisoning	32.07	14.98	4	144561	25268	79574555
Rheumatoid lung	31.99	14.98	39	144526	4206	79595617
Guttate psoriasis	31.87	14.98	16	144549	451	79599372
Subcutaneous abscess	31.75	14.98	54	144511	7895	79591928
Walking aid user	31.73	14.98	62	144503	10086	79589737
Spondylitis	31.73	14.98	41	144524	4690	79595133
Hepatotoxicity	31.47	14.98	28	144537	51324	79548499
Myoclonus	31.41	14.98	6	144559	27654	79572169
Subdural haematoma	31.38	14.98	9	144556	31425	79568398
Haemorrhage intracranial	31.24	14.98	5	144560	26188	79573635
Feeling cold	31.04	14.98	7	144558	28722	79571101
Pyoderma gangrenosum	31.01	14.98	38	144527	4120	79595703
Cervical dysplasia	30.99	14.98	28	144537	2133	79597690
Product container seal issue	30.89	14.98	10	144555	84	79599739
Nightmare	30.70	14.98	5	144560	25856	79573967
Speech disorder	30.67	14.98	32	144533	54413	79545410
Metastases to bone	30.67	14.98	4	144561	24423	79575400
Adrenal insufficiency	30.66	14.98	7	144558	28480	79571343
Femur fracture	30.45	14.98	16	144549	38636	79561187
Muscle swelling	30.37	14.98	19	144546	826	79598997
Swollen tongue	30.18	14.98	20	144545	42550	79557273
Pregnancy	30.02	14.98	112	144453	26739	79573084
Blood potassium increased	29.94	14.98	8	144557	29267	79570556
Cholangitis sclerosing	29.88	14.98	30	144535	2607	79597216
Incorrect route of product administration	29.79	14.98	134	144431	34795	79565028
Anaphylactic shock	29.72	14.98	14	144551	35982	79563841
Sinus bradycardia	29.70	14.98	5	144560	25242	79574581
Pneumocystis jirovecii pneumonia	29.48	14.98	11	144554	32497	79567326
Injection related reaction	29.19	14.98	20	144545	1016	79598807
Nervousness	29.16	14.98	12	144553	33403	79566420
Product packaging quantity issue	28.78	14.98	22	144543	1327	79598496
Periumbilical abscess	28.75	14.98	9	144556	67	79599756
Device dislocation	28.73	14.98	6	144559	25964	79573859
Pityriasis rubra pilaris	28.50	14.98	10	144555	110	79599713
Chronic recurrent multifocal osteomyelitis	28.41	14.98	9	144556	70	79599753
Lymphopenia	28.28	14.98	10	144555	30547	79569276
Blood albumin decreased	28.09	14.98	5	144560	24238	79575585
Hypoalbuminaemia	27.95	14.98	3	144562	21294	79578529
Lichen myxoedematosus	27.78	14.98	8	144557	43	79599780
Drug hypersensitivity	27.77	14.98	724	143841	298192	79301631
Flushing	27.46	14.98	76	144489	88192	79511631
Hepatic steatosis	27.26	14.98	138	144427	37600	79562223
Cutaneous sporotrichosis	27.18	14.98	8	144557	47	79599776
Bronchopulmonary aspergillosis	27.17	14.98	4	144561	22290	79577533
Skin exfoliation	27.10	14.98	182	144383	54918	79544905
Product use in unapproved indication	27.04	14.98	619	143946	249740	79350083
Hot flush	26.91	14.98	36	144529	54841	79544982
Interferon gamma release assay positive	26.76	14.98	8	144557	50	79599773
Pulmonary arterial hypertension	26.74	14.98	9	144556	28357	79571466
Myopathy	26.72	14.98	3	144562	20560	79579263
Delusion	26.49	14.98	3	144562	20420	79579403
Hyperbilirubinaemia	26.44	14.98	6	144559	24512	79575311
Cytopenia	26.42	14.98	3	144562	20380	79579443
Wrong schedule	26.24	14.98	13	144552	356	79599467
Full blood count decreased	26.19	14.98	8	144557	26811	79573012
Product distribution issue	26.18	14.98	21	144544	1359	79598464
Injection site papule	26.17	14.98	18	144547	920	79598903
Oesophagitis	26.08	14.98	6	144559	24283	79575540
Hypoacusis	26.03	14.98	11	144554	30139	79569684
Gastrointestinal bacterial infection	25.88	14.98	18	144547	937	79598886
Chest pain	25.57	14.98	359	144206	281945	79317878
Device issue	25.41	14.98	107	144458	27001	79572822
Injection site pain	25.36	14.98	135	144430	129703	79470120
Blood glucose decreased	25.30	14.98	8	144557	26226	79573597
Bronchiectasis	25.12	14.98	5	144560	22381	79577442
Granuloma	25.11	14.98	50	144515	8247	79591576
Joint ankylosis	25.07	14.98	25	144540	2155	79597668
Skin ulcer	24.94	14.98	176	144389	53974	79545849
Glioblastoma	24.78	14.98	22	144543	1638	79598185
SARS-CoV-2 test positive	24.60	14.98	61	144504	11655	79588168
Sporotrichosis	24.58	14.98	9	144556	113	79599710
Chromaturia	24.57	14.98	8	144557	25738	79574085
Pollakiuria	24.53	14.98	19	144546	37298	79562525
Presyncope	24.43	14.98	23	144542	41031	79558792
Dermatologic examination abnormal	24.40	14.98	6	144559	15	79599808
Vision blurred	24.25	14.98	104	144461	105794	79494029
Nephropathy toxic	24.12	14.98	4	144561	20415	79579408
Restless legs syndrome	23.59	14.98	4	144561	20088	79579735
Tooth disorder	23.58	14.98	9	144556	26224	79573599
Rales	23.45	14.98	4	144561	19997	79579826
Transfusion	23.44	14.98	5	144560	21325	79578498
Proteinuria	23.41	14.98	15	144550	32487	79567336
Hyperlipidaemia	23.37	14.98	9	144556	26084	79573739
Hypophosphataemia	23.30	14.98	4	144561	19909	79579914
Mastitis	23.14	14.98	24	144541	2167	79597656
Plasma cell myeloma	23.13	14.98	38	144527	53221	79546602
Glaucoma	23.06	14.98	4	144561	19757	79580066
Hidradenitis	23.00	14.98	28	144537	3016	79596807
Unevaluable event	22.91	14.98	41	144524	55544	79544279
Anal stenosis	22.85	14.98	13	144552	474	79599349
Sneezing	22.76	14.98	83	144482	19600	79580223
Bacterial vulvovaginitis	22.75	14.98	14	144551	591	79599232
Purpura	22.68	14.98	4	144561	19523	79580300
Post procedural infection	22.58	14.98	58	144507	11326	79588497
Product administration error	22.52	14.98	15	144550	31831	79567992
Fear	22.50	14.98	6	144559	21980	79577843
Lung neoplasm malignant	22.50	14.98	105	144460	27687	79572136
Small intestine operation	22.26	14.98	7	144558	53	79599770
Hepatocellular carcinoma	22.24	14.98	50	144515	8971	79590852
Anxiety	22.16	14.98	317	144248	248195	79351628
Skin discolouration	22.14	14.98	25	144540	41009	79558814
Aspergillus infection	22.09	14.98	4	144561	19157	79580666
Gastritis	22.02	14.98	33	144532	47960	79551863
Neutrophil count increased	21.96	14.98	13	144552	29383	79570440
Neck pain	21.95	14.98	67	144498	75350	79524473
Anaplastic large-cell lymphoma	21.94	14.98	10	144555	226	79599597
Genital cyst	21.92	14.98	7	144558	56	79599767
Dactylitis	21.88	14.98	26	144539	2731	79597092
Status epilepticus	21.84	14.98	9	144556	25032	79574791
Product substitution issue	21.76	14.98	5	144560	20251	79579572
Blood pressure diastolic decreased	21.68	14.98	14	144551	30202	79569621
Dry eye	21.61	14.98	21	144544	36910	79562913
Generalised oedema	21.54	14.98	8	144557	23701	79576122
Infected dermal cyst	21.47	14.98	18	144547	1240	79598583
Drug tolerance	21.29	14.98	48	144517	8627	79591196
Product label confusion	21.24	14.98	20	144545	1606	79598217
Stoma site abscess	21.24	14.98	10	144555	244	79599579
Device ineffective	21.23	14.98	9	144556	170	79599653
Erysipelas	21.23	14.98	55	144510	10795	79589028
Pneumoretroperitoneum	21.18	14.98	9	144556	171	79599652
Infected cyst	21.07	14.98	18	144547	1272	79598551
Osteoporosis	21.04	14.98	169	144396	53943	79545880
Myocardial ischaemia	20.95	14.98	10	144555	25509	79574314
Alcoholic liver disease	20.66	14.98	13	144552	571	79599252
Mania	20.65	14.98	4	144561	18256	79581567
Cardiomegaly	20.62	14.98	11	144554	26341	79573482
Brain oedema	20.59	14.98	10	144555	25253	79574570
Psychomotor hyperactivity	20.59	14.98	3	144562	16846	79582977
Blindness	20.58	14.98	13	144552	28370	79571453
Body temperature decreased	20.34	14.98	17	144548	32128	79567695
Renal disorder	20.26	14.98	28	144537	42077	79557746
Faeces discoloured	20.22	14.98	14	144551	29113	79570710
Mouth ulceration	20.06	14.98	24	144541	38370	79561453
Bronchospasm	20.02	14.98	10	144555	24849	79574974
Mood altered	20.00	14.98	4	144561	17843	79581980
Haemolytic anaemia	19.95	14.98	4	144561	17816	79582007
Gastrointestinal inflammation	19.94	14.98	43	144522	7501	79592322
Tonsillitis	19.77	14.98	40	144525	6674	79593149
Stoma creation	19.71	14.98	7	144558	80	79599743
Toxic skin eruption	19.46	14.98	8	144557	22285	79577538
Pneumonia	19.26	14.98	1417	143148	658829	78940994
Flank pain	19.23	14.98	6	144559	19838	79579985
Chest discomfort	19.17	14.98	159	144406	137885	79461938
Hepatic encephalopathy	19.04	14.98	10	144555	24156	79575667
Adverse reaction	19.04	14.98	48	144517	9266	79590557
Skin injury	19.01	14.98	27	144538	3379	79596444
Affect lability	18.95	14.98	54	144511	11205	79588618
Seronegative arthritis	18.91	14.98	32	144533	4660	79595163
Nodule	18.89	14.98	9	144556	22985	79576838
Maternal exposure timing unspecified	18.86	14.98	36	144529	5756	79594067
Onychomadesis	18.85	14.98	34	144531	5208	79594615
Swelling face	18.83	14.98	66	144499	71146	79528677
Haemophagocytic lymphohistiocytosis	18.80	14.98	8	144557	21829	79577994
Drug delivery system issue	18.76	14.98	7	144558	93	79599730
Urinary tract infection	18.64	14.98	368	144197	274144	79325679
Large intestine anastomosis	18.49	14.98	7	144558	97	79599726
Cardiomyopathy	18.47	14.98	15	144550	28759	79571064
Device defective	18.45	14.98	20	144545	1900	79597923
Muscle twitching	18.43	14.98	11	144554	24753	79575070
Dysphonia	18.42	14.98	48	144517	56824	79542999
Dermatitis psoriasiform	18.40	14.98	24	144541	2770	79597053
Respiratory tract congestion	18.11	14.98	78	144487	19876	79579947
IgA nephropathy	18.02	14.98	19	144546	1749	79598074
Injection site mass	18.02	14.98	7	144558	20177	79579646
Mental impairment	18.02	14.98	6	144559	19030	79580793
Thrombotic microangiopathy	18.00	14.98	7	144558	20162	79579661
Inflammatory pain	17.98	14.98	15	144550	1026	79598797
Secretion discharge	17.92	14.98	64	144501	14958	79584865
Metastases to liver	17.88	14.98	15	144550	28299	79571524
Cardiac failure acute	17.86	14.98	6	144559	18923	79580900
Shock haemorrhagic	17.84	14.98	7	144558	20053	79579770
Sensory loss	17.83	14.98	58	144507	12933	79586890
Stoma site ulcer	17.73	14.98	9	144556	260	79599563
Metastases to central nervous system	17.67	14.98	4	144561	16371	79583452
Face oedema	17.65	14.98	15	144550	28121	79571702
Pulmonary congestion	17.56	14.98	14	144551	27086	79572737
Defaecation urgency	17.51	14.98	35	144530	5789	79594034
Retching	17.44	14.98	5	144560	17462	79582361
Bone cyst	17.40	14.98	26	144539	3407	79596416
Ventricular extrasystoles	17.32	14.98	7	144558	19697	79580126
Impaired work ability	17.28	14.98	7	144558	19674	79580149
Dysstasia	17.16	14.98	15	144550	27731	79572092
Colostomy	17.13	14.98	15	144550	1096	79598727
Nail psoriasis	17.11	14.98	12	144553	633	79599190
Prostate infection	16.96	14.98	12	144553	642	79599181
Benign laryngeal neoplasm	16.90	14.98	5	144560	30	79599793
Eosinophil count increased	16.89	14.98	5	144560	17100	79582723
Intervertebral disc degeneration	16.75	14.98	4	144561	15781	79584042
Proctectomy	16.74	14.98	8	144557	202	79599621
Pulmonary fibrosis	16.73	14.98	137	144428	43975	79555848
Psychotic disorder	16.65	14.98	31	144534	41371	79558452
Klebsiella infection	16.65	14.98	4	144561	15716	79584107
Platelet count increased	16.61	14.98	10	144555	22396	79577427
Eye disorder	16.59	14.98	11	144554	23401	79576422
Flavivirus infection	16.56	14.98	4	144561	9	79599814
Urine output decreased	16.51	14.98	6	144559	18016	79581807
Heart rate irregular	16.47	14.98	21	144544	32658	79567165
Hemiplegia	16.44	14.98	62	144503	14877	79584946
Sleep disorder due to a general medical condition	16.42	14.98	3	144562	14274	79585549
Neuralgia	16.26	14.98	22	144543	33362	79566461
Poor quality product administered	16.23	14.98	26	144539	3619	79596204
Cytomegalovirus infection	16.22	14.98	33	144532	42611	79557212
Invasive ductal breast carcinoma	16.05	14.98	34	144531	5858	79593965
Blood test abnormal	16.04	14.98	6	144559	17704	79582119
Notalgia paraesthetica	15.94	14.98	3	144562	0	79599823
Lung infiltration	15.92	14.98	11	144554	22901	79576922
Fracture	15.78	14.98	10	144555	21791	79578032
Medical device site fistula	15.77	14.98	5	144560	39	79599784
Myelodysplastic syndrome	15.77	14.98	19	144546	30282	79569541
Hepatitis cholestatic	15.74	14.98	3	144562	13849	79585974
Pleomorphic adenoma	15.74	14.98	4	144561	12	79599811
Diverticulitis	15.50	14.98	139	144426	45797	79554026
Eyelid oedema	15.48	14.98	3	144562	13684	79586139
Hypercalcaemia	15.48	14.98	121	144444	38309	79561514
Abdominal pain lower	15.43	14.98	21	144544	31761	79568062
Sudden death	15.39	14.98	11	144554	22500	79577323
Premature delivery	15.36	14.98	12	144553	23455	79576368
Depression	15.21	14.98	289	144276	216501	79383322
Breath sounds abnormal	15.19	14.98	5	144560	15979	79583844
Proctocolectomy	15.09	14.98	7	144558	165	79599658
Large intestinal stenosis	15.01	14.98	22	144543	2834	79596989
Myositis	15.00	14.98	8	144557	19160	79580663
Polyneuropathy	15	14.98	13	144552	24138	79575685

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	L04AC05	ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS IMMUNOSUPPRESSANTS IMMUNOSUPPRESSANTS Interleukin inhibitors
MeSH PA	D003879	Dermatologic Agents
FDA MoA	N0000192796	Interleukin-12 Antagonists
FDA EPC	N0000192797	Interleukin-12 Antagonist
FDA MoA	N0000192798	Interleukin-23 Antagonists
FDA EPC	N0000192799	Interleukin-23 Antagonist

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

Disease	Relation	SNOMED_ID	DOID
Psoriasis	indication	9014002	DOID:8893
Psoriasis with arthropathy	indication	33339001
Crohn's disease	indication	34000006
Ulcerative colitis	indication	64766004	DOID:8577
Plaque psoriasis	indication	200965009

🐶 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
Interleukin-12	Cytokine	P29459 P29460	IL12A_HUMAN IL12B_HUMAN	ANTIBODY BINDING				DRUG LABEL	DRUG LABEL
Interleukin-23	Cytokine	P29460 Q9NPF7	IL12B_HUMAN IL23A_HUMAN	ANTIBODY BINDING				DRUG LABEL	DRUG LABEL

External reference:

ID	Source
D09214	KEGG_DRUG
4029348	VUID
N0000180304	NUI
4029348	VANDF
CHEMBL1201835	ChEMBL_ID
6885	IUPHAR_LIGAND_ID
DB05679	DRUGBANK_ID
847083	RXNORM
160966	MMSL
26198	MMSL
d07396	MMSL
013009	NDDF
443465002	SNOMEDCT_US
443644001	SNOMEDCT_US
C1608841	UMLSCUI
D000069549	MESH_DESCRIPTOR_UI
8954	INN_ID
FU77B4U5Z0	UNII

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Stelara	HUMAN PRESCRIPTION DRUG LABEL	1	57894-054	SOLUTION	130 mg	INTRAVENOUS	BLA	34 sections
Stelara	HUMAN PRESCRIPTION DRUG LABEL	1	57894-054	SOLUTION	130 mg	INTRAVENOUS	BLA	34 sections
STELARA	HUMAN PRESCRIPTION DRUG LABEL	1	57894-060	INJECTION, SOLUTION	45 mg	SUBCUTANEOUS	BLA	34 sections
STELARA	HUMAN PRESCRIPTION DRUG LABEL	1	57894-060	INJECTION, SOLUTION	45 mg	SUBCUTANEOUS	BLA	34 sections
STELARA	HUMAN PRESCRIPTION DRUG LABEL	1	57894-061	INJECTION, SOLUTION	90 mg	SUBCUTANEOUS	BLA	34 sections
STELARA	HUMAN PRESCRIPTION DRUG LABEL	1	57894-061	INJECTION, SOLUTION	90 mg	SUBCUTANEOUS	BLA	34 sections