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

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

Stem definition	Drug id	CAS RN
human origin	4967	476181-74-5

Description:

Molecule	Description
Synonyms: golimumab simponi CNTO 148 CNTO-148	Golimumab plus MTX effectively reduces the signs and symptoms of RA and is generally well tolerated in patients with an inadequate response to MTX. Molecular weight: Formula: CLOGP: LIPINSKI: None HAC: None HDO: None TPSA: ALOGS: ROTB: None

Drug dosage:

Dose	Unit	Route
1.66	mg	P

ADMET properties:

None

Approvals:

Date	Agency	Company	Orphan
Oct. 1, 2009	EMA
April 24, 2009	FDA	CENTOCOR ORTHO BIOTECH INC

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
Contraindicated product administered	3677.34	23.46	4679	278333	212969	62993041
Pemphigus	3354.89	23.46	4108	278904	179618	63026392
Glossodynia	3150.27	23.46	3928	279084	174948	63031062
Systemic lupus erythematosus	3011.61	23.46	4157	278855	204761	63001249
Drug ineffective	2701.03	23.46	10435	272577	1034330	62171680
Drug intolerance	2588.12	23.46	4795	278217	303866	62902144
Hand deformity	2582.36	23.46	3360	279652	156097	63049913
Joint swelling	2426.26	23.46	4829	278183	322837	62883173
Swelling	2417.54	23.46	4365	278647	271013	62934997
Therapeutic product effect decreased	2402.40	23.46	3585	279427	189602	63016408
Arthropathy	2376.57	23.46	3964	279048	230828	62975182
Alopecia	2327.60	23.46	4830	278182	332706	62873304
Synovitis	2105.52	23.46	3314	279698	183604	63022406
Abdominal discomfort	2100.13	23.46	4496	278516	316389	62889621
Wound	2083.73	23.46	3068	279944	160195	63045815
Treatment failure	2020.20	23.46	3366	279646	195677	63010333
Anti-cyclic citrullinated peptide antibody positive	1831.75	23.46	2418	280594	113794	63092216
Pericarditis	1735.08	23.46	2512	280500	129067	63076943
Discomfort	1667.30	23.46	2808	280204	164566	63041444
Hypersensitivity	1471.67	23.46	3700	279312	288985	62917025
Lower respiratory tract infection	1464.90	23.46	2329	280683	129978	63076032
Product use issue	1410.06	23.46	3064	279948	217456	62988554
Folliculitis	1211.71	23.46	1530	281482	68787	63137223
Rheumatoid factor positive	1199.55	23.46	1671	281341	82735	63123275
Muscle injury	1191.91	23.46	1463	281549	63882	63142128
Death	1176.17	23.46	144	282868	374237	62831773
Pain	1165.17	23.46	6415	276597	734213	62471797
Irritable bowel syndrome	1149.48	23.46	1617	281395	80795	63125215
Duodenal ulcer perforation	1138.43	23.46	1658	281354	85551	63120459
Helicobacter infection	1129.39	23.46	1707	281305	91078	63114932
Hepatic enzyme increased	1095.14	23.46	2633	280379	199695	63006315
Blister	1010.75	23.46	1958	281054	127856	63078154
Maternal exposure during pregnancy	1003.64	23.46	2684	280328	217378	62988632
Infusion related reaction	995.94	23.46	2869	280143	242652	62963358
Anaemia	987.85	23.46	87	282925	293343	62912667
Ill-defined disorder	923.09	23.46	1453	281559	80302	63125708
Toxicity to various agents	893.31	23.46	52	282960	247198	62958812
Impaired healing	882.92	23.46	1615	281397	100927	63105083
Sleep disorder due to general medical condition, insomnia type	872.17	23.46	1119	281893	51098	63154912
Drug interaction	870.04	23.46	35	282977	229096	62976914
Hypotension	862.65	23.46	102	282910	272502	62933508
Acute kidney injury	850.00	23.46	92	282920	263323	62942687
Rash	822.05	23.46	4772	278240	556099	62649911
Psoriatic arthropathy	817.85	23.46	1465	281547	90055	63115955
Infection	774.56	23.46	2513	280499	226660	62979350
Constipation	706.98	23.46	86	282926	224857	62981153
Peripheral swelling	688.07	23.46	2671	280341	263271	62942739
Musculoskeletal stiffness	653.99	23.46	2058	280954	182560	63023450
Neutropenia	634.36	23.46	36	282976	174969	63031041
Rheumatic fever	614.21	23.46	855	282157	42256	63163754
Arthralgia	603.54	23.46	4470	278542	565240	62640770
Gastrointestinal disorder	586.57	23.46	1590	281422	129649	63076361
Dehydration	578.65	23.46	53	282959	173301	63032709
Fall	565.19	23.46	550	282462	391784	62814226
Sinusitis	542.15	23.46	2222	280790	224431	62981579
Stomatitis	514.66	23.46	1572	281440	137153	63068857
Thrombocytopenia	507.72	23.46	45	282967	151112	63054898
Knee arthroplasty	507.55	23.46	886	282126	53320	63152690
Febrile neutropenia	500.19	23.46	5	283007	118444	63087566
Hip arthroplasty	495.37	23.46	816	282196	46830	63159180
Swollen joint count increased	492.71	23.46	701	282311	35353	63170657
Rheumatoid arthritis	474.12	23.46	2312	280700	251507	62954503
Hyponatraemia	438.81	23.46	13	282999	111887	63094123
Tremor	426.67	23.46	46	282966	132193	63073817
Nausea	407.67	23.46	2197	280815	852274	62353736
Type 2 diabetes mellitus	405.20	23.46	886	282126	62982	63143028
Platelet count decreased	396.98	23.46	32	282980	116090	63089920
Mobility decreased	396.32	23.46	1315	281697	119844	63086166
Cardiac arrest	395.06	23.46	3	283009	92542	63113468
Disease progression	380.41	23.46	49	282963	122709	63083301
Anxiety	380.40	23.46	251	282761	217290	62988720
Liver injury	370.86	23.46	828	282184	59692	63146318
Dizziness	370.13	23.46	859	282153	429066	62776944
Cough	366.58	23.46	460	282552	292283	62913727
Seizure	366.01	23.46	73	282939	132561	63073449
Haemoglobin decreased	360.24	23.46	101	282911	145384	63060626
Somnolence	342.10	23.46	185	282827	178500	63027510
Renal failure	339.13	23.46	58	282954	117594	63088416
C-reactive protein abnormal	330.12	23.46	672	282340	45424	63160586
Weight decreased	322.05	23.46	459	282553	276339	62929671
Tachycardia	317.83	23.46	69	282943	118087	63087923
Respiratory failure	317.18	23.46	40	282972	101818	63104192
White blood cell count decreased	315.16	23.46	113	282899	138991	63067019
Blood cholesterol increased	313.15	23.46	1027	281985	93005	63113005
Sepsis	310.37	23.46	147	282865	152976	63053034
Therapeutic product effect incomplete	305.64	23.46	1235	281777	123821	63082189
Fatigue	304.57	23.46	5596	277416	882432	62323578
Chest discomfort	300.33	23.46	62	282950	109907	63096103
Pancytopenia	299.57	23.46	39	282973	96894	63109116
Balance disorder	294.94	23.46	21	282991	84401	63121609
Cardiac failure congestive	290.98	23.46	35	282977	92398	63113612
Gastrointestinal haemorrhage	287.07	23.46	19	282993	81157	63124853
Hyperhidrosis	285.95	23.46	65	282947	107771	63098239
Cardiac failure	284.99	23.46	32	282980	89110	63116900
Loss of personal independence in daily activities	284.93	23.46	1018	281994	96272	63109738
Feeling abnormal	283.48	23.46	154	282858	148238	63057772
Bradycardia	281.74	23.46	10	283002	73217	63132793
Diarrhoea	280.54	23.46	1954	281058	713412	62492598
Oxygen saturation decreased	280.20	23.46	33	282979	88552	63117458
Red blood cell sedimentation rate increased	277.61	23.46	609	282403	43373	63162637
Overdose	275.51	23.46	85	282927	114993	63091017
Pulmonary embolism	274.34	23.46	89	282923	116595	63089415
Blood pressure increased	269.92	23.46	197	282815	161865	63044145
Dysphagia	268.15	23.46	38	282974	88547	63117463
Injection site pain	267.07	23.46	122	282890	129678	63076332
Nasopharyngitis	266.61	23.46	1993	281019	252264	62953746
Intentional product use issue	264.67	23.46	1201	281811	126691	63079319
Drug tolerance decreased	263.02	23.46	356	282656	17117	63188893
Neuropathy peripheral	252.96	23.46	95	282917	113572	63092438
Bone erosion	251.67	23.46	351	282661	17366	63188644
Cardio-respiratory arrest	250.93	23.46	3	283009	59956	63146054
Depressed level of consciousness	247.86	23.46	6	283006	62072	63143938
Adverse event	246.91	23.46	762	282250	66797	63139213
Vision blurred	244.53	23.46	55	282957	91869	63114141
Coma	243.48	23.46	10	283002	64354	63141656
Suicide attempt	242.80	23.46	6	283006	60912	63145098
Condition aggravated	242.43	23.46	2799	280213	399418	62806592
Myalgia	240.28	23.46	181	282831	146348	63059662
Foot deformity	239.76	23.46	439	282573	27414	63178596
Hypoxia	237.89	23.46	6	283006	59786	63146224
Agitation	234.02	23.46	7	283005	59750	63146260
Hypokalaemia	232.25	23.46	86	282926	103718	63102292
Hypoglycaemia	231.78	23.46	8	283004	60057	63145953
Oedema peripheral	229.57	23.46	305	282707	189206	63016804
Cerebrovascular accident	229.38	23.46	97	282915	107927	63098083
Blood pressure decreased	224.76	23.46	17	282995	65005	63141005
Renal impairment	221.16	23.46	60	282952	88295	63117715
Device malfunction	214.74	23.46	327	282685	17530	63188480
Palpitations	212.49	23.46	119	282893	112651	63093359
Muscle spasticity	211.44	23.46	362	282650	21432	63184578
Vomiting	210.02	23.46	1547	281465	558070	62647940
Blood glucose increased	209.40	23.46	57	282955	83699	63122311
Multiple organ dysfunction syndrome	207.60	23.46	11	283001	56741	63149269
Epistaxis	207.02	23.46	37	282975	72688	63133322
Fibromyalgia	204.24	23.46	804	282208	79616	63126394
Night sweats	201.57	23.46	575	282437	48239	63157771
Chills	200.50	23.46	129	282883	113249	63092761
Grip strength decreased	200.39	23.46	358	282654	21929	63184081
Dyspnoea exertional	199.57	23.46	19	282993	60283	63145727
Pleural effusion	197.41	23.46	84	282928	93126	63112884
Ear pain	193.62	23.46	469	282543	35649	63170361
General physical health deterioration	193.32	23.46	1547	281465	199855	63006155
Chronic obstructive pulmonary disease	191.81	23.46	26	282986	62660	63143350
Neutrophil count decreased	191.46	23.46	16	282996	56390	63149620
International normalised ratio increased	191.32	23.46	3	283009	46422	63159588
Heart rate increased	190.08	23.46	91	282921	94147	63111863
Gastrooesophageal reflux disease	188.89	23.46	95	282917	95544	63110466
Chronic kidney disease	182.74	23.46	4	283008	45394	63160616
Abdominal pain	182.62	23.46	682	282330	292774	62913236
Inflammation	182.51	23.46	789	282223	81484	63124526
Dyspnoea	177.55	23.46	1990	281022	659323	62546687
Injection site erythema	176.06	23.46	75	282937	83099	63122911
Urinary tract infection	175.41	23.46	599	282413	264085	62941925
Asthenia	174.93	23.46	999	282013	382605	62823405
Cognitive disorder	173.53	23.46	22	282990	55793	63150217
Rheumatoid nodule	171.78	23.46	289	282723	16866	63189144
Erythema	171.10	23.46	327	282685	175424	63030586
Muscle spasms	169.74	23.46	271	282741	155879	63050131
Depression	168.34	23.46	393	282619	196099	63009911
Chest pain	167.90	23.46	454	282558	215505	62990505
Hyperglycaemia	167.32	23.46	4	283008	41863	63164147
Leukopenia	166.33	23.46	68	282944	77222	63128788
Mucosal inflammation	165.86	23.46	11	283001	46917	63159093
Dysarthria	163.71	23.46	6	283006	42705	63163305
Hallucination	160.19	23.46	26	282986	54791	63151219
Flushing	160.06	23.46	67	282945	75020	63130990
Encephalopathy	157.06	23.46	3	283009	38617	63167393
Disorientation	156.78	23.46	4	283008	39448	63166562
Blood alkaline phosphatase increased	155.07	23.46	9	283003	42958	63163052
Atrial fibrillation	154.58	23.46	175	282837	116461	63089549
Blood creatinine increased	153.87	23.46	101	282911	87743	63118267
Dysgeusia	153.83	23.46	15	282997	46695	63159315
Ankylosing spondylitis	152.49	23.46	210	282802	10264	63195746
Bone pain	150.83	23.46	30	282982	54611	63151399
Blood bilirubin increased	150.57	23.46	3	283009	37137	63168873
Hot flush	150.09	23.46	24	282988	51135	63154875
Wrong technique in product usage process	149.25	23.46	46	282966	62294	63143716
Drug delivery system malfunction	148.37	23.46	81	282931	1059	63204951
Cardiac disorder	146.49	23.46	25	282987	50791	63155219
Contusion	146.34	23.46	1157	281855	148887	63057123
Pulmonary oedema	145.58	23.46	33	282979	54840	63151170
Ascites	145.57	23.46	9	283003	40719	63165291
Sciatica	145.29	23.46	408	282604	33916	63172094
Suicidal ideation	144.25	23.46	49	282963	62372	63143638
Mental status changes	143.82	23.46	8	283004	39591	63166419
Oropharyngeal pain	143.29	23.46	126	282886	94361	63111649
Fluid retention	141.18	23.46	45	282967	59641	63146369
Disturbance in attention	140.94	23.46	7	283005	38182	63167828
Body temperature increased	139.11	23.46	423	282589	36769	63169241
Unresponsive to stimuli	136.03	23.46	3	283009	33813	63172197
Joint stiffness	131.04	23.46	448	282564	41421	63164589
Respiratory arrest	130.91	23.46	3	283009	32642	63173368
Pulmonary fibrosis	130.82	23.46	433	282579	39376	63166634
Intentional product misuse	128.81	23.46	55	282957	60862	63145148
Haematocrit decreased	126.02	23.46	14	282998	39326	63166684
Heart rate decreased	125.78	23.46	25	282987	45535	63160475
Hypophagia	124.86	23.46	3	283009	31256	63174754
Syncope	124.47	23.46	207	282805	117178	63088832
Dry skin	124.11	23.46	49	282963	56838	63149172
Needle issue	123.33	23.46	189	282823	10187	63195823
Skin exfoliation	122.51	23.46	22	282990	43080	63162930
Pulmonary hypertension	122.04	23.46	12	283000	37111	63168899
Respiratory disorder	121.28	23.46	417	282595	38665	63167345
Blood potassium decreased	120.43	23.46	21	282991	42005	63164005
Myocardial infarction	119.63	23.46	162	282850	99731	63106279
Pneumonia aspiration	119.45	23.46	9	283003	34531	63171479
Angioedema	119.21	23.46	33	282979	47932	63158078
Deep vein thrombosis	118.54	23.46	119	282893	83681	63122329
Pallor	118.18	23.46	4	283008	30564	63175446
Orthostatic hypotension	118.06	23.46	12	283000	36148	63169862
Cholelithiasis	117.36	23.46	26	282986	43899	63162111
Gamma-glutamyltransferase increased	117.31	23.46	9	283003	34022	63171988
Blood parathyroid hormone decreased	117.30	23.46	179	282833	9612	63196398
Granuloma skin	116.62	23.46	165	282847	8272	63197738
Hypothyroidism	116.43	23.46	24	282988	42608	63163402
Osteonecrosis of jaw	116.39	23.46	11	283001	35112	63170898
Bone marrow failure	116.27	23.46	3	283009	29287	63176723
Coronary artery disease	116.18	23.46	7	283005	32370	63173640
Lethargy	116.15	23.46	52	282960	55955	63150055
Aphasia	115.84	23.46	8	283004	32992	63173018
Abdominal distension	115.80	23.46	129	282883	86486	63119524
Generalised tonic-clonic seizure	115.08	23.46	3	283009	29013	63176997
Urinary incontinence	114.64	23.46	7	283005	32007	63174003
Onychomycosis	113.92	23.46	158	282854	7774	63198236
Melaena	113.89	23.46	5	283007	30360	63175650
Hepatic failure	113.43	23.46	13	282999	35643	63170367
Lymphocyte count decreased	113.43	23.46	5	283007	30252	63175758
Adverse drug reaction	112.99	23.46	674	282338	79040	63126970
Haemorrhage	112.62	23.46	66	282946	60956	63145054
Respiratory distress	111.54	23.46	11	283001	33940	63172070
Acute respiratory failure	111.16	23.46	12	283000	34473	63171537
Decreased appetite	110.97	23.46	660	282352	250392	62955618
Injection site swelling	110.51	23.46	37	282975	47535	63158475
Restlessness	109.98	23.46	5	283007	29448	63176562
Adjustment disorder with depressed mood	109.02	23.46	177	282835	10027	63195983
Off label use	108.36	23.46	3844	279168	670618	62535392
Hypercholesterolaemia	107.94	23.46	271	282741	21063	63184947
Septic shock	107.00	23.46	84	282928	66545	63139465
Blood pressure fluctuation	105.91	23.46	37	282975	46280	63159730
Blood creatine phosphokinase increased	105.03	23.46	8	283004	30422	63175588
Rash erythematous	104.25	23.46	30	282982	42480	63163530
Blood urea increased	103.61	23.46	3	283009	26376	63179634
Panniculitis	102.49	23.46	183	282829	11202	63194808
Vertigo	101.99	23.46	71	282941	59816	63146194
Nervousness	101.87	23.46	10	283002	30969	63175041
Leukocytosis	101.68	23.46	3	283009	25932	63180078
Premature delivery	101.64	23.46	9	283003	30272	63175738
Transient ischaemic attack	101.57	23.46	22	282990	37731	63168279
Injury	101.05	23.46	615	282397	72632	63133378
Dyskinesia	100.98	23.46	12	283000	31990	63174020
Cholestasis	100.86	23.46	8	283004	29426	63176584
Dislocation of vertebra	100.82	23.46	156	282856	8479	63197531
Device dislocation	100.68	23.46	3	283009	25702	63180308
Influenza like illness	100.24	23.46	90	282922	66734	63139276
Breast cancer stage III	100.06	23.46	172	282840	10214	63195796
Irritability	99.72	23.46	12	283000	31682	63174328
Abortion spontaneous	99.16	23.46	43	282969	47152	63158858
Prescribed overdose	98.72	23.46	356	282656	33797	63172213
Haematoma	98.47	23.46	18	282994	34802	63171208
Agranulocytosis	98.20	23.46	3	283009	25131	63180879
Seronegative arthritis	98.13	23.46	104	282908	3855	63202155
Bedridden	97.40	23.46	176	282836	10875	63195135
Productive cough	97.39	23.46	83	282929	63125	63142885
Lip swelling	97.15	23.46	12	283000	31051	63174959
Haematuria	96.97	23.46	9	283003	29148	63176862
Thrombosis	96.19	23.46	88	282924	64667	63141343
Foetal exposure during pregnancy	96.02	23.46	14	282998	31948	63174062
Urinary retention	94.05	23.46	12	283000	30289	63175721
Pruritus	93.64	23.46	2189	280823	359264	62846746
Plasma cell myeloma	92.47	23.46	23	282989	35882	63170128
Arrhythmia	91.55	23.46	28	282984	38112	63167898
Abdominal pain lower	90.79	23.46	6	283006	25672	63180338
Injury associated with device	90.33	23.46	96	282916	3570	63202440
Confusional state	90.28	23.46	1518	281494	234862	62971148
Colitis	90.24	23.46	52	282960	48476	63157534
Lymphadenopathy	89.18	23.46	30	282982	38428	63167582
Altered state of consciousness	88.90	23.46	6	283006	25224	63180786
Bronchitis	88.01	23.46	275	282737	124660	63081350
Throat irritation	87.94	23.46	29	282983	37618	63168392
Sinus tachycardia	87.83	23.46	5	283007	24263	63181747
Shock	87.55	23.46	4	283008	23459	63182551
Renal disorder	87.12	23.46	20	282992	32954	63173056
Joint dislocation	87.06	23.46	231	282781	18569	63187441
Tenosynovitis	86.99	23.46	191	282821	13604	63192406
Pericardial effusion	86.17	23.46	15	282997	30043	63175967
Ejection fraction decreased	86.06	23.46	3	283009	22329	63183681
Burning sensation	85.60	23.46	70	282942	54337	63151673
Stevens-Johnson syndrome	84.88	23.46	7	283005	24943	63181067
Enthesopathy	84.76	23.46	144	282868	8470	63197540
Pain in jaw	84.67	23.46	44	282968	43452	63162558
Head injury	84.67	23.46	11	283001	27385	63178625
Red blood cell sedimentation rate	84.09	23.46	106	282906	4748	63201262
Joint range of motion decreased	83.73	23.46	326	282686	32102	63173908
Drug ineffective for unapproved indication	83.60	23.46	24	282988	34039	63171971
Blood lactate dehydrogenase increased	82.93	23.46	5	283007	23111	63182899
Back injury	82.79	23.46	152	282860	9508	63196502
Hepatic function abnormal	82.66	23.46	31	282981	37111	63168899
Dysuria	82.38	23.46	24	282988	33714	63172296
Hepatocellular injury	82.24	23.46	12	283000	27369	63178641
Acute myocardial infarction	81.91	23.46	21	282991	32103	63173907
Sleep disorder	81.68	23.46	633	282379	80933	63125077
Haematemesis	81.25	23.46	18	282994	30394	63175616
Haemoptysis	80.91	23.46	15	282997	28711	63177299
Flatulence	80.59	23.46	27	282985	34675	63171335
Therapy non-responder	80.47	23.46	597	282415	75304	63130706
Lower limb fracture	80.06	23.46	264	282748	23957	63182053
Live birth	79.97	23.46	274	282738	25356	63180654
Panic attack	79.60	23.46	5	283007	22326	63183684
Blood sodium decreased	79.30	23.46	8	283004	24244	63181766
Feeling hot	78.95	23.46	65	282947	50289	63155721
Device deployment issue	78.65	23.46	92	282920	3810	63202200
Product label confusion	78.32	23.46	65	282947	1757	63204253
Eye swelling	77.92	23.46	8	283004	23910	63182100
Prescribed underdose	77.91	23.46	300	282712	29389	63176621
Paraesthesia	77.88	23.46	397	282615	156569	63049441
Depressed mood	77.73	23.46	41	282971	40150	63165860
Exostosis	77.23	23.46	214	282798	17648	63188362
Blood glucose decreased	76.81	23.46	4	283008	20948	63185062
Facet joint syndrome	76.47	23.46	168	282844	11970	63194040
Red blood cell count decreased	76.37	23.46	43	282969	40602	63165408
Emotional distress	76.16	23.46	25	282987	32524	63173486
Deep vein thrombosis postoperative	75.80	23.46	161	282851	11208	63194802
Eosinophilia	75.74	23.46	7	283005	22749	63183261
Skin necrosis	75.66	23.46	182	282830	13768	63192242
Osteonecrosis	75.44	23.46	10	283002	24520	63181490
Intestinal obstruction	75.41	23.46	22	282990	30877	63175133
Presyncope	75.13	23.46	16	282996	27769	63178241
Drug hypersensitivity	75.08	23.46	1864	281148	308823	62897187
Circulatory collapse	75.06	23.46	6	283006	21932	63184078
Unevaluable event	74.94	23.46	71	282941	51315	63154695
Diabetic ketoacidosis	74.90	23.46	4	283008	20501	63185509
Lip dry	74.62	23.46	193	282819	15277	63190733
Muscle twitching	74.56	23.46	3	283009	19665	63186345
Hyperlipidaemia	74.14	23.46	3	283009	19568	63186442
Pollakiuria	73.70	23.46	17	282995	27920	63178090
Rectal haemorrhage	73.57	23.46	66	282946	48964	63157046
Transaminases increased	73.55	23.46	24	282988	31343	63174667
Malaise	73.38	23.46	1359	281653	414595	62791415
Sinus disorder	73.19	23.46	11	283001	24542	63181468
Premature baby	72.86	23.46	5	283007	20730	63185280
Ventricular tachycardia	72.66	23.46	4	283008	19975	63186035
Skin discolouration	72.55	23.46	39	282973	37789	63168221
Nightmare	72.52	23.46	3	283009	19191	63186819
Injection site pruritus	72.28	23.46	57	282955	45059	63160951
Nasal congestion	72.20	23.46	113	282899	65547	63140463
Diplopia	72.20	23.46	10	283002	23718	63182292
Mental disorder	72.01	23.46	14	282998	25905	63180105
Nail disorder	71.88	23.46	171	282841	12844	63193166
Heart rate irregular	71.76	23.46	8	283004	22413	63183597
Eating disorder	71.76	23.46	3	283009	19013	63186997
Onychomadesis	71.71	23.46	108	282904	5732	63200278
Weight increased	71.69	23.46	1593	281419	259199	62946811
Cerebral haemorrhage	71.20	23.46	24	282988	30705	63175305
Rash macular	70.73	23.46	10	283002	23354	63182656
Sleep apnoea syndrome	70.62	23.46	21	282991	29112	63176898
Myelosuppression	69.79	23.46	11	283001	23692	63182318
Hypoacusis	69.34	23.46	12	283000	24139	63181871
Angina pectoris	68.81	23.46	24	282988	30054	63175956
Upper respiratory tract infection	68.68	23.46	166	282846	81881	63124129
Fungal infection	67.87	23.46	40	282972	36834	63169176
Red blood cell sedimentation rate abnormal	67.52	23.46	218	282794	19564	63186446
Metastases to liver	67.32	23.46	12	283000	23627	63182383
Pancreatitis acute	66.92	23.46	19	282993	27147	63178863
Visual acuity reduced	66.88	23.46	9	283003	21817	63184193
No adverse event	66.73	23.46	52	282960	41353	63164657
Femur fracture	66.59	23.46	53	282959	41703	63164307
Tinnitus	66.50	23.46	38	282974	35590	63170420
Retinitis	65.54	23.46	107	282905	6089	63199921
Back pain	65.45	23.46	808	282204	263337	62942673
Face oedema	65.23	23.46	7	283005	20205	63185805
Anti-cyclic citrullinated peptide antibody	65.21	23.46	112	282900	6646	63199364
Incorrect dose administered	65.18	23.46	104	282908	59864	63146146
Gastritis	65.15	23.46	43	282969	37260	63168750
X-ray abnormal	65.00	23.46	124	282888	7986	63198024
Upper gastrointestinal haemorrhage	64.94	23.46	5	283007	18847	63187163
Acute respiratory distress syndrome	64.78	23.46	13	282999	23521	63182489
Ankle arthroplasty	64.40	23.46	58	282954	1755	63204255
Macular degeneration	63.97	23.46	15	282997	24361	63181649
Hemiparesis	63.79	23.46	13	282999	23269	63182741
Illness	63.46	23.46	75	282937	48984	63157026
Coeliac disease	63.11	23.46	161	282851	12636	63193374
Disseminated intravascular coagulation	63.03	23.46	6	283006	19045	63186965
Systemic lupus erythematosus rash	62.76	23.46	63	282949	2189	63203821
Swelling face	62.68	23.46	117	282895	63358	63142652
Cardiomegaly	62.62	23.46	4	283008	17610	63188400
Cardiomyopathy	62.49	23.46	4	283008	17580	63188430
Injection site bruising	62.19	23.46	57	282955	41853	63164157
Feeling cold	62.10	23.46	15	282997	23873	63182137
Myelodysplastic syndrome	62.05	23.46	3	283009	16751	63189259
White blood cell count increased	62.01	23.46	75	282937	48486	63157524
Eye pruritus	61.46	23.46	6	283006	18665	63187345
Asthma	61.37	23.46	326	282686	127235	63078775
Pancreatitis	61.34	23.46	77	282935	48978	63157032
Cystitis	61.07	23.46	94	282918	54897	63151113
Vaginal haemorrhage	61.07	23.46	23	282989	27464	63178546
Restless legs syndrome	60.88	23.46	6	283006	18525	63187485
C-reactive protein increased	60.81	23.46	668	282344	94039	63111971
Mitral valve incompetence	60.23	23.46	8	283004	19586	63186424
Nerve injury	59.67	23.46	135	282877	9811	63196199
Clostridium difficile colitis	59.54	23.46	10	283002	20559	63185451
Nervous system disorder	59.30	23.46	7	283005	18759	63187251
Mycotic allergy	58.54	23.46	43	282969	967	63205043
Myoclonus	58.26	23.46	3	283009	15865	63190145
Hospitalisation	58.00	23.46	190	282822	84891	63121119
Deformity	57.63	23.46	147	282865	11537	63194473
Haemorrhoids	57.40	23.46	14	282998	22136	63183874
Cyanosis	56.93	23.46	5	283007	16930	63189080
Arthritis	56.80	23.46	777	282235	115144	63090866
Rash maculo-papular	56.75	23.46	36	282976	31860	63174150
Drug tolerance	56.63	23.46	107	282905	6842	63199168
Paraesthesia oral	56.55	23.46	9	283003	19247	63186763
Injection site mass	56.44	23.46	8	283004	18648	63187362
Peptic ulcer haemorrhage	56.40	23.46	43	282969	1025	63204985
Arthrodesis	56.39	23.46	66	282946	2735	63203275
Chromaturia	56.02	23.46	5	283007	16712	63189298
Ischaemic stroke	56.00	23.46	7	283005	17950	63188060
Peripheral venous disease	55.97	23.46	174	282838	15303	63190707
Therapeutic response decreased	55.89	23.46	467	282545	61058	63144952
Blood pressure systolic increased	55.59	23.46	78	282934	47319	63158691
Transfusion	55.48	23.46	3	283009	15214	63190796
Product quality issue	55.36	23.46	47	282965	35818	63170192
Eczema	55.35	23.46	38	282974	32253	63173757
Small intestinal obstruction	55.16	23.46	8	283004	18329	63187681
Tubulointerstitial nephritis	54.77	23.46	11	283001	19892	63186118
Therapeutic response unexpected	54.57	23.46	9	283003	18750	63187260
Blood iron abnormal	53.86	23.46	76	282936	3800	63202210
Liver function test abnormal	53.85	23.46	82	282930	48099	63157911
Faeces discoloured	53.58	23.46	9	283003	18500	63187510
Lacrimation increased	53.54	23.46	13	282999	20618	63185392
Walking aid user	53.03	23.46	135	282877	10582	63195428
Hip fracture	52.81	23.46	33	282979	29441	63176569
Diabetes mellitus inadequate control	52.14	23.46	4	283008	15122	63190888
Basal cell carcinoma	52.07	23.46	255	282757	27736	63178274
Toothache	52.03	23.46	11	283001	19188	63186822
Wound infection	51.07	23.46	210	282802	21200	63184810
Mental impairment	50.95	23.46	3	283009	14148	63191862
Bronchospasm	50.92	23.46	8	283004	17272	63188738
Liver function test increased	50.75	23.46	284	282728	32527	63173483
Thirst	50.48	23.46	3	283009	14038	63191972
Throat tightness	50.21	23.46	24	282988	24863	63181147
Memory impairment	49.83	23.46	267	282745	103991	63102019
Hiatus hernia	49.80	23.46	17	282995	21577	63184433
Lupus vulgaris	49.72	23.46	93	282919	5901	63200109
COVID-19	49.55	23.46	298	282714	112805	63093205
Fear	49.52	23.46	6	283006	15760	63190250
Lung infiltration	49.36	23.46	4	283008	14459	63191551
Rash papular	49.26	23.46	6	283006	15696	63190314
Eye pain	49.10	23.46	47	282965	33807	63172203
Loss of consciousness	48.77	23.46	317	282695	117804	63088206
Bunion operation	48.36	23.46	43	282969	1279	63204731
Uveitis	48.08	23.46	144	282868	12409	63193601
Hepatic cytolysis	48.06	23.46	6	283006	15401	63190609
Hypersomnia	47.60	23.46	11	283001	18044	63187966
Complication associated with device	47.53	23.46	9	283003	16969	63189041
Speech disorder	47.51	23.46	67	282945	40562	63165448
Seasonal allergy	47.44	23.46	17	282995	20933	63185077
Blood pressure diastolic decreased	47.20	23.46	21	282991	22685	63183325
Malignant mediastinal neoplasm	46.96	23.46	44	282968	1402	63204608
Dysphonia	46.80	23.46	88	282924	47526	63158484
Cerebral infarction	46.76	23.46	24	282988	23869	63182141
Impaired quality of life	46.52	23.46	4	283008	13779	63192231
Limb injury	46.38	23.46	28	282984	25449	63180561
Anticipatory anxiety	46.37	23.46	41	282971	1210	63204800
Pneumonia	45.83	23.46	1621	281391	455146	62750864
Caesarean section	45.66	23.46	10	283002	17022	63188988
Sputum discoloured	45.05	23.46	9	283003	16338	63189672
Osteoarthritis	45.05	23.46	635	282377	94708	63111302
Product prescribing error	44.98	23.46	31	282981	26258	63179752
Dry eye	44.95	23.46	70	282942	40691	63165319
Gastric ulcer	44.34	23.46	26	282986	24011	63181999
Alanine aminotransferase increased	44.11	23.46	276	282736	103494	63102516
Blood triglycerides increased	43.91	23.46	3	283009	12485	63193525
Anger	43.78	23.46	3	283009	12453	63193557
Pyrexia	43.77	23.46	1685	281327	468793	62737217
Hypocalcaemia	43.74	23.46	46	282966	31667	63174343
Epilepsy	43.60	23.46	34	282978	27031	63178979
Maternal exposure timing unspecified	43.42	23.46	97	282915	6990	63199020
Foot operation	43.21	23.46	98	282914	7133	63198877
Bacteraemia	42.98	23.46	12	283000	17336	63188674
Oral pain	42.86	23.46	38	282974	28356	63177654
Spinal fracture	42.80	23.46	14	282998	18257	63187753
Sneezing	42.61	23.46	14	282998	18204	63187806
Cytomegalovirus infection	42.58	23.46	20	282992	20932	63185078
Glomerular filtration rate decreased	42.50	23.46	5	283007	13436	63192574
Cardiac murmur	42.29	23.46	7	283005	14545	63191465
Aphthous ulcer	42.11	23.46	6	283006	13932	63192078
Rales	42.01	23.46	4	283008	12693	63193317
Laboratory test abnormal	41.86	23.46	35	282977	26877	63179133
Neutrophil count increased	41.76	23.46	11	283001	16516	63189494
Muscle tightness	41.43	23.46	3	283009	11897	63194113
Tongue disorder	41.13	23.46	122	282890	10458	63195552
Hypoalbuminaemia	41.03	23.46	3	283009	11802	63194208
Hypoaesthesia oral	40.84	23.46	5	283007	13028	63192982
Staphylococcal infection	40.77	23.46	76	282936	41180	63164830
Musculoskeletal pain	40.60	23.46	607	282405	91670	63114340
Poor quality sleep	40.56	23.46	19	282993	19916	63186094
Tricuspid valve incompetence	40.40	23.46	8	283004	14613	63191397
Blood pressure diastolic abnormal	40.09	23.46	8	283004	14534	63191476
Incorrect product administration duration	39.95	23.46	3	283009	11543	63194467
Administration site pain	39.93	23.46	32	282980	822	63205188
Peripheral coldness	39.80	23.46	4	283008	12161	63193849
Injection site rash	39.72	23.46	17	282995	18792	63187218
Extremity contracture	39.63	23.46	38	282974	1247	63204763
Candida infection	39.24	23.46	41	282971	28310	63177700
Acne	39.15	23.46	28	282984	23265	63182745
Autoimmune disorder	39.03	23.46	166	282846	17011	63188999
Sensory disturbance	38.80	23.46	7	283005	13665	63192345
Pulmonary toxicity	38.64	23.46	111	282901	9344	63196666
Oral discomfort	38.56	23.46	109	282903	9092	63196918
Pseudomonas infection	38.55	23.46	3	283009	11210	63194800
Drug use disorder	38.47	23.46	75	282937	4909	63201101
Myopathy	38.46	23.46	3	283009	11188	63194822
Acute generalised exanthematous pustulosis	38.07	23.46	3	283009	11096	63194914
Blindness	37.91	23.46	25	282987	21674	63184336
Lymphoedema	37.85	23.46	4	283008	11688	63194322
Chronic sinusitis	37.72	23.46	6	283006	12837	63193173
Vitamin D deficiency	37.56	23.46	8	283004	13884	63192126
Multiple sclerosis	37.54	23.46	32	282980	24340	63181670
Pneumonitis	37.42	23.46	62	282950	35160	63170850
Full blood count abnormal	37.39	23.46	52	282960	31665	63174345
Metastases to lung	37.35	23.46	6	283006	12744	63193266
Device breakage	37.24	23.46	4	283008	11538	63194472
Malnutrition	37.13	23.46	11	283001	15287	63190723
Ageusia	36.92	23.46	8	283004	13720	63192290
Blood pressure abnormal	36.76	23.46	11	283001	15187	63190823
Post procedural complication	36.76	23.46	15	282997	17059	63188951
Hypermobility syndrome	36.71	23.46	30	282982	793	63205217
Bone disorder	36.68	23.46	25	282987	21301	63184709
Purpura	36.59	23.46	4	283008	11381	63194629
Skin lesion	36.58	23.46	50	282962	30671	63175339
Colitis ischaemic	36.44	23.46	3	283009	10705	63195305
Hepatomegaly	36.20	23.46	5	283007	11884	63194126
Hepatic steatosis	36.13	23.46	45	282967	28724	63177286
Progressive multifocal leukoencephalopathy	36.05	23.46	7	283005	12964	63193046
Device related infection	35.68	23.46	31	282981	23361	63182649
Osteopenia	35.66	23.46	22	282990	19763	63186247
Decubitus ulcer	35.65	23.46	3	283009	10517	63195493
Joint injury	35.65	23.46	240	282772	29332	63176678
Rib fracture	35.63	23.46	29	282983	22568	63183442
Petechiae	35.59	23.46	9	283003	13888	63192122
Musculoskeletal disorder	35.53	23.46	184	282828	20460	63185550
Pelvic fracture	35.45	23.46	8	283004	13340	63192670
Acute myeloid leukaemia	35.42	23.46	16	282996	17131	63188879
Neuralgia	35.31	23.46	38	282974	25888	63180122
Dialysis	35.26	23.46	3	283009	10424	63195586
Skin burning sensation	35.12	23.46	7	283005	12727	63193283
Injection site warmth	34.97	23.46	12	283000	15183	63190827
Foetal death	34.93	23.46	4	283008	10976	63195034
Immobile	34.91	23.46	80	282932	5863	63200147
Cold sweat	34.56	23.46	6	283006	12041	63193969
Metastases to central nervous system	34.52	23.46	8	283004	13097	63192913
Sensory loss	34.47	23.46	3	283009	10235	63195775
Delusion	34.44	23.46	6	283006	12011	63193999
Injection site urticaria	34.38	23.46	10	283002	14063	63191947
Facial paralysis	34.26	23.46	10	283002	14031	63191979
Fine motor skill dysfunction	34.12	23.46	70	282942	4755	63201255
Troponin increased	33.99	23.46	3	283009	10118	63195892
Muscular weakness	33.87	23.46	365	282647	121988	63084022
Oral candidiasis	33.83	23.46	31	282981	22767	63183243
Pustular psoriasis	33.76	23.46	68	282944	4558	63201452
Emotional disorder	33.62	23.46	9	283003	13370	63192640
Disease susceptibility	33.38	23.46	17	282995	191	63205819
Device difficult to use	33.33	23.46	8	283004	12788	63193222
Supraventricular tachycardia	33.32	23.46	11	283001	14260	63191750
Rhinitis allergic	33.29	23.46	6	283006	11721	63194289
Schizophrenia	33.28	23.46	3	283009	9949	63196061
Ileus	33.25	23.46	12	283000	14713	63191297
Amenorrhoea	33.13	23.46	3	283009	9911	63196099
Lipase increased	33.07	23.46	3	283009	9897	63196113
Shock haemorrhagic	33.05	23.46	3	283009	9892	63196118
Ulcer	32.75	23.46	214	282798	25893	63180117
Cholecystitis	32.31	23.46	14	282998	15363	63190647
Osteoporosis	32.14	23.46	394	282618	56944	63149066
Intervertebral disc degeneration	32.00	23.46	15	282997	15717	63190293
Hypertensive crisis	31.99	23.46	14	282998	15272	63190738
Skin fissures	31.96	23.46	6	283006	11382	63194628
Urine output decreased	31.88	23.46	6	283006	11364	63194646
Laryngitis	31.86	23.46	155	282857	16812	63189198
Toxic skin eruption	31.76	23.46	9	283003	12876	63193134
Motor dysfunction	31.67	23.46	5	283007	10756	63195254
Subarachnoid haemorrhage	31.65	23.46	12	283000	14271	63191739
Acute coronary syndrome	31.45	23.46	4	283008	10122	63195888
Product administration error	31.44	23.46	32	282980	22365	63183645
Hyperthyroidism	31.41	23.46	13	282999	14660	63191350
Central nervous system lesion	31.16	23.46	5	283007	10630	63195380
Haemophagocytic lymphohistiocytosis	31.13	23.46	5	283007	10622	63195388
Aspartate aminotransferase increased	31.12	23.46	255	282757	90022	63115988
Polyneuropathy	31.11	23.46	13	282999	14576	63191434
Frequent bowel movements	31.07	23.46	34	282978	22988	63183022
Adverse reaction	30.89	23.46	108	282904	10095	63195915
Breast cancer female	30.70	23.46	11	283001	13548	63192462
Urticaria	30.49	23.46	961	282051	164841	63041169
Sudden death	30.42	23.46	5	283007	10444	63195566
Breast cancer metastatic	30.36	23.46	8	283004	12010	63194000
Heavy menstrual bleeding	30.35	23.46	21	282991	17752	63188258
Premature labour	30.33	23.46	9	283003	12495	63193515
Head discomfort	30.18	23.46	11	283001	13404	63192606
Sinus congestion	30.18	23.46	22	282990	18101	63187909
Joint destruction	30.15	23.46	78	282934	6174	63199836
C-reactive protein	30.11	23.46	67	282945	4815	63201195
Procedural pain	30.07	23.46	31	282981	21538	63184472
Hepatitis acute	29.84	23.46	3	283009	9117	63196893
Atelectasis	29.81	23.46	31	282981	21452	63184558
Concomitant disease aggravated	29.80	23.46	3	283009	9109	63196901
Musculoskeletal chest pain	29.73	23.46	30	282982	21053	63184957
Product complaint	29.68	23.46	10	283002	12799	63193211
Transplant rejection	29.57	23.46	6	283006	10774	63195236
Oesophagitis	29.48	23.46	15	282997	14993	63191017
Escherichia infection	29.48	23.46	10	283002	12744	63193266
Swollen tongue	29.44	23.46	70	282942	34730	63171280
Pneumothorax	29.42	23.46	18	282994	16243	63189767
Hepatic cirrhosis	29.37	23.46	200	282812	24534	63181476
Therapy interrupted	29.31	23.46	63	282949	32392	63173618
Wrist fracture	29.14	23.46	12	283000	13575	63192435
Hydronephrosis	29.11	23.46	6	283006	10656	63195354
Ventricular extrasystoles	29.11	23.46	8	283004	11679	63194331
Skin laceration	29.06	23.46	35	282977	22673	63183337
Stress cardiomyopathy	28.71	23.46	4	283008	9446	63196564
Blood pressure diastolic increased	28.68	23.46	5	283007	10005	63196005
Rhinorrhoea	28.60	23.46	173	282839	65404	63140606
Dementia	28.55	23.46	25	282987	18769	63187241
Apathy	28.49	23.46	3	283009	8791	63197219
Dermatitis contact	28.44	23.46	7	283005	11001	63195009
Deafness	28.37	23.46	23	282989	17934	63188076
Peritonitis	28.33	23.46	21	282991	17133	63188877
Intestinal perforation	28.32	23.46	9	283003	11954	63194056
Lupus-like syndrome	28.20	23.46	139	282873	15156	63190854
Emphysema	28.17	23.46	7	283005	10931	63195079
Food allergy	28.03	23.46	8	283004	11393	63194617
Spinal osteoarthritis	27.80	23.46	19	282993	16167	63189843
Skin irritation	27.62	23.46	5	283007	9736	63196274
Anal incontinence	27.53	23.46	13	282999	13563	63192447
Abortion induced	27.48	23.46	6	283006	10236	63195774
Polyuria	27.46	23.46	3	283009	8539	63197471
Poor venous access	27.26	23.46	16	282996	14769	63191241
Increased appetite	27.18	23.46	5	283007	9625	63196385
Pain of skin	27.10	23.46	9	283003	11625	63194385
Clostridium difficile infection	27.09	23.46	58	282954	29864	63176146
Cardiac failure acute	26.76	23.46	5	283007	9518	63196492
Bladder disorder	26.68	23.46	4	283008	8942	63197068
Enteritis	26.41	23.46	3	283009	8283	63197727
Upper-airway cough syndrome	26.31	23.46	9	283003	11409	63194601
Cholecystitis acute	26.30	23.46	3	283009	8257	63197753
Breast pain	26.09	23.46	4	283008	8794	63197216
Choking	26.08	23.46	6	283006	9873	63196137
Mass	26.03	23.46	15	282997	13985	63192025
Skin abrasion	26.00	23.46	5	283007	9324	63196686
Hemiplegia	25.97	23.46	5	283007	9318	63196692
Eye irritation	25.92	23.46	36	282976	21935	63184075
Gingival pain	25.90	23.46	3	283009	8159	63197851
Weight fluctuation	25.85	23.46	6	283006	9813	63196197
Nocturia	25.81	23.46	3	283009	8138	63197872
Renal cyst	25.76	23.46	7	283005	10295	63195715
Ovarian cyst	25.72	23.46	20	282992	15925	63190085
Dental caries	25.71	23.46	8	283004	10771	63195239
Atrial flutter	25.67	23.46	6	283006	9766	63196244
Major depression	25.31	23.46	3	283009	8015	63197995
Pelvic floor muscle weakness	25.27	23.46	10	283002	58	63205952
Disability	25.26	23.46	154	282858	18193	63187817
Klebsiella infection	25.16	23.46	4	283008	8562	63197448
Nail operation	24.99	23.46	25	282987	865	63205145
Glycosylated haemoglobin increased	24.94	23.46	12	283000	12386	63193624
Autoimmune hepatitis	24.94	23.46	4	283008	8506	63197504
Aplastic anaemia	24.89	23.46	6	283006	9563	63196447
Anaphylactic reaction	24.51	23.46	183	282829	65917	63140093
Intestinal sepsis	24.48	23.46	16	282996	296	63205714
Renal injury	24.39	23.46	6	283006	9433	63196577
Scab	24.27	23.46	3	283009	7760	63198250
Ocular hyperaemia	24.24	23.46	47	282965	25097	63180913
Obesity	23.90	23.46	221	282791	29731	63176279
Concussion	23.65	23.46	6	283006	9238	63196772
Gait inability	23.53	23.46	349	282663	52610	63153400
Diverticulum	23.53	23.46	12	283000	11979	63194031

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
Drug ineffective	873.49	20.27	1411	26745	455340	34473435
Synovitis	480.68	20.27	232	27924	13834	34914941
Treatment failure	467.83	20.27	349	27807	46348	34882427
Rheumatoid arthritis	394.55	20.27	291	27865	37947	34890828
Therapeutic product effect decreased	364.25	20.27	267	27889	34476	34894299
Product dose omission issue	354.39	20.27	458	27698	119253	34809522
Psoriatic arthropathy	289.84	20.27	187	27969	19611	34909164
Product use issue	261.22	20.27	287	27869	62929	34865846
Ankylosing spondylitis	245.98	20.27	110	28046	5494	34923281
Enthesopathy	243.08	20.27	103	28053	4510	34924265
C-reactive protein abnormal	219.48	20.27	117	28039	8593	34920182
Lower respiratory tract infection	213.67	20.27	188	27968	31449	34897326
Drug hypersensitivity	213.10	20.27	292	27864	80237	34848538
Drug intolerance	211.38	20.27	250	27906	59320	34869455
Tenosynovitis	211.16	20.27	93	28063	4477	34924298
Device deployment issue	189.49	20.27	41	28115	144	34928631
Device malfunction	189.38	20.27	113	28043	10308	34918467
Contraindicated product administered	187.27	20.27	148	28008	21333	34907442
Alanine aminotransferase abnormal	183.58	20.27	85	28071	4603	34924172
Drug specific antibody present	175.23	20.27	74	28082	3211	34925564
Uveitis	172.52	20.27	95	28061	7440	34921335
Acute kidney injury	171.46	20.27	22	28134	304966	34623809
Pain	171.25	20.27	453	27703	204222	34724553
Joint swelling	165.67	20.27	222	27934	59668	34869107
Tongue disorder	158.27	20.27	80	28076	5259	34923516
Musculoskeletal stiffness	154.20	20.27	189	27967	46491	34882284
Needle issue	147.43	20.27	80	28076	6085	34922690
Toxicity to various agents	143.03	20.27	4	28152	200358	34728417
Arthralgia	121.89	20.27	356	27800	169685	34759090
Drug interaction	120.53	20.27	19	28137	225927	34702848
Off label use	116.23	20.27	652	27504	418872	34509903
Red blood cell sedimentation rate abnormal	115.89	20.27	57	28099	3532	34925243
Death	114.69	20.27	92	28064	397957	34530818
Drug use disorder	107.54	20.27	57	28099	4134	34924641
Tendonitis	104.22	20.27	74	28082	9066	34919709
Inflammation	103.97	20.27	121	28035	28174	34900601
Drug delivery system malfunction	102.78	20.27	29	28127	358	34928417
Arthropathy	100.43	20.27	116	28040	26791	34901984
Accidental exposure to product	98.43	20.27	82	28074	12720	34916055
Therapeutic response decreased	97.25	20.27	119	28037	29194	34899581
Dyspnoea	96.60	20.27	97	28059	376685	34552090
Bone erosion	92.94	20.27	51	28105	3964	34924811
Pulmonary tuberculosis	92.78	20.27	54	28102	4700	34924075
Therapeutic product effect incomplete	89.18	20.27	152	28004	50389	34878386
Infection	88.00	20.27	213	27943	90702	34838073
Anaemia	83.39	20.27	42	28114	233293	34695482
Arthritis	83.24	20.27	114	28042	31232	34897543
Joint ankylosis	82.46	20.27	35	28121	1537	34927238
Confusional state	81.79	20.27	10	28146	144150	34784625
Hypotension	80.55	20.27	39	28117	221610	34707165
Oral herpes	80.13	20.27	52	28104	5495	34923280
Gait inability	78.31	20.27	90	28066	20668	34908107
Product storage error	75.16	20.27	58	28098	8064	34920711
Inappropriate schedule of product administration	73.62	20.27	158	27998	62138	34866637
Neutropenia	73.42	20.27	18	28138	156760	34772015
Loss of personal independence in daily activities	68.28	20.27	107	28049	33072	34895703
Psoriasis	67.49	20.27	116	28040	38696	34890079
Thrombocytopenia	67.44	20.27	21	28135	156226	34772549
Pneumonia	66.64	20.27	509	27647	362118	34566657
Tuberculosis	63.99	20.27	54	28102	8523	34920252
Gastrointestinal infection	63.93	20.27	46	28110	5752	34923023
Dehydration	62.66	20.27	14	28142	129955	34798820
Bone cyst	62.60	20.27	29	28127	1571	34927204
Injury associated with device	62.24	20.27	26	28130	1097	34927678
Rheumatoid nodule	61.58	20.27	35	28121	2912	34925863
Red blood cell sedimentation rate	60.83	20.27	26	28130	1162	34927613
Granuloma skin	58.98	20.27	26	28130	1253	34927522
Nasopharyngitis	58.35	20.27	155	28001	69813	34858962
Kidney infection	57.66	20.27	42	28114	5352	34923423
Mobility decreased	57.65	20.27	94	28062	30034	34898741
Platelet count decreased	57.50	20.27	13	28143	119704	34809071
Panniculitis	56.53	20.27	29	28127	1965	34926810
Anti-cyclic citrullinated peptide antibody positive	55.74	20.27	28	28128	1815	34926960
Disease progression	55.52	20.27	10	28146	108067	34820708
Influenza	55.28	20.27	123	28033	49543	34879232
Headache	53.94	20.27	310	27846	200325	34728450
Colitis ulcerative	53.05	20.27	66	28090	16454	34912321
Blood parathyroid hormone decreased	52.28	20.27	25	28131	1455	34927320
Skin injury	52.11	20.27	29	28127	2316	34926459
Hand deformity	51.56	20.27	34	28122	3691	34925084
Constipation	49.85	20.27	24	28132	136958	34791817
Neuropathy peripheral	49.15	20.27	5	28151	83258	34845517
Hepatic steatosis	49.06	20.27	67	28089	18295	34910480
Underdose	49.05	20.27	58	28098	13722	34915053
Pain in extremity	48.41	20.27	216	27940	126297	34802478
Haematochezia	48.18	20.27	112	28044	46422	34882353
Tachycardia	47.76	20.27	6	28150	84766	34844009
Seizure	47.22	20.27	13	28143	104844	34823931
Cardiac arrest	47.06	20.27	10	28146	96149	34832626
Neck pain	47.02	20.27	78	28078	25271	34903504
Pyrexia	46.63	20.27	127	28029	332886	34595889
C-reactive protein increased	46.26	20.27	121	28035	53977	34874798
Basal cell carcinoma	45.53	20.27	67	28089	19591	34909184
Osteoarthritis	44.45	20.27	68	28088	20574	34908201
Hyponatraemia	43.90	20.27	7	28149	82684	34846091
Post procedural infection	43.45	20.27	34	28122	4822	34923953
Vomiting	43.05	20.27	84	28072	247537	34681238
Decreased appetite	42.29	20.27	43	28113	166349	34762426
Osteolysis	41.80	20.27	28	28128	3120	34925655
Malignant melanoma	40.95	20.27	41	28115	8049	34920726
Pelvic pain	40.18	20.27	25	28131	2455	34926320
Cellulitis	39.84	20.27	113	28043	52838	34875937
Haemoglobin decreased	39.78	20.27	24	28132	120748	34808027
Bradycardia	38.67	20.27	7	28149	75411	34853364
Somnolence	38.14	20.27	21	28135	111095	34817680
Cardiac failure congestive	38.10	20.27	10	28146	83260	34845515
Oedema peripheral	37.83	20.27	25	28131	119787	34808988
Multiple organ dysfunction syndrome	37.38	20.27	8	28148	76558	34852217
Terminal insomnia	37.31	20.27	15	28141	573	34928202
Gastric disorder	37.24	20.27	48	28108	12393	34916382
Drug tolerance	36.75	20.27	25	28131	2857	34925918
Respiratory failure	36.57	20.27	21	28135	108551	34820224
Renal failure	36.39	20.27	31	28125	130526	34798249
Latent tuberculosis	36.28	20.27	19	28137	1344	34927431
Colectomy	36.01	20.27	21	28135	1833	34926942
White blood cell count decreased	35.83	20.27	16	28140	95429	34833346
Exostosis	35.77	20.27	30	28126	4693	34924082
Rhabdomyolysis	35.66	20.27	6	28150	68157	34860618
Blood creatinine increased	35.53	20.27	16	28140	94960	34833815
Injection site reaction	35.49	20.27	48	28108	12985	34915790
Herpes zoster	34.73	20.27	82	28074	34317	34894458
Therapy non-responder	33.91	20.27	88	28068	39058	34889717
Cardio-respiratory arrest	33.46	20.27	3	28153	55270	34873505
Hypoglycaemia	32.98	20.27	3	28153	54637	34874138
Lymphoproliferative disorder	32.98	20.27	23	28133	2736	34926039
Pancreatic carcinoma	32.56	20.27	38	28118	8863	34919912
Localised infection	32.46	20.27	54	28102	17533	34911242
Fear of injection	31.26	20.27	18	28138	1534	34927241
Rheumatoid factor increased	30.97	20.27	13	28143	555	34928220
Pharyngitis	30.89	20.27	35	28121	7909	34920866
Hallucination	30.63	20.27	3	28153	51495	34877280
Rheumatoid factor	30.44	20.27	8	28148	74	34928701
Hypersensitivity	30.28	20.27	113	28043	60922	34867853
Agitation	30.14	20.27	5	28151	57394	34871381
Chest pain	29.71	20.27	35	28121	126727	34802048
Syringe issue	29.21	20.27	29	28127	5635	34923140
Sacroiliitis	29.18	20.27	17	28139	1481	34927294
Oral candidiasis	29.09	20.27	42	28114	12068	34916707
Pancytopenia	28.51	20.27	21	28135	95136	34833639
Tooth abscess	28.41	20.27	29	28127	5824	34922951
Prostate cancer	28.26	20.27	83	28073	39566	34889209
Surgery	28.20	20.27	45	28111	14112	34914663
Drug dependence	28.09	20.27	61	28095	24156	34904619
Neutrophil count decreased	27.86	20.27	4	28152	51100	34877675
Atrial fibrillation	27.41	20.27	35	28121	122358	34806417
Epistaxis	26.63	20.27	7	28149	58244	34870531
Hypokalaemia	26.60	20.27	7	28149	58207	34870568
Hepatic fibrosis	26.41	20.27	25	28131	4582	34924193
Blood cholesterol abnormal	26.25	20.27	17	28139	1789	34926986
Tonsillitis	26.25	20.27	19	28137	2397	34926378
Pregnancy of partner	26.08	20.27	10	28146	336	34928439
Musculoskeletal pain	25.80	20.27	70	28086	31893	34896882
COVID-19	25.66	20.27	127	28029	77423	34851352
Diarrhoea haemorrhagic	24.95	20.27	29	28127	6735	34922040
Overdose	24.90	20.27	22	28134	91037	34837738
Skin necrosis	24.85	20.27	27	28129	5826	34922949
Therapy cessation	24.73	20.27	47	28109	16926	34911849
Lower respiratory tract congestion	24.10	20.27	14	28142	1213	34927562
Swelling	24.06	20.27	82	28074	42284	34886491
Syphilis	23.84	20.27	10	28146	426	34928349
Carbon dioxide abnormal	23.81	20.27	8	28148	182	34928593
Administration site pain	23.63	20.27	9	28147	297	34928478
Tendon disorder	23.31	20.27	19	28137	2856	34925919
Erythema	23.01	20.27	136	28020	88644	34840131
Penile cancer	22.99	20.27	8	28148	203	34928572
X-ray abnormal	22.90	20.27	10	28146	471	34928304
Knee arthroplasty	22.72	20.27	29	28127	7415	34921360
Iridocyclitis	22.67	20.27	15	28141	1637	34927138
Lymphoma	22.54	20.27	38	28118	12469	34916306
Bladder transitional cell carcinoma stage II	22.41	20.27	6	28150	60	34928715
Skin cancer	22.28	20.27	34	28122	10263	34918512
Injection site mass	22.12	20.27	27	28129	6599	34922176
Injection site warmth	21.91	20.27	16	28140	2046	34926729
Intentional product misuse	21.78	20.27	5	28151	45606	34883169
Ulcer	21.75	20.27	31	28125	8804	34919971
Abdominal distension	21.64	20.27	10	28146	58482	34870293
Dermatitis psoriasiform	21.55	20.27	14	28142	1482	34927293
Ear neoplasm	21.34	20.27	6	28150	73	34928702
Blood creatine phosphokinase increased	21.26	20.27	5	28151	44852	34883923
Gastrointestinal haemorrhage	21.18	20.27	24	28132	88453	34840322
Disseminated tuberculosis	20.95	20.27	16	28140	2189	34926586
Blood glucose increased	20.94	20.27	14	28142	66704	34862071
Wheezing	20.88	20.27	4	28152	41398	34887377
Lyme disease	20.84	20.27	12	28144	1023	34927752
Arthritis bacterial	20.71	20.27	23	28133	5083	34923692
Scab	20.69	20.27	22	28134	4632	34924143

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
Contraindicated product administered	2891.69	21.94	2803	215132	154735	79371718
Drug intolerance	2879.01	21.94	3571	214364	260548	79265905
Synovitis	2639.15	21.94	2614	215321	148120	79378333
Joint swelling	2513.15	21.94	3495	214440	285151	79241302
Therapeutic product effect decreased	2420.95	21.94	2594	215341	161269	79365184
Pemphigus	2344.59	21.94	2038	215897	97544	79428909
Drug ineffective	2275.80	21.94	7271	210664	1073642	78452811
Hand deformity	2198.55	21.94	2002	215933	101917	79424536
Systemic lupus erythematosus	2136.21	21.94	2110	215825	119039	79407414
Glossodynia	2044.83	21.94	1918	216017	101419	79425034
Treatment failure	1982.32	21.94	2384	215551	168102	79358351
Arthropathy	1928.64	21.94	2396	215539	174715	79351738
Anti-cyclic citrullinated peptide antibody positive	1919.14	21.94	1683	216252	81460	79444993
Swelling	1721.25	21.94	2514	215421	214197	79312256
Alopecia	1653.82	21.94	2555	215380	228800	79297653
Pericarditis	1653.24	21.94	1715	216220	102521	79423932
Wound	1548.98	21.94	1744	216191	114435	79412018
Abdominal discomfort	1471.80	21.94	2533	215402	248194	79278259
Discomfort	1339.94	21.94	1683	216252	123934	79402519
Hypersensitivity	1327.50	21.94	2484	215451	259755	79266698
Rheumatoid factor positive	1251.02	21.94	1146	216789	58693	79467760
Duodenal ulcer perforation	1200.80	21.94	1172	216763	65039	79461414
Helicobacter infection	1179.30	21.94	1188	216747	68516	79457937
Lower respiratory tract infection	1160.50	21.94	1591	216344	127629	79398824
Product use issue	1120.93	21.94	2035	215900	207787	79318666
Acute kidney injury	1082.56	21.94	91	217844	519313	79007140
Hepatic enzyme increased	1066.65	21.94	1842	216093	180768	79345685
Death	1027.26	21.94	161	217774	566353	78960100
Irritable bowel syndrome	1014.86	21.94	1040	216895	61201	79465252
Folliculitis	1003.53	21.94	980	216955	54400	79472053
Muscle injury	981.87	21.94	913	217022	47648	79478805
Pain	965.40	21.94	4136	213799	699666	78826787
Drug interaction	947.16	21.94	45	217890	415138	79111315
Toxicity to various agents	944.84	21.94	51	217884	421489	79104964
Psoriatic arthropathy	918.43	21.94	1099	216836	76900	79449553
Sleep disorder due to general medical condition, insomnia type	902.06	21.94	830	217105	42726	79483727
Rheumatoid arthritis	892.94	21.94	1842	216093	206628	79319825
Musculoskeletal stiffness	887.16	21.94	1660	216275	173348	79353105
Anaemia	854.39	21.94	106	217829	444909	79081544
Blister	840.12	21.94	1311	216624	118165	79408288
Arthralgia	823.80	21.94	3413	214522	568390	78958063
Infusion related reaction	800.69	21.94	1871	216064	228366	79298087
Hypotension	793.44	21.94	127	217808	440190	79086263
Infection	774.65	21.94	1903	216032	239809	79286644
Maternal exposure during pregnancy	760	21.94	1349	216586	135189	79391264
Impaired healing	753.11	21.94	1057	216878	86598	79439855
Peripheral swelling	705.70	21.94	1968	215967	267649	79258804
Sinusitis	676.46	21.94	1586	216349	193915	79332538
Completed suicide	648.19	21.94	4	217931	245763	79280690
Neutropenia	625.46	21.94	41	217894	287669	79238784
Ill-defined disorder	622.55	21.94	832	217103	65043	79461410
Febrile neutropenia	598.26	21.94	6	217929	230993	79295460
Thrombocytopenia	555.92	21.94	45	217890	265214	79261239
Rheumatic fever	554.72	21.94	525	217410	28000	79498453
C-reactive protein abnormal	543.83	21.94	666	217269	47701	79478752
Rash	524.63	21.94	3026	214909	575332	78951121
Knee arthroplasty	519.73	21.94	616	217319	42632	79483821
Dehydration	496.21	21.94	51	217884	248136	79278317
Constipation	493.18	21.94	89	217846	282961	79243492
Hip arthroplasty	488.15	21.94	544	217391	35212	79491241
Gastrointestinal disorder	484.46	21.94	1047	216888	121158	79405295
Cardiac arrest	422.30	21.94	10	217925	172086	79354367
Hyponatraemia	415.93	21.94	16	217919	177832	79348621
Swollen joint count increased	415.61	21.94	406	217529	22521	79503932
Mobility decreased	411.13	21.94	981	216954	121194	79405259
Fibromyalgia	397.33	21.94	666	217269	63674	79462779
Platelet count decreased	396.93	21.94	37	217898	194627	79331826
Therapeutic product effect incomplete	391.88	21.94	1056	216879	140589	79385864
Loss of personal independence in daily activities	386.23	21.94	861	217074	101719	79424734
Stomatitis	386.00	21.94	1074	216861	145683	79380770
Inflammation	379.24	21.94	810	217125	92943	79433510
Red blood cell sedimentation rate increased	359.20	21.94	530	217405	45412	79481041
Disease progression	355.51	21.94	43	217892	184319	79342134
Nasopharyngitis	346.40	21.94	1493	216442	252388	79274065
Renal failure	335.56	21.94	70	217865	200898	79325555
Respiratory failure	330.30	21.94	50	217885	180861	79345592
Foot deformity	326.39	21.94	365	217570	23709	79502744
Somnolence	322.08	21.94	125	217810	238856	79287597
Seizure	318.95	21.94	64	217871	188770	79337683
Drug hypersensitivity	317.23	21.94	1634	216301	297282	79229171
Adverse event	316.88	21.94	581	217354	59633	79466820
Type 2 diabetes mellitus	314.38	21.94	562	217373	56560	79469893
Bone erosion	312.24	21.94	310	217625	17537	79508916
Tachycardia	311.43	21.94	55	217880	177713	79348740
Bradycardia	307.66	21.94	15	217920	135542	79390911
Haemoglobin decreased	302.94	21.94	114	217821	222005	79304448
Fall	296.42	21.94	551	217384	487078	79039375
Sepsis	292.35	21.94	188	217747	269240	79257213
Rheumatoid nodule	286.93	21.94	293	217642	17145	79509308
Gastrointestinal haemorrhage	285.89	21.94	34	217901	147685	79378768
Ankylosing spondylitis	283.00	21.94	248	217687	11957	79514496
Blood cholesterol increased	279.12	21.94	670	217265	83050	79443403
Pancytopenia	278.18	21.94	57	217878	165688	79360765
Cardiac failure congestive	275.04	21.94	33	217902	142369	79384084
Cardio-respiratory arrest	271.33	21.94	5	217930	108505	79417948
Multiple organ dysfunction syndrome	267.55	21.94	15	217920	120231	79406222
Cardiac failure	258.31	21.94	54	217881	154788	79371665
Hypoxia	257.17	21.94	5	217930	103238	79423215
Rhabdomyolysis	256.87	21.94	5	217930	103126	79423327
Overdose	255.44	21.94	92	217843	184114	79342339
Hypoglycaemia	245.05	21.94	7	217928	101587	79424866
Hyperhidrosis	242.31	21.94	58	217877	151434	79375019
Renal impairment	241.64	21.94	66	217869	157717	79368736
Depressed level of consciousness	235.59	21.94	6	217929	96646	79429807
Tenosynovitis	233.78	21.94	249	217686	15305	79511148
Grip strength decreased	232.68	21.94	293	217642	21576	79504877
White blood cell count decreased	230.64	21.94	113	217822	188175	79338278
Enthesopathy	230.14	21.94	216	217719	11392	79515061
Drug tolerance decreased	228.08	21.94	226	217709	12752	79513701
Agitation	226.36	21.94	11	217924	99704	79426749
Tremor	225.74	21.94	91	217844	169992	79356461
Arthritis	224.53	21.94	758	217177	114122	79412331
Pulmonary embolism	224.33	21.94	94	217841	171560	79354893
Dyspnoea	220.68	21.94	1406	216529	855619	78670834
Dysphagia	220.06	21.94	35	217900	122101	79404352
Device malfunction	219.73	21.94	282	217653	21166	79505287
Coma	219.53	21.94	14	217921	100635	79425818
Drug delivery system malfunction	218.72	21.94	80	217855	637	79525816
Contusion	215.94	21.94	892	217043	147884	79378569
Night sweats	210.45	21.94	450	217485	51645	79474808
Liver injury	208.28	21.94	471	217464	56143	79470310
Sciatica	206.50	21.94	345	217590	32877	79493576
Chest discomfort	205.35	21.94	61	217874	137983	79388470
Oxygen saturation decreased	205.21	21.94	50	217885	128997	79397456
Atrial fibrillation	203.98	21.94	146	217789	197740	79328713
Epistaxis	200.81	21.94	32	217903	111483	79414970
Neutrophil count decreased	196.51	21.94	16	217919	93943	79432510
Blood parathyroid hormone decreased	193.59	21.94	188	217747	10348	79516105
Needle issue	190.76	21.94	206	217729	12862	79513591
Granuloma skin	190.16	21.94	175	217760	8999	79517454
Hypokalaemia	189.62	21.94	78	217857	143962	79382491
Suicide attempt	188.72	21.94	9	217926	82923	79443530
Cerebrovascular accident	185.96	21.94	96	217839	155196	79371257
Device deployment issue	181.98	21.94	112	217823	3100	79523353
Panniculitis	178.81	21.94	194	217741	12177	79514276
Blood pressure decreased	175.85	21.94	30	217905	99436	79427017
Condition aggravated	173.65	21.94	2112	215823	499012	79027441
Hyperglycaemia	172.81	21.94	4	217931	70331	79456122
Balance disorder	172.18	21.94	31	217904	98826	79427627
Dizziness	170.73	21.94	799	217136	525642	79000811
Leukopenia	170.55	21.94	53	217882	116460	79409993
Ear pain	170.17	21.94	315	217620	32554	79493899
Dyspnoea exertional	168.55	21.94	20	217915	87053	79439400
Neuropathy peripheral	168.23	21.94	88	217847	141217	79385236
Joint stiffness	166.42	21.94	354	217581	40476	79485977
Ascites	166.32	21.94	10	217925	75552	79450901
Cough	164.46	21.94	487	217448	366302	79160151
Product dose omission issue	164.33	21.94	1199	216736	246338	79280115
Red blood cell sedimentation rate abnormal	161.17	21.94	240	217695	20723	79505730
Injury associated with device	160.79	21.94	107	217828	3399	79523054
Oedema peripheral	160.27	21.94	277	217658	252011	79274442
Blood creatinine increased	158.99	21.94	115	217820	154942	79371511
Adverse drug reaction	158.98	21.94	470	217465	65922	79460531
Vision blurred	158.94	21.94	46	217889	105852	79420601
Mental status changes	156.56	21.94	6	217929	66953	79459500
Drug reaction with eosinophilia and systemic symptoms	156.51	21.94	4	217931	64240	79462213
Breast cancer stage III	156.04	21.94	162	217773	9664	79516789
Hallucination	155.75	21.94	24	217911	85721	79440732
Joint range of motion decreased	155.09	21.94	305	217630	32977	79493476
Dysarthria	154.96	21.94	7	217928	67615	79458838
Anxiety	153.21	21.94	278	217657	248234	79278219
Osteoarthritis	153.19	21.94	556	217379	86753	79439700
Blood glucose increased	151.74	21.94	62	217873	114913	79411540
Pleural effusion	151.21	21.94	106	217829	145156	79381297
Muscle spasticity	151.17	21.94	236	217699	21239	79505214
Chronic kidney disease	151.10	21.94	7	217928	66147	79460306
Vomiting	150.95	21.94	1133	216802	664695	78861758
Dislocation of vertebra	149.29	21.94	143	217792	7737	79518716
Encephalopathy	148.09	21.94	9	217926	67388	79459065
Weight decreased	146.96	21.94	489	217446	354709	79171744
Lower limb fracture	146.84	21.94	243	217692	22972	79503481
Off label use	145.19	21.94	3369	214566	903846	78622607
Chills	144.26	21.94	135	217800	160099	79366354
Tongue disorder	143.54	21.94	184	217751	13791	79512662
Red blood cell sedimentation rate	143.11	21.94	120	217815	5445	79521008
Blood creatine phosphokinase increased	141.75	21.94	10	217925	66080	79460373
Intentional product misuse	141.61	21.94	42	217893	95123	79431330
Disorientation	139.10	21.94	8	217927	62768	79463685
Facet joint syndrome	139.06	21.94	163	217772	11139	79515314
Blood pressure increased	137.97	21.94	228	217707	211132	79315321
Unresponsive to stimuli	137.73	21.94	3	217932	55785	79470668
Coronary artery disease	137.32	21.94	11	217924	65463	79460990
Intentional product use issue	137.13	21.94	796	217139	151316	79375137
Syncope	136.35	21.94	174	217761	179275	79347178
Blood alkaline phosphatase increased	135.49	21.94	10	217925	63654	79462799
Pulmonary oedema	134.92	21.94	37	217898	88217	79438236
Pneumonia aspiration	133.09	21.94	14	217921	66953	79459500
Alanine aminotransferase abnormal	131.57	21.94	141	217794	8726	79517727
Blood bilirubin increased	131.24	21.94	14	217921	66218	79460235
Lip dry	130.88	21.94	185	217750	15233	79511220
Seronegative arthritis	130.74	21.94	106	217829	4586	79521867
Myocardial infarction	130.34	21.94	188	217747	183941	79342512
Myalgia	129.01	21.94	192	217743	185449	79341004
Deep vein thrombosis postoperative	127.22	21.94	152	217783	10600	79515853
C-reactive protein increased	126.08	21.94	690	217245	128337	79398116
Palpitations	125.80	21.94	97	217838	126513	79399940
Chest pain	125.62	21.94	376	217559	281928	79244525
Onychomycosis	125.47	21.94	133	217802	8128	79518325
Cognitive disorder	123.80	21.94	21	217914	69905	79456548
Septic shock	123.39	21.94	93	217842	122708	79403745
Haematuria	123.36	21.94	20	217915	68816	79457637
Prescribed overdose	122.79	21.94	300	217635	37583	79488870
Chronic obstructive pulmonary disease	121.21	21.94	41	217894	85378	79441075
Therapeutic response decreased	120.89	21.94	430	217505	66423	79460030
Skin necrosis	119.37	21.94	193	217742	17894	79508559
Respiratory distress	119.08	21.94	11	217924	58328	79468125
Hepatic failure	118.61	21.94	14	217921	61198	79465255
Disturbance in attention	117.26	21.94	5	217930	50796	79475657
Adjustment disorder with depressed mood	116.75	21.94	134	217801	8952	79517501
Orthostatic hypotension	116.23	21.94	10	217925	56154	79470299
Blood urea increased	115.35	21.94	4	217931	48786	79477667
Therapy non-responder	114.43	21.94	528	217407	91777	79434676
Feeling abnormal	114.20	21.94	161	217774	159038	79367415
Haematocrit decreased	114.03	21.94	16	217919	61296	79465157
Drug use disorder	113.55	21.94	129	217806	8522	79517931
Bone marrow failure	111.76	21.94	7	217928	51100	79475353
Cholestasis	111.42	21.94	8	217927	52101	79474352
Acute myocardial infarction	111.02	21.94	36	217899	77000	79449453
Acute respiratory failure	109.66	21.94	16	217919	59525	79466928
Hypercholesterolaemia	109.24	21.94	213	217722	22882	79503571
Fatigue	108.62	21.94	3314	214621	926413	78600040
Melaena	108.43	21.94	18	217917	60872	79465581
Musculoskeletal pain	107.23	21.94	558	217377	101796	79424657
Pulmonary fibrosis	107.23	21.94	314	217621	43798	79482655
Onychomadesis	106.71	21.94	99	217836	5143	79521310
Gait inability	106.56	21.94	379	217556	58538	79467915
Drug tolerance	106.54	21.94	125	217810	8550	79517903
Agranulocytosis	105.39	21.94	4	217931	45026	79481427
Gamma-glutamyltransferase increased	104.73	21.94	13	217922	54667	79471786
Heart rate decreased	104.67	21.94	31	217904	70285	79456168
Exostosis	104.66	21.94	175	217760	16683	79509770
Mucosal inflammation	104.29	21.94	38	217897	75542	79450911
Injury	104.10	21.94	454	217481	77042	79449411
Restlessness	102.78	21.94	6	217929	46486	79479967
Pyrexia	102.31	21.94	1276	216659	677433	78849020
Wrong technique in product usage process	102.17	21.94	37	217898	73838	79452615
Lymphocyte count decreased	101.86	21.94	7	217928	47282	79479171
Nail disorder	101.77	21.94	143	217792	11709	79514744
Shock	101.47	21.94	4	217931	43544	79482909
General physical health deterioration	101.24	21.94	1174	216761	274064	79252389
Anti-cyclic citrullinated peptide antibody	101.15	21.94	101	217834	5751	79520702
Uveitis	100.89	21.94	172	217763	16658	79509795
Aphasia	100.42	21.94	7	217928	46725	79479728
Wound infection	100.07	21.94	210	217725	23781	79502672
Peripheral venous disease	99.91	21.94	166	217769	15743	79510710
Eosinophilia	99.79	21.94	6	217929	45339	79481114
Dysgeusia	99.40	21.94	18	217917	57159	79469294
Haemoptysis	98.73	21.94	17	217918	55982	79470471
Pallor	98.12	21.94	11	217924	50051	79476402
Suicidal ideation	96.21	21.94	44	217891	76296	79450157
Generalised tonic-clonic seizure	96.06	21.94	6	217929	43904	79482549
Hot flush	96.00	21.94	17	217918	54860	79471593
Heart rate increased	95.96	21.94	113	217822	120611	79405842
Pruritus	95.58	21.94	1562	216373	393086	79133367
Leukocytosis	94.88	21.94	6	217929	43449	79483004
Fluid retention	94.80	21.94	36	217899	69773	79456680
Sleep disorder	94.57	21.94	474	217461	85203	79441250
Pulmonary hypertension	93.15	21.94	11	217924	48069	79478384
Altered state of consciousness	92.91	21.94	7	217928	43815	79482638
Nausea	92.89	21.94	1954	215981	955242	78571211
Upper gastrointestinal haemorrhage	92.52	21.94	5	217930	41375	79485078
Hepatic function abnormal	92.35	21.94	42	217893	73065	79453388
Urinary retention	91.86	21.94	21	217914	56609	79469844
Basal cell carcinoma	91.76	21.94	267	217668	37108	79489345
Tendonitis	90.69	21.94	201	217734	23629	79502824
Hypothyroidism	89.99	21.94	17	217918	52375	79474078
Blood lactate dehydrogenase increased	89.93	21.94	4	217931	39166	79487287
Flushing	89.76	21.94	66	217869	88202	79438251
Retinitis	89.54	21.94	93	217842	5550	79520903
Abdominal pain	89.45	21.94	660	217275	388909	79137544
Lethargy	89.06	21.94	56	217879	81236	79445217
Live birth	88.81	21.94	173	217762	18571	79507882
Coeliac disease	88.75	21.94	131	217804	11220	79515233
Blood iron abnormal	88.67	21.94	52	217883	1315	79525138
Injection site pain	88.52	21.94	136	217799	129702	79396751
Joint dislocation	88.50	21.94	163	217772	16776	79509677
Asthenia	87.93	21.94	934	217001	510755	79015698
Autoimmune disorder	86.98	21.94	160	217775	16452	79510001
Loss of consciousness	86.50	21.94	208	217727	167735	79358718
Systemic lupus erythematosus rash	85.86	21.94	57	217878	1803	79524650
Maternal exposure timing unspecified	85.76	21.94	92	217843	5700	79520753
Administration site pain	85.46	21.94	38	217897	524	79525929
Cerebral haemorrhage	84.80	21.94	26	217909	57647	79468806
Bedridden	83.98	21.94	132	217803	11947	79514506
Stevens-Johnson syndrome	83.77	21.94	6	217929	39160	79487293
Ulcer	83.30	21.94	224	217711	29748	79496705
Haemorrhage	82.89	21.94	76	217859	91042	79435411
Cardiac disorder	82.71	21.94	38	217897	65719	79460734
Dyskinesia	82.52	21.94	12	217923	44761	79481692
Deep vein thrombosis	82.11	21.94	127	217808	120792	79405661
Abdominal distension	81.88	21.94	125	217810	119525	79406928
Ejection fraction decreased	81.17	21.94	3	217932	34574	79491879
Angioedema	81.08	21.94	54	217881	75981	79450472
Sinus tachycardia	80.87	21.94	5	217930	36903	79489550
Osteonecrosis of jaw	78.72	21.94	12	217923	43214	79483239
Haematemesis	77.86	21.94	23	217912	52241	79474212
Diarrhoea	77.17	21.94	1826	216109	878663	78647790
Gastrooesophageal reflux disease	76.17	21.94	104	217831	104142	79422311
Respiratory disorder	75.58	21.94	282	217653	44574	79481879
Lip swelling	75.32	21.94	11	217924	40900	79485553
Kidney infection	75.07	21.94	177	217758	21674	79504779
Arthrodesis	74.83	21.94	58	217877	2349	79524104
Arrhythmia	73.13	21.94	38	217897	61234	79465219
Urinary incontinence	73.04	21.94	12	217923	40897	79485556
Deformity	72.45	21.94	109	217826	9496	79516957
Transient ischaemic attack	71.84	21.94	27	217908	52668	79473785
Pancreatitis acute	71.79	21.94	23	217912	49581	79476872
Cholelithiasis	71.77	21.94	27	217908	52637	79473816
Hepatocellular injury	70.80	21.94	21	217914	47572	79478881
Haematoma	70.73	21.94	27	217908	52168	79474285
Weight increased	70.50	21.94	1107	216828	276279	79250174
Rash erythematous	70.19	21.94	35	217900	57734	79468719
Body temperature increased	69.69	21.94	273	217662	44147	79482306
Myelosuppression	69.37	21.94	13	217922	40283	79486170
Irritability	69.30	21.94	14	217921	41130	79485323
Dry skin	68.93	21.94	51	217884	67944	79458509
Blood sodium decreased	68.59	21.94	6	217929	33249	79493204
Oropharyngeal pain	68.52	21.94	121	217814	109232	79417221
Blood potassium decreased	68.33	21.94	21	217914	46491	79479962
Plasma cell myeloma	68.20	21.94	30	217905	53229	79473224
Pericardial effusion	67.70	21.94	21	217914	46216	79480237
Pancreatitis	67.51	21.94	53	217882	68522	79457931
Disseminated intravascular coagulation	67.49	21.94	9	217926	35833	79490620
Lymphopenia	67.37	21.94	4	217931	30553	79495900
Blood potassium increased	67.17	21.94	3	217932	29272	79497181
Subdural haematoma	66.70	21.94	5	217930	31429	79495024
Bursitis	65.17	21.94	231	217704	35613	79490840
Blood pressure fluctuation	64.72	21.94	53	217882	67092	79459361
Malignant mediastinal neoplasm	64.45	21.94	43	217892	1372	79525081
Rash maculo-papular	63.70	21.94	37	217898	56041	79470412
Anticipatory anxiety	63.21	21.94	40	217895	1164	79525289
Ischaemic stroke	63.15	21.94	8	217927	33123	79493330
Circulatory collapse	63.06	21.94	13	217922	37655	79488798
Myoclonus	62.92	21.94	3	217932	27657	79498796
Acute respiratory distress syndrome	62.78	21.94	21	217914	44046	79482407
Abdominal pain lower	62.24	21.94	7	217928	31775	79494678
Laryngitis	61.84	21.94	136	217799	15903	79510550
Mycotic allergy	61.68	21.94	43	217892	1476	79524977
Diplopia	61.61	21.94	9	217926	33457	79492996
Presyncope	61.28	21.94	18	217917	41036	79485417
Depressed mood	61.00	21.94	28	217907	48452	79478001
Joint injury	60.49	21.94	206	217729	31129	79495324
Renal disorder	60.09	21.94	20	217915	42085	79484368
Decreased appetite	59.96	21.94	622	217313	341796	79184657
Cardiomyopathy	59.87	21.94	5	217930	28769	79497684
Exposure during pregnancy	59.79	21.94	477	217458	100655	79425798
Foot operation	59.69	21.94	76	217859	5657	79520796
Heart rate irregular	59.67	21.94	9	217926	32670	79493783
Drug ineffective for unapproved indication	59.36	21.94	33	217902	51205	79475248
Joint destruction	59.26	21.94	77	217858	5848	79520605
Lymphadenopathy	59.26	21.94	36	217899	53211	79473242
Disability	59.16	21.94	139	217796	16981	79509472
Haemorrhage intracranial	59.08	21.94	3	217932	26190	79500263
Skin exfoliation	58.93	21.94	39	217896	55061	79471392
Myelodysplastic syndrome	58.53	21.94	7	217928	30294	79496159
Device dislocation	58.49	21.94	3	217932	25967	79500486
Head injury	58.37	21.94	15	217920	37354	79489099
Neutropenic sepsis	58.31	21.94	4	217931	27060	79499393
Nightmare	58.21	21.94	3	217932	25858	79500595
Urticaria	58.12	21.94	767	217168	184434	79342019
Pregnancy	57.64	21.94	183	217752	26668	79499785
Lupus-like syndrome	57.44	21.94	121	217814	13736	79512717
Thrombosis	57.40	21.94	88	217847	84012	79442441
White blood cell count increased	57.03	21.94	72	217863	74561	79451892
Nerve injury	56.31	21.94	96	217839	9296	79517157
Pulmonary tuberculosis	56.14	21.94	87	217848	7778	79518675
Bunion operation	55.99	21.94	34	217901	918	79525535
Osteoporosis	55.96	21.94	294	217641	53818	79472635
Injection site swelling	55.12	21.94	30	217905	47102	79479351
Rash macular	55.03	21.94	7	217928	28892	79497561
Tubulointerstitial nephritis	54.85	21.94	18	217917	38217	79488236
Clostridium difficile colitis	54.34	21.94	11	217924	32272	79494181
Neutrophil count increased	53.90	21.94	8	217927	29388	79497065
Bone pain	53.72	21.94	44	217891	55698	79470755
Red blood cell count decreased	53.47	21.94	47	217888	57466	79468987
C-reactive protein	53.42	21.94	67	217868	4912	79521541
Hepatic cytolysis	53.12	21.94	6	217929	27145	79499308
Hyperlipidaemia	53.03	21.94	5	217930	26088	79500365
Liver function test abnormal	52.68	21.94	59	217876	64416	79462037
Colitis	52.68	21.94	74	217861	73233	79453220
Productive cough	52.44	21.94	101	217834	88230	79438223
Vertigo	52.42	21.94	67	217868	69015	79457438
Muscle twitching	52.37	21.94	4	217931	24760	79501693
Angina pectoris	52.18	21.94	39	217896	51693	79474760
Chromaturia	52.15	21.94	5	217930	25741	79500712
Cerebral infarction	52.08	21.94	30	217905	45646	79480807
Walking aid user	50.95	21.94	96	217839	10052	79516401
Intestinal obstruction	50.87	21.94	27	217908	42993	79483460
Gastric ulcer	50.36	21.94	15	217920	33890	79492563
Rheumatoid lung	50.20	21.94	60	217875	4185	79522268
Nervous system disorder	49.96	21.94	7	217928	26849	79499604
Bacteraemia	49.71	21.94	14	217921	32810	79493643
Skin discolouration	49.64	21.94	25	217910	41009	79485444
Hepatic cirrhosis	49.56	21.94	208	217727	34698	79491755
Metastases to bone	48.81	21.94	5	217930	24422	79502031
Face oedema	48.60	21.94	9	217926	28127	79498326
Psoriasis	48.37	21.94	414	217521	89173	79437280
Pneumonitis	48.31	21.94	57	217878	60803	79465650
Dysuria	48.14	21.94	41	217894	50910	79475543
Extremity contracture	47.98	21.94	39	217896	1693	79524760
Ankle arthroplasty	47.96	21.94	37	217898	1488	79524965
Joint ankylosis	47.95	21.94	43	217892	2137	79524316
Adverse reaction	47.87	21.94	89	217846	9225	79517228
Musculoskeletal disorder	47.71	21.94	148	217787	21300	79505153
Atrial flutter	47.17	21.94	3	217932	21622	79504831
Respiratory rate increased	47.10	21.94	3	217932	21597	79504856
Fear of injection	46.95	21.94	78	217857	7396	79519057
Faeces discoloured	46.84	21.94	11	217924	29116	79497337
Obesity	46.56	21.94	205	217730	34920	79491533
Fine motor skill dysfunction	46.54	21.94	65	217870	5292	79521161
Hemiparesis	46.46	21.94	17	217918	33716	79492737
Mental disorder	46.22	21.94	14	217921	31288	79495165
Ileus	46.11	21.94	8	217927	26203	79500250
Emotional distress	45.93	21.94	26	217909	39943	79486510
Cyanosis	45.83	21.94	7	217928	25175	79501278
Panic attack	45.79	21.94	6	217929	24210	79502243
Visual acuity reduced	45.70	21.94	12	217923	29457	79496996
X-ray abnormal	45.32	21.94	67	217868	5746	79520707
Drug specific antibody present	45.29	21.94	72	217863	6580	79519873
Fear	45.26	21.94	4	217931	21982	79504471
Bronchospasm	45.04	21.94	7	217928	24852	79501601
Splenomegaly	44.91	21.94	3	217932	20751	79505702
Myopathy	44.41	21.94	3	217932	20560	79505893
Cardiomegaly	44.31	21.94	9	217926	26343	79500110
Gastric disorder	44.08	21.94	211	217724	37222	79489231
Throat irritation	43.76	21.94	29	217906	40917	79485536
Transfusion	43.58	21.94	4	217931	21326	79505127
Hypoalbuminaemia	43.50	21.94	4	217931	21293	79505160
Thrombotic microangiopathy	43.39	21.94	3	217932	20166	79506287
Nervousness	42.50	21.94	19	217916	33396	79493057
Respiratory tract congestion	41.92	21.94	135	217800	19819	79506634
Mitral valve incompetence	41.77	21.94	13	217922	28552	79497901
Nodule	41.64	21.94	148	217787	22846	79503607
Hypocalcaemia	41.54	21.94	45	217890	49879	79476574
Pain in jaw	41.37	21.94	39	217896	46112	79480341
Pustular psoriasis	41.28	21.94	58	217877	4748	79521705
Cytopenia	41.18	21.94	4	217931	20379	79506074
Epilepsy	40.95	21.94	31	217904	40829	79485624
Injection site erythema	40.91	21.94	96	217839	78101	79448352
Hypersomnia	40.71	21.94	7	217928	23079	79503374
Tuberculosis	40.65	21.94	112	217823	15086	79511367
Shock haemorrhagic	40.36	21.94	4	217931	20056	79506397
Lung infiltration	40.29	21.94	7	217928	22905	79503548
Rales	40.21	21.94	4	217931	19997	79506456
Blood glucose decreased	40.08	21.94	11	217924	26223	79500230
Pseudomonas infection	39.95	21.94	5	217930	20898	79505555
Haemophagocytic lymphohistiocytosis	39.90	21.94	6	217929	21831	79504622
Rectal haemorrhage	39.66	21.94	94	217841	76206	79450247
Cytomegalovirus infection	39.46	21.94	35	217900	42609	79483844
Sudden death	39.31	21.94	7	217928	22504	79503949
Skin ulcer	39.18	21.94	268	217667	53882	79472571
Gastritis	39.12	21.94	44	217891	47949	79478504
Lupus vulgaris	39.09	21.94	47	217888	3299	79523154
Dialysis	38.99	21.94	3	217932	18459	79507994
Multiple allergies	38.42	21.94	87	217848	10373	79516080
Flatulence	38.42	21.94	36	217899	42688	79483765
Transaminases increased	38.42	21.94	51	217884	51692	79474761
Acute coronary syndrome	38.17	21.94	6	217929	21127	79505326
Back injury	38.07	21.94	87	217848	10436	79516017
Mental impairment	37.77	21.94	4	217931	19032	79507421
Muscle spasms	37.68	21.94	301	217634	174429	79352024
Injection site reaction	37.20	21.94	267	217668	54518	79471935
Eye swelling	37.03	21.94	13	217922	26455	79499998
Bronchopulmonary aspergillosis	36.69	21.94	8	217927	22286	79504167
Prescribed underdose	36.68	21.94	169	217766	29345	79497108
Purpura	36.53	21.94	5	217930	19522	79506931
Pollakiuria	36.53	21.94	29	217906	37288	79489165
Delusion	36.44	21.94	6	217929	20417	79506036
Osteonecrosis	36.06	21.94	20	217915	31075	79495378
Subarachnoid haemorrhage	36.02	21.94	11	217924	24454	79501999
Acute generalised exanthematous pustulosis	35.89	21.94	3	217932	17251	79509202
Blood pressure systolic abnormal	35.88	21.94	3	217932	17244	79509209
Acute myeloid leukaemia	35.62	21.94	20	217915	30865	79495588
Feeling cold	35.51	21.94	17	217918	28712	79497741
Small intestinal obstruction	35.49	21.94	15	217920	27257	79499196
Malnutrition	35.21	21.94	9	217926	22493	79503960
Aplastic anaemia	34.92	21.94	4	217931	17901	79508552
Feeling hot	34.85	21.94	69	217866	59665	79466788
Mood altered	34.78	21.94	4	217931	17843	79508610
Arteriosclerosis coronary artery	34.70	21.94	4	217931	17812	79508641
Tinnitus	34.68	21.94	42	217893	44291	79482162
Immune thrombocytopenia	34.67	21.94	4	217931	17801	79508652
Liver disorder	34.65	21.94	326	217609	72091	79454362
Petechiae	34.63	21.94	7	217928	20558	79505895
Metastases to liver	34.63	21.94	17	217918	28297	79498156
Urinary tract infection	34.44	21.94	535	217400	273977	79252476
Foot fracture	34.40	21.94	135	217800	21846	79504607
Thirst	34.29	21.94	5	217930	18614	79507839
Supraventricular tachycardia	34.27	21.94	8	217927	21262	79505191
Abortion spontaneous	34.18	21.94	19	217916	29488	79496965
Transplant rejection	34.04	21.94	6	217929	19431	79507022
Lipase increased	33.88	21.94	3	217932	16463	79509990
Product label confusion	33.66	21.94	31	217904	1595	79524858
Therapy partial responder	33.65	21.94	4	217931	17393	79509060
Polyneuropathy	33.55	21.94	12	217923	24139	79502314
Hypermobility syndrome	33.54	21.94	20	217915	522	79525931
Sputum discoloured	33.44	21.94	9	217926	21734	79504719
Spinal fusion surgery	33.35	21.94	55	217880	5183	79521270
Toxic skin eruption	32.86	21.94	10	217925	22283	79504170
Urine output decreased	32.82	21.94	5	217930	18017	79508436
Depression	32.73	21.94	407	217528	216383	79310070
Erythema	32.67	21.94	422	217513	222868	79303585
Paraesthesia oral	32.39	21.94	8	217927	20463	79505990
Oesophagitis	32.19	21.94	13	217922	24276	79502177
Product storage error	31.60	21.94	107	217828	16119	79510334
Angina unstable	31.48	21.94	4	217931	16523	79509930
Disease susceptibility	31.24	21.94	16	217919	307	79526146
Therapeutic response unexpected	31.16	21.94	8	217927	19938	79506515
Colitis ischaemic	31.06	21.94	3	217932	15356	79511097
Limb discomfort	30.93	21.94	174	217761	32676	79493777
Hyperthyroidism	30.91	21.94	11	217924	22198	79504255
Unevaluable event	30.91	21.94	66	217869	55519	79470934
Eye pruritus	30.73	21.94	9	217926	20561	79505892
Hypercalcaemia	30.71	21.94	195	217740	38235	79488218
Tricuspid valve incompetence	30.62	21.94	8	217927	19704	79506749
Hunger	30.61	21.94	54	217881	5374	79521079
Ventricular extrasystoles	30.60	21.94	8	217927	19696	79506757
Diabetes mellitus inadequate control	30.54	21.94	14	217921	24250	79502203
Polyuria	30.19	21.94	3	217932	15011	79511442
Blood pressure diastolic decreased	30.19	21.94	23	217912	30193	79496260
Renal injury	30.14	21.94	5	217930	16922	79509531
Fungal infection	30.13	21.94	42	217893	41706	79484747
Paranoia	29.97	21.94	8	217927	19424	79507029
Klebsiella infection	29.47	21.94	4	217931	15716	79510737
Atrioventricular block complete	29.37	21.94	5	217930	16605	79509848
Haemorrhoids	29.32	21.94	22	217913	29106	79497347
Sleep apnoea syndrome	29.13	21.94	34	217901	36444	79490009
Hepatitis acute	29.03	21.94	4	217931	15538	79510915
Diverticulitis	28.98	21.94	220	217715	45716	79480737
Accidental exposure to product	28.90	21.94	165	217770	31157	79495296
Impaired quality of life	28.60	21.94	3	217932	14383	79512070
Pemphigoid	28.47	21.94	4	217931	15311	79511142
Speech disorder	28.35	21.94	67	217868	54378	79472075
Ear infection	28.31	21.94	176	217759	34256	79492197
Blood triglycerides increased	28.31	21.94	11	217924	21029	79505424
Cold sweat	28.27	21.94	8	217927	18691	79507762
Sinus disorder	28.22	21.94	13	217922	22451	79504002
Myocarditis	28.21	21.94	12	217923	21721	79504732
Allergy to chemicals	27.89	21.94	35	217900	2567	79523886
Restless legs syndrome	27.88	21.94	10	217925	20082	79506371
Aspergillus infection	27.52	21.94	9	217926	19152	79507301
Device related infection	27.34	21.94	32	217903	34262	79492191
Blood pressure systolic increased	27.10	21.94	93	217842	66893	79459560
Intervertebral disc compression	27.07	21.94	25	217910	1291	79525162
Metastases to lung	27.04	21.94	8	217927	18155	79508298
Hiatus hernia	27.02	21.94	15	217920	23297	79503156
Thyroid cancer	26.99	21.94	52	217883	5536	79520917
Influenza like illness	26.74	21.94	103	217832	71604	79454849
Escherichia infection	26.71	21.94	8	217927	18009	79508444
Duodenal ulcer	26.69	21.94	6	217929	16363	79510090
Liver function test increased	26.52	21.94	193	217742	39580	79486873
Enterocolitis	26.49	21.94	4	217931	14508	79511945
No adverse event	26.27	21.94	38	217897	37154	79489299
Polyarthritis	26.04	21.94	83	217852	12119	79514334
Blood pressure diastolic abnormal	25.90	21.94	10	217925	19192	79507261
Myositis	25.83	21.94	10	217925	19158	79507295
Progressive multifocal leukoencephalopathy	25.75	21.94	12	217923	20588	79505865
Glomerular filtration rate decreased	25.75	21.94	15	217920	22687	79503766
Peripheral coldness	25.74	21.94	6	217929	15964	79510489
Tooth abscess	25.73	21.94	100	217835	16110	79510343
Hydronephrosis	25.42	21.94	8	217927	17446	79509007
Nasal congestion	25.41	21.94	115	217820	76437	79450016
Cardiac murmur	25.40	21.94	6	217929	15818	79510635
Hip fracture	25.29	21.94	28	217907	30733	79495720
Tendon graft	25.29	21.94	6	217929	6	79526447
Anal incontinence	25.29	21.94	9	217926	18159	79508294
Hypoacusis	25.28	21.94	27	217908	30123	79496330
Embolism	25.19	21.94	4	217931	13978	79512475
Decubitus ulcer	25.08	21.94	6	217929	15681	79510772
Hyperthermia	24.99	21.94	9	217926	18028	79508425
Eczema	24.81	21.94	46	217889	40772	79485681
Hypertensive crisis	24.61	21.94	13	217922	20757	79505696
Enteritis	24.48	21.94	5	217930	14578	79511875
Nocturia	24.45	21.94	4	217931	13677	79512776
Toothache	24.40	21.94	12	217923	19958	79506495
Oral discomfort	24.22	21.94	70	217865	9690	79516763
Complication associated with device	23.79	21.94	9	217926	17487	79508966
Central nervous system lesion	23.69	21.94	4	217931	13364	79513089
Acute pulmonary oedema	23.64	21.94	5	217930	14225	79512228
Intestinal perforation	23.63	21.94	9	217926	17417	79509036
Product prescribing error	23.45	21.94	55	217880	44758	79481695
Intestinal ischaemia	23.45	21.94	4	217931	13266	79513187
Throat tightness	23.39	21.94	25	217910	27882	79498571
Hemiplegia	23.32	21.94	6	217929	14933	79511520
Gout	23.27	21.94	20	217915	24729	79501724
Atrioventricular block	23.19	21.94	5	217930	14036	79512417
Blood pressure abnormal	23.06	21.94	9	217926	17160	79509293
Metastases to central nervous system	22.98	21.94	8	217927	16367	79510086
Rash papular	22.78	21.94	16	217919	21900	79504553
Atelectasis	22.74	21.94	33	217902	32224	79494229
Muscle tightness	22.59	21.94	4	217931	12910	79513543
Nail operation	22.53	21.94	17	217918	661	79525792
Large intestine perforation	22.46	21.94	6	217929	14561	79511892
Cardiac failure acute	22.20	21.94	12	217923	18917	79507536
Nephrolithiasis	22.14	21.94	233	217702	53058	79473395
Mass	22.12	21.94	10	217925	17462	79508991
Hepatomegaly	22.09	21.94	12	217923	18862	79507591
Blindness	22.08	21.94	27	217908	28356	79498097

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	L04AB06	ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS IMMUNOSUPPRESSANTS IMMUNOSUPPRESSANTS Tumor necrosis factor alpha (TNF-alpha) inhibitors
FDA MoA	N0000175451	Tumor Necrosis Factor Receptor Blocking Activity
MeSH PA	D000893	Anti-Inflammatory Agents
MeSH PA	D007155	Immunologic Factors
MeSH PA	D007166	Immunosuppressive Agents
MeSH PA	D000079424	Tumor Necrosis Factor Inhibitors
FDA EPC	N0000175610	Tumor Necrosis Factor Blocker

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

Disease	Relation	SNOMED_ID	DOID
Ankylosing spondylitis	indication	9631008	DOID:7147
Psoriasis with arthropathy	indication	33339001
Ulcerative colitis	indication	64766004	DOID:8577
Rheumatoid arthritis	indication	69896004	DOID:7148
Juvenile idiopathic arthritis	indication	410502007
Nonradiographic axial spondyloarthritis	indication	713777005
Polyarticular juvenile idiopathic arthritis	indication	16044800000000000

🐶 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
Tumor necrosis factor	Cytokine	P01375	TNFA_HUMAN	ANTIBODY BINDING				DRUG LABEL	DRUG LABEL

External reference:

ID	Source
D04358	KEGG_DRUG
4028717	VUID
N0000178413	NUI
4028717	VANDF
CHEMBL1201833	ChEMBL_ID
C529000	MESH_SUPPLEMENTAL_RECORD_UI
6776	IUPHAR_LIGAND_ID
DB06674	DRUGBANK_ID
819300	RXNORM
164144	MMSL
164146	MMSL
26409	MMSL
d07435	MMSL
013091	NDDF
442318002	SNOMEDCT_US
442435002	SNOMEDCT_US
C2353893	UMLSCUI
8497	INN_ID
91X1KLU43E	UNII

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Simponi	HUMAN PRESCRIPTION DRUG LABEL	1	57894-070	INJECTION, SOLUTION	50 mg	SUBCUTANEOUS	BLA	30 sections
Simponi	HUMAN PRESCRIPTION DRUG LABEL	1	57894-070	INJECTION, SOLUTION	50 mg	SUBCUTANEOUS	BLA	30 sections
Simponi	HUMAN PRESCRIPTION DRUG LABEL	1	57894-071	INJECTION, SOLUTION	100 mg	SUBCUTANEOUS	BLA	30 sections
Simponi	HUMAN PRESCRIPTION DRUG LABEL	1	57894-071	INJECTION, SOLUTION	100 mg	SUBCUTANEOUS	BLA	30 sections
SIMPONI ARIA	HUMAN PRESCRIPTION DRUG LABEL	1	57894-350	SOLUTION	50 mg	INTRAVENOUS	BLA	29 sections
SIMPONI ARIA	HUMAN PRESCRIPTION DRUG LABEL	1	57894-350	SOLUTION	50 mg	INTRAVENOUS	BLA	29 sections