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

Stem definition	Drug id	CAS RN
antiulcer, benzimidazole derivatives	1055	119141-88-7

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: esomeprazole magnesium dihydrate esomeprazole (S)-Esomeprazole (S)-Omeprazole (-)-Omeprazole esomeprazole magnesium esomeprazole sodium nexium control esomeprazole magnesium hydrate esomeprazole strontium	The S-isomer of omeprazole. Molecular weight: 345.42 Formula: C17H19N3O3S CLOGP: 2.56 LIPINSKI: 0 HAC: 6 HDO: 1 TPSA: 77.10 ALOGS: -2.98 ROTB: 5 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

esomeprazole magnesium dihydrate
esomeprazole
(S)-Esomeprazole
(S)-Omeprazole
(-)-Omeprazole
esomeprazole magnesium
esomeprazole sodium
nexium control
esomeprazole magnesium hydrate
esomeprazole strontium

The S-isomer of omeprazole.

Molecular weight: 345.42
Formula: C17H19N3O3S
CLOGP: 2.56
LIPINSKI: 0
HAC: 6
HDO: 1
TPSA: 77.10
ALOGS: -2.98
ROTB: 5

Status: OFP

Legend:
OFP - off patent
OFM - off market
ONP - on patent

Drug dosage:

Dose	Unit	Route
30	mg	O
30	mg	P
0.50	g	O

ADMET properties:

Property	Value	Reference
BDDCS (Biopharmaceutical Drug Disposition Classification System)	1	Benet LZ, Broccatelli F, Oprea TI
S (Water solubility)	0.50 mg/mL	Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine)	0.50 %	Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose)	5.79 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability)	53 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution)	0.20 L/kg	Lombardo F, Berellini G, Obach RS
CL (Clearance)	3.85 mL/min/kg	Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma)	0.03 %	Lombardo F, Berellini G, Obach RS
t_half (Half-life)	0.83 hours	Lombardo F, Berellini G, Obach RS

Approvals:

Date	Agency	Company	Orphan
Feb. 20, 2001	FDA	ASTRAZENECA PHARMS

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
Chronic kidney disease	870.21	9.36	965	240297	44433	63203327
Pemphigus	615.29	9.36	18	241244	183708	63064052
Drug ineffective	499.80	9.36	2164	239098	1042601	62205159
Glossodynia	497.48	9.36	51	241211	178825	63068935
Maternal exposure during pregnancy	438.17	9.36	145	241117	219917	63027843
Hand deformity	429.36	9.36	51	241211	159406	63088354
Systemic lupus erythematosus	427.78	9.36	131	241131	208787	63038973
Synovitis	383.02	9.36	117	241145	186801	63060959
Anti-cyclic citrullinated peptide antibody positive	379.67	9.36	14	241248	116198	63131562
Wound	361.13	9.36	88	241174	163175	63084585
Renal injury	329.32	9.36	279	240983	9160	63238600
Contraindicated product administered	308.62	9.36	226	241036	217422	63030338
Alopecia	308.19	9.36	505	240757	337031	62910729
Acute kidney injury	304.37	9.36	1875	239387	261540	62986220
Duodenal ulcer perforation	290.16	9.36	9	241253	87200	63160560
End stage renal disease	278.02	9.36	219	241043	6474	63241286
Arthropathy	275.94	9.36	291	240971	234501	63013259
Completed suicide	259.83	9.36	114	241148	145559	63102201
Pericarditis	254.31	9.36	91	241171	131488	63116272
Off label use	247.45	9.36	1527	239735	672935	62574825
Helicobacter infection	236.95	9.36	35	241227	92750	63155010
Discomfort	221.76	9.36	186	241076	167188	63080572
Drug intolerance	211.79	9.36	544	240718	308117	62939643
Folliculitis	200.78	9.36	18	241244	70299	63177461
Rheumatoid factor positive	199.74	9.36	39	241223	84367	63163393
Infusion related reaction	194.81	9.36	400	240862	245121	63002639
Treatment failure	194.64	9.36	284	240978	198759	63049001
Muscle injury	194.17	9.36	14	241248	65331	63182429
Carotid artery thrombosis	193.87	9.36	125	241137	2669	63245091
Hepatocellular injury	193.52	9.36	362	240900	27019	63220741
Neurologic neglect syndrome	191.94	9.36	123	241139	2598	63245162
Exposure during pregnancy	186.92	9.36	189	241073	155358	63092402
Joint swelling	186.72	9.36	630	240632	327036	62920724
Swelling	186.07	9.36	489	240773	274889	62972871
Hepatic enzyme increased	186.04	9.36	301	240961	202027	63045733
Cholestasis	185.83	9.36	371	240891	29063	63218697
Adjustment disorder	176.90	9.36	124	241138	3054	63244706
Sensitisation	174.38	9.36	126	241136	3260	63244500
Interstitial lung disease	165.51	9.36	565	240697	61343	63186417
Product use issue	161.91	9.36	375	240887	220145	63027615
Personality disorder	157.58	9.36	149	241113	5662	63242098
Cholecystitis chronic	154.81	9.36	194	241068	10167	63237593
Polycystic ovaries	153.59	9.36	131	241131	4340	63243420
Therapeutic product effect decreased	151.28	9.36	317	240945	192870	63054890
Toxicity to various agents	140.33	9.36	476	240786	246774	63000986
Hyponatraemia	139.45	9.36	813	240449	111087	63136673
Gastrooesophageal reflux disease	137.30	9.36	722	240540	94917	63152843
Renal failure	137.16	9.36	840	240422	116812	63130948
Ejection fraction	136.54	9.36	95	241167	2311	63245449
Tubulointerstitial nephritis	135.52	9.36	259	241003	19644	63228116
Hemiplegia	135.23	9.36	172	241090	9151	63238609
Abdominal discomfort	125.39	9.36	711	240551	320174	62927586
Product use in unapproved indication	122.39	9.36	316	240946	178764	63068996
Fatigue	121.72	9.36	2515	238747	885513	62362247
Blister	121.26	9.36	191	241071	129623	63118137
Psoriatic arthropathy	118.36	9.36	104	241158	91416	63156344
Dysphagia	117.84	9.36	655	240607	87930	63159830
Death	117.21	9.36	887	240375	373494	62874266
Coordination abnormal	115.18	9.36	196	241066	13577	63234183
Biliary dyskinesia	112.71	9.36	89	241173	2640	63245120
Rhinitis allergic	104.90	9.36	172	241090	11555	63236205
Sleep disorder due to general medical condition, insomnia type	101.03	9.36	36	241226	52181	63195579
Hypertensive nephropathy	99.72	9.36	49	241213	603	63247157
C-reactive protein abnormal	97.73	9.36	27	241235	46069	63201691
Irritable bowel syndrome	96.84	9.36	102	241160	82310	63165450
Affect lability	94.98	9.36	160	241102	10991	63236769
Motor dysfunction	93.79	9.36	156	241106	10605	63237155
Peripheral swelling	91.97	9.36	612	240650	265330	62982430
Inappropriate antidiuretic hormone secretion	88.28	9.36	187	241075	15275	63232485
Sleep apnoea syndrome	86.89	9.36	276	240986	28857	63218903
Lower respiratory tract infection	83.96	9.36	242	241020	132065	63115695
Rash maculo-papular	83.39	9.36	289	240973	31607	63216153
Agranulocytosis	82.30	9.36	246	241016	24888	63222872
Mobility decreased	81.82	9.36	215	241047	120944	63126816
Systemic lupus erythematosus rash	81.51	9.36	68	241194	2184	63245576
Ill-defined disorder	81.47	9.36	115	241147	81640	63166120
Condition aggravated	80.23	9.36	1062	240200	401155	62846605
Eosinophilia	79.56	9.36	228	241034	22528	63225232
Sensory loss	79.48	9.36	141	241121	10097	63237663
Abdominal pain upper	77.72	9.36	1158	240104	205286	63042474
Knee arthroplasty	77.10	9.36	56	241206	54150	63193610
Intentional product use issue	76.79	9.36	240	241022	127652	63120108
Toxic skin eruption	74.92	9.36	157	241105	12728	63235032
Hypersensitivity	74.72	9.36	731	240531	291954	62955806
Device expulsion	73.02	9.36	21	241241	34901	63212859
Nephrectomy	72.87	9.36	54	241208	1454	63246306
Hypomagnesaemia	70.50	9.36	255	241007	28482	63219278
Hemiparesis	68.00	9.36	219	241043	23063	63224697
Hypocalcaemia	65.16	9.36	266	240996	31447	63216313
Gastritis	64.48	9.36	297	240965	37006	63210754
Hip arthroplasty	64.22	9.36	52	241210	47594	63200166
Anxiety	64.02	9.36	1172	240090	216369	63031391
Loss of employment	63.65	9.36	59	241203	2185	63245575
Drug reaction with eosinophilia and systemic symptoms	63.45	9.36	276	240986	33560	63214200
Bronchial neoplasm	63.11	9.36	33	241229	467	63247293
Hiatus hernia	62.96	9.36	203	241059	21391	63226369
Carpal tunnel syndrome	62.80	9.36	198	241064	20619	63227141
Epigastric discomfort	62.76	9.36	101	241161	6679	63241081
Nephropathy	62.20	9.36	97	241165	6244	63241516
Pain	62.16	9.36	2247	239015	738381	62509379
Cardiospasm	61.71	9.36	54	241208	1853	63245907
Palmoplantar keratoderma	61.29	9.36	55	241207	1952	63245808
Rash	61.02	9.36	1644	239618	559227	62688533
Blood test abnormal	60.98	9.36	163	241099	15466	63232294
Hypothyroidism	59.88	9.36	320	240942	42312	63205448
Impaired healing	59.06	9.36	196	241066	102346	63145414
Pruritus genital	58.88	9.36	61	241201	2593	63245167
Renal disorder	58.83	9.36	265	240997	32709	63215051
Gastric polyps	57.77	9.36	68	241194	3337	63244423
Aphasia	57.23	9.36	263	240999	32737	63215023
Nasopharyngitis	56.78	9.36	655	240607	253602	62994158
Pleural fibrosis	56.70	9.36	68	241194	3404	63244356
Ejection fraction abnormal	56.67	9.36	50	241212	1735	63246025
Pregnancy	56.49	9.36	35	241227	36801	63210959
Live birth	56.25	9.36	14	241248	25616	63222144
Eating disorder	54.75	9.36	178	241084	18838	63228922
Acute generalised exanthematous pustulosis	54.09	9.36	126	241136	10973	63236787
Presbyacusis	53.30	9.36	60	241202	2805	63244955
Sleep disorder due to a general medical condition	52.58	9.36	132	241130	12056	63235704
Hepatic cytolysis	51.58	9.36	152	241110	15255	63232505
Gallbladder disorder	50.36	9.36	172	241090	18670	63229090
Nasal turbinate hypertrophy	50.16	9.36	33	241229	730	63247030
Sleep terror	49.64	9.36	56	241206	2624	63245136
Stomatitis	49.54	9.36	316	240946	138409	63109351
Gallbladder injury	49.51	9.36	42	241220	1381	63246379
Blood magnesium increased	48.80	9.36	59	241203	2979	63244781
Arterial occlusive disease	48.78	9.36	84	241178	5874	63241886
Diabetic nephropathy	48.72	9.36	42	241220	1412	63246348
Nephrogenic anaemia	48.52	9.36	50	241212	2112	63245648
Rebound acid hypersecretion	48.10	9.36	24	241238	306	63247454
Pleural thickening	47.97	9.36	57	241205	2826	63244934
Abortion spontaneous	47.39	9.36	66	241196	47129	63200631
Bronchial haemorrhage	47.39	9.36	29	241233	563	63247197
Therapy non-responder	47.28	9.36	140	241122	75761	63171999
Impaired work ability	47.13	9.36	160	241102	17315	63230445
Angioedema	47.02	9.36	328	240934	47637	63200123
Palpitations	46.95	9.36	644	240618	112126	63135634
Bronchial disorder	46.79	9.36	39	241223	1251	63246509
Tension headache	46.30	9.36	76	241186	5110	63242650
Premature delivery	46.12	9.36	29	241233	30252	63217508
Tenosynovitis stenosans	45.56	9.36	60	241202	3304	63244456
Angina pectoris	45.16	9.36	230	241032	29848	63217912
Infection	44.91	9.36	607	240655	228566	63019194
General physical health deterioration	43.34	9.36	523	240739	200879	63046881
Atrial tachycardia	43.18	9.36	66	241196	4174	63243586
Deafness neurosensory	43.14	9.36	71	241191	4784	63242976
Rheumatoid nodule	42.74	9.36	153	241109	17002	63230758
Musculoskeletal stiffness	42.21	9.36	473	240789	184145	63063615
Carotid artery occlusion	42.19	9.36	69	241193	4625	63243135
Pancreatitis	42.11	9.36	325	240937	48730	63199030
Nephritic syndrome	41.90	9.36	22	241240	314	63247446
Osteosclerosis	41.70	9.36	62	241200	3826	63243934
Pancreatitis acute	41.67	9.36	209	241053	26957	63220803
Drug abuse	41.48	9.36	139	241123	72379	63175381
Gastric disorder	41.12	9.36	263	240999	37106	63210654
Muscular weakness	40.93	9.36	673	240589	121680	63126080
Prescription form tampering	40.45	9.36	26	241236	552	63247208
Fall	39.33	9.36	1845	239417	390489	62857271
Prescribed overdose	39.30	9.36	43	241219	34110	63213650
Immunisation	39.04	9.36	34	241228	1159	63246601
Dysarthria	38.36	9.36	286	240976	42425	63205335
Cross sensitivity reaction	38.06	9.36	44	241218	2118	63245642
Phlebitis	38.01	9.36	81	241181	6643	63241117
Liver injury	37.43	9.36	112	241150	60408	63187352
Cholecystitis	37.33	9.36	136	241126	15241	63232519
Transient ischaemic attack	36.91	9.36	258	241004	37495	63210265
Endometrial ablation	36.75	9.36	30	241232	934	63246826
Anaemia	36.38	9.36	1411	239851	292019	62955741
Drug resistance	36.27	9.36	21	241241	22912	63224848
Respiratory tract congestion	36.18	9.36	149	241113	17683	63230077
Abdominal pain	36.12	9.36	1410	239852	292046	62955714
Therapy interrupted	36.10	9.36	42	241220	32413	63215347
Cholelithiasis	36.04	9.36	288	240974	43637	63204123
Iron deficiency anaemia	36.00	9.36	161	241101	19808	63227952
Intentional overdose	35.38	9.36	153	241109	73999	63173761
Gamma-glutamyltransferase increased	35.31	9.36	236	241026	33795	63213965
Axonal neuropathy	35.22	9.36	30	241232	992	63246768
Red blood cell sedimentation rate abnormal	34.43	9.36	16	241246	19766	63227994
Dry eye	34.40	9.36	269	240993	40492	63207268
Injection site erythema	34.21	9.36	181	241081	82993	63164767
Electric shock	34.19	9.36	33	241229	1287	63246473
Adverse drug reaction	34.18	9.36	171	241091	79543	63168217
Type 2 diabetes mellitus	34.13	9.36	126	241136	63742	63184018
Post cholecystectomy syndrome	33.86	9.36	21	241241	418	63247342
Anal abscess	33.67	9.36	62	241200	4570	63243190
Hypokalaemia	33.62	9.36	568	240694	103236	63144524
Drug hypersensitivity	33.60	9.36	911	240351	309776	62937984
Drug interaction	33.59	9.36	1123	240139	228008	63019752
Rhabdomyolysis	32.76	9.36	282	240980	43669	63204091
Ulcer	32.69	9.36	190	241072	25917	63221843
Sinus congestion	32.59	9.36	146	241116	17977	63229783
Crepitations	32.53	9.36	85	241177	7955	63239805
Dermatitis bullous	32.45	9.36	88	241174	8420	63239340
Macular degeneration	32.35	9.36	27	241235	24349	63223411
Asthma	32.32	9.36	672	240590	126889	63120871
Pancreatic neuroendocrine tumour	31.69	9.36	20	241242	411	63247349
Muscle spasticity	31.57	9.36	165	241097	21629	63226131
Bone erosion	31.35	9.36	14	241248	17703	63230057
Synovial fluid analysis	30.82	9.36	42	241220	2391	63245369
Dehydration	30.55	9.36	869	240393	172485	63075275
Occupational asthma	30.52	9.36	14	241248	146	63247614
Urate nephropathy	30.30	9.36	13	241249	114	63247646
Chest pain	30.03	9.36	1052	240210	214907	63032853
Burning sensation	29.69	9.36	327	240935	54080	63193680
Malnutrition	29.61	9.36	126	241136	15172	63232588
Vascular purpura	29.30	9.36	32	241230	1446	63246314
Gastric antral vascular ectasia	29.29	9.36	22	241240	605	63247155
No adverse event	29.07	9.36	72	241190	41333	63206427
Cardiac disorder	28.93	9.36	308	240954	50508	63197252
Bone cyst	28.69	9.36	39	241223	2215	63245545
Cell death	28.65	9.36	42	241220	2559	63245201
Asthenia	28.63	9.36	1755	239507	381849	62865911
Cholestatic liver injury	28.54	9.36	42	241220	2568	63245192
Anosmia	28.24	9.36	73	241189	6787	63240973
Diplopia	27.98	9.36	170	241092	23558	63224202
Accidental exposure to product	27.84	9.36	38	241224	27367	63220393
Caesarean section	27.80	9.36	15	241247	17017	63230743
Rheumatoid arthritis	27.49	9.36	744	240518	253075	62994685
Kidney infection	27.30	9.36	166	241096	23010	63224750
Gangrene	27.13	9.36	67	241195	6056	63241704
Erythema dyschromicum perstans	27.11	9.36	10	241252	56	63247704
Myelosuppression	27.10	9.36	30	241232	23673	63224087
Disease progression	27.07	9.36	317	240945	122441	63125319
Scleritis	26.97	9.36	55	241207	4373	63243387
Muscle contractions involuntary	26.89	9.36	39	241223	2353	63245407
Contusion	26.70	9.36	405	240857	149639	63098121
Eosinophilic fasciitis	26.31	9.36	13	241249	162	63247598
Obesity	26.15	9.36	46	241216	29906	63217854
Lung disorder	26.08	9.36	356	240906	61905	63185855
Blood cholesterol increased	26.03	9.36	230	241032	93802	63153958
Face oedema	25.89	9.36	148	241114	20064	63227696
Nerve injury	25.89	9.36	90	241172	9856	63237904
Angina bullosa haemorrhagica	25.60	9.36	12	241250	132	63247628
Renal impairment	25.59	9.36	475	240787	87880	63159880
Nasal discharge discolouration	25.49	9.36	37	241225	2234	63245526
Autoimmune disorder	25.41	9.36	17	241245	17160	63230600
Subacute cutaneous lupus erythematosus	25.32	9.36	40	241222	2603	63245157
Cutaneous lupus erythematosus	24.56	9.36	40	241222	2672	63245088
Foetal exposure during pregnancy	24.52	9.36	53	241209	31909	63215851
Diverticulum	24.17	9.36	100	241162	11891	63235869
Adverse event	24.05	9.36	154	241108	67405	63180355
Drug eruption	24.01	9.36	189	241073	28505	63219255
Multi-organ disorder	23.69	9.36	29	241233	1483	63246277
Neutropenic sepsis	23.35	9.36	17	241245	16421	63231339
Nephritis allergic	23.34	9.36	13	241249	210	63247550
Oesophageal dilatation	23.15	9.36	16	241246	385	63247375
Liver function test increased	23.08	9.36	57	241205	32754	63215006
Hunger	22.93	9.36	58	241204	5321	63242439
Eczema	22.93	9.36	205	241057	32086	63215674
Gallbladder polyp	22.92	9.36	21	241241	766	63246994
Blood alkaline phosphatase increased	22.88	9.36	257	241005	42710	63205050
Haemoglobin decreased	22.84	9.36	719	240543	144766	63102994
Ventricular tachycardia	22.84	9.36	142	241120	19837	63227923
Arthralgia	22.76	9.36	1860	239402	567850	62679910
Poisoning	22.45	9.36	12	241250	13688	63234072
Muscle haemorrhage	22.42	9.36	42	241220	3137	63244623
Nausea	22.39	9.36	3633	237629	850838	62396922
Neurotoxicity	22.33	9.36	19	241243	16971	63230789
Supraventricular extrasystoles	22.25	9.36	52	241210	4537	63243223
Aspartate aminotransferase	21.91	9.36	16	241246	421	63247339
Bunion operation	21.77	9.36	26	241236	1296	63246464
Hepatic steatosis	21.65	9.36	185	241077	28584	63219176
Grip strength decreased	21.55	9.36	32	241230	22255	63225505
Hypergastrinaemia	21.50	9.36	10	241252	108	63247652
Schizophreniform disorder	21.48	9.36	9	241253	74	63247686
Cerebrovascular accident	21.44	9.36	550	240712	107474	63140286
Vitamin B12 deficiency	21.39	9.36	56	241206	5247	63242513
Mesenteric panniculitis	21.34	9.36	10	241252	110	63247650
Hallucination	21.18	9.36	309	240953	54508	63193252
Hypocapnia	21.17	9.36	15	241247	376	63247384
Blindness	21.04	9.36	148	241114	21551	63226209
Synovial cyst	21.03	9.36	87	241175	10346	63237414
Rhinalgia	20.86	9.36	28	241234	1571	63246189
Haematotoxicity	20.81	9.36	5	241257	9371	63238389
Intervertebral discitis	20.74	9.36	41	241221	3187	63244573
Febrile bone marrow aplasia	20.58	9.36	68	241194	7257	63240503
Dermatitis exfoliative generalised	20.54	9.36	45	241217	3762	63243998
Dislocation of vertebra	20.40	9.36	4	241258	8631	63239129
Medication error	20.28	9.36	116	241146	52168	63195592
Tooth infection	20.26	9.36	127	241135	17793	63229967
Vertigo	20.23	9.36	330	240932	59557	63188203
Eyelid oedema	20.04	9.36	86	241176	10393	63237367
Cholecystitis acute	20.01	9.36	73	241189	8187	63239573
Gallbladder hypofunction	19.99	9.36	17	241245	561	63247199
Product dose omission issue	19.95	9.36	709	240553	233604	63014156
Subarachnoid haemorrhage	19.91	9.36	107	241155	14176	63233584
Sedation	19.80	9.36	78	241184	38731	63209029
Lip oedema	19.62	9.36	45	241217	3879	63243881
Flatulence	19.59	9.36	210	241052	34492	63213268
Gastrointestinal motility disorder	19.58	9.36	53	241209	5066	63242694
Therapy partial responder	19.53	9.36	8	241254	10650	63237110
Nephrosclerosis	19.48	9.36	22	241240	1032	63246728
Bile duct stone	19.48	9.36	43	241219	3613	63244147
Facet joint syndrome	19.36	9.36	11	241251	12127	63235633
Vasculitis	19.32	9.36	127	241135	18082	63229678
Injection site pain	19.29	9.36	362	240900	129438	63118322
Cerebral haematoma	19.26	9.36	43	241219	3640	63244120
Granulocyte count increased	18.97	9.36	20	241242	868	63246892
Vulvovaginal burning sensation	18.95	9.36	31	241231	2078	63245682
International normalised ratio increased	18.85	9.36	264	240998	46161	63201599
Rash papular	18.83	9.36	113	241149	15589	63232171
Breast cancer stage II	18.73	9.36	5	241257	8731	63239029
Photophobia	18.72	9.36	123	241139	17512	63230248
Immunodeficiency	18.71	9.36	30	241232	20224	63227536
Dry mouth	18.68	9.36	407	240855	77456	63170304
X-ray abnormal	18.65	9.36	4	241258	8106	63239654
Rectosigmoid cancer	18.61	9.36	10	241252	150	63247610
Cyst	18.56	9.36	104	241158	13995	63233765
Weight increased	18.53	9.36	806	240456	259986	62987774
Gastrointestinal haemorrhage	18.43	9.36	421	240841	80755	63167005
Haematoma	18.41	9.36	208	241054	34612	63213148
Illness	18.41	9.36	110	241152	48949	63198811
Small cell carcinoma	18.26	9.36	10	241252	156	63247604
Injection site swelling	18.20	9.36	106	241156	47466	63200294
Sciatica	18.15	9.36	68	241194	34256	63213504
Mixed liver injury	18.09	9.36	49	241213	4686	63243074
Ingrowing nail	18.08	9.36	33	241229	2416	63245344
Acute hepatitis B	18.00	9.36	13	241249	336	63247424
Breath sounds abnormal	17.96	9.36	86	241176	10887	63236873
Pleuritic pain	17.82	9.36	69	241193	7960	63239800
Congenital osteodystrophy	17.70	9.36	6	241256	25	63247735
Pneumobilia	17.62	9.36	9	241253	121	63247639
Fear of injection	17.61	9.36	3	241259	7161	63240599
Allergy to chemicals	17.61	9.36	37	241225	3005	63244755
Blood immunoglobulin A increased	17.47	9.36	18	241244	760	63247000
Normal newborn	17.46	9.36	5	241257	8336	63239424
Salpingo-oophorectomy unilateral	17.34	9.36	19	241243	862	63246898
Throat irritation	17.32	9.36	219	241043	37428	63210332
Adenocarcinoma gastric	17.13	9.36	15	241247	515	63247245
Dysphonia	17.07	9.36	265	240997	47349	63200411
Glomerular filtration rate increased	17.04	9.36	19	241243	879	63246881
Cholecystectomy	16.98	9.36	83	241179	10594	63237166
Jaundice	16.98	9.36	178	241084	29073	63218687
Bradypnoea	16.97	9.36	40	241222	3510	63244250
Crohn's disease	16.95	9.36	49	241213	4864	63242896
Rhonchi	16.89	9.36	33	241229	2543	63245217
Hepatitis cholestatic	16.84	9.36	61	241201	6817	63240943
Anaemia macrocytic	16.60	9.36	39	241223	3415	63244345
IIIrd nerve paresis	16.58	9.36	9	241253	138	63247622
Arterial spasm	16.55	9.36	7	241255	59	63247701
Genital infection female	16.46	9.36	8	241254	96	63247664
Haemorrhoids	16.44	9.36	142	241120	22008	63225752
Rhinitis	16.42	9.36	86	241176	11280	63236480
Melaena	16.34	9.36	182	241080	30183	63217577
Injection site bruising	16.24	9.36	93	241169	41817	63205943
Muscle swelling	16.21	9.36	14	241248	472	63247288
Creatinine renal clearance decreased	16.18	9.36	23	241239	16285	63231475
Hepatotoxicity	16.14	9.36	79	241183	36962	63210798
Tetany	16.10	9.36	28	241234	1973	63245787
Herpes simplex test positive	16.05	9.36	11	241251	261	63247499
Myocardial infarction	16.02	9.36	495	240767	99398	63148362
Hepatitis B DNA increased	16.01	9.36	11	241251	262	63247498
Non-economic loss	16.01	9.36	5	241257	15	63247745
Device dependence	16.01	9.36	5	241257	15	63247745
Deformity	15.93	9.36	87	241175	11597	63236163
Angina unstable	15.77	9.36	61	241201	7034	63240726
Livedo reticularis	15.76	9.36	31	241231	2401	63245359
Pathological fracture	15.76	9.36	71	241191	8763	63238997
Oesophagitis ulcerative	15.73	9.36	15	241247	576	63247184
Escherichia pyelonephritis	15.68	9.36	13	241249	414	63247346
Chondrocalcinosis pyrophosphate	15.66	9.36	21	241241	1177	63246583
Hyperhidrosis	15.64	9.36	528	240734	107308	63140452
Renal cyst	15.62	9.36	79	241183	10223	63237537
Skin lesion	15.57	9.36	182	241080	30539	63217221
Tinnitus	15.45	9.36	205	241057	35423	63212337
Gastrointestinal disorder	15.44	9.36	380	240882	130859	63116901
Facial pain	15.32	9.36	80	241182	10481	63237279
Pancreatitis chronic	15.30	9.36	31	241231	2453	63245307
Disability	15.29	9.36	29	241233	18318	63229442
Diarrhoea	15.28	9.36	3010	238252	712356	62535404
Anaemia folate deficiency	15.25	9.36	10	241252	220	63247540
Blood chromogranin A increased	15.24	9.36	11	241251	284	63247476
Peripheral venous disease	15.18	9.36	22	241240	15455	63232305
Hyperparathyroidism secondary	15.17	9.36	23	241239	1444	63246316
Lip dry	15.17	9.36	22	241240	15448	63232312
Hyperchlorhydria	15.10	9.36	26	241236	1818	63245942
Blood creatine phosphokinase decreased	15.09	9.36	14	241248	519	63247241
Neutropenia	15.01	9.36	529	240733	174476	63073284
Purpura	15.00	9.36	84	241178	11301	63236459
Complication of device insertion	15	9.36	5	241257	7559	63240201
Injection site pruritus	14.97	9.36	105	241157	45011	63202749
Pre-eclampsia	14.97	9.36	8	241254	9125	63238635
Gait inability	14.89	9.36	129	241133	52830	63194930
Pulmonary embolism	14.88	9.36	563	240699	116121	63131639
Renal tubular disorder	14.81	9.36	32	241230	2650	63245110
Osteopenia	14.77	9.36	127	241135	19658	63228102
Dermatitis exfoliative	14.73	9.36	50	241212	5409	63242351
Deja vu	14.70	9.36	7	241255	80	63247680
Oesophageal polyp	14.66	9.36	4	241258	6	63247754
Renal tubular necrosis	14.58	9.36	86	241176	11792	63235968
Atelectasis	14.55	9.36	135	241127	21348	63226412
Sinus disorder	14.53	9.36	150	241112	24403	63223357
Purging	14.46	9.36	6	241256	48	63247712
Retinal artery occlusion	14.45	9.36	24	241238	1629	63246131
Cerebellar haematoma	14.45	9.36	12	241250	383	63247377
Emotional distress	14.41	9.36	188	241074	32361	63215399
Chest discomfort	14.36	9.36	532	240730	109437	63138323
Proteinuria	14.35	9.36	123	241139	19022	63228738
Oesophagitis	14.34	9.36	102	241160	14906	63232854
Keratoacanthoma	14.29	9.36	13	241249	470	63247290
Vitamin D deficiency	14.20	9.36	96	241166	13796	63233964
Device dislocation	14.20	9.36	50	241212	25655	63222105
Dysgeusia	14.18	9.36	253	241009	46457	63201303
Body temperature increased	14.16	9.36	83	241179	37109	63210651
Cough	14.14	9.36	1294	239968	291449	62956311
Premature labour	14.10	9.36	16	241246	12488	63235272
Antinuclear antibody positive	14.05	9.36	64	241198	7935	63239825
Uveal melanoma	13.94	9.36	4	241258	8	63247752
Blood potassium increased	13.92	9.36	118	241144	18191	63229569
Finger deformity	13.89	9.36	6	241256	7739	63240021
Neurosis	13.86	9.36	10	241252	258	63247502
Early satiety	13.85	9.36	18	241244	978	63246782
Calcium metabolism disorder	13.80	9.36	8	241254	140	63247620
Dialysis	13.78	9.36	77	241185	10350	63237410
Meningitis aseptic	13.75	9.36	45	241217	4778	63242982
Gastrointestinal tract mucosal pigmentation	13.65	9.36	14	241248	588	63247172
Musculoskeletal disorder	13.65	9.36	37	241225	20607	63227153
Deep vein thrombosis	13.64	9.36	416	240846	83384	63164376
Sneezing	13.63	9.36	117	241145	18101	63229659
Chronic kidney disease-mineral and bone disorder	13.58	9.36	7	241255	96	63247664
Genotype drug resistance test positive	13.49	9.36	12	241250	421	63247339
Maternal exposure before pregnancy	13.46	9.36	6	241256	7597	63240163
Lower limb fracture	13.46	9.36	47	241215	24174	63223586
Erosive oesophagitis	13.45	9.36	24	241238	1726	63246034
Female sterilisation	13.40	9.36	14	241248	601	63247159
Gastric ulcer	13.36	9.36	145	241117	23892	63223868
Hepatitis	13.34	9.36	219	241043	39569	63208191
Hypoplastic anaemia	13.33	9.36	4	241258	10	63247750
Tenosynovitis	13.32	9.36	94	241168	13701	63234059
Hyponatraemic seizure	13.25	9.36	12	241250	431	63247329
Erythema	13.24	9.36	805	240457	174946	63072814
Post-traumatic stress disorder	13.22	9.36	47	241215	5204	63242556
Hyperkalaemia	13.21	9.36	284	240978	53919	63193841
Antipsychotic drug level above therapeutic	13.20	9.36	18	241244	1025	63246735
Sputum increased	13.19	9.36	29	241233	2430	63245330
Teeth brittle	13.15	9.36	13	241249	522	63247238
Brucellosis	13.13	9.36	6	241256	62	63247698
Intestinal infarction	13.11	9.36	18	241244	1032	63246728
Prothrombin time ratio decreased	13.09	9.36	13	241249	525	63247235
Musculoskeletal chest pain	13.05	9.36	130	241132	20953	63226807
Hypofibrinogenaemia	13.04	9.36	19	241243	1151	63246609
Protein-losing gastroenteropathy	13.04	9.36	9	241253	216	63247544
Campylobacter colitis	13.00	9.36	5	241257	32	63247728
Bladder sphincter atony	13.00	9.36	8	241254	157	63247603
Skin haemorrhage	12.99	9.36	74	241188	10020	63237740
Pyelonephritis acute	12.96	9.36	43	241219	4598	63243162
Blood loss anaemia	12.93	9.36	68	241194	8933	63238827
Breast cancer stage I	12.90	9.36	5	241257	6884	63240876
Glossitis	12.90	9.36	33	241229	3049	63244711
Clinically isolated syndrome	12.87	9.36	5	241257	33	63247727
Thymus disorder	12.83	9.36	10	241252	291	63247469
Abortion induced	12.80	9.36	12	241250	10230	63237530
Congenital bowing of long bones	12.80	9.36	6	241256	66	63247694
Coeliac disease	12.74	9.36	18	241244	12779	63234981
Therapy cessation	12.67	9.36	66	241196	30391	63217369
Thrombocytopenia	12.66	9.36	699	240563	150458	63097302
Renal haemangioma	12.62	9.36	5	241257	35	63247725
Aspartate aminotransferase increased	12.58	9.36	440	240822	89837	63157923
Pulmonary congestion	12.58	9.36	111	241151	17307	63230453
Laboratory test abnormal	12.55	9.36	56	241206	26856	63220904
Joint range of motion decreased	12.54	9.36	72	241190	32356	63215404
Malabsorption	12.53	9.36	39	241223	4033	63243727
Rheumatoid factor increased	12.51	9.36	24	241238	1825	63245935
Lordosis	12.48	9.36	10	241252	303	63247457
Sudden death	12.41	9.36	75	241187	10374	63237386
Unintended pregnancy	12.40	9.36	4	241258	6175	63241585
Tongue oedema	12.37	9.36	42	241220	4544	63243216
Hyperthermia	12.36	9.36	68	241194	9088	63238672
Exposure to toxic agent	12.36	9.36	3	241259	5584	63242176
Rash scarlatiniform	12.36	9.36	7	241255	117	63247643
Hyperphosphatasaemia	12.34	9.36	4	241258	14	63247746
Atrioventricular block complete	12.32	9.36	63	241199	8188	63239572
Hepatic function abnormal	12.29	9.36	204	241058	36938	63210822
Renal atrophy	12.27	9.36	21	241241	1461	63246299
Monoclonal gammopathy	12.26	9.36	14	241248	665	63247095
Small intestinal stenosis	12.26	9.36	13	241249	568	63247192
Unintentional medical device removal	12.20	9.36	4	241258	6111	63241649
Colitis ischaemic	12.17	9.36	76	241186	10632	63237128
Vitreous detachment	12.14	9.36	25	241237	2002	63245758
Cushingoid	12.12	9.36	64	241198	8421	63239339
Paranasal sinus inflammation	12.12	9.36	12	241250	483	63247277
Febrile neutropenia	12.09	9.36	350	240912	118099	63129661
Erythema multiforme	12.08	9.36	73	241189	10096	63237664
Aeromonas infection	12.06	9.36	6	241256	76	63247684
Seizure	12.05	9.36	398	240864	132236	63115524
Rectal cancer metastatic	12.00	9.36	9	241253	247	63247513
Poor personal hygiene	11.96	9.36	10	241252	322	63247438
Transplant rejection	11.94	9.36	14	241248	10766	63236994
Low turnover osteopathy	11.89	9.36	39	241223	4146	63243614
Gastrointestinal ischaemia	11.89	9.36	8	241254	184	63247576
Hypoosmolar state	11.89	9.36	8	241254	184	63247576
Crystal arthropathy	11.86	9.36	10	241252	326	63247434
Anaemia vitamin B12 deficiency	11.85	9.36	11	241251	408	63247352
Essential hypertension	11.79	9.36	44	241218	4989	63242771
Device difficult to use	11.77	9.36	19	241243	12777	63234983
Lipase increased	11.72	9.36	71	241191	9829	63237931
Sinus bradycardia	11.71	9.36	95	241167	14456	63233304
Hyperlipasaemia	11.70	9.36	14	241248	699	63247061
Rectal haemorrhage	11.67	9.36	256	241006	48774	63198986
Gastric adenoma	11.66	9.36	3	241259	3	63247757
Platelet adhesiveness decreased	11.66	9.36	3	241259	3	63247757
Disturbance in attention	11.65	9.36	207	241055	37982	63209778
Stent placement	11.59	9.36	36	241226	3719	63244041
Infusion site scar	11.55	9.36	12	241250	512	63247248
Infusion site thrombosis	11.53	9.36	7	241255	134	63247626
Lactic acidosis	11.49	9.36	207	241055	38080	63209680
Swollen tongue	11.47	9.36	191	241071	34609	63213151
Sinusitis fungal	11.46	9.36	23	241239	1808	63245952
Polyglandular autoimmune syndrome type II	11.45	9.36	5	241257	46	63247714
Vitamin B12 decreased	11.44	9.36	35	241227	3585	63244175
Faeces discoloured	11.39	9.36	114	241148	18395	63229365
Concussion	11.39	9.36	67	241195	9177	63238583
Gastrointestinal tract mucosal discolouration	11.38	9.36	4	241258	19	63247741
Foetal death	11.38	9.36	15	241247	10965	63236795
Burns second degree	11.38	9.36	24	241238	1954	63245806
Hypoparathyroidism secondary	11.35	9.36	5	241257	47	63247713
Eructation	11.33	9.36	62	241200	8271	63239489
Therapeutic response decreased	11.30	9.36	165	241097	61360	63186400
Tongue pruritus	11.28	9.36	12	241250	526	63247234
Dilatation atrial	11.27	9.36	24	241238	1967	63245793
Coronary artery occlusion	11.17	9.36	61	241201	8130	63239630
Night sweats	11.16	9.36	125	241137	48689	63199071
Purple glove syndrome	11.14	9.36	8	241254	205	63247555
Enterocolitis haemorrhagic	11.14	9.36	20	241242	1446	63246314
Epiglottic oedema	11.11	9.36	6	241256	91	63247669
Diverticulum oesophageal	11.08	9.36	7	241255	144	63247616
Eye irritation	11.06	9.36	130	241132	21841	63225919
Acute coronary syndrome	10.97	9.36	71	241191	10055	63237705
Vulval disorder	10.96	9.36	15	241247	857	63246903
Eye pain	10.86	9.36	185	241077	33669	63214091
Vulvovaginal pruritus	10.86	9.36	32	241230	3211	63244549
COVID-19	10.85	9.36	337	240925	112766	63134994
Purpura senile	10.83	9.36	12	241250	551	63247209
Wrong technique in product usage process	10.83	9.36	169	241093	62171	63185589
Renal hypertrophy	10.83	9.36	5	241257	53	63247707
Granuloma	10.80	9.36	47	241215	5714	63242046
Chronic cutaneous lupus erythematosus	10.80	9.36	10	241252	370	63247390
Type I hypersensitivity	10.79	9.36	30	241232	2912	63244848
Blood thyroid stimulating hormone increased	10.79	9.36	55	241207	7139	63240621
Eyelid haematoma	10.76	9.36	4	241258	23	63247737
Renal hypertension	10.75	9.36	7	241255	152	63247608
Gastric ulcer haemorrhage	10.75	9.36	42	241220	4866	63242894
Acute cutaneous lupus erythematosus	10.74	9.36	9	241253	291	63247469
Dyslipidaemia	10.72	9.36	56	241206	7337	63240423
Muscle enzyme increased	10.71	9.36	7	241255	153	63247607
Dermatosis	10.71	9.36	9	241253	292	63247468
Vitamin B12 increased	10.71	9.36	17	241245	1111	63246649
Affective disorder	10.67	9.36	49	241213	6097	63241663
Nikolsky's sign	10.66	9.36	6	241256	99	63247661
Iron deficiency	10.65	9.36	55	241207	7175	63240585
Hypoparathyroidism	10.62	9.36	13	241249	665	63247095
Placental calcification	10.61	9.36	4	241258	24	63247736
Therapeutic response shortened	10.61	9.36	18	241244	11870	63235890
Gingival pain	10.61	9.36	60	241202	8102	63239658
Oedema peripheral	10.60	9.36	847	240415	188664	63059096
Thrombocytopenic purpura	10.60	9.36	19	241243	1372	63246388
Tooth disorder	10.59	9.36	158	241104	27999	63219761
Blood magnesium decreased	10.53	9.36	86	241176	13112	63234648
Tachycardia paroxysmal	10.53	9.36	9	241253	299	63247461
Dystonia	10.53	9.36	23	241239	13796	63233964
Bronchopneumopathy	10.50	9.36	8	241254	225	63247535
Resorption bone increased	10.48	9.36	18	241244	1256	63246504
Cardiothoracic ratio increased	10.48	9.36	4	241258	25	63247735
Red blood cell target cells present	10.46	9.36	3	241259	6	63247754
Malignant neoplasm progression	10.43	9.36	235	241027	81886	63165874
Carnitine deficiency	10.40	9.36	7	241255	161	63247599
Septic shock	10.37	9.36	329	240933	66300	63181460
Catarrh	10.35	9.36	20	241242	1529	63246231
Blood gastrin increased	10.35	9.36	4	241258	26	63247734
Dysuria	10.33	9.36	183	241079	33555	63214205
Hepatobiliary scan abnormal	10.29	9.36	5	241257	60	63247700
Oedema mouth	10.27	9.36	26	241236	2387	63245373
Pulmonary arterial hypertension	10.24	9.36	131	241131	22446	63225314
Portal vein dilatation	10.22	9.36	4	241258	27	63247733
Blepharospasm	10.20	9.36	5	241257	5991	63241769
Cholangitis	10.15	9.36	45	241217	5516	63242244
Tri-iodothyronine free decreased	10.13	9.36	9	241253	315	63247445
Neoplasm progression	10.12	9.36	89	241173	36339	63211421
Bronchitis	10.12	9.36	576	240686	124359	63123401
Spinal osteoarthritis	10.11	9.36	100	241162	16086	63231674
Regurgitation	10.10	9.36	21	241241	1693	63246067
Neuroleptic malignant syndrome	10.09	9.36	19	241243	12037	63235723
Flank pain	10.07	9.36	101	241161	16309	63231451
Incorrect route of product administration	10.06	9.36	62	241200	27390	63220370
Renal infarct	10.06	9.36	19	241243	1428	63246332
Multiple sclerosis	10.06	9.36	139	241123	24233	63223527
Fracture nonunion	10.05	9.36	25	241237	2270	63245490
Actinic keratosis	10.00	9.36	27	241235	2577	63245183
Acute sinusitis	9.97	9.36	35	241227	3852	63243908
Vagus nerve disorder	9.97	9.36	6	241256	113	63247647
Language disorder	9.96	9.36	24	241238	2136	63245624
Atrophy	9.95	9.36	21	241241	1711	63246049
Renal lymphocele	9.93	9.36	5	241257	65	63247695
Alanine aminotransferase increased	9.93	9.36	486	240776	103284	63144476
Coma acidotic	9.92	9.36	6	241256	114	63247646
Vulvovaginal inflammation	9.90	9.36	14	241248	825	63246935
Mandibular mass	9.89	9.36	7	241255	175	63247585
Arterial fibrosis	9.86	9.36	3	241259	8	63247752
Heat stroke	9.79	9.36	14	241248	834	63246926
Extremity necrosis	9.78	9.36	20	241242	1593	63246167
Product storage error	9.74	9.36	27	241235	14929	63232831
Cardiac failure	9.72	9.36	423	240839	88719	63159041
Device malfunction	9.69	9.36	35	241227	17822	63229938
Localised infection	9.69	9.36	71	241191	30139	63217621
Fungal oesophagitis	9.66	9.36	13	241249	731	63247029
Gastric haemorrhage	9.65	9.36	49	241213	6349	63241411
Biliary colic	9.65	9.36	33	241229	3584	63244176
Atypical fracture	9.65	9.36	12	241250	624	63247136
Haemorrhage foetal	9.61	9.36	3	241259	9	63247751
Carotid artery stenosis	9.56	9.36	42	241220	5128	63242632
Lumbar spinal stenosis	9.55	9.36	40	241222	4782	63242978
Dental restoration failure	9.54	9.36	15	241247	972	63246788
Vascular encephalopathy	9.54	9.36	10	241252	431	63247329
Oesophageal irritation	9.52	9.36	6	241256	123	63247637
Renal tuberculosis	9.43	9.36	4	241258	34	63247726
Liver abscess	9.40	9.36	28	241234	2826	63244934
Complication associated with device	9.40	9.36	33	241229	16945	63230815
Peripheral artery thrombosis	9.38	9.36	22	241240	1924	63245836

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
Chronic kidney disease	529.14	10.19	738	140340	40472	34775381
Toxicity to various agents	247.92	10.19	266	140812	200096	34615757
Drug ineffective	231.85	10.19	1004	140074	455747	34360106
Death	222.60	10.19	842	140236	397207	34418646
Drug abuse	211.84	10.19	68	141010	99028	34716825
End stage renal disease	192.33	10.19	207	140871	8654	34807199
Completed suicide	171.65	10.19	91	140987	98077	34717776
Acute kidney injury	168.47	10.19	1925	139153	303063	34512790
Off label use	154.27	10.19	1027	140051	418497	34397356
Cholestasis	145.23	10.19	330	140748	26618	34789235
Hepatocellular injury	137.93	10.19	288	140790	21923	34793930
Interstitial lung disease	137.57	10.19	575	140503	64707	34751146
Toxic skin eruption	134.35	10.19	196	140882	11189	34804664
Renal injury	132.50	10.19	193	140885	11002	34804851
Hypomagnesaemia	98.78	10.19	250	140828	21601	34794252
Cardiospasm	92.01	10.19	65	141013	1523	34814330
Eosinophilia	91.64	10.19	273	140805	25949	34789904
Treatment failure	80.53	10.19	44	141034	46653	34769200
Palmoplantar keratoderma	80.03	10.19	65	141013	1888	34813965
Agranulocytosis	79.48	10.19	244	140834	23577	34792276
Hypocalcaemia	74.80	10.19	242	140836	24047	34791806
Tension headache	71.22	10.19	74	141004	2968	34812885
Pruritus genital	71.20	10.19	64	141014	2140	34813713
Product use in unapproved indication	70.96	10.19	240	140838	117259	34698594
Nephrogenic anaemia	67.12	10.19	62	141016	2149	34813704
Tubulointerstitial nephritis	67.04	10.19	212	140866	20812	34795041
Sleep terror	66.52	10.19	63	141015	2255	34813598
Immunisation	64.53	10.19	45	141033	1032	34814821
Anosmia	63.82	10.19	80	140998	3944	34811909
Renal failure	63.79	10.19	806	140272	129751	34686102
Hepatic cytolysis	62.56	10.19	163	140915	14333	34801520
Atrial tachycardia	58.66	10.19	73	141005	3572	34812281
Occult blood	58.50	10.19	39	141039	829	34815024
Facial pain	56.15	10.19	72	141006	3632	34812221
Carotid artery occlusion	55.64	10.19	72	141006	3665	34812188
Hepatojugular reflux	55.57	10.19	33	141045	568	34815285
Pericarditis	54.48	10.19	135	140943	11510	34804343
Pancreatitis acute	50.24	10.19	236	140842	27905	34787948
Drug resistance	49.94	10.19	21	141057	25906	34789947
Foetal exposure during pregnancy	49.92	10.19	48	141030	38053	34777800
Hypertensive nephropathy	48.14	10.19	28	141050	463	34815390
Electrocardiogram Q wave abnormal	47.75	10.19	27	141051	422	34815431
Product dose omission issue	46.27	10.19	288	140790	119423	34696430
Gamma-glutamyltransferase increased	43.60	10.19	233	140845	28998	34786855
Systolic dysfunction	43.21	10.19	54	141024	2654	34813199
Drug reaction with eosinophilia and systemic symptoms	43.18	10.19	254	140824	32758	34783095
Ventricular hypokinesia	42.97	10.19	79	140999	5473	34810380
Hypergastrinaemia	42.90	10.19	15	141063	65	34815788
Jaundice	42.80	10.19	247	140831	31635	34784218
Degenerative mitral valve disease	41.36	10.19	21	141057	261	34815592
Hyperkalaemia	39.85	10.19	442	140636	68947	34746906
Disease progression	39.73	10.19	264	140814	107813	34708040
Migraine	39.18	10.19	157	140921	17321	34798532
Drug ineffective for unapproved indication	38.53	10.19	24	141054	23691	34792162
Nipple swelling	38.43	10.19	21	141057	306	34815547
Gastric polyps	38.43	10.19	35	141043	1191	34814662
Colitis microscopic	37.92	10.19	47	141031	2290	34813563
Nicotine dependence	37.44	10.19	26	141052	592	34815261
Therapy non-responder	37.10	10.19	63	141015	39083	34776770
Drug intolerance	37.08	10.19	120	140958	59450	34756403
Pulmonary vascular disorder	36.98	10.19	27	141051	667	34815186
Nephropathy	35.88	10.19	76	141002	5841	34810012
Rash maculo-papular	34.72	10.19	215	140863	28236	34787617
Lung disorder	34.40	10.19	249	140829	34447	34781406
Diabetic nephropathy	33.26	10.19	42	141036	2086	34813767
Chest pain	33.12	10.19	706	140372	126056	34689797
Pain of skin	33.10	10.19	75	141003	6034	34809819
Hepatitis cholestatic	32.91	10.19	88	140990	7859	34807994
Cholestatic liver injury	32.81	10.19	44	141034	2320	34813533
Tinnitus	32.52	10.19	164	140914	19954	34795899
Therapeutic product effect incomplete	32.02	10.19	101	140977	50440	34765413
Chronic kidney disease-mineral and bone disorder	31.91	10.19	20	141058	381	34815472
Physical deconditioning	31.71	10.19	33	141045	1326	34814527
Gastrooesophageal reflux disease	31.40	10.19	261	140817	37663	34778190
Drug hypersensitivity	30.96	10.19	194	140884	80335	34735518
Thrombocytopenia	30.47	10.19	836	140242	155411	34660442
Hypokalaemia	30.37	10.19	364	140714	57850	34758003
Hiatus hernia	30.00	10.19	83	140995	7562	34808291
Cell death	29.89	10.19	42	141036	2315	34813538
Palpitations	29.87	10.19	269	140809	39717	34776136
Acute generalised exanthematous pustulosis	28.02	10.19	75	141003	6701	34809152
Subarachnoid haemorrhage	27.92	10.19	113	140965	12522	34803331
Hyponatraemia	27.90	10.19	479	140599	82212	34733641
Intentional overdose	27.86	10.19	87	140991	43587	34772266
Eye injury	27.86	10.19	25	141053	834	34815019
Hemiplegia	27.66	10.19	76	141002	6896	34808957
Vascular purpura	27.64	10.19	35	141043	1743	34814110
Mixed liver injury	27.62	10.19	45	141033	2828	34813025
Anaemia macrocytic	27.22	10.19	46	141032	2980	34812873
Transient ischaemic attack	26.70	10.19	197	140881	27416	34788437
Inferior vena cava dilatation	26.41	10.19	23	141055	737	34815116
Idiopathic pulmonary fibrosis	25.74	10.19	49	141029	3485	34812368
Occupational dermatitis	25.66	10.19	11	141067	90	34815763
Abdominal pain upper	25.17	10.19	417	140661	71073	34744780
Eczema	24.85	10.19	143	140935	18293	34797560
Cardiac failure	24.73	10.19	511	140567	90737	34725116
Ocular myasthenia	24.58	10.19	14	141064	222	34815631
Eosinophilic colitis	24.53	10.19	14	141064	223	34815630
Granulomatous rosacea	24.00	10.19	12	141066	144	34815709
Helicobacter gastritis	23.59	10.19	27	141051	1209	34814644
Therapy interrupted	23.47	10.19	13	141065	13684	34802169
Tubulointerstitial nephritis and uveitis syndrome	23.41	10.19	10	141068	81	34815772
Eye pruritus	23.40	10.19	75	141003	7414	34808439
Product used for unknown indication	23.17	10.19	24	141054	959	34814894
Face oedema	23.11	10.19	100	140978	11416	34804437
Contraindicated product administered	22.81	10.19	32	141046	21449	34794404
Weight increased	22.64	10.19	253	140825	92780	34723073
Injection site pain	22.62	10.19	81	140997	38924	34776929
Ventricular tachycardia	22.58	10.19	184	140894	26395	34789458
Hypophosphataemic osteomalacia	22.45	10.19	11	141067	126	34815727
Nipple pain	22.31	10.19	23	141055	914	34814939
Radiation pneumonitis	22.26	10.19	39	141039	2601	34813252
Dermatitis bullous	22.24	10.19	70	141008	6852	34809001
Joint swelling	22.14	10.19	146	140932	59744	34756109
Inappropriate antidiuretic hormone secretion	22.06	10.19	106	140972	12647	34803206
Rhabdomyolysis	21.97	10.19	392	140686	67771	34748082
Cholangitis	21.89	10.19	81	140997	8608	34807245
Cardiac aneurysm	21.84	10.19	23	141055	937	34814916
Helicobacter test positive	21.78	10.19	22	141056	853	34815000
Brain scan abnormal	21.67	10.19	22	141056	858	34814995
Device dependence	21.49	10.19	8	141070	43	34815810
Premature baby	21.10	10.19	29	141049	19604	34796249
Gastroenteritis eosinophilic	21.03	10.19	12	141066	191	34815662
Overlap syndrome	21.00	10.19	10	141068	107	34815746
Acute pulmonary oedema	20.68	10.19	71	141007	7272	34808581
Occupational exposure to air contaminants	20.58	10.19	11	141067	153	34815700
Muscle haemorrhage	20.54	10.19	46	141032	3672	34812181
Carotid arteriosclerosis	20.50	10.19	31	141047	1827	34814026
Hospitalisation	20.39	10.19	140	140938	56762	34759091
Poisoning	20.38	10.19	12	141066	12214	34803639
Diplopia	20.37	10.19	127	140951	16716	34799137
Vasculitis	20.35	10.19	95	140983	11201	34804652
Hyperchlorhydria	20.34	10.19	19	141059	668	34815185
Eosinophilic oesophagitis	20.31	10.19	14	141064	315	34815538
Febrile bone marrow aplasia	20.24	10.19	76	141002	8133	34807720
Myelosuppression	20.16	10.19	29	141049	19236	34796617
Neurotoxicity	19.96	10.19	26	141052	17984	34797869
Ureteric compression	19.89	10.19	13	141065	267	34815586
Renal cyst	19.84	10.19	81	140997	9012	34806841
Hyperthermia	19.83	10.19	90	140988	10487	34805366
Mitral valve incompetence	19.55	10.19	115	140963	14828	34801025
Respiratory depression	19.55	10.19	22	141056	16223	34799630
Gastric cancer	19.50	10.19	64	141014	6405	34809448
Cardiac arrest	19.46	10.19	272	140806	95887	34719966
Multiple sclerosis relapse	19.07	10.19	15	141063	13118	34802735
Hyperkaliuria	19.01	10.19	9	141069	95	34815758
Rash papular	18.93	10.19	87	140991	10191	34805662
Haematotoxicity	18.63	10.19	5	141073	8189	34807664
Cataract	18.46	10.19	174	140904	26012	34789841
Physical examination abnormal	18.31	10.19	13	141065	307	34815546
Urticaria papular	18.20	10.19	8	141070	70	34815783
Nerve degeneration	18.14	10.19	11	141067	197	34815656
Cardiac failure congestive	18.13	10.19	232	140846	83038	34732815
Polyp	18.08	10.19	45	141033	3847	34812006
Condition aggravated	18.02	10.19	615	140463	191581	34624272
Phaeochromocytoma malignant	18.00	10.19	8	141070	72	34815781
Hypotension	17.93	10.19	722	140356	220927	34594926
Cross sensitivity reaction	17.87	10.19	25	141053	1372	34814481
Hepatic haematoma	17.55	10.19	14	141064	396	34815457
Pulmonary valve disease	17.50	10.19	13	141065	330	34815523
Craniotabes	17.47	10.19	5	141073	9	34815844
Poisoning deliberate	17.43	10.19	5	141073	7839	34808014
Troponin T increased	17.43	10.19	33	141045	2338	34813515
Muscle twitching	17.39	10.19	85	140993	10213	34805640
Myoglobinaemia	17.37	10.19	9	141069	117	34815736
Wheezing	17.36	10.19	97	140981	41305	34774548
Neuropsychiatric lupus	17.13	10.19	5	141073	10	34815843
Duodenal polyp	17.04	10.19	11	141067	221	34815632
Synovitis	16.98	10.19	19	141059	14047	34801806
Lethargy	16.88	10.19	97	140981	41025	34774828
Hypovitaminosis	16.63	10.19	16	141062	584	34815269
No adverse event	16.59	10.19	43	141035	22884	34792969
Sensitisation	16.55	10.19	10	141068	178	34815675
Xerosis	16.54	10.19	16	141062	588	34815265
Amnesia	16.54	10.19	172	140906	26391	34789462
Hypoparathyroidism	16.52	10.19	16	141062	589	34815264
Carotid artery stenosis	16.35	10.19	51	141027	4968	34810885
Type III immune complex mediated reaction	16.35	10.19	12	141066	299	34815554
Pathogen resistance	16.24	10.19	9	141069	9473	34806380
Anticoagulation drug level increased	16.12	10.19	15	141063	525	34815328
Febrile neutropenia	16.01	10.19	425	140653	136424	34679429
Dermatitis exfoliative	15.98	10.19	61	141017	6578	34809275
Coronary artery stenosis	15.97	10.19	79	140999	9537	34806316
Aggression	15.95	10.19	92	140986	38872	34776981
Acute coronary syndrome	15.68	10.19	101	140977	13444	34802409
Pancreatitis	15.64	10.19	232	140846	38659	34777194
Oesophagitis ulcerative	15.60	10.19	18	141060	813	34815040
Sepsis	15.60	10.19	533	140545	166028	34649825
Sudden death	15.59	10.19	110	140968	15091	34800762
Akinesia	15.56	10.19	30	141048	2154	34813699
Fixed eruption	15.50	10.19	26	141052	1674	34814179
Immune reconstitution inflammatory syndrome	15.47	10.19	8	141070	8751	34807102
Prurigo	15.45	10.19	16	141062	639	34815214
Large intestine polyp	15.33	10.19	68	141010	7846	34808007
Circumoral oedema	15.29	10.19	7	141071	68	34815785
Ventricular arrhythmia	15.17	10.19	53	141025	5475	34810378
Vitamin B12 deficiency	15.07	10.19	43	141035	3988	34811865
Hepatotoxicity	15.01	10.19	41	141037	21444	34794409
Jaundice cholestatic	14.97	10.19	48	141030	4746	34811107
Respiratory distress	14.83	10.19	214	140864	35451	34780402
Cerebral artery thrombosis	14.82	10.19	17	141061	763	34815090
Duodenitis	14.76	10.19	48	141030	4780	34811073
Bladder cancer	14.69	10.19	27	141051	16251	34799602
Brief psychotic disorder with marked stressors	14.66	10.19	10	141068	221	34815632
Dehydration	14.65	10.19	653	140425	129316	34686537
Renal haemangioma	14.62	10.19	5	141073	20	34815833
Peripheral venous disease	14.56	10.19	33	141045	2655	34813198
Blindness	14.53	10.19	107	140971	14879	34800974
Venoocclusive liver disease	14.48	10.19	7	141071	7959	34807894
Ventricular fibrillation	14.44	10.19	46	141032	22908	34792945
Hyperkinetic heart syndrome	14.44	10.19	8	141070	120	34815733
Pericardial disease	14.40	10.19	13	141065	437	34815416
Disturbance in attention	14.31	10.19	164	140914	25781	34790072
Low birth weight baby	14.29	10.19	7	141071	7898	34807955
Neuroleptic malignant syndrome	14.27	10.19	32	141046	17902	34797951
Drug dependence	14.23	10.19	50	141028	24167	34791686
High frequency ablation	14.20	10.19	9	141069	175	34815678
COVID-19	14.08	10.19	224	140854	77326	34738527
Psychotic disorder	14.03	10.19	51	141027	24401	34791452
Aortic valve incompetence	14.01	10.19	54	141024	5850	34810003
Therapy partial responder	13.94	10.19	11	141067	9605	34806248
Haematoma muscle	13.94	10.19	22	141056	1346	34814507
Essential hypertension	13.90	10.19	35	141043	3013	34812840
Fracture delayed union	13.90	10.19	6	141072	50	34815803
Antiphospholipid antibodies positive	13.86	10.19	11	141067	309	34815544
Infection	13.83	10.19	271	140807	90644	34725209
Cholecystitis	13.82	10.19	82	140996	10606	34805247
Hepatic encephalopathy	13.76	10.19	104	140974	14581	34801272
Ischaemic stroke	13.74	10.19	123	140955	18127	34797726
Accidental exposure to product	13.66	10.19	19	141059	12783	34803070
Neuropathy peripheral	13.65	10.19	245	140833	83018	34732835
Benign abdominal neoplasm	13.65	10.19	7	141071	89	34815764
Food interaction	13.63	10.19	18	141060	935	34814918
Echocardiogram abnormal	13.57	10.19	19	141059	1044	34814809
Acquired cystic kidney disease	13.55	10.19	3	141075	0	34815853
Bronchial injury	13.55	10.19	3	141075	0	34815853
Eructation	13.54	10.19	46	141032	4685	34811168
Ventricular enlargement	13.52	10.19	15	141063	649	34815204
Dyspnoea at rest	13.51	10.19	40	141038	3788	34812065
Musculoskeletal stiffness	13.40	10.19	122	140956	46558	34769295
Crohn's disease	13.40	10.19	35	141043	3082	34812771
Respiratory arrest	13.28	10.19	63	141015	27980	34787873
Intentional product use issue	13.26	10.19	166	140912	59650	34756203
Loss of personal independence in daily activities	13.23	10.19	79	140999	33100	34782753
Neutropenic sepsis	13.18	10.19	22	141056	13745	34802108
Nephropathy toxic	13.12	10.19	19	141059	12569	34803284
Prostatitis Escherichia coli	13.12	10.19	5	141073	29	34815824
Oesophageal adenocarcinoma	13.10	10.19	17	141061	868	34814985
Septic shock	13.04	10.19	381	140697	71453	34744400
Unresponsive to stimuli	13.02	10.19	62	141016	27507	34788346
Chest expansion decreased	13.01	10.19	8	141070	147	34815706
Mucormycosis	12.82	10.19	4	141074	5938	34809915
Oesophageal candidiasis	12.81	10.19	43	141035	4353	34811500
Antibody test abnormal	12.81	10.19	9	141069	209	34815644
Rash	12.81	10.19	752	140326	222000	34593853
Essential tremor	12.77	10.19	16	141062	788	34815065
Laboratory test abnormal	12.73	10.19	41	141037	20350	34795503
Hepatitis	12.69	10.19	150	140928	23754	34792099
Cardiac discomfort	12.68	10.19	14	141064	602	34815251
C-reactive protein abnormal	12.58	10.19	10	141068	8700	34807153
Rebound acid hypersecretion	12.57	10.19	7	141071	106	34815747
Cancer pain	12.52	10.19	31	141047	2641	34813212
Treatment noncompliance	12.24	10.19	65	141013	28035	34787818
Blood alkaline phosphatase increased	12.15	10.19	185	140893	30990	34784863
Appendicitis	12.12	10.19	26	141052	14781	34801072
Thrombocytopenic purpura	12.09	10.19	19	141059	1158	34814695
Epstein-Barr virus infection	12.01	10.19	8	141070	7620	34808233
Exposure during pregnancy	12.00	10.19	11	141067	8923	34806930
Renal atrophy	11.99	10.19	19	141059	1166	34814687
Progressive multifocal leukoencephalopathy	11.99	10.19	13	141065	9751	34806102
Hepatocellular carcinoma	11.98	10.19	61	141017	7448	34808405
Renal mass	11.91	10.19	24	141054	1780	34814073
Abnormal behaviour	11.88	10.19	56	141022	24913	34790940
Hyperparathyroidism secondary	11.74	10.19	22	141056	1546	34814307
Oral pustule	11.67	10.19	9	141069	242	34815611
Pruritus	11.63	10.19	692	140386	141289	34674564
Intestinal obstruction	11.59	10.19	142	140936	22680	34793173
Fatigue	11.52	10.19	1315	139763	369338	34446515
Infective exacerbation of chronic obstructive airways disease	11.48	10.19	24	141054	1827	34814026
Achlorhydria	11.48	10.19	3	141075	3	34815850
Renal tubular disorder	11.46	10.19	43	141035	4600	34811253
Malnutrition	11.35	10.19	89	140989	12620	34803233
Arthropathy	11.30	10.19	63	141015	26844	34789009
Excessive cerumen production	11.29	10.19	10	141068	328	34815525
Stevens-Johnson syndrome	11.27	10.19	120	140958	18519	34797334
Hyperhidrosis	11.26	10.19	392	140686	75300	34740553
Pulmonary oedema	11.26	10.19	130	140948	47399	34768454
Pain	11.22	10.19	694	140384	203981	34611872
Prostate cancer	11.22	10.19	104	140974	39545	34776308
Sacroiliitis	11.20	10.19	21	141057	1477	34814376
Oedema peripheral	11.19	10.19	591	140487	119221	34696632
False negative investigation result	11.12	10.19	8	141070	193	34815660
Nasopharyngitis	11.12	10.19	207	140871	69761	34746092
Septic arthritis staphylococcal	11.10	10.19	12	141066	504	34815349
Gastritis	11.06	10.19	136	140942	21737	34794116
Dyspepsia	11.04	10.19	209	140869	36523	34779330
Major depression	11.00	10.19	42	141036	4530	34811323
Suicide attempt	10.89	10.19	103	140975	39013	34776840
Cardiorenal syndrome	10.87	10.19	14	141064	709	34815144
Dialysis	10.85	10.19	80	140998	11128	34804725
Thrombosis	10.82	10.19	141	140937	50317	34765536
Enterochromaffin cell hyperplasia	10.82	10.19	4	141074	21	34815832
Dry skin	10.82	10.19	182	140896	31105	34784748
Cerebral haematoma	10.78	10.19	42	141036	4573	34811280
Erythema of eyelid	10.76	10.19	16	141062	929	34814924
Blood urea decreased	10.75	10.19	17	141061	1042	34814811
Toxic epidermal necrolysis	10.69	10.19	134	140944	21512	34794341
Anal erosion	10.67	10.19	4	141074	22	34815831
Lumbar radiculopathy	10.64	10.19	15	141063	829	34815024
Intentional self-injury	10.61	10.19	25	141053	13746	34802107
Therapeutic response decreased	10.56	10.19	72	141006	29241	34786612
Heat stroke	10.50	10.19	16	141062	949	34814904
Carbohydrate antigen 19-9 increased	10.48	10.19	8	141070	212	34815641
Oesophageal dilatation	10.44	10.19	8	141070	213	34815640
Insulin autoimmune syndrome	10.37	10.19	9	141069	287	34815566
Microcytic anaemia	10.37	10.19	27	141051	2373	34813480
Acute graft versus host disease in skin	10.36	10.19	4	141074	5197	34810656
Drug interaction	10.33	10.19	1052	140026	224894	34590959
Barrett's oesophagus	10.29	10.19	11	141067	456	34815397
Coombs negative haemolytic anaemia	10.29	10.19	7	141071	154	34815699
Thrombotic cerebral infarction	10.28	10.19	10	141068	370	34815483
Platelet toxicity	10.28	10.19	3	141075	6	34815847
Psoriatic arthropathy	10.26	10.19	43	141035	19755	34796098
Nasal crusting	10.26	10.19	10	141068	371	34815482
Syringe issue	10.26	10.19	5	141073	5659	34810194

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
Chronic kidney disease	596.68	9.27	993	313211	65161	79365023
Drug ineffective	466.83	9.27	2437	311767	1078476	78351708
Completed suicide	453.84	9.27	200	314004	245567	79184617
Toxicity to various agents	368.96	9.27	687	313517	420853	79009331
Hepatocellular injury	316.44	9.27	626	313578	46967	79383217
Interstitial lung disease	307.49	9.27	1060	313144	111540	79318644
Cholestasis	302.40	9.27	648	313556	51461	79378723
Off label use	300.04	9.27	2220	311984	904995	78525189
Pemphigus	298.75	9.27	25	314179	99557	79330627
Synovitis	290.47	9.27	115	314089	150619	79279565
Acute kidney injury	289.08	9.27	3222	310982	516182	78914002
Death	273.14	9.27	1226	312978	565288	78864896
Anti-cyclic citrullinated peptide antibody positive	272.80	9.27	13	314191	83130	79347054
Hand deformity	252.43	9.27	51	314153	103868	79326316
Drug abuse	243.10	9.27	172	314032	162519	79267665
Glossodynia	240.26	9.27	56	314148	103281	79326903
Maternal exposure during pregnancy	239.72	9.27	119	314085	136419	79293765
Duodenal ulcer perforation	221.68	9.27	9	314195	66202	79363982
End stage renal disease	219.96	9.27	256	313948	11964	79418220
Wound	196.89	9.27	106	314098	116073	79314111
Toxic skin eruption	186.83	9.27	324	313880	21969	79408215
Carotid artery thrombosis	186.73	9.27	128	314076	2925	79427259
Neurologic neglect syndrome	180.46	9.27	123	314081	2784	79427400
Systemic lupus erythematosus	179.75	9.27	129	314075	121020	79309164
Eosinophilia	166.31	9.27	473	313731	44872	79385312
Arthropathy	164.26	9.27	278	313926	176833	79253351
Sensitisation	163.80	9.27	122	314082	3189	79426995
Hypomagnesaemia	159.24	9.27	476	313728	46435	79383749
Product use in unapproved indication	158.95	9.27	483	313721	249876	79180308
Treatment failure	154.09	9.27	272	313932	170214	79259970
Contraindicated product administered	152.89	9.27	240	313964	157298	79272886
Hemiplegia	152.02	9.27	237	313967	14702	79415482
Helicobacter infection	152.00	9.27	43	314161	69661	79360523
Cardiospasm	146.49	9.27	114	314090	3187	79426997
Adjustment disorder	145.50	9.27	123	314081	3877	79426307
Agranulocytosis	145.43	9.27	449	313755	44581	79385603
Hypocalcaemia	142.36	9.27	477	313727	49447	79380737
Tubulointerstitial nephritis	141.35	9.27	400	313804	37835	79392349
Folliculitis	141.29	9.27	24	314180	55356	79374828
Polycystic ovaries	139.10	9.27	117	314087	3662	79426522
Joint swelling	137.36	9.27	627	313577	288019	79142165
Drug intolerance	137.14	9.27	555	313649	263564	79166620
Personality disorder	136.96	9.27	144	314060	6002	79424182
Hyponatraemia	136.04	9.27	1180	313024	176668	79253516
Cholecystitis chronic	135.74	9.27	181	314023	9725	79420459
Palmoplantar keratoderma	134.62	9.27	114	314090	3602	79426582
Discomfort	130.02	9.27	183	314021	125434	79304750
Muscle injury	128.50	9.27	19	314185	48542	79381642
Rheumatoid factor positive	128.48	9.27	38	314166	59801	79370383
Pruritus genital	127.53	9.27	120	314084	4366	79425818
Renal failure	122.17	9.27	1270	312934	199698	79230486
Gastrooesophageal reflux disease	120.46	9.27	763	313441	103483	79326701
Alopecia	120.19	9.27	486	313718	230869	79199315
Ejection fraction	119.91	9.27	87	314117	2182	79428002
Exposure during pregnancy	117.47	9.27	135	314069	100997	79329187
Sleep terror	114.93	9.27	113	314091	4345	79425839
Infusion related reaction	113.19	9.27	494	313710	229743	79200441
Renal injury	112.91	9.27	223	313981	16704	79413480
Rash maculo-papular	109.60	9.27	475	313729	55603	79374581
Tension headache	105.38	9.27	136	314068	7075	79423109
Biliary dyskinesia	102.46	9.27	83	314121	2462	79427722
Swelling	102.30	9.27	472	313732	216239	79213945
Psoriatic arthropathy	100.87	9.27	95	314109	77904	79352280
Hepatic enzyme increased	99.03	9.27	377	313827	182233	79247951
C-reactive protein abnormal	98.01	9.27	34	314170	48333	79381851
Immunisation	96.52	9.27	75	314129	2092	79428092
Atrial tachycardia	95.70	9.27	129	314075	7004	79423180
Carotid artery occlusion	94.63	9.27	133	314071	7514	79422670
Drug reaction with eosinophilia and systemic symptoms	92.22	9.27	498	313706	63746	79366438
Dysphagia	92.12	9.27	808	313396	121328	79308856
Anosmia	90.96	9.27	141	314063	8703	79421481
Rhinitis allergic	90.89	9.27	169	314035	12100	79418084
Abdominal pain upper	90.18	9.27	1309	312895	222510	79207674
Inappropriate antidiuretic hormone secretion	89.29	9.27	267	313937	26046	79404138
Drug resistance	86.70	9.27	29	314175	42184	79388000
Nephrogenic anaemia	86.20	9.27	91	314113	3811	79426373
Therapeutic product effect decreased	83.33	9.27	347	313857	163516	79266668
Pancreatitis acute	80.56	9.27	398	313806	49206	79380978
Gastric polyps	80.32	9.27	86	314118	3661	79426523
Acute generalised exanthematous pustulosis	79.55	9.27	196	314008	17058	79413126
Irritable bowel syndrome	77.93	9.27	78	314126	62163	79368021
Condition aggravated	77.25	9.27	1450	312754	499674	78930510
Coordination abnormal	77.01	9.27	194	314010	17118	79413066
Intentional overdose	75.66	9.27	193	314011	105767	79324417
Blister	75.39	9.27	231	313973	119245	79310939
Hypertensive nephropathy	75.33	9.27	48	314156	966	79429218
Hiatus hernia	74.84	9.27	232	313972	23080	79407104
Affect lability	74.69	9.27	148	314056	11111	79419073
Product use issue	74.46	9.27	502	313702	209320	79220864
Sleep disorder due to general medical condition, insomnia type	73.39	9.27	40	314164	43516	79386668
Mobility decreased	73.05	9.27	242	313962	121933	79308251
Gamma-glutamyltransferase increased	71.91	9.27	414	313790	54266	79375918
Motor dysfunction	70.73	9.27	170	314034	14563	79415621
Pericarditis	70.53	9.27	195	314009	104041	79326143
Therapy non-responder	68.35	9.27	165	314039	92140	79338044
Palpitations	67.62	9.27	780	313424	125830	79304354
Hepatic cytolysis	65.85	9.27	246	313958	26905	79403279
Fatigue	65.35	9.27	2997	311207	926730	78503454
Systemic lupus erythematosus rash	65.21	9.27	56	314148	1804	79428380
Transient ischaemic attack	62.28	9.27	388	313816	52307	79377877
Peripheral swelling	62.07	9.27	721	313483	268896	79161288
Intentional product use issue	61.72	9.27	349	313855	151763	79278421
Knee arthroplasty	61.61	9.27	48	314156	43200	79386984
Bronchial neoplasm	61.49	9.27	33	314171	475	79429709
Sensory loss	61.40	9.27	149	314055	12842	79417342
Sleep apnoea syndrome	60.17	9.27	294	313910	36184	79394000
Vascular purpura	59.29	9.27	67	314137	3031	79427153
Nephrectomy	59.02	9.27	56	314148	2059	79428125
Hypokalaemia	58.20	9.27	843	313361	143197	79286987
Hypergastrinaemia	58.09	9.27	24	314180	182	79430002
Facial pain	57.68	9.27	141	314063	12209	79417975
Hip arthroplasty	57.16	9.27	35	314169	35721	79394463
Loss of employment	56.56	9.27	60	314144	2527	79427657
Nephropathy	56.35	9.27	121	314083	9617	79420567
Pancreatitis	56.08	9.27	462	313742	68113	79362071
Lower respiratory tract infection	55.43	9.27	291	313913	128929	79301255
Hypothyroidism	55.34	9.27	375	313829	52017	79378167
Jaundice	55.25	9.27	380	313824	52969	79377215
Carpal tunnel syndrome	55.14	9.27	186	314018	19342	79410842
Disease progression	54.54	9.27	464	313740	183898	79246286
Gastritis	54.01	9.27	349	313855	47644	79382540
Cholestatic liver injury	53.95	9.27	81	314123	4860	79425324
Cross sensitivity reaction	52.67	9.27	69	314135	3643	79426541
Ill-defined disorder	52.62	9.27	113	314091	65762	79364422
Pregnancy	52.49	9.27	20	314184	26831	79403353
Hepatojugular reflux	51.46	9.27	32	314172	616	79429568
Device expulsion	51.00	9.27	19	314185	25842	79404342
Hypersensitivity	50.83	9.27	727	313477	261512	79168672
Ejection fraction abnormal	50.54	9.27	55	314149	2385	79427799
Dermatitis bullous	49.71	9.27	146	314058	14099	79416085
Sedation complication	49.67	9.27	3	314201	15666	79414518
Therapy interrupted	49.66	9.27	31	314173	31310	79398874
Stomatitis	49.16	9.27	357	313847	146400	79283784
Diplopia	48.41	9.27	260	313944	33206	79396978
Presbyacusis	48.33	9.27	56	314148	2604	79427580
Epigastric discomfort	47.88	9.27	100	314104	7796	79422388
Bone erosion	47.18	9.27	7	314197	17840	79412344
Lung disorder	46.97	9.27	505	313699	80052	79350132
Subarachnoid haemorrhage	46.85	9.27	206	313998	24259	79405925
Hyperkalaemia	45.21	9.27	667	313537	113731	79316453
Nasopharyngitis	44.69	9.27	717	313487	253164	79177020
Rhabdomyolysis	44.63	9.27	611	313593	102520	79327664
Myelosuppression	44.43	9.27	56	314148	40240	79389944
Anxiety	44.42	9.27	1288	312916	247224	79182960
Angioedema	44.03	9.27	476	313728	75559	79354625
Weight increased	43.78	9.27	799	313405	276587	79153597
Diabetic nephropathy	43.72	9.27	56	314148	2891	79427293
Hepatitis cholestatic	43.68	9.27	137	314067	13715	79416469
Eczema	43.61	9.27	293	313911	40525	79389659
Tenosynovitis stenosans	43.34	9.27	57	314147	3021	79427163
Chest pain	43.26	9.27	1436	312768	280868	79149316
Occult blood	43.17	9.27	43	314161	1680	79428504
Cell death	42.95	9.27	71	314133	4628	79425556
Poisoning	42.88	9.27	23	314181	25249	79404935
Gallbladder disorder	42.63	9.27	170	314034	19170	79411014
Cholecystitis	42.52	9.27	187	314017	22025	79408159
Musculoskeletal stiffness	42.22	9.27	463	313741	174545	79255639
Pain of skin	41.98	9.27	140	314064	14473	79415711
Tinnitus	41.96	9.27	309	313895	44024	79386160
Eating disorder	41.73	9.27	177	314027	20520	79409664
Thrombocytopenia	41.60	9.27	1353	312851	263906	79166278
Angina pectoris	41.48	9.27	347	313857	51385	79378799
Nasal turbinate hypertrophy	41.43	9.27	29	314175	686	79429498
Ventricular tachycardia	41.25	9.27	295	313909	41640	79388544
Cardiac failure	41.07	9.27	847	313357	153995	79276189
Iron deficiency anaemia	40.98	9.27	205	313999	25467	79404717
Renal disorder	40.73	9.27	295	313909	41810	79388374
Premature delivery	40.34	9.27	21	314183	23446	79406738
Mixed liver injury	40.27	9.27	91	314113	7487	79422697
Pleural thickening	40.11	9.27	54	314150	2928	79427256
Aphasia	39.92	9.27	318	313886	46414	79383770
Drug hypersensitivity	39.70	9.27	886	313318	298030	79132154
Cardiac arrest	39.66	9.27	460	313744	171636	79258548
Degenerative mitral valve disease	39.64	9.27	21	314183	294	79429890
Nipple swelling	39.27	9.27	21	314183	300	79429884
Hemiparesis	39.00	9.27	247	313957	33486	79396698
Nephritic syndrome	38.73	9.27	23	314181	406	79429778
Muscle haemorrhage	38.45	9.27	80	314124	6220	79423964
Neurotoxicity	38.19	9.27	43	314161	32475	79397709
Pleural fibrosis	38.14	9.27	63	314141	4104	79426080
Product dose omission issue	38.13	9.27	716	313488	246821	79183363
Endometrial ablation	37.81	9.27	30	314174	863	79429321
Vasculitis	37.66	9.27	197	314007	24905	79405279
Electrocardiogram Q wave abnormal	37.56	9.27	26	314178	604	79429580
Obesity	37.51	9.27	50	314154	35075	79395109
Neutropenic sepsis	37.35	9.27	31	314173	27033	79403151
Gallbladder injury	37.30	9.27	34	314170	1187	79428997
Anaemia	37.27	9.27	2126	312078	442889	78987295
Red blood cell sedimentation rate abnormal	37.18	9.27	18	314186	20945	79409239
Haematotoxicity	36.88	9.27	8	314196	15511	79414673
Live birth	36.58	9.27	14	314190	18730	79411454
Rash papular	36.40	9.27	177	314027	21739	79408445
Chronic kidney disease-mineral and bone disorder	36.24	9.27	24	314180	517	79429667
Accidental exposure to product	36.15	9.27	42	314162	31280	79398904
Face oedema	35.67	9.27	211	313993	27925	79402259
Device dependence	34.79	9.27	12	314192	51	79430133
Blood test abnormal	34.58	9.27	150	314054	17560	79412624
Pain	34.17	9.27	2351	311853	701451	78728733
Vitamin B12 deficiency	34.17	9.27	83	314121	7158	79423026
Dry eye	33.59	9.27	255	313949	36676	79393508
Phlebitis	33.24	9.27	93	314111	8737	79421447
Impaired work ability	32.72	9.27	159	314045	19522	79410662
Injection site pain	32.72	9.27	340	313864	129498	79300686
Infection	32.49	9.27	715	313489	240997	79189187
Blood magnesium increased	32.08	9.27	53	314151	3453	79426731
Sleep disorder due to a general medical condition	31.87	9.27	126	314078	14151	79416033
Arterial occlusive disease	31.77	9.27	89	314115	8367	79421817
Dehydration	31.75	9.27	1237	312967	246950	79183234
Blindness	31.69	9.27	206	313998	28177	79402007
Drug ineffective for unapproved indication	31.65	9.27	100	314104	51138	79379046
Post transplant lymphoproliferative disorder	31.48	9.27	4	314200	11460	79418724
Pancreatic neuroendocrine tumour	31.46	9.27	24	314180	651	79429533
Impaired healing	31.42	9.27	209	313995	87446	79342738
Bronchial haemorrhage	31.34	9.27	32	314172	1288	79428896
Cholangitis	31.18	9.27	116	314088	12660	79417524
Osteosclerosis	31.06	9.27	56	314148	3915	79426269
Malnutrition	30.65	9.27	172	314032	22330	79407854
Synovial fluid analysis	30.64	9.27	42	314162	2317	79427867
Anaemia macrocytic	30.63	9.27	68	314136	5529	79424655
Rheumatoid nodule	30.53	9.27	143	314061	17295	79412889
Occupational dermatitis	30.46	9.27	14	314190	141	79430043
Respiratory arrest	30.41	9.27	120	314084	57430	79372754
Eosinophilic fasciitis	30.32	9.27	17	314187	268	79429916
Post cholecystectomy syndrome	30.23	9.27	19	314185	373	79429811
Gastric disorder	29.96	9.27	251	313953	37182	79393002
Muscle spasticity	29.82	9.27	165	314039	21310	79408874
Muscle contractions involuntary	29.32	9.27	53	314151	3712	79426472
Sudden death	29.31	9.27	170	314034	22341	79407843
Acute graft versus host disease	29.29	9.27	3	314201	10164	79420020
Therapy partial responder	29.27	9.27	16	314188	17381	79412803
Drug interaction	29.26	9.27	1954	312250	413229	79016955
Cardiac disorder	29.03	9.27	391	313813	65366	79364818
Systolic dysfunction	29.02	9.27	53	314151	3742	79426442
Muscular weakness	28.68	9.27	833	313371	159896	79270288
Febrile neutropenia	28.61	9.27	692	313512	230307	79199877
Idiopathic pulmonary fibrosis	28.56	9.27	56	314148	4172	79426012
Eye pruritus	28.53	9.27	158	314046	20412	79409772
Urate nephropathy	28.32	9.27	14	314190	168	79430016
Electric shock	28.14	9.27	31	314173	1363	79428821
Medication error	28.09	9.27	157	314047	68485	79361699
Bunion operation	28.09	9.27	26	314178	926	79429258
Contusion	27.91	9.27	415	313789	148361	79281823
Rash	27.87	9.27	1933	312271	576425	78853759
Respiratory depression	27.84	9.27	41	314163	27589	79402595
Drug dependence	27.77	9.27	76	314128	40693	79389491
Injection site erythema	27.75	9.27	187	314017	78010	79352174
Sinus congestion	27.71	9.27	153	314051	19743	79410441
Synovial cyst	27.65	9.27	95	314109	9970	79420214
Pulmonary vascular disorder	27.50	9.27	27	314177	1036	79429148
Bronchial disorder	27.46	9.27	41	314163	2448	79427736
Gait inability	27.37	9.27	129	314075	58788	79371396
Therapeutic response decreased	27.31	9.27	153	314051	66700	79363484
Disturbance in attention	27.12	9.27	313	313891	50488	79379696
Laboratory test abnormal	26.93	9.27	43	314161	28005	79402179
Autoimmune disorder	26.92	9.27	16	314188	16596	79413588
Ventricular hypokinesia	26.75	9.27	89	314115	9190	79420994
Cholelithiasis	26.57	9.27	321	313883	52343	79377841
Hepatitis	26.54	9.27	336	313868	55391	79374793
Oesophagitis ulcerative	26.47	9.27	28	314176	1175	79429009
Rhinitis	26.35	9.27	122	314082	14685	79415499
Erythema dyschromicum perstans	26.32	9.27	10	314194	59	79430125
Blood alkaline phosphatase increased	26.25	9.27	374	313830	63290	79366894
Scleritis	26.22	9.27	55	314149	4301	79425883
Respiratory tract congestion	26.18	9.27	151	314053	19803	79410381
Inferior vena cava dilatation	26.11	9.27	24	314180	847	79429337
Nicotine dependence	26.11	9.27	25	314179	930	79429254
Hepatotoxicity	25.92	9.27	109	314095	51243	79378941
Adjustment disorder with depressed mood	25.36	9.27	3	314201	9083	79421101
Gallbladder polyp	25.34	9.27	25	314179	965	79429219
Febrile bone marrow aplasia	25.21	9.27	110	314094	12910	79417274
Neuroleptic malignant syndrome	24.85	9.27	44	314160	27515	79402669
Cholecystitis acute	24.81	9.27	112	314092	13339	79416845
Facet joint syndrome	24.58	9.27	7	314197	11295	79418889
Ulcer	24.54	9.27	202	314002	29770	79400414
Eyelid oedema	24.52	9.27	113	314091	13574	79416610
Immunodeficiency	24.26	9.27	30	314174	21738	79408446
Prescribed overdose	24.06	9.27	73	314131	37810	79392374
Aggression	24.01	9.27	111	314093	50847	79379337
Eosinophilic colitis	23.99	9.27	18	314186	476	79429708
Drug eruption	23.59	9.27	271	313933	43664	79386520
Carotid artery stenosis	23.49	9.27	82	314122	8676	79421508
Mucosal inflammation	23.34	9.27	188	314016	75392	79354792
Exposure to toxic agent	23.29	9.27	4	314200	9154	79421030
Abortion spontaneous	23.24	9.27	51	314153	29456	79400728
Hypoparathyroidism	23.18	9.27	25	314179	1073	79429111
Unresponsive to stimuli	23.16	9.27	127	314077	55661	79374523
Adenovirus infection	23.07	9.27	3	314201	8444	79421740
Nasal discharge discolouration	22.92	9.27	38	314166	2483	79427701
Dermatitis exfoliative	22.92	9.27	94	314110	10735	79419449
Radiation pneumonitis	22.91	9.27	49	314155	3884	79426300
Vulvovaginal burning sensation	22.85	9.27	30	314174	1587	79428597
Crepitations	22.84	9.27	89	314115	9928	79420256
Cerebral haematoma	22.74	9.27	76	314128	7866	79422318
Hyperthermia	22.70	9.27	135	314069	17902	79412282
Nerve injury	22.69	9.27	85	314119	9307	79420877
Abdominal discomfort	22.50	9.27	785	313419	249942	79180242
Grip strength decreased	22.47	9.27	32	314172	21837	79408347
Injection site pruritus	22.44	9.27	88	314116	42195	79387989
Burning sensation	22.43	9.27	340	313864	58292	79371892
Helicobacter test positive	22.38	9.27	27	314177	1311	79428873
Renal cyst	22.36	9.27	116	314088	14616	79415568
Lip oedema	22.29	9.27	65	314139	6251	79423933
Respiratory distress	22.20	9.27	338	313866	58001	79372183
Dry skin	22.17	9.27	384	313820	67611	79362573
Injection site bruising	21.98	9.27	85	314119	40917	79389267
Caesarean section	21.87	9.27	11	314193	12524	79417660
Diverticulum	21.73	9.27	116	314088	14780	79415404
Deafness neurosensory	21.54	9.27	68	314136	6830	79423354
Urticaria papular	21.52	9.27	12	314192	187	79429997
Axonal neuropathy	21.48	9.27	33	314171	2021	79428163
Nephrosclerosis	21.42	9.27	31	314173	1799	79428385
Injection site swelling	21.42	9.27	104	314100	47028	79383156
Physical examination abnormal	21.41	9.27	14	314190	295	79429889
Aspartate aminotransferase	21.36	9.27	18	314186	565	79429619
Nipple pain	21.18	9.27	22	314182	904	79429280
Pyelocaliectasis	21.04	9.27	22	314182	911	79429273
Lip dry	20.86	9.27	18	314186	15400	79414784
Occupational exposure to air contaminants	20.83	9.27	11	314193	153	79430031
Ocular myasthenia	20.82	9.27	15	314189	372	79429812
Disability	20.81	9.27	22	314182	17098	79413086
Hepatic haematoma	20.68	9.27	21	314183	840	79429344
Granulomatous rosacea	20.61	9.27	12	314192	204	79429980
Hypovitaminosis	20.47	9.27	24	314180	1130	79429054
Dermatitis exfoliative generalised	20.47	9.27	69	314135	7172	79423012
Acute coronary syndrome	20.40	9.27	148	314056	20985	79409199
Muscle twitching	20.33	9.27	167	314037	24597	79405587
Pathogen resistance	20.32	9.27	16	314188	14326	79415858
Subacute cutaneous lupus erythematosus	20.32	9.27	44	314160	3517	79426667
Hunger	20.26	9.27	57	314147	5371	79424813
Acute graft versus host disease in skin	20.25	9.27	3	314201	7655	79422529
Hyperparathyroidism secondary	20.15	9.27	37	314167	2623	79427561
Migraine	20.13	9.27	469	313735	87024	79343160
Fall	20.11	9.27	2205	311999	485424	78944760
Ureteric compression	20.04	9.27	13	314191	270	79429914
Rectosigmoid cancer	20.04	9.27	13	314191	270	79429914
Deformity	20.03	9.27	83	314121	9522	79420662
Nephropathy toxic	19.89	9.27	31	314173	20388	79409796
Campylobacter colitis	19.89	9.27	7	314197	32	79430152
Illness	19.79	9.27	105	314099	46406	79383778
Helicobacter gastritis	19.75	9.27	35	314169	2414	79427770
Breast cancer stage II	19.68	9.27	4	314200	8116	79422068
Cardiac aneurysm	19.68	9.27	27	314177	1491	79428693
Fear of injection	19.60	9.27	3	314201	7471	79422713
Troponin T increased	19.51	9.27	43	314161	3479	79426705
Tetany	19.49	9.27	37	314167	2691	79427493
Allergy to chemicals	19.47	9.27	36	314168	2566	79427618
Renal tubular disorder	19.40	9.27	63	314141	6423	79423761
Colitis microscopic	19.37	9.27	89	314115	10679	79419505
Pruritus	19.35	9.27	1806	312398	392842	79037342
Hyperlipidaemia	19.33	9.27	172	314032	25921	79404263
Hepatic encephalopathy	19.32	9.27	162	314042	24004	79406180
Cataract	19.25	9.27	348	313856	61772	79368412
Rebound acid hypersecretion	19.21	9.27	9	314195	95	79430089
Pulmonary valve disease	19.04	9.27	13	314191	295	79429889
Carotid arteriosclerosis	18.94	9.27	36	314168	2620	79427564
Immune reconstitution inflammatory syndrome	18.92	9.27	16	314188	13825	79416359
Mucormycosis	18.88	9.27	5	314199	8464	79421720
Acute pulmonary oedema	18.87	9.27	108	314096	14122	79416062
Hepatic function abnormal	18.75	9.27	398	313806	72709	79357475
Hypotension	18.72	9.27	1487	312717	438830	78991354
Genital infection female	18.68	9.27	8	314196	67	79430117
Hallucination	18.62	9.27	456	313748	85289	79344895
Dystonia	18.55	9.27	35	314169	21364	79408820
Hyperchlorhydria	18.45	9.27	31	314173	2048	79428136
Creatinine renal clearance decreased	18.37	9.27	29	314175	18973	79411211
Multi-organ disorder	18.36	9.27	35	314169	2553	79427631
Kidney infection	18.28	9.27	148	314056	21703	79408481
Abdominal pain	18.25	9.27	1777	312427	387792	79042392
Localised infection	18.21	9.27	81	314123	37494	79392690
Phaeochromocytoma malignant	18.19	9.27	8	314196	72	79430112
Therapy cessation	18.18	9.27	81	314123	37481	79392703
Pre-eclampsia	18.07	9.27	3	314201	7038	79423146
Renal tubular necrosis	18.01	9.27	164	314040	24875	79405309
Duodenal polyp	17.95	9.27	13	314191	325	79429859
Angina bullosa haemorrhagica	17.77	9.27	11	314193	210	79429974
Brain scan abnormal	17.77	9.27	23	314181	1200	79428984
Dialysis	17.65	9.27	129	314075	18333	79411851
Ischaemic stroke	17.62	9.27	204	314000	32927	79397257
Gangrene	17.56	9.27	76	314128	8888	79421296
Coronary artery stenosis	17.39	9.27	96	314108	12388	79417796
Nerve degeneration	17.32	9.27	12	314192	279	79429905
Heat stroke	17.30	9.27	27	314177	1676	79428508
Diarrhoea	17.26	9.27	3819	310385	876670	78553514
Substance abuse	17.25	9.27	10	314194	10516	79419668
Chronic graft versus host disease	17.16	9.27	3	314201	6778	79423406
Type III immune complex mediated reaction	17.13	9.27	17	314187	661	79429523
Gastric antral vascular ectasia	17.12	9.27	20	314184	938	79429246
Suicide attempt	17.09	9.27	227	313977	82705	79347479
Vertigo	17.05	9.27	374	313830	68708	79361476
Thrombocytopenic purpura	17.04	9.27	33	314171	2436	79427748
No adverse event	16.94	9.27	82	314122	37110	79393074
Dislocation of vertebra	16.92	9.27	5	314199	7875	79422309
Bone cyst	16.90	9.27	40	314164	3393	79426791
Myoglobinaemia	16.86	9.27	9	314195	128	79430056
Venoocclusive liver disease	16.85	9.27	13	314191	11758	79418426
Osteopenia	16.81	9.27	127	314077	18237	79411947
Hyperkinetic heart syndrome	16.80	9.27	9	314195	129	79430055
Psychotic disorder	16.77	9.27	95	314109	41307	79388877
Rash scarlatiniform	16.65	9.27	11	314193	236	79429948
Eructation	16.63	9.27	86	314118	10823	79419361
Hyperhidrosis	16.61	9.27	743	313461	150749	79279435
Hepatocellular carcinoma	16.55	9.27	75	314129	8946	79421238
Essential hypertension	16.51	9.27	57	314147	5996	79424188
Mesenteric panniculitis	16.44	9.27	13	314191	372	79429812
Bicytopenia	16.43	9.27	48	314156	4622	79425562
Septic shock	16.38	9.27	615	313589	122186	79307998
Haematoma	16.38	9.27	293	313911	51902	79378282
Cerebral infarction	16.38	9.27	262	313942	45414	79384770
Appendicitis	16.33	9.27	36	314168	20758	79409426
Liver function test increased	16.26	9.27	91	314113	39682	79390502
Prescription form tampering	16.24	9.27	13	314191	379	79429805
Overdose	16.22	9.27	578	313626	183628	79246556
Cerebellar haematoma	16.17	9.27	16	314188	620	79429564
Pleuritic pain	16.15	9.27	81	314123	10071	79420113
Injection site haemorrhage	16.11	9.27	56	314148	27814	79402370
Angina unstable	16.10	9.27	116	314088	16411	79413773
Nausea	16.09	9.27	4123	310081	953073	78477111
CSF volume increased	15.99	9.27	6	314198	34	79430150
Blood lactic acid increased	15.92	9.27	16	314188	12728	79417456
Salpingo-oophorectomy unilateral	15.90	9.27	18	314186	816	79429368
Cardiotoxicity	15.71	9.27	15	314189	12224	79417960
Bradypnoea	15.66	9.27	56	314148	5996	79424188
Bile duct stone	15.57	9.27	53	314151	5536	79424648
Lip swelling	15.56	9.27	237	313967	40674	79389510
Hyperphosphatasaemia	15.55	9.27	8	314196	105	79430079
Cardiothoracic ratio increased	15.54	9.27	7	314197	67	79430117
Antinuclear antibody positive	15.54	9.27	67	314137	7823	79422361
Regurgitation	15.41	9.27	34	314170	2753	79427431
Anticoagulation drug level increased	15.31	9.27	17	314187	754	79429430
Diverticulum oesophageal	15.30	9.27	9	314195	156	79430028
Gastrointestinal motility disorder	15.29	9.27	56	314148	6066	79424118
Inappropriate schedule of product administration	15.27	9.27	405	313799	133223	79296961
Schizophreniform disorder	15.25	9.27	9	314195	157	79430027
Myocardial infarction	15.24	9.27	879	313325	183250	79246934
Pulmonary arterial hypertension	15.24	9.27	175	314029	28191	79401993
Tongue oedema	15.24	9.27	62	314142	7055	79423129
Premature labour	15.19	9.27	7	314197	8383	79421801
Seizure	15.19	9.27	599	313605	188235	79241949
Purging	15.18	9.27	6	314198	40	79430144
Alanine aminotransferase abnormal	15.15	9.27	8	314196	8859	79421325
Melaena	15.14	9.27	330	313874	60560	79369624
Supraventricular extrasystoles	15.06	9.27	61	314143	6926	79423258
Adverse event	15.03	9.27	158	314046	60056	79370128
COVID-19	14.99	9.27	490	313714	157184	79273000
Transplant rejection	14.98	9.27	34	314170	19403	79410781
Oesophagitis	14.97	9.27	154	314050	24135	79406049
Stevens-Johnson syndrome	14.93	9.27	227	313977	38939	79391245
Cutaneous lupus erythematosus	14.79	9.27	35	314169	2968	79427216
Coronary artery disease	14.76	9.27	350	313854	65124	79365060
Transplant dysfunction	14.76	9.27	5	314199	7216	79422968
Graft versus host disease in skin	14.70	9.27	3	314201	6070	79424114
Sciatica	14.70	9.27	74	314130	33148	79397036
Microcytic anaemia	14.68	9.27	50	314154	5224	79424960
Hyperkaliuria	14.67	9.27	9	314195	169	79430015
Gastric cancer	14.66	9.27	79	314125	10100	79420084
Large intestine polyp	14.66	9.27	93	314111	12615	79417569
High frequency ablation	14.62	9.27	11	314193	292	79429892
Tooth disorder	14.62	9.27	163	314041	26070	79404114
Gastroenteritis eosinophilic	14.56	9.27	11	314193	294	79429890
Intervertebral discitis	14.54	9.27	47	314157	4781	79425403
Type I hypersensitivity	14.33	9.27	44	314160	4354	79425830
Prurigo	14.32	9.27	22	314182	1347	79428837
Escherichia pyelonephritis	14.29	9.27	14	314190	536	79429648
Normal newborn	14.28	9.27	5	314199	7067	79423117
Thrombophlebitis	14.21	9.27	56	314148	6279	79423905
Hypocapnia	14.21	9.27	15	314189	628	79429556
Chronic cutaneous lupus erythematosus	14.09	9.27	13	314191	461	79429723
Renal impairment	13.99	9.27	758	313446	157025	79273159
Malaise	13.95	9.27	2166	312038	487703	78942481
Treatment noncompliance	13.94	9.27	135	314069	52133	79378051
Amnesia	13.89	9.27	336	313868	62721	79367463
Small cell carcinoma	13.85	9.27	11	314193	317	79429867
Pancreatitis chronic	13.84	9.27	41	314163	3978	79426206
IIIrd nerve paresis	13.79	9.27	9	314195	189	79429995
Acute hepatitis B	13.75	9.27	13	314191	476	79429708
Sleep disorder	13.74	9.27	246	313958	85431	79344753
Shock haemorrhagic	13.73	9.27	130	314074	19930	79410254
Duodenitis	13.70	9.27	65	314139	7902	79422282
Complication of device insertion	13.69	9.27	4	314200	6346	79423838
Oesophageal adenocarcinoma	13.68	9.27	17	314187	851	79429333
Product used for unknown indication	13.67	9.27	23	314181	1521	79428663
Blood creatine phosphokinase decreased	13.67	9.27	18	314186	955	79429229
Systemic infection	13.67	9.27	11	314193	9741	79420443
Tooth demineralisation	13.62	9.27	3	314201	0	79430184
Bladder cancer	13.60	9.27	36	314168	19490	79410694
Haemorrhage intracranial	13.59	9.27	55	314149	26138	79404046
Blood immunoglobulin A increased	13.53	9.27	18	314186	965	79429219
Pericardial disease	13.52	9.27	14	314190	573	79429611
Xerosis	13.50	9.27	20	314184	1186	79428998
Haematoma muscle	13.45	9.27	31	314173	2584	79427600
Device difficult to use	13.35	9.27	20	314184	13365	79416819
Vulvovaginal pruritus	13.31	9.27	31	314173	2602	79427582
Food interaction	13.31	9.27	24	314180	1678	79428506
Cytomegalovirus infection reactivation	13.29	9.27	9	314195	8707	79421477
Gait disturbance	13.26	9.27	675	313529	206831	79223353
Renal hypertension	13.19	9.27	9	314195	204	79429980
Cardiorenal syndrome	13.19	9.27	23	314181	1566	79428618
Lethargy	13.17	9.27	233	313971	81059	79349125
Occupational exposure to product	13.16	9.27	15	314189	685	79429499
Unintentional medical device removal	13.11	9.27	7	314197	7705	79422479
Hypoalbuminaemia	13.11	9.27	135	314069	21162	79409022
Drug use disorder	13.10	9.27	9	314195	8642	79421542
Liver disorder	13.10	9.27	376	313828	72041	79358143
Angiopathy	13.08	9.27	59	314145	7023	79423161
Neurosis	13.02	9.27	12	314192	425	79429759
Epstein-Barr virus infection	13.01	9.27	23	314181	14393	79415791
Vitreous detachment	12.99	9.27	28	314176	2231	79427953
Drug specific antibody present	12.93	9.27	5	314199	6647	79423537
Pleurisy	12.92	9.27	78	314126	10397	79419787
Uveal melanoma	12.92	9.27	4	314200	11	79430173
Renal infarct	12.86	9.27	31	314173	2660	79427524
Aspergillus infection	12.84	9.27	36	314168	19125	79411059
Parkinsonism	12.79	9.27	29	314175	16555	79413629
Flatulence	12.76	9.27	238	313966	42486	79387698
Adrenocorticotropic hormone deficiency	12.76	9.27	21	314183	1364	79428820
Bronchopulmonary aspergillosis	12.75	9.27	45	314159	22249	79407935
Graft versus host disease	12.65	9.27	25	314179	15001	79415183
Nephritis allergic	12.65	9.27	15	314189	715	79429469
Cardio-respiratory arrest	12.63	9.27	328	313876	108182	79322002
Thymus disorder	12.62	9.27	10	314194	287	79429897
Sedation	12.62	9.27	137	314067	51758	79378426
Ventricular enlargement	12.62	9.27	15	314189	717	79429467
Cutaneous vasculitis	12.54	9.27	65	314139	8187	79421997
Granulocyte count increased	12.54	9.27	20	314184	1265	79428919
Catarrh	12.53	9.27	27	314177	2151	79428033
Gallbladder hypofunction	12.52	9.27	13	314191	534	79429650
Neutrophilia	12.41	9.27	8	314196	7943	79422241
General physical health deterioration	12.39	9.27	925	313279	274313	79155871
Ear infection	12.39	9.27	82	314122	34350	79395834
Sickle cell anaemia with crisis	12.32	9.27	8	314196	7914	79422270
Subdural haematoma	12.30	9.27	183	314021	31251	79398933
Cytomegalovirus infection	12.30	9.27	108	314096	42536	79387648
Burns second degree	12.27	9.27	30	314174	2598	79427586
Pneumobilia	12.26	9.27	9	314195	230	79429954
Sinus disorder	12.25	9.27	139	314065	22325	79407859
Renal atrophy	12.12	9.27	24	314180	1801	79428383
Photophobia	12.11	9.27	129	314075	20399	79409785
Cardiac murmur functional	12.09	9.27	5	314199	38	79430146
Multiple sclerosis relapse	12.07	9.27	121	314083	46412	79383772
Glomerular filtration rate increased	12.03	9.27	19	314185	1192	79428992
Placental calcification	11.99	9.27	4	314200	15	79430169
Cytomegalovirus viraemia	11.99	9.27	20	314184	12801	79417383
Intestinal infarction	11.96	9.27	20	314184	1316	79428868
Circumoral oedema	11.94	9.27	10	314194	311	79429873
X-ray abnormal	11.93	9.27	4	314200	5809	79424375
Drug tolerance	11.89	9.27	10	314194	8665	79421519
Cytokine release syndrome	11.84	9.27	88	314116	35910	79394274
Cerebral artery thrombosis	11.83	9.27	18	314186	1093	79429091
Withdrawal syndrome	11.78	9.27	60	314144	26794	79403390
Clinically isolated syndrome	11.77	9.27	5	314199	41	79430143
Ingrowing nail	11.73	9.27	31	314173	2816	79427368
Brain injury	11.69	9.27	17	314187	11500	79418684
Suicidal ideation	11.68	9.27	221	313983	76119	79354065
Dermatophytosis of nail	11.66	9.27	8	314196	183	79430001
Bronchopneumopathy	11.66	9.27	15	314189	778	79429406
Teeth brittle	11.65	9.27	12	314192	488	79429696
Gastric ulcer haemorrhage	11.64	9.27	68	314136	8959	79421225
Hyperuricaemia	11.60	9.27	83	314121	11716	79418468
Tubulointerstitial nephritis and uveitis syndrome	11.57	9.27	10	314194	325	79429859
Wrong technique in product usage process	11.57	9.27	213	313991	73662	79356522
Cellulitis	11.57	9.27	334	313870	108726	79321458
Platelet adhesiveness decreased	11.55	9.27	3	314201	3	79430181
Respiratory syncytial virus infection	11.52	9.27	12	314192	9390	79420794
Chest expansion decreased	11.51	9.27	8	314196	187	79429997
Ventricular fibrillation	11.50	9.27	76	314128	31850	79398334
Nocardiosis	11.49	9.27	4	314200	5675	79424509
Erosive oesophagitis	11.49	9.27	31	314173	2851	79427333
Haemolytic anaemia	11.47	9.27	114	314090	17706	79412478
Device use error	11.28	9.27	7	314197	7094	79423090
Colitis ischaemic	11.25	9.27	101	314103	15258	79414926
Therapeutic product effect incomplete	11.24	9.27	450	313754	141195	79288989
Hypomania	11.23	9.27	8	314196	7536	79422648
Purple glove syndrome	11.22	9.27	9	314195	263	79429921
Tricuspid valve incompetence	11.22	9.27	123	314081	19589	79410595
Vulval disorder	11.21	9.27	13	314191	605	79429579
Enterochromaffin cell hyperplasia	11.20	9.27	6	314198	86	79430098
Haemorrhoids	11.17	9.27	169	314035	28959	79401225
Aortic valve incompetence	11.15	9.27	70	314134	9460	79420724
Miosis	11.15	9.27	103	314101	15686	79414498
Eye injury	11.12	9.27	29	314175	2614	79427570
Traumatic haematoma	11.11	9.27	25	314179	2051	79428133
Mitral valve incompetence	11.06	9.27	166	314038	28399	79401785
Hypertriglyceridaemia	11.05	9.27	87	314117	12653	79417531
Rhinalgia	11.03	9.27	27	314177	2340	79427844
Finger deformity	11.02	9.27	8	314196	7466	79422718
Neutropenia	10.95	9.27	980	313224	286730	79143454
Creatinine renal clearance abnormal	10.94	9.27	12	314192	525	79429659
Heart rate decreased	10.93	9.27	203	314001	70113	79360071
Lipase increased	10.92	9.27	106	314098	16360	79413824
Hypoplastic anaemia	10.91	9.27	4	314200	21	79430163
Product substitution issue	10.90	9.27	125	314079	20131	79410053
Infusion site scar	10.88	9.27	10	314194	353	79429831
Drug effective for unapproved indication	10.88	9.27	5	314199	5996	79424188
Anal erythema	10.88	9.27	8	314196	205	79429979
Post-traumatic stress disorder	10.83	9.27	43	314161	4838	79425346
Erythema	10.80	9.27	1021	313183	222269	79207915
Arthralgia	10.78	9.27	2037	312167	569766	78860418
Abdominal strangulated hernia	10.73	9.27	6	314198	94	79430090
Lower limb fracture	10.68	9.27	51	314153	23164	79407020
Blood gastrin increased	10.66	9.27	5	314199	53	79430131
Hyponatraemic seizure	10.62	9.27	12	314192	543	79429641
Dyspepsia	10.62	9.27	527	313677	108160	79322024
Abnormal behaviour	10.61	9.27	92	314112	36329	79393855
Cerebrovascular accident	10.40	9.27	728	313476	154564	79275620
Hypoparathyroidism secondary	10.39	9.27	8	314196	220	79429964
Campylobacter gastroenteritis	10.36	9.27	19	314185	1346	79428838
Tongue pruritus	10.36	9.27	12	314192	558	79429626
Oesophageal candidiasis	10.35	9.27	67	314137	9151	79421033
Surgery	10.35	9.27	81	314123	32685	79397499
Hyperammonaemic encephalopathy	10.33	9.27	3	314201	4779	79425405
Tongue disorder	10.33	9.27	25	314179	13950	79416234
Arterial spasm	10.32	9.27	7	314197	157	79430027
Hypopnoea	10.30	9.27	45	314159	5284	79424900
Pericardial haemorrhage	10.30	9.27	40	314164	4455	79425729
Faecal vomiting	10.30	9.27	17	314187	1107	79429077
Nightmare	10.29	9.27	151	314053	25710	79404474
Cholecystectomy	10.25	9.27	68	314136	9364	79420820
Brief psychotic disorder with marked stressors	10.22	9.27	9	314195	300	79429884
Anaemia folate deficiency	10.22	9.27	9	314195	300	79429884
Feeling jittery	10.22	9.27	86	314118	12755	79417429
Distal intestinal obstruction syndrome	10.20	9.27	14	314190	773	79429411
Enterocolitis haemorrhagic	10.19	9.27	25	314179	2169	79428015
Anaemia vitamin B12 deficiency	10.19	9.27	14	314190	774	79429410
Circulatory collapse	10.17	9.27	97	314107	37571	79392613
False negative investigation result	10.15	9.27	9	314195	303	79429881
Hallucination, olfactory	10.11	9.27	11	314193	477	79429707
Neoplasm progression	10.09	9.27	143	314061	51539	79378645
Dysarthria	10.09	9.27	343	313861	67279	79362905
Extra dose administered	10.02	9.27	11	314193	8404	79421780
Biliary tract disorder	10.00	9.27	21	314183	1643	79428541
Eosinophilic oesophagitis	9.96	9.27	12	314192	582	79429602
Device malfunction	9.94	9.27	47	314157	21401	79408783
Hepatobiliary scan abnormal	9.90	9.27	5	314199	63	79430121
Anaphylactoid reaction	9.89	9.27	45	314159	5377	79424807
Prothrombin time ratio decreased	9.87	9.27	15	314189	910	79429274
Oedema peripheral	9.85	9.27	1137	313067	251151	79179033
Intentional self-injury	9.84	9.27	81	314123	32338	79397846
Purpura	9.84	9.27	119	314085	19408	79410776
Incorrect route of product administration	9.83	9.27	89	314115	34840	79395344
Therapeutic embolisation	9.83	9.27	11	314193	492	79429692
Catatonia	9.83	9.27	12	314192	8744	79421440
Vulvovaginal erythema	9.83	9.27	8	314196	239	79429945
Dyshidrotic eczema	9.81	9.27	12	314192	591	79429593
Wheelchair user	9.80	9.27	6	314198	6126	79424058
Dermatosis	9.79	9.27	12	314192	592	79429592
Lactic acidosis	9.78	9.27	354	313850	70005	79360179
Hospice care	9.75	9.27	16	314188	10308	79419876
Polyomavirus-associated nephropathy	9.73	9.27	5	314199	5622	79424562
Nephrolithiasis	9.72	9.27	277	313927	53014	79377170
Gastrointestinal tract mucosal discolouration	9.72	9.27	4	314200	30	79430154
Chondrocalcinosis	9.71	9.27	16	314188	1040	79429144
Prostate cancer	9.70	9.27	84	314120	33184	79397000
Toxic epidermal necrolysis	9.65	9.27	237	313967	44344	79385840
Cyst	9.63	9.27	90	314114	13750	79416434
Small intestinal stenosis	9.57	9.27	14	314190	821	79429363
Hepatitis fulminant	9.56	9.27	55	314149	7207	79422977
Pyelonephritis acute	9.54	9.27	48	314156	5975	79424209
Erythema multiforme	9.53	9.27	109	314095	17542	79412642
Prinzmetal angina	9.53	9.27	21	314183	1699	79428485
Haemorrhage foetal	9.50	9.27	3	314201	9	79430175
Cystitis glandularis	9.50	9.27	3	314201	9	79430175
Altered state of consciousness	9.50	9.27	233	313971	43589	79386595
Coeliac disease	9.46	9.27	19	314185	11332	79418852
Herpes simplex test positive	9.45	9.27	10	314194	420	79429764
Muscle swelling	9.44	9.27	14	314190	831	79429353
Blood loss anaemia	9.42	9.27	98	314106	15400	79414784
Enterocolitis	9.42	9.27	93	314111	14419	79415765
Insulin autoimmune syndrome	9.41	9.27	10	314194	422	79429762
Anastomotic ulcer	9.39	9.27	13	314191	724	79429460
Purpura senile	9.37	9.27	11	314193	519	79429665
Gastritis erosive	9.36	9.27	74	314130	10773	79419411
Vitamin B12 increased	9.35	9.27	17	314187	1196	79428988
Walking aid user	9.33	9.27	16	314188	10132	79420052
Hypoosmolar state	9.33	9.27	9	314195	338	79429846
Endophthalmitis	9.33	9.27	7	314197	6421	79423763
Gastrointestinal disorder	9.32	9.27	390	313814	121815	79308369
Rhonchi	9.32	9.27	36	314168	4000	79426184
Pyelonephritis	9.31	9.27	122	314082	20266	79409918
Adverse drug reaction	9.31	9.27	195	314009	66197	79363987
Dysgeusia	9.29	9.27	293	313911	56884	79373300
Arteriovenous fistula site haematoma	9.29	9.27	4	314200	34	79430150
Cushingoid	9.28	9.27	67	314137	9485	79420699

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	A02BC05	ALIMENTARY TRACT AND METABOLISM DRUGS FOR ACID RELATED DISORDERS DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD) Proton pump inhibitors
ATC	A02BD06	ALIMENTARY TRACT AND METABOLISM DRUGS FOR ACID RELATED DISORDERS DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD) Combinations for eradication of Helicobacter pylori
ATC	M01AE52	MUSCULO-SKELETAL SYSTEM ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS, NON-STEROIDS Propionic acid derivatives
FDA MoA	N0000000147	Proton Pump Inhibitors
FDA EPC	N0000175525	Proton Pump Inhibitor
MeSH PA	D000897	Anti-Ulcer Agents
MeSH PA	D004791	Enzyme Inhibitors
MeSH PA	D005765	Gastrointestinal Agents
MeSH PA	D054328	Proton Pump Inhibitors
CHEBI has role	CHEBI:35623	anticonvulsants
CHEBI has role	CHEBI:49200	proton pump inhibitors
CHEBI has role	CHEBI:49201	anti-ulcer drugs
CHEBI has role	CHEBI:50183	P450 inhibitors
CHEBI has role	CHEBI:77746	Homo sapiens metabolite
FDA MoA	N0000182140	Cytochrome P450 2C19 Inhibitors
CHEBI has role	CHEBI:37956	antihistamines
CHEBI has role	CHEBI:38623	monoamine oxidase inhibitors

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

Disease	Relation	SNOMED_ID	DOID
Peptic ulcer	indication	13200003	DOID:750
Erosive esophagitis	indication	40719004
Zollinger-Ellison syndrome	indication	53132006	DOID:0050782
Peptic reflux disease	indication	57643001
Gastroesophageal reflux disease	indication	235595009	DOID:8534
Maintenance of Healing Erosive Esophagitis	indication
Osteoarthritis in Patients at High Ulcer Risk	indication
Duodenal Ulcer due to H. Pylori	indication
Rheumatoid Arthritis in Patient at High Ulcer Risk	indication
Prevention of NSAID-Induced Gastric Ulcer	indication
Pathological Gastric Hypersecretory Condition	indication
Upper gastrointestinal hemorrhage	off-label use	37372002
Hepatic failure	contraindication	59927004
Osteoporosis	contraindication	64859006	DOID:11476
Atrophic gastritis	contraindication	84568007	DOID:8929
Fracture of bone	contraindication	125605004
Hypomagnesemia	contraindication	190855004

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	9.71	acidic
pKa2	4.44	Basic
pKa3	2.53	Basic

Orange Book patent data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Patent number	Patent expiration date	Patent use
EQ 20MG BASE;375MG	VIMOVO	HORIZON	N022511	April 30, 2010	RX	TABLET, DELAYED RELEASE	ORAL	9393208	Sept. 3, 2029	RISK-REDUCTION OF NSAID-ASSOCIATED GASTRIC ULCER IN PATIENTS REQUIRING NSAID TREATMENT
EQ 20MG BASE;500MG	VIMOVO	HORIZON	N022511	April 30, 2010	RX	TABLET, DELAYED RELEASE	ORAL	9393208	Sept. 3, 2029	RISK-REDUCTION OF NSAID-ASSOCIATED GASTRIC ULCER IN PATIENTS REQUIRING NSAID TREATMENT
EQ 20MG BASE;500MG	VIMOVO	HORIZON	N022511	April 30, 2010	RX	TABLET, DELAYED RELEASE	ORAL	9220698	March 10, 2031	RISK-REDUCTION OF NSAID-ASSOCIATED GASTRIC ULCER IN PATIENTS REQUIRING NSAID TREATMENT
EQ 20MG BASE;375MG	VIMOVO	HORIZON	N022511	April 30, 2010	RX	TABLET, DELAYED RELEASE	ORAL	8945621	Oct. 17, 2031	RISK-REDUCTION OF NSAID-ASSOCIATED GASTRIC ULCERS IN PATIENTS ALSO TAKING LOW DOSE ASPIRIN
EQ 20MG BASE;500MG	VIMOVO	HORIZON	N022511	April 30, 2010	RX	TABLET, DELAYED RELEASE	ORAL	8945621	Oct. 17, 2031	RISK-REDUCTION OF NSAID-ASSOCIATED GASTRIC ULCERS IN PATIENTS ALSO TAKING LOW DOSE ASPIRIN

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
Potassium-transporting ATPase	Transporter	P20648 P51164	ATP4A_HUMAN ATP4B_HUMAN	INHIBITOR				CHEMBL	CHEMBL

External reference:

ID	Source
4021259	VUID
N0000189434	NUI
D01984	KEGG_DRUG
217087-10-0	SECONDARY_CAS_RN
217087-09-7	SECONDARY_CAS_RN
161796-78-7	SECONDARY_CAS_RN
4019439	VANDF
4021259	VANDF
4021260	VANDF
4025229	VANDF
4032661	VANDF
C0937846	UMLSCUI
CHEBI:50275	CHEBI
CHEBI:7772	CHEBI
1C6	PDB_CHEM_ID
CHEMBL1201320	ChEMBL_ID
DB00736	DRUGBANK_ID
CHEMBL2146133	ChEMBL_ID
CHEMBL1200470	ChEMBL_ID
D064098	MESH_DESCRIPTOR_UI
4594	PUBCHEM_CID
5488	IUPHAR_LIGAND_ID
7766	INN_ID
934714-36-0	SECONDARY_CAS_RN
N3PA6559FT	UNII
1294569	RXNORM
19233	MMSL
205449	MMSL
211151	MMSL
232889	MMSL
29630	MMSL
45807	MMSL
5201	MMSL
d00325	MMSL
d04749	MMSL
003476	NDDF
008590	NDDF
008918	NDDF
008919	NDDF
015173	NDDF
129489006	SNOMEDCT_US
25673006	SNOMEDCT_US
317331009	SNOMEDCT_US
387137007	SNOMEDCT_US
396047003	SNOMEDCT_US
426956003	SNOMEDCT_US
725855001	SNOMEDCT_US
C0028978	UMLSCUI
CHEMBL2146140	ChEMBL_ID
DB00338	DRUGBANK_ID
5081	INN_ID
D009853	MESH_DESCRIPTOR_UI

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Esomeprazole Magnesium	HUMAN PRESCRIPTION DRUG LABEL	1	0093-6450	CAPSULE, DELAYED RELEASE	20 mg	ORAL	ANDA	28 sections
Esomeprazole Magnesium	HUMAN PRESCRIPTION DRUG LABEL	1	0093-6450	CAPSULE, DELAYED RELEASE	20 mg	ORAL	ANDA	28 sections
Esomeprazole Magnesium	HUMAN PRESCRIPTION DRUG LABEL	1	0093-6450	CAPSULE, DELAYED RELEASE	20 mg	ORAL	ANDA	28 sections
Esomeprazole Magnesium	HUMAN PRESCRIPTION DRUG LABEL	1	0093-6451	CAPSULE, DELAYED RELEASE	40 mg	ORAL	ANDA	28 sections
Esomeprazole Magnesium	HUMAN PRESCRIPTION DRUG LABEL	1	0093-6451	CAPSULE, DELAYED RELEASE	40 mg	ORAL	ANDA	28 sections
Esomeprazole Magnesium	HUMAN PRESCRIPTION DRUG LABEL	1	0093-6451	CAPSULE, DELAYED RELEASE	40 mg	ORAL	ANDA	28 sections
good sense esomeprazole magnesium	HUMAN OTC DRUG LABEL	1	0113-0651	CAPSULE, DELAYED RELEASE	20 mg	ORAL	ANDA	15 sections
basic care esomeprazole magnesium	HUMAN OTC DRUG LABEL	1	0113-0732	CAPSULE, DELAYED RELEASE	20 mg	ORAL	ANDA	15 sections
Good Sense Esomeprazole Magnesium	HUMAN OTC DRUG LABEL	1	0113-0898	CAPSULE, DELAYED RELEASE	20 mg	ORAL	ANDA	15 sections
Good Sense Esomeprazole Magnesium	HUMAN OTC DRUG LABEL	1	0113-0898	CAPSULE, DELAYED RELEASE	20 mg	ORAL	ANDA	15 sections
Esomeprazole magnesium	HUMAN PRESCRIPTION DRUG LABEL	1	0186-0382	CAPSULE, DELAYED RELEASE	20 mg	ORAL	NDA authorized generic	28 sections
Esomeprazole magnesium	HUMAN PRESCRIPTION DRUG LABEL	1	0186-0384	CAPSULE, DELAYED RELEASE	40 mg	ORAL	NDA authorized generic	28 sections
NEXIUM	HUMAN PRESCRIPTION DRUG LABEL	1	0186-4010	GRANULE, DELAYED RELEASE	10 mg	ORAL	NDA	27 sections
NEXIUM	HUMAN PRESCRIPTION DRUG LABEL	1	0186-4010	GRANULE, DELAYED RELEASE	10 mg	ORAL	NDA	27 sections
NEXIUM	HUMAN PRESCRIPTION DRUG LABEL	1	0186-4010	GRANULE, DELAYED RELEASE	10 mg	ORAL	NDA	27 sections
NEXIUM	HUMAN PRESCRIPTION DRUG LABEL	1	0186-4010	GRANULE, DELAYED RELEASE	10 mg	ORAL	NDA	27 sections
NEXIUM	HUMAN PRESCRIPTION DRUG LABEL	1	0186-4020	GRANULE, DELAYED RELEASE	20 mg	ORAL	NDA	27 sections
NEXIUM	HUMAN PRESCRIPTION DRUG LABEL	1	0186-4020	GRANULE, DELAYED RELEASE	20 mg	ORAL	NDA	27 sections
NEXIUM	HUMAN PRESCRIPTION DRUG LABEL	1	0186-4020	GRANULE, DELAYED RELEASE	20 mg	ORAL	NDA	27 sections
NEXIUM	HUMAN PRESCRIPTION DRUG LABEL	1	0186-4020	GRANULE, DELAYED RELEASE	20 mg	ORAL	NDA	27 sections
NEXIUM	HUMAN PRESCRIPTION DRUG LABEL	1	0186-4025	GRANULE, DELAYED RELEASE	2.50 mg	ORAL	NDA	27 sections
NEXIUM	HUMAN PRESCRIPTION DRUG LABEL	1	0186-4025	GRANULE, DELAYED RELEASE	2.50 mg	ORAL	NDA	27 sections
NEXIUM	HUMAN PRESCRIPTION DRUG LABEL	1	0186-4025	GRANULE, DELAYED RELEASE	2.50 mg	ORAL	NDA	27 sections
NEXIUM	HUMAN PRESCRIPTION DRUG LABEL	1	0186-4025	GRANULE, DELAYED RELEASE	2.50 mg	ORAL	NDA	27 sections
NEXIUM	HUMAN PRESCRIPTION DRUG LABEL	1	0186-4040	GRANULE, DELAYED RELEASE	40 mg	ORAL	NDA	27 sections
NEXIUM	HUMAN PRESCRIPTION DRUG LABEL	1	0186-4040	GRANULE, DELAYED RELEASE	40 mg	ORAL	NDA	27 sections
NEXIUM	HUMAN PRESCRIPTION DRUG LABEL	1	0186-4040	GRANULE, DELAYED RELEASE	40 mg	ORAL	NDA	27 sections
NEXIUM	HUMAN PRESCRIPTION DRUG LABEL	1	0186-4040	GRANULE, DELAYED RELEASE	40 mg	ORAL	NDA	27 sections
NEXIUM	HUMAN PRESCRIPTION DRUG LABEL	1	0186-4050	GRANULE, DELAYED RELEASE	5 mg	ORAL	NDA	27 sections
NEXIUM	HUMAN PRESCRIPTION DRUG LABEL	1	0186-4050	GRANULE, DELAYED RELEASE	5 mg	ORAL	NDA	27 sections