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	877.06	9.29	948	219573	41108	56030438
Pemphigus	553.54	9.29	13	220508	157199	55914347
Drug ineffective	463.23	9.29	1946	218575	917043	55154503
Glossodynia	431.45	9.29	47	220474	152411	55919135
Systemic lupus erythematosus	405.09	9.29	103	220418	179975	55891571
Maternal exposure during pregnancy	381.68	9.29	133	220388	189420	55882126
Hand deformity	376.65	9.29	43	220478	134449	55937097
Synovitis	361.36	9.29	93	220428	161212	55910334
Renal injury	334.52	9.29	278	220243	8609	56062937
Anti-cyclic citrullinated peptide antibody positive	329.49	9.29	13	220508	98587	55972959
Wound	301.49	9.29	85	220436	138719	55932827
Pericarditis	299.57	9.29	37	220484	108886	55962660
Alopecia	295.96	9.29	432	220089	293026	55778520
Acute kidney injury	290.19	9.29	1772	218749	238991	55832555
Contraindicated product administered	286.10	9.29	189	220332	186097	55885449
Gastrooesophageal reflux disease	281.42	9.29	840	219681	82417	55989129
End stage renal disease	280.97	9.29	215	220306	5896	56065650
Rheumatoid arthritis	263.53	9.29	705	219816	381899	55689647
Arthropathy	247.01	9.29	252	220269	200023	55871523
Completed suicide	241.34	9.29	111	220410	133722	55937824
Duodenal ulcer perforation	231.80	9.29	8	220513	68334	56003212
Off label use	222.49	9.29	1275	219246	554905	55516641
Discomfort	200.36	9.29	157	220364	141604	55929942
Drug intolerance	197.61	9.29	468	220053	264350	55807196
Rheumatoid factor positive	196.01	9.29	21	220500	69039	56002507
Infusion related reaction	192.01	9.29	327	220194	208604	55862942
Hepatocellular injury	190.25	9.29	359	220162	26155	56045391
Helicobacter infection	182.79	9.29	33	220488	73235	55998311
Carotid artery thrombosis	179.29	9.29	111	220410	2133	56069413
Joint swelling	176.76	9.29	565	219956	289235	55782311
Cholestasis	176.73	9.29	351	220170	26562	56044984
Treatment failure	176.35	9.29	246	220275	170146	55901400
Neurologic neglect syndrome	176.32	9.29	109	220412	2089	56069457
Swelling	171.56	9.29	433	220088	239338	55832208
Hepatic enzyme increased	165.12	9.29	260	220261	171124	55900422
Interstitial lung disease	160.92	9.29	541	219980	56522	56015024
Cholecystitis chronic	159.56	9.29	194	220327	9554	56061992
Exposure during pregnancy	158.62	9.29	180	220341	136162	55935384
Adjustment disorder	158.47	9.29	104	220417	2219	56069327
Folliculitis	155.30	9.29	17	220504	54962	56016584
Muscle injury	154.13	9.29	14	220507	52486	56019060
Hyponatraemia	147.19	9.29	789	219732	101350	55970196
Therapeutic product effect decreased	143.32	9.29	279	220242	169173	55902373
Product use issue	142.52	9.29	324	220197	185717	55885829
Personality disorder	141.31	9.29	135	220386	5038	56066508
Renal failure	133.89	9.29	815	219706	109685	55961861
Toxicity to various agents	125.81	9.29	454	220067	224110	55847436
Hemiplegia	122.77	9.29	158	220363	8246	56063300
Abdominal discomfort	120.18	9.29	618	219903	276656	55794890
Sensitisation	117.03	9.29	87	220434	2281	56069265
Peripheral swelling	115.91	9.29	499	220022	234227	55837319
Biliary dyskinesia	115.25	9.29	89	220432	2474	56069072
Fatigue	110.91	9.29	2304	218217	786248	55285298
Dysphagia	108.00	9.29	618	219903	81329	55990217
Death	107.81	9.29	839	219682	340587	55730959
Tubulointerstitial nephritis	107.79	9.29	216	220305	16449	56055097
Product use in unapproved indication	107.20	9.29	246	220275	140576	55930970
Intentional product use issue	102.11	9.29	145	220376	99588	55971958
Polycystic ovaries	99.20	9.29	91	220430	3223	56068323
Hypertensive nephropathy	92.13	9.29	44	220477	490	56071056
Ejection fraction	91.52	9.29	66	220455	1649	56069897
Blister	91.39	9.29	180	220341	108707	55962839
Coordination abnormal	90.66	9.29	171	220350	12450	56059096
Psoriatic arthropathy	90.14	9.29	94	220427	73914	55997632
Sleep disorder due to general medical condition, insomnia type	89.57	9.29	29	220492	43309	56028237
Agranulocytosis	88.53	9.29	241	220280	22418	56049128
Motor dysfunction	85.87	9.29	142	220379	9315	56062231
Affect lability	83.95	9.29	146	220375	9979	56061567
Inappropriate antidiuretic hormone secretion	81.54	9.29	172	220349	13584	56057962
Rash maculo-papular	81.41	9.29	274	220247	28633	56042913
Eosinophilia	79.90	9.29	215	220306	19862	56051684
Rhinitis allergic	77.96	9.29	128	220393	8346	56063200
Lower respiratory tract infection	76.91	9.29	214	220307	114580	55956966
C-reactive protein abnormal	75.42	9.29	25	220496	36784	56034762
Hypersensitivity	75.39	9.29	642	219879	255766	55815780
Toxic skin eruption	72.17	9.29	149	220372	11590	56059956
Pain	71.72	9.29	2015	218506	661169	55410377
Irritable bowel syndrome	71.59	9.29	98	220423	68360	56003186
Gastritis	71.11	9.29	297	220224	34405	56037141
Ill-defined disorder	69.81	9.29	100	220421	68443	56003103
Sensory loss	69.13	9.29	125	220396	8810	56062736
Abdominal pain upper	67.99	9.29	1028	219493	177285	55894261
Hypomagnesaemia	66.84	9.29	233	220288	24782	56046764
Nephrectomy	65.46	9.29	47	220474	1166	56070380
Systemic lupus erythematosus rash	65.05	9.29	57	220464	1899	56069647
Condition aggravated	64.07	9.29	958	219563	343940	55727606
Device expulsion	63.59	9.29	20	220501	30429	56041117
Drug reaction with eosinophilia and systemic symptoms	63.38	9.29	261	220260	30043	56041503
Gastric polyps	61.26	9.29	69	220452	3129	56068417
Epigastric discomfort	61.06	9.29	97	220424	6151	56065395
Hemiparesis	60.78	9.29	204	220317	21286	56050260
Rash	59.53	9.29	1474	219047	491573	55579973
Hiatus hernia	58.66	9.29	190	220331	19462	56052084
Bronchial neoplasm	58.50	9.29	31	220490	437	56071109
Hypocalcaemia	56.48	9.29	243	220278	28517	56043029
Knee arthroplasty	56.42	9.29	54	220467	44205	56027341
Hepatic cytolysis	56.29	9.29	129	220392	10777	56060769
Sleep apnoea syndrome	55.72	9.29	226	220295	25835	56045711
Eating disorder	55.30	9.29	170	220351	16935	56054611
Pleural fibrosis	55.25	9.29	68	220453	3391	56068155
Loss of employment	53.76	9.29	51	220470	1886	56069660
Gallbladder disorder	53.02	9.29	169	220352	17165	56054381
Presbyacusis	52.27	9.29	60	220461	2778	56068768
Anxiety	52.16	9.29	1054	219467	192118	55879428
Gallbladder injury	51.71	9.29	42	220479	1258	56070288
Aphasia	51.53	9.29	246	220275	30169	56041377
Pregnancy	51.33	9.29	33	220488	33000	56038546
Nephropathy	49.29	9.29	83	220438	5526	56066020
Pleural thickening	49.20	9.29	57	220464	2666	56068880
Acute generalised exanthematous pustulosis	49.04	9.29	115	220406	9754	56061792
Blood magnesium increased	48.73	9.29	59	220462	2892	56068654
Rebound acid hypersecretion	48.39	9.29	24	220497	292	56071254
Mobility decreased	47.84	9.29	212	220309	98779	55972767
Nephrogenic anaemia	46.98	9.29	47	220474	1857	56069689
Nasal turbinate hypertrophy	46.41	9.29	31	220490	682	56070864
Diabetic nephropathy	45.87	9.29	40	220481	1324	56070222
Nasopharyngitis	45.86	9.29	600	219921	220359	55851187
Abortion spontaneous	45.37	9.29	63	220458	43690	56027856
Impaired healing	45.04	9.29	181	220340	86660	55984886
Hip arthroplasty	44.87	9.29	51	220470	38572	56032974
Bronchial disorder	44.50	9.29	37	220484	1146	56070400
Angina pectoris	44.33	9.29	222	220299	27754	56043792
Arterial occlusive disease	43.54	9.29	77	220444	5333	56066213
Anaemia	43.44	9.29	1363	219158	266148	55805398
Deafness neurosensory	43.27	9.29	71	220450	4627	56066919
Bronchial haemorrhage	43.10	9.29	27	220494	530	56071016
Osteosclerosis	43.09	9.29	62	220459	3601	56067945
Live birth	42.54	9.29	12	220509	19593	56051953
Drug abuse	42.38	9.29	130	220391	67480	56004066
Cholelithiasis	42.14	9.29	282	220239	39182	56032364
Hypothyroidism	42.03	9.29	275	220246	37921	56033625
Premature delivery	40.74	9.29	28	220493	27032	56044514
Prescription form tampering	39.93	9.29	26	220495	547	56070999
Gamma-glutamyltransferase increased	39.63	9.29	232	220289	30773	56040773
Therapy non-responder	39.16	9.29	117	220404	61238	56010308
Abdominal pain	39.00	9.29	1307	219214	257498	55814048
Carpal tunnel syndrome	38.51	9.29	157	220364	17987	56053559
Pancreatitis	38.30	9.29	305	220216	44775	56026771
Pancreatitis acute	38.15	9.29	197	220324	24927	56046619
Asthenia	38.13	9.29	1675	218846	341298	55730248
Gastric disorder	37.70	9.29	241	220280	32969	56038577
Adverse drug reaction	37.53	9.29	130	220391	65002	56006544
Musculoskeletal stiffness	36.78	9.29	412	220109	155595	55915951
Cholecystitis	36.46	9.29	132	220389	14303	56057243
Axonal neuropathy	36.20	9.29	30	220491	925	56070621
Hypokalaemia	35.77	9.29	544	219977	93893	55977653
Stomatitis	35.67	9.29	302	220219	120508	55951038
Fall	35.64	9.29	1727	218794	355783	55715763
Dermatitis bullous	35.21	9.29	86	220435	7487	56064059
COVID-19	34.91	9.29	163	220358	74895	55996651
Lung disorder	34.88	9.29	337	220184	52260	56019286
Red blood cell sedimentation rate abnormal	34.39	9.29	15	220506	18658	56052888
Dysarthria	34.37	9.29	269	220252	39281	56032265
Cross sensitivity reaction	34.28	9.29	41	220480	1984	56069562
Nephritic syndrome	34.27	9.29	18	220503	249	56071297
Infection	34.11	9.29	565	219956	199641	55871905
Foetal exposure during pregnancy	33.79	9.29	50	220471	33773	56037773
Endometrial ablation	33.41	9.29	28	220493	877	56070669
Tenosynovitis stenosans	33.35	9.29	46	220475	2568	56068978
Injection site erythema	32.69	9.29	174	220347	77274	55994272
Drug resistance	32.64	9.29	20	220501	20522	56051024
Drug interaction	32.53	9.29	1063	219458	208692	55862854
Renal disorder	32.48	9.29	213	220308	29392	56042154
Impaired work ability	32.46	9.29	128	220393	14444	56057102
Dyspepsia	32.07	9.29	482	220039	82989	55988557
Iron deficiency anaemia	31.86	9.29	147	220374	17772	56053774
Intentional overdose	31.64	9.29	148	220373	67969	56003577
Phlebitis	31.50	9.29	73	220448	6143	56065403
Vascular purpura	30.90	9.29	32	220489	1318	56070228
Cholestatic liver injury	30.81	9.29	41	220480	2211	56069335
Drug hypersensitivity	30.65	9.29	832	219689	274373	55797173
Gastric antral vascular ectasia	30.22	9.29	22	220499	558	56070988
Urate nephropathy	29.92	9.29	13	220508	114	56071432
Bone cyst	29.77	9.29	39	220482	2071	56069475
Rhabdomyolysis	29.72	9.29	266	220255	40392	56031154
Caesarean section	29.52	9.29	13	220508	16078	56055468
Dry eye	29.44	9.29	240	220281	35476	56036070
Sleep disorder due to a general medical condition	29.06	9.29	90	220431	9000	56062546
Hypergastrinaemia	28.56	9.29	12	220509	96	56071450
Cell death	28.38	9.29	40	220481	2279	56069267
Palpitations	27.92	9.29	547	219974	99125	55972421
Anal abscess	27.86	9.29	55	220466	4142	56067404
Nausea	27.84	9.29	3408	217113	760770	55310776
Arthralgia	27.70	9.29	1646	218875	500023	55571523
Malnutrition	27.23	9.29	118	220403	13890	56057656
Nephritis allergic	26.89	9.29	13	220508	149	56071397
Erythema dyschromicum perstans	26.81	9.29	10	220511	56	56071490
Muscle spasticity	26.58	9.29	151	220370	19809	56051737
Respiratory tract congestion	26.33	9.29	126	220395	15465	56056081
Synovial fluid analysis	26.08	9.29	35	220486	1903	56069643
Accidental exposure to product	26.05	9.29	35	220486	24612	56046934
Muscular weakness	25.90	9.29	563	219958	103889	55967657
Sinus congestion	25.78	9.29	126	220395	15598	56055948
Occupational asthma	25.74	9.29	12	220509	126	56071420
Chest pain	25.70	9.29	947	219574	188850	55882696
Therapy interrupted	25.48	9.29	38	220483	25587	56045959
Angina bullosa haemorrhagica	25.25	9.29	12	220509	132	56071414
Blood test abnormal	25.09	9.29	108	220413	12676	56058870
Ejection fraction abnormal	25.04	9.29	26	220495	1074	56070472
Renal impairment	25.04	9.29	450	220071	80263	55991283
Bone erosion	24.61	9.29	14	220507	14960	56056586
Muscle contractions involuntary	24.54	9.29	35	220486	2016	56069530
Dry mouth	24.37	9.29	370	220151	63835	56007711
No adverse event	24.20	9.29	68	220453	36306	56035240
Face oedema	24.18	9.29	139	220382	18313	56053233
Crepitations	24.07	9.29	71	220450	6913	56064633
Eosinophilic fasciitis	23.77	9.29	12	220509	152	56071394
Gangrene	23.75	9.29	61	220460	5479	56066067
Cutaneous lupus erythematosus	23.73	9.29	39	220482	2545	56069001
Gallbladder polyp	23.56	9.29	21	220500	716	56070830
Muscle haemorrhage	23.50	9.29	42	220479	2933	56068613
Kidney infection	23.28	9.29	150	220371	20575	56050971
Macular degeneration	23.03	9.29	24	220497	18884	56052662
Rheumatoid nodule	22.91	9.29	117	220404	14740	56056806
Oesophagitis	22.59	9.29	112	220409	13945	56057601
Lip oedema	22.39	9.29	45	220476	3433	56068113
Cyst	22.11	9.29	104	220417	12674	56058872
Asthma	21.95	9.29	588	219933	112182	55959364
Mesenteric panniculitis	21.79	9.29	10	220511	101	56071445
Hypocapnia	21.73	9.29	15	220506	349	56071197
Electric shock	21.62	9.29	24	220497	1071	56070475
Scleritis	21.53	9.29	46	220475	3665	56067881
Pancreatic neuroendocrine tumour	21.47	9.29	16	220505	421	56071125
Injection site pain	21.44	9.29	326	220195	116792	55954754
Cerebral haematoma	21.40	9.29	43	220478	3280	56068266
Schizophreniform disorder	21.32	9.29	9	220512	73	56071473
General physical health deterioration	21.31	9.29	505	220016	169505	55902041
Neutropenic sepsis	21.20	9.29	17	220504	15168	56056378
Poisoning	21.03	9.29	12	220509	12801	56058745
Gastrointestinal haemorrhage	20.99	9.29	416	220105	75535	55996011
Febrile bone marrow aplasia	20.95	9.29	65	220456	6507	56065039
Gallbladder hypofunction	20.88	9.29	17	220504	511	56071035
Herpes simplex test positive	20.70	9.29	11	220510	156	56071390
Haematoma	20.66	9.29	204	220317	31815	56039731
Neurotoxicity	20.45	9.29	19	220502	15776	56055770
Dehydration	20.42	9.29	788	219733	158037	55913509
Adverse event	20.38	9.29	130	220391	55246	56016300
Flatulence	20.02	9.29	199	220322	31089	56040457
Oesophageal dilatation	19.97	9.29	14	220507	334	56071212
Nephrosclerosis	19.95	9.29	22	220499	974	56070572
Cholecystectomy	19.92	9.29	83	220438	9601	56061945
Subacute cutaneous lupus erythematosus	19.64	9.29	34	220487	2315	56069231
Blood alkaline phosphatase increased	19.53	9.29	236	220285	38709	56032837
Contusion	19.45	9.29	370	220151	128060	55943486
Hepatic steatosis	19.41	9.29	172	220349	26042	56045504
Burning sensation	19.40	9.29	283	220238	48413	56023133
Supraventricular extrasystoles	19.38	9.29	47	220474	4073	56067473
Type 2 diabetes mellitus	19.38	9.29	106	220415	46756	56024790
Gastrointestinal motility disorder	19.33	9.29	51	220470	4655	56066891
Haemoglobin decreased	19.30	9.29	674	219847	133463	55938083
Myelosuppression	19.26	9.29	24	220497	17431	56054115
Medication error	19.06	9.29	93	220428	42242	56029304
Tetany	18.97	9.29	28	220493	1664	56069882
Haematotoxicity	18.43	9.29	5	220516	8378	56063168
Liver function test increased	18.42	9.29	53	220468	28080	56043466
Small cell carcinoma	18.38	9.29	10	220511	149	56071397
International normalised ratio increased	18.36	9.29	258	220263	43783	56027763
Therapeutic response decreased	18.34	9.29	126	220395	52632	56018914
Rectosigmoid cancer	18.32	9.29	10	220511	150	56071396
Hepatitis cholestatic	18.23	9.29	61	220460	6353	56065193
Hepatotoxicity	18.06	9.29	62	220459	31091	56040455
Acute hepatitis B	17.95	9.29	13	220508	327	56071219
Pneumobilia	17.83	9.29	9	220512	114	56071432
Bradypnoea	17.78	9.29	39	220482	3164	56068382
Congenital osteodystrophy	17.52	9.29	6	220515	25	56071521
Anaemia macrocytic	17.47	9.29	38	220483	3065	56068481
Bile duct stone	17.36	9.29	40	220481	3354	56068192
Normal newborn	17.31	9.29	4	220517	7466	56064080
Gastric ulcer	17.21	9.29	149	220372	22414	56049132
Nerve injury	17.15	9.29	75	220446	8862	56062684
Hyperchlorhydria	17.07	9.29	26	220495	1589	56069957
Drug eruption	17.04	9.29	165	220356	25598	56045948
Device dependence	16.96	9.29	5	220516	11	56071535
Livedo reticularis	16.95	9.29	31	220490	2204	56069342
Ulcer	16.89	9.29	148	220373	22337	56049209
Erosive oesophagitis	16.77	9.29	26	220495	1614	56069932
Muscle swelling	16.75	9.29	14	220507	437	56071109
Osteopenia	16.66	9.29	125	220396	18016	56053530
Sedation	16.61	9.29	75	220446	34779	56036767
Bunion operation	16.58	9.29	22	220499	1183	56070363
Eczema	16.57	9.29	166	220355	25987	56045559
Injection site bruising	16.56	9.29	86	220435	38435	56033111
Emotional distress	16.55	9.29	184	220337	29579	56041967
IIIrd nerve paresis	16.49	9.29	9	220512	135	56071411
Anaemia folate deficiency	16.48	9.29	10	220511	185	56071361
Mixed liver injury	16.47	9.29	43	220478	3901	56067645
Pathological fracture	16.39	9.29	69	220452	8020	56063526
Genital infection female	16.37	9.29	8	220513	94	56071452
Arterial spasm	16.35	9.29	7	220514	59	56071487
Hunger	16.34	9.29	48	220473	4663	56066883
Diverticulum	16.27	9.29	86	220435	10980	56060566
Injection site swelling	16.19	9.29	102	220419	43476	56028070
Skin lesion	16.14	9.29	175	220346	27960	56043586
Vertigo	16.13	9.29	302	220219	54270	56017276
Cerebrovascular accident	16.12	9.29	506	220015	98764	55972782
Angina unstable	16.08	9.29	61	220460	6760	56064786
Oesophageal polyp	15.96	9.29	4	220517	3	56071543
Tooth infection	15.88	9.29	111	220410	15641	56055905
Non-economic loss	15.86	9.29	5	220516	15	56071531
Escherichia pyelonephritis	15.79	9.29	13	220508	397	56071149
Jaundice	15.76	9.29	170	220351	27124	56044422
Cardiac disorder	15.73	9.29	260	220261	45627	56025919
Injection site pruritus	15.66	9.29	98	220423	41833	56029713
Nasal discharge discolouration	15.58	9.29	27	220494	1840	56069706
Renal cyst	15.55	9.29	75	220446	9234	56062312
Photophobia	15.54	9.29	112	220409	15938	56055608
Blood chromogranin A increased	15.49	9.29	11	220510	268	56071278
Angioedema	15.38	9.29	238	220283	41215	56030331
Transient ischaemic attack	15.35	9.29	200	220321	33377	56038169
Rhonchi	15.35	9.29	31	220490	2373	56069173
Prescribed overdose	15.34	9.29	41	220480	22255	56049291
Blood potassium increased	15.33	9.29	118	220403	17143	56054403
Deformity	15.28	9.29	80	220441	10175	56061371
Prothrombin time ratio decreased	15.28	9.29	13	220508	416	56071130
Chondrocalcinosis pyrophosphate	15.17	9.29	21	220500	1176	56070370
Pancreatitis chronic	15.15	9.29	30	220491	2264	56069282
Oesophagitis ulcerative	15.14	9.29	14	220507	501	56071045
Proteinuria	14.99	9.29	119	220402	17451	56054095
Early satiety	14.99	9.29	18	220503	875	56070671
Adenocarcinoma gastric	14.93	9.29	14	220507	510	56071036
Thrombocytopenia	14.80	9.29	664	219857	135560	55935986
Weight increased	14.79	9.29	742	219779	228961	55842585
Therapy partial responder	14.74	9.29	6	220515	7779	56063767
Keratoacanthoma	14.69	9.29	13	220508	439	56071107
Dialysis	14.68	9.29	76	220445	9626	56061920
Cerebellar haematoma	14.67	9.29	12	220509	363	56071183
Product dose omission issue	14.65	9.29	654	219867	204099	55867447
Premature labour	14.56	9.29	15	220506	11867	56059679
Synovial cyst	14.51	9.29	73	220448	9141	56062405
Meningitis aseptic	14.48	9.29	44	220477	4355	56067191
Renal tubular disorder	14.46	9.29	31	220490	2475	56069071
Disease progression	14.42	9.29	308	220213	104865	55966681
Eyelid oedema	14.42	9.29	76	220445	9692	56061854
Hyperparathyroidism secondary	14.30	9.29	22	220499	1357	56070189
Sudden death	14.29	9.29	75	220446	9550	56061996
Drug tolerance decreased	14.22	9.29	19	220502	13392	56058154
Neutropenia	14.19	9.29	492	220029	157675	55913871
Pleuritic pain	14.14	9.29	60	220461	6997	56064549
Hepatitis	14.13	9.29	206	220315	35235	56036311
Hyperthermia	14.02	9.29	67	220454	8218	56063328
Melaena	14.00	9.29	171	220350	28119	56043427
Ingrowing nail	13.92	9.29	28	220493	2137	56069409
Body temperature increased	13.86	9.29	78	220443	34164	56037382
Pre-eclampsia	13.85	9.29	8	220513	8478	56063068
Dermatitis exfoliative	13.85	9.29	49	220472	5250	56066296
Protein-losing gastroenteropathy	13.84	9.29	9	220512	189	56071357
Uveal melanoma	13.82	9.29	4	220517	8	56071538
Calcium metabolism disorder	13.78	9.29	8	220513	136	56071410
Chronic cutaneous lupus erythematosus	13.76	9.29	10	220511	253	56071293
Oedema peripheral	13.75	9.29	811	219710	170443	55901103
Purging	13.67	9.29	6	220515	54	56071492
Haemorrhoids	13.66	9.29	130	220391	20076	56051470
Gastrinoma	13.64	9.29	3	220518	0	56071546
Erythema	13.59	9.29	744	219777	155195	55916351
Type I hypersensitivity	13.56	9.29	30	220491	2448	56069098
Gastrointestinal tract mucosal pigmentation	13.47	9.29	14	220507	579	56070967
Multi-organ disorder	13.45	9.29	21	220500	1312	56070234
Renal hypertrophy	13.41	9.29	5	220516	28	56071518
Faeces discoloured	13.36	9.29	113	220408	16883	56054663
Teeth brittle	13.35	9.29	13	220508	497	56071049
Vitamin B12 decreased	13.33	9.29	34	220487	3041	56068505
Illness	13.23	9.29	80	220441	34431	56037115
Hypoplastic anaemia	13.21	9.29	4	220517	10	56071536
Abortion induced	13.21	9.29	11	220510	9634	56061912
Creatinine renal clearance decreased	13.15	9.29	23	220498	14536	56057010
Hyponatraemic seizure	13.13	9.29	12	220509	423	56071123
Musculoskeletal chest pain	13.09	9.29	126	220395	19515	56052031
Liver injury	13.08	9.29	103	220418	41745	56029801
Lordosis	13.07	9.29	10	220511	274	56071272
Brucellosis	13.04	9.29	6	220515	61	56071485
Renal haemangioma	12.98	9.29	5	220516	31	56071515
Atelectasis	12.94	9.29	124	220397	19184	56052362
Intestinal infarction	12.94	9.29	18	220503	1013	56070533
Campylobacter colitis	12.85	9.29	5	220516	32	56071514
Female sterilisation	12.82	9.29	13	220508	522	56071024
Chest discomfort	12.82	9.29	491	220030	98366	55973180
Antinuclear antibody positive	12.82	9.29	57	220464	6784	56064762
Bladder sphincter atony	12.77	9.29	8	220513	157	56071389
Renal atrophy	12.76	9.29	21	220500	1372	56070174
Thymus disorder	12.74	9.29	10	220511	285	56071261
Sinus bradycardia	12.70	9.29	94	220427	13492	56058054
Lipase increased	12.67	9.29	69	220452	8910	56062636
Congenital bowing of long bones	12.63	9.29	6	220515	66	56071480
Hyperlipasaemia	12.62	9.29	13	220508	532	56071014
Rash scarlatiniform	12.60	9.29	7	220514	109	56071437
Clinically isolated syndrome	12.59	9.29	5	220516	34	56071512
Musculoskeletal disorder	12.58	9.29	36	220485	19111	56052435
Eructation	12.58	9.29	61	220460	7527	56064019
Renal tubular necrosis	12.55	9.29	79	220442	10749	56060797
Hyperkalaemia	12.55	9.29	274	220247	50591	56020955
Sneezing	12.52	9.29	104	220417	15456	56056090
Bursitis	12.49	9.29	164	220357	27418	56044128
Monoclonal gammopathy	12.48	9.29	14	220507	632	56070914
Immunodeficiency	12.46	9.29	28	220493	16129	56055417
Disability	12.46	9.29	27	220494	15753	56055793
Hyperphosphatasaemia	12.45	9.29	4	220517	13	56071533
Rectal haemorrhage	12.44	9.29	230	220291	41237	56030309
Malabsorption	12.37	9.29	38	220483	3783	56067763
Sinus disorder	12.37	9.29	130	220391	20604	56050942
Paranasal sinus inflammation	12.34	9.29	12	220509	458	56071088
Infusion site scar	12.32	9.29	11	220510	376	56071170
Tongue oedema	12.28	9.29	39	220482	3953	56067593
Purpura	12.26	9.29	76	220445	10286	56061260
Gastrointestinal ischaemia	12.14	9.29	8	220513	172	56071374
Obesity	12.14	9.29	46	220475	22402	56049144
Intervertebral discitis	12.13	9.29	31	220490	2776	56068770
Aspartate aminotransferase increased	12.11	9.29	416	220105	82186	55989360
Regurgitation	12.10	9.29	21	220500	1433	56070113
Complication of device insertion	12.09	9.29	5	220516	6419	56065127
Hypoosmolar state	12.02	9.29	8	220513	175	56071371
Coronary artery occlusion	12.01	9.29	61	220460	7668	56063878
Neurosis	11.94	9.29	9	220512	241	56071305
Diarrhoea	11.92	9.29	2748	217773	635759	55435787
Essential hypertension	11.92	9.29	43	220478	4650	56066896
Poor personal hygiene	11.86	9.29	10	220511	316	56071230
Drug ineffective for unapproved indication	11.82	9.29	56	220465	25637	56045909
Device dislocation	11.79	9.29	47	220474	22559	56048987
Maternal exposure before pregnancy	11.77	9.29	6	220515	6817	56064729
Allergy to chemicals	11.71	9.29	28	220493	2405	56069141
Dilatation atrial	11.69	9.29	24	220497	1859	56069687
Wrong technique in product usage process	11.66	9.29	159	220362	58009	56013537
Crystal arthropathy	11.66	9.29	9	220512	250	56071296
Aeromonas infection	11.62	9.29	6	220515	80	56071466
Hypofibrinogenaemia	11.59	9.29	18	220503	1119	56070427
Hypoparathyroidism secondary	11.59	9.29	5	220516	43	56071503
Vitreous detachment	11.59	9.29	24	220497	1871	56069675
Platelet adhesiveness decreased	11.57	9.29	3	220518	3	56071543
Gastric adenoma	11.57	9.29	3	220518	3	56071543
Colitis ischaemic	11.55	9.29	73	220448	9947	56061599
Colitis	11.55	9.29	229	220292	41582	56029964
Atrioventricular block complete	11.54	9.29	59	220462	7435	56064111
Loss of personal independence in daily activities	11.53	9.29	237	220284	81132	55990414
Rhinalgia	11.50	9.29	18	220503	1127	56070419
Breast cancer stage I	11.48	9.29	5	220516	6225	56065321
Unintentional medical device removal	11.43	9.29	4	220517	5690	56065856
Muscle enzyme increased	11.42	9.29	7	220514	132	56071414
Polyglandular autoimmune syndrome type II	11.40	9.29	5	220516	45	56071501
Hypertensive crisis	11.39	9.29	94	220427	13942	56057604
Enterocolitis haemorrhagic	11.35	9.29	20	220501	1381	56070165
Dysphonia	11.33	9.29	229	220292	41718	56029828
Therapeutic response shortened	11.33	9.29	12	220509	9374	56062172
Gastric ulcer haemorrhage	11.29	9.29	42	220479	4611	56066935
Retinal artery occlusion	11.25	9.29	21	220500	1517	56070029
Stent placement	11.21	9.29	35	220486	3516	56068030
Septic shock	11.21	9.29	315	220206	60520	56011026
Vulvovaginal burning sensation	11.19	9.29	22	220499	1652	56069894
Hepatic function abnormal	11.18	9.29	194	220327	34364	56037182
Tachycardia paroxysmal	11.15	9.29	9	220512	267	56071279
Purpura senile	11.15	9.29	12	220509	517	56071029
Vulval disorder	11.10	9.29	14	220507	716	56070830
Rectal cancer metastatic	11.07	9.29	9	220512	270	56071276
Blood thyroid stimulating hormone increased	11.05	9.29	53	220468	6510	56065036
Finger deformity	11.02	9.29	6	220515	6571	56064975
Anaemia vitamin B12 deficiency	11.02	9.29	10	220511	349	56071197
Blood magnesium decreased	11.01	9.29	82	220439	11792	56059754
Nikolsky's sign	10.94	9.29	6	220515	91	56071455
Dysgeusia	10.93	9.29	223	220298	40692	56030854
Dermatosis	10.93	9.29	9	220512	275	56071271
Purple glove syndrome	10.92	9.29	8	220513	205	56071341
Hypoparathyroidism	10.90	9.29	13	220508	627	56070919
Diverticulum oesophageal	10.89	9.29	7	220514	144	56071402
Iron deficiency	10.88	9.29	51	220470	6205	56065341
Dystonia	10.88	9.29	20	220501	12401	56059145
Dysuria	10.86	9.29	175	220346	30554	56040992
Acute sinusitis	10.84	9.29	35	220486	3578	56067968
Thrombocytopenic purpura	10.84	9.29	19	220502	1307	56070239
Seizure	10.80	9.29	391	220130	124728	55946818
Lumbar spinal stenosis	10.79	9.29	40	220481	4383	56067163
Blood gastrin increased	10.78	9.29	4	220517	22	56071524
Throat irritation	10.77	9.29	184	220337	32499	56039047
Bicytopenia	10.75	9.29	25	220496	2108	56069438
Heat stroke	10.74	9.29	14	220507	740	56070806
Affective disorder	10.74	9.29	47	220474	5556	56065990
Concussion	10.73	9.29	62	220459	8184	56063362
Renal hypertension	10.72	9.29	7	220514	148	56071398
Gastric haemorrhage	10.72	9.29	49	220472	5901	56065645
Gastrointestinal disorder	10.71	9.29	348	220173	112354	55959192
Laboratory test abnormal	10.69	9.29	55	220466	24640	56046906
Acute cutaneous lupus erythematosus	10.66	9.29	9	220512	285	56071261
Cholangitis	10.64	9.29	43	220478	4906	56066640
Vulvovaginal inflammation	10.61	9.29	14	220507	749	56070797
Transplant rejection	10.60	9.29	14	220507	9920	56061626
Oesophageal ulcer	10.58	9.29	38	220483	4101	56067445
Gastric cancer	10.55	9.29	37	220484	3946	56067600
Acute coronary syndrome	10.54	9.29	70	220451	9698	56061848
Dislocation of vertebra	10.54	9.29	4	220517	5411	56066135
Carnitine deficiency	10.52	9.29	7	220514	153	56071393
Placental calcification	10.50	9.29	4	220517	24	56071522
Oedema mouth	10.49	9.29	26	220495	2284	56069262
Dyslipidaemia	10.48	9.29	51	220470	6302	56065244
Cholecystitis acute	10.47	9.29	57	220464	7359	56064187
Pyelonephritis acute	10.44	9.29	39	220482	4290	56067256
Antipsychotic drug level above therapeutic	10.42	9.29	16	220505	985	56070561
Acute myeloid leukaemia	10.37	9.29	33	220488	16939	56054607
Bronchopneumopathy	10.37	9.29	8	220513	222	56071324
Hepatobiliary scan abnormal	10.37	9.29	5	220516	57	56071489
Cardiothoracic ratio increased	10.36	9.29	4	220517	25	56071521
Resorption bone increased	10.33	9.29	18	220503	1232	56070314
Vomiting	10.33	9.29	2155	218366	496073	55575473
Pulmonary embolism	10.32	9.29	516	220005	106608	55964938
Abdominal adhesions	10.31	9.29	30	220491	2899	56068647
Peripheral artery thrombosis	10.28	9.29	22	220499	1755	56069791
Renal infarct	10.27	9.29	19	220502	1363	56070183
Tongue pruritus	10.24	9.29	11	220510	473	56071073
Eye haematoma	10.23	9.29	4	220517	26	56071520
Pulmonary artery stenosis	10.21	9.29	7	220514	161	56071385
Crohn's disease	10.18	9.29	51	220470	6376	56065170
Deep vein thrombosis	10.14	9.29	383	220138	76594	55994952
Skin haemorrhage	10.14	9.29	62	220459	8351	56063195
Tonic clonic movements	10.12	9.29	18	220503	1252	56070294
Portal vein dilatation	10.10	9.29	4	220517	27	56071519
Language disorder	10.06	9.29	23	220498	1918	56069628
Respiratory depression	10.05	9.29	21	220500	12414	56059132
Fracture nonunion	10.04	9.29	25	220496	2202	56069344
Erythema multiforme	10.03	9.29	68	220453	9486	56062060
Breast cancer stage II	10.02	9.29	5	220516	5753	56065793
Tri-iodothyronine free decreased	10.02	9.29	9	220512	310	56071236
Cough	10.00	9.29	1164	219357	258797	55812749
Fungal oesophagitis	9.95	9.29	12	220509	586	56070960
Blood loss anaemia	9.91	9.29	61	220460	8236	56063310
Urinary incontinence	9.91	9.29	167	220354	29418	56042128
Hypoxic-ischaemic encephalopathy	9.90	9.29	36	220485	3909	56067637
Atypical fracture	9.85	9.29	12	220509	592	56070954
Vagus nerve disorder	9.84	9.29	6	220515	112	56071434
Small intestinal stenosis	9.83	9.29	11	220510	495	56071051
Unintended pregnancy	9.83	9.29	4	220517	5187	56066359
Hypertriglyceridaemia	9.82	9.29	47	220474	5769	56065777
Spinal osteoarthritis	9.80	9.29	95	220426	14741	56056805
Renal lymphocele	9.79	9.29	5	220516	65	56071481
Arterial fibrosis	9.77	9.29	3	220518	8	56071538
Coma acidotic	9.75	9.29	6	220515	114	56071432
Renal tuberculosis	9.74	9.29	4	220517	30	56071516
Oesophageal irritation	9.70	9.29	6	220515	115	56071431
Mandibular mass	9.70	9.29	7	220514	175	56071371
Subdural haematoma	9.70	9.29	88	220433	13411	56058135
Blood creatine phosphokinase decreased	9.69	9.29	10	220511	410	56071136
Rhinitis	9.69	9.29	64	220457	8852	56062694
Liver abscess	9.67	9.29	28	220493	2698	56068848
Grip strength decreased	9.66	9.29	32	220489	16224	56055322
Lichen planus	9.61	9.29	24	220497	2118	56069428
Neuroleptic malignant syndrome	9.60	9.29	19	220502	11459	56060087
Microcytic anaemia	9.59	9.29	31	220490	3171	56068375
Low turnover osteopathy	9.57	9.29	36	220485	3972	56067574
Actinic keratosis	9.56	9.29	25	220496	2270	56069276
Blood cholesterol increased	9.53	9.29	214	220307	72365	55999181
Therapy cessation	9.53	9.29	65	220456	27199	56044347
Haemorrhagic cyst	9.50	9.29	7	220514	181	56071365
Diverticulum intestinal	9.43	9.29	50	220471	6390	56065156
Body height decreased	9.42	9.29	65	220456	9120	56062426
Renal tubular atrophy	9.39	9.29	13	220508	728	56070818
Biliary colic	9.36	9.29	32	220489	3370	56068176
Tenosynovitis	9.35	9.29	82	220439	12379	56059167
Vertigo positional	9.32	9.29	27	220494	2602	56068944
Vitamin B12 deficiency	9.31	9.29	38	220483	4355	56067191

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	552.21	10.03	728	129143	37247	31530226
Toxicity to various agents	218.76	10.03	253	129618	181234	31386239
End stage renal disease	201.38	10.03	205	129666	7904	31559569
Death	194.66	10.03	790	129081	359779	31207694
Drug abuse	190.69	10.03	61	129810	87697	31479776
Acute kidney injury	187.77	10.03	1858	128013	277856	31289617
Drug ineffective	178.85	10.03	925	128946	394648	31172825
Completed suicide	161.18	10.03	87	129784	91427	31476046
Cholestasis	152.21	10.03	325	129546	24750	31542723
Gastrooesophageal reflux disease	142.79	10.03	381	129490	33490	31533983
Off label use	142.55	10.03	838	129033	346436	31221037
Hepatocellular injury	139.82	10.03	287	129584	21257	31546216
Toxic skin eruption	130.88	10.03	184	129687	9996	31557477
Renal injury	130.10	10.03	188	129683	10477	31556996
Interstitial lung disease	129.76	10.03	547	129324	60856	31506617
Hypomagnesaemia	95.56	10.03	229	129642	18829	31548644
Eosinophilia	92.41	10.03	256	129615	22997	31544476
Agranulocytosis	80.59	10.03	230	129641	21017	31546456
Hypocalcaemia	76.74	10.03	231	129640	21747	31545726
Hepatic cytolysis	75.97	10.03	149	129722	10674	31556799
Treatment failure	75.93	10.03	36	129835	40756	31526717
Renal failure	68.64	10.03	790	129081	122540	31444933
Product use in unapproved indication	66.15	10.03	198	129673	98973	31468500
Nephrogenic anaemia	65.07	10.03	60	129811	2043	31565430
Tubulointerstitial nephritis	64.20	10.03	194	129677	18302	31549171
Foetal exposure during pregnancy	59.55	10.03	48	129823	40828	31526645
Occult blood	55.02	10.03	34	129837	621	31566852
COVID-19	54.23	10.03	88	129783	54733	31512740
Hypertensive nephropathy	49.39	10.03	28	129843	433	31567040
Hepatojugular reflux	49.22	10.03	30	129841	534	31566939
Drug reaction with eosinophilia and systemic symptoms	48.98	10.03	248	129623	29770	31537703
Pancreatitis acute	48.64	10.03	221	129650	25379	31542094
Hyperkalaemia	47.08	10.03	436	129435	63915	31503558
Gamma-glutamyltransferase increased	45.48	10.03	230	129641	27595	31539878
Drug resistance	44.72	10.03	20	129851	23433	31544040
Hypergastrinaemia	43.83	10.03	15	129856	59	31567414
Jaundice	41.79	10.03	239	129632	30048	31537425
Ventricular hypokinesia	41.05	10.03	72	129799	4734	31562739
Electrocardiogram Q wave abnormal	39.56	10.03	23	129848	374	31567099
Degenerative mitral valve disease	39.49	10.03	19	129852	205	31567268
Nephropathy	39.14	10.03	76	129795	5403	31562070
Rash maculo-papular	37.51	10.03	206	129665	25513	31541960
Nicotine dependence	37.11	10.03	24	129847	476	31566997
Lung disorder	37.01	10.03	243	129628	32069	31535404
Colitis microscopic	36.31	10.03	43	129828	1967	31565506
Hepatitis cholestatic	35.96	10.03	86	129785	7060	31560413
Thrombocytopenia	35.63	10.03	800	129071	141947	31425526
Systolic dysfunction	35.02	10.03	46	129825	2340	31565133
Pulmonary vascular disorder	34.64	10.03	25	129846	597	31566876
Product dose omission issue	34.03	10.03	273	129598	105313	31462160
Cholestatic liver injury	33.98	10.03	41	129830	1913	31565560
Gastric polyps	33.73	10.03	31	129840	1051	31566422
Cell death	33.26	10.03	42	129829	2054	31565419
Intentional product use issue	33.25	10.03	98	129773	49249	31518224
Vascular purpura	32.94	10.03	35	129836	1419	31566054
Hiatus hernia	32.19	10.03	81	129790	6866	31560607
Chronic kidney disease-mineral and bone disorder	31.95	10.03	20	129851	374	31567099
Drug intolerance	31.79	10.03	108	129763	51925	31515548
Diabetic nephropathy	31.28	10.03	40	129831	1981	31565492
Hyponatraemia	30.97	10.03	449	129422	73350	31494123
Hypokalaemia	30.56	10.03	345	129526	53229	31514244
Eye injury	28.34	10.03	23	129848	657	31566816
Mixed liver injury	28.21	10.03	41	129830	2296	31565177
Intentional overdose	28.03	10.03	82	129789	41307	31526166
Hemiplegia	27.69	10.03	75	129796	6647	31560826
Therapy non-responder	27.52	10.03	61	129810	33750	31533723
Drug hypersensitivity	26.10	10.03	182	129689	72417	31495056
Drug ineffective for unapproved indication	25.77	10.03	21	129850	17769	31549704
Physical deconditioning	25.68	10.03	25	129846	912	31566561
Eosinophilic colitis	25.30	10.03	14	129857	206	31567267
Therapeutic product effect incomplete	25.15	10.03	93	129778	43603	31523870
Disease progression	25.12	10.03	243	129628	90221	31477252
Face oedema	24.31	10.03	97	129774	10519	31556954
Occupational dermatitis	24.27	10.03	10	129861	72	31567401
Anaemia macrocytic	24.19	10.03	43	129828	2857	31564616
Eczema	24.19	10.03	126	129745	15291	31552182
Inferior vena cava dilatation	24.07	10.03	21	129850	664	31566809
Rhabdomyolysis	24.03	10.03	380	129491	63201	31504272
Ocular myasthenia	24.00	10.03	14	129857	229	31567244
Granulomatous rosacea	23.54	10.03	12	129859	148	31567325
Tubulointerstitial nephritis and uveitis syndrome	23.37	10.03	10	129861	80	31567393
Cholangitis	23.36	10.03	79	129792	7907	31559566
Gastroenteritis eosinophilic	23.33	10.03	12	129859	151	31567322
Pain	23.24	10.03	585	129286	186174	31381299
Hypophosphataemic osteomalacia	22.84	10.03	11	129860	119	31567354
Idiopathic pulmonary fibrosis	22.19	10.03	51	129820	4079	31563394
Chest pain	21.93	10.03	631	129240	116326	31451147
Overlap syndrome	21.89	10.03	10	129861	95	31567378
Brain scan abnormal	21.86	10.03	22	129849	836	31566637
Device dependence	21.84	10.03	8	129863	40	31567433
Renal cyst	21.82	10.03	80	129791	8336	31559137
Cardiac failure	21.50	10.03	482	129389	85471	31482002
Hyperchlorhydria	21.25	10.03	19	129852	621	31566852
Dermatitis bullous	21.19	10.03	65	129806	6180	31561293
Peripheral swelling	21.15	10.03	177	129694	67688	31499785
Dyspepsia	21.06	10.03	215	129656	32338	31535135
Ureteric compression	21.01	10.03	13	129858	238	31567235
Contraindicated product administered	20.24	10.03	31	129840	19741	31547732
Hyperthermia	20.23	10.03	88	129783	9916	31557557
Radiation pneumonitis	20.08	10.03	36	129835	2408	31565065
Acute pulmonary oedema	19.83	10.03	69	129802	7007	31560466
Gastric cancer	19.66	10.03	62	129809	5983	31561490
Helicobacter test positive	19.64	10.03	20	129851	771	31566702
Adverse drug reaction	19.28	10.03	47	129824	25154	31542319
Plasma cell myeloma	19.21	10.03	144	129727	56387	31511086
Injection site pain	19.10	10.03	75	129796	34559	31532914
Low birth weight baby	18.80	10.03	3	129868	6967	31560506
Acute generalised exanthematous pustulosis	18.78	10.03	61	129810	5979	31561494
Therapy interrupted	18.74	10.03	10	129861	10586	31556887
Cross sensitivity reaction	18.64	10.03	25	129846	1298	31566175
Occupational exposure to air contaminants	18.57	10.03	10	129861	139	31567334
Cardiac aneurysm	18.38	10.03	20	129851	833	31566640
Fixed eruption	18.28	10.03	26	129845	1427	31566046
Mitral valve incompetence	18.23	10.03	109	129762	13924	31553549
Phaeochromocytoma malignant	17.89	10.03	8	129863	72	31567401
Premature baby	17.85	10.03	29	129842	18037	31549436
Hepatic haematoma	17.83	10.03	14	129857	381	31567092
Hyperkaliuria	17.73	10.03	9	129862	110	31567363
Multiple sclerosis relapse	17.72	10.03	14	129857	12033	31555440
Acute coronary syndrome	17.69	10.03	101	129770	12688	31554785
Circumoral oedema	17.66	10.03	7	129864	45	31567428
Cardiac arrest	17.51	10.03	258	129613	88804	31478669
Febrile bone marrow aplasia	17.41	10.03	71	129800	7775	31559698
Craniotabes	17.40	10.03	5	129866	9	31567464
Hypoparathyroidism	17.34	10.03	16	129855	545	31566928
Hospitalisation	17.34	10.03	126	129745	49681	31517792
Duodenal polyp	17.33	10.03	11	129860	211	31567262
Respiratory distress	17.32	10.03	212	129659	33341	31534132
Haematotoxicity	17.29	10.03	4	129867	7133	31560340
Pathogen resistance	17.26	10.03	7	129864	8694	31558779
Helicobacter gastritis	17.25	10.03	23	129848	1187	31566286
Carotid arteriosclerosis	17.23	10.03	28	129843	1729	31565744
Inappropriate antidiuretic hormone secretion	17.13	10.03	92	129779	11295	31556178
Essential hypertension	17.04	10.03	35	129836	2592	31564881
Type III immune complex mediated reaction	16.68	10.03	12	129859	285	31567188
Myelosuppression	16.65	10.03	22	129849	14898	31552575
Anaemia	16.59	10.03	1050	128821	212472	31355001
Anticoagulation drug level increased	16.51	10.03	15	129856	501	31566972
Oesophagitis ulcerative	16.45	10.03	17	129854	667	31566806
Weight increased	16.40	10.03	240	129631	82707	31484766
Xerosis	16.38	10.03	15	129856	506	31566967
Nerve degeneration	16.36	10.03	10	129861	179	31567294
Joint swelling	16.36	10.03	140	129731	53291	31514182
Abdominal pain upper	16.34	10.03	360	129511	63642	31503831
Vitamin B12 deficiency	16.27	10.03	41	129830	3478	31563995
Aggression	16.25	10.03	88	129783	37203	31530270
Dermatitis exfoliative	16.23	10.03	61	129810	6431	31561042
Hypovitaminosis	16.21	10.03	15	129856	513	31566960
Ischaemic stroke	16.13	10.03	122	129749	16849	31550624
Duodenitis	16.12	10.03	46	129825	4202	31563271
Sudden death	16.11	10.03	108	129763	14349	31553124
Neurotoxicity	16.08	10.03	26	129845	16200	31551273
Hepatitis	15.86	10.03	149	129722	21917	31545556
Cardiac failure congestive	15.59	10.03	230	129641	79157	31488316
Respiratory depression	15.59	10.03	22	129849	14488	31552985
Carotid artery stenosis	15.40	10.03	48	129823	4604	31562869
Poisoning	15.38	10.03	12	129859	10379	31557094
Eosinophilic oesophagitis	15.37	10.03	11	129860	259	31567214
Brief psychotic disorder with marked stressors	15.30	10.03	10	129861	202	31567271
Loss of personal independence in daily activities	15.13	10.03	62	129809	28226	31539247
Nipple swelling	15.06	10.03	8	129863	108	31567365
Neuroleptic malignant syndrome	14.94	10.03	29	129842	16840	31550633
Hyperkinetic heart syndrome	14.93	10.03	8	129863	110	31567363
Cerebral artery thrombosis	14.92	10.03	17	129854	746	31566727
Lethargy	14.82	10.03	95	129776	38546	31528927
Immune-mediated hepatic disorder	14.78	10.03	15	129856	576	31566897
Intentional product misuse	14.71	10.03	93	129778	37858	31529615
Jaundice cholestatic	14.68	10.03	46	129825	4424	31563049
Hypotension	14.66	10.03	687	129184	203931	31363542
Eructation	14.65	10.03	44	129827	4135	31563338
Venoocclusive liver disease	14.64	10.03	6	129865	7406	31560067
Gastritis	14.58	10.03	137	129734	20155	31547318
Hepatic encephalopathy	14.56	10.03	101	129770	13570	31553903
Tachycardia	14.55	10.03	222	129649	75985	31491488
Renal haemangioma	14.54	10.03	5	129866	20	31567453
Sensitisation	14.53	10.03	9	129862	165	31567308
Antiphospholipid antibodies positive	14.34	10.03	11	129860	289	31567184
Haematoma muscle	14.31	10.03	21	129850	1186	31566287
High frequency ablation	14.30	10.03	9	129862	170	31567303
Coronary artery stenosis	14.26	10.03	73	129798	8797	31558676
Prurigo	14.18	10.03	15	129856	605	31566868
Fatigue	14.15	10.03	1182	128689	334024	31233449
Peripheral venous disease	14.12	10.03	31	129840	2405	31565068
Immune reconstitution inflammatory syndrome	14.05	10.03	8	129863	8170	31559303
Psoriasis	14.04	10.03	123	129748	46596	31520877
Ventricular arrhythmia	13.97	10.03	48	129823	4843	31562630
No adverse event	13.93	10.03	38	129833	19587	31547886
Ventricular enlargement	13.89	10.03	13	129858	451	31567022
Blood alkaline phosphatase increased	13.89	10.03	183	129688	29270	31538203
Accidental exposure to product	13.83	10.03	16	129855	11479	31555994
Fracture delayed union	13.81	10.03	6	129865	50	31567423
Psychotic disorder	13.79	10.03	46	129825	22247	31545226
Echocardiogram abnormal	13.76	10.03	18	129853	912	31566561
Mucormycosis	13.74	10.03	3	129868	5567	31561906
Essential tremor	13.74	10.03	16	129855	719	31566754
Pancreatitis	13.59	10.03	214	129657	35557	31531916
Benign abdominal neoplasm	13.55	10.03	7	129864	89	31567384
Oesophageal adenocarcinoma	13.52	10.03	17	129854	828	31566645
Muscle haemorrhage	13.51	10.03	38	129833	3442	31564031
Bronchial injury	13.51	10.03	3	129868	0	31567473
Acquired cystic kidney disease	13.51	10.03	3	129868	0	31567473
Stevens-Johnson syndrome	13.35	10.03	119	129752	17253	31550220
Oesophageal dilatation	13.35	10.03	8	129863	138	31567335
Cancer pain	13.30	10.03	31	129840	2502	31564971
Antibody test abnormal	13.15	10.03	9	129862	197	31567276
Thrombocytopenic purpura	13.07	10.03	19	129852	1064	31566409
Neutropenic sepsis	13.07	10.03	19	129852	12360	31555113
Prostatitis Escherichia coli	13.04	10.03	5	129866	29	31567444
Cataract	12.98	10.03	152	129719	23655	31543818
Chest expansion decreased	12.90	10.03	8	129863	147	31567326
Poisoning deliberate	12.88	10.03	7	129864	7337	31560136
Rebound acid hypersecretion	12.83	10.03	7	129864	100	31567373
Synovitis	12.82	10.03	19	129852	12264	31555209
Sepsis	12.77	10.03	501	129370	151428	31416045
Myoglobinaemia	12.71	10.03	7	129864	102	31567371
Urticaria papular	12.70	10.03	6	129865	62	31567411
Excessive cerumen production	12.61	10.03	10	129861	276	31567197
Oesophageal candidiasis	12.52	10.03	41	129830	4036	31563437
Bladder cancer	12.45	10.03	26	129845	14699	31552774
Renal atrophy	12.39	10.03	19	129852	1116	31566357
Drug dependence	12.38	10.03	49	129822	22530	31544943
Renal tubular disorder	12.35	10.03	43	129828	4367	31563106
Psoriatic arthropathy	12.32	10.03	41	129830	19842	31547631
Physical examination abnormal	12.22	10.03	10	129861	289	31567184
Dyspnoea at rest	12.21	10.03	37	129834	3494	31563979
Hyperparathyroidism secondary	12.19	10.03	22	129849	1479	31565994
Aortic valve incompetence	12.18	10.03	50	129821	5491	31561982
Suicide attempt	12.12	10.03	96	129775	37152	31530321
Progressive multifocal leukoencephalopathy	12.00	10.03	12	129859	9201	31558272
Renal mass	11.99	10.03	23	129848	1620	31565853
Cholecystitis	11.96	10.03	75	129796	9742	31557731
Prostate cancer	11.74	10.03	98	129773	37503	31529970
Malnutrition	11.71	10.03	84	129787	11409	31556064
Oedema peripheral	11.64	10.03	556	129315	109283	31458190
Pulmonary valve disease	11.57	10.03	10	129861	312	31567161
Oral pustule	11.55	10.03	9	129862	242	31567231
Febrile neutropenia	11.54	10.03	396	129475	121453	31446020
Hepatotoxicity	11.47	10.03	40	129831	19086	31548387
Cutaneous vasculitis	11.45	10.03	37	129834	3617	31563856
Exposure during pregnancy	11.43	10.03	11	129860	8587	31558886
Respiratory arrest	11.42	10.03	62	129809	26195	31541278
Intestinal obstruction	11.42	10.03	132	129739	20478	31546995
Microcytic anaemia	11.40	10.03	26	129845	2069	31565404
Crohn's disease	11.39	10.03	40	129831	4081	31563392
Erythema of eyelid	11.17	10.03	15	129856	780	31566693
Sacroiliitis	11.15	10.03	20	129851	1338	31566135
Rash	11.15	10.03	694	129177	200792	31366681
Dialysis	11.10	10.03	78	129793	10525	31556948
Septic arthritis staphylococcal	11.09	10.03	12	129859	497	31566976
Food interaction	11.08	10.03	16	129855	891	31566582
Cardiorenal syndrome	11.06	10.03	14	129857	686	31566787
Lumbar radiculopathy	11.03	10.03	15	129856	789	31566684
Thrombotic cerebral infarction	11.00	10.03	10	129861	334	31567139
Carbohydrate antigen 19-9 increased	10.94	10.03	8	129863	195	31567278
Bronchomalacia	10.92	10.03	6	129865	87	31567386
Heat stroke	10.91	10.03	16	129855	903	31566570
Laboratory test abnormal	10.85	10.03	40	129831	18774	31548699
Enterochromaffin cell hyperplasia	10.76	10.03	4	129867	21	31567452
Wheezing	10.70	10.03	95	129776	35891	31531582
Unresponsive to stimuli	10.64	10.03	62	129809	25738	31541735
Musculoskeletal stiffness	10.63	10.03	113	129758	41212	31526261
Pericarditis	10.63	10.03	70	129801	9246	31558227
Anal erosion	10.61	10.03	4	129867	22	31567451
Hypotrichosis	10.61	10.03	4	129867	22	31567451
Drug interaction	10.60	10.03	992	128879	207551	31359922
Oesophagitis	10.56	10.03	87	129784	12329	31555144
Abnormal behaviour	10.51	10.03	56	129815	23772	31543701
Nephropathy toxic	10.51	10.03	19	129852	11334	31556139
Coombs negative haemolytic anaemia	10.44	10.03	7	129864	148	31567325
Bicytopenia	10.36	10.03	25	129846	2064	31565409
Injection site reaction	10.34	10.03	20	129851	11631	31555842
Epstein-Barr virus infection	10.33	10.03	8	129863	6945	31560528
Hypoalbuminaemia	10.33	10.03	79	129792	10949	31556524
Barrett's oesophagus	10.31	10.03	11	129860	448	31567025
Septic shock	10.29	10.03	349	129522	65809	31501664
Rheumatoid arthritis	10.28	10.03	136	129735	47673	31519800
Microcytosis	10.27	10.03	7	129864	152	31567321
C-reactive protein abnormal	10.25	10.03	10	129861	7759	31559714
Platelet toxicity	10.23	10.03	3	129868	6	31567467
Infective exacerbation of chronic obstructive airways disease	10.20	10.03	22	129849	1686	31565787
Conjunctival ulcer	10.15	10.03	5	129866	57	31567416
Nasal crusting	10.13	10.03	10	129861	371	31567102
Diverticulum	10.13	10.03	53	129818	6441	31561032
Haemorrhage intracranial	10.13	10.03	30	129841	15058	31552415
Biliary anastomosis complication	10.09	10.03	6	129865	102	31567371
Tongue oedema	10.06	10.03	29	129842	2664	31564809

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	611.38	9.18	972	284446	60085	70582941
Completed suicide	421.77	9.18	193	285225	226942	70416084
Drug ineffective	408.14	9.18	2175	283243	937577	69705449
Toxicity to various agents	323.48	9.18	657	284761	381515	70261511
Gastrooesophageal reflux disease	318.70	9.18	945	284473	89894	70553132
Hepatocellular injury	316.45	9.18	622	284796	45469	70597557
Cholestasis	301.20	9.18	623	284795	47249	70595777
Acute kidney injury	296.04	9.18	3063	282355	471561	70171465
Interstitial lung disease	293.32	9.18	1008	284410	103677	70539349
Synovitis	270.73	9.18	91	285327	129137	70513889
Off label use	268.44	9.18	1821	283597	741239	69901787
Pemphigus	266.68	9.18	17	285401	83019	70560007
Death	236.00	9.18	1153	284265	508908	70134118
Anti-cyclic citrullinated peptide antibody positive	229.53	9.18	13	285405	70172	70572854
End stage renal disease	228.14	9.18	252	285166	10881	70632145
Drug abuse	223.41	9.18	160	285258	147096	70495930
Hand deformity	215.26	9.18	43	285375	86439	70556587
Maternal exposure during pregnancy	200.37	9.18	107	285311	115238	70527788
Glossodynia	195.43	9.18	53	285365	86434	70556592
Systemic lupus erythematosus	180.74	9.18	92	285326	101810	70541216
Toxic skin eruption	178.79	9.18	304	285114	19858	70623168
Carotid artery thrombosis	173.35	9.18	115	285303	2431	70640595
Duodenal ulcer perforation	171.77	9.18	8	285410	51104	70591922
Eosinophilia	166.38	9.18	445	284973	39874	70603152
Neurologic neglect syndrome	165.64	9.18	109	285309	2272	70640754
Wound	159.50	9.18	100	285318	98632	70544394
Alopecia	153.78	9.18	358	285060	198132	70444894
Agranulocytosis	153.58	9.18	432	284986	39866	70603160
Hypomagnesaemia	150.49	9.18	432	284986	40332	70602694
Hyponatraemia	147.39	9.18	1126	284292	158961	70484065
Product use in unapproved indication	144.61	9.18	395	285023	207083	70435943
Arthropathy	142.63	9.18	240	285178	149817	70493209
Pericarditis	142.14	9.18	82	285336	84623	70558403
Hemiplegia	141.45	9.18	223	285195	13672	70629354
Cholecystitis chronic	140.58	9.18	181	285237	9195	70633831
Contraindicated product administered	137.69	9.18	205	285213	134407	70508619
Hypocalcaemia	135.34	9.18	443	284975	44416	70598610
Treatment failure	134.74	9.18	233	285185	143909	70499117
Rheumatoid factor positive	129.30	9.18	20	285398	48380	70594646
Drug intolerance	128.92	9.18	470	284948	225217	70417809
Adjustment disorder	127.75	9.18	104	285314	3040	70639986
Joint swelling	125.30	9.18	558	284860	252653	70390373
Rheumatoid arthritis	124.29	9.18	678	284740	291127	70351899
Renal failure	124.00	9.18	1234	284184	187836	70455190
Personality disorder	123.15	9.18	131	285287	5417	70637609
Sensitisation	118.15	9.18	90	285328	2383	70640643
Tubulointerstitial nephritis	114.87	9.18	343	285075	32733	70610293
Renal injury	112.62	9.18	219	285199	15875	70627151
Helicobacter infection	111.72	9.18	42	285376	55614	70587412
Rash maculo-papular	111.64	9.18	451	284967	50094	70592932
Discomfort	110.33	9.18	158	285260	105278	70537748
Infusion related reaction	109.12	9.18	417	285001	197117	70445909
Intentional product use issue	107.07	9.18	200	285218	119942	70523084
Biliary dyskinesia	105.24	9.18	83	285335	2316	70640710
Folliculitis	102.16	9.18	23	285395	42547	70600479
Muscle injury	98.19	9.18	18	285400	38476	70604550
Polycystic ovaries	98.17	9.18	86	285332	2786	70640240
Drug reaction with eosinophilia and systemic symptoms	97.40	9.18	477	284941	57536	70585490
Peripheral swelling	96.70	9.18	557	284861	236006	70407020
Exposure during pregnancy	93.21	9.18	130	285288	87587	70555439
Swelling	92.32	9.18	417	285001	188122	70454904
Dysphagia	88.82	9.18	766	284652	112068	70530958
Ejection fraction	88.34	9.18	66	285352	1696	70641330
Hepatic enzyme increased	83.75	9.18	336	285082	156654	70486372
Nephrogenic anaemia	83.10	9.18	87	285331	3531	70639495
Gamma-glutamyltransferase increased	78.92	9.18	408	285010	50277	70592749
Psoriatic arthropathy	78.23	9.18	87	285331	64684	70578342
Gastric polyps	78.10	9.18	82	285336	3339	70639687
Drug resistance	78.03	9.18	28	285390	38162	70604864
Inappropriate antidiuretic hormone secretion	77.65	9.18	238	285180	23038	70619988
Hepatic cytolysis	77.33	9.18	210	285208	18982	70624044
Therapeutic product effect decreased	75.71	9.18	307	285111	142711	70500315
Pancreatitis acute	75.31	9.18	371	285047	44853	70598173
Rhinitis allergic	74.41	9.18	134	285284	9161	70633865
Hypertensive nephropathy	73.23	9.18	45	285373	829	70642197
C-reactive protein abnormal	72.73	9.18	32	285386	38547	70604479
Abdominal pain upper	71.76	9.18	1136	284282	192466	70450560
Hiatus hernia	71.35	9.18	217	285201	20917	70622109
Affect lability	68.49	9.18	136	285282	10010	70633016
Intentional overdose	68.08	9.18	188	285230	98247	70544779
Motor dysfunction	67.32	9.18	157	285261	12913	70630113
COVID-19	66.62	9.18	211	285207	105546	70537480
Hypergastrinaemia	66.59	9.18	26	285392	163	70642863
Fatigue	65.60	9.18	2683	282735	821636	69821390
Vascular purpura	64.81	9.18	67	285351	2679	70640347
Acute generalised exanthematous pustulosis	64.58	9.18	171	285247	15226	70627800
Gastritis	63.33	9.18	350	285068	44241	70598785
Hypokalaemia	62.27	9.18	804	284614	130384	70512642
Sleep disorder due to general medical condition, insomnia type	62.24	9.18	33	285385	35699	70607327
Coordination abnormal	60.97	9.18	172	285246	15894	70627132
Lung disorder	60.70	9.18	483	284935	69001	70574025
Product use issue	58.74	9.18	453	284965	179484	70463542
Bronchial neoplasm	57.22	9.18	31	285387	445	70642581
Cholestatic liver injury	57.13	9.18	77	285341	4091	70638935
Therapy non-responder	56.92	9.18	142	285276	76773	70566253
Sensory loss	55.38	9.18	134	285284	11285	70631741
Irritable bowel syndrome	54.38	9.18	75	285343	50775	70592251
Systemic lupus erythematosus rash	54.18	9.18	48	285370	1579	70641447
Jaundice	53.88	9.18	366	285052	49742	70593284
Nephrectomy	51.85	9.18	49	285369	1754	70641272
Pain	51.57	9.18	2039	283379	626777	70016249
Anaemia	51.56	9.18	2048	283370	401375	70241651
Blister	51.20	9.18	219	285199	100307	70542719
Dermatitis bullous	50.81	9.18	139	285279	12618	70630408
Cross sensitivity reaction	50.36	9.18	66	285352	3412	70639614
Hypothyroidism	50.27	9.18	336	285082	45419	70597607
Condition aggravated	50.02	9.18	1324	284094	426311	70216715
Hyperkalaemia	49.63	9.18	651	284767	105940	70537086
Pancreatitis	49.59	9.18	426	284992	62242	70580784
Hypersensitivity	48.61	9.18	642	284776	229170	70413856
Gallbladder disorder	48.20	9.18	169	285249	17543	70625483
Lower respiratory tract infection	48.13	9.18	259	285159	111654	70531372
Loss of employment	47.78	9.18	52	285366	2207	70640819
Presbyacusis	47.77	9.18	56	285362	2581	70640445
Thrombocytopenia	47.69	9.18	1280	284138	237830	70405196
Epigastric discomfort	47.68	9.18	96	285322	7137	70635889
Nephropathy	47.65	9.18	108	285310	8717	70634309
Pregnancy	47.63	9.18	18	285400	23763	70619263
Hepatitis cholestatic	47.59	9.18	135	285283	12515	70630511
Cell death	46.39	9.18	70	285348	4130	70638896
Mobility decreased	45.06	9.18	237	285181	102762	70540264
Hepatojugular reflux	44.98	9.18	29	285389	583	70642443
Rhabdomyolysis	44.64	9.18	585	284833	95175	70547851
Ill-defined disorder	43.75	9.18	97	285321	54644	70588382
Eating disorder	43.68	9.18	169	285249	18396	70624630
Device expulsion	42.65	9.18	18	285400	22228	70620798
Sedation complication	42.30	9.18	3	285415	13407	70629619
Angina pectoris	42.08	9.18	336	285082	48047	70594979
Knee arthroplasty	41.50	9.18	46	285372	34255	70608771
Pleural thickening	41.41	9.18	54	285364	2778	70640248
Abdominal discomfort	41.01	9.18	612	284806	214046	70428980
Diabetic nephropathy	40.74	9.18	53	285365	2720	70640306
Sleep apnoea syndrome	40.74	9.18	248	285170	32465	70610561
Hip arthroplasty	40.52	9.18	32	285386	28008	70615018
Therapy interrupted	40.21	9.18	25	285393	24777	70618249
Nasal turbinate hypertrophy	40.16	9.18	27	285391	584	70642442
Carpal tunnel syndrome	39.91	9.18	155	285263	16902	70626124
Cholecystitis	39.72	9.18	177	285241	20524	70622502
Mixed liver injury	38.90	9.18	81	285337	6168	70636858
Bone erosion	38.90	9.18	7	285411	15166	70627860
Therapeutic response decreased	38.67	9.18	114	285304	58339	70584687
Aphasia	38.52	9.18	302	285116	42947	70600079
Gallbladder injury	38.39	9.18	34	285384	1118	70641908
Iron deficiency anaemia	38.21	9.18	189	285229	22883	70620143
Occult blood	38.08	9.18	38	285380	1456	70641570
Pleural fibrosis	37.47	9.18	63	285355	4076	70638950
Degenerative mitral valve disease	37.34	9.18	19	285399	238	70642788
Cardiac failure	37.29	9.18	797	284621	142744	70500282
Premature delivery	36.63	9.18	20	285398	21284	70621742
Dyspepsia	36.57	9.18	532	284886	88545	70554481
Poisoning	36.40	9.18	23	285395	22599	70620427
Neutropenic sepsis	36.31	9.18	28	285390	24802	70618224
Device dependence	35.93	9.18	12	285406	44	70642982
Hemiparesis	35.72	9.18	233	285185	31236	70611790
Injection site pain	35.66	9.18	302	285116	117317	70525709
Musculoskeletal stiffness	35.30	9.18	402	285016	147358	70495668
Cardiac arrest	35.08	9.18	443	284975	159391	70483635
Face oedema	34.91	9.18	199	285219	25440	70617586
Accidental exposure to product	34.62	9.18	37	285381	28014	70615012
Stomatitis	34.61	9.18	340	285078	128171	70514855
Endometrial ablation	34.58	9.18	28	285390	812	70642214
Nasopharyngitis	34.16	9.18	659	284759	221547	70421479
Eczema	34.11	9.18	243	285175	33538	70609488
Myelosuppression	33.72	9.18	43	285375	30102	70612924
Haematotoxicity	33.60	9.18	7	285411	13667	70629359
Red blood cell sedimentation rate abnormal	33.36	9.18	18	285400	19285	70623741
Blood magnesium increased	33.27	9.18	53	285365	3278	70639748
Osteosclerosis	33.02	9.18	56	285362	3649	70639377
Cholangitis	33.00	9.18	112	285306	11437	70631589
Neurotoxicity	32.89	9.18	43	285375	29783	70613243
Muscle haemorrhage	32.88	9.18	73	285345	5811	70637215
Weight increased	32.74	9.18	734	284684	241597	70401429
Drug hypersensitivity	32.67	9.18	805	284613	261654	70381372
Nephritic syndrome	32.57	9.18	19	285399	317	70642709
Disease progression	31.91	9.18	441	284977	156231	70486795
Drug ineffective for unapproved indication	31.86	9.18	67	285351	38471	70604555
Tenosynovitis stenosans	31.83	9.18	43	285375	2290	70640736
Sudden death	31.71	9.18	168	285250	20896	70622130
Chronic kidney disease-mineral and bone disorder	31.17	9.18	24	285394	646	70642380
Hepatitis	30.69	9.18	322	285096	49658	70593368
Electrocardiogram Q wave abnormal	30.17	9.18	22	285396	544	70642482
Urate nephropathy	30.09	9.18	14	285404	142	70642884
Chest pain	30.07	9.18	1267	284151	249993	70393033
Cholelithiasis	30.02	9.18	307	285111	47033	70595993
Arterial occlusive disease	29.49	9.18	83	285335	7659	70635367
Phlebitis	29.42	9.18	86	285332	8108	70634918
Drug interaction	29.39	9.18	1844	283574	379597	70263429
Occupational dermatitis	29.10	9.18	13	285405	119	70642907
Post transplant lymphoproliferative disorder	28.99	9.18	4	285414	10541	70632485
Anaemia macrocytic	28.85	9.18	64	285354	5091	70637935
Malnutrition	28.53	9.18	159	285259	20158	70622868
Bronchial haemorrhage	28.27	9.18	30	285388	1237	70641789
Dry eye	27.97	9.18	224	285194	32058	70610968
Eosinophilic fasciitis	27.96	9.18	16	285402	257	70642769
Respiratory arrest	27.76	9.18	117	285301	53816	70589210
Medication error	27.75	9.18	126	285292	56786	70586240
Muscle contractions involuntary	27.71	9.18	49	285369	3302	70639724
Oesophagitis ulcerative	27.53	9.18	26	285392	930	70642096
Palpitations	27.50	9.18	611	284807	110142	70532884
Rash	27.46	9.18	1729	283689	508833	70134193
Gastric disorder	27.14	9.18	228	285190	33094	70609932
Adverse drug reaction	26.67	9.18	117	285301	53227	70589799
Abdominal pain	26.54	9.18	1655	283763	340472	70302554
Respiratory distress	26.36	9.18	336	285082	54314	70588712
Synovial fluid analysis	26.34	9.18	35	285383	1834	70641192
Muscle spasticity	26.27	9.18	152	285266	19537	70623489
Respiratory depression	26.17	9.18	37	285381	24794	70618232
Gallbladder polyp	26.15	9.18	25	285393	908	70642118
Hepatotoxicity	26.14	9.18	90	285328	43896	70599130
Erythema dyschromicum perstans	26.12	9.18	10	285408	59	70642967
Eosinophilic colitis	25.85	9.18	18	285400	413	70642613
Pulmonary vascular disorder	25.68	9.18	25	285393	929	70642097
Bronchial disorder	25.67	9.18	39	285379	2315	70640711
Ventricular hypokinesia	25.57	9.18	82	285336	8130	70634896
Injection site erythema	25.50	9.18	180	285238	72744	70570282
Blood alkaline phosphatase increased	25.41	9.18	353	285065	58168	70584858
Renal disorder	25.32	9.18	249	285169	37760	70605266
Neuroleptic malignant syndrome	25.24	9.18	41	285377	25966	70617060
Live birth	25.08	9.18	12	285406	13767	70629259
Laboratory test abnormal	24.79	9.18	41	285377	25782	70617244
Anxiety	24.79	9.18	1104	284314	219226	70423800
Idiopathic pulmonary fibrosis	24.68	9.18	58	285360	4793	70638233
Drug dependence	24.53	9.18	73	285345	37248	70605778
Hyperthermia	24.44	9.18	132	285286	16539	70626487
Hypoparathyroidism	24.40	9.18	25	285393	989	70642037
Tetany	24.09	9.18	37	285381	2217	70640809
Nicotine dependence	24.05	9.18	23	285395	836	70642190
Product dose omission issue	23.89	9.18	679	284739	216789	70426237
Inferior vena cava dilatation	23.74	9.18	22	285396	768	70642258
Lip oedema	23.41	9.18	62	285356	5521	70637505
Febrile bone marrow aplasia	23.36	9.18	103	285315	11888	70631138
Aggression	23.18	9.18	108	285310	48338	70594688
Dermatitis exfoliative	23.17	9.18	94	285324	10457	70632569
Sinus congestion	23.10	9.18	134	285284	17239	70625787
Oesophagitis	22.90	9.18	163	285255	22489	70620537
Caesarean section	22.89	9.18	9	285409	11598	70631428
Pancreatic neuroendocrine tumour	22.70	9.18	20	285398	653	70642373
Renal cyst	22.58	9.18	110	285308	13235	70629791
Bunion operation	22.44	9.18	22	285396	825	70642201
Nephrosclerosis	22.39	9.18	31	285387	1690	70641336
Acute coronary syndrome	22.38	9.18	148	285270	19931	70623095
Pyelocaliectasis	22.37	9.18	22	285396	828	70642198
Cerebral haematoma	22.37	9.18	73	285345	7305	70635721
Axonal neuropathy	22.33	9.18	33	285385	1911	70641115
Deafness neurosensory	22.29	9.18	68	285350	6564	70636462
Mucormycosis	22.13	9.18	3	285415	8011	70635015
Injection site pruritus	22.12	9.18	82	285336	39128	70603898
Sleep disorder due to a general medical condition	21.96	9.18	92	285326	10384	70632642
Ejection fraction abnormal	21.81	9.18	31	285387	1732	70641294
Vitamin B12 deficiency	21.75	9.18	63	285355	5909	70637117
Cardiac disorder	21.74	9.18	348	285070	59067	70583959
Systolic dysfunction	21.71	9.18	45	285373	3416	70639610
Bone cyst	21.20	9.18	40	285378	2834	70640192
Injection site bruising	21.16	9.18	80	285338	37952	70605074
Ureteric compression	21.13	9.18	13	285405	240	70642786
Carotid artery stenosis	21.06	9.18	77	285341	8159	70634867
Hepatic haematoma	20.99	9.18	21	285397	807	70642219
Eyelid oedema	20.89	9.18	104	285314	12623	70630403
Radiation pneumonitis	20.84	9.18	46	285372	3647	70639379
Respiratory tract congestion	20.83	9.18	132	285286	17521	70625505
Hyperchlorhydria	20.72	9.18	31	285387	1815	70641211
Mesenteric panniculitis	20.71	9.18	13	285405	249	70642777
Pathogen resistance	20.69	9.18	14	285404	13265	70629761
Hyperparathyroidism secondary	20.63	9.18	37	285381	2521	70640505
Contusion	20.50	9.18	377	285041	127659	70515367
Hyperlipidaemia	20.35	9.18	165	285253	23698	70619328
Scleritis	20.31	9.18	45	285373	3577	70639449
Hypovitaminosis	20.29	9.18	23	285395	1022	70642004
Abortion spontaneous	20.28	9.18	48	285370	26431	70616595
Infection	20.25	9.18	670	284748	210115	70432911
Rectosigmoid cancer	20.13	9.18	13	285405	262	70642764
Fall	20.13	9.18	2061	283357	442035	70200991
Ocular myasthenia	20.02	9.18	15	285403	387	70642639
Granulomatous rosacea	20.02	9.18	12	285406	211	70642815
Hepatic encephalopathy	20.00	9.18	155	285263	21963	70621063
Renal tubular disorder	19.94	9.18	62	285356	6048	70636978
Impaired healing	19.92	9.18	197	285221	74177	70568849
Deformity	19.91	9.18	76	285342	8221	70634805
Campylobacter colitis	19.74	9.18	7	285411	32	70642994
Arthralgia	19.66	9.18	1751	283667	501639	70141387
Injection site swelling	19.60	9.18	98	285320	43059	70599967
Rebound acid hypersecretion	19.46	9.18	9	285409	90	70642936
Obesity	19.35	9.18	50	285368	26721	70616305
Bicytopenia	19.25	9.18	47	285371	3981	70639045
Unresponsive to stimuli	19.24	9.18	126	285292	51805	70591221
Osteopenia	19.18	9.18	124	285294	16573	70626453
Drug eruption	19.12	9.18	243	285175	39253	70603773
Helicobacter test positive	19.01	9.18	24	285394	1195	70641831
Acute graft versus host disease in skin	18.94	9.18	3	285415	7134	70635892
Acute pulmonary oedema	18.86	9.18	105	285313	13307	70629719
Colitis microscopic	18.81	9.18	79	285339	8926	70634100
Febrile neutropenia	18.79	9.18	653	284765	203665	70439361
Occupational exposure to air contaminants	18.74	9.18	10	285408	139	70642887
Stevens-Johnson syndrome	18.71	9.18	224	285194	35683	70607343
Duodenal polyp	18.68	9.18	13	285405	298	70642728
Dialysis	18.64	9.18	127	285291	17275	70625751
Heat stroke	18.63	9.18	27	285391	1536	70641490
Haematoma	18.63	9.18	286	285132	48132	70594894
Genital infection female	18.63	9.18	8	285410	66	70642960
Gastric antral vascular ectasia	18.59	9.18	20	285398	838	70642188
Impaired work ability	18.56	9.18	121	285297	16219	70626807
Immune reconstitution inflammatory syndrome	18.55	9.18	15	285403	12975	70630051
Mucosal inflammation	18.47	9.18	179	285239	67671	70575355
Bradypnoea	18.37	9.18	56	285362	5403	70637623
Therapy partial responder	18.32	9.18	14	285404	12460	70630566
Type I hypersensitivity	18.32	9.18	44	285374	3688	70639338
Dystonia	18.26	9.18	32	285386	19674	70623352
Disability	18.23	9.18	20	285398	14963	70628063
Essential hypertension	18.22	9.18	56	285362	5428	70637598
Thrombocytopenic purpura	18.17	9.18	33	285385	2271	70640755
Hepatic function abnormal	18.12	9.18	379	285039	67617	70575409
Renal tubular necrosis	18.05	9.18	157	285261	23014	70620012
Phaeochromocytoma malignant	18.03	9.18	8	285410	72	70642954
Brain scan abnormal	18.01	9.18	23	285395	1159	70641867
Suicide attempt	17.95	9.18	219	285199	79291	70563735
Transient ischaemic attack	17.91	9.18	272	285146	45672	70597354
Electric shock	17.81	9.18	23	285395	1172	70641854
Type III immune complex mediated reaction	17.75	9.18	17	285401	619	70642407
Ischaemic stroke	17.73	9.18	196	285222	30624	70612402
Angina bullosa haemorrhagica	17.70	9.18	11	285407	207	70642819
Immunodeficiency	17.68	9.18	27	285391	17528	70625498
Eructation	17.64	9.18	82	285336	9678	70633348
Chronic graft versus host disease	17.63	9.18	3	285415	6767	70636259
Kidney infection	17.40	9.18	136	285282	19319	70623707
Chronic cutaneous lupus erythematosus	17.33	9.18	13	285405	336	70642690
Fear of injection	17.28	9.18	3	285415	6669	70636357
Burning sensation	17.27	9.18	304	285114	52566	70590460
Hyperkinetic heart syndrome	17.26	9.18	9	285409	119	70642907
Cataract	17.13	9.18	317	285101	55328	70587698
Crepitations	17.09	9.18	75	285343	8639	70634387
Memory impairment	17.03	9.18	266	285152	92375	70550651
Angina unstable	17.03	9.18	116	285302	15777	70627249
Venoocclusive liver disease	16.98	9.18	11	285407	10667	70632359
Synovial cyst	16.96	9.18	75	285343	8667	70634359
Carotid arteriosclerosis	16.95	9.18	33	285385	2394	70640632
Eye injury	16.92	9.18	27	285391	1672	70641354
Rash scarlatiniform	16.85	9.18	11	285407	226	70642800
Nausea	16.84	9.18	3772	281646	848316	69794710
Gastric cancer	16.75	9.18	76	285342	8879	70634147
Psoriasis	16.65	9.18	287	285131	98146	70544880
Rhinitis	16.64	9.18	91	285327	11456	70631570
Hyperphosphatasaemia	16.63	9.18	8	285410	88	70642938
Pre-eclampsia	16.61	9.18	3	285415	6482	70636544
Nerve injury	16.60	9.18	72	285346	8252	70634774
Cerebellar haematoma	16.54	9.18	16	285402	590	70642436
Diverticulum	16.54	9.18	103	285315	13590	70629436
Gastroenteritis eosinophilic	16.48	9.18	11	285407	235	70642791
Tongue oedema	16.41	9.18	59	285359	6200	70636826
Prescription form tampering	16.35	9.18	13	285405	367	70642659
Nephropathy toxic	16.32	9.18	31	285387	18483	70624543
Cardiac aneurysm	16.31	9.18	24	285394	1384	70641642
Helicobacter gastritis	16.27	9.18	32	285386	2339	70640687
Tachycardia	16.17	9.18	500	284918	158046	70484980
Rheumatoid nodule	16.16	9.18	110	285308	14957	70628069
Regurgitation	16.15	9.18	31	285387	2225	70640801
Premature labour	16.11	9.18	6	285412	7994	70635032
Microcytic anaemia	16	9.18	49	285369	4740	70638286
Gastrointestinal motility disorder	15.92	9.18	54	285364	5512	70637514
Gangrene	15.91	9.18	71	285347	8238	70634788
Subacute cutaneous lupus erythematosus	15.90	9.18	38	285380	3175	70639851
Creatinine renal clearance decreased	15.88	9.18	28	285390	17172	70625854
CSF volume increased	15.87	9.18	6	285412	34	70642992
Substance abuse	15.83	9.18	10	285408	9827	70633199
Nipple swelling	15.74	9.18	8	285410	100	70642926
Thrombophlebitis	15.71	9.18	56	285362	5860	70637166
Coronary artery stenosis	15.61	9.18	90	285328	11554	70631472
Nerve degeneration	15.51	9.18	11	285407	260	70642766
Schizophreniform disorder	15.43	9.18	9	285409	150	70642876
Dehydration	15.37	9.18	1082	284336	225060	70417966
Occupational exposure to product	15.31	9.18	17	285401	738	70642288
Diverticulum oesophageal	15.28	9.18	9	285409	153	70642873
Escherichia pyelonephritis	15.27	9.18	14	285404	482	70642544
Localised infection	15.23	9.18	75	285343	33083	70609943
Urticaria papular	15.23	9.18	9	285409	154	70642872
Duodenitis	15.08	9.18	62	285356	6940	70636086
Sedation	15.07	9.18	118	285300	46613	70596413
Physical examination abnormal	15.02	9.18	11	285407	274	70642752
Allergy to chemicals	15.00	9.18	28	285390	1968	70641058
Renal impairment	14.84	9.18	715	284703	143222	70499804
Gait inability	14.80	9.18	120	285298	47055	70595971
Liver disorder	14.76	9.18	338	285080	61230	70581796
High frequency ablation	14.74	9.18	11	285407	282	70642744
Psychotic disorder	14.72	9.18	90	285328	37611	70605415
Hypocapnia	14.71	9.18	15	285403	590	70642436
Purging	14.69	9.18	6	285412	43	70642983
Cerebral infarction	14.66	9.18	249	285169	42760	70600266
Septic shock	14.54	9.18	571	284847	111687	70531339
IIIrd nerve paresis	14.54	9.18	9	285409	168	70642858
Subdural haematoma	14.50	9.18	181	285237	29117	70613909
Acute hepatitis B	14.44	9.18	13	285405	437	70642589
Cutaneous lupus erythematosus	14.44	9.18	34	285384	2814	70640212
Cardiotoxicity	14.34	9.18	14	285404	11056	70631970
Antinuclear antibody positive	14.32	9.18	60	285358	6773	70636253
Vulvovaginal burning sensation	14.25	9.18	21	285397	1213	70641813
Transplant dysfunction	14.23	9.18	5	285413	6904	70636122
Nasal discharge discolouration	14.17	9.18	28	285390	2053	70640973
Anticoagulation drug level increased	14.17	9.18	16	285402	708	70642318
Hunger	14.12	9.18	47	285371	4751	70638275
Oesophageal adenocarcinoma	14.12	9.18	17	285401	806	70642220
Pleuritic pain	14.11	9.18	72	285346	8825	70634201
Flatulence	14.10	9.18	224	285194	37957	70605069
Small cell carcinoma	14.10	9.18	11	285407	302	70642724
Hyperkaliuria	14.09	9.18	9	285409	178	70642848
Gastrinoma	14.08	9.18	5	285413	23	70643003
Pancreatitis chronic	14.06	9.18	40	285378	3714	70639312
Gallbladder hypofunction	14.02	9.18	13	285405	454	70642572
Coronary artery disease	13.99	9.18	341	285077	62395	70580631
Normal newborn	13.97	9.18	4	285414	6296	70636730
Therapy cessation	13.89	9.18	79	285339	33597	70609429
Haemorrhage intracranial	13.86	9.18	52	285366	24725	70618301
Bile duct stone	13.80	9.18	49	285369	5117	70637909
Cardiorenal syndrome	13.76	9.18	23	285395	1481	70641545
Nephritis allergic	13.76	9.18	15	285403	638	70642388
Blood test abnormal	13.61	9.18	103	285315	14487	70628539
Exposure to toxic agent	13.61	9.18	4	285414	6190	70636836
Loss of personal independence in daily activities	13.59	9.18	250	285168	84660	70558366
Graft versus host disease in skin	13.59	9.18	3	285415	5627	70637399
Tooth demineralisation	13.56	9.18	3	285415	0	70643026
Erosive oesophagitis	13.50	9.18	32	285386	2659	70640367
Erythema	13.41	9.18	954	284464	198609	70444417
Melaena	13.39	9.18	309	285109	56046	70586980
Injection site haemorrhage	13.37	9.18	55	285363	25472	70617554
Cognitive disorder	13.34	9.18	169	285249	60787	70582239
Haematoma muscle	13.32	9.18	29	285389	2278	70640748
Cardiothoracic ratio increased	13.24	9.18	6	285412	57	70642969
Alanine aminotransferase abnormal	13.23	9.18	8	285410	8051	70634975
Cutaneous vasculitis	13.22	9.18	61	285357	7177	70635849
Aspergillus infection	13.20	9.18	33	285385	17835	70625191
Hypotension	13.20	9.18	1425	283993	402956	70240070
Bronchopneumopathy	13.19	9.18	15	285403	669	70642357
Renal hypertension	13.14	9.18	9	285409	201	70642825
Oedema peripheral	13.11	9.18	1077	284341	227014	70416012
Gastric ulcer	13.09	9.18	190	285228	31600	70611426
Transplant rejection	13.09	9.18	34	285384	18137	70624889
Vitreous detachment	13.06	9.18	27	285391	2046	70640980
Diarrhoea	12.99	9.18	3441	281977	779900	69863126
No adverse event	12.95	9.18	76	285342	32077	70610949
Cholecystectomy	12.95	9.18	68	285350	8429	70634597
Hyperuricaemia	12.94	9.18	82	285336	10884	70632142
Gastric ulcer haemorrhage	12.86	9.18	68	285350	8450	70634576
Intentional product misuse	12.85	9.18	234	285184	79361	70563665
Uveal melanoma	12.84	9.18	4	285414	11	70643015
Pneumobilia	12.83	9.18	9	285409	209	70642817
Heart rate decreased	12.82	9.18	174	285244	61841	70581185
Renal atrophy	12.79	9.18	24	285394	1693	70641333
Pulmonary valve disease	12.74	9.18	10	285408	277	70642749
Ventricular enlargement	12.71	9.18	13	285405	513	70642513
Supraventricular extrasystoles	12.66	9.18	54	285364	6144	70636882
Pleurisy	12.65	9.18	75	285343	9724	70633302
Renal infarct	12.55	9.18	30	285388	2507	70640519
Thymus disorder	12.53	9.18	10	285408	284	70642742
Graft versus host disease	12.52	9.18	26	285392	14997	70628029
Circumoral oedema	12.50	9.18	10	285408	285	70642741
Angiopathy	12.48	9.18	56	285362	6511	70636515
Seizure	12.44	9.18	587	284831	177375	70465651
Blood lactic acid increased	12.43	9.18	16	285402	11157	70631869
Adverse event	12.43	9.18	133	285285	49328	70593698
Parkinsonism	12.37	9.18	27	285391	15298	70627728
Schizophrenia	12.37	9.18	31	285387	16737	70626289
Adrenocorticotropic hormone deficiency	12.34	9.18	18	285400	1030	70641996
Tooth disorder	12.33	9.18	149	285269	23789	70619237
Myoglobinaemia	12.31	9.18	7	285411	111	70642915
Appendicitis	12.29	9.18	31	285387	16702	70626324
Juvenile idiopathic arthritis	12.29	9.18	4	285414	5796	70637230
Ulcer	12.27	9.18	158	285260	25596	70617430
Asthenia	12.21	9.18	2057	283361	455609	70187417
Infusion site scar	12.21	9.18	10	285408	295	70642731
Dermatophytosis of nail	12.19	9.18	8	285410	166	70642860
Drug use disorder	12.16	9.18	9	285409	8142	70634884
Prurigo	12.13	9.18	20	285398	1273	70641753
Neutrophilia	12.10	9.18	7	285411	7214	70635812
Vertigo	12.08	9.18	334	285084	62309	70580717
Dry mouth	12.03	9.18	370	285048	70087	70572939
Intestinal infarction	12.03	9.18	20	285398	1282	70641744
Inappropriate schedule of product administration	12.01	9.18	335	285083	107220	70535806
Cardiac murmur functional	11.99	9.18	5	285413	38	70642988
Cyst	11.98	9.18	90	285328	12629	70630397
Cholecystitis acute	11.95	9.18	86	285332	11908	70631118
Hypertriglyceridaemia	11.94	9.18	85	285333	11726	70631300
Device use error	11.93	9.18	6	285412	6690	70636336
Placental calcification	11.91	9.18	4	285414	15	70643011
Teeth brittle	11.85	9.18	12	285406	468	70642558
Cerebral artery thrombosis	11.83	9.18	18	285400	1070	70641956
Unintentional medical device removal	11.80	9.18	7	285411	7117	70635909
Bronchopulmonary aspergillosis	11.80	9.18	44	285374	20958	70622068
Fixed eruption	11.79	9.18	29	285389	2467	70640559
Clinically isolated syndrome	11.77	9.18	5	285413	40	70642986
Shock haemorrhagic	11.76	9.18	118	285300	17988	70625038
Lipase increased	11.72	9.18	103	285315	15143	70627883
Wrong technique in product usage process	11.72	9.18	200	285218	68498	70574528
Dermatitis exfoliative generalised	11.68	9.18	54	285364	6360	70636666
Colitis ischaemic	11.65	9.18	97	285321	14040	70628986
Tubulointerstitial nephritis and uveitis syndrome	11.65	9.18	10	285408	315	70642711
Liver function test increased	11.61	9.18	84	285334	33763	70609263
Blood gastrin increased	11.56	9.18	5	285413	42	70642984
Food interaction	11.54	9.18	22	285396	1571	70641455
Traumatic haematoma	11.54	9.18	25	285393	1957	70641069
Hypoplastic anaemia	11.51	9.18	4	285414	17	70643009
Platelet adhesiveness decreased	11.49	9.18	3	285415	3	70643023
Overdose	11.45	9.18	562	284856	169183	70473843
Vulval disorder	11.44	9.18	12	285406	488	70642538
Prothrombin time ratio decreased	11.44	9.18	15	285403	776	70642250
Haemorrhoids	11.37	9.18	155	285263	25433	70617593
Chest expansion decreased	11.36	9.18	8	285410	187	70642839
Lethargy	11.29	9.18	224	285194	75026	70568000
Anal erythema	11.29	9.18	8	285410	189	70642837
Product substitution issue	11.24	9.18	119	285299	18394	70624632
Cytomegalovirus infection	11.20	9.18	104	285314	39654	70603372
Hypoalbuminaemia	11.18	9.18	122	285296	19000	70624026
Pruritus	11.17	9.18	1570	283848	343990	70299036
Xerosis	11.16	9.18	17	285401	1011	70642015
Creatinine renal clearance abnormal	11.13	9.18	12	285406	504	70642522
Purple glove syndrome	11.12	9.18	9	285409	261	70642765
Mitral valve incompetence	11.11	9.18	160	285258	26568	70616458
Sinus disorder	11.10	9.18	121	285297	18838	70624188
Enterochromaffin cell hyperplasia	11.08	9.18	6	285412	86	70642940
Hypoparathyroidism secondary	11.04	9.18	8	285410	196	70642830
Blood thyroid stimulating hormone increased	11.02	9.18	65	285353	8414	70634612
Hyponatraemic seizure	11.01	9.18	12	285406	510	70642516
Epstein-Barr virus infection	10.86	9.18	23	285395	13175	70629851
Abdominal strangulated hernia	10.84	9.18	6	285412	90	70642936
Enterocolitis haemorrhagic	10.82	9.18	25	285393	2043	70640983
Therapeutic product effect incomplete	10.82	9.18	384	285034	119498	70523528
Multi-organ disorder	10.79	9.18	27	285391	2322	70640704
Breast cancer stage II	10.78	9.18	4	285414	5342	70637684
Complication of device insertion	10.74	9.18	4	285414	5328	70637698
Respiratory syncytial virus infection	10.73	9.18	9	285409	7646	70635380
Brief psychotic disorder with marked stressors	10.61	9.18	9	285409	279	70642747
Drug specific antibody present	10.50	9.18	5	285413	5753	70637273
Dermatosis	10.46	9.18	12	285406	540	70642486
Photophobia	10.45	9.18	118	285300	18532	70624494
Idiosyncratic drug reaction	10.45	9.18	18	285400	1188	70641838
Campylobacter gastroenteritis	10.44	9.18	18	285400	1189	70641837
Bladder cancer	10.43	9.18	35	285383	17207	70625819
Systemic infection	10.39	9.18	7	285411	6650	70636376
Toxic epidermal necrolysis	10.38	9.18	220	285198	39337	70603689
Oesophageal candidiasis	10.28	9.18	64	285354	8443	70634583
Hallucination, olfactory	10.24	9.18	11	285407	460	70642566
Coagulation factor decreased	10.23	9.18	7	285411	156	70642870
Anaemia folate deficiency	10.18	9.18	9	285409	295	70642731
Vulvovaginal erythema	10.18	9.18	8	285410	222	70642804
Pericardial haemorrhage	10.16	9.18	39	285379	4229	70638797
Aortic valve incompetence	10.15	9.18	66	285352	8838	70634188
Facet joint syndrome	10.13	9.18	6	285412	6107	70636919
Vulval oedema	10.12	9.18	4	285414	26	70643000
Haematuria	10.11	9.18	331	285087	63242	70579784
Drug tolerance	10.09	9.18	9	285409	7419	70635607
Nocardiosis	10.08	9.18	4	285414	5125	70637901
Brain injury	10.06	9.18	17	285401	10600	70632426
Hepatocellular carcinoma	10.05	9.18	73	285345	10135	70632891
Biliary tract disorder	10.05	9.18	20	285398	1474	70641552
Sinus bradycardia	10.05	9.18	142	285276	23481	70619545
Acute myeloid leukaemia	10.03	9.18	78	285340	30862	70612164
Dyshidrotic eczema	9.98	9.18	12	285406	568	70642458
Arterial spasm	9.96	9.18	7	285411	163	70642863
Withdrawal syndrome	9.96	9.18	59	285359	24845	70618181
Pyelonephritis	9.93	9.18	115	285303	18174	70624852
Cytomegalovirus viraemia	9.93	9.18	20	285398	11665	70631361
Illness	9.91	9.18	81	285337	31710	70611316
Enterocolitis	9.90	9.18	88	285330	12978	70630048
Prostate cancer	9.90	9.18	79	285339	31084	70611942
Intervertebral discitis	9.89	9.18	38	285380	4123	70638903
Therapeutic embolisation	9.88	9.18	11	285407	479	70642547
Herpes simplex test positive	9.86	9.18	10	285408	391	70642635
Vulvovaginal inflammation	9.84	9.18	11	285407	481	70642545
Neurosis	9.83	9.18	10	285408	392	70642634
Hepatobiliary scan abnormal	9.80	9.18	5	285413	63	70642963
Muscle swelling	9.77	9.18	14	285404	788	70642238
Eosinophilic oesophagitis	9.74	9.18	11	285407	487	70642539
Unevaluable event	9.73	9.18	149	285269	51914	70591112
Intentional self-injury	9.71	9.18	81	285337	31569	70611457
Impaired quality of life	9.68	9.18	13	285405	8903	70634123
Change in seizure presentation	9.67	9.18	9	285409	316	70642710
Zinc deficiency	9.66	9.18	5	285413	65	70642961
Faecal vomiting	9.63	9.18	16	285402	1025	70642001
Tarsal tunnel syndrome	9.61	9.18	11	285407	494	70642532
False negative investigation result	9.59	9.18	8	285410	242	70642784
Hepatitis fulminant	9.57	9.18	52	285366	6529	70636497
Malaise	9.54	9.18	1927	283491	431005	70212021
Brain contusion	9.53	9.18	18	285400	1276	70641750
Carbohydrate antigen 19-9 increased	9.53	9.18	10	285408	407	70642619
Hyperammonaemic encephalopathy	9.52	9.18	3	285415	4440	70638586
Multiple sclerosis relapse	9.51	9.18	119	285299	42898	70600128
Purpura senile	9.50	9.18	11	285407	500	70642526
Acute sinusitis	9.49	9.18	38	285380	4203	70638823
Circulatory collapse	9.48	9.18	94	285324	35380	70607646
Cytomegalovirus infection reactivation	9.47	9.18	8	285410	6773	70636253
Eosinophilic pneumonia	9.45	9.18	42	285376	4863	70638163
Mesenteric artery stenosis	9.44	9.18	3	285415	9	70643017
Tongue pruritus	9.43	9.18	11	285407	504	70642522
Aspartate aminotransferase increased	9.41	9.18	612	284806	126366	70516660
Grip strength decreased	9.38	9.18	32	285386	15653	70627373
Altered state of consciousness	9.37	9.18	219	285199	39803	70603223
Hyperbilirubinaemia	9.34	9.18	135	285283	22433	70620593
Tongue disorder	9.34	9.18	25	285393	13202	70629824
Abnormal behaviour	9.27	9.18	92	285326	34617	70608409
Oesophageal ulcer	9.24	9.18	51	285367	6443	70636583
Lordosis	9.23	9.18	9	285409	335	70642691
Tricuspid valve incompetence	9.22	9.18	111	285307	17706	70625320
Endophthalmitis	9.21	9.18	7	285411	6248	70636778
Arteriovenous fistula site haematoma	9.21	9.18	4	285414	34	70642992
Rhonchi	9.20	9.18	34	285384	3621	70639405

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
Prevention of NSAID-Induced Gastric Ulcer	indication
Osteoarthritis in Patients at High Ulcer Risk	indication
Rheumatoid Arthritis in Patient at High Ulcer Risk	indication
Pathological Gastric Hypersecretory Condition	indication
Duodenal Ulcer due to H. Pylori	indication
Maintenance of Healing Erosive Esophagitis	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	8852636	May 31, 2022	RELIEF OF SIGNS AND SYMPTOMS OF ARTHRITIS AND RISK-REDUCTION OF NSAID-ASSOCIATED GASTRIC ULCER
EQ 20MG BASE;375MG	VIMOVO	HORIZON	N022511	April 30, 2010	RX	TABLET, DELAYED RELEASE	ORAL	8858996	May 31, 2022	RELIEF OF SIGNS AND SYMPTOMS OF ARTHRITIS AND RISK-REDUCTION OF NSAID-ASSOCIATED GASTRIC ULCER
EQ 20MG BASE;375MG	VIMOVO	HORIZON	N022511	April 30, 2010	RX	TABLET, DELAYED RELEASE	ORAL	9161920	May 31, 2022	RISK-REDUCTION OF NSAID GASTRIC ULCER IN PATIENTS REQUIRING CHRONIC NSAID TREATMENT
EQ 20MG BASE;375MG	VIMOVO	HORIZON	N022511	April 30, 2010	RX	TABLET, DELAYED RELEASE	ORAL	9198888	May 31, 2022	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	8852636	May 31, 2022	RELIEF OF SIGNS AND SYMPTOMS OF ARTHRITIS AND RISK-REDUCTION OF NSAID-ASSOCIATED GASTRIC ULCER
EQ 20MG BASE;500MG	VIMOVO	HORIZON	N022511	April 30, 2010	RX	TABLET, DELAYED RELEASE	ORAL	8858996	May 31, 2022	RELIEF OF SIGNS AND SYMPTOMS OF ARTHRITIS AND RISK-REDUCTION OF NSAID-ASSOCIATED GASTRIC ULCER
EQ 20MG BASE;500MG	VIMOVO	HORIZON	N022511	April 30, 2010	RX	TABLET, DELAYED RELEASE	ORAL	9161920	May 31, 2022	RISK-REDUCTION OF NSAID GASTRIC ULCER IN PATIENTS REQUIRING CHRONIC NSAID TREATMENT
EQ 20MG BASE;500MG	VIMOVO	HORIZON	N022511	April 30, 2010	RX	TABLET, DELAYED RELEASE	ORAL	9198888	May 31, 2022	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	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
DB00338	DRUGBANK_ID
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
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	0093-6451	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
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	0186-4020	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	0186-4040	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
NEXIUM	HUMAN PRESCRIPTION DRUG LABEL	1	0186-4050	GRANULE, DELAYED RELEASE	5 mg	ORAL	NDA	27 sections
NEXIUM	HUMAN PRESCRIPTION DRUG LABEL	1	0186-5020	CAPSULE, DELAYED RELEASE	20 mg	ORAL	NDA	27 sections
NEXIUM	HUMAN PRESCRIPTION DRUG LABEL	1	0186-5020	CAPSULE, DELAYED RELEASE	20 mg	ORAL	NDA	27 sections
NEXIUM	HUMAN PRESCRIPTION DRUG LABEL	1	0186-5020	CAPSULE, DELAYED RELEASE	20 mg	ORAL	NDA	27 sections
NEXIUM	HUMAN PRESCRIPTION DRUG LABEL	1	0186-5040	CAPSULE, DELAYED RELEASE	40 mg	ORAL	NDA	27 sections
NEXIUM	HUMAN PRESCRIPTION DRUG LABEL	1	0186-5040	CAPSULE, DELAYED RELEASE	40 mg	ORAL	NDA	27 sections
NEXIUM	HUMAN PRESCRIPTION DRUG LABEL	1	0186-5040	CAPSULE, DELAYED RELEASE	40 mg	ORAL	NDA	27 sections