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

Stem definition	Drug id	CAS RN
angiotensin II receptor antagonists, antihypertensive (non-peptidic)	2806	137862-53-4

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: diovan cardopan valsartanin valsartan CGP 48933 CGP-48933	A tetrazole derivative and ANGIOTENSIN II TYPE 1 RECEPTOR BLOCKER that is used to treat HYPERTENSION. It has been approved in combination with sacubitril (under the name ENTRESTO) for the treatment of heart failure. Molecular weight: 435.53 Formula: C24H29N5O3 CLOGP: 4.86 LIPINSKI: 0 HAC: 8 HDO: 2 TPSA: 112.07 ALOGS: -4.28 ROTB: 10 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

diovan
cardopan
valsartanin
valsartan
CGP 48933
CGP-48933

A tetrazole derivative and ANGIOTENSIN II TYPE 1 RECEPTOR BLOCKER that is used to treat HYPERTENSION. It has been approved in combination with sacubitril (under the name ENTRESTO) for the treatment of heart failure.

Molecular weight: 435.53
Formula: C24H29N5O3
CLOGP: 4.86
LIPINSKI: 0
HAC: 8
HDO: 2
TPSA: 112.07
ALOGS: -4.28
ROTB: 10

Status: OFP

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

Drug dosage:

Dose	Unit	Route
80	mg	O

ADMET properties:

Property	Value	Reference
BDDCS (Biopharmaceutical Drug Disposition Classification System)	4	Benet LZ, Broccatelli F, Oprea TI
S (Water solubility)	0.18 mg/mL	Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine)	13 %	Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose)	10.50 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability)	23 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution)	0.22 L/kg	Lombardo F, Berellini G, Obach RS
CL (Clearance)	0.49 mL/min/kg	Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma)	0.04 %	Lombardo F, Berellini G, Obach RS
t_half (Half-life)	9.50 hours	Lombardo F, Berellini G, Obach RS

Approvals:

Date	Agency	Company
Sept. 22, 2000	PMDA	Ciba-Geigy Japan
Dec. 23, 1996	FDA
Nov. 19, 2015	EMA	Novartis Europharm Limited

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
Blood pressure inadequately controlled	376.61	9.70	187	111608	4193	50489136
Blood pressure increased	322.34	9.70	826	110969	132306	50361023
Pemphigus	222.97	9.70	10	111785	120156	50373173
Hyponatraemia	214.67	9.70	579	111216	95560	50397769
Macular degeneration	209.04	9.70	205	111590	14183	50479146
Off label use	201.05	9.70	472	111323	473954	50019375
Glossodynia	187.20	9.70	19	111776	115550	50377779
Systemic lupus erythematosus	184.94	9.70	42	111753	140580	50352749
Myocardial infarction	182.73	9.70	520	111275	88507	50404822
Hand deformity	174.57	9.70	12	111783	100187	50393142
Cardiac failure congestive	162.69	9.70	482	111313	83900	50409429
Hyperkalaemia	157.36	9.70	336	111459	47753	50445576
Oligohydramnios	155.53	9.70	117	111678	5633	50487696
Completed suicide	150.01	9.70	52	111743	131837	50361492
Oedema peripheral	139.61	9.70	704	111091	157257	50336072
Infusion related reaction	136.36	9.70	105	111690	169452	50323877
Cerebral infarction	132.96	9.70	199	111596	21405	50471924
Coronary artery disease	124.08	9.70	230	111565	29496	50463833
Acute kidney injury	123.20	9.70	894	110901	227164	50266165
Dizziness	119.50	9.70	1229	110566	345140	50148189
Maternal exposure during pregnancy	118.54	9.70	107	111688	159671	50333658
Alopecia	117.50	9.70	227	111568	244820	50248509
Product use issue	113.41	9.70	98	111697	149377	50343952
Contraindicated product administered	112.60	9.70	98	111697	148860	50344469
Pericarditis	110.70	9.70	20	111775	78669	50414660
Wound	108.32	9.70	49	111746	105745	50387584
Hypertensive crisis	103.00	9.70	136	111659	13018	50480311
Arthropathy	101.02	9.70	120	111675	157786	50335543
Blood creatinine increased	97.23	9.70	379	111416	75781	50417548
Therapeutic product effect decreased	95.18	9.70	96	111699	135954	50357375
Colitis microscopic	94.89	9.70	93	111702	6427	50486902
Renal failure	93.95	9.70	475	111320	106158	50387171
Glaucoma	92.99	9.70	142	111653	15544	50477785
Blood glucose increased	91.91	9.70	356	111439	70968	50422361
Diabetes mellitus	90.59	9.70	276	111519	48757	50444572
Pain	89.67	9.70	833	110962	578070	49915259
Cerebrovascular accident	89.27	9.70	430	111365	94250	50399079
Toxicity to various agents	86.06	9.70	216	111579	212283	50281046
Syncope	83.94	9.70	449	111346	102553	50390776
Treatment failure	83.41	9.70	109	111686	137528	50355801
Hypotension	82.22	9.70	838	110957	234631	50258698
Joint swelling	81.36	9.70	274	111521	245012	50248317
Duodenal ulcer perforation	80.79	9.70	5	111790	45606	50447723
Rash	77.71	9.70	607	111188	436864	50056465
Atrial fibrillation	76.52	9.70	434	111361	101311	50392018
Thyroid disorder	74.07	9.70	114	111681	12563	50480766
Drug ineffective	70.60	9.70	1332	110463	818001	49675328
Discomfort	68.61	9.70	83	111712	108297	50385032
Swelling	68.22	9.70	222	111573	200650	50292679
Cardiac failure	67.14	9.70	339	111456	75701	50417628
Blood pressure decreased	66.35	9.70	272	111523	55637	50437692
Product use in unapproved indication	65.87	9.70	96	111699	115723	50377606
Angina pectoris	63.74	9.70	163	111632	26025	50467304
Folliculitis	62.07	9.70	7	111788	39218	50454111
Blood urea increased	61.82	9.70	151	111644	23434	50469895
Drug intolerance	59.61	9.70	265	111530	218839	50274490
Bronchial haemorrhage	59.40	9.70	27	111768	493	50492836
Helicobacter infection	59.29	9.70	18	111777	49684	50443645
Muscle injury	57.79	9.70	7	111788	37104	50456225
Diabetes mellitus inadequate control	57.74	9.70	104	111691	13041	50480288
Bronchial neoplasm	57.54	9.70	25	111770	408	50492921
Synovitis	56.49	9.70	118	111677	123747	50369582
Rheumatoid factor positive	56.06	9.70	20	111775	49839	50443490
Fall	55.41	9.70	1043	110752	333889	50159440
Condition aggravated	54.14	9.70	409	111386	296649	50196680
Infection	54.08	9.70	198	111597	172756	50320573
Exposure during pregnancy	51.32	9.70	120	111675	120895	50372434
Rheumatoid arthritis	50.95	9.70	252	111543	202298	50291031
Nasal turbinate hypertrophy	50.00	9.70	26	111769	644	50492685
Hypertension	49.97	9.70	698	111097	210505	50282824
Diverticulitis	49.76	9.70	174	111621	33008	50460321
Fatigue	48.95	9.70	1191	110604	706410	49786919
Blood pressure diastolic decreased	46.73	9.70	110	111685	16671	50476658
Hyperuricaemia	45.61	9.70	54	111741	4626	50488703
Intentional product use issue	45.47	9.70	62	111733	76856	50416473
Total lung capacity increased	45.24	9.70	25	111770	702	50492627
Product prescribing error	44.47	9.70	124	111671	20837	50472492
Renal impairment	44.47	9.70	303	111492	75358	50417971
Death	44.43	9.70	482	111313	324897	50168432
Diverticulum intestinal	44.39	9.70	60	111735	5873	50487456
Bronchial disorder	44.34	9.70	29	111766	1113	50492216
Blister	43.64	9.70	76	111719	85342	50407987
Abortion spontaneous	43.28	9.70	19	111776	41753	50451576
Labile hypertension	43.14	9.70	21	111774	450	50492879
Fear of disease	42.78	9.70	26	111769	876	50492453
Haematoma	42.35	9.70	156	111639	30354	50462975
Mitral valve incompetence	41.75	9.70	108	111687	17363	50475966
Endometrial ablation	41.25	9.70	25	111770	838	50492491
Drug abuse	40.95	9.70	43	111752	59803	50433526
Asthenia	40.82	9.70	957	110838	318085	50175244
Drug hypersensitivity	40.04	9.70	358	111437	250652	50242677
Cardiovascular disorder	40.04	9.70	78	111717	10376	50482953
Transient ischaemic attack	40.03	9.70	159	111636	32051	50461278
Product dose omission issue	40.01	9.70	240	111555	183598	50309731
Obstructive airways disorder	38.69	9.70	98	111697	15554	50477775
Forced expiratory volume decreased	38.43	9.70	48	111747	4346	50488983
Neutropenia	38.40	9.70	182	111613	147783	50345546
Febrile neutropenia	38.16	9.70	101	111694	97566	50395763
Arthralgia	37.91	9.70	712	111083	437990	50055339
Blood uric acid increased	36.97	9.70	44	111751	3790	50489539
Dehydration	36.90	9.70	506	111289	151943	50341386
Tachyarrhythmia	36.16	9.70	45	111750	4060	50489269
Pulmonary hypoplasia	36.13	9.70	16	111779	274	50493055
Chest pain	36.10	9.70	570	111225	176312	50317017
Acute myocardial infarction	35.97	9.70	144	111651	29129	50464200
Rhonchi	35.63	9.70	34	111761	2273	50491056
Cardiomegaly	35.49	9.70	96	111699	15849	50477480
Chronic kidney disease	34.87	9.70	177	111618	39594	50453735
Pregnancy	34.76	9.70	11	111784	29566	50463763
Angioedema	34.67	9.70	170	111625	37506	50455823
Skin reaction	34.60	9.70	78	111717	11490	50481839
Sinusitis	34.36	9.70	228	111567	170330	50322999
Abdominal discomfort	34.10	9.70	337	111458	231304	50262025
Asthma	34.04	9.70	324	111471	89013	50404316
Lymphatic fistula	33.99	9.70	21	111774	729	50492600
Femoral hernia incarcerated	33.71	9.70	21	111774	740	50492589
Musculoskeletal stiffness	32.77	9.70	159	111636	128322	50365007
Pancreatic steatosis	32.24	9.70	22	111773	907	50492422
Brain stem stroke	32.03	9.70	14	111781	232	50493097
Blood sodium decreased	31.80	9.70	111	111684	21036	50472293
Lower respiratory tract infection	31.74	9.70	106	111689	95095	50398234
Blood pressure abnormal	31.70	9.70	80	111715	12667	50480662
Product impurity	31.46	9.70	9	111786	37	50493292
Ill-defined disorder	31.35	9.70	45	111750	54609	50438720
Arrhythmia	30.85	9.70	150	111645	32982	50460347
Angina unstable	30.66	9.70	54	111741	6652	50486677
Anaemia	30.65	9.70	752	111043	251704	50241625
Blood lactate dehydrogenase increased	30.56	9.70	104	111691	19458	50473871
Vascular resistance pulmonary decreased	30.17	9.70	10	111785	73	50493256
Arterial haemorrhage	30.03	9.70	26	111769	1531	50491798
Psoriatic arthropathy	29.77	9.70	36	111759	46996	50446333
Hip arthroplasty	29.74	9.70	15	111780	30414	50462915
Nervousness	29.29	9.70	130	111665	27521	50465808
Adverse drug reaction	29.25	9.70	48	111747	55174	50438155
COVID-19	29.23	9.70	36	111759	46626	50446703
Blood pressure systolic increased	29.16	9.70	155	111640	35294	50458035
Venous pressure jugular increased	29.10	9.70	17	111778	532	50492797
Recalled product administered	29.06	9.70	16	111779	446	50492883
Intentional overdose	28.94	9.70	59	111736	62445	50430884
Migraine	28.53	9.70	79	111716	75201	50418128
Hypochromic anaemia	28.12	9.70	26	111769	1670	50491659
Hepatic enzyme increased	27.98	9.70	183	111612	137197	50356132
Irritable bowel syndrome	27.91	9.70	44	111751	51397	50441932
Injection site reaction	27.91	9.70	42	111753	49990	50443339
Tricuspid valve incompetence	27.54	9.70	76	111719	12694	50480635
Injection site pain	27.39	9.70	139	111656	110885	50382444
Bradycardia	27.25	9.70	239	111556	64187	50429142
Antinuclear antibody negative	27.18	9.70	12	111783	204	50493125
Altered state of consciousness	27.10	9.70	108	111687	21802	50471527
Breast cancer	26.54	9.70	174	111621	42716	50450613
Gastrointestinal disorder	26.40	9.70	113	111682	94343	50398986
Hypokalaemia	26.38	9.70	304	111491	87688	50405641
Wound infection pseudomonas	26.07	9.70	22	111773	1251	50492078
Disease progression	26.00	9.70	116	111679	95750	50397579
Product contamination chemical	25.59	9.70	5	111790	0	50493329
Blood potassium increased	25.46	9.70	87	111708	16311	50477018
Thrombotic stroke	25.46	9.70	15	111780	477	50492852
Left-to-right cardiac shunt	25.42	9.70	10	111785	125	50493204
Hospitalisation	25.23	9.70	72	111723	67865	50425464
Impaired healing	25.16	9.70	75	111720	69711	50423618
Lymphocyte stimulation test positive	25.07	9.70	15	111780	491	50492838
Blood creatine phosphokinase increased	25.00	9.70	120	111675	26247	50467082
Product odour abnormal	24.96	9.70	20	111775	1057	50492272
Coombs positive haemolytic anaemia	24.85	9.70	13	111782	326	50493003
Hypertensive cardiomyopathy	24.80	9.70	11	111784	189	50493140
Bundle branch block left	24.49	9.70	47	111748	6183	50487146
Seroma	24.47	9.70	25	111770	1816	50491513
Stomatitis	24.36	9.70	128	111667	101216	50392113
Gastric ulcer haemorrhage	24.36	9.70	39	111756	4445	50488884
Drug resistance	24.29	9.70	6	111789	18983	50474346
Nasopharyngitis	24.24	9.70	291	111504	192636	50300693
Atrioventricular block complete	24.07	9.70	51	111744	7204	50486125
Hiatus hernia	23.97	9.70	92	111703	18252	50475077
Peripheral swelling	23.87	9.70	316	111479	205620	50287709
Sinus node dysfunction	23.71	9.70	36	111759	3919	50489410
Aortic valve stenosis	23.66	9.70	31	111764	2944	50490385
Hemiplegia	23.47	9.70	51	111744	7330	50485999
Rhabdomyolysis	23.34	9.70	157	111638	38870	50454459
Gamma-glutamyltransferase increased	23.33	9.70	128	111667	29495	50463834
Renal cyst	23.17	9.70	56	111739	8631	50484698
Dyschezia	23.08	9.70	24	111771	1780	50491549
Metastatic bronchial carcinoma	23.06	9.70	9	111786	110	50493219
Liver function test increased	23.03	9.70	14	111781	25592	50467737
Spinal osteoarthritis	22.97	9.70	76	111719	14016	50479313
Forced vital capacity decreased	22.93	9.70	18	111777	923	50492406
Coronary artery stenosis	22.88	9.70	37	111758	4252	50489077
Renal artery stenosis	22.76	9.70	23	111772	1649	50491680
Basal ganglion degeneration	22.60	9.70	13	111782	395	50492934
Concomitant disease progression	22.29	9.70	25	111770	2020	50491309
Gastrointestinal haemorrhage	22.28	9.70	254	111541	73067	50420262
Hypoglycaemia	22.26	9.70	198	111597	53383	50439946
Ventricular extrasystoles	22.10	9.70	62	111733	10454	50482875
Myocardial ischaemia	22.03	9.70	66	111729	11547	50481782
Injection site erythema	21.97	9.70	88	111707	74848	50418481
Coronary arterial stent insertion	21.81	9.70	28	111767	2606	50490723
Acral lentiginous melanoma	21.66	9.70	5	111790	6	50493323
Dementia Alzheimer's type	21.44	9.70	18	111777	1016	50492313
Tissue infiltration	21.37	9.70	14	111781	539	50492790
Live birth	21.35	9.70	5	111790	16403	50476926
Frustration tolerance decreased	21.32	9.70	42	111753	5632	50487697
Multiple sclerosis relapse	21.24	9.70	39	111756	42925	50450404
Hypochloraemia	21.23	9.70	22	111773	1625	50491704
Gastritis haemorrhagic	21.21	9.70	20	111775	1317	50492012
Complex regional pain syndrome	21.10	9.70	24	111771	1969	50491360
Ophthalmic vein thrombosis	20.76	9.70	9	111786	146	50493183
Neonatal seizure	20.70	9.70	12	111783	370	50492959
Pneumothorax traumatic	20.33	9.70	9	111786	154	50493175
Hepatic cyst	20.31	9.70	36	111759	4457	50488872
Herpes simplex reactivation	20.27	9.70	12	111783	385	50492944
Faecaloma	20.23	9.70	47	111748	7061	50486268
Impaired work ability	20.22	9.70	3	111792	13637	50479692
Lung diffusion test decreased	20.14	9.70	14	111781	595	50492734
Loss of consciousness	20.04	9.70	333	111462	104020	50389309
Colon cancer	20.02	9.70	53	111742	8638	50484691
Retrograde amnesia	19.89	9.70	12	111783	399	50492930
Ear infection	19.70	9.70	17	111778	25953	50467376
C-reactive protein increased	19.63	9.70	229	111566	66245	50427084
Coronary artery occlusion	19.62	9.70	48	111747	7455	50485874
Therapy interrupted	19.59	9.70	10	111785	20142	50473187
Monocyte count abnormal	19.52	9.70	9	111786	170	50493159
Psychotic disorder	19.51	9.70	12	111783	21800	50471529
Cough	19.47	9.70	683	111112	240581	50252748
Diabetic nephropathy	19.30	9.70	19	111776	1320	50492009
Multiple injuries	19.05	9.70	21	111774	1665	50491664
Suicidal ideation	18.91	9.70	61	111734	55324	50438005
Nephrogenic anaemia	18.85	9.70	21	111774	1684	50491645
Withdrawal hypertension	18.67	9.70	8	111787	126	50493203
Hypertensive heart disease	18.59	9.70	24	111771	2246	50491083
Ischaemic stroke	18.44	9.70	77	111718	15871	50477458
Rectal prolapse	18.42	9.70	21	111774	1728	50491601
Myalgia	18.41	9.70	381	111414	123938	50369391
Lacunar infarction	18.37	9.70	28	111767	3059	50490270
Peak expiratory flow rate decreased	18.24	9.70	13	111782	575	50492754
Neutrophil function disorder	18.22	9.70	5	111790	17	50493312
Cardiac failure chronic	18.01	9.70	30	111765	3533	50489796
No adverse event	17.95	9.70	29	111766	33549	50459780
Intestinal polyp	17.77	9.70	17	111778	1140	50492189
Feeling abnormal	17.74	9.70	382	111413	125110	50368219
Device dislocation	17.73	9.70	13	111782	21533	50471796
Iron deficiency anaemia	17.72	9.70	79	111716	16755	50476574
Cardiac failure acute	17.69	9.70	49	111746	8201	50485128
Urine albumin/creatinine ratio increased	17.68	9.70	9	111786	213	50493116
Monoplegia	17.64	9.70	26	111769	2757	50490572
Cardiac pacemaker insertion	17.46	9.70	30	111765	3623	50489706
Therapeutic drug monitoring analysis incorrectly performed	17.45	9.70	8	111787	149	50493180
Stenosis	17.45	9.70	17	111778	1166	50492163
Gastric cancer	17.43	9.70	27	111768	2991	50490338
Interstitial lung disease	17.43	9.70	187	111608	52989	50440340
Renin decreased	17.35	9.70	7	111788	94	50493235
Inguinal hernia	17.15	9.70	20	111775	1686	50491643
Glycosylated haemoglobin increased	17.11	9.70	57	111738	10549	50482780
Uterine enlargement	17.01	9.70	16	111779	1050	50492279
Aortic arteriosclerosis	16.90	9.70	37	111758	5345	50487984
Hypertensive emergency	16.85	9.70	19	111776	1544	50491785
Kyphosis	16.85	9.70	23	111772	2272	50491057
Post-anoxic myoclonus	16.85	9.70	5	111790	24	50493305
Transitional cell cancer of the renal pelvis and ureter	16.82	9.70	4	111791	6	50493323
Hyponatraemic syndrome	16.82	9.70	12	111783	532	50492797
Haemarthrosis	16.77	9.70	26	111769	2882	50490447
Arteriosclerosis	16.66	9.70	51	111744	9026	50484303
Infarction	16.60	9.70	23	111772	2305	50491024
Loss of personal independence in daily activities	16.54	9.70	89	111706	69961	50423368
Cardiac disorder	16.42	9.70	156	111639	42823	50450506
Intentional product misuse	16.29	9.70	51	111744	46683	50446646
Dyspnoea	16.22	9.70	1412	110383	546196	49947133
Gout	16.21	9.70	59	111736	11411	50481918
Ventricular hypertrophy	16.16	9.70	27	111768	3188	50490141
Anaphylactic reaction	16.14	9.70	63	111732	53992	50439337
Anaesthesia	16.11	9.70	10	111785	350	50492979
Drug ineffective for unapproved indication	16.06	9.70	14	111781	21267	50472062
Melaena	16.02	9.70	108	111687	26756	50466573
Breast neoplasm	15.96	9.70	17	111778	1296	50492033
Lipoedema	15.93	9.70	9	111786	264	50493065
Fear	15.86	9.70	69	111726	14480	50478849
Bronchitis	15.67	9.70	320	111475	103839	50389490
Bone marrow failure	15.59	9.70	23	111772	27601	50465728
Malaise	15.43	9.70	897	110898	334635	50158694
Carotid artery disease	15.40	9.70	18	111777	1521	50491808
Body height decreased	15.38	9.70	49	111746	8859	50484470
Coronary artery bypass	15.38	9.70	22	111773	2271	50491058
Intentional self-injury	15.37	9.70	17	111778	23095	50470234
Diapedesis	15.35	9.70	3	111792	0	50493329
Hypersensitivity	15.34	9.70	360	111435	214801	50278528
Angiotensin converting enzyme inhibitor foetopathy	15.27	9.70	5	111790	35	50493294
Multiple drug therapy	15.12	9.70	20	111775	1917	50491412
Palpitations	15.11	9.70	293	111502	94213	50399116
Nodal rhythm	14.95	9.70	18	111777	1569	50491760
Gastrointestinal stromal tumour	14.91	9.70	14	111781	917	50492412
Malignant neoplasm progression	14.76	9.70	89	111706	68035	50425294
Brain contusion	14.59	9.70	11	111784	531	50492798
Cranial sutures widening	14.48	9.70	4	111791	14	50493315
Incorrect route of product administration	14.43	9.70	12	111783	18654	50474675
Gingival ulceration	14.41	9.70	13	111782	809	50492520
Mydriasis	14.31	9.70	3	111792	10624	50482705
General physical health deterioration	14.30	9.70	414	111381	142020	50351309
Pyometra	14.27	9.70	6	111789	90	50493239
Blood pressure fluctuation	14.17	9.70	131	111664	35692	50457637
Pyrexia	14.16	9.70	691	111104	379512	50113817
Renal cell carcinoma	14.12	9.70	25	111770	3092	50490237
Product contamination	14.10	9.70	11	111784	559	50492770
Hyperlipidaemia	14.06	9.70	76	111719	17414	50475915
Device issue	14.06	9.70	14	111781	19958	50473371
Status epilepticus	14.04	9.70	6	111789	13400	50479929
Subarachnoid haemorrhage	14.04	9.70	54	111741	10722	50482607
Cataract	13.98	9.70	163	111632	47137	50446192
Coronary angioplasty	13.97	9.70	6	111789	95	50493234
Antiphospholipid syndrome	13.96	9.70	17	111778	1500	50491829
Blood aldosterone increased	13.89	9.70	7	111788	162	50493167
Visual acuity reduced	13.88	9.70	84	111711	20055	50473274
Left ventricular hypertrophy	13.75	9.70	32	111763	4813	50488516
Granuloma	13.69	9.70	32	111763	4826	50488503
Hepatic function abnormal	13.69	9.70	121	111674	32560	50460769
Bezold-Jarisch reflex	13.69	9.70	4	111791	18	50493311
Mobility decreased	13.62	9.70	112	111683	79836	50413493
Product taste abnormal	13.59	9.70	18	111777	1727	50491602
Chronic obstructive pulmonary disease	13.58	9.70	179	111616	53256	50440073
Injection site swelling	13.58	9.70	47	111748	41726	50451603
Gastroenteritis	13.53	9.70	93	111702	23188	50470141
Haematochezia	13.42	9.70	141	111654	39741	50453588
Mouth ulceration	13.36	9.70	26	111769	27998	50465331
Carpal tunnel syndrome	13.30	9.70	73	111722	16820	50476509
Fabry's disease	13.28	9.70	3	111792	3	50493326
Ulcer	13.28	9.70	15	111780	20185	50473144
Renal neoplasm	13.12	9.70	14	111781	1070	50492259
Diabetic retinopathy	13.09	9.70	20	111775	2190	50491139
Merycism	13.08	9.70	7	111788	184	50493145
Eructation	13.06	9.70	40	111755	7081	50486248
Arrhythmogenic right ventricular dysplasia	13.03	9.70	4	111791	22	50493307
Asthmatic crisis	13.00	9.70	17	111778	1611	50491718
Urticaria chronic	12.98	9.70	10	111785	499	50492830
Prosthesis implantation	12.97	9.70	5	111790	59	50493270
Brain natriuretic peptide increased	12.96	9.70	30	111765	4497	50488832
Renal cancer	12.85	9.70	26	111769	3554	50489775
Myelosuppression	12.71	9.70	7	111788	13510	50479819
Therapeutic product effect incomplete	12.67	9.70	135	111660	91380	50401949
Skin texture abnormal	12.67	9.70	9	111786	396	50492933
Respiration abnormal	12.67	9.70	32	111763	5070	50488259
Pulmonary thrombosis	12.59	9.70	41	111754	7500	50485829
Low density lipoprotein increased	12.57	9.70	34	111761	5612	50487717
Swollen tongue	12.51	9.70	107	111688	28523	50464806
Deafness	12.49	9.70	68	111727	15623	50477706
Sedation	12.45	9.70	31	111764	30579	50462750
Sinus arrest	12.44	9.70	17	111778	1681	50491648
Ischaemic cardiomyopathy	12.41	9.70	20	111775	2292	50491037
Stress cardiomyopathy	12.38	9.70	42	111753	7845	50485484
Neutropenic sepsis	12.35	9.70	8	111787	14139	50479190
Fixed eruption	12.27	9.70	12	111783	827	50492502
Metastases to bone	12.23	9.70	13	111782	17982	50475347
Bradycardia neonatal	12.18	9.70	12	111783	834	50492495
Cytomegalovirus infection	12.18	9.70	13	111782	17949	50475380
Cardiac myxoma	12.16	9.70	7	111788	213	50493116
Postural tremor	12.13	9.70	7	111788	214	50493115
Osteoarthritis	12.11	9.70	216	111579	68390	50424939
Upper-airway cough syndrome	12.10	9.70	44	111751	8506	50484823
Lymphostasis	12.07	9.70	3	111792	6	50493323
Therapeutic drug monitoring analysis not performed	12.06	9.70	11	111784	694	50492635
Marasmus	12.00	9.70	9	111786	431	50492898
Groin pain	11.95	9.70	45	111750	8846	50484483
Occult blood positive	11.93	9.70	24	111771	3267	50490062
Blood sodium increased	11.84	9.70	20	111775	2382	50490947
Ligament injury	11.82	9.70	13	111782	1028	50492301
Movement disorder	11.81	9.70	73	111722	17559	50475770
Hypertensive encephalopathy	11.77	9.70	10	111785	574	50492755
Gastritis	11.76	9.70	118	111677	32865	50460464
Heat illness	11.67	9.70	6	111789	145	50493184
Hypercholesterolaemia	11.63	9.70	54	111741	11649	50481680
Inflammatory marker increased	11.63	9.70	33	111762	5601	50487728
Microalbuminuria	11.57	9.70	8	111787	337	50492992
Multi-organ disorder	11.46	9.70	14	111781	1239	50492090
Duodenal ulcer	11.46	9.70	37	111758	6738	50486591
Hyperglycaemia	11.46	9.70	127	111668	36278	50457051
Therapy non-responder	11.40	9.70	66	111729	50956	50442373
Cutaneous lymphoma	11.38	9.70	6	111789	153	50493176
Cardiogenic shock	11.35	9.70	66	111729	15533	50477796
Affective disorder	11.34	9.70	31	111764	5150	50488179
Coronary artery restenosis	11.32	9.70	8	111787	349	50492980
Gastrointestinal cancer metastatic	11.27	9.70	5	111790	86	50493243
Cerebral haemorrhage	11.25	9.70	100	111695	26952	50466377
Product substitution issue	11.24	9.70	61	111734	13996	50479333
Ear pain	11.23	9.70	29	111766	28254	50465075
Perihepatic discomfort	11.21	9.70	3	111792	9	50493320
Knee arthroplasty	11.21	9.70	41	111754	35805	50457524
Seizure	11.18	9.70	188	111607	117686	50375643
Dyspnoea exertional	11.16	9.70	167	111628	51066	50442263
Erysipelas	11.10	9.70	36	111759	6572	50486757
Disease recurrence	11.06	9.70	17	111778	20064	50473265
Carotid artery stenosis	11.05	9.70	29	111766	4702	50488627
Pollakiuria	10.88	9.70	90	111705	23761	50469568
Therapy cessation	10.85	9.70	26	111769	25985	50467344
Pulmonary oedema	10.85	9.70	160	111635	48778	50444551
Hepatic cancer	10.84	9.70	23	111772	3252	50490077
Cell marker increased	10.76	9.70	7	111788	266	50493063
Infusion site pain	10.76	9.70	7	111788	12339	50480990
Cerebral arteriosclerosis	10.74	9.70	7	111788	267	50493062
Catheterisation cardiac	10.73	9.70	26	111769	4014	50489315
Skin ulcer	10.65	9.70	41	111754	35277	50458052
Atrioventricular block	10.61	9.70	35	111760	6443	50486886
Eye haemorrhage	10.59	9.70	38	111757	7297	50486032
Renal disorder	10.59	9.70	100	111695	27405	50465924
Dementia	10.57	9.70	66	111729	15931	50477398
Anuria	10.53	9.70	51	111744	11193	50482136
Hot flush	10.49	9.70	56	111739	44113	50449216
Overdose	10.48	9.70	156	111639	99571	50393758
Ankle fracture	10.47	9.70	65	111730	15657	50477672
Adverse reaction	10.44	9.70	3	111792	8583	50484746
Lymphocyte count decreased	10.42	9.70	27	111768	26280	50467049
Polyuria	10.38	9.70	37	111758	7084	50486245
Parkinson's disease	10.37	9.70	13	111782	1182	50492147
Duodenal polyp	10.36	9.70	5	111790	105	50493224
Oedema	10.35	9.70	215	111580	69966	50423363
Mood swings	10.32	9.70	12	111783	15942	50477387
Cutaneous listeriosis	10.32	9.70	4	111791	48	50493281
Neuropathy peripheral	10.29	9.70	151	111644	96606	50396723
Panniculitis	10.28	9.70	3	111792	8500	50484829
Blood chloride decreased	10.18	9.70	29	111766	4932	50488397
Acute phosphate nephropathy	10.18	9.70	3	111792	14	50493315
Mesothelioma malignant	10.17	9.70	4	111791	50	50493279
Clostridium difficile infection	10.16	9.70	26	111769	25413	50467916
Haemorrhage subcutaneous	10.16	9.70	20	111775	2681	50490648
Large intestinal ulcer haemorrhage	10.15	9.70	5	111790	110	50493219
Anxiety disorder	10.14	9.70	24	111771	3649	50489680
Breath sounds abnormal	10.11	9.70	39	111756	7753	50485576
Device related infection	10.09	9.70	19	111776	20716	50472613
Renal artery stent placement	10.07	9.70	5	111790	112	50493217
Liver disorder	10.01	9.70	126	111669	37096	50456233
Eczema	10.00	9.70	85	111710	22617	50470712
Meniere's disease	9.93	9.70	6	111789	200	50493129
Dysaesthesia	9.88	9.70	24	111771	3711	50489618
Caesarean section	9.86	9.70	12	111783	15627	50477702
Brain stem haemorrhage	9.86	9.70	10	111785	720	50492609
Carcinogenicity	9.85	9.70	3	111792	16	50493313
Hydrothorax	9.85	9.70	10	111785	721	50492608
Diverticulum	9.84	9.70	48	111747	10566	50482763
Inappropriate antidiuretic hormone secretion	9.82	9.70	56	111739	13087	50480242
Haematuria	9.80	9.70	93	111702	25520	50467809
Gait disturbance	9.79	9.70	415	111380	149590	50343739
Septic shock	9.78	9.70	80	111715	57095	50436234
Varicose vein ruptured	9.76	9.70	4	111791	56	50493273
Pigmentation disorder	9.76	9.70	24	111771	3740	50489589
Invasive ductal breast carcinoma	9.71	9.70	32	111763	5889	50487440

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
Off label use	217.69	10.35	293	78876	300507	29194851
Blood pressure inadequately controlled	209.54	10.35	110	79059	2276	29493082
Drug abuse	179.82	10.35	8	79161	79875	29415483
Blood pressure increased	171.84	10.35	510	78659	73293	29422065
Death	129.52	10.35	476	78693	341608	29153750
Blood creatinine increased	127.71	10.35	508	78661	84594	29410764
Cerebral infarction	115.76	10.35	224	78945	24451	29470907
Toxicity to various agents	111.77	10.35	183	78986	173478	29321880
Drug ineffective	97.81	10.35	572	78597	362598	29132760
Hyperkalaemia	97.34	10.35	373	78796	61019	29434339
Completed suicide	95.46	10.35	62	79107	90184	29405174
Myocardial infarction	87.81	10.35	550	78619	109746	29385612
Blood urea increased	87.13	10.35	216	78953	27896	29467462
Cardiac failure	72.44	10.35	410	78759	78877	29416481
Febrile neutropenia	71.45	10.35	119	79050	112121	29383237
Hypertensive crisis	69.39	10.35	95	79074	7753	29487605
Renal failure	66.23	10.35	543	78626	118056	29377302
Neutropenia	64.05	10.35	163	79006	131548	29363810
Dizziness	60.92	10.35	775	78394	188909	29306449
Product use in unapproved indication	59.17	10.35	88	79081	86787	29408571
Cerebrovascular accident	58.35	10.35	379	78790	76532	29418826
Fear of disease	55.60	10.35	22	79147	227	29495131
Syncope	52.85	10.35	386	78783	80985	29414373
Cardiac failure congestive	52.47	10.35	368	78801	76213	29419145
Angina pectoris	52.40	10.35	179	78990	27671	29467687
Product dose omission issue	48.61	10.35	117	79052	96266	29399092
Angioedema	48.17	10.35	191	78978	31724	29463634
Acute myocardial infarction	46.55	10.35	254	78915	48184	29447174
Treatment failure	45.38	10.35	21	79148	36918	29458440
Renal impairment	44.61	10.35	371	78798	80962	29414396
Interstitial lung disease	43.49	10.35	284	78885	57434	29437924
Sepsis	40.75	10.35	220	78949	142462	29352896
Hospitalisation	40.49	10.35	38	79131	45950	29449408
Blood pressure diastolic decreased	39.54	10.35	69	79100	6953	29488405
Blood lactic acid	39.33	10.35	19	79150	327	29495031
Blood creatine phosphokinase increased	38.29	10.35	212	78957	40432	29454926
Eosinophilic colitis	38.14	10.35	16	79153	194	29495164
Coronary artery disease	37.38	10.35	224	78945	43966	29451392
Cardiac failure chronic	37.01	10.35	64	79105	6403	29488955
Oxygen saturation increased	36.47	10.35	17	79152	269	29495089
Blood pressure decreased	35.62	10.35	226	78943	45251	29450107
Lymphocyte stimulation test positive	34.04	10.35	22	79147	679	29494679
Bundle branch block left	33.90	10.35	55	79114	5222	29490136
Product impurity	33.67	10.35	10	79159	38	29495320
Aortic aneurysm	33.58	10.35	60	79109	6160	29489198
Product use issue	33.20	10.35	54	79115	51390	29443968
Intentional product use issue	33.05	10.35	39	79130	42459	29452899
Gamma-glutamyltransferase increased	32.60	10.35	150	79019	26587	29468771
Arrhythmia	31.98	10.35	167	79002	31146	29464212
Blood glucose increased	31.76	10.35	268	78901	58716	29436642
Brain natriuretic peptide abnormal	31.60	10.35	16	79153	306	29495052
Fractured coccyx	31.49	10.35	13	79156	151	29495207
Sinus arrest	31.26	10.35	28	79141	1419	29493939
Glomerular filtration rate decreased	31.20	10.35	83	79086	11183	29484175
Hemiplegia	31.07	10.35	60	79109	6534	29488824
Arteriosclerosis	30.92	10.35	78	79091	10178	29485180
Drug dependence	30.70	10.35	9	79160	20972	29474386
Infusion related reaction	30.30	10.35	44	79125	43842	29451516
Disease progression	30.13	10.35	115	79054	81801	29413557
Mitral valve incompetence	30.05	10.35	91	79078	13202	29482156
Atrial fibrillation	29.83	10.35	422	78747	105224	29390134
Diabetes mellitus	29.39	10.35	195	78974	39636	29455722
N-terminal prohormone brain natriuretic peptide abnormal	29.07	10.35	13	79156	186	29495172
Cerebral haemorrhage	28.98	10.35	163	79006	31263	29464095
Lymphocyte count abnormal	28.79	10.35	19	79150	608	29494750
Hyponatraemia	28.70	10.35	292	78877	67341	29428017
Pulmonary arterial pressure abnormal	28.63	10.35	13	79156	193	29495165
Hypotension	28.49	10.35	701	78468	193653	29301705
Blood potassium increased	28.29	10.35	95	79074	14556	29480802
Pancreatic neoplasm	28.15	10.35	21	79148	820	29494538
Acute kidney injury	27.85	10.35	917	78252	264350	29231008
Left ventricular dilatation	27.64	10.35	19	79150	651	29494707
Clostridium difficile infection	27.44	10.35	5	79164	16136	29479222
Conduction disorder	27.34	10.35	29	79140	1811	29493547
Cell marker increased	27.33	10.35	16	79153	412	29494946
Blood triglycerides increased	27.28	10.35	86	79083	12748	29482610
Aggression	27.22	10.35	33	79136	35508	29459850
Shock	26.78	10.35	121	79048	21283	29474075
Pulmonary valve stenosis congenital	26.62	10.35	11	79158	128	29495230
Oedema peripheral	26.62	10.35	407	78762	103150	29392208
Blood uric acid increased	26.59	10.35	52	79117	5716	29489642
Thrombocytopenia	26.06	10.35	233	78936	134590	29360768
Painful respiration	25.93	10.35	23	79146	1151	29494207
Blood cholesterol increased	25.71	10.35	96	79073	15499	29479859
Gastric cancer	25.56	10.35	46	79123	4748	29490610
Blood thyroid stimulating hormone abnormal	25.47	10.35	13	79156	253	29495105
Suicidal ideation	24.77	10.35	34	79135	34682	29460676
Intentional overdose	24.34	10.35	41	79128	38487	29456871
Lung diffusion disorder	24.12	10.35	9	79160	78	29495280
Pneumonia	24.09	10.35	663	78506	319509	29175849
Cerebellar ischaemia	24.08	10.35	10	79159	118	29495240
Colon cancer	23.89	10.35	59	79110	7596	29487762
Breast discomfort	23.70	10.35	6	79163	10	29495348
Electrocardiogram QRS complex abnormal	23.68	10.35	13	79156	295	29495063
Urine albumin/creatinine ratio increased	23.29	10.35	10	79159	129	29495229
Walking aid user	23.24	10.35	24	79145	1453	29493905
Orthostatic intolerance	23.21	10.35	17	79152	645	29494713
Intentional self-injury	23.14	10.35	3	79166	12458	29482900
Microalbuminuria	23.07	10.35	17	79152	651	29494707
Agitation	23.01	10.35	66	79103	51238	29444120
Sedation	22.80	10.35	9	79160	17396	29477962
Bradycardia	22.64	10.35	272	78897	65357	29430001
Mucosal inflammation	22.48	10.35	31	79138	31564	29463794
Pemphigoid	22.17	10.35	57	79112	7524	29487834
COVID-19	22.13	10.35	39	79130	35975	29459383
Chronic kidney disease	22.06	10.35	170	78999	36246	29459112
Melaena	22.02	10.35	151	79018	31025	29464333
Atrioventricular block	21.99	10.35	54	79115	6928	29488430
Type 2 diabetes mellitus	21.89	10.35	83	79086	13498	29481860
Myocardial ischaemia	21.87	10.35	93	79076	15935	29479423
Chronic pigmented purpura	21.84	10.35	9	79160	104	29495254
Idiopathic pulmonary fibrosis	21.70	10.35	34	79135	3134	29492224
Goitre	21.58	10.35	23	79146	1444	29493914
Foetal exposure during pregnancy	21.43	10.35	36	79133	33831	29461527
Hyperglycaemia	21.29	10.35	161	79008	34126	29461232
Pancytopenia	21.17	10.35	133	79036	83035	29412323
Subacute hepatic failure	20.99	10.35	8	79161	74	29495284
Condition aggravated	20.94	10.35	271	78898	146024	29349334
Renal artery stenosis	20.85	10.35	26	79143	1935	29493423
Gastritis erosive	20.60	10.35	45	79124	5348	29490010
Aortic valve incompetence	20.50	10.35	43	79126	4970	29490388
Adrenal adenoma	20.46	10.35	12	79157	310	29495048
Hyperuricaemia	20.35	10.35	52	79117	6837	29488521
Chest injury	20.26	10.35	22	79147	1411	29493947
Blood lactate dehydrogenase increased	19.99	10.35	103	79066	19106	29476252
Drug resistance	19.91	10.35	17	79152	21523	29473835
Pulmonary hypoplasia	19.78	10.35	13	79156	413	29494945
Lateropulsion	19.70	10.35	4	79165	0	29495358
Ventricular hypokinesia	19.66	10.35	40	79129	4525	29490833
Vomiting	19.63	10.35	426	78743	211834	29283524
Deep vein thrombosis	19.57	10.35	83	79086	57316	29438042
Prostate cancer	19.45	10.35	126	79043	25401	29469957
Sprue-like enteropathy	19.40	10.35	13	79156	427	29494931
Gouty arthritis	19.34	10.35	18	79151	959	29494399
Synovitis	19.33	10.35	3	79166	10887	29484471
Patent ductus arteriosus	19.26	10.35	32	79137	3099	29492259
Rhythm idioventricular	19.23	10.35	11	79158	271	29495087
Dyslipidaemia	19.22	10.35	47	79122	6014	29489344
Drug ineffective for unapproved indication	19.21	10.35	7	79162	14207	29481151
Status epilepticus	19.10	10.35	3	79166	10791	29484567
Drug intolerance	19.04	10.35	66	79103	48313	29447045
Coronary arterial stent insertion	19.03	10.35	36	79133	3861	29491497
Cardiac failure acute	19.00	10.35	61	79108	9131	29486227
Pyonephrosis	18.73	10.35	7	79162	61	29495297
Coronary artery restenosis	18.65	10.35	18	79151	1004	29494354
Hypoparathyroidism	18.52	10.35	13	79156	461	29494897
Ventricular extrasystoles	18.16	10.35	66	79103	10516	29484842
Angioplasty	17.98	10.35	17	79152	924	29494434
Vertigo	17.96	10.35	110	79059	21751	29473607
Malignant neoplasm progression	17.83	10.35	120	79049	73739	29421619
Transient ischaemic attack	17.82	10.35	115	79054	23155	29472203
Coronary artery stenosis	17.81	10.35	57	79112	8516	29486842
Psychotic disorder	17.70	10.35	17	79152	20337	29475021
Lacunar infarction	17.59	10.35	29	79140	2790	29492568
Oscillopsia	17.44	10.35	6	79163	40	29495318
Osteoarthritis	17.42	10.35	95	79074	18008	29477350
Pyrexia	17.37	10.35	613	78556	287009	29208349
Neuropathy peripheral	17.35	10.35	115	79054	70912	29424446
Hypertrophic osteoarthropathy	17.29	10.35	7	79162	77	29495281
Brain stem infarction	17.13	10.35	18	79151	1112	29494246
Bundle branch block right	17.12	10.35	48	79121	6669	29488689
Quality of life decreased	17.01	10.35	31	79138	3231	29492127
Blood pressure abnormal	16.79	10.35	48	79121	6742	29488616
Intentional product misuse	16.73	10.35	43	79126	34618	29460740
Urticaria chronic	16.39	10.35	7	79162	89	29495269
Merycism	16.29	10.35	6	79163	50	29495308
Retinopathy	16.28	10.35	22	79147	1773	29493585
Nephrogenic anaemia	16.02	10.35	23	79146	1962	29493396
Liver function test increased	15.81	10.35	6	79163	11879	29483479
Chest pain	15.81	10.35	402	78767	111571	29383787
Leukopenia	15.79	10.35	85	79084	55118	29440240
Periarthritis calcarea	15.79	10.35	6	79163	55	29495303
Cardiac vein perforation	15.74	10.35	5	79164	25	29495333
Peripheral arterial occlusive disease	15.71	10.35	39	79130	5037	29490321
Surfactant protein increased	15.68	10.35	4	79165	7	29495351
Articular calcification	15.51	10.35	6	79163	58	29495300
Neurotoxicity	15.48	10.35	10	79159	14603	29480755
Bile duct cancer	15.47	10.35	13	79156	604	29494754
Pericardial haemorrhage	15.47	10.35	28	79141	2903	29492455
Disease recurrence	15.40	10.35	12	79157	15902	29479456
Diabetic nephropathy	15.35	10.35	22	79147	1873	29493485
Blood pressure systolic increased	15.28	10.35	87	79082	16758	29478600
Erectile dysfunction	15.03	10.35	91	79078	17918	29477440
Seizure	15.03	10.35	168	79001	92955	29402403
Myelosuppression	14.94	10.35	7	79162	12220	29483138
Septic shock	14.92	10.35	102	79067	62458	29432900
Cardiac pacemaker insertion	14.80	10.35	25	79144	2454	29492904
Angina unstable	14.79	10.35	63	79106	10802	29484556
Blepharochalasis	14.78	10.35	3	79166	0	29495358
Renal dysplasia	14.75	10.35	8	79161	177	29495181
Acquired C1 inhibitor deficiency	14.72	10.35	4	79165	10	29495348
Loss of consciousness	14.62	10.35	279	78890	73777	29421581
Dyspnoea	14.56	10.35	1038	78131	325694	29169664
Atrial thrombosis	14.51	10.35	22	79147	1971	29493387
Myoglobin blood increased	14.49	10.35	22	79147	1973	29493385
Fear	14.43	10.35	57	79112	9447	29485911
Generalised tonic-clonic seizure	14.41	10.35	18	79151	19121	29476237
Cytomegalovirus infection	14.39	10.35	25	79144	23190	29472168
Abnormal behaviour	14.25	10.35	25	79144	23102	29472256
Ischaemic stroke	14.15	10.35	82	79087	15895	29479463
Nausea	14.09	10.35	632	78537	288623	29206735
Immature granulocyte count increased	14.00	10.35	6	79163	77	29495281
Rheumatoid arthritis	13.95	10.35	42	79127	32110	29463248
Product substitution issue	13.92	10.35	55	79114	9117	29486241
Chest discomfort	13.90	10.35	186	78983	45797	29449561
Glycosylated haemoglobin increased	13.88	10.35	56	79113	9370	29485988
Abdominal tenderness	13.81	10.35	30	79139	3552	29491806
Bursitis	13.79	10.35	36	79133	4796	29490562
Serotonin syndrome	13.69	10.35	16	79153	17496	29477862
Adrenal cyst	13.66	10.35	6	79163	82	29495276
Hypertensive heart disease	13.59	10.35	22	79147	2085	29493273
Diabetic retinopathy	13.57	10.35	19	79150	1583	29493775
Carotid artery stenosis	13.48	10.35	34	79135	4435	29490923
Malabsorption	13.47	10.35	21	79148	1927	29493431
Colitis	13.43	10.35	41	79128	31207	29464151
Therapeutic product effect incomplete	13.29	10.35	57	79112	39248	29456110
Small intestine carcinoma	13.28	10.35	11	79158	501	29494857
Chest wall haematoma	13.28	10.35	7	79162	146	29495212
Lipid metabolism disorder	13.18	10.35	9	79160	305	29495053
Eyelid ptosis congenital	13.10	10.35	6	79163	91	29495267
Rales	13.02	10.35	47	79122	7463	29487895
Ejection fraction decreased	12.87	10.35	80	79089	15898	29479460
Dystonia	12.84	10.35	5	79164	9744	29485614
Legionella test positive	12.71	10.35	3	79166	3	29495355
Constipation	12.69	10.35	222	78947	113938	29381420
Bacteraemia	12.66	10.35	15	79154	16308	29479050
Hypocapnia	12.63	10.35	7	79162	162	29495196
Ejection fraction abnormal	12.61	10.35	13	79156	785	29494573
Graft versus host disease	12.58	10.35	5	79164	9623	29485735
Atrioventricular block first degree	12.58	10.35	37	79132	5282	29490076
Malignant melanoma	12.57	10.35	45	79124	7116	29488242
Coronary artery occlusion	12.57	10.35	57	79112	10037	29485321
Tricuspid valve incompetence	12.47	10.35	50	79119	8344	29487014
Neutropenic sepsis	12.46	10.35	8	79161	11719	29483639
Hepatic calcification	12.44	10.35	9	79160	335	29495023
Costal cartilage fracture	12.43	10.35	8	79161	245	29495113
Cholangiocarcinoma	12.42	10.35	14	79155	936	29494422
Protein urine present	12.41	10.35	34	79135	4660	29490698
Renal cell carcinoma	12.40	10.35	34	79135	4662	29490696
Blood pressure systolic decreased	12.39	10.35	30	79139	3814	29491544
Pulmonary embolism	12.37	10.35	138	79031	76396	29418962
Tachycardia	12.33	10.35	129	79040	72281	29423077
Cardiovascular disorder	12.31	10.35	52	79117	8883	29486475
Erythema multiforme	12.30	10.35	47	79122	7670	29487688
Therapy non-responder	12.28	10.35	42	79127	30869	29464489
Extrasystoles	12.16	10.35	28	79141	3446	29491912
Adrenomegaly	12.14	10.35	9	79160	348	29495010
Atrioventricular block complete	12.12	10.35	48	79121	7963	29487395
Respiratory depression	12.10	10.35	11	79158	13512	29481846
Abdominal compartment syndrome	12.07	10.35	13	79156	826	29494532
Palpitations	12.06	10.35	137	79032	32467	29462891
Extrapyramidal disorder	12.05	10.35	7	79162	10824	29484534
Oedema neonatal	11.98	10.35	4	79165	24	29495334
Thrombotic stroke	11.98	10.35	8	79161	261	29495097
Lower respiratory tract infection	11.95	10.35	34	79135	26468	29468890
Loss of personal independence in daily activities	11.94	10.35	32	79137	25408	29469950
Choroidal detachment	11.92	10.35	9	79160	358	29495000
Malaise	11.76	10.35	531	78638	159071	29336287
Primary hyperaldosteronism	11.75	10.35	5	79164	63	29495295
Osteitis deformans	11.71	10.35	4	79165	26	29495332
Hepatic cancer	11.71	10.35	41	79128	6415	29488943
Nodal rhythm	11.70	10.35	16	79153	1304	29494054
Influenza	11.69	10.35	65	79104	41816	29453542
Electrocardiogram ST segment depression	11.69	10.35	21	79148	2164	29493194
Coronary angioplasty	11.68	10.35	9	79160	369	29494989
Genital candidiasis	11.68	10.35	5	79164	64	29495294
Dyspnoea exertional	11.61	10.35	149	79020	36341	29459017
Dyslalia	11.59	10.35	10	79159	482	29494876
Metamyelocyte count increased	11.51	10.35	9	79160	377	29494981
Pancreatitis chronic	11.51	10.35	20	79149	2008	29493350
Miscarriage of partner	11.50	10.35	3	79166	6	29495352
Lymphocyte count	11.47	10.35	5	79164	67	29495291
Ventricular hypertrophy	11.39	10.35	31	79138	4233	29491125
Neuromyopathy	11.34	10.35	13	79156	886	29494472
pH body fluid increased	11.28	10.35	5	79164	70	29495288
Ischaemic cardiomyopathy	11.27	10.35	37	79132	5601	29489757
Plasma cell myeloma	11.26	10.35	56	79113	37059	29458299
Hallucination	11.11	10.35	72	79097	44640	29450718
Carcinoid tumour	11.06	10.35	7	79162	208	29495150
Bladder cancer	11.02	10.35	55	79114	10072	29485286
Cardiac valve sclerosis	10.97	10.35	5	79164	75	29495283
Renal cyst	10.88	10.35	46	79123	7861	29487497
Emotional distress	10.84	10.35	69	79100	13826	29481532
Feeling cold	10.78	10.35	51	79118	9140	29486218
Small intestinal haemorrhage	10.78	10.35	19	79150	1930	29493428
Candida infection	10.77	10.35	15	79154	15210	29480148
Acute coronary syndrome	10.75	10.35	63	79106	12262	29483096
Hepatitis E antibody positive	10.74	10.35	6	79163	141	29495217
Renal failure neonatal	10.73	10.35	5	79164	79	29495279
Hepatic function abnormal	10.73	10.35	156	79013	39103	29456255
Joint stiffness	10.71	10.35	6	79163	9467	29485891
Adverse drug reaction	10.69	10.35	31	79138	23989	29471369
Bronchitis	10.68	10.35	148	79021	36720	29458638
Aortic aneurysm rupture	10.68	10.35	13	79156	944	29494414
Hypercholesterolaemia	10.66	10.35	43	79126	7195	29488163
Hypocalvaria	10.64	10.35	3	79166	9	29495349
Product residue present	10.64	10.35	22	79147	2517	29492841
Post streptococcal glomerulonephritis	10.59	10.35	4	79165	36	29495322
Concomitant disease progression	10.54	10.35	21	79148	2340	29493018
Aneurysm	10.45	10.35	17	79152	1617	29493741
Blood zinc decreased	10.41	10.35	3	79166	10	29495348
Injection site pain	10.40	10.35	48	79121	32398	29462960
Eczema	10.38	10.35	68	79101	13758	29481600

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
Blood pressure inadequately controlled	304.52	9.76	175	144955	5209	64348393
Off label use	287.31	9.76	624	144506	632182	63721420
Blood pressure increased	232.45	9.76	884	144246	171668	64181934
Completed suicide	230.93	9.76	108	145022	224306	64129296
Hyperkalaemia	225.53	9.76	616	144514	100513	64253089
Cardiac failure congestive	221.57	9.76	722	144408	129858	64223744
Myocardial infarction	213.91	9.76	838	144292	164983	64188619
Hyponatraemia	201.42	9.76	762	144368	147577	64206025
Cerebral infarction	176.45	9.76	325	144805	40719	64312883
Drug abuse	164.29	9.76	47	145083	132327	64221275
Toxicity to various agents	156.72	9.76	368	144762	363145	63990457
Coronary artery disease	153.96	9.76	387	144743	60046	64293556
Drug ineffective	141.79	9.76	1211	143919	839036	63514566
Hypertensive crisis	139.16	9.76	188	144942	18060	64335542
Acute kidney injury	135.41	9.76	1575	143555	447665	63905937
Blood creatinine increased	128.20	9.76	625	144505	135157	64218445
Renal failure	128.04	9.76	772	144358	180916	64172686
Death	127.93	9.76	605	144525	482100	63871502
Syncope	117.63	9.76	680	144450	156955	64196647
Hand deformity	116.35	9.76	6	145124	62765	64290837
Oedema peripheral	106.63	9.76	824	144306	209493	64144109
Febrile neutropenia	104.33	9.76	163	144967	187494	64166108
Infusion related reaction	103.23	9.76	131	144999	164336	64189266
Dizziness	95.98	9.76	1428	143702	428735	63924867
Systemic lupus erythematosus	95.46	9.76	28	145102	77584	64276018
Product use in unapproved indication	94.80	9.76	157	144973	176461	64177141
Cardiac failure	92.27	9.76	561	144569	131812	64221790
Product use issue	91.97	9.76	124	145006	151591	64202011
Glossodynia	90.00	9.76	18	145112	64678	64288924
Pemphigus	84.21	9.76	17	145113	60684	64292918
Atrial fibrillation	83.74	9.76	665	144465	170424	64183178
Acute myocardial infarction	83.10	9.76	344	144786	69374	64284228
Blood urea increased	82.92	9.76	253	144877	43900	64309702
Hypotension	82.32	9.76	1258	143872	379716	63973886
Cerebrovascular accident	82.32	9.76	561	144569	137022	64216580
Colitis microscopic	79.90	9.76	91	145039	7341	64346261
Angina pectoris	78.83	9.76	252	144878	44829	64308773
Renal impairment	78.09	9.76	546	144584	134471	64219131
Blood glucose increased	75.68	9.76	427	144703	97646	64255956
Alopecia	74.29	9.76	164	144966	165526	64188076
Pericarditis	72.53	9.76	25	145105	62491	64291111
Oligohydramnios	69.34	9.76	57	145073	3067	64350535
Mitral valve incompetence	66.54	9.76	165	144965	25373	64328229
Neutropenia	66.48	9.76	295	144835	239329	64114273
Angioedema	65.95	9.76	295	144835	61526	64292076
Joint swelling	63.53	9.76	259	144871	215123	64138479
Treatment failure	62.51	9.76	104	145026	116712	64236890
Condition aggravated	62.34	9.76	537	144593	371889	63981713
Arthropathy	61.72	9.76	111	145019	120856	64232746
Bundle branch block left	61.25	9.76	93	145037	9941	64343661
Maternal exposure during pregnancy	60.52	9.76	76	145054	95808	64257794
Cardiac failure chronic	58.34	9.76	86	145044	8955	64344647
Bronchial neoplasm	56.55	9.76	25	145105	418	64353184
Duodenal ulcer perforation	56.55	9.76	6	145124	34619	64318983
Intentional product use issue	54.73	9.76	81	145049	95283	64258319
Nasal turbinate hypertrophy	53.31	9.76	26	145104	549	64353053
Wound	53.26	9.76	56	145074	76421	64277181
Bradycardia	53.23	9.76	451	144679	117768	64235834
Interstitial lung disease	52.88	9.76	389	144741	97343	64256259
Pain	52.52	9.76	903	144227	552608	63800994
Labile hypertension	52.09	9.76	25	145105	509	64353093
Therapeutic product effect decreased	51.83	9.76	114	145016	115237	64238365
Product dose omission issue	51.47	9.76	244	144886	194503	64159099
Blood creatine phosphokinase increased	51.29	9.76	264	144866	58294	64295308
Product prescribing error	50.98	9.76	185	144945	35084	64318518
Intentional overdose	50.07	9.76	78	145052	89866	64263736
Product impurity	49.29	9.76	15	145115	78	64353524
Drug intolerance	47.67	9.76	239	144891	187753	64165849
Anaemia	46.90	9.76	1149	143981	377531	63976071
Glaucoma	46.21	9.76	109	145021	16239	64337363
Exposure during pregnancy	45.53	9.76	65	145065	77610	64275992
Total lung capacity increased	45.43	9.76	25	145105	683	64352919
Angina unstable	44.67	9.76	104	145026	15363	64338239
Diabetes mellitus inadequate control	44.63	9.76	127	145003	21194	64332408
Rheumatoid arthritis	44.49	9.76	204	144926	164090	64189512
Chest pain	44.41	9.76	762	144368	235218	64118384
Sleep disorder due to general medical condition, insomnia type	44.35	9.76	4	145126	26266	64327336
Melaena	43.19	9.76	236	144894	53312	64300290
Endometrial ablation	42.55	9.76	25	145105	776	64352826
Sinus arrest	42.31	9.76	43	145087	3047	64350555
Thyroid disorder	42.18	9.76	86	145044	11606	64341996
Contraindicated product administered	41.83	9.76	115	145015	107714	64245888
Blood pressure decreased	41.55	9.76	334	144796	85865	64267737
Synovitis	41.25	9.76	102	145028	98988	64254614
Hospitalisation	41.12	9.76	66	145064	75141	64278461
Blood lactate dehydrogenase increased	40.81	9.76	165	144965	32913	64320689
Transient ischaemic attack	40.66	9.76	202	144928	43980	64309622
Helicobacter infection	40.12	9.76	18	145112	38344	64315258
Chronic kidney disease	40.02	9.76	245	144885	57674	64295928
Obstructive airways disorder	39.07	9.76	128	145002	23057	64330545
Arteriosclerosis	38.67	9.76	100	145030	15777	64337825
Folliculitis	38.57	9.76	10	145120	30067	64323535
Infection	38.28	9.76	251	144879	184629	64168973
Coronary arterial stent insertion	37.97	9.76	55	145075	5637	64347965
Gamma-glutamyltransferase increased	37.92	9.76	212	144918	48298	64305304
Asthenia	37.48	9.76	1243	143887	426801	63926801
Bronchial haemorrhage	37.43	9.76	27	145103	1195	64352407
Blood lactic acid	37.21	9.76	19	145111	444	64353158
Forced expiratory volume decreased	36.86	9.76	60	145070	6807	64346795
Disease progression	36.55	9.76	179	144951	141501	64212101
Blood potassium increased	36.47	9.76	135	144995	25845	64327757
Tricuspid valve incompetence	36.29	9.76	102	145028	16901	64336701
Swelling	36.03	9.76	212	144918	160006	64193596
Ischaemic stroke	35.96	9.76	145	144985	28890	64324712
Foetal disorder	35.95	9.76	13	145117	124	64353478
Rash	35.80	9.76	773	144357	457776	63895826
Diverticulitis	35.14	9.76	176	144954	38442	64315160
Cerebral haemorrhage	34.60	9.76	215	144915	50875	64302727
N-terminal prohormone brain natriuretic peptide abnormal	34.59	9.76	15	145115	239	64353363
Myocardial ischaemia	34.48	9.76	123	145007	23128	64330474
Injection site pain	34.07	9.76	132	144998	111276	64242326
Cardiac failure acute	33.87	9.76	97	145033	16247	64337355
Aortic aneurysm	33.83	9.76	61	145069	7513	64346089
Arrhythmia	33.50	9.76	219	144911	52725	64300877
Diverticulum intestinal	33.45	9.76	60	145070	7360	64346242
Lymphatic fistula	33.43	9.76	21	145109	737	64352865
Femoral hernia incarcerated	33.35	9.76	21	145109	740	64352862
Drug hypersensitivity	33.33	9.76	358	144772	237457	64116145
Suicidal ideation	33.09	9.76	62	145068	66480	64287122
Abortion spontaneous	32.93	9.76	8	145122	25135	64328467
Drug resistance	32.93	9.76	19	145111	35083	64318519
Fear of disease	32.40	9.76	22	145108	883	64352719
Psoriatic arthropathy	32.08	9.76	30	145100	43251	64310351
Intentional product misuse	32.02	9.76	72	145058	72223	64281379
Arthralgia	31.84	9.76	755	144375	441505	63912097
Hyperglycaemia	31.46	9.76	240	144890	60728	64292874
Atrioventricular block complete	31.27	9.76	87	145043	14331	64339271
COVID-19	31.25	9.76	62	145068	65078	64288524
Rheumatoid factor positive	31.25	9.76	20	145110	34918	64318684
Dyspnoea	31.02	9.76	1942	143188	716732	63636870
Eosinophilic colitis	30.83	9.76	16	145114	387	64353215
Cardiovascular disorder	30.75	9.76	92	145038	15789	64337813
Lymphocyte stimulation test positive	30.64	9.76	23	145107	1083	64352519
Rhabdomyolysis	30.38	9.76	328	144802	91398	64262204
Pancreatic steatosis	30.26	9.76	22	145108	986	64352616
Pancreatic neoplasm	30.02	9.76	25	145105	1370	64352232
Bronchial disorder	30.00	9.76	30	145100	2085	64351517
Dehydration	29.94	9.76	668	144462	216095	64137507
Thrombotic stroke	29.86	9.76	19	145111	682	64352920
Hemiplegia	29.65	9.76	79	145051	12689	64340913
Coronary artery stenosis	29.65	9.76	73	145057	11175	64342427
Vascular resistance pulmonary decreased	29.64	9.76	10	145120	76	64353526
Diabetic retinopathy	29.24	9.76	34	145096	2805	64350797
Pemphigoid	28.80	9.76	79	145051	12907	64340695
Liver function test increased	28.71	9.76	17	145113	30953	64322649
Bronchitis	28.58	9.76	372	144758	108371	64245231
Atrioventricular block	28.57	9.76	75	145055	11940	64341662
Rhonchi	28.43	9.76	37	145093	3426	64350176
Hypertension	28.35	9.76	774	144356	258487	64095115
Cardiomegaly	28.31	9.76	117	145013	23567	64330035
Muscle injury	28.28	9.76	12	145118	26425	64327177
Blood uric acid increased	28.22	9.76	59	145071	8104	64345498
Status epilepticus	28.17	9.76	7	145123	21656	64331946
Fall	28.14	9.76	1176	143954	415650	63937952
Renal artery stenosis	28.01	9.76	34	145096	2935	64350667
Haematoma	27.87	9.76	189	144941	46061	64307541
Oxygen saturation increased	27.51	9.76	16	145114	487	64353115
Coronary artery occlusion	27.40	9.76	81	145049	13810	64339792
Stomatitis	27.39	9.76	140	144990	109465	64244137
Coronary artery restenosis	27.33	9.76	23	145107	1279	64352323
Discomfort	27.26	9.76	92	145038	80786	64272816
Device dislocation	27.23	9.76	7	145123	21171	64332431
Left ventricular dilatation	27.20	9.76	20	145110	912	64352690
Left-to-right cardiac shunt	27.06	9.76	10	145120	102	64353500
Disease recurrence	26.89	9.76	19	145111	31491	64322111
Ischaemic cardiomyopathy	26.72	9.76	52	145078	6786	64346816
Pregnancy	26.63	9.76	7	145123	20858	64332744
Renal cyst	26.43	9.76	75	145055	12495	64341107
Hypoglycaemia	26.41	9.76	314	144816	89578	64264024
Cell marker increased	26.36	9.76	17	145113	625	64352977
Drug ineffective for unapproved indication	26.27	9.76	19	145111	31114	64322488
Tachyarrhythmia	26.24	9.76	48	145082	5978	64347624
Sedation	26.01	9.76	33	145097	41429	64312173
Diabetes mellitus	26.00	9.76	246	144884	66228	64287374
Hip arthroplasty	25.71	9.76	8	145122	21343	64332259
Blood pressure systolic increased	25.69	9.76	195	144935	49258	64304344
Psychotic disorder	25.59	9.76	24	145106	34554	64319048
Intentional self-injury	25.47	9.76	17	145113	29027	64324575
Injection site reaction	25.46	9.76	41	145089	46623	64306979
Dyslipidaemia	25.45	9.76	61	145069	9181	64344421
Blister	25.35	9.76	95	145035	80872	64272730
Brain natriuretic peptide abnormal	25.24	9.76	17	145113	673	64352929
Myelosuppression	25.20	9.76	11	145119	23819	64329783
Blood sodium decreased	25.17	9.76	132	144998	29350	64324252
Arterial haemorrhage	25.15	9.76	28	145102	2203	64351399
Cytomegalovirus infection	25.05	9.76	28	145102	37171	64316431
Drug dependence	24.79	9.76	23	145107	33289	64320313
Ventricular hypertrophy	24.79	9.76	49	145081	6467	64347135
Lower respiratory tract infection	24.71	9.76	119	145011	94495	64259107
Clostridium difficile infection	24.60	9.76	27	145103	36136	64317466
Brain stem stroke	24.47	9.76	14	145116	413	64353189
Idiopathic pulmonary fibrosis	24.30	9.76	36	145094	3764	64349838
Haematochezia	24.18	9.76	242	144888	66131	64287471
Wound infection pseudomonas	24.09	9.76	23	145107	1510	64352092
Lacunar infarction	24.01	9.76	44	145086	5488	64348114
Colon cancer	23.91	9.76	73	145057	12666	64340936
Gastric cancer	23.71	9.76	48	145082	6445	64347157
Coronary angioplasty	23.66	9.76	13	145117	354	64353248
Sinusitis	23.65	9.76	212	144918	145716	64207886
Glomerular filtration rate decreased	23.64	9.76	97	145033	19475	64334127
Hyperuricaemia	23.61	9.76	63	145067	10128	64343474
Hypokalaemia	23.39	9.76	395	144735	121508	64232094
Orthostatic intolerance	23.26	9.76	23	145107	1577	64352025
Hepatic function abnormal	23.19	9.76	234	144896	64079	64289523
Musculoskeletal stiffness	23.16	9.76	172	144958	123034	64230568
Pyrexia	23.05	9.76	1025	144105	557619	63795983
Ventricular extrasystoles	22.88	9.76	89	145041	17440	64336162
Lung diffusion disorder	22.76	9.76	9	145121	112	64353490
Monoplegia	22.57	9.76	33	145097	3410	64350192
Nodal rhythm	22.50	9.76	30	145100	2844	64350758
Shock	22.29	9.76	155	144975	38085	64315517
Chronic pigmented purpura	22.21	9.76	10	145120	175	64353427
Hypochromic anaemia	22.15	9.76	27	145103	2341	64351261
Renal cell carcinoma	22.14	9.76	45	145085	6059	64347543
Adverse drug reaction	22.04	9.76	43	145087	45421	64308181
Eructation	21.47	9.76	57	145073	9134	64344468
Hypertensive heart disease	21.46	9.76	34	145096	3770	64349832
Septic shock	21.38	9.76	144	144986	105293	64248309
Electrocardiogram QRS complex abnormal	21.11	9.76	14	145116	540	64353062
Graft versus host disease	21.07	9.76	3	145127	13810	64339792
Bone marrow failure	21.03	9.76	48	145082	47904	64305698
Blood aldosterone increased	20.64	9.76	10	145120	208	64353394
Adrenomegaly	20.58	9.76	12	145118	367	64353235
Gastrointestinal disorder	20.53	9.76	118	145012	89591	64264011
Lateropulsion	20.40	9.76	4	145126	0	64353602
Bundle branch block right	20.37	9.76	60	145070	10209	64343393
Device issue	20.21	9.76	13	145117	22635	64330967
Respiratory arrest	20.17	9.76	57	145073	52928	64300674
Inguinal hernia	20.07	9.76	41	145089	5540	64348062
General physical health deterioration	20.03	9.76	602	144528	203823	64149779
Therapy interrupted	20.03	9.76	10	145120	20026	64333576
Prostate cancer	20.02	9.76	93	145037	19702	64333900
Vertigo	19.99	9.76	212	144918	58799	64294803
Chest injury	19.98	9.76	26	145104	2407	64351195
Migraine	19.98	9.76	73	145057	62604	64290998
Retrograde amnesia	19.96	9.76	13	145117	486	64353116
Venous pressure jugular increased	19.94	9.76	19	145111	1244	64352358
Neutropenic sepsis	19.90	9.76	14	145116	23258	64330344
Loss of consciousness	19.78	9.76	455	144675	147910	64205692
Atrial thrombosis	19.72	9.76	29	145101	3013	64350589
Impaired work ability	19.63	9.76	5	145125	15214	64338388
Gastric ulcer haemorrhage	19.53	9.76	51	145079	8092	64345510
Hepatic cyst	19.45	9.76	39	145091	5201	64348401
Rhythm idioventricular	19.41	9.76	13	145117	510	64353092
Neuropathy peripheral	19.36	9.76	170	144960	117355	64236247
Carotid artery stenosis	19.32	9.76	50	145080	7891	64345711
Decreased appetite	19.27	9.76	795	144335	280494	64073108
Adrenal adenoma	19.21	9.76	17	145113	1012	64352590
Carotid artery disease	19.16	9.76	24	145106	2139	64351463
Neurotoxicity	19.15	9.76	20	145110	27384	64326218
Cardio-respiratory arrest	19.15	9.76	136	144994	98257	64255345
Low density lipoprotein increased	19.11	9.76	49	145081	7691	64345911
Malabsorption	19.08	9.76	35	145095	4368	64349234
Glycosylated haemoglobin increased	19.04	9.76	79	145051	15940	64337662
Thrombocytopenia	18.98	9.76	372	144758	223429	64130173
Gastritis erosive	18.97	9.76	56	145074	9539	64344063
Skin reaction	18.88	9.76	66	145064	12286	64341316
Product substitution issue	18.87	9.76	85	145045	17776	64335826
Conduction disorder	18.81	9.76	28	145102	2940	64350662
Forced vital capacity decreased	18.79	9.76	20	145110	1496	64352106
Pulmonary arterial pressure abnormal	18.69	9.76	14	145116	657	64352945
Sepsis	18.60	9.76	386	144744	229955	64123647
Injection site erythema	18.51	9.76	89	145041	70711	64282891
Fatigue	18.44	9.76	1443	143687	747287	63606315
Brain contusion	18.36	9.76	18	145112	1221	64352381
Rectal prolapse	18.33	9.76	21	145109	1705	64351897
Cytopenia	18.27	9.76	6	145124	15465	64338137
Multiple sclerosis relapse	18.18	9.76	41	145089	41094	64312508
Concomitant disease progression	18.14	9.76	29	145101	3240	64350362
C-reactive protein increased	18.01	9.76	307	144823	94602	64259000
Ventricular hypokinesia	17.97	9.76	48	145082	7721	64345881
Blood triglycerides increased	17.89	9.76	87	145043	18779	64334823
Ophthalmic vein thrombosis	17.87	9.76	9	145121	204	64353398
Lipid metabolism disorder	17.73	9.76	10	145120	287	64353315
Fear	17.70	9.76	91	145039	20080	64333522
Pyonephrosis	17.64	9.76	7	145123	88	64353514
Irritable bowel syndrome	17.55	9.76	36	145094	37333	64316269
Product odour abnormal	17.55	9.76	17	145113	1136	64352466
Blood thyroid stimulating hormone abnormal	17.38	9.76	14	145116	732	64352870
Mucosal inflammation	17.35	9.76	77	145053	62507	64291095
Asthma	17.34	9.76	306	144824	94919	64258683
Peak expiratory flow rate decreased	17.26	9.76	13	145117	615	64352987
Basal ganglion degeneration	17.24	9.76	11	145119	397	64353205
Neutrophil function disorder	17.11	9.76	5	145125	22	64353580
Aortic arteriosclerosis	17.10	9.76	46	145084	7430	64346172
Gastrointestinal haemorrhage	17.09	9.76	404	144726	131908	64221694
Impaired healing	17.01	9.76	74	145056	60399	64293203
Infective pulmonary exacerbation of cystic fibrosis	17.00	9.76	3	145127	11793	64341809
Pneumothorax traumatic	17.00	9.76	9	145121	227	64353375
Seroma	16.95	9.76	22	145108	2032	64351570
Transplant rejection	16.93	9.76	9	145121	17392	64336210
Aortic valve stenosis	16.89	9.76	34	145096	4546	64349056
Myalgia	16.88	9.76	472	144658	158145	64195457
Haemorrhage subcutaneous	16.84	9.76	33	145097	4328	64349274
Pericardial haemorrhage	16.83	9.76	32	145098	4104	64349498
Uterine enlargement	16.81	9.76	14	145116	767	64352835
Periarthritis calcarea	16.80	9.76	6	145124	55	64353547
Hiatus hernia	16.80	9.76	89	145041	19868	64333734
Sinus node dysfunction	16.62	9.76	43	145087	6785	64346817
Cardiac vein perforation	16.59	9.76	5	145125	25	64353577
Post-anoxic myoclonus	16.59	9.76	5	145125	25	64353577
Seizure	16.49	9.76	270	144860	166622	64186980
Neoplasm progression	16.40	9.76	43	145087	40921	64312681
Gout	16.35	9.76	93	145037	21320	64332282
Renin decreased	16.29	9.76	7	145123	109	64353493
Immune reconstitution inflammatory syndrome	16.27	9.76	4	145126	12466	64341136
Malignant melanoma	16.26	9.76	65	145065	12899	64340703
Blood pressure abnormal	16.24	9.76	70	145060	14365	64339237
Toxic skin eruption	16.23	9.76	86	145044	19198	64334404
Hepatic cancer	16.21	9.76	45	145085	7403	64346199
Pancytopenia	16.16	9.76	226	144904	143083	64210519
Hypercholesterolaemia	16.12	9.76	73	145057	15300	64338302
Product monitoring error	16.11	9.76	37	145093	5417	64348185
Dyspnoea exertional	16.05	9.76	244	144886	73486	64280116
Blood alkaline phosphatase increased	15.83	9.76	195	144935	56084	64297518
Dementia Alzheimer's type	15.81	9.76	15	145115	977	64352625
Therapeutic drug monitoring analysis incorrectly performed	15.78	9.76	8	145122	184	64353418
Cardiac myxoma	15.78	9.76	7	145123	118	64353484
Nausea	15.72	9.76	1539	143591	784261	63569341
Tissue infiltration	15.69	9.76	12	145118	581	64353021
Altered state of consciousness	15.69	9.76	142	144988	37760	64315842
Hypertrophic osteoarthropathy	15.68	9.76	7	145123	120	64353482
Gouty arthritis	15.61	9.76	17	145113	1305	64352297
Coronary artery bypass	15.60	9.76	38	145092	5777	64347825
Erectile dysfunction	15.58	9.76	63	145067	12564	64341038
Microalbuminuria	15.57	9.76	14	145116	851	64352751
Pigmentation disorder	15.56	9.76	33	145097	4579	64349023
Aggression	15.30	9.76	53	145077	46179	64307423
Renal injury	15.24	9.76	72	145058	15357	64338245
Hypertensive emergency	15.19	9.76	22	145108	2254	64351348
Acute hepatic failure	15.15	9.76	22	145108	26090	64327512
Pyometra	15.15	9.76	6	145124	75	64353527
Somnolence	15.07	9.76	346	144784	203299	64150303
Aortic valve incompetence	15.05	9.76	47	145083	8254	64345348
Goitre	14.98	9.76	34	145096	4939	64348663
Subacute hepatic failure	14.93	9.76	8	145122	207	64353395
Mydriasis	14.78	9.76	8	145122	15304	64338298
Merycism	14.76	9.76	8	145122	212	64353390
Myoglobin blood increased	14.74	9.76	24	145106	2723	64350879
Acquired C1 inhibitor deficiency	14.64	9.76	4	145126	13	64353589
Left ventricular dysfunction	14.54	9.76	76	145054	16878	64336724
Haemophagocytic lymphohistiocytosis	14.53	9.76	11	145119	17598	64336004
Nephrotic syndrome	14.52	9.76	51	145079	9516	64344086
Hyperlipidaemia	14.51	9.76	95	145035	22881	64330721
Acral lentiginous melanoma	14.49	9.76	5	145125	41	64353561
Adrenal cyst	14.35	9.76	6	145124	87	64353515
Hypercreatininaemia	14.30	9.76	13	145117	802	64352800
Progressive multifocal leukoencephalopathy	14.28	9.76	12	145118	18220	64335382
Metastatic bronchial carcinoma	14.26	9.76	8	145122	227	64353375
Fractured coccyx	14.25	9.76	14	145116	952	64352650
Malignant neoplasm progression	14.19	9.76	174	144956	112697	64240905
Diverticulum intestinal haemorrhagic	14.19	9.76	26	145104	3243	64350359
Loss of personal independence in daily activities	14.17	9.76	100	145030	72354	64281248
Abdominal tenderness	14.16	9.76	50	145080	9355	64344247
Diastolic dysfunction	14.07	9.76	48	145082	8827	64344775
Painful respiration	14	9.76	25	145105	3056	64350546
Duodenal ulcer	14.00	9.76	67	145063	14368	64339234
Therapy partial responder	13.94	9.76	3	145127	10245	64343357
Macular degeneration	13.94	9.76	36	145094	5674	64347928
Articular calcification	13.93	9.76	6	145124	94	64353508
Nephrogenic anaemia	13.87	9.76	26	145104	3299	64350303
Hypochloraemia	13.87	9.76	20	145110	2041	64351561
Carotid artery occlusion	13.85	9.76	29	145101	3988	64349614
Mouth ulceration	13.81	9.76	33	145097	32411	64321191
Surfactant protein increased	13.80	9.76	4	145126	17	64353585
Abdominal discomfort	13.71	9.76	309	144821	182013	64171589
Staphylococcal infection	13.66	9.76	63	145067	50615	64302987
Costal cartilage fracture	13.65	9.76	8	145122	247	64353355
Accidental exposure to product	13.61	9.76	24	145106	26340	64327262
Anhedonia	13.57	9.76	64	145066	13642	64339960
Rhinitis	13.52	9.76	54	145076	10711	64342891
Venoocclusive liver disease	13.49	9.76	3	145127	10012	64343590
Lung diffusion test decreased	13.46	9.76	15	145115	1181	64352421
Hepatic calcification	13.39	9.76	9	145121	355	64353247
Anaphylactic reaction	13.31	9.76	95	145035	68569	64285033
Extrasystoles	13.30	9.76	39	145091	6619	64346983
Miscarriage of partner	13.22	9.76	3	145127	3	64353599
Faecaloma	13.19	9.76	50	145080	9678	64343924
Azotaemia	13.17	9.76	42	145088	7460	64346142
Recalled product administered	13.15	9.76	12	145118	744	64352858
Blood cholesterol increased	13.03	9.76	171	144959	49895	64303707
Cerebral arteriosclerosis	13.00	9.76	12	145118	755	64352847
Kyphosis	12.97	9.76	21	145109	2372	64351230
Dystonia	12.92	9.76	14	145116	18851	64334751
Iron deficiency anaemia	12.92	9.76	89	145041	21800	64331802
Hepatic enzyme increased	12.91	9.76	210	144920	129733	64223869
Transitional cell cancer of the renal pelvis and ureter	12.88	9.76	5	145125	59	64353543
Cognitive disorder	12.85	9.76	72	145058	55015	64298587
Epstein-Barr virus infection	12.84	9.76	6	145124	12482	64341120
Bezold-Jarisch reflex	12.67	9.76	4	145126	24	64353578
Nasopharyngitis	12.65	9.76	340	144790	195733	64157869
Erythema multiforme	12.52	9.76	69	145061	15632	64337970
Premature delivery	12.51	9.76	14	145116	18575	64335027
Emotional distress	12.46	9.76	130	145000	35908	64317694
Urticaria	12.44	9.76	245	144885	147072	64206530
Arrhythmogenic right ventricular dysplasia	12.40	9.76	4	145126	26	64353576
Peripheral swelling	12.39	9.76	367	144763	208786	64144816
Therapy non-responder	12.38	9.76	92	145038	65807	64287795
Device related infection	12.37	9.76	32	145098	30594	64323008
Infusion site pain	12.33	9.76	4	145126	10393	64343209
Anaesthesia	12.25	9.76	9	145121	410	64353192
Bladder cancer	12.18	9.76	53	145077	10921	64342681
Liver disorder	12.17	9.76	178	144952	53173	64300429
Immunodeficiency	12.16	9.76	11	145119	16113	64337489
Live birth	12.12	9.76	5	145125	11199	64342403
Electrocardiogram ST segment depression	12.12	9.76	29	145101	4360	64349242
Metastases to bone	12.07	9.76	17	145113	20418	64333184
Actinic keratosis	12.03	9.76	32	145098	5133	64348469
Renal artery stent placement	12.02	9.76	4	145126	29	64353573
Prerenal failure	11.98	9.76	24	145106	3198	64350404
Oedema	11.95	9.76	281	144849	91654	64261948
Gait disturbance	11.87	9.76	487	144643	171668	64181934
Withdrawal hypertension	11.83	9.76	8	145122	319	64353283
Hypersensitivity	11.81	9.76	344	144786	196108	64157494
Chronic obstructive pulmonary disease	11.78	9.76	225	144905	70823	64282779
Haemangioma	11.75	9.76	20	145110	2354	64351248
Sprue-like enteropathy	11.75	9.76	13	145117	1016	64352586
Neutrophil count decreased	11.70	9.76	114	145016	77082	64276520
Chronic leukaemia	11.70	9.76	3	145127	7	64353595
Hepatitis E antibody positive	11.68	9.76	6	145124	142	64353460
Putamen haemorrhage	11.66	9.76	9	145121	442	64353160
Aortic valve sclerosis	11.63	9.76	16	145114	1563	64352039
Eczema	11.62	9.76	110	145020	29610	64323992
Therapy cessation	11.61	9.76	36	145094	32453	64321149
Multiple injuries	11.59	9.76	24	145106	3275	64350327
Right ventricular failure	11.58	9.76	19	145111	21452	64332150
Basal ganglia haemorrhage	11.51	9.76	15	145115	1391	64352211
Cytomegalovirus viraemia	11.45	9.76	5	145125	10823	64342779
Cerebellar ischaemia	11.42	9.76	6	145124	149	64353453
Frustration tolerance decreased	11.40	9.76	35	145095	6090	64347512
Injection site swelling	11.39	9.76	51	145079	41302	64312300
Acute phosphate nephropathy	11.37	9.76	4	145126	35	64353567
Joint stiffness	11.36	9.76	33	145097	30371	64323231
Osteoarthritis	11.34	9.76	203	144927	63133	64290469
Activated partial thromboplastin time prolonged	11.34	9.76	58	145072	12773	64340829
Pulmonary oedema	11.33	9.76	244	144886	78430	64275172
Stenosis	11.33	9.76	17	145113	1798	64351804
Incorrect route of product administration	11.32	9.76	22	145108	23276	64330326
Panniculitis	11.29	9.76	3	145127	8876	64344726
Sudden cardiac death	11.28	9.76	29	145101	4558	64349044
Peripheral vascular disorder	11.27	9.76	39	145091	7222	64346380
Brain stem infarction	11.27	9.76	17	145113	1806	64351796
Body height decreased	11.23	9.76	40	145090	7514	64346088
Multiple drug therapy	11.17	9.76	19	145111	2235	64351367
Perihepatic discomfort	11.16	9.76	3	145127	9	64353593
Hepatobiliary cancer	11.16	9.76	3	145127	9	64353593
Bronchopulmonary aspergillosis	11.15	9.76	16	145114	19069	64334533
Hyponatraemic syndrome	11.15	9.76	11	145119	752	64352850
Low density lipoprotein decreased	11.13	9.76	13	145117	1077	64352525
Fibromyalgia	11.13	9.76	42	145088	35689	64317913
Anuria	11.13	9.76	77	145053	18887	64334715
Acute coronary syndrome	11.09	9.76	78	145052	19232	64334370
Cutaneous lymphoma	11.08	9.76	7	145123	248	64353354
Hypoxia	11.04	9.76	136	144994	88013	64265589
Large intestine polyp	11.02	9.76	51	145079	10786	64342816
Metamyelocyte count increased	10.97	9.76	10	145120	619	64352983
Arteriosclerosis coronary artery	10.92	9.76	66	145064	15463	64338139
Hepatitis E virus test positive	10.87	9.76	6	145124	165	64353437
Suspected suicide	10.86	9.76	3	145127	8651	64344951
Renal neoplasm	10.86	9.76	16	145114	1665	64351937
Mood swings	10.86	9.76	14	145116	17454	64336148
Aortic dissection	10.84	9.76	24	145106	3428	64350174
Angioplasty	10.83	9.76	16	145114	1669	64351933
Orthopnoea	10.82	9.76	45	145085	9089	64344513
Blood chloride decreased	10.80	9.76	39	145091	7377	64346225
Exercise tolerance decreased	10.77	9.76	40	145090	7670	64345932
Infarction	10.75	9.76	26	145104	3934	64349668
Post streptococcal glomerulonephritis	10.72	9.76	4	145126	42	64353560
Chest wall haematoma	10.69	9.76	8	145122	375	64353227
Rash maculo-papular	10.68	9.76	62	145068	46964	64306638
Small intestine carcinoma	10.62	9.76	11	145119	797	64352805
Left ventricular hypertrophy	10.62	9.76	46	145084	9460	64344142
Ear infection	10.61	9.76	23	145107	23381	64330221
Subdural haematoma	10.56	9.76	103	145027	27951	64325651
Protein urine present	10.51	9.76	44	145086	8912	64344690
Oscillopsia	10.46	9.76	6	145124	178	64353424
Haematocrit decreased	10.44	9.76	177	144953	54478	64299124
Skin texture abnormal	10.43	9.76	8	145122	389	64353213
Haemodialysis	10.41	9.76	70	145060	17007	64336595
Peripheral arterial occlusive disease	10.39	9.76	37	145093	6950	64346652
Blood phosphorus abnormal	10.37	9.76	7	145123	278	64353324
Brain stem haemorrhage	10.36	9.76	15	145115	1536	64352066
Laryngeal haemorrhage	10.32	9.76	4	145126	47	64353555
Subarachnoid haemorrhage	10.31	9.76	74	145056	18364	64335238
Aspergillus infection	10.31	9.76	13	145117	16366	64337236
Leukopenia	10.26	9.76	163	144967	101079	64252523
Cutaneous listeriosis	10.24	9.76	4	145126	48	64353554
Choroidal detachment	10.21	9.76	9	145121	533	64353069
Bacteraemia	10.21	9.76	29	145101	26882	64326720
Liver function test abnormal	10.19	9.76	85	145045	59316	64294286
Cardiac valve sclerosis	10.19	9.76	5	145125	107	64353495
Diabetic nephropathy	10.15	9.76	20	145110	2634	64350968
Incision site oedema	10.13	9.76	3	145127	14	64353588
Hallucination, auditory	10.10	9.76	14	145116	16925	64336677
Grip strength decreased	10.10	9.76	7	145123	11717	64341885
Sleep disorder due to a general medical condition	10.07	9.76	3	145127	8231	64345371
Lipoedema	10.05	9.76	6	145124	192	64353410
Cholangiocarcinoma	9.98	9.76	17	145113	2001	64351601
Aspartate aminotransferase increased	9.97	9.76	346	144784	119442	64234160
No adverse event	9.96	9.76	32	145098	28529	64325073
Gastrointestinal stromal tumour	9.95	9.76	14	145116	1397	64352205
Eosinophil count increased	9.94	9.76	60	145070	14052	64339550
Product complaint	9.85	9.76	53	145077	11901	64341701
Labelled drug-drug interaction medication error	9.83	9.76	84	145046	21978	64331624
Reaction to colouring	9.80	9.76	3	145127	16	64353586
Hypoparathyroidism	9.77	9.76	11	145119	876	64352726

FDA Adverse Event Reporting System (Pediatric)

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
Renal failure	38.31	28.83	19	294	254	84111

Pharmacologic Action:

Source	Code	Description
ATC	C09CA03	CARDIOVASCULAR SYSTEM AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM ANGIOTENSIN II RECEPTOR BLOCKERS (ARBs), PLAIN Angiotensin II receptor blockers (ARBs), plain
ATC	C09DA03	CARDIOVASCULAR SYSTEM AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM ANGIOTENSIN II RECEPTOR BLOCKERS (ARBs), COMBINATIONS Angiotensin II receptor blockers (ARBs) and diuretics
ATC	C09DB01	CARDIOVASCULAR SYSTEM AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM ANGIOTENSIN II RECEPTOR BLOCKERS (ARBs), COMBINATIONS Angiotensin II receptor blockers (ARBs) and calcium channel blockers
ATC	C09DB08	CARDIOVASCULAR SYSTEM AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM ANGIOTENSIN II RECEPTOR BLOCKERS (ARBs), COMBINATIONS Angiotensin II receptor blockers (ARBs) and calcium channel blockers
ATC	C09DX01	CARDIOVASCULAR SYSTEM AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM ANGIOTENSIN II RECEPTOR BLOCKERS (ARBs), COMBINATIONS Angiotensin II receptor blockers (ARBs), other combinations
ATC	C09DX02	CARDIOVASCULAR SYSTEM AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM ANGIOTENSIN II RECEPTOR BLOCKERS (ARBs), COMBINATIONS Angiotensin II receptor blockers (ARBs), other combinations
ATC	C09DX04	CARDIOVASCULAR SYSTEM AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM ANGIOTENSIN II RECEPTOR BLOCKERS (ARBs), COMBINATIONS Angiotensin II receptor blockers (ARBs), other combinations
ATC	C09DX05	CARDIOVASCULAR SYSTEM AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM ANGIOTENSIN II RECEPTOR BLOCKERS (ARBs), COMBINATIONS Angiotensin II receptor blockers (ARBs), other combinations
ATC	C10BX10	CARDIOVASCULAR SYSTEM LIPID MODIFYING AGENTS LIPID MODIFYING AGENTS, COMBINATIONS Lipid modifying agents in combination with other drugs
FDA MoA	N0000000070	Angiotensin 2 Receptor Antagonists
FDA EPC	N0000175561	Angiotensin 2 Receptor Blocker
MeSH PA	D047228	Angiotensin II Type 1 Receptor Blockers
MeSH PA	D057911	Angiotensin Receptor Antagonists
MeSH PA	D000959	Antihypertensive Agents
MeSH PA	D002317	Cardiovascular Agents
CHEBI has role	CHEBI:35674	antihypertensive drugs
CHEBI has role	CHEBI:35703	Xenobiotic
CHEBI has role	CHEBI:61016	angiotensin receptor antagonists
CHEBI has role	CHEBI:78298	environmental contaminants

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

Disease	Relation	SNOMED_ID	DOID
Hypertensive disorder	indication	38341003	DOID:10763
Chronic heart failure	indication	48447003
Left ventricular cardiac dysfunction	indication	429589006
Atrial fibrillation	off-label use	49436004	DOID:0060224
Diabetic renal disease	off-label use	127013003
Diastolic heart failure	off-label use	418304008	DOID:9775
Nondiabetic Proteinuric Nephropathy	off-label use
Anuria	contraindication	2472002	DOID:2983
Hypercholesterolemia	contraindication	13644009
Hyperkalemia	contraindication	14140009
Secondary angle-closure glaucoma	contraindication	21571006
Hypovolemia	contraindication	28560003
Obstruction of bile duct	contraindication	30144000
Dehydration	contraindication	34095006
Hyperuricemia	contraindication	35885006	DOID:1920
Angioedema	contraindication	41291007	DOID:1558
Hypokalemia	contraindication	43339004
Low blood pressure	contraindication	45007003
Systemic lupus erythematosus	contraindication	55464009	DOID:9074
Sympathectomy	contraindication	57071006
Acute nephropathy	contraindication	58574008
Hepatic failure	contraindication	59927004
Hypercalcemia	contraindication	66931009	DOID:12678
Hyperparathyroidism	contraindication	66999008	DOID:13543
Hypochloremic alkalosis	contraindication	70134007
Hepatic coma	contraindication	72836002	DOID:12550
Diabetes mellitus	contraindication	73211009	DOID:9351
Chronic idiopathic constipation	contraindication	82934008
Hyponatremia	contraindication	89627008
Gout	contraindication	90560007	DOID:13189
Hypomagnesemia	contraindication	190855004
Acute pancreatitis	contraindication	197456007	DOID:2913
Impaired renal function disorder	contraindication	197663003
Disease of liver	contraindication	235856003	DOID:409
Neonatal hyperbilirubinemia	contraindication	281610001
Pregnancy, function	contraindication	289908002
Renal artery stenosis	contraindication	302233006
Neutropenic disorder	contraindication	303011007	DOID:1227
Azotemia	contraindication	445009001
Severe Aortic Valve Stenosis	contraindication

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	3.8	acidic
pKa2	4.44	acidic

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
24MG;26MG	ENTRESTO	NOVARTIS PHARMS CORP	N207620	July 7, 2015	RX	TABLET	ORAL	8796331	Jan. 14, 2023	TREATMENT OF HEART FAILURE
49MG;51MG	ENTRESTO	NOVARTIS PHARMS CORP	N207620	July 7, 2015	RX	TABLET	ORAL	8796331	Jan. 14, 2023	TREATMENT OF HEART FAILURE
97MG;103MG	ENTRESTO	NOVARTIS PHARMS CORP	N207620	July 7, 2015	RX	TABLET	ORAL	8796331	Jan. 14, 2023	TREATMENT OF HEART FAILURE
24MG;26MG	ENTRESTO	NOVARTIS PHARMS CORP	N207620	July 7, 2015	RX	TABLET	ORAL	9388134	Nov. 8, 2026	TREATMENT OF HEART FAILURE
49MG;51MG	ENTRESTO	NOVARTIS PHARMS CORP	N207620	July 7, 2015	RX	TABLET	ORAL	9388134	Nov. 8, 2026	TREATMENT OF HEART FAILURE
97MG;103MG	ENTRESTO	NOVARTIS PHARMS CORP	N207620	July 7, 2015	RX	TABLET	ORAL	9388134	Nov. 8, 2026	TREATMENT OF HEART FAILURE
EQ 5MG BASE;80MG	BYVALSON	ALLERGAN	N206302	June 3, 2016	DISCN	TABLET	ORAL	7838552	Oct. 4, 2027	METHOD OF TREATING HYPERTENSION
24MG;26MG	ENTRESTO	NOVARTIS PHARMS CORP	N207620	July 7, 2015	RX	TABLET	ORAL	11135192	Aug. 22, 2033	TREATMENT OF HEART FAILURE WITH PRESERVED EJECTION FRACTION
24MG;26MG	ENTRESTO	NOVARTIS PHARMS CORP	N207620	July 7, 2015	RX	TABLET	ORAL	9517226	Aug. 22, 2033	TREATMENT OF HEART FAILURE WITH PRESERVED EJECTION FRACTION
24MG;26MG	ENTRESTO	NOVARTIS PHARMS CORP	N207620	July 7, 2015	RX	TABLET	ORAL	9937143	Aug. 22, 2033	TREATMENT OF HEART FAILURE WITH PRESERVED EJECTION FRACTION
49MG;51MG	ENTRESTO	NOVARTIS PHARMS CORP	N207620	July 7, 2015	RX	TABLET	ORAL	11135192	Aug. 22, 2033	TREATMENT OF HEART FAILURE WITH PRESERVED EJECTION FRACTION
49MG;51MG	ENTRESTO	NOVARTIS PHARMS CORP	N207620	July 7, 2015	RX	TABLET	ORAL	9517226	Aug. 22, 2033	TREATMENT OF HEART FAILURE WITH PRESERVED EJECTION FRACTION
49MG;51MG	ENTRESTO	NOVARTIS PHARMS CORP	N207620	July 7, 2015	RX	TABLET	ORAL	9937143	Aug. 22, 2033	TREATMENT OF HEART FAILURE WITH PRESERVED EJECTION FRACTION
97MG;103MG	ENTRESTO	NOVARTIS PHARMS CORP	N207620	July 7, 2015	RX	TABLET	ORAL	11135192	Aug. 22, 2033	TREATMENT OF HEART FAILURE WITH PRESERVED EJECTION FRACTION
97MG;103MG	ENTRESTO	NOVARTIS PHARMS CORP	N207620	July 7, 2015	RX	TABLET	ORAL	9517226	Aug. 22, 2033	TREATMENT OF HEART FAILURE WITH PRESERVED EJECTION FRACTION
97MG;103MG	ENTRESTO	NOVARTIS PHARMS CORP	N207620	July 7, 2015	RX	TABLET	ORAL	9937143	Aug. 22, 2033	TREATMENT OF HEART FAILURE WITH PRESERVED EJECTION FRACTION
24MG;26MG	ENTRESTO	NOVARTIS PHARMS CORP	N207620	July 7, 2015	RX	TABLET	ORAL	11058667	May 9, 2036	TREATING CHRONIC HEART FAILURE WITH REDUCED EJECTION FRACTION IN PATIENTS NOT TAKING AN ACE INHIBITOR OR AN ARB OR PREVIOUSLY TAKING LOW DOSES OF THESE AGENTS, BY TITRATING UP FROM HALF THE USUALLY RECOMMENDED STARTING DOSE
49MG;51MG	ENTRESTO	NOVARTIS PHARMS CORP	N207620	July 7, 2015	RX	TABLET	ORAL	11058667	May 9, 2036	TREATING CHRONIC HEART FAILURE WITH REDUCED EJECTION FRACTION IN PATIENTS NOT TAKING AN ACE INHIBITOR OR AN ARB OR PREVIOUSLY TAKING LOW DOSES OF THESE AGENTS, BY TITRATING UP FROM HALF THE USUALLY RECOMMENDED STARTING DOSE
97MG;103MG	ENTRESTO	NOVARTIS PHARMS CORP	N207620	July 7, 2015	RX	TABLET	ORAL	11058667	May 9, 2036	TREATING CHRONIC HEART FAILURE WITH REDUCED EJECTION FRACTION IN PATIENTS NOT TAKING AN ACE INHIBITOR OR AN ARB OR PREVIOUSLY TAKING LOW DOSES OF THESE AGENTS, BY TITRATING UP FROM HALF THE USUALLY RECOMMENDED STARTING DOSE

Orange Book exclusivity data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Exclusivity date	Description
24MG;26MG	ENTRESTO	NOVARTIS PHARMS CORP	N207620	July 7, 2015	RX	TABLET	ORAL	Oct. 1, 2022	NEW PATIENT POPULATION
49MG;51MG	ENTRESTO	NOVARTIS PHARMS CORP	N207620	July 7, 2015	RX	TABLET	ORAL	Oct. 1, 2022	NEW PATIENT POPULATION
97MG;103MG	ENTRESTO	NOVARTIS PHARMS CORP	N207620	July 7, 2015	RX	TABLET	ORAL	Oct. 1, 2022	NEW PATIENT POPULATION
24MG;26MG	ENTRESTO	NOVARTIS PHARMS CORP	N207620	July 7, 2015	RX	TABLET	ORAL	April 1, 2023	PEDIATRIC EXCLUSIVITY
49MG;51MG	ENTRESTO	NOVARTIS PHARMS CORP	N207620	July 7, 2015	RX	TABLET	ORAL	April 1, 2023	PEDIATRIC EXCLUSIVITY
97MG;103MG	ENTRESTO	NOVARTIS PHARMS CORP	N207620	July 7, 2015	RX	TABLET	ORAL	April 1, 2023	PEDIATRIC EXCLUSIVITY
24MG;26MG	ENTRESTO	NOVARTIS PHARMS CORP	N207620	July 7, 2015	RX	TABLET	ORAL	Feb. 16, 2024	LABELING REVISIONS RELATED TO CLINICAL STUDIES
49MG;51MG	ENTRESTO	NOVARTIS PHARMS CORP	N207620	July 7, 2015	RX	TABLET	ORAL	Feb. 16, 2024	LABELING REVISIONS RELATED TO CLINICAL STUDIES
97MG;103MG	ENTRESTO	NOVARTIS PHARMS CORP	N207620	July 7, 2015	RX	TABLET	ORAL	Feb. 16, 2024	LABELING REVISIONS RELATED TO CLINICAL STUDIES
160MG	DIOVAN	NOVARTIS	N021283	July 18, 2001	RX	TABLET	ORAL	April 19, 2024	NEW PATIENT POPULATION
40MG	DIOVAN	NOVARTIS	N021283	Aug. 14, 2002	RX	TABLET	ORAL	April 19, 2024	NEW PATIENT POPULATION
80MG	DIOVAN	NOVARTIS	N021283	July 18, 2001	RX	TABLET	ORAL	April 19, 2024	NEW PATIENT POPULATION

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
Type-1 angiotensin II receptor	GPCR	P30556	AGTR1_HUMAN	ANTAGONIST	Ki	5.33	CHEMBL	CHEMBL
Platelet glycoprotein VI	Unclassified	Q9HCN6	GPVI_HUMAN		Kd	4	CHEMBL
Type-1B angiotensin II receptor	GPCR		AGTRB_RAT		IC50	8.72	CHEMBL
Type-1A angiotensin II receptor	GPCR		AGTRA_RAT		IC50	8.47	CHEMBL
Angiotensin II receptor (AT-1) type-1	GPCR		AGTRA_RAT AGTRB_RAT		IC50	8.57	CHEMBL

External reference:

ID	Source
D00400	KEGG_DRUG
4020986	VANDF
C0216784	UMLSCUI
CHEBI:9927	CHEBI
U35	PDB_CHEM_ID
CHEMBL1069	ChEMBL_ID
D000068756	MESH_DESCRIPTOR_UI
DB00177	DRUGBANK_ID
3937	IUPHAR_LIGAND_ID
7016	INN_ID
80M03YXJ7I	UNII
60846	PUBCHEM_CID
216652	RXNORM
53010	MMSL
5663	MMSL
8844	MMSL
d04113	MMSL
006279	NDDF
108581009	SNOMEDCT_US
386876001	SNOMEDCT_US

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Diovan HCT	HUMAN PRESCRIPTION DRUG LABEL	2	0078-0314	TABLET, FILM COATED	80 mg	ORAL	NDA	31 sections
Diovan HCT	HUMAN PRESCRIPTION DRUG LABEL	2	0078-0314	TABLET, FILM COATED	80 mg	ORAL	NDA	31 sections
Diovan HCT	HUMAN PRESCRIPTION DRUG LABEL	2	0078-0315	TABLET, FILM COATED	160 mg	ORAL	NDA	31 sections
Diovan HCT	HUMAN PRESCRIPTION DRUG LABEL	2	0078-0315	TABLET, FILM COATED	160 mg	ORAL	NDA	31 sections
Diovan	HUMAN PRESCRIPTION DRUG LABEL	1	0078-0358	TABLET	80 mg	ORAL	NDA	33 sections
Diovan	HUMAN PRESCRIPTION DRUG LABEL	1	0078-0358	TABLET	80 mg	ORAL	NDA	33 sections
Diovan	HUMAN PRESCRIPTION DRUG LABEL	1	0078-0359	TABLET	160 mg	ORAL	NDA	33 sections
Diovan	HUMAN PRESCRIPTION DRUG LABEL	1	0078-0359	TABLET	160 mg	ORAL	NDA	33 sections
Diovan	HUMAN PRESCRIPTION DRUG LABEL	1	0078-0360	TABLET	320 mg	ORAL	NDA	33 sections
Diovan	HUMAN PRESCRIPTION DRUG LABEL	1	0078-0360	TABLET	320 mg	ORAL	NDA	33 sections
Diovan HCT	HUMAN PRESCRIPTION DRUG LABEL	2	0078-0383	TABLET, FILM COATED	160 mg	ORAL	NDA	31 sections
Diovan HCT	HUMAN PRESCRIPTION DRUG LABEL	2	0078-0383	TABLET, FILM COATED	160 mg	ORAL	NDA	31 sections
Diovan	HUMAN PRESCRIPTION DRUG LABEL	1	0078-0423	TABLET	40 mg	ORAL	NDA	33 sections
Diovan	HUMAN PRESCRIPTION DRUG LABEL	1	0078-0423	TABLET	40 mg	ORAL	NDA	33 sections
Diovan HCT	HUMAN PRESCRIPTION DRUG LABEL	2	0078-0471	TABLET, FILM COATED	320 mg	ORAL	NDA	31 sections
Diovan HCT	HUMAN PRESCRIPTION DRUG LABEL	2	0078-0471	TABLET, FILM COATED	320 mg	ORAL	NDA	31 sections
Diovan HCT	HUMAN PRESCRIPTION DRUG LABEL	2	0078-0472	TABLET, FILM COATED	320 mg	ORAL	NDA	31 sections
Diovan HCT	HUMAN PRESCRIPTION DRUG LABEL	2	0078-0472	TABLET, FILM COATED	320 mg	ORAL	NDA	31 sections
Exforge	HUMAN PRESCRIPTION DRUG LABEL	2	0078-0488	TABLET, FILM COATED	160 mg	ORAL	NDA	31 sections
Exforge	HUMAN PRESCRIPTION DRUG LABEL	2	0078-0488	TABLET, FILM COATED	160 mg	ORAL	NDA	31 sections
Exforge	HUMAN PRESCRIPTION DRUG LABEL	2	0078-0489	TABLET, FILM COATED	160 mg	ORAL	NDA	31 sections
Exforge	HUMAN PRESCRIPTION DRUG LABEL	2	0078-0489	TABLET, FILM COATED	160 mg	ORAL	NDA	31 sections
Exforge	HUMAN PRESCRIPTION DRUG LABEL	2	0078-0490	TABLET, FILM COATED	320 mg	ORAL	NDA	31 sections
Exforge	HUMAN PRESCRIPTION DRUG LABEL	2	0078-0490	TABLET, FILM COATED	320 mg	ORAL	NDA	31 sections
Exforge	HUMAN PRESCRIPTION DRUG LABEL	2	0078-0491	TABLET, FILM COATED	320 mg	ORAL	NDA	31 sections
Exforge	HUMAN PRESCRIPTION DRUG LABEL	2	0078-0491	TABLET, FILM COATED	320 mg	ORAL	NDA	31 sections
Exforge HCT	HUMAN PRESCRIPTION DRUG LABEL	3	0078-0559	TABLET, FILM COATED	160 mg	ORAL	NDA	31 sections
Exforge HCT	HUMAN PRESCRIPTION DRUG LABEL	3	0078-0559	TABLET, FILM COATED	160 mg	ORAL	NDA	31 sections
Exforge HCT	HUMAN PRESCRIPTION DRUG LABEL	3	0078-0560	TABLET, FILM COATED	160 mg	ORAL	NDA	31 sections
Exforge HCT	HUMAN PRESCRIPTION DRUG LABEL	3	0078-0560	TABLET, FILM COATED	160 mg	ORAL	NDA	31 sections