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

Stem definition	Drug id	CAS RN
beta-adrenoreceptor antagonists	1887	118457-14-0

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: nebivolol nebivolol hydrochloride vasoxen bystolic nebivolol HCl	A cardioselective ADRENERGIC BETA-1 RECEPTOR ANTAGONIST (beta-blocker) that functions as a VASODILATOR through the endothelial L-arginine/ NITRIC OXIDE system. It is used to manage HYPERTENSION and chronic HEART FAILURE in elderly patients. Molecular weight: 405.44 Formula: C22H25F2NO4 CLOGP: 3.50 LIPINSKI: 0 HAC: 5 HDO: 3 TPSA: 70.95 ALOGS: -4 ROTB: 6 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

nebivolol
nebivolol hydrochloride
vasoxen
bystolic
nebivolol HCl

A cardioselective ADRENERGIC BETA-1 RECEPTOR ANTAGONIST (beta-blocker) that functions as a VASODILATOR through the endothelial L-arginine/ NITRIC OXIDE system. It is used to manage HYPERTENSION and chronic HEART FAILURE in elderly patients.

Molecular weight: 405.44
Formula: C22H25F2NO4
CLOGP: 3.50
LIPINSKI: 0
HAC: 5
HDO: 3
TPSA: 70.95
ALOGS: -4
ROTB: 6

Status: OFP

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

Drug dosage:

Dose	Unit	Route
5	mg	O

ADMET properties:

Property	Value	Reference
MRTD (Maximum Recommended Therapeutic Daily Dose)	0.35 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability)	50 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution)	11 L/kg	Lombardo F, Berellini G, Obach RS
CL (Clearance)	14 mL/min/kg	Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma)	0.02 %	Lombardo F, Berellini G, Obach RS
t_half (Half-life)	10 hours	Lombardo F, Berellini G, Obach RS

Approvals:

Date	Agency	Company	Orphan
Dec. 17, 2007	FDA	FOREST LABS

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
Bradycardia	179.12	11.34	199	27837	64227	50512861
Acute kidney injury	171.52	11.34	385	27651	227673	50349415
Hyponatraemia	126.33	11.34	206	27830	95933	50481155
Hypertensive crisis	126.30	11.34	83	27953	13071	50564017
Hypotension	86.75	11.34	307	27729	235162	50341926
Drug interaction	82.94	11.34	271	27765	199350	50377738
Anaemia	78.72	11.34	312	27724	252144	50324944
Systemic lupus erythematosus	65.24	11.34	3	28033	140619	50436469
Joint swelling	62.30	11.34	29	28007	245257	50331831
Acute motor-sensory axonal neuropathy	57.89	11.34	16	28020	272	50576816
Fall	56.87	11.34	348	27688	334584	50242504
Lip oedema	53.89	11.34	29	28007	3164	50573924
Synovitis	53.33	11.34	4	28032	123861	50453227
Treatment failure	52.62	11.34	7	28029	137630	50439458
Syncope	51.22	11.34	149	27887	102853	50474235
Traumatic coma	50.86	11.34	11	28025	61	50577027
Pain	49.92	11.34	160	27876	578743	49998345
Maternal exposure during pregnancy	48.80	11.34	14	28022	159764	50417324
Rheumatoid arthritis	45.47	11.34	28	28008	202522	50374566
Arthropathy	44.39	11.34	16	28020	157890	50419198
Glossodynia	43.88	11.34	6	28030	115563	50461525
Ischaemic stroke	43.80	11.34	49	27987	15899	50561189
Drug ineffective	43.22	11.34	272	27764	819061	49758027
Hyperkalaemia	40.32	11.34	85	27951	48004	50529084
Cardiac failure	39.73	11.34	112	27924	75928	50501160
Angina pectoris	39.72	11.34	60	27976	26128	50550960
Product prescribing error	39.11	11.34	53	27983	20908	50556180
Therapeutic product effect decreased	37.87	11.34	14	28022	136036	50441052
Dyspnoea	37.00	11.34	464	27572	547144	50029944
Atrial fibrillation	35.94	11.34	131	27905	101614	50475474
Melaena	35.81	11.34	58	27978	26806	50550282
General physical health deterioration	35.75	11.34	165	27871	142269	50434819
Sopor	35.18	11.34	49	27987	19830	50557258
Rhabdomyolysis	35.08	11.34	71	27965	38956	50538132
Cerebellar ataxia	33.53	11.34	14	28022	864	50576224
Infusion related reaction	33.35	11.34	27	28009	169530	50407558
Vertigo	32.81	11.34	82	27954	51750	50525338
Exposure during pregnancy	32.77	11.34	13	28023	121002	50456086
Hepatocellular injury	31.87	11.34	54	27982	25893	50551195
Contraindicated product administered	30.20	11.34	23	28013	148935	50428153
Hypomagnesaemia	29.52	11.34	49	27987	23107	50553981
Hypokalaemia	29.15	11.34	111	27925	87881	50489207
Swelling	27.48	11.34	43	27993	200829	50376259
Drug hypersensitivity	27.09	11.34	62	27974	250948	50326140
Erythrosis	25.95	11.34	6	28030	47	50577041
Systemic infection	25.87	11.34	16	28020	2267	50574821
Miosis	25.74	11.34	24	28012	6286	50570802
Primary hyperaldosteronism	25.41	11.34	6	28030	52	50577036
Abdominal discomfort	25.16	11.34	57	27979	231584	50345504
Tongue oedema	24.74	11.34	19	28017	3820	50573268
Retroperitoneal haematoma	23.73	11.34	16	28020	2627	50574461
Chronic pigmented purpura	23.06	11.34	6	28030	80	50577008
Asthenia	23.04	11.34	274	27762	318768	50258320
Arthralgia	22.81	11.34	146	27890	438556	50138532
Resting tremor	22.54	11.34	10	28026	716	50576372
Walking disability	22.52	11.34	12	28024	1284	50575804
Renin decreased	22.11	11.34	6	28030	95	50576993
Infection	21.82	11.34	39	27997	172915	50404173
Arrhythmia	21.58	11.34	53	27983	33079	50544009
Angioedema	21.16	11.34	57	27979	37619	50539469
Drug intolerance	20.62	11.34	58	27978	219046	50358042
Pericarditis	20.42	11.34	9	28027	78680	50498408
Cholestasis	20.25	11.34	44	27992	25357	50551731
Disorientation	20.25	11.34	54	27982	35430	50541658
Arterial spasm	19.70	11.34	5	28031	60	50577028
Haematoma muscle	19.35	11.34	9	28027	719	50576369
Agranulocytosis	19.28	11.34	39	27997	21382	50555706
Blood aldosterone increased	19.06	11.34	6	28030	163	50576925
Peripheral ischaemia	18.88	11.34	17	28019	4259	50572829
Sprue-like enteropathy	18.84	11.34	8	28028	515	50576573
Cerebral haematoma	18.76	11.34	15	28021	3196	50573892
Adenocarcinoma metastatic	18.67	11.34	5	28031	75	50577013
Hypoosmolar state	18.59	11.34	6	28030	177	50576911
Aeromonas infection	18.55	11.34	5	28031	77	50577011
Oedema peripheral	18.41	11.34	150	27886	157811	50419277
Presyncope	18.25	11.34	41	27995	24157	50552931
Rash	18.21	11.34	155	27881	437316	50139772
Discomfort	18.09	11.34	20	28016	108360	50468728
Urine output increased	18.06	11.34	10	28026	1154	50575934
Hemiparesis	17.45	11.34	36	28000	20012	50557076
Blood loss anaemia	17.38	11.34	22	28014	8117	50568971
Nocturia	17.33	11.34	20	28016	6710	50570378
Drop attacks	17.03	11.34	8	28028	654	50576434
Haematoma	16.97	11.34	46	27990	30464	50546624
Product use issue	16.86	11.34	36	28000	149439	50427649
Rectal haemorrhage	16.54	11.34	53	27983	38505	50538583
Cerebral salt-wasting syndrome	16.25	11.34	4	28032	42	50577046
Elephantiasis	16.20	11.34	3	28033	6	50577082
Hypersensitivity pneumonitis	16.09	11.34	12	28024	2310	50574778
Wound	16.08	11.34	21	28015	105773	50471315
Dry gangrene	16.04	11.34	7	28029	482	50576606
Hypoglycaemia	15.65	11.34	65	27971	53516	50523572
Platelet disorder	15.61	11.34	10	28026	1507	50575581
Metabolic acidosis	15.43	11.34	52	27984	38773	50538315
Nasopharyngitis	15.39	11.34	55	27981	192872	50384216
Diffuse large B-cell lymphoma stage II	15.26	11.34	4	28032	55	50577033
Wrong schedule	15.22	11.34	5	28031	156	50576932
Electrolyte imbalance	15.15	11.34	31	28005	17138	50559950
Microcytic anaemia	15.09	11.34	13	28023	3071	50574017
Orthostatic hypotension	14.97	11.34	43	27993	29438	50547650
Hypersensitivity	14.84	11.34	65	27971	215096	50361992
Anuria	14.61	11.34	24	28012	11220	50565868
Musculoskeletal stiffness	14.44	11.34	31	28005	128450	50448638
Nasal mucosal erosion	14.36	11.34	4	28032	70	50577018
Vascular encephalopathy	14.16	11.34	6	28030	384	50576704
Loss of personal independence in daily activities	13.95	11.34	11	28025	70039	50507049
Renal function test abnormal	13.92	11.34	12	28024	2837	50574251
Impaired healing	13.85	11.34	11	28025	69775	50507313
Hyperammonaemia	13.81	11.34	15	28021	4709	50572379
Intraventricular haemorrhage	13.71	11.34	10	28026	1860	50575228
Sinus bradycardia	13.07	11.34	25	28011	13158	50563930
Diaphragmatic disorder	12.98	11.34	6	28030	473	50576615
Intra-abdominal haematoma	12.97	11.34	9	28027	1548	50575540
Renal failure	12.82	11.34	102	27934	106531	50470557
Product measured potency issue	12.73	11.34	4	28032	108	50576980
Hypovolaemic shock	12.66	11.34	15	28021	5173	50571915
Thrombocytopenia	12.65	11.34	117	27919	127556	50449532
Cardiac failure acute	12.65	11.34	19	28017	8231	50568857
Disease progression	12.64	11.34	21	28015	95845	50481243
Haemorrhagic stroke	12.57	11.34	15	28021	5213	50571875
Ductal adenocarcinoma of pancreas	12.49	11.34	4	28032	115	50576973
Peripheral artery stenosis	12.41	11.34	6	28030	523	50576565
Cerebral haemorrhage	12.35	11.34	38	27998	27014	50550074
Prescription drug used without a prescription	12.26	11.34	9	28027	1691	50575397
Blood pressure increased	12.20	11.34	120	27916	133012	50444076
Gastrointestinal disorder	12.17	11.34	21	28015	94435	50482653
Action tremor	12.15	11.34	5	28031	297	50576791
Arterial thrombosis	12.11	11.34	8	28028	1269	50575819
Mucosal hyperaemia	12.06	11.34	3	28033	33	50577055
Withdrawal hypertension	12.02	11.34	4	28032	130	50576958
Toxic skin eruption	11.98	11.34	22	28014	11229	50565859
Psychotic behaviour	11.95	11.34	6	28030	567	50576521
Labelled drug-drug interaction medication error	11.81	11.34	21	28015	10456	50566632
Coronavirus infection	11.68	11.34	11	28025	2918	50574170
Hypocalcaemia	11.63	11.34	37	27999	26779	50550309
Haemodynamic instability	11.62	11.34	18	28018	8006	50569082
International normalised ratio increased	11.56	11.34	51	27985	43101	50533987
Diarrhoea	11.56	11.34	416	27620	588060	49989028
Sinusitis	11.47	11.34	52	27984	170506	50406582
Hypotonia	11.44	11.34	18	28018	8116	50568972
Attention deficit hyperactivity disorder	11.40	11.34	10	28026	2419	50574669
Disorganised speech	11.37	11.34	7	28029	984	50576104

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
Acute kidney injury	132.50	11.60	473	22097	264794	29287163
Hyperkalaemia	120.51	11.60	188	22382	61204	29490753
Lactic acidosis	80.35	11.60	107	22463	30140	29521817
Bradycardia	71.57	11.60	156	22414	65473	29486484
Hypoparathyroidism	45.00	11.60	16	22554	458	29551499
Toxicity to various agents	43.61	11.60	41	22529	173620	29378337
Syncope	38.52	11.60	143	22427	81228	29470729
Hypokalaemia	38.26	11.60	104	22466	50099	29501858
Hypotension	38.00	11.60	266	22304	194088	29357869
Cerebral haematoma	35.35	11.60	28	22542	4268	29547689
Hypertensive crisis	34.58	11.60	36	22534	7812	29544145
Death	32.91	11.60	142	22428	341942	29210015
Renal artery thrombosis	32.01	11.60	11	22559	284	29551673
Burnout syndrome	30.52	11.60	9	22561	139	29551818
Shock haemorrhagic	30.42	11.60	37	22533	9514	29542443
Product monitoring error	30.21	11.60	21	22549	2624	29549333
Ischaemic stroke	28.64	11.60	47	22523	15930	29536027
Pemphigoid	28.53	11.60	32	22538	7549	29544408
Anaemia	28.25	11.60	255	22315	200696	29351261
Cerebellar ischaemia	27.34	11.60	8	22562	120	29551837
Presyncope	27.06	11.60	46	22524	16043	29535914
Blood lactic acid	26.61	11.60	10	22560	336	29551621
Renal failure	26.55	11.60	168	22402	118431	29433526
Cutaneous lupus erythematosus	25.43	11.60	12	22558	716	29551241
Cerebellar syndrome	25.40	11.60	17	22553	1997	29549960
Intercapillary glomerulosclerosis	24.88	11.60	6	22564	40	29551917
Cardiac failure	24.85	11.60	123	22447	79164	29472793
Coma uraemic	24.76	11.60	6	22564	41	29551916
Fungal endocarditis	24.60	11.60	9	22561	280	29551677
Febrile neutropenia	24.25	11.60	30	22540	112210	29439747
Melaena	24.16	11.60	65	22505	31111	29520846
Vitamin B12 decreased	24.01	11.60	13	22557	1039	29550918
Brief psychotic disorder with marked stressors	23.95	11.60	8	22562	189	29551768
Vascular purpura	23.07	11.60	14	22556	1389	29550568
Laryngeal cancer metastatic	22.82	11.60	6	22564	59	29551898
Vertigo	22.70	11.60	51	22519	21810	29530147
Angina pectoris	22.52	11.60	59	22511	27791	29524166
Decreased ventricular preload	22.48	11.60	5	22565	22	29551935
Cholestasis	22.45	11.60	53	22517	23409	29528548
Renal ischaemia	22.36	11.60	10	22560	527	29551430
Cardiac failure chronic	22.15	11.60	26	22544	6441	29545516
Labelled drug-drug interaction medication error	22.10	11.60	36	22534	12123	29539834
Hepatocellular injury	21.43	11.60	49	22521	21194	29530763
Bronchitis bacterial	20.42	11.60	10	22560	648	29551309
White blood cell count decreased	19.38	11.60	21	22549	83341	29468616
Enzyme induction	19.13	11.60	5	22565	48	29551909
Potentiating drug interaction	18.91	11.60	20	22550	4418	29547539
Platelet count decreased	18.66	11.60	32	22538	104640	29447317
Agoraphobia	18.63	11.60	7	22563	235	29551722
Infective exacerbation of chronic obstructive airways disease	18.61	11.60	13	22557	1637	29550320
Left ventricle outflow tract obstruction	18.40	11.60	6	22564	131	29551826
Neurosis	17.95	11.60	6	22564	142	29551815
Hepatic function abnormal	17.92	11.60	4	22566	39255	29512702
Acute coronary syndrome	17.84	11.60	33	22537	12292	29539665
Carbohydrate metabolism disorder	17.56	11.60	4	22566	20	29551937
Retinal disorder	17.47	11.60	10	22560	890	29551067
Metabolic alkalosis	16.97	11.60	11	22559	1225	29550732
Anticoagulation drug level increased	16.82	11.60	8	22562	486	29551471
Dialysis device insertion	16.68	11.60	4	22566	26	29551931
Haematoma	16.60	11.60	47	22523	23165	29528792
Transient ischaemic attack	16.52	11.60	47	22523	23223	29528734
Normocytic anaemia	16.42	11.60	13	22557	1979	29549978
Electrocardiogram T wave abnormal	16.07	11.60	11	22559	1340	29550617
Drug interaction	16.04	11.60	225	22345	197160	29354797
Coma	15.94	11.60	66	22504	39384	29512573
Blood creatine phosphokinase MB increased	15.64	11.60	12	22558	1745	29550212
Neutrophil count decreased	15.36	11.60	7	22563	43560	29508397
Hypomagnesaemia	15.15	11.60	38	22532	17430	29534527
Perioral dermatitis	15.01	11.60	5	22565	117	29551840
Disseminated aspergillosis	14.89	11.60	7	22563	414	29551543
Diabetic nephropathy	14.84	11.60	12	22558	1883	29550074
Haemorrhagic erosive gastritis	14.78	11.60	5	22565	123	29551834
Hypertensive nephropathy	14.72	11.60	7	22563	425	29551532
Drug abuse	14.62	11.60	24	22546	79859	29472098
Atrial tachycardia	14.59	11.60	12	22558	1929	29550028
Traumatic haemothorax	14.59	11.60	6	22564	257	29551700
Brain natriuretic peptide increased	14.48	11.60	17	22553	4213	29547744
Funguria	13.93	11.60	4	22566	56	29551901
Dermatosis	13.85	11.60	6	22564	293	29551664
Interstitial lung disease	13.67	11.60	83	22487	57635	29494322
Extrasystoles	13.65	11.60	15	22555	3459	29548498
Carcinogenicity	13.61	11.60	4	22566	61	29551896
Congenital inguinal hernia	13.59	11.60	5	22565	158	29551799
Palpitations	13.53	11.60	55	22515	32549	29519408
Orthostatic hypotension	13.51	11.60	43	22527	22586	29529371
Haemoglobinaemia	13.51	11.60	5	22565	161	29551796
Electrocardiogram QT prolonged	13.47	11.60	59	22511	36078	29515879
Oral lichen planus	13.36	11.60	5	22565	166	29551791
Cardioactive drug level decreased	13.15	11.60	4	22566	69	29551888
Anuria	13.13	11.60	25	22545	9516	29542441
Epilepsy	12.86	11.60	37	22533	18395	29533562
Gingival discomfort	12.84	11.60	4	22566	75	29551882
Albumin urine present	12.58	11.60	6	22564	367	29551590
Pain	12.55	11.60	78	22492	171354	29380603
IIIrd nerve disorder	12.24	11.60	4	22566	88	29551869
Acute pulmonary oedema	12.22	11.60	20	22550	6759	29545198
Malpositioned teeth	12.08	11.60	3	22567	23	29551934
Tachyarrhythmia	11.98	11.60	13	22557	2956	29549001
Pancreatitis acute	11.64	11.60	43	22527	24342	29527615

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
Acute kidney injury	300.69	10.71	824	43163	448416	64006329
Bradycardia	202.41	10.71	320	43667	117899	64336846
Hyperkalaemia	155.75	10.71	261	43726	100868	64353877
Hypertensive crisis	153.28	10.71	115	43872	18133	64436612
Hypotension	104.92	10.71	525	43462	380449	64074296
Anaemia	103.69	10.71	521	43466	378159	64076586
Hyponatraemia	101.52	10.71	275	43712	148064	64306681
Syncope	84.60	10.71	268	43719	157367	64297378
Drug interaction	82.61	10.71	474	43513	361609	64093136
Lactic acidosis	78.33	10.71	146	43841	61264	64393481
Ischaemic stroke	67.64	10.71	91	43896	28944	64425801
Melaena	58.17	10.71	119	43868	53429	64401316
Vertigo	56.99	10.71	125	43862	58886	64395859
Pain	56.08	10.71	192	43795	553319	63901426
Fall	55.64	10.71	479	43508	416347	64038398
Synovitis	52.32	10.71	4	43983	99086	64355659
Cardiac failure	51.92	10.71	203	43784	132170	64322575
Cerebral haematoma	51.01	10.71	41	43946	7144	64447601
Hepatocellular injury	50.88	10.71	102	43885	45133	64409612
Hypokalaemia	49.48	10.71	189	43798	121714	64333031
Acute motor-sensory axonal neuropathy	48.96	10.71	16	43971	396	64454349
Angina pectoris	48.75	10.71	100	43887	44981	64409764
Joint swelling	46.44	10.71	47	43940	215335	64239410
Traumatic coma	45.03	10.71	10	43977	50	64454695
Cholestasis	43.27	10.71	95	43892	44777	64409968
Presyncope	42.96	10.71	82	43905	35007	64419738
Rheumatoid arthritis	42.59	10.71	30	43957	164264	64290481
Toxicity to various agents	41.76	10.71	119	43868	363394	64091351
General physical health deterioration	40.38	10.71	258	43729	204167	64250578
Lip oedema	39.82	10.71	31	43956	5158	64449587
Shock haemorrhagic	39.68	10.71	53	43934	16738	64438007
Treatment failure	39.67	10.71	15	43972	116801	64337944
Infusion related reaction	38.86	10.71	33	43954	164434	64290311
Systemic lupus erythematosus	38.63	10.71	4	43983	77608	64377137
Maternal exposure during pregnancy	38.58	10.71	9	43978	95875	64358870
Drug hypersensitivity	37.86	10.71	65	43922	237750	64216995
Therapeutic product effect decreased	37.23	10.71	16	43971	115335	64339410
Exposure during pregnancy	36.20	10.71	5	43982	77670	64377075
Hypomagnesaemia	35.89	10.71	79	43908	37297	64417448
Arthropathy	35.65	10.71	19	43968	120948	64333797
Haematoma	32.85	10.71	87	43900	46163	64408582
Drug ineffective	32.58	10.71	392	43595	839855	63614890
Dyspnoea	32.53	10.71	678	43309	717996	63736749
Renal failure	32.06	10.71	223	43764	181465	64273280
Labelled drug-drug interaction medication error	31.36	10.71	55	43932	22007	64432738
Pemphigus	30.54	10.71	3	43984	60698	64394047
Hepatic function abnormal	30.30	10.71	4	43983	64309	64390436
Retro-orbital neoplasm	29.52	10.71	7	43980	49	64454696
Anuria	29.22	10.71	49	43938	18915	64435830
Arthralgia	28.87	10.71	180	43807	442080	64012665
Renal artery thrombosis	28.61	10.71	11	43976	442	64454303
Acute coronary syndrome	28.57	10.71	49	43938	19261	64435484
Product monitoring error	28.28	10.71	26	43961	5428	64449317
Atrial fibrillation	26.74	10.71	204	43783	170885	64283860
Cerebellar ataxia	26.45	10.71	16	43971	1767	64452978
Orthostatic hypotension	26.45	10.71	81	43906	46657	64408088
Metabolic acidosis	26.34	10.71	107	43880	70851	64383894
Agranulocytosis	26.23	10.71	71	43916	38158	64416587
Pemphigoid	26.21	10.71	38	43949	12948	64441797
Haemorrhagic stroke	25.99	10.71	33	43954	9918	64444827
Vascular purpura	25.77	10.71	18	43969	2538	64452207
Coma uraemic	25.30	10.71	6	43981	42	64454703
Nasopharyngitis	24.90	10.71	61	43926	196012	64258733
Asthenia	24.89	10.71	420	43567	427624	64027121
Blood lactic acid	24.87	10.71	10	43977	453	64454292
Hypoglycaemia	24.70	10.71	124	43863	89768	64364977
Death	24.06	10.71	212	43775	482493	63972252
Cardiac failure chronic	23.64	10.71	30	43957	9011	64445734
White blood cell count decreased	23.44	10.71	45	43942	157792	64296953
Sopor	23.34	10.71	58	43929	29603	64425142
Intercapillary glomerulosclerosis	23.22	10.71	6	43981	62	64454683
Product prescribing error	22.70	10.71	64	43923	35205	64419540
Brief psychotic disorder with marked stressors	22.33	10.71	8	43979	263	64454482
Infective exacerbation of chronic obstructive airways disease	21.89	10.71	16	43971	2422	64452323
Retroperitoneal haematoma	21.64	10.71	21	43966	4690	64450055
Carbohydrate metabolism disorder	21.61	10.71	5	43982	31	64454714
Interstitial lung disease	21.57	10.71	127	43860	97605	64357140
Blood loss anaemia	21.54	10.71	36	43951	13856	64440889
Hypoparathyroidism	21.51	10.71	11	43976	876	64453869
Cerebral haemorrhage	21.36	10.71	80	43907	51010	64403735
Burnout syndrome	21.33	10.71	8	43979	300	64454445
Decreased ventricular preload	21.21	10.71	5	43982	34	64454711
Musculoskeletal stiffness	21.16	10.71	32	43955	123174	64331571
Hyperlactacidaemia	21.15	10.71	21	43966	4823	64449922
Walking disability	20.95	10.71	14	43973	1837	64452908
Acute pulmonary oedema	20.95	10.71	34	43953	12775	64441970
Glossodynia	20.83	10.71	9	43978	64687	64390058
Erythrosis	20.70	10.71	6	43981	98	64454647
Cutaneous lupus erythematosus	20.53	10.71	16	43971	2666	64452079
Cerebellar syndrome	20.53	10.71	21	43966	4995	64449750
Sinusitis	20.47	10.71	43	43944	145885	64308860
Bronchitis bacterial	20.44	10.71	12	43975	1255	64453490
Renin decreased	20.05	10.71	6	43981	110	64454635
Platelet count decreased	19.89	10.71	54	43933	167657	64287088
Pancreatitis acute	19.52	10.71	69	43918	42786	64411959
Laryngeal cancer metastatic	19.50	10.71	5	43982	50	64454695
Sinus bradycardia	19.33	10.71	46	43941	22847	64431898
Primary hyperaldosteronism	19.07	10.71	6	43981	131	64454614
Neutrophil count decreased	18.83	10.71	15	43972	77181	64377564
Cerebellar ischaemia	18.34	10.71	6	43981	149	64454596
Hypocalcaemia	17.97	10.71	66	43921	41687	64413058
Loss of personal independence in daily activities	17.77	10.71	14	43973	72440	64382305
Contraindicated product administered	17.58	10.71	29	43958	107800	64346945
Arterial thrombosis	17.53	10.71	14	43973	2416	64452329
Fungal endocarditis	17.52	10.71	8	43979	496	64454249
Electrolyte imbalance	17.43	10.71	47	43940	25196	64429549
Chronic pigmented purpura	17.30	10.71	6	43981	179	64454566
Sprue-like enteropathy	17.27	10.71	10	43977	1019	64453726
Jaundice	17.09	10.71	72	43915	48440	64406305
Epistaxis	17.03	10.71	120	43867	98011	64356734
Febrile neutropenia	17.02	10.71	68	43919	187589	64267156
Renal ischaemia	16.80	10.71	10	43977	1073	64453672
Angioedema	16.78	10.71	85	43902	61736	64393009
Helicobacter infection	16.67	10.71	3	43984	38359	64416386
Haematoma muscle	16.63	10.71	12	43975	1781	64452964
Diabetic nephropathy	16.45	10.71	14	43973	2640	64452105
Adenocarcinoma metastatic	16.45	10.71	5	43982	97	64454648
Blood aldosterone increased	16.34	10.71	6	43981	212	64454533
Urine output increased	16.23	10.71	12	43975	1849	64452896
Contraindicated product prescribed	16.11	10.71	10	43977	1157	64453588
Enzyme induction	15.85	10.71	5	43982	110	64454635
Muscle mass	15.77	10.71	7	43980	406	64454339
Drug reaction with eosinophilia and systemic symptoms	15.75	10.71	76	43911	54141	64400604
Pericarditis	15.43	10.71	12	43975	62504	64392241
Abdominal discomfort	15.34	10.71	68	43919	182254	64272491
Haemoglobinaemia	15.29	10.71	6	43981	255	64454490
Intracranial mass	15.23	10.71	12	43975	2031	64452714
Hypoosmolar state	15.22	10.71	6	43981	258	64454487
Fibromyalgia	15.09	10.71	3	43984	35728	64419017
Infection	14.93	10.71	70	43917	184810	64269935
Palpitations	14.89	10.71	122	43865	104366	64350379
Hepatic mass	14.82	10.71	12	43975	2112	64452633
Elephantiasis	14.72	10.71	3	43984	9	64454736
Hypotonia	14.71	10.71	27	43960	11185	64443560
Poisoning deliberate	14.71	10.71	30	43957	13428	64441317
Atrioventricular block	14.61	10.71	28	43959	11987	64442758
Dermatosis	14.42	10.71	7	43980	499	64454246
Disease progression	14.38	10.71	49	43938	141631	64313114
Resting tremor	14.35	10.71	10	43977	1404	64453341
Vitamin B12 decreased	14.19	10.71	13	43974	2702	64452043
Language disorder	14.18	10.71	13	43974	2704	64452041
Dialysis device insertion	14.18	10.71	4	43983	59	64454686
Arterial spasm	14.17	10.71	5	43982	157	64454588
Mobility decreased	14.07	10.71	23	43964	85817	64368928
Systemic infection	14.02	10.71	16	43971	4305	64450440
Oedema peripheral	13.93	10.71	211	43776	210106	64244639
Coronavirus infection	13.91	10.71	18	43969	5512	64449233
Renal impairment	13.88	10.71	147	43840	134870	64319875
Body temperature increased	13.68	10.71	4	43983	36662	64418083
Drug dependence	13.65	10.71	3	43984	33309	64421436
Nasal mucosal erosion	13.54	10.71	4	43983	70	64454675
Brain natriuretic peptide increased	13.50	10.71	21	43966	7612	64447133
Renal function test abnormal	13.38	10.71	15	43972	3959	64450786
Erysipelas	13.37	10.71	23	43964	9058	64445687
Sinus rhythm	13.36	10.71	7	43980	586	64454159
Dermatitis bullous	13.33	10.71	27	43960	12027	64442718
Back pain	13.27	10.71	108	43879	250063	64204682
Product use issue	13.11	10.71	56	43931	151659	64303086
Product measured potency issue	13.07	10.71	5	43982	198	64454547
Carcinogenicity	12.90	10.71	4	43983	83	64454662
Traumatic haemothorax	12.82	10.71	6	43981	394	64454351
Tongue oedema	12.78	10.71	18	43969	5972	64448773
Hypersensitivity	12.76	10.71	80	43907	196372	64258373
Extrasystoles	12.74	10.71	19	43968	6639	64448106
Blood creatinine increased	12.66	10.71	145	43842	135637	64319108
Blood creatine phosphokinase MB increased	12.64	10.71	12	43975	2609	64452136
Disseminated aspergillosis	12.58	10.71	7	43980	661	64454084
Rhabdomyolysis	12.48	10.71	106	43881	91620	64363125
Anticoagulation drug level increased	12.47	10.71	7	43980	672	64454073
Stomatitis	12.46	10.71	36	43951	109569	64345176
Arrhythmia	12.46	10.71	70	43917	52874	64401871
Polyuria	12.45	10.71	27	43960	12616	64442129
Diffuse large B-cell lymphoma stage II	12.39	10.71	4	43983	95	64454650
Electrocardiogram abnormal	12.38	10.71	28	43959	13453	64441292
Loss of consciousness	12.32	10.71	155	43832	148210	64306535
Drop attacks	12.27	10.71	8	43979	1007	64453738
Rash	12.14	10.71	230	43757	458319	63996426
IIIrd nerve disorder	12.13	10.71	4	43983	102	64454643
Malaise	11.90	10.71	354	43633	395893	64058852
Bundle branch block left	11.73	10.71	23	43964	10011	64444734
Potentiating drug interaction	11.71	10.71	20	43967	7832	64446913
Cerebral salt-wasting syndrome	11.71	10.71	4	43983	114	64454631
Perioral dermatitis	11.64	10.71	5	43982	268	64454477
Alanine aminotransferase increased	11.60	10.71	52	43935	138979	64315766
Lower respiratory tract infection	11.56	10.71	30	43957	94584	64360161
Rectal haemorrhage	11.56	10.71	77	43910	61740	64393005
Mitral valve incompetence	11.53	10.71	41	43946	25497	64429248
Eosinophilia	11.51	10.71	54	43933	38022	64416723
Microcytic anaemia	11.51	10.71	15	43972	4623	64450122
Sedation	11.51	10.71	7	43980	41455	64413290
Toxic skin eruption	11.45	10.71	34	43953	19250	64435495
Thrombocytopenia	11.34	10.71	215	43772	223586	64231159
Tonic clonic movements	11.33	10.71	10	43977	1979	64452766
Intra-abdominal haematoma	11.29	10.71	11	43976	2468	64452277
Atrial tachycardia	11.25	10.71	13	43974	3546	64451199
Diarrhoea	11.21	10.71	601	43386	722103	63732642
Dry gangrene	11.19	10.71	7	43980	821	64453924
Lymphocyte count decreased	11.12	10.71	7	43980	40692	64414053
Hypertensive nephropathy	11.09	10.71	7	43980	834	64453911
Swelling	11.06	10.71	64	43923	160154	64294591
Malpositioned teeth	11.06	10.71	3	43984	38	64454707
Agoraphobia	11.04	10.71	6	43981	541	64454204
Osteonecrosis of jaw	10.98	10.71	55	43932	39770	64414975
Left ventricle outflow tract obstruction	10.89	10.71	5	43982	314	64454431
Urinary retention	10.89	10.71	64	43923	49137	64405608
Wrong schedule	10.85	10.71	5	43982	317	64454428
Vascular encephalopathy	10.79	10.71	6	43981	566	64454179
Condition aggravated	10.73	10.71	184	43803	372242	64082503

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	C07AB12	CARDIOVASCULAR SYSTEM BETA BLOCKING AGENTS BETA BLOCKING AGENTS Beta blocking agents, selective
ATC	C07BB12	CARDIOVASCULAR SYSTEM BETA BLOCKING AGENTS BETA BLOCKING AGENTS AND THIAZIDES Beta blocking agents, selective, and thiazides
ATC	C07FB12	CARDIOVASCULAR SYSTEM BETA BLOCKING AGENTS BETA BLOCKING AGENTS, OTHER COMBINATIONS Beta blocking agents and calcium channel blockers
ATC	C09DX05	CARDIOVASCULAR SYSTEM AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM ANGIOTENSIN II RECEPTOR BLOCKERS (ARBs), COMBINATIONS Angiotensin II receptor blockers (ARBs), other combinations
FDA MoA	N0000000161	Adrenergic beta-Antagonists
FDA EPC	N0000175556	beta-Adrenergic Blocker
MeSH PA	D018663	Adrenergic Agents
MeSH PA	D000322	Adrenergic Agonists
MeSH PA	D058665	Adrenergic beta-1 Receptor Agonists
MeSH PA	D000318	Adrenergic beta-Agonists
MeSH PA	D000959	Antihypertensive Agents
MeSH PA	D002317	Cardiovascular Agents
MeSH PA	D018377	Neurotransmitter Agents
MeSH PA	D014665	Vasodilator Agents
CHEBI has role	CHEBI:35530	beta-adrenergic blockers
CHEBI has role	CHEBI:35620	vasodilator agents
CHEBI has role	CHEBI:35674	antihypertensive drugs
CHEBI has role	CHEBI:176497	geroprotectors

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	off-label use	48447003
Atrial fibrillation	off-label use	49436004	DOID:0060224
Angina pectoris	off-label use	194828000
Myocardial Reinfarction Prevention	off-label use
Bronchospasm	contraindication	4386001
Complete atrioventricular block	contraindication	27885002
Sick sinus syndrome	contraindication	36083008	DOID:13884
Bradycardia	contraindication	48867003
Acute nephropathy	contraindication	58574008
Hepatic failure	contraindication	59927004
Diabetes mellitus	contraindication	73211009	DOID:9351
Cardiogenic shock	contraindication	89138009
Second degree atrioventricular block	contraindication	195042002
Decompensated cardiac failure	contraindication	195111005
Disease of liver	contraindication	235856003	DOID:409
Hypoglycemic disorder	contraindication	237630007
Peripheral vascular disease	contraindication	400047006

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	7.87	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 5MG BASE;80MG	BYVALSON	ALLERGAN	N206302	June 3, 2016	DISCN	TABLET	ORAL	7838552	Oct. 4, 2027	METHOD OF TREATING HYPERTENSION

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
Beta-1 adrenergic receptor	GPCR	P08588	ADRB1_HUMAN	ANTAGONIST	Ki	8.50	WOMBAT-PK	CHEMBL
Beta-2 adrenergic receptor	GPCR	P07550	ADRB2_HUMAN	ANTAGONIST	Ki	7.50	WOMBAT-PK	CHEMBL
5-hydroxytryptamine receptor 1A	GPCR	P08908	5HT1A_HUMAN		Ki	8	WOMBAT-PK
Beta-3 adrenergic receptor	GPCR	P13945	ADRB3_HUMAN	ANTAGONIST	Ki	5.66	IUPHAR

External reference:

ID	Source
4027169	VUID
N0000179202	NUI
D05127	KEGG_DRUG
152520-56-4	SECONDARY_CAS_RN
4027169	VANDF
C0068475	UMLSCUI
CHEBI:64022	CHEBI
CHEMBL434394	ChEMBL_ID
CHEMBL1201731	ChEMBL_ID
D000068577	MESH_DESCRIPTOR_UI
DB04861	DRUGBANK_ID
71301	PUBCHEM_CID
7246	IUPHAR_LIGAND_ID
5969	INN_ID
030Y90569U	UNII
236883	RXNORM
130026	MMSL
18486	MMSL
29969	MMSL
52690	MMSL
d05265	MMSL
007077	NDDF
007078	NDDF
318638009	SNOMEDCT_US
395808005	SNOMEDCT_US
734565001	SNOMEDCT_US

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Bystolic	HUMAN PRESCRIPTION DRUG LABEL	1	0456-1402	TABLET	2.50 mg	ORAL	NDA	26 sections
Bystolic	HUMAN PRESCRIPTION DRUG LABEL	1	0456-1402	TABLET	2.50 mg	ORAL	NDA	26 sections
Bystolic	HUMAN PRESCRIPTION DRUG LABEL	1	0456-1405	TABLET	5 mg	ORAL	NDA	26 sections
Bystolic	HUMAN PRESCRIPTION DRUG LABEL	1	0456-1405	TABLET	5 mg	ORAL	NDA	26 sections
Bystolic	HUMAN PRESCRIPTION DRUG LABEL	1	0456-1410	TABLET	10 mg	ORAL	NDA	26 sections
Bystolic	HUMAN PRESCRIPTION DRUG LABEL	1	0456-1410	TABLET	10 mg	ORAL	NDA	26 sections
Bystolic	HUMAN PRESCRIPTION DRUG LABEL	1	0456-1420	TABLET	20 mg	ORAL	NDA	26 sections
Bystolic	HUMAN PRESCRIPTION DRUG LABEL	1	0456-1420	TABLET	20 mg	ORAL	NDA	26 sections
nebivolol	HUMAN PRESCRIPTION DRUG LABEL	1	0904-7189	TABLET	5 mg	ORAL	ANDA	24 sections
nebivolol	HUMAN PRESCRIPTION DRUG LABEL	1	0904-7190	TABLET	10 mg	ORAL	ANDA	24 sections
nebivolol	HUMAN PRESCRIPTION DRUG LABEL	1	0904-7225	TABLET	2.50 mg	ORAL	ANDA	24 sections
nebivolol	HUMAN PRESCRIPTION DRUG LABEL	1	0904-7226	TABLET	20 mg	ORAL	ANDA	24 sections
nebivolol	HUMAN PRESCRIPTION DRUG LABEL	1	13668-353	TABLET	2.50 mg	ORAL	ANDA	24 sections
nebivolol	HUMAN PRESCRIPTION DRUG LABEL	1	13668-353	TABLET	2.50 mg	ORAL	ANDA	24 sections
nebivolol	HUMAN PRESCRIPTION DRUG LABEL	1	13668-354	TABLET	5 mg	ORAL	ANDA	24 sections
nebivolol	HUMAN PRESCRIPTION DRUG LABEL	1	13668-354	TABLET	5 mg	ORAL	ANDA	24 sections
nebivolol	HUMAN PRESCRIPTION DRUG LABEL	1	13668-355	TABLET	10 mg	ORAL	ANDA	24 sections
nebivolol	HUMAN PRESCRIPTION DRUG LABEL	1	13668-355	TABLET	10 mg	ORAL	ANDA	24 sections
nebivolol	HUMAN PRESCRIPTION DRUG LABEL	1	13668-356	TABLET	20 mg	ORAL	ANDA	24 sections
nebivolol	HUMAN PRESCRIPTION DRUG LABEL	1	13668-356	TABLET	20 mg	ORAL	ANDA	24 sections
Nebivolol	Human Prescription Drug Label	1	27241-179	TABLET	2.50 mg	ORAL	ANDA	25 sections
Nebivolol	Human Prescription Drug Label	1	27241-180	TABLET	5 mg	ORAL	ANDA	25 sections
Nebivolol	Human Prescription Drug Label	1	27241-181	TABLET	10 mg	ORAL	ANDA	25 sections
Nebivolol	Human Prescription Drug Label	1	27241-182	TABLET	20 mg	ORAL	ANDA	25 sections
Nebivolol Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	29300-375	TABLET	2.50 mg	ORAL	ANDA	23 sections
Nebivolol Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	29300-376	TABLET	5 mg	ORAL	ANDA	23 sections
Nebivolol Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	29300-377	TABLET	10 mg	ORAL	ANDA	23 sections
Nebivolol Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	29300-378	TABLET	20 mg	ORAL	ANDA	23 sections
Nebivolol	HUMAN PRESCRIPTION DRUG LABEL	1	31722-585	TABLET	2.50 mg	ORAL	ANDA	24 sections
Nebivolol	HUMAN PRESCRIPTION DRUG LABEL	1	31722-586	TABLET	5 mg	ORAL	ANDA	24 sections