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Bystolic

Nebivolol

An oral daily medication used to treat high blood pressure.

Generic name
Nebivolol
Brand name
Bystolic
Route
Oral
Marketed by
Allergan
First FDA approval
17 Dec 2007

Where Nebivolol is approved

All regulators →

Of the three regulators tracked here, the first to approve Nebivolol was the US, on 17 Dec 2007. It is approved in 2 of the 3 regulators tracked here.

USUnited States (FDA)
17 Dec 2007
Bystolic
NDA021742 on Drugs@FDA
First original NDA/BLA approval
EUEuropean Union (EMA)
No centralised EU authorisation (it may be authorised nationally)
First centralised authorisation
CACanada (Health Canada)
21 Dec 2012
Bystolic
Notice of Compliance 13962
First new-drug NOC

From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.

What health systems spend on Nebivolol

All medicines →
ENNHS England
£9.1m
713,582 items dispensed, Aug 2025 to Jul 2026
+15% on the previous 12 months
Net ingredient cost, community prescriptions
USUS Medicaid
$2.5m
106,267 prescriptions in 2025 · Nebivolol, Nebivolol, Bystolic
-46% on 2024
Amount Medicaid reimbursed, before rebates

From NHSBSA Prescription Cost Analysis (Open Government Licence v3.0) and CMS State Drug Utilization Data. Both are gross amounts: neither system publishes its discounts or rebates per drug. Products combining several substances are not counted here.

How Nebivolol works

All drug targets →
  • Beta-1 adrenergic receptor antagonist Antagonist
    Target: ADRB1 adrenoceptor beta 1
    ✓ In ChEMBL and the Guide to Pharmacology
  • Beta-2 adrenergic receptor antagonist Antagonist
    Target: ADRB2 adrenoceptor beta 2
    ✓ In ChEMBL and the Guide to Pharmacology
Diseases it has been tested for in clinical trials, by furthest phase
  • Aortic root aneurysmPhase 3
  • Marfan syndromePhase 3
  • Angina pectorisPhase 3
  • Aortic aneurysmPhase 3
  • Essential hypertensionPhase 3
  • Peripheral arterial diseasePhase 3
  • Chronic obstructive pulmonary diseasePhase 2/3
  • Diabetic neuropathyPhase 2/3
  • Type 2 diabetes mellitusPhase 2/3
  • Breast cancerPhase 2
13 diseases in all

Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL434394, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3), ligand 7246, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.

Patient leaflets for Nebivolol

The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.

Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.

Reference identifiers for Nebivolol

ATC code
C07AB12
ChEMBL
CHEMBL434394
DrugBank
DB04861
PubChem CID
71301
CAS number
99200-09-6
FDA UNII
030Y90569U
Wikidata
Q418130
Wikipedia
Nebivolol

Codes that identify this medicine in other databases, from Wikidata (CC0), matched by its ChEMBL ID. The ATC code is the WHO classification of what the medicine is used for.

What Bystolic is used for

1. INDICATIONS AND USAGE BYSTOLIC is a beta-adrenergic blocking agent indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.1 ) 1.1 Hypertension BYSTOLIC is indicated for the treatment of hypertension, to lower blood pressure [see Clinical Studies ( 14.1 )]. BYSTOLIC may be used alone or in combination with other antihypertensive agents [see Drug Interactions ( 7 )]. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction wi…

How it works

12.1 Mechanism of Action The mechanism of action of the antihypertensive response of BYSTOLIC has not been definitively established. Possible factors that may be involved include: (1) decreased heart rate, (2) decreased myocardial contractility, (3) diminution of tonic sympathetic outflow to the periphery from cerebral vasomotor centers, (4) suppression of renin activity and (5) vasodilation and decreased peripheral vascular resistance.

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How this page is built

The facts on this page are pulled directly from official U.S. FDA datasets — they are not written from memory. Each field below names the dataset it came from, so you can check it yourself.

Plain-English summaries and drug-class explainers are written and reviewed by Sreepriya Prasannan (MSc Digital Transformation of Life Sciences (Innopharma Education / Griffith College); MSc & BSc Botany). Data is retrieved automatically from the sources above and cross-checked with AI-assisted verification (Anthropic's Claude) — brand and generic names are matched against the exact FDA product record so that a combination product or a different formulation cannot be mistaken for the drug on this page. An editor reviews the result before publication. We describe this in full in our editorial standards and corrections policy. The FDA data on this page was last retrieved on 8 Oct 2026. How every register is built: methodology · fixes we have made: corrections log.

Please verify before you rely on this. This page is general information for life-science and pharmaceutical professionals. It is not medical advice, and it has not been reviewed by a clinician — our editorial team holds life-science qualifications, not clinical ones. It is not exhaustive and may not reflect the most recent label change. Always check the official prescribing information (US Prescribing Information or EU SmPC) and speak to your doctor or pharmacist before acting on anything here. Drugs in the same class are not automatically interchangeable, and approvals, brand names and indications differ between the US, the EU/Ireland (EMA/HPRA) and other regions. Spotted an error? Tell us — we correct promptly and log it.