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Prescription medicine

Nebivolol Brand names: Bystolic

Nebivolol (Bystolic) is a prescription medicine with an FDA approval on record since 2007. FDA's NDC Directory lists it from 23 generic labelers, and pharmacies paid $0.141 per nebivolol 10 mg tablet in the October 7, 2026 NADAC survey.

  • Generic listed
  • A presentation discontinued

Check it at the source: the nebivolol FDA label on DailyMed (effective August 1, 2024, Allergan, Inc.); the NDA 21742 record on Drugs@FDA; every nebivolol label on DailyMed.

Highlights of the record

FDA label of August 1, 2024; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026

Used for

From the label: indications and usage

INDICATIONS AND USAGE BYSTOLIC is a beta-adrenergic blocking agent indicated for the treatment of hypertension, to lower blood pressure.

Forms and strengths

  • 2.5 mg
  • 5 mg
  • 10 mg
  • 20 mg

Tablet.

On the market

Earliest approval on file
December 17, 2007 Bystolic, Allergan; Drugs@FDA’s file, where older or withdrawn approvals can be missing
Generic approvals
18 first April 16, 2015; 13 with a marketed status in Drugs@FDA
Labelers listed (NDC)
24 of which 23 under generic applications, 1 under brand applications, repackagers included

Supply and safety

Pharmacy cost (NADAC)
$0.141 per tablet Nebivolol 10 mg tablet
Shortage (FDA)
None current 16 past records
Recalls by its makers (FDA)
5 since 2013 0 Class I among all firms' recalls; latest November 18, 2025; 1 more by firms not listed as its makers
FAERS reports
33,555 through July 30, 2026

What is nebivolol used for?

From the label: indications and usage

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. […]

Conditions named in the indications of nebivolol's FDA labels, with every medicine labeled for each:

FDA pharmacologic class: beta-Adrenergic Blocker.

Source: FDA drug label (Bystolic), Allergan, Inc., effective August 1, 2024 (SPL set 8b8ad213-1dc8-454e-a524-075685c0e1a8), via openFDA; the full label on DailyMed

Is there a generic for nebivolol (Bystolic)?

The FDA approved the first generic nebivolol on April 16, 2015. 18 generic applications are approved; 13 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale. Drugs@FDA also holds 1 tentative approval: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.

FDA's NDC Directory lists nebivolol from 23 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.

  • 2007 earliest approval on file
  • 2015 first generic approved
  • red ticks recalls

Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)

What do pharmacies pay for nebivolol (Bystolic)?

In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.141 per Nebivolol 10 mg tablet, about the same as a year earlier. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.

  • Nebivolol 5 mg tablet (generic)
  • Bystolic 10 mg tablet (brand)
$6.43
$0.0878
January 2024October 2026
NADAC per unit, October 7, 2026
Strength and formBrand or genericPharmacy cost30 tablets, or one pen or vial12-month change
Nebivolol 10 mg tabletGeneric$0.141 per tablet$4.24+0.8%
Nebivolol 2.5 mg tabletGeneric$0.117 per tablet$3.51+7%
Nebivolol 20 mg tabletGeneric$0.175 per tablet$5.25-7%
Nebivolol 5 mg tabletGeneric$0.113 per tablet$3.40+3%
Bystolic 10 mg tabletBrand$6.41 per tablet many times the lowest per-tablet cost; NADAC records the price, not why$192.28+4%
Bystolic 2.5 mg tabletBrand$6.45 per tablet many times the lowest per-tablet cost; NADAC records the price, not why$193.39+5%
Bystolic 20 mg tabletBrand$6.42 per tablet many times the lowest per-tablet cost; NADAC records the price, not why$192.66+5%
Bystolic 5 mg tabletBrand$6.45 per tablet many times the lowest per-tablet cost; NADAC records the price, not why$193.54+5%

Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price

Is nebivolol in shortage?

No nebivolol presentation is listed as in shortage in the FDA Drug Shortage Database (read October 8, 2026); its 16 records are all marked to be discontinued, the latest updated March 25, 2026. ASHP keeps a separate shortage list, which can differ.

PresentationCompanyStatusUpdated
Nebivolol Hydrochloride, Tablet, 10 mg (NDC 13668-355-01)Torrent Pharmaceuticals LimitedTo Be DiscontinuedMarch 25, 2026
Nebivolol Hydrochloride, Tablet, 10 mg (NDC 13668-355-05)Torrent Pharmaceuticals LimitedTo Be DiscontinuedMarch 25, 2026
Nebivolol Hydrochloride, Tablet, 10 mg (NDC 13668-355-30)Torrent Pharmaceuticals LimitedTo Be DiscontinuedMarch 25, 2026
Nebivolol Hydrochloride, Tablet, 10 mg (NDC 13668-355-90)Torrent Pharmaceuticals LimitedTo Be DiscontinuedMarch 25, 2026
Nebivolol Hydrochloride, Tablet, 2.5 mg (NDC 13668-353-01)Torrent Pharmaceuticals LimitedTo Be DiscontinuedMarch 25, 2026
Nebivolol Hydrochloride, Tablet, 2.5 mg (NDC 13668-353-05)Torrent Pharmaceuticals LimitedTo Be DiscontinuedMarch 25, 2026
Nebivolol Hydrochloride, Tablet, 2.5 mg (NDC 13668-353-30)Torrent Pharmaceuticals LimitedTo Be DiscontinuedMarch 25, 2026
Nebivolol Hydrochloride, Tablet, 2.5 mg (NDC 13668-353-90)Torrent Pharmaceuticals LimitedTo Be DiscontinuedMarch 25, 2026

Every nebivolol presentation in the FDA shortage database

Source: FDA Drug Shortage Database via openFDA, updated October 8, 2026

Has nebivolol been recalled?

The FDA's Enforcement Report lists 6 recalls naming nebivolol since 2013: 0 Class I (the most serious), 5 Class II, 1 Class III; 2 still ongoing. 1 of them is by a firm that FDA's NDC Directory does not list as a maker of nebivolol and that holds no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.

StartedClassCompanyReason
November 18, 2025Class IIIGlenmark Pharmaceuticals Inc., USACross Contamination with Other Products
December 6, 2024Class IIAurobindo Pharma USA IncCGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso Nebivolol above acceptable intake (AI) limit.
September 26, 2014Class IIForest Pharmaceuticals IncFailed Dissolution Specification; at the 6-month stability time point
June 19, 2014Class IIForest Pharmaceuticals IncFailed Dissolution Specifications: Drug failed stage III dissolution testing.
May 12, 2014Class IIForest Pharmaceuticals IncFailed Dissolution Specifications: One lot of product is being voluntarily recalled because dissolution test results failed to meet specification throughout …
July 2, 2013Class IIAidapak Services, LLC not a listed makerLabeling: Label Mixup: NEBIVOLOL HCL, Tablet, 5 mg may have potentially been mislabeled as one of the following drugs: THYROID, Tablet, 30 mg, NDC 00456045801 …

Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026

What does the nebivolol label say about other medicines?

The nebivolol label names 11 other medicines in its interaction, contraindication or warning sections. The labels of 4 other medicines name nebivolol. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.

Medicine namedSectionWhat the label says
Clonidinedrug interactionsDRUG INTERACTIONS CYP2D6 enzyme inhibitors may increase nebivolol levels. ( 7.1 ) Reserpine or clonidine may produce excessive reduction of sympathetic activity. ( 7.2 ) Both digitalis glycosides and β-blockers slow atrioventricular conduction and decrease heart rate.
Diltiazemdrug interactionsCalcium Channel Blockers BYSTOLIC can exacerbate the effects of myocardial depressants or inhibitors of AV conduction, such as certain calcium antagonists (particularly of the phenylalkylamine [verapamil] and benzothiazepine [diltiazem] classes), or antiarrhythmic agents, such as disopyramide.
Disopyramidedrug interactionsCalcium Channel Blockers BYSTOLIC can exacerbate the effects of myocardial depressants or inhibitors of AV conduction, such as certain calcium antagonists (particularly of the phenylalkylamine [verapamil] and benzothiazepine [diltiazem] classes), or antiarrhythmic agents, such as disopyramide.
Dobutaminewarnings and precautionsThe β-blocking effects of BYSTOLIC can be reversed by β-agonists, e.g., dobutamine or isoproterenol.
Epinephrinewarnings and precautionsSuch patients may be unresponsive to the usual doses of epinephrine used to treat allergic reactions.
Fluoxetinedrug interactionsUse caution when BYSTOLIC is co-administered with CYP2D6 inhibitors (quinidine, propafenone, fluoxetine, paroxetine, etc.) [see Clinical Pharmacology ( 12.5 )].
Isoproterenolwarnings and precautionsThe β-blocking effects of BYSTOLIC can be reversed by β-agonists, e.g., dobutamine or isoproterenol.
Paroxetinedrug interactionsUse caution when BYSTOLIC is co-administered with CYP2D6 inhibitors (quinidine, propafenone, fluoxetine, paroxetine, etc.) [see Clinical Pharmacology ( 12.5 )].
Propafenonedrug interactionsUse caution when BYSTOLIC is co-administered with CYP2D6 inhibitors (quinidine, propafenone, fluoxetine, paroxetine, etc.) [see Clinical Pharmacology ( 12.5 )].
Quinidinedrug interactionsUse caution when BYSTOLIC is co-administered with CYP2D6 inhibitors (quinidine, propafenone, fluoxetine, paroxetine, etc.) [see Clinical Pharmacology ( 12.5 )].
Verapamildrug interactionsCalcium Channel Blockers BYSTOLIC can exacerbate the effects of myocardial depressants or inhibitors of AV conduction, such as certain calcium antagonists (particularly of the phenylalkylamine [verapamil] and benzothiazepine [diltiazem] classes), or antiarrhythmic agents, such as disopyramide.

Other labels that name nebivolol

Check nebivolol against other medicines

Source: FDA drug label (Bystolic), Allergan, Inc., effective August 1, 2024 (SPL set 8b8ad213-1dc8-454e-a524-075685c0e1a8), via openFDA; the full label on DailyMed

What do FAERS reports show for nebivolol?

The FDA Adverse Event Reporting System holds 33,555 reports that list nebivolol among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 2,385 are coded as a death and 13,128 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.

Reports received each year

The most reported reactions

  • Fatigue (named in the label)1,861
  • Diarrhoea (named in the label)1,794
  • Dyspnoea (named in the label)1,724
  • Drug Ineffective (a use or a product term, not a reaction)1,627
  • Nausea (named in the label)1,616
  • Headache (named in the label)1,441
  • Dizziness (named in the label)1,405
  • Acute Kidney Injury1,293

Side effects: the label's list and every FAERS reaction

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026

What else is labeled for the same conditions as nebivolol?

75 other medicines are given the same way (oral) and in the same FDA class as nebivolol or labeled mainly for the same use (high blood pressure), the same class first. High blood pressure lists all 88 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.

MedicineShared indicationGeneric labelers (oral)Pharmacy costShortage
MetoprololHigh blood pressure64 labelers$0.085 per tablet 100 mg tabletA presentation being discontinued
PropranololHigh blood pressure38 labelers$0.0493 per tablet 20 mg tabletIn shortage
CarvedilolHigh blood pressure41 labelers$0.0179 per tablet 6.25 mg tabletNo current entry
AtenololHigh blood pressure35 labelers$0.0217 per tablet 25 mg tabletNo current entry
LabetalolHigh blood pressure31 labelers$0.215 per tablet 300 mg tabletNo current entry
NadololHigh blood pressure16 labelers$0.147 per tablet 20 mg tabletNo current entry
BisoprololHigh blood pressure24 labelers$0.114 per tablet 5 mg tabletNo current entry
Bisoprolol and hydrochlorothiazideHigh blood pressure11 labelers$0.209 per tablet 10-6.25 mg tabletNo current entry

Every medicine labeled for the same conditions as nebivolol

Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)

How does nebivolol compare with medicines for the same use?

14 side-by-side pages set nebivolol beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.

What next?

Alternatives to nebivolol
75 medicines for the same use
Other beta blockers
the pharmacologic class, with prices and generics
Nebivolol side effects
the label's list beside FAERS reports
Nebivolol shortage record
every presentation, company and date
Check an interaction
what two or more labels say about each other