Prescription medication · Beta-1 Selective Blocker
nebivolol
Also sold as Bystolic. Nebivolol treats high blood pressure.
Data updated 2026-05-15
- 14,997
- FDA reportsModerately reported
- 7
- InteractionsFew interactions
- 98% less
- Generic vs brandHuge savings
- 1
- Recall record
What the data shows
nebivolol (Bystolic) is a prescription Beta-1 Selective Blocker, reported less often than most tracked drugs (14,997 FDA reports), whose generic costs a fraction of the brand (about 98% less).
Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.
nebivolol (Bystolic) is a prescription Beta-1 Selective Blocker. Nebivolol treats high blood pressure.
Nebivolol is a medicine that lowers high blood pressure. Lowering blood pressure helps prevent strokes and heart attacks.
Verify with FDA → · CMS NADAC pricing →
Drug Pricing (NADAC)
Brand Price
$5.84/unit
Generic Price
$0.13/unit
Generic Savings
98%
Generic Available
Yes (13 manufacturers)
Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →
What it does
Nebivolol treats high blood pressure.
Common side effects
Headache, Tiredness, Dizziness
Key warnings
Do not stop taking nebivolol suddenly if you have heart disease.
The sections below are summarized in plain English from nebivolol's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
How It Works
Nebivolol is a beta-blocker that mainly affects the heart. It works by relaxing blood vessels and slowing down your heart rate. This makes it easier for your heart to pump blood and lowers blood pressure.
Side Effects (from patient reports)
Based on 14,997 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for nebivolol, by number of reports
- Acute Kidney Injury
Acute Kidney Injury
922 reports
- Dyspnoea
Dyspnoea
773 reports
- Diarrhoea
Diarrhoea
724 reports
- Drug Interaction
Drug Interaction
616 reports
- Hypotension
Hypotension
611 reports
- Anaemia
Anaemia
598 reports
- Nausea
Nausea
573 reports
- Fatigue
Fatigue
519 reports
- Fall
Fall
513 reports
- Dizziness
Dizziness
477 reports
What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.
Reports over time
Adverse-event reports filed for nebivolol each year to the FDA Adverse Event Reporting System (FAERS).
Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.
Where nebivolol sits
nebivolol has more FDA adverse-event reports than 48% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.
Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is nebivolol; the line is the median (50th percentile).
FDA Adverse Event Report Analysis
Detailed analysis of 14,997 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2004–2025.
Total Reports
14,997
Reports Mentioning Death
1,464
9.8% of reports — not proof of cause
Hospitalization Reports
8,438
Top Indication
Product Used For Unknown Indication
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 1 | ACUTE KIDNEY INJURY | 922 |
| 2 | DYSPNOEA | 773 |
| 3 | DIARRHOEA | 724 |
| 4 | DRUG INTERACTION | 616 |
| 5 | HYPOTENSION | 611 |
| 6 | ANAEMIA | 598 |
| 7 | NAUSEA | 573 |
| 10 | FATIGUE | 519 |
| 11 | FALL | 513 |
| 12 | DIZZINESS | 477 |
| 13 | ASTHENIA | 472 |
| 14 | HEADACHE | 449 |
| 15 | VOMITING | 419 |
| 16 | HYPERTENSION | 410 |
| 17 | GENERAL PHYSICAL HEALTH DETERIORATION | 385 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation
Serious Warnings
Do not stop taking nebivolol suddenly if you have heart disease. This can make chest pain worse or cause a heart attack. Talk to your doctor before stopping nebivolol. They will likely lower your dose slowly over 1 to 2 weeks.
Known Drug Interactions
( 7.4 ) 7.1 CYP2D6 Inhibitors Use caution when nebivolol is co-administered with CYP2D6 inhibitors (quinidine, propafenone, fluoxetine, paroxetine, etc.) [ see Clinical Pharmacology ( 12.5 ) ].
Mechanism: Fluoxetine blocks the liver protein responsible for breaking down nebivolol, which can lead to higher levels of the drug in your blood.
( 7.4 ) 7.1 CYP2D6 Inhibitors Use caution when nebivolol is co-administered with CYP2D6 inhibitors (quinidine, propafenone, fluoxetine, paroxetine, etc.) [ see Clinical Pharmacology ( 12.5 ) ].
Mechanism: Propafenone slows down the body's ability to process nebivolol, which could cause the medication to build up to higher levels.
7 DRUG INTERACTIONS CYP2D6 enzyme inhibitors may increase nebivolol levels ( 7.1 ) Reserpine or clonidine may produce excessive reduction of sympathetic activity. In patients who are receiving nebivolol and clonidine, discontinue nebivolol tablets for several days before the gradual tapering of clonidine.
Mechanism: Both drugs work to slow down the body's nervous system activity. Taking them together can cause an safely large drop in this activity.
( 7.3 ) Verapamil- or diltiazem-type calcium channel blockers may cause excessive reductions in heart rate, blood pressure, and cardiac contractility. 7.4 Calcium Channel Blockers Nebivolol 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.
Mechanism: Both of these medicines slow the heart rate and lower blood pressure. Using them together can cause your heart to beat too slowly or weaken its pumping strength.
( 7.3 ) Verapamil- or diltiazem-type calcium channel blockers may cause excessive reductions in heart rate, blood pressure, and cardiac contractility. 7.4 Calcium Channel Blockers Nebivolol 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.
Mechanism: These drugs both act on the heart to slow it down and lower blood pressure. Combining them can cause your heart rate or blood pressure to drop to levels that are too low.
This is a plain-language summary of FDA-label interaction records and does not provide individual medication-combination directions.
Common Questions
Can I drink alcohol while taking nebivolol?
Will nebivolol cure my high blood pressure?
Can I take nebivolol if I have asthma?
What should I do if I feel dizzy after taking nebivolol?
Can nebivolol affect my blood sugar?
Does nebivolol interact with other medications?
How long does it take for nebivolol to start working?
Can I exercise while taking nebivolol?
What if I need surgery?
Can nebivolol cause weight gain?
What are the common side effects of nebivolol?
Does nebivolol interact with other medications?
What drug class is nebivolol?
Is there a generic version of nebivolol?
What pregnancy or breastfeeding source fields are listed for nebivolol?
Has nebivolol been recalled?
Active Recalls
Cross Contamination with Other Products
Glenmark Pharmaceuticals Inc., USA
Related Medications in Beta-1 Selective Blocker
Other drugs grouped near nebivolol - same-class peers and common alternatives.
acebutolol
Sectral
Acebutolol is a medicine that helps lower blood pressure and control irregular heartbeats.
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aliskiren
Tekturna
Tekturna is a medicine used to treat high blood pressure.
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amiloride
Midamor
Amiloride is a water pill that helps your body hold onto potassium.
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amlodipine
Norvasc
Amlodipine (Norvasc) is a drug that lowers blood pressure and treats chest pain.
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amlodipine/benazepril
Lotrel
Lotrel is a combination medicine that contains amlodipine and benazepril.
Compare with nebivolol →
Compare beyond drug class
Nationwide peers by FAERS volume & death-report share
Two PlainMeds-derived comparison paths for nebivolol: nearest FDA FAERS report volume and nearest death-report share among drugs with at least 1,000 logged reports, excluding same-class neighbors listed above. Counts reflect reporting volume, not proven individual harm.
Similar FAERS report volume
Nearest drugs by total FAERS reports. This record: 14,997.
Similar death-report share
Nearest drugs by FAERS death-report share. This record: 9.76%.
- promethazine Δ 0.00 pts · 17,969 reports · Phenothiazine Antiemetic / Antihistamine 9.76%death share
- doxycycline Δ 0.00 pts · 64,488 reports · Tetracycline Antibiotic 9.76%death share
- sarilumab Δ 0.00 pts · 23,683 reports · IL-6 Receptor Antagonist 9.77%death share
- cyanocobalamin Δ 0.02 pts · 31,083 reports · Vitamin B12 Supplement 9.78%death share
Medication Guides
Understanding Drug Interactions
How CYP450 enzymes, inhibitors, and inducers affect your medications
Generic vs Brand Name Drugs
FDA requirements, cost savings, and when the difference matters
Narrow Therapeutic Index Drugs
FDA bioequivalence and label-record context for narrow therapeutic index medicines
Common Drug Interactions
Dangerous medication combinations and how to protect yourself
Save on nebivolol
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What the FDA Data Shows for nebivolol
The FDA label for nebivolol (sold under brand names such as Bystolic) classifies it as a prescription-only medication in the Beta-1 Selective Blocker class. Nebivolol treats high blood pressure. Official labeling lists 6 commonly reported side effects, including Headache, Tiredness, Dizziness.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 14,997 voluntary reports. The database also lists 7 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated moderate severity. NADAC pricing from CMS shows a generic unit cost of $0.13 versus $5.84 for the brand - a 98% generic savings.
Report counts do not establish causation, a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history (currently 1 recall record on file), and patent information are separate source-record fields. This page is a public FDA/CMS registry and does not provide medical, treatment, substitution, or medication-change directions.
Data Sources
Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).
FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. This registry does not provide medication decisions.
Last updated: October 31, 2024
PlainMeds is rendered directly from FDA openFDA/FAERS extracts, DailyMed labels, and CMS drug-pricing files, no number is typed in by an editor. FAERS counts, recalls, shortages, and price figures on this page are queried live from those federal extracts. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of 2026-05-15. Primary sources: openFDA / FAERS, DailyMed and CMS Part B ASP.
Read our methodology - how this data is sourced, computed, and verified.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled from the source snapshot dated . See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a data issue.
All federal data sources used on this page
- FDA Orange Book - approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed - NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) - post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm - standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files - federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database - current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages