Nebivolol is a beta-adrenergic blocker indicated for the treatment of hypertension, to lower blood pressure. It is available as tablets for oral use. MedsAcross supplies Nebivolol for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
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.
Source: US FDA prescribing information
The mechanism of action of the antihypertensive response of BYSTOLIC has not been definitively established. Possible factors that may be involved include: decreased heart rate, decreased myocardial contractility, diminution of tonic sympathetic outflow to the periphery from cerebral vasomotor centers, suppression of renin activity and vasodilation and decreased peripheral vascular resistance.
Source: US FDA prescribing information
2. DOSAGE AND ADMINISTRATION Can be taken with and without food. Individualize to the needs of the patient and monitor during up-titration. Hypertension: Most patients start at 5 mg once daily. Dose can be increased at 2-week intervals up to 40 mg.
Source: US FDA prescribing information
4. CONTRAINDICATIONS BYSTOLIC is contraindicated in the following conditions: Severe bradycardia Heart block greater than first degree Patients with cardiogenic shock Decompensated cardiac failure Sick sinus syndrome (unless a permanent pacemaker is in place) Patients with severe hepatic impairment (Child-Pugh >B) Patients who are hypersensitive to any component of this product. Severe bradycardia. Heart block greater than first degree. Patients with cardiogenic shock. Decompensated cardiac failure. Sick sinus syndrome (unless a permanent pacemaker is in place). Patients with severe hepatic impairment (Child-Pugh >B). Hypersensitive to any component of this product
Source: US FDA prescribing information
5. WARNINGS AND PRECAUTIONS Acute exacerbation of coronary artery disease upon cessation of therapy: Do not abruptly discontinue. Diabetes: May mask symptoms of hypoglycemia and alter glucose levels, monitor
Source: US FDA prescribing information
6. ADVERSE REACTIONS Most common adverse reactions: Headache, fatigue
Source: US FDA prescribing information
7. DRUG INTERACTIONS CYP2D6 enzyme inhibitors may increase nebivolol levels. Reserpine or clonidine may produce excessive reduction of sympathetic activity. Both digitalis glycosides and β-blockers slow atrioventricular conduction and decrease heart rate. Concomitant use can increase the risk of bradycardia. Verapamil- or diltiazem-type calcium channel blockers may cause excessive reductions in heart rate, blood pressure, and cardiac contractility.
Source: US FDA prescribing information
Store at 20° to 25°C (68° to 77°F).
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
8 presentations of Nebivolol, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Nebivolol 5 mg tabletOralGeneric name | — | US FDA | Available on request |
| Nebivolol 10 mg tabletOralGeneric name | — | US FDA | Available on request |
| Nebivolol 20 mg tabletOralGeneric name | — | US FDA | Available on request |
| Nebivolol 2.5 mg tabletOralGeneric name | — | US FDA | Available on request |
| Bystolic 10 mg tabletOral | Allergan | US FDA | Available on request |
| Bystolic 2.5 mg tabletOral | Allergan | US FDA | Available on request |
| Bystolic 20 mg tabletOral | Allergan | US FDA | Available on request |
| Bystolic 5 mg tabletOral | Allergan | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
| Register | Status | Source |
|---|---|---|
| US FDA | First approved 17 December 2007 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Conditions linked to Nebivolol in public data. This is not a list of approved uses, see the clinical information.
Yes, on request. MedsAcross lists 8 presentations of Nebivolol and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Nebivolol, including Bystolic.
Yes. The US FDA first approved Nebivolol on 17 December 2007, according to Drugs@FDA.
No listed presentation of Nebivolol is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Nebivolol is classified under ATC code C07AB12 (Nebivolol).
Tell us the strength, quantity and destination country. Our team replies with availability, lead time and the import documents needed.