Nebivolol

ATC code

C07AB12

Therapeutic class

Selective beta-blocking agent · Selective beta-1 blocker with nitric oxide-mediated vasodilating properties

Forms

oral tablet

Brand names

Bystolic (US) · Corpres (AR) · INSUCOR (ES) · Nebilet (EU)

Overall confidence

high

Regulatory sources consulted

openfda-label-089ab51c-85fc-44ad-80fc-7e56469ad9f5
aemps-ft-83604
ansm-rcp-68091113
Pharmacist Clinical Knowledge
OpenFDA · C07AB12
RxNorm rxcui 31555 ↗

Approved indications

Treatment of hypertension, to lower blood pressure.
Treatment of stable mild to moderate chronic heart failure as an adjunct to standard therapies in elderly patients ≥ 70 years.

Contraindications

Absolute

Severe bradycardia
Heart block greater than first degree (without a pacemaker)
Cardiogenic shock
Decompensated cardiac failure
Severe hepatic impairment (Child-Pugh > B)
Hypersensitivity to nebivolol or any of its components

Clinical warnings

Major warning · Abrupt cessation of therapy may exacerbate angina pectoris and increase the risk of myocardial infarction. Taper off gradually. — FDA

Drug interactions

ModerateStrong CYP2D6 inhibitors (e.g., Fluoxetine, Paroxetine)N06AB03
Mechanism: Inhibition of nebivolol metabolism (CYP2D6 substrate), increasing its plasma concentrations and risk of adverse effects such as bradycardia.
Recommendation: Use with caution. Monitor heart rate and signs of beta-blocker toxicity. Consider nebivolol dose adjustment.
FDA label
HighVerapamil or DiltiazemC08DA01
Mechanism: Additive negative inotropic and chronotropic effects. Increased risk of severe bradycardia, hypotension, and AV block.
Recommendation: Combination is generally not recommended. If necessary, use under strict clinical and electrocardiographic monitoring.
FDA labelEMA SPC
ModerateDigoxinC01AA05
Mechanism: Both drugs slow atrioventricular conduction and decrease heart rate. Additive effect.
Recommendation: Concomitant use can increase the risk of bradycardia. Monitor heart rate.
FDA label

Adverse events

Common (≥1%)

headache · fatigue · dizziness · bradycardia · nausea

Rare but serious

atrioventricular block · heart failure decompensation · bronchospasm · syncope

Pregnancy and lactation

Insufficient data in pregnancy. Use of beta-blockers in the third trimester may cause bradycardia, hypoglycemia, and hypotension in the neonate. Breastfeeding is not recommended.