Carvedilol

ATC code

C07AG02

Therapeutic class

Alpha and beta-adrenergic blocking agent · Non-selective beta-blocker (β1/β2) with α1-blockade

Forms

oral tablet

Brand names

Carvedilol (US) · Coreg (US) · CARVEDILOL CINFA (ES) · CARVEDILOL TEVA (FR)

Overall confidence

high

Regulatory sources consulted

openfda-label-518bf5ef-f275-ba4d-e063-6294a90a9f66
aemps-cima-ft-68328
ansm-bdpm-rcp-69855425
OpenFDA · C07AG02
RxNorm rxcui 20352 ↗

Approved indications

Treatment of mild-to-severe chronic heart failure of ischemic or cardiomyopathic origin, to increase survival and also to reduce the risk of hospitalization.
Left ventricular dysfunction following myocardial infarction in clinically stable patients to reduce cardiovascular mortality.
Management of essential hypertension, alone or in combination with other antihypertensive agents.

Contraindications

Absolute

Bronchial asthma or related bronchospastic conditions.
Second- or third-degree AV block, sick sinus syndrome, or severe bradycardia (unless a permanent pacemaker is in place).
Cardiogenic shock or decompensated heart failure requiring intravenous inotropic therapy.
Severe hepatic impairment.
Previous serious hypersensitivity to carvedilol.

Clinical warnings

Major warning · Do not abruptly discontinue therapy, particularly in patients with coronary artery disease, due to risk of severe arrhythmias, myocardial infarction, or sudden death. — ANSM

Drug interactions

ModerateCyclosporineL04AD01
Mechanism: Carvedilol may increase cyclosporine concentrations. The exact mechanism is unclear, possibly via P-glycoprotein inhibition.
Recommendation: Monitor cyclosporine concentrations and adjust dose as needed when starting or modifying carvedilol therapy.
OpenFDA labelANSM RCP
HighRifampinJ04AB02
Mechanism: Rifampin is a potent inducer of CYP enzymes, which drastically reduces carvedilol plasma concentrations and effects.
Recommendation: Avoid concomitant use. If necessary, a significant increase in carvedilol dosage may be required with close clinical monitoring.
OpenFDA labelANSM RCP
ModerateAmiodaroneC01BD01
Mechanism: Amiodarone may increase carvedilol levels and has additive effects on heart rate and AV conduction.
Recommendation: Monitor heart rate and ECG for excessive bradycardia or heart block. A reduction in carvedilol dose may be necessary.
OpenFDA labelANSM RCP
ModerateFluoxetineN06AB03
Mechanism: Fluoxetine is a potent CYP2D6 inhibitor, increasing concentrations of the R(+) enantiomer of carvedilol, enhancing its vasodilating (α-blocking) effects.
Recommendation: Monitor for increased adverse effects such as dizziness and hypotension, especially during dose titration.
OpenFDA label

Adverse events

Common (≥1%)

dizziness · fatigue · hypotension · diarrhea · hyperglycemia · asthenia · bradycardia · weight increase

Rare but serious

bronchospasm · complete AV block · worsening heart failure · Stevens-Johnson syndrome · anaphylactic reaction

Pregnancy and lactation

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