Prescription medication · Beta-Blocker (Alpha/Beta)

carvedilol

Name: carvedilol - FDA Drug Safety & Adverse Event Data
Creator: PlainMeds
License: https://creativecommons.org/publicdomain/zero/1.0/

Also sold as Coreg. Carvedilol treats a few different heart conditions.

Compiled by PlainMeds Editorial, Drug Information Editorial Team

Data updated 2026-05-15

130,791
FDA reportsHeavily reported: 13
InteractionsSeveral interactions: 10
Recall records

What the data shows

carvedilol (Coreg) is a prescription Beta-Blocker (Alpha/Beta), more reported than roughly 9 in 10 tracked drugs (130,791 FDA reports), with 13 documented drug interactions.

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.

carvedilol (Coreg) is a prescription Beta-Blocker (Alpha/Beta). Carvedilol treats a few different heart conditions.

Carvedilol is a medicine that lowers blood pressure and helps your heart work better. It belongs to a class of drugs called alpha/beta-blockers.

Verify with FDA → · CMS NADAC pricing →

Drug Pricing (NADAC)

Generic Price

$0.02/unit

Generic Available

Yes (11 manufacturers)

Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →

View Alternatives → Compare with Another Drug → Full Side Effects Report →

What it does

Carvedilol treats a few different heart conditions.

Common side effects

Dizziness, Tiredness, Low blood pressure

Key warnings

Do not stop taking carvedilol suddenly if you have heart problems.

The sections below are summarized in plain English from carvedilol's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.

How It Works

Carvedilol works by blocking the effects of certain natural chemicals in your body, such as adrenaline. This helps to relax blood vessels and slows down your heart rate. As a result, it lowers blood pressure and makes it easier for your heart to pump blood.

How to Take It

Take carvedilol with food to help your body absorb it and to avoid feeling dizzy. Your doctor will adjust your dose over time, starting with a low dose. For heart failure, you'll likely start at 3.125 mg twice a day. Your doctor may increase it every 2 weeks to 6.25 mg, 12.5 mg, and then 25 mg twice daily, as you tolerate it. Follow your doctor's instructions carefully.

This is a plain-language summary of carvedilol's FDA labeling, not individualized dosing advice. Ask a pharmacist or prescriber before changing how you take this medication.

Pregnancy & Breastfeeding

It is not known if carvedilol will harm your unborn baby. Tell your doctor if you are pregnant or plan to become pregnant. Beta-blockers like carvedilol may cause low blood pressure, slow heart rate, and breathing problems in newborns.

This is a plain-language summary of carvedilol's FDA labeling, not individualized advice. Ask a pharmacist or prescriber about pregnancy or breastfeeding on this medication.

Missed Dose

If you miss a dose, take it as soon as you remember. If it is close to your next dose, skip the missed dose and continue with your regular schedule.

This is a plain-language summary of carvedilol's FDA labeling, not individualized advice. Ask a pharmacist or prescriber what to do about your specific missed dose.

Storage

Store carvedilol at room temperature (68°F to 77°F) and protect it from moisture.

Side Effects (from patient reports)

Based on 130,791 FDA adverse event reports.

Tiredness

8,668
Difficulty breathing

8,176
Diarrhea

6,867
Dizziness

6,776
Feeling sick to your stomach

6,489
Death

5,631
Low blood pressure

5,603
Weakness

5,345
Congestive heart failure

4,430
Sudden kidney damage

4,408

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 carvedilol 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 carvedilol sits

carvedilol has more FDA adverse-event reports than 90% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.

fewest reports most reports

Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is carvedilol; the line is the median (50th percentile).

FDA Adverse Event Report Analysis

Detailed analysis of 130,791 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2003–2025.

Total Reports

130,791

Reports Mentioning Death

15,919

12.2% of reports — not proof of cause

Hospitalization Reports

53,070

Top Indication

Product Used For Unknown Indication

Gender Distribution

Female 57,183 (47%)

Male 65,450 (53%)

Age Distribution

0–17 900

18–44 5,607

45–64 28,089

65–74 26,227

75+ 26,948

Most Reported Adverse Reactions (FAERS)

#	Reaction	Reports
1	FATIGUE	8,669
2	DYSPNOEA	8,178
3	DIARRHOEA	6,867
4	DIZZINESS	6,776
5	NAUSEA	6,492
7	DEATH	5,632
8	HYPOTENSION	5,601
9	ASTHENIA	5,344
10	CARDIAC FAILURE CONGESTIVE	4,427
11	ACUTE KIDNEY INJURY	4,408
13	PAIN	4,341
14	FALL	4,335
15	HEADACHE	4,197
16	RENAL FAILURE	4,183
17	CHRONIC KIDNEY DISEASE	4,025

Reactions in Death Reports

DEATH 5,616

COMPLETED SUICIDE 1,202

RENAL FAILURE 1,049

CARDIAC FAILURE CONGESTIVE 1,030

DYSPNOEA 869

PNEUMONIA 868

CARDIAC ARREST 855

ACUTE KIDNEY INJURY 799

CARDIAC FAILURE 735

HYPOTENSION 710

Reactions in Hospitalization Reports

DYSPNOEA 4,434

CARDIAC FAILURE CONGESTIVE 3,622

PNEUMONIA 3,344

HYPOTENSION 3,313

FATIGUE 3,000

FALL 2,876

ASTHENIA 2,781

MYOCARDIAL INFARCTION 2,733

NAUSEA 2,666

DIARRHOEA 2,663

Source: FDA FAERS (Adverse Event Reporting System) FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation

Serious Warnings

Do not stop taking carvedilol suddenly if you have heart problems. This can make chest pain worse and may cause a heart attack. If you need to stop taking carvedilol, your doctor will slowly lower your dose over 1 to 2 weeks. Carvedilol can also cause your heart rate to slow down too much or lower your blood pressure too much. If your pulse rate drops below 55 beats per minute, talk to your doctor about lowering the dose.

Known Drug Interactions

moderate clonidine

( 7.1 , 7.5 ) Hypotensive agents (e.g., reserpine, MAO inhibitors, clonidine) may increase the risk of hypotension and/or severe bradycardia. Concomitant administration of clonidine with a β-blocker may cause hypotension and bradycardia. When concomitant treatment with a β-blocker and clonidine is to be terminated, the β-blocker should be discontinued first.

Mechanism: Both drugs lower blood pressure and slow down the heart rate. Taking them together can make these effects too strong, causing a dangerously slow heart or very low blood pressure.

What to do: Your doctor should monitor your heart rate and blood pressure. If you need to stop these medicines, follow your doctor's specific order to stop the beta-blocker first.

minor fluoxetine

( 7.8 ) 7.1 CYP2D6 Inhibitors and Poor Metabolizers Interactions of carvedilol with potent inhibitors of CYP2D6 isoenzyme (such as quinidine, fluoxetine, paroxetine, and propafenone) have not been studied, but these drugs would be expected to increase blood levels of the R(+) enantiomer of carvedilol [see Clinical Pharmacology ( 12.3 )] .

Mechanism: Fluoxetine blocks the enzyme that normally clears carvedilol from your blood. This can lead to higher levels of carvedilol in your body.

What to do: Your doctor should monitor your heart rate and blood pressure closely. They may need to adjust your carvedilol dose.

minor paroxetine

Mechanism: Paroxetine prevents your body from breaking down carvedilol as it should. This can cause the level of carvedilol in your blood to increase.

What to do: Your healthcare provider may need to adjust your medication levels. Be sure to report any feelings of dizziness or a very slow heartbeat.

minor diltiazem

( 7.6 ) Verapamil- or diltiazem-type calcium channel blockers may affect ECG and/or blood pressure. 7.7 Calcium Channel Blockers Conduction disturbance (rarely with hemodynamic compromise) has been observed when carvedilol tablet is coadministered with diltiazem. As with other β-blocker, if carvedilol tablet is administered with calcium channel blockers of the verapamil or diltiazem type, it is recommended that ECG and blood pressure be monitored.

Mechanism: Both drugs slow down the heart's electrical signals and lower blood pressure. This can cause the heart to beat too slowly or change its rhythm.

What to do: Your doctor should monitor your heart rhythm and blood pressure closely while you are taking both medications.

minor fluconazole

The concomitant administration of amiodarone or other CYP2C9 inhibitors such as fluconazole with carvedilol may enhance the β-blocking activity, resulting in further slowing of the heart rate or cardiac conduction.

Mechanism: Fluconazole prevents the body from breaking down carvedilol properly. This leads to higher levels of the drug in your system, which can slow your heart rate too much.

What to do: Your doctor may need to watch your heart rate and adjust your medication if it becomes too slow.

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This is a plain-language summary of interactions documented in FDA labeling, not individualized advice. Ask a pharmacist or prescriber before combining medications.

Common Questions

Can I drink alcohol while taking carvedilol?

Talk to your doctor about drinking alcohol while taking carvedilol, as it may lower your blood pressure further.

What should I do if I feel dizzy after taking carvedilol?

Lie down when you feel dizzy, especially after taking a dose. Avoid driving or operating machinery until you know how carvedilol affects you.

Can carvedilol affect my blood sugar?

Yes, carvedilol can affect your blood sugar levels. If you have diabetes, monitor your blood sugar closely and talk to your doctor about any changes.

How long does it take for carvedilol to start working?

Carvedilol starts working right away to lower blood pressure, but it may take several weeks to feel the full effects, especially for heart failure.

Can I take carvedilol with other medications?

Tell your doctor about all the medications you take, including over-the-counter drugs and supplements, as some medications can interact with carvedilol.

What if I have asthma?

You should not take carvedilol if you have asthma or related breathing problems.

Does carvedilol cause weight gain?

Weight gain is a possible side effect of carvedilol.

Can carvedilol cause depression?

Although rare, carvedilol may cause depression in some people. Tell your doctor if you experience changes in mood.

Is it safe to exercise while taking carvedilol?

Talk to your doctor before starting any new exercise program while taking carvedilol.

What are the symptoms of low blood pressure?

Symptoms of low blood pressure include dizziness, lightheadedness, fainting, and blurred vision.

What are the common side effects of carvedilol?

The most commonly reported side effects of carvedilol include Dizziness, Tiredness, Low blood pressure, Diarrhea, High blood sugar. Based on 130,791 FDA adverse event reports. Always consult your healthcare provider about potential side effects.

Does carvedilol interact with other medications?

Yes, carvedilol has 13 known drug interactions. Notable interactions include clonidine, fluoxetine, paroxetine. Always inform your doctor about all medications you are taking.

What drug class is carvedilol?

carvedilol belongs to the Beta-Blocker (Alpha/Beta) drug class. It requires a prescription (Rx). Carvedilol treats a few different heart conditions.

Is carvedilol safe during pregnancy?

It is not known if carvedilol will harm your unborn baby. Tell your doctor if you are pregnant or plan to become pregnant. Always consult your healthcare provider before using any medication during pregnancy or breastfeeding.

Has carvedilol been recalled?

There are 10 recalls associated with carvedilol products. CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level. Check the recalls section below for full details and affected products.

Active Recalls

Class II August 7, 2025

CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level.