Prescription medicine
Carvedilol Brand names: Coreg
Carvedilol (Coreg) is a prescription medicine with an FDA approval on record since 1995. FDA's NDC Directory lists it from 41 generic labelers, and pharmacies paid $0.0179 per carvedilol 6.25 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the carvedilol FDA label on DailyMed (effective July 31, 2026, Waylis Therapeutics LLC); the NDA 20297 record on Drugs@FDA; every carvedilol label on DailyMed.
Highlights of the record
FDA label of July 31, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageINDICATIONS AND USAGE COREG is an alpha-/beta-adrenergic blocking agent indicated for the treatment of: mild to severe chronic heart failure ( 1.1 ) left ventricular dysfunction following myocardial infarction in clinically stable patients ( 1.2 ) hypertension ( 1.3 ) 1.1 Heart Failure COREG is indicated for the treatment of mild-to-severe chronic heart failure of ischemic or cardiomyopathic origin, usually in additi
Forms and strengths
- 3.125 mg
- 6.25 mg
- 10 mg
- 12.5 mg
- 20 mg
- 25 mg
- 40 mg
- 80 mg
Film-coated tablet; extended-release capsule.
On the market
- Earliest approval on file
- September 14, 1995 Coreg, Waylis Therap; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 19 first September 5, 2007; 12 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 42 of which 41 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- March 11, 2026 Coreg CR capsules; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $0.0179 per tablet Carvedilol 6.25 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 22 since 2013 0 Class I among all firms' recalls; latest August 20, 2025; 1 more by firms not listed as its makers
- FAERS reports
- 137,029 through July 30, 2026
What is carvedilol used for?
From the label: indications and usageINDICATIONS AND USAGE COREG is an alpha-/beta-adrenergic blocking agent indicated for the treatment of: mild to severe chronic heart failure ( 1.1 ) left ventricular dysfunction following myocardial infarction in clinically stable patients ( 1.2 ) hypertension ( 1.3 ) 1.1 Heart Failure COREG is indicated for the treatment of mild-to-severe chronic heart failure of ischemic or cardiomyopathic origin, usually in addition to diuretics, ACE inhibitors, and digitalis, to increase survival and, also, to reduce the risk of hospitalization [see Drug Interactions (7.4), Clinical Studies (14.1) ]. 1.2 Left Ventricular Dysfunction following Myocardial Infarction COREG is indicated to reduce […]
Conditions named in the indications of carvedilol's FDA labels, with every medicine labeled for each:
From other carvedilol labelsHigh blood pressure: Hypertension COREG is indicated for the management of essential hypertension [see Clinical Studies (14.3 , 14.4) ].
FDA pharmacologic class: alpha-Adrenergic Blocker and beta-Adrenergic Blocker.
Source: FDA drug label (Coreg), Waylis Therapeutics LLC, effective July 31, 2026 (SPL set 07c619c6-4a0c-445e-94fa-664a54f68a39), via openFDA; the full label on DailyMed
What does the patient leaflet for carvedilol say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What should I avoid while taking COREG?COREG can cause you to feel dizzy, tired, or faint. Do not drive a car, use machinery, or do anything that needs you to be alert if you have these symptoms.
From the patient leaflet: How should I store COREG?Store COREG at less than 86°F (30°C). Keep the tablets dry. Safely, throw away COREG that is out of date or no longer needed. Keep COREG and all medicines out of the reach of children. General Information about COREG Medicines are sometimes prescribed for conditions other than those described in patient information leaflets. Do not use COREG for a condition for which it was not prescribed. Do not give COREG to other people, even if they have the same symptoms you have. It may harm them. This leaflet summarizes the most important information about COREG. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about COREG that is written for healthcare professionals.
Source: FDA drug label (Coreg), Waylis Therapeutics LLC, effective July 31, 2026 (SPL set 07c619c6-4a0c-445e-94fa-664a54f68a39), via openFDA; the full label on DailyMed
Is there a generic for carvedilol (Coreg)?
The FDA approved the first generic carvedilol on September 5, 2007. 19 generic applications are approved; 12 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists carvedilol from 41 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists 1 patent for Coreg CR capsules, the last expiring on March 11, 2026. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 1995 earliest approval on file
- 2007 first generic approved
- 2026 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for carvedilol (Coreg)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.0179 per Carvedilol 6.25 mg tablet, down 4% from $0.0187 on October 8, 2025. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Carvedilol 6.25 mg tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Carvedilol 12.5 mg tablet | Generic | $0.0216 per tablet | $0.648 | +0.1% |
| Carvedilol 25 mg tablet | Generic | $0.0323 per tablet | $0.970 | +4% |
| Carvedilol 3.125 mg tablet | Generic | $0.0166 per tablet | $0.499 | +0.1% |
| Carvedilol 6.25 mg tablet | Generic | $0.0179 per tablet | $0.538 | -4% |
| Carvedilol ER 10 mg capsule | Generic | $6.52 per capsule many times the lowest per-tablet cost; NADAC records the price, not why | $195.61 | +14% |
| Carvedilol ER 20 mg capsule | Generic | $6.74 per capsule many times the lowest per-tablet cost; NADAC records the price, not why | $202.10 | +42% |
| Carvedilol ER 40 mg capsule | Generic | $6.38 per capsule many times the lowest per-tablet cost; NADAC records the price, not why | $191.36 | +12% |
| Carvedilol ER 80 mg capsule | Generic | $5.79 per capsule many times the lowest per-tablet cost; NADAC records the price, not why | $173.75 | +5% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has carvedilol been recalled?
The FDA's Enforcement Report lists 23 recalls naming carvedilol since 2013: 0 Class I (the most serious), 21 Class II, 2 Class III; 13 still ongoing. 1 of them is by a firm that FDA's NDC Directory does not list as a maker of carvedilol and that holds no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| August 20, 2025 | Class II | The Harvard Drug Group LLC dba Major Pharmaceuticals and … | CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm |
| August 7, 2025 | Class II | Glenmark Pharmaceuticals Inc., USA | CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level. |
| August 6, 2025 | Class II | Glenmark Pharmaceuticals Inc., USA | CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm |
| March 13, 2025 | Class II | Glenmark Pharmaceuticals Inc., USA | CGMP Deviations |
| February 28, 2025 | Class II | Glenmark Pharmaceuticals Inc., USA | CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit |
| January 24, 2025 | Class II | RemedyRepack Inc. | CGMP deviations: presence of N-Nitroso Carvedilol Impurity-1 (NNC 1), above the FDA recommended acceptable intake limit. |
| January 22, 2025 | Class II | Glenmark Pharmaceuticals Inc., USA | CGMP Deviations:N-Nitroso Carvedilol I impurity (NNCI-I) were found to be failing per current FDA recommended limit. |
| October 21, 2022 | Class II | Viatris Inc | Failed Tablet/Capsule Specifications: Tablets exceeds specification for weight and thickness. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the carvedilol label say about other medicines?
The carvedilol label names 15 other medicines in its interaction, contraindication or warning sections. The labels of 12 other medicines name carvedilol. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Amiodarone | drug interactions | Concomitant use can increase the risk of bradycardia. ( 7.4 ) Amiodarone may increase carvedilol levels resulting in further slowing of the heart rate or cardiac conduction. ( 7.6 ) Verapamil- or diltiazem-type calcium channel blockers may affect ECG and/or blood pressure. … |
| Cimetidine | drug interactions | Cimetidine increased AUC by about 30% but caused no change in C max [see Clinical Pharmacology (12.5) ]. |
| Clonidine | drug interactions | DRUG INTERACTIONS CYP P450 2D6 enzyme inhibitors may increase and rifampin may decrease carvedilol levels. ( 7.1 , 7.5 ) Hypotensive agents (e.g., reserpine, MAO inhibitors, clonidine) may increase the risk of hypotension and/or severe bradycardia. ( 7.4 ) Cyclosporine or digoxin levels may increase. … |
| Cyclosporine | drug interactions | DRUG INTERACTIONS CYP P450 2D6 enzyme inhibitors may increase and rifampin may decrease carvedilol levels. ( 7.1 , 7.5 ) Hypotensive agents (e.g., reserpine, MAO inhibitors, clonidine) may increase the risk of hypotension and/or severe bradycardia. ( 7.4 ) Cyclosporine or digoxin levels may increase. … |
| Digoxin | drug interactions | Digoxin concentrations are increased by about 15% when digoxin and carvedilol are administered concomitantly. |
| Diltiazem | drug interactions | As with other β-blockers, if COREG is administered with calcium channel blockers of the verapamil or diltiazem type, it is recommended that ECG and blood pressure be monitored. |
| Epinephrine | warnings and precautions | Such patients may be unresponsive to the usual doses of epinephrine used to treat allergic reaction. |
| Fluconazole | drug interactions | The concomitant administration of amiodarone or other CYP2C9 inhibitors such as fluconazole with COREG may enhance the β-blocking activity resulting in further slowing of the heart rate or cardiac conduction. |
| Fluoxetine | drug interactions | 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) ]. |
| Pantoprazole | drug interactions | There is no clinically meaningful increase in AUC and C max with concomitant administration of carvedilol extended-release capsules with pantoprazole. |
| Paroxetine | drug interactions | 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) ]. |
| Propafenone | drug interactions | 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) ]. |
| Quinidine | drug interactions | 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) ]. |
| Rifampin | drug interactions | DRUG INTERACTIONS CYP P450 2D6 enzyme inhibitors may increase and rifampin may decrease carvedilol levels. ( 7.1 , 7.5 ) Hypotensive agents (e.g., reserpine, MAO inhibitors, clonidine) may increase the risk of hypotension and/or severe bradycardia. ( 7.4 ) Cyclosporine or digoxin levels may increase. … |
Every other medicine the carvedilol label names
| Medicine named | Section | What the label says |
|---|---|---|
| Verapamil | drug interactions | As with other β-blockers, if COREG is administered with calcium channel blockers of the verapamil or diltiazem type, it is recommended that ECG and blood pressure be monitored. |
Other labels that name carvedilol
Source: FDA drug label (Coreg), Waylis Therapeutics LLC, effective July 31, 2026 (SPL set 07c619c6-4a0c-445e-94fa-664a54f68a39), via openFDA; the full label on DailyMed
What do FAERS reports show for carvedilol?
The FDA Adverse Event Reporting System holds 137,029 reports that list carvedilol among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 16,484 are coded as a death and 54,875 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as carvedilol?
46 other medicines are given the same way (oral) and in the same FDA class as carvedilol or labeled mainly for the same use (heart failure), the same class first. Heart failure lists all 37 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Metoprolol | High blood pressure, Heart failure | 64 labelers | $0.085 per tablet 100 mg tablet | A presentation being discontinued |
| Propranolol | High blood pressure | 38 labelers | $0.0493 per tablet 20 mg tablet | In shortage |
| Doxazosin | High blood pressure | 29 labelers | $0.0752 per tablet 1 mg tablet | No current entry |
| Atenolol | High blood pressure | 35 labelers | $0.0217 per tablet 25 mg tablet | No current entry |
| Labetalol | High blood pressure | 31 labelers | $0.215 per tablet 300 mg tablet | No current entry |
| Prazosin | High blood pressure | 33 labelers | $0.0842 per capsule 1 mg capsule | A presentation being discontinued |
| Nebivolol | High blood pressure | 23 labelers | $0.141 per tablet 10 mg tablet | A presentation being discontinued |
| Terazosin | High blood pressure | 21 labelers | $0.106 per capsule 2 mg capsule | No current entry |
Every medicine labeled for the same conditions as carvedilol
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does carvedilol compare with medicines for the same use?
20 side-by-side pages set carvedilol beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to carvedilol
- 46 medicines for the same use
- Other alpha blockers
- the pharmacologic class, with prices and generics
- Carvedilol side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other