alpha-Adrenergic Blocker · Brand: Coreg Cr, Coreg
Carvedilol Side Effects: Common, Serious & FDA Warnings
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Quick answer
Based on 135,000+ FDA adverse event reports, the most-reported carvedilol reactions include fatigue, dyspnoea, and diarrhoea. FDA reports 13 active Class II recalls of carvedilol, primarily for failed dissolution specifications. The FDA-approved label does not carry a boxed warning.
For information only. MedivaScan summarizes public FDA data and is not medical advice. Consult a healthcare professional before changing any medication. If you experience a serious reaction, contact your doctor or call 911.
Common Side Effects of Carvedilol
The most-reported reactions in the FDA Adverse Event Reporting System (FAERS) for carvedilol. Percentages reflect the share of reports mentioning each reaction; a single report may include multiple reactions. Reports indicate co-occurrence, not causation.
| Reaction | Reports | % of total |
|---|---|---|
| Fatigue | 9,014 | 6.7% |
| Dyspnoea | 8,429 | 6.2% |
| Diarrhoea | 7,114 | 5.3% |
| Dizziness | 7,115 | 5.3% |
| Nausea | 6,719 | 5.0% |
| Hypotension | 5,730 | 4.2% |
| Asthenia | 5,489 | 4.1% |
| Acute Kidney Injury | 4,456 | 3.3% |
| Cardiac Failure Congestive | 4,491 | 3.3% |
| Pain | 4,451 | 3.3% |
Serious Outcomes and FDA Warnings
FAERS reports flagged with a serious outcome (death, hospitalization, life-threatening, disability, or congenital anomaly), plus reactions surfaced in the FDA-approved label's Warnings section. Reports indicate co-occurrence, not causation.
| Outcome flag | Reports | % of total |
|---|---|---|
| Serious reports (any flag) | — | — |
| Hospitalization | — | — |
| Death reported as outcome FAERS outcome flag, not a reaction term. The patient was on the drug when the report was filed; causation is not established. | 5,790 | 4.3% |
From the FDA-approved label, Section 5.1: Cessation of Therapy
Patients with coronary artery disease, who are being treated with carvedilol tablets, should be advised against abrupt discontinuation of therapy. Severe exacerbation of angina and the occurrence of myocardial infarction and ventricular arrhythmias have been reported in patients with angina following the abrupt discontinuation of therapy with β-blockers. The last 2 complications may occur with or without preceding exacerbation of the angina pectoris.Show full Section 5.1
As with other β-blockers, when discontinuation of carvedilol tablets are planned, the patients should be carefully observed and advised to limit physical activity to a minimum. Carvedilol tablets should be discontinued over 1 to 2 weeks whenever possible. If the angina worsens or acute coronary insufficiency develops, it is recommended that carvedilol tablets be promptly reinstituted, at least temporarily. Because coronary artery disease is common and may be unrecognized, it may be prudent not to discontinue therapy with carvedilol abruptly even in patients treated only for hypertension or heart failure.
From the FDA-approved label, Section 5.4: Heart Failure/Fluid Retention
Worsening heart failure or fluid retention may occur during up-titration of carvedilol. If such symptoms occur, diuretics should be increased and the carvedilol dose should not be advanced until clinical stability resumes [see Dosage and Administration ( 2 )] . Occasionally it is necessary to lower the carvedilol dose or temporarily discontinue it. Such episodes do not preclude subsequent successful titration of, or a favorable response to, carvedilol.Show full Section 5.4
In a placebo-controlled trial of subjects with severe heart failure, worsening heart failure during the first 3 months was reported to a similar degree with carvedilol and with placebo. When treatment was maintained beyond 3 months, worsening heart failure was reported less frequently in subjects treated with carvedilol than with placebo. Worsening heart failure observed during long-term therapy is more likely to be related to the patients' underlying disease than to treatment with carvedilol.
Carvedilol Recalls
FDA enforcement actions matched to carvedilol via openFDA's structured generic_name field and the NDC bridge. Ongoing recalls are listed below (verify on FDA →); closed recalls are grouped in the disclosure that follows.
| Date | Reason | Class | Quantity | Status |
|---|---|---|---|---|
| 2025-08-27 | CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories | Class II | 26,628 cartons | Ongoing |
| 2025-08-20 | CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm Glenmark Pharmaceuticals Inc., USA | Class II | 17, 496 bottles | Ongoing |
| 2025-08-20 | CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level. Glenmark Pharmaceuticals Inc., USA | Class II | 4,800 bottles | Ongoing |
| 2025-08-20 | CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level. Glenmark Pharmaceuticals Inc., USA | Class II | 44,328 bottles | Ongoing |
| 2025-08-20 | CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level. Glenmark Pharmaceuticals Inc., USA | Class II | 6,432 bottles | Ongoing |
| 2025-08-20 | CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm Glenmark Pharmaceuticals Inc., USA | Class II | 14,976 bottles | Ongoing |
| 2025-06-04 | CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit Glenmark Pharmaceuticals Inc., USA | Class II | [100 Tablet Bottles] 90,000 bottles; [500 Tablet Bottles] 324,288 bottles | Ongoing |
| 2025-06-04 | CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit Glenmark Pharmaceuticals Inc., USA | Class II | 18,696 bottles | Ongoing |
| 2025-06-04 | CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit Glenmark Pharmaceuticals Inc., USA | Class II | 84,048 bottles | Ongoing |
| 2025-06-04 | CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit Glenmark Pharmaceuticals Inc., USA | Class II | [100 Tablet Bottles] 59,952 bottles; [500 Tablet Bottles] 155,976 bottles | Ongoing |
| 2025-04-16 | CGMP Deviations Glenmark Pharmaceuticals Inc., USA | Class II | N/A | Ongoing |
| 2025-02-12 | CGMP Deviations:N-Nitroso Carvedilol I impurity (NNCI-I) were found to be failing per current FDA recommended limit. Glenmark Pharmaceuticals Inc., USA | Class II | — | Ongoing |
| 2025-02-12 | CGMP Deviations:N-Nitroso Carvedilol I impurity (NNCI-I) were found to be failing per current FDA recommended limit. Glenmark Pharmaceuticals Inc., USA | Class II | — | Ongoing |
Show 4 closed recalls (2019 to 2021)
Includes resolved and terminated recalls matched to carvedilol. Most recent first.
| Date | Reason | Class | Quantity | Status |
|---|---|---|---|---|
| 2021-12-01 | Failed Impurities/Degradation Specifications Aurobindo Pharma USA Inc. | Class III | 7296 containers | Terminated |
| 2021-08-25 | Presence of Foreign Tablets/Capsules; report of two Paroxetine tablets were found in the bottle Zydus Pharmaceuticals (USA) Inc | Class II | 2880 bottles | Terminated |
| 2019-05-15 | Labeling; Label Mix-up; report received of one bottle labeled as Acyclovir Tablets USP 400 mg actually contained Carvedilol Tablets 6.25 mg Zydus Pharmaceuticals USA Inc | Class II | 3900 | Terminated |
| 2019-05-01 | Presence of Foreign Tablets/Capsules: Customer complaint for a small, solid, light yellow substance, identified as a fragmented tablet of another drug product, found mixed with tablets in a bottle of Carvedilol tablets 3.125mg. Zydus Pharmaceuticals USA Inc | Class III | 7668 bottles | Terminated |
Carvedilol Shortages
FDA-listed shortages of carvedilol products. Strength and dosage-form level detail.
No active or recent shortages of carvedilol are listed. We refresh this view daily.
Is Carvedilol Safe?
Carvedilol is FDA-approved and the label does not carry a boxed warning. The label's Warnings and Precautions section covers cessation of therapy (Section 5.1), bradycardia (Section 5.2), hypotension (Section 5.3), heart failure/fluid retention (Section 5.4), non-allergic bronchospasm (Section 5.5), effects on blood sugar (Section 5.6), peripheral vascular (Section 5.7), deterioration of renal function (Section 5.8), major surgery (Section 5.9), thyrotoxicosis β-adrenergic blockade may mask clinical signs of hyperthyroidism, such as tachycardia. (Section 5.10), pheochromocytoma (Section 5.11), prinzmetal’s variant angina (Section 5.12), risk of anaphylactic reaction (Section 5.13), intraoperative floppy iris syndrome (Section 5.14).
As with any prescription, the assessment of safety is individual; consult a clinician about your own risk profile.
FDA-Approved Indications
Carvedilol is FDA-approved for use in the condition categories below. The FDA-approved label’s Indications and Usage section is shown verbatim.
Carvedilol tablets are 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 Carvedilol tablets are 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.Show full Indications and Usage
4 ), Clinical Studies ( 14.1 )] . 1.2 Left Ventricular Dysfunction following Myocardial Infarction Carvedilol tablets are indicated to reduce cardiovascular mortality in clinically stable patients who have survived the acute phase of a myocardial infarction and have a left ventricular ejection fraction of less than or equal to 40% (with or without symptomatic heart failure) [see Clinical Studies ( 14.2 )] . 1.3 Hypertension Carvedilol tablets are indicated for the management of essential hypertension [see Clinical Studies ( 14.3 , 14.4 )] . It can be used alone or in combination with other antihypertensive agents, especially thiazide-type diuretics [see Drug Interactions ( 7.2 )] .
Frequently Asked Questions
What are the most-reported side effects of carvedilol?
Fatigue, dyspnoea, and diarrhoea are among the most-reported reactions in FDA FAERS data for carvedilol. The full ranking, with reaction counts and the share of total reports, is in the Common Side Effects table above. Reports indicate co-occurrence, not causation; consult a clinician about your specific case.
Is carvedilol the same as Coreg Cr?
Carvedilol is the generic name; Coreg Cr is a brand name for the same active ingredient. Other brand names include Coreg. The active ingredient is identical; formulation and inactive ingredients may vary by manufacturer.
Has carvedilol been recalled?
Yes. Carvedilol has active and closed recalls on record in the FDA enforcement database. Reasons are dominated by CGMP deviations, contamination or foreign material, and mislabeling. See the recalls table on this page for current counts, firm names, dates, and lot quantities.
What are carvedilol's current ongoing recalls about?
Active carvedilol recalls are listed in the recalls table above with their class, reason, firm, and affected lots. The dominant reason across these recalls is CGMP deviations. For lot numbers, distribution patterns, and the FDA enforcement record for any individual recall, follow the verify-on-FDA link from each row.
What do FDA recall classes mean?
Class I means a reasonable probability of serious adverse health consequences or death. Class II means temporary or medically reversible adverse health consequences with remote probability of serious harm. Class III means use of the product is unlikely to cause adverse health consequences. The class assignment is the FDA's, not the manufacturer's.
Data Sources & Methodology
How each section of this page is sourced, and how often the data is refreshed.
| Source | Endpoint | Refresh |
|---|---|---|
| FAERS reactions | openFDA /drug/event.json count API. Aggregated per drug per reaction term; we do not store individual reports. | Daily |
| Recalls | openFDA /drug/enforcement.json. Drugs matched via three confidence-tracked strategies: structured generic name (HIGH), NDC code bridge (MEDIUM), text token parse (LOW). Only HIGH and MEDIUM matches surface here. | 6 hours |
| Shortages | FDA Drug Shortages list. | Daily |
| Boxed warnings & label sections | openFDA /drug/label.json. Labels are stable; monthly cadence is sufficient. | Monthly |
| Condition categories | Synonym-mapped from drug_labels.indications. Methodology at /methodology/. | Per-drug |
What we do not do. We do not invent, paraphrase, or extrapolate drug claims. Every figure on this page comes from a query against an openFDA endpoint. If the data is unavailable, the section gracefully omits rather than filling the space with editorial guesswork.