What the label lists and what reports show
Carvedilol side effects
Carvedilol's FDA label: “Most common adverse events ( 6.1 ): Heart failure and left ventricular dysfunction following myocardial infarction (≤10%): Dizziness, fatigue, hypotension, diarrhea, hyperglycemia, asthenia, bradycardia, weight increase.” FAERS holds 137,029 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is fatigue (9,140 reports).
- Generic listed
Check it at the source: the carvedilol FDA label on DailyMed (effective July 31, 2026, Waylis Therapeutics LLC); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are possible side effects of COREG?Low blood pressure (which may cause dizziness or fainting when you stand up). If these happen, sit or lie down right away and tell your doctor. Tiredness. If you feel tired or dizzy you should not drive, use machinery, or do anything that needs you to be alert. Slow heartbeat. Changes in your blood sugar. If you have diabetes, tell your doctor if you have any changes in your blood sugar levels. COREG may hide some of the symptoms of low blood sugar, especially a fast heartbeat. COREG may mask the symptoms of hyperthyroidism (overactive thyroid). Worsening of severe allergic reactions. Rare but serious allergic reactions (including hives or swelling of the face, lips, tongue, and/or throat that may cause difficulty in breathing or swallowing) have happened in patients who were on COREG. These reactions can be life-threatening. […]
Source: FDA drug label, Waylis Therapeutics LLC, effective July 31, 2026 (SPL set 07c619c6-4a0c-445e-94fa-664a54f68a39), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse events ( 6.1 ): Heart failure and left ventricular dysfunction following myocardial infarction (≤10%): Dizziness, fatigue, hypotension, diarrhea, hyperglycemia, asthenia, bradycardia, weight increase.
Table 1. Adverse Events (%) Occurring More Frequently with COREG than with Placebo in Subjects with Mild-to-Moderate Heart Failure (HF) Enrolled in U.S. Heart Failure Trials or in Subjects with Severe Heart Failure in…
| Reaction | COREG (n = 765) | Placebo (n = 437) | COREG (n = 1,156) | Placebo (n = 1,133) |
|---|---|---|---|---|
| Asthenia | 7 | 7 | 11 | 9 |
| Fatigue | 24 | 22 | – | – |
| Digoxin level increased | 5 | 4 | 2 | 1 |
| Edema generalized | 5 | 3 | 6 | 5 |
| Edema dependent | 4 | 2 | – | – |
| Bradycardia | 9 | 1 | 10 | 3 |
| Hypotension | 9 | 3 | 14 | 8 |
| Syncope | 3 | 3 | 8 | 5 |
| Angina pectoris | 2 | 3 | 6 | 4 |
| Dizziness | 32 | 19 | 24 | 17 |
| Headache | 8 | 7 | 5 | 3 |
| Diarrhea | 12 | 6 | 5 | 3 |
| Nausea | 9 | 5 | 4 | 3 |
| Vomiting | 6 | 4 | 1 | 2 |
| Hyperglycemia | 12 | 8 | 5 | 3 |
| Weight increase | 10 | 7 | 12 | 11 |
| BUN increased | 6 | 5 | – | – |
| NPN increased | 6 | 5 | – | – |
| Hypercholesterolemia | 4 | 3 | 1 | 1 |
| Edema peripheral | 2 | 1 | 7 | 6 |
| Arthralgia | 6 | 5 | 1 | 1 |
| Cough increased | 8 | 9 | 5 | 4 |
| Rales | 4 | 4 | 4 | 2 |
| Vision abnormal | 5 | 2 | – | – |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedMost common adverse events ( 6.1 ): Heart failure and left ventricular dysfunction following myocardial infarction (≤10%): Dizziness, fatigue, hypotension, diarrhea, hyperglycemia, asthenia, bradycardia, weight increase. Hypertension (≥5%): Dizziness. To report SUSPECTED ADVERSE REACTIONS, contact Waylis Therapeutics LLC at 1-844-200-7910 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Studies Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice. COREG has been evaluated for safety in subjects with heart failure (mild, moderate, and severe), in subjects with left ventricular dysfunction following myocardial infarction and in hypertensive subjects The observed adverse event profile was consistent with the pharmacology of the drug and the health status of the subjects in the clinical trials. Adverse events reported for each of these patient populations are provided below. Excluded are adverse events considered too general to be informative, and those not reasonably associated with the use of the drug because they were associated with the condition being treated or are very common in the treated population. …
Source: FDA drug label, 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?
137,029 reports list carvedilol among the medicines taken, 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. Of the 20 reactions below, 12 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Carvedilol: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions