82/100 · Critical
Manufactured by Waylis Therapeutics LLC
Carvedilol Adverse Events: High Serious Reaction Rate and Widespread Safety Concerns
250,588 FDA adverse event reports analyzed
Last updated: 2026-05-12
CARVEDILOL is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Waylis Therapeutics LLC. Based on analysis of 250,588 FDA adverse event reports, CARVEDILOL has a safety score of 82 out of 100. This score indicates a relatively favorable safety profile, with fewer or less severe adverse events compared to many other tracked medications. The most commonly reported adverse reactions for CARVEDILOL include FATIGUE, DYSPNOEA, DIARRHOEA, DIZZINESS, NAUSEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for CARVEDILOL.
Carvedilol has a safety concern score of 82 out of 100, placing it in the high concern category based on analysis of FDA adverse event data. The FDA has received approximately 250,588 adverse event reports for this medication, which is primarily manufactured by Waylis Therapeutics Llc.
The most commonly reported adverse events include Fatigue, Dyspnoea, Diarrhoea. Of classified reports, 69.9% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Carvedilol reports show a high rate of serious adverse events, particularly related to cardiac and renal issues.
A wide range of reactions are reported, indicating diverse safety concerns. Significant reports of death, cardiac failure, and kidney injury highlight critical safety issues.
Patients taking Carvedilol should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Carvedilol can cause significant hypotension and bradycardia, and it is contraindicated in patients with severe heart failure or bradycardia. It may also interact with other drugs, leading to adverse effects. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Carvedilol received a safety concern score of 82/100 (high concern). This is based on a 69.9% serious event ratio across 130,730 classified reports. The score accounts for 250,588 total adverse event reports and 100 distinct reaction types. This high score reflects a significant proportion of serious adverse events in the reporting data.
Adverse event reports by sex: Male: 65,449, Female: 57,172, Unknown: 135. The most frequently reported age groups are age 70 (2,776 reports), age 69 (2,746 reports), age 73 (2,691 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 130,730 classified reports for CARVEDILOL:
The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.
Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.
Carvedilol can cause significant hypotension and bradycardia, and it is contraindicated in patients with severe heart failure or bradycardia. It may also interact with other drugs, leading to adverse effects.
If you are taking Carvedilol, here are important things to know. The most commonly reported side effects include fatigue, dyspnoea, diarrhoea, dizziness, nausea. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Monitor patients closely for signs of hypotension, bradycardia, and renal or cardiac issues, especially in elderly patients. Avoid prescribing Carvedilol to patients with severe heart failure or bradycardia. Be cautious when co-administering Carvedilol with other drugs that can affect blood pressure or heart rate. If you experience a serious adverse reaction, seek emergency medical attention immediately or call 911. You can report side effects to the FDA's MedWatch program at 1-800-FDA-1088.
The FDA continues to monitor Carvedilol for safety, and healthcare providers should be vigilant about potential serious adverse events, especially in elderly patients.
The FDA has received approximately 250,588 adverse event reports associated with Carvedilol. These reports come from healthcare professionals, consumers, and manufacturers through the FDA Adverse Event Reporting System (FAERS). Note that the number of reports does not directly indicate the frequency of side effects, as adverse events are voluntarily reported and may be underrepresented.
The most frequently reported adverse events for Carvedilol include Fatigue, Dyspnoea, Diarrhoea, Dizziness, Nausea. By volume, the top reported reactions are: Fatigue (8,670 reports), Dyspnoea (8,177 reports), Diarrhoea (6,869 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Carvedilol.
Out of 130,730 classified reports, 91,414 (69.9%) were classified as serious and 39,316 as non-serious. The FDA classifies an event as "serious" if it results in death, hospitalization, disability, or other medically significant outcomes. A higher serious-event ratio warrants closer attention but does not necessarily mean the drug is unsafe.
Adverse event reports for Carvedilol break down by patient sex as follows: Male: 65,449, Female: 57,172, Unknown: 135. This distribution reflects reporting patterns rather than actual risk differences between groups. Reporting rates can be influenced by prescribing patterns, disease demographics, and reporting behavior.
The most frequently reported age groups for Carvedilol adverse events are: age 70: 2,776 reports, age 69: 2,746 reports, age 73: 2,691 reports, age 71: 2,659 reports, age 67: 2,646 reports. Age-related reporting patterns can reflect both the demographics of the patient population and potential age-related susceptibility to certain side effects.
The primary manufacturer associated with Carvedilol adverse event reports is Waylis Therapeutics Llc. Multiple manufacturers may produce generic versions of this drug. The manufacturer listed reflects the most frequently reported brand in FDA adverse event data.
Beyond the most common reactions, other reported adverse events for Carvedilol include: Drug Ineffective, Death, Hypotension, Asthenia, Cardiac Failure Congestive. Less common side effects can still be clinically significant. Patients should report any unusual symptoms to their healthcare provider.
You can report adverse events from Carvedilol to the FDA through their MedWatch program at www.fda.gov/medwatch, by calling 1-800-FDA-1088, or by completing Form FDA 3500. Healthcare professionals, consumers, and manufacturers can all submit reports. Reporting helps the FDA monitor drug safety after approval.
Carvedilol has a safety concern score of 82 out of 100 (high concern). This score is calculated from the ratio of serious to non-serious adverse events, the diversity of reported reactions, and the overall volume of reports relative to usage. Carvedilol reports show a high rate of serious adverse events, particularly related to cardiac and renal issues.
Key safety signals identified in Carvedilol's adverse event data include: High number of serious reactions (91,414 out of 130,730, 69.9%). Multiple reports of fatal outcomes (5,630 deaths reported). Cardiac failure and renal injury are among the most frequently reported serious adverse events. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Carvedilol can cause significant hypotension and bradycardia, and it is contraindicated in patients with severe heart failure or bradycardia. It may also interact with other drugs, leading to adverse effects. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Carvedilol.
Monitor patients closely for signs of hypotension, bradycardia, and renal or cardiac issues, especially in elderly patients. Avoid prescribing Carvedilol to patients with severe heart failure or bradycardia. Be cautious when co-administering Carvedilol with other drugs that can affect blood pressure or heart rate.
Carvedilol has 250,588 adverse event reports on file with the FDA. A wide range of reactions are reported, indicating diverse safety concerns. The volume of reports for Carvedilol reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor Carvedilol for safety, and healthcare providers should be vigilant about potential serious adverse events, especially in elderly patients. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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