72/100 · Elevated
Manufactured by Ascend Laboratories, LLC
Metoprolol Succinate ER Tablets: Common Adverse Reactions Include Fatigue and Dyspnea
112,351 FDA adverse event reports analyzed
Last updated: 2026-05-12
METOPROLOL SUCCINATE ER TABLETS is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Ascend Laboratories, LLC. Based on analysis of 112,351 FDA adverse event reports, METOPROLOL SUCCINATE ER TABLETS has a safety score of 72 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 METOPROLOL SUCCINATE ER TABLETS include FATIGUE, DIARRHOEA, DYSPNOEA, NAUSEA, DIZZINESS. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for METOPROLOL SUCCINATE ER TABLETS.
Metoprolol Succinate Er Tablets has a safety concern score of 72 out of 100, placing it in the elevated concern category based on analysis of FDA adverse event data. The FDA has received approximately 112,351 adverse event reports for this medication, which is primarily manufactured by Ascend Laboratories, Llc.
The most commonly reported adverse events include Fatigue, Diarrhoea, Dyspnoea. Of classified reports, 63.9% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Fatigue and dyspnea are the most common adverse reactions reported.
Serious adverse events, such as death and pneumonia, are also reported but less frequently. Drug interactions and ineffective drug performance are notable concerns. Atrial fibrillation and myocardial infarction are significant cardiovascular risks. Weight loss and decreased appetite are frequently reported, indicating potential metabolic effects.
Patients taking Metoprolol Succinate Er Tablets should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Metoprolol Succinate ER tablets can interact with other drugs, leading to potential adverse effects. Patients should inform their healthcare provider of all medications they are taking. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Metoprolol Succinate Er Tablets received a safety concern score of 72/100 (elevated concern). This is based on a 63.9% serious event ratio across 58,201 classified reports. The score accounts for 112,351 total adverse event reports and 100 distinct reaction types. This elevated score indicates a notable proportion of serious adverse events and warrants careful monitoring.
Adverse event reports by sex: Female: 29,406, Male: 24,379, Unknown: 29. The most frequently reported age groups are age 73 (1,123 reports), age 77 (1,106 reports), age 71 (1,101 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 58,201 classified reports for METOPROLOL SUCCINATE ER TABLETS:
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.
Metoprolol Succinate ER tablets can interact with other drugs, leading to potential adverse effects. Patients should inform their healthcare provider of all medications they are taking.
If you are taking Metoprolol Succinate Er Tablets, here are important things to know. The most commonly reported side effects include fatigue, diarrhoea, dyspnoea, nausea, dizziness. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Inform your healthcare provider about any existing conditions or medications you are taking. Monitor for signs of serious adverse events such as chest pain, shortness of breath, and confusion. Report any side effects to your healthcare provider promptly. 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 the safety of Metoprolol Succinate ER tablets. Healthcare providers should be vigilant in managing patient symptoms and monitoring for serious adverse events.
The FDA has received approximately 112,351 adverse event reports associated with Metoprolol Succinate Er Tablets. 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 Metoprolol Succinate Er Tablets include Fatigue, Diarrhoea, Dyspnoea, Nausea, Dizziness. By volume, the top reported reactions are: Fatigue (4,484 reports), Diarrhoea (3,635 reports), Dyspnoea (3,488 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Metoprolol Succinate Er Tablets.
Out of 58,201 classified reports, 37,197 (63.9%) were classified as serious and 21,004 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 Metoprolol Succinate Er Tablets break down by patient sex as follows: Female: 29,406, Male: 24,379, Unknown: 29. 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 Metoprolol Succinate Er Tablets adverse events are: age 73: 1,123 reports, age 77: 1,106 reports, age 71: 1,101 reports, age 70: 1,093 reports, age 68: 1,090 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 Metoprolol Succinate Er Tablets adverse event reports is Ascend Laboratories, 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 Metoprolol Succinate Er Tablets include: Off Label Use, Drug Ineffective, Headache, Death, Asthenia. 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 Metoprolol Succinate Er Tablets 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.
Metoprolol Succinate Er Tablets has a safety concern score of 72 out of 100 (elevated 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. Fatigue and dyspnea are the most common adverse reactions reported.
Key safety signals identified in Metoprolol Succinate Er Tablets's adverse event data include: Frequent reports of serious adverse events like death and pneumonia.. High incidence of cardiovascular issues including atrial fibrillation and myocardial infarction.. Common gastrointestinal issues such as nausea, diarrhea, and vomiting.. Significant drug interactions and ineffective drug performance.. Reports of decreased appetite and weight loss.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Metoprolol Succinate ER tablets can interact with other drugs, leading to potential adverse effects. Patients should inform their healthcare provider of all medications they are taking. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Metoprolol Succinate Er Tablets.
Inform your healthcare provider about any existing conditions or medications you are taking. Monitor for signs of serious adverse events such as chest pain, shortness of breath, and confusion. Report any side effects to your healthcare provider promptly.
Metoprolol Succinate Er Tablets has 112,351 adverse event reports on file with the FDA. Serious adverse events, such as death and pneumonia, are also reported but less frequently. The volume of reports for Metoprolol Succinate Er Tablets reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor the safety of Metoprolol Succinate ER tablets. Healthcare providers should be vigilant in managing patient symptoms and monitoring for serious adverse events. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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