78/100 · Elevated
Manufactured by Alembic Pharmaceuticals Inc.
Metoprolol Adverse Events: High Serious Reaction Rate
463,809 FDA adverse event reports analyzed
Last updated: 2026-05-12
METOPROLOL is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Alembic Pharmaceuticals Inc.. Based on analysis of 463,809 FDA adverse event reports, METOPROLOL has a safety score of 78 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 include FATIGUE, DYSPNOEA, DIARRHOEA, NAUSEA, DRUG INEFFECTIVE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for METOPROLOL.
Metoprolol has a safety concern score of 78 out of 100, placing it in the high concern category based on analysis of FDA adverse event data. The FDA has received approximately 463,809 adverse event reports for this medication, which is primarily manufactured by Alembic Pharmaceuticals Inc..
The most commonly reported adverse events include Fatigue, Dyspnoea, Diarrhoea. Of classified reports, 70.2% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Metoprolol reports include a high percentage of serious adverse events, particularly respiratory and cardiovascular issues.
The most common reactions are fatigue, dyspnea, and diarrhea, indicating a broad range of potential side effects. Drug interactions and off-label use are also frequently reported, highlighting the need for careful monitoring.
Patients taking Metoprolol should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Metoprolol can interact with various drugs, including beta-blockers, calcium channel blockers, and anticoagulants. Off-label use is also a concern. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Metoprolol received a safety concern score of 78/100 (high concern). This is based on a 70.2% serious event ratio across 246,170 classified reports. The score accounts for 463,809 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: Female: 122,550, Male: 107,688, Unknown: 296. The most frequently reported age groups are age 70 (5,170 reports), age 72 (5,170 reports), age 71 (5,060 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 246,170 classified reports for METOPROLOL:
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 can interact with various drugs, including beta-blockers, calcium channel blockers, and anticoagulants. Off-label use is also a concern.
If you are taking Metoprolol, here are important things to know. The most commonly reported side effects include fatigue, dyspnoea, diarrhoea, nausea, drug ineffective. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Monitor patients for signs of respiratory distress and cardiovascular issues, especially in elderly patients. Ensure proper dosing and avoid off-label use to reduce the risk of adverse events. 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 closely monitors Metoprolol due to its high rate of serious adverse events, particularly in older adults.
The FDA has received approximately 463,809 adverse event reports associated with Metoprolol. 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 include Fatigue, Dyspnoea, Diarrhoea, Nausea, Drug Ineffective. By volume, the top reported reactions are: Fatigue (15,964 reports), Dyspnoea (14,127 reports), Diarrhoea (13,636 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.
Out of 246,170 classified reports, 172,821 (70.2%) were classified as serious and 73,349 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 break down by patient sex as follows: Female: 122,550, Male: 107,688, Unknown: 296. 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 adverse events are: age 70: 5,170 reports, age 72: 5,170 reports, age 71: 5,060 reports, age 73: 5,058 reports, age 69: 5,044 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 adverse event reports is Alembic Pharmaceuticals Inc.. 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 include: Dizziness, Off Label Use, Death, Asthenia, Pain. 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 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 has a safety concern score of 78 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. Metoprolol reports include a high percentage of serious adverse events, particularly respiratory and cardiovascular issues.
Key safety signals identified in Metoprolol's adverse event data include: High percentage of serious reactions (70.2%). Frequent reports of respiratory issues like pneumonia and bronchitis. Cardiovascular events such as atrial fibrillation and myocardial infarction are common. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Metoprolol can interact with various drugs, including beta-blockers, calcium channel blockers, and anticoagulants. Off-label use is also a concern. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Metoprolol.
Monitor patients for signs of respiratory distress and cardiovascular issues, especially in elderly patients. Ensure proper dosing and avoid off-label use to reduce the risk of adverse events.
Metoprolol has 463,809 adverse event reports on file with the FDA. The most common reactions are fatigue, dyspnea, and diarrhea, indicating a broad range of potential side effects. The volume of reports for Metoprolol reflects both the drug's usage level and the vigilance of the reporting community.
The FDA closely monitors Metoprolol due to its high rate of serious adverse events, particularly in older adults. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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