78/100 · Elevated
Manufactured by Fresenius Kabi USA, LLC
Metoprolol Tartrate Adverse Events: High Serious Reaction Rate
501,809 FDA adverse event reports analyzed
Last updated: 2026-05-12
METOPROLOL TARTRATE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Fresenius Kabi USA, LLC. Based on analysis of 501,809 FDA adverse event reports, METOPROLOL TARTRATE 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 TARTRATE 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 TARTRATE.
Metoprolol Tartrate 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 501,809 adverse event reports for this medication, which is primarily manufactured by Fresenius Kabi Usa, Llc.
The most commonly reported adverse events include Fatigue, Dyspnoea, Diarrhoea. Of classified reports, 70.6% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. High rate of serious reactions, including death and cardiovascular issues.
Significant gastrointestinal and respiratory symptoms reported. Common side effects include fatigue, dyspnea, and dizziness. Atrial fibrillation and myocardial infarction are notable cardiovascular concerns. Drug interactions and dose omissions are frequently reported.
Patients taking Metoprolol Tartrate should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Metoprolol Tartrate can interact with various drugs, including beta-blockers, calcium channel blockers, and anticoagulants. Dose adjustments and monitoring are recommended. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Metoprolol Tartrate received a safety concern score of 78/100 (high concern). This is based on a 70.6% serious event ratio across 264,827 classified reports. The score accounts for 501,809 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: 132,028, Male: 116,197, Unknown: 320. The most frequently reported age groups are age 72 (5,578 reports), age 70 (5,559 reports), age 73 (5,467 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 264,827 classified reports for METOPROLOL TARTRATE:
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 Tartrate can interact with various drugs, including beta-blockers, calcium channel blockers, and anticoagulants. Dose adjustments and monitoring are recommended.
If you are taking Metoprolol Tartrate, 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 for signs of serious adverse reactions, especially in elderly patients. Be aware of potential drug interactions and inform healthcare providers of all medications used. 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 Metoprolol Tartrate for safety, particularly in elderly patients and those with pre-existing conditions. Regular follow-ups are advised.
The FDA has received approximately 501,809 adverse event reports associated with Metoprolol Tartrate. 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 Tartrate include Fatigue, Dyspnoea, Diarrhoea, Nausea, Drug Ineffective. By volume, the top reported reactions are: Fatigue (16,954 reports), Dyspnoea (15,245 reports), Diarrhoea (14,553 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 Tartrate.
Out of 264,827 classified reports, 187,090 (70.6%) were classified as serious and 77,737 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 Tartrate break down by patient sex as follows: Female: 132,028, Male: 116,197, Unknown: 320. 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 Tartrate adverse events are: age 72: 5,578 reports, age 70: 5,559 reports, age 73: 5,467 reports, age 71: 5,436 reports, age 69: 5,411 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 Tartrate adverse event reports is Fresenius Kabi Usa, 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 Tartrate include: Dizziness, Death, Off Label Use, 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 Tartrate 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 Tartrate 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. High rate of serious reactions, including death and cardiovascular issues.
Key safety signals identified in Metoprolol Tartrate's adverse event data include: High number of serious reactions (187,090 out of 264,827 total, 70.6%). Frequent reports of cardiovascular issues like atrial fibrillation and myocardial infarction. Common gastrointestinal symptoms such as nausea and diarrhea. Multiple reports of respiratory issues including pneumonia and dyspnea. High incidence of drug interactions and dose omissions. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Metoprolol Tartrate can interact with various drugs, including beta-blockers, calcium channel blockers, and anticoagulants. Dose adjustments and monitoring are recommended. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Metoprolol Tartrate.
Monitor for signs of serious adverse reactions, especially in elderly patients. Be aware of potential drug interactions and inform healthcare providers of all medications used.
Metoprolol Tartrate has 501,809 adverse event reports on file with the FDA. Significant gastrointestinal and respiratory symptoms reported. The volume of reports for Metoprolol Tartrate reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor Metoprolol Tartrate for safety, particularly in elderly patients and those with pre-existing conditions. Regular follow-ups are advised. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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