82/100 · Critical
Manufactured by Advagen Pharma Limited
Metoprolol Tartrate Adverse Reactions: High Serious Event Rate
123,274 FDA adverse event reports analyzed
Last updated: 2026-05-12
METOROPROLOL TARTRATE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Advagen Pharma Limited. Based on analysis of 123,274 FDA adverse event reports, METOROPROLOL TARTRATE 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 METOROPROLOL TARTRATE include FATIGUE, DIARRHOEA, NAUSEA, DYSPNOEA, DEATH. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for METOROPROLOL TARTRATE.
Metoroprolol Tartrate 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 123,274 adverse event reports for this medication, which is primarily manufactured by Advagen Pharma Limited.
The most commonly reported adverse events include Fatigue, Diarrhoea, Nausea. Of classified reports, 68.2% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. High frequency of serious adverse events, including death and cardiac issues.
A wide range of reactions, indicating diverse safety concerns. Significant report volume, with over 120,000 total reports. Common gastrointestinal and cardiovascular side effects. Notable drug interactions and warnings, particularly with other cardiovascular medications.
Patients taking Metoroprolol 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 other cardiovascular medications, leading to adverse effects such as bradycardia and hypotension. Healthcare providers should monitor patients for these interactions. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Metoroprolol Tartrate received a safety concern score of 82/100 (high concern). This is based on a 68.2% serious event ratio across 63,316 classified reports. The score accounts for 123,274 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: 31,343, Male: 28,117, Unknown: 55. The most frequently reported age groups are age 72 (1,273 reports), age 70 (1,272 reports), age 69 (1,205 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 63,316 classified reports for METOROPROLOL 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 other cardiovascular medications, leading to adverse effects such as bradycardia and hypotension. Healthcare providers should monitor patients for these interactions.
If you are taking Metoroprolol Tartrate, here are important things to know. The most commonly reported side effects include fatigue, diarrhoea, nausea, dyspnoea, death. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Monitor for serious side effects such as heart problems and respiratory issues. Follow prescribed dosages and report any drug interactions to your healthcare provider. 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 Tartrate due to its high serious event rate. Patients should report any adverse reactions to their healthcare provider immediately.
The FDA has received approximately 123,274 adverse event reports associated with Metoroprolol 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 Metoroprolol Tartrate include Fatigue, Diarrhoea, Nausea, Dyspnoea, Death. By volume, the top reported reactions are: Fatigue (4,503 reports), Diarrhoea (3,785 reports), Nausea (3,648 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Metoroprolol Tartrate.
Out of 63,316 classified reports, 43,181 (68.2%) were classified as serious and 20,135 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 Metoroprolol Tartrate break down by patient sex as follows: Female: 31,343, Male: 28,117, Unknown: 55. 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 Metoroprolol Tartrate adverse events are: age 72: 1,273 reports, age 70: 1,272 reports, age 69: 1,205 reports, age 75: 1,189 reports, age 71: 1,172 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 Metoroprolol Tartrate adverse event reports is Advagen Pharma Limited. 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 Metoroprolol Tartrate include: Dizziness, Drug Ineffective, Asthenia, Pain, Headache. 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 Metoroprolol 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.
Metoroprolol Tartrate 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. High frequency of serious adverse events, including death and cardiac issues.
Key safety signals identified in Metoroprolol Tartrate's adverse event data include: High number of serious events (43,181 out of 63,316, 68.2%). Multiple cardiovascular issues, including atrial fibrillation and myocardial infarction. Significant renal and gastrointestinal side effects. High incidence of drug interactions and warnings. Reported fatalities (2,915 cases). 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 other cardiovascular medications, leading to adverse effects such as bradycardia and hypotension. Healthcare providers should monitor patients for these interactions. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Metoroprolol Tartrate.
Monitor for serious side effects such as heart problems and respiratory issues. Follow prescribed dosages and report any drug interactions to your healthcare provider.
Metoroprolol Tartrate has 123,274 adverse event reports on file with the FDA. A wide range of reactions, indicating diverse safety concerns. The volume of reports for Metoroprolol Tartrate reflects both the drug's usage level and the vigilance of the reporting community.
The FDA closely monitors Metoprolol Tartrate due to its high serious event rate. Patients should report any adverse reactions to their healthcare provider immediately. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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