85/100 · Critical
Manufactured by TruPharma, LLC
High Safety Concerns with BISOPROLOL FUMARATE: Frequent Serious Adverse Reactions
256,068 FDA adverse event reports analyzed
Last updated: 2026-05-12
BISOPROLOL FUMARATE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by TruPharma, LLC. Based on analysis of 256,068 FDA adverse event reports, BISOPROLOL FUMARATE has a safety score of 85 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 BISOPROLOL FUMARATE include DYSPNOEA, ACUTE KIDNEY INJURY, FATIGUE, DIARRHOEA, NAUSEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for BISOPROLOL FUMARATE.
Bisoprolol Fumarate has a safety concern score of 85 out of 100, placing it in the high concern category based on analysis of FDA adverse event data. The FDA has received approximately 256,068 adverse event reports for this medication, which is primarily manufactured by Trupharma, Llc.
The most commonly reported adverse events include Dyspnoea, Acute Kidney Injury, Fatigue. Of classified reports, 96.8% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Frequent serious reactions such as acute kidney injury and cardiac failure indicate significant safety concerns.
A high volume of reports related to drug interactions and off-label use suggests potential misuse or interaction risks. Significant adverse reactions like bradycardia and hypotension are common, posing risks to patient safety.
Patients taking Bisoprolol Fumarate should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Bisoprolol fumarate can interact with other medications and should be used with caution, especially in combination with drugs that affect heart rate or blood pressure. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Bisoprolol Fumarate received a safety concern score of 85/100 (high concern). This is based on a 96.8% serious event ratio across 129,663 classified reports. The score accounts for 256,068 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: 61,254, Female: 57,154, Unknown: 188. The most frequently reported age groups are age 75 (3,599 reports), age 76 (3,501 reports), age 72 (3,424 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 129,663 classified reports for BISOPROLOL FUMARATE:
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.
Bisoprolol fumarate can interact with other medications and should be used with caution, especially in combination with drugs that affect heart rate or blood pressure.
If you are taking Bisoprolol Fumarate, here are important things to know. The most commonly reported side effects include dyspnoea, acute kidney injury, fatigue, diarrhoea, nausea. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Patients should strictly follow prescribed dosages and consult their healthcare provider before making any changes to their medication regimen. Be aware of potential side effects and report any unusual symptoms 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 bisoprolol fumarate, and healthcare providers should be vigilant in managing patient safety and monitoring for adverse reactions.
The FDA has received approximately 256,068 adverse event reports associated with Bisoprolol Fumarate. 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 Bisoprolol Fumarate include Dyspnoea, Acute Kidney Injury, Fatigue, Diarrhoea, Nausea. By volume, the top reported reactions are: Dyspnoea (8,878 reports), Acute Kidney Injury (6,854 reports), Fatigue (6,806 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Bisoprolol Fumarate.
Out of 129,663 classified reports, 125,502 (96.8%) were classified as serious and 4,161 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 Bisoprolol Fumarate break down by patient sex as follows: Male: 61,254, Female: 57,154, Unknown: 188. 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 Bisoprolol Fumarate adverse events are: age 75: 3,599 reports, age 76: 3,501 reports, age 72: 3,424 reports, age 73: 3,409 reports, age 77: 3,332 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 Bisoprolol Fumarate adverse event reports is Trupharma, 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 Bisoprolol Fumarate include: Dizziness, Drug Interaction, Off Label Use, Hypotension, Fall. 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 Bisoprolol Fumarate 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.
Bisoprolol Fumarate has a safety concern score of 85 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. Frequent serious reactions such as acute kidney injury and cardiac failure indicate significant safety concerns.
Key safety signals identified in Bisoprolol Fumarate's adverse event data include: Acute kidney injury and cardiac failure are among the most serious reactions reported.. A high number of reports involving drug interactions and off-label use.. Frequent occurrences of bradycardia and hypotension indicate potential cardiovascular risks.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Bisoprolol fumarate can interact with other medications and should be used with caution, especially in combination with drugs that affect heart rate or blood pressure. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Bisoprolol Fumarate.
Patients should strictly follow prescribed dosages and consult their healthcare provider before making any changes to their medication regimen. Be aware of potential side effects and report any unusual symptoms to your healthcare provider promptly.
Bisoprolol Fumarate has 256,068 adverse event reports on file with the FDA. A high volume of reports related to drug interactions and off-label use suggests potential misuse or interaction risks. The volume of reports for Bisoprolol Fumarate reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor the safety of bisoprolol fumarate, and healthcare providers should be vigilant in managing patient safety and monitoring for adverse reactions. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
The following drugs share commonly reported adverse reactions with BISOPROLOL FUMARATE:
Drugs related to BISOPROLOL FUMARATE based on therapeutic use, drug class, or shared indications: