65/100 · Elevated
Manufactured by Aurobindo Pharma Limited
Moderate Safety Concerns with Nebivolol Hydrochloride
55,073 FDA adverse event reports analyzed
Last updated: 2026-05-12
NEBIVOLOL HYDROCHLORIDE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Aurobindo Pharma Limited. Based on analysis of 55,073 FDA adverse event reports, NEBIVOLOL HYDROCHLORIDE has a safety score of 65 out of 100. This moderate score indicates a notable volume of adverse event reports that patients and providers should be aware of. The most commonly reported adverse reactions for NEBIVOLOL HYDROCHLORIDE include FATIGUE, DIARRHOEA, DYSPNOEA, DRUG INEFFECTIVE, NAUSEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for NEBIVOLOL HYDROCHLORIDE.
Nebivolol Hydrochloride has a safety concern score of 65 out of 100, placing it in the elevated concern category based on analysis of FDA adverse event data. The FDA has received approximately 55,073 adverse event reports for this medication, which is primarily manufactured by Aurobindo Pharma Limited.
The most commonly reported adverse events include Fatigue, Diarrhoea, Dyspnoea. Of classified reports, 70.2% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Frequent reports of serious adverse events such as acute kidney injury and renal failure.
Significant number of drug interactions and ineffective drug reports. Common gastrointestinal issues like nausea and diarrhea.
Patients taking Nebivolol Hydrochloride should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Nebivolol Hydrochloride can cause hypotension and bradycardia, which may lead to drug interactions. Patients should be monitored for these conditions and advised to avoid driving or operating heavy machinery. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Nebivolol Hydrochloride received a safety concern score of 65/100 (elevated concern). This is based on a 70.2% serious event ratio across 32,452 classified reports. The score accounts for 55,073 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: 16,902, Male: 13,387, Unknown: 52. The most frequently reported age groups are age 70 (797 reports), age 72 (760 reports), age 73 (716 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 32,452 classified reports for NEBIVOLOL HYDROCHLORIDE:
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.
Nebivolol Hydrochloride can cause hypotension and bradycardia, which may lead to drug interactions. Patients should be monitored for these conditions and advised to avoid driving or operating heavy machinery.
If you are taking Nebivolol Hydrochloride, here are important things to know. The most commonly reported side effects include fatigue, diarrhoea, dyspnoea, drug ineffective, nausea. 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 hypotension and bradycardia, especially in elderly patients. Report any serious adverse events 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 has not issued any specific warnings for Nebivolol Hydrochloride, but patients should report any serious adverse events immediately. Regular monitoring of kidney function and blood pressure is recommended.
The FDA has received approximately 55,073 adverse event reports associated with Nebivolol Hydrochloride. 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 Nebivolol Hydrochloride include Fatigue, Diarrhoea, Dyspnoea, Drug Ineffective, Nausea. By volume, the top reported reactions are: Fatigue (1,811 reports), Diarrhoea (1,747 reports), Dyspnoea (1,682 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Nebivolol Hydrochloride.
Out of 32,452 classified reports, 22,775 (70.2%) were classified as serious and 9,677 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 Nebivolol Hydrochloride break down by patient sex as follows: Female: 16,902, Male: 13,387, Unknown: 52. 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 Nebivolol Hydrochloride adverse events are: age 70: 797 reports, age 72: 760 reports, age 73: 716 reports, age 76: 689 reports, age 75: 674 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 Nebivolol Hydrochloride adverse event reports is Aurobindo 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 Nebivolol Hydrochloride include: Headache, Dizziness, Acute Kidney Injury, Off Label Use, 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 Nebivolol Hydrochloride 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.
Nebivolol Hydrochloride has a safety concern score of 65 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. Frequent reports of serious adverse events such as acute kidney injury and renal failure.
Key safety signals identified in Nebivolol Hydrochloride's adverse event data include: Acute kidney injury and renal failure are reported frequently.. Drug interactions and ineffectiveness are common.. Gastrointestinal issues are prevalent.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Nebivolol Hydrochloride can cause hypotension and bradycardia, which may lead to drug interactions. Patients should be monitored for these conditions and advised to avoid driving or operating heavy machinery. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Nebivolol Hydrochloride.
Monitor for signs of hypotension and bradycardia, especially in elderly patients. Report any serious adverse events to your healthcare provider promptly.
Nebivolol Hydrochloride has 55,073 adverse event reports on file with the FDA. Significant number of drug interactions and ineffective drug reports. The volume of reports for Nebivolol Hydrochloride reflects both the drug's usage level and the vigilance of the reporting community.
The FDA has not issued any specific warnings for Nebivolol Hydrochloride, but patients should report any serious adverse events immediately. Regular monitoring of kidney function and blood pressure is recommended. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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