72/100 · Elevated
Manufactured by Almatica Pharma LLC
Atenolol Adverse Events: Significant Serious Reactions and Widespread Mild Symptoms
252,348 FDA adverse event reports analyzed
Last updated: 2026-05-12
ATENOLOL is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Almatica Pharma LLC. Based on analysis of 252,348 FDA adverse event reports, ATENOLOL has a safety score of 72 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 ATENOLOL include DRUG INEFFECTIVE, NAUSEA, FATIGUE, DIARRHOEA, DYSPNOEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for ATENOLOL.
Atenolol has a safety concern score of 72 out of 100, placing it in the elevated concern category based on analysis of FDA adverse event data. The FDA has received approximately 252,348 adverse event reports for this medication, which is primarily manufactured by Almatica Pharma Llc.
The most commonly reported adverse events include Drug Ineffective, Nausea, Fatigue. Of classified reports, 70.2% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. A significant proportion of adverse events are serious, with 70.2% of reports being serious.
The most common reactions include nausea, fatigue, and dizziness, indicating a broad range of mild to moderate side effects. Drug interactions and renal failure are notable safety concerns, with 2708 reports of drug interactions and 2700 reports of renal failure.
Patients taking Atenolol should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Atenolol can interact with other drugs, and patients should be monitored for signs of renal impairment, as this is a common adverse event. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Atenolol received a safety concern score of 72/100 (elevated concern). This is based on a 70.2% serious event ratio across 130,911 classified reports. The score accounts for 252,348 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: 74,443, Male: 50,041, Unknown: 200. The most frequently reported age groups are age 72 (2,719 reports), age 69 (2,679 reports), age 70 (2,630 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 130,911 classified reports for ATENOLOL:
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.
Atenolol can interact with other drugs, and patients should be monitored for signs of renal impairment, as this is a common adverse event.
If you are taking Atenolol, here are important things to know. The most commonly reported side effects include drug ineffective, nausea, fatigue, diarrhoea, dyspnoea. 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 renal impairment, especially in elderly patients. Report any serious adverse events to your healthcare provider immediately. 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 Atenolol for safety, and patients should report any serious adverse events to their healthcare provider.
The FDA has received approximately 252,348 adverse event reports associated with Atenolol. 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 Atenolol include Drug Ineffective, Nausea, Fatigue, Diarrhoea, Dyspnoea. By volume, the top reported reactions are: Drug Ineffective (7,894 reports), Nausea (7,812 reports), Fatigue (7,569 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Atenolol.
Out of 130,911 classified reports, 91,919 (70.2%) were classified as serious and 38,992 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 Atenolol break down by patient sex as follows: Female: 74,443, Male: 50,041, Unknown: 200. 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 Atenolol adverse events are: age 72: 2,719 reports, age 69: 2,679 reports, age 70: 2,630 reports, age 74: 2,608 reports, age 65: 2,584 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 Atenolol adverse event reports is Almatica Pharma 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 Atenolol include: Dizziness, Headache, Pain, Asthenia, 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 Atenolol 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.
Atenolol has a safety concern score of 72 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. A significant proportion of adverse events are serious, with 70.2% of reports being serious.
Key safety signals identified in Atenolol's adverse event data include: Serious reactions such as death, myocardial infarction, and renal failure are frequent.. A wide variety of reactions are reported, suggesting a complex safety profile.. High report volume for drug interactions and renal failure indicates these are significant safety concerns.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Atenolol can interact with other drugs, and patients should be monitored for signs of renal impairment, as this is a common adverse event. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Atenolol.
Monitor for signs of renal impairment, especially in elderly patients. Report any serious adverse events to your healthcare provider immediately.
Atenolol has 252,348 adverse event reports on file with the FDA. The most common reactions include nausea, fatigue, and dizziness, indicating a broad range of mild to moderate side effects. The volume of reports for Atenolol reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor Atenolol for safety, and patients should report any serious adverse events to their healthcare provider. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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