82/100 · Critical
Manufactured by Amneal Pharmaceuticals NY LLC
Enalapril Adverse Events: High Seriousness and Diverse Reactions
97,976 FDA adverse event reports analyzed
Last updated: 2026-05-12
ENALAPRIL is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Amneal Pharmaceuticals NY LLC. Based on analysis of 97,976 FDA adverse event reports, ENALAPRIL 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 ENALAPRIL include DIARRHOEA, DYSPNOEA, NAUSEA, DRUG INEFFECTIVE, FATIGUE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for ENALAPRIL.
Enalapril 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 97,976 adverse event reports for this medication, which is primarily manufactured by Amneal Pharmaceuticals Ny Llc.
The most commonly reported adverse events include Diarrhoea, Dyspnoea, Nausea. Of classified reports, 84.3% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Enalapril reports show a high percentage of serious adverse events, particularly kidney and cardiovascular issues.
The drug is associated with a wide range of reactions, indicating potential for diverse side effects. Reports indicate a significant number of cases involving falls and respiratory issues, which may be related to dizziness and hypotension.
Patients taking Enalapril should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Enalapril can cause hypotension and dizziness, increasing the risk of falls. It may also interact with other drugs, particularly those affecting blood pressure and electrolyte levels. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Enalapril received a safety concern score of 82/100 (high concern). This is based on a 84.3% serious event ratio across 54,343 classified reports. The score accounts for 97,976 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: 25,807, Male: 25,587, Unknown: 102. The most frequently reported age groups are age 67 (1,154 reports), age 72 (1,139 reports), age 70 (1,136 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 54,343 classified reports for ENALAPRIL:
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.
Enalapril can cause hypotension and dizziness, increasing the risk of falls. It may also interact with other drugs, particularly those affecting blood pressure and electrolyte levels.
If you are taking Enalapril, here are important things to know. The most commonly reported side effects include diarrhoea, dyspnoea, nausea, drug ineffective, fatigue. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Monitor blood pressure and electrolyte levels regularly, especially in elderly patients. Inform healthcare providers about all medications to avoid potential drug interactions. 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.
Regulatory oversight is ongoing, with a focus on monitoring serious adverse events and ensuring patient safety, especially in elderly populations.
The FDA has received approximately 97,976 adverse event reports associated with Enalapril. 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 Enalapril include Diarrhoea, Dyspnoea, Nausea, Drug Ineffective, Fatigue. By volume, the top reported reactions are: Diarrhoea (2,805 reports), Dyspnoea (2,660 reports), Nausea (2,574 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Enalapril.
Out of 54,343 classified reports, 45,815 (84.3%) were classified as serious and 8,528 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 Enalapril break down by patient sex as follows: Female: 25,807, Male: 25,587, Unknown: 102. 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 Enalapril adverse events are: age 67: 1,154 reports, age 72: 1,139 reports, age 70: 1,136 reports, age 71: 1,127 reports, age 75: 1,093 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 Enalapril adverse event reports is Amneal Pharmaceuticals Ny 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 Enalapril include: Drug Interaction, Dizziness, Acute Kidney Injury, Vomiting, 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 Enalapril 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.
Enalapril 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. Enalapril reports show a high percentage of serious adverse events, particularly kidney and cardiovascular issues.
Key safety signals identified in Enalapril's adverse event data include: Acute kidney injury and renal failure are frequent and serious adverse events.. Cardiac failure and myocardial infarction are also common, highlighting cardiovascular risks.. Drug interactions and ineffective drug performance are reported, suggesting potential issues with efficacy and compatibility.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Enalapril can cause hypotension and dizziness, increasing the risk of falls. It may also interact with other drugs, particularly those affecting blood pressure and electrolyte levels. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Enalapril.
Monitor blood pressure and electrolyte levels regularly, especially in elderly patients. Inform healthcare providers about all medications to avoid potential drug interactions.
Enalapril has 97,976 adverse event reports on file with the FDA. The drug is associated with a wide range of reactions, indicating potential for diverse side effects. The volume of reports for Enalapril reflects both the drug's usage level and the vigilance of the reporting community.
Regulatory oversight is ongoing, with a focus on monitoring serious adverse events and ensuring patient safety, especially in elderly populations. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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