65/100 · Elevated
Manufactured by Upsher-Smith Laboratories, LLC
Lisinopril Adverse Events: Moderate Safety Concerns
581,851 FDA adverse event reports analyzed
Last updated: 2026-05-12
LISINOPRIL is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Upsher-Smith Laboratories, LLC. Based on analysis of 581,851 FDA adverse event reports, LISINOPRIL 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 LISINOPRIL include FATIGUE, NAUSEA, DRUG INEFFECTIVE, DIARRHOEA, DYSPNOEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for LISINOPRIL.
Lisinopril 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 581,851 adverse event reports for this medication, which is primarily manufactured by Upsher-Smith Laboratories, Llc.
The most commonly reported adverse events include Fatigue, Nausea, Drug Ineffective. Of classified reports, 61.1% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Frequent reports of serious conditions like acute kidney injury and chronic kidney disease indicate significant safety concerns.
Common reactions include fatigue, nausea, and dizziness, suggesting a broad range of mild to moderate side effects. The high volume of reports, especially for serious conditions, warrants ongoing monitoring and patient education.
Patients taking Lisinopril should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Lisinopril can cause hypotension and bradycardia, which may interact with other antihypertensive drugs. Patients should be monitored for signs of hypotension, especially when starting or adjusting the dose. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Lisinopril received a safety concern score of 65/100 (elevated concern). This is based on a 61.1% serious event ratio across 297,576 classified reports. The score accounts for 581,851 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: 145,328, Male: 134,976, Unknown: 336. The most frequently reported age groups are age 65 (6,033 reports), age 63 (5,713 reports), age 68 (5,630 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 297,576 classified reports for LISINOPRIL:
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.
Lisinopril can cause hypotension and bradycardia, which may interact with other antihypertensive drugs. Patients should be monitored for signs of hypotension, especially when starting or adjusting the dose.
If you are taking Lisinopril, here are important things to know. The most commonly reported side effects include fatigue, nausea, drug ineffective, diarrhoea, dyspnoea. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Patients should report any new or worsening symptoms to their healthcare provider immediately. Follow the prescribed dosage and schedule to avoid drug interactions and overdose. 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 lisinopril's safety profile, particularly for renal function and serious adverse events. Healthcare providers should report any adverse events to the FDA's MedWatch program.
The FDA has received approximately 581,851 adverse event reports associated with Lisinopril. 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 Lisinopril include Fatigue, Nausea, Drug Ineffective, Diarrhoea, Dyspnoea. By volume, the top reported reactions are: Fatigue (19,346 reports), Nausea (17,993 reports), Drug Ineffective (17,185 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Lisinopril.
Out of 297,576 classified reports, 181,762 (61.1%) were classified as serious and 115,814 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 Lisinopril break down by patient sex as follows: Female: 145,328, Male: 134,976, Unknown: 336. 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 Lisinopril adverse events are: age 65: 6,033 reports, age 63: 5,713 reports, age 68: 5,630 reports, age 67: 5,619 reports, age 62: 5,572 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 Lisinopril adverse event reports is Upsher-Smith Laboratories, 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 Lisinopril include: Pain, Dizziness, Headache, Asthenia, Vomiting. 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 Lisinopril 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.
Lisinopril 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 conditions like acute kidney injury and chronic kidney disease indicate significant safety concerns.
Key safety signals identified in Lisinopril's adverse event data include: Acute kidney injury and chronic kidney disease are reported frequently, indicating potential renal toxicity.. Reports of angioedema and anaphylaxis highlight the risk of severe allergic reactions.. Falls and gait disturbance are common, suggesting a risk of falls and balance issues.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Lisinopril can cause hypotension and bradycardia, which may interact with other antihypertensive drugs. Patients should be monitored for signs of hypotension, especially when starting or adjusting the dose. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Lisinopril.
Patients should report any new or worsening symptoms to their healthcare provider immediately. Follow the prescribed dosage and schedule to avoid drug interactions and overdose.
Lisinopril has 581,851 adverse event reports on file with the FDA. Common reactions include fatigue, nausea, and dizziness, suggesting a broad range of mild to moderate side effects. The volume of reports for Lisinopril reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor lisinopril's safety profile, particularly for renal function and serious adverse events. Healthcare providers should report any adverse events to the FDA's MedWatch program. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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