85/100 · Critical
Manufactured by Aurobindo Pharma Limited
Ramipril Adverse Events: High Seriousness and Diverse Reactions
314,718 FDA adverse event reports analyzed
Last updated: 2026-05-12
RAMIPRIL is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Aurobindo Pharma Limited. Based on analysis of 314,718 FDA adverse event reports, RAMIPRIL 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 RAMIPRIL include DYSPNOEA, FATIGUE, NAUSEA, DIARRHOEA, DIZZINESS. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for RAMIPRIL.
Ramipril 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 314,718 adverse event reports for this medication, which is primarily manufactured by Aurobindo Pharma Limited.
The most commonly reported adverse events include Dyspnoea, Fatigue, Nausea. Of classified reports, 93.4% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Ramipril reports predominantly involve serious conditions like acute kidney injury and cardiovascular issues.
A wide range of reactions are reported, indicating diverse safety concerns. The majority of reported reactions are serious, with a high percentage of serious events (93.4%).
Patients taking Ramipril should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Ramipril can interact with other drugs, leading to adverse effects. Warnings include contraindications during pregnancy and specific drug interactions. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Ramipril received a safety concern score of 85/100 (high concern). This is based on a 93.4% serious event ratio across 119,511 classified reports. The score accounts for 314,718 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: 56,528, Female: 52,124, Unknown: 178. The most frequently reported age groups are age 71 (2,737 reports), age 72 (2,691 reports), age 69 (2,671 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 119,511 classified reports for RAMIPRIL:
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.
Ramipril can interact with other drugs, leading to adverse effects. Warnings include contraindications during pregnancy and specific drug interactions.
If you are taking Ramipril, here are important things to know. The most commonly reported side effects include dyspnoea, fatigue, nausea, diarrhoea, dizziness. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Monitor for serious side effects such as kidney injury and cardiovascular issues. Be aware of potential drug interactions and inform your healthcare provider of all medications you are taking. 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 the FDA monitoring these adverse events closely. Patients should report any side effects to their healthcare provider.
The FDA has received approximately 314,718 adverse event reports associated with Ramipril. 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 Ramipril include Dyspnoea, Fatigue, Nausea, Diarrhoea, Dizziness. By volume, the top reported reactions are: Dyspnoea (8,082 reports), Fatigue (7,878 reports), Nausea (7,336 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Ramipril.
Out of 119,511 classified reports, 111,591 (93.4%) were classified as serious and 7,920 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 Ramipril break down by patient sex as follows: Male: 56,528, Female: 52,124, Unknown: 178. 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 Ramipril adverse events are: age 71: 2,737 reports, age 72: 2,691 reports, age 69: 2,671 reports, age 75: 2,601 reports, age 67: 2,596 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 Ramipril 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 Ramipril include: Off Label Use, Drug Ineffective, Vomiting, Pain, 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 Ramipril 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.
Ramipril 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. Ramipril reports predominantly involve serious conditions like acute kidney injury and cardiovascular issues.
Key safety signals identified in Ramipril's adverse event data include: Acute kidney injury is a significant safety signal, with 5292 reports.. Cardiovascular events, including atrial fibrillation and pericarditis, are also notable.. Drug interactions and ineffective drug performance are common, with 4283 and 6279 reports respectively.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Ramipril can interact with other drugs, leading to adverse effects. Warnings include contraindications during pregnancy and specific drug interactions. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Ramipril.
Monitor for serious side effects such as kidney injury and cardiovascular issues. Be aware of potential drug interactions and inform your healthcare provider of all medications you are taking.
Ramipril has 314,718 adverse event reports on file with the FDA. A wide range of reactions are reported, indicating diverse safety concerns. The volume of reports for Ramipril reflects both the drug's usage level and the vigilance of the reporting community.
Regulatory oversight is ongoing, with the FDA monitoring these adverse events closely. Patients should report any side effects 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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