65/100 · Elevated
Manufactured by Viatris Specialty LLC
Sildenafil Citrate Safety Profile: Moderate Concern with Respiratory and Cardiovascular Reactions
242,442 FDA adverse event reports analyzed
Last updated: 2026-05-12
SILDENAFIL CITRATE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Viatris Specialty LLC. Based on analysis of 242,442 FDA adverse event reports, SILDENAFIL CITRATE 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 SILDENAFIL CITRATE include DYSPNOEA, DRUG INEFFECTIVE, HEADACHE, DEATH, DIARRHOEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for SILDENAFIL CITRATE.
Sildenafil Citrate 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 242,442 adverse event reports for this medication, which is primarily manufactured by Viatris Specialty Llc.
The most commonly reported adverse events include Dyspnoea, Drug Ineffective, Headache. Of classified reports, 66.6% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Respiratory and cardiovascular reactions are the most common serious adverse events.
Drug ineffectiveness and off-label use are frequent, indicating potential misuse. Serious adverse events account for 66.6% of all reports, highlighting significant risks.
Patients taking Sildenafil Citrate should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Sildenafil citrate can cause respiratory and cardiovascular issues, and patients should be warned about potential drug interactions, especially with nitrates. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Sildenafil Citrate received a safety concern score of 65/100 (elevated concern). This is based on a 66.6% serious event ratio across 123,932 classified reports. The score accounts for 242,442 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: Male: 63,415, Female: 51,112, Unknown: 323. The most frequently reported age groups are age 64 (2,066 reports), age 67 (2,059 reports), age 65 (2,032 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 123,932 classified reports for SILDENAFIL CITRATE:
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.
Sildenafil citrate can cause respiratory and cardiovascular issues, and patients should be warned about potential drug interactions, especially with nitrates.
If you are taking Sildenafil Citrate, here are important things to know. The most commonly reported side effects include dyspnoea, drug ineffective, headache, death, diarrhoea. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Patients should avoid using sildenafil with nitrates or nitroglycerin as it can lead to a dangerous drop in blood pressure. Inform healthcare providers about all medications and supplements to avoid 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.
The FDA continues to monitor the safety of sildenafil citrate, particularly for serious adverse events, and has not issued any new warnings based on this data.
The FDA has received approximately 242,442 adverse event reports associated with Sildenafil Citrate. 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 Sildenafil Citrate include Dyspnoea, Drug Ineffective, Headache, Death, Diarrhoea. By volume, the top reported reactions are: Dyspnoea (13,049 reports), Drug Ineffective (12,626 reports), Headache (9,928 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Sildenafil Citrate.
Out of 123,932 classified reports, 82,573 (66.6%) were classified as serious and 41,359 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 Sildenafil Citrate break down by patient sex as follows: Male: 63,415, Female: 51,112, Unknown: 323. 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 Sildenafil Citrate adverse events are: age 64: 2,066 reports, age 67: 2,059 reports, age 65: 2,032 reports, age 66: 2,024 reports, age 62: 2,011 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 Sildenafil Citrate adverse event reports is Viatris Specialty 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 Sildenafil Citrate include: Nausea, Fatigue, Dizziness, Pneumonia, Cough. 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 Sildenafil Citrate 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.
Sildenafil Citrate 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. Respiratory and cardiovascular reactions are the most common serious adverse events.
Key safety signals identified in Sildenafil Citrate's adverse event data include: Respiratory issues like pneumonia and dyspnoea are frequent.. Cardiovascular events such as cardiac failure and hypertension are notable.. Death reports are significant, contributing to the high serious event rate.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Sildenafil citrate can cause respiratory and cardiovascular issues, and patients should be warned about potential drug interactions, especially with nitrates. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Sildenafil Citrate.
Patients should avoid using sildenafil with nitrates or nitroglycerin as it can lead to a dangerous drop in blood pressure. Inform healthcare providers about all medications and supplements to avoid drug interactions.
Sildenafil Citrate has 242,442 adverse event reports on file with the FDA. Drug ineffectiveness and off-label use are frequent, indicating potential misuse. The volume of reports for Sildenafil Citrate reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor the safety of sildenafil citrate, particularly for serious adverse events, and has not issued any new warnings based on this data. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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