82/100 · Critical
Manufactured by ANI Pharmaceuticals, Inc.
Sildenafil Adverse Events: High Serious Reaction Rate
132,502 FDA adverse event reports analyzed
Last updated: 2026-05-12
SILDENAFIL is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by ANI Pharmaceuticals, Inc.. Based on analysis of 132,502 FDA adverse event reports, SILDENAFIL 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 SILDENAFIL include DYSPNOEA, HEADACHE, DIARRHOEA, NAUSEA, DEATH. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for SILDENAFIL.
Sildenafil 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 132,502 adverse event reports for this medication, which is primarily manufactured by Ani Pharmaceuticals, Inc..
The most commonly reported adverse events include Dyspnoea, Headache, Diarrhoea. Of classified reports, 73.9% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Sildenafil reports include a high proportion of serious adverse events, particularly respiratory issues and cardiovascular events.
The most common reactions are dyspnea, headache, and diarrhea, indicating a broad range of potential side effects. Reports show a significant number of cardiovascular and respiratory adverse events, suggesting a need for careful monitoring.
Patients taking Sildenafil should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Sildenafil can cause serious cardiovascular and respiratory adverse events, and caution is advised in patients with pre-existing conditions. Drug interactions, particularly with nitrates, are a known risk. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Sildenafil received a safety concern score of 82/100 (high concern). This is based on a 73.9% serious event ratio across 55,248 classified reports. The score accounts for 132,502 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: 28,779, Male: 22,266, Unknown: 57. The most frequently reported age groups are age 67 (998 reports), age 64 (954 reports), age 61 (949 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 55,248 classified reports for SILDENAFIL:
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 can cause serious cardiovascular and respiratory adverse events, and caution is advised in patients with pre-existing conditions. Drug interactions, particularly with nitrates, are a known risk.
If you are taking Sildenafil, here are important things to know. The most commonly reported side effects include dyspnoea, headache, diarrhoea, nausea, death. 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. Avoid sildenafil if you have a history of cardiovascular disease or respiratory conditions. 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 closely monitors sildenafil adverse events and has issued warnings about serious cardiovascular and respiratory risks. Healthcare providers should be vigilant and consider patient history and current health status.
The FDA has received approximately 132,502 adverse event reports associated with Sildenafil. 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 include Dyspnoea, Headache, Diarrhoea, Nausea, Death. By volume, the top reported reactions are: Dyspnoea (7,729 reports), Headache (5,655 reports), Diarrhoea (4,447 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.
Out of 55,248 classified reports, 40,825 (73.9%) were classified as serious and 14,423 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 break down by patient sex as follows: Female: 28,779, Male: 22,266, Unknown: 57. 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 adverse events are: age 67: 998 reports, age 64: 954 reports, age 61: 949 reports, age 66: 944 reports, age 65: 943 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 adverse event reports is Ani Pharmaceuticals, Inc.. 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 include: Fatigue, Dizziness, Drug Ineffective, Cough, Pneumonia. 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 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 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. Sildenafil reports include a high proportion of serious adverse events, particularly respiratory issues and cardiovascular events.
Key safety signals identified in Sildenafil's adverse event data include: High rate of serious adverse events (73.9%). Common reactions include dyspnea, headache, and diarrhea. Significant cardiovascular and respiratory adverse events reported. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Sildenafil can cause serious cardiovascular and respiratory adverse events, and caution is advised in patients with pre-existing conditions. Drug interactions, particularly with nitrates, are a known risk. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Sildenafil.
Patients should report any new or worsening symptoms to their healthcare provider immediately. Avoid sildenafil if you have a history of cardiovascular disease or respiratory conditions.
Sildenafil has 132,502 adverse event reports on file with the FDA. The most common reactions are dyspnea, headache, and diarrhea, indicating a broad range of potential side effects. The volume of reports for Sildenafil reflects both the drug's usage level and the vigilance of the reporting community.
The FDA closely monitors sildenafil adverse events and has issued warnings about serious cardiovascular and respiratory risks. Healthcare providers should be vigilant and consider patient history and current health status. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
Explore other medications manufactured by ANI Pharmaceuticals, Inc. and compare their safety profiles:
The following drugs share commonly reported adverse reactions with SILDENAFIL:
Drugs related to SILDENAFIL based on therapeutic use, drug class, or shared indications: