85/100 · Critical
Manufactured by ANI Pharmaceuticals, Inc.
High Serious Adverse Events with Sildenafil Powder
76,536 FDA adverse event reports analyzed
Last updated: 2026-05-12
SILDENAFIL POWDER, is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by ANI Pharmaceuticals, Inc.. Based on analysis of 76,536 FDA adverse event reports, SILDENAFIL POWDER, 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 SILDENAFIL POWDER, include DYSPNOEA, HEADACHE, DEATH, DIARRHOEA, NAUSEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for SILDENAFIL POWDER,.
Sildenafil Powder, 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 76,536 adverse event reports for this medication, which is primarily manufactured by Ani Pharmaceuticals, Inc..
The most commonly reported adverse events include Dyspnoea, Headache, Death. Of classified reports, 79.8% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. The most common serious reactions include death, pneumonia, and pulmonary arterial hypertension.
A significant number of reports involve cardiovascular issues such as hypotension and cardiac failure. Drug interactions and off-label use are also reported, indicating potential misuse.
Patients taking Sildenafil Powder, should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Sildenafil powder may interact with other drugs, leading to hypotension and other cardiovascular issues. Off-label use should be strictly monitored. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Sildenafil Powder, received a safety concern score of 85/100 (high concern). This is based on a 79.8% serious event ratio across 34,407 classified reports. The score accounts for 76,536 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: 17,357, Male: 14,234, Unknown: 39. The most frequently reported age groups are age 67 (689 reports), age 64 (647 reports), age 66 (637 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 34,407 classified reports for SILDENAFIL POWDER,:
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 powder may interact with other drugs, leading to hypotension and other cardiovascular issues. Off-label use should be strictly monitored.
If you are taking Sildenafil Powder,, here are important things to know. The most commonly reported side effects include dyspnoea, headache, death, diarrhoea, nausea. 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 serious adverse events immediately to their healthcare provider. Avoid using sildenafil powder for off-label purposes and follow prescribed dosages. 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 critical, and healthcare providers should be vigilant about monitoring patients for serious adverse events and cardiovascular issues.
The FDA has received approximately 76,536 adverse event reports associated with Sildenafil Powder,. 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 Powder, include Dyspnoea, Headache, Death, Diarrhoea, Nausea. By volume, the top reported reactions are: Dyspnoea (4,448 reports), Headache (2,835 reports), Death (2,631 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 Powder,.
Out of 34,407 classified reports, 27,456 (79.8%) were classified as serious and 6,951 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 Powder, break down by patient sex as follows: Female: 17,357, Male: 14,234, Unknown: 39. 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 Powder, adverse events are: age 67: 689 reports, age 64: 647 reports, age 66: 637 reports, age 65: 624 reports, age 69: 607 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 Powder, 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 Powder, include: Fatigue, Dizziness, Drug Ineffective, Pneumonia, Pulmonary Arterial Hypertension. 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 Powder, 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 Powder, 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. The most common serious reactions include death, pneumonia, and pulmonary arterial hypertension.
Key safety signals identified in Sildenafil Powder,'s adverse event data include: Death and serious respiratory issues like pneumonia and pulmonary arterial hypertension are frequent.. Cardiovascular events, including hypotension and cardiac failure, are notable safety signals.. Drug interactions and off-label use are key safety concerns.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Sildenafil powder may interact with other drugs, leading to hypotension and other cardiovascular issues. Off-label use should be strictly monitored. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Sildenafil Powder,.
Patients should report any serious adverse events immediately to their healthcare provider. Avoid using sildenafil powder for off-label purposes and follow prescribed dosages.
Sildenafil Powder, has 76,536 adverse event reports on file with the FDA. A significant number of reports involve cardiovascular issues such as hypotension and cardiac failure. The volume of reports for Sildenafil Powder, reflects both the drug's usage level and the vigilance of the reporting community.
Regulatory oversight is critical, and healthcare providers should be vigilant about monitoring patients for serious adverse events and cardiovascular issues. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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