65/100 · Elevated
Manufactured by Bausch Health US, LLC
Moderate Safety Concerns with Sulfacetamide Sodium
1,112 FDA adverse event reports analyzed
Last updated: 2026-05-12
SULFACETAMIDE SODIUM is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Bausch Health US, LLC. Based on analysis of 1,112 FDA adverse event reports, SULFACETAMIDE SODIUM 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 SULFACETAMIDE SODIUM include DRUG HYPERSENSITIVITY, DRUG INEFFECTIVE, DYSPNOEA, NAUSEA, HEADACHE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for SULFACETAMIDE SODIUM.
Sulfacetamide Sodium 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 1,112 adverse event reports for this medication, which is primarily manufactured by Bausch Health Us, Llc.
The most commonly reported adverse events include Drug Hypersensitivity, Drug Ineffective, Dyspnoea. Of classified reports, 44.8% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Drug hypersensitivity reactions are the most common serious adverse events.
A wide range of reactions indicates potential for diverse side effects. Reports of serious adverse events (44.8%) are concerning. Off-label use is a significant reported issue.
Patients taking Sulfacetamide Sodium should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Interactions and warnings include potential for drug hypersensitivity and off-label use, which may require careful monitoring. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Sulfacetamide Sodium received a safety concern score of 65/100 (elevated concern). This is based on a 44.8% serious event ratio across 460 classified reports. The score accounts for 1,112 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: 290, Male: 135. The most frequently reported age groups are age 61 (12 reports), age 55 (9 reports), age 47 (8 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 460 classified reports for SULFACETAMIDE SODIUM:
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.
Interactions and warnings include potential for drug hypersensitivity and off-label use, which may require careful monitoring.
If you are taking Sulfacetamide Sodium, here are important things to know. The most commonly reported side effects include drug hypersensitivity, drug ineffective, dyspnoea, nausea, headache. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Always follow prescribed usage and avoid off-label use. Report any adverse reactions to healthcare providers promptly. 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 necessary given the high rate of serious adverse events and diverse reactions.
The FDA has received approximately 1,112 adverse event reports associated with Sulfacetamide Sodium. 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 Sulfacetamide Sodium include Drug Hypersensitivity, Drug Ineffective, Dyspnoea, Nausea, Headache. By volume, the top reported reactions are: Drug Hypersensitivity (61 reports), Drug Ineffective (43 reports), Dyspnoea (29 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Sulfacetamide Sodium.
Out of 460 classified reports, 206 (44.8%) were classified as serious and 254 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 Sulfacetamide Sodium break down by patient sex as follows: Female: 290, Male: 135. 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 Sulfacetamide Sodium adverse events are: age 61: 12 reports, age 55: 9 reports, age 47: 8 reports, age 62: 8 reports, age 49: 7 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 Sulfacetamide Sodium adverse event reports is Bausch Health Us, 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 Sulfacetamide Sodium include: Off Label Use, Weight Decreased, Fatigue, Rash, 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 Sulfacetamide Sodium 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.
Sulfacetamide Sodium 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. Drug hypersensitivity reactions are the most common serious adverse events.
Key safety signals identified in Sulfacetamide Sodium's adverse event data include: Drug hypersensitivity reactions. Serious adverse events (44.8%). Off-label use. Diverse reaction types. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Interactions and warnings include potential for drug hypersensitivity and off-label use, which may require careful monitoring. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Sulfacetamide Sodium.
Always follow prescribed usage and avoid off-label use. Report any adverse reactions to healthcare providers promptly.
Sulfacetamide Sodium has 1,112 adverse event reports on file with the FDA. A wide range of reactions indicates potential for diverse side effects. The volume of reports for Sulfacetamide Sodium reflects both the drug's usage level and the vigilance of the reporting community.
Regulatory oversight is necessary given the high rate of serious adverse events and diverse reactions. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
Explore other medications manufactured by Bausch Health US, LLC and compare their safety profiles:
The following drugs share commonly reported adverse reactions with SULFACETAMIDE SODIUM:
Drugs related to SULFACETAMIDE SODIUM based on therapeutic use, drug class, or shared indications: