78/100 · Elevated
Manufactured by Pfizer Laboratories Div Pfizer Inc
Silver Sulfadiazine Adverse Events: High Serious Reaction Rate
5,140 FDA adverse event reports analyzed
Last updated: 2026-05-12
SILVER SULFADIAZINE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Pfizer Laboratories Div Pfizer Inc. Based on analysis of 5,140 FDA adverse event reports, SILVER SULFADIAZINE has a safety score of 78 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 SILVER SULFADIAZINE include PAIN, FATIGUE, OFF LABEL USE, PRODUCT USE IN UNAPPROVED INDICATION, NAUSEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for SILVER SULFADIAZINE.
Silver Sulfadiazine has a safety concern score of 78 out of 100, placing it in the high concern category based on analysis of FDA adverse event data. The FDA has received approximately 5,140 adverse event reports for this medication, which is primarily manufactured by Pfizer Laboratories Div Pfizer Inc.
The most commonly reported adverse events include Pain, Fatigue, Off Label Use. Of classified reports, 65.6% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Pain and fatigue are the most common reported adverse events.
Serious reactions, including death and chronic kidney disease, are prevalent. Drug ineffectiveness and product misuse are significant concerns. A wide range of reactions indicates potential for diverse side effects.
Patients taking Silver Sulfadiazine should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Silver Sulfadiazine may interact with other drugs, leading to adverse effects. Patients should inform their healthcare providers of all medications they are taking. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Silver Sulfadiazine received a safety concern score of 78/100 (high concern). This is based on a 65.6% serious event ratio across 2,190 classified reports. The score accounts for 5,140 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: 1,175, Male: 856, Unknown: 3. The most frequently reported age groups are age 54 (56 reports), age 53 (42 reports), age 70 (40 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 2,190 classified reports for SILVER SULFADIAZINE:
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.
Silver Sulfadiazine may interact with other drugs, leading to adverse effects. Patients should inform their healthcare providers of all medications they are taking.
If you are taking Silver Sulfadiazine, here are important things to know. The most commonly reported side effects include pain, fatigue, off label use, product use in unapproved indication, nausea. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Follow prescribed dosage and usage instructions carefully to avoid drug ineffectiveness and misuse. Inform your healthcare provider about any existing health conditions or other 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.
The FDA continues to monitor Silver Sulfadiazine for safety. Healthcare providers should report any adverse events to the FDA's MedWatch program.
The FDA has received approximately 5,140 adverse event reports associated with Silver Sulfadiazine. 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 Silver Sulfadiazine include Pain, Fatigue, Off Label Use, Product Use In Unapproved Indication, Nausea. By volume, the top reported reactions are: Pain (151 reports), Fatigue (147 reports), Off Label Use (141 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Silver Sulfadiazine.
Out of 2,190 classified reports, 1,437 (65.6%) were classified as serious and 753 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 Silver Sulfadiazine break down by patient sex as follows: Female: 1,175, Male: 856, Unknown: 3. 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 Silver Sulfadiazine adverse events are: age 54: 56 reports, age 53: 42 reports, age 70: 40 reports, age 57: 37 reports, age 69: 37 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 Silver Sulfadiazine adverse event reports is Pfizer Laboratories Div Pfizer 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 Silver Sulfadiazine include: Death, Diarrhoea, Drug Ineffective, Chronic Kidney Disease, Dyspnoea. 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 Silver Sulfadiazine 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.
Silver Sulfadiazine has a safety concern score of 78 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. Pain and fatigue are the most common reported adverse events.
Key safety signals identified in Silver Sulfadiazine's adverse event data include: High incidence of serious reactions (65.6%). Multiple reports of renal failure and kidney disease. Significant number of drug ineffectiveness and product misuse reports. Multiple cases of pneumonia and sepsis reported. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Silver Sulfadiazine may interact with other drugs, leading to adverse effects. Patients should inform their healthcare providers of all medications they are taking. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Silver Sulfadiazine.
Follow prescribed dosage and usage instructions carefully to avoid drug ineffectiveness and misuse. Inform your healthcare provider about any existing health conditions or other medications you are taking.
Silver Sulfadiazine has 5,140 adverse event reports on file with the FDA. Serious reactions, including death and chronic kidney disease, are prevalent. The volume of reports for Silver Sulfadiazine reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor Silver Sulfadiazine for safety. Healthcare providers should report any adverse events to the FDA's MedWatch program. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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