85/100 · Critical
Manufactured by Sun Pharmaceutical Industries, Inc
High Safety Concerns with Sulfamethoxazole and Trimethoprim
191,160 FDA adverse event reports analyzed
Last updated: 2026-05-12
SULFAMETHOXAZOLE AND TRIMETHOPRIM is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Sun Pharmaceutical Industries, Inc. Based on analysis of 191,160 FDA adverse event reports, SULFAMETHOXAZOLE AND TRIMETHOPRIM 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 SULFAMETHOXAZOLE AND TRIMETHOPRIM include PYREXIA, OFF LABEL USE, FATIGUE, DIARRHOEA, NAUSEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for SULFAMETHOXAZOLE AND TRIMETHOPRIM.
Sulfamethoxazole And Trimethoprim 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 191,160 adverse event reports for this medication, which is primarily manufactured by Sun Pharmaceutical Industries, Inc.
The most commonly reported adverse events include Pyrexia, Off Label Use, Fatigue. Of classified reports, 83.1% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. The drug is associated with a high number of serious adverse events, including infections, kidney injury, and respiratory issues.
A wide range of reactions are reported, indicating potential for diverse side effects. Report volume is substantial, with over 190,000 reports, suggesting widespread use and potential for frequent adverse events. The majority of reported reactions are non-serious, but the serious reactions are concerning, particularly infections and kidney issues. There are significant reports of drug hypersensitivity and allergic reactions.
Patients taking Sulfamethoxazole And Trimethoprim should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Sulfamethoxazole and Trimethoprim can cause severe drug hypersensitivity reactions and should be used with caution in patients with a history of allergies or hypersensitivity to sulfonamides. Warnings include the potential for severe infections and k This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Sulfamethoxazole And Trimethoprim received a safety concern score of 85/100 (high concern). This is based on a 83.1% serious event ratio across 81,275 classified reports. The score accounts for 191,160 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: Male: 37,267, Female: 36,575, Unknown: 124. The most frequently reported age groups are age 69 (1,405 reports), age 64 (1,400 reports), age 65 (1,384 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 81,275 classified reports for SULFAMETHOXAZOLE AND TRIMETHOPRIM:
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.
Sulfamethoxazole and Trimethoprim can cause severe drug hypersensitivity reactions and should be used with caution in patients with a history of allergies or hypersensitivity to sulfonamides. Warnings include the potential for severe infections and k
If you are taking Sulfamethoxazole And Trimethoprim, here are important things to know. The most commonly reported side effects include pyrexia, off label use, fatigue, 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 inform their healthcare provider of any existing allergies or hypersensitivity to sulfonamides before starting this medication. Monitor for signs of severe reactions, including fever, rash, and difficulty breathing, and seek medical attention immediately if these symptoms occur. 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 Sulfamethoxazole and Trimethoprim, and healthcare providers should report any adverse events to the FDA's MedWatch program.
The FDA has received approximately 191,160 adverse event reports associated with Sulfamethoxazole And Trimethoprim. 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 Sulfamethoxazole And Trimethoprim include Pyrexia, Off Label Use, Fatigue, Diarrhoea, Nausea. By volume, the top reported reactions are: Pyrexia (6,173 reports), Off Label Use (5,424 reports), Fatigue (5,209 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Sulfamethoxazole And Trimethoprim.
Out of 81,275 classified reports, 67,580 (83.1%) were classified as serious and 13,695 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 Sulfamethoxazole And Trimethoprim break down by patient sex as follows: Male: 37,267, Female: 36,575, Unknown: 124. 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 Sulfamethoxazole And Trimethoprim adverse events are: age 69: 1,405 reports, age 64: 1,400 reports, age 65: 1,384 reports, age 67: 1,362 reports, age 68: 1,334 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 Sulfamethoxazole And Trimethoprim adverse event reports is Sun Pharmaceutical Industries, 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 Sulfamethoxazole And Trimethoprim include: Rash, Dyspnoea, Pain, Vomiting, Drug Ineffective. 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 Sulfamethoxazole And Trimethoprim 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.
Sulfamethoxazole And Trimethoprim 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 drug is associated with a high number of serious adverse events, including infections, kidney injury, and respiratory issues.
Key safety signals identified in Sulfamethoxazole And Trimethoprim's adverse event data include: High number of serious reactions (67,580 out of 81,275 total outcomes, 83.1%). Multiple reports of kidney injury and respiratory issues. A wide variety of reactions, including gastrointestinal, dermatological, and hematological issues. Significant reports of drug hypersensitivity and allergic reactions. Reports of severe infections, including pneumonia and sepsis. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Sulfamethoxazole and Trimethoprim can cause severe drug hypersensitivity reactions and should be used with caution in patients with a history of allergies or hypersensitivity to sulfonamides. Warnings include the potential for severe infections and k Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Sulfamethoxazole And Trimethoprim.
Patients should inform their healthcare provider of any existing allergies or hypersensitivity to sulfonamides before starting this medication. Monitor for signs of severe reactions, including fever, rash, and difficulty breathing, and seek medical attention immediately if these symptoms occur.
Sulfamethoxazole And Trimethoprim has 191,160 adverse event reports on file with the FDA. A wide range of reactions are reported, indicating potential for diverse side effects. The volume of reports for Sulfamethoxazole And Trimethoprim reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor the safety of Sulfamethoxazole and Trimethoprim, and 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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