85/100 · Critical
Manufactured by Pfizer Laboratories Div Pfizer Inc
Sulfasalazine Adverse Events: High Serious Reaction Rate
583,229 FDA adverse event reports analyzed
Last updated: 2026-05-12
SULFASALAZINE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Pfizer Laboratories Div Pfizer Inc. Based on analysis of 583,229 FDA adverse event reports, SULFASALAZINE 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 SULFASALAZINE include DRUG INEFFECTIVE, RHEUMATOID ARTHRITIS, PAIN, DRUG INTOLERANCE, ARTHRALGIA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for SULFASALAZINE.
Sulfasalazine 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 583,229 adverse event reports for this medication, which is primarily manufactured by Pfizer Laboratories Div Pfizer Inc.
The most commonly reported adverse events include Drug Ineffective, Rheumatoid Arthritis, Pain. Of classified reports, 83.6% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Sulfasalazine has a high rate of serious adverse events, particularly skin reactions and gastrointestinal issues.
The most common reactions include pain, fatigue, and joint swelling, indicating a broad spectrum of potential side effects. Drug ineffectiveness and off-label use are also reported, suggesting issues with efficacy and proper usage.
Patients taking Sulfasalazine should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Sulfasalazine can interact with other drugs, and its use is contraindicated in certain conditions. Consult a healthcare provider for specific interactions and warnings. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Sulfasalazine received a safety concern score of 85/100 (high concern). This is based on a 83.6% serious event ratio across 76,269 classified reports. The score accounts for 583,229 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: 52,101, Male: 15,844, Unknown: 77. The most frequently reported age groups are age 43 (2,616 reports), age 44 (2,606 reports), age 59 (1,519 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 76,269 classified reports for SULFASALAZINE:
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.
Sulfasalazine can interact with other drugs, and its use is contraindicated in certain conditions. Consult a healthcare provider for specific interactions and warnings.
If you are taking Sulfasalazine, here are important things to know. The most commonly reported side effects include drug ineffective, rheumatoid arthritis, pain, drug intolerance, arthralgia. 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 dosages and usage instructions to minimize the risk of adverse effects. Inform your healthcare provider about any existing conditions or medications you are taking to avoid potential drug interactions. 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 Sulfasalazine for safety. Healthcare providers should report any adverse events to the FDA's MedWatch program.
The FDA has received approximately 583,229 adverse event reports associated with Sulfasalazine. 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 Sulfasalazine include Drug Ineffective, Rheumatoid Arthritis, Pain, Drug Intolerance, Arthralgia. By volume, the top reported reactions are: Drug Ineffective (29,012 reports), Rheumatoid Arthritis (19,190 reports), Pain (15,659 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Sulfasalazine.
Out of 76,269 classified reports, 63,765 (83.6%) were classified as serious and 12,504 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 Sulfasalazine break down by patient sex as follows: Female: 52,101, Male: 15,844, Unknown: 77. 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 Sulfasalazine adverse events are: age 43: 2,616 reports, age 44: 2,606 reports, age 59: 1,519 reports, age 60: 1,498 reports, age 63: 1,379 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 Sulfasalazine 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 Sulfasalazine include: Fatigue, Joint Swelling, Off Label Use, Rash, Abdominal Discomfort. 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 Sulfasalazine 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.
Sulfasalazine 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. Sulfasalazine has a high rate of serious adverse events, particularly skin reactions and gastrointestinal issues.
Key safety signals identified in Sulfasalazine's adverse event data include: High rate of serious reactions (83.6%). Common skin reactions like rash and alopecia. Gastrointestinal issues such as abdominal discomfort and diarrhea. Joint-related issues including arthralgia and synovitis. Potential for drug intolerance and hypersensitivity. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Sulfasalazine can interact with other drugs, and its use is contraindicated in certain conditions. Consult a healthcare provider for specific interactions and warnings. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Sulfasalazine.
Always follow prescribed dosages and usage instructions to minimize the risk of adverse effects. Inform your healthcare provider about any existing conditions or medications you are taking to avoid potential drug interactions.
Sulfasalazine has 583,229 adverse event reports on file with the FDA. The most common reactions include pain, fatigue, and joint swelling, indicating a broad spectrum of potential side effects. The volume of reports for Sulfasalazine reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor Sulfasalazine 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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