65/100 · Elevated
Manufactured by Allergan, Inc.
Moderate Safety Concerns with SUCRALFATE Based on FDA Adverse Event Data
55,920 FDA adverse event reports analyzed
Last updated: 2026-05-12
SUCRALFATE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Allergan, Inc.. Based on analysis of 55,920 FDA adverse event reports, SUCRALFATE 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 SUCRALFATE include NAUSEA, FATIGUE, DIARRHOEA, PAIN, HEADACHE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for SUCRALFATE.
Sucralfate 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 55,920 adverse event reports for this medication, which is primarily manufactured by Allergan, Inc..
The most commonly reported adverse events include Nausea, Fatigue, Diarrhoea. Of classified reports, 69.0% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Nausea, fatigue, and diarrhea are the most common adverse reactions reported.
Serious adverse events, including death and renal failure, are reported but at a lower rate. A wide range of reactions, including gastrointestinal and respiratory issues, are reported.
Patients taking Sucralfate should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. SUCRALFATE has been associated with various drug interactions, including potential exacerbation of gastrointestinal conditions and respiratory issues. It is important to consult a healthcare provider for proper use and monitoring. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Sucralfate received a safety concern score of 65/100 (elevated concern). This is based on a 69.0% serious event ratio across 23,024 classified reports. The score accounts for 55,920 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: 14,613, Male: 7,069, Unknown: 35. The most frequently reported age groups are age 65 (446 reports), age 64 (420 reports), age 71 (413 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 23,024 classified reports for SUCRALFATE:
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.
SUCRALFATE has been associated with various drug interactions, including potential exacerbation of gastrointestinal conditions and respiratory issues. It is important to consult a healthcare provider for proper use and monitoring.
If you are taking Sucralfate, here are important things to know. The most commonly reported side effects include nausea, fatigue, diarrhoea, pain, headache. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Monitor for gastrointestinal symptoms and report any serious adverse events to your healthcare provider. Follow prescribed dosing instructions and do not use the drug for off-label indications without medical supervision. 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 SUCRALFATE for safety. Patients should report any adverse reactions to their healthcare provider and the FDA's MedWatch program.
The FDA has received approximately 55,920 adverse event reports associated with Sucralfate. 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 Sucralfate include Nausea, Fatigue, Diarrhoea, Pain, Headache. By volume, the top reported reactions are: Nausea (2,264 reports), Fatigue (1,733 reports), Diarrhoea (1,700 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Sucralfate.
Out of 23,024 classified reports, 15,882 (69.0%) were classified as serious and 7,142 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 Sucralfate break down by patient sex as follows: Female: 14,613, Male: 7,069, Unknown: 35. 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 Sucralfate adverse events are: age 65: 446 reports, age 64: 420 reports, age 71: 413 reports, age 63: 410 reports, age 62: 390 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 Sucralfate adverse event reports is Allergan, 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 Sucralfate include: Vomiting, Dyspnoea, Drug Ineffective, Off Label Use, Dizziness. 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 Sucralfate 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.
Sucralfate 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. Nausea, fatigue, and diarrhea are the most common adverse reactions reported.
Key safety signals identified in Sucralfate's adverse event data include: High frequency of gastrointestinal issues like nausea, diarrhea, and abdominal pain.. Multiple reports of serious conditions such as renal failure and pneumonia.. Significant number of reactions related to drug ineffectiveness and off-label use.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
SUCRALFATE has been associated with various drug interactions, including potential exacerbation of gastrointestinal conditions and respiratory issues. It is important to consult a healthcare provider for proper use and monitoring. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Sucralfate.
Monitor for gastrointestinal symptoms and report any serious adverse events to your healthcare provider. Follow prescribed dosing instructions and do not use the drug for off-label indications without medical supervision.
Sucralfate has 55,920 adverse event reports on file with the FDA. Serious adverse events, including death and renal failure, are reported but at a lower rate. The volume of reports for Sucralfate reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor SUCRALFATE for safety. Patients should report any adverse reactions to their healthcare provider and 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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