65/100 · Elevated
Manufactured by Allergan, Inc.
Moderate Safety Concerns with SUCRALFATE ORAL
33,418 FDA adverse event reports analyzed
Last updated: 2026-05-12
SUCRALFATE ORAL is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Allergan, Inc.. Based on analysis of 33,418 FDA adverse event reports, SUCRALFATE ORAL 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 ORAL 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 ORAL.
Sucralfate Oral 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 33,418 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, 71.6% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. The most common reactions include nausea, fatigue, and diarrhea, indicating gastrointestinal side effects.
Serious reactions such as chronic kidney disease, renal failure, and death are reported, though less frequently. There is a notable number of drug interactions and off-label use reports, suggesting potential risks. Weight changes, both increase and decrease, are reported, indicating possible impact on metabolism.
Patients taking Sucralfate Oral should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Drug interactions and off-label use are common, and patients should be aware of potential risks and consult healthcare providers for appropriate use. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Sucralfate Oral received a safety concern score of 65/100 (elevated concern). This is based on a 71.6% serious event ratio across 13,501 classified reports. The score accounts for 33,418 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: 8,206, Male: 4,433, Unknown: 18. The most frequently reported age groups are age 65 (308 reports), age 64 (281 reports), age 71 (271 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 13,501 classified reports for SUCRALFATE ORAL:
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.
Drug interactions and off-label use are common, and patients should be aware of potential risks and consult healthcare providers for appropriate use.
If you are taking Sucralfate Oral, 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 such as nausea, diarrhea, and abdominal pain. Be aware of potential drug interactions and off-label use, and consult a healthcare provider for appropriate use. 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 monitors these reports and may take action if significant safety concerns arise. Patients should report any adverse reactions to their healthcare provider.
The FDA has received approximately 33,418 adverse event reports associated with Sucralfate Oral. 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 Oral include Nausea, Fatigue, Diarrhoea, Pain, Headache. By volume, the top reported reactions are: Nausea (1,364 reports), Fatigue (985 reports), Diarrhoea (977 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 Oral.
Out of 13,501 classified reports, 9,668 (71.6%) were classified as serious and 3,833 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 Oral break down by patient sex as follows: Female: 8,206, Male: 4,433, Unknown: 18. 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 Oral adverse events are: age 65: 308 reports, age 64: 281 reports, age 71: 271 reports, age 63: 253 reports, age 66: 249 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 Oral 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 Oral include: Off Label Use, Drug Ineffective, Vomiting, Dyspnoea, Chronic Kidney Disease. 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 Oral 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 Oral 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. The most common reactions include nausea, fatigue, and diarrhea, indicating gastrointestinal side effects.
Key safety signals identified in Sucralfate Oral's adverse event data include: Chronic kidney disease and renal failure are reported as serious outcomes.. Death and acute kidney injury are also reported, though less frequently.. Drug interactions and off-label use are common, indicating potential risks.. A variety of gastrointestinal reactions are reported, including nausea, diarrhea, and abdominal pain.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Drug interactions and off-label use are common, and patients should be aware of potential risks and consult healthcare providers for appropriate use. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Sucralfate Oral.
Monitor for gastrointestinal symptoms such as nausea, diarrhea, and abdominal pain. Be aware of potential drug interactions and off-label use, and consult a healthcare provider for appropriate use.
Sucralfate Oral has 33,418 adverse event reports on file with the FDA. Serious reactions such as chronic kidney disease, renal failure, and death are reported, though less frequently. The volume of reports for Sucralfate Oral reflects both the drug's usage level and the vigilance of the reporting community.
The FDA monitors these reports and may take action if significant safety concerns arise. Patients should report any adverse reactions to their healthcare provider. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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