78/100 · Elevated
Manufactured by Endo USA, Inc.
Cholestyramine Adverse Events: High Serious Reaction Rate
26,398 FDA adverse event reports analyzed
Last updated: 2026-05-12
CHOLESTYRAMINE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Endo USA, Inc.. Based on analysis of 26,398 FDA adverse event reports, CHOLESTYRAMINE 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 CHOLESTYRAMINE include DIARRHOEA, OFF LABEL USE, DRUG INEFFECTIVE, FATIGUE, NAUSEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for CHOLESTYRAMINE.
Cholestyramine 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 26,398 adverse event reports for this medication, which is primarily manufactured by Endo Usa, Inc..
The most commonly reported adverse events include Diarrhoea, Off Label Use, Drug Ineffective. Of classified reports, 66.8% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Diarrhoea and nausea are the most common adverse events, with a serious reaction rate of 66.8%.
The majority of reports come from older adults, with the highest number of reports from those aged 72. There is a notable increase in serious reactions, including pneumonia, dyspnoea, and renal failure.
Patients taking Cholestyramine should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Cholestyramine can interact with other medications, potentially affecting their absorption. It is important to consult a healthcare provider before combining it with other drugs. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Cholestyramine received a safety concern score of 78/100 (high concern). This is based on a 66.8% serious event ratio across 11,539 classified reports. The score accounts for 26,398 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: 6,640, Male: 3,962, Unknown: 20. The most frequently reported age groups are age 72 (250 reports), age 71 (218 reports), age 73 (207 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 11,539 classified reports for CHOLESTYRAMINE:
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.
Cholestyramine can interact with other medications, potentially affecting their absorption. It is important to consult a healthcare provider before combining it with other drugs.
If you are taking Cholestyramine, here are important things to know. The most commonly reported side effects include diarrhoea, off label use, drug ineffective, fatigue, nausea. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Monitor for signs of serious reactions such as respiratory distress or renal issues. Follow prescribed dosing instructions carefully to avoid drug ineffectiveness or overdose. 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 closely monitors cholestyramine for safety, and any new or severe adverse events should be reported to the FDA's MedWatch program.
The FDA has received approximately 26,398 adverse event reports associated with Cholestyramine. 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 Cholestyramine include Diarrhoea, Off Label Use, Drug Ineffective, Fatigue, Nausea. By volume, the top reported reactions are: Diarrhoea (1,633 reports), Off Label Use (1,051 reports), Drug Ineffective (896 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Cholestyramine.
Out of 11,539 classified reports, 7,707 (66.8%) were classified as serious and 3,832 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 Cholestyramine break down by patient sex as follows: Female: 6,640, Male: 3,962, Unknown: 20. 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 Cholestyramine adverse events are: age 72: 250 reports, age 71: 218 reports, age 73: 207 reports, age 70: 202 reports, age 63: 200 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 Cholestyramine adverse event reports is Endo Usa, 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 Cholestyramine include: Arthralgia, Headache, Abdominal Pain, Vomiting, Weight Decreased. 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 Cholestyramine 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.
Cholestyramine 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. Diarrhoea and nausea are the most common adverse events, with a serious reaction rate of 66.8%.
Key safety signals identified in Cholestyramine's adverse event data include: High rate of serious reactions (66.8%). Common gastrointestinal issues like diarrhoea and nausea. Increased risk of respiratory and renal issues. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Cholestyramine can interact with other medications, potentially affecting their absorption. It is important to consult a healthcare provider before combining it with other drugs. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Cholestyramine.
Monitor for signs of serious reactions such as respiratory distress or renal issues. Follow prescribed dosing instructions carefully to avoid drug ineffectiveness or overdose.
Cholestyramine has 26,398 adverse event reports on file with the FDA. The majority of reports come from older adults, with the highest number of reports from those aged 72. The volume of reports for Cholestyramine reflects both the drug's usage level and the vigilance of the reporting community.
The FDA closely monitors cholestyramine for safety, and any new or severe adverse events should be reported 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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