72/100 · Elevated
Manufactured by Kenvue Brands LLC
Safety Concerns with Loperamide Hydrochloride and Dimethicone
73,319 FDA adverse event reports analyzed
Last updated: 2026-05-12
LOPERAMIDE HYDROCHLORIDE AND DIMETHICONE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Kenvue Brands LLC. Based on analysis of 73,319 FDA adverse event reports, LOPERAMIDE HYDROCHLORIDE AND DIMETHICONE has a safety score of 72 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 LOPERAMIDE HYDROCHLORIDE AND DIMETHICONE include DIARRHOEA, DRUG INEFFECTIVE, NAUSEA, FATIGUE, OFF LABEL USE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for LOPERAMIDE HYDROCHLORIDE AND DIMETHICONE.
Loperamide Hydrochloride And Dimethicone has a safety concern score of 72 out of 100, placing it in the elevated concern category based on analysis of FDA adverse event data. The FDA has received approximately 73,319 adverse event reports for this medication, which is primarily manufactured by Kenvue Brands Llc.
The most commonly reported adverse events include Diarrhoea, Drug Ineffective, Nausea. Of classified reports, 58.8% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. The most common reactions include diarrhea, drug ineffectiveness, and nausea, indicating potential gastrointestinal issues.
Serious adverse events such as pneumonia, death, and sepsis are reported, highlighting significant risks. Overdose and incorrect dosing are frequent, suggesting a need for careful administration. Age distribution shows a higher incidence in older adults, possibly due to chronic use or comorbidities. Drug ineffectiveness and off-label use are significant, indicating potential misuse or inappropriate use.
Patients taking Loperamide Hydrochloride And Dimethicone should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Interactions with other drugs are not specified in the data, but patients should be cautious with concurrent use of other medications, especially those affecting the gastrointestinal tract. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Loperamide Hydrochloride And Dimethicone received a safety concern score of 72/100 (elevated concern). This is based on a 58.8% serious event ratio across 30,982 classified reports. The score accounts for 73,319 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: 18,033, Male: 10,606, Unknown: 21. The most frequently reported age groups are age 64 (662 reports), age 71 (582 reports), age 75 (557 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 30,982 classified reports for LOPERAMIDE HYDROCHLORIDE AND DIMETHICONE:
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.
Interactions with other drugs are not specified in the data, but patients should be cautious with concurrent use of other medications, especially those affecting the gastrointestinal tract.
If you are taking Loperamide Hydrochloride And Dimethicone, here are important things to know. The most commonly reported side effects include diarrhoea, drug ineffective, nausea, fatigue, off label use. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Always follow the prescribed dosage and instructions for use. Report any serious adverse events to your healthcare provider immediately. 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 this combination, and healthcare providers should be vigilant about potential serious adverse events, especially in older adults.
The FDA has received approximately 73,319 adverse event reports associated with Loperamide Hydrochloride And Dimethicone. 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 Loperamide Hydrochloride And Dimethicone include Diarrhoea, Drug Ineffective, Nausea, Fatigue, Off Label Use. By volume, the top reported reactions are: Diarrhoea (6,287 reports), Drug Ineffective (3,086 reports), Nausea (2,985 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Loperamide Hydrochloride And Dimethicone.
Out of 30,982 classified reports, 18,213 (58.8%) were classified as serious and 12,769 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 Loperamide Hydrochloride And Dimethicone break down by patient sex as follows: Female: 18,033, Male: 10,606, Unknown: 21. 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 Loperamide Hydrochloride And Dimethicone adverse events are: age 64: 662 reports, age 71: 582 reports, age 75: 557 reports, age 74: 553 reports, age 72: 549 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 Loperamide Hydrochloride And Dimethicone adverse event reports is Kenvue Brands Llc. 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 Loperamide Hydrochloride And Dimethicone include: Vomiting, Constipation, Weight Decreased, Incorrect Dose Administered, Abdominal Pain. 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 Loperamide Hydrochloride And Dimethicone 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.
Loperamide Hydrochloride And Dimethicone has a safety concern score of 72 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 diarrhea, drug ineffectiveness, and nausea, indicating potential gastrointestinal issues.
Key safety signals identified in Loperamide Hydrochloride And Dimethicone's adverse event data include: High incidence of serious adverse events like pneumonia and death.. Frequent reports of overdose and incorrect dosing.. Significant gastrointestinal issues including diarrhea and nausea.. Drug ineffectiveness and off-label use are common.. Higher incidence in older adults.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Interactions with other drugs are not specified in the data, but patients should be cautious with concurrent use of other medications, especially those affecting the gastrointestinal tract. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Loperamide Hydrochloride And Dimethicone.
Always follow the prescribed dosage and instructions for use. Report any serious adverse events to your healthcare provider immediately.
Loperamide Hydrochloride And Dimethicone has 73,319 adverse event reports on file with the FDA. Serious adverse events such as pneumonia, death, and sepsis are reported, highlighting significant risks. The volume of reports for Loperamide Hydrochloride And Dimethicone reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor the safety of this combination, and healthcare providers should be vigilant about potential serious adverse events, especially in older adults. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
Explore other medications manufactured by Kenvue Brands LLC and compare their safety profiles:
The following drugs share commonly reported adverse reactions with LOPERAMIDE HYDROCHLORIDE AND DIMETHICONE:
Drugs related to LOPERAMIDE HYDROCHLORIDE AND DIMETHICONE based on therapeutic use, drug class, or shared indications: