72/100 · Elevated
Manufactured by Kenvue Brands LLC
High Incidence of Gastrointestinal and General Symptoms with Loperamide Hydrochloride
100,013 FDA adverse event reports analyzed
Last updated: 2026-05-12
LOPERAMIDE HYDROCHLORIDE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Kenvue Brands LLC. Based on analysis of 100,013 FDA adverse event reports, LOPERAMIDE HYDROCHLORIDE 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 include DIARRHOEA, NAUSEA, DRUG INEFFECTIVE, 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.
Loperamide Hydrochloride 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 100,013 adverse event reports for this medication, which is primarily manufactured by Kenvue Brands Llc.
The most commonly reported adverse events include Diarrhoea, Nausea, Drug Ineffective. Of classified reports, 61.6% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Gastrointestinal symptoms such as diarrhea, nausea, and abdominal pain are frequently reported.
General symptoms like fatigue, dizziness, and headache are also common. Serious adverse events, including pneumonia and death, are reported but less frequently.
Patients taking Loperamide Hydrochloride should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Loperamide Hydrochloride can cause gastrointestinal issues and should be used with caution, especially in combination with other drugs that affect the gastrointestinal tract. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Loperamide Hydrochloride received a safety concern score of 72/100 (elevated concern). This is based on a 61.6% serious event ratio across 42,604 classified reports. The score accounts for 100,013 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: 24,240, Male: 14,741, Unknown: 25. The most frequently reported age groups are age 64 (869 reports), age 72 (763 reports), age 69 (761 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 42,604 classified reports for LOPERAMIDE HYDROCHLORIDE:
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.
Loperamide Hydrochloride can cause gastrointestinal issues and should be used with caution, especially in combination with other drugs that affect the gastrointestinal tract.
If you are taking Loperamide Hydrochloride, here are important things to know. The most commonly reported side effects include diarrhoea, nausea, drug ineffective, 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. Follow prescribed dosages and do not exceed recommended limits. Report any serious adverse events to healthcare providers 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 closely monitors Loperamide Hydrochloride due to its potential for serious adverse events, particularly in higher doses or off-label use.
The FDA has received approximately 100,013 adverse event reports associated with Loperamide Hydrochloride. 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 include Diarrhoea, Nausea, Drug Ineffective, Fatigue, Off Label Use. By volume, the top reported reactions are: Diarrhoea (8,465 reports), Nausea (4,090 reports), Drug Ineffective (3,914 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.
Out of 42,604 classified reports, 26,264 (61.6%) were classified as serious and 16,340 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 break down by patient sex as follows: Female: 24,240, Male: 14,741, Unknown: 25. 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 adverse events are: age 64: 869 reports, age 72: 763 reports, age 69: 761 reports, age 75: 759 reports, age 71: 756 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 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 include: Vomiting, Constipation, Weight Decreased, Headache, Dyspnoea. 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 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 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. Gastrointestinal symptoms such as diarrhea, nausea, and abdominal pain are frequently reported.
Key safety signals identified in Loperamide Hydrochloride's adverse event data include: Diarrhea and nausea are the most common reactions.. Reports of serious events like pneumonia and death indicate potential severe risks.. Off-label use and incorrect dose administration are significant safety signals.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Loperamide Hydrochloride can cause gastrointestinal issues and should be used with caution, especially in combination with other drugs that affect the gastrointestinal tract. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Loperamide Hydrochloride.
Follow prescribed dosages and do not exceed recommended limits. Report any serious adverse events to healthcare providers immediately.
Loperamide Hydrochloride has 100,013 adverse event reports on file with the FDA. General symptoms like fatigue, dizziness, and headache are also common. The volume of reports for Loperamide Hydrochloride reflects both the drug's usage level and the vigilance of the reporting community.
The FDA closely monitors Loperamide Hydrochloride due to its potential for serious adverse events, particularly in higher doses or off-label use. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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