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loperamide

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Brand names: Imodium

Antidiarrheal (Opioid Receptor Agonist) OTC

Loperamide (Imodium) helps control diarrhea symptoms. It is also used for Traveler's Diarrhea.

Drug Pricing (NADAC)

Generic Price

$0.03/unit

Generic Available

Yes (23 manufacturers)

Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →

What it does

This medicine treats diarrhea.

Common side effects

Headache, Dizziness, Constipation

Key warnings

Taking too much loperamide can cause serious heart problems.

How It Works

Loperamide works by slowing down your intestines. This allows more water to be absorbed from your stool. This makes your stools less watery and reduces how often you need to go to the bathroom.

How to Take It

Drink plenty of clear fluids to avoid dehydration. Use the dosing cup that comes with the medicine. Shake the bottle well before each use. Follow the dosage chart to find the right dose based on your weight or age.

Pregnancy & Breastfeeding

Talk to your doctor before taking this medicine if you are pregnant or breastfeeding. It is not known if loperamide can harm your unborn baby or pass into breast milk.

Missed Dose

Take the next dose after your next loose stool. Do not take more medicine than the maximum daily dose.

Storage

Store between 68-77°F (20-25°C).

Side Effects (from patient reports)

Based on 34,073 FDA adverse event reports.

Diarrhea
8,466
Feeling sick to your stomach
4,091
Medicine not working
3,916
Feeling tired
3,692
Using the medicine for something it's not approved for
3,095
Throwing up
2,673
Having trouble pooping
2,352
Weight loss
2,019
Headache
1,890
Difficulty breathing
1,879

FDA Adverse Event Report Analysis

Detailed analysis of 42,665 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 1999–2025.

Total Reports

42,665

Death-Related Reports

3,775

Hospitalization Reports

15,486

Top Indication

Product Used For Unknown Indication

Gender Distribution

Female 24,237 (62%)
Male 14,741 (38%)

Age Distribution

0–17 626
18–44 3,374
45–64 8,862
65–74 7,274
75+ 6,499

Most Reported Adverse Reactions (FAERS)

# Reaction Reports
1 DIARRHOEA 8,463
2 NAUSEA 4,092
3 DRUG INEFFECTIVE 3,915
4 FATIGUE 3,690
5 OFF LABEL USE 3,095
6 VOMITING 2,674
7 CONSTIPATION 2,352
8 WEIGHT DECREASED 2,018
9 HEADACHE 1,890
10 DYSPNOEA 1,879
11 ABDOMINAL PAIN 1,759
12 ASTHENIA 1,745
13 DECREASED APPETITE 1,712
14 DIZZINESS 1,615
15 PAIN 1,595

Reactions in Death Reports

DEATH 1,282
DIARRHOEA 588
NAUSEA 301
PNEUMONIA 291
FATIGUE 270
OFF LABEL USE 230
DYSPNOEA 226
VOMITING 224
ASTHENIA 214
SEPSIS 202

Reactions in Hospitalization Reports

DIARRHOEA 3,268
NAUSEA 1,982
VOMITING 1,533
FATIGUE 1,413
PNEUMONIA 1,314
DEHYDRATION 1,200
PYREXIA 1,064
DYSPNOEA 1,063
OFF LABEL USE 1,018
WEIGHT DECREASED 996

Source: FDA FAERS (Adverse Event Reporting System) FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation

Serious Warnings

Taking too much loperamide can cause serious heart problems. Always follow the recommended dose.

Known Drug Interactions

moderate eluxadoline

Examples: cyclosporine, gemfibrozil, antiretrovirals (atazanavir, lopinavir, ritonavir, saquinavir, tipranavir), rifampin, eltrombopag Drugs that Cause Constipation Clinical Impact: Increased risk for constipation related adverse reactions and potential for constipation related serious adverse reactions Intervention: Avoid use with other drugs that may cause constipation (see below); loperamide may be used occasionally for acute management of severe diarrhea but avoid chronic use. Discontinue loperamide immediately if constipation occurs.

Mechanism: These medicines both work to slow down your bowels, and using them together can cause dangerous levels of constipation.

What to do: Do not use loperamide long-term with this drug, and stop it immediately if you become constipated.

Aprepitant Loperamide a Monitor for adverse reactions.

Mechanism: Itraconazole can stop your body from breaking down loperamide properly, leading to higher levels of the medicine in your blood.

What to do: You should be monitored for any unusual reactions or side effects.

Common Questions

How much should I take?
Follow the dosage chart on the package. Use your weight if possible, otherwise use your age.
Can I use a regular spoon to measure the dose?
No, only use the dosing cup that comes with the medicine.
What should I do if I still have diarrhea after taking this medicine?
Drink plenty of fluids. If your diarrhea lasts longer than 48 hours, talk to your doctor.
Can I take this medicine if I have a fever?
Talk to your doctor before taking this medicine if you have a fever.
Can I take this with other medicines?
Talk to your doctor or pharmacist before taking this medicine with other medicines.
What is the maximum amount I can take in a day?
Adults and children 12 years and over should not take more than 60 mL in 24 hours. Children 9-11 years should not take more than 45 mL in 24 hours. Children 6-8 years should not take more than 30 mL in 24 hours.
Can children under 2 years old take this medicine?
No, do not give this medicine to children under 2 years old.
What do I do if I accidentally take too much?
Seek medical help right away.
Does this medicine expire?
Yes, check the expiration date on the package.
Can I drive while taking this medicine?
This medicine may cause dizziness. Be careful driving or operating machinery until you know how it affects you.
What are the common side effects of loperamide?
The most commonly reported side effects of loperamide include Headache, Dizziness, Constipation, Nausea. Based on 34,073 FDA adverse event reports. Always consult your healthcare provider about potential side effects.
Does loperamide interact with other medications?
Yes, loperamide has 2 known drug interactions. Notable interactions include eluxadoline, itraconazole. Always inform your doctor about all medications you are taking.
What drug class is loperamide?
loperamide belongs to the Antidiarrheal (Opioid Receptor Agonist) drug class. It is available over the counter (OTC). This medicine treats diarrhea.
Is loperamide safe during pregnancy?
Talk to your doctor before taking this medicine if you are pregnant or breastfeeding. It is not known if loperamide can harm your unborn baby or pass into breast milk. Always consult your healthcare provider before using any medication during pregnancy or breastfeeding.
Has loperamide been recalled?
There is 1 recall associated with loperamide products. CGMP Deviations: product held outside appropriate storage temperature conditions. Check the recalls section below for full details and affected products.

Active Recalls

Class II June 23, 2022

CGMP Deviations: product held outside appropriate storage temperature conditions.

Family Dollar Stores, Llc.

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Medication Guides

Related Health & Safety Data

What the FDA Data Shows for loperamide

The FDA label for loperamide (sold under brand names such as Imodium) classifies it as an over-the-counter product in the Antidiarrheal (Opioid Receptor Agonist) class. This medicine treats diarrhea. Official labeling lists 4 commonly reported side effects, including Headache, Dizziness, Constipation.

Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 34,073 voluntary reports. The database also lists 2 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated moderate severity. NADAC pricing from CMS shows a generic unit cost of $0.03.

Report counts do not establish causation — a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history (currently 1 recall record on file), and patent information further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice — always consult a licensed healthcare provider before starting, stopping, or changing any medication.

Data Sources

Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).

FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. Always consult a healthcare professional before making medication decisions.

Last updated: April 11, 2025

All federal data sources used on this page