Prescription and over-the-counter medicine
Loperamide Brand names: Anti-Diarrheal, Imodium
Loperamide (Imodium) is a prescription and over-the-counter medicine with an FDA approval on record since 1976. FDA's NDC Directory lists it from 95 generic labelers, and pharmacies paid $0.0549 per loperamide 2 mg capsule in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
Check it at the source: the loperamide FDA label on DailyMed (effective June 3, 2026, Aurobindo Pharma Limited); the NDA 17690 record on Drugs@FDA; every loperamide label on DailyMed.
Highlights of the record
FDA label of June 3, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
WARNING: TORSADES DE POINTES AND SUDDEN DEATH.
Cases of Torsades de Pointes, cardiac arrest, and death have been reported with the use of a higher than recommended dosages of Loperamide Hydrochloride Capsules (see WARNINGS and OVERDOSAGE). Loperamide Hydrochloride Capsules is contraindicated in pediatric patients less than 2 years of age (see CONTRAINDICATIONS). Avoid Loperamide Hydrochloride Capsules dosages higher than recommended in adults and pediatric patients 2 years of age and older due to the risk of serious cardiac adverse reactions (see DOSAGE AND ADMINISTRATION).
This box is printed on the prescription label of loperamide; the over-the-counter label quoted on this page has none.
Used for
From the label: indications and usagecontrols symptoms of diarrhea, including Travelers' Diarrhea
Forms and strengths
- 2 mg
- 1 mg/7.5ml
Tablet; capsule; liquid-filled capsule; film-coated tablet; solution.
On the market
- Earliest approval on file
- December 28, 1976 Imodium, J And J Consumer Inc; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 30 first August 30, 1991; 18 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 106 of which 95 under generic applications, 25 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.0549 per capsule Loperamide 2 mg capsule
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 2 since 2018 0 Class I among all firms' recalls; latest April 13, 2022
- FAERS reports
- 50,250 through July 30, 2026
What is loperamide used for?
From the label: indications and usagecontrols symptoms of diarrhea, including Travelers' Diarrhea
Conditions named in the indications of loperamide's FDA labels, with every medicine labeled for each:
From other loperamide labelsDiarrhea: INDICATIONS AND USAGE Loperamide hydrochloride capsules are indicated for the control and symptomatic relief of acute nonspecific diarrhea in patients 2 years of age and older and of chronic diarrhea in adults associated with inflammatory …
FDA pharmacologic class: Opioid Agonist.
Source: FDA drug label (Loperamide Hydrochloride), Aurobindo Pharma Limited, effective June 3, 2026 (SPL set 8e4004be-bf79-4631-9e38-c4e7b6726313), via openFDA; the full label on DailyMed
Is there a generic for loperamide (Imodium)?
The FDA approved the first generic loperamide on August 30, 1991. 30 generic applications are approved; 18 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists loperamide from 95 labelers under a generic (ANDA) application and from 25 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1976 earliest approval on file
- 1991 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for loperamide (Imodium)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.0549 per Loperamide 2 mg capsule, down 31% from $0.0798 on October 8, 2025. The survey records the price, not the reason for a change; large moves often follow a new generic or a list-price change. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Loperamide 2 mg capsule (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Anti-diarrheal 1 mg/7.5 mL solution | Generic | $0.0264 per mL | n/a | -0.4% |
| Anti-diarrheal 2 mg caplet | Generic | $0.130 per unit | n/a | -11% |
| Anti-diarrheal 2 mg softgel | Generic | $0.136 per unit | n/a | +0.5% |
| Ft anti-diarrheal 1 mg/7.5 mL | Generic | $0.0264 per mL | n/a | -0.4% |
| Ft anti-diarrheal 2 mg caplet | Generic | $0.130 per unit | n/a | -11% |
| Ft anti-diarrheal 2 mg softgel | Generic | $0.136 per unit | n/a | +0.5% |
| Gnp anti-diarrheal 2 mg tablet | Generic | $0.130 per tablet | $3.90 | -11% |
| Gs anti-diarrheal 1 mg/7.5 mL | Generic | $0.0264 per mL | n/a | -0.4% |
| Gs anti-diarrheal 2 mg caplet | Generic | $0.130 per unit | n/a | -11% |
| Loperamide 1 mg/7.5 mL solution | Generic | $0.0264 per mL | n/a | -0.4% |
| Loperamide 2 mg capsule | Generic | $0.0549 per capsule | $1.65 | -31% |
| Qc anti-diarrheal 2 mg caplet | Generic | $0.130 per unit | n/a | -11% |
| Qc anti-diarrheal 2 mg softgel | Generic | $0.136 per unit | n/a | +0.5% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has loperamide been recalled?
The FDA's Enforcement Report lists 2 recalls naming loperamide since 2018: 0 Class I (the most serious), 1 Class II, 1 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| April 13, 2022 | Class II | Mckesson Medical-Surgical Inc. Corporate Office | cGMP deviations: Temperature abuse |
| December 26, 2018 | Class III | Sun Pharmaceutical Industries, Inc. | Labeling Not Elsewhere Classified: The front panel indicates 24 caplets whereas the side panel indicates 12 caplets. … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the loperamide label say about other medicines?
The loperamide label names 4 other medicines in its interaction, contraindication or warning sections. The labels of 23 other medicines name loperamide. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Gemfibrozil | drug interactions (prescription label) | DRUG INTERACTIONS Effects of Other Drugs on Loperamide Concomitant use of Loperamide Hydrochloride Capsules with inhibitors of CYP3A4 (e.g., itraconazole) or CYP2C8 (e.g., gemfibrozil) or inhibitors of P-glycoprotein (e.g., quinidine, ritonavir) can increase exposure to loperamide. |
| Itraconazole | drug interactions (prescription label) | DRUG INTERACTIONS Effects of Other Drugs on Loperamide Concomitant use of Loperamide Hydrochloride Capsules with inhibitors of CYP3A4 (e.g., itraconazole) or CYP2C8 (e.g., gemfibrozil) or inhibitors of P-glycoprotein (e.g., quinidine, ritonavir) can increase exposure to loperamide. |
| Quinidine | drug interactions (prescription label) | DRUG INTERACTIONS Effects of Other Drugs on Loperamide Concomitant use of Loperamide Hydrochloride Capsules with inhibitors of CYP3A4 (e.g., itraconazole) or CYP2C8 (e.g., gemfibrozil) or inhibitors of P-glycoprotein (e.g., quinidine, ritonavir) can increase exposure to loperamide. |
| Ritonavir | drug interactions (prescription label) | DRUG INTERACTIONS Effects of Other Drugs on Loperamide Concomitant use of Loperamide Hydrochloride Capsules with inhibitors of CYP3A4 (e.g., itraconazole) or CYP2C8 (e.g., gemfibrozil) or inhibitors of P-glycoprotein (e.g., quinidine, ritonavir) can increase exposure to loperamide. |
Other labels that name loperamide
Source: FDA drug label (Loperamide Hydrochloride), Aurobindo Pharma Limited, effective June 3, 2026 (SPL set 8e4004be-bf79-4631-9e38-c4e7b6726313), via openFDA; the full label on DailyMed
What do FAERS reports show for loperamide?
The FDA Adverse Event Reporting System holds 50,250 reports that list loperamide among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 4,591 are coded as a death and 18,273 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as loperamide?
9 other medicines are given the same way (oral) and in the same FDA class as loperamide or labeled mainly for the same use (diarrhea), the same class first. Diarrhea lists all 16 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Bismuth subsalicylate | Diarrhea | none listed | $0.0817 per tablet 262 mg tablet chewable | No current entry |
| Ciprofloxacin | Diarrhea | 46 labelers | $0.123 per tablet 500 mg tablet | No current entry |
| Atropine and diphenoxylate | Diarrhea | 19 labelers | $0.139 per tablet 2.5-0.025 mg tablet | No current entry |
| Nitazoxanide | Diarrhea | 4 labelers | $82.20 per tablet 500 mg tablet | No current entry |
| Rifaximin | Diarrhea | none listed | n/a | No current entry |
| Atropine and difenoxin | Diarrhea | none listed | $6.91 per tablet 1-0.025 mg tablet | No current entry |
| Octreotide | Diarrhea | none listed | n/a | No current entry |
| Telotristat | Diarrhea | none listed | n/a | No current entry |
Every medicine labeled for the same conditions as loperamide
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does loperamide compare with medicines for the same use?
1 side-by-side page set loperamide beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to loperamide
- 9 medicines for the same use
- Other opioids
- the pharmacologic class, with prices and generics
- Loperamide side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other