Atropine / Difenoxin
Atropine/difenoxin (Motofen) is an oral combination used to treat acute nonspecific diarrhea and acute flare-ups of chronic functional diarrhea in adults.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 2 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
Motofen pairs difenoxin, which slows the bowel so it absorbs more fluid, with a tiny dose of atropine added only to make overuse unpleasant; it is a short-term add-on for sudden diarrhea and flare-ups of chronic functional diarrhea, a less familiar relative of Lomotil, on the U.S. market since about 2017. Short courses are usually well tolerated, though drowsiness, dizziness and dry mouth are common. The boxed warning is overdose, which can cause dangerously slowed breathing, coma or death, especially in children, so keep it locked away. If diarrhea is not better within 48 hours, stop and call your prescriber.
Clinical pearls
- If a child swallows any tablets, get emergency help at once, since breathing problems can start 12 to 30 hours later.
- Keep drinking fluids and electrolyte drinks, because Motofen firms stools but does not replace the water and salts already lost.
- Skip alcohol while taking it; opioids, sleep aids and MAO inhibitor antidepressants are risky combinations that need checking first.
- A swollen or bloated belly can signal toxic megacolon, a dangerously stretched colon, so stop the medicine and call your doctor.
Patient information guide A plain-language walkthrough of Atropine / Difenoxin, written from its FDA label.
What Atropine / Difenoxin is used for
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Atropine/difenoxin is an oral combination medication used to help manage diarrhea. It is used alongside other supportive care — not as a standalone cure.
- Motofen tablets are approved as adjunctive (add-on) therapy for acute nonspecific diarrhea in adults
- Motofen tablets are also approved for acute exacerbations (flare-ups) of chronic functional diarrhea in adults
- Motofen is not appropriate for diarrhea caused by bacterial infections such as Salmonella, Shigella, or toxin-producing E. coli, or for antibiotic-associated pseudomembranous colitis
How Atropine / Difenoxin works
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Difenoxin — the principal active ingredient — works by slowing intestinal motility (the muscular contractions that move contents through your gut). This local effect on the gut wall gives the intestines more time to absorb water, which helps firm up loose stools. Atropine is added in a very small, subtherapeutic (below-treatment-level) dose purely to discourage misuse: taking excessive amounts would produce unpleasant side effects from the atropine rather than a desirable effect.
Atropine / Difenoxin dosage
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Motofen is taken by mouth as a tablet. The usual approach is two tablets at the start, followed by one tablet after each loose stool or one tablet every three to four hours as needed — up to a maximum of eight tablets in any 24-hour period. Treatment for acute diarrhea or a flare-up of functional diarrhea is typically short, often not needed beyond 48 hours. If symptoms are not improving within 48 hours, stop taking it and call your prescriber. Always follow your prescriber's specific instructions and the directions on your label.
Dosing details from the FDA-approved label
From the Atropine / Difenoxin prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.
- Adults (diarrhea)
- 2 tablets then 1 tablet after each loose stool or 1 tablet every 3 to 4 hours as needed
- Maximum: 8 tablets during any 24-hour treatment period
- If clinical improvement is not observed in 48 hours, continued administration is not recommended; for acute diarrheas and acute exacerbations of functional diarrhea, treatment beyond 48 hours is usually not necessary
- Children below the age of 12
- Studies in children below the age of 12 have been inadequate to evaluate the safety and effectiveness
- No regimen stated
- Contraindicated in children under 2 years of age
Read the label’s full dosing text
DOSAGE AND ADMINISTRATION The recommended starting dose of MOTOFEN ® tablets in adults is 2 tablets then 1 tablet after each loose stool or 1 tablet every 3 to 4 hours as needed, but the total dosage during any 24-hour treatment period should not exceed 8 tablets. In the treatment of diarrhea, if clinical improvement is not observed in 48 hours, continued administration of this type of medication is not recommended. For acute diarrheas and acute exacerbations of functional diarrhea, treatment beyond 48 hours is usually not necessary. Studies in children below the age of 12 have been inadequate to evaluate the safety and effectiveness of MOTOFEN ® in this age group. MOTOFEN ® is contraindicated in children under 2 years of age.
Read the full Dosage and Administration section on DailyMed →
Atropine / Difenoxin side effects
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The most commonly reported side effects with Motofen include:
Common side effects
- Nausea
- Dizziness or light-headedness
- Drowsiness
- Dry mouth
- Headache
- Vomiting
- Stomach discomfort
- Blurred vision or burning eyes
When to get medical help
- Call your doctor right away if your abdomen becomes swollen or bloated — this could signal a dangerous complication called toxic megacolon
- Seek emergency care immediately if you notice slow, shallow, or difficult breathing — this is a sign of overdose
- Get help right away if you or someone who took this medicine becomes very drowsy, limp, or unresponsive
- Stop taking Motofen and call your doctor if you have signs of severe dehydration (extreme thirst, little or no urination, rapid heartbeat)
- Tell your doctor immediately if you develop signs of liver problems such as yellowing of the skin or eyes (jaundice)
Atropine / Difenoxin warnings and precautions
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- Overdose risk: Too much Motofen can cause severe respiratory depression (slowed, dangerous breathing), coma, permanent brain damage, or death. Symptoms may not appear for 12 to 30 hours after ingestion. Children are especially vulnerable — always store this medication in a child-resistant container out of their reach.
- Dehydration: Motofen slows the gut and can trap fluid in the colon, making dehydration and electrolyte (body salt) imbalance worse. Fluid and electrolyte replacement are still essential — Motofen does not substitute for hydration.
- Ulcerative colitis: In people with acute ulcerative colitis, slowing gut movement may trigger toxic megacolon (dangerous colon swelling). Stop Motofen immediately and contact your doctor if your abdomen becomes distended.
- Liver and kidney disease: People with advanced liver or kidney disease, or abnormal liver tests, face a higher risk of serious complications including hepatic coma. Use only with extreme caution under medical supervision.
- Atropine effects in children: Even at recommended doses, children — especially those with Down's syndrome — may experience signs of atropinism (rapid heart rate, flushing, fever, dry skin). Watch closely.
Atropine / Difenoxin interactions
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Motofen can interact with several medications and substances — tell your prescriber and pharmacist about everything you take:
- MAO inhibitors (certain antidepressants): may trigger a dangerous spike in blood pressure — this combination should be avoided
- Barbiturates (sedative medications): Motofen can amplify their sedating effects
- Tranquilizers: increased sedation when used together — monitor closely
- Narcotic pain medicines (opioids): effects may be intensified — use together only under direct medical supervision
- Alcohol: increases drowsiness and sedation — avoid alcohol while taking Motofen
- Other medications processed by the liver: difenoxin may slow the breakdown of other drugs, potentially raising their levels in the bloodstream
Interactions listed in the FDA-approved label
From the Atropine / Difenoxin prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
- Monoamine oxidase inhibitors: Because difenoxin hydrochloride is chemically similar to meperidine hydrochloride, concurrent use may, in theory, precipitate a hypertensive crisis.
- Barbiturates: MOTOFEN may potentiate the action of barbiturates. When used concomitantly, the patient should be closely monitored.
- Tranquilizers: MOTOFEN may potentiate the action of tranquilizers. When used concomitantly, the patient should be closely monitored.
- Narcotics: MOTOFEN may potentiate the action of narcotics. When used concomitantly, the patient should be closely monitored.
- Alcohol: MOTOFEN may potentiate the action of alcohol. When used concomitantly, the patient should be closely monitored.
- Drugs whose elimination depends on the hepatic microsomal drug metabolizing enzyme system: Diphenoxylate hydrochloride, from which difenoxin is derived, inhibited the hepatic microsomal enzyme system at 2 mg/kg/day in male rats, so difenoxin has the potential to prolong the biological half-lives of such drugs.
Read the label’s full interactions text
Drug Interactions Since the chemical structure of difenoxin hydrochloride is similar to meperidine hydrochloride, the concurrent use of MOTOFEN ® with monoamine oxidase inhibitors may, in theory, precipitate a hypertensive crisis. MOTOFEN ® may potentiate the action of barbiturates, tranquilizers, narcotics, and alcohol. When these medications are used concomitantly with MOTOFEN ® , the patient should be closely monitored. Diphenoxylate hydrochloride, from which the principal active metabolite difenoxin is derived, was found to inhibit the hepatic microsomal enzyme system at a dose of 2 mg/kg/day in studies conducted with male rats. Therefore, difenoxin has the potential to prolong the biological half-lives of drugs for which the rate of elimination is dependent on the microsomal drug metabolizing enzyme system.
Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.
Before taking Atropine / Difenoxin
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- Children under 2 years: Motofen is contraindicated — must not be used
- Children under 12: Safety and effectiveness have not been adequately established — consult a prescriber
- Children with Down's syndrome: At higher risk for atropine-related side effects even at normal doses
- Liver disease or abnormal liver function tests: Risk of hepatic coma — use with extreme caution
- Advanced kidney disease: Use with extreme caution
- Acute ulcerative colitis: Risk of toxic megacolon — requires careful monitoring
- Allergy to difenoxin, atropine, or any Motofen ingredient: Do not take this medication
- Jaundice (yellow skin or eyes): Motofen is contraindicated
- Bacterial diarrhea (Salmonella, Shigella, toxigenic E. coli) or antibiotic-associated colitis: Motofen is contraindicated — it can worsen these conditions
- Conditions where anticholinergic drugs are contraindicated: Motofen should be avoided — the atropine component means anticholinergic precautions apply
Atropine / Difenoxin overdose
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An overdose of Motofen is a medical emergency. Early signs may include dry, flushed skin, fever, and rapid heartbeat, followed by extreme drowsiness, limp muscles, pinpoint pupils, and severely slowed breathing. Breathing problems can be delayed — appearing 12 to 30 hours after the overdose — so all suspected overdoses must be treated as serious and watched for at least 48 hours, preferably in a hospital. Call 911 or poison control immediately if an overdose is suspected.
What Atropine / Difenoxin does in the body
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Difenoxin slows intestinal motility — meaning it reduces the muscular contractions that push contents through the gut. This local effect on the gastrointestinal wall allows more time for the intestine to absorb water and electrolytes from stool, resulting in firmer, less frequent bowel movements. The atropine included in each tablet is present at a subtherapeutic dose and is not intended to produce a clinical anticholinergic effect at recommended doses.
How your body processes Atropine / Difenoxin
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After taking a Motofen tablet by mouth, difenoxin is rapidly and extensively absorbed — peak blood levels are typically reached within 40 to 60 minutes. Blood levels then fall quickly: within 24 hours they drop to less than 10% of their peak, and within 72 hours to less than 1%. Difenoxin is broken down in the body to an inactive metabolite, and both the drug and its breakdown products are excreted mainly in urine and feces.
How to store Atropine / Difenoxin
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Store at 20°-25°C (68°-77°F) .
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Atropine / Difenoxin: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Atropine / Difenoxin — the kind of thing our pharmacy team would talk through with you at the counter.
What exactly is Motofen used for?
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How quickly does Motofen work, and how long should I take it?
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Can I drink alcohol or take sleep aids while using Motofen?
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Is Motofen safe for my child?
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What side effects should I watch out for?
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I have liver disease — is Motofen safe for me?
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Is Atropine / Difenoxin available over the counter?
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Is Atropine / Difenoxin a controlled substance?
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When was Atropine / Difenoxin first available?
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Who makes Atropine / Difenoxin?
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Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Atropine / Difenoxin on HelloPharmacist
Atropine / Difenoxin forms and strengths (how it comes)
Atropine / Difenoxin is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Need a version that does not list lactose, a gluten source, a dye or gelatin? Inactive ingredients differ by manufacturer: see Atropine / Difenoxin inactive ingredients by manufacturer.
Tablet
How this form is used
- Motofen tablets are used as adjunctive (supportive) therapy for acute nonspecific diarrhea in adults
- Motofen tablets are used for acute flare-ups of chronic functional diarrhea in adults
- Motofen tablets are taken by mouth — start with two tablets, then take one after each loose stool or one every three to four hours as needed
- Motofen: do not exceed eight tablets in any 24-hour period
- Motofen: stop taking and contact your prescriber if there is no improvement within 48 hours
- Motofen is contraindicated in children under 2 years of age; safety in children under 12 has not been adequately established
Atropine / Difenoxin on the U.S. market: products, makers and brands
How Atropine / Difenoxin appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
2 companies list 2 Atropine / Difenoxin product records with the FDA, mostly as tablet; the earliest marketing or approval year on record is 2017. Brand names on the directory include Motofen; the rest are generics.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
Compare Atropine / Difenoxin products
A representative set of FDA-listed product records for Atropine / Difenoxin — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Tablet | ||||
| DIFENOXIN HYDROCHLORIDE 1 mg/1; ATROPINE SULFATE 0.025 mg | Oral | Legacy Pharma USA Inc. | NDA | View NDC → |
| DIFENOXIN HYDROCHLORIDE 1 mg/1; ATROPINE SULFATE 0.025 mg | Oral | Sebela Pharmaceuticals Inc. | NDA | View NDC → |
Showing 2 of 2 products — FDA National Drug Code Directory. See every product, package size and price: browse all 2 Atropine / Difenoxin NDCs →
Atropine / Difenoxin side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Atropine / Difenoxin — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Atropine / Difenoxin in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
Atropine / Difenoxin FDA approval history
How Atropine / Difenoxin went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
Atropine / Difenoxin recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
The FDA’s enforcement reports list no Atropine / Difenoxin recalls since July 2021.
✅No Atropine / Difenoxin recalls on record since July 2021Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one exact multiple-ingredient concept (MIN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). A product with a different ingredient combination belongs on a different page.
RxCUI 214261 1 dose form · 1 strength
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Dose form (SCDF) Oral Tablet RxCUI 371827In current FDA listingsClinical drug / strength (SCD) atropine sulfate 0.025 MG / difenoxin hydrochloride 1 MGRxCUI 1190738
Look up RxCUI 214261 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
Atropine / Difenoxin supply and shortage status
Whether Atropine / Difenoxin is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
💵 What Atropine / Difenoxin costs pharmacies (NADAC benchmark)
The national average invoice price pharmacies pay for the drug itself, from CMS's NADAC survey (data as of Sep 30, 2026). This is a supply-cost benchmark — not a retail price and not what you'd pay at the counter.
| Form | Strength | Pharmacy acquisition benchmark | |
|---|---|---|---|
| Tablet · Oral | DIFENOXIN HYDROCHLORIDE 1 mg/1; ATROPINE SULFATE 0.025 mg | $6.91 per tablet | NDC details & price history |
| Tablet · Oral | 0.025; 1 mg/1; mg | $6.91 per tablet | NDC details & price history |
Source: CMS National Average Drug Acquisition Cost (NADAC), a survey of retail pharmacy invoice prices. Benchmarks shown are the range across package sizes of a representative product for each form and strength — other manufacturers' products may differ.
Atropine / Difenoxin brand names
Atropine / Difenoxin is sold under one brand name in the FDA directory — Motofen. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Atropine / Difenoxin: manufacturers and labelers
2 companies list Atropine / Difenoxin products with the FDA. By number of product records, the largest are Legacy Pharma USA Inc., Sebela Pharmaceuticals Inc.. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
Atropine / Difenoxin drug class (RxNorm)
Atropine / Difenoxin belongs to the Anticholinergic class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
Sources for this Atropine / Difenoxin page
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How this page is built
HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Legacy Pharma USA Inc. is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →