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Lomotil Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Lomotil (diphenoxylate and atropine) is a combination antidiarrheal medication, and an anticholinergic used to treat diarrhea. Lomotil medication is available in generic form. Common side effects of Lomotil include drowsiness, dizziness, headache, tiredness, restlessness, blurred vision, dry mouth, nausea, vomiting, upset stomach, loss of appetite, skin rash, or itching.
The recommended initial adult dosage is two Lomotil tablets four times daily or 10 ml (two regular tsp) of Lomotil liquid four times daily (20 mg per day). The pediatric dose is determined by the child's weight. Lomotil may interact with barbiturates or MAO inhibitors. Lomotil may interact with other drugs. Tell your doctor all prescription and over-the-counter medications and supplements you use. During pregnancy, Lomotil should be used only when prescribed. This medication passes into breast milk. Consult your doctor before breast-feeding.
Our Lomotil (diphenoxylate and atropine) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Lomotil in Detail - Patient Information: Side Effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop using this medication and call your doctor at once if you have any of these serious side effects:
- stomach pain or bloating;
- ongoing or worsening diarrhea;
- diarrhea that is watery or bloody;
- numbness in your hands or feet;
- depressed mood;
- confusion, unusual thoughts or behavior;
- fast heart rate; or
- urinating less than usual or not at all.
Less serious side effects may include:
- drowsiness, dizziness, headache;
- tired or restless feeling;
- nausea, vomiting, upset stomach, loss of appetite; or
- skin rash, or itching.
This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Lomotil (Diphenoxylate and Atropine)
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Lomotil Overview - Patient Information: Side Effects
Drowsiness, dizziness, headache, tiredness, blurred vision, dry mouth, and loss of appetite may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor immediately if any of these unlikely but serious side effects occur: stomach/abdominal pain or swelling, severe nausea, vomiting, mental/mood changes (e.g., confusion, depression), restlessness, numbness/tingling of arms/legs.
Get medical help right away if you have any very serious side effects, including: eye pain/swelling/redness, vision changes (such as seeing rainbows around lights at night).
A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Lomotil (Diphenoxylate and Atropine)
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Lomotil FDA Prescribing Information: Side Effects
At therapeutic doses, the following have been reported; they are listed
in decreasing order of severity, but not of frequency:
Nervous system: numbness of extremities, euphoria, depression, malaise/lethargy, confusion, sedation/drowsiness, dizziness, restlessness, headache.
Allergic: anaphylaxis, angioneurotic edema, urticaria, swelling of the gums, pruritus.
Gastrointestinal system: toxic megacolon, paralytic ileus, pancreatitis, vomiting, nausea, anorexia, abdominal discomfort.
The following atropine sulfate effects are listed in decreasing order of severity, but not of frequency: hyperthermia, tachycardia, urinary retention, flushing, dryness of the skin and mucous membranes. These effects may occur, especially in children.
THIS MEDICATION SHOULD BE KEPT IN A CHILD-RESISTANT CONTAINER AND OUT OF THE REACH OF CHILDREN SINCE AN OVERDOSAGE MAY RESULT IN SEVERE RESPIRATORY DEPRESSION AND COMA, POSSIBLY LEADING TO PERMANENT BRAIN DAMAGE OR DEATH.
Drug Abuse and Dependence
Controlled substance: Lomotil (diphenoxylate and atropine) is classified as a Schedule V controlled substance by federal regulation. Diphenoxylate hydrochloride is chemically related to the narcotic analgesic meperidine.
Drug abuse and dependence: In doses used for the treatment of diarrhea, whether acute or chronic, diphenoxylate has not produced addiction. Diphenoxylate hydrochloride is devoid of morphine-like subjective effects at therapeutic doses. At high doses it exhibits codeine-like subjective effects. The dose which produces antidiarrheal action is widely separated from the dose which causes central nervous system effects. The insolubility of diphenoxylate hydrochloride in commonly available aqueous media precludes intravenous self-administration. A dose of 100 to 300 mg/day, which is equivalent to 40 to 120 tablets, administered to humans for 40 to 70 days, produced opiate withdrawal symptoms. Since addiction to diphenoxylate hydrochloride is possible at high doses, the recommended dosage should not be exceeded.
Read the entire FDA prescribing information for Lomotil (Diphenoxylate and Atropine)
Additional Lomotil Information
Lomotil - User Reviews
Lomotil User Reviews
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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