Medical Editor: John P. Cunha, DO, FACOEP
Motofen (difenoxin hydrochloride and atropine sulfate) is an anticholinergic used to treat diarrhea. Common side effects of Motofen include:
- blurred vision
- dry mouth
- loss of appetite
- upset stomach
- insomnia, and
- burning sensation in the eyes
Tell your doctor if you have unlikely but serious side effects of Motofen including:
- stomach or abdominal pain or swelling,
- severe nausea,
- mental/mood changes (e.g., confusion, depression),
- restlessness, or
- numbness or tingling of arms or legs.
The recommended starting dose of Motofen in adults is 2 tablets (2 mg), then 1 tablet (1 mg) after each loose stool or 1 tablet (1 mg) every 3 to 4 hours as needed, but the total dosage during any 24-hour treatment period should not exceed 8 tablets (8 mg). Motofen may interact with ambenonium, pramlintide, MAO inhibitors, naltrexone, potassium supplements, or drugs that cause drowsiness such as antihistamines, anti-seizure drugs, barbiturates, medicine for sleep or anxiety, muscle relaxants, narcotics, or psychiatric medicines. Tell your doctor all medications and supplements you use. During pregnancy, Motofen should be used only if prescribed. This drug passes into breast milk. Consult your doctor before breastfeeding. Withdrawal symptoms may occur if you suddenly stop taking this medication.
Our Motofen (difenoxin hydrochloride and atropine sulfate) 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.
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, blurred vision).
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 Motofen (Difenoxin and Atropine)
In view of the small amount of atropine present (0.025 mg/tablet), such effects such as dryness of the skin and mucous membranes, flushing, hyperthermia, tachycardia and urinary retention are very unlikely to occur, except perhaps in children. Many of the adverse effects reported during clinical investigation of MOTOFEN® are difficult to distinguish from symptoms associated with the diarrheal syndrome. However, the following events were reported at the stated frequencies:
Gastrointestinal: Nausea, 1 in 15 patients; vomiting, 1 in 30 patients; dry mouth, 1 in 30 patients; epigastric distress, 1 in 100 patients; and constipation, 1 in 300 patients.
Central Nervous System: Dizziness and light-headedness, 1 in 20 patients; drowsiness, 1 in 25 patients; and headache, 1 in 40 patients; tiredness, nervousness, insomnia and confusion ranged from 1 in 200 to 1 in 600 patients.
Other less frequent reactions: Burning eyes and blurred vision occurred in a few cases.
The following adverse reactions have been reported in patients receiving chemically-related drugs: numbness of extremities, euphoria, depression, sedation, anaphylaxis, angioneurotic edema, urticaria, swelling of the gums, pruritus, toxic megacolon, paralytic ileus, pancreatitis, and anorexia.
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
MOTOFEN® tablets are a Schedule IV controlled substance.
Addiction to (dependence on) difenoxin hydrochloride is theoretically possible at high dosage. Therefore, the recommended dosage should not be exceeded. Because of the structural and pharmacological similarities of difenoxin hydrochloride to drugs with a definite addiction potential, MOTOFEN® should be administered with considerable caution to patients who are receiving addicting drugs, to individuals known to be addiction prone, or to those in whom histories suggest may increase dosage on their own initiative.
Read the entire FDA prescribing information for Motofen (Difenoxin and Atropine)
© Motofen Patient Information is supplied by Cerner Multum, Inc. and Motofen Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.