Atropine / difenoxin Side Effects

For the Consumer

Applies to atropine / difenoxin: oral tablet

Along with its needed effects, atropine / difenoxin may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking atropine / difenoxin:

• Bloating
• constipation
• loss of appetite
• stomach pain (severe) with nausea and vomiting

Get emergency help immediately if any of the following symptoms of overdose occur while taking atropine / difenoxin:

• Blurred vision (continuing) or changes in near vision
• drowsiness (severe)
• dryness of mouth, nose, and throat (severe)
• fast heartbeat
• shortness of breath or troubled breathing (severe)
• unusual excitement, nervousness, restlessness, or irritability
• unusual warmth, dryness, and flushing of skin

Some side effects of atropine / difenoxin may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Blurred vision
• confusion
• difficult urination
• dizziness or lightheadedness
• drowsiness
• dryness of skin and mouth
• fever
• headache
• trouble in sleeping
• unusual tiredness or weakness

After you stop using this medicine, it may still produce some side effects that need attention. During this period of time, check with your doctor immediately if you notice the following side effects:

• Increased sweating
• muscle cramps
• nausea or vomiting
• shivering or trembling
• stomach cramps

For Healthcare Professionals

Applies to atropine / difenoxin: oral tablet

Gastrointestinal

Gastrointestinal side effects have included 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).

In patients receiving chemically-related drugs, toxic megacolon, paralytic ileus, pancreatitis, and anorexia have been reported.^[Ref]

Cardiovascular

Cardiovascular side effects have included tachycardia with the use of atropine.^[Ref]

Nervous system

Nervous system side effects have included dizziness (1 in 20 patients), lightheadedness (1 in 20 patients), drowsiness (1 in 25 patients), headache (1 in 40 patients). Other less common side effects have included tiredness and insomnia.

Patients receiving chemically-related drugs have reported confusion, numbness of extremities, euphoria, depression, and sedation.^[Ref]

Hypersensitivity

Hypersensitivity side effects have included anaphylaxis, angioneurotic edema, urticaria, swelling of the gums, and pruritus.^[Ref]

Ocular

Ocular side effects have included burning eyes and blurred vision.^[Ref]

General

General side effects reported with use of atropine have included flushing and hyperthermia.^[Ref]

Genitourinary

Genitourinary side effects have included urinary retention with use of atropine.^[Ref]

Some side effects of atropine / difenoxin may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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