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Imotil Side Effects

Generic name: loperamide

Medically reviewed by Drugs.com. Last updated on Jan 17, 2024.

Note: This document contains side effect information about loperamide. Some dosage forms listed on this page may not apply to the brand name Imotil.

Applies to loperamide: oral capsule, oral capsule liquid filled, oral liquid, oral solution, oral suspension, oral tablet.

Warning

Oral route (Capsule)

Cases of Torsades de Pointes, cardiac arrest, and death have been reported with the use of a higher than recommended dosages of loperamide hydrochloride. Loperamide hydrochloride is contraindicated in pediatric patients less than 2 years of age. Avoid loperamide hydrochloride dosages higher than recommended in adults and pediatric patients 2 years of age and older due to the risk of serious cardiac adverse reactions.

Serious side effects of Imotil

Along with its needed effects, loperamide (the active ingredient contained in Imotil) 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 loperamide:

Rare

Incidence not known

Other side effects of Imotil

Some side effects of loperamide 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:

Rare

For Healthcare Professionals

Applies to loperamide: compounding powder, oral capsule, oral liquid, oral suspension, oral tablet, oral tablet chewable.

General

The most common adverse events were constipation, flatulence, headache, nausea, and dizziness.

Gastrointestinal

Common (1% to 10%): Constipation, nausea, flatulence, dry mouth, abdominal cramp, colic, vomiting, meteorism, abdominal pain

Uncommon (0.1% to 1%): Abdominal discomfort, abdominal pain upper, dyspepsia

Rare (less than 0.1%): Ileus (including paralytic ileus), megacolon (including toxic megacolon), abdominal distension[Ref]

Nervous system

Common (1% to 10%): Headache, dizziness

Uncommon (0.1% to 1%): Somnolence

Rare (less than 0.1%): Loss of consciousness, stupor, depressed level of consciousness, hypertonia, coordination abnormality

Postmarketing reports: Syncope[Ref]

Other

Rare (less than 0.1%): Fatigue

Postmarketing reports: Death, tiredness[Ref]

Hypersensitivity

Rare (less than 0.1%): Hypersensitivity reaction, anaphylactic reaction (including anaphylactic shock), anaphylactoid reaction[Ref]

Cardiovascular

Postmarketing reports: QT/QTc prolongation, Torsades de Pointes, other ventricular arrhythmias, cardiac arrest[Ref]

Dermatologic

Uncommon (0.1% to 1%): Rash

Rare (less than 0.1%): Bullous eruption (including Stevens-Johnson syndrome, toxic epidermal necrolysis, and erythema multiforme), angioedema, urticaria, pruritus[Ref]

Genitourinary

Rare (less than 0.1%): Urinary retention[Ref]

Ocular

Rare (less than 0.1%): Miosis

Frequently asked questions

References

1. Ericsson CD, Johnson PC. Safety and efficacy of loperamide. Am J Med. 1990;88:s10-4.

2. Brown JW. Toxic megacolon associated with loperamide therapy. JAMA. 1979;241:501-2.

3. Walley T, Milson D. Loperamide related toxic megacolon in Clostridium difficile colitis. Postgrad Med J. 1990;66:582.

4. Katz JP, Sturmann KM. Appendicitis associated with loperamide hydrochloride abuse. Ann Pharmacother. 1993;27:369-70.

5. Olm M, Gonzalez FJ, Garcia-Valdecasas JC, Fuster J, Bertran A, Milla J. Necrotising colitis with perforation in diarrhoic patients treated with loperamide. Eur J Clin Pharmacol. 1991;40:415-6.

6. Product Information. Imodium (loperamide). Janssen Pharmaceuticals. 2001;PROD.

7. Product Information. Loperamide Hydrochloride (loperamide). Teva Pharmaceuticals USA. 2018.

8. Hill MA, Greason FC. Loperamide dependence. J Clin Psychiatry. 1992;53:450.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.