Applies to loperamide: oral capsules, oral solution or suspension, oral tablets.
Warning
-
Torsades de Pointes and Sudden Death
- Cases of torsades de pointes, cardiac arrest, and death reported with use of higher than recommended dosage.124 (See Cardiovascular Effects under Cautions.)
- Contraindicated in pediatric patients <2 years of age.124 (See Pediatric Use under Cautions.)
- Avoid dosages higher than recommended in adults and pediatric patients ≥2 years of age due to risk of serious adverse cardiac effects.124 (See Dosage under Dosage and Administration.)
Side effects include:
Nausea, constipation, abdominal cramps, dizziness.
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
