| In clinical trials, constipation and dizziness have been reported with greater frequency in loperamide hydrochloride treated patients than placebo treated patients. The following adverse events have also been reported with use of loperamide hydrochloride: Immune system disorders Very rare: isolated occurrences of allergic reactions and in some cases severe hypersensitivity reactions including anaphylactic shock and anaphylactoid reactions.Psychiatric disorders Very rare: drowsinessNervous system disorders Very rare: Loss of consciousness, depressed level of consciousness, dizzinessGastrointestinal disorders Very rare: abdominal pain, ileus, abdominal distension, nausea, constipation, vomiting, megacolon including toxic megacolon, flatulence, and dyspepsia.Skin and subcutaneous tissue disorders Very rare: rash, urticaria and pruritus.Isolated occurrences of angioedema, and bullous eruptions including Stevens-Johnson Syndrome, erythema multiforme, and toxic epidermal necrolysis.Renal and urinary disorders Very rare: isolated reports of urinary retention. A number of the adverse events reported during the clinical investigations and post-marketing experience with loperamide are frequent symptoms of the underlying diarrhoeal syndrome (abdominal pain/discomfort, nausea, vomiting, dry mouth, tiredness, drowsiness, dizziness, constipation, and flatulence). These symptoms are often difficult to distinguish from undesirable drug effects. | |