ADVERSE REACTIONS
Clinical Trial Data
The adverse effects reported during clinical investigations of IMODIUM® (loperamide hydrochloride) are difficult to distinguish from symptoms associated with the diarrheal syndrome. Adverse experiences recorded during clinical studies with IMODIUM® were generally of a minor and self-limiting nature. They were more commonly observed during the treatment of chronic diarrhea.
The adverse events reported are summarized irrespective of the causality assessment of the investigators.
1) Adverse events from 4 placebo-controlled studies in patients with acute diarrhea
The adverse events with an incidence of 1.0% or greater, which were reported at least as often in patients on loperamide hydrochloride as on placebo, are presented in the table below.
| Acute Diarrhea |
|---|
| Loperamide Hydrochloride | Placebo |
|---|
| No. of treated patients | 231 | 236 |
| Gastrointestinal AE% | | |
| Constipation | 2.6% | 0.8% |
The adverse events with an incidence of 1.0% or greater, which were more frequently reported in patients on placebo than on loperamide hydrochloride, were: dry mouth, flatulence, abdominal cramp and colic.
2) Adverse events from 20 placebo-controlled studies in patients with chronic diarrhea
The adverse events with an incidence of 1.0% or greater, which were reported at least as often in patients on loperamide hydrochloride as on placebo, are presented below in the table below.
| Chronic Diarrhea |
|---|
| Loperamide Hydrochloride | Placebo |
|---|
| No. of treated patients | 285 | 277 |
| Gastrointestinal AE% | | |
| Constipation | 5.3% | 0.0% |
| Central and peripheral nervous system AE% | | |
| Dizziness | 1.4% | 0.7% |
The adverse events with an incidence of 1.0% or greater, which were more frequently reported in patients on placebo than on loperamide hydrochloride were: nausea, vomiting, headache, meteorism, abdominal pain, abdominal cramp and colic.
3) Adverse events from seventy-six controlled and uncontrolled studies in patients with acute or chronic diarrhea
The adverse events with an incidence of 1.0% or greater in patients from all studies are given in the table below.
| Acute Diarrhea | Chronic Diarrhea | All Studies All patients in all studies, including those in which it was not specified if the adverse events occurred in patients with acute or chronic diarrhea. |
|---|
| No. of treated patients | 1913 | 1371 | 3740 |
| Gastrointestinal AE% | | | |
| Nausea | 0.7% | 3.2% | 1.8% |
| Constipation | 1.6% | 1.9% | 1.7% |
| Abdominal cramps | 0.5% | 3.0% | 1.4% |
Post –marketing experience
The following adverse events have been reported:
Skin and subcutaneous tissue disorders
Rash, pruritus, urticaria, angioedema, and extremely rare cases of bullous eruption including erythema multiforme, Stevens-Johnson syndrome and Toxic Epidermal Necrolysis have been reported with use of IMODIUM
Immune system disorders
Isolated occurrences of allergic reactions and in some cases severe hypersensitivity reactions including anaphylactic shock and anaphylactoid reactions have been reported with the use of IMODIUM.
Gastrointestinal disorders
Dry mouth, abdominal pain, distention or discomfort, nausea, vomiting, flatulence, dyspepsia, constipation, paralytic ileus, megacolon, including toxic megacolon (see Contraindications and Warnings).
Renal and urinary disorders
Urinary retention
Nervous system disorders
Drowsiness, dizziness
General disorders and administrative site conditions
Tiredness
A number of the adverse events reported during the clinical investigations and post-marketing experience with loperamide are frequent symptoms of the underlying diarrheal 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.
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