Imodium Side Effects
Generic Name: Loperamide
Please note - some side effects for Imodium may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).
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For the consumer For the professional
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Side Effects of Imodium - for the consumer
Imodium Multi-Symptom Relief
All medicines may cause side effects, but many people have no, or minor, side effects. No COMMON side effects have been reported with Imodium Multi-Symptom Relief. Seek medical attention right away if any of these SEVERE side effects occur when using Imodium Multi-Symptom Relief:
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); constipation; decreased urination; red, swollen, blistered, or peeling skin; stomach bloating, swelling, or pain.
Imodium
All medicines may cause side effects, but many people have no, or minor, side effects. No COMMON side effects have been reported with Imodium. Seek medical attention right away if any of these SEVERE side effects occur when using Imodium:
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); constipation; decreased urination; red, swollen, blistered, or peeling skin; stomach bloating, swelling, or pain.
Imodium A-D
All medicines may cause side effects, but many people have no, or minor, side effects. No COMMON side effects have been reported with Imodium A-D. Seek medical attention right away if any of these SEVERE side effects occur when using Imodium A-D:
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); constipation; decreased urination; red, swollen, blistered, or peeling skin; stomach bloating, swelling, or pain.
Imodium A-D Solution
All medicines may cause side effects, but many people have no, or minor, side effects. No COMMON side effects have been reported for with Imodium A-D Solution. Seek medical attention right away if any of these SEVERE side effects occur when using Imodium A-D Solution:
TopSevere allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); constipation; decreased urination; red, swollen, blistered, or peeling skin; stomach bloating, swelling, or pain.
For the professional
Imodium
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 * | |
|---|---|---|---|
| |||
| 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.
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.
TopMore resources:
Diar-Aid - Includes detailed dosage instructions.
Imodium - Includes detailed dosage instructions.
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