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Imodium (Loperamide Hydrochloride) - Side Effects and Adverse Reactions

 
 



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 HydrochloridePlacebo
No. of treated patients 231 236
Gastrointestinal AE%
Constipation2.6%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 HydrochloridePlacebo
No. of treated patients 285 277
Gastrointestinal AE%
Constipation5.3%0.0%
Central and peripheral nervous system AE%
Dizziness1.4%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 DiarrheaChronic DiarrheaAll 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%
Nausea0.7%3.2%1.8%
Constipation1.6%1.9%1.7%
Abdominal cramps0.5%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.



REPORTS OF SUSPECTED IMODIUM SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Imodium. The information is not vetted and should not be considered as verified clinical evidence.

Possible Imodium side effects / adverse reactions in 52 year old female

Reported by a consumer/non-health professional from United States on 2011-10-11

Patient: 52 year old female weighing 72.1 kg (158.7 pounds)

Reactions: Agitation, Productive Cough, Pruritus, Lymphadenopathy, Oropharyngeal Pain, Serotonin Syndrome, Accidental Overdose, Oral Mucosal Exfoliation, Rash Pruritic, Tongue Disorder, Feeling Hot, LIP Exfoliation, Blood Pressure Systolic Increased, Restlessness, Chromaturia, Drug Withdrawal Syndrome, Tremor, Exercise Tolerance Decreased, Irritability, Rash Erythematous, Ocular Icterus, Meningitis Aseptic, LIP Swelling, Drug Ineffective, Chills, Somnolence, Suicidal Ideation, Impulse-Control Disorder, Fatigue, Dizziness, Musculoskeletal Stiffness, Candidiasis, Rash Pustular, Swelling Face, Drug Hypersensitivity, Rash, Eye Pain, Logorrhoea, Anxiety, Diarrhoea, Heart Rate Increased, Asthenia

Adverse event resulted in: hospitalization

Suspect drug(s):
Risperidone
    Dosage: 0.75 mg

Abilify
    Dosage: 5 mg;qd ; 15 mg;qd ; 5 mg;qd
    End date: 2011-06-01

Abilify
    Dosage: 5 mg;qd ; 15 mg;qd ; 5 mg;qd
    Start date: 2011-06-01
    End date: 2011-06-01

Abilify
    Dosage: 5 mg;qd ; 15 mg;qd ; 5 mg;qd
    Start date: 2011-06-01
    End date: 2011-08-01

Zyprexa
    Dosage: 10 mg;hs

Imodium
    Indication: Diarrhoea
    Start date: 2011-08-01
    End date: 2011-08-01

Lamotrigine
    Dosage: 200 mg;qd;po ; 175 mg;qd;po ; 150 mg;qd;po
    Administration route: Oral
    Indication: Bipolar Disorder
    Start date: 2011-01-01
    End date: 2011-01-01

Lamotrigine
    Dosage: 200 mg;qd;po ; 175 mg;qd;po ; 150 mg;qd;po
    Administration route: Oral
    Indication: Bipolar Disorder
    Start date: 2011-09-01

Lamotrigine
    Dosage: 200 mg;qd;po ; 175 mg;qd;po ; 150 mg;qd;po
    Administration route: Oral
    Indication: Bipolar Disorder
    Start date: 2010-11-01
    End date: 2011-01-01

Other drugs received by patient: Klonopin; Seroquel; Albuterol; Levothyroxine Sodium



Possible Imodium side effects / adverse reactions in 61 year old male

Reported by a health professional (non-physician/pharmacist) from France on 2011-10-13

Patient: 61 year old male

Reactions: Blood Albumin Increased, Haemoglobin Decreased, Dermatitis Contact, Drug Eruption, Blood Urea Increased, Breath Sounds Abnormal, Blood Lactate Dehydrogenase Increased, Pyrexia, Thrombocytopenia, Toxic Skin Eruption

Adverse event resulted in: hospitalization

Suspect drug(s):
Imodium
    Dosage: 3 dosage forms daily if needed

Lyrica
    Dosage: 25 mg, 2x/day

Atarax
    Dosage: 25 mg, 3x/day

Valganciclovir
    Dosage: 450 mg, 2x/day

Other drugs received by patient: Dexeryl



Possible Imodium side effects / adverse reactions in 40 year old female

Reported by a pharmacist from Germany on 2011-12-02

Patient: 40 year old female

Reactions: Overdose, Arteriosclerosis Coronary Artery

Adverse event resulted in: death

Suspect drug(s):
Imodium



See index of all Imodium side effect reports >>

Drug label data at the top of this Page last updated: 2008-02-26

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