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Imodium Adverse Events Reported to the FDA Over Time

How are Imodium adverse event reports trending over time?

This graph shows volume of adverse events submitted to the FDA by quarter for Imodium, as well as related generic and/or brandname drugs containing the same primary active ingredients. Adverse events are counted if Imodium is flagged as the suspect drug causing the adverse event.

Most Common Imodium Adverse Events Reported to the FDA

What are the most common Imodium adverse events reported to the FDA?

Diarrhoea
255 (3.47%)
Overdose
146 (1.98%)
Drug Ineffective
129 (1.75%)
Vomiting
117 (1.59%)
Constipation
106 (1.44%)
Haematochezia
100 (1.36%)
Drug Interaction
93 (1.26%)
Abdominal Pain
87 (1.18%)
Intentional Drug Misuse
71 (.97%)
Dehydration
70 (.95%)
Dyspnoea
68 (.92%)
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Nausea
67 (.91%)
Somnolence
66 (.9%)
Suicide Attempt
63 (.86%)
Pyrexia
62 (.84%)
Incorrect Dose Administered
56 (.76%)
Weight Decreased
54 (.73%)
Abdominal Distension
50 (.68%)
Abdominal Pain Upper
49 (.67%)
Dizziness
49 (.67%)
Intestinal Obstruction
47 (.64%)
Malaise
45 (.61%)
Rash
45 (.61%)
Toxic Epidermal Necrolysis
45 (.61%)
Loss Of Consciousness
44 (.6%)
Fatigue
43 (.58%)
Multiple Drug Overdose Intentional
41 (.56%)
Renal Failure Acute
39 (.53%)
Death
38 (.52%)
Asthenia
37 (.5%)
Urinary Retention
37 (.5%)
Completed Suicide
35 (.48%)
International Normalised Ratio Incr...
34 (.46%)
Renal Failure
34 (.46%)
Faeces Discoloured
33 (.45%)
Thrombocytopenia
33 (.45%)
Rectal Haemorrhage
32 (.44%)
Anaemia
31 (.42%)
Chest Pain
31 (.42%)
Ileus
30 (.41%)
Intentional Overdose
30 (.41%)
Anxiety
29 (.39%)
Confusional State
29 (.39%)
Expired Drug Administered
29 (.39%)
Fall
29 (.39%)
Product Quality Issue
29 (.39%)
Stevens-johnson Syndrome
28 (.38%)
Hyponatraemia
27 (.37%)
Pain
27 (.37%)
Syncope
27 (.37%)
Inappropriate Schedule Of Drug Admi...
26 (.35%)
Sepsis
26 (.35%)
Tachycardia
26 (.35%)
Blood Glucose Increased
25 (.34%)
Cholestasis
25 (.34%)
Decreased Appetite
25 (.34%)
Haemorrhage
25 (.34%)
Multiple Drug Overdose
25 (.34%)
Pruritus
25 (.34%)
Urticaria
25 (.34%)
Choking
24 (.33%)
Hypotension
24 (.33%)
Wrong Technique In Drug Usage Proce...
24 (.33%)
Anaphylactic Reaction
23 (.31%)
Dysphagia
23 (.31%)
Headache
23 (.31%)
Heart Rate Increased
23 (.31%)
Muscle Spasms
23 (.31%)
Septic Shock
23 (.31%)
Colitis Ischaemic
22 (.3%)
Faecaloma
22 (.3%)
Gastrointestinal Disorder
22 (.3%)
Abdominal Discomfort
21 (.29%)
Agitation
21 (.29%)
Condition Aggravated
21 (.29%)
Drug Abuse
21 (.29%)
Dysuria
21 (.29%)
Haemoglobin Decreased
21 (.29%)
Incorrect Drug Administration Durat...
21 (.29%)
Megacolon
21 (.29%)
Suicidal Ideation
21 (.29%)
Coma
20 (.27%)
Drug Exposure During Pregnancy
20 (.27%)
Leukopenia
20 (.27%)
Neutropenia
20 (.27%)
Alanine Aminotransferase Increased
19 (.26%)
Cardiac Arrest
19 (.26%)
Drug Dependence
19 (.26%)
Flatulence
19 (.26%)
Hypersensitivity
19 (.26%)
Pain In Extremity
19 (.26%)
Anaphylactic Shock
18 (.24%)
Contusion
18 (.24%)
Cytolytic Hepatitis
18 (.24%)
Depressed Level Of Consciousness
18 (.24%)
Drug Toxicity
18 (.24%)
Gamma-glutamyltransferase Increased
18 (.24%)
Oedema Peripheral
18 (.24%)
Atrial Fibrillation
17 (.23%)
Cholelithiasis
17 (.23%)
Dry Mouth
17 (.23%)

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This graph shows the top adverse events submitted to the FDA for Imodium, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Imodium is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Adverse Event Categories for Imodium

What are the most common Imodium adverse events reported to the FDA?

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This graph shows the top categories of adverse events submitted to the FDA for Imodium, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Imodium is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Common Uses of Imodium According to Those Reporting Adverse Events

Why are people taking Imodium, according to those reporting adverse events to the FDA?

Diarrhoea
3150
Drug Use For Unknown Indication
801
Product Used For Unknown Indication
588
Crohns Disease
261
Irritable Bowel Syndrome
101
Prophylaxis Against Diarrhoea
57
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Prophylaxis
50
Colitis Ulcerative
50
Gastroenteritis
37
Antidiarrhoeal Supportive Care
28
Ill-defined Disorder
24
Colitis
22
Suicide Attempt
20
Constipation
20
Short-bowel Syndrome
18
Post Procedural Diarrhoea
17
Gastrointestinal Disorder
17
Abdominal Pain
16
Enteritis Infectious
16
Vomiting
14
Drug Exposure During Pregnancy
12
Functional Gastrointestinal Disorde...
11
Abdominal Discomfort
10
Cholinergic Syndrome
10
Nausea
9
Migraine
9
Gastroenteritis Viral
8
Diverticulitis
8
Abdominal Pain Upper
8
Gastric Disorder
7
Flatulence
7
Pain
7
Diarrhoea Infectious
6
Gastrointestinal Motility Disorder
6
Accidental Exposure
6
Frequent Bowel Movements
6
Enterocolitis
6
Dyspepsia
6
Premedication
5
Colectomy
5
Faecal Volume Increased
4
Suicidal Ideation
4
Palliative Care
4
Faecal Incontinence
4
Defaecation Urgency
4
Overdose
4
Bowel Movement Irregularity
3
Influenza Like Illness
3
Diverticulum
3
Intentional Drug Misuse
3
Bone Marrow Conditioning Regimen
3

Drug Labels

LabelLabelerEffective
Imodiuma-dMcNeil Consumer Healthcare Div McNeil-PPC, Inc06-OCT-10
Imodium A-dMcNeil Consumer Healthcare Div. McNeil-PPC, Inc30-NOV-10
Imodium A-dMcNeil Consumer Healthcare Div McNeil-PPC, Inc04-APR-12
Imodium AdLil' Drug Store Products, Inc.03-JAN-13

Imodium Case Reports

What Imodium safety concerns are being reported by doctors and researchers in the medical literature?

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About Results

This report contains aggregated drug side effects and adverse events for Imodium. The data has been pulled from the United States Food and Drug Administration's (US FDA) Adverse Event Reporting System (AERS), a database containing more than 4,000,000 adverse event reports.

DrugCite expands your query using the Unified Medical Language System (UMLS) to include generic drugs and primary active ingredients. While the core of DrugCite's advanced drug filtering algorithm is based on the industry standard UMLS, DrugCite's proprietary filtering system also includes dozens of additional steps to reconcile malformed drug names in the FDA's data.

DrugCite only counts a drug if the submitter of the adverse event indicates that the drug is suspected to have caused the adverse event.

Depending on how the data is aggregated, different counts may occur. When someone submits an adverse event to the FDA, the submitter can attribute multiple adverse events to one or more drugs. For example, an individual taking Paxil could submit the adverse events "anxiety" and "suicidal ideation" for the same individual safety report (ISR). This means when DrugCite aggregates by adverse event, two distinct adverse events are counted in the adverse event graph; once for "anxiety" and again for "suicidal ideation". However, when DrugCite aggregates by individual safety reports irrespective of the details of the adverse events contained within the safety report, the report is only counted once.

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