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LOPERAMIDE

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Loperamide Adverse Events Reported to the FDA Over Time

How are Loperamide adverse event reports trending over time?

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

Most Common Loperamide Adverse Events Reported to the FDA

What are the most common Loperamide 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 Loperamide, 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 Loperamide 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 Loperamide

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

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This graph shows the top categories of adverse events submitted to the FDA for Loperamide, 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 Loperamide 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 Loperamide According to Those Reporting Adverse Events

Why are people taking Loperamide, 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
Loperamide HydrochlorideMylan Pharmaceuticals Inc.12-JUL-06
Loperamide HydrochloridePD-Rx Pharmaceuticals, Inc.12-JUL-06
Loperamide HydrochlorideRoxane Laboratories, Inc20-OCT-09
Loperamide HydrochlorideState of Florida DOH Central Pharmacy05-MAR-10
Loperamide HydrochlorideLake Erie Medical DBA Quality Care Products LLC01-OCT-10
Loperamide HydrochlorideUDL Laboratories, Inc.12-NOV-10
Loperamide HydrochlorideRebel Distributors Corp29-DEC-10
Loperamide HydrochloridePreferred Pharmaceuticals, Inc28-JAN-11
Loperamide HydrochlorideCardinal Health10-MAY-11
Loperamide HydrochlorideCardinal Health22-JUN-11
Loperamide Hcl Anti-diarrhealP and L Development of New York Company30-AUG-11
Loperamide HydrochloridePD-Rx Pharmaceuticals, Inc.23-SEP-11
Loperamide HydrochloridePD-Rx Pharmaceuticals, Inc.23-SEP-11
Loperamide HydrochlorideREMEDYREPACK INC. 16-NOV-11
Loperamide HydrochlorideMcKesson Contract Packaging07-FEB-12
Loperamide HydrochloridePrecision Dose Inc.17-FEB-12
Loperamide HydrochlorideCardinal Health17-APR-12
Loperamide HydrochlorideOhm Laboratories Inc.20-APR-12
Loperamide HydrochloridePhysicians Total Care, Inc.26-APR-12
Equate Loperamide HydrochlorideWal-Mart Stores Inc21-MAY-12
Health Mart Loperamide HydrochlorideMcKesson19-JUN-12
Loperamide HclMcKesson26-JUN-12
Loperamide HydrochlorideHi-Tech Pharmacal Co., Inc.29-JUN-12
Loperamide HydrochloridePremier Value23-JUL-12
Loperamide HydrochloridePreferred Pharmaceuticals, Inc.25-JUL-12
Loperamide HydrochlorideMajor Pharmaceuticals02-AUG-12
Loperamide HydrochlorideTeva Pharmaceuticals USA Inc03-AUG-12
Loperamide HydrochlorideREMEDYREPACK INC. 21-AUG-12
Good Sense Loperamide HydrochlorideL Perrigo Company23-AUG-12
Leader Loperamide HydrochlorideCardinal Health29-AUG-12
Loperamide HydrochlorideCVS Pharmacy29-AUG-12
Loperamide HydrochlorideWalgreen Company30-AUG-12
Loperamide HydrochlorideH E B30-AUG-12
Loperamide HydrochlorideHyVee Inc13-SEP-12
Good Neighbor Pharmacy Loperamide HydrochlorideAmerisource Bergen13-SEP-12
Loperamide HydrochlorideChain Drug Marketing Association Inc.13-SEP-12
Smart Sense Loperamide HydrochlorideKmart Corporation13-SEP-12
Topcare Loperamide HydrochlorideTopco Associates LLC14-SEP-12
Careone Loperamide HydrochlorideAmerican Sales Company14-SEP-12
Loperamide HydrochlorideWestern Family Foods Inc14-SEP-12
Loperamide HydrochlorideMeijer Distribution Inc14-SEP-12
Equaline Loperamide HydrochlorideSupervalu Inc16-SEP-12
Loperamide HydrochlorideFamily Dollar Services, Inc.17-SEP-12
Loperamide HydrochlorideRite Aid Corporation17-SEP-12
Loperamide HydrochloridePhysicians Total Care, Inc.18-SEP-12
Loperamide HydrochlorideSelect Brand27-SEP-12
Anti-diarrhealloperamide HclMckesson (Sunmark)02-OCT-12
Loperamide HydrochlorideDispensing Solutions, Inc.03-OCT-12
Dg Health Loperamide HydrochlorideDolgencorp Inc08-OCT-12
Anti-diarrhealloperamide HclWestern Family Foods, Inc.10-OCT-12
Loperamide Hydrochloride STAT Rx USA LLC12-OCT-12
Loperamide HydrochlorideAmerisource Bergen23-OCT-12
Loperamide HydrochlorideNCS HealthCare of KY, Inc dba Vangard Labs02-NOV-12
Anti-diarrhealValu Merchandisers Company (Best Choice)19-NOV-12
Loperamide HclChain Drug Consortium, LLC05-DEC-12
Anti-diarrhealGeiss, Destin & Dunn, Inc (Goodsense)19-DEC-12
Anti-diarrhealCVS Pharmacy21-DEC-12
Anti-diarrhealCare One (American Sales Company)27-DEC-12
Loperamide HydrochlorideFred's Inc.07-JAN-13
Anti-diarrhealFreds Inc09-JAN-13
Loperamide HydrochlorideBryant Ranch Prepack21-JAN-13
Loperamide HydrochlorideValu Merchandisers Company24-JAN-13
Loperamide HydrochlorideShopko Stores Operating Co., LLC06-FEB-13
Loperamide HydrochlorideREMEDYREPACK INC. 11-FEB-13
Loperamide HydrochloridePreferred Pharmaceuticals, Inc.08-MAR-13
Loperamide HydrochlorideREMEDYREPACK INC. 18-MAR-13
Loperamide HydrochlorideMedline Industries, Inc.22-MAR-13
Anti-diarrhealDolgencorp, Inc. (DOLLAR GENERAL & REXALL)02-MAY-13

Loperamide Case Reports

What Loperamide 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 Loperamide. 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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