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Osmoprep Adverse Events Reported to the FDA Over Time

How are Osmoprep adverse event reports trending over time?

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

Most Common Osmoprep Adverse Events Reported to the FDA

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

Renal Failure Acute
60 (3.68%)
Vomiting
48 (2.94%)
Nausea
41 (2.51%)
Renal Failure
40 (2.45%)
Dehydration
32 (1.96%)
Asthenia
30 (1.84%)
Diarrhoea
27 (1.65%)
Nephrocalcinosis
25 (1.53%)
Dizziness
23 (1.41%)
Headache
20 (1.23%)
Paraesthesia
20 (1.23%)
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Nephropathy
19 (1.16%)
Tremor
19 (1.16%)
Blood Potassium Decreased
18 (1.1%)
Hyponatraemia
17 (1.04%)
Abdominal Pain
15 (.92%)
Hyperphosphataemia
15 (.92%)
Hypoaesthesia
15 (.92%)
Loss Of Consciousness
15 (.92%)
Anaemia
14 (.86%)
Hypokalaemia
14 (.86%)
Malaise
14 (.86%)
Dialysis
13 (.8%)
Dyspnoea
13 (.8%)
Pain
13 (.8%)
Back Pain
12 (.74%)
Blood Creatinine Increased
12 (.74%)
Chest Pain
12 (.74%)
Tubulointerstitial Nephritis
12 (.74%)
Abdominal Distension
11 (.67%)
Convulsion
11 (.67%)
Haemodialysis
11 (.67%)
Heart Rate Increased
11 (.67%)
Hypersensitivity
11 (.67%)
Hypertension
11 (.67%)
Electrolyte Imbalance
10 (.61%)
Fatigue
10 (.61%)
Renal Impairment
10 (.61%)
Weight Decreased
10 (.61%)
Anaphylactic Reaction
9 (.55%)
Renal Tubular Necrosis
9 (.55%)
Feeling Abnormal
8 (.49%)
Hypotension
8 (.49%)
Myocardial Infarction
8 (.49%)
Pyrexia
8 (.49%)
Somnolence
8 (.49%)
Urticaria
8 (.49%)
Fall
7 (.43%)
Hypocalcaemia
7 (.43%)
Hypophagia
7 (.43%)
Hypovolaemia
7 (.43%)
Renal Failure Chronic
7 (.43%)
Renal Tubular Atrophy
7 (.43%)
Abdominal Pain Upper
6 (.37%)
Blood Sodium Decreased
6 (.37%)
Chills
6 (.37%)
Colitis Ischaemic
6 (.37%)
Confusional State
6 (.37%)
Depression
6 (.37%)
Diabetes Mellitus
6 (.37%)
Incorrect Dose Administered
6 (.37%)
Kidney Fibrosis
6 (.37%)
Lethargy
6 (.37%)
Muscle Spasms
6 (.37%)
Pleural Effusion
6 (.37%)
Pneumonia
6 (.37%)
Tetany
6 (.37%)
Anuria
5 (.31%)
Aspiration
5 (.31%)
Blood Calcium Decreased
5 (.31%)
Blood Glucose Increased
5 (.31%)
Blood Urea Increased
5 (.31%)
Condition Aggravated
5 (.31%)
Decreased Appetite
5 (.31%)
Diverticulitis
5 (.31%)
Drug Hypersensitivity
5 (.31%)
Dysuria
5 (.31%)
Fluid Overload
5 (.31%)
Gastrooesophageal Reflux Disease
5 (.31%)
Overdose
5 (.31%)
Palpitations
5 (.31%)
Procedural Complication
5 (.31%)
Pruritus
5 (.31%)
Renal Injury
5 (.31%)
Renal Tubular Disorder
5 (.31%)
Swelling Face
5 (.31%)
Amnesia
4 (.25%)
Anorexia
4 (.25%)
Arteriosclerosis
4 (.25%)
Atrial Fibrillation
4 (.25%)
Blood Potassium Abnormal
4 (.25%)
Blood Pressure Decreased
4 (.25%)
Blood Pressure Increased
4 (.25%)
Burning Sensation
4 (.25%)
Cardiac Arrest
4 (.25%)
Cardiac Failure
4 (.25%)
Colitis Erosive
4 (.25%)
Constipation
4 (.25%)
Drug Dispensing Error
4 (.25%)
Faecal Incontinence
4 (.25%)
Influenza
4 (.25%)

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This graph shows the top adverse events submitted to the FDA for Osmoprep, 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 Osmoprep 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 Osmoprep

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

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

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

Colonoscopy
196
Bowel Preparation
58
Preoperative Care
13
Constipation
2
Gastrointestinal Disorder
2
Pain
2
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Product Used For Unknown Indication
1

Drug Labels

LabelLabelerEffective
OsmoprepPhysicians Total Care, Inc.04-JUN-10
OsmoprepSalix Pharmaceuticals, Inc.27-MAR-13

Osmoprep Case Reports

What Osmoprep 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 Osmoprep. 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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