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POLYETHYLENE GLYCOL

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Polyethylene Glycol Adverse Events Reported to the FDA Over Time

How are Polyethylene Glycol adverse event reports trending over time?

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

Most Common Polyethylene Glycol Adverse Events Reported to the FDA

What are the most common Polyethylene Glycol adverse events reported to the FDA?

Death
82 (2.69%)
Diarrhoea
47 (1.54%)
Haemoglobin Decreased
45 (1.48%)
Pyrexia
40 (1.31%)
Vomiting
34 (1.12%)
Atrial Fibrillation
32 (1.05%)
Dyspnoea
32 (1.05%)
Pneumonia
31 (1.02%)
Cerebrovascular Accident
30 (.99%)
Acute Myocardial Infarction
27 (.89%)
Peripheral Arterial Occlusive Disea...
27 (.89%)
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Arteriovenous Fistula Thrombosis
26 (.85%)
Colitis Ischaemic
26 (.85%)
Drug Ineffective
26 (.85%)
Dysgeusia
25 (.82%)
Ischaemic Stroke
25 (.82%)
Sepsis
25 (.82%)
Gastroenteritis
24 (.79%)
Hypotension
23 (.76%)
Femoral Artery Occlusion
22 (.72%)
Nausea
22 (.72%)
Myocardial Infarction
21 (.69%)
Pulmonary Embolism
21 (.69%)
Abdominal Pain
19 (.62%)
Incorrect Drug Administration Durat...
19 (.62%)
Chest Pain
18 (.59%)
Convulsion
18 (.59%)
Hyponatraemia
17 (.56%)
Renal Failure Chronic
17 (.56%)
Renal Impairment
17 (.56%)
Angina Pectoris
16 (.53%)
Carotid Artery Stenosis
16 (.53%)
Overdose
16 (.53%)
Pruritus
16 (.53%)
Thrombosis
16 (.53%)
Abdominal Distension
15 (.49%)
Anaemia
15 (.49%)
Gastrointestinal Haemorrhage
15 (.49%)
Thrombocytopenia
15 (.49%)
Cardiac Failure
14 (.46%)
Hypersensitivity
14 (.46%)
Hypertension
14 (.46%)
Platelet Count Decreased
14 (.46%)
Pleural Effusion
14 (.46%)
Rash
14 (.46%)
Asthenia
13 (.43%)
Bacterial Infection
13 (.43%)
Device Malfunction
13 (.43%)
Pulmonary Oedema
13 (.43%)
Upper Gastrointestinal Haemorrhage
13 (.43%)
Urticaria
13 (.43%)
Bile Duct Cancer
12 (.39%)
Cellulitis
12 (.39%)
Diverticulum Intestinal
12 (.39%)
Fall
12 (.39%)
Oedema Peripheral
12 (.39%)
Tremor
12 (.39%)
Abdominal Pain Upper
11 (.36%)
Constipation
11 (.36%)
Dehydration
11 (.36%)
Dizziness
11 (.36%)
Ill-defined Disorder
11 (.36%)
Lymphangitis
11 (.36%)
Optic Ischaemic Neuropathy
11 (.36%)
Pancytopenia
11 (.36%)
Renal Failure Acute
11 (.36%)
Back Pain
10 (.33%)
Cardio-respiratory Arrest
10 (.33%)
Diarrhoea Infectious
10 (.33%)
Drug Interaction
10 (.33%)
Haemorrhage
10 (.33%)
Haemorrhagic Anaemia
10 (.33%)
Headache
10 (.33%)
Malaise
10 (.33%)
Oesophagitis
10 (.33%)
Off Label Use
10 (.33%)
Pseudomembranous Colitis
10 (.33%)
Rectal Haemorrhage
10 (.33%)
Spinal Osteoarthritis
10 (.33%)
Sudden Death
10 (.33%)
Arrhythmia
9 (.3%)
Arthralgia
9 (.3%)
Blood Potassium Increased
9 (.3%)
Cardiac Arrest
9 (.3%)
Confusional State
9 (.3%)
Drug Effect Decreased
9 (.3%)
Extremity Necrosis
9 (.3%)
Inappropriate Schedule Of Drug Admi...
9 (.3%)
Lung Neoplasm Malignant
9 (.3%)
Urinary Tract Infection
9 (.3%)
Angina Unstable
8 (.26%)
Bradycardia
8 (.26%)
Cardiac Failure Congestive
8 (.26%)
Chronic Myeloid Leukaemia
8 (.26%)
Condition Aggravated
8 (.26%)
Drug Hypersensitivity
8 (.26%)
Gastrointestinal Necrosis
8 (.26%)
Hyperkalaemia
8 (.26%)
Hypoglycaemia
8 (.26%)
Hypokalaemia
8 (.26%)
Intestinal Ischaemia
8 (.26%)

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

What are the most common Polyethylene Glycol adverse events reported to the FDA?

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

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

Constipation
412
Product Used For Unknown Indication
160
Drug Use For Unknown Indication
78
Colonoscopy
34
Dry Eye
20
Hepatitis C
18
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Laxative Supportive Care
18
Bowel Preparation
16
Irritable Bowel Syndrome
11
Nephrogenic Anaemia
11
Infection Prophylaxis
11
Prophylaxis
9
Constipation Prophylaxis
9
Gastrointestinal Disorder
8
Bowel Movement Irregularity
8
Anaemia
6
Supplementation Therapy
5
Hypertensive Nephropathy
5
Diarrhoea
4
Acute Lymphocytic Leukaemia
3
Crohns Disease
2
Gastrointestinal Hypomotility
2
Sepsis
2
Herpes Zoster
2
Ill-defined Disorder
2
Pituitary Tumour Benign
2
Dyslipidaemia
2
Intestinal Dilatation
1
Breast Cancer Metastatic
1
Corrective Lens User
1
Pregnancy
1
Blepharitis
1
Dysgeusia
1
Quadriplegia
1
Congenital Megacolon
1
Gastric Disorder
1
Hypertension
1
Contact Lens Therapy
1
Antiemetic Supportive Care
1
Ileus Paralytic
1
Pollakiuria
1
Visual Disturbance
1
Off Label Use
1
Eye Irritation
1
Hyponatraemia
1
Multiple Myeloma
1
Intestinal Polyp
1
Enema Administration
1
Faeces Hard
1
Therapeutic Procedure
1
Hypogammaglobulinaemia
1

Drug Labels

LabelLabelerEffective
Polyethylene Glycol-3350, Sodium Chloride, Potassium Chloride And Sodium BicarbonateNovel Laboratories, Inc.28-MAY-09
Polyethylene Glycol-3350 And Electrolytes With Flavor PackNovel Laboratories, Inc.01-JUN-09
Polyethylene Glycol-3350 And ElectrolytesNovel Laboratories, Inc.01-JUN-09
Polyethylene Glycol-3350Novel Laboratories, Inc.06-OCT-09
Polyethylene Glycol 3350, Nf Powder For Solution, LaxativeNexgen Pharma, Inc.07-OCT-09
GavilaxGAVIS Pharmaceuticals, LLC07-OCT-09
Polyethylene Glycol 3350Perrigo New York Inc13-OCT-09
Polyethylene Glycol (3350)UDL Laboratories Inc17-NOV-09
Polyethylene Glycol 3350Paddock Laboratories, Inc.30-DEC-09
Polyethylene Glycol 3350 And ElectrolytesMylan Pharmaceuticals Inc.26-JAN-10
Polyethylene Glycol 3350 And ElectrolytesPaddock Laboratories, Inc.05-FEB-10
Polyethylene Glycol 3350 And Electrolytes With Flavor PacksPaddock Laboratories, Inc.05-FEB-10
Polyethylene Glycol 3350, Sodium Chloride, Sodium Bicarbonate And Potassium ChloridePaddock Laboratories, Inc.01-MAR-10
Polyethylene Glycol 3350Kremers Urban05-MAR-10
Clenz-lytePaddock Laboratories, Inc.15-JUN-10
Polyethylene Glycol 3350, Nf Powder For Solution, LaxativeRebel Distributors Corp01-DEC-10
Polyethylene Glycol 3350Kremers Urban Pharmaceuticals Inc.01-AUG-11
Polyethylene Glycol 3350Nexgen Pharma, Inc.10-AUG-11
Polyethylene Glycol 3350Nexgen Pharma, Inc.10-AUG-11
Polyethylene Glycol 3350Breckenridge Pharmaceutical, Inc.20-JAN-12
Polyethylene Glycol 3350Geri-Care Pharmaceutical Corp25-APR-12
Polyethylene Glycol 3350Physicians Total Care, Inc.01-MAY-12
Polyethylene Glycol 3350Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC12-JUN-12
Polyethylene Glycol 3350Emcure Pharmaceuticals USA Inc.18-JAN-13
Polyethylene Glycol 3350Cardinal Health22-MAR-13
Polyethylene Glycol (3350)Cardinal Health22-MAR-13

Polyethylene Glycol Case Reports

What Polyethylene Glycol 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 Polyethylene Glycol. 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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