ASACOL

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Asacol Adverse Events Reported to the FDA Over Time

How are Asacol adverse event reports trending over time?

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

Most Common Asacol Adverse Events Reported to the FDA

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

Pyrexia	35 (1.89%)
Diarrhoea	34 (1.83%)
Condition Aggravated	32 (1.72%)
Medication Residue	26 (1.4%)
Chest Pain	24 (1.29%)
Colitis Ulcerative	24 (1.29%)
Drug Hypersensitivity	21 (1.13%)
Fatigue	21 (1.13%)
Abdominal Pain	20 (1.08%)
Dehydration	19 (1.02%)
Pancreatitis	19 (1.02%)
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Drug Ineffective	18 (.97%)
Dyspnoea	18 (.97%)
Nausea	18 (.97%)
Vomiting	16 (.86%)
Drug Exposure During Pregnancy	15 (.81%)
Pericarditis	15 (.81%)
Headache	14 (.75%)
Pericardial Effusion	14 (.75%)
Rash	14 (.75%)
Anaemia	13 (.7%)
Arthralgia	13 (.7%)
Cough	13 (.7%)
Pulmonary Embolism	12 (.65%)
Renal Failure	12 (.65%)
Weight Decreased	12 (.65%)
Asthenia	11 (.59%)
Pleural Effusion	11 (.59%)
Rectal Haemorrhage	11 (.59%)
Renal Failure Chronic	11 (.59%)
Back Pain	10 (.54%)
Renal Impairment	10 (.54%)
Atelectasis	9 (.48%)
Drug Interaction	9 (.48%)
Dysphagia	9 (.48%)
Haematochezia	9 (.48%)
Haemoglobin Decreased	9 (.48%)
Leukopenia	9 (.48%)
Thrombocytopenia	9 (.48%)
Eosinophilia	8 (.43%)
Malaise	8 (.43%)
Neutropenia	8 (.43%)
Pneumonia	8 (.43%)
Blood Creatinine Increased	7 (.38%)
Chest Discomfort	7 (.38%)
Diarrhoea Haemorrhagic	7 (.38%)
Haemorrhage	7 (.38%)
Myalgia	7 (.38%)
Pain	7 (.38%)
Pain In Extremity	7 (.38%)
Pancytopenia	7 (.38%)
Pleuritic Pain	7 (.38%)
Pneumonitis	7 (.38%)
Agranulocytosis	6 (.32%)
Alopecia	6 (.32%)
Anorexia	6 (.32%)
Anxiety	6 (.32%)
Cardiac Failure Congestive	6 (.32%)
Chills	6 (.32%)
Colitis	6 (.32%)
Dialysis	6 (.32%)
Dizziness	6 (.32%)
Hepatitis	6 (.32%)
Hypersensitivity	6 (.32%)
Hypotension	6 (.32%)
Lung Infiltration	6 (.32%)
Maternal Drugs Affecting Foetus	6 (.32%)
Oedema Peripheral	6 (.32%)
Premature Baby	6 (.32%)
Renal Failure Acute	6 (.32%)
Viral Infection	6 (.32%)
White Blood Cell Count Increased	6 (.32%)
Abdominal Discomfort	5 (.27%)
Abdominal Pain Upper	5 (.27%)
Alanine Aminotransferase Increased	5 (.27%)
Antinuclear Antibody Positive	5 (.27%)
Aspartate Aminotransferase Increase...	5 (.27%)
Contusion	5 (.27%)
Feeling Abnormal	5 (.27%)
Gastrointestinal Disorder	5 (.27%)
Gastrointestinal Haemorrhage	5 (.27%)
Gastrointestinal Inflammation	5 (.27%)
Haematuria	5 (.27%)
Neutropenic Sepsis	5 (.27%)
Off Label Use	5 (.27%)
Pulmonary Fibrosis	5 (.27%)
Red Blood Cell Sedimentation Rate I...	5 (.27%)
Sinusitis	5 (.27%)
Treatment Noncompliance	5 (.27%)
Tremor	5 (.27%)
Abdominal Pain Lower	4 (.22%)
Amnesia	4 (.22%)
Anal Atresia	4 (.22%)
Atrioventricular Block First Degree	4 (.22%)
Bladder Cancer	4 (.22%)
Bradycardia	4 (.22%)
Bronchitis	4 (.22%)
Congenital Hearing Disorder	4 (.22%)
Flatulence	4 (.22%)
Gastritis	4 (.22%)
Hepatic Enzyme Increased	4 (.22%)

Share/Embed Graph Export Data

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

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

Gastrointestinal Signs	92 (4.96%)
Respiratory	61 (3.29%)
Infections - Pathogen Unspecified	56 (3.02%)
Renal Disorders	55 (2.96%)
Gastrointestinal Motility And Defec...	49 (2.64%)
Gastrointestinal Inflammatory Condi...	47 (2.53%)
Hematology Investigations	46 (2.48%)
Lower Respiratory Tract Disorders	45 (2.42%)
Epidermal And Dermal Conditions	44 (2.37%)
Therapeutic And Nontherapeutic Effe...	43 (2.32%)
Body Temperature Conditions	35 (1.89%)
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White Blood Cell	33 (1.78%)
Gastrointestinal Hemorrhages	32 (1.72%)
Musculoskeletal And Connective Tiss...	32 (1.72%)
Pericardial	31 (1.67%)
Allergic Conditions	29 (1.56%)
Cardiac Arrhythmias	28 (1.51%)
Product Quality Issues	28 (1.51%)
Anemias Nonhemolytic And Marrow Dep...	27 (1.45%)
Electrolyte And Fluid Balance Condi...	25 (1.35%)
Medication Errors	24 (1.29%)
Neurological	24 (1.29%)
Exocrine Pancreas Conditions	23 (1.24%)
Injuries	23 (1.24%)
Chemical Injury And Poisoning	21 (1.13%)
Nephropathies	20 (1.08%)
Physical Examination Topics	19 (1.02%)
Headaches	18 (.97%)
Hepatobiliary	18 (.97%)
Joint	18 (.97%)
Muscle	18 (.97%)
Renal And Urinary Tract Investigati...	18 (.97%)
Pulmonary Vascular	15 (.81%)
Urinary Tract Signs	15 (.81%)
Viral Infectious	15 (.81%)
Pleural	14 (.75%)
Skin Appendage Conditions	14 (.75%)
Hepatic And Hepatobiliary	13 (.7%)
Anxiety Disorders	12 (.65%)
Cardiac And Vascular Investigations	12 (.65%)
Central Nervous System Vascular	11 (.59%)
Gastrointestinal Stenosis And Obstr...	11 (.59%)
Immunology And Allergy	11 (.59%)
Appetite And General Nutritional	10 (.54%)
Platelet	10 (.54%)
Procedural And Device Related Injur...	10 (.54%)
Gastrointestinal Ulceration And Per...	9 (.48%)
Myocardial	9 (.48%)
Neonatal And Perinatal Conditions	9 (.48%)
Oral Soft Tissue Conditions	9 (.48%)
Bone And Joint Injuries	8 (.43%)
Bronchial Disorders	8 (.43%)
Embolism And Thrombosis	8 (.43%)
Enzyme	8 (.43%)
Gastrointestinal Conditions	8 (.43%)
Hematological And Lymphoid Tissue T...	8 (.43%)
Lifestyle Issues	8 (.43%)
Mental Impairment	8 (.43%)
Vascular Hemorrhagic	8 (.43%)
Bacterial Infectious	7 (.38%)
Fungal Infectious	7 (.38%)
Gastrointestinal	7 (.38%)
Heart Failures	7 (.38%)
Renal And Urinary Tract Neoplasms M...	7 (.38%)
Connective Tissue Disorders	6 (.32%)
Coronary Artery	6 (.32%)
Decreased And Nonspecific Blood Pre...	6 (.32%)
Fetal Complications	6 (.32%)
Inner Ear And Viiith Cranial Nerve	6 (.32%)
Microbiology And Serology	6 (.32%)
Movement Disorders	6 (.32%)
Therapeutic Procedures And Supporti...	6 (.32%)
Upper Respiratory Tract Disorders	6 (.32%)
Vision	6 (.32%)
Cardiac Disorder Signs	5 (.27%)
Eye	5 (.27%)
Hearing	5 (.27%)
Metabolic, Nutritional And Blood Ga...	5 (.27%)
Protein And Chemistry Analyses	5 (.27%)
Respiratory And Mediastinal Neoplas...	5 (.27%)
Water, Electrolyte And Mineral	5 (.27%)
Abortions And Stillbirth	4 (.22%)
Angiedema And Urticaria	4 (.22%)
Bile Duct	4 (.22%)
Cardiac Valve	4 (.22%)
Deliria	4 (.22%)
Depressed Mood Disorders	4 (.22%)
Diverticular	4 (.22%)
Ear And Labyrinthine Disorders Cong...	4 (.22%)
Gastrointestinal Neoplasms Malignan...	4 (.22%)
Gastrointestinal Therapeutic Proced...	4 (.22%)
Gastrointestinal Tract Disorders Co...	4 (.22%)
Mycoplasmal Infectious	4 (.22%)
Skin And Subcutaneous Tissue	4 (.22%)
Suicidal And Self-injurious Behavio...	4 (.22%)
Tongue Conditions	4 (.22%)
Urolithiases	4 (.22%)
Vascular Inflammations	4 (.22%)
Abdominal Hernias And Other Abdomin...	3 (.16%)
Administration Site Reactions	3 (.16%)
Anal And Rectal Conditions	3 (.16%)

Share/Embed Graph Export Data

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

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

Crohns Disease	785
Colitis Ulcerative	684
Product Used For Unknown Indication	431
Colitis	218
Drug Use For Unknown Indication	179
Inflammatory Bowel Disease	27
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Irritable Bowel Syndrome	19
Gastrointestinal Disorder	14
Diarrhoea	13
Inflammation	9
Colitis Microscopic	7
Psoriasis	7
Hypertension	6
Prophylaxis	5
Gastric Disorder	4
Blood Cholesterol Increased	4
Proctitis Ulcerative	4
Dyspepsia	4
Gastrooesophageal Reflux Disease	3
Proctitis	3
Enteritis	3
Ill-defined Disorder	2
Pain	2
Colitis Collagenous	2
Diverticulum	2
Vomiting	2
Infection	2
Nausea	2
Stomach Discomfort	2
Gastrointestinal Infection	2
Intestinal Functional Disorder	2
Abdominal Discomfort	2
Coeliac Disease	1
Diarrhoea Haemorrhagic	1
Drug Exposure During Pregnancy	1
Anorectal Disorder	1
Arthritis	1
Sigmoiditis	1
Proctitis Haemorrhagic	1
Abdominal Pain Upper	1
Ulcer	1
Proctocolitis	1
Suicide Attempt	1
Haematochezia	1
Gastroenteritis	1
Colon Cancer	1
Bacterial Infection	1
Sickle Cell Anaemia	1
Renal Failure Acute	1
Gastritis	1
Ileitis	1

Drug Labels

Label	Labeler	Effective
Asacol Hd	Procter & Gamble Pharmaceuticals, Inc.	30-MAY-09
Asacol	Procter & Gamble Pharmaceuticals, Inc.	05-OCT-09
Asacol	State of Florida DOH Central Pharmacy	12-MAR-10
Asacol Hd	Warner Chilcott (US), LLC	14-OCT-10
Asacol	REMEDYREPACK INC.	09-MAR-11
Asacol	Warner Chilcott (US), LLC	30-MAY-11
Asacol	REMEDYREPACK INC.	17-AUG-11
Asacol	Cardinal Health	06-OCT-11
Asacol	American Health Packaging	23-JAN-12
Asacol	KAISER FOUNDATION HOSPITALS	24-FEB-12
Asacol	Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC	23-MAR-12
Asacol	REMEDYREPACK INC.	30-MAR-12
Asacol	Cardinal Health	07-MAR-13

Asacol Case Reports

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

About Results

This report contains aggregated drug side effects and adverse events for Asacol. 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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