MESALAMINE

Mesalamine Adverse Events Reported to the FDA Over Time

How are Mesalamine adverse event reports trending over time?

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

Most Common Mesalamine Adverse Events Reported to the FDA

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

Pyrexia	62 (2.16%)
Anaemia	51 (1.78%)
Condition Aggravated	47 (1.64%)
Eosinophilia	35 (1.22%)
Nausea	35 (1.22%)
Diarrhoea	33 (1.15%)
Renal Failure Acute	33 (1.15%)
Colitis Ulcerative	29 (1.01%)
Leukopenia	28 (.98%)
Thrombocytopenia	28 (.98%)
Cough	27 (.94%)
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Pancreatitis Acute	27 (.94%)
Rash	26 (.91%)
Neutropenia	25 (.87%)
Weight Decreased	25 (.87%)
Drug Ineffective	24 (.84%)
Fatigue	24 (.84%)
Abdominal Pain	23 (.8%)
Vomiting	23 (.8%)
Diarrhoea Haemorrhagic	21 (.73%)
Off Label Use	21 (.73%)
Chest Pain	20 (.7%)
Dehydration	20 (.7%)
Headache	20 (.7%)
Dyspnoea	18 (.63%)
Pancreatitis	18 (.63%)
Pleural Effusion	18 (.63%)
Contusion	17 (.59%)
Malaise	17 (.59%)
Neutropenic Sepsis	17 (.59%)
Agranulocytosis	16 (.56%)
Asthenia	16 (.56%)
Colitis	16 (.56%)
Eosinophilic Pneumonia	16 (.56%)
Haematochezia	16 (.56%)
Haemoglobin Decreased	16 (.56%)
Arthralgia	15 (.52%)
Drug Hypersensitivity	15 (.52%)
Lung Disorder	15 (.52%)
Pleurisy	14 (.49%)
Tubulointerstitial Nephritis	14 (.49%)
Dizziness	13 (.45%)
Interstitial Lung Disease	13 (.45%)
Pancytopenia	13 (.45%)
Pneumonia	13 (.45%)
White Blood Cell Count Increased	13 (.45%)
Abdominal Pain Upper	12 (.42%)
Deep Vein Thrombosis	12 (.42%)
Drug Toxicity	12 (.42%)
Gastrointestinal Haemorrhage	12 (.42%)
Hyponatraemia	12 (.42%)
Myocarditis	12 (.42%)
Drug Exposure During Pregnancy	11 (.38%)
Drug Interaction	11 (.38%)
Lung Infiltration	11 (.38%)
Myalgia	11 (.38%)
Pain	11 (.38%)
Oedema Peripheral	10 (.35%)
Pneumonitis	10 (.35%)
Sepsis	10 (.35%)
Chills	9 (.31%)
Convulsion	9 (.31%)
Hypokalaemia	9 (.31%)
Infection	9 (.31%)
Organising Pneumonia	9 (.31%)
Pericardial Effusion	9 (.31%)
Pericarditis	9 (.31%)
Alanine Aminotransferase Increased	8 (.28%)
Back Pain	8 (.28%)
Hypophagia	8 (.28%)
Hypotension	8 (.28%)
Lymphocyte Stimulation Test Positiv...	8 (.28%)
Rash Erythematous	8 (.28%)
Respiratory Failure	8 (.28%)
Abasia	7 (.24%)
Abscess	7 (.24%)
Alopecia	7 (.24%)
Disease Progression	7 (.24%)
Disease Recurrence	7 (.24%)
Dysphagia	7 (.24%)
Dyspnoea Exertional	7 (.24%)
Eosinophilic Colitis	7 (.24%)
General Physical Health Deteriorati...	7 (.24%)
Heart Rate Increased	7 (.24%)
Muscular Weakness	7 (.24%)
Myopericarditis	7 (.24%)
Night Sweats	7 (.24%)
Proteinuria	7 (.24%)
Treatment Failure	7 (.24%)
Vena Cava Thrombosis	7 (.24%)
Viral Infection	7 (.24%)
White Blood Cell Count Decreased	7 (.24%)
Aplastic Anaemia	6 (.21%)
Blood Creatinine Increased	6 (.21%)
Blood Lactate Dehydrogenase Increas...	6 (.21%)
Cardiac Murmur	6 (.21%)
Clostridial Infection	6 (.21%)
Epstein-barr Virus Test Positive	6 (.21%)
Haemorrhage	6 (.21%)
Hepatitis	6 (.21%)
Hypersensitivity	6 (.21%)

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

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

Gastrointestinal Signs	126 (4.39%)
Infections - Pathogen Unspecified	123 (4.29%)
White Blood Cell	114 (3.98%)
Respiratory	105 (3.66%)
Lower Respiratory Tract Disorders	93 (3.24%)
Hematology Investigations	87 (3.03%)
Anemias Nonhemolytic And Marrow Dep...	82 (2.86%)
Epidermal And Dermal Conditions	81 (2.83%)
Gastrointestinal Inflammatory Condi...	73 (2.55%)
Gastrointestinal Motility And Defec...	63 (2.2%)
Body Temperature Conditions	62 (2.16%)
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Therapeutic And Nontherapeutic Effe...	57 (1.99%)
Renal Disorders	54 (1.88%)
Exocrine Pancreas Conditions	52 (1.81%)
Electrolyte And Fluid Balance Condi...	50 (1.74%)
Cardiac Arrhythmias	41 (1.43%)
Neurological	40 (1.4%)
Muscle	39 (1.36%)
Gastrointestinal Hemorrhages	38 (1.33%)
Physical Examination Topics	38 (1.33%)
Myocardial	35 (1.22%)
Pleural	33 (1.15%)
Bacterial Infectious	32 (1.12%)
Hepatic And Hepatobiliary	32 (1.12%)
Platelet	32 (1.12%)
Viral Infectious	32 (1.12%)
Urinary Tract Signs	31 (1.08%)
Cardiac And Vascular Investigations	28 (.98%)
Nephropathies	28 (.98%)
Allergic Conditions	26 (.91%)
Hepatobiliary	26 (.91%)
Joint	26 (.91%)
Chemical Injury And Poisoning	25 (.87%)
Embolism And Thrombosis	24 (.84%)
Fungal Infectious	24 (.84%)
Injuries	24 (.84%)
Therapeutic Procedures And Supporti...	23 (.8%)
Musculoskeletal And Connective Tiss...	22 (.77%)
Enzyme	21 (.73%)
Appetite And General Nutritional	20 (.7%)
Headaches	20 (.7%)
Pericardial	20 (.7%)
Water, Electrolyte And Mineral	19 (.66%)
Metabolic, Nutritional And Blood Ga...	18 (.63%)
Microbiology And Serology	17 (.59%)
Respiratory And Pulmonary Investiga...	17 (.59%)
Skin Appendage Conditions	16 (.56%)
Central Nervous System Vascular	15 (.52%)
Movement Disorders	15 (.52%)
Renal And Urinary Tract Investigati...	15 (.52%)
Coronary Artery	14 (.49%)
Cardiac Disorder Signs	13 (.45%)
Lifestyle Issues	13 (.45%)
Gastrointestinal Ulceration And Per...	12 (.42%)
Medication Errors	12 (.42%)
Protein And Chemistry Analyses	12 (.42%)
Fatal Outcomes	11 (.38%)
Procedural And Device Related Injur...	11 (.38%)
Upper Respiratory Tract Disorders	11 (.38%)
Gastrointestinal Stenosis And Obstr...	10 (.35%)
Seizures	10 (.35%)
Cardiac Valve	9 (.31%)
Immunology And Allergy	9 (.31%)
Skin Vascular Abnormalities	9 (.31%)
Decreased And Nonspecific Blood Pre...	8 (.28%)
Gastrointestinal Conditions	8 (.28%)
Gastrointestinal Neoplasms Malignan...	8 (.28%)
Skin And Subcutaneous Tissue	8 (.28%)
Skin Neoplasms Malignant And Unspec...	8 (.28%)
Gastrointestinal	7 (.24%)
Investigations, Imaging And Histopa...	7 (.24%)
Oral Soft Tissue Conditions	7 (.24%)
Product Quality Issues	7 (.24%)
Spleen, Lymphatic And Reticulendoth...	7 (.24%)
Vascular	7 (.24%)
Anal And Rectal Conditions	6 (.21%)
Bone, Calcium, Magnesium And Phosph...	6 (.21%)
Bronchial Disorders	6 (.21%)
Coagulopathies And Bleeding Diathes...	6 (.21%)
Connective Tissue Disorders	6 (.21%)
Deliria	6 (.21%)
Hemolyses And Related Conditions	6 (.21%)
Miscellaneous And Site Unspecified ...	6 (.21%)
Respiratory And Mediastinal Neoplas...	6 (.21%)
Vascular Hemorrhagic	6 (.21%)
Abortions And Stillbirth	5 (.17%)
Lymphomas Non-hodgkins B-cell	5 (.17%)
Lymphomas Non-hodgkins T-cell	5 (.17%)
Metastases	5 (.17%)
Neuromuscular	5 (.17%)
Peripheral Neuropathies	5 (.17%)
Protein And Amino Acid Metabolism	5 (.17%)
Bone Disorders	4 (.14%)
Eye	4 (.14%)
Fetal Complications	4 (.14%)
Gallbladder	4 (.14%)
Hematological And Lymphoid Tissue T...	4 (.14%)
Hematopoietic Neoplasms	4 (.14%)
Inner Ear And Viiith Cranial Nerve	4 (.14%)
Leukemias	4 (.14%)
Metabolism	4 (.14%)

Share/Embed Graph Export Data

This graph shows the top categories of adverse events submitted to the FDA for Mesalamine, 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 Mesalamine 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.