LOTRONEX

Lotronex Adverse Events Reported to the FDA Over Time

How are Lotronex adverse event reports trending over time?

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

Most Common Lotronex Adverse Events Reported to the FDA

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

Drug Ineffective	87 (7.13%)
Colitis Ischaemic	69 (5.65%)
Abdominal Pain	64 (5.24%)
Constipation	64 (5.24%)
Diarrhoea	52 (4.26%)
Rectal Haemorrhage	37 (3.03%)
Adverse Event	35 (2.87%)
Nausea	25 (2.05%)
Abdominal Pain Upper	19 (1.56%)
Haematochezia	19 (1.56%)
Vomiting	17 (1.39%)
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Death	15 (1.23%)
Intestinal Obstruction	14 (1.15%)
Abdominal Distension	12 (.98%)
Back Pain	12 (.98%)
Colitis	10 (.82%)
Diarrhoea Haemorrhagic	10 (.82%)
Dehydration	9 (.74%)
Malaise	9 (.74%)
Pain	9 (.74%)
Faecaloma	8 (.66%)
Pyrexia	8 (.66%)
Blood Glucose Increased	7 (.57%)
Flatulence	7 (.57%)
Haemorrhoidal Haemorrhage	7 (.57%)
Therapeutic Response Decreased	7 (.57%)
Weight Increased	7 (.57%)
Condition Aggravated	6 (.49%)
Fatigue	6 (.49%)
Haematemesis	6 (.49%)
Intestinal Perforation	6 (.49%)
Platelet Count Increased	6 (.49%)
Pruritus	6 (.49%)
Abortion Spontaneous	5 (.41%)
Asthenia	5 (.41%)
Disease Complication	5 (.41%)
Dizziness	5 (.41%)
Faeces Hard	5 (.41%)
Gastritis	5 (.41%)
Haemorrhoids	5 (.41%)
Headache	5 (.41%)
Myalgia	5 (.41%)
Weight Decreased	5 (.41%)
White Blood Cell Count Increased	5 (.41%)
Abdominal Discomfort	4 (.33%)
Blood Alkaline Phosphatase Increase...	4 (.33%)
Cerebrovascular Accident	4 (.33%)
Clostridial Infection	4 (.33%)
Diabetes Mellitus	4 (.33%)
Discomfort	4 (.33%)
Faecal Incontinence	4 (.33%)
Fall	4 (.33%)
Hepatic Cirrhosis	4 (.33%)
Insomnia	4 (.33%)
Loss Of Consciousness	4 (.33%)
Proctalgia	4 (.33%)
Rash	4 (.33%)
Abdominal Pain Lower	3 (.25%)
Alopecia	3 (.25%)
Blindness Unilateral	3 (.25%)
Blood Calcium Increased	3 (.25%)
Blood Pressure Increased	3 (.25%)
Deep Vein Thrombosis	3 (.25%)
Defaecation Urgency	3 (.25%)
Depression	3 (.25%)
Diverticulum	3 (.25%)
Diverticulum Intestinal	3 (.25%)
Drug Effect Decreased	3 (.25%)
Drug Exposure During Pregnancy	3 (.25%)
Enterocolitis Infectious	3 (.25%)
Erectile Dysfunction	3 (.25%)
Feeling Abnormal	3 (.25%)
Gastrooesophageal Reflux Disease	3 (.25%)
Hypokalaemia	3 (.25%)
Ileus Paralytic	3 (.25%)
Irritable Bowel Syndrome	3 (.25%)
Menstrual Disorder	3 (.25%)
Muscle Spasms	3 (.25%)
Oedema	3 (.25%)
Palpitations	3 (.25%)
Pleural Effusion	3 (.25%)
Pregnancy	3 (.25%)
Pulmonary Embolism	3 (.25%)
Sepsis	3 (.25%)
Septic Shock	3 (.25%)
Small Intestinal Obstruction	3 (.25%)
Speech Disorder	3 (.25%)
Syncope	3 (.25%)
Therapeutic Response Unexpected	3 (.25%)
Viral Infection	3 (.25%)
Abdominal Tenderness	2 (.16%)
Abnormal Faeces	2 (.16%)
Abscess Intestinal	2 (.16%)
Alanine Aminotransferase Increased	2 (.16%)
Amnesia	2 (.16%)
Anaemia	2 (.16%)
Arthralgia	2 (.16%)
Aspartate Aminotransferase Increase...	2 (.16%)
Blood Creatine Phosphokinase Increa...	2 (.16%)
Blood Homocysteine Increased	2 (.16%)
Blood Lactic Acid Increased	2 (.16%)

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

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

Gastrointestinal Signs	180 (14.74%)
Gastrointestinal Motility And Defec...	143 (11.71%)
Therapeutic And Nontherapeutic Effe...	138 (11.3%)
Gastrointestinal Inflammatory Condi...	91 (7.45%)
Gastrointestinal Hemorrhages	65 (5.32%)
Neurological	25 (2.05%)
Infections - Pathogen Unspecified	23 (1.88%)
Hematology Investigations	22 (1.8%)
Gastrointestinal Stenosis And Obstr...	19 (1.56%)
Epidermal And Dermal Conditions	18 (1.47%)
Musculoskeletal And Connective Tiss...	17 (1.39%)
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Hepatic And Hepatobiliary	16 (1.31%)
Fatal Outcomes	15 (1.23%)
Metabolic, Nutritional And Blood Ga...	15 (1.23%)
Electrolyte And Fluid Balance Condi...	14 (1.15%)
Gastrointestinal Vascular Condition...	14 (1.15%)
Physical Examination Topics	14 (1.15%)
Gastrointestinal Ulceration And Per...	13 (1.06%)
Muscle	11 (.9%)
Hepatobiliary	9 (.74%)
Bacterial Infectious	8 (.66%)
Body Temperature Conditions	8 (.66%)
Cardiac Disorder Signs	8 (.66%)
Cardiac And Vascular Investigations	7 (.57%)
Respiratory	7 (.57%)
Anal And Rectal Conditions	6 (.49%)
Chemical Injury And Poisoning	6 (.49%)
Diverticular	6 (.49%)
Enzyme	6 (.49%)
Headaches	6 (.49%)
Injuries	6 (.49%)
Medication Errors	6 (.49%)
Skin Appendage Conditions	6 (.49%)
Vision	6 (.49%)
Water, Electrolyte And Mineral	6 (.49%)
Abortions And Stillbirth	5 (.41%)
Gastrointestinal Conditions	5 (.41%)
Lifestyle Issues	5 (.41%)
Renal Disorders	5 (.41%)
Urinary Tract Signs	5 (.41%)
Viral Infectious	5 (.41%)
Appetite And General Nutritional	4 (.33%)
Cardiac Arrhythmias	4 (.33%)
Central Nervous System Vascular	4 (.33%)
Gastrointestinal Therapeutic Proced...	4 (.33%)
Glucose Metabolism Disorders	4 (.33%)
Protein And Chemistry Analyses	4 (.33%)
Pulmonary Vascular	4 (.33%)
Retina, Choroid And Vitreous Hemorr...	4 (.33%)
Sexual Function And Fertility	4 (.33%)
Sleep Disorders	4 (.33%)
Therapeutic Procedures And Supporti...	4 (.33%)
Bone And Joint Therapeutic Procedur...	3 (.25%)
Bone Disorders	3 (.25%)
Depressed Mood Disorders	3 (.25%)
Embolism And Thrombosis	3 (.25%)
Gastrointestinal	3 (.25%)
Immunology And Allergy	3 (.25%)
Joint	3 (.25%)
Menstrual Cycle And Uterine Bleedin...	3 (.25%)
Pleural	3 (.25%)
Pregnancy, Labour, Delivery And Pos...	3 (.25%)
Suicidal And Self-injurious Behavio...	3 (.25%)
Vascular Hypertensive	3 (.25%)
Abdominal Hernias And Other Abdomin...	2 (.16%)
Acid-base	2 (.16%)
Anemias Nonhemolytic And Marrow Dep...	2 (.16%)
Anxiety Disorders	2 (.16%)
Benign Neoplasms Gastrointestinal	2 (.16%)
Communication Disorders	2 (.16%)
Decreased And Nonspecific Blood Pre...	2 (.16%)
Deliria	2 (.16%)
Dental And Gingival Conditions	2 (.16%)
Exocrine Pancreas Conditions	2 (.16%)
Eye	2 (.16%)
Heart Failures	2 (.16%)
Hematological And Lymphoid Tissue T...	2 (.16%)
Hepatobiliary Therapeutic Procedure...	2 (.16%)
Investigations, Imaging And Histopa...	2 (.16%)
Iron And Trace Metal Metabolism	2 (.16%)
Lipid Analyses	2 (.16%)
Lymphomas	2 (.16%)
Mental Impairment	2 (.16%)
Microbiology And Serology	2 (.16%)
Plasma Cell Neoplasms	2 (.16%)
Procedural And Device Related Injur...	2 (.16%)
Renal And Urinary Tract Investigati...	2 (.16%)
Uterine, Pelvic And Broad Ligament	2 (.16%)
Vascular	2 (.16%)
Vascular Hemorrhagic	2 (.16%)
Vitamin Related	2 (.16%)
White Blood Cell	2 (.16%)
Angiedema And Urticaria	1 (.08%)
Arteriosclerosis, Stenosis, Vascula...	1 (.08%)
Breast	1 (.08%)
Cardiac Therapeutic Procedures	1 (.08%)
Coronary Artery	1 (.08%)
Disturbances In Thinking	1 (.08%)
Encephalopathies	1 (.08%)
Gallbladder	1 (.08%)
Gastrointestinal Neoplasms Malignan...	1 (.08%)

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