OXYBUTYNIN

Oxybutynin Adverse Events Reported to the FDA Over Time

How are Oxybutynin adverse event reports trending over time?

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

Most Common Oxybutynin Adverse Events Reported to the FDA

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

Drug Ineffective	121 (2.59%)
Dry Mouth	117 (2.5%)
Dizziness	77 (1.65%)
Confusional State	72 (1.54%)
Constipation	68 (1.46%)
Somnolence	53 (1.13%)
Fall	50 (1.07%)
Nausea	45 (.96%)
Pain	44 (.94%)
Completed Suicide	41 (.88%)
Vomiting	41 (.88%)
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Drug Interaction	40 (.86%)
Urinary Incontinence	38 (.81%)
Dyspnoea	37 (.79%)
Fatigue	35 (.75%)
Vision Blurred	35 (.75%)
Hypertension	33 (.71%)
Urinary Tract Infection	33 (.71%)
Pollakiuria	32 (.69%)
Headache	31 (.66%)
Chest Pain	30 (.64%)
Death	30 (.64%)
Malaise	30 (.64%)
Pruritus	30 (.64%)
Pyrexia	30 (.64%)
Urinary Retention	30 (.64%)
Asthenia	29 (.62%)
Dysuria	29 (.62%)
Insomnia	29 (.62%)
Oedema Peripheral	28 (.6%)
Abdominal Pain Upper	27 (.58%)
Anxiety	27 (.58%)
Dyspepsia	26 (.56%)
Dehydration	24 (.51%)
Gait Disturbance	23 (.49%)
Abdominal Pain	22 (.47%)
Drug Exposure During Pregnancy	22 (.47%)
Overdose	22 (.47%)
Hallucination	20 (.43%)
Talipes	20 (.43%)
Condition Aggravated	19 (.41%)
Dry Eye	19 (.41%)
Mental Status Changes	19 (.41%)
Rash	19 (.41%)
Agitation	18 (.39%)
Chest Discomfort	18 (.39%)
Delirium	18 (.39%)
Diarrhoea	18 (.39%)
Intestinal Obstruction	18 (.39%)
Loss Of Consciousness	18 (.39%)
Back Pain	17 (.36%)
Cognitive Disorder	17 (.36%)
Cystitis	17 (.36%)
Disorientation	17 (.36%)
Drug Toxicity	17 (.36%)
Nocturia	17 (.36%)
Tachycardia	17 (.36%)
Balance Disorder	16 (.34%)
Renal Failure Acute	16 (.34%)
Weight Decreased	16 (.34%)
Alanine Aminotransferase Increased	15 (.32%)
Amnesia	15 (.32%)
Aspartate Aminotransferase Increase...	15 (.32%)
Medication Error	15 (.32%)
Muscle Spasms	15 (.32%)
Respiratory Arrest	15 (.32%)
Aggression	14 (.3%)
Anorexia	14 (.3%)
Blood Alkaline Phosphatase Increase...	14 (.3%)
Cardiac Arrest	14 (.3%)
Congenital Musculoskeletal Anomaly	14 (.3%)
Feeling Abnormal	14 (.3%)
Heart Rate Increased	14 (.3%)
Hyponatraemia	14 (.3%)
Myalgia	14 (.3%)
Renal Failure	14 (.3%)
Unevaluable Event	14 (.3%)
Urticaria	14 (.3%)
Cerebrovascular Accident	13 (.28%)
Convulsion	13 (.28%)
Decreased Appetite	13 (.28%)
Dysphagia	13 (.28%)
Gastrooesophageal Reflux Disease	13 (.28%)
Haematuria	13 (.28%)
Memory Impairment	13 (.28%)
Muscular Weakness	13 (.28%)
Rib Hypoplasia	13 (.28%)
Speech Disorder	13 (.28%)
Spine Malformation	13 (.28%)
Blood Pressure Increased	12 (.26%)
Depression	12 (.26%)
Dysarthria	12 (.26%)
Hallucination, Visual	12 (.26%)
Hypertonic Bladder	12 (.26%)
Hypotension	12 (.26%)
Product Quality Issue	12 (.26%)
Psychotic Disorder	12 (.26%)
Suicidal Ideation	12 (.26%)
Tremor	12 (.26%)
Alopecia	11 (.24%)
Anaemia	11 (.24%)

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

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

Neurological	293 (6.27%)
Gastrointestinal Signs	221 (4.73%)
Urinary Tract Signs	220 (4.71%)
Therapeutic And Nontherapeutic Effe...	208 (4.45%)
Epidermal And Dermal Conditions	125 (2.68%)
Salivary Gland Conditions	121 (2.59%)
Gastrointestinal Motility And Defec...	114 (2.44%)
Respiratory	114 (2.44%)
Deliria	107 (2.29%)
Injuries	105 (2.25%)
Infections - Pathogen Unspecified	99 (2.12%)
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Medication Errors	94 (2.01%)
Musculoskeletal And Connective Tiss...	77 (1.65%)
Cardiac Arrhythmias	73 (1.56%)
Mental Impairment	59 (1.26%)
Renal Disorders	59 (1.26%)
Electrolyte And Fluid Balance Condi...	58 (1.24%)
Suicidal And Self-injurious Behavio...	57 (1.22%)
Anxiety Disorders	56 (1.2%)
Vision	56 (1.2%)
Chemical Injury And Poisoning	55 (1.18%)
Movement Disorders	55 (1.18%)
Musculoskeletal And Connective Tiss...	55 (1.18%)
Muscle	51 (1.09%)
Psychiatric	51 (1.09%)
Cardiac And Vascular Investigations	48 (1.03%)
Disturbances In Thinking	48 (1.03%)
Hepatobiliary	45 (.96%)
Body Temperature Conditions	40 (.86%)
Eye	39 (.83%)
Fatal Outcomes	39 (.83%)
Sleep Disorders	38 (.81%)
Hepatic And Hepatobiliary	37 (.79%)
Skin Appendage Conditions	36 (.77%)
Vascular Hypertensive	33 (.71%)
Headaches	32 (.69%)
Physical Examination Topics	32 (.69%)
Seizures	31 (.66%)
Appetite And General Nutritional	30 (.64%)
Gastrointestinal Stenosis And Obstr...	29 (.62%)
Lower Respiratory Tract Disorders	28 (.6%)
Product Quality Issues	28 (.6%)
Joint	27 (.58%)
Renal And Urinary Tract Investigati...	27 (.58%)
Decreased And Nonspecific Blood Pre...	25 (.54%)
Hematology Investigations	25 (.54%)
Metabolic, Nutritional And Blood Ga...	24 (.51%)
Upper Respiratory Tract Disorders	24 (.51%)
Central Nervous System Vascular	23 (.49%)
Lifestyle Issues	23 (.49%)
Water, Electrolyte And Mineral	22 (.47%)
Bladder And Bladder Neck Disorders	21 (.45%)
Depressed Mood Disorders	21 (.45%)
Respiratory Disorders Congenital	21 (.45%)
Enzyme	20 (.43%)
Administration Site Reactions	19 (.41%)
Angiedema And Urticaria	19 (.41%)
Bacterial Infectious	19 (.41%)
Heart Failures	19 (.41%)
Personality Disorders	19 (.41%)
Procedural And Device Related Injur...	19 (.41%)
Dental And Gingival Conditions	16 (.34%)
Allergic Conditions	15 (.32%)
Bone And Joint Injuries	15 (.32%)
Therapeutic Procedures And Supporti...	15 (.32%)
Mood Disorders	14 (.3%)
Ocular Neuromuscular	14 (.3%)
Oral Soft Tissue Conditions	14 (.3%)
Anemias Nonhemolytic And Marrow Dep...	13 (.28%)
Bone And Joint Therapeutic Procedur...	13 (.28%)
Congenital And Hereditary	13 (.28%)
Encephalopathies	13 (.28%)
Schizophrenia And Other Psychotic	13 (.28%)
Neuromuscular	12 (.26%)
Pulmonary Vascular	12 (.26%)
Coronary Artery	11 (.24%)
Gastrointestinal Neoplasms Malignan...	11 (.24%)
Musculoskeletal And Connective Tiss...	11 (.24%)
Obstetric And Gynecological Therape...	11 (.24%)
Cardiac Disorder Signs	10 (.21%)
Gastrointestinal Conditions	10 (.21%)
Arteriosclerosis, Stenosis, Vascula...	9 (.19%)
Bone Disorders	9 (.19%)
Lipid Analyses	9 (.19%)
Structural Brain	9 (.19%)
Tongue Conditions	9 (.19%)
Bronchial Disorders	8 (.17%)
Gallbladder	8 (.17%)
Glaucoma And Ocular Hypertension	8 (.17%)
Inner Ear And Viiith Cranial Nerve	8 (.17%)
Neonatal Respiratory	8 (.17%)
Ocular Infections, Irritations And ...	8 (.17%)
Ocular Structural Change, Deposit A...	8 (.17%)
Vascular	8 (.17%)
Vascular Hemorrhagic	8 (.17%)
White Blood Cell	8 (.17%)
Changes In Physical Activity	7 (.15%)
Hypothalamus And Pituitary Gland	7 (.15%)
Maternal Complications Of Labour An...	7 (.15%)
Neonatal And Perinatal Conditions	7 (.15%)
Neurological, Special Senses And Ps...	7 (.15%)

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