URBANYL

Urbanyl Adverse Events Reported to the FDA Over Time

How are Urbanyl adverse event reports trending over time?

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

Most Common Urbanyl Adverse Events Reported to the FDA

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

Drug Exposure During Pregnancy	45 (2.99%)
Somnolence	28 (1.86%)
Condition Aggravated	22 (1.46%)
Confusional State	20 (1.33%)
Thrombocytopenia	19 (1.26%)
Fall	18 (1.19%)
Abnormal Behaviour	17 (1.13%)
Premature Baby	17 (1.13%)
Pyrexia	16 (1.06%)
Bradycardia	14 (.93%)
Hyponatraemia	14 (.93%)
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Agranulocytosis	13 (.86%)
Caesarean Section	13 (.86%)
Hepatitis Cholestatic	13 (.86%)
Hypotonia	13 (.86%)
Asthenia	12 (.8%)
Coma	12 (.8%)
Convulsion	12 (.8%)
Drug Interaction	12 (.8%)
Histiocytosis Haematophagic	12 (.8%)
Pancytopenia	12 (.8%)
Orthostatic Hypotension	11 (.73%)
Septic Shock	11 (.73%)
Agitation	10 (.66%)
Cytolytic Hepatitis	10 (.66%)
Disorientation	10 (.66%)
Eosinophilia	10 (.66%)
Headache	10 (.66%)
Vomiting	10 (.66%)
Disturbance In Attention	9 (.6%)
General Physical Health Deteriorati...	9 (.6%)
Hypotonia Neonatal	9 (.6%)
Alanine Aminotransferase Increased	8 (.53%)
Anxiety	8 (.53%)
Cholestasis	8 (.53%)
Multi-organ Failure	8 (.53%)
Status Epilepticus	8 (.53%)
Toxic Epidermal Necrolysis	8 (.53%)
Depressed Level Of Consciousness	7 (.46%)
Dizziness	7 (.46%)
Gamma-glutamyltransferase Increased	7 (.46%)
Hyperammonaemia	7 (.46%)
Miosis	7 (.46%)
Oedema	7 (.46%)
Rash Maculo-papular	7 (.46%)
Retrognathia	7 (.46%)
Toxic Skin Eruption	7 (.46%)
Abdominal Pain	6 (.4%)
Acute Respiratory Distress Syndrome	6 (.4%)
Drug Ineffective	6 (.4%)
Dyspnoea	6 (.4%)
Electrocardiogram Qt Prolonged	6 (.4%)
Epilepsy	6 (.4%)
Face Oedema	6 (.4%)
Hypothermia	6 (.4%)
Leukopenia	6 (.4%)
Malaise	6 (.4%)
Anaemia	5 (.33%)
Balance Disorder	5 (.33%)
Carotid Artery Stenosis	5 (.33%)
Cerebellar Syndrome	5 (.33%)
Cerebral Haemorrhage	5 (.33%)
Cognitive Disorder	5 (.33%)
Drug Toxicity	5 (.33%)
Dysmorphism	5 (.33%)
Ear Malformation	5 (.33%)
Fatigue	5 (.33%)
Grand Mal Convulsion	5 (.33%)
Hepatic Steatosis	5 (.33%)
Hypercapnia	5 (.33%)
Leukaemia	5 (.33%)
Maternal Drugs Affecting Foetus	5 (.33%)
Microcytic Anaemia	5 (.33%)
Nausea	5 (.33%)
Neutropenia	5 (.33%)
Optic Neuropathy	5 (.33%)
Overdose	5 (.33%)
Pancreatic Atrophy	5 (.33%)
Plagiocephaly	5 (.33%)
Premature Labour	5 (.33%)
Renal Failure	5 (.33%)
Renal Failure Acute	5 (.33%)
Respiratory Distress	5 (.33%)
Sinus Arrhythmia	5 (.33%)
Suicidal Ideation	5 (.33%)
Tremor	5 (.33%)
Urticaria	5 (.33%)
Ventricular Extrasystoles	5 (.33%)
Vertigo	5 (.33%)
Aggression	4 (.27%)
Anorexia	4 (.27%)
Aspartate Aminotransferase Increase...	4 (.27%)
Blood Alkaline Phosphatase Increase...	4 (.27%)
C-reactive Protein Increased	4 (.27%)
Cachexia	4 (.27%)
Cheilitis	4 (.27%)
Chills	4 (.27%)
Cholinergic Syndrome	4 (.27%)
Clostridium Difficile Colitis	4 (.27%)
Congenital Torticollis	4 (.27%)
Conjunctivitis	4 (.27%)

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

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

Neurological	92 (6.1%)
Chemical Injury And Poisoning	58 (3.85%)
Hepatic And Hepatobiliary	57 (3.78%)
Epidermal And Dermal Conditions	50 (3.32%)
Seizures	39 (2.59%)
White Blood Cell	39 (2.59%)
Respiratory	38 (2.52%)
Cardiac Arrhythmias	36 (2.39%)
Deliria	34 (2.26%)
Gastrointestinal Signs	31 (2.06%)
Bacterial Infectious	29 (1.92%)
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Hepatobiliary	28 (1.86%)
Infections - Pathogen Unspecified	26 (1.73%)
Injuries	26 (1.73%)
Anemias Nonhemolytic And Marrow Dep...	24 (1.59%)
Body Temperature Conditions	24 (1.59%)
Musculoskeletal And Connective Tiss...	24 (1.59%)
Neuromuscular	24 (1.59%)
Electrolyte And Fluid Balance Condi...	23 (1.53%)
Mental Impairment	23 (1.53%)
Therapeutic And Nontherapeutic Effe...	22 (1.46%)
Medication Errors	19 (1.26%)
Neonatal And Perinatal Conditions	19 (1.26%)
Platelet	19 (1.26%)
Anxiety Disorders	18 (1.19%)
Muscle	18 (1.19%)
Psychiatric And Behavioural Symptom...	17 (1.13%)
Cardiac And Vascular Investigations	16 (1.06%)
Obstetric And Gynecological Therape...	16 (1.06%)
Renal Disorders	15 (1%)
Decreased And Nonspecific Blood Pre...	14 (.93%)
Hematopoietic Neoplasms	12 (.8%)
Lower Respiratory Tract Disorders	12 (.8%)
Central Nervous System Vascular	11 (.73%)
Hematology Investigations	11 (.73%)
Toxicology And Therapeutic Drug Mon...	11 (.73%)
Appetite And General Nutritional	10 (.66%)
Ear And Labyrinthine Disorders Cong...	10 (.66%)
Gastrointestinal Motility And Defec...	10 (.66%)
Headaches	10 (.66%)
Metabolic, Nutritional And Blood Ga...	10 (.66%)
Oral Soft Tissue Conditions	10 (.66%)
Protein And Amino Acid Metabolism	10 (.66%)
Maternal Complications Of Labour An...	9 (.6%)
Movement Disorders	9 (.6%)
Musculoskeletal And Connective Tiss...	9 (.6%)
Urinary Tract Signs	9 (.6%)
Depressed Mood Disorders	8 (.53%)
Ocular Neuromuscular	8 (.53%)
Physical Examination Topics	8 (.53%)
Suicidal And Self-injurious Behavio...	8 (.53%)
Bone And Joint Injuries	7 (.46%)
Congenital And Hereditary	7 (.46%)
Exocrine Pancreas Conditions	7 (.46%)
Neonatal Respiratory	7 (.46%)
Skin Vascular Abnormalities	7 (.46%)
Vision	7 (.46%)
Angiedema And Urticaria	6 (.4%)
Cardiac And Vascular Disorders Cong...	6 (.4%)
Personality Disorders	6 (.4%)
Pregnancy, Labour, Delivery And Pos...	6 (.4%)
Bone, Calcium, Magnesium And Phosph...	5 (.33%)
Disturbances In Thinking	5 (.33%)
Endocrine Investigations	5 (.33%)
Hearing	5 (.33%)
Heart Failures	5 (.33%)
Inner Ear And Viiith Cranial Nerve	5 (.33%)
Leukemias	5 (.33%)
Sleep Disorders	5 (.33%)
Water, Electrolyte And Mineral	5 (.33%)
Abdominal Hernias And Other Abdomin...	4 (.27%)
Acid-base	4 (.27%)
Bile Duct	4 (.27%)
Enzyme	4 (.27%)
Gastrointestinal Stenosis And Obstr...	4 (.27%)
Gastrointestinal Ulceration And Per...	4 (.27%)
Investigations, Imaging And Histopa...	4 (.27%)
Lifestyle Issues	4 (.27%)
Musculoskeletal And Connective Tiss...	4 (.27%)
Neurological Disorders Congenital	4 (.27%)
Neurological, Special Senses And Ps...	4 (.27%)
Ocular Infections, Irritations And ...	4 (.27%)
Protein And Chemistry Analyses	4 (.27%)
Psychiatric	4 (.27%)
Respiratory Tract Therapeutic Proce...	4 (.27%)
Skin Appendage Conditions	4 (.27%)
Therapeutic Procedures And Supporti...	4 (.27%)
Thoracic Disorders	4 (.27%)
Bone Disorders	3 (.2%)
Central Nervous System Infections A...	3 (.2%)
Changes In Physical Activity	3 (.2%)
Cranial Nerve Disorders	3 (.2%)
Fatal Outcomes	3 (.2%)
Fetal Complications	3 (.2%)
Glucose Metabolism Disorders	3 (.2%)
Joint	3 (.2%)
Mood Disorders	3 (.2%)
Nervous System Neoplasms Malignant ...	3 (.2%)
Salivary Gland Conditions	3 (.2%)
Sexual Function And Fertility	3 (.2%)
Vascular Hemorrhagic	3 (.2%)

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