BUTRANS

Butrans Adverse Events Reported to the FDA Over Time

How are Butrans adverse event reports trending over time?

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

Most Common Butrans Adverse Events Reported to the FDA

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

Inadequate Analgesia	52 (2.54%)
Death	44 (2.15%)
Nausea	44 (2.15%)
Dyspnoea	40 (1.95%)
Headache	39 (1.91%)
Drug Ineffective	37 (1.81%)
Pain	37 (1.81%)
Vomiting	34 (1.66%)
Dizziness	31 (1.51%)
Incorrect Dose Administered	26 (1.27%)
Application Site Pruritus	25 (1.22%)
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Diarrhoea	25 (1.22%)
Hospitalisation	25 (1.22%)
Surgery	23 (1.12%)
Application Site Erythema	20 (.98%)
Neoplasm Malignant	20 (.98%)
Somnolence	20 (.98%)
Myocardial Infarction	19 (.93%)
Application Site Vesicles	18 (.88%)
Drug Interaction	18 (.88%)
Fall	18 (.88%)
Intra-uterine Death	18 (.88%)
Loss Of Consciousness	17 (.83%)
Application Site Burn	16 (.78%)
Application Site Rash	16 (.78%)
Confusional State	16 (.78%)
Drug Withdrawal Syndrome	16 (.78%)
Pneumonia	16 (.78%)
Heart Rate Increased	15 (.73%)
Sleep Apnoea Syndrome	15 (.73%)
Suicidal Ideation	15 (.73%)
Application Site Pain	14 (.68%)
Arthralgia	14 (.68%)
Application Site Exfoliation	13 (.64%)
Overdose	13 (.64%)
Anxiety	12 (.59%)
Asthenia	12 (.59%)
Completed Suicide	12 (.59%)
Application Site Discolouration	11 (.54%)
Feeling Abnormal	11 (.54%)
Hallucination	11 (.54%)
Hypotension	11 (.54%)
Palpitations	11 (.54%)
Pancreatitis	11 (.54%)
Wrong Technique In Drug Usage Proce...	11 (.54%)
Abdominal Pain	10 (.49%)
Cerebrovascular Accident	10 (.49%)
Constipation	10 (.49%)
Drug Exposure During Pregnancy	10 (.49%)
Fatigue	10 (.49%)
Gait Disturbance	10 (.49%)
Hyperhidrosis	10 (.49%)
Knee Arthroplasty	10 (.49%)
Malaise	10 (.49%)
Muscle Spasms	10 (.49%)
Application Site Irritation	9 (.44%)
Cardiac Failure	9 (.44%)
Convulsion	9 (.44%)
Hypertension	9 (.44%)
Insomnia	9 (.44%)
Respiratory Distress	9 (.44%)
Unevaluable Event	9 (.44%)
Chest Discomfort	8 (.39%)
Chest Pain	8 (.39%)
Chronic Obstructive Pulmonary Disea...	8 (.39%)
Disturbance In Attention	8 (.39%)
Drug Effect Decreased	8 (.39%)
Intestinal Obstruction	8 (.39%)
Memory Impairment	8 (.39%)
Rash	8 (.39%)
Adverse Drug Reaction	7 (.34%)
Application Site Swelling	7 (.34%)
Breakthrough Pain	7 (.34%)
Disorientation	7 (.34%)
Hypoaesthesia	7 (.34%)
Pain In Extremity	7 (.34%)
Pruritus	7 (.34%)
Visual Impairment	7 (.34%)
Atrial Fibrillation	6 (.29%)
Back Pain	6 (.29%)
Balance Disorder	6 (.29%)
Blindness Transient	6 (.29%)
Cardiac Disorder	6 (.29%)
Drug Abuse	6 (.29%)
Drug Effect Increased	6 (.29%)
Drug Hypersensitivity	6 (.29%)
Hypersensitivity	6 (.29%)
Oedema Peripheral	6 (.29%)
Paraesthesia	6 (.29%)
Renal Impairment	6 (.29%)
Sensory Loss	6 (.29%)
Sepsis	6 (.29%)
Tremor	6 (.29%)
Abdominal Distension	5 (.24%)
Abdominal Pain Upper	5 (.24%)
Anger	5 (.24%)
Ankle Fracture	5 (.24%)
Application Site Hypersensitivity	5 (.24%)
Blood Glucose Decreased	5 (.24%)
Depression	5 (.24%)
Diplopia	5 (.24%)

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

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

Administration Site Reactions	179 (8.74%)
Neurological	137 (6.69%)
Gastrointestinal Signs	116 (5.67%)
Respiratory	98 (4.79%)
Therapeutic And Nontherapeutic Effe...	97 (4.74%)
Medication Errors	62 (3.03%)
Procedural And Device Related Injur...	55 (2.69%)
Therapeutic Procedures And Supporti...	53 (2.59%)
Fatal Outcomes	44 (2.15%)
Gastrointestinal Motility And Defec...	44 (2.15%)
Epidermal And Dermal Conditions	43 (2.1%)
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Headaches	43 (2.1%)
Injuries	32 (1.56%)
Cardiac And Vascular Investigations	31 (1.51%)
Infections - Pathogen Unspecified	29 (1.42%)
Musculoskeletal And Connective Tiss...	28 (1.37%)
Suicidal And Self-injurious Behavio...	28 (1.37%)
Anxiety Disorders	26 (1.27%)
Coronary Artery	26 (1.27%)
Deliria	26 (1.27%)
Mental Impairment	26 (1.27%)
Psychiatric	23 (1.12%)
Vision	23 (1.12%)
Abortions And Stillbirth	22 (1.07%)
Cardiac Arrhythmias	22 (1.07%)
Joint	20 (.98%)
Miscellaneous And Site Unspecified ...	20 (.98%)
Bone And Joint Injuries	18 (.88%)
Disturbances In Thinking	18 (.88%)
Movement Disorders	18 (.88%)
Cardiac Disorder Signs	17 (.83%)
Mood Disorders	17 (.83%)
Bronchial Disorders	16 (.78%)
Heart Failures	16 (.78%)
Chemical Injury And Poisoning	14 (.68%)
Decreased And Nonspecific Blood Pre...	14 (.68%)
Muscle	14 (.68%)
Skin Appendage Conditions	14 (.68%)
Sleep Disorders	14 (.68%)
Electrolyte And Fluid Balance Condi...	13 (.64%)
Allergic Conditions	12 (.59%)
Bone And Joint Therapeutic Procedur...	12 (.59%)
Exocrine Pancreas Conditions	12 (.59%)
Gastrointestinal Stenosis And Obstr...	12 (.59%)
Toxicology And Therapeutic Drug Mon...	12 (.59%)
Renal Disorders	11 (.54%)
Seizures	11 (.54%)
Central Nervous System Vascular	10 (.49%)
Depressed Mood Disorders	10 (.49%)
Lifestyle Issues	10 (.49%)
Metabolic, Nutritional And Blood Ga...	10 (.49%)
Hepatic And Hepatobiliary	9 (.44%)
Oral Soft Tissue Conditions	9 (.44%)
Vascular Hypertensive	9 (.44%)
Cardiac Valve	8 (.39%)
Nervous System, Skull And Spine The...	8 (.39%)
Eye	6 (.29%)
Lower Respiratory Tract Disorders	6 (.29%)
Physical Examination Topics	6 (.29%)
Product Quality Issues	6 (.29%)
Bacterial Infectious	5 (.24%)
Pericardial	5 (.24%)
Upper Respiratory Tract Disorders	5 (.24%)
Angiedema And Urticaria	4 (.2%)
Arteriosclerosis, Stenosis, Vascula...	4 (.2%)
Body Temperature Conditions	4 (.2%)
Hearing	4 (.2%)
Hematology Investigations	4 (.2%)
Ocular Sensory Symptoms	4 (.2%)
Personality Disorders	4 (.2%)
Reproductive Neoplasms Male Maligna...	4 (.2%)
Retina, Choroid And Vitreous Hemorr...	4 (.2%)
Schizophrenia And Other Psychotic	4 (.2%)
Tongue Conditions	4 (.2%)
Vascular	4 (.2%)
Anemias Nonhemolytic And Marrow Dep...	3 (.15%)
Appetite And General Nutritional	3 (.15%)
Breast Neoplasms Malignant And Unsp...	3 (.15%)
Coagulopathies And Bleeding Diathes...	3 (.15%)
Communication Disorders	3 (.15%)
Environmental Issues	3 (.15%)
Gastrointestinal Neoplasms Malignan...	3 (.15%)
Pleural	3 (.15%)
Renal And Urinary Tract Neoplasms M...	3 (.15%)
Spinal Cord And Nerve Root	3 (.15%)
Urinary Tract Signs	3 (.15%)
Viral Infectious	3 (.15%)
Dental And Gingival Conditions	2 (.1%)
Embolism And Thrombosis	2 (.1%)
Fractures	2 (.1%)
Gallbladder	2 (.1%)
Hepatobiliary	2 (.1%)
Immunology And Allergy	2 (.1%)
Inner Ear And Viiith Cranial Nerve	2 (.1%)
Neuromuscular	2 (.1%)
Ocular Hemorrhages And Vascular	2 (.1%)
Ocular Infections, Irritations And ...	2 (.1%)
Psychiatric And Behavioural Symptom...	2 (.1%)
Water, Electrolyte And Mineral	2 (.1%)
Acid-base	1 (.05%)
Demyelinating	1 (.05%)

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