BUPRENORPHINE

Buprenorphine Adverse Events Reported to the FDA Over Time

How are Buprenorphine adverse event reports trending over time?

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

Most Common Buprenorphine Adverse Events Reported to the FDA

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

Drug Exposure During Pregnancy	1433 (2.8%)
Drug Withdrawal Syndrome	1389 (2.71%)
Insomnia	974 (1.9%)
Suicidal Ideation	905 (1.77%)
Convulsion	875 (1.71%)
Vomiting	812 (1.58%)
Nausea	773 (1.51%)
Anxiety	732 (1.43%)
Depression	727 (1.42%)
Substance Abuse	658 (1.28%)
Headache	655 (1.28%)
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Pain	648 (1.26%)
Drug Dependence	604 (1.18%)
Intentional Drug Misuse	602 (1.17%)
Loss Of Consciousness	529 (1.03%)
Hallucination	499 (.97%)
Fatigue	491 (.96%)
Hyperhidrosis	485 (.95%)
Somnolence	438 (.85%)
Oedema Peripheral	436 (.85%)
Drug Withdrawal Syndrome Neonatal	434 (.85%)
Abortion Spontaneous	424 (.83%)
Back Pain	421 (.82%)
Constipation	396 (.77%)
Dizziness	393 (.77%)
Dyspnoea	369 (.72%)
Overdose	369 (.72%)
Decreased Appetite	354 (.69%)
Malaise	345 (.67%)
Fall	323 (.63%)
Asthenia	310 (.6%)
Tremor	302 (.59%)
Death	292 (.57%)
Diarrhoea	290 (.57%)
Feeling Abnormal	290 (.57%)
Pneumonia	284 (.55%)
Pain In Extremity	277 (.54%)
Pyrexia	272 (.53%)
Condition Aggravated	269 (.52%)
Underdose	256 (.5%)
Road Traffic Accident	252 (.49%)
Premature Baby	250 (.49%)
Off Label Use	246 (.48%)
Weight Decreased	244 (.48%)
Withdrawal Syndrome	229 (.45%)
Wrong Technique In Drug Usage Proce...	226 (.44%)
Incorrect Route Of Drug Administrat...	211 (.41%)
Chest Pain	208 (.41%)
Abdominal Pain Upper	198 (.39%)
Arthralgia	188 (.37%)
Muscle Spasms	183 (.36%)
Euphoric Mood	181 (.35%)
Panic Attack	178 (.35%)
Suicide Attempt	177 (.35%)
Drug Abuse	176 (.34%)
Hospitalisation	171 (.33%)
Weight Increased	170 (.33%)
Hypertension	167 (.33%)
Myocardial Infarction	163 (.32%)
Agitation	154 (.3%)
Memory Impairment	154 (.3%)
Confusional State	152 (.3%)
Irritability	147 (.29%)
Premature Labour	146 (.28%)
Abdominal Pain	144 (.28%)
Drug Ineffective	144 (.28%)
Nervousness	141 (.28%)
Migraine	139 (.27%)
Paranoia	134 (.26%)
Dehydration	132 (.26%)
Drug Interaction	132 (.26%)
Nasopharyngitis	129 (.25%)
Blood Pressure Increased	128 (.25%)
Chills	128 (.25%)
Hallucination, Auditory	124 (.24%)
Abortion Induced	120 (.23%)
Influenza	120 (.23%)
Completed Suicide	119 (.23%)
Stress	117 (.23%)
Cerebrovascular Accident	115 (.22%)
Crying	115 (.22%)
Pregnancy	115 (.22%)
Intentional Overdose	112 (.22%)
Pruritus	111 (.22%)
Coma	108 (.21%)
Hypoaesthesia	106 (.21%)
Amnesia	103 (.2%)
Gait Disturbance	99 (.19%)
Head Injury	99 (.19%)
Restlessness	99 (.19%)
Cardiac Arrest	98 (.19%)
Heart Rate Increased	96 (.19%)
Palpitations	94 (.18%)
Psychotic Disorder	92 (.18%)
Hallucination, Visual	91 (.18%)
Hypotension	91 (.18%)
Lethargy	91 (.18%)
Muscle Twitching	90 (.18%)
Rash	89 (.17%)
Syncope	89 (.17%)
Tooth Disorder	88 (.17%)

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

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

Neurological	2697 (5.26%)
Psychiatric	2422 (4.73%)
Therapeutic And Nontherapeutic Effe...	2365 (4.61%)
Gastrointestinal Signs	2273 (4.43%)
Chemical Injury And Poisoning	1632 (3.18%)
Anxiety Disorders	1518 (2.96%)
Medication Errors	1518 (2.96%)
Infections - Pathogen Unspecified	1435 (2.8%)
Respiratory	1317 (2.57%)
Injuries	1277 (2.49%)
Suicidal And Self-injurious Behavio...	1264 (2.47%)
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Sleep Disorders	1252 (2.44%)
Seizures	1023 (2%)
Musculoskeletal And Connective Tiss...	982 (1.92%)
Disturbances In Thinking	899 (1.75%)
Depressed Mood Disorders	881 (1.72%)
Gastrointestinal Motility And Defec...	810 (1.58%)
Headaches	808 (1.58%)
Skin Appendage Conditions	663 (1.29%)
Epidermal And Dermal Conditions	613 (1.2%)
Abortions And Stillbirth	555 (1.08%)
Movement Disorders	540 (1.05%)
Mood Disorders	524 (1.02%)
Muscle	521 (1.02%)
Appetite And General Nutritional	519 (1.01%)
Therapeutic Procedures And Supporti...	468 (.91%)
Physical Examination Topics	458 (.89%)
Bone And Joint Injuries	444 (.87%)
Joint	401 (.78%)
Cardiac And Vascular Investigations	389 (.76%)
Bacterial Infectious	383 (.75%)
Cardiac Arrhythmias	371 (.72%)
Neonatal And Perinatal Conditions	370 (.72%)
Hepatic And Hepatobiliary	364 (.71%)
Mental Impairment	363 (.71%)
Fatal Outcomes	349 (.68%)
Viral Infectious	311 (.61%)
Vision	300 (.59%)
Deliria	294 (.57%)
Body Temperature Conditions	289 (.56%)
Electrolyte And Fluid Balance Condi...	275 (.54%)
Personality Disorders	272 (.53%)
Coronary Artery	262 (.51%)
Dental And Gingival Conditions	240 (.47%)
Central Nervous System Vascular	224 (.44%)
Cardiac Disorder Signs	222 (.43%)
Urinary Tract Signs	212 (.41%)
Lifestyle Issues	211 (.41%)
Obstetric And Gynecological Therape...	200 (.39%)
Maternal Complications Of Labour An...	193 (.38%)
Lower Respiratory Tract Disorders	181 (.35%)
Tongue Conditions	175 (.34%)
Embolism And Thrombosis	174 (.34%)
Vascular Hypertensive	168 (.33%)
Renal Disorders	158 (.31%)
Decreased And Nonspecific Blood Pre...	152 (.3%)
Pregnancy, Labour, Delivery And Pos...	149 (.29%)
Tissue	149 (.29%)
Ocular Neuromuscular	146 (.28%)
Oral Soft Tissue Conditions	146 (.28%)
Allergic Conditions	141 (.28%)
Bronchial Disorders	137 (.27%)
Hepatobiliary	137 (.27%)
Maternal Complications Of Pregnancy	135 (.26%)
Legal Issues	132 (.26%)
Metabolic, Nutritional And Blood Ga...	132 (.26%)
Gallbladder	131 (.26%)
Manic And Bipolar Mood Disorders	130 (.25%)
Glucose Metabolism Disorders	129 (.25%)
Changes In Physical Activity	122 (.24%)
Inner Ear And Viiith Cranial Nerve	122 (.24%)
Procedural And Device Related Injur...	122 (.24%)
Schizophrenia And Other Psychotic	121 (.24%)
Heart Failures	118 (.23%)
Gastrointestinal Conditions	113 (.22%)
Sleep Disturbances	108 (.21%)
Administration Site Reactions	106 (.21%)
Psychiatric And Behavioural Symptom...	97 (.19%)
Pulmonary Vascular	97 (.19%)
Bone Disorders	92 (.18%)
Urolithiases	92 (.18%)
Exocrine Pancreas Conditions	91 (.18%)
Vascular	91 (.18%)
Arteriosclerosis, Stenosis, Vascula...	90 (.18%)
Musculoskeletal And Connective Tiss...	90 (.18%)
Neonatal Respiratory	88 (.17%)
Product Quality Issues	84 (.16%)
Gastrointestinal Hemorrhages	83 (.16%)
Cardiac Valve	81 (.16%)
Communication Disorders	80 (.16%)
Fungal Infectious	79 (.15%)
Eye	78 (.15%)
Myocardial	77 (.15%)
Anemias Nonhemolytic And Marrow Dep...	76 (.15%)
Peripheral Neuropathies	76 (.15%)
Uterine, Pelvic And Broad Ligament	75 (.15%)
Upper Respiratory Tract Disorders	72 (.14%)
Breast	71 (.14%)
Musculoskeletal And Connective Tiss...	71 (.14%)
Hematology Investigations	70 (.14%)
Placental, Amniotic And Cavity Diso...	70 (.14%)

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