BUSPIRONE

Buspirone Adverse Events Reported to the FDA Over Time

How are Buspirone adverse event reports trending over time?

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

Most Common Buspirone Adverse Events Reported to the FDA

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

Completed Suicide	192 (3.85%)
Drug Ineffective	110 (2.2%)
Anxiety	105 (2.1%)
Dizziness	86 (1.72%)
Headache	81 (1.62%)
Nausea	76 (1.52%)
Insomnia	71 (1.42%)
Depression	65 (1.3%)
Suicide Attempt	63 (1.26%)
Cardiac Arrest	58 (1.16%)
Drug Interaction	58 (1.16%)
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Respiratory Arrest	53 (1.06%)
Tremor	53 (1.06%)
Agitation	50 (1%)
Somnolence	49 (.98%)
Confusional State	46 (.92%)
Intentional Overdose	44 (.88%)
Overdose	44 (.88%)
Diarrhoea	38 (.76%)
Death	37 (.74%)
Dyspnoea	36 (.72%)
Vision Blurred	36 (.72%)
Vomiting	36 (.72%)
Chest Pain	34 (.68%)
Fatigue	34 (.68%)
Poisoning	32 (.64%)
Serotonin Syndrome	32 (.64%)
Cardio-respiratory Arrest	31 (.62%)
Fall	31 (.62%)
Multiple Drug Overdose	31 (.62%)
Hyperhidrosis	30 (.6%)
Weight Decreased	30 (.6%)
Rash	28 (.56%)
Malaise	27 (.54%)
Suicidal Ideation	27 (.54%)
Coma	26 (.52%)
Convulsion	26 (.52%)
Feeling Abnormal	26 (.52%)
Lethargy	26 (.52%)
Panic Attack	26 (.52%)
Tinnitus	23 (.46%)
Weight Increased	23 (.46%)
Abnormal Behaviour	22 (.44%)
Condition Aggravated	22 (.44%)
Dyspepsia	22 (.44%)
Hypotension	22 (.44%)
Disturbance In Attention	21 (.42%)
Heart Rate Increased	21 (.42%)
Mental Status Changes	21 (.42%)
Abdominal Pain	20 (.4%)
Aggression	20 (.4%)
Decreased Appetite	19 (.38%)
Nervousness	19 (.38%)
Oedema Peripheral	19 (.38%)
Syncope	19 (.38%)
Abdominal Discomfort	18 (.36%)
Multiple Drug Overdose Intentional	18 (.36%)
Pyrexia	18 (.36%)
Blood Pressure Increased	17 (.34%)
Depressed Level Of Consciousness	17 (.34%)
Diabetes Mellitus Inadequate Contro...	17 (.34%)
Drug Exposure During Pregnancy	17 (.34%)
Drug Toxicity	17 (.34%)
Loss Of Consciousness	17 (.34%)
Pain	17 (.34%)
Paraesthesia	17 (.34%)
Restlessness	17 (.34%)
Disorientation	16 (.32%)
Dysarthria	16 (.32%)
Electrocardiogram Qt Prolonged	16 (.32%)
Fear Of Weight Gain	16 (.32%)
Mydriasis	16 (.32%)
Pregnancy	16 (.32%)
Anger	15 (.3%)
Asthenia	15 (.3%)
Burning Sensation	15 (.3%)
Hypertension	15 (.3%)
Renal Failure Acute	15 (.3%)
Urinary Tract Infection	15 (.3%)
Balance Disorder	14 (.28%)
Generalised Anxiety Disorder	14 (.28%)
Hypoaesthesia	14 (.28%)
Hypoglycaemia	14 (.28%)
Medication Error	14 (.28%)
Chills	13 (.26%)
Delirium	13 (.26%)
Drug Withdrawal Syndrome	13 (.26%)
Incorrect Dose Administered	13 (.26%)
Mania	13 (.26%)
Memory Impairment	13 (.26%)
Muscle Spasms	13 (.26%)
Muscle Twitching	13 (.26%)
Myoclonus	13 (.26%)
Ventricular Septal Defect	13 (.26%)
Abdominal Pain Upper	12 (.24%)
Anaemia	12 (.24%)
Atelectasis	12 (.24%)
Constipation	12 (.24%)
Gastrointestinal Disorder	12 (.24%)
Intentional Drug Misuse	12 (.24%)
Irritability	12 (.24%)

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

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

Neurological	438 (8.77%)
Suicidal And Self-injurious Behavio...	290 (5.81%)
Anxiety Disorders	248 (4.97%)
Therapeutic And Nontherapeutic Effe...	215 (4.31%)
Gastrointestinal Signs	212 (4.25%)
Medication Errors	194 (3.89%)
Respiratory	165 (3.3%)
Cardiac Arrhythmias	131 (2.62%)
Sleep Disorders	104 (2.08%)
Movement Disorders	94 (1.88%)
Headaches	92 (1.84%)
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Cardiac And Vascular Investigations	82 (1.64%)
Chemical Injury And Poisoning	76 (1.52%)
Deliria	75 (1.5%)
Depressed Mood Disorders	74 (1.48%)
Injuries	72 (1.44%)
Epidermal And Dermal Conditions	69 (1.38%)
Physical Examination Topics	69 (1.38%)
Gastrointestinal Motility And Defec...	65 (1.3%)
Muscle	60 (1.2%)
Fatal Outcomes	55 (1.1%)
Psychiatric	52 (1.04%)
Mood Disorders	50 (1%)
Disturbances In Thinking	48 (.96%)
Infections - Pathogen Unspecified	47 (.94%)
Seizures	46 (.92%)
Skin Appendage Conditions	46 (.92%)
Neuromuscular	45 (.9%)
Mental Impairment	43 (.86%)
Vision	43 (.86%)
Metabolic, Nutritional And Blood Ga...	42 (.84%)
Glucose Metabolism Disorders	41 (.82%)
Personality Disorders	39 (.78%)
Lower Respiratory Tract Disorders	36 (.72%)
Musculoskeletal And Connective Tiss...	36 (.72%)
Appetite And General Nutritional	33 (.66%)
Decreased And Nonspecific Blood Pre...	32 (.64%)
Hepatobiliary	31 (.62%)
Renal Disorders	31 (.62%)
Electrolyte And Fluid Balance Condi...	30 (.6%)
Toxicology And Therapeutic Drug Mon...	29 (.58%)
Urinary Tract Signs	29 (.58%)
Inner Ear And Viiith Cranial Nerve	26 (.52%)
Ocular Neuromuscular	26 (.52%)
Water, Electrolyte And Mineral	26 (.52%)
Body Temperature Conditions	24 (.48%)
Cardiac And Vascular Disorders Cong...	24 (.48%)
Changes In Physical Activity	24 (.48%)
Psychiatric And Behavioural Symptom...	24 (.48%)
Upper Respiratory Tract Disorders	24 (.48%)
Gastrointestinal Conditions	22 (.44%)
Hepatic And Hepatobiliary	22 (.44%)
Allergic Conditions	21 (.42%)
Pregnancy, Labour, Delivery And Pos...	21 (.42%)
Lifestyle Issues	19 (.38%)
Cardiac Disorder Signs	18 (.36%)
Enzyme	18 (.36%)
Manic And Bipolar Mood Disorders	18 (.36%)
Myocardial	18 (.36%)
Vascular	18 (.36%)
Bone And Joint Injuries	17 (.34%)
Hematology Investigations	17 (.34%)
Sexual Function And Fertility	17 (.34%)
Coronary Artery	16 (.32%)
Vascular Hypertensive	15 (.3%)
Eye	14 (.28%)
Gastrointestinal Hemorrhages	14 (.28%)
Gastrointestinal Ulceration And Per...	14 (.28%)
Anemias Nonhemolytic And Marrow Dep...	13 (.26%)
Arteriosclerosis, Stenosis, Vascula...	13 (.26%)
Joint	13 (.26%)
Hearing	12 (.24%)
Heart Failures	12 (.24%)
Salivary Gland Conditions	12 (.24%)
Angiedema And Urticaria	11 (.22%)
Bronchial Disorders	10 (.2%)
Gastrointestinal Stenosis And Obstr...	10 (.2%)
Neonatal Respiratory	10 (.2%)
Thyroid Gland	10 (.2%)
Breast	9 (.18%)
Cranial Nerve Disorders	9 (.18%)
Platelet	9 (.18%)
Sexual Dysfunctions, Disturbances A...	9 (.18%)
Bone Disorders	8 (.16%)
Increased Intracranial Pressure And...	8 (.16%)
Lipid Analyses	8 (.16%)
Musculoskeletal And Connective Tiss...	8 (.16%)
Peripheral Neuropathies	8 (.16%)
Renal And Urinary Tract Investigati...	8 (.16%)
Therapeutic Procedures And Supporti...	8 (.16%)
Tongue Conditions	8 (.16%)
White Blood Cell	8 (.16%)
Hypothalamus And Pituitary Gland	7 (.14%)
Product Quality Issues	7 (.14%)
Dental And Gingival Conditions	6 (.12%)
Lipid Metabolism	6 (.12%)
Maternal Complications Of Pregnancy	6 (.12%)
Schizophrenia And Other Psychotic	6 (.12%)
Vulvovaginal Disorders	6 (.12%)
Aural	5 (.1%)
Bone, Calcium, Magnesium And Phosph...	5 (.1%)

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