BI SIFROL TABLETS

Bi Sifrol Tablets Adverse Events Reported to the FDA Over Time

How are Bi Sifrol Tablets adverse event reports trending over time?

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

Most Common Bi Sifrol Tablets Adverse Events Reported to the FDA

What are the most common Bi Sifrol Tablets adverse events reported to the FDA?

Neuroleptic Malignant Syndrome	51 (3.41%)
Somnolence	51 (3.41%)
Fall	50 (3.34%)
Hallucination	45 (3.01%)
Sudden Onset Of Sleep	45 (3.01%)
Delirium	44 (2.94%)
Road Traffic Accident	33 (2.2%)
Pneumonia	32 (2.14%)
Oedema Peripheral	31 (2.07%)
Posture Abnormal	28 (1.87%)
Pyrexia	24 (1.6%)
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Pneumonia Aspiration	22 (1.47%)
Interstitial Lung Disease	21 (1.4%)
Inappropriate Antidiuretic Hormone ...	20 (1.34%)
Constipation	18 (1.2%)
Cardiac Failure	15 (1%)
Death	15 (1%)
Delusion	14 (.94%)
Disseminated Intravascular Coagulat...	14 (.94%)
Dyskinesia	14 (.94%)
Femur Fracture	14 (.94%)
Liver Disorder	14 (.94%)
Anaemia	13 (.87%)
Confusional State	13 (.87%)
Hallucination, Visual	13 (.87%)
Dehydration	12 (.8%)
Loss Of Consciousness	12 (.8%)
Pleural Effusion	12 (.8%)
Altered State Of Consciousness	11 (.73%)
Anorexia	11 (.73%)
Hyponatraemia	10 (.67%)
Blood Creatine Phosphokinase Increa...	9 (.6%)
Cholelithiasis	9 (.6%)
Depressed Level Of Consciousness	9 (.6%)
Drowning	9 (.6%)
Hepatic Function Abnormal	9 (.6%)
Insomnia	9 (.6%)
Nausea	9 (.6%)
Sleep Attacks	9 (.6%)
Vomiting	9 (.6%)
Acute Respiratory Failure	8 (.53%)
Blood Pressure Fluctuation	8 (.53%)
Coma	8 (.53%)
Contusion	8 (.53%)
Dizziness	8 (.53%)
Fracture	8 (.53%)
Melaena	8 (.53%)
Pain	8 (.53%)
Shock	8 (.53%)
Tremor	8 (.53%)
Cardio-respiratory Arrest	7 (.47%)
Cellulitis	7 (.47%)
Cholangitis	7 (.47%)
Dysphagia	7 (.47%)
Hyperglycaemia	7 (.47%)
Impulse-control Disorder	7 (.47%)
Influenza	7 (.47%)
Pleurisy	7 (.47%)
Abnormal Behaviour	6 (.4%)
Cardiac Failure Acute	6 (.4%)
Coma Hepatic	6 (.4%)
Congestive Cardiomyopathy	6 (.4%)
Convulsion	6 (.4%)
Hallucination, Auditory	6 (.4%)
Persecutory Delusion	6 (.4%)
Platelet Count Decreased	6 (.4%)
Pleural Haemorrhage	6 (.4%)
Respiratory Arrest	6 (.4%)
Respiratory Failure	6 (.4%)
Salivary Hypersecretion	6 (.4%)
Thermal Burn	6 (.4%)
Aspartate Aminotransferase Increase...	5 (.33%)
Disorientation	5 (.33%)
Fractured Ischium	5 (.33%)
Ileus	5 (.33%)
Large Intestine Carcinoma	5 (.33%)
Leukopenia	5 (.33%)
Overdose	5 (.33%)
Rash	5 (.33%)
Rhabdomyolysis	5 (.33%)
Urinary Tract Infection	5 (.33%)
White Blood Cell Count Increased	5 (.33%)
Abdominal Pain	4 (.27%)
Agitation	4 (.27%)
Akathisia	4 (.27%)
Alanine Aminotransferase Increased	4 (.27%)
Alopecia	4 (.27%)
Ankle Fracture	4 (.27%)
Atonic Seizures	4 (.27%)
Back Pain	4 (.27%)
Bipolar Disorder	4 (.27%)
Bipolar I Disorder	4 (.27%)
Blood Alkaline Phosphatase Increase...	4 (.27%)
Cardiac Valve Disease	4 (.27%)
Cerebral Infarction	4 (.27%)
Cholecystitis	4 (.27%)
Depression	4 (.27%)
Diarrhoea	4 (.27%)
Dyspepsia	4 (.27%)
Eyelid Oedema	4 (.27%)
Generalised Erythema	4 (.27%)

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This graph shows the top adverse events submitted to the FDA for Bi Sifrol Tablets, 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 Bi Sifrol Tablets 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 Bi Sifrol Tablets

What are the most common Bi Sifrol Tablets adverse events reported to the FDA?

Neurological	124 (8.28%)
Injuries	112 (7.48%)
Disturbances In Thinking	84 (5.61%)
Deliria	62 (4.14%)
Neuromuscular	54 (3.61%)
Infections - Pathogen Unspecified	50 (3.34%)
Lower Respiratory Tract Disorders	48 (3.21%)
Sleep Disturbances	45 (3.01%)
Bone And Joint Injuries	44 (2.94%)
Gastrointestinal Signs	37 (2.47%)
Musculoskeletal And Connective Tiss...	34 (2.27%)
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Movement Disorders	29 (1.94%)
Hepatic And Hepatobiliary	28 (1.87%)
Respiratory	27 (1.8%)
Pleural	26 (1.74%)
Electrolyte And Fluid Balance Condi...	25 (1.67%)
Body Temperature Conditions	24 (1.6%)
Fatal Outcomes	24 (1.6%)
Sleep Disorders	24 (1.6%)
Decreased And Nonspecific Blood Pre...	22 (1.47%)
Gastrointestinal Motility And Defec...	22 (1.47%)
Heart Failures	21 (1.4%)
Hypothalamus And Pituitary Gland	20 (1.34%)
Central Nervous System Vascular	17 (1.14%)
Gallbladder	16 (1.07%)
Hepatobiliary	15 (1%)
Coagulopathies And Bleeding Diathes...	14 (.94%)
Muscle	14 (.94%)
Anemias Nonhemolytic And Marrow Dep...	13 (.87%)
Cardiac Arrhythmias	13 (.87%)
Enzyme	13 (.87%)
Epidermal And Dermal Conditions	13 (.87%)
Appetite And General Nutritional	12 (.8%)
Glucose Metabolism Disorders	12 (.8%)
Hematology Investigations	12 (.8%)
Impulse Control	11 (.73%)
Renal Disorders	11 (.73%)
Seizures	10 (.67%)
Bacterial Infectious	9 (.6%)
Manic And Bipolar Mood Disorders	9 (.6%)
Gastrointestinal Hemorrhages	8 (.53%)
Gastrointestinal Stenosis And Obstr...	8 (.53%)
Psychiatric And Behavioural Symptom...	8 (.53%)
White Blood Cell	8 (.53%)
Bile Duct	7 (.47%)
Myocardial	7 (.47%)
Salivary Gland Conditions	7 (.47%)
Viral Infectious	7 (.47%)
Cardiac Valve	6 (.4%)
Gastrointestinal Neoplasms Malignan...	6 (.4%)
Injuries By Physical Agents	6 (.4%)
Medication Errors	6 (.4%)
Therapeutic And Nontherapeutic Effe...	6 (.4%)
Therapeutic Procedures And Supporti...	6 (.4%)
Urinary Tract Signs	6 (.4%)
Anxiety Disorders	5 (.33%)
Coronary Artery	5 (.33%)
Depressed Mood Disorders	5 (.33%)
Mental Impairment	5 (.33%)
Metabolic, Nutritional And Blood Ga...	5 (.33%)
Cardiac And Vascular Investigations	4 (.27%)
Gastrointestinal Ulceration And Per...	4 (.27%)
Headaches	4 (.27%)
Hemolyses And Related Conditions	4 (.27%)
Mood Disorders	4 (.27%)
Musculoskeletal And Connective Tiss...	4 (.27%)
Nephropathies	4 (.27%)
Ocular Infections, Irritations And ...	4 (.27%)
Oral Soft Tissue Conditions	4 (.27%)
Skin Appendage Conditions	4 (.27%)
Bladder And Bladder Neck Disorders	3 (.2%)
Changes In Physical Activity	3 (.2%)
Chemical Injury And Poisoning	3 (.2%)
Connective Tissue Disorders	3 (.2%)
Embolism And Thrombosis	3 (.2%)
Immunology And Allergy	3 (.2%)
Metastases	3 (.2%)
Platelet	3 (.2%)
Renal And Urinary Tract Investigati...	3 (.2%)
Abdominal Hernias And Other Abdomin...	2 (.13%)
Cardiac And Vascular Disorders Cong...	2 (.13%)
Dissociative	2 (.13%)
Gender Related Factors	2 (.13%)
Lifestyle Issues	2 (.13%)
Miscellaneous And Site Unspecified ...	2 (.13%)
Personality Disorders	2 (.13%)
Physical Examination Topics	2 (.13%)
Suicidal And Self-injurious Behavio...	2 (.13%)
Toxicology And Therapeutic Drug Mon...	2 (.13%)
Vascular	2 (.13%)
Vascular Hemorrhagic	2 (.13%)
Eating Disorders	1 (.07%)
Fungal Infectious	1 (.07%)
Gastrointestinal Therapeutic Proced...	1 (.07%)
Hematological And Lymphoid Tissue T...	1 (.07%)
Musculoskeletal And Connective Tiss...	1 (.07%)
Neurological Disorders Of The Eye	1 (.07%)
Ocular Neuromuscular	1 (.07%)
Pericardial	1 (.07%)
Peritoneal And Retroperitoneal Cond...	1 (.07%)
Procedural And Device Related Injur...	1 (.07%)

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This graph shows the top categories of adverse events submitted to the FDA for Bi Sifrol Tablets, 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 Bi Sifrol Tablets 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.