Biperiden Hydrochloride Tab combined with Risperidone

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Muscle Hypertrophy Hospitalization 16 Female 1/9/2006 Physician Japan
Primary
Concomitant
Unevaluable Event Other Serious 12/4/2005 Female 1/20/2006 France
Primary
Secondary
Concomitant
Treatment Noncompliance Hospitalization 1/31/2006 Male 4/10/2006 Physician France
Primary
Secondary
Concomitant
Drug Withdrawal Syndrome Neonatal Hospitalization 3/1/2006 4/14/2006 Physician Japan
Primary
Secondary
Drug Withdrawal Syndrome Neonatal Hospitalization 3/1/2006 Male 5/2/2006 Physician Japan
Primary
Secondary
Emphysema Hospitalization 58 Male 5/12/2006 Physician Brazil
Primary
Concomitant
Rhabdomyolysis Life Threatening 1/1/2005 40 Male 6/2/2006 Germany
Primary
Secondary
Concomitant
Tremor Neonatal Hospitalization 3/1/2006 Male 6/21/2006 Physician Japan
Primary
Secondary
Rhabdomyolysis Life Threatening 40 Male 7/31/2006 Physician Germany
Primary
Secondary
Concomitant
Sudden Death Death 7/29/2006 31 Male 8/17/2006 Other Health Professional Japan
Primary
Concomitant
Rhabdomyolysis Other Serious 40 Male 8/18/2006 Physician Germany
Primary
Secondary
Concomitant
Sudden Death Death 7/29/2006 31 Male 9/5/2006 Other Health Professional Japan
Primary
Concomitant
Cardiac Failure Death 32 Female 9/5/2006 Physician Japan
Primary
Secondary
Concomitant
Tremor Neonatal Other Serious 3/1/2006 Male 9/7/2006 Physician Japan
Primary
Secondary
Concomitant
Diabetic Ketoacidosis Hospitalization 8/24/2006 30 Female 9/12/2006 Other Health Professional Japan
Primary
Concomitant
Cardiac Failure Death 8/17/2006 32 Female 9/13/2006 Physician Japan
Primary
Secondary
Concomitant
Irritability Death 8/17/2006 32 Female 9/19/2006 Consumer United States
Primary
Secondary
Concomitant
Diabetic Ketoacidosis Hospitalization 8/24/2006 30 Female 9/19/2006 Other Health Professional Japan
Primary
Concomitant
Rhabdomyolysis Required Intervention 1/1/2005 40 Male 9/14/2006 Physician Germany
Primary
Concomitant
Tremor Other Serious 3/1/2006 Male 9/28/2006 Physician Japan
Primary
Secondary
Concomitant
Cardiac Failure Death 8/17/2006 32 Female 10/3/2006 Other Health Professional Japan
Primary
Secondary
Concomitant
Diabetic Ketoacidosis Hospitalization 8/24/2006 30 Female 10/6/2006 Other Health Professional Japan
Primary
Concomitant
Grand Mal Convulsion Other Serious 10/25/2006 36 Female 11/13/2006 Physician Japan
Primary
Concomitant
Grand Mal Convulsion Other Serious 10/25/2006 36 Female 11/22/2006 Physician Japan
Primary
Concomitant
Restlessness Hospitalization 8/10/2006 65 Male 11/28/2006 Physician Japan
Primary
Concomitant
Self Injurious Behaviour Other Serious 8/11/2006 64 Male 12/4/2006 Physician Japan
Primary
Secondary
Concomitant
Grand Mal Convulsion Other Serious 10/25/2006 36 Female 12/6/2006 Physician Japan
Primary
Concomitant
Psychomotor Hyperactivity Hospitalization 11/17/2006 47 Male 12/8/2006 Physician Japan
Primary
Concomitant
Emphysema Other Serious 58 Male 12/15/2006 Physician Brazil
Primary
Concomitant
Therapy Non-responder Required Intervention Male 11/14/2006 Physician Germany
Primary
Secondary
Concomitant
Thalassaemia Beta Other Serious 54 Female 6/8/2007 Turkey
Primary
Secondary
Hepatic Failure Death 59 Male 6/13/2007 Other Health Professional Japan
Primary
Secondary
Concomitant
Pneumonia Other Serious 6/4/2007 78 Female 6/20/2007 Physician Japan
Primary
Secondary
Concomitant
Lipase Increased Other Serious 8/1/2005 38 Female 7/5/2007
Primary
Concomitant
Urinary Incontinence Hospitalization 54 Female 6/29/2007 Turkey
Primary
Concomitant
Pneumonia Other Serious 6/4/2007 78 Female 7/9/2007 Physician Japan
Primary
Secondary
Concomitant
Urinary Incontinence Hospitalization 1/1/2006 54 Female 7/16/2007 Turkey
Primary
Concomitant
Aggression Hospitalization 6/18/2004 Male 110 lb 8/10/2007 Peru
Primary
Concomitant
Weight Decreased Death 3/23/2007 59 Male 8/29/2007 Physician Japan
Primary
Secondary
Concomitant
Weight Decreased Death 3/23/2007 59 Male 8/29/2007 Physician Japan
Primary
Secondary
Concomitant
Weight Decreased Death 3/23/2007 59 Male 8/29/2007 Physician Japan
Primary
Secondary
Concomitant
Weight Decreased Death 3/23/2007 59 Male 9/12/2007 Physician Japan
Primary
Secondary
Concomitant
Initial Insomnia Other Serious 62 Female 9/19/2007 Japan
Primary
Concomitant
Initial Insomnia Other Serious 62 Female 9/24/2007 Japan
Primary
Concomitant
Death Death 9/19/2007 50 Female 10/3/2007 Physician Japan
Primary
Concomitant
Guillain-barre Syndrome Hospitalization 12/14/2005 40 Male 10/3/2007 Physician Japan
Primary
Concomitant
Initial Insomnia Other Serious 62 Female 10/12/2007 Japan
Primary
Concomitant
Suicide Attempt Death 7/14/2007 Female 154 lb 10/12/2007 Physician Japan
Primary
Secondary
Concomitant
Initial Insomnia Other Serious 62 Female 10/16/2007 Japan
Primary
Concomitant
Dry Eye Other Serious 8/1/2003 17 Male 11/2/2007 Physician Switzerland
Primary
Concomitant
Suicide Attempt Death 7/14/2007 Female 154 lb 11/6/2007 Physician Japan
Primary
Secondary
Concomitant
Paranoia Hospitalization 10/1/2007 34 Female 11/14/2007 Other Health Professional Japan
Primary
Concomitant
Dry Eye Other Serious 8/1/2003 17 Male 11/30/2007 Physician Switzerland
Primary
Concomitant
Weight Increased Other Serious 8/1/2003 Male 168 lb 11/30/2007 Other Health Professional Switzerland
Primary
Concomitant
Paranoia Other Serious 8/1/2007 57 Female 12/6/2007 Other Health Professional Japan
Primary
Concomitant
Tremor Hospitalization 17 Male 12/1/2007 Switzerland
Primary
Secondary
Concomitant
Paranoia Other Serious 8/1/2007 57 Female 12/14/2007 Other Health Professional Japan
Primary
Concomitant
Hallucination Other Serious 11/1/2007 68 Female 12/17/2007 Other Health Professional Japan
Primary
Concomitant
Dry Eye Other Serious 8/1/2003 17 Male 12/29/2007 Physician Switzerland
Primary
Concomitant
Weight Increased Hospitalization 1/1/2004 Male 198 lb 1/3/2008 Physician Japan
Primary
Concomitant
Weight Increased Hospitalization Male 231 lb 2/5/2008 Physician Brazil
Primary
Secondary
Concomitant
Weight Increased Hospitalization Male 231 lb 2/8/2008 Physician Brazil
Primary
Concomitant
Initial Insomnia Other Serious 62 Female 3/4/2008 Japan
Primary
Concomitant
Rib Fracture Other Serious 11/1/2007 68 Female 97 lb 3/6/2008 Other Health Professional Japan
Primary
Secondary
Concomitant
Thirst Other Serious 62 Female 3/14/2008 Japan
Primary
Concomitant
Rib Fracture Other Serious 11/1/2007 68 Female 97 lb 3/14/2008 Other Health Professional Japan
Primary
Secondary
Concomitant
Thirst Other Serious 62 Female 3/17/2008 Japan
Primary
Concomitant
Condition Aggravated Other Serious 1/21/2008 32 Male 4/15/2008 Other Health Professional Japan
Primary
Concomitant
Condition Aggravated Other Serious 1/21/2008 32 Male 4/17/2008 Other Health Professional Japan
Primary
Concomitant
Neuroleptic Malignant Syndrome Other Serious 58 Male 88 lb 5/5/2008 Japan
Primary
Secondary
Concomitant
Unevaluable Event Hospitalization 3/12/2008 21 Male 6/13/2008 Physician United States
Primary
Secondary
Concomitant
Unevaluable Event Other Serious 3/12/2008 21 Male 6/19/2008 Physician United States
Primary
Secondary
Concomitant
Unevaluable Event Other Serious 3/12/2008 21 Male 6/30/2008 Physician United States
Primary
Secondary
Concomitant
Dystonia Hospitalization 27 Female 8/4/2008 Other Health Professional Japan
Primary
Secondary
Somnolence Hospitalization 13 Female 10/10/2008 Other Health Professional Japan
Primary
Concomitant
Hallucination Other Serious 8/1/2008 57 Male 86 lb 10/30/2008 Other Health Professional Japan
Primary
Concomitant
Muscular Weakness Other Serious 7/29/2008 57 Male 86 lb 11/11/2008 Other Health Professional Japan
Primary
Concomitant
Tremor Other Serious 35 Male 11/24/2008 Other Health Professional Croatia (Local Name: Hrvatska)
Primary
Concomitant
Muscular Weakness Other Serious 7/29/2008 57 Male 86 lb 11/26/2008 Other Health Professional Japan
Primary
Concomitant
Torticollis Hospitalization 35 Male 12/23/2008 Croatia (Local Name: Hrvatska)
Primary
Secondary
Concomitant
Hallucination Hospitalization 6/9/2007 67 Male 212 lb 1/29/2009 Other Health Professional Japan
Primary
Concomitant
Hallucination Hospitalization 6/9/2008 67 Male 212 lb 2/4/2009 Other Health Professional Japan
Primary
Concomitant
Mood Altered Other Serious 27 Female 3/25/2009 Physician Japan
Primary
Concomitant
Schizophrenia Hospitalization 65 Female 4/14/2009 Other Health Professional Japan
Primary
Concomitant
Psychiatric Symptom Hospitalization 12/24/2008 55 Male 5/22/2009 Other Health Professional Japan
Primary
Concomitant
Psychiatric Symptom Hospitalization 6/3/2008 55 Male 6/5/2009 Other Health Professional Japan
Primary
Concomitant
Psychiatric Symptom Hospitalization 6/3/2008 55 Male 6/22/2009 Other Health Professional Japan
Primary
Concomitant
Psychomotor Hyperactivity Other Serious 46 Female 9/15/2009
Primary
Secondary
Concomitant
Dissociative Fugue Hospitalization 6/17/2009 54 Male 137 lb 9/25/2009 Physician Japan
Primary
Concomitant
Weight Increased Other Serious 8/1/2008 29 Male 9/24/2009 Physician Switzerland
Primary
Concomitant
Schizophrenia Hospitalization 65 Female 9/29/2009 Other Health Professional Japan
Primary
Concomitant
Shock Hospitalization 6/17/2009 54 Male 137 lb 10/12/2009 Physician Japan
Primary
Concomitant
Weight Increased Other Serious 23 Female 10/15/2009 Physician United Kingdom
Primary
Secondary
Concomitant
Weight Increased Other Serious 23 Female 10/15/2009 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Vomiting Hospitalization 8/28/2009 56 Male 10/9/2009 Physician Spain
Primary
Secondary
Concomitant
Supraventricular Tachycardia Other Serious 19 Male 10/23/2009 Physician Taiwan, Province Of China
Primary
Secondary
Concomitant
Interacting
Suicidal Ideation Hospitalization 41 Female 181 lb 11/9/2009 Physician Netherlands
Primary
Secondary
Concomitant
White Blood Cell Count Increased Other Serious 1/1/2004 Male 234 lb 11/30/2009 Consumer Brazil
Primary
Concomitant
Interacting
White Blood Cell Count Decreased Hospitalization 6/5/2004 30 Male 122 lb 12/4/2009 Physician Japan
Primary
Secondary
Concomitant
Pleurothotonus Other Serious 31 Female 12/14/2009
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Hospitalization 6/5/2004 30 Male 122 lb 1/22/2010 Physician Japan
Primary
Secondary
Concomitant
Tardive Dyskinesia Other Serious 30 Female 3/2/2010
Primary
Secondary
Concomitant
Withdrawal Syndrome Other Serious 1/1/2004 Male 234 lb 3/29/2010 Consumer Brazil
Primary
Concomitant
Interacting
Weight Increased Other Serious 55 Male 4/1/2010 Consumer Japan
Primary
Concomitant
Self-injurious Ideation Hospitalization 1/1/2005 61 Female 4/20/2010 Consumer Turkey
Primary
Concomitant
Somnolence Required Intervention 34 Female 220 lb 4/28/2010 Other Health Professional Japan
Primary
Secondary
Acute Psychosis Other Serious 4/22/2010 47 Male 165 lb 5/6/2010 Physician Austria
Primary
Concomitant
Withdrawal Syndrome Other Serious 1/1/2004 29 Male 236 lb 5/25/2010 Consumer Brazil
Primary
Concomitant
Interacting
Pulmonary Embolism Death 46 Male 5/27/2010 Other Health Professional Sweden
Primary
Secondary
Overdose Death 39 Male 7/12/2010 Other Health Professional United States
Primary
Secondary
Rhabdomyolysis Other Serious 40 Male 7/12/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Feeding Disorder Other Serious 7/23/2010 Physician Israel
Primary
Secondary
Muscle Contractions Involuntary Other Serious 24 Female 7/28/2010
Primary
Secondary
Psychotic Disorder Other Serious 4/22/2010 47 Male 165 lb 8/2/2010 Physician Austria
Primary
Secondary
Concomitant
Cystitis Haemorrhagic Hospitalization 6/7/2010 55 Female 104 lb 8/26/2010 Physician Japan
Primary
Concomitant
Tardive Dyskinesia Other Serious 6/1/2004 61 Female 9/22/2010
Primary
Secondary
Thalassaemia Beta Other Serious 54 Female 10/27/2010 Turkey
Primary
Concomitant
Interacting
Schizophrenia Hospitalization 10/6/2010 64 Male 154 lb 11/9/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Schizophrenia Hospitalization 10/6/2010 64 Male 154 lb 11/11/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Restlessness Other Serious 63 Male 12/7/2010 Physician Japan
Primary
Secondary
Concomitant
Toxic Epidermal Necrolysis Other Serious 37 Male 12/9/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Vomiting Other Serious 16 Male 12/28/2010 Physician Turkey
Primary
Secondary
Toxic Epidermal Necrolysis Other Serious 37 Male 1/7/2011 Physician Japan
Primary
Secondary
Concomitant
Obsessive Thoughts Hospitalization 43 Female 1/14/2011 Other Health Professional Netherlands
Primary
Secondary
Concomitant
Inappropriate Antidiuretic Hormone Secretion Hospitalization 11/8/2010 61 Female 2/21/2011 Consumer Japan
Primary
Concomitant
Hepatitis Toxic Hospitalization 25 Male 3/8/2011 Other Health Professional Spain
Primary
Secondary
Parkinson's Disease Other Serious 12/29/2008 63 Male 129 lb 4/7/2011 Physician Taiwan, Province Of China
Primary
Secondary
Concomitant
Lymphocyte Stimulation Test Positive Other Serious 37 Male 5/5/2011 Physician Japan
Primary
Secondary
Concomitant
Salivary Hypersecretion Other Serious 28 Female 5/18/2011 Physician Japan
Primary
Secondary
Tardive Dyskinesia Other Serious 40 Female 5/18/2011 Physician Japan
Primary
Secondary
Loss Of Consciousness Hospitalization 5/18/2011 Other Health Professional Japan
Primary
Secondary
Bone Marrow Failure Other Serious Female 6/1/2011 Consumer Germany
Primary
Concomitant
Gamma-glutamyltransferase Increased Other Serious 37 Male 7/11/2011 Other Health Professional Japan
Primary
Secondary
Autonomic Nervous System Imbalance Life Threatening 7/12/2011 62 Male 8/30/2011 Other Health Professional Japan
Primary
Concomitant
Emotional Disorder Other Serious 1/1/2009 29 Male 9/22/2011 Physician Croatia (Local Name: Hrvatska)
Primary
Secondary
Drug Ineffective Hospitalization 43 Female 10/17/2011 Physician Turkey
Primary
Secondary
Urinary Tract Infection Hospitalization 82 Male 10/17/2011 Physician Spain
Primary
Secondary
Concomitant
Confusional State Hospitalization 82 Male 10/24/2011 Physician Spain
Primary
Secondary
Concomitant
Tardive Dyskinesia Other Serious 18 Male 10/31/2011 Physician Hungary
Primary
Secondary
Concomitant
Myocarditis Death 11 Female 11/1/2011 Other Health Professional United States
Primary
Concomitant
Tardive Dyskinesia Other Serious 18 Male 11/1/2011 Physician Hungary
Primary
Secondary
Concomitant
Major Depression Other Serious 24 Female 11/1/2011 Physician Turkey
Primary
Secondary
Concomitant
Dystonia Other Serious 18 Male 11/4/2011 Hungary
Primary
Secondary
Concomitant
Respiratory Distress Hospitalization 19 Male 11/10/2011 Other Health Professional Denmark
Primary
Secondary
Dystonia Other Serious 18 Male 11/22/2011 Hungary
Primary
Secondary
Concomitant
Leukocytoclastic Vasculitis Hospitalization 39 Female 12/12/2011 Physician Turkey
Primary
Concomitant
Leukocytoclastic Vasculitis Hospitalization 39 Female 12/19/2011 Physician Turkey
Primary
Concomitant
Self Injurious Behaviour Hospitalization 9/1/2009 1/17/2012 Hungary
Primary
Secondary
Concomitant
Hepatitis Toxic Hospitalization 25 Male 1/18/2012 Other Health Professional Spain
Primary
Secondary
Large Intestine Perforation Hospitalization 82 Female 1/25/2012 Physician Greece
Primary
Concomitant

Drug Data