Clobazam combined with Phenytoin

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Tachycardia Other Serious 4/26/2004 57 Female 5/1/2006 France
Primary
Concomitant
Interacting
Tachycardia Other Serious 4/26/2004 57 Female 6/2/2006 France
Primary
Concomitant
Interacting
Paraesthesia Hospitalization 25 Male 9/1/2006 United States
Primary
Secondary
Myoclonic Epilepsy Other Serious 7 Female 10/17/2006 Japan
Primary
Concomitant
Muscular Weakness Hospitalization 25 Male 10/23/2006 United States
Primary
Concomitant
Epilepsy Other Serious 10/20/2006 38 Male 11/3/2006 Physician Japan
Primary
Concomitant
Somnolence Other Serious 1/1/2006 55 Male 12/1/2006 Physician Japan
Primary
Concomitant
Pyrexia Other Serious 12/18/2006 2/2/2007 Physician Japan
Primary
Concomitant
Head Injury Other Serious Female 3/8/2007 Hong Kong
Primary
Secondary
Therapeutic Agent Toxicity Hospitalization 2/15/2007 Male 111 lb 3/23/2007 Physician Japan
Primary
Secondary
Hepatitis Hospitalization 2/19/2007 72 Male 4/10/2007 United Kingdom
Primary
Secondary
Concomitant
Head Injury Other Serious 31 Female 5/4/2007 Hong Kong
Primary
Concomitant
Hepatitis Hospitalization 2/19/2007 72 Male 5/16/2007 United Kingdom
Primary
Secondary
Concomitant
Haematochezia Other Serious 1/1/2003 25 Male 97 lb 6/11/2007 Japan
Primary
Concomitant
Constipation Hospitalization 63 Female 138 lb 7/27/2007 Canada
Primary
Concomitant
Constipation Hospitalization 63 Female 138 lb 8/10/2007 Canada
Primary
Concomitant
Epilepsy Hospitalization 13 Male 8/15/2007 Japan
Primary
Concomitant
Epilepsy Hospitalization 13 Male 8/28/2007 Japan
Primary
Concomitant
Electroencephalogram Abnormal Other Serious 16 Male 9/6/2007 Belgium
Primary
Concomitant
Interacting
Somnolence Hospitalization 22 Female 9/8/2007 Japan
Primary
Concomitant
Somnolence Hospitalization 22 Female 9/20/2007 Japan
Primary
Concomitant
Hypocalcaemia Other Serious 3/6/2007 Male 147 lb 10/19/2007 Physician Japan
Primary
Concomitant
Breast Cancer Other Serious 7/1/2005 38 11/1/2007 Japan
Primary
Concomitant
Somnolence Other Serious 20 Male 11/9/2007 United Kingdom
Primary
Secondary
Concomitant
Metastasis Other Serious 7/1/2005 38 Female 11/13/2007 Japan
Primary
Concomitant
Suicide Attempt Other Serious 36 Female 11/13/2007 Japan
Primary
Concomitant
Sepsis Hospitalization 11/15/2007 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Metastasis Other Serious 7/1/2005 38 Female 11/16/2007 Japan
Primary
Concomitant
Leukopenia Other Serious Female 11/29/2007 United Kingdom
Primary
Concomitant
Pancytopenia Hospitalization 56 Male 176 lb 3/5/2008 United Kingdom
Primary
Concomitant
Grand Mal Convulsion Other Serious 3/1/1984 Female 5/30/2008 Physician France
Primary
Secondary
Concomitant
Drug Exposure During Pregnancy Other Serious 34 Female 6/20/2008
Primary
Concomitant
Vesicoureteric Reflux Congenital Anomaly 8/5/2008 Other Health Professional Ireland
Primary
Concomitant
Vesicoureteric Reflux Congenital Anomaly 8/5/2008 Other Health Professional Ireland
Primary
Concomitant
Vesicoureteric Reflux Congenital Anomaly 8/5/2008 Other Health Professional Ireland
Primary
Concomitant
Vesicoureteric Reflux Congenital Anomaly 8/5/2008 Other Health Professional Ireland
Primary
Concomitant
Vesicoureteric Reflux Congenital Anomaly 8/5/2008 Other Health Professional Ireland
Primary
Concomitant
Vesicoureteric Reflux Congenital Anomaly 8/5/2008 Other Health Professional Ireland
Primary
Concomitant
Vesicoureteric Reflux Congenital Anomaly 8/5/2008 Other Health Professional Ireland
Primary
Concomitant
Vesicoureteric Reflux Congenital Anomaly 8/5/2008 Other Health Professional Ireland
Primary
Concomitant
Vesicoureteric Reflux Congenital Anomaly 8/5/2008 Other Health Professional Ireland
Primary
Concomitant
Vesicoureteric Reflux Congenital Anomaly 8/5/2008 Other Health Professional Ireland
Primary
Concomitant
Tracheo-oesophageal Fistula Congenital Anomaly 8/5/2008 Other Health Professional Ireland
Primary
Concomitant
Tracheo-oesophageal Fistula Congenital Anomaly 8/5/2008 Other Health Professional Ireland
Primary
Concomitant
Tracheo-oesophageal Fistula Congenital Anomaly 8/5/2008 Other Health Professional Ireland
Primary
Concomitant
Tracheo-oesophageal Fistula Congenital Anomaly 8/5/2008 Other Health Professional Ireland
Primary
Concomitant
Tracheo-oesophageal Fistula Congenital Anomaly 8/5/2008 Other Health Professional Ireland
Primary
Concomitant
Tracheo-oesophageal Fistula Congenital Anomaly 8/5/2008 Other Health Professional Ireland
Primary
Concomitant
Tracheo-oesophageal Fistula Congenital Anomaly 8/5/2008 Other Health Professional Ireland
Primary
Concomitant
Tracheo-oesophageal Fistula Congenital Anomaly 8/5/2008 Other Health Professional Ireland
Primary
Concomitant
Tracheo-oesophageal Fistula Congenital Anomaly 8/5/2008 Other Health Professional Ireland
Primary
Concomitant
Tracheo-oesophageal Fistula Congenital Anomaly 8/5/2008 Other Health Professional Ireland
Primary
Concomitant
Tracheo-oesophageal Fistula Congenital Anomaly 8/5/2008 Other Health Professional Ireland
Primary
Concomitant
Tracheo-oesophageal Fistula Congenital Anomaly 8/5/2008 Other Health Professional Ireland
Primary
Concomitant
Tracheo-oesophageal Fistula Congenital Anomaly 8/5/2008 Other Health Professional Ireland
Primary
Concomitant
Status Epilepticus Other Serious 12 1/20/2009 Other Health Professional Japan
Primary
Concomitant
Metastasis Other Serious 7/1/2005 39 Female 1/29/2009 Other Health Professional Japan
Primary
Concomitant
Treatment Noncompliance Death 7/1/2005 39 Female 2/3/2009 Other Health Professional Japan
Primary
Concomitant
Liver Transplant Required Intervention 33 Female 3/2/2009 United Kingdom
Primary
Concomitant
Hepatic Neoplasm Malignant Death 2/14/2009 3/18/2009 Other Health Professional United Kingdom
Primary
Concomitant
Hyponatraemia Other Serious 5/1/1993 17 Female 4/1/2009 Other Health Professional France
Primary
Secondary
Toxic Epidermal Necrolysis Hospitalization 10/1/2008 4 Male 6/2/2009 Japan
Primary
Secondary
Renal Failure Hospitalization 4/14/2009 Male 77 lb 6/3/2009 Physician Brazil
Primary
Concomitant
Vomiting Other Serious 24 Female 7/16/2009 Other Health Professional Canada
Primary
Concomitant
Oedema Hospitalization 9 Male 12/23/2009 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Selective Mutism Other Serious 23 Male 12/30/2009 Physician Japan
Primary
Concomitant
Pneumonia Mycoplasmal Hospitalization 2/18/2010 40 Female 102 lb 5/4/2010 Other Health Professional Japan
Primary
Concomitant
Status Epilepticus Life Threatening 4/7/2010 25 Female 110 lb 5/26/2010 Physician Japan
Primary
Concomitant
Myoclonus Other Serious 11 Male 8/6/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Logorrhoea Other Serious 3/10/2010 23 Male 170 lb 8/12/2010 Physician Belgium
Primary
Concomitant
Myoclonus Other Serious 11 Male 8/27/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Somnolence 5/23/2010 33 Female 9/8/2010 Other Health Professional Ireland
Primary
Concomitant
Paranoia Other Serious 22 Female 10/21/2010 Other Health Professional Japan
Primary
Concomitant
Somnolence Other Serious 5/23/2010 33 Female 10/21/2010 Other Health Professional Ireland
Primary
Concomitant
Paranoia Other Serious 22 Female 11/8/2010 Other Health Professional Japan
Primary
Concomitant
White Blood Cell Count Increased Hospitalization 8/12/2010 38 Male 154 lb 12/17/2010 Other Health Professional Japan
Primary
Secondary
White Blood Cell Count Increased Hospitalization 8/12/2010 38 Male 154 lb 12/29/2010 Other Health Professional Japan
Primary
Secondary
Tachycardia Hospitalization 4/26/2004 57 Female 12/29/2010 Consumer United Kingdom
Primary
Concomitant
Tongue Blistering Female 1/21/2011 Physician Canada
Primary
Concomitant
Speech Disorder Other Serious 21 Female 2/2/2011 Other Health Professional Denmark
Primary
Secondary
Concomitant
Facial Bones Fracture Hospitalization 19 Female 2/28/2011 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Grand Mal Convulsion Hospitalization 19 Female 3/15/2011 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Hypotonia Hospitalization 5 5/6/2011 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Hypoxic-ischaemic Encephalopathy Hospitalization 5 5/16/2011 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Motor Dysfunction Hospitalization 5 Male 5/18/2011 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Brain Oedema Hospitalization 5 Male 5/20/2011 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Aphasia Hospitalization 5 Male 5/20/2011 Consumer United Kingdom
Primary
Secondary
Concomitant
Movement Disorder Hospitalization 5 Male 5/22/2011 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Movement Disorder Hospitalization 5 Male 5/22/2011 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Learning Disorder Hospitalization 5 Male 5/22/2011 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Hypotonia Hospitalization 5 Male 5/22/2011 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Aphasia Hospitalization 5 Male 5/23/2011 Physician United Kingdom
Primary
Secondary
Concomitant
Hypoxic-ischaemic Encephalopathy Hospitalization 5 Male 5/24/2011 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Movement Disorder Other Serious Male 5/25/2011 United Kingdom
Primary
Secondary
Concomitant
Ischaemia Other Serious Male 5/25/2011 United Kingdom
Primary
Secondary
Concomitant
Brain Oedema Other Serious Male 5/25/2011 United Kingdom
Primary
Secondary
Concomitant
Brain Oedema Hospitalization 5 Male 5/27/2011 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Encephalopathy Disability 5 Male 5/18/2011 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Mycoplasma Infection Hospitalization 5 Male 6/2/2011 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Atrophy Hospitalization 5 Male 6/2/2011 Consumer United Kingdom
Primary
Secondary
Concomitant
Status Epilepticus Hospitalization 5 Male 6/2/2011 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Atonic Seizures Hospitalization 5 Male 6/3/2011 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Cerebral Atrophy Hospitalization 5 Male 6/6/2011 Physician United Kingdom
Primary
Secondary
Concomitant
Dystonia Other Serious 5 Male 6/8/2011 Consumer United States
Primary
Secondary
Concomitant
Aphasia Other Serious 5 Male 6/10/2011 Physician United Kingdom
Primary
Secondary
Concomitant
Developmental Delay Other Serious 5 Male 6/15/2011 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Movement Disorder Other Serious 15 Male 8/2/2011 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Hepatic Function Abnormal Other Serious 11 Male 8/2/2011 Other Health Professional Japan
Primary
Concomitant
Incorrect Route Of Drug Administration Hospitalization 10 Male 9/8/2011 Other Health Professional Turkey
Primary
Secondary
Lethargy Hospitalization 8/16/2011 1 Male 25 lb 9/21/2011 Pharmacist United Kingdom
Primary
Concomitant
Epilepsy Other Serious Male 9/30/2011 Brazil
Primary
Secondary
Concomitant
Pregnancy Other Serious 1/1/2011 28 Female 132 lb 12/1/2011 Physician Australia
Primary
Secondary
Drug Interaction Other Serious 3 Female 23 lb 12/9/2011 Other Health Professional India
Primary
Concomitant
Interacting
Disinhibition Hospitalization 1/1/2011 20 Male 12/14/2011 Physician Japan
Primary
Concomitant
Foetal Exposure During Pregnancy Other Serious 1/1/2011 0 Female 5 lb 12/14/2011 Physician Australia
Primary
Secondary
Concomitant
Pregnancy Other Serious 1/1/2011 28 Female 132 lb 12/14/2011 Physician Australia
Primary
Secondary
Concomitant
Foetal Exposure During Pregnancy Other Serious 1/1/2011 0 Female 5 lb 12/20/2011 Physician Australia
Primary
Secondary
Concomitant
Inappropriate Antidiuretic Hormone Secretion Other Serious 8 Male 1/3/2012 United States
Primary
Secondary
Concomitant
Epidermal Necrosis Other Serious 1/9/2012 Consumer Japan
Primary
Secondary
Mass Disability 1/15/2008 48 Male 183 lb 1/9/2012 Physician United Kingdom
Primary
Concomitant
Mass Other Serious 1/15/2008 48 Male 183 lb 1/18/2012 Physician United Kingdom
Primary
Concomitant
Brain Oedema Hospitalization 5 Male 1/19/2012 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Psychiatric Symptom Other Serious 10/10/2011 45 Female 2/1/2012 Physician Japan
Primary
Secondary
Concomitant
Dizziness Other Serious 10/10/2011 45 Female 3/2/2012 Physician Japan
Primary
Secondary
Concomitant
Loss Of Consciousness Other Serious Female 3/12/2012 Consumer United Kingdom
Primary
Concomitant
Psychiatric Symptom Other Serious 10/10/2011 45 Female 3/16/2012 Physician Japan
Primary
Secondary
Concomitant
Drug Ineffective Other Serious 12 Male 4/27/2012 Other Health Professional Australia
Primary
Secondary
Drug Ineffective Other Serious 12 Male 55 lb 5/2/2012 Other Health Professional Australia
Primary
Secondary
Aggression Hospitalization 42 Male 5/14/2012 Physician Germany
Primary
Secondary
Stomatitis Other Serious Female 68 lb 6/4/2012 Consumer Brazil
Primary
Secondary
Concomitant
Partial Seizures Other Serious 31 Female 6/20/2012 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Protrusion Tongue Other Serious 31 Female 7/9/2012 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Movement Disorder Other Serious 31 Female 7/10/2012 Consumer United Kingdom
Primary
Secondary
Concomitant
Mobility Decreased Other Serious 31 Female 7/10/2012 Consumer United Kingdom
Primary
Secondary
Concomitant
Tongue Coated Hospitalization 6/27/2011 32 Female 60 lb 7/24/2012 Physician Japan
Primary
Secondary
Concomitant
Paralysis Other Serious Female 68 lb 8/9/2012 Consumer Brazil
Primary
Secondary
Concomitant
Drug Ineffective Other Serious 17 Female 8/9/2012 Physician Japan
Primary
Secondary
Concomitant
Convulsion Other Serious 7 Male 8/9/2012 Physician Japan
Primary
Secondary
Concomitant
Drug Ineffective Other Serious 20 Male 8/9/2012 Physician Japan
Primary
Secondary
Concomitant
Fall Other Serious 5 Male 8/9/2012 Physician Japan
Primary
Secondary
Concomitant
Fall Other Serious 6 Female 8/9/2012 Physician Japan
Primary
Secondary
Concomitant
Insomnia Other Serious 6/1/2009 7/31/2012 Consumer United States
Primary
Concomitant
Drug Ineffective Other Serious 6 Female 8/16/2012 Physician Japan
Primary
Secondary
Concomitant
Atonic Seizures Other Serious 17 Female 8/16/2012 Physician Japan
Primary
Secondary
Concomitant
Atonic Seizures Other Serious 7 Male 8/16/2012 Physician Japan
Primary
Secondary
Concomitant
Drug Ineffective Other Serious 20 Male 8/16/2012 Physician Japan
Primary
Secondary
Concomitant
Atonic Seizures Other Serious 5 Male 8/16/2012 Physician Japan
Primary
Secondary
Concomitant
Drug Ineffective Other Serious 17 Female 10/16/2012 Physician Country Not Specified
Primary
Secondary
Concomitant
Drug Ineffective Other Serious 7 Male 10/16/2012 Physician Country Not Specified
Primary
Secondary
Concomitant
Drug Ineffective Other Serious 20 Male 10/16/2012 Physician Country Not Specified
Primary
Secondary
Concomitant

Drug Data