Fentanyl Citrate combined with Midazolam Hcl

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Renal Impairment Disability 12/10/2005 80 Male 126 lb 1/12/2006 Physician Japan
Primary
Concomitant
Loss Of Consciousness Hospitalization 51 Female 2/13/2006 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Renal Failure Hospitalization 75 Female 2/15/2006 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Loss Of Consciousness Hospitalization 1/1/2006 51 Female 2/13/2006 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Loss Of Consciousness Other Serious 51 Male 2/28/2006
Primary
Secondary
Concomitant
Supraventricular Extrasystoles Hospitalization 12/15/2005 72 Male 2/22/2006 Physician France
Primary
Secondary
Concomitant
Loss Of Consciousness Hospitalization 51 Male 3/1/2006 Consumer United Kingdom
Primary
Secondary
Concomitant
Respiratory Distress Life Threatening 8/19/2005 66 Male 3/1/2006 Physician Switzerland
Primary
Secondary
Concomitant
Ventricular Fibrillation Required Intervention 11/27/2005 64 Male 2/24/2006 Pharmacist Japan
Primary
Concomitant
Loss Of Consciousness Hospitalization 51 Female 3/6/2006 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Loss Of Consciousness Other Serious 51 Male 3/8/2006
Primary
Secondary
Concomitant
Sepsis Hospitalization 64 Male 3/7/2006 Consumer United States
Primary
Concomitant
Loss Of Consciousness Hospitalization 51 Female 3/7/2006 Consumer United Kingdom
Primary
Secondary
Concomitant
Sepsis Hospitalization 64 Male 3/7/2006 Consumer United States
Primary
Concomitant
Loss Of Consciousness Hospitalization 51 Female 3/7/2006 Consumer United Kingdom
Primary
Secondary
Concomitant
Torsade De Pointes Other Serious 8 Male 64 lb 3/9/2006 France
Primary
Concomitant
White Blood Cell Count Increased Death 30 Male 161 lb 3/10/2006 Other Health Professional Spain
Primary
Secondary
Concomitant
Neonatal Tachypnoea Other Serious 7/6/2005 0 Male 3/8/2006 Japan
Primary
Secondary
Concomitant
Respiratory Arrest Required Intervention 3/21/2006 62 Male 233 lb 3/21/2006 Pharmacist United States
Primary
Secondary
Supraventricular Extrasystoles Hospitalization 12/15/2005 72 Male 3/24/2006 Physician France
Primary
Secondary
Concomitant
Ventricular Fibrillation Required Intervention 11/27/2005 64 Male 4/12/2006 Pharmacist Japan
Primary
Concomitant
Vascular Injury Other Serious 3/1/2006 71 Female 4/19/2006 United States
Primary
Concomitant
Rash Erythematous Life Threatening 1/31/2006 61 Male 5/16/2006 Consumer Australia
Primary
Secondary
Neonatal Disorder Other Serious 5/12/2006 Physician United States
Primary
Secondary
Concomitant
Cerebral Infarction Other Serious 3/1/2006 71 Female 6/6/2006 Other Health Professional Japan
Primary
Concomitant
Vascular Injury Other Serious 3/1/2006 71 Female 6/6/2006 United States
Primary
Concomitant
Cerebral Infarction Life Threatening 3/28/2006 71 Female 6/19/2006 Other Health Professional Japan
Primary
Concomitant
Rash Erythematous Life Threatening 1/31/2006 61 Male 7/18/2006 Consumer Australia
Primary
Secondary
Hypoalbuminaemia Required Intervention 1/17/2006 40 Female 106 lb 9/20/2006 Physician Japan
Primary
Concomitant
Post Procedural Complication Required Intervention 1/31/2006 37 Female 123 lb 10/4/2006 Physician Japan
Primary
Concomitant
Hypoxic Encephalopathy Death 35 Male 154 lb 10/19/2006 Other Health Professional Japan
Primary
Concomitant
Musculoskeletal Stiffness Hospitalization 15 Female 10/30/2006 Other Health Professional Japan
Primary
Secondary
Concomitant
Respiratory Rate Increased Life Threatening 1/18/2007 59 Female 1/22/2007 Pharmacist United States
Primary
Secondary
Respiratory Rate Increased Life Threatening 1/18/2007 80 Female 1/22/2007 Pharmacist United States
Primary
Secondary
Tongue Oedema Hospitalization 70 Female 86 lb 2/12/2007 Other Health Professional Japan
Primary
Concomitant
Ventricular Fibrillation Other Serious 60 Male 2/17/2007 Japan
Primary
Concomitant
Syncope Vasovagal 1/29/2007 43 Male 240 lb 3/13/2007 United States
Primary
Secondary
Concomitant
Procedural Complication 4/12/2007 Physician United States
Primary
Secondary
Disease Progression Death 3/25/2007 72 Male 143 lb 4/25/2007 United States
Primary
Concomitant
Respiratory Depression Other Serious 78 Female 5/7/2007 Other Health Professional United Kingdom
Primary
Concomitant
Interacting
Ventricular Fibrillation Required Intervention 4/21/2006 66 235 lb 2/13/2007 Physician United States
Primary
Concomitant
Post Procedural Complication Hospitalization Male 116 lb 7/11/2007 Physician Japan
Primary
Concomitant
Status Epilepticus Hospitalization 1/1/2006 4 Male 7/25/2007 Physician United States
Primary
Secondary
Vein Disorder Required Intervention 22 Male 8/8/2007 Physician United States
Primary
Secondary
Concomitant
Sensory Loss Required Intervention 15 Male 152 lb 8/8/2007 Physician Australia
Primary
Secondary
Concomitant
Mediastinitis Hospitalization 10/27/2006 Male 116 lb 8/10/2007 Physician Japan
Primary
Concomitant
Sedation Life Threatening 2/6/2007 Female 10/5/2007 Pharmacist United States
Primary
Secondary
Sepsis Life Threatening 12/24/2006 Male 174 lb 10/17/2007 Consumer United States
Primary
Secondary
Concomitant
Tachycardia Life Threatening 9/28/2007 21 Female 150 lb 11/21/2007 Consumer United States
Primary
Secondary
Concomitant
Unresponsive To Stimuli Life Threatening 9/28/2007 21 Female 150 lb 12/3/2007 Physician United States
Primary
Secondary
Concomitant
Sepsis Death 12/31/2007 65 Male 239 lb 1/10/2008 Physician United States
Primary
Secondary
Concomitant
Septic Shock Death 12/31/2007 65 Male 239 lb 1/16/2008 Physician United States
Primary
Secondary
Concomitant
Sepsis Death 12/31/2007 65 Male 239 lb 1/31/2008 Physician United States
Primary
Secondary
Concomitant
Blood Bilirubin Increased Other Serious 2/3/2007 Male 2/8/2008 Other Health Professional Japan
Primary
Secondary
Withdrawal Syndrome Other Serious 1/19/2008 Female 86 lb 2/25/2008 Physician Japan
Primary
Concomitant
Procedural Complication Life Threatening 10/1/2007 64 Male 2/22/2008 Physician Canada
Primary
Secondary
Concomitant
Medication Error 1/4/2008 United States
Primary
Secondary
Neonatal Hypotension Other Serious 2/13/2008 0 Male 2 lb 2/19/2008 Physician Spain
Primary
Concomitant
Cerebral Haemorrhage Other Serious 2/13/2008 0 Male 2 lb 2/28/2008 Physician Spain
Primary
Concomitant
Withdrawal Syndrome Other Serious 1/19/2008 Female 86 lb 3/19/2008 Physician Japan
Primary
Concomitant
Drug Interaction Required Intervention 53 Female 3/13/2008 Other Health Professional United States
Primary
Secondary
Concomitant
Blood Bilirubin Increased Other Serious 2/3/2007 Male 4/4/2008 Other Health Professional Japan
Primary
Secondary
Asthma 49 Female 4/2/2008 Japan
Primary
Secondary
Concomitant
Prolonged Expiration 49 Female 4/11/2008 Japan
Primary
Secondary
Concomitant
Ventricular Fibrillation Life Threatening 12/1/2005 65 Male 4/18/2008 Physician United States
Primary
Concomitant
Skin Test Positive Required Intervention 19 Male 139 lb 4/18/2008 Physician Mexico
Primary
Secondary
Concomitant
Weight Bearing Difficulty Hospitalization 47 Male 4/24/2008 Other Health Professional Australia
Primary
Concomitant
Urinary Retention Hospitalization 4/1/2008 36 Female 161 lb 4/28/2008 Other Health Professional United States
Primary
Secondary
Concomitant
Migraine With Aura Other Serious 15 Male 152 lb 4/30/2008 Other Health Professional Australia
Primary
Secondary
Concomitant
Deafness Neurosensory Other Serious 38 Female 5/1/2008 United States
Primary
Secondary
Concomitant
Blood Bilirubin Increased Other Serious 2/3/2007 Male 5/15/2008 Other Health Professional Japan
Primary
Secondary
Pharmaceutical Product Counterfeit Hospitalization 4/6/2008 50 Male 5/16/2008 Physician Mexico
Primary
Concomitant
Pharmaceutical Product Counterfeit Hospitalization 4/27/2008 47 Male 198 lb 5/16/2008 Physician Mexico
Primary
Concomitant
Psychotic Disorder Other Serious 33 Female 5/16/2008
Primary
Secondary
Concomitant
Serotonin Syndrome Other Serious 25 Male 5/20/2008 Physician Turkey
Primary
Concomitant
Delayed Recovery From Anaesthesia Other Serious 66 Male 106 lb 6/11/2008 Physician Japan
Primary
Concomitant
Delayed Recovery From Anaesthesia Other Serious 66 Male 106 lb 6/17/2008 Physician Japan
Primary
Concomitant
Ventricular Tachycardia Life Threatening 5/15/2008 45 Female 129 lb 6/17/2008 Other Health Professional Portugal
Primary
Secondary
Apnoea Required Intervention 6/4/2008 45 Male 231 lb 6/27/2008 Pharmacist United States
Primary
Secondary
Toxic Epidermal Necrolysis Other Serious 53 Female 7/10/2008 Japan
Primary
Secondary
Toxic Epidermal Necrolysis Death 53 Female 7/18/2008 Consumer Japan
Primary
Secondary
Toxic Epidermal Necrolysis Other Serious 53 Female 7/21/2008 Japan
Primary
Secondary
Toxic Epidermal Necrolysis Death 53 Female 7/28/2008 Consumer Japan
Primary
Secondary
Ventricular Tachycardia Life Threatening 5/15/2008 45 Female 129 lb 7/21/2008 Other Health Professional Portugal
Primary
Secondary
Toxic Epidermal Necrolysis Other Serious 53 Female 7/31/2008 Japan
Primary
Secondary
Vomiting Hospitalization 20 Male 165 lb 7/31/2008 Other Health Professional United States
Primary
Secondary
Concomitant
Drug Ineffective Hospitalization 38 Male 8/7/2008
Primary
Secondary
Concomitant
Toxic Epidermal Necrolysis Other Serious 53 Female 8/13/2008 Japan
Primary
Secondary
Psychotic Disorder Hospitalization 1/1/2008 20 Male 165 lb 9/10/2008 Other Health Professional United States
Primary
Secondary
Concomitant
Myoclonus Other Serious 8/19/2008 34 Male 112 lb 8/21/2008 Other Health Professional United States
Primary
Concomitant
Tricuspid Valve Incompetence Hospitalization 1/1/2008 Female 176 lb 9/18/2008 Physician United States
Primary
Concomitant
Interacting
Renal Impairment Hospitalization 9/3/2008 66 Male 10/20/2008 Other Health Professional Japan
Primary
Secondary
Concomitant
Haemodynamic Instability Other Serious 13 Male 10/21/2008 Brazil
Primary
Concomitant
Renal Impairment Hospitalization 9/3/2008 66 Male 10/21/2008 Consumer Japan
Primary
Secondary
Concomitant
Pneumonia Aspiration Life Threatening 3/17/2008 Male 95 lb 10/27/2008 Physician Japan
Primary
Concomitant
Prothrombin Time Prolonged Required Intervention 8/6/2007 73 Male 154 lb 11/20/2008 Physician Japan
Primary
Concomitant
Hallucination, Visual Other Serious 12/19/2008 Physician Japan
Primary
Secondary
Concomitant
Postoperative Fever Other Serious 3/12/2008 Male 1/13/2009 Other Health Professional Japan
Primary
Secondary
Concomitant
Sinus Tachycardia Life Threatening 27 Male 1/14/2009 Other Health Professional Australia
Primary
Concomitant
Interacting
Sinus Tachycardia Life Threatening 59 Female 1/14/2009 Other Health Professional Australia
Primary
Concomitant
Interacting
Cardiac Arrest Life Threatening 10/17/2008 176 lb 1/21/2009 Other Health Professional Israel
Primary
Concomitant
Shock Other Serious 11/23/2008 76 Male 185 lb 1/9/2009 Other Health Professional Canada
Primary
Concomitant
Threatened Labour Hospitalization 6/22/2008 40 Female 2/6/2009 Japan
Primary
Secondary
Concomitant
Peripheral Vascular Disorder Hospitalization 2/24/2009 Male 3/6/2009 United Kingdom
Primary
Concomitant
Ventricular Fibrillation Other Serious 1/10/2008 82 Female 165 lb 3/3/2009 Physician United States
Primary
Secondary
Concomitant
Tachycardia Other Serious 58 Male 3/25/2009 Other Health Professional United States
Primary
Secondary
Serotonin Syndrome Other Serious 4/1/2009 Other Health Professional Netherlands
Primary
Secondary
Concomitant
Unresponsive To Stimuli Required Intervention 11/11/2008 81 4/10/2009 Pharmacist United States
Primary
Secondary
Vision Blurred Other Serious 3/24/2003 45 Female 138 lb 5/18/2009 United States
Primary
Concomitant
Nodal Rhythm Other Serious 9 Male 44 lb 7/10/2009 Other Health Professional Japan
Primary
Secondary
Concomitant
Neuromuscular Block Prolonged 8/22/2008 40 Female 7/23/2009 Japan
Primary
Secondary
Concomitant
Nodal Rhythm Other Serious 9 Male 44 lb 8/7/2009 Physician Japan
Primary
Secondary
Concomitant
Type 2 Diabetes Mellitus Other Serious 4/15/2003 48 Female 165 lb 9/23/2009 United States
Primary
Concomitant
Grand Mal Convulsion Disability 9/30/2009 Male 194 lb 9/30/2009 Pharmacist United States
Primary
Secondary
Cerebellar Infarction Death 48 Female 10/20/2009 Other Health Professional United States
Primary
Secondary
Sinus Arrest Death 9/20/2009 33 Female 10/21/2009 Consumer Norway
Primary
Concomitant
Respiratory Failure Death 1/1/2008 0 Male 1/25/2010 Other Health Professional United Kingdom
Primary
Secondary
Vertigo Disability 4/27/2009 66 Female 190 lb 1/14/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Visual Impairment Other Serious 11/27/2007 58 Female 123 lb 2/2/2010 Lawyer United States
Primary
Secondary
Concomitant
White Blood Cell Count Increased Death 63 Male 247 lb 2/10/2010 Other Health Professional Canada
Primary
Concomitant
Ventricular Hypertrophy Other Serious 5/17/2006 Male 2/19/2010 Other Health Professional United States
Primary
Concomitant
Varices Oesophageal Hospitalization 39 Female 2/9/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Somnolence Life Threatening 39 Female 2/23/2010 Other Health Professional United States
Primary
Concomitant
Interacting
Somnolence Life Threatening 39 Female 2/24/2010 Other Health Professional United States
Primary
Concomitant
Interacting
Vomiting Life Threatening 12/14/2007 69 Male 3/4/2010 Lawyer United States
Primary
Secondary
Concomitant
Dissociative Disorder Other Serious 1/1/2009 52 Female 108 lb 3/5/2010 Other Health Professional United States
Primary
Secondary
Urine Chloride Decreased Other Serious 16 Male 123 lb 3/10/2010 Other Health Professional Canada
Primary
Concomitant
Somnolence Death 51 Female 3/9/2010 Physician United States
Primary
Secondary
Ventricular Hypertrophy Other Serious 5/17/2006 Male 3/18/2010 Other Health Professional United States
Primary
Concomitant
Unresponsive To Stimuli Hospitalization 10/1/2009 76 Male 128 lb 10/30/2009 Pharmacist United States
Primary
Secondary
Unresponsive To Stimuli Other Serious 44 Female 3/24/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Wound Drainage Other Serious 2/1/2002 3/31/2010 Physician United States
Primary
Secondary
Concomitant
Hepatitis Acute Hospitalization 6 Male 3/31/2010 Other Health Professional Australia
Primary
Concomitant
Liver Injury Hospitalization 11/25/2004 51 Female 3/31/2010 Other Health Professional Australia
Primary
Concomitant
Thrombocytopenia Other Serious 11/1/2007 58 Female 123 lb 4/26/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Thrombocytopenia Other Serious 12/29/2009 75 Male 5/4/2010 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Ventricular Hypertrophy Other Serious 5/17/2006 79 Male 5/4/2010 United States
Primary
Concomitant
Serotonin Syndrome Other Serious 39 Female 5/12/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Serotonin Syndrome Other Serious 44 Female 5/20/2010 Physician United States
Primary
Secondary
Concomitant
Respiratory Failure Hospitalization 2 Male 24 lb 5/20/2010 Physician Japan
Primary
Concomitant
Vomiting Other Serious 1/2/2007 69 Male 187 lb 6/7/2010 Lawyer United States
Primary
Secondary
Concomitant
Sputum Abnormal Hospitalization 19 Female 154 lb 6/2/2010 Pharmacist United States
Primary
Secondary
Concomitant
Stem Cell Transplant Hospitalization 4/12/2010 2 Male 24 lb 6/7/2010 Physician Japan
Primary
Concomitant
Vomiting Other Serious 2/1/2008 61 Male 6/22/2010 Lawyer United States
Primary
Concomitant
Serotonin Syndrome Hospitalization 59 Female 6/16/2010 Physician United States
Primary
Secondary
Concomitant
Serotonin Syndrome Hospitalization 46 Female 6/16/2010 Physician United States
Primary
Secondary
Concomitant
Hypoxia Hospitalization 6/7/2010 64 Male 6/23/2010 Physician United States
Primary
Concomitant
Anaphylactic Reaction Life Threatening 5/17/2010 57 Male 6/18/2010 Other Health Professional United Kingdom
Primary
Secondary
Stem Cell Transplant Hospitalization 4/12/2010 2 Male 24 lb 6/18/2010 Physician Japan
Primary
Concomitant
Hypoxia Hospitalization 6/7/2010 64 Male 6/25/2010 Other Health Professional United States
Primary
Secondary
Concomitant

Drug Data