FLUMAZENIL Side Effects

6781529-8 | Cardiac Disorder, Decerebration, Hypoxia, Respiratory Arrest, Tachyarrhythmia
on Jun 11, 2010 Male patient from SPAIN , 59 years of age, weighting 242.5 lb, was treated with Flumazenil (View Usage). Patient experienced the following unwanted or unexpected effects: cardiac disorder, decerebration, hypoxia, respiratory arrest, tachyarrhythmia. Flumazenil dosage: . During the same period patient was treated with MIDAZOLAM HCL (View Midazolam Hcl Review and Midazolam Hcl Label ), REMIFENTANIL (Form: Infusion, Dose: 0.1ugkg-1min-1) (View Remifentanil Review and Remifentanil Label ), PROPOFOL (Dose: 1 Mg Kg-1 H-1, Form: Infusion) (View Propofol Review and Propofol Label ), NALOXONE (View Naloxone Review and Naloxone Label ).

6340311-6 | Endotracheal Intubation, Hallucination, Hepatic Function Abnormal, International Normalised Ratio Increased, Metabolic Acidosis, Status Epilepticus
Patient was taking Flumazenil (View Usage). Patient had the following side effects: endotracheal intubation, hallucination, hepatic function abnormal, international normalised ratio increased, metabolic acidosis, status epilepticus on Aug 20, 2009 from DENMARK Additional patient health information: Female patient , 75 years of age, was diagnosed with intentional overdose and. Flumazenil dosage: 0.4, 0.3, 0.3 Mg During The First Hour, Aural. During the same period patient was treated with BENZODIAZEPINES (NO INGREDIENTS/SUBSTANCES) (View Benzodiazepines (no Ingredients/substances) Review and Benzodiazepines (no Ingredients/substances) Label ), WARFARIN SODIUM (View Warfarin Sodium Review and Warfarin Sodium Label ), FLUPENTIXOL (FLUPENTIXOL) (View Flupentixol (flupentixol) Review and Flupentixol (flupentixol) Label ), TRAMADOL HCL (View Tramadol Hcl Review and Tramadol Hcl Label ), TRICYCLIC ANTIDEPRESSANTS (NO INGREDIENTS/SUBSTANCES) (View Tricyclic Antidepressants (no Ingredients/substances) Review and Tricyclic Antidepressants (no Ingredients/substances) Label ), NALOXONE (View Naloxone Review and Naloxone Label ), ACETYLCYSTEINE (View Acetylcysteine Review and Acetylcysteine Label ).

6336533-0 | Panic Attack, Psychotic Disorder
Adverse event was reported on Aug 24, 2009 by a Female patient taking Flumazenil (View Usage) (Dosage: ) . Location: JAPAN , 46 years of age, After Flumazenil was administered, patient had the following side effects: panic attack, psychotic disorder (What is psychotic disorder?). During the same period patient was treated with DIAZEPAM (View Diazepam Review and Diazepam Label ), ATROPINE (View Atropine Review and Atropine Label ), THIOPENTAL SODIUM (View Thiopental Sodium Review and Thiopental Sodium Label ), SUCCINYLCHOLINE (View Succinylcholine Review and Succinylcholine Label ), NICARDIPINE HYDROCHLORIDE (View Nicardipine Hydrochloride Review and Nicardipine Hydrochloride Label ), NITRAZEPAM (View Nitrazepam Review and Nitrazepam Label ).

6335386-4 | Altered State Of Consciousness, International Normalised Ratio Increased, Overdose, Status Epilepticus, Suicide Attempt
on Aug 17, 2009 Female patient from DENMARK , 75 years of age, was diagnosed with therapeutic agent toxicity and was treated with Flumazenil (View Usage). Patient experienced the following unwanted or unexpected effects: altered state of consciousness, international normalised ratio increased, overdose, status epilepticus, suicide attempt. Flumazenil dosage: 0.4 + 0.3 + 0.3mg Within 1 Hour. During the same period patient was treated with FLUPENTIXOL (View Flupentixol Review and Flupentixol Label ), WARFARIN SODIUM (View Warfarin Sodium Review and Warfarin Sodium Label ), TRAMADOL HCL (View Tramadol Hcl Review and Tramadol Hcl Label ), NALOXONE (0.4 + 0.4mg) (View Naloxone Review and Naloxone Label ). Patient was hospitalized.


6254503-8 | Alcohol Use, Convulsion
on Jul 01, 2009 Male patient from UNITED STATES , 51 years of age, weighting 187.1 lb, was diagnosed with overdose and was treated with Flumazenil (View Usage). Patient had the following side effects: alcohol use, convulsion. Flumazenil dosage: 0.5 Mg One Time Only Iv Bolus.

6254157-0 | Convulsion
Patient was taking Flumazenil (View Usage). After Flumazenil was administered, patient had the following side effects: convulsion on Jun 30, 2009 from UNITED STATES Additional patient health information: Male patient , 51 years of age, weighting 187.1 lb, was diagnosed with overdose and. Flumazenil dosage: 0.5 Mg One Time Only Iv Bolus.

6232137-9 | Venous Thrombosis
Adverse event was reported on Jun 08, 2009 by a Female patient taking Flumazenil (View Usage) (Dosage: Administered As An Infusion. Stopped After One Day Due To A Blockage In The Delivery Line.) . Location: AUSTRALIA , 37 years of age, Patient experienced the following unwanted or unexpected effects: venous thrombosis. During the same period patient was treated with DEXAMPHETAMINE (View Dexamphetamine Review and Dexamphetamine Label ), PAROXETINE HCL (View Paroxetine Hcl Review and Paroxetine Hcl Label ), QUETIAPINE FUMARATE (View Quetiapine Fumarate Review and Quetiapine Fumarate Label ), DIAZEPAM (View Diazepam Review and Diazepam Label ), ALPRAZOLAM (View Alprazolam Review and Alprazolam Label ).

6199253-1 | No Adverse Event
on May 19, 2009 Male patient from UNITED STATES , weighting 213.4 lb, was diagnosed with agitation and was treated with Flumazenil (View Usage). Patient had the following side effects: no adverse event. Flumazenil dosage: 0.5 Mg Twice Iv Bolus.

6185317-5 | Coma, Convulsion
on May 05, 2009 Female patient from SWITZERLAND , 38 years of age, was treated with Flumazenil (View Usage). After Flumazenil was administered, patient had the following side effects: coma, convulsion. Flumazenil dosage: Form: Vials. During the same period patient was treated with RIVOTRIL (View Rivotril Review and Rivotril Label ), CIPRALEX (Form: Film Coated Tablets) (View Cipralex Review and Cipralex Label ), RISPERDAL CONSTA (View Risperdal Consta Review and Risperdal Consta Label ). Patient was hospitalized.

6132067-7 | Respiratory Arrest
Patient was taking Flumazenil (View Usage). Patient experienced the following unwanted or unexpected effects: respiratory arrest on Mar 18, 2009 from GERMANY Additional patient health information: Female patient , weighting 48.50 lb, was diagnosed with anaesthesia reversal and. Flumazenil dosage: . During the same period patient was treated with DORMICUM (View Dormicum Review and Dormicum Label ), KETANEST (View Ketanest Review and Ketanest Label ), PROPOFOL (View Propofol Review and Propofol Label ), REMIFENTANIL (View Remifentanil Review and Remifentanil Label ).

6102381-X | Shock
Adverse event was reported on Feb 19, 2009 by a Female patient taking Flumazenil (View Usage) (Dosage: ) was diagnosed with delayed recovery from anaesthesia and. Location: JAPAN , weighting 115.1 lb, Patient had the following side effects: shock. During the same period patient was treated with DORMICUM (View Dormicum Review and Dormicum Label ), GLUCAGON (View Glucagon Review and Glucagon Label ).

6097697-X | Shock
on Feb 19, 2009 Female patient from JAPAN , weighting 115.1 lb, was diagnosed with delayed recovery from anaesthesia, sedation and was treated with Flumazenil (View Usage). After Flumazenil was administered, patient had the following side effects: shock. Flumazenil dosage: Route: Iv Nos; Daily Dose: 0.25, Uid/qd. During the same period patient was treated with DORMICUM (INJ) (Route: Iv Nos; Daily Dose: 2.5 Mg, Uid/qd) (View Dormicum (inj) Review and Dormicum (inj) Label ), GLUCAGON (View Glucagon Review and Glucagon Label ).

6092799-6 | Respiratory Arrest
on Feb 13, 2009 Female patient from GERMANY , child 5 years of age, was diagnosed with anaesthesia reversal and was treated with Flumazenil (View Usage). Patient experienced the following unwanted or unexpected effects: respiratory arrest. Flumazenil dosage: . During the same period patient was treated with MIDAZOLAM HCL (View Midazolam Hcl Review and Midazolam Hcl Label ), KETANEST (View Ketanest Review and Ketanest Label ), PROPOFOL (View Propofol Review and Propofol Label ), REMIFENTANIL (View Remifentanil Review and Remifentanil Label ).

6076227-2 | Delayed Recovery From Anaesthesia, Shock
Patient was taking Flumazenil (View Usage). Patient had the following side effects: delayed recovery from anaesthesia, shock on Feb 04, 2009 from JAPAN Additional patient health information: Female patient , weighting 115.1 lb, was diagnosed with delayed recovery from anaesthesia, sedation and. Flumazenil dosage: Route: Iv Nos; Daily Dose: 0.25, Uid/qd. During the same period patient was treated with DORMICUM (INJ) (Route: Iv Nos; Daily Dose: 2.5 Mg, Uid/qd) (View Dormicum (inj) Review and Dormicum (inj) Label ), GLUCAGON (View Glucagon Review and Glucagon Label ).

5968958-7 | Leukopenia
Adverse event was reported on Nov 14, 2008 by a Female patient taking Flumazenil (View Usage) (Dosage: ) . Location: JAPAN , 61 years of age, After Flumazenil was administered, patient had the following side effects: leukopenia. During the same period patient was treated with ROCURONIUM BROMIDE (View Rocuronium Bromide Review and Rocuronium Bromide Label ), DIPRIVAN (View Diprivan Review and Diprivan Label ), FENTANEST (View Fentanest Review and Fentanest Label ), ATROPINE (View Atropine Review and Atropine Label ), VAGOSTIGMIN (View Vagostigmin Review and Vagostigmin Label ), ROPION (View Ropion Review and Ropion Label ), PRIMPERAN TAB (View Primperan Tab Review and Primperan Tab Label ).

5946604-6 | Blood Pressure Decreased, Urticaria
on Oct 30, 2008 Male patient from JAPAN , 65 years of age, was diagnosed with anaesthesia and was treated with Flumazenil (View Usage). Patient experienced the following unwanted or unexpected effects: blood pressure decreased, urticaria. Flumazenil dosage: . During the same period patient was treated with MIDAZOLAM HCL (View Midazolam Hcl Review and Midazolam Hcl Label ), XYLOCAINE (View Xylocaine Review and Xylocaine Label ).

5939492-5 | Sedation
on Oct 20, 2008 Female patient from JAPAN , 83 years of age, weighting 89.29 lb, was diagnosed with anaesthesia and was treated with Flumazenil (View Usage). Patient had the following side effects: sedation. Flumazenil dosage: 0.2 Mg. During the same period patient was treated with PROPOFOL (50 Mg, Once/single; 60 Mg, Qh, Infusion; 100 Mg, Qh, Infusion) (View Propofol Review and Propofol Label ), VECURONIUM BROMIDE (View Vecuronium Bromide Review and Vecuronium Bromide Label ), FENTANYL 100 (View Fentanyl-100 Review and Fentanyl-100 Label ), SEVOFLURANE (View Sevoflurane Review and Sevoflurane Label ), MIDAZOLAM (MIDAZLAM) (View Midazolam (midazlam) Review and Midazolam (midazlam) Label ), DEXMEDETOMIDINE (DEXMEDETOMIDINE) (View Dexmedetomidine (dexmedetomidine) Review and Dexmedetomidine (dexmedetomidine) Label ), NALOXONE (MALOXONE) (View Naloxone (maloxone) Review and Naloxone (maloxone) Label ).

5928797-X | Sedation
Patient was taking Flumazenil (View Usage). After Flumazenil was administered, patient had the following side effects: sedation on Oct 09, 2008 from JAPAN Additional patient health information: Female patient , 83 years of age, was diagnosed with anaesthesia and. Flumazenil dosage: 0.2 Mg. During the same period patient was treated with PROPOFOL (50 Mg, Once/single; 60 Mg, Qh, Infusion; 100 Mg, Qh, Infusion) (View Propofol Review and Propofol Label ), VECURONIUM BROMIDE (View Vecuronium Bromide Review and Vecuronium Bromide Label ), FENTANYL 100 (View Fentanyl-100 Review and Fentanyl-100 Label ), SEVOFLURANE (View Sevoflurane Review and Sevoflurane Label ), MIDAZOLAM HCL (View Midazolam Hcl Review and Midazolam Hcl Label ), DEXMEDETOMIDINE (DEXMEDETOMIDINE) (View Dexmedetomidine (dexmedetomidine) Review and Dexmedetomidine (dexmedetomidine) Label ), NALOXONE (View Naloxone Review and Naloxone Label ).

5907713-0 |
Adverse event was reported on Jan 18, 1994 by a Male patient taking Flumazenil (View Usage) (Dosage: ) was diagnosed with sedation and. Location: UNITED STATES , 50 years of age, weighting 172.0 lb, . During the same period patient was treated with HEPARIN (View Heparin Review and Heparin Label ), FAMOTIDINE (View Famotidine Review and Famotidine Label ), CEFTAZIDIME (View Ceftazidime Review and Ceftazidime Label ), METHYLPREDNISOLONE (View Methylprednisolone Review and Methylprednisolone Label ), QUINIDINE HCL (View Quinidine Hcl Review and Quinidine Hcl Label ), VERAPAMIL (View Verapamil Review and Verapamil Label ).

5714723-5 |
on Feb 11, 1991 Female patient from SWITZERLAND , 25 years of age, was treated with Flumazenil (View Usage). . Flumazenil dosage: . During the same period patient was treated with NALOXONE (View Naloxone Review and Naloxone Label ), PHYSOSTIGMINE (View Physostigmine Review and Physostigmine Label ).

5689130-4 | Coma
on Oct 08, 1986 Male patient from HONG KONG , 20 years of age, weighting 134.5 lb, was diagnosed with light anaesthesia and was treated with Flumazenil (View Usage). After Flumazenil was administered, patient had the following side effects: coma. Flumazenil dosage: . During the same period patient was treated with MIDAZOLAM HCL (View Midazolam Hcl Review and Midazolam Hcl Label ), DIATRIZOATE MEGLUMINE (View Diatrizoate Meglumine Review and Diatrizoate Meglumine Label ), TRANSAMIN (View Transamin Review and Transamin Label ), MANNITOL (View Mannitol Review and Mannitol Label ). Patient was hospitalized.

5689118-3 | Coma, Hypoxia, Pulmonary Embolism
Patient was taking Flumazenil (View Usage). Patient experienced the following unwanted or unexpected effects: coma, hypoxia, pulmonary embolism (What is pulmonary embolism?) on Jun 18, 1986 from NORWAY Additional patient health information: Male patient , 66 years of age, was diagnosed with coma and. Flumazenil dosage: . During the same period patient was treated with MIDAZOLAM HCL (View Midazolam Hcl Review and Midazolam Hcl Label ), MORPHINE (View Morphine Review and Morphine Label ), HALOPERIDOL (View Haloperidol Review and Haloperidol Label ), DIAZEPAM (View Diazepam Review and Diazepam Label ), KETOGAN (View Ketogan Review and Ketogan Label ). Patient was hospitalized.

5688836-0 | Blood Pressure Increased, Cardio-respiratory Arrest, Overdose
Adverse event was reported on Sep 09, 2002 by a Male patient taking Flumazenil (View Usage) (Dosage: ) was diagnosed with reversal of sedation and. Location: FRANCE , 68 years of age, Patient had the following side effects: blood pressure increased, cardio-respiratory arrest, overdose. During the same period patient was treated with CLOPIXOL (View Clopixol Review and Clopixol Label ), TRANXENE (View Tranxene Review and Tranxene Label ), PHENERGAN HCL (View Phenergan Hcl Review and Phenergan Hcl Label ), EQUANIL (View Equanil Review and Equanil Label ), PIPORTIL (View Piportil Review and Piportil Label ). Patient was hospitalized.

5564748-8 | Cerebral Haemorrhage, Coma
on Dec 07, 2007 Male patient from FRANCE , 48 years of age, was diagnosed with deep vein thrombosis (What is deep vein thrombosis?) and was treated with Flumazenil (View Usage). After Flumazenil was administered, patient had the following side effects: cerebral haemorrhage, coma. Flumazenil dosage: . During the same period patient was treated with MIDAZOLAM HCL (View Midazolam Hcl Review and Midazolam Hcl Label ), CLAFORAN (View Claforan Review and Claforan Label ), NICARDIPINE HCL (View Nicardipine Hcl Review and Nicardipine Hcl Label ), OMEPRAZOLE (View Omeprazole Review and Omeprazole Label ), ULTIVA (View Ultiva Review and Ultiva Label ), LASIX (View Lasix Review and Lasix Label ), ARIXTRA (Strength: 7.5 Mg/0.6 Ml) (View Arixtra Review and Arixtra Label ), HEPARIN (View Heparin Review and Heparin Label ).

5481294-0 | Coma
on Sep 27, 2007 Male patient from FRANCE , 63 years of age, was diagnosed with off label use and was treated with Flumazenil (View Usage). Patient experienced the following unwanted or unexpected effects: coma. Flumazenil dosage: Form Reported As Injectable Solution.. Patient was hospitalized.