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Flumazenil Side Effects summary

Total Flumazenil reports: 6.
Flumazenil FDA safety alerts: No.
Reported deaths: 6    Reported hospitalizations: 4.
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Flumazenil Side Effects:
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Flumazenil Side Effects reported to FDA

Flumazenil Side Effects Report #5481294-0
Pharmacist from FRANCE reported FLUMAZENIL problem on Sept 27, 2007. Male patient, 63 years of age, was diagnosed with off label use and was treated with FLUMAZENIL. After drug was administered, patient experienced the following problems/side effects: coma. FLUMAZENIL dosage: unknown. Patient was hospitalized. Patient recovered.



Flumazenil Side Effects Report #5564748-8
FLUMAZENIL problem was reported by a Physician from FRANCE on Dec 07, 2007. Male patient, 48 years of age, was diagnosed with deep vein thrombosis and was treated with FLUMAZENIL. After drug was administered, patient experienced the following problems/side effects: cerebral haemorrhage, coma. FLUMAZENIL dosage: unknown. During the same period patient was treated with MIDAZOLAM, CLAFORAN, NICARDIPINE, OMEPRAZOLE, ULTIVA, LASIX, ARIXTRA, HEPARIN. Patient died on 10/11/2007.



Flumazenil Side Effects Report #5688836-0
Physician from FRANCE reported FLUMAZENIL problem on Sept 09, 2002. Male patient, 68 years of age, was diagnosed with reversal of sedation and was treated with FLUMAZENIL. After drug was administered, patient experienced the following problems/side effects: blood pressure increased, cardio-respiratory arrest, overdose. FLUMAZENIL dosage: unknown. During the same period patient was treated with CLOPIXOL, TRANXENE, PHENERGAN, EQUANIL, PIPORTIL. Patient was hospitalized. Patient died on 09/05/2002.



Flumazenil Side Effects Report #5689118-3
FLUMAZENIL problem was reported by a Physician from NORWAY on June 18, 1986. Male patient, 66 years of age, was diagnosed with coma and was treated with FLUMAZENIL. After drug was administered, patient experienced the following problems/side effects: coma, hypoxia, pulmonary embolism. FLUMAZENIL dosage: unknown. During the same period patient was treated with MIDAZOLAM, MORPHINE, HALOPERIDOL, DIAZEPAM, KETOGAN. Patient was hospitalized. Patient died on 06/17/1986.




Flumazenil Side Effects Report #5689130-4
Physician from HONG KONG reported FLUMAZENIL problem on Oct 08, 1986. Male patient, 20 years of age, weighting 134.5 lb, was diagnosed with light anaesthesia and was treated with FLUMAZENIL. After drug was administered, patient experienced the following problems/side effects: coma. FLUMAZENIL dosage: unknown. During the same period patient was treated with MIDAZOLAM, DIATRIZOATE MEGLUMINE, TRANSAMIN, MANNITOL. Patient was hospitalized. Patient died on 10/06/1986.



Flumazenil Side Effects Report #5714723-5
FLUMAZENIL problem was reported by a Physician from SWITZERLAND on Feb 11, 1991. Female patient, 25 years of age, was treated with FLUMAZENIL. FLUMAZENIL dosage: unknown. During the same period patient was treated with NALOXONE, PHYSOSTIGMINE. Patient died.




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, Flumazenil was diagnosed with off label use and Flumazenil was diagnosed with deep vein thrombosis and Flumazenil was diagnosed with reversal of sedation and