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Felbatol Safety Reports
Total Felbatol reports: 11.Felbatol FDA safety alerts: 2008 .
Reported deaths: 2 Reported hospitalizations: 6.
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Reported Felbatol Side Effects: aplastic anaemia, white blood cell count increased, respiratory rate increased, platelet count increased, pancytopenia, infection, heart rate increased, body temperature decreased, platelet count decreased, bacteraemia, vomiting.
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Felbatol Side Effects Report #5216831-4
Physician from UNITED STATES reported FELBATOL problem on Nov 16, 2006. Female patient, 42 years of age, was diagnosed with complex partial seizures and was treated with FELBATOL. After drug was administered, patient experienced the following problems/side effects: aplastic anaemia, enterobacter sepsis, fall, head injury. FELBATOL dosage: unknown. Patient was hospitalized and became disabled. Patient recovered.
Felbatol Side Effects Report #5281491-3
FELBATOL problem was reported by a Consumer or non-health professional from UNITED STATES on Mar 23, 2007. Female patient, weighting 130.0 lb, was diagnosed with epilepsy and was treated with FELBATOL. After drug was administered, patient experienced the following problems/side effects: muscle spasms. FELBATOL dosage: 400 MG 3 TIMES DAILY PO. Patient recovered.
Felbatol Side Effects Report #5069108-4
Physician from UNITED STATES reported FELBATOL problem on July 18, 2006. Male patient, 17 years of age, weighting 50.71 lb, was diagnosed with lennox-gastaut syndrome, asthma and was treated with FELBATOL. After drug was administered, patient experienced the following problems/side effects: disease progression, gastric ulcer, haemorrhage, lennox-gastaut syndrome, pyrexia, refusal of treatment by relative. FELBATOL dosage: 38 MG/KG/DAY. During the same period patient was treated with CORTICOSTEROID, MYSOLINE, KLONOPIN, TOPAMAX. Patient recovered.
Felbatol Side Effects Report #5092159-0
FELBATOL problem was reported by a Physician from UNITED STATES on Aug 28, 2006. Female patient, weighting 132.0 lb, was diagnosed with convulsion and was treated with FELBATOL. After drug was administered, patient experienced the following problems/side effects: anencephaly. FELBATOL dosage: 600 MG ORAL TAB TAKE TWO AND ONE. H PO. During the same period patient was treated with FELBAMATE. Patient recovered.
Felbatol Side Effects Report #5096101-8
Physician from UNITED STATES reported FELBATOL problem on Aug 17, 2006. Female patient, 13 years of age, weighting 102.0 lb, was diagnosed with complex partial seizures and was treated with FELBATOL. After drug was administered, patient experienced the following problems/side effects: aplastic anaemia, bone marrow failure, idiopathic thrombocytopenic purpura, menorrhagia. FELBATOL dosage: 1600 MG BID (MG), PO. During the same period patient was treated with RITALIN, PREDNISONE. Patient was hospitalized and became disabled. Patient died on 01/01/1996.
Felbatol Side Effects Report #5197385-8
FELBATOL problem was reported by a Physician from UNITED STATES on Aug 30, 2005. Female patient, child 6 years of age, weighting 37.48 lb, was diagnosed with partial seizures, infected insect bite and was treated with FELBATOL. After drug was administered, patient experienced the following problems/side effects: hepatitis, infected insect bite, status epilepticus. FELBATOL dosage: 750 MG BID, P.O.. During the same period patient was treated with CEFTRIAXONE, TOPAMAX, KEPPRA, PHENOBARBITAL. Patient was hospitalized. Patient recovered.
Felbatol Side Effects Report #5197387-1
Physician from UNITED STATES reported FELBATOL problem on Mar 29, 2006. Female patient, 24 years of age, was diagnosed with epilepsy and was treated with FELBATOL. After drug was administered, patient experienced the following problems/side effects: white blood cell count decreased. FELBATOL dosage: unknown. During the same period patient was treated with ZONEGRAN, KEPPRA, MIDRIN, TRANXENE. Patient recovered.
Felbatol Side Effects Report #5197388-3
FELBATOL problem was reported by a Pharmacist from UNITED STATES on June 28, 2006. Male patient, 16 years of age, was diagnosed with epilepsy and was treated with FELBATOL. After drug was administered, patient experienced the following problems/side effects: blood sodium decreased, vomiting. FELBATOL dosage: 800 MG VIA J-TUBE (3 IN 1 D). During the same period patient was treated with PREVACID, BACLOFEN, PHENOBARBITAL, ROBINAL. Patient was hospitalized. Patient recovered.
Felbatol Side Effects Report #5189791-2
Physician from UNITED STATES reported FELBATOL problem on Dec 07, 2006. Male patient, weighting 16.80 lb, was diagnosed with infantile spasms and was treated with FELBATOL. After drug was administered, patient experienced the following problems/side effects: bacteraemia. FELBATOL dosage: unknown. During the same period patient was treated with TOPAMAX. Patient died on 12/04/2006.
Felbatol Side Effects Report #5449517-1
FELBATOL problem was reported by a Physician from UNITED STATES on Aug 22, 2007. Female patient, 14 years of age, was diagnosed with status epilepticus and was treated with FELBATOL. After drug was administered, patient experienced the following problems/side effects: aplastic anaemia, platelet count decreased. FELBATOL dosage: 3600 MG (1200 MG, 3 IN 1 D). During the same period patient was treated with PHENOBARBITAL, KEPPRA, DILANTIN, PENTOBARBITAL CAP, VALPROIC ACID. Patient was hospitalized. Patient recovered.
Felbatol Side Effects Report #5475266-X
Physician from UNITED STATES reported FELBATOL problem on Sept 12, 2007. Female patient, 14 years of age, weighting 125.0 lb, was diagnosed with status epilepticus and was treated with FELBATOL. After drug was administered, patient experienced the following problems/side effects: aplastic anaemia, body temperature decreased, heart rate increased, infection, pancytopenia, platelet count increased, respiratory rate increased, white blood cell count increased. FELBATOL dosage: 3600 MG (1200 MG, 3 IN 1 D). During the same period patient was treated with TOPAMAX, PHENOBARBITAL, KEPPRA, DILANTIN, PENTOBARBITAL CAP, VALPROIC ACID. Patient was hospitalized. Patient recovered.
