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Felbatol (Felbamate) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Felbatol (Felbamate) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.

Reports by Event Outcome

All Cases (20)
Death (1)

Reports by Reaction Type

Grand MAL Convulsion (7)Decreased Appetite (6)Convulsion (6)Weight Decreased (5)Gastrooesophageal Reflux Disease (5)Condition Aggravated (4)Product Substitution Issue (3)Pyrexia (3)Constipation (3)Treatment Noncompliance (3)Vomiting (3)Drug Withdrawal Convulsions (3)

Possible Felbatol side effects in

Reported by a individual with unspecified qualification from United States on 2012-07-18

Patient:

Reactions: Abdominal Pain, Weight Decreased, Vomiting, Helicobacter Infection, Pyrexia, Constipation, Staring, Gastrooesophageal Reflux Disease, Decreased Appetite

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Felbatol
    Dosage: 1800 mg am and 900 mg pm
    Administration route: Oral
    Start date: 2008-01-01

Felbatol
    Dosage: 900 mg am and 600 mg pm
    Administration route: Oral
    Start date: 2003-05-01

Felbatol
    Dosage: 1500 mg am and 1200 mg pm
    Administration route: Oral
    Start date: 2005-06-01

Felbatol
    Dosage: unk
    Administration route: Oral
    Indication: Myoclonic Epilepsy
    Start date: 1990-01-01

Felbatol
    Dosage: 1200 mg, bid
    Administration route: Oral
    Start date: 2004-01-01

Felbatol
    Dosage: 1800 mg am and 1200 mg pm
    Administration route: Oral
    Start date: 2006-05-01

Felbatol
    Dosage: 900 mg, bid
    Administration route: Oral
    Start date: 2003-10-01

Other drugs received by patient: Melatonin; Selenium (Unspecified); Zonegran; Keppra; Keppra; Vimpat; Hydroxocobalamin; Keppra; Banzel; Keppra; Zonegran



Possible Felbatol side effects in

Reported by a physician from United States on 2012-07-17

Patient:

Reactions: Drug Withdrawal Convulsions

Drug(s) suspected as cause:
Felbatol
    Dosage: 600 mg per 5 ml
    Administration route: Oral
    Indication: Epilepsy
    Start date: 1998-01-01
    End date: 2012-06-19

Felbatol
    Dosage: 600 mg per 5 ml
    Administration route: Oral
    Start date: 2012-01-01

Other drugs received by patient: Clonazepam; Zonisamide; Lamotrigine; Clonidine; Prozac; Risperdal



Possible Felbatol side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-17

Patient:

Reactions: Intentional Drug Misuse, Convulsion

Drug(s) suspected as cause:
Felbatol
    Dosage: 3 df, bid
    Administration route: Oral
    Start date: 2008-01-01

Felbatol
    Dosage: 1 df, qd
    Administration route: Oral



Possible Felbatol side effects in

Reported by a physician from United States on 2012-07-13

Patient:

Reactions: Weight Decreased, Abdominal Pain, Vomiting, Pyrexia, Helicobacter Infection, Constipation, Staring, Gastrooesophageal Reflux Disease, Decreased Appetite

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Felbatol
    Dosage: 900 mg, bid
    Administration route: Oral
    Start date: 2003-10-01

Felbatol
    Dosage: unk
    Administration route: Oral
    Indication: Myoclonic Epilepsy
    Start date: 1990-01-01

Felbatol
    Dosage: 1800 mg am and 1200 mg pm
    Administration route: Oral
    Start date: 2006-05-01

Felbatol
    Dosage: 1800 mg am and 900 mg pm
    Administration route: Oral
    Start date: 2008-01-01

Felbatol
    Dosage: 900 mg am and 600 mg pm
    Administration route: Oral
    Start date: 2003-05-01

Felbatol
    Dosage: 1200 mg, bid
    Administration route: Oral
    Start date: 2004-01-01

Felbatol
    Dosage: 1500 mg am and 1200 mg pm
    Administration route: Oral
    Start date: 2005-06-01

Other drugs received by patient: Melatonin; Keppra; Keppra; Banzel; Zonegran; Zonegran; Keppra; Selenium (Unspecified); Hydroxocobalamin; Keppra; Vimpat



Possible Felbatol side effects in 19 year old male

Reported by a physician from United States on 2012-07-11

Patient: 19 year old male, weighing 68.0 kg (149.7 pounds)

Reactions: Drug Withdrawal Convulsions

Drug(s) suspected as cause:
Felbatol
    Dosage: 600 mg/5 ml (10 mg, 3 in 1 d), oral, 600 mg/5 ml (10 milliliter, 3 in 1 d), oral
    Administration route: Oral
    Indication: Epilepsy
    Start date: 1998-01-01
    End date: 2012-06-19

Felbatol
    Dosage: 600 mg/5 ml (10 mg, 3 in 1 d), oral, 600 mg/5 ml (10 milliliter, 3 in 1 d), oral
    Administration route: Oral
    Indication: Epilepsy
    Start date: 2012-01-01

Other drugs received by patient: Risperdal; Clonidine; Zonisamide; Prozac; Clonazepam; Lamotrigine



Possible Felbatol side effects in male

Reported by a physician from United States on 2012-07-11

Patient: male, weighing 71.2 kg (156.7 pounds)

Reactions: White Blood Cell Count Decreased, Weight Decreased, Vomiting, Pyrexia, Constipation, Eating Disorder, Grand MAL Convulsion, Gastrointestinal Disorder, Gastrooesophageal Reflux Disease

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Felbatol
    Dosage: see image
    Administration route: Oral
    Indication: Myoclonic Epilepsy
    Start date: 2003-05-01

Felbatol
    Dosage: see image
    Administration route: Oral
    Indication: Myoclonic Epilepsy
    Start date: 2004-01-01

Felbatol
    Dosage: see image
    Administration route: Oral
    Indication: Myoclonic Epilepsy
    Start date: 2005-06-01

Felbatol
    Dosage: see image
    Administration route: Oral
    Indication: Myoclonic Epilepsy
    Start date: 2006-05-01

Felbatol
    Dosage: see image
    Administration route: Oral
    Indication: Myoclonic Epilepsy
    Start date: 2008-01-01

Felbatol
    Dosage: see image
    Administration route: Oral
    Indication: Myoclonic Epilepsy
    Start date: 1990-01-01

Felbatol
    Dosage: see image
    Administration route: Oral
    Indication: Myoclonic Epilepsy
    Start date: 2003-10-01

Other drugs received by patient: Hydroxy B12 (Hydroxocobalamin); Vimpat; Banzel (Rufinamide); Keppra; Methyl B12 (Methylcobalamin); Zonegran; Melatonin (Melatonin); Amino Acids Plus Glutathione (Glutathione, Amino Acids)



Possible Felbatol side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-06

Patient: female

Reactions: Convulsion

Drug(s) suspected as cause:
Felbatol



Possible Felbatol side effects in 19 year old male

Reported by a consumer/non-health professional from United States on 2012-07-06

Patient: 19 year old male, weighing 68.0 kg (149.7 pounds)

Reactions: Drug Withdrawal Convulsions

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Felbatol

Other drugs received by patient: Clonazepam; Lamotrigine; Clonidine; Risperdal; Prozac; Zonisamide



Possible Felbatol side effects in male

Reported by a consumer/non-health professional from United States on 2012-06-12

Patient: male, weighing 71.2 kg (156.7 pounds)

Reactions: Grand MAL Convulsion, Gastrointestinal Disorder, Gastrooesophageal Reflux Disease, Decreased Appetite

Drug(s) suspected as cause:
Felbatol
    Dosage: (900 mg, once daily in the am), oral (600 mg, once daily in the pm), oral
    Administration route: Oral
    Indication: Myoclonic Epilepsy
    Start date: 1990-01-01

Felbatol
    Dosage: (900 mg, once daily in the am), oral (600 mg, once daily in the pm), oral
    Administration route: Oral
    Indication: Myoclonic Epilepsy
    Start date: 1990-01-01

Other drugs received by patient: Banzel (Rufinamide)



Possible Felbatol side effects in male

Reported by a consumer/non-health professional from United States on 2012-05-29

Patient: male

Reactions: Grand MAL Convulsion, Gastrooesophageal Reflux Disease, Decreased Appetite

Drug(s) suspected as cause:
Felbatol
    Dosage: 900 mg, once daily in the am, oral; 600 once daily in the pm. oral
    Administration route: Oral
    Indication: Myoclonic Epilepsy
    Start date: 1990-01-01

Felbatol
    Dosage: 900 mg, once daily in the am, oral; 600 once daily in the pm. oral
    Administration route: Oral
    Indication: Myoclonic Epilepsy
    Start date: 1990-01-01

Other drugs received by patient: Banzel (Rufinamide)



Possible Felbatol side effects in male

Reported by a consumer/non-health professional from United States on 2012-05-04

Patient: male, weighing 75.1 kg (165.2 pounds)

Reactions: Product Substitution Issue, Drug Ineffective, Dyskinesia, Depressed Level of Consciousness, Muscle Twitching

Drug(s) suspected as cause:
Felbatol
    Dosage: 6ml bid po
    Administration route: Oral
    Indication: Cerebral Palsy
    Start date: 2007-07-01

Felbatol
    Dosage: 6ml bid po
    Administration route: Oral
    Indication: Epilepsy
    Start date: 2007-07-01



Possible Felbatol side effects in female

Reported by a consumer/non-health professional from United States on 2012-04-03

Patient: female, weighing 90.8 kg (199.8 pounds)

Reactions: Grand MAL Convulsion, Treatment Noncompliance, Convulsion

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Depakote
    Dosage: 500 mg qam and 1000 qpm
    Administration route: Oral
    Start date: 2011-10-01

Depakote
    Administration route: Oral
    Indication: Convulsion
    Start date: 1992-01-01
    End date: 2011-10-01

Felbatol
    Administration route: Oral
    Indication: Convulsion
    Start date: 1992-01-01
    End date: 2011-11-01

Felbatol
    Start date: 2011-11-01



Possible Felbatol side effects in female

Reported by a physician from United States on 2012-03-29

Patient: female

Reactions: Apparent Death, Product Substitution Issue, Road Traffic Accident, Drug Level Decreased, Convulsion

Drug(s) suspected as cause:
Felbamate
    Start date: 2012-01-01

Felbatol
    End date: 2012-01-01



Possible Felbatol side effects in female

Reported by a consumer/non-health professional from United States on 2012-03-08

Patient: female, weighing 90.8 kg (199.8 pounds)

Reactions: Grand MAL Convulsion, Condition Aggravated, Treatment Noncompliance

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Depakote
    Administration route: Oral
    Indication: Convulsion
    Start date: 1992-01-01
    End date: 2011-10-01

Depakote
    Dosage: 500 mg qam and 1000 qpm
    Administration route: Oral
    Start date: 2011-10-01

Felbatol
    Administration route: Oral
    Indication: Convulsion
    Start date: 1992-01-01
    End date: 2011-11-01

Felbatol
    Start date: 2011-11-01



Possible Felbatol side effects in 51 year old female

Reported by a physician from United States on 2012-02-08

Patient: 51 year old female, weighing 90.7 kg (199.6 pounds)

Reactions: Refusal of Treatment by Patient, Condition Aggravated, Treatment Noncompliance, Convulsion

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Depakote
    Dosage: 1000 mg (500 mg, 2 in 1 d), oral
    Administration route: Oral
    Indication: Convulsion
    Start date: 1992-01-01
    End date: 2011-10-01

Felbatol
    Dosage: 1200 mg (600 mg, 2 in 1 d), oral
    Administration route: Oral
    Indication: Convulsion
    Start date: 1992-01-01
    End date: 2011-11-01



Possible Felbatol side effects in male

Reported by a individual with unspecified qualification from United States on 2012-01-27

Patient: male, weighing 85.3 kg (187.7 pounds)

Reactions: Product Substitution Issue, Convulsion

Drug(s) suspected as cause:
Felbatol
    Dosage: 1 1/2 bid po
    Administration route: Oral
    Indication: Epilepsy
    Start date: 2005-11-01

Felbatol
    Dosage: 1 1/2 bid po
    Administration route: Oral
    Indication: Autism
    Start date: 2005-11-01



Possible Felbatol side effects in 18 year old male

Reported by a physician from United States on 2011-12-08

Patient: 18 year old male, weighing 54.4 kg (119.7 pounds)

Reactions: Weight Decreased, Grand MAL Convulsion, Vagal Nerve Stimulator Implantation, Seizure Cluster, Decreased Appetite

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Felbatol

Other drugs received by patient: Levetiracetam; Depakote; Diastat



Possible Felbatol side effects in 70 year old

Reported by a pharmacist from United States on 2011-11-25

Patient: 70 year old , weighing 95.3 kg (209.6 pounds)

Reactions: Product Quality Issue, Simple Partial Seizures, Poor Quality Drug Administered, Fall, Transient Ischaemic Attack

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Felbatol
    Dosage: 1800 mg (600 mg,3 in 1 d),oral
    Administration route: Oral
    Indication: Epilepsy

Tegretol-XR
    Dosage: oral
    Administration route: Oral
    Indication: Epilepsy

Other drugs received by patient: Plavix



Possible Felbatol side effects in 18 year old male

Reported by a consumer/non-health professional from United States on 2011-10-17

Patient: 18 year old male, weighing 54.4 kg (119.7 pounds)

Reactions: Grand MAL Convulsion, Weight Decreased, Condition Aggravated, Decreased Appetite

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Felbatol
    Dosage: 2400;1200 mg (1200;600 mg, 2 in 1 d)
    Indication: Lennox-Gastaut Syndrome
    Start date: 2011-08-01

Felbatol
    Dosage: 2400;1200 mg (1200;600 mg, 2 in 1 d)
    Indication: Lennox-Gastaut Syndrome
    End date: 2011-08-01

Other drugs received by patient: Depakote



Possible Felbatol side effects in male

Reported by a consumer/non-health professional from United States on 2011-10-11

Patient: male

Reactions: Condition Aggravated, Petit MAL Epilepsy, Sinusitis

Drug(s) suspected as cause:
Felbatol

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