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 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 2012-07-17
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 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 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 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 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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