Felbatol Side Effects

Generic Name: felbamate

Please note - some side effects for Felbatol may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Felbatol - for the Consumer

Felbatol

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Felbatol:

Constipation; diarrhea; difficulty sleeping; dizziness; drowsiness; headache; itching; loss of appetite; nausea; tiredness; upset stomach; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); agitation; chest pain; dark urine; fever, chills, or sore throat; mental or mood changes (eg, depression, mood swings); mouth sores; nervousness or anxiety; suicidal thoughts or actions; unusual bruising or bleeding; vision changes; weakness; yellowing of the eyes or skin.

Felbatol Suspension

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Felbatol Suspension:

Constipation; diarrhea; difficulty sleeping; dizziness; drowsiness; headache; itching; loss of appetite; nausea; tiredness; upset stomach; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); agitation; chest pain; dark urine; fever, chills, or sore throat; mental or mood changes (eg, depression, mood swings); mouth sores; nervousness or anxiety; suicidal thoughts or actions; unusual bruising or bleeding; vision changes; weakness; yellowing of the eyes or skin.

Side Effects by Body System

Nervous system

In controlled trials with felbamate as monotherapy, no nervous system effect occurred with a frequency greater than 7%. However, the frequency of nervous system effects (particularly sedative effects) was much greater in controlled studies of felbamate as adjuvant therapy with other antiepileptic agents. Ataxia, tremor, involuntary movements, psychosis, and blurred vision have also been reported rarely.

One prospective investigation found 20 of 60 (33%) epileptic patients to have reported a headache. The headache was pounding in 11 patients, steady in 9 patients, and moderate or severe in 19 patients. Patients who had the headaches reported that they occurred at least once a week.

Nervous system side effects are common and include insomnia, headache, anxiety, dizziness, somnolence, fatigue, and lethargy.

Gastrointestinal

Gastrointestinal side effects are common and include nausea, vomiting, dyspepsia, constipation, diarrhea, and bad taste in mouth. Some clinicians have reported that anorexia and weight loss occur commonly.

Dyspepsia and vomiting occur in as many as 9% of treated patients.

Hepatic

Hepatic side effects include mild elevations of liver function tests which occur in as many as 5% of treated patients. The manufacturer reports that several cases of acute liver failure have also occurred in patients taking felbamate. A case of massive acute hepatic necrosis and death within 40 days of initiation of felbamate therapy has also been reported.

Dermatologic

Dermatologic side effects including rashes and acne occur in approximately 3% of treated patients. The Stevens-Johnson syndrome has been reported rarely. A case of toxic epidermal necrolysis has also been reported.

Metabolic

Metabolic side effects including hypophosphatemia have been reported in approximately 3% of treated patients.

Hematologic

Hematologic side effects include leukopenia, thrombocytopenia, and agranulocytosis rarely. Nine cases of aplastic anemia have been reported in the United States from the time of commercial release of felbamate to August 1, 1994.

Genitourinary

Genitourinary side effects including a case of urolithiasis have been reported.

Hypersensitivity

Hypersensitivity side effects including a case of felbamate induced delayed anaphylaxis have been reported.

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