Felbamate: Side Effects, Uses & Monitoring

Facts extracted from current FDA product labeling for Felbamate. Educational only — not medical advice.

Reported adverse reactions

ReactionHighest frequency reported*
Nausea34.2%
Somnolence19.3%
Anorexia19.3%
Dizziness18.4%
Headache18%
Purpura12.9%
Hiccup9.7%
Insomnia8.6%
Dyspepsia8.6%
Vomiting8.6%
Urinary incontinence7.4%
Nervousness7%
Upper respiratory tract infection7%
Fatigue6.9%
Constipation6.9%
Rhinitis6.9%
Pain6.5%
Thinking abnormal6.5%
Emotional lability6.5%
Miosis6.5%

*Highest percentage across placebo-controlled trial tables summarized in current labeling.

Labeled uses

Felbamate oral suspension is not indicated as a first line antiepileptic treatment (see Warnings ). Felbamate oral suspension is recommended for use only in those patients who respond inadequately to alternative treatments and whose epilepsy is so severe that a substantial risk of aplastic anemia and/or liver failure is deemed acceptable in light of the benefits conferred by its use. If these criteria are met and the patient has been fully advised of the risk, and has provided written acknowledgment, felbamate oral suspension can be considered for either monotherapy or adjunctive therapy in the treatment of partial seizures, with and without generalization, in adults with epilepsy and as adjunctive therapy in the treatment of partial and generalized seizures associated with Lennox-Gastaut syndrome in children.

Source: FDA labeling via NIH DailyMed (set 2e325d79…). Not affiliated with FDA or NIH.

Medical disclaimer: Always consult a qualified healthcare professional about any medication.