PEGANONE SIDE EFFECTS

SIDE EFFECTS

Adverse reactions associated with PEGANONE, in decreasing order of severity, are:

Isolated cases of lymphadenopathy and systemic lupus erythematosus have been reported in patients taking hydantoin compounds, and lymphadenopathy has occurred with PEGANONE. Withdrawal of therapy has resulted in remission of the clinical and pathological findings. Therefore, if a lymphomalike syndrome develops, the drug should be withdrawn and the patient should be closely observed for regression of signs and symptoms before treatment is resumed.

Ataxia and gum hypertrophy have occurred only rarely–usually only in patients receiving an additional hydantoin derivative. It is of interest to note that ataxia and gum hypertrophy have subsided in patients receiving other hydantoins when PEGANONE (ethotoin tablets, USP) was given as a substitute antiepileptic.

Occasionally, vomiting or nausea after ingestion of PEGANONE has been reported, but if the drug is administered after meals, the incidence of gastric distress is reduced. Other side effects have included chest pain, nystagmus, diplopia, fever, dizziness, diarrhea, headache, insomnia, fatigue, numbness, skin rash, and Stevens-Johnson syndrome.

To report SUSPECTED ADVERSE REACTIONS, contact Recordati Rare Diseases Inc. at 1- 888-575-8344 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.