Peganone Side Effects

Generic Name: ethotoin

Please note - some side effects for Peganone may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Peganone - for the Consumer

Peganone

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 Peganone:

Diarrhea; dizziness; nausea; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blurred vision or other vision changes; chest pain; clumsiness or unsteadiness; dark urine; fever, chills, or sore throat; general body discomfort; headache; joint pain; loss of coordination; new or worsening mental or mood changes (eg, depression); nosebleed; numbness; reddened, swollen, blistered or peeling skin; slurred speech; small red spots under the skin; suicidal thoughts or attempts; swollen glands; trouble sleeping; unusual bruising or bleeding; unusual eye movements; unusual weakness or fatigue; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Peganone Side Effects - for the Professional

Peganone

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 Therefore, if a lymphoma-like syndrome develops, the drug should be withdrawn and the patient should be closely observed for regression of signs and symptoms before treatment is resumed.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 Lundbeck Inc. at 1-800-455-1141 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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