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Peganone

Last reviewed on RxList: 7/24/2017
Peganone Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 7/24/2017

Peganone (ethotoin) tablets is an oral antiepileptic medication, also called an anticonvulsant, used alone or in combination with other medications to treat seizures in adults and children. Common side effects of Peganone include:

  • headache
  • nausea
  • vomiting
  • diarrhea
  • dizziness
  • drowsiness
  • tiredness
  • numbness/tingling
  • trouble sleeping (insomnia)
  • swelling in your gums, or
  • lack of balance or coordination

Antiepileptic drugs (AEDs) such as Peganone may increase the risk of suicidal thoughts or behavior. Tell your doctor if this occurs while taking Peganone. Tell your doctor if you have serious side effects of Peganone including:

  • chest pain,
  • vision problems,
  • signs of infection (such as fever,
  • chills,
  • sore throat,
  • flu symptoms,
  • easy bruising or bleeding,
  • mouth sores,
  • unusual weakness),
  • stomach pain,
  • loss of appetite,
  • dark urine,
  • clay-colored stools,
  • yellowing of the skin or eyes (jaundice),
  • joint pain or swelling with fever,
  • swollen glands,
  • muscle aches,
  • patchy skin color,
  • red spots,
  • butterfly-shaped skin rash over your cheeks and nose (worsens in sunlight),
  • worsening of seizures, or fever,
  • sore throat,
  • and headache with a severe blistering,
  • peeling,
  • and red skin rash

For adults, the initial daily dose of Peganone should be 1 g or less, with subsequent gradual dosage increases over a period of several days. The usual adult maintenance dose is 2 to 3 g daily. Peganone may interact with medicines to prevent blood clots, antibiotics, antidepressants, heart rhythm medications, medicines to treat psychiatric disorders, NSAIDs (nonsteroidal anti-inflammatory drugs), other seizure medications, sulfa drugs, thyroid replacement medications, and type 2 diabetes medications. Tell your doctor all medications and supplements you use. During pregnancy, Peganone should be used only when prescribed. It may harm a fetus. However, since untreated seizures are a serious condition that can harm both a pregnant woman and her unborn baby; do not stop taking this medication unless directed by your doctor. If you are planning pregnancy, become pregnant, or think you may be pregnant, talk to your doctor about using this medication during pregnancy. Birth control pills, patches, implants, and injections may not work if taken with this medication. Discuss birth control with your doctor. The use of anti-seizure drugs during pregnancy may increase the risk of bleeding in the newborn baby. Your doctor may order vitamin K injections for you/your newborn. This medication passes into breast milk. Consult your doctor before breastfeeding.

Our Peganone (ethotoin tablets) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Peganone Consumer Information

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, depression, anxiety, or if you feel agitated, hostile, restless, hyperactive (mentally or physically), or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have any of these serious side effects:

  • chest pain;
  • vision problems;
  • signs of infection such as fever, chills, sore throat, flu symptoms, easy bruising or bleeding (nosebleeds, bleeding gums), mouth sores, unusual weakness;
  • nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • joint pain or swelling with fever, swollen glands, muscle aches, chest pain;
  • patchy skin color, red spots, or a butterfly-shaped skin rash over your cheeks and nose (worsens in sunlight);
  • fever, sore throat, and headache with a severe blistering, peeling, and red skin rash; or
  • worsening of seizures.

Less serious side effects may include:

  • dizziness, headache, tired feeling;
  • vomiting, diarrhea;
  • swelling in your gums;
  • sleep problems (insomnia); or
  • lack of balance or coordination.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Peganone (Ethotoin)

Peganone Professional Information

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.

Read the entire FDA prescribing information for Peganone (Ethotoin)

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© Peganone Patient Information is supplied by Cerner Multum, Inc. and Peganone Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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