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Peganone Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
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:
- trouble sleeping (insomnia)
- swelling in your gums, or lack of balance or coordination
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.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Peganone in Detail - Patient Information: Side Effects
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.
Read the entire detailed patient monograph for Peganone (Ethotoin)
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Peganone Overview - Patient Information: Side Effects
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor immediately if any of these unlikely but serious side effects occur: loss of coordination, fainting, swollen glands (lymph nodes), butterfly-shaped rash on the nose/cheeks, vision changes (e.g., blurred vision, double vision), uncontrolled side-to-side eye movements (nystagmus).
A small number of people who take anticonvulsants for any condition (such as seizure, bipolar disorder, pain) may experience depression, suicidal thoughts/attempts, or other mental/mood problems. Tell your doctor immediately if you or your family/caregiver notice any unusual/sudden changes in your mood, thoughts, or behavior including signs of depression, suicidal thoughts/attempts, thoughts about harming yourself.
Severe (rarely fatal) blood disorders (aplastic anemia, pancytopenia) and liver problems have occurred with ethotoin. Discuss the risks and benefits with your doctor before starting ethotoin.
Tell your doctor immediately if any of these rare but very serious side effects occur: unusual bleeding/bruising, symptoms of infection (fever, chills, persistent sore throat), symptoms of anemia (tiredness, pale skin/fingernails, fast heartbeat), liver problems (e.g., severe stomach/abdominal pain, unusual weakness/tiredness, pale stools, dark urine, yellowing eyes/skin).
A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Peganone (Ethotoin)
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Peganone FDA Prescribing 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 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 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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