It’s important to know about side effects that are possible with
. Be sure to talk with your healthcare team if you have any questions.

What is FYCOMPA (perampanel)?

FYCOMPA is a prescription medicine used:

  • To treat partial-onset seizures with or without secondarily generalized seizures in people with epilepsy who are 4 years of age and older

  • With other medicines to treat primary generalized tonic-clonic seizures in people with epilepsy who are 12 years of age and older

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Can FYCOMPA affect my mood and behavior?

FYCOMPA may cause mental (psychiatric) problems, including: new or worse aggressive behavior (including homicidal behavior), hostility, anger, anxiety, or irritability; being suspicious or distrustful (believing things that are not true); seeing objects or hearing things that are not there; confusion; difficulty with memory; other unusual or extreme changes in behavior or mood. Tell your healthcare provider right away if you have any new or worsening mental problems while taking FYCOMPA.

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How can I watch for early symptoms of suicidal thoughts or actions and when should I call my healthcare provider?

Like other antiepileptic drugs, FYCOMPA may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. Call your healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you:

  • Thoughts about suicide or dying

  • New or worse depression

  • Feeling agitated or restless

  • Trouble sleeping (insomnia)

  • Acting aggressive

  • Being angry or violent

  • An extreme increase in activity and talking (mania)

  • Attempt to commit suicide

  • New or worse anxiety

  • Panic attacks

  • New or worse irritability

  • Acting on dangerous impulses

  • Other unusual changes in behavior or mood

Suicidal thoughts or actions can be caused by things other than medicines. If you have suicidal thoughts or actions, your healthcare provider may check for other causes.

Pay attention to any changes especially sudden changes in mood, behaviors, thoughts, or feelings and keep all follow-up visits with your healthcare provider as scheduled. Call your healthcare provider between visits as needed, especially if you are worried about symptoms.

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Can I stop taking FYCOMPA?

Do not stop FYCOMPA without first talking with your healthcare provider. Stopping suddenly can cause serious problems and can cause you to have seizures more often.

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What do I need to tell my healthcare provider before taking FYCOMPA?

Before taking FYCOMPA, tell your healthcare provider about all of your medical conditions, including if you:

  • Have or have had depression, mood problems, aggressive or hostile behavior (for example, homicidal behavior), suicidal thoughts or behavior, or other psychiatric problems

  • Have liver or kidney problems

  • Drink alcohol

  • Have abused prescription medicines, street drugs, or alcohol in the past

  • Are pregnant or plan to become pregnant. It is not known if FYCOMPA will harm your unborn baby. If you become pregnant while taking FYCOMPA, talk to your healthcare provider about registering with the North American Antiepileptic Drug Pregnancy Registry (1-888-233-2334)

  • Are breastfeeding or plan to breastfeed. Talk to your healthcare provider about the best way to feed your baby if you take FYCOMPA and to decide if you will take FYCOMPA or breastfeed. You should not do both

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Taking FYCOMPA with certain other medicines can cause side effects or reduce either drug’s benefit. These medicines include: birth control, carbamazepine, phenytoin, oxcarbazepine, rifampin, and St. John’s Wort.

FYCOMPA may lower your contraceptive's ability to prevent pregnancy if your contraceptive contains levonorgestrel. Use an additional non-hormonal form of contraception (like condoms or a diaphragm and spermicide) while using FYCOMPA and for 1 month after you have stopped taking FYCOMPA.

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What should I avoid while taking FYCOMPA?

Do not drive, operate heavy machinery, or do other dangerous activities until you know how FYCOMPA affects you. FYCOMPA may make you dizzy, sleepy, or tired. While on FYCOMPA, do not drink alcohol or take other medicines that make you sleepy or dizzy until you talk to your healthcare provider. FYCOMPA taken with alcohol or medicines that cause sleepiness or dizziness may make your sleepiness or dizziness worse. FYCOMPA when taken with alcohol may also make your mood worse, increase anger, confusion, and depression.

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What are the possible side effects of FYCOMPA?

FYCOMPA may cause other serious side effects, including: Dizziness, vertigo (sense of spinning), and problems walking normally. You may have problems walking normally if you are unsteady because you feel dizzy. These symptoms can increase when your dose of FYCOMPA is increased. Your risk of feeling dizzy and having problems walking normally may be higher if you are elderly; Sleepiness and tiredness; Increased risk of falls. Taking FYCOMPA can increase your chance of falling. These falls can cause serious injuries. Your risk of falling may be higher if you are elderly; A serious allergic reaction that may affect your skin or other parts of your body such as your liver, kidneys, heart, or blood cells. This allergic reaction can be life-threatening and can cause death. Call your healthcare provider right away if you have: a skin rash, hives; fever or swollen glands that do not go away; swelling of your face; shortness of breath; swelling of the legs; yellowing of the skin or whites of the eyes; or dark urine.

The most common side effects of FYCOMPA include: dizziness; sleepiness; tiredness; irritability; falls; nausea and vomiting; weight gain; vertigo (sense of spinning); problems walking normally; problems with muscle coordination; headache; bruising; abdominal pain; and anxiety.

These are not all of the possible side effects of FYCOMPA. For more information ask your healthcare provider or pharmacist. It is important to talk to your healthcare team about any side effects that you are experiencing.

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What else do I need to know about FYCOMPA?

FYCOMPA is a controlled substance (CIII) because it can be abused or lead to drug dependence. Keep FYCOMPA in a safe place to protect it from theft and never give it to anyone else because it may harm them. Selling or giving away FYCOMPA is against the law.

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