NOW APPROVED
TO BE USED ALONE TO TREAT secondarily generalized CONVULSIVE seizures
TALK TO YOUR DOCTOR TO LEARN MORE

What is FYCOMPA® (perampanel)?

FYCOMPA is a prescription medicine used in people with epilepsy aged 12 and older alone or with other medicines to treat partial-onset seizures with or without secondarily generalized seizures and with other medicines to treat primary generalized tonic-clonic seizures

Important Safety Information

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.

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.

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.

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.

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. 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.

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; anxiety

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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Side Effects of FYCOMPA®

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


Can FYCOMPA cause serious mental (psychiatric) problems?

FYCOMPA may cause:

  • New or worse aggressive behavior
  • Homicidal thoughts or threats
  • Hostility
  • Anger
  • Anxiety
  • Irritability
  • Being suspicious or distrustful (believing things that are not true)
  • Other unusual or extreme changes in behavior or mood

Patients, their caregivers, and families should monitor for these changes and call their healthcare provider right away if they have any new or worsening mental problems while taking FYCOMPA. The combination of alcohol and FYCOMPA significantly worsened mood and increased anger. Patients taking FYCOMPA should avoid the use of alcohol.
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What if I have or had mental problems, aggressive or hostile behavior?

Before taking FYCOMPA, patients should tell their healthcare provider if they have or had mental problems, aggression or hostile behavior.
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Can FYCOMPA cause suicidal thoughts and actions?

Antiepileptic drugs, including FYCOMPA, may cause suicidal thoughts or actions in a very small number of people, about 1 in 500.
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When should I call my healthcare provider?

Patients should call their healthcare providers right away if they have any of the following symptoms, especially if they are new, worse, or worrisome:

  • Thoughts about suicide or dying
  • Thoughts of self-harm
  • Attempt to commit suicide
  • New or worse depression, new or worse anxiety
  • Feeling agitated or restless
  • Panic attacks
  • Trouble sleeping (insomnia)
  • New or worse irritability
  • Acting aggressive, being angry or violent
  • Acting on dangerous impulses, an extreme increase in activity and talking (mania), and other unusual changes in behavior or mood

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Can FYCOMPA make me feel dizzy?

Patients may have problems walking normally if they are unsteady because they feel dizzy. These symptoms may increase when their dose of FYCOMPA is increased. A patient’s risk of feeling dizzy and having problems walking normally may be higher if they are elderly.
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Can FYCOMPA make me feel sleepy?

FYCOMPA may make patients feel sleepy or tired. Patients should not drive, operate heavy machinery, or do other dangerous activities until they know how FYCOMPA affects them. A patient’s risk of feeling sleepy and tired may be higher if they are elderly.
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Is there a risk of falling with FYCOMPA?

Taking FYCOMPA may increase a patient’s chance of falling. These falls can cause serious injuries. A patient’s risk of falling may be higher if they are elderly.
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What if I want to stop FYCOMPA?

Patients must not stop FYCOMPA without first talking to their healthcare provider. Stopping FYCOMPA suddenly can cause serious problems and can cause patients to have seizures more often.
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What are the most common side effects seen when taking FYCOMPA?

The most common side effects seen in patients receiving FYCOMPA were dizziness, sleepiness, headache, tiredness, irritability, falls, nausea, problems with muscle coordination, problems walking normally, vertigo, and weight gain. Tell your healthcare provider about any side effect that bothers you or does not go away.
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What if I take FYCOMPA with other medicines?

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 other medicines include:

  • Birth control
  • Carbamazepine
  • Phenytoin
  • Oxcarbazepine
  • Rifampin
  • St. John’s wort

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Can I drink alcohol with FYCOMPA?

  • Before taking FYCOMPA, patients should tell their healthcare provider if they drink alcohol
  • Patients should not drink alcohol or take other medicines that make them sleepy or dizzy while taking FYCOMPA until they talk to their healthcare provider
  • FYCOMPA taken with alcohol or medicines that cause sleepiness or dizziness may make their sleepiness or dizziness worse

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What if I’m pregnant and nursing?

Before taking FYCOMPA, patients should tell their healthcare provider if they are pregnant or plan to become pregnant while taking FYCOMPA. It is not known if FYCOMPA will harm your unborn baby. If a patient becomes pregnant while taking FYCOMPA, they should talk to their healthcare provider about registering with the North American Antiepileptic Drug Pregnancy Registry (1-888-233-2334).

Before taking FYCOMPA, patients should tell their healthcare provider if they are breastfeeding or plan to breastfeed. Patients should talk to their healthcare provider about the best way to feed their baby if they take FYCOMPA. Patients should not take FYCOMPA if they breastfeed.
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What if I have liver and kidney problems?

Before taking FYCOMPA, patients should tell their healthcare provider if they have liver or kidney problems. They should not take FYCOMPA if they have severe kidney or liver problems.
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What do I need to know about drug abuse and dependence?

FYCOMPA is a controlled substance (CIII) because it can be abused or lead to drug dependence. Before taking FYCOMPA, patients should tell their healthcare provider if they have abused prescription medicines, street drugs, or alcohol in the past. Patients should keep their FYCOMPA in a safe place to protect it from theft and should never give it to anyone else because it may harm them. Selling or giving away FYCOMPA is against the law.
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What should families and caregivers know?

If someone you care for is taking FYCOMPA, you should be aware of how it might affect him or her:

  • FYCOMPA may increase the risk of mental (psychiatric) events and suicidal thoughts and behavior
  • Be alert for signs of depression or any unusual changes in mood or behavior
  • Be alert for signs of suicidal thoughts, behavior, or thoughts of self-harm

These changes may happen when someone starts or stops FYCOMPA. This can also happen when the dose is changed. The doctor may change the dose of FYCOMPA if these symptoms continue, are serious, or get worse. The doctor can also connect the person with a psychiatrist. Contact the doctor right away if you are concerned.

Read more tips for caregivers>

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NOW APPROVED
to be used alone to treat secondarily generalized convulsive seizures

Indication and Important Safety Information

What is FYCOMPA (perampanel)?

FYCOMPA® is a prescription medicine used in people with epilepsy aged 12 and older alone or with other medicines to treat partial-onset seizures with or without secondarily generalized seizures and with other medicines to treat primary generalized tonic-clonic seizures

Important Safety Information

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.

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.

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.

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.

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. 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.

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; anxiety

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.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.