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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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Indication and Important Safety Information

Indication

FYCOMPA (perampanel) is a prescription medicine used with other medicines to treat partial-onset seizures with or without secondarily generalized seizures and primary generalized tonic-clonic seizures in people with epilepsy who are 12 years of age and older.

Important Safety Information

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), and other unusual or extreme changes in behavior or mood. Before taking FYCOMPA, patients should tell their healthcare provider if they have or had mental problems, aggression or hostile behavior.

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.

Antiepileptic drugs, including FYCOMPA, may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. 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.

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. 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.

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.

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.

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.

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, and St. John’s wort.

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.

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.

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.

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.