Fycompa Side Effects Center

Last updated on RxList: 5/18/2022
Fycompa Side Effects Center

What Is Fycompa?

Fycompa (perampanel) is a non-competitive AMPA receptor antagonist, which belongs to a new class of drugs to treat drug-resistant partial-onset seizures in patients with epilepsy ages 12 years and older.

What Are Side Effects of Fycompa?

Side effects of Fycompa include:

  • dizziness,
  • sleepiness,
  • drowsiness,
  • tiredness,
  • fatigue,
  • headache,
  • irritability,
  • nausea,
  • weight gain,
  • joint pain,
  • back pain, and
  • problems maintaining balance.

Contact your doctor if you experience serious psychiatric and behavioral side effects of Fycompa including:

  • changes in mood, behavior, or personality,
  • aggression,
  • hostility,
  • irritability,
  • anger,
  • anxiety,
  • unusual thoughts,
  • paranoid behavior,
  • panic attacks,
  • thoughts about hurting someone else, and
  • suicidal or homicidal ideation and threats.

Tell your doctor if you have serious side effects of Fycompa including trouble sleeping, talking more than usual, trouble walking, loss of balance or coordination, an accidental fall, severe dizziness, spinning sensation (vertigo), or feeling like you might pass out.

Dosage for Fycompa

Starting dose of Fycompa is 2 mg taken once daily at bedtime. Patients taking anti-eleptic drugs (AEDs) should start on 4 mg of Fycompa. Dosage may be increased based on how well patients tolerate Fycompa. The maximum recommended dose is 12 mg taken once daily. Fycompa is not recommended for patients with decreased liver or kidney function, or patients on dialysis.

What Drugs, Substances, or Supplements Interact with Fycompa?

Fycompa may interact with other drugs that make you sleepy or slow your breathing (sleeping pills, narcotic pain medicines, muscle relaxers, or medicines for anxiety, depression, or seizures), bosentan, nafcillin, pentobarbital, St. John's wort, rifabutin, rifapentine, rifampin, and HIV medications. Tell your doctor all medications and supplements you use.

Fycompa During Pregnancy and Breastfeeding

Fycompa is not recommended for use during pregnancy. It may cause fetal harm. It is not known if Fycompa passes into breast milk. Nursing mothers and their doctors should decide if the patient will take Fycompa or breastfeed. Patients should not do both. If a patient withdraws from Fycompa, there may be an increase in the frequency of seizures.

Additional Information

Our Fycompa (perampanel) 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.


If you have had a seizure, it means you have epilepsy. See Answer
Fycompa Consumer Information

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

Seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include: skin rash, fever, swollen glands, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes.

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, fear, panic attacks, trouble sleeping, or if you feel irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), or have thoughts about suicide or hurting yourself or someone else.

Call your doctor at once if you have:

  • severe dizziness, spinning sensation, feeling like you might pass out;
  • trouble walking, loss of balance or coordination;
  • feeling very weak or tired;
  • an accidental fall; or
  • memory problems, confusion, hallucinations.

Accidental falls may occur more often in elderly patients who take perampanel. Use caution to avoid falling or accidental injury while taking this medicine.

Common side effects may include:

  • headache, dizziness, drowsiness;
  • feeling anxious, tired, or irritable;
  • nausea, vomiting, stomach pain;
  • bruising;
  • weight gain; or
  • loss of 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.


What Is Epilepsy? Symptoms, Causes, and Treatments See Slideshow
Fycompa Professional Information


The following serious adverse reactions are described below and elsewhere in the labeling:

  • Serious Psychiatric and Behavioral Reactions [see WARNINGS AND PRECAUTIONS]
  • Suicidal Behavior and Ideation [see WARNINGS AND PRECAUTIONS]
  • Neurologic Effects [see WARNINGS AND PRECAUTIONS]
  • Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan Hypersensitivity [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

Partial-Onset Seizures

Adult And Adolescent Patients (12 years of age and older)

A total of 1,038 patients receiving FYCOMPA (2, 4, 8, or 12 mg once daily) constituted the safety population in the pooled analysis of the placebo-controlled trials (Studies 1, 2, and 3) in patients with partial-onset seizures. Approximately 51% of patients were female, and the mean age was 35 years.

Adverse Reactions Leading To Discontinuation

In controlled clinical trials (Studies 1, 2, and 3), the rate of discontinuation as a result of an adverse reaction was 3%, 8%, and 19% in patients randomized to receive FYCOMPA at the recommended doses of 4 mg, 8 mg, and 12 mg per day, respectively, and 5% in patients randomized to receive placebo [see Clinical Studies]. The adverse reactions most commonly leading to discontinuation (≥1% in the 8 mg or 12 mg FYCOMPA group and greater than placebo) were dizziness, somnolence, vertigo, aggression, anger, ataxia, blurred vision, irritability, and dysarthria [see WARNINGS AND PRECAUTIONS].

Most Common Adverse Reactions

Table 2 gives the incidence in the controlled clinical trials (Studies 1, 2, and 3) of the adverse reactions that occurred in ≥2% of patients with partial-onset seizures in the FYCOMPA 12 mg dose group and more frequent than placebo (in order of decreasing frequency for the 12 mg dose group).

The most common dose-related adverse reactions in patients receiving FYCOMPA at doses of 8 mg or 12 mg (≥4% and occurring at least 1% higher than the placebo group) included dizziness (36%), somnolence (16%), fatigue (10%), irritability (9%), falls (7%), nausea (7%), ataxia (5%), balance disorder (4%), gait disturbance (4%), vertigo (4%), and weight gain (4%). For almost every adverse reaction, rates were higher on 12 mg and more often led to dose reduction or discontinuation.

Table 2: Adverse Reactions in Pooled Placebo-Controlled Trials in Adult and Adolescent Patients with Partial-Onset Seizures (Studies 1, 2, and 3) (Reactions ≥ 2% of Patients in Highest FYCOMPA Dose (12 mg) Group and More Frequent than Placebo)

n=442 %
4 mg
n=172 %
8 mg
n=431 %
12 mg
n=255 %
Dizziness 9 16 32 43
Somnolence 7 9 16 18
Headache 11 11 11 13
Irritability 3 4 7 12
Fatigue 5 8 8 12
Falls 3 2 5 10
Ataxia 0 1 3 8
Nausea 5 3 6 8
Vertigo 1 4 3 5
Back pain 2 2 2 5
Dysarthria 0 1 3 4
Anxiety 1 2 3 4
Blurred vision 1 1 3 4
Gait disturbance 1 1 4 4
Weight gain 1 4 4 4
Cough 3 1 1 4
Upper respiratory tract infection 3 3 3 4
Vomiting 3 2 3 4
Hypersomnia 0 1 2 3
Anger <1 0 1 3
Aggression 1 1 2 3
Balance disorder 1 0 5 3
Diplopia 1 1 1 3
Head injury 1 1 1 3
Hypoaesthesia 1 0 0 3
Pain in extremity 1 0 2 3
Constipation 2 2 2 3
Myalgia 2 1 1 3
Coordination abnormal 0 1 <1 2
Euphoric mood 0 0 <1 2
Confusional state <1 1 1 2
Hyponatremia <1 0 0 2
Limb injury <1 1 1 2
Mood altered <1 1 <1 2
Arthralgia 1 0 3 2
Asthenia 1 1 2 2
Contusion 1 0 2 2
Memory impairment 1 0 1 2
Musculoskeletal pain 1 1 1 2
Oropharyngeal pain 1 2 2 2
Paraesthesia 1 0 1 2
Peripheral edema 1 1 1 2
Skin laceration 1 0 2 2

Pediatric Patients (4 to <12 years of age)

In two studies in pediatric patients 4 to <12 years of age with epilepsy, a total of 225 patients received FYCOMPA, with 110 patients exposed for at least 6 months, and 21 patients for at least 1 year. Adverse reactions in pediatric patients 4 to <12 years of age were similar to those seen in patients 12 years of age and older.

Primary Generalized Tonic-Clonic Seizures

A total of 81 patients receiving FYCOMPA 8 mg once daily constituted the safety population in the placebo-controlled trial in patients with primary generalized tonic-clonic seizures (Study 4). Approximately 57% of patients were female, and the mean age was 27 years.

In the controlled primary generalized tonic-clonic seizure clinical trial (Study 4), the adverse reaction profile was similar to that noted for the controlled partial-onset seizure clinical trials (Studies 1, 2, and 3).

Table 3 gives the incidence of adverse reactions in patients receiving FYCOMPA 8 mg (≥4% and higher than in the placebo group) in Study 4. The most common adverse reactions in patients receiving FYCOMPA (≥10% and greater than placebo) were dizziness (32%), fatigue (15%), headache (12%), somnolence (11%), and irritability (11%).

The adverse reactions most commonly leading to discontinuation in patients receiving FYCOMPA 8 mg (≥2% and greater than placebo) were vomiting (2%) and dizziness (2%).

Table 3: Adverse Reactions in a Placebo-Controlled Trial in Patients with Primary Generalized Tonic-Clonic Seizures (Study 4) (Reactions ≥ 4% of Patients in FYCOMPA Group and More Frequent than Placebo)

n=82 %
n=81 %
Dizziness 6 32
Fatigue 6 15
Headache 10 12
Somnolence 4 11
Irritability 2 11
Vertigo 2 9
Vomiting 2 9
Weight gain 4 7
Contusion 4 6
Nausea 5 6
Abdominal pain 1 5
Anxiety 4 5
Urinary tract infection 1 4
Ligament sprain 0 4
Balance disorder 1 4
Rash 1 4

Weight Gain

Weight gain has occurred with FYCOMPA.

In controlled partial-onset seizure clinical trials, FYCOMPA-treated adults gained an average of 1.1 kg (2.5 lbs) compared to an average of 0.3 kg (0.7 lbs) in placebo-treated adults with a median exposure of 19 weeks. The percentages of adults who gained at least 7% and 15% of their baseline body weight in FYCOMPA-treated patients were 9.1% and 0.9%, respectively, as compared to 4.5% and 0.2% of placebo-treated patients, respectively. Clinical monitoring of weight is recommended.

Similar increases in weight were also observed in adult and adolescent patients treated with FYCOMPA in the primary generalized tonic-clonic seizure clinical trial.

Elevated Triglycerides

Increases in triglycerides have occurred with FYCOMPA use.

Comparison Of Sex And Race

No significant sex differences were noted in the incidence of adverse reactions.

Although there were few non-Caucasian patients, no differences in the incidence of adverse reactions compared to Caucasian patients were observed.

Postmarketing Experience

The following adverse reactions have been identified during post approval use of FYCOMPA. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.


Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) [see WARNINGS AND PRECAUTIONS]


Acute psychosis, hallucinations, delusions, paranoia, delirium, confusional state, disorientation, memory impairment [see WARNINGS AND PRECAUTIONS].



With concomitant use, FYCOMPA at a dose of 12 mg per day reduced levonorgestrel exposure by approximately 40% [see CLINICAL PHARMACOLOGY]. Use of FYCOMPA with contraceptives containing levonorgestrel may render them less effective. Additional non-hormonal forms of contraception are recommended [see Use In Specific Populations].

Moderate And Strong CYP3A4 Inducers

The concomitant use of known moderate and strong CYP3A4 inducers including carbamazepine, phenytoin, or oxcarbazepine with FYCOMPA decreased the plasma levels of perampanel by approximately 50-67% [see CLINICAL PHARMACOLOGY]. The starting doses for FYCOMPA should be increased in the presence of moderate or strong CYP3A4 inducers [see DOSAGE AND ADMINISTRATION].

When these moderate or strong CYP3A4 inducers are introduced or withdrawn from a patient's treatment regimen, the patient should be closely monitored for clinical response and tolerability. Dose adjustment of FYCOMPA may be necessary [see DOSAGE AND ADMINISTRATION].

Alcohol And Other CNS Depressants

The concomitant use of FYCOMPA and CNS depressants including alcohol may increase CNS depression. A pharmacodynamic interaction study in healthy subjects found that the effects of FYCOMPA on complex tasks such as driving ability were additive or supra-additive to the impairment effects of alcohol [see CLINICAL PHARMACOLOGY]. Multiple dosing of FYCOMPA 12 mg per day also enhanced the effects of alcohol to interfere with vigilance and alertness, and increased levels of anger, confusion, and depression. These effects may also be seen when FYCOMPA is used in combination with other CNS depressants. Care should be taken when administering FYCOMPA with these agents. Patients should limit activity until they have experience with concomitant use of CNS depressants (e.g., benzodiazepines, narcotics, barbiturates, sedating antihistamines). Advise patients not to drive or operate machinery until they have gained sufficient experience on FYCOMPA to gauge whether it adversely affects these activities.

Drug Abuse And Dependence

Controlled Substance

FYCOMPA contains perampanel and is listed as a Schedule III controlled substance.


Prescription drug abuse is the intentional non-therapeutic use of a drug, even once, for its rewarding psychological or physiological effects. Drug addiction, which develops after repeated drug abuse, is characterized by a strong desire to take a drug despite harmful consequences, difficulty in controlling its use, giving a higher priority to drug use than to obligations, increased tolerance, and sometimes physical withdrawal. Drug abuse and drug addiction are separate and distinct from physical dependence (for example, abuse may not be accompanied by physical dependence) [see Drug Abuse And Dependence].

Studies of human abuse potential were performed to evaluate the abuse potential of FYCOMPA (8 mg, 24 mg, and 36 mg) as compared to alprazolam C-IV (1.5 mg and 3 mg), and oral ketamine C-III (100 mg) in recreational polydrug users. Supra-therapeutic doses of FYCOMPA 24 and 36 mg produced responses for “Euphoria” that were similar to ketamine 100 mg and alprazolam 3 mg. For “High,” FYCOMPA 24 mg and 36 mg produced responses comparable to ketamine 100 mg and significantly higher than both doses of alprazolam on a visual analog scale (VAS). “Drug Liking,” “Overall Drug Liking,” and “Take Drug Again” for FYCOMPA were each statistically lower than ketamine 100 mg. In addition, for “Bad Drug Effects,” FYCOMPA 24 mg and 36 mg produced responses significantly higher than ketamine 100 mg. For “Sedation,” FYCOMPA 24 and 36 mg produced responses similar to alprazolam 3 mg and higher than ketamine 100 mg.

Additionally, on VAS measures related to dissociative phenomena such as “Floating,” “Spaced Out,” and “Detached,” FYCOMPA at supratherapeutic doses produced responses similar to ketamine 100 mg and greater than both doses of alprazolam tested. Of note, due to somnolence a number of subjects had missing data around Tmax of FYCOMPA. The above described data might represent an underestimate of FYCOMPA’s effects. The duration of effects of higher doses of FYCOMPA on the majority of measures was much greater than alprazolam 3 mg and ketamine 100 mg.

In this study, the incidence of euphoria following FYCOMPA administration 8 mg, 24 mg, and 36 mg was 37%, 46%, 46%, respectively, which was higher than alprazolam 3 mg (13%) but lower than ketamine 100 mg (89%).


Physical dependence is characterized by withdrawal symptoms after abrupt discontinuation or a significant dose reduction of a drug.

A nonclinical dependence study in rats demonstrated withdrawal symptoms, including hyperreactivity to handling, muscle rigidity, and decreases in food consumption and body weights.

FYCOMPA may cause dependence and withdrawal symptoms that may include anxiety, nervousness, irritability, fatigue, lethargy, asthenia, mood swings, and insomnia.

Read the entire FDA prescribing information for Fycompa (Perampanel Tablets, for Oral Use)


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

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