Fycompa Side Effects

Generic name: perampanel

Medically reviewed by Philip Thornton, DipPharm. Last updated on May 12, 2024.

Note: This document provides detailed information about Fycompa Side Effects associated with perampanel. Some dosage forms listed on this page may not apply specifically to the brand name Fycompa.

Applies to perampanel: oral suspension, oral tablet.

Precautions

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it.

This medicine may cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. Also tell your doctor if you or your child have sudden or strong feelings, such as feeling nervous, angry, restless, violent, or scared. If you, your child, or your caregiver notice any of these side effects, tell your doctor right away.

This medicine may cause some people to become dizzy, drowsy, clumsy, faint, unsteady, or less alert than they are normally. It may also cause trouble with controlling body movements, which may lead to falls, fractures, or other injuries. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

Check with your doctor right away if you have a fever, chills, cough, sore throat, swollen, painful, or tender lymph glands in the neck, armpit, or groin, or yellow skin or eyes while using this medicine. These could be symptoms of a serious condition, called drug reaction with eosinophilia and systemic symptoms (DRESS).

This medicine may be habit-forming. If you feel that the medicine is not working as well, do not use more than your prescribed dose. Call your doctor for instructions.

Do not Stop taking perampanel (the active ingredient contained in Fycompa) without checking first with your doctor. Stopping the medicine suddenly may cause your seizures to return or to occur more often. Your doctor may want you to gradually reduce the amount you are taking before stopping it completely.

Birth control pills containing levonorgestrel may not work as well while you are using this medicine. Use another form of birth control together with your pills during treatment and for at least 1 month after the last dose to avoid getting pregnant. Talk to your doctor if you have questions.

This medicine will add to the effects of alcohol and other CNS depressants (medicines that make you drowsy or less alert). Some examples of CNS depressants are antihistamines, medicines for hay fever, allergies or colds, sedatives, tranquilizers, or sleeping medicines, prescription pain medicines or narcotics, and other medicines for seizures. Check with your doctor before taking any of these medicines together with perampanel.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John's wort) or vitamin supplements.

Serious side effects of Fycompa

Along with its needed effects, perampanel may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking perampanel:

Other side effects of Fycompa

Some side effects of perampanel may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

For healthcare professionals

Applies to perampanel: oral suspension, oral tablet.

General adverse events

The more commonly reported adverse events have included dizziness, somnolence, fatigue, irritability, falls, nausea, weight gain, vertigo, and ataxia; in clinical trials, the highest dose (12 mg) resulted in greater reductions in seizure rates but with a substantial increase in adverse reactions.^[Ref]

Nervous system

• Very common (10% or more): Dizziness/vertigo (47%), somnolence (18%), gait disturbance (13%), headache (13%), irritability (12%)
• Common (1% to 10%): Ataxia, dysarthria, gait disturbance, balance disorder, hypoesthesia, abnormal coordination, memory impairment, paresthesia^[Ref]

Dizziness, somnolence, fatigue, and gait disturbance events appear to be dose-related and occurred mostly during the titration phase.^[Ref]

Psychiatric

• Very common (10% or more): Hostility- and aggression-related reactions (20%), irritability (11%)
• Common (1% to 10%): Anxiety, anger, hypersomnia, euphoric mood, disorientation/confusional state, altered mood
• Uncommon (0.1% to 1%): Homicidal ideation and/or threat, suicidal ideation, suicide attempt
• Frequency not reported: Belligerence, affect lability, agitation, physical assault, paranoia, changed mental status, delusions
• Postmarketing reports: Acute psychosis, hallucinations, delirium, delusions, paranoia, confusional state, disorientation, memory impairment^[Ref]

Psychiatric and behavioral reactions appear to be dose-related, and typically appear early on in treatment (within the first 6 weeks, although have been reported 37 weeks out). Compared to placebo, patients treated with this drug experienced more hostility and aggression related events that were serious, severe, and led to dose reduction, interruption, and discontinuation. Homicidal ideation and/or threat were reported in 0.1% of the 4368 patients in controlled and open label trials (included some non-epilepsy trials). Patients with active psychotic disorders and unstable recurrent affective disorders were excluded from clinical trials.

Healthy volunteers taking this drug experienced paranoia, euphoric mood, agitation, anger, mental status changes, and disorientation/confusional state.^[Ref]

Other

• Very common (10% or more): Fatigue/asthenia/lethargy (15%), falls (10%), limb injury
• Common (1% to 10%): Head injury, peripheral edema^[Ref]

Dermatologic

• Common (1% to 10%): Contusion, skin laceration, rash
• Postmarketing reports: Drug reaction with eosinophilia and systemic symptoms (DRESS)^[Ref]

Gastrointestinal

• Common (1% to 10%): Nausea, vomiting, constipation, abdominal pain^[Ref]

Metabolic

• Common (1% to 10%): Weight gain, hyponatremia, decreased appetite, increased appetite
• Frequency not reported: Increased triglycerides^[Ref]

In adult trials, weight gain of at least 7% and 15% of baseline body weight occurred in 9.1% and 0.9% of treated patients compared to 4.5% and 0.2% of placebo-treated patients, respectively. Similar increases were observed in adolescents.^[Ref]

Musculoskeletal

• Common (1% to 10%): Back pain, myalgia, pain in extremity, arthralgia, musculoskeletal pain, ligament sprain
• Frequency not reported: Bone fractures^[Ref]

Ocular

• Common (1% to 10%): Blurred vision, diplopia^[Ref]

Respiratory

• Common (1% to 10%): Cough, upper respiratory tract infection, oropharyngeal pain^[Ref]

See also:

Frequently asked questions

• Is Fycompa a controlled substance?
• Does Fycompa cause weight gain?
• Can Fycompa cause hair loss?

Further information

Fycompa side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer