Quick answers
- What is Perampanel used for?
- The FDA-approved label (Fycompa, Catalyst Pharmaceuticals, Inc., January 5, 2024) says: “FYCOMPA, a non-competitive AMPA glutamate receptor antagonist, is indicated for: Treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy 4 years of age and older Adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients with epilepsy 12 years of age and older 1.1 Partial-Onset Seizures FYCOMPA is indicated for the treatment of …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Perampanel have a boxed warning?
- Yes. The FDA label for Fycompa has a boxed warning (“WARNING: SERIOUS PSYCHIATRIC AND BEHAVIORAL REACTIONS”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Perampanel?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Perampanel been recalled?
- FDA enforcement reports list 1 recall of products of this medicine; the newest started June 17, 2026 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Perampanel?
- 6 companies list prescription products of Perampanel in the FDA NDC Directory, including Sun Pharmaceutical Industries, Inc., Eisai Inc. and Catalyst Pharmaceuticals, Inc..
What Perampanel is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
FYCOMPA, a non-competitive AMPA glutamate receptor antagonist, is indicated for: Treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy 4 years of age and older Adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients with epilepsy 12 years of age and older 1.1 Partial-Onset Seizures FYCOMPA is indicated for the treatment of …
— FDA label: Fycompa, Catalyst Pharmaceuticals, Inc., effective January 5, 2024. Read the full label on DailyMed →
The FDA has 7 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Its heading: WARNING: SERIOUS PSYCHIATRIC AND BEHAVIORAL REACTIONS
. Read it on the full label →
7 of 7 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet, film coated · Tablet · Suspension |
|---|---|
| Route | Oral |
| Prescription products | 40 in the FDA NDC Directory |
| Brand names | Fycompa |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| perampanel 0.5 mg/mL suspension | Generic | $3.88 per mL |
| perampanel 0.5 mg/mL suspension | Brand: Fycompa | $4.45 per mL |
| perampanel 10 mg tablet | Brand: Fycompa | $39.10 per tablet |
| perampanel 10 mg tablet, film coated | Generic | $14.40 per tablet |
| perampanel 12 mg tablet | Brand: Fycompa | $39.08 per tablet |
| perampanel 12 mg tablet, film coated | Generic | $14.03 per tablet |
| perampanel 2 mg tablet | Brand: Fycompa | $19.72 per tablet |
| perampanel 2 mg tablet, film coated | Generic | $6.56 per tablet |
| perampanel 4 mg tablet | Brand: Fycompa | $39.11 per tablet |
| perampanel 4 mg tablet, film coated | Generic | $15.08 per tablet |
| perampanel 6 mg tablet | Brand: Fycompa | $39.15 per tablet |
| perampanel 6 mg tablet, film coated | Generic | $18.60 per tablet |
| perampanel 8 mg tablet | Brand: Fycompa | $39.07 per tablet |
| perampanel 8 mg tablet, film coated | Generic | $17.68 per tablet |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Sun Pharmaceutical Industries, Inc.7 products
- Eisai Inc.7 products
- Catalyst Pharmaceuticals, Inc.7 products
- Novadoz Pharmaceuticals LLC7 products
- Aurobindo Pharma Limited6 products
- Teva Pharmaceuticals, Inc.6 products
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA202834 FYCOMPA | Catalyst Pharms | October 22, 2012 | 16, latest December 5, 2023 2023: Labeling · 2023: Labeling · 2019: Labeling |
| NDA208277 FYCOMPA | Catalyst Pharms | April 29, 2016 | 5, latest May 23, 2023 2023: Manufacturing (CMC) · 2021: Manufacturing (CMC) · 2019: Labeling |
Generic approvals (6)
- ANDA209801Teva Pharms USA Inc · May 23, 2025
- ANDA218152Msn · July 11, 2025
- ANDA209538Taro · November 25, 2025
- ANDA218178Msn · November 25, 2025
- ANDA219052Taro · June 15, 2026
- ANDA220492Aurobindo Pharma Ltd · October 2, 2026
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
June 17, 2026 · Class II · Ongoing · D-0628-2026
Labeling: Label Mix-up: 10mg Perampanel CIII tablet was found in a Perampanel CIII bottle labeled Perampanel 6 mg tablets.
Perampanel CIII Tablets, 6mg, Rx only, 30 Tablets, Mfd.by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761, Dist. by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 51672-4206-6 — SUN PHARMACEUTICAL INDUSTRIES INC
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Fycompa, Catalyst Pharmaceuticals, Inc., effective January 5, 2024; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →