Reported Reactions

Drugs › Noncompetitive AMPA glutamate receptor antagonist

Generic name

Perampanel: adverse event reports filed with FDA

1,908 reports list it as a suspect or interacting product, 2013–2026. Class: Noncompetitive AMPA glutamate receptor antagonist.

1,908
reports as suspect product
0% of all reports · about 142 a year
253
reports, 12 months to June 2026
271 in the 12 months before
93.1%
marked serious by the reporter
84.5% across the class
4.6%
record death among outcomes, as reported
88 reports · not verified by FDA

1,908 adverse event reports received by FDA list perampanel, a generic name as a suspect or interacting product, from February 2013 to June 2026. A further 1,072 reports list it only as a concomitant medication, and those are not counted in the figures on this page.

In the 12 months to June 2026, 253 reports listed it, close to the 271 of the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Over its reporting history that is about 142 reports a year and 0% of the 20,646,523 reports in the database, and 38.4% of the reports for the noncompetitive AMPA glutamate receptor antagonist class. How many people take it is not in the data, so a count is not a rate of occurrence.

The reactions recorded most often are drug ineffective (33.6%), off label use (15.3%) and multiple-drug resistance (12.8%). A report can list several reactions, so shares add to more than 100%; 375 different terms appear across these reports. Drug ineffective is recorded in 33.6% of these reports, a larger share than in the median noncompetitive AMPA glutamate receptor antagonist drug (19.4%).

93.1% of the reports are marked serious by the reporter (84.5% across the class); 4.6% record death among the outcomes and 42% record hospitalisation, as reported. 54.7% of the reports came from other health professionals, and the largest patient age group is 18 to 44 (36%). FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."

Reports by month, five years

02958Jul 2021: 15Aug 2021: 26Sep 2021: 15Oct 2021: 20Nov 2021: 7Dec 2021: 342022Jan 2022: 17Feb 2022: 13Mar 2022: 16Apr 2022: 19May 2022: 24Jun 2022: 11Jul 2022: 10Aug 2022: 22Sep 2022: 32Oct 2022: 16Nov 2022: 29Dec 2022: 262023Jan 2023: 28Feb 2023: 14Mar 2023: 14Apr 2023: 14May 2023: 27Jun 2023: 26Jul 2023: 23Aug 2023: 26Sep 2023: 21Oct 2023: 24Nov 2023: 58Dec 2023: 282024Jan 2024: 29Feb 2024: 18Mar 2024: 27Apr 2024: 33May 2024: 21Jun 2024: 22Jul 2024: 31Aug 2024: 28Sep 2024: 17Oct 2024: 22Nov 2024: 37Dec 2024: 272025Jan 2025: 17Feb 2025: 19Mar 2025: 16Apr 2025: 15May 2025: 22Jun 2025: 20Jul 2025: 25Aug 2025: 15Sep 2025: 24Oct 2025: 24Nov 2025: 19Dec 2025: 152026Jan 2026: 11Feb 2026: 17Mar 2026: 27Apr 2026: 21May 2026: 17Jun 2026: 38

Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

By year received

01563122013: 420132014: 222015: 3420152016: 232017: 3220172018: 922019: 12620192020: 1682021: 19520212022: 2352023: 30320232024: 3122025: 23120252026: 131

2026 covers reports received through June 2026 only.

Reactions recorded in the reports

share of Perampanel reports recording the termmedian drug in noncompetitive ampa glutamate receptor antagonist

  1. Drug ineffectivethe medicine did not work as expected33.6%641
  2. Off label useused for a purpose or in a way not on the label15.3%291
  3. Multiple-drug resistance12.8%245
  4. Seizurea fit or convulsion11.7%223
  5. Drug interactionan interaction between medicines8.4%160
  6. Aggressionaggressive behaviour6.2%118
  7. Condition aggravatedthe condition being treated got worse5.9%112
  8. Epilepsy5.3%102
  9. Somnolencedrowsiness5.2%99
  10. Treatment failurethe treatment did not work3.9%74
  11. Fatiguetiredness3.8%72
  12. Dizzinesslight-headedness or unsteadiness3.7%70
  13. Product use in unapproved indicationused for a purpose not on the label3.7%70
  14. Toxicity to various agentspoisoning or toxic effect of one or more substances3.7%70
  15. Cognitive disorderproblems with thinking or memory3.5%66
  16. Irritabilityirritability3%57
  17. Gait disturbancedifficulty walking2.7%52
  18. Maternal exposure during pregnancythe mother took the medicine during pregnancy2.6%50
  19. Intentional overdosea deliberate overdose2.4%45
  20. Suicide attempta suicide attempt2.3%44
  21. Suicidal ideationthoughts of suicide2.3%43
  22. Foetal exposure during pregnancythe unborn baby was exposed to the medicine2.1%40
  23. Hallucinationseeing or hearing things that are not there2.1%40
  24. Nauseafeeling sick1.9%36

Top 30 of 375 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 2 drugs in the noncompetitive ampa glutamate receptor antagonist class; it describes the reports, not the patients. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Outcomes recorded

Death4.6%88
Life-threatening11%209
Hospitalisation (initial or prolonged)42%802
Disability1.7%32
Congenital anomaly1.7%32
Other serious69.8%1,331
Not serious6.9%132

Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 4,967 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."

Patients and reporters

Patient age

Under 23.1%60
2 to 1111.4%218
12 to 178.7%166
18 to 4436%687
45 to 6411.3%215
65 to 744.2%81
75 and over1.9%37
Age not given23.3%444

Patient sex

Female50.6%965
Male35.2%672
Not given14.2%271

Who reported

Physician40.7%776
Pharmacist1.3%24
Other health professional54.7%1,044
Lawyer0%0
Consumer or non-health professional2.9%55
Not given0.5%9

Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 19.7% of reports give the United States as the country of the event or reporter.

Reason for use recorded

Indication as recorded (MedDRA)ReportsShare
Epilepsy39720.8%
Status epilepticus29215.3%
Seizure26213.7%
Partial seizures1749.1%
New onset refractory status epilepticus703.7%
Generalised tonic-clonic seizure573%

The indication field is filled in by the reporter and is often blank; shares are of all 1,908 reports.

Drugs most often listed in the same reports

Drug (any role in the report)ReportsShare of Perampanel reports
Levetiracetam1,28067.1%
Lacosamide94249.4%
Clobazam64333.7%
Valproic acid59030.9%
Topiramate56729.7%
Lamotrigine54928.8%
Phenobarbital51727.1%
Phenytoin43522.8%
Midazolam40321.1%
Zonisamide40221.1%

Other products listed in reports where Perampanel is a suspect product, whatever their own role. Co-listing means the two were recorded together; it says nothing about either product's part in the event. Only the 2,500 most-reported names are counted here.

In context

MeasurePerampanelNoncompetitive AMPA glutamate receptor antagonistAll reports
Reports as suspect product1,9084,96720,646,523
Share of that pool—38.4%0%
Reports, latest 12 months253—1,332,454
Marked serious93.1%84.5%57.4%
Death recorded among outcomes, per 1,000 reports465491
Hospitalisation recorded, per 1,000 reports420396213
Consumer-filed share2.9%13.1%45.8%
Top term, share of reportsDrug ineffective 33.6%median 19.4%6.3%

Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Other drugs in the noncompetitive ampa glutamate receptor antagonist class

DrugName typeReportsLatest 12 monthsMarked serious
Fycompabrand3,05922579.1%

Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." A brand and its generic are separate rows because reporters name them separately.

Questions about Perampanel reports

How many adverse event reports has FDA received for Perampanel?

1,908 reports list Perampanel as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 253 of them arrived in the latest 12 months. Another 1,072 list it only as a concomitant medication.

What reactions are recorded in Perampanel reports?

drug ineffective (33.6%), off label use (15.3%), multiple-drug resistance (12.8%), seizure (11.7%) and status epilepticus (8.6%). These are MedDRA preferred terms coded from what the reporter described; a report can list several, and a term's presence is not a finding that Perampanel was responsible.

How serious are the reports?

93.1% are marked serious by the reporter. Among the outcomes recorded, 4.6% of reports include death and 42% include hospitalisation. FDA has not verified these outcomes and states that the reports "cannot be used to estimate the incidence" of the events.

Who files these reports?

other health professional (54.7%), physician (40.7%) and consumer or non-health professional (2.9%). Most reports reach FDA through the manufacturer, which must forward reports it receives.

Are reports for Perampanel rising?

253 reports in the 12 months to June 2026, close to the 271 of the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Counts also move with how many people take a product, its time on the market and publicity.

Do these reports show that Perampanel was responsible for these reactions?

No. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event." The reaction may relate to the condition being treated, to other medicines, or to something else.

Is this a list of the side effects of Perampanel?

No. It is a count of what was reported to FDA. The adverse reactions observed in clinical studies are printed on the FDA-approved label, which a pharmacist or clinician can go through with you.

How do I report an adverse event?

Consumers and health professionals can report to FDA through MedWatch (Form FDA 3500 online, or 1-800-FDA-1088), or to the manufacturer, which must pass reports on. See the guide on how to report.

Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A report counts here when it lists Perampanel as a suspect or interacting product; reports listing it only as a concomitant medication (1,072) are excluded. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.