What the label lists and what reports show
Perampanel side effects
Perampanel's FDA label: “Most common adverse reactions (≥ 5% and ≥ 1% higher than placebo) include dizziness, somnolence, fatigue, irritability, falls, nausea, weight gain, vertigo, ataxia, headache, vomiting, contusion, abdominal pain, and anxiety ( 6.1 ) To report SUSPECTED ADVERSE …” FAERS holds 7,532 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is somnolence (513 reports).
- Generic listed
- Boxed warning
- DEA Schedule III
Check it at the source: the perampanel FDA label on DailyMed (effective September 1, 2024, Teva Pharmaceuticals, Inc.); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of perampanel tablets?See “What is the most important information I should know about perampanel tablets?” Perampanel tablets may cause other serious side effects, including: Dizziness, vertigo (sense of spinning), and problems walking normally. You may have problems walking normally if you are unsteady because you feel dizzy. These symptoms can increase when the dose of perampanel tablets is increased. Your risk of feeling dizzy and having problems walking normally may be higher if you are elderly. Sleepiness and tiredness. See “ What should I avoid while taking perampanel tablets? ” Increased risk of falls. Taking perampanel tablets can increase your chance of falling. These falls can cause serious injuries. Your risk of falling may be higher if you are elderly. A serious allergic reaction that may affect your skin or other parts of your body such as your liver, kidneys, heart, or blood cells. […]
Source: FDA drug label, Teva Pharmaceuticals, Inc., effective September 1, 2024 (SPL set bc8f7cf2-c19c-4235-859f-9ff1dd21908e), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions (≥ 5% and ≥ 1% higher than placebo) include dizziness, somnolence, fatigue, irritability, falls, nausea, weight gain, vertigo, ataxia, headache, vomiting, contusion, abdominal pain, and anxiety ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Teva at 1-888-838-2872 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Table 3. Adverse Reactions in a Placebo-Controlled Trial in Patients with Primary Generalized Tonic-Clonic Seizures (Study 4) (Reactions ≥4% of Patients in Perampanel Group and More Frequent than Placebo)
| Reaction | Placebo n=82 % | Perampanel 8 mg 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 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following serious adverse reactions are described below and elsewhere in the labeling: Serious Psychiatric and Behavioral Reactions [see Warnings and Precautions ( 5.1 )] Suicidal Behavior and Ideation [see Warnings and Precautions ( 5.2 )] Neurologic Effects [see Warnings and Precautions ( 5.3 )] Falls [see Warnings and Precautions ( 5.4 )] Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan Hypersensitivity [see Warnings and Precautions ( 5.5 )] Most common adverse reactions (≥ 5% and ≥ 1% higher than placebo) include dizziness, somnolence, fatigue, irritability, falls, nausea, weight gain, vertigo, ataxia, headache, vomiting, contusion, abdominal pain, and anxiety ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Teva at 1-888-838-2872 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 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. …
Source: FDA drug label, Teva Pharmaceuticals, Inc., effective September 1, 2024 (SPL set bc8f7cf2-c19c-4235-859f-9ff1dd21908e), via openFDA; the full label on DailyMed
What do FAERS reports show?
7,532 reports list perampanel among the medicines taken, each a report of something that happened, not proof the medicine caused it; 466 are coded as a death and 2,899 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 17 reactions below, 9 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Perampanel: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions