Keppra XRlevetiracetam
According to the FDA label: Levetiracetam is indicated for the treatment of partial-onset seizures in patients 1 month of age and older (1.1) Levetiracetam is indicated for adjunctive therapy for the treatment of: Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy (1.2) Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy (1.3) 1.1 Partial-Onset Seizures Levetiracetam tablets are indicated for the treatment of…
130,397 adverse event reports submitted to the FDA (2002–2026)
Top Reported Adverse Events
The most frequently reported events in association with Keppra XR in the FAERS database. These are events reported by patients taking this medication, not necessarily caused by it. A single report may include multiple events.
Show these terms with plain-language definitions
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Seizure 15,686 reports
A sudden burst of electrical activity in the brain that can cause shaking, altered awareness, or other temporary changes.
Full definition in the glossary →Drug Ineffective 12,078 reports
A report that the medication did not work as expected for the person taking it. This is a reporting category, not a sign the drug is defective. It simply means someone felt it was not helping their condition.
Full definition in the glossary →Off Label Use 9,236 reports
Using a medication for a condition or in a way that the FDA has not officially approved. This is common and often legal, and a report of it does not mean something went wrong. Doctors sometimes prescribe drugs off label based on their judgment.
Full definition in the glossary →Fatigue 5,501 reports
Extreme tiredness or lack of energy that does not improve with rest.
Full definition in the glossary → See all drugs reporting this event →Convulsion 4,078 reports
Uncontrolled shaking of the body caused by sudden muscle contractions, often associated with a seizure.
Full definition in the glossary →Somnolence 4,066 reports
Drowsiness or strong sleepiness.
Full definition in the glossary → See all drugs reporting this event →Epilepsy 4,047 reports
A condition of the brain that causes repeated seizures. It often appears in reports as a condition being treated.
Full definition in the glossary →Fall 3,710 reports
A report that the person fell down. Falls are tracked because they can signal issues like dizziness, weakness, or balance problems.
Full definition in the glossary →Headache 3,674 reports
Pain in the head or upper neck.
Full definition in the glossary → See all drugs reporting this event →Maternal Exposure During Pregnancy 3,614 reports
A report noting that a pregnant person was exposed to a medication. This is a tracking category for monitoring use during pregnancy, not a description of harm by itself.
Full definition in the glossary →Nausea 3,536 reports
The feeling of sickness in your stomach that often comes before vomiting.
Full definition in the glossary → See all drugs reporting this event →Dizziness 3,535 reports
A feeling of being lightheaded, unsteady, or like the room is spinning.
Full definition in the glossary → See all drugs reporting this event →Drug Interaction 3,403 reports
A report that two or more medications may have affected each other when taken together.
Full definition in the glossary →Diarrhoea 3,176 reports
Loose or watery bowel movements, often frequent. Also spelled diarrhea in American English.
Full definition in the glossary → See all drugs reporting this event →Death 3,172 reports
A report that the person died. A death appearing in reports for a drug does not mean the drug caused it. Reports record that a death occurred while the medication was being used, which can happen for many unrelated reasons.
Full definition in the glossary →
Ranked by frequency of reports, not severity. The most-reported event is not necessarily the most dangerous or the most common in patients taking this drug.
Who Is Reporting
Demographics of patients in FAERS reports that included this information. Not all reports include patient demographics.
By Sex
View reporter sex data as a table
| Sex | Reports |
|---|---|
| Female | 61,359 |
| Male | 50,644 |
| Unknown | 375 |
By Age Group
View age group data as a table
| Age group | Reports |
|---|---|
| 0-17 | 16,137 |
| 18-34 | 15,947 |
| 35-49 | 13,728 |
| 50-64 | 17,679 |
| 65-74 | 10,991 |
| 75+ | 9,640 |
This shows who filed reports, reflecting who takes this drug and who tends to report, not who is at greatest risk.
Reported Outcomes
Outcomes recorded in FAERS reports that included Keppra XR. A single report may involve multiple reactions, each with a different outcome. These categories are defined by FDA reporting guidelines, not by PillSignal.
View outcome data as a table
| Outcome | Reports |
|---|---|
| Other Serious | 72,938 |
| Hospitalization | 48,229 |
| Non-Serious | 22,330 |
| Death | 11,779 |
| Life-Threatening | 7,925 |
| Disability | 2,769 |
Serious outcomes are far more likely to be reported than mild ones, so this overstates how often outcomes are serious. A recorded death does not mean the drug caused it.
Report Volume Over Time
Number of FAERS reports received per quarter for Keppra XR. Changes in volume may reflect shifts in prescribing rates, media attention, or reporting behavior, not changes in the medication's safety profile.
View report trend as a table
| Year | Reports |
|---|---|
| 2002 | 4 |
| 2004 | 515 |
| 2005 | 758 |
| 2006 | 908 |
| 2007 | 1,181 |
| 2008 | 1,358 |
| 2009 | 2,211 |
| 2010 | 2,463 |
| 2011 | 3,069 |
| 2012 | 4,027 |
| 2013 | 4,131 |
| 2014 | 4,698 |
| 2015 | 6,500 |
| 2016 | 8,419 |
| 2017 | 7,673 |
| 2018 | 10,371 |
| 2019 | 12,024 |
| 2020 | 9,948 |
| 2021 | 10,131 |
| 2022 | 8,971 |
| 2023 | 9,604 |
| 2024 | 9,957 |
| 2025 | 8,872 |
| 2026 (partial) | 2,604 |
The steep increase around 2004 reflects the FDA's move to electronic submission, not a change in this drug's safety. Trends track reporting volume, not risk.
Medications commonly reported with Keppra XR
In FDA adverse event reports that mention Keppra XR, these medications appeared most often in the same report.
- Lacosamide (15,164 reports)
- Lamotrigine (15,114 reports)
- Lamotirigine (10,350 reports)
- Lamotrigine Dispersible (10,350 reports)
- Topiramate (9,807 reports)
This reflects co-occurrence in submitted reports, not evidence of drug interaction or combined risk. People often report several medications taken for the same condition or for unrelated reasons. Talk to a doctor or pharmacist about your specific medications.
Related Drugs
Other medications with similar adverse event profiles in FDA FAERS reports.
Data Source
This data is sourced from the FDA's Adverse Event Monitoring System (AEMS), formerly FAERS, via the OpenFDA API. PillSignal is not affiliated with the FDA.
View this data on the FDA website →Data last updated: June 2026