Roweepralevetiracetam
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…
75,249 adverse event reports submitted to the FDA (2002–2026)
Top Reported Adverse Events
The most frequently reported events in association with Roweepra 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.
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Drug Ineffective 8,854 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 →Seizure 8,681 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 →Off Label Use 6,282 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 →Maternal Exposure During Pregnancy 3,015 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 →Epilepsy 2,712 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 →Foetal Exposure During Pregnancy 2,474 reports
A report noting that a developing baby was exposed to a medication during pregnancy. This is a tracking category for monitoring, not a description of harm by itself. Also spelled fetal in American English.
Full definition in the glossary →Drug Interaction 2,445 reports
A report that two or more medications may have affected each other when taken together.
Full definition in the glossary →Fatigue 2,405 reports
Extreme tiredness or lack of energy that does not improve with rest.
Full definition in the glossary → See all drugs reporting this event →Condition Aggravated 2,222 reports
A report that the person's existing health condition got worse. This describes a worsening of something the person already had, not necessarily a new problem caused by the drug.
Full definition in the glossary →Status Epilepticus 2,029 reports
A seizure that lasts a long time or repeated seizures without recovery in between. It is a medical emergency.
Full definition in the glossary →Somnolence 2,006 reports
Drowsiness or strong sleepiness.
Full definition in the glossary → See all drugs reporting this event →Generalised Tonic-Clonic Seizure 1,958 reports
A type of seizure involving loss of consciousness and full-body muscle stiffening and jerking, once called a grand mal seizure. Also spelled generalized in American English.
Full definition in the glossary →Fall 1,814 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 →Toxicity to Various Agents 1,787 reports
A broad reporting category used when the body has a harmful response, sometimes involving more than one substance.
Full definition in the glossary →Dizziness 1,720 reports
A feeling of being lightheaded, unsteady, or like the room is spinning.
Full definition in the glossary → See all drugs reporting this event →
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 | 34,328 |
| Male | 29,031 |
| Unknown | 212 |
By Age Group
View age group data as a table
| Age group | Reports |
|---|---|
| 0-17 | 10,943 |
| 18-34 | 10,232 |
| 35-49 | 7,781 |
| 50-64 | 9,797 |
| 65-74 | 6,559 |
| 75+ | 5,887 |
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 Roweepra. 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 | 47,954 |
| Hospitalization | 27,538 |
| Non-Serious | 8,624 |
| Death | 6,970 |
| Life-Threatening | 5,600 |
| Disability | 1,449 |
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 Roweepra. 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 | 3 |
| 2004 | 87 |
| 2005 | 118 |
| 2006 | 93 |
| 2007 | 161 |
| 2008 | 214 |
| 2009 | 665 |
| 2010 | 685 |
| 2011 | 993 |
| 2012 | 1,436 |
| 2013 | 1,616 |
| 2014 | 1,555 |
| 2015 | 2,386 |
| 2016 | 3,296 |
| 2017 | 4,570 |
| 2018 | 7,115 |
| 2019 | 7,969 |
| 2020 | 6,820 |
| 2021 | 6,804 |
| 2022 | 6,131 |
| 2023 | 6,860 |
| 2024 | 7,533 |
| 2025 | 6,475 |
| 2026 (partial) | 1,664 |
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 Roweepra
In FDA adverse event reports that mention Roweepra, these medications appeared most often in the same report.
- Lacosamide (9,660 reports)
- Lamotrigine (9,249 reports)
- Lamotirigine (8,404 reports)
- Lamotrigine Dispersible (8,404 reports)
- Clobazam (6,336 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