This grade answers one narrow question: how strong is the public evidence and safety record behind this drug, and how clean is its money trail and court record? It is not a verdict on whether the drug is right for you.
Warnings the FDA chose to announce publicly after approval, as opposed to quiet label edits. Class-wide items name the drug's class, not this drug specifically.
Listed on the WHO Model List of Essential Medicines: a global expert panel judged it among the medicines a health system should always have, on evidence of value, not marketing.
® is indicated for the treatment of partial-onset seizures in patients 12 years of age and older. KEPPRA XR is indicated for the treatment of partial-onset seizures in patients 12 years of age and older ( 1 )
is contraindicated in patients with a hypersensitivity to levetiracetam . Reactions have included anaphylaxis and angioedema [see Warnings and Precautions (5.4) ] . Known hypersensitivity to levetiracetam; angioedema and anaphylaxis have occurred ( 4 , 5.4 )
Behavioral abnormalities including psychotic symptoms, suicidal ideation, irritability, and aggressive behavior have been observed; monitor patients for psychiatric signs and symptoms ( 5.1 ) Suicidal Behavior and Ideation: Monitor patients for new or worsening depression, suicidal thoughts/behavior, and/or unusual changes in mood or behavior ( 5.2 ) Monitor for somnolence and fatigue and advise patients not to drive or operate machinery until they have gained sufficient experience on KEPPRA XR ( 5.3 ) Serious Dermatological Reactions: Discontinue KEPPRA at the first sign of rash unless clearly not drug related ( 5.5 ) Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan Hypersensitivity: Discontinue if no alternative etiology ( 5.6 ) Coordination Difficulties: Monitor for ataxia, abnormal gait, and incoordination. Advise patients to not drive or operate machinery until they have gained experience on KEPPRA ( 5.7 ) Withdrawal Seizures: KEPPRA XR must be gradually withdrawn ( 5.8 ) 5.1 Behavioral Abnormalities and Psychotic Symptoms KEPPRA XR may cause behavioral abnormalities and psychotic symptoms. Patients treated with KEPPRA XR should be monitored for psychia...
The following adverse reactions are discussed in more details in other sections of labeling: Behavioral abnormalities and Psychotic Symptoms [see Warnings and Precautions (5.1) ] Suicidal Behavior and Ideation [see Warnings and Precautions (5.2) ] Somnolence and Fatigue [see Warnings and Precautions (5.3) ] Anaphylaxis and Angioedema [see Warnings and Precautions (5.4) ] Serious Dermatological Reactions [see Warnings and Precautions (5.5) ] Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan Hypersensitivity [see Warnings and Precautions (5.6) ] Coordination Difficulties [see Warnings and Precautions (5.7) ] Hematologic Abnormalities [see Warnings and Precautions (5.9) ] Most common adverse reactions (incidence ≥5% more than placebo) include: somnolence and irritability ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact UCB, Inc. at (844) 599-CARE (2273) 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 ref...
Warnings and Precautions ( 5.6 ) 3/2024
Source: FDA SPL label for Keppra XR (UCB, Inc.), effective 20250624. Full label on DailyMed.
These are counts of reports people filed, not rates of harm. Anyone can file one, and nobody checks whether the drug was the cause. Millions of doses are taken for every report sent, so the useful part is how this drug compares with the average across all drugs.
| 2019 | 2020 | 2021 | 2022 | 2023 | 2024 | 2025 | 2026 |
|---|---|---|---|---|---|---|---|
| 12,890 | 10,708 | 10,598 | 8,940 | 9,586 | 9,958 | 8,907 | 4,885 |
4,785 reports blaming this drug for every million Medicare prescriptions filled, which is 1.7× the typical drug on this site. (23,410 reports in 2024–2026, against 4,892,277 Medicare fills in one year. This is the one number here that accounts for how many people take the drug.)
Source: the FDA's Adverse Event Reporting System (FAERS). Reports are voluntary and unverified. Drugs that are prescribed a lot, in the news, or in lawsuits attract more reports, so the percentages are compared with the whole database to correct for that partly, not fully.
| Date | Class | Firm | Reason |
|---|---|---|---|
| 03/2020 | Class II | Aurobindo Pharma USA Inc. | CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed |
| 07/2019 | Class II | Ucb, Inc | Failed Dissolution Specifications. |
| 07/2012 | Class II | Mylan Pharmaceuticals Inc. | Adulterated Presence of Foreign Tablets: Pharmaceutical manufacturer may have distributed foreign tablets in bottles of Levetiracetam Tablets, USP 500 mg. |
Class I = reasonable probability of serious harm. Class II = temporary or reversible harm. Class III = unlikely to harm. Most generic recalls are manufacturing or labeling defects for one lot, not a verdict on the molecule.
Counts measure how much evidence exists and how transparent it is, not how big the benefit is. For that, ask your prescriber: if 100 people like me took this, how many would get better because of it, and how many would be harmed? (Doctors call these the "number needed to treat" and "number needed to harm.") It differs by condition and is the number drug ads leave out. Sources: PubMed, ClinicalTrials.gov.
In 2024, drug companies reported $72 in payments to US physicians and hospitals tied to this drug across 4 transactions (Spritam $72).
No pending federal MDL names this drug or its brands.
Not named in any federal pharmaceutical settlement of $100M or more on record.
Sources: CMS Open Payments (Sunshine Act); Judicial Panel on Multidistrict Litigation pending docket list; DOJ settlements as tabulated on Wikipedia with links to the primary record. State-court and individual suits are not included.
| Product | Fills | $/fill |
|---|---|---|
| Levetiracetam | 4,664,870 | $31 |
| Levetiracetam ER | 174,566 | $74 |
| Keppra | 37,683 | $1,903 |
| Keppra XR | 13,615 | $1,833 |
| Spritam | 1,498 | $987 |
| Roweepra | 45 | $17 |
No same-class alternatives found in RxClass.