Prescription medicine
Levetiracetam Brand names: Keppra, Spritam, Elepsia, Roweepra
Levetiracetam (Keppra) is a prescription medicine with an FDA approval on record since 1999. FDA's NDC Directory lists it from 84 generic labelers, and pharmacies paid $0.0736 per levetiracetam 500 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the levetiracetam FDA label on DailyMed (effective January 28, 2026, UCB, Inc.); the NDA 21035 record on Drugs@FDA; every levetiracetam label on DailyMed.
Highlights of the record
FDA label of January 28, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageKEPPRA is indicated for the treatment of partial-onset seizures in patients 1 month of age and older ( 1.1 ) KEPPRA 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 Seizur
Forms and strengths
- 250 mg
- 500 mg
- 750 mg
- 1000 mg
- 1500 mg
- 5 mg/ml
- 10 mg/ml
- 15 mg/ml
- 100 mg/ml
- 500 mg/5ml
- 500 mg/100ml
- 1000 mg/100ml
Film-coated tablet; injection; tablet; solution; film-coated extended-release tablet.
On the market
- Earliest approval on file
- November 30, 1999 Keppra, Ucb Inc; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 106 first November 4, 2008; 66 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 89 of which 84 under generic applications, 5 under brand applications, repackagers included
- Last listed patent
- December 7, 2031 Keppra tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $0.0736 per tablet Levetiracetam 500 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 15 since 2012 3 Class I among all firms' recalls; latest March 13, 2025; 1 more by firms not listed as its makers
- FAERS reports
- 132,823 through July 30, 2026
What is levetiracetam used for?
From the label: indications and usageKEPPRA is indicated for the treatment of partial-onset seizures in patients 1 month of age and older ( 1.1 ) KEPPRA 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 KEPPRA is indicated for the treatment of partial-onset seizures in patients 1 month of age and older. 1.2 Myoclonic Seizures in Patients with Juvenile Myoclonic Epilepsy KEPPRA is indicated as adjunctive therapy for the treatment of myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy. 1.3 Primary Generalized Tonic-Clonic Seizures KEPPRA is indicated as adjunctive therapy for the treatment of primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy. […]
Conditions named in the indications of levetiracetam's FDA labels, with every medicine labeled for each:
Source: FDA drug label (Keppra), NDA021505 (Ucb Inc), as published by UCB, Inc., effective January 28, 2026 (SPL set 3ca9df05-a506-4ec8-a4fe-320f1219ab21), via openFDA; the full label on DailyMed
What does the patient leaflet for levetiracetam say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about KEPPRA?Like other antiepileptic drugs, KEPPRA may cause suicidal thoughts or actions in a very small number of people, about 1 in 500 people taking it. Call a healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you: thoughts about suicide or dying attempts to commit suicide new or worse depression new or worse anxiety feeling agitated or restless panic attacks trouble sleeping (insomnia) new or worse irritability acting aggressive, being angry, or violent acting on dangerous impulses an extreme increase in activity and talking (mania) other unusual changes in behavior or mood Do not stop KEPPRA without first talking to a healthcare provider. Stopping KEPPRA suddenly can cause serious problems. Stopping a seizure medicine suddenly can cause seizures that will not stop (status epilepticus). Suicidal thoughts or actions can be caused by things other than medicines. If you have suicidal thoughts or actions, your healthcare provider may check for other causes. How can I watch for early symptoms of suicidal thoughts and actions? Pay attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. Keep all follow-up visits with your healthcare provider as scheduled. Call your healthcare provider between visits as needed, especially if you are worried about symptoms
From the patient leaflet: What should I avoid while taking KEPPRA?Do not drive, operate machinery or do other dangerous activities until you know how KEPPRA affects you. KEPPRA may make you dizzy or sleepy.
From the patient leaflet: How should I store KEPPRA?Store KEPPRA at room temperature, between 59°F to 86°F (15°C to 30°C) away from heat and light. Keep KEPPRA and all medicines out of the reach of children.
Source: FDA drug label (Keppra), NDA021505 (Ucb Inc), as published by UCB, Inc., effective January 28, 2026 (SPL set 3ca9df05-a506-4ec8-a4fe-320f1219ab21), via openFDA; the full label on DailyMed
Is there a generic for levetiracetam (Keppra)?
The FDA approved the first generic levetiracetam on November 4, 2008. 106 generic applications are approved; 66 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale. Drugs@FDA also holds 1 tentative approval: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
FDA's NDC Directory lists levetiracetam from 84 labelers under a generic (ANDA) application and from 5 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists 1 patent for Keppra tablets, the last expiring on December 7, 2031; a patent listed only for Spritam tablets runs to March 14, 2034. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 1999 earliest approval on file
- 2008 first generic approved
- 2031 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for levetiracetam (Keppra)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.0736 per Levetiracetam 500 mg tablet, down 5% from $0.0773 on October 8, 2025. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Levetiracetam 500 mg tablet (generic)
- Keppra 100 mg/mL oral solution (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Levetiracetam 1,000 mg tablet | Generic | $0.160 per tablet | $4.79 | -0.4% |
| Levetiracetam 100 mg/mL solution | Generic | $0.0301 per mL | n/a | -1% |
| Levetiracetam 250 mg tablet | Generic | $0.0562 per tablet | $1.69 | -6% |
| Levetiracetam 500 mg tablet | Generic | $0.0736 per tablet | $2.21 | -5% |
| Levetiracetam 750 mg tablet | Generic | $0.109 per tablet | $3.28 | -5% |
| Levetiracetam ER 500 mg tablet | Generic | $0.174 per tablet | $5.21 | -2% |
| Levetiracetam ER 750 mg tablet | Generic | $0.223 per tablet | $6.70 | -14% |
| Roweepra 500 mg tablet | Generic | $0.0736 per tablet | $2.21 | -5% |
| Keppra 1,000 mg tablet | Brand | $19.87 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $596.14 | +2% |
| Keppra 100 mg/mL oral solution | Brand | $1.92 per mL | n/a | +2% |
| Keppra 250 mg tablet | Brand | $8.08 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $242.36 | +2% |
| Keppra 500 mg tablet | Brand | $9.92 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $297.51 | +3% |
| Keppra 750 mg tablet | Brand | $13.46 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $403.84 | +2% |
| Keppra XR 500 mg tablet | Brand | $9.02 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $270.73 | +3% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has levetiracetam been recalled?
The FDA's Enforcement Report lists 16 recalls naming levetiracetam since 2012: 3 Class I (the most serious), 11 Class II, 2 Class III; 2 still ongoing. 1 of them is by a firm that FDA's NDC Directory does not list as a maker of levetiracetam and that holds no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| March 13, 2025 | Class I | Dr. Reddy's Laboratories, Inc. | LABELING: LABEL MIX-UP: The infusion bag is incorrectly labeled as Levetiracetam in 0.82% Sodium Chloride Injection 500 mg/100 mL, while the aluminum overwrap … |
| April 26, 2023 | Class II | Akorn, Inc. not a listed maker | CGMP Deviations: Firm went out of business and could no longer continue stability studies. |
| May 26, 2021 | Class III | McKesson Corporation dba McKesson Drug Company | Labeling; Wrong Barcode; error in the machine-readable barcode which could result in some units being read as Naproxen Tablets 500 mg. … |
| December 28, 2020 | Class II | Akorn, Inc. | Defective container: Customer complaints for oral solution leaking from bottles. |
| November 10, 2020 | Class II | EYWA PHARMA INC | Presence of foreign tablet/capsule: A 1000 mg Levetiracetam Tablet was found in 500 gram bottle of Levetiracetam Tablets. |
| March 18, 2020 | Class II | Aurobindo Pharma USA Inc. | CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed |
| December 6, 2019 | Class I | Lannett Company, Inc. | Microbial Contamination of Non-sterile Products: Out-of-specification results obtained for Total Aerobic Microbial Count. |
| October 11, 2019 | Class III | X-Gen Pharmaceuticals Inc. | Labeling: Incorrect or Missing Package Insert - the incorrect package insert version was attached. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the levetiracetam label say about other medicines?
The levetiracetam label names 12 other medicines in its interaction, contraindication or warning sections. The labels of 2 other medicines name levetiracetam. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Carbamazepine | drug interactions | Other Antiepileptic Drugs Potential drug interactions between levetiracetam and other AEDs (carbamazepine, gabapentin, lamotrigine, phenobarbital, phenytoin, primidone and valproate) were also assessed by evaluating the serum concentrations of levetiracetam and these AEDs during placebo-controlled clinical studies. |
| Digoxin | drug interactions | Potential pharmacokinetic interactions of or with levetiracetam were assessed in clinical pharmacokinetic studies (phenytoin, valproate, warfarin, digoxin, oral contraceptive, probenecid) and through pharmacokinetic screening in the placebo-controlled clinical studies in epilepsy patients. |
| Divalproex | drug interactions | In addition, levetiracetam does not affect the in vitro glucuronidation of valproic acid. |
| Gabapentin | drug interactions | Other Antiepileptic Drugs Potential drug interactions between levetiracetam and other AEDs (carbamazepine, gabapentin, lamotrigine, phenobarbital, phenytoin, primidone and valproate) were also assessed by evaluating the serum concentrations of levetiracetam and these AEDs during placebo-controlled clinical studies. |
| Lamotrigine | drug interactions | Other Antiepileptic Drugs Potential drug interactions between levetiracetam and other AEDs (carbamazepine, gabapentin, lamotrigine, phenobarbital, phenytoin, primidone and valproate) were also assessed by evaluating the serum concentrations of levetiracetam and these AEDs during placebo-controlled clinical studies. |
| Levonorgestrel | drug interactions | Oral Contraceptives Levetiracetam (500 mg twice daily) did not influence the pharmacokinetics of an oral contraceptive containing 0.03 mg ethinyl estradiol and 0.15 mg levonorgestrel, or of the luteinizing hormone and progesterone levels, indicating that impairment of contraceptive efficacy is unlikely. |
| Phenobarbital | drug interactions | Other Antiepileptic Drugs Potential drug interactions between levetiracetam and other AEDs (carbamazepine, gabapentin, lamotrigine, phenobarbital, phenytoin, primidone and valproate) were also assessed by evaluating the serum concentrations of levetiracetam and these AEDs during placebo-controlled clinical studies. |
| Phenytoin | drug interactions | Other Antiepileptic Drugs Potential drug interactions between levetiracetam and other AEDs (carbamazepine, gabapentin, lamotrigine, phenobarbital, phenytoin, primidone and valproate) were also assessed by evaluating the serum concentrations of levetiracetam and these AEDs during placebo-controlled clinical studies. |
| Primidone | drug interactions | Other Antiepileptic Drugs Potential drug interactions between levetiracetam and other AEDs (carbamazepine, gabapentin, lamotrigine, phenobarbital, phenytoin, primidone and valproate) were also assessed by evaluating the serum concentrations of levetiracetam and these AEDs during placebo-controlled clinical studies. |
| Probenecid | drug interactions | Renal clearance of ucb L057 in the presence of probenecid decreased 60%, probably related to competitive inhibition of tubular secretion of ucb L057. |
| Valproic acid | drug interactions | In addition, levetiracetam does not affect the in vitro glucuronidation of valproic acid. |
| Warfarin | drug interactions | Potential pharmacokinetic interactions of or with levetiracetam were assessed in clinical pharmacokinetic studies (phenytoin, valproate, warfarin, digoxin, oral contraceptive, probenecid) and through pharmacokinetic screening in the placebo-controlled clinical studies in epilepsy patients. |
Source: FDA drug label (Keppra), NDA021505 (Ucb Inc), as published by UCB, Inc., effective January 28, 2026 (SPL set 3ca9df05-a506-4ec8-a4fe-320f1219ab21), via openFDA; the full label on DailyMed
What do FAERS reports show for levetiracetam?
The FDA Adverse Event Reporting System holds 132,823 reports that list levetiracetam among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 11,940 are coded as a death and 49,185 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.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as levetiracetam?
18 other medicines are given the same way (oral) and in the same FDA class as levetiracetam or labeled mainly for the same use (seizures and epilepsy), the same class first. Seizures and epilepsy lists all 27 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Topiramate | Seizures and epilepsy | 47 labelers | $0.0567 per tablet 100 mg tablet | No current entry |
| Lamotrigine | Seizures and epilepsy | 50 labelers | $0.0268 per tablet 25 mg tablet | A presentation being discontinued |
| Phenobarbital | Seizures and epilepsy | none listed | $0.213 per tablet 100 mg tablet | A presentation being discontinued |
| Clonazepam | Seizures and epilepsy | 31 labelers | $0.0244 per tablet 1 mg tablet | In shortage |
| Lacosamide | Seizures and epilepsy | 43 labelers | $0.174 per tablet 100 mg tablet | No current entry |
| Oxcarbazepine | Seizures and epilepsy | 43 labelers | $0.167 per tablet 300 mg tablet | No current entry |
| Brivaracetam | Seizures and epilepsy | 14 labelers | $0.259 per tablet 100 mg tablet | No current entry |
| Zonisamide | Seizures and epilepsy | 20 labelers | $0.106 per capsule 100 mg capsule | No current entry |
Every medicine labeled for the same conditions as levetiracetam
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does levetiracetam compare with medicines for the same use?
13 side-by-side pages set levetiracetam beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to levetiracetam
- 18 medicines for the same use
- Levetiracetam side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other