{
 "query": "levetiracetam",
 "ingredient": "levetiracetam",
 "slug": "levetiracetam",
 "rxcui": "114477",
 "brands": [
  "Keppra",
  "Spritam",
  "Roweepra",
  "Elepsia"
 ],
 "names": [
  "levetiracetam"
 ],
 "classes": [],
 "alternatives": [],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 122,
   "INTRAVENOUS": 37
  },
  "boxed_warning": "",
  "indications_and_usage": "\u00ae 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 )",
  "contraindications": "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 )",
  "warnings_and_cautions": "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operate machinery until they have gained experience on KEPPRA ( 5.7 ) Withdrawal Seizures: KEPPRA XR must be gradually withdrawn ( 5.8 ) 5.1 Behavioral Abnormalities and Psychotic Symptoms KEPPRA XR may cause behavioral abnormalities and psychotic symptoms.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...",
  "warnings": "",
  "adverse_reactions": "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 \u22655% 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...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "Warnings and Precautions ( 5.6 ) 3/2024",
  "information_for_patients": "Advise the patient to read the FDA-approved patient labeling (Medication Guide). The Medication Guide accompanies the product and can also be accessed on www.keppraxr.com or by calling 1-844-599-2273. Psychiatric Reactions and Changes in Behavior Advise patients that KEPPRA XR may cause changes in behavior (e.g. irritability and aggression). In addition, patients should be advised that they may experience changes in behavior that have been seen with other formulations of KEPPRA, which include agitation, anger, anxiety, apathy, depression, hostility, and psychotic symptoms [see Warnings and Precautions (5.1) ] . Suicidal Behavior and Ideation Counsel patients, their caregivers, and/or families that antiepileptic drugs (AEDs), including KEPPRA XR, may increase the risk of suicidal thoughts and behavior and advise patients to be alert for the emergence or worsening of symptoms of depression; unusual changes in mood or behavior; or suicidal thoughts, behavior, or thoughts about self-harm. Advise patients, their caregivers, and/or families to immediately report behaviors of concern to a healthcare provider [see Warnings and Precautions (5.2) ] . Effects on Driving or Operating Machinery...",
  "spl_medguide": "MEDICATION GUIDE KEPPRA XR \u00ae (KEPP-ruh XR ) (levetiracetam) extended-release tablets, for oral use This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: 3/2024 Read this Medication Guide before you start taking KEPPRA XR and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment. What is the most important information I should know about KEPPRA XR? Like other antiepileptic drugs, KEPPRA XR 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 XR without first talking to a h...",
  "clinical_studies": "The effectiveness of KEPPRA XR for the treatment of partial-onset seizures in adults was established in one multicenter, randomized, double-blind, placebo-controlled clinical study in patients who had refractory partial-onset seizures with or without secondary generalization. This was supported by the demonstration of efficacy of immediate-release KEPPRA tablets (see below) in partial seizures in three multicenter, randomized, double-blind, placebo-controlled clinical studies in adults, as well as a demonstration of comparable bioavailability between the XR and immediate-release formulations [see Clinical Pharmacology (12.3) ] in adults. The effectiveness for KEPPRA XR for the treatment of partial-onset seizures in pediatric patients, 12 years of age and older, was based upon a single pharmacokinetic study showing comparable pharmacokinetics of KEPPRA XR in adults and adolescents [see Clinical Pharmacology (12.3) ] . All studies are described below. 14.1 KEPPRA XR in Adults The effectiveness of KEPPRA XR for the treatment of partial-onset seizures in adults was established in one multicenter, randomized, double-blind, placebo-controlled clinical study across 7 countries in patients...",
  "brand_name": "Keppra XR",
  "manufacturer": "UCB, Inc.",
  "application_number": "NDA022285",
  "pharm_class_epc": [],
  "route": [
   "ORAL"
  ],
  "effective_time": "20250624",
  "set_id": "2919e43b-69a8-434c-a2d2-1f3ecd7554c0",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 115756,
  "serious": 94789,
  "death": 10225,
  "hospitalization": 41835,
  "primary_suspect": 115137,
  "top_reactions": [
   [
    "Seizure",
    16506
   ],
   [
    "Drug Ineffective",
    11631
   ],
   [
    "Off Label Use",
    9603
   ],
   [
    "Fatigue",
    4818
   ],
   [
    "Epilepsy",
    3890
   ],
   [
    "Maternal Exposure During Pregnancy",
    3615
   ],
   [
    "Somnolence",
    3569
   ],
   [
    "Fall",
    3195
   ],
   [
    "Headache",
    3116
   ],
   [
    "Dizziness",
    3034
   ],
   [
    "Generalised Tonic-Clonic Seizure",
    3023
   ],
   [
    "Nausea",
    3017
   ],
   [
    "Drug Interaction",
    2930
   ],
   [
    "Death",
    2889
   ],
   [
    "Diarrhoea",
    2791
   ]
  ],
  "by_year": {
   "2019": 12890,
   "2020": 10708,
   "2021": 10598,
   "2022": 8940,
   "2023": 9586,
   "2024": 9958,
   "2025": 8907,
   "2026": 4885
  },
  "by_year_primary": {
   "2019": 12876,
   "2020": 10687,
   "2021": 10558,
   "2022": 8851,
   "2023": 9487,
   "2024": 9751,
   "2025": 8820,
   "2026": 4839
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class II",
   "date": "20200318",
   "reason": "CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed",
   "firm": "Aurobindo Pharma USA Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20190718",
   "reason": "Failed Dissolution Specifications.",
   "firm": "Ucb, Inc",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20120727",
   "reason": "Adulterated Presence of Foreign Tablets: Pharmaceutical manufacturer may have distributed foreign tablets in bottles of Levetiracetam Tablets, USP 500 mg.",
   "firm": "Mylan Pharmaceuticals Inc.",
   "status": "Terminated"
  }
 ],
 "recall_total": 3,
 "drugsfda": {
  "applications": 113,
  "nda": 7,
  "anda": 106,
  "first_approval": "19991130",
  "rems": false,
  "rems_last": "20120720",
  "labeling_supplements": 92,
  "labeling_recent": 16,
  "sponsors": [
   "ACCORD HLTHCARE",
   "ACTAVIS ELIZABETH",
   "ACTAVIS LABS FL INC",
   "ACTAVIS MID ATLANTIC",
   "ADAPTIS",
   "AIPING PHARM INC",
   "AJENAT PHARMS",
   "ALEMBIC"
  ],
  "unapproved": false,
  "first_approval_fmt": "11/30/1999"
 },
 "trials": {
  "total": 308,
  "completed": 202,
  "terminated": 33,
  "with_results": 92,
  "industry": 137,
  "phase3": 71,
  "results_share": 0.45544554455445546,
  "terminated_share": 0.10714285714285714
 },
 "pubmed": {
  "rct": 204,
  "meta": 103,
  "recent_rct": 39,
  "cochrane": [
   {
    "pmid": "35658745",
    "title": "Levetiracetam add-on for drug-resistant focal epilepsy",
    "year": "2020"
   },
   {
    "pmid": "25000215",
    "title": "Levetiracetam for neuropathic pain in adults",
    "year": "2014"
   },
   {
    "pmid": "22972056",
    "title": "Levetiracetam add-on for drug-resistant focal epilepsy: an updated Cochrane Review",
    "year": "2012"
   },
   {
    "pmid": "11279737",
    "title": "Levetiracetam add-on for drug-resistant localization related (partial) epilepsy",
    "year": "2001"
   }
  ]
 },
 "payments": {
  "year": "2024",
  "usd": 72.49,
  "records": 4,
  "by_name": [
   [
    "Spritam",
    72.49
   ]
  ],
  "names_checked": [
   "levetiracetam",
   "Keppra",
   "Spritam",
   "Roweepra",
   "Elepsia"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 4892277,
  "beneficiaries": 849278,
  "spend": 255153452.56,
  "by_brand": [
   {
    "brand": "Levetiracetam",
    "claims": 4664870,
    "per_claim": 30.888236292,
    "is_generic": true
   },
   {
    "brand": "Levetiracetam ER",
    "claims": 174566,
    "per_claim": 74.100933572,
    "is_generic": false
   },
   {
    "brand": "Keppra",
    "claims": 37683,
    "per_claim": 1902.5264321,
    "is_generic": false
   },
   {
    "brand": "Keppra XR",
    "claims": 13615,
    "per_claim": 1832.9558076,
    "is_generic": false
   },
   {
    "brand": "Spritam",
    "claims": 1498,
    "per_claim": 987.31423899,
    "is_generic": false
   },
   {
    "brand": "Roweepra",
    "claims": 45,
    "per_claim": 16.634888889,
    "is_generic": false
   }
  ],
  "per_claim": 52.154334793389665
 },
 "mdl": [],
 "dsc": [
  {
   "date": "20231128",
   "title": "FDA warns of rare but serious drug reaction to the antiseizure medicines levetiracetam (Keppra, Keppra XR, Elepsia XR, Spritam) and clobazam (Onfi, Sympazan)",
   "url": "https://www.fda.gov/drugs/drug-safety-communications/fda-warns-rare-serious-drug-reaction-antiseizure-medicines-levetiracetam-keppra-keppra-xr-elepsia-xr",
   "kind": "drug",
   "matched": "keppra"
  }
 ],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": true,
  "status": "AddedToEml",
  "name": "levetiracetam",
  "matched": "levetiracetam",
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 23410,
  "fills": 4892277,
  "per_million": 4785.09291276843,
  "ratio": 1.7281255848785528,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 82,
   "letter": "B",
   "why": [
    "FDA issued 1 Drug Safety Communication(s) naming this drug since 2010, most recently 2023 (-8)",
    "4,785 FDA reports naming it as the suspect drug per million Medicare fills, 1.7x the median drug on this site (-5)",
    "Death share in reports is near or below the FAERS average (1.0x)",
    "Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 72,
   "letter": "C",
   "why": [
    "204 randomized trials and 103 systematic reviews/meta-analyses indexed in PubMed",
    "On the WHO Model List of Essential Medicines (shown for context; no score effect)",
    "4 independent Cochrane review(s) exist",
    "Only 46% of completed registered trials posted results (-8)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 84,
   "letter": "B",
   "why": [
    "Recalls since 2016: 0 Class I, 2 Class II, 0 Class III across 106 generic makers (-3)",
    "16 label changes approved since 2021: the safety story is still moving (-8)",
    "Label lists recent major changes to warnings or indications (-5)"
   ],
   "weight": 0.15
  },
  "conflict": {
   "score": 100,
   "letter": "A",
   "why": [
    "Pharma paid doctors $72 tied to this drug last year: negligible",
    "Not named in any pending federal MDL"
   ],
   "weight": 0.15
  },
  "options": {
   "score": 70,
   "letter": "C",
   "why": [
    "Generic versions approved (106 applications)",
    "No same-class alternatives found: little leverage to switch (-30)"
   ],
   "weight": 0.1
  }
 },
 "total": 81,
 "grade": "B",
 "questions": [
  "In 2023 the FDA issued a safety communication about this drug (FDA warns of rare but serious drug reaction to the antiseizure medicines levetiracetam (Keppra, Keppra XR, Ele). Does that risk apply to me?",
  "The most-reported problems in FDA's adverse event data are seizure, fatigue. How would we recognize and handle those?",
  "Off-label use is among the most-reported items for this drug. Is my use on-label, and if not, what evidence supports it?",
  "What result are we expecting, by when, and what is the plan if it does not happen?",
  "If 100 people like me took this drug, how many would actually get better because of it, and how many would be harmed by it? (Doctors call these the number needed to treat and the number needed to harm.)"
 ]
}