{
 "query": "gabapentin",
 "ingredient": "gabapentin",
 "slug": "gabapentin",
 "rxcui": "25480",
 "brands": [
  "Gralise",
  "Neurontin",
  "Gabarone",
  "Relgaabi"
 ],
 "names": [
  "gabapentin"
 ],
 "classes": [
  {
   "id": "N02BF",
   "name": "Gabapentinoids"
  }
 ],
 "alternatives": [
  "pregabalin"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 388
  },
  "boxed_warning": "",
  "indications_and_usage": "Gabapentin is indicated for: Management of postherpetic neuralgia in adults Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy Gabapentin is indicated for: Postherpetic neuralgia in adults ( 1 ) Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy ( 1 )",
  "contraindications": "Gabapentin is contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients. Known hypersensitivity to gabapentin or its ingredients ( 4 )",
  "warnings_and_cautions": "Drug Reaction with Eosinophilia and Systemic Symptoms (Multiorgan hypersensitivity): Discontinue if alternative etiology is not established ( 5.1 ) Anaphylaxis and Angioedema: Discontinue and evaluate patient immediately ( 5.2 ) Driving Impairment; Somnolence/Sedation and Dizziness: Warn patients not to drive until they have gained sufficient experience to assess whether their ability to drive or operate heavy machinery will be impaired ( 5.3 , 5.4 ) Increased seizure frequency may occur in patients with seizure disorders if gabapentin is abruptly discontinued ( 5.5 ) Suicidal Behavior and Ideation: Monitor for suicidal thoughts/behavior ( 5.6 ) Respiratory Depression: May occur with gabapentin when used with concomitant central nervous system (CNS) depressants, including opioids, or in the setting of underlying respiratory impairment. Monitor patients and adjust dosage as appropriate ( 5.7 ) Neuropsychiatric Adverse Reactions in Children 3 to 12 Years of Age: Monitor for such events ( 5.8 ) 5.1 Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan Hypersensitivity Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), also known as multiorgan hypersensit...",
  "warnings": "",
  "adverse_reactions": "The following serious adverse reactions are discussed in greater detail in other sections: Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan Hypersensitivity [see Warnings and Precautions (5.1) ] Anaphylaxis and Angioedema [see Warnings and Precautions (5.2) ] Somnolence/Sedation and Dizziness [see Warnings and Precautions (5.4) ] Withdrawal Precipitated Seizure, Status Epilepticus [see Warnings and Precautions (5.5) ] Suicidal Behavior and Ideation [see Warnings and Precautions (5.6) ] Respiratory Depression [see Warnings and Precautions (5.7) ] Neuropsychiatric Adverse Reactions (Pediatric Patients 3 to 12 Years of Age) [see Warnings and Precautions (5.8) ] Sudden and Unexplained Death in Patients with Epilepsy [see Warnings and Precautions (5.10) ] Most common adverse reactions (incidence \u2265 8% and at least twice that for placebo) were: Postherpetic neuralgia: Dizziness, somnolence, and peripheral edema ( 6.1 ) Epilepsy in patients > 12 years of age: Somnolence, dizziness, ataxia, fatigue, and nystagmus ( 6.1 ) Epilepsy in patients 3 to 12 years of age: Viral infection, fever, nausea and/or vomiting, somnolence, and hostility ( 6.1 ) To report SUSPECTED ADV...",
  "drug_abuse_and_dependence": "9.1 Controlled Substance Gabapentin is not a scheduled drug. 9.2 Abuse Abuse is the intentional, non-therapeutic use of a drug, even once, for its desirable psychological or physiological effects. Misuse is the intentional use, for therapeutic purposes, of a drug by an individual in a way other than prescribed by a health care provider or for whom it was not prescribed. Gabapentin does not exhibit affinity for benzodiazepine, opioid (mu, delta or kappa), or cannabinoid 1 receptor sites. Gabapentin misuse and abuse have been reported in the postmarketing setting and published literature. Most of the individuals described in these reports had a history of polysubstance abuse. Some of these individuals were taking higher than recommended doses of gabapentin for unapproved uses. When prescribing gabapentin, carefully evaluate patients for a history of drug abuse and observe them for signs and symptoms of gabapentin misuse or abuse (e.g., self-dose escalation and drug-seeking behavior). The abuse potential of gabapentin has not been evaluated in human studies. 9.3 Dependence Physical dependence is a state that develops as a result of physiological adaptation in response to repeated drug...",
  "controlled_substance": "9.1 Controlled Substance Gabapentin is not a scheduled drug.",
  "recent_major_changes": "Warnings and Precautions, Respiratory Depression ( 5.7 ) 04/2020",
  "information_for_patients": "Advise the patient to read the FDA-approved patient labeling (Medication Guide). Administration Information Inform patients that gabapentin is taken orally with or without food. Inform patients that, should they divide the scored 600 mg or 800 mg tablet in order to administer a half-tablet, they should take the unused half-tablet as the next dose. Advise patients to discard half-tablets not used within 28 days of dividing the scored tablet. Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan Hypersensitivity Prior to initiation of treatment with gabapentin, instruct patients that a rash or other signs or symptoms of hypersensitivity (such as fever or lymphadenopathy) may herald a serious medical event and that the patient should report any such occurrence to a physician immediately [see Warnings and Precautions (5.1) ] . Anaphylaxis and Angioedema Advise patients to discontinue gabapentin and seek medical care if they develop signs or symptoms of anaphylaxis or angioedema [see Warnings and Precautions (5.2) ] . Dizziness and Somnolence and Effects on Driving and Operating Heavy Machinery Advise patients that gabapentin may cause dizziness, somnolence, and other...",
  "spl_medguide": "MEDICATION GUIDE Gabapentin Tablets, USP (GA-ba-PEN-tin) What is the most important information I should know about gabapentin tablets? Do not stop taking gabapentin tablets without first talking to your healthcare provider. Stopping gabapentin tablets suddenly can cause serious problems. Gabapentin tablets can cause serious side effects including: Suicidal Thoughts. Like other antiepileptic drugs, gabapentin tablets may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. 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 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 y...",
  "clinical_studies": "14.1 Postherpetic Neuralgia Gabapentin was evaluated for the management of postherpetic neuralgia (PHN) in two randomized, double-blind, placebo-controlled, multicenter studies. The intent-to-treat (ITT) population consisted of a total of 563 patients with pain for more than 3 months after healing of the herpes zoster skin rash (Table 6). TABLE 6. Controlled PHN Studies: Duration, Dosages, and Number of Patients Study Study Duration Gabapentin (mg/day) Given in 3 divided doses (TID) Target Dose Patients Receiving Gabapentin Patients Receiving Placebo 1 8 weeks 3,600 113 116 2 7 weeks 1,800, 2,400 223 111 Total 336 227 Each study included a 7- or 8-week double-blind phase (3 or 4 weeks of titration and 4 weeks of fixed dose). Patients initiated treatment with titration to a maximum of 900 mg/day gabapentin over 3 days. Dosages were then to be titrated in 600 to 1,200 mg/day increments at 3- to 7-day intervals to the target dose over 3 to 4 weeks. Patients recorded their pain in a daily diary using an 11-point numeric pain rating scale ranging from 0 (no pain) to 10 (worst possible pain). A mean pain score during baseline of at least 4 was required for randomization. Analyses were co...",
  "brand_name": "Gabapentin",
  "manufacturer": "NuCare Pharmaceuticals,Inc.",
  "application_number": "ANDA207057",
  "pharm_class_epc": [],
  "route": [
   "ORAL"
  ],
  "effective_time": "20250203",
  "set_id": "07871ab8-254b-e3c2-e063-6294a90a29ab",
  "has_boxed_warning": false,
  "controlled": true,
  "mentions_rems": false
 },
 "faers": {
  "total": 300251,
  "serious": 185337,
  "death": 27681,
  "hospitalization": 86090,
  "primary_suspect": 299250,
  "top_reactions": [
   [
    "Drug Ineffective",
    23797
   ],
   [
    "Fatigue",
    21880
   ],
   [
    "Nausea",
    18774
   ],
   [
    "Off Label Use",
    18675
   ],
   [
    "Pain",
    16775
   ],
   [
    "Diarrhoea",
    15640
   ],
   [
    "Headache",
    14878
   ],
   [
    "Dizziness",
    13271
   ],
   [
    "Fall",
    12798
   ],
   [
    "Dyspnoea",
    11578
   ],
   [
    "Death",
    9877
   ],
   [
    "Vomiting",
    9802
   ],
   [
    "Arthralgia",
    9659
   ],
   [
    "Asthenia",
    9547
   ],
   [
    "Pain In Extremity",
    9226
   ]
  ],
  "by_year": {
   "2019": 33654,
   "2020": 29204,
   "2021": 24186,
   "2022": 21989,
   "2023": 21173,
   "2024": 20555,
   "2025": 21443,
   "2026": 10117
  },
  "by_year_primary": {
   "2019": 33632,
   "2020": 29178,
   "2021": 24105,
   "2022": 21783,
   "2023": 20947,
   "2024": 20406,
   "2025": 21285,
   "2026": 10003
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class II",
   "date": "20251010",
   "reason": "Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity .",
   "firm": "The Harvard Drug Group LLC",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20250619",
   "reason": "Defective container; blister packaging inadequately sealed.",
   "firm": "The Harvard Drug Group LLC",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20250313",
   "reason": "CGMP Deviations",
   "firm": "Glenmark Pharmaceuticals Inc., USA",
   "status": "Ongoing"
  },
  {
   "class": "Class III",
   "date": "20250304",
   "reason": "Cross Contamination",
   "firm": "SUN PHARMACEUTICAL INDUSTRIES INC",
   "status": "Ongoing"
  },
  {
   "class": "Class III",
   "date": "20250304",
   "reason": "Cross Contamination",
   "firm": "SUN PHARMACEUTICAL INDUSTRIES INC",
   "status": "Ongoing"
  },
  {
   "class": "Class III",
   "date": "20230424",
   "reason": "Product mixup: one foreign tablet found in product.",
   "firm": "The Harvard Drug Group",
   "status": "Terminated"
  },
  {
   "class": "Class III",
   "date": "20230217",
   "reason": "Presence of Foreign Tablets/Capsules: Pharmacist reported presence of some Gabapentin tablets 800 mg comingled in Gabapentin 600 mg 500 count bottles.",
   "firm": "Sciegen Pharmaceuticals Inc",
   "status": "Terminated"
  },
  {
   "class": "Class III",
   "date": "20200514",
   "reason": "Failed Impurities/Degradation Specifications; failure of Impurity A test at the 12-month long-term stability testing.",
   "firm": "InvaGen Pharmaceuticals, Inc.",
   "status": "Terminated"
  },
  {
   "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": "20141215",
   "reason": "Failed Capsule/Tablet Specifications: Actavis has received several complaint for clumping and breaking of capsules with some bottles showing popped out bottle bottom (round bottom) and creased labels from one distribution center.",
   "firm": "Actavis Elizabeth LLC",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20141215",
   "reason": "Failed Capsule/Tablet Specifications: Actavis has received several complaint for clumping and breaking of capsules with some bottles showing popped out bottle bottom (round bottom) and creased labels from one distribution center.",
   "firm": "Actavis Elizabeth LLC",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20141215",
   "reason": "Failed Capsule/Tablet Specifications: Actavis has received several complaint for clumping and breaking of capsules with some bottles showing popped out bottle bottom (round bottom) and creased labels from one distribution center.",
   "firm": "Actavis Elizabeth LLC",
   "status": "Terminated"
  }
 ],
 "recall_total": 14,
 "drugsfda": {
  "applications": 78,
  "nda": 8,
  "anda": 70,
  "first_approval": "19931230",
  "rems": false,
  "rems_last": "20130409",
  "labeling_supplements": 65,
  "labeling_recent": 7,
  "sponsors": [
   "ABON PHARMS LLC",
   "ACELLA PHARMS LLC",
   "ACTAVIS ELIZABETH",
   "AJENAT PHARMS",
   "ALKEM",
   "ALKEM LABS LTD",
   "ALMATICA",
   "AMNEAL PHARMS"
  ],
  "unapproved": false,
  "first_approval_fmt": "12/30/1993"
 },
 "trials": {
  "total": 583,
  "completed": 369,
  "terminated": 79,
  "with_results": 164,
  "industry": 114,
  "phase3": 111,
  "results_share": 0.4444444444444444,
  "terminated_share": 0.13550600343053174
 },
 "pubmed": {
  "rct": 536,
  "meta": 120,
  "recent_rct": 73,
  "cochrane": [
   {
    "pmid": "33434292",
    "title": "Gabapentin add-on treatment for drug-resistant focal epilepsy",
    "year": "2021"
   },
   {
    "pmid": "30357813",
    "title": "Gabapentin add-on treatment for drug-resistant focal epilepsy",
    "year": "2018"
   },
   {
    "pmid": "28597471",
    "title": "Gabapentin for chronic neuropathic pain in adults",
    "year": "2017"
   },
   {
    "pmid": "28045473",
    "title": "Gabapentin for fibromyalgia pain in adults",
    "year": "2017"
   },
   {
    "pmid": "24771480",
    "title": "Gabapentin for chronic neuropathic pain and fibromyalgia in adults",
    "year": "2014"
   },
   {
    "pmid": "23888424",
    "title": "Gabapentin add-on for drug-resistant partial epilepsy",
    "year": "2013"
   },
   {
    "pmid": "23797675",
    "title": "Gabapentin or pregabalin for the prophylaxis of episodic migraine in adults",
    "year": "2013"
   },
   {
    "pmid": "23797674",
    "title": "Antiepileptics other than gabapentin, pregabalin, topiramate, and valproate for the prophylaxis of episodic migraine in adults",
    "year": "2013"
   },
   {
    "pmid": "21412914",
    "title": "Gabapentin for chronic neuropathic pain and fibromyalgia in adults",
    "year": "2011"
   },
   {
    "pmid": "21412888",
    "title": "WITHDRAWN: Gabapentin for acute and chronic pain",
    "year": "2011"
   },
   {
    "pmid": "20464764",
    "title": "Single dose oral gabapentin for established acute postoperative pain in adults",
    "year": "2010"
   },
   {
    "pmid": "16034978",
    "title": "Gabapentin for acute and chronic pain",
    "year": "2005"
   }
  ]
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "gabapentin",
   "Gralise",
   "Neurontin",
   "Gabarone",
   "Relgaabi"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 36837037,
  "beneficiaries": 7968946,
  "spend": 579085199.59,
  "by_brand": [
   {
    "brand": "Gabapentin",
    "claims": 36804628,
    "per_claim": 14.784949738,
    "is_generic": true
   },
   {
    "brand": "Gralise",
    "claims": 12576,
    "per_claim": 994.51003419,
    "is_generic": false
   },
   {
    "brand": "Neurontin",
    "claims": 11760,
    "per_claim": 1578.2034881,
    "is_generic": false
   },
   {
    "brand": "Gabapentin ER",
    "claims": 8073,
    "per_claim": 478.63164499,
    "is_generic": false
   }
  ],
  "per_claim": 15.720189427559008
 },
 "mdl": [],
 "dsc": [
  {
   "date": "20191219",
   "title": "FDA warns about serious breathing problems with seizure and nerve pain medicines gabapentin (Neurontin, Gralise, Horizant) and pregabalin (Lyrica, Lyrica CR) when used with CNS depressants or in patients with lung problems",
   "url": "https://www.fda.gov/safety/medical-product-safety-information/neurontin-gralise-horizant-gabapentin-and-lyrica-lyrica-cr-pregabalin-drug-safety-communication",
   "lang": "en",
   "kind": "drug",
   "matched": "gabapentin"
  }
 ],
 "settlements": [
  {
   "year": 2004,
   "company": "Pfizer",
   "amount_usd": 430000000.0,
   "amount_text": "$430 million",
   "violations": "Off-label promotion",
   "products": "Neurontin",
   "laws": "False Claims Act, FDCA",
   "urls": [],
   "matched": "neurontin"
  }
 ],
 "prescrire": null,
 "eml": {
  "listed": false,
  "status": "ApplicationRejected",
  "name": "gabapentin",
  "matched": "gabapentin",
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 51694,
  "fills": 36837037,
  "per_million": 1403.3159073027507,
  "ratio": 0.5068043959200554,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 77,
   "letter": "B",
   "why": [
    "FDA issued 1 Drug Safety Communication(s) naming this drug since 2010, most recently 2019 (-8)",
    "1,403 FDA reports naming it as the suspect drug per million Medicare fills, 0.5x the median drug on this site",
    "Federally controlled substance: dependence and misuse risk (-10)",
    "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": 75,
   "letter": "B",
   "why": [
    "536 randomized trials and 120 systematic reviews/meta-analyses indexed in PubMed",
    "12 independent Cochrane review(s) exist",
    "Only 44% of completed registered trials posted results (-8)",
    "'Drug ineffective' is the single most-reported item about this drug in FAERS (-5)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 80,
   "letter": "B",
   "why": [
    "Recalls since 2016: 0 Class I, 4 Class II, 5 Class III across 70 generic makers (-7)",
    "7 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": 85,
   "letter": "B",
   "why": [
    "Maker paid $430 million in 2004 to settle federal allegations naming this drug (Off-label promotion) (-15)",
    "Pharma paid doctors $0 tied to this drug last year: negligible",
    "Not named in any pending federal MDL"
   ],
   "weight": 0.15
  },
  "options": {
   "score": 90,
   "letter": "A",
   "why": [
    "Generic versions approved (70 applications)",
    "1 same-class alternative(s) (-10)"
   ],
   "weight": 0.1
  }
 },
 "total": 79,
 "grade": "B",
 "questions": [
  "In 2019 the FDA issued a safety communication about this drug (FDA warns about serious breathing problems with seizure and nerve pain medicines gabapentin (Neurontin, Gralis). Does that risk apply to me?",
  "The maker paid $430 million in 2004 to settle federal allegations about how this drug was marketed. Is my use one of the uses that was promoted improperly?",
  "This is a controlled substance. What is the plan for how long I take it and how I stop?",
  "The most-reported problems in FDA's adverse event data are fatigue, nausea. 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?",
  "Why this one over pregabalin? What would make you pick one of those instead?",
  "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.)"
 ]
}