{
 "query": "pregabalin",
 "ingredient": "pregabalin",
 "slug": "pregabalin",
 "rxcui": "187832",
 "brands": [
  "Lyrica"
 ],
 "names": [
  "pregabalin"
 ],
 "classes": [
  {
   "id": "N02BF",
   "name": "Gabapentinoids"
  }
 ],
 "alternatives": [
  "gabapentin"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 225
  },
  "boxed_warning": "",
  "indications_and_usage": "is indicated for: \u2022 Management of neuropathic pain associated with diabetic peripheral neuropathy \u2022 Management of postherpetic neuralgia \u2022 Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older \u2022 Management of fibromyalgia \u2022 Management of neuropathic pain associated with spinal cord injury LYRICA is indicated for: \u2022 Neuropathic pain associated with diabetic peripheral neuropathy (DPN) ( 1 ) \u2022 Postherpetic neuralgia (PHN) ( 1 ) \u2022 Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older ( 1 ) \u2022 Fibromyalgia ( 1 ) \u2022 Neuropathic pain associated with spinal cord injury ( 1 )",
  "contraindications": "is contraindicated in patients with known hypersensitivity to pregabalin or any of its components. Angioedema and hypersensitivity reactions have occurred in patients receiving pregabalin therapy [see Warnings and Precautions (5.2) ]. \u2022 Known hypersensitivity to pregabalin or any of its components. ( 4 )",
  "warnings_and_cautions": "\u2022 Angioedema (e.g., swelling of the throat, head and neck) can occur, and may be associated with life-threatening respiratory compromise requiring emergency treatment. Discontinue LYRICA immediately in these cases. ( 5.1 ) \u2022 Hypersensitivity reactions (e.g., hives, dyspnea, and wheezing) can occur. Discontinue LYRICA immediately in these patients. ( 5.2 ) \u2022 Antiepileptic drugs, including LYRICA, increase the risk of suicidal thoughts or behavior. ( 5.3 ) \u2022 Respiratory depression: May occur with LYRICA, when used with concomitant CNS depressants or in the setting of underlying respiratory impairment. Monitor patients and adjust dosage as appropriate. ( 5.4 ) \u2022 LYRICA may cause dizziness and somnolence and impair patients' ability to drive or operate machinery. ( 5.5 ) \u2022 Increased seizure frequency or other adverse reactions may occur if LYRICA is rapidly discontinued. Withdraw LYRICA gradually over a minimum of 1 week. ( 5.6 ) \u2022 LYRICA may cause peripheral edema. Exercise caution when co-administering LYRICA and thiazolidinedione antidiabetic agents. ( 5.7 ) 5.1 Angioedema There have been postmarketing reports of angioedema in patients during initial and chronic treatment with LYRIC...",
  "warnings": "",
  "adverse_reactions": "The following serious adverse reactions are described elsewhere in the labeling: \u2022 Angioedema [see Warnings and Precautions (5.1) ] \u2022 Hypersensitivity [see Warnings and Precautions (5.2) ] \u2022 Suicidal Behavior and Ideation [see Warnings and Precautions (5.3) ] \u2022 Respiratory Depression [see Warnings and Precautions (5.4) ] \u2022 Dizziness and Somnolence [see Warnings and Precautions (5.5) ] \u2022 Increased Risk of Adverse Reactions with Abrupt or Rapid Discontinuation [see Warnings and Precautions (5.6) ] \u2022 Peripheral Edema [see Warnings and Precautions (5.7) ] \u2022 Weight Gain [see Warnings and Precautions (5.8) ] \u2022 Tumorigenic Potential [see Warnings and Precautions (5.9) ] \u2022 Ophthalmological Effects [see Warnings and Precautions (5.10) ] \u2022 Creatine Kinase Elevations [see Warnings and Precautions (5.11) ] \u2022 Decreased Platelet Count [see Warnings and Precautions (5.12) ] \u2022 PR Interval Prolongation [see Warnings and Precautions (5.13) ] Most common adverse reactions (greater than or equal to 5% and twice placebo) in adults are dizziness, somnolence, dry mouth, edema, blurred vision, weight gain, and thinking abnormal (primarily difficulty with concentration/attention). ( 6.1 ) Most common adver...",
  "drug_abuse_and_dependence": "9.1 Controlled Substance LYRICA is a Schedule V controlled substance. LYRICA is not known to be active at receptor sites associated with drugs of abuse. As with any CNS active drug, carefully evaluate patients for history of drug abuse and observe them for signs of LYRICA misuse or abuse (e.g., development of tolerance, dose escalation, drug-seeking behavior). 9.2 Abuse In a study of recreational users (N=15) of sedative/hypnotic drugs, including alcohol, LYRICA (450 mg, single dose) received subjective ratings of \"good drug effect,\" \"high\" and \"liking\" to a degree that was similar to diazepam (30 mg, single dose). In controlled clinical studies in over 5500 patients, 4 % of LYRICA-treated patients and 1 % of placebo-treated patients overall reported euphoria as an adverse reaction, though in some patient populations studied, this reporting rate was higher and ranged from 1 to 12%. 9.3 Dependence In clinical studies, following abrupt or rapid discontinuation of LYRICA, some patients reported symptoms including insomnia, nausea, headache or diarrhea [see Warnings and Precautions (5.6) ] , consistent with physical dependence. In the postmarketing experience, in addition to these repo...",
  "controlled_substance": "9.1 Controlled Substance LYRICA is a Schedule V controlled substance. LYRICA is not known to be active at receptor sites associated with drugs of abuse. As with any CNS active drug, carefully evaluate patients for history of drug abuse and observe them for signs of LYRICA misuse or abuse (e.g., development of tolerance, dose escalation, drug-seeking behavior).",
  "recent_major_changes": "Warnings and Precautions, Respiratory Depression ( 5.4 ) 4/2020",
  "information_for_patients": "Advise the patient to read the FDA-approved patient labeling (Medication Guide). Angioedema Advise patients that LYRICA may cause angioedema, with swelling of the face, mouth (lip, gum, tongue) and neck (larynx and pharynx) that can lead to life-threatening respiratory compromise. Instruct patients to discontinue LYRICA and immediately seek medical care if they experience these symptoms [see Warnings and Precautions (5.1) ] . Hypersensitivity Advise patients that LYRICA has been associated with hypersensitivity reactions such as wheezing, dyspnea, rash, hives, and blisters. Instruct patients to discontinue LYRICA and immediately seek medical care if they experience these symptoms [see Warnings and Precautions (5.2) ] . Suicidal Thinking and Behavior Patients, their caregivers, and families should be counseled that AEDs, including LYRICA, may increase the risk of suicidal thoughts and behavior and should be advised of the need to be alert for the emergence or worsening of symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts about self-harm. Report behaviors of concern immediately to healthcare providers [see Wa...",
  "spl_medguide": "MEDICATION GUIDE LYRICA (LEER-i-kah) (pregabalin) Capsules, CV LYRICA (LEER-i-kah) (pregabalin) Oral Solution, CV This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: 4/2020 Read this Medication Guide before you start taking LYRICA 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. If you have any questions about LYRICA, ask your healthcare provider or pharmacist. What is the most important information I should know about LYRICA? LYRICA may cause serious side effects including: \u2022 serious, even life-threatening, allergic reactions \u2022 suicidal thoughts or actions \u2022 serious breathing problems \u2022 swelling of your hands, legs and feet \u2022 dizziness and sleepiness These serious side effects are described below: \u2022 Serious, even life-threatening, allergic reactions. Stop taking LYRICA and call your healthcare provider right away if you have any of these signs of a serious allergic reaction: \u2022 swelling of your face, mouth, lips, gums, tongue, throat or neck \u2022 trouble breathing \u2022 rash, hives (raised bumps) or blisters \u2022 Like o...",
  "clinical_studies": "14.1 Neuropathic Pain Associated with Diabetic Peripheral Neuropathy The efficacy of the maximum recommended dose of LYRICA for the management of neuropathic pain associated with diabetic peripheral neuropathy was established in three double-blind, placebo-controlled, multicenter studies with three times a day dosing, two of which studied the maximum recommended dose. Patients were enrolled with either Type 1 or Type 2 diabetes mellitus and a diagnosis of painful distal symmetrical sensorimotor polyneuropathy for 1 to 5 years. A total of 89% of patients completed Studies DPN 1 and DPN 2. The patients had a minimum mean baseline pain score of greater than or equal to 4 on an 11-point numerical pain rating scale ranging from 0 (no pain) to 10 (worst possible pain). The baseline mean pain scores across the two studies ranged from 6.1 to 6.7. Patients were permitted up to 4 grams of acetaminophen per day as needed for pain, in addition to pregabalin. Patients recorded their pain daily in a diary. Study DPN 1: This 5-week study compared LYRICA 25, 100, or 200 mg three times a day with placebo. Treatment with LYRICA 100 and 200 mg three times a day statistically significantly improved th...",
  "brand_name": "Lyrica",
  "manufacturer": "Parke-Davis Div of Pfizer Inc",
  "application_number": "NDA021446",
  "pharm_class_epc": [],
  "route": [
   "ORAL"
  ],
  "effective_time": "20200615",
  "set_id": "60185c88-ecfd-46f9-adb9-b97c6b00a553",
  "has_boxed_warning": false,
  "controlled": true,
  "mentions_rems": false
 },
 "faers": {
  "total": 205767,
  "serious": 140116,
  "death": 18767,
  "hospitalization": 64632,
  "primary_suspect": 204772,
  "top_reactions": [
   [
    "Drug Ineffective",
    20968
   ],
   [
    "Pain",
    20294
   ],
   [
    "Fatigue",
    13001
   ],
   [
    "Off Label Use",
    12485
   ],
   [
    "Nausea",
    11658
   ],
   [
    "Headache",
    10654
   ],
   [
    "Malaise",
    10413
   ],
   [
    "Dizziness",
    9980
   ],
   [
    "Pain In Extremity",
    8985
   ],
   [
    "Fall",
    8675
   ],
   [
    "Diarrhoea",
    8635
   ],
   [
    "Dyspnoea",
    8445
   ],
   [
    "Arthralgia",
    8173
   ],
   [
    "Somnolence",
    8138
   ],
   [
    "Condition Aggravated",
    8126
   ]
  ],
  "by_year": {
   "2019": 23580,
   "2020": 19844,
   "2021": 15340,
   "2022": 13304,
   "2023": 11913,
   "2024": 13529,
   "2025": 12995,
   "2026": 6039
  },
  "by_year_primary": {
   "2019": 23568,
   "2020": 19804,
   "2021": 15264,
   "2022": 13113,
   "2023": 11743,
   "2024": 13346,
   "2025": 12804,
   "2026": 5933
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class III",
   "date": "20240516",
   "reason": "Presence of Foreign Tablets/Capsules: Complaint received from a re-packager, American Health Packaging (AHP), where a foreign tablet was discovered in one of the bottles during packaging set up. Tablet identified as pantoprazole tablet 20mg",
   "firm": "Rising Pharma Holding, Inc.",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20211022",
   "reason": "Failed Tablet/Capsule Specifications: Out of Specification results for particle Size Distribution and Bulk Density of the Active Pharmaceutical Ingredient.",
   "firm": "SUN PHARMACEUTICAL INDUSTRIES INC",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20210315",
   "reason": "CGMP Deviations: Intermittent exposure to temperature excursion during storage.",
   "firm": "Cardinal Health Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20160111",
   "reason": "FAILED TABLET/CAPSULE SPECIFICATIONS: Firm is recalling specific lots of pregabalin capsules due to the potential presence of deformed or damaged capsules.",
   "firm": "Pfizer Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20160111",
   "reason": "FAILED TABLET/CAPSULE SPECIFICATIONS: Firm is recalling specific lots of pregabalin capsules due to the potential presence of deformed or damaged capsules.",
   "firm": "Pfizer Inc.",
   "status": "Terminated"
  }
 ],
 "recall_total": 5,
 "drugsfda": {
  "applications": 63,
  "nda": 5,
  "anda": 52,
  "first_approval": "20041230",
  "rems": false,
  "rems_last": "20110426",
  "labeling_supplements": 28,
  "labeling_recent": 6,
  "sponsors": [
   "ACTAVIS ELIZABETH",
   "AIPING PHARM INC",
   "ALEMBIC",
   "ALKEM LABS LTD",
   "ALVOGEN",
   "AMNEAL PHARMS CO",
   "ANDA REPOSITORY",
   "APOTEX"
  ],
  "unapproved": false,
  "first_approval_fmt": "12/30/2004"
 },
 "trials": {
  "total": 636,
  "completed": 380,
  "terminated": 74,
  "with_results": 169,
  "industry": 268,
  "phase3": 150,
  "results_share": 0.44473684210526315,
  "terminated_share": 0.11635220125786164
 },
 "pubmed": {
  "rct": 463,
  "meta": 140,
  "recent_rct": 85,
  "cochrane": [
   {
    "pmid": "35349176",
    "title": "Pregabalin add-on for drug-resistant focal epilepsy",
    "year": "2022"
   },
   {
    "pmid": "31287157",
    "title": "Pregabalin add-on for drug-resistant focal epilepsy",
    "year": "2019"
   },
   {
    "pmid": "30673120",
    "title": "Pregabalin for neuropathic pain in adults",
    "year": "2019"
   },
   {
    "pmid": "27763691",
    "title": "Pregabalin for essential tremor",
    "year": "2016"
   },
   {
    "pmid": "27684492",
    "title": "Pregabalin for pain in fibromyalgia in adults",
    "year": "2016"
   },
   {
    "pmid": "26836292",
    "title": "Pregabalin for decreasing pancreatic pain in chronic pancreatitis",
    "year": "2016"
   },
   {
    "pmid": "24623260",
    "title": "Pregabalin add-on for drug-resistant partial epilepsy",
    "year": "2014"
   },
   {
    "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": "23076957",
    "title": "Pregabalin monotherapy for epilepsy",
    "year": "2012"
   },
   {
    "pmid": "22895982",
    "title": "Pregabalin for chronic prostatitis",
    "year": "2012"
   },
   {
    "pmid": "19588419",
    "title": "Pregabalin for acute and chronic pain in adults",
    "year": "2009"
   }
  ]
 },
 "payments": {
  "year": "2024",
  "usd": 19431.2,
  "records": 5,
  "by_name": [
   [
    "Lyrica",
    19431.2
   ]
  ],
  "names_checked": [
   "pregabalin",
   "Lyrica"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 7578719,
  "beneficiaries": 1506154,
  "spend": 263138234.38,
  "by_brand": [
   {
    "brand": "Pregabalin",
    "claims": 7507278,
    "per_claim": 26.538947215,
    "is_generic": true
   },
   {
    "brand": "Lyrica",
    "claims": 65724,
    "per_claim": 943.87900219,
    "is_generic": false
   },
   {
    "brand": "Pregabalin ER",
    "claims": 5417,
    "per_claim": 287.2585767,
    "is_generic": false
   },
   {
    "brand": "Lyrica Cr",
    "claims": 300,
    "per_claim": 1037.9885333,
    "is_generic": false
   }
  ],
  "per_claim": 34.72067434879166
 },
 "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": "pregabalin"
  }
 ],
 "settlements": [
  {
   "year": 2009,
   "company": "Pfizer",
   "amount_usd": 2300000000.0,
   "amount_text": "$2.3 billion",
   "violations": "Off-label promotion, kickbacks",
   "products": "Bextra, Geodon, Zyvox, Lyrica",
   "laws": "False Claims Act, FDCA",
   "urls": [
    "https://www.justice.gov/opa/pr/justice-department-announces-largest-health-care-fraud-settlement-its-history"
   ],
   "matched": "lyrica"
  }
 ],
 "prescrire": null,
 "eml": {
  "listed": false,
  "status": "",
  "name": "",
  "matched": null,
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 32083,
  "fills": 7578719,
  "per_million": 4233.301168706743,
  "ratio": 1.5288472327501565,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 73,
   "letter": "C",
   "why": [
    "FDA issued 1 Drug Safety Communication(s) naming this drug since 2010, most recently 2019 (-8)",
    "4,233 FDA reports naming it as the suspect drug per million Medicare fills, 1.5x the median drug on this site (-4)",
    "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": [
    "463 randomized trials and 140 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": 81,
   "letter": "B",
   "why": [
    "Recalls since 2016: 0 Class I, 4 Class II, 1 Class III across 52 generic makers (-6)",
    "6 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": 75,
   "letter": "B",
   "why": [
    "Maker paid $2.3 billion in 2009 to settle federal allegations naming this drug (Off-label promotion, kickbacks) (-25)",
    "Pharma paid doctors $19,431 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 (52 applications)",
    "1 same-class alternative(s) (-10)"
   ],
   "weight": 0.1
  }
 },
 "total": 77,
 "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 $2.3 billion in 2009 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 pain, 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?",
  "Why this one over gabapentin? 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.)"
 ]
}