{
 "query": "lidocaine",
 "ingredient": "lidocaine",
 "slug": "lidocaine",
 "rxcui": "6387",
 "brands": [
  "ZTlido",
  "Glydo",
  "Lidoderm",
  "Xylocaine",
  "Akten",
  "Alocane",
  "AneCream",
  "Bruselix",
  "Burn Jel Plus",
  "Lido King",
  "Lidocan",
  "Lidocream",
  "Lidoguard",
  "Lidoguard Pain Relief",
  "Lidotral",
  "Lidotran",
  "Lipocaine",
  "LMX",
  "Lydexa",
  "RadiaGuard",
  "Recticare",
  "Regenecare",
  "Solarcaine",
  "Topicaine",
  "Topicaine Ultra",
  "Tranzarel",
  "Tridacaine",
  "Xolido",
  "Zingo",
  "Zionodil"
 ],
 "names": [
  "lidocaine",
  "lidocaine hydrochloride",
  "lidocaine hydrochloride anhydrous"
 ],
 "classes": [
  {
   "id": "C01BB",
   "name": "Antiarrhythmics, class Ib"
  },
  {
   "id": "C05AD",
   "name": "Local anesthetics"
  },
  {
   "id": "D04AB",
   "name": "Anesthetics for topical use"
  },
  {
   "id": "N01BB",
   "name": "Amides"
  },
  {
   "id": "R02AD",
   "name": "Anesthetics, local"
  },
  {
   "id": "S01HA",
   "name": "Local anesthetics"
  },
  {
   "id": "S02DA",
   "name": "Analgesics and anesthetics"
  }
 ],
 "alternatives": [
  "ambroxol",
  "antipyrine",
  "aprindine",
  "articaine",
  "benoxinate",
  "benzocaine",
  "bupivacaine",
  "chloroprocaine",
  "cocaine",
  "dibucaine",
  "dyclonine",
  "etidocaine",
  "levobupivacaine",
  "mepivacaine",
  "mexiletine",
  "pramoxine",
  "prilocaine",
  "procaine",
  "proparacaine",
  "ropivacaine",
  "tetracaine",
  "tocainide"
 ],
 "label": {
  "route_mode": "TOPICAL",
  "route_counts": {
   "TOPICAL": 1330,
   "INFILTRATION": 116,
   "PERINEURAL": 102,
   "EPIDURAL": 44,
   "TRANSDERMAL": 44,
   "INTRACAUDAL": 43,
   "CUTANEOUS": 40,
   "INTRAVENOUS": 30,
   "RECTAL": 24,
   "ORAL": 22,
   "SUBMUCOSAL": 17,
   "PERCUTANEOUS": 8,
   "AURICULAR (OTIC)": 3,
   "EXTRACORPOREAL": 2,
   "OROPHARYNGEAL": 2,
   "OPHTHALMIC": 1,
   "PERIODONTAL": 1,
   "RETROBULBAR": 1,
   "TRANSTRACHEAL": 1
  },
  "boxed_warning": "",
  "indications_and_usage": "is indicated for relief of pain associated with post-herpetic neuralgia (PHN) in adults. ZTLIDO contains lidocaine, an amide local anesthetic, and is indicated for relief of pain associated with post-herpetic neuralgia (PHN) in adults ( 1 ).",
  "contraindications": "is contraindicated in patients with a known history of sensitivity to local anesthetics of the amide type, or to any other component of the product. ZTLIDO is contraindicated in patients with a known history of sensitivity to local anesthetics of the amide type, or to any other component of the product. ( 4 )",
  "warnings_and_cautions": "Accidental Exposure : Even a used ZTLIDO topical system contains residual lidocaine after use. It is important for patients to store and dispose of ZTLIDO properly and keep out of the reach of children, pets, and others. ( 5.1 ) Excessive Dosing/Overexposure : Applying ZTLIDO to larger surface areas or for a longer duration than recommended could lead to increased absorption and high blood concentrations of lidocaine, leading to adverse effects. ( 5.2 ) Increased Absorption on Non-Intact Skin : May result in higher blood concentrations of lidocaine. ( 5.2 ) Risk of Overexposure with External Heat Sources : Applying external heat sources to ZTLIDO may result in increased drug exposure. ( 5.2 ) Methemoglobinemia : Cases of methemoglobinemia have been reported in association with local anesthetic use. ( 5.3 ) Application Site Reactions : During or immediately after treatment with ZTLIDO, application site reactions may develop. ( 5.4 ) Hypersensitivity Reactions : Cross sensitivity to ZTLIDO in patients with a history of drug sensitivity to para-aminobenzoic acid (PABA) derivatives is possible. ( 5.5 ) Eye Exposure : Immediately wash out the eye with water or saline and protect the eye...",
  "warnings": "",
  "adverse_reactions": "The following serious adverse reactions are described elsewhere in the labeling: Excessive Dosing/Overexposure to Lidocaine [see Warnings and Precautions (5.2) ] Methemoglobinemia [see Warnings and Precautions (5.3) ] Application Site Reactions [see Warnings and Precautions (5.4) ] Hypersensitivity Reactions [see Warnings and Precautions (5.5) ] Eye Irritation [see Warnings and Precautions (5.6) ] The following adverse reactions from voluntary reports or clinical studies have been reported with lidocaine. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Skin and subcutaneous tissues : blisters, bruising, burning sensation, depigmentation, dermatitis, discoloration, edema, erosions, erythema, exfoliation, flushing, irritation, papules, petechia, pruritus, vesicles, and abnormal sensation. Immune system : angioedema, bronchospasm, dermatitis, dyspnea, hypersensitivity, laryngospasm, pruritus, shock, and urticaria. Central Nervous System : lightheadedness, nervousness, apprehension, euphoria, confusion, dizziness, drowsiness,...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "Dosage and Administration ( 2.1 ) 4/2021",
  "information_for_patients": "Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use). Accidental Exposure and Disposal Advise patients to store ZTLIDO out of the reach of children, pets, and others. Advise patients to dispose of used ZTLIDO by folding used ZTLIDO so that the adhesive side sticks to itself and safely discarding used ZTLIDO or pieces of cut ZTLIDO where children, pets, and others cannot come in contact with them [see Warnings and Precautions (5.1) ] . Proper Application Advise patients: not to apply more than the prescribed number (up to 3 ZTLIDO) [see Dosage and Administration (2.2) , Warnings and Precautions (5.2) ]. not to wear ZTLIDO longer than the recommended wearing time (12 hours of every 24 hours) [see Dosage and Administration (2.2) , Warnings and Precautions (5.2) ]. to apply ZTLIDO to intact skin [see Warnings and Precautions (5.2) ]. to reattach by pressing firmly on the edges of ZTLIDO that are lifting. If a ZTLIDO topical system comes off completely and will not stick to patient's skin, it should be removed and properly disposed of and a new ZTLIDO topical system should be applied for a total duration of 12 hours of used and new ...",
  "spl_medguide": "",
  "clinical_studies": "Single-dose treatment with lidocaine patch (currently preferred dosage form term for a patch is topical system) was compared to treatment with vehicle patch (without lidocaine), and to no treatment (observation only) in a double-blind, crossover clinical trial with 35 post-herpetic neuralgia patients. Pain intensity and pain relief scores were evaluated periodically for 12 hours. Lidocaine patch performed statistically better than vehicle patch in terms of pain intensity from 4 to 12 hours. Multiple-dose, two-week treatment with lidocaine patch was compared to vehicle patch (without lidocaine) in a double-blind, crossover clinical trial of withdrawal-type design conducted in 32 patients, who were considered as responders to the open-label use of lidocaine patch prior to the study. The constant type of pain was evaluated but not the pain induced by sensory stimuli (dysesthesia). Statistically significant differences favoring lidocaine patch were observed in terms of time to exit from the trial (14 versus 3.8 days at p-value <0.001), daily average pain relief, and patient's preference of treatment. About half of the patients also took oral medication commonly used in the treatment of...",
  "brand_name": "Ztlido",
  "manufacturer": "Scilex Pharmaceuticals Inc.",
  "application_number": "NDA207962",
  "pharm_class_epc": [
   "Amide Local Anesthetic [EPC]",
   "Antiarrhythmic [EPC]"
  ],
  "route": [
   "TOPICAL"
  ],
  "effective_time": "20241101",
  "set_id": "a1b17507-4560-490d-a388-74e7fd7eaa5e",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 69512,
  "serious": 44901,
  "death": 5872,
  "hospitalization": 22287,
  "primary_suspect": 69357,
  "top_reactions": [
   [
    "Drug Ineffective",
    5654
   ],
   [
    "Off Label Use",
    4870
   ],
   [
    "Nausea",
    3929
   ],
   [
    "Fatigue",
    3912
   ],
   [
    "Pain",
    3719
   ],
   [
    "Headache",
    3593
   ],
   [
    "Product Adhesion Issue",
    3544
   ],
   [
    "Product Quality Issue",
    3303
   ],
   [
    "Dyspnoea",
    2891
   ],
   [
    "Diarrhoea",
    2735
   ],
   [
    "Pneumonia",
    2459
   ],
   [
    "Vomiting",
    2337
   ],
   [
    "Sinusitis",
    2265
   ],
   [
    "Dizziness",
    2258
   ],
   [
    "Fall",
    2129
   ]
  ],
  "by_year": {
   "2019": 6819,
   "2020": 8154,
   "2021": 5443,
   "2022": 4683,
   "2023": 5525,
   "2024": 5965,
   "2025": 6115,
   "2026": 3059
  },
  "by_year_primary": {
   "2019": 6817,
   "2020": 8153,
   "2021": 5414,
   "2022": 4651,
   "2023": 5507,
   "2024": 5926,
   "2025": 6092,
   "2026": 3052
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class II",
   "date": "20260831",
   "reason": "Failed Content Uniformity Specifications. Out of Specification for Assay during analysis at the 24- month long term stability station, at (25\u00bfC,60%RH).",
   "firm": "SUN PHARMA /TARO",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20260716",
   "reason": "Presence of Particulate Matter: Hair was found in products",
   "firm": "Fresenius Kabi USA, LLC",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20260608",
   "reason": "Lack of Assurance of Sterility",
   "firm": "Asclemed USA Inc.",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20260608",
   "reason": "Lack of Assurance of Sterility",
   "firm": "Asclemed USA Inc.",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20260512",
   "reason": "Lack of Assurance of Sterility",
   "firm": "Spectra Medical Devices, Llc",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20260402",
   "reason": "Lack of Assurance of Sterility",
   "firm": "Huons Co., Ltd.",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20260402",
   "reason": "Lack of Assurance of Sterility",
   "firm": "Huons Co., Ltd.",
   "status": "Ongoing"
  },
  {
   "class": "Class III",
   "date": "20230420",
   "reason": "Labeling: Typographical error on the upper left-hand side of the box and individual patch label that has the incorrect dosage form stating, each tablet contains instead of each adhesive patch contains.",
   "firm": "Bryant Ranch Prepack, Inc.",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20220413",
   "reason": "cGMP deviations: Temperature abuse",
   "firm": "Mckesson Medical-Surgical Inc. Corporate Office",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20211130",
   "reason": "Superpotent Drug: Minimally superpotent",
   "firm": "Teligent Pharma, Inc.",
   "status": "Ongoing"
  },
  {
   "class": "Class I",
   "date": "20211130",
   "reason": "Superpotent Drug",
   "firm": "Teligent Pharma, Inc.",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20211012",
   "reason": "CGMP Deviations: Lots recalled because they were manufactured at the same facility using the same components as the products that had cracked seals in caps that were found to be superpotent.",
   "firm": "Teligent Pharma, Inc.",
   "status": "Terminated"
  }
 ],
 "recall_total": 16,
 "drugsfda": {
  "applications": 150,
  "nda": 29,
  "anda": 118,
  "first_approval": "19481119",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 159,
  "labeling_recent": 6,
  "sponsors": [
   "ABBOTT",
   "ABRAXIS PHARM",
   "ACTAVIS LABS UT INC",
   "ACTAVIS MID ATLANTIC",
   "ALEMBIC",
   "ALKEM LABS LTD",
   "AM REGENT",
   "AMNEAL"
  ],
  "unapproved": false,
  "first_approval_fmt": "11/19/1948"
 },
 "trials": {
  "total": 4169,
  "completed": 2352,
  "terminated": 364,
  "with_results": 549,
  "industry": 408,
  "phase3": 419,
  "results_share": 0.23341836734693877,
  "terminated_share": 0.08731110578076277
 },
 "pubmed": {
  "rct": 2486,
  "meta": 199,
  "recent_rct": 433,
  "cochrane": [
   {
    "pmid": "35658539",
    "title": "Topical anaesthesia plus intracameral lidocaine versus topical anaesthesia alone for phacoemulsification cataract surgery in adults",
    "year": "2020"
   },
   {
    "pmid": "31786810",
    "title": "Transient neurological symptoms (TNS) following spinal anaesthesia with lidocaine versus other local anaesthetics in adult surgical patients: a network meta-analysis",
    "year": "2019"
   },
   {
    "pmid": "29864216",
    "title": "Continuous intravenous perioperative lidocaine infusion for postoperative pain and recovery in adults",
    "year": "2018"
   },
   {
    "pmid": "26888026",
    "title": "Lidocaine for reducing propofol-induced pain on induction of anaesthesia in adults",
    "year": "2016"
   },
   {
    "pmid": "26295202",
    "title": "Prophylactic lidocaine for myocardial infarction",
    "year": "2015"
   },
   {
    "pmid": "26184397",
    "title": "Continuous intravenous perioperative lidocaine infusion for postoperative pain and recovery",
    "year": "2015"
   },
   {
    "pmid": "26171894",
    "title": "Lidocaine for preventing postoperative sore throat",
    "year": "2015"
   },
   {
    "pmid": "25993661",
    "title": "WITHDRAWN: Adjusting the pH of lidocaine for reducing pain on injection",
    "year": "2015"
   },
   {
    "pmid": "25840001",
    "title": "WITHDRAWN: Lidocaine-prilocaine cream for analgesia during circumcision in newborn boys",
    "year": "2015"
   },
   {
    "pmid": "25790261",
    "title": "Adrenaline with lidocaine for digital nerve blocks",
    "year": "2015"
   },
   {
    "pmid": "25321859",
    "title": "Intravenous lidocaine for the treatment of background or procedural burn pain",
    "year": "2014"
   },
   {
    "pmid": "25058164",
    "title": "Topical lidocaine for neuropathic pain in adults",
    "year": "2014"
   }
  ]
 },
 "payments": {
  "year": "2024",
  "usd": 746228.14,
  "records": 17572,
  "by_name": [
   [
    "ZTlido",
    466123.79
   ],
   [
    "Akten",
    255890.64
   ],
   [
    "Lidoderm",
    21403.25
   ],
   [
    "lidocaine",
    1765.26
   ],
   [
    "Glydo",
    1045.2
   ]
  ],
  "names_checked": [
   "lidocaine",
   "ZTlido",
   "Glydo",
   "Lidoderm",
   "Xylocaine",
   "Akten",
   "Alocane",
   "AneCream",
   "Bruselix",
   "Burn Jel Plus",
   "Lido King",
   "Lidocan",
   "Lidocream",
   "Lidoguard",
   "Lidoguard Pain Relief",
   "Lidotral",
   "Lidotran",
   "Lipocaine",
   "LMX",
   "Lydexa",
   "RadiaGuard",
   "Recticare",
   "Regenecare",
   "Solarcaine",
   "Topicaine",
   "Topicaine Ultra",
   "Tranzarel",
   "Tridacaine",
   "Xolido",
   "Zingo",
   "Zionodil"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 2303013,
  "beneficiaries": 966744,
  "spend": 226780696.99,
  "by_brand": [
   {
    "brand": "Lidocaine",
    "claims": 1671489,
    "per_claim": 95.743812337,
    "is_generic": true
   },
   {
    "brand": "Lidocaine HCl Viscous",
    "claims": 410786,
    "per_claim": 15.305799054,
    "is_generic": false
   },
   {
    "brand": "Lidocaine HCl",
    "claims": 127427,
    "per_claim": 15.331317696,
    "is_generic": true
   },
   {
    "brand": "Ztlido",
    "claims": 81208,
    "per_claim": 621.35133497,
    "is_generic": false
   },
   {
    "brand": "Glydo",
    "claims": 8472,
    "per_claim": 45.39684136,
    "is_generic": false
   },
   {
    "brand": "Dermacinrx Lidocan",
    "claims": 1567,
    "per_claim": 3085.2608488,
    "is_generic": false
   },
   {
    "brand": "Lidoderm",
    "claims": 583,
    "per_claim": 1102.051235,
    "is_generic": false
   },
   {
    "brand": "Dermacinrx Lidogel",
    "claims": 477,
    "per_claim": 2649.8956813,
    "is_generic": false
   },
   {
    "brand": "Lidocan III",
    "claims": 363,
    "per_claim": 1424.0147658,
    "is_generic": false
   },
   {
    "brand": "Xylocaine",
    "claims": 306,
    "per_claim": 10.160326797,
    "is_generic": false
   },
   {
    "brand": "Lidocan IV",
    "claims": 157,
    "per_claim": 1104.584586,
    "is_generic": false
   },
   {
    "brand": "Lidocan V",
    "claims": 141,
    "per_claim": 646.74184397,
    "is_generic": false
   },
   {
    "brand": "Tridacaine III",
    "claims": 37,
    "per_claim": 3672.922973,
    "is_generic": false
   }
  ],
  "per_claim": 98.47130562875677
 },
 "mdl": [],
 "dsc": [
  {
   "date": "20140626",
   "title": "FDA recommends not using lidocaine to treat teething pain and requires new Boxed Warning",
   "url": "https://www.fda.gov/Drugs/DrugSafety/ucm402240.htm",
   "kind": "drug",
   "matched": "lidocaine"
  }
 ],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": true,
  "status": "AddedToEml",
  "name": "lidocaine",
  "matched": "lidocaine",
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 15070,
  "fills": 2303013,
  "per_million": 6543.601794692431,
  "ratio": 2.3632071278053473,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 60,
   "letter": "D",
   "why": [
    "FDA issued 1 Drug Safety Communication(s) naming this drug since 2010, most recently 2014 (-8)",
    "6,544 FDA reports naming it as the suspect drug per million Medicare fills, 2.4x the median drug on this site (-7)",
    "Death share in reports is near or below the FAERS average (0.9x)",
    "Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)",
    "3 Class I recall(s): reasonable probability of serious harm (-20)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 76,
   "letter": "B",
   "why": [
    "2486 randomized trials and 199 systematic reviews/meta-analyses indexed in PubMed",
    "On the WHO Model List of Essential Medicines (shown for context; no score effect)",
    "12 independent Cochrane review(s) exist",
    "Only 23% of completed registered trials posted results (-15)",
    "'Drug ineffective' is the single most-reported item about this drug in FAERS (-5)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 58,
   "letter": "D",
   "why": [
    "Recalls since 2016: 1 Class I, 11 Class II, 2 Class III across 118 generic makers (-29)",
    "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": 85,
   "letter": "B",
   "why": [
    "Pharma paid doctors $746,228 tied to this drug last year (-15)",
    "Not named in any pending federal MDL"
   ],
   "weight": 0.15
  },
  "options": {
   "score": 100,
   "letter": "A",
   "why": [
    "Generic versions approved (118 applications)",
    "22 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 71,
 "grade": "C",
 "questions": [
  "In 2014 the FDA issued a safety communication about this drug (FDA recommends not using lidocaine to treat teething pain and requires new Boxed Warning). Does that risk apply to me?",
  "The most-reported problems in FDA's adverse event data are nausea, 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 ambroxol, antipyrine, aprindine? 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.)"
 ]
}