{
 "query": "terbinafine",
 "ingredient": "terbinafine",
 "slug": "terbinafine",
 "rxcui": "37801",
 "brands": [
  "Lamisil",
  "Silka Cream"
 ],
 "names": [
  "terbinafine",
  "terbinafine hydrochloride"
 ],
 "classes": [
  {
   "id": "D01BA",
   "name": "Antifungals for systemic use"
  }
 ],
 "alternatives": [
  "griseofulvin"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 39,
   "TOPICAL": 34
  },
  "boxed_warning": "",
  "indications_and_usage": "1. INDICATIONS AND USAGE Terbinafine tablets are indicated for the treatment of onychomycosis of the toenail or fingernail due to dermatophytes (tinea unguium). Prior to initiating treatment, appropriate nail specimens for laboratory testing [potassium hydroxide (KOH) preparation, fungal culture, or nail biopsy] should be obtained to confirm the diagnosis of onychomycosis. Terbinafine tablets are an allylamine antifungal indicated for the treatment of onychomycosis of the toenail or fingernail due to dermatophytes (tinea unguium). ( 1 )",
  "contraindications": "4. CONTRAINDICATIONS Terbinafine tablets are contraindicated in patients with: \u2022 History of allergic reaction to oral terbinafine because of the risk of anaphylaxis [see Adverse Reactions (6.2) ] \u2022 Chronic or active liver disease [see Warnings and Precautions (5.1) ] \u2022 History of allergic reaction to oral terbinafine because of the risk of anaphylaxis. ( 4 ) \u2022 Chronic or active liver disease. ( 4 )",
  "warnings_and_cautions": "5. WARNINGS AND PRECAUTIONS \u2022 Liver failure, sometimes leading to liver transplant or death, has occurred with the use of oral terbinafine. Obtain pretreatment serum transaminases. Prior to initiating treatment and periodically during therapy, assess liver function tests. Discontinue Terbinafine tablets if liver injury develops. ( 5.1 ) \u2022 Taste disturbance, including taste loss, has been reported with the use of Terbinafine tablets. Taste disturbance can be severe, may be prolonged, or may be permanent. Discontinue Terbinafine tablets if taste disturbance occurs. ( 5.2 ) \u2022 Smell disturbance, including loss of smell, has been reported with the use of Terbinafine tablets. Smell disturbance may be prolonged, or may be permanent. Discontinue Terbinafine tablets if smell disturbance occurs. ( 5.3 ) \u2022 Depressive symptoms have been reported with terbinafine use. Prescribers should be alert to the development of depressive symptoms. ( 5.4 ) \u2022 Severe neutropenia has been reported. If the neutrophil count is less than or equal to 1000 cells/mm 3 , Terbinafine tablets should be discontinued. ( 5.5 ) \u2022 Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, exfoliative derma...",
  "warnings": "",
  "adverse_reactions": "6. ADVERSE REACTIONS Common (greater than 2% of patients treated with Terbinafine tablets) reported adverse events include headache, diarrhea, rash, dyspepsia, liver enzyme abnormalities, pruritus, taste disturbance, nausea, abdominal pain, and flatulence. ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Breckenridge Pharmaceutical, Inc. at 1-800-367-3395, or go to www.bpirx.com, 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 in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The most frequently reported adverse events observed in the 3 US/Canadian placebo-controlled trials are listed in the table below. The adverse events reported encompass gastrointestinal symptoms (including diarrhea, dyspepsia, and abdominal pain), liver test abnormalities, rashes, urticaria, pruritus, and taste disturbances. Changes in the ocular lens and retina have been reported following the use of Terbinafine tablets in controlled trials. The clinical significance o...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "Dosage and Administration: Assessment Prior to Initiation ( 2.1 ) 8/2016 Contraindications ( 4 ) 8/2016 Warnings and Precautions: Hepatotoxicty ( 5.1 ) 8/2016 Warnings and Precautions: Thrombotic Microangiopathy ( 5.8 ) 1/2017",
  "information_for_patients": "17. PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-Approved Medication Guide. Patients taking Terbinafine tablets should receive the following information and instructions: \u2022 Advise patients to immediately report to their physician or get emergency help if they experience any of the following symptoms: hives, mouth sores, blistering and peeling of skin, swelling of face, lips, tongue, or throat, difficulty swallowing or breathing. Terbinafine tablets treatment should be discontinued. \u2022 Advise patients to immediately report to their physician any symptoms of persistent nausea, anorexia, fatigue, vomiting, right upper abdominal pain, jaundice, dark urine, or pale stools. Terbinafine tablets treatment should be discontinued. \u2022 Advise patients to report to their physician any signs of taste disturbance, smell disturbance and/or depressive symptoms, fever, skin eruption, lymph node enlargement, erythema, scaling, loss of pigment, and unusual photosensitivity that can result in a rash. Terbinafine tablets treatment should be discontinued. \u2022 Advise patients to minimize exposure to natural and artificial sunlight (tanning beds or UVA/B treatment) while using Terbinafine ...",
  "spl_medguide": "MEDICATION GUIDE TERBINAFINE (ter' bin a feen) hydrochloride Tablets What is the most important information I should know about Terbinafine tablets? Terbinafine tablets may cause serious side effects, including: \u2022 Liver problems that can lead to the need for a liver transplant or death . This can happen in people who have liver problems and in people who have never had liver problems. Tell your doctor right away if you get any of these symptoms of liver problems: Your doctor should do a blood test to check you for liver problems before you start treatment with Terbinafine tablets. Your doctor may also check you for liver problems during treatment, and tell you to stop taking Terbinafine tablets if you develop liver problems. \u2022 nausea \u2022 poor appetite \u2022 tiredness \u2022 vomiting \u2022 upper right stomach-area (abdomen) pain \u2022 yellowing of your skin or eyes (jaundice) \u2022 dark (tea-colored) urine \u2022 pale or light colored stools What are Terbinafine tablets? Terbinafine tablets are a prescription medicine used to treat fungal infections of the fingernails and toenails (onychomycosis). Your doctor should do tests to check you for fungal infection of your nails before you start Terbinafine tablets. ...",
  "clinical_studies": "14. CLINICAL STUDIES The efficacy of Terbinafine tablets in the treatment of onychomycosis is illustrated by the response of subjects with toenail and/or fingernail infections who participated in 3 US/Canadian placebo-controlled clinical trials. Results of the first toenail trial, as assessed at week 48 (12 weeks of treatment with 36 weeks follow-up after completion of therapy), demonstrated mycological cure, defined as simultaneous occurrence of negative KOH plus negative culture, in 70% of subjects. Fifty-nine percent (59%) of subjects experienced effective treatment (mycological cure plus 0% nail involvement or greater than 5mm of new unaffected nail growth); 38% of subjects demonstrated mycological cure plus clinical cure (0% nail involvement). In a second toenail trial of dermatophytic onychomycosis, in which nondermatophytes were also cultured, similar efficacy against the dermatophytes was demonstrated. The pathogenic role of the nondermatophytes cultured in the presence of dermatophytic onychomycosis has not been established. The clinical significance of this association is unknown. Results of the fingernail trial, as assessed at week 24 (6 weeks of treatment with 18 weeks ...",
  "brand_name": "Terbinafine Hydrochloride",
  "manufacturer": "Aphena Pharma Solutions - Tennessee, LLC",
  "application_number": "ANDA077714",
  "pharm_class_epc": [],
  "route": [
   "ORAL"
  ],
  "effective_time": "20171215",
  "set_id": "808dab18-43f1-4895-a023-edbde722863e",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 11478,
  "serious": 7901,
  "death": 576,
  "hospitalization": 2818,
  "primary_suspect": 11415,
  "top_reactions": [
   [
    "Drug Ineffective",
    1188
   ],
   [
    "Rash",
    627
   ],
   [
    "Pruritus",
    579
   ],
   [
    "Fatigue",
    561
   ],
   [
    "Nausea",
    506
   ],
   [
    "Off Label Use",
    494
   ],
   [
    "Pain",
    476
   ],
   [
    "Ageusia",
    416
   ],
   [
    "Headache",
    406
   ],
   [
    "Diarrhoea",
    386
   ],
   [
    "Dyspnoea",
    347
   ],
   [
    "Product Use In Unapproved Indication",
    346
   ],
   [
    "Arthralgia",
    327
   ],
   [
    "Weight Decreased",
    321
   ],
   [
    "Condition Aggravated",
    310
   ]
  ],
  "by_year": {
   "2019": 1195,
   "2020": 1140,
   "2021": 888,
   "2022": 773,
   "2023": 838,
   "2024": 843,
   "2025": 855,
   "2026": 365
  },
  "by_year_primary": {
   "2019": 1194,
   "2020": 1139,
   "2021": 878,
   "2022": 758,
   "2023": 830,
   "2024": 830,
   "2025": 852,
   "2026": 358
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [],
 "recall_total": 0,
 "drugsfda": {
  "applications": 25,
  "nda": 8,
  "anda": 13,
  "first_approval": "19921230",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 32,
  "labeling_recent": 0,
  "sponsors": [
   "ANDRX PHARM",
   "AUROBINDO PHARMA",
   "BRECKENRIDGE PHARM",
   "CHARTWELL",
   "CIPLA",
   "EMED MEDCL",
   "GEDEON RICHTER USA",
   "GLENMARK PHARMS LTD"
  ],
  "unapproved": false,
  "first_approval_fmt": "12/30/1992"
 },
 "trials": {
  "total": 64,
  "completed": 35,
  "terminated": 4,
  "with_results": 9,
  "industry": 39,
  "phase3": 14,
  "results_share": 0.2571428571428571,
  "terminated_share": 0.0625
 },
 "pubmed": {
  "rct": 179,
  "meta": 15,
  "recent_rct": 8,
  "cochrane": []
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "terbinafine",
   "Lamisil",
   "Silka Cream"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 799100,
  "beneficiaries": 457511,
  "spend": 9669314.77,
  "by_brand": [
   {
    "brand": "Terbinafine HCl",
    "claims": 799100,
    "per_claim": 12.100256251,
    "is_generic": true
   }
  ],
  "per_claim": 12.10025625078213
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": true,
  "status": "AddedToEml",
  "name": "terbinafine",
  "matched": "terbinafine",
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 2040,
  "fills": 799100,
  "per_million": 2552.8719809786007,
  "ratio": 0.9219639964517055,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 100,
   "letter": "A",
   "why": [
    "2,553 FDA reports naming it as the suspect drug per million Medicare fills, 0.9x the median drug on this site",
    "Death share in reports is near or below the FAERS average (0.6x)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 42,
   "letter": "F",
   "why": [
    "179 randomized trials and 15 systematic reviews/meta-analyses indexed in PubMed",
    "On the WHO Model List of Essential Medicines (shown for context; no score effect)",
    "No Cochrane review found (-5)",
    "Only 26% 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": 95,
   "letter": "A",
   "why": [
    "No recalls on record since 2016",
    "Label lists recent major changes to warnings or indications (-5)"
   ],
   "weight": 0.15
  },
  "conflict": {
   "score": 100,
   "letter": "A",
   "why": [
    "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 (13 applications)",
    "1 same-class alternative(s) (-10)"
   ],
   "weight": 0.1
  }
 },
 "total": 84,
 "grade": "B",
 "questions": [
  "The most-reported problems in FDA's adverse event data are rash, pruritus, 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 griseofulvin? 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.)"
 ]
}