{
 "query": "ciclopirox",
 "ingredient": "ciclopirox",
 "slug": "ciclopirox",
 "rxcui": "21090",
 "brands": [
  "Ciclodan",
  "Loprox"
 ],
 "names": [
  "ciclopirox",
  "ciclopirox olamine"
 ],
 "classes": [],
 "alternatives": [],
 "label": {
  "route_mode": "TOPICAL",
  "route_counts": {
   "TOPICAL": 38
  },
  "boxed_warning": "",
  "indications_and_usage": "INDICATIONS AND USAGE (To understand fully the indication for this product, please read the entire INDICATIONS AND USAGE section of the labeling.) Ciclopirox Topical Solution, 8% as a component of a comprehensive management program, is indicated as topical treatment in immunocompetent patients with mild to moderate onychomycosis of fingernails and toenails without lunula involvement, due to Trichophyton rubrum . The comprehensive management program includes removal of the unattached, infected nails as frequently as monthly, by a health care professional who has special competence in the diagnosis and treatment of nail disorders, including minor nail procedures. \u2022 No studies have been conducted to determine whether ciclopirox might reduce the effectiveness of systemic antifungal agents for onychomycosis. Therefore, the concomitant use of 8% ciclopirox topical solution and systemic antifungal agents for onychomycosis, is not recommended. \u2022 Ciclopirox Topical Solution, 8% should be used only under medical supervision as described above. \u2022 The effectiveness and safety of ciclopirox topical solution, 8% in the following populations has not been studied. The clinical trials with use of c...",
  "contraindications": "CONTRAINDICATIONS Ciclopirox Topical Solution, 8% is contraindicated in individuals who have shown hypersensitivity to any of its components.",
  "warnings_and_cautions": "",
  "warnings": "WARNINGS Ciclopirox Topical Solution, 8% is not for ophthalmic, oral, or intravaginal use. It is for use on nails and immediately adjacent skin only.",
  "adverse_reactions": "ADVERSE REACTIONS In the vehicle-controlled clinical trials conducted in the United States, 9% (30/327) of patients treated with ciclopirox topical solution, 8%, and 7% (23/328) of patients treated with vehicle reported treatment-emergent adverse events (TEAE) considered by the investigator to be causally related to the test material. The incidence of these adverse events, within each body system, was similar between the treatment groups except for skin and appendages: 8% (27/327) and 4% (14/328) of subjects in the ciclopirox and vehicle groups reported at least one adverse event, respectively. The most common were rash-related adverse events: periungual erythema and erythema of the proximal nail fold were reported more frequently in patients treated with ciclopirox topical solution, 8%, (5% [16/327]) than in patients treated with vehicle (1% [3/328]). Other TEAEs thought to be causally related included nail disorders such as shape change, irritation, ingrown toenail, and discoloration. The incidence of nail disorders was similar between the treatment groups (2% [6/327] in the ciclopirox topical solution, 8%, group and 2% [7/328] in the vehicle group). Moreover, application site re...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "",
  "information_for_patients": "Information for Patients Patients should have detailed instructions regarding the use of Ciclopirox Topical Solution, 8% as a component of a comprehensive management program for onychomycosis in order to achieve maximum benefit with the use of this product. The patient should be told to: 1. Use Ciclopirox Topical Solution, 8% as directed by a health care professional. Avoid contact with the eyes and mucous membranes. Contact with skin other than skin immediately surrounding the treated nail(s) should be avoided. Ciclopirox Topical Solution, 8% is for external use only. 2. Ciclopirox Topical Solution, 8% should be applied evenly over the entire nail plate and 5 mm of surrounding skin. If possible, Ciclopirox Topical Solution, 8% should be applied to the nail bed, hyponychium, and the under surface of the nail plate when it is free of the nail bed (e.g., onycholysis). Contact with the surrounding skin may produce mild, transient irritation (redness). 3. Removal of the unattached, infected nail, as frequently as monthly, by a health care professional is needed with use of this medication. Inform a health care professional if they have diabetes or problems with numbness in the toes or ...",
  "spl_medguide": "",
  "clinical_studies": "Clinical Trials Data - The results of use of ciclopirox topical solution, 8% in treatment of onychomycosis of the toenail without lunula involvement were obtained from two double-blind, placebo-controlled studies conducted in the United States. In these studies, patients with onychomycosis of the great toenails without lunula involvement were treated with ciclopirox topical solution, 8% in conjunction with monthly removal of the unattached, infected toenail by the investigator. Ciclopirox topical solution, 8%, was applied for 48 weeks. At baseline, patients had 20\u201365% involvement of the target great toenail plate. Statistical significance was demonstrated in one of two studies for the endpoint \"complete cure\" (clear nail and negative mycology), and in two studies for the endpoint \"almost clear\" (\u226410% nail involvement and negative mycology) at the end of study. These results are presented below. At Week 48 (plus Last Observation Carried Forward) for the Intent-to-Treat (ITT) Population Study 312 Study 313 Active Vehicle Active Vehicle Complete Cure* 6/110 (5.5%) 1/109 (0.9%) 10/118 (8.5%) 0/117 (0%) Almost Clear** 7/107 (6.5%) 1/108 (0.9%) 14/116 (12%) 1/115 (0.9%) Negative Mycology...",
  "brand_name": "Ciclopirox",
  "manufacturer": "Padagis Israel Pharmaceuticals Ltd",
  "application_number": "ANDA077623",
  "pharm_class_epc": [],
  "route": [
   "TOPICAL"
  ],
  "effective_time": "20230124",
  "set_id": "02f46b6e-b424-4210-83bf-e79618df4344",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 3033,
  "serious": 1579,
  "death": 110,
  "hospitalization": 780,
  "primary_suspect": 3031,
  "top_reactions": [
   [
    "Drug Ineffective",
    465
   ],
   [
    "Fatigue",
    176
   ],
   [
    "Pain",
    162
   ],
   [
    "Diarrhoea",
    150
   ],
   [
    "Rash",
    141
   ],
   [
    "Pruritus",
    139
   ],
   [
    "Off Label Use",
    137
   ],
   [
    "Headache",
    128
   ],
   [
    "Dyspnoea",
    113
   ],
   [
    "Arthralgia",
    105
   ],
   [
    "Fall",
    105
   ],
   [
    "Nausea",
    105
   ],
   [
    "Product Use In Unapproved Indication",
    105
   ],
   [
    "Chronic Kidney Disease",
    94
   ],
   [
    "Device Malfunction",
    93
   ]
  ],
  "by_year": {
   "2019": 315,
   "2020": 300,
   "2021": 268,
   "2022": 286,
   "2023": 283,
   "2024": 246,
   "2025": 322,
   "2026": 165
  },
  "by_year_primary": {
   "2019": 315,
   "2020": 300,
   "2021": 268,
   "2022": 286,
   "2023": 283,
   "2024": 245,
   "2025": 322,
   "2026": 165
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class III",
   "date": "20190213",
   "reason": "Failed Degradation/Impurities Specifications: Out of specification related substance results during stability testing.",
   "firm": "Perrigo New York, Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class III",
   "date": "20180119",
   "reason": "Discoloration: Product is supposed to be a white to off white homogenous cream and may have intermittent yellow discoloration.",
   "firm": "G & W  Laboratories, Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class III",
   "date": "20170320",
   "reason": "Labeling: Incorrect or Missing Package Insert: product lots packaged with an out-of-date insert.",
   "firm": "G & W  Laboratories, Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class III",
   "date": "20131016",
   "reason": "Subpotent. drug",
   "firm": "Taro Pharmaceuticals U.S.A., Inc.",
   "status": "Terminated"
  }
 ],
 "recall_total": 4,
 "drugsfda": {
  "applications": 32,
  "nda": 5,
  "anda": 27,
  "first_approval": "19821230",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 19,
  "labeling_recent": 2,
  "sponsors": [
   "ACELLA",
   "ACTAVIS MID ATLANTIC",
   "ALVOGEN",
   "BAUSCH",
   "CHARTWELL RX",
   "COSETTE PHARMS NC",
   "ENCUBE",
   "EPIC PHARMA LLC"
  ],
  "unapproved": false,
  "first_approval_fmt": "12/30/1982"
 },
 "trials": {
  "total": 20,
  "completed": 9,
  "terminated": 2,
  "with_results": 3,
  "industry": 10,
  "phase3": 4,
  "results_share": 0.3333333333333333,
  "terminated_share": 0.1
 },
 "pubmed": {
  "rct": 28,
  "meta": 2,
  "recent_rct": 1,
  "cochrane": []
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "ciclopirox",
   "Ciclodan",
   "Loprox"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 1407379,
  "beneficiaries": 715142,
  "spend": 39766960.370000005,
  "by_brand": [
   {
    "brand": "Ciclopirox",
    "claims": 889514,
    "per_claim": 30.157655754,
    "is_generic": true
   },
   {
    "brand": "Ciclopirox",
    "claims": 517825,
    "per_claim": 24.989245324,
    "is_generic": false
   },
   {
    "brand": "Ciclodan",
    "claims": 40,
    "per_claim": 31.18525,
    "is_generic": false
   }
  ],
  "per_claim": 28.256042167745864
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": false,
  "status": "ApplicationRejected",
  "name": "ciclopirox",
  "matched": "ciclopirox",
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 732,
  "fills": 1407379,
  "per_million": 520.1157612839186,
  "ratio": 0.1878386419153787,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 100,
   "letter": "A",
   "why": [
    "520 FDA reports naming it as the suspect drug per million Medicare fills, 0.2x the median drug on this site",
    "Death share in reports is near or below the FAERS average (0.4x)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 33,
   "letter": "F",
   "why": [
    "28 randomized trials and 2 systematic reviews/meta-analyses indexed in PubMed",
    "No Cochrane review found (-5)",
    "'Drug ineffective' is the single most-reported item about this drug in FAERS (-5)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 95,
   "letter": "A",
   "why": [
    "Recalls since 2016: 0 Class I, 0 Class II, 3 Class III across 27 generic makers (-1)",
    "2 label changes approved since 2021 (-4)"
   ],
   "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": 70,
   "letter": "C",
   "why": [
    "Generic versions approved (27 applications)",
    "No same-class alternatives found: little leverage to switch (-30)"
   ],
   "weight": 0.1
  }
 },
 "total": 80,
 "grade": "B",
 "questions": [
  "The most-reported problems in FDA's adverse event data are fatigue, pain, diarrhoea. How would we recognize and handle those?",
  "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.)"
 ]
}