{
 "query": "minocycline",
 "ingredient": "minocycline",
 "slug": "minocycline",
 "rxcui": "6980",
 "brands": [
  "Zilxi",
  "Amzeeq",
  "Minocin",
  "Arestin",
  "Cleeravue-M",
  "Emrosi",
  "Minolira",
  "Solodyn",
  "Ximino"
 ],
 "names": [
  "minocycline",
  "minocycline hydrochloride"
 ],
 "classes": [
  {
   "id": "A01AB",
   "name": "Antiinfectives and antiseptics for local oral treatment"
  },
  {
   "id": "D10AF",
   "name": "Antiinfectives for treatment of acne"
  },
  {
   "id": "J01AA",
   "name": "Tetracyclines"
  }
 ],
 "alternatives": [
  "amphotericin b",
  "benzoxonium chloride",
  "chloramphenicol",
  "chlorhexidine",
  "chlortetracycline",
  "clindamycin",
  "clomocycline",
  "clotrimazole",
  "demeclocycline",
  "domiphen",
  "doxycycline",
  "eravacycline",
  "erythromycin",
  "hexetidine",
  "hydrogen peroxide",
  "lymecycline",
  "meclocycline",
  "methacycline",
  "metronidazole",
  "miconazole",
  "natamycin",
  "neomycin",
  "octenidine",
  "omadacycline",
  "oxyquinoline",
  "oxytetracycline",
  "polynoxylin",
  "rolitetracycline",
  "sarecycline",
  "sodium perborate",
  "sulfacetamide",
  "tetracycline",
  "tibezonium iodide",
  "tigecycline"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 70,
   "TOPICAL": 2,
   "INTRAVENOUS": 1
  },
  "boxed_warning": "",
  "indications_and_usage": "Minocycline hydrochloride extended-release tablets USP are tetracycline-class drug indicated to treat only inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older. ( 1 ) 1.1 Indication Minocycline hydrochloride extended-release tablets USP are indicated to treat only inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older. 1.2 Limitations of Use Minocycline hydrochloride extended-release tablets USP did not demonstrate any effect on non-inflammatory acne lesions. Safety of minocycline hydrochloride extended-release tablets USP have not been established beyond 12 weeks of use. This formulation of minocycline has not been evaluated in the treatment of infections [see CLINICAL STUDIES ( 14 )] To reduce the development of drug-resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, minocycline hydrochloride extended-release tablets USP should be used only as indicated [see WARNINGS AND PRECAUTIONS ( 5.11 )]",
  "contraindications": "This drug is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines. ( 4 ) This drug is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines.",
  "warnings_and_cautions": "The use of minocycline hydrochloride extended-release tablets during tooth development (last half of pregnancy, infancy, and childhood up to the age of 8 years) may cause permanent discoloration of the teeth (yellow-gray-brown). ( 5.1 ) If pseudomembranous colitis occurs, discontinue minocycline hydrochloride extended-release tablets. ( 5.2 ) If liver injury is suspected, discontinue minocycline hydrochloride extended-release tablets. ( 5.3 ) If renal impairment exists, minocycline hydrochloride extended-release tablets doses may need to be adjusted to avoid excessive systemic accumulations of the drug and possible liver toxicity. ( 5.4 ) Minocycline may cause central nervous system side effects including light-headedness, dizziness, or vertigo. Advise patients. ( 5.5 ) Minocycline may cause pseudotumor cerebri (benign intracranial hypertension) in adults and adolescents. Discontinue minocycline hydrochloride extended-release tablets if symptoms occur. ( 5.6 ) Minocycline has been associated with autoimmune syndromes; discontinue minocycline hydrochloride extended-release tablets immediately if symptoms occur. ( 5.7 ) Minocycline has been associated with anaphylaxis, serious skin r...",
  "warnings": "",
  "adverse_reactions": "The most commonly observed adverse reactions (incidence \u2265 5%) are headache, fatigue, dizziness, and pruritus. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Lupin Pharmaceuticals, Inc. at 1-800-399-2561 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 observed 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 following table summarizes selected adverse reactions reported in clinical trials at a rate of \u22651% for minocycline hydrochloride extended-release tablets. Table 2: Selected Treatment-Emergent Adverse Reactions in at least 1% of Clinical Trial Subjects Adverse Reactions Minocycline hydrochloride extended - release tablets ( 1 mg / kg ) N = 674 (%) Placebo N = 364 (%) At least one treatment-emergent event 379 (56) 197 (54) Headache 152 (23) 83 (23) Fatigue 62 (9) 24 (7) Dizziness 59 (9) 17 (5) Pruritus 31 (5) 16 (4) Malaise 26 (4) 9 (3) Mood alteration 17 (3) 9 (3) Somnolence 13 (2) 3 (1) Urticaria 10 (2) 1 (0) Tinnitus 10 (2) 5 (1) ...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "",
  "information_for_patients": "[See FDA-Approved Patient Labeling (Patient Labeling) ] Patients taking Minocycline hydrochloride (minocycline HCl, USP) extended-release tablets should receive the following information and instructions: Minocycline hydrochloride extended-release tablets should not be used by pregnant women or women attempting to conceive a child [see USE IN SPECIFIC POPULATIONS (8.1) , NONCLINICAL TOXICOLOGY (13.1) ]. It is recommended that minocycline hydrochloride extended-release tablets not be used by men who are attempting to father a child [see NONCLINICAL TOXICOLOGY (13.1) ]. Patients should be advised that pseudomembranous colitis can occur with minocycline therapy. If patients develop watery or bloody stools, they should seek medical attention. Patients should be counseled about the possibility of hepatotoxicity. Patients should seek medical advice if they experience symptoms which can include loss of appetite, tiredness, diarrhea, skin turning yellow, bleeding easily, confusion, and sleepiness. Patients who experience central nervous system symptoms [see WARNINGS AND PRECAUTIONS (5.5) ] should be cautioned about driving vehicles or using hazardous machinery while on minocycline therapy....",
  "spl_medguide": "",
  "clinical_studies": "The safety and efficacy of minocycline hydrochloride extended-release tablets in the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris was assessed in two 12-week, multi-center, randomized, double-blind, placebo-controlled, trials in subjects \u2265 12 years. The mean age of subjects was 20 years and subjects were from the following racial groups: White (73%), Hispanic (13%), Black (11%), Asian/Pacific Islander (2%), and Other (2%). In two efficacy and safety trials, a total of 924 subjects with non-nodular moderate to severe acne vulgaris received minocycline hydrochloride extended-release tablets or placebo for a total of 12 weeks, according to the following dose assignments. Table 3: Clinical Studies Dosing Table Subject's Weight ( lbs .) Subject's Weight ( kg ) Available Tablet Strength ( mg ) Actual mg / kg Dose 99 - 131 45 - 59 45 1 - 0.76 132 - 199 60 - 90 90 1.5 - 1 200 - 300 91 - 136 135 1.48 - 0.99 The two primary efficacy endpoints were: 1) Mean percent change in inflammatory lesion counts from Baseline to 12 weeks. 2) Percentage of subjects with an Evaluator's Global Severity Assessment (EGSA) of clear or almost clear at 12 weeks. Efficacy res...",
  "brand_name": "Minocycline Hydrochloride",
  "manufacturer": "Lupin Pharmaceuticals, Inc.",
  "application_number": "ANDA091424",
  "pharm_class_epc": [],
  "route": [
   "ORAL"
  ],
  "effective_time": "20231030",
  "set_id": "3b1e1cf1-ebd2-4aba-a219-9f9939fdb03b",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 12530,
  "serious": 9618,
  "death": 2518,
  "hospitalization": 4480,
  "primary_suspect": 12508,
  "top_reactions": [
   [
    "Drug Ineffective",
    2559
   ],
   [
    "Off Label Use",
    2134
   ],
   [
    "Pain",
    1488
   ],
   [
    "Drug Intolerance",
    1447
   ],
   [
    "Nausea",
    1428
   ],
   [
    "Rheumatoid Arthritis",
    1392
   ],
   [
    "Arthralgia",
    1325
   ],
   [
    "Rash",
    1314
   ],
   [
    "Drug Hypersensitivity",
    1284
   ],
   [
    "Fatigue",
    1225
   ],
   [
    "Joint Swelling",
    1205
   ],
   [
    "Condition Aggravated",
    1132
   ],
   [
    "Pneumonia",
    1109
   ],
   [
    "General Physical Health Deterioration",
    1082
   ],
   [
    "Headache",
    1075
   ]
  ],
  "by_year": {
   "2019": 1174,
   "2020": 1477,
   "2021": 1147,
   "2022": 1096,
   "2023": 1253,
   "2024": 1684,
   "2025": 1598,
   "2026": 511
  },
  "by_year_primary": {
   "2019": 1174,
   "2020": 1477,
   "2021": 1145,
   "2022": 1086,
   "2023": 1250,
   "2024": 1681,
   "2025": 1596,
   "2026": 511
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class II",
   "date": "20260601",
   "reason": "Failed Dissolution Specifications: An out-of-specification (OOS) result was observed during the 9th month of dissolution test analysis",
   "firm": "Ascend Laboratories, LLC",
   "status": "Ongoing"
  },
  {
   "class": "Class III",
   "date": "20200122",
   "reason": "Failed Dissolution Specifications: low out of specification results for dissolution testing.",
   "firm": "Ascend Laboratories LLC",
   "status": "Terminated"
  }
 ],
 "recall_total": 2,
 "drugsfda": {
  "applications": 41,
  "nda": 12,
  "anda": 27,
  "first_approval": "19710630",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 96,
  "labeling_recent": 11,
  "sponsors": [
   "ALKEM LABS LTD",
   "ALVOGEN",
   "AUROBINDO PHARMA",
   "AUROBINDO PHARMA LTD",
   "BARR LABS INC",
   "BAUSCH",
   "CHARTWELL RX",
   "EPI HLTH"
  ],
  "unapproved": false,
  "first_approval_fmt": "06/30/1971"
 },
 "trials": {
  "total": 324,
  "completed": 190,
  "terminated": 39,
  "with_results": 84,
  "industry": 80,
  "phase3": 58,
  "results_share": 0.4421052631578947,
  "terminated_share": 0.12037037037037036
 },
 "pubmed": {
  "rct": 261,
  "meta": 43,
  "recent_rct": 55,
  "cochrane": [
   {
    "pmid": "22895927",
    "title": "Minocycline for acne vulgaris: efficacy and safety",
    "year": "2012"
   },
   {
    "pmid": "12535427",
    "title": "Minocycline for acne vulgaris: efficacy and safety",
    "year": "2003"
   },
   {
    "pmid": "10796856",
    "title": "Minocycline for acne vulgaris: efficacy and safety",
    "year": "2000"
   }
  ]
 },
 "payments": {
  "year": "2024",
  "usd": 243571.78,
  "records": 7205,
  "by_name": [
   [
    "Arestin",
    243571.78
   ]
  ],
  "names_checked": [
   "minocycline",
   "Zilxi",
   "Amzeeq",
   "Minocin",
   "Arestin",
   "Cleeravue-M",
   "Emrosi",
   "Minolira",
   "Solodyn",
   "Ximino"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 352832,
  "beneficiaries": 160361,
  "spend": 10786434.56,
  "by_brand": [
   {
    "brand": "Minocycline HCl",
    "claims": 350488,
    "per_claim": 25.96122124,
    "is_generic": true
   },
   {
    "brand": "Zilxi",
    "claims": 901,
    "per_claim": 477.38327414,
    "is_generic": false
   },
   {
    "brand": "Amzeeq",
    "claims": 764,
    "per_claim": 482.31077225,
    "is_generic": false
   },
   {
    "brand": "Minocycline HCl ER",
    "claims": 473,
    "per_claim": 256.81799154,
    "is_generic": false
   },
   {
    "brand": "Minocin",
    "claims": 206,
    "per_claim": 3724.5406796,
    "is_generic": false
   }
  ],
  "per_claim": 30.57102122256485
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": false,
  "status": "",
  "name": "",
  "matched": null,
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 3788,
  "fills": 352832,
  "per_million": 10735.987665517867,
  "ratio": 3.877277892392693,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 75,
   "letter": "B",
   "why": [
    "10,736 FDA reports naming it as the suspect drug per million Medicare fills, 3.9x the median drug on this site (-12)",
    "Death appears in 2.2x the share of reports seen across all of FAERS (-8)",
    "Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 64,
   "letter": "C",
   "why": [
    "261 randomized trials and 43 systematic reviews/meta-analyses indexed in PubMed",
    "3 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": 90,
   "letter": "A",
   "why": [
    "Recalls since 2016: 0 Class I, 1 Class II, 1 Class III across 27 generic makers (-2)",
    "11 label changes approved since 2021: the safety story is still moving (-8)"
   ],
   "weight": 0.15
  },
  "conflict": {
   "score": 85,
   "letter": "B",
   "why": [
    "Pharma paid doctors $243,572 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 (27 applications)",
    "34 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 78,
 "grade": "B",
 "questions": [
  "The most-reported problems in FDA's adverse event data are pain, drug intolerance. 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 amphotericin b, benzoxonium chloride, chloramphenicol? 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.)"
 ]
}