{
 "query": "doxycycline",
 "ingredient": "doxycycline",
 "slug": "doxycycline",
 "rxcui": "3640",
 "brands": [
  "Oracea",
  "Vibramycin",
  "Targadox",
  "Acticlate",
  "Adoxa",
  "Alodox",
  "Avidoxy",
  "Doryx",
  "Doxy",
  "Mondoxyne",
  "Morgidox",
  "Periostat"
 ],
 "names": [
  "doxycycline",
  "doxycycline anhydrous",
  "doxycycline calcium",
  "doxycycline hyclate",
  "doxycycline hydrochloride",
  "doxycycline monohydrate"
 ],
 "classes": [
  {
   "id": "A01AB",
   "name": "Antiinfectives and antiseptics for local oral treatment"
  },
  {
   "id": "J01AA",
   "name": "Tetracyclines"
  }
 ],
 "alternatives": [
  "amphotericin b",
  "benzoxonium chloride",
  "chlorhexidine",
  "chlortetracycline",
  "clomocycline",
  "clotrimazole",
  "demeclocycline",
  "domiphen",
  "eravacycline",
  "hexetidine",
  "hydrogen peroxide",
  "lymecycline",
  "methacycline",
  "metronidazole",
  "miconazole",
  "minocycline",
  "natamycin",
  "neomycin",
  "octenidine",
  "omadacycline",
  "oxyquinoline",
  "oxytetracycline",
  "polynoxylin",
  "rolitetracycline",
  "sarecycline",
  "sodium perborate",
  "tetracycline",
  "tibezonium iodide",
  "tigecycline"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 215,
   "INTRAVENOUS": 21
  },
  "boxed_warning": "",
  "indications_and_usage": "Doxycycline hyclate delayed-release tablets are a tetracycline-class drug indicated for: Rickettsial infections ( 1.1 ) Sexually transmitted infections ( 1.2 ) Respiratory tract infections ( 1.3 ) Specific bacterial infections ( 1.4 ) Ophthalmic infections ( 1.5 ) Anthrax, including inhalational anthrax (post-exposure) ( 1.6 ) Alternative treatment for selected infections when penicillin is contraindicated ( 1.7 ) Adjunctive therapy in acute intestinal amebiasis and severe acne ( 1.8 ) Prophylaxis of malaria ( 1.9 ) Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of doxycycline hyclate delayed-release tablets and other antibacterial drugs, Doxycycline hyclate delayed-release tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. ( 1.10 ) 1.1 Rickettsial Infections Doxycycline hyclate delayed-release tablets are indicated for treatment of Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox, and tick fevers caused by Rickettsiae . 1.2 Sexually Transmitted Infections Doxycycline hyclate delayed-release tablets are indicated for treatment of...",
  "contraindications": "Doxycycline hyclate delayed-release tablets are contraindicated in persons who have shown hypersensitivity to any of the tetracyclines. Doxycycline hyclate delayed-release tablets are contraindicated in persons who have shown hypersensitivity to any of the tetracyclines. ( 4 )",
  "warnings_and_cautions": "The use of drugs of the tetracycline-class during tooth development (last half of pregnancy, infancy and childhood to the age of 8 years) may cause permanent discoloration of the teeth (yellow-gray-brown). ( 5.1 ) Clostridioides difficile -associated diarrhea (CDAD) has been reported: Evaluate patients if diarrhea occurs. ( 5.2 ) Photosensitivity manifested by an exaggerated sunburn reaction has been observed in some individuals taking tetracyclines. Limit sun exposure. ( 5.3 ) Overgrowth of non-susceptible organisms, including fungi, may occur. If such infections occur, discontinue use and institute appropriate therapy. ( 5.4 ) 5.1 Tooth Development The use of drugs of the tetracycline-class during tooth development (last half of pregnancy, infancy and childhood to the age of 8 years) may cause permanent discoloration of the teeth (yellow-gray-brown). This adverse reaction is more common during long-term use of the drugs but it has been observed following repeated short-term courses. Enamel hypoplasia has also been reported. Use doxycycline hyclate delayed-release tablets in pediatric patients 8 years of age or less only when the potential benefits are expected to outweigh the ris...",
  "warnings": "",
  "adverse_reactions": "Adverse reactions observed in patients receiving tetracyclines include anorexia, nausea, vomiting, diarrhea, rash, photosensitivity, urticaria, and hemolytic anemia. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Mayne Pharma at 1-844-825-8500 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trial Experience The safety and efficacy of doxycycline hyclate delayed-release tablets, 200 mg as a single daily dose was evaluated in a multicenter, randomized, double-blind, active-controlled study. Doxycycline hyclate delayed-release tablets, 200 mg was given orally once-a-day for 7 days and compared to doxycycline hyclate capsules 100 mg given orally twice daily for 7 days for the treatment of men and women with uncomplicated urogenital C. trachomatis infection. Adverse reactions in the Safety Population were reported by 99 (40.2%) subjects in the doxycycline hyclate delayed-release tablets, 200 mg treatment group and 132 (53.2%) subjects in the doxycycline hyclate capsules reference treatment group. Most adverse reactions were mild in intensity. The most commonly reported adverse reactions in both treatment groups were nausea, vomiting, diarrhea, and bacterial vaginit...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "Warnings and Precautions, Severe Skin Reactions ( 5.5 ) 03/2025",
  "information_for_patients": "Advise patients taking doxycycline for malaria prophylaxis: that no present-day antimalarial agent, including doxycycline, guarantees protection against malaria. to avoid being bitten by mosquitoes by using personal protective measures that help avoid contact with mosquitoes, especially from dusk to dawn (for example, staying in well-screened areas, using mosquito nets, covering the body with clothing, and using an effective insect repellent). that doxycycline prophylaxis: should begin 1 to 2 days before travel to the malarious area, should be continued daily while in the malarious area and after leaving the malarious area, should be continued for 4 further weeks to avoid development of malaria after returning from an endemic area, should not exceed 4 months. Advise all patients taking doxycycline: to avoid excessive sunlight or artificial ultraviolet light while receiving doxycycline and to discontinue therapy if phototoxicity (for example, skin eruptions, etc.) occurs. Sunscreen or sunblock should be considered [ see Warnings and Precautions (5.3) ]. to drink fluids liberally along with doxycycline to reduce the risk of esophageal irritation and ulceration [ see Adverse Reactions...",
  "spl_medguide": "",
  "clinical_studies": "This was a randomized, double-blind, active-controlled, multicenter trial which enrolled 495 subjects, between 19 to 45 years of age with a confirmed diagnosis of urogenital C. trachomatis infection less than 14 days prior to enrollment, or partner(s) of a subject with a known positive test for urogenital C. trachomatis infection. The primary purpose of this study was to evaluate the efficacy and safety of doxycycline hyclate delayed-release tablets Tablets, 200 mg once daily versus doxycycline hyclate capsules, 100 mg twice daily for seven days for the treatment of uncomplicated urogenital C. trachomatis infection. The primary efficacy objective was to demonstrate non-inferiority of the doxycycline hyclate delayed-release tablets, 200 mg once daily treatment regimen versus the doxycycline 100 mg twice daily treatment regimen for the indication using a negative nucleic acid amplification test (NAAT) at the test of cure visit (day 28) in the mITT population (subjects who were positive at baseline and took at least one day of study drug). Table 2: Primary Efficacy Outcome \u2013 Microbiological Cure of C. trachomatis at Day 28 mITT Population Doxycycline hyclate delayed-release tablets, 2...",
  "brand_name": "Doxycycline Hyclate",
  "manufacturer": "Mayne Pharma Commercial LLC",
  "application_number": "NDA050795",
  "pharm_class_epc": [],
  "route": [
   "ORAL"
  ],
  "effective_time": "20250414",
  "set_id": "cd2ab9b8-9619-4199-8a5d-83377b3274d1",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 63422,
  "serious": 45687,
  "death": 6198,
  "hospitalization": 19478,
  "primary_suspect": 63251,
  "top_reactions": [
   [
    "Drug Ineffective",
    5058
   ],
   [
    "Off Label Use",
    4730
   ],
   [
    "Nausea",
    4683
   ],
   [
    "Fatigue",
    4503
   ],
   [
    "Rash",
    3963
   ],
   [
    "Diarrhoea",
    3901
   ],
   [
    "Drug Hypersensitivity",
    3754
   ],
   [
    "Dyspnoea",
    3726
   ],
   [
    "Headache",
    3687
   ],
   [
    "Vomiting",
    3539
   ],
   [
    "Pain",
    3522
   ],
   [
    "Malaise",
    2834
   ],
   [
    "Condition Aggravated",
    2818
   ],
   [
    "Chronic Kidney Disease",
    2776
   ],
   [
    "Pruritus",
    2747
   ]
  ],
  "by_year": {
   "2019": 6674,
   "2020": 6165,
   "2021": 5105,
   "2022": 5255,
   "2023": 5846,
   "2024": 5158,
   "2025": 6854,
   "2026": 3168
  },
  "by_year_primary": {
   "2019": 6671,
   "2020": 6163,
   "2021": 5097,
   "2022": 5219,
   "2023": 5812,
   "2024": 5142,
   "2025": 6804,
   "2026": 3147
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class II",
   "date": "20250929",
   "reason": "Failed dissolution specifications: Stability testing found that the lot did not meet dissolution specifications.",
   "firm": "Acella Pharmaceuticals, LLC",
   "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": "20220413",
   "reason": "cGMP deviations: Temperature abuse",
   "firm": "Mckesson Medical-Surgical Inc. Corporate Office",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20220126",
   "reason": "CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.",
   "firm": "CARDINAL HEALTHCARE",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20200522",
   "reason": "Failed Dissolution Specification: The dissolution test at the 24 month time point (end of shelf life) yielded an out-of-specification result.",
   "firm": "The Harvard Drug Group",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20200519",
   "reason": "Failed dissolution specification - dissolution results of 59% (spec. NLT 85%) at the 24 month time point (end of shelf life).",
   "firm": "American Health Packaging",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20200515",
   "reason": "Failed dissolution specifications",
   "firm": "PD-Rx Pharmaceuticals, Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20200513",
   "reason": "Failed dissolution specification: The dissolution test at the 24 month time point (end of shelf life) yielded an out of specification result.",
   "firm": "West-Ward Columbus Inc",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20200313",
   "reason": "CGMP Deviations: Doxycycline capsules were not manufactured under Current Good Manufacturing Practice conditions.",
   "firm": "Sun Pharmaceutical Industries, Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20200313",
   "reason": "CGMP Deviations: Doxycycline capsules were not manufactured under Current Good Manufacturing Practice conditions.",
   "firm": "Sun Pharmaceutical Industries, Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20180807",
   "reason": "Failed Dissolution Specifications: manufacturer West-Ward Pharm Corp. recalled these repackaged lots due to failed dissolution results.",
   "firm": "PD-Rx Pharmaceuticals, Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20180801",
   "reason": "Failed Dissolution Specifications: Out of specification result for the dissolution test.",
   "firm": "American Health Packaging",
   "status": "Terminated"
  }
 ],
 "recall_total": 15,
 "drugsfda": {
  "applications": 151,
  "nda": 17,
  "anda": 120,
  "first_approval": "19671205",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 171,
  "labeling_recent": 19,
  "sponsors": [
   "ACELLA",
   "ACTAVIS ELIZABETH",
   "ACTAVIS LABS FL INC",
   "AIPING PHARM INC",
   "AJANTA PHARMA LTD",
   "ALEMBIC",
   "AMNEAL",
   "AMNEAL PHARMS"
  ],
  "unapproved": false,
  "first_approval_fmt": "12/05/1967"
 },
 "trials": {
  "total": 486,
  "completed": 273,
  "terminated": 49,
  "with_results": 100,
  "industry": 81,
  "phase3": 87,
  "results_share": 0.3663003663003663,
  "terminated_share": 0.10082304526748971
 },
 "pubmed": {
  "rct": 608,
  "meta": 53,
  "recent_rct": 89,
  "cochrane": [
   {
    "pmid": "26771164",
    "title": "Doxycycline plus ivermectin versus ivermectin alone for treatment of patients with onchocerciasis",
    "year": "2016"
   },
   {
    "pmid": "23152242",
    "title": "Doxycycline for osteoarthritis of the knee or hip",
    "year": "2012"
   },
   {
    "pmid": "19821404",
    "title": "Doxycycline for osteoarthritis of the knee or hip",
    "year": "2009"
   }
  ]
 },
 "payments": {
  "year": "2024",
  "usd": 10344.27,
  "records": 630,
  "by_name": [
   [
    "Oracea",
    10344.27
   ]
  ],
  "names_checked": [
   "doxycycline",
   "Oracea",
   "Vibramycin",
   "Targadox",
   "Acticlate",
   "Adoxa",
   "Alodox",
   "Avidoxy",
   "Doryx",
   "Doxy",
   "Mondoxyne",
   "Morgidox",
   "Periostat"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 8616947,
  "beneficiaries": 6089766,
  "spend": 128121500.59,
  "by_brand": [
   {
    "brand": "Doxycycline Hyclate",
    "claims": 6667052,
    "per_claim": 12.227770649,
    "is_generic": true
   },
   {
    "brand": "Doxycycline Monohydrate",
    "claims": 1931472,
    "per_claim": 15.671958304,
    "is_generic": true
   },
   {
    "brand": "Doxycycline Ir-Dr",
    "claims": 14645,
    "per_claim": 861.7987354,
    "is_generic": false
   },
   {
    "brand": "Oracea",
    "claims": 2605,
    "per_claim": 1245.1826372,
    "is_generic": false
   },
   {
    "brand": "Doxy 100",
    "claims": 895,
    "per_claim": 236.57620112,
    "is_generic": false
   },
   {
    "brand": "Doryx Mpc",
    "claims": 244,
    "per_claim": 999.1775,
    "is_generic": false
   },
   {
    "brand": "Vibramycin",
    "claims": 20,
    "per_claim": 19.9805,
    "is_generic": false
   },
   {
    "brand": "Targadox",
    "claims": 14,
    "per_claim": 549.37928571,
    "is_generic": false
   }
  ],
  "per_claim": 14.868549219346482
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": true,
  "status": "AddedToEml",
  "name": "doxycycline",
  "matched": "doxycycline",
  "stewardship": [
   "KeyAccessGroup",
   "AccessGroup"
  ]
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 15093,
  "fills": 8616947,
  "per_million": 1751.5484312483297,
  "ratio": 0.6325677917595359,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 95,
   "letter": "A",
   "why": [
    "1,752 FDA reports naming it as the suspect drug per million Medicare fills, 0.6x the median drug on this site",
    "Death share in reports is near or below the FAERS average (1.1x)",
    "Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 71,
   "letter": "C",
   "why": [
    "608 randomized trials and 53 systematic reviews/meta-analyses indexed in PubMed",
    "On the WHO Model List of Essential Medicines (shown for context; no score effect)",
    "3 independent Cochrane review(s) exist",
    "Only 37% 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, 15 Class II, 0 Class III across 120 generic makers (-6)",
    "19 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": 100,
   "letter": "A",
   "why": [
    "Pharma paid doctors $10,344 tied to this drug last year: negligible",
    "Not named in any pending federal MDL"
   ],
   "weight": 0.15
  },
  "options": {
   "score": 100,
   "letter": "A",
   "why": [
    "Generic versions approved (120 applications)",
    "29 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 88,
 "grade": "A",
 "questions": [
  "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 amphotericin b, benzoxonium chloride, chlorhexidine? 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.)"
 ]
}