pharmacopeia
GET
/api/v1/drug/doxycycline
2D structure
(4S,4aR,5S,5aR,6R,12aR)-4-(dimethylamino)-1,5,10,11,12a-pentahydroxy-6-methyl-3,12-dioxo-4a,5,5a,6-tetrahydro-4H-tetracene-2-carboxamide
SMILES C[C@@H]1[C@H]2[C@@H]([C@H]3[C@@H](C(=O)C(=C([C@]3(C(=O)C2=C(C4=C1C=CC=C4O)O)O)O)C(=O)N)N(C)C)O
InChIKey SGKRLCUYIXIAHR-AKNGSSGZSA-N

Mechanism of action

Sourced from openFDA

Mechanism-of-action class: Protein Synthesis Inhibitors.

Protein Synthesis

Indications

Sourced from openFDA
  • To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline and other antibacterial drugs, doxycycline should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy.

Contraindications

Sourced from openFDA
  • This drug is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines.contraindicated

Dosage & administration

Sourced from openFDA

The usual dosage and frequency of administration of doxycycline differs from that of the other tetracyclines. Exceeding the recommended dosage may result in an increased incidence of side effects. Adults: The usual dose of oral doxycycline is 200 mg on the first day of treatment (administered 100 mg every 12 hours) followed by a maintenance dose of 100 mg/day. In the management of more severe infections (particularly chronic infections of the urinary tract), 100 mg every 12 hours is recommended. Pediatric Patients: For all pediatric patients weighing less than 45 kg with severe or life-threatening infections (e.g., anthrax, Rocky Mountain spotted fever), the recommended dosage is 2.2 mg/kg of body weight administered every 12 hours. Children weighing 45 kg or more should receive the adult dose. (See WARNINGS and PRECAUTIONS .) For pediatric patients with less severe disease (greater than 8 years of age and weighing less than 45 kg), the recommended dosage schedule is 4.4 mg/kg of body weight divided into two doses on the first day of treatment, followed by a maintenance dose of 2.2 mg/kg of body weight (given as a single daily dose or divided into twice daily doses). For pediatric patients weighing over 45 kg, the usual adult dose should be used. The therapeutic antibacterial serum activity will usually persist for 24 hours following recommended dosage. When used in streptococcal infections, therapy should be continued for 10 days.

Warnings & precautions

Sourced from openFDA

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 in pediatric patients 8 years of age or less only when the potential benefits are expected to outweigh the risks in severe or life-threatening conditions (e.g., anthrax, Rocky Mountain spotted fever), particularly when there are no alternative therapies. Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including doxycycline, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile . C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following the use of antibacterial drugs. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents. If CDAD is suspected or confirmed, ongoing use of antibacterial drugs not directed against C.

Adverse reactions

Sourced from openFDA

Due to oral doxycycline's virtually complete absorption, side effects of the lower bowel, particularly diarrhea, have been infrequent. The following adverse reactions have been observed in patients receiving tetracyclines: Gastrointestinal: anorexia, nausea, vomiting, diarrhea, glossitis, dysphagia, enterocolitis, inflammatory lesions (with monilial overgrowth) in the anogenital region, and pancreatitis. Hepatotoxicity has been reported rarely. These reactions have been caused by both the oral and parenteral administration of tetracyclines. Superficial discoloration of the adult permanent dentition, reversible upon drug discontinuation and professional dental cleaning has been reported. Permanent tooth discoloration and enamel hypoplasia may occur with drugs of the tetracycline class when used during tooth development. (See WARNINGS .) Rare instances of esophagitis and esophageal ulcerations have been reported in patients receiving capsule and tablet forms of the drugs in the tetracycline class. Most of these patients took medications immediately before going to bed. (See D OSAGE AND ADMINISTRATION .) Skin: toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme, skin hyperpigmentation, maculopapular and erythematous rashes. Exfoliative dermatitis has been reported but is uncommon. Photosensitivity is discussed above. (See WARNINGS .) Renal toxicity: Rise in BUN has been reported and is apparently dose related.

Use in specific populations

Sourced from openFDA

Pregnancy: Teratogenic Effects There are no adequate and well-controlled studies on the use of doxycycline in pregnant women. The vast majority of reported experience with doxycycline during human pregnancy is short-term, first trimester exposure. There are no human data available to assess the effects of long-term therapy of doxycycline in pregnant women, such as that proposed for treatment of anthrax exposure. An expert review of published data on experiences with doxycycline use during pregnancy by TERIS-the Teratogen Information System-concluded that therapeutic doses during pregnancy are unlikely to pose a substantial teratogenic risk (the quantity and quality of data were assessed as limited to fair), but the data are insufficient to state that there is no risk. 1 A case-control study (18,515 mothers of infants with congenital anomalies and 32,804 mothers of infants with no congenital anomalies) shows a weak but marginally statistically significant association with total malformations and use of doxycycline anytime during pregnancy. Sixty-three (0.19%) of the controls and fifty-six (0.30%) of the cases were treated with doxycycline.

Overdosage

Sourced from openFDA

In case of overdosage, discontinue medication, treat symptomatically and institute supportive measures. Dialysis does not alter serum half-life and thus would not be of benefit in treating cases of overdosage.

Approval history

Sourced from openFDA
  • Nov 8, 1982ANDAANDA062269Epic Pharma Llc
  • Feb 2, 1983ANDAANDA062421Actavis Labs Fl Inc
  • Dec 9, 1983ANDAANDA062475Fresenius Kabi Usa
  • Dec 29, 1989NDANDA050641Chartwell Rx
  • May 6, 2005NDANDA050795Mayne Pharma
  • May 26, 2006NDANDA050805Galderma Labs Lp
  • Jul 25, 2014NDANDA205931Chartwell Rx
  • Apr 26, 2016NDANDA208253Chartwell Rx

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
67,913 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Drug Ineffective5,2537.7%
  2. 2Nausea5,0147.4%
  3. 3Fatigue4,6736.9%
  4. 4Off Label Use4,6696.9%
  5. 5Rash4,1516.1%
  6. 6Diarrhoea4,0395.9%
  7. 7Dyspnoea4,0215.9%
  8. 8Pain4,0005.9%
  9. 9Headache3,9605.8%
  10. 10Vomiting3,8455.7%
  11. 11Drug Hypersensitivity3,7665.5%
  12. 12Malaise3,0034.4%
  13. 13Dizziness2,9444.3%
  14. 14Condition Aggravated2,9394.3%
  15. 15Pruritus2,8944.3%

Literature

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Recent PubMed references pinned to Doxycycline as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 471 ClinicalTrials.gov registrations naming Doxycycline as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Structural analogs

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Ranked by 2D fingerprint (Tanimoto) similarity over PubChem structures. Structural proximity only — not a claim of therapeutic equivalence.

Frequently asked questions

How does Doxycycline work?
Mechanism-of-action class: Protein Synthesis Inhibitors.
What is Doxycycline used for?
According to FDA labeling, Doxycycline carries indications including: To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline and other antibacterial drugs, doxycycline should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Doxycycline?
Doxycycline is classified as Antiinfectives and antiseptics for local oral treatment, Tetracyclines, Tetracycline-class Drug, Protein Synthesis Inhibitors, Cell Membrane Alteration, Decreased Mitosis, Decreased Protein Synthesis.
What are the brand names for Doxycycline?
Doxycycline is marketed under brand names including Acticlate, Adoxa, Alodox, Avidoxy, Doryx, Doxy, Mondoxyne, Monodox.
What are the contraindications for Doxycycline?
Doxycycline labeling lists contraindications including: This drug is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines.. Always consult the full prescribing information and a clinician.
Note. Data for doxycycline is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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