pharmacopeia

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 the effectiveness of tetracycline hydrochloride and other antibacterial drugs, tetracycline hydrochloride should be used only to treat 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

Adults Usual daily dose, 1 gram as 500 mg twice a day or 250 mg four times a day. Higher doses such as 500 mg four times a day may be required for severe infections or for those infections which do not respond to the smaller doses. For pediatric patients above eight years of age Usual daily dose, 10 mg/lb to 20 mg/lb (25mg/kg to 50 mg/kg) body weight divided in four equal doses. Administration of adequate amounts of fluid with the capsule formulation of tetracycline is recommended to wash down the drug and reduce the risk of esophageal irritation and ulceration (see ADVERSE REACTIONS ). Absorption of tetracycline is impaired by antacids containing aluminum, calcium or magnesium and preparations containing iron, zinc or sodium bicarbonate. Food and some dairy products also interfere with absorption. When used in streptococcal infections, therapy should be continued for 10 days. For treatment of brucellosis, 500 mg tetracycline four times a day for three weeks accompanied by streptomycin, 1 gram intramuscularly twice daily the first week and once daily the second week. For the treatment of syphilis in patients allergic to penicillin, the following dosage of tetracycline is recommended: early syphilis (less than one year's duration), 500 mg four times a day for 15 days. Syphilis of more than one year's duration (except neurosyphilis), 500 mg four times a day for 30 days. For treatment of gonorrhea, the recommended dose is 500 mg by mouth four times a day for seven days.

Warnings & precautions

Sourced from openFDA

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. Tetracycline drugs should not be used in this age group, except for anthrax, unless other drugs are not likely to be effective or are contraindicated. Clostridium difficile Associated Diarrhea Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including tetracyclines, 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 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. difficile need to be discontinued.

Adverse reactions

Sourced from openFDA

Gastrointestinal: anorexia, nausea, epigastric distress, vomiting, diarrhea, glossitis, black hairy tongue, dysphagia, enterocolitis, and inflammatory lesions (with Candida overgrowth) in the anogenital region. Esophagitis and esophageal ulceration have been reported in patients receiving particularly the capsule and also the tablet forms of tetracyclines. Most of the patients were reported to have taken medication immediately before going to bed (see DOSAGE AND ADMINISTRATION ). Teeth : permanent discoloration of teeth may be caused during tooth development. Enamel hypoplasia has been reported (see WARNINGS ). Skin : fixed drug eruption, maculopapular and erythematous rashes. Exfoliative dermatitis has been reported. Onycholysis and discoloration of the nails have been reported. Photosensitivity is discussed in WARNINGS . Renal Toxicity : an increase in BUN has been reported and is dose related. Liver : hepatotoxicity and liver failure have been observed in patients receiving tetracycline and in tetracycline-treated patients with renal impairment. Hypersensitivity Reactions : urticaria, angioneurotic edema, anaphylaxis, anaphylactoid purpura, pericarditis, exacerbation of systemic lupus erythematosus, and serum sickness-like reactions, as fever, rash, and arthralgia. Blood : hemolytic anemia, thrombocytopenia, thrombocytopenic purpura, neutropenia and eosinophilia have been reported. When given over prolonged periods, tetracyclines have been reported to produce brown-black microscopic discoloration of thyroid glands.

Use in specific populations

Sourced from openFDA

Pregnancy Teratogenic Effects Pregnancy Category D (see WARNINGS ) Nonteratogenic Effects (see WARNINGS ) Pregnant women with renal disease may be more prone to develop tetracycline-associated liver failure.

Overdosage

Sourced from openFDA

In case of overdosage, discontinue medication, treat symptomatically and institute supportive measures. Tetracycline is not dialyzable.

Approval history

Sourced from openFDA
  • Oct 8, 1957NDANDA050278Avet
  • Feb 10, 1971ANDAANDA061147Strides Pharma Intl
  • Dec 24, 1974ANDAANDA061837Watson Labs
  • Aug 12, 1988ANDAANDA062752Chartwell Tetra
  • Sep 28, 2006NDANDA050786Labs Juvise
  • Sep 18, 2018ANDAANDA210674Amneal Pharms Ny
  • Nov 7, 2018ANDAANDA210662Breckenridge
  • Mar 6, 2023ANDAANDA205770Ph Health

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.
1,842 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. 1Off Label Use28515%
  2. 2Nausea20311%
  3. 3Diarrhoea1659.0%
  4. 4Drug Hypersensitivity1628.8%
  5. 5Vomiting1618.7%
  6. 6Headache1578.5%
  7. 7Dizziness1447.8%
  8. 8Hypersensitivity1387.5%
  9. 9Asthenia1286.9%
  10. 10Arthralgia1196.5%
  11. 11Fatigue1196.5%
  12. 12Pain In Extremity1166.3%
  13. 13Drug Ineffective1136.1%
  14. 14Muscular Weakness1106.0%
  15. 15Urticaria1095.9%

Literature

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Recent PubMed references pinned to Tetracycline 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 817 ClinicalTrials.gov registrations naming Tetracycline as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Tetracycline work?
Mechanism-of-action class: Protein Synthesis Inhibitors.
What is Tetracycline used for?
According to FDA labeling, Tetracycline carries indications including: To reduce the development of drug-resistant bacteria and maintain the effectiveness of tetracycline hydrochloride and other antibacterial drugs, tetracycline hydrochloride should be used only to treat 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 Tetracycline?
Tetracycline is classified as Antibiotics, Antiinfectives, Antiinfectives and antiseptics for local oral treatment, Tetracycline and derivatives, Tetracyclines, Tetracycline-class Antimicrobial, Protein Synthesis Inhibitors, Cell Membrane Alteration, Decreased Mitosis, Decreased Protein Synthesis.
What are the brand names for Tetracycline?
Tetracycline is marketed under brand names including Pylera, Viabecline, Vitastem.
What are the contraindications for Tetracycline?
Tetracycline 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 tetracycline 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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