pharmacopeia
GET
/api/v1/drug/minocycline
2D structure
(4S,4aS,5aR,12aR)-4,7-bis(dimethylamino)-1,10,11,12a-tetrahydroxy-3,12-dioxo-4a,5,5a,6-tetrahydro-4H-tetracene-2-carboxamide
SMILES CN(C)[C@H]1[C@@H]2C[C@@H]3CC4=C(C=CC(=C4C(=C3C(=O)[C@@]2(C(=C(C1=O)C(=O)N)O)O)O)O)N(C)C
InChIKey FFTVPQUHLQBXQZ-KVUCHLLUSA-N

Mechanism of action

Sourced from openFDA

The tetracyclines are primarily bacteriostatic and are thought to exert their antimicrobial effect by the inhibition of protein synthesis. The tetracyclines, including minocycline, have a similar antimicrobial spectrum of activity against a wide range of gram-positive and gram-negative organisms.

Protein Synthesis

Indications

Sourced from openFDA
  • Minocycline hydrochloride capsules USP are indicated in the treatment of the following infections due to susceptible strains of the designated microorganisms: Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox and tick fevers caused by rickettsiae. Respiratory tract infections caused by Mycoplasma pneumoniae .

Contraindications

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

Dosage & administration

Sourced from openFDA

THE USUAL DOSAGE AND FREQUENCY OF ADMINISTRATION OF MINOCYCLINE DIFFER FROM THAT OF THE OTHER TETRACYCLINES. EXCEEDING THE RECOMMENDED DOSAGE MAY RESULT IN AN INCREASED INCIDENCE OF SIDE EFFECTS. Minocycline hydrochloride capsules may be taken with or without food (see CLINICAL PHARMACOLOGY ). Ingestion of adequate amounts of fluids along with capsule and tablet forms of drugs in the tetracycline-class is recommended to reduce the risk of esophageal irritation and ulceration. The capsules should be swallowed whole. For Pediatric Patients above 8 Years of Age Usual pediatric dose: 4 mg/kg initially followed by 2 mg/kg every 12 hours, not to exceed the usual adult dose. Adults The usual dosage of minocycline hydrochloride capsules is 200 mg initially followed by 100 mg every 12 hours. Alternatively, if more frequent doses are preferred, two or four 50 mg capsules may be given initially followed by one 50 mg capsule 4 times daily. Uncomplicated gonococcal infections other than urethritis and anorectal infections in men: 200 mg initially, followed by 100 mg every 12 hours for a minimum of 4 days, with post-therapy cultures within 2 to 3 days. In the treatment of uncomplicated gonococcal urethritis in men, 100 mg every 12 hours for 5 days is recommended. For the treatment of syphilis, the usual dosage of minocycline hydrochloride should be administered over a period of 10 to 15 days. Close follow-up, including laboratory tests, is recommended. In the treatment of meningococcal carrier state, the recommended dosage is 100 mg every 12 hours for 5 days.

Warnings & precautions

Sourced from openFDA

Tooth Development Minocycline hydrochloride capsules, like other tetracycline-class antibiotics, can cause fetal harm when administered to a pregnant woman. If any tetracycline is used during pregnancy or if the patient becomes pregnant while taking these drugs, the patient should be apprised of the potential hazard to the fetus. 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 drug but has been observed following repeated short-term courses. Enamel hypoplasia has also been reported. Tetracycline drugs, therefore, should not be used during tooth development unless other drugs are not likely to be effective or are contraindicated. Skeletal Development All tetracyclines form a stable calcium complex in any bone-forming tissue. A decrease in the fibula growth rate has been observed in premature human infants given oral tetracycline in doses of 25 mg/kg every six hours. This reaction was shown to be reversible when the drug was discontinued. Use in Pregnancy Results of animal studies indicate that tetracyclines cross the placenta, are found in fetal tissues, and can have toxic effects on the developing fetus (often related to retardation of skeletal development). Evidence of embryotoxicity has been noted in animals treated early in pregnancy. The safety of minocycline hydrochloride for use during pregnancy has not been established.

Adverse reactions

Sourced from openFDA

Due to oral minocycline's virtually complete absorption, side effects to the lower bowel, particularly diarrhea, have been infrequent. The following adverse reactions have been observed in patients receiving tetracyclines: Body as a whole : Fever and discoloration of secretions. Gastrointestinal : Anorexia, nausea, vomiting, diarrhea, dyspepsia, stomatitis, glossitis, dysphagia, enamel hypoplasia, enterocolitis, pseudomembranous colitis, pancreatitis, inflammatory lesions (with monilial overgrowth) in the oral and anogenital regions. Instances of esophagitis and esophageal ulcerations have been reported in patients taking the tetracycline-class antibiotics in capsule and tablet form. Most of these patients took the medication immediately before going to bed (see DOSAGE AND ADMINISTRATION ). Genitourinary : Vulvovaginitis. Hepatic toxicity : Hyperbilirubinemia, hepatic cholestasis, increases in liver enzymes, fatal hepatic failure, and jaundice. Hepatitis, including autoimmune hepatitis, and liver failure have been reported (see PRECAUTIONS ). Skin : Alopecia, erythema nodosum, hyperpigmentation of nails, pruritus, toxic epidermal necrolysis, vasculitis, maculopapular rash and erythematous rash. Exfoliative dermatitis has been reported. Fixed drug eruptions have been reported. Lesions occurring on the glans penis have caused balanitis. Erythema multiforme and Stevens-Johnson syndrome have been reported. Photosensitivity is discussed above (see WARNINGS-Photosensitivity ). Pigmentation of the skin and mucous membranes has been reported.

Use in specific populations

Sourced from openFDA

Pregnancy Risk Summary All pregnancies have a background risk of birth defects, loss, or other adverse outcome regardless of drug exposure. There are no adequate and well-controlled studies on the use of minocycline in pregnant women. Minocycline, like other tetracycline-class antibiotics, crosses the placenta and may cause fetal harm when administered to a pregnant woman. Rare spontaneous reports of congenital anomalies including limb reduction have been reported in postmarketing experience. Only limited information is available regarding these reports; therefore, no conclusion on causal association can be established. If minocycline is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus. Nonteratogenic Effects: (see WARNINGS .)

Overdosage

Sourced from openFDA

The adverse events more commonly seen in overdose are dizziness, nausea, and vomiting. No specific antidote for minocycline is known. In case of overdosage, discontinue medication, treat symptomatically, and institute supportive measures. Minocycline is not removed in significant quantities by hemodialysis or peritoneal dialysis.

Approval history

Sourced from openFDA
  • Oct 26, 1972NDANDA050444Rempex
  • Dec 30, 1991ANDAANDA063181Watson Labs Teva
  • Dec 30, 1991ANDAANDA063065Watson Labs
  • Mar 2, 1992ANDAANDA063009Zydus
  • Feb 16, 2001NDANDA050781Orapharma
  • Oct 18, 2019NDANDA212379Journey
  • May 28, 2020NDANDA213690Journey
  • Nov 1, 2024NDANDA219015Journey

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.
16,283 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 Ineffective2,81117%
  2. 2Off Label Use2,11913%
  3. 3Nausea1,6189.9%
  4. 4Pain1,6089.9%
  5. 5Arthralgia1,4829.1%
  6. 6Drug Intolerance1,4629.0%
  7. 7Rash1,4308.8%
  8. 8Fatigue1,4298.8%
  9. 9Rheumatoid Arthritis1,4188.7%
  10. 10Drug Hypersensitivity1,3708.4%
  11. 11Headache1,2407.6%
  12. 12Joint Swelling1,2397.6%
  13. 13Condition Aggravated1,1877.3%
  14. 14Pneumonia1,1737.2%
  15. 15Diarrhoea1,1076.8%

Literature

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Recent PubMed references pinned to Minocycline 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 318 ClinicalTrials.gov registrations naming Minocycline 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 Minocycline work?
The tetracyclines are primarily bacteriostatic and are thought to exert their antimicrobial effect by the inhibition of protein synthesis. The tetracyclines, including minocycline, have a similar antimicrobial spectrum of activity against a wide range of gram-positive and gram-negative organisms.
What is Minocycline used for?
According to FDA labeling, Minocycline carries indications including: Minocycline hydrochloride capsules USP are indicated in the treatment of the following infections due to susceptible strains of the designated microorganisms: Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox and tick fevers caused by rickettsiae. Respiratory tract infections caused by Mycoplasma pneumoniae .. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Minocycline?
Minocycline is classified as Antiinfectives and antiseptics for local oral treatment, Antiinfectives for treatment of acne, Tetracyclines, Tetracycline-class Drug, Protein Synthesis Inhibitors, Decreased Mitosis, Decreased Protein Modification, Decreased Prothrombin Activity.
What are the brand names for Minocycline?
Minocycline is marketed under brand names including Amzeeq, Arestin, Cleeravue-M, Emrosi, Minocin, Minolira, Solodyn, Ximino.
What are the contraindications for Minocycline?
Minocycline labeling lists contraindications including: This drug is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines or to any of the components of the product formulation.. Always consult the full prescribing information and a clinician.
Note. Data for minocycline 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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