pharmacopeia

Dexamethasone

CorticosteroidsCorticosteroids/antiinfectives/mydriatics in combinationCorticosteroids, combinations for treatment of acneCorticosteroids for local oral treatmentCorticosteroids, moderately potent (group II)Corticosteroids, moderately potent, other combinationsCorticosteroids, plainGlucocorticoidsCorticosteroidCorticosteroid Hormone Receptor AgonistsGlucocorticoid Receptor AgonistsLipoxygenase InhibitorsCarbohydrate Metabolism AlterationDecreased Adhesion Factor ActivityDecreased Capillary PermeabilityDecreased Complement ProductionDecreased Fibroblast MigrationDecreased Glucocorticoid SecretionDecreased Histamine ActivityDecreased Intravascular VolumeDecreased Kinin ActivityDecreased Leukotriene ActivityDecreased Lysosomal FunctionDecreased Myeloid Cell ProductionDecreased Polymorphonuclear Leukocyte MigrationDecreased Prostaglandin ActivityDecreased Protein SynthesisDecreased Thromboxane ActivityLipid Metabolism AlterationUS-FDASourced from openFDA
GET
/api/v1/drug/dexamethasone
2D structure
(8S,9R,10S,11S,13S,14S,16R,17R)-9-fluoro-11,17-dihydroxy-17-(2-hydroxyacetyl)-10,13,16-trimethyl-6,7,8,11,12,14,15,16-octahydrocyclopenta[a]phenanthren-3-one
SMILES C[C@@H]1C[C@H]2[C@@H]3CCC4=CC(=O)C=C[C@@]4([C@]3([C@H](C[C@@]2([C@]1(C(=O)CO)O)C)O)F)C
InChIKey UREBDLICKHMUKA-CXSFZGCWSA-N

Mechanism of action

Sourced from openFDA

Mechanism-of-action classes: Corticosteroid Hormone Receptor Agonists; Glucocorticoid Receptor Agonists; Lipoxygenase Inhibitors.

Corticosteroid Hormone ReceptorGlucocorticoid ReceptorLipoxygenase

Indications

Sourced from openFDA
  • A l l ergic States: Control of severe or incapacitating a llergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis, and serum sickness. Dermatologic Diseases: Bul l ous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, and severe erythema multiforme (Stevens-Johnson syndrome).ICD-10: J30.9, J45.909, L20.9

Contraindications

Sourced from openFDA
  • Contraindicated in systemic fungal infections (see WARNINGS : Infections: Fungal Infections ) and patients with known hypersensitivity to the product and its consituents.contraindicated

Dosage & administration

Sourced from openFDA

For Oral Administration The initial dosage varies from 0.75 to 9 mg a day depending on the disease being treated. It Should Be Emphasized That Dosage Requirements Are Variable And Must Be Individualized On The Basis Of The Disease Under Treatment And The Response Of The Patient. After a favorable response is noted, the proper maintenance dosage should be determined by decreasing the initial drug dosage in small decrements at appropriate time intervals until the lowest dosage that maintains an adequate clinical response is reached. Situations which may make dosage adjustments necessary are changes in clinical status secondary to remissions or exacerbations in the disease process, the patient's individual drug responsiveness, and the effect of patient exposure to stressful situations not directly related to the disease entity under treatment. In this latter situation it may be necessary to increase the dosage of the corticosteroid for a period of time consistent with the patient's condition. If after long-term therapy the drug is to be stopped, it is recommended that it be withdrawn gradually rather than abruptly. In the treatment of acute exacerbations of multiple sclerosis, daily doses of 30 mg of dexamethasone for a week followed by 4 to 12 mg every other day for one month have been shown to be effective (see PRECAUTIONS : Neuro-Psychiatric ). In pediatric patients, the initial dose of dexamethasone may vary depending on the specific disease entity being treated. The range of initial doses is 0.02 to 0.3 mg/kg/day in three or four divided doses (0.6 to 9 mg/m2bsa/day).

Warnings & precautions

Sourced from openFDA

General Rare instances of anaphylactoid reactions have occurred in patients receiving corticosteroid therapy (see ADVERSE REACTIONS ). Increased dosage of rapidly acting corticosteroids is indicated in patients on corticosteroid therapy subjected to any unusual stress before, during, and after the stressful situation. Cardio-Renal Average and large doses of corticosteroids can cause elevation of blood pressure, sodium and water retention, and increased excretion of potassium. These effects are less likely to occur with the synthetic derivatives except when used in large doses. Dietary salt restriction and potassium supplementation may be necessary. All corticosteroids increase calcium excretion. Literature reports suggest an apparent association between use of corticosteroids and left ventricular free wall rupture after a recent myocardial infarction; therefore, therapy with corticosteroids should be used with great caution in these patients. Endocrine Corticosteroids can produce reversible hypothalamic-pituitary adrenal (HPA) axis suppression with the potential for corticosteroid insufficiency after withdrawal of treatment. Adrenocortical insufficiency may result from too rapid withdrawal of corticosteroids and may be minimized by gradual reduction of dosage. This type of relative insufficiency may persist for months after discontinuation of therapy; therefore, in any situation of stress occurring during that period, hormone therapy should be reinstituted. If the patient is receiving steroids already, dosage may have to be increased.

Adverse reactions

Sourced from openFDA

(listed alphabetica ll y, under each subsection) The following adverse reactions have been reported with dexamethasone or other corticosteroids: A ll ergic Reactions: Anaphylactoid reaction, anaphylaxis, angioedema. Cardiovascular: Bradycardia, cardiac arrest, cardiac arrhythmias, cardiac enlargement, circulatory co l apse, congestive heart failure, fat embolism, hypertension, hypertrophic cardiomyopathy in premature infants, myocardial rupture following recent myocardial infarction (see WARNINGS: Cardio-Renal ), edema, pulmonary edema, syncope, tachycardia, thromboembolism, thrombophlebitis, vasculitis. Dermatologic: Acne, allergic dermatitis, dry scaly skin, ecchymoses and petechiae, erythema, impaired wound healing, increased sweating, rash, striae, suppression of reactions to skin tests, thin fragile skin, thinning scalp hair, urticaria. Endocrine: Decreased carbohydrate and glucose tolerance, development of cushingoid state, hyperglycemia, glycosuria, hirsutism, hypertrichosis, increased requirements for insulin or oral hypoglycemic agents in diabetes, manifestations of latent diabetes mellitus, menstrual irregularities, secondary adrenocortical and pituitary unresponsiveness (particularly in times of stress, as in trauma, surgery, or ill ness), suppression of growth in pediatric patients. Fluid and Electrolyte Disturbances: Congestive heart failure in susceptible patients, fluid retention, hypokalemic alkalosis, potassium loss, sodium retention, tumor lysis syndrome.

Use in specific populations

Sourced from openFDA

Pregnancy Teratogenic Effects: Pregnancy Category C. Corticosteroids have been shown to be teratogenic in many species when given in doses equivalent to the human dose. Animal studies in which corticosteroids have been given to pregnant mice, rats, and rabbits have yielded an increased incidence of cleft palate in the offspring. There are no adequate and well-controlled studies in pregnant women. Corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Infants born to mothers who have received substantial doses of corticosteroids during pregnancy should be carefully observed for signs of hypoadrenalism.

Approval history

Sourced from openFDA
  • Jun 20, 1962NDANDA013422Harrow Eye
  • Jun 6, 1963NDANDA050023Harrow Eye
  • Jul 19, 1963NDANDA050065Sandoz
  • Aug 18, 1988NDANDA050592Sandoz
  • Sep 28, 1988NDANDA050616Novartis
  • Jul 18, 2003NDANDA021537Sandoz
  • Feb 13, 2009NDANDA050818Harrow Eye
  • Jun 17, 2009NDANDA022315Abbvie

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.
303,301 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 Use23,1537.6%
  2. 2Fatigue17,4145.7%
  3. 3Diarrhoea17,2855.7%
  4. 4Nausea14,4294.8%
  5. 5Plasma Cell Myeloma14,1084.7%
  6. 6Pneumonia13,9044.6%
  7. 7Death13,5844.5%
  8. 8Drug Ineffective13,4064.4%
  9. 9Neutropenia11,7173.9%
  10. 10Pyrexia11,4003.8%
  11. 11Thrombocytopenia10,7243.5%
  12. 12Dyspnoea10,5643.5%
  13. 13Anaemia9,3233.1%
  14. 14Febrile Neutropenia9,1823.0%
  15. 15Vomiting9,1013.0%

Literature

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Recent PubMed references pinned to Dexamethasone 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 4,674 ClinicalTrials.gov registrations naming Dexamethasone 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 Dexamethasone work?
Mechanism-of-action classes: Corticosteroid Hormone Receptor Agonists; Glucocorticoid Receptor Agonists; Lipoxygenase Inhibitors.
What is Dexamethasone used for?
According to FDA labeling, Dexamethasone carries indications including: A l l ergic States: Control of severe or incapacitating a llergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis, and serum sickness. Dermatologic Diseases: Bul l ous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, and severe erythema multiforme (Stevens-Johnson syndrome).. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Dexamethasone?
Dexamethasone is classified as Corticosteroids, Corticosteroids/antiinfectives/mydriatics in combination, Corticosteroids, combinations for treatment of acne, Corticosteroids for local oral treatment, Corticosteroids, moderately potent (group II), Corticosteroids, moderately potent, other combinations, Corticosteroids, plain, Glucocorticoids, Corticosteroid, Corticosteroid Hormone Receptor Agonists, Glucocorticoid Receptor Agonists, Lipoxygenase Inhibitors, Carbohydrate Metabolism Alteration, Decreased Adhesion Factor Activity, Decreased Capillary Permeability, Decreased Complement Production, Decreased Fibroblast Migration, Decreased Glucocorticoid Secretion, Decreased Histamine Activity, Decreased Intravascular Volume, Decreased Kinin Activity, Decreased Leukotriene Activity, Decreased Lysosomal Function, Decreased Myeloid Cell Production, Decreased Polymorphonuclear Leukocyte Migration, Decreased Prostaglandin Activity, Decreased Protein Synthesis, Decreased Thromboxane Activity, Lipid Metabolism Alteration.
What are the brand names for Dexamethasone?
Dexamethasone is marketed under brand names including Ciprodex, Decadron, Dexasone, Dexium, Dextenza, Dexycu, Hemady, Maxidex.
What are the contraindications for Dexamethasone?
Dexamethasone labeling lists contraindications including: Contraindicated in systemic fungal infections (see WARNINGS : Infections: Fungal Infections ) and patients with known hypersensitivity to the product and its consituents.. Always consult the full prescribing information and a clinician.
Note. Data for dexamethasone 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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