pharmacopeia
GET
/api/v1/drug/methylprednisolone
2D structure
(6S,8S,9S,10R,11S,13S,14S,17R)-11,17-dihydroxy-17-(2-hydroxyacetyl)-6,10,13-trimethyl-7,8,9,11,12,14,15,16-octahydro-6H-cyclopenta[a]phenanthren-3-one
SMILES C[C@H]1C[C@H]2[C@@H]3CC[C@@]([C@]3(C[C@@H]([C@@H]2[C@@]4(C1=CC(=O)C=C4)C)O)C)(C(=O)CO)O
InChIKey VHRSUDSXCMQTMA-PJHHCJLFSA-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
  • Methylprednisolone tablets are indicated in the following conditions: 1. Endocrine Disorders Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance).

Contraindications

Sourced from openFDA
  • Systemic fungal infections and known hypersensitivity to components.contraindicated

Dosage & administration

Sourced from openFDA

The initial dosage of methylprednisolone tablets may vary from 4 mg to 48 mg of methylprednisolone per day depending on the specific disease entity being treated. In situations of less severity lower doses will generally suffice while in selected patients higher initial doses may be required. The initial dosage should be maintained or adjusted until a satisfactory response is noted. If after a reasonable period of time there is a lack of satisfactory clinical response, methylprednisolone tablets should be discontinued and the patient transferred to other appropriate therapy. 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 which will maintain an adequate clinical response is reached. It should be kept in mind that constant monitoring is needed in regard to drug dosage. Included in the 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 methylprednisolone tablets for a period of time consistent with the patient's condition.

Warnings & precautions

Sourced from openFDA

In patients on corticosteroid therapy subjected to unusual stress, increased dosage of rapidly acting corticosteroids before, during, and after the stressful situation is indicated. Corticosteroids may mask some signs of infection, and new infections may appear during their use. Infections with any pathogen including viral, bacterial, fungal, protozoan or helminthic infections, in any location of the body, may be associated with the use of corticosteroids alone or in combination with other immunosuppressive agents that affect cellular immunity, humoral immunity, or neutrophil function. 1 These infections may be mild, but can be severe and at times fatal. With increasing doses of corticosteroids, the rate of occurrence of infectious complications increases. 2 There may be decreased resistance and inability to localize infection when corticosteroids are used. Prolonged use of corticosteroids may produce posterior subcapsular cataracts, glaucoma with possible damage to the optic nerves, and may enhance the establishment of secondary ocular infections due to fungi or viruses. Usage in pregnancy: Since adequate human reproduction studies have not been done with corticosteroids, the use of these drugs in pregnancy, nursing mothers or women of child-bearing potential requires that the possible benefits of the drug be weighed against the potential hazards to the mother and embryo or fetus. Infants born of mothers who have received substantial doses of corticosteroids during pregnancy, should be carefully observed for signs of hypoadrenalism.

Adverse reactions

Sourced from openFDA

Fluid and Electrolyte Disturbances Sodium retention Congestive heart failure in susceptible patients Hypertension Fluid retention Potassium loss Hypokalemic alkalosis Musculoskeletal Muscle weakness Loss of muscle mass Steroid myopathy Osteoporosis Tendon rupture, particularly of the Achilles tendon Vertebral compression fractures Aseptic necrosis of femoral and humeral heads Pathologic fracture of long bones Gastrointestinal Peptic ulcer with possible perforation and hemorrhage Pancreatitis Abdominal distention Ulcerative esophagitis Increases in alanine transaminase (ALT, SGPT), aspartate transaminase (AST, SGOT), and alkaline phosphatase have been observed following corticosteroid treatment. These changes are usually small, not associated with any clinical syndrome and are reversible upon discontinuation.

Approval history

Sourced from openFDA
  • Oct 24, 1957NDANDA011153Pfizer
  • May 18, 1959NDANDA011856Pharmacia And Upjohn
  • May 27, 1959NDANDA011757Pfizer
  • Dec 22, 1998ANDAANDA040183Ph Health
  • Jul 30, 2004ANDAANDA040583Fresenius Kabi Usa
  • Aug 12, 2004ANDAANDA040612Fresenius Kabi Usa
  • Dec 15, 2015ANDAANDA207667Eugia Pharma
  • Feb 16, 2016ANDAANDA202691Hikma

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.
167,050 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 Use25,03815%
  2. 2Drug Ineffective18,29011%
  3. 3Fatigue10,2876.2%
  4. 4Pain9,8105.9%
  5. 5Nausea9,3625.6%
  6. 6Headache9,3355.6%
  7. 7Pyrexia9,0135.4%
  8. 8Dyspnoea8,6225.2%
  9. 9Arthralgia8,1524.9%
  10. 10Pneumonia8,0544.8%
  11. 11Diarrhoea7,9344.7%
  12. 12Condition Aggravated7,4324.4%
  13. 13Infusion Related Reaction7,1464.3%
  14. 14Rash6,9864.2%
  15. 15Hypertension6,4953.9%

Literature

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Recent PubMed references pinned to Methylprednisolone 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 2,298 ClinicalTrials.gov registrations naming Methylprednisolone 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 Methylprednisolone work?
Mechanism-of-action classes: Corticosteroid Hormone Receptor Agonists; Glucocorticoid Receptor Agonists; Lipoxygenase Inhibitors.
What is Methylprednisolone used for?
According to FDA labeling, Methylprednisolone carries indications including: Methylprednisolone tablets are indicated in the following conditions: 1. Endocrine Disorders Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance).. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Methylprednisolone?
Methylprednisolone is classified as Corticosteroids, combinations for treatment of acne, Corticosteroids, weak (group I), Glucocorticoids, Corticosteroid, Corticosteroid Hormone Receptor Agonists, Glucocorticoid Receptor Agonists, Lipoxygenase Inhibitors, Carbohydrate Metabolism Alteration, Decreased Capillary Permeability, Decreased Fibroblast Migration, Decreased Glucocorticoid Secretion, Decreased Leukotriene Activity, Decreased Polymorphonuclear Leukocyte Migration, Decreased Prostaglandin Activity, Decreased Protein Synthesis, Decreased Thromboxane Activity, Lipid Metabolism Alteration, Lysosomal Function Alteration.
What are the brand names for Methylprednisolone?
Methylprednisolone is marketed under brand names including Depo-Medrol, HybriSil, Medrol, Solu-Medrol.
What are the contraindications for Methylprednisolone?
Methylprednisolone labeling lists contraindications including: Systemic fungal infections and known hypersensitivity to components.. Always consult the full prescribing information and a clinician.
Note. Data for methylprednisolone 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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