Dexamethasone 4mg: clinical trials recruiting now
FDA drug label
- FDA-approved
- Yes. Dexamethasone 4mg appears in the FDA drug-label database. Marketed as Dexamethasone.
- Drug class
- Corticosteroid (FDA established pharmacologic class)
- Mechanism of action
- Corticosteroid Hormone Receptor Agonists (as stated on the FDA label)
FDA-approved use
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). Endocrine Disorders: Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; may be used in conjunction with synthetic mineralocorticoid analogs where applicable; in infancy mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, and nonsuppurative thyroiditis. Gastrointestinal Diseases: To tide the patient over a critical period of the disease in regional enteritis and ulcerative colitis. Hematologic Disorders: Acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond-Blackfan anemia), idiopathic thrombocytopenic purpura in adults, pure red cell aplasia, and selected cases of seconda…
FDA recalls / enforcement
| Reason (FDA) | Classification | Status | Initiated |
|---|---|---|---|
| Failed Impurities/Degradation Specifications: high out of specification results for Dexamethasone adduct (related compound). — West-Ward Pharmaceuticals Corp. | Class III (FDA: unlikely to cause harm) | Terminated | 2017-11-06 |
| Labeling: Incorrect or missing package insert. — Sandoz Inc | Class III (FDA: unlikely to cause harm) | Terminated | 2019-10-17 |
| Failed Impurities/Degradation Specifications: impurity sulfonic acid adduct of dexamethasone phosphate results were above spec. — Eugia US LLC | Class II (FDA: may cause temporary or reversible harm) | Ongoing | 2024-05-23 |
| Temperature Abuse — Sandoz Inc | Class II (FDA: may cause temporary or reversible harm) | Ongoing | 2025-08-13 |
| cGMP deviations: Temperature abuse — Mckesson Medical-Surgical Inc. Corporate Office | Class II (FDA: may cause temporary or reversible harm) | Terminated | 2022-04-13 |
Phase breakdown
Conditions being studied
| Condition | Trials |
|---|---|
| Osteoarthritis · Dexamethasone 4mg for Osteoarthritis | 3 |
| Hip Osteoarthritis | 2 |
| Knee Osteoarthritis | 1 |
| Obesity | 1 |
| Osteoarthritis, Hip | 1 |
| Shoulder Surgery | 1 |
Recruiting trials involving Dexamethasone 4mg
- Dexamethasone vs Dexmedetomidine for iPACK + ACB in TKA
- Interscalene vs Phrenic-sparing Blocks in Obesity and Effect of Maximum Inspiratory Pressure
- Intravenous Dexamethasone (0 vs 4 vs 8 mg) as an Adjunct to PENG Block for Postoperative Analgesia in Total Hip Arthroplasty: A Randomized Double-Blind Trial
- Three Variants of the PENG Block With and Without Perineural Adjuvants in Older Adults
Common questions
Is Dexamethasone 4mg FDA-approved?
Yes, marketed as Dexamethasone.
How many recruiting trials involve Dexamethasone 4mg?
4 recruiting trials across 6 conditions.
Is this list of trials complete?
No. For the full record, search ClinicalTrials.gov.