Hydrocortisone
RxNorm 203105· HYDROCORTISONE· TOPICAL
Corticosteroid [EPC] · E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC
Indications and usage
INDICATIONS AND USAGE Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
Dosage and administration
DOSAGE AND ADMINISTRATION Topical corticosteroids are generally applied to the affected area as a thin film three or four times a day depending on the severity of the condition. Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions. If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.
Contraindications
CONTRAINDICATIONS Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.
Pregnancy
Pregnancy Teratogenic effects Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels. The more potent corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. There are no adequate and well-controlled studies in pregnant women on teratogenic effects from topically applied corticosteroids. Therefore, topical corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Drugs of this class should not be used extensively on pregnant patients, in large amounts, or for prolonged periods of time.
Nursing mothers
Nursing Mothers It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Systemically administered corticosteroids are secreted into breast milk in quantities not likely to have a deleterious effect on the infant. Nevertheless, caution should be exercised when topical corticosteroids are administered to a nursing woman.
Adverse events
Most frequently reported events (FDA FAERS). Report frequency does not imply causation.
- off label use14,652
- drug ineffective13,676
- fatigue12,268
- pain10,632
- arthralgia9,481
- nausea9,405
- diarrhoea8,870
- rash8,762
- condition aggravated8,725
- headache8,495
- dyspnoea8,231
- pyrexia7,324
- vomiting6,931
- malaise6,467
- pruritus6,436
- infusion related reaction6,156
Adverse reactions (label)
ADVERSE REACTIONS The following local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximate decreasing order of occurrence: burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae and miliaria.
View more: Full FDA label on DailyMed →Label effective 20260128