Fludroxycortide Other names: Flurandrenolide Flurandrenolone

Chemical formula: C₂₄H₃₃FO₆  Molecular mass: 436.514 g/mol  PubChem compound: 15209

Pregnancy

Pregnancy Category C

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 cortico-steroids. 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 for pregnant patients or in large amounts or for prolonged periods of time.

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.

Carcinogenesis, mutagenesis and fertility

Long-term animal studies have not been performed to evaluate the carcinogenic potential or the effect on fertility of topical corticosteroids.

Studies to determine mutagenicity with prednisolone and hydrocortisone have revealed negative results.

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
  • Acneform eruptions
  • Hypopigmentation
  • Perioral dermatitis
  • Allergic contact dermatitis

The following may occur more frequently with occlusive dressings:

  • Maceration of the skin
  • Secondary infection
  • Skin atrophy
  • Striae
  • Miliaria

Postmarketing Adverse Reactions

The following adverse reactions have been identified during post approval use of flurandrenolide lotion. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Skin: skin striae, hypersensitivity, skin atrophy, contact dermatitis, and skin discoloration.

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