Dexamethasone

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This page reprints a manufacturer label. Everything below in quotation marks is copied from , published by FDA and retrieved on 2026-09-16. Nothing has been added, reworded or left out of the sections shown. It is the manufacturer’s label, reproduced as published.

This page reprints the FDA label for by Bimeda, Inc, a dexamethasone product labelled for dogs. The sections below are copied from that label without change, with the set id and the date it was retrieved from DailyMed. 1 other stored label carries the same active ingredient and is listed at the end.

The label

Product: . Manufacturer: Bimeda, Inc. FDA Structured Product Label set id 3f6e8445-7335-4776-aa84-c34f61d43e40. Label effective 2025-03-19. Retrieved 2026-09-16 from the DailyMed animal label release, and readable on DailyMed.

Indications

Dexamethasone-SP (dexamethasone sodium phosphate injection) is indicated as a rapid adrenal glucocorticoid and/or anti-inflammatory agent in horses.

Dosage and Administration

For Intravenous Use Only. Horses: The usual intravenous dosage is 2.5 to 5 mg (based on 3 mg per mL of dexamethasone content). If permanent corticosteroid effect is required, oral therapy with dexamethasone may be substituted. When therapy is to be withdrawn after prolonged corticosteroid administration, the daily dose should be reduced gradually over a number of days, in stepwise fashion.

Contraindications

Do not use in viral infections. Except when used for emergency therapy, dexamethasone sodium phosphate is contraindicated in animals with tuberculosis and chronic nephritis. Existence of congestive heart failure, osteoporosis and diabetes are relative contraindications. In the presence of infection appropriate antibacterial agents should also be administered and should be continued for at least 3 days after discontinuance of the hormone and disappearance of all signs of infection.

Warnings

Clinical and experimental data have demonstrated that corticosteroids administered orally or by injection to animals may induce the first stage of parturition if used during the last trimester of pregnancy and may precipitate premature parturition followed by dystocia, fetal death, retained placenta and metritis. Additionally, corticosteroids administered to dogs, rabbits, and rodents during pregnancy have produced cleft palate. Other congenital anomalies including deformed forelegs, phocomelia, and anasarca have been reported in offspring of dogs which received corticosteroids during pregnancy.

Precautions

Because of the anti-inflammatory action of corticosteroids, signs of infection may be hidden and it may be necessary to stop treatment until diagnosis is made. Overdosage of some glucocorticoids may result in sodium retention, fluid retention, potassium loss and weight gains. In infections characterized by overwhelming toxicity, dexamethasone sodium phosphate therapy, in conjunction with indicated antibacterial therapy, is effective in reducing mortality. It is essential that the causative organism be known and an effective antibacterial agent be administered concurrently. The injudicious use of adrenal hormones in animals with infections can be hazardous. Use of corticosteroids, depending on dose, duration and specific steroid, may result in inhibition of endogenous steroid production following drug withdrawal. In patients presently receiving or recently withdrawn from systemic corticosteroid treatments, therapy with a rapidly acting corticosteroid should be considered in unusually stressful situations.

Adverse Reactions

The therapeutic use of dexamethasone sodium phosphate injection is unlikely to cause undesired accentuation of metabolic effects. However, if continued corticosteroid therapy is anticipated, a high protein intake should be provided to keep the animal in positive nitrogen balance. A retardant effect on wound healing should be considered when it is used in conjunction with surgery. Euphoria or an improvement of attitude, and increased appetite are the usual manifestations. Side effects such as glycosuria, hyperglycemia, diarrhea, polydipsia and polyuria have been observed in some species. Side effects such as SAP and SGPT enzyme elevations, eosinopenia, and vomiting have occurred following use of synthetic corticosteroids in dogs. Cushing's Syndrome in dogs has been reported in association with prolonged or repeated steroid therapy. Corticosteroids reportedly cause laminitis in horses.

Description

Dexamethasone sodium phosphate (a synthetic adrenocortical steroid), is a white or slightly yellow crystalline powder. It is freely soluble in water and is exceedingly hygroscopic. Each mL of Dexamethasone-SP (dexamethasone sodium phosphate injection) contains Dexamethasone Sodium Phosphate 4 mg (equivalent to dexamethasone 3 mg), Sodium Citrate 10 mg, Sodium Bisulfite 2 mg, Benzyl Alcohol 1.5% as a preservative, in Water for Injection q.s. Sodium Hydroxide and/or Hydrochloric Acid to adjust pH to between 7.0 and 8.5.

Other labels for this ingredient

These labels are also stored for the same active ingredient. They are not identical to the one reprinted above, and each is listed by product and set id rather than merged with it.

  • , MWI/VetOne. Set id ab07d4d7-073d-4c03-a57f-6893e9a7b6a2.

FDA adverse event reports

The FDA Center for Veterinary Medicine publishes the adverse event reports it receives through openFDA. The counts below are the reports naming dexamethasone as an active ingredient for each species this label names, as returned on 2026-09-16, coded by the VeDDRA reaction term the reporter chose. Reactions are counted per report, so one report can appear under several terms.

These are counts, not rates. Reporting is voluntary, the number of animals treated is not known, and a widely used product accumulates reports for that reason alone. A report records that an event followed a dose; it does not establish that the product caused it. The counts say nothing about how one product compares with another.

Dogs: 3,506 reports

Reactions most often coded in dogs, 3,506 reports
VeDDRA reaction termReports
Vomiting966
Lethargy (see also Central nervous system depression in 'Neurological')616
Diarrhoea412
Anaphylaxis365
Death337
Other abnormal test result NOS308
Death by euthanasia302
Anorexia301
Pale mucous membrane278
Elevated alanine aminotransferase (ALT)275
Leucocytosis NOS243
Lethargy (see also Central nervous system depression in Neurological)242
Fever240
Not eating239
Panting225

Outcome as recorded by the reporter: Ongoing 1,214; Recovered/Normal 738; Outcome Unknown 607; Died 358; Euthanized 295; Recovered with Sequela 30.

Queries: reports, reactions, outcomes. Dataset: openFDA Animal and Veterinary Adverse Event Reports.

Sources

  • FDA · retrieved 2026-09-16
    For Intravenous Use Only. Horses: The usual intravenous dosage is 2.5 to 5 mg (based on 3 mg per mL of dexamethasone content). If permanent corticosteroid effect is required, oral therapy with dexamethasone may be substi (Dosage and Administration)
  • openFDA Animal and Veterinary Adverse Event ReportsFDA · retrieved 2026-09-16

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