Betamethasone

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This page reprints a manufacturer label. Everything below in quotation marks is copied from BETAVET ® (Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension), 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 BETAVET ® (Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension) by American Regent, Inc, a betamethasone 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.

The label

Product: BETAVET ® (Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension). Manufacturer: American Regent, Inc. FDA Structured Product Label set id 3eb6b1d3-4485-4b25-aaab-92de9b2fb322. Label effective 2024-10-07. Retrieved 2026-09-16 from the DailyMed animal label release, and readable on DailyMed.

Indications

BETAVET is indicated for the control of pain and inflammation associated with osteoarthritis in horses.

Dosage and Administration

Shake well immediately before use . Using strict aseptic technique, administer 1.5 mL BETAVET (9 mg total betamethasone) per joint by intra-articular injection. BETAVET may be administered concurrently in up to 2 joints per horse. Use immediately after opening, then discard any remaining contents.

Contraindications

BETAVET is contraindicated in horses with hypersensitivity to betamethasone. Intra-articular injection of corticosteroids for local effect is contraindicated in the presence of septic arthritis.

Warnings

Do not use in horses intended for human consumption. Clinical and experimental data have demonstrated that corticosteroids administered orally or parenterally to animals may induce the first stage of parturition when administered 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 resulted in cleft palate in offspring. Corticosteroids administered to dogs during pregnancy have also resulted in other congenital anomalies including deformed forelegs, phocomelia and anasarca. Therefore, before use of corticosteroids in pregnant animals, the possible benefits to the pregnant animal should be weighed against potential hazards to its developing embryo or fetus. Human Warnings: Not for use in humans. For use in animals only. Keep this and all medications out of the reach of children. Consult a physician in the case of accidental human exposure.

Precautions

Corticosteroids, including BETAVET, administered intraarticularly are systemically absorbed. Do not use in horses with acute infections. Acute moderate to severe exacerbation of pain, further loss of joint motion, fever, or malaise within several days following intra-articular injection may indicate a septic process. Because of the anti-inflammatory action of corticosteroids, signs of infection in the treated joint may be masked. Appropriate examination of joint fluid is necessary to exclude a septic process. If a bacterial infection is present, appropriate antibacterial therapy should be instituted immediately. Additional doses of corticosteroids should not be administered until joint sepsis has been definitively ruled out. Due to the potential for exacerbation of clinical signs of laminitis, glucocorticoids should be used with caution in horses with a history of laminitis, or horses otherwise at a higher risk for laminitis. Use with caution in horses with chronic nephritis, equine pituitary pars intermedia dysfunction (PPID), and congestive heart failure. Concurrent use of other anti-inflammatory drugs, such as NSAIDs or other corticosteroids, should be approached with caution. Due to the potential for systemic exposure, concomitant use of NSAIDs and corticosteroids may increase the risk of gastrointestinal, renal, and other toxicity. Consider appropriate wash out times prior to administering additional NSAIDs or corticosteroids.

Adverse Reactions

Adverse reactions reported during a field study of 239 horses of various breeds which had been administered either BETAVET (n=119) or a saline control (n=120) are summarized in Table 1. One BETAVET treated horse was removed from the study for onset of acute non-weight bearing lameness on Day 4. Treatment for presumed joint sepsis was instituted immediately, but the horse was eventually euthanized several weeks later due to a thromboembolic event associated with prolonged intravenous catheter placement. One BETAVET treated horse developed bilateral forelimb lameness on Day 8, with snow packed in the shoes and poor hoof conformation noted by the investigator. The horse was diagnosed with laminitis. Radiographs showed no abnormalities, and the horse was sound shortly after shoeing changes were implemented. Table 1. Adverse Reactions Adverse Reaction Number (%) of BETAVET treated horses Number (%) of saline treated horses Acute joint effusion and/or local injection site swelling (within 2 days of injection) 18 (15%) 16 (13%) Increased lameness (within the first 5 days) 8 (6.7%) 10 (8.3%) Loose stool 7 (5.9%) 10 (8.3%) Increased heat in joint 3 (2.5%) 6 (5%) Depression 7 (5.9%) 2 (1.6%) Agitation/anxiety 5 (4.2%) 3 (2.5%) Delayed swelling of treated joint (5 or more days after injection) 3 (2.5%) 4 (3.3%) Inappetance 4 (3.4%) 3 (2.5%) Dry stool 2 (1.7%) 0 (0%) Excessive sweating 1 (0.8%) 0 (0%) Acute non-weight bearing lameness 1 (0.8%) 0 (0%) Laminitis 1 (0.8%) 0 (0%)

Description

BETAVET ® is a sterile aqueous suspension of betamethasone acetate in betamethasone sodium phosphate injection. The combined betamethasone content of the suspension is 6 mg/mL where each mL contains 3.15 mg betamethasone (as betamethasone sodium phosphate); 2.85 mg betamethasone (as betamethasone acetate); 7.1 mg dibasic sodium phosphate; 3.4 mg monobasic sodium phosphate; 0.1 mg edetate disodium; and 0.2 mg benzalkonium chloride, as a preservative in water for injection. The pH is adjusted to between 6.8 and 7.2. The formula for betamethasone sodium phosphate is C 22 H 28 FNa 2 O 8 P and it has a molecular weight of 516.41. Chemically, it is 9-Fluoro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione 21-(disodium phosphate). The formula for betamethasone acetate is C 24 H 31 FO 6 and it has a molecular weight of 434.50. Chemically, it is 9-Fluoro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione 21-acetate. The chemical structures for betamethasone sodium phosphate and betamethasone acetate are as follows: betamethasone sodium phosphate betamethasone acetate Betamethasone sodium phosphate is a white to practically white, odorless powder, and is hygroscopic. It is freely soluble in water and in methanol, but is practically insoluble in acetone and in chloroform. Betamethasone acetate is a white to creamy white, odorless powder that sinters and resolidifies at about 165ºC, and remelts at about 200ºC-220ºC with decomposition. It is practically insoluble in water, but freely soluble in acetone, and is soluble in alcohol and in chloroform. betamethasone sodium phosphate betamethasone acetate

Storage

Store at 20° to 25°C (68° to 77°F) (See USP Controlled Room Temperature). Protect from light. Use carton to protect contents from light until used.

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 betamethasone 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: 4,875 reports

Reactions most often coded in dogs, 4,875 reports
VeDDRA reaction termReports
Deafness1,427
Lack of efficacy - NOS1,260
Vomiting254
Partial deafness246
Ear discharge187
Lethargy (see also Central nervous system depression in 'Neurological')180
Loss of hearing176
Diarrhoea140
Other abnormal test result NOS125
Head shake - ear disorder121
Behavioural disorder NOS115
Head tilt - ear disorder97
Emesis95
Hearing decreased92
Ear pain85

Outcome as recorded by the reporter: Outcome Unknown 1,739; Ongoing 854; Recovered/Normal 643; Recovered with Sequela 98; Died 77; Euthanized 53.

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

Sources

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