Capromorelin

Indications

ENTYCE (capromorelin oral solution) is indicated for appetite stimulation in dogs.

Dosage and Administration

Administer ENTYCE orally at a dose of 3 mg/kg (1.4 mg/lb) body weight once daily. To administer ENTYCE follow the written instructions below and see illustrations 1 through 4 for administration steps. 1. Gently shake the bottle. 2. Remove the bottle cap and insert the provided dosing syringe firmly into the opening of the bottle. 3. Turn the bottle upside down and withdraw the appropriate volume of solution. Return the bottle to the upright position before removing the syringe, and replace the cap. 4. Administer the solution with the syringe into the dog's mouth. Rinse the syringe and plunger with water between treatment doses. Leave the syringe and plunger apart to dry. Wash hands immediately after use. The effectiveness of ENTYCE has not been evaluated beyond 4 days of treatment in the clinical field study (See Effectiveness ). Dosage and Administration

Contraindications

ENTYCE should not be used in dogs that have a hypersensitivity to capromorelin.

Warnings

User Safety Warnings: Not for use in humans. Keep this drug, including used syringes, out of reach of children. Wash hands immediately after use as this product may be dermally absorbed. Consult a physician in case of accidental ingestion by humans. To obtain a Safety Data Sheet(s), contact Elanco US Inc. at 1-888-545-5973. For use in dogs only. Animal Safety Warnings: Keep ENTYCE in a secure location out of reach of dogs, cats, and other animals to prevent accidental ingestion or overdose.

Precautions

Use with caution in dogs with hepatic dysfunction. ENTYCE is metabolized by CYP3A4 and CYP3A5 enzymes (See Clinical Pharmacology ). Use with caution in dogs with renal insufficiency. ENTYCE is excreted approximately 37% in urine and 62% in feces (See Adverse Reactions and Clinical Pharmacology ). Use with caution in dogs that may have cardiac disease or severe dehydration. ENTYCE can cause transient decreases in heart rate and blood pressure following dose administration. Some dogs may exhibit clinical signs of bradycardia or hypotension following administration of ENTYCE (See Post-Approval Experience ). Use with caution in dogs with diabetes mellitus as hyperglycemia has been reported following administration of ENTYCE (See Post-Approval Experience ). The safe use of ENTYCE has not been evaluated in dogs used for breeding or pregnant or lactating bitches.

Adverse Reactions

In a controlled field study, 244 dogs were evaluated for safety when administered either ENTYCE or a vehicle control (solution minus capromorelin) at a dose of 3 mg/kg once daily for 4 days. Enrolled dogs had a reduced or absent appetite for a minimum of 2 days prior to day 0 and had various medical conditions: arthritis (40); gastrointestinal disease (24); allergy (22); dental disease (22); cardiovascular disease (16); renal disease (13); and others. Some dogs may have experienced more than one of the adverse reactions during the study. The following adverse reactions were observed: Table 1: Adverse Reactions reported in dogs administered ENTYCE oral solution compared to vehicle control Adverse Reactions ENTYCE (n = 171) n (%) Vehicle Control (n = 73) n (%) GASTROINTESTINAL Diarrhea 12 (7.0 %) 5 (6.8 %) Vomiting 11 (6.4 %) 4 (5.5 %) Hypersalivation 4 (2.3 %) 0 (0.0 %) Abdominal discomfort 2 (1.2 %) 0 (0.0 %) Flatulence 2 (1.2 %) 0 (0.0 %) Nausea 2 (1.2 %) 0 (0.0 %) CLINICAL PATHOLOGY Elevated blood urea nitrogen 7 (4.1 %) 2 (2.7 %) Elevated phosphorus 4 (2.3 %) 1 (1.4 %) Elevated creatinine 1 (0.6 %) 1 (1.4 %) OTHER Polydipsia 7 (4.1 %) 1 (1.4 %) Lethargy/depression 2 (1.2 %) 0 (0.0 %) The following adverse reactions were reported in < 1% of dogs administered ENTYCE: hyperactivity, increase fecal volume, increase gut sounds, and polyuria. Post-Approval Experience (2025): The following adverse events are based on post-approval adverse drug experience reporting for ENTYCE. Not all adverse events are reported to FDA/CVM. It is not always possible to reliably estimate the adverse event frequency or establish a causal relationship to product exposure using these data. The following adverse events in dogs are categorized in order of decreasing reporting frequency by body system and in decreasing order of reporting frequency within each body system: Gastrointestinal: vomiting, hypersalivation, diarrhea General: lethargy, polydipsia, weakness, hyperglycemia, recumbency Behavioral: Unusual behaviors (some of these behaviors were related to avoidance of medication), vocalization, hyperactivity Neurological: ataxia, loss of consciousness, disorientation, sedation Respiratory: panting, dyspnea Cardiovascular: bradycardia, hypotension

Description

ENTYCE (capromorelin oral solution) is a selective ghrelin receptor agonist that binds to receptors and affects signaling in the hypothalamus to cause appetite stimulation and binds to the growth hormone secretagogue receptor in the pituitary gland to increase growth hormone secretion. The empirical formula is C 28 H 35 N 5 O 4 ·C 4 H 6 O 6 and the molecular weight 655.70. The chemical name is 2-amino-N-[2-(3aR-benzyl-2-methyl-3-oxo-2,3,3a,4,6,7-hexahydro-pyrazolo[4,3-c]pyridin-5-yl)1R-benzyloxymethyl-2-oxo-ethyl]-isobutyramide L-tartrate. The chemical structure of capromorelin tartrate is: Chemical Structure of Capromorelin Tartrate

Storage

Store at or below 86° F (30° C)

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.

• Elura™, Elanco US Inc.. Set id be4beb9c-f39b-4b23-9c35-f72a049a3250.

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 capromorelin 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.