This page reprints a manufacturer label. Everything below in quotation marks is copied from CLEVOR ®, 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 CLEVOR ® by Vetoquinol USA, Inc, a ropinirole 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: CLEVOR ®. Manufacturer: Vetoquinol USA, Inc. FDA Structured Product Label set id b8cfb2c3-18a7-4e35-a807-2b9b13aa10c2. Label effective 2022-08-25. Retrieved 2026-09-16 from the DailyMed animal label release, and readable on DailyMed.
Indications
For induction of vomiting in dogs.
Dosage and Administration
This product should be administered by veterinary personnel. Dosing Instructions: Administer the appropriate number of eye drops topically according to Table 1. The number of eye drops administered corresponding to body weight results in a target dose of 3.75 mg/m 2 (dose band 2.7 - 5.4 mg/m 2 ). If the dog does not vomit within 20 minutes of the first dose, then a second dose may be administered. Table 1. Dose Administration Body weight in kilograms Body weight in pounds Total number of eye drops Example administration 1.8 - 5 4 - 11.1 1 1 drop into either left or right eye 5.1 - 10 11.2 - 22.1 2 1 drop each eye 10.1 - 20 22.2 - 44.1 3 2 drops in one eye and 1 drop in the other eye 20.1 - 35 44.2 - 77.2 4 2 drops in each eye 35.1 - 60 77.3 - 132.3 6 An initial dose of 2 drops in each eye, followed 2 minutes later by 1 drop in each eye 60.1 - 100 132.4 - 220.5 8 An initial dose of 2 drops in each eye, followed 2 minutes later by 2 drops in each eye Dose Administration: Wear gloves and protective eye wear when handling or administering this product to prevent accidental exposure. Open the dropper by twisting off the tail. Keep the dog's head steady in a slightly upright position. Hold the dropper in an upright position without touching the eye. Rest your finger on the forehead of your dog to maintain the distance between the dropper and the eye. Squeeze the prescribed number of drops in to the eye(s). CLEVOR is a single use dropper and is light sensitive. After administration, with gloves on, return the dropper to the aluminum pouch and place in the carton. If the dog does not vomit, a second dose can be given 20 minutes after administration of the first dose. This second dose is the same number of drops as the first dose. Thirty minutes after opening, with gloves on, dispose of dropper, aluminum pouch, and carton. Refer to the Animal Safety Warnings section for treatment of protracted vomiting. Image Image Image Image
Contraindications
Do not use in dogs with central nervous system depression or seizures. Do not use in cases of ingestion of sharp foreign objects, corrosive agents (acids or alkalis), volatile substances or organic solvents. Do not use in cases with corneal ulceration, ocular irritation, or ocular injury. Do not use when there is a known sensitivity to ropinirole or the inactive ingredients.
Warnings
Human Safety Warnings: Not for use in humans. Keep out of reach of children. Wear gloves and protective eye wear when handling or administering this product to prevent accidental exposure. In case of accidental eye, oral or skin exposure, flush with water. If wearing contact lenses, eyes should be rinsed first, then remove contact lenses and continue rinsing. Remove contaminated clothing. Ropinirole is a dopamine agonist. Seek medical attention if accidental exposure occurs and show the package insert or label to the physician. Exposure to this drug may cause adverse reactions such as headache, nausea, vomiting, dizziness, orthostatic hypotension, and sleepiness. Avoid contact with the product if pregnant, planning to become pregnant, or breast-feeding, as exposure has been shown to have adverse effects on embryo-fetal development based on rodent studies. Animal Safety Warnings: This product should be administered by veterinary personnel. Dogs should be monitored for CLEVOR-associated clinical signs, including protracted vomiting, salivation, muscle tremors, evidence of abdominal discomfort, lethargy, transient tachycardia, transient decrease in blood pressure and signs of ocular irritation, including conjunctival hyperemia, mild blepharospasm, and protrusion of the third eyelid. These clinical signs are related to the pharmacological action of ropinirole. To stop protracted vomiting, administer metoclopramide (dopamine D2 antagonist) at a dose of 0.5 mg/kg intravenously (IV) or subcutaneously (SQ). Metoclopramide also decreases the prevalence of most CLEVOR-associated clinical signs.
Precautions
The safe use of CLEVOR has not been evaluated in dogs with cardiac disease or cardiovascular compromise. CLEVOR can cause transient tachycardia and transient decreased systolic blood pressure. The safe use of CLEVOR has not been evaluated in dogs with hepatic impairment. CLEVOR is metabolized by the liver. The safe use of CLEVOR has not been evaluated in dogs younger than 4.5 months of age and weight less than 4 pounds. The safe use of CLEVOR has not been evaluated in dogs that are pregnant, lactating, or intended for breeding.
Adverse Reactions
Safety was evaluated during a field study that enrolled 132 dogs (100 in the CLEVOR group and 32 in the vehicle control group). CLEVOR was administered as drops into the eyes at the dose as directed by the dosing table (see
Description
CLEVOR (ropinirole ophthalmic solution) is a full dopamine agonist with selectivity for the dopamine D2-like receptor family. Each mL of CLEVOR contains 30 mg ropinirole (equivalent to 34.2 mg ropinirole hydrochloride). The chemical name of ropinirole hydrochloride is 2H-Indol-2- one, 4-[2- (dipropylamino)ethyl]-1,3-dihydro-, monohydrochloride. It is pale cream to yellow powder having a molecular weight of 296.84. The molecular formula is C16 H24 N2O ∙HCL and the structural formula is: Inactive ingredients: citric acid monohydrate, sodium citrate, sodium chloride. Chemical Structure
Storage
Store in the original package in order to protect from light at controlled room temperature 20-25˚C (68-77˚F) with excursions permitted to 15-30˚C (59-86˚F). After the first dosing, the opened dropper should be kept in the aluminum pouch. The content should be used and discarded within 30 minutes after opening the aluminum pouch.
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 ropinirole 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: 307 reports
| VeDDRA reaction term | Reports |
|---|---|
| Lack of efficacy - NOS | 173 |
| Vomiting | 34 |
| Tachycardia | 27 |
| Lethargy (see also Central nervous system depression in Neurological) | 23 |
| Sedation | 17 |
| Hypersalivation | 14 |
| Diarrhoea | 12 |
| INEFFECTIVE, OTHER DRUG(S) | 12 |
| Lethargy (see also Central nervous system depression in 'Neurological') | 12 |
| Nausea | 11 |
| Overdose | 11 |
| Eye redness | 10 |
| Retching | 10 |
| Collapse NOS (see also Cardio-vascular and Neurological disorders) | 8 |
| Partial lack of efficacy | 8 |
Outcome as recorded by the reporter: Recovered/Normal 225; Outcome Unknown 54; Ongoing 10; Recovered with Sequela 7; Died 6; Euthanized 6.
Queries: reports, reactions, outcomes. Dataset: openFDA Animal and Veterinary Adverse Event Reports.
Sources
- CLEVOR ®FDA · retrieved 2026-09-16
“This product should be administered by veterinary personnel.” (Dosage and Administration)
- openFDA Animal and Veterinary Adverse Event ReportsFDA · retrieved 2026-09-16
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