Pregabalin

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This page reprints a manufacturer label. Everything below in quotation marks is copied from Bonqat®, 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 Bonqat® by Zoetis Inc, a pregabalin product labelled for dogs and cats. 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: Bonqat®. Manufacturer: Zoetis Inc. FDA Structured Product Label set id 4f7f35b4-59ec-4a3c-8c71-d28cf0c4f0eb. Label effective 2024-03-27. Retrieved 2026-09-16 from the DailyMed animal label release, and readable on DailyMed.

Indications

BONQAT is indicated for alleviation of acute anxiety and fear associated with transportation and veterinary visits in cats.

Dosage and Administration

Client Information Sheet is on the reverse of this package insert. Always provide client information sheet with prescription. BONQAT is administered orally as a single dose of 5 mg/kg (0.1 mL/kg) approximately 1.5 hours before the start of the transportation or veterinary visit and can be given on two consecutive days. If the cat weighs more than 22 pounds, the total dose will need to be calculated and given in two separate doses as the syringe holds a maximum of 1 mL of solution. A small amount of food can be given with BONQAT.

Contraindications

Do not use in case of hypersensitivity to pregabalin or to any of the excipients (sodium benzoate, ethyl maltol, hydrochloric acid, sodium hydroxide).

Warnings

Human Safety Warnings: Not for human use. Appropriate precautions should be taken while handling BONQAT. Avoid skin contact, eye contact, or contact with mucous membranes. Symptoms of exposure to pregabalin include dizziness, sleepiness, blurred vision, weakness, dry mouth, and difficulty with concentration or attention. In case of accidental eye or mucosal exposure, flush with water for 15 minutes. If wearing contact lenses, eyes should be rinsed first, then remove contact lenses and continue rinsing. Seek medical advice if symptoms occur. In case of skin contact, wash with soap and water immediately. Remove contaminated clothing. Seek medical advice if symptoms occur. In case of accidental ingestion, seek medical advice if symptoms occur. Do not drive as sleepiness may occur. In case of ingestion by a child, seek medical attention immediately. Show the package insert or the label to the physician. Drug Abuse, Addiction, and Diversion Controlled Substance: BONQAT contains pregabalin, a Schedule V controlled substance. Abuse: Abuse is defined as the intentional, non-therapeutic use of a drug, even once, to achieve a desired psychological or physiological effect. Pregabalin is not known to be active at receptor sites associated with drugs of abuse. However, pregabalin is associated with drug liking and is known to be misused and abused in the community, particularly in combination with opioids. Consider the potential risks of misuse or abuse before prescribing this product. Signs of pregabalin misuse or abuse include drug seeking behavior. Pregabalin should be handled appropriately to minimize the risk of diversion, including restriction of access, the use of accounting procedures, and proper disposal methods, as appropriate to the clinical setting and as required by law. Note to physician : BONQAT contains pregabalin. The safety data sheet (SDS) contains more detailed occupational safety information. To report adverse reactions in users or to obtain a copy of the SDS for BONQAT contact Zoetis Inc. at 1-888-963-8471. Animal Safety Warnings : Some cats may experience hypothermia, depression, drowsiness, muscle tremors, and/or ataxia. These cats should be kept warm and not offered food or water until BONQAT’s effects have worn off (usually within 6 hours). (See TARGET ANIMAL SAFETY ) Keep BONQAT in a secure location out of reach of dogs, cats, and other animals to prevent accidental ingestion or overdose.

Precautions

Use with caution in cats with concurrent cardiac disease or hypertension because BONQAT may cause bradycardia and reflex hypertension. The safety of BONQAT has not been evaluated in cats with concurrent cardiac disease or hypertension. The safe use of BONQAT in cats younger than 7 months of age has not been evaluated. The safe use of BONQAT used in conjunction with opioids and other sedatives has not been evaluated. Use with caution in cats with pre-existing renal disease (See Clinical Pharmacology ). The safe use of BONQAT in cats with severe systemic disorders has not been evaluated. Use with caution in cats with severe systemic disorder. The safe use of BONQAT in breeding, pregnant, and lactating cats has not been evaluated.

Adverse Reactions

In a well-controlled European field study, which included a total of 238 cats (108 treated with BONQAT at the label dose of 5 mg/kg, 29 treated with BONQAT at a dose of 2.5 mg/kg, and 101 administered placebo control), 5 months to 15 years of age and weighing 1.8 to 10.3 kg, the following adverse reactions were reported: Table 1. Adverse reactions Adverse reaction Pregabalin 5 mg/kg N=108 Pregabalin 2.5 mg/kg N=29 Placebo N=101 Ataxia 5 (4.6%) 1 (3.4%) 0 Lethargy 3 (2.8%) 2 (6.9%) 0 Emesis 2 (1.9%) 0 0 Proprioception abnormality 1 (0.9%) 1 (3.4%) 0 Muscle tremor 1 (0.9%) 0 0 Anorexia 1 (0.9%) 0 0 Weight loss 1 (0.9%) 0 0 Mydriasis 0 1 (3.4%) 0

Description

Each mL of BONQAT contains 50 mg pregabalin. The chemical name of pregabalin is (3S)-3-(aminomethyl)-5-methylhexanoic acid. It is a white or almost white powder having a molecular weight of 159.23g /mol. The molecular formula is C 8 H 17 NO 2 and the structural formula is: Structural Formula

Information for Owners

Possible side effects on BONQAT include incoordination, tiredness, and vomiting. Some cats might be more sensitive to BONQAT; if the cat appears to be uncoordinated or overly tired, it should be kept warm and not offered food or water until the effect of BONQAT has worn off. This will normally happen within a few hours. If there are further concerns related to side effects after dosing the veterinarian should be contacted. BONQAT must not be re-dosed if the cat spits part of the dose, vomits after treatment, or in case of hypersalivation, or if BONQAT does not seem to have any effect. Always provide the Client Information Sheet with prescription. Keep BONQAT in a secure location out of reach of children, dogs, cats, and other animals to prevent accidental ingestion or overdose.

Storage

Store the bottle in a refrigerator at 2-8°C (36-46°F). Use bottle contents within six months after the first opening of the bottle. Up to one month of this time the bottle can be stored at or below 25°C (77°F).

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 pregabalin 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: 64 reports

Reactions most often coded in dogs, 64 reports
VeDDRA reaction termReports
Death by euthanasia13
Lethargy (see also Central nervous system depression in Neurological)13
Seizure NOS9
Vomiting9
Lack of efficacy - NOS8
Limb weakness8
Ataxia7
Bone and joint disorder NOS7
Pain NOS7
Decreased appetite6
Not eating6
Abnormal radiograph finding5
Inappropriate urination5
Lameness5
Medication error NOS5

Outcome as recorded by the reporter: Ongoing 25; Euthanized 13; Outcome Unknown 12; Recovered/Normal 10; Died 4.

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

Cats: 127 reports

Reactions most often coded in cats, 127 reports
VeDDRA reaction termReports
Lack of efficacy - NOS34
Lethargy (see also Central nervous system depression in Neurological)20
Ataxia18
Overdose14
Wobbliness13
Sedation10
Intentional misuse9
Medication error NOS9
Partial lack of efficacy9
Vomiting8
Behavioural disorder NOS6
Death by euthanasia6
Diarrhoea6
Not himself/herself6
Bradycardia5

Outcome as recorded by the reporter: Ongoing 51; Recovered/Normal 35; Outcome Unknown 32; Euthanized 6; Died 2; Recovered with Sequela 1.

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

Sources

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