Imidocarb

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This page reprints a manufacturer label. Everything below in quotation marks is copied from Imizol ® (IMIDOCARB DIPROPIONATE), 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 Imizol ® (IMIDOCARB DIPROPIONATE) by Merck Sharp & Dohme Corp, a imidocarb 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: Imizol ® (IMIDOCARB DIPROPIONATE). Manufacturer: Merck Sharp & Dohme Corp. FDA Structured Product Label set id c7bfe38c-9249-466d-8718-8b8e82b99a8d. Label effective 2025-11-25. Retrieved 2026-09-16 from the DailyMed animal label release, and readable on DailyMed.

Indications

For the treatment of dogs with clinical signs of babesiosis and/or demonstrated Babesia organisms in the blood.

Dosage and Administration

Use intramuscularly or subcutaneously at a rate of 6.6 mg/kg (3mg/lb) body weight. Repeat the dose in two (2) weeks, for a total of two (2) treatments. IMIZOL ® DOSING GUIDE 6.6 mg/kg Body Weight Animal Weight IMIZOL Dosage Animal Weight IMIZOL Dosage 10 lb (4.5 kg) 0.25 mL 60 lb (27.3 kg) 1.50 mL 20 lb (9.1 kg) 0.50 mL 80 lb (36.4 kg) 2.00 mL 30 lb (13.6 kg) 0.75 mL 100 lb (45.5 kg) 2.50 mL 40 lb (18.2 kg) 1.00 mL WARNING: NOT FOR HUMAN USE. KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. IN THE EVENT OF HUMAN EXPOSURE IMMEDIATELY CALL 303-595-4869, FOR MEDICAL ADVICE FOR HUMANS. Oncogenesis: Increased incidence of tumors was observed in rats given imidocarb.

Precautions

MUST NOT BE ADMINISTERED INTRAVENOUSLY. The safety and effectiveness of imidocarb have not been determined in puppies or in breeding, lactating, or pregnant animals. Risk versus benefit should be considered before using this drug in dogs with impaired lung, liver, or kidney function. Do not use this product simultaneously with exposure to cholinesterase-inhibiting drugs, pesticides, or chemicals. ADVERSE EFFECTS: Adverse effects commonly seen are pain during injection and mild cholinergic signs such as salivation, nasal drip, or brief episodes of vomiting. Other effects seen less frequently are panting, restlessness, diarrhea, and mild injection site inflammation lasting one to several days. Rarely, injection site ulceration occurs, but the lesion is not resistant to healing. If sever cholinergic signs occur, they may be reversed with atropine sulfate. To report an adverse reaction, product-related problem, human exposure, or to obtain a copy of the Safety Data Sheet (SDS), please call Merck Animal Health Technical Services at 1-800-224-5318. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDAVETS or http://www.fda.gov/reportanimalae. TOXICOLOGY: IMIZOL solution was administered subcutaneously to four groups of 5 dogs at 2.2, 5.5, 7.7, or 9.9 mg/kg. The treatment was repeated 2 weeks later. There were no effects attributed to IMIZOL on body temperature, body weight, hematology, most clinical chemistries or gross pathology. At 9.9 mg/kg there was a slight increase in serum alanine aminotransferase (ALT, SGPT) and arginine aminotransferase (AST, SGOT) indicative of mild liver injury. Other effects noted were pain on injection, injection site swelling, and vomiting. Two of the injection sites ulcerated but healed readily without complication. In a 90-day toxicity study, imidocarb was given orally to three groups of 8 dogs at the rate of 5, 20, or 80 mg/kg/day. The target organs of toxicity were liver and intestines. These results may have been influenced by the oral dosing route. In a pharmacokinetic study by Abdullah et al (1984) 1 , imidocarb was administered to dogs intravenously at a dose of 4 mg/kg. One of 13 dogs died. The target organs of toxicity in this dog were lungs and kidneys, and some changes were noted in the liver and spleen. The toxic syndrome involves lethargy, weakness, and anorexia, with possible signs of gastrointestinal, liver, kidney, and lung dysfunction. PHARMACODYNAMICS: The pharmacodynamics of imidocarb were studied in various species as described by Rao et al (1980) 2 . The study suggests that there is a potential for adverse reactions mediated by the autonomic nervous system and especially through anticholinesterase mechanisms. Clinical experience in dogs at therapeutic dosages of less than 10 mg/kg body weight given intramuscularly or subcutaneously has established a pattern of adverse reactions. These reactions in descending order of frequency are: salivation, vomiting, and occasionally diarrhea. HOW SUPPLIED: IMIZOL ® solution is packaged in 10 mL glass, sterile, multiple-dose vials. STORAGE: Store between 2° and 25°C (36° and 77°F). Use within 28 days of first puncture and puncture a maximum of 16 times. Protect from light.

Description

IMIZOL (imidocarb dipropionate) is a sterile solution containing 120 mg/mL of imidocarb dipropionate suitable for intramuscular or subcutaneous administration. Imidocarb is chemically described as N,N' -bis[3-(4,5- dihydro-1 H -imidazol-2-yl)-phenyl]urea dipropionate and has a molecular weight of 496.6. In addition to the active component, imidocarb dipropionate, the formulation also contains propionic acid (22.34 mg/mL), and water for injection.

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 imidocarb 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: 144 reports

Reactions most often coded in dogs, 144 reports
VeDDRA reaction termReports
Vomiting28
Death25
Hypersalivation24
Diarrhoea21
Injection site swelling19
Depression15
Fever14
Injection site pain9
Weakness9
Injection site ulcer8
Elevated alanine aminotransferase (ALT)7
Trembling7
Anorexia6
Polypnoea6
Ataxia5

Outcome as recorded by the reporter: Died 32; Ongoing 14; Recovered/Normal 12; Outcome Unknown 6; Euthanized 2.

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

Sources

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