What the data show
The approval was supported by a double-masked, placebo-controlled field effectiveness study enrolling 77 client-owned cats diagnosed with systemic hypertension. At Day 28, 64.1% of Amodip-treated cats met the primary effectiveness criteria of a lower indirect systolic blood pressure (SBP) measurement compared to only 17.6% of cats in the control group.2 The Amodip group achieved a mean SBP reduction of 28.2 mm Hg from baseline, versus 9.9 mm Hg in the control group.2
Additional support came from a prospective open-label study of 225 client-owned cats treated with amlodipine once daily for one year. That study, according to the FDA, found improvement in ophthalmic fundic lesions, which is a marker of hypertensive target organ damage.2 However, cats with severe vision loss at the start of treatment were less likely to regain visual function, even when retinal detachment improved.2
A six-month target animal safety study in healthy cats administered up to five times the maximum starting dose found an adequate margin of safety across all dose levels. One notable finding was gingival hyperplasia in all cats receiving Amodip, beginning around weeks 10 to 12. The effect was dose- and time-dependent and is a known class effect of calcium channel blockers that veterinarians should monitor in long-term patients.2
Dosing and monitoring
Amodip should be administered beginning at the standard dose of 0.125-0.25 mg/kg per day according to weight. If blood pressure remains inadequately controlled after 14 days, the dose may be increased to 0.25 to 0.5 mg/kg based on weight once daily based on indirect SBP measurements.1,2 Amodip cannot be accurately dosed in cats weighing less than 2.5 kg.1
Because amlodipine can affect kidney and liver values, the FDA advises monitoring bloodwork early in treatment. “Prescribing veterinarians should monitor blood pressure regularly and adjust the dose as needed to maintain blood pressure at the optimal level for the cat. A cat’s bloodwork should also be monitored early in treatment for potential changes in kidney and liver values,” the FDA wrote in a news release.1
Pet owners should be advised to monitor for decreased appetite, vomiting, and diarrhea and report any concerns to their veterinarian. As a prescription product, Amodip requires veterinary oversight for diagnosis, dosing, and ongoing monitoring.1
References
- FDA approves first veterinary amlodipine product to control systemic hypertension in cats. US Food and Drug Administration. April 29, 2026. Accessed April 29, 2026.
https://www.fda.gov/animal-veterinary/news-events/cvm-updates - Freedom of information summary: Amodip (amlodipine besylate tablets) chewable tablets. NADA 141-613. US Food and Drug Administration. April 29, 2026. Accessed April 29, 2026.
https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/18370
