FDA approves first veterinary amlodipine drug for feline hypertension

For years, veterinarians treating cats with high blood pressure have relied on off-label human amlodipine in the absence of an FDA-approved veterinary formulation. That gap has now closed. On April 29, 2026, the FDA approved amlodipine besylate chewable tablets (Amodip), the first amlodipine product approved specifically for cats and only the second FDA-approved treatment for controlling systemic hypertension in cats.¹ Amodip is sponsored by Ceva Santé Animale, based in France.¹

A common condition with a long-awaited approval

Systemic hypertension is a well-recognized condition in cats, occurring most often as a complication of chronic kidney disease but also arising on its own or alongside other chronic conditions. If left unmanaged, persistently elevated blood pressure can cause damage to the eyes, kidneys, heart, brain, and central nervous system.¹

The active ingredient in this treatment, amlodipine, is a calcium channel blocker. It lowers blood pressure by relaxing blood vessels and reducing cardiac workload. The drug has long been used off-label in cats but now provides veterinarians with a species-specific, FDA-vetted formulation supported by established dosing and safety data.

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 treated cats met the primary effectiveness criterion of lower indirect systolic blood pressure (SBP) than in the control group (17.6%).² The treated group achieved a mean SBP reduction of 28.2 mm Hg from baseline vs 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 1 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 6-month target animal safety study in healthy cats administered up to 5 times the maximum starting dose and found an adequate margin of safety across all dose levels. One notable finding was gingival hyperplasia in all cats receiving amlodipine besylate, 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

Amlodipine besylate should be administered at the standard dose of 0.125 to 0.25 mg/kg per day, adjusted 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 once daily based on weight and indirect SBP measurements.^1,2 This drug 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 blood work 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 blood work 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, this treatment requires veterinary oversight for diagnosis, dosing, and ongoing monitoring.¹

References

1. FDA approves first veterinary amlodipine product to control systemic hypertension in cats. FDA. April 29, 2026. Accessed April 29, 2026. https://www.fda.gov/animal-veterinary/cvm-updates/fda-approves-first-veterinary-amlodipine-product-control-systemic-hypertension-cats
2. Freedom of information summary: Amodip (amlodipine besylate tablets) chewable tablets. FDA. April 29, 2026. Accessed April 29, 2026. https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/18370