Trifexis
banner image

Is Trifexis safe?

Trifexis (spinosad + milbemycin oxime) has been rigorously tested and approved as safe by the FDA and other regulatory authorities around the world. Currently, more than 15,000 veterinarians in the U.S. trust Trifexis to protect their canine patients and have prescribed more than 90 million doses since it became available in 2011.¹

“Many veterinarians around the country have such confidence in the safety and efficacy of Trifexis that they prescribe it for their own dogs.”Dr. Jeff Werber, Veterinarian

View video transcript

[Dr. Jeff Werber: Trifexis is a safe, effective monthly tablet that is available from your veterinarian by prescription only. It’s a combination of two active ingredients – spinosad and milbemycin oxime – that have both been approved for use in dogs for many years. In the United States alone, more than 50 million doses of Trifexis have been dispensed through more than 15,000 veterinary clinics like mine.* In fact, many veterinarians around the country have such confidence in the safety and efficacy of Trifexis, they prescribe it for their own dogs.

Trifexis has been shown to be safe for dogs and puppies of all breeds 8 weeks of age or older and weighing 5 pounds or more. This beef-flavored tablet is not only convenient, it’s a smart way to give your dog his monthly preventative. Unlike topicals applied to your dog’s skin, Trifexis can’t be washed off or rubbed onto furniture or clothing. So there’s no need to isolate your dog from children or other pets after treatment.

All products have some risk. It’s important to read the label and understand what the most common adverse reactions that are associated with the drug. If your dog has a reaction to Trifexis, or any drug, report it to the manufacturer or FDA using the phone numbers found on the label. Given as directed, Trifexis is a safe, effective and convenient way to help protect your dog from parasites. If your dog has been using Trifexis successfully, there is no reason to expect that should change.

Ask about Trifexis, the combination product that kills fleas and prevents infestations, prevents heartworm disease, and treats and controls hookworm, roundworm and whipworm infections. See the full product label for complete safety information.

Serious adverse reactions have been reported following concomitant extra-label use of ivermectin with spinosad alone, one of the components of Trifexis. Treatment with fewer than three monthly doses after the last exposure to mosquitoes may not provide complete heartworm prevention. Prior to administration of Trifexis, dogs should be tested for existing heartworm infection. Use with caution in dogs with pre-existing epilepsy.

The most common adverse reactions reported are vomiting, depression/lethargy, pruritus, anorexia, diarrhea, trembling/shaking, ataxia, seizures, hypersalvation and skin reddening. To ensure heartworm prevention, observe your dog for one hour after administration. If vomiting occurs within an hour of administration, redose.

*VetStreet. "Based on total canine combination parasiticide product data (flea, tick, heartworm)." Dec. 2016.]


Pet safety is our top priority

Elanco takes the safety of our products very seriously, and the health of your pet is always our top priority. So when news stories explored some dog owners’ claims that Trifexis may have played a role in the death of their dogs, we promptly investigated. However, there has been no causal link established between Trifexis use and death.

In fact, we conduct continuous, ongoing monitoring on Trifexis to determine if there are any signals or trends in the data, or any increases in frequency of certain types of reports. We also report all potential adverse events to the FDA.

banner image

Protecting your dog

Pets need protection from the very real threat of heartworm disease, which can kill dogs. According to the American Heartworm Society, it is estimated that 1 million dogs have this potentially fatal disease.² For your dog’s safety, we recommend talking to your veterinarian about the best way to protect your dog from heartworms and other parasites.

One option is Trifexis. In the United States alone, veterinarians have prescribed more than 90 million doses¹, giving them and Elanco, the maker of Trifexis, confidence in the safety and efficacy of the product. Today, it remains a safe and highly recommended choice of veterinarians. Trifexis kills fleas and prevents infestations, prevents heartworm disease and treats and controls adult hookworm*, roundworm and whipworm infections.

In order for your vet to prescribe Trifexis, it first had to be rigorously tested and proven safe when used according to label directions.

*Ancylostoma caninum


REPORT AN ADVERSE EVENT

Adverse events are undesirable effects that occur while on therapy with a medication, medical device, pesticide, or vaccine or other biological product. They may, or may not, be caused by the product or device.

If you suspect an adverse event has occurred with an Elanco product, please call us at 1-888-545-5973.

Please inform us that you would like to report an adverse event or Adverse Drug Experience (ADE). The technical services team will ask a series of questions about the event, complete FDA 1932 form and forward the report to the FDA Center for Veterinary Medicine (CVM). The technical services team member you speak with may also contact the veterinarian who treated your pet to obtain more information.

For additional information about adverse drug experience reporting for animal drugs, contact the FDA at 1-888-332-8387 or online.

The identities of all persons and animals is held in strict confidence by the FDA and protected to the fullest extent of the law. The reporter’s identity may be shared with Elanco unless requested otherwise. However, the FDA will not disclose the reporter’s identity to a request from the public, pursuant to the Freedom of Information Act.


Important safety information

The use of ivermectin at higher than FDA-approved doses at the same time as Trifexis can result in serious side effects. Treatment with fewer than three monthly doses after the last exposure to mosquitoes may not provide complete heartworm prevention. Prior to administration of Trifexis, dogs should be tested for existing heartworm infection. Use with caution in breeding females. The safe use of Trifexis in breeding males has not been evaluated. Use with caution in dogs with pre-existing epilepsy.

The most common adverse reactions reported are vomiting, depression/lethargy, itching, decreased appetite, and diarrhea. To ensure heartworm prevention, observe your dog for one hour after administration. If vomiting occurs within an hour of administration, redose with another full dose. Puppies less than 14 weeks of age may experience a higher rate of vomiting. Like all medications, keep Trifexis out of reach of children.

View full product label (PDF) for complete safety information.


More information

If you would like more detailed information on the safety of Trifexis, please refer to these documents.

pdf
Trifexis Adverse Event Technical Bulletin
pdf
TRIFEXIS CLIENT INFORMATION SHEET
pdf
TRIFEXIS DETAILER
pdf
TRIFEXIS PRODUCT LABEL
pdf
TRIFEXIS FACT SHEET
pdf
TRIFEXIS SAFETY AND EFFICACY TECHNICAL BULLETIN
pdf
Independent Pathology Review
FDA Center for Veterinary Medicine
(FDA.GOV)

MEDIA REQUESTS

If you represent a media outlet and would like to contact Elanco, please call 1-877-352-6261 and ask to speak with media relations.

1. Elanco Animal Health. Data on File.
2. American Heartworm Society data; https://www.heartwormsociety.org/images/pdf/AHS_InfoGraphic.pdf, Accessed 5/2/17.