Sarolaner for dogs

Disclaimer: This information is provided for educational purposes only and should not replace professional veterinary advice. Always consult with your veterinarian before starting, stopping, or changing any medication for your pet. Your veterinarian can determine whether this medication is appropriate for your pet’s specific condition and health status.

Content review: This content has been written and reviewed by licensed veterinary professionals. For complete prescribing information, consult the official product labeling or speak with your veterinarian.

Sarolaner is the active ingredient in Simparica. Simparica is an FDA-approved monthly chewable parasite control product for dogs that provides protection against fleas and several types of ticks. Guidelines from both the Companion Animal Parasite Council (CAPC) and Canadian Parasitology Expert Panel (CPEP) emphasize the importance of regular protection against fleas and ticks, given their prevalence and the health risks they pose to both pets and people.

Simparica is used to prevent and treat fleas and certain species of ticks. It’s manufactured as an oral medication for dogs under the brand name Simparica. It’s manufactured by Zoetis® and is available by veterinary prescription only.

Important Safety Information: Sarolaner belongs to the isoxazoline class of drugs. The FDA reports that this class of drug has been associated with neurologic adverse effects, like tremors, ataxia, and seizures. Seizures have been reported in dogs receiving isoxazoline class drugs, even in dogs without a history of seizures. Caution is advised when prescribing this drug for dogs with a history of seizures or neurological disorders. Research into a potential link between isoxazolines and seizures is ongoing, and experts continue to evaluate safety data to better understand these reports. The overall consensus is currently that isoxazolines are generally safe and effective when used as directed.

Sarolaner, the active ingredient in Simparica, rapidly kills adult fleas and certain tick species after they bite a dog that has taken the medication orally within the previous 30 days. Your veterinarian may prescribe Simparica to your dog for flea and tick treatment or prevention.

Flea populations thrive because a single female can lay dozens of eggs every day, allowing infestations to grow rapidly if not controlled. Sarolaner works by interrupting a flea’s nerve and muscle function. This loss of motor control makes it much harder for fleas to mate and lay eggs, which in turn reduces the number of new fleas developing in the environment.

For Simparica to be most effective, all pets in a household must be considered in the plan for flea treatment or prevention. The right approach can vary depending on whether you have dogs, cats, or other pets because different species will need different products. Since veterinary experts recommend year-round flea and tick protection for all dogs, Simparica is often prescribed as part of an ongoing prevention strategy.

Studies show that rapid elimination of adult fleas reduces allergen exposure, which may lead to improvement in flea allergy symptoms. This includes a reduction of hair loss, itchiness, and skin redness and infection. Since flea saliva is a common allergen, vets often recommend preventatively treating dogs who have allergic dermatitis for fleas year-round.

Simparica also protects dogs against several common tick species, including the deer tick, which can spread the bacteria that causes Lyme disease. The same as with fleas, sarolaner works by interrupting a tick’s nerve and muscle function. By killing ticks quickly, Simparica helps prevent Lyme disease infections. Simparica kills several tick species, including the lone star tick, Gulf Coast tick, American dog tick, brown dog tick, and Asian longhorned tick.

Specific products containing sarolaner vary, but some examples include:

• Simparica Chewables for Dogs: Contains only sarolaner. For use against fleas and ticks.
• Simparica TRIO Chewables for Dogs: Contains sarolaner, moxidectin, and pyrantel. For use against fleas, ticks, heartworms, roundworms, and hookworms.

Off-label use* notice: While Simparica is FDA approved specifically for flea and tick prevention and treatment, veterinarians may prescribe it for additional conditions beyond its approved indications, including:

• Demodectic mange
• Sarcoptic mange
• Ear mites
• Off-label use means using an FDA-approved medication for a condition, species, or dosage that differs from what appears on the official drug label. Some geographical jurisdictions may differ in their official drug labels. While veterinarians often prescribe medications for off-label uses based on their clinical judgment, your veterinarian can determine whether this medication is appropriate for your pet’s specific needs.

Simparica is given orally to dogs every 30 days. Simparica can be given with or without food. The tablets are not scored, which means splitting them is not advised. Careful observation of your dog is important to ensure they have eaten the entire dose.

Simparica comes in different sizes of chewable flavored tablets. The tablets are flavored with pork liver to give them a better taste. Because of this, they are not appropriate for dogs on a food allergy trial that excludes pork or for those with a known pork allergy. Packages are available with one, three, or six tablets. Each package is color coded to distinguish between tablet sizes.

For flea prevention, dosing can begin at any time of year. Veterinary guidelines in the United States recommend year-round flea and tick prevention for all dogs, while Canadian recommendations vary by region and season, with year-round protection advised in higher-risk areas.

For an existing flea infestation, treating all household pets for fleas is critical in eliminating environmental sources and preventing reinfection from untreated pets. Simparica is only effective against adult fleas, not flea eggs, larvae, or pupae. Approximately 30 days after administration, the medication wears off, so if monthly doses are not continued on time, the dog will no longer be protected. This not only puts the dog at risk for new exposures, it also can allow an existing infestation to quickly rebound. Simparica should be administered once a month for at least three months so that enough fleas that are newly hatched from the pupae are killed before they can mature and reproduce, breaking the flea life cycle.

For tick prevention, Simparica is prescribed on a monthly schedule, either year-round or at least one month before ticks become active where you live.

Always follow the directions on the drug label provided by your veterinarian.

Simparica is tolerated well in most dogs.

In clinical studies, uncommon adverse effects (less that 1 percent of dogs) include:

• Vomiting
• Diarrhea
• Lethargy
• Appetite loss (anorexia)

The following adverse effects have been reported since market introduction (listed from most to least frequently reported):

• Vomiting
• Tremors
• Lethargy
• Seizures
• Diarrhea (with and without blood)
• Loss of appetite (anorexia)
• Wobbliness or lack of coordination (ataxia)
• Itchy skin (pruritus)
• Excessive drooling (ptyalism)
• Restlessness and agitation (hyperactivity)

Understanding side effects

Reading through the list of side effects may feel alarming, but it’s important to understand how these lists are created. In clinical studies, every symptom that occurs is recorded, whether or not the medication is the cause. For example, if a dog develops diarrhea while in a trial, it must be noted, even if the diarrhea was due to something unrelated. Dogs receiving a placebo often show the same kinds of symptoms. Scientists compare these groups carefully to determine whether a medication is safe and effective.

Reported side effects are those that are reported to Zoetis by a veterinary professional or pet owner who has administered Simparica. Though the reported symptoms are seen after giving the medication, it’s very difficult to reliably confirm that the medication was the direct cause of the symptom noted.

The list of side effects is comprehensive, but it doesn’t mean your dog is likely to have them. If you’re still feeling unsure, your vet can help you weigh the risks and benefits for your unique situation.

Are side effects more likely to happen with the first dose?

Some side effects appear soon after the first dose because this is the first time the body has been exposed to this drug. Others may not emerge until a medication is used for a longer period of time. Even if a symptom appears shortly after starting a new medication, your vet may need to investigate further to determine whether the medication is truly the cause.

What should I do if I notice changes in my dog right after starting a new medication?

If your dog shows new symptoms after starting a medication, veterinary input is important for understanding whether the change is related to the drug or some other cause. This is especially important if you see serious signs needing urgent action, like:

• Difficulty breathing
• Trouble standing up
• Severe vomiting or diarrhea
• Pale gums
• Seizures
• Collapse

These are emergency signs. Though these symptoms are rarely related to sarolaner, they always need to be urgently evaluated by a vet. Decisions about stopping, adjusting, or switching a medication are safest when made with guidance from your veterinarian.

Where can I find more information?

The drug label and package insert contain the most significant information, including the list of side effects seen during scientific studies. These studies are done in a controlled environment to limit external factors from influencing the data. Clinical studies are designed to carefully measure both the benefits and potential risks of a medication in a controlled environment.

If you have questions about whether this medication is right for your dog, your veterinarian is the best person to ask.

For more details about Simparica, visit the Zoetis website.

There are no known drug interactions when using Simparica with other medications. However, studies are limited. Always check with a veterinarian before giving your dog any new medications, and make sure they are aware of all other medications and supplements you give your dog.

Various research studies show Simparica to have a strong safety profile. Overall, Simparica is well tolerated in dogs, but as with any medication, some dogs may be at higher risk for side effects than others. Your veterinarian can determine whether Simparica is right for your dog. Here are some of the main concerns:

• Species and age: Simparica is not for use in puppies under six months of age.
• Weight: Simparica is not for use in dogs weighing less than 2.8 pounds.
• Existing and pre-existing health conditions: Veterinarians may be hesitant to recommend Simparica for a dog with a history of seizures or other neurological symptoms. If your dog has a chronic illness, always talk to your vet before starting any new medication.
• Pregnancy and nursing: The safe use of Simparica has not been evaluated in breeding, pregnant, or lactating dogs.
• Breed considerations: There are no known breed-specific risks for sarolaner. Afoxolaner is also generally safe for dogs with MDR1 drug sensitivity when given as directed.

Veterinarians can take into account your dog’s specific health condition and circumstance. If at any time you have questions or concerns about the safety of a medication for your dog, your vet can provide professional guidance tailored to your and your dog’s unique situation and needs.

There are important safety guidelines you need to follow if you give your dog medications that contain sarolaner.

Human safety

• Not for human use; keep out of reach of children.
• In case of accidental eye contact, flush immediately with water and seek medical attention if necessary.
• In case of accidental ingestion, seek medical attention immediately.

Storage

• Simparica should be stored at or below 30° Celsius (86° Fahrenheit), with excursions allowed if below 40° Celsius (104° Fahrenheit).
• Do not use after the expiration date on the label.
• Dispose of unused or expired medication according to local regulations or as directed by your veterinarian or pharmacist.

Use and administration

• Use Simparica only as directed by a veterinarian, and follow the label instructions exactly. The medication should not be stopped and doses should not be skipped unless directed by a veterinarian.
• Verify that your pet’s species, age, and weight match the prescribed dose.
• Do not give Simparica to your dog if they have an allergy to pork or are in a food allergy trial that excludes pork.
• Do not give Simparica to a dog with a known allergy to sarolaner or any other ingredients listed.
• Do not use Simparica in cats.

Overdosage

Contact your veterinarian/a poison control center immediately if your dog receives more than the prescribed amount of Simparica.

Talk to your vet

Before starting Simparica, your vet needs to know if your dog has ever had:

• Seizures or other neurological symptoms
• Frequent upset stomach or other medical problems

When prescribing Simparica, your vet needs to be aware of every medication and supplement your dog receives, including over-the-counter products. This information helps prevent drug interactions, avoids duplicate therapies, and guides safe dosing and monitoring. It’s also important to let your vet know if your dog is pregnant, nursing, or you plan to breed your dog.

Accidental ingestion by other pets or people

Veterinary prescription medications are directly prescribed for an individual pet. Before prescribing a medication, a vet can take into account their species, weight, age, physical examination, and previously existing conditions, among other details. It’s unsafe to give a veterinary prescription to a human or to an animal other than the pet it’s prescribed for.

If another pet of any species, including another dog, accidentally receives or ingests the medication, contact a veterinarian, physician, or poison control center immediately for advice.

For complete safety and handling information, including situations when it might be harmful to use this medication, see the package insert for the specific product containing sarolaner.

Emergency contacts:

• Pet Emergency: Contact your local emergency veterinary clinic
• Pet Poison Helpline: (855) 764-7661 (fee may apply)
• ASPCA Animal Poison Control: (888) 426-4435 (fee may apply)
• Human Poison Control: Contact your local poison control center or emergency services
• FDA Adverse Event Reporting: Report suspected adverse reactions to the FDA Center for Veterinary Medicine at 1-888-FDA-VETS or online at www.fda.gov/reportanimalae
• To report a suspected adverse reaction to a veterinary drug in Canada, contact the Veterinary Drugs Directorate (VDD) by calling 1-877-838-7322 or emailing pv-vet@hc-sc.gc.ca
• Manufacturer: Contact Zoetis Services at in Canada at 800-461-0917, in the US at 1-888-Zoetis1 (1-888-963-8471), in the UK at 0345 300 8034, or visit https://www.zoetis.com/contact-us.

If a dose is missed, it can be given as soon as possible and then continued on the regular monthly schedule from there. Do not give double doses or extra doses.

Simparica provides protection against six different species of tick. Based on your pet’s individual circumstances and condition, your veterinarian may recommend other kinds of medications and products in addition to or in place of Simparica. Your vet may also take into account ease of administration when recommending an alternative to Simparica.

Alternatives in the same family (isoxazolines)

Isoxazolines are a group of modern flea and tick medications that work in a similar way (they kill parasites on your dog after the parasite bites). Common options include sarolaner (Simparica/Simparica TRIO), afoxolaner (NexGardⓇ/NexGard PLUSⓇ), fluralaner (BravectoⓇ chews and some topical forms), and lotilaner (CredelioⓇ, with newer US combos including Credelio Quattro™). All target fleas and several tick species, but they differ in dosing schedules, tick-species coverage, and add-on protections.

Most are monthly, though some fluralaner products work for up to 12 weeks for certain ticks. Some products bundle heartworm and intestinal worm prevention (e.g., Simparica TRIO, NexGard PLUS, Credelio Quattro), while single-ingredient versions focus on fleas and ticks only.

Age/weight minimums and exact label claims vary by product and country, so the best fit for your dog depends on their size, their lifestyle, and which parasites are common where you live. Isoxazoline products carry similar important safety language noting that rare neurologic events have been reported, but overall, regulators consider the class safe and effective when used as directed.

Alternative or additional flea and tick treatments outside of the isoxazoline family include:

• Prescription oral and topical (spot-on) medications
• Over-the-counter (OTC) medications
• Topical treatments

Compared with older, traditional flea products (for example, OTC pyrethroid or fipronil/imidacloprid spot-ons), isoxazolines are systemic medicines that kill fleas quickly after a bite, cover multiple tick species, and keep working even with routine bathing. Recent veterinary guidance prefers an oral isoxazoline as a first-line option, but many other products remain effective when used as labeled.

Each product has different advantages and disadvantages and plays a different role in parasite treatment and prevention. Talk to a veterinarian to determine which options are right for you and your unique situation.

When exposed to or infested with parasites like fleas or ticks, a dog may be at risk for other conditions or diseases. If needed, your vet can recommend treatments additional to or in place of sarolaner. Here are some examples of conditions and diseases that are commonly associated with fleas and ticks:

• Flea allergy dermatitis
• Atopic dermatitis
• Tapeworm
• Lyme disease
• Ehrlichiosis
• Anaplasmosis

• If anything unexpected happens when your dog is taking this medication, contact a veterinarian.
• Sarolaner should be used only for the pet it was prescribed for and only for the specific condition your veterinarian intended.
• Follow the exact dosing instructions. Never adjust the dose, split doses, or share the medication with other pets.

• Zoetis: Simparica product page
• Simparica Chewables Prescribing Information
• European Commission Health Document

Regulatory information:

This product information is based on FDA-approved labeling. For the most current prescribing information, safety updates, and regulatory status, consult the official product labeling or contact the manufacturer directly.

This educational content was developed independently by our veterinary editorial team without financial compensation, input, or approval from any pharmaceutical manufacturer. All information is based solely on FDA-approved labeling, published scientific literature, and independent veterinary professional judgment. While our organization may have separate business relationships with pharmaceutical companies, these do not influence our editorial content or medical recommendations.