Q: Should I take ivermectin to prevent or treat COVID-19?
A: No. While there are approved uses for ivermectin in people and animals, it is not approved for the prevention or treatment of COVID-19. You should not take any medicine to treat or prevent COVID-19 unless it has been prescribed to you by your health care provider and acquired from a legitimate source.
A recently released research article described the effect of ivermectin on SARS-CoV-2 in a laboratory setting. These types of laboratory studies are commonly used at an early stage of drug development. Additional testing is needed to determine whether ivermectin might be appropriate to prevent or treat coronavirus or COVID-19.
Q: Is there an emergency use authorization for ivermectin in the U.S. to prevent or treat coronavirus or COVID-19?
A: No. FDA has created a special emergency program for possible therapies, the Coronavirus Treatment Acceleration Program (CTAP). It uses every available method to move new treatments to patients as quickly as possible, while at the same time finding out whether they are helpful or harmful. We continue to support clinical trials that are testing new treatments for COVID so that we can gain valuable knowledge about their safety and effectiveness.
Q: What is ivermectin approved for in the U.S.?
A: Ivermectin tablets are approved for use in humans for the treatment of some parasitic worms (intestinal strongyloidiasis and onchocerciasis) and ivermectin topical formulations are approved for human use by prescription only for the treatment of external parasites such as headlice and for skin conditions such as rosacea.
Ivermectin is FDA-approved for use in animals for prevention of heartworm disease in some small animal species, and for treatment of certain internal and external parasites in various animal species. People should never take animal drugs, as the FDA has only evaluated their safety and effectiveness in the particular species for which they are labeled. Using these products in humans could cause serious harm.
Q: Is there any danger to humans taking ivermectin?
A: At this time, there are no FDA-approved drug products to treat COVID-19. The FDA is working with sponsors to expedite the development and availability of COVID-19 treatments.
Some of the side-effects that may be associated with ivermectin include skin rash, nausea, vomiting, diarrhea, stomach pain, facial or limb swelling, neurologic adverse events (dizziness, seizures, confusion), sudden drop in blood pressure, severe skin rash potentially requiring hospitalization and liver injury (hepatitis). Laboratory test abnormalities include decrease in white cell count and elevated liver tests. Any use of ivermectin for the prevention or treatment of COVID-19 should be avoided as its benefits and safety for these purposes have not been established. Data from clinical trials are necessary for us to determine whether ivermectin is safe and effective in treating or preventing COVID-19.
Q: What should I do if the ivermectin products I purchase for use in my animals are not available at my typical retailer?
A: Ivermectin is an important part of a parasite control program for certain species and should only be given to animals for approved uses or as prescribed by a veterinarian in compliance with the requirements for extra-label drug use. Due to potentially elevated interest in ivermectin following the new research, some products may not be available. If you are having difficulty locating a particular ivermectin product for your animal(s), the FDA recommends that you consult with your veterinarian.
Q: What is the FDA doing to protect people from fraudulent COVID-19 products?
A: We have established a cross-agency task force dedicated to closely monitoring for fraudulent COVID-19 products. We have reached out to major retailers to ask for their help in monitoring online marketplaces for fraudulent COVID-19 products. Products sold are subject to FDA investigation and potential enforcement action if they claim to prevent, diagnose, treat, or cure COVID-19 and have not demonstrated safety and effectiveness for that intended use. The task force has already worked with retailers to remove dozens of these types of product listings online.
The FDA and the Federal Trade Commission (FTC) issue warning letters to companies that violate federal law and pose significant risks to patient health by selling unapproved products with fraudulent claims to treat or prevent COVID-19. View the warning letters for more information.