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[Posted 04/10/2020]
AUDIENCE: Consumer, Health Professional, Pharmacy, Veterinary
ISSUE: FDA is concerned about the health of consumers who may self-medicate by taking ivermectin products intended for animals, thinking they can be a substitute for ivermectin intended for humans.
BACKGROUND: The FDA's Center for Veterinary Medicine has recently become aware of increased public visibility of the antiparasitic drug ivermectin after the announcement of a research article that described the effect of ivermectin on SARS-CoV-2 in a laboratory setting. The Antiviral Research pre-publication paper, "The FDA-approved drug ivermectin inhibits the replication of SARS-CoV-2 in vitro" documents how SARS-CoV-2 (the virus that causes COVID-19) responded to ivermectin when exposed in a petri dish.
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.
RECOMMENDATION:
For more information visit the FDA website at: http://www.fda.gov/Safety/MedWatch/SafetyInformation and http://www.fda.gov/Drugs/DrugSafety.
WHY is this medicine prescribed?
Ivermectin is used to treat strongyloidiasis (threadworm; infection with a type of roundworm that enters the body through the skin, moves through the airways and lives in the intestines). Ivermectin is also used to control onchocerciasis (river blindness; infection with a type of roundworm that may cause rash, bumps under the skin, and vision problems including vision loss or blindness). Ivermectin is in a class of medications called anthelmintics. It treats strongyloidosis by killing the worms in the intestines. It treats onchocerciasis by killing the developing worms. Ivermectin does not kill the adult worms that cause onchocerciasis and therefore it will not cure this type of infection.
HOW should this medicine be used?
Ivermectin comes as a tablet to take by mouth. It is usually taken as a single dose on an empty stomach with water. If you are taking ivermectin to treat onchocerciasis, additional doses 3, 6, or 12 months later may be necessary to control your infection. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take ivermectin exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
If you are taking ivermectin to treat strongyloidiasis, you will need to have a stool exam at least three times during the first 3 months after your treatment to see if your infection has cleared. If your infection has not cleared, your doctor will probably prescribe additional doses of ivermectin.
Are there OTHER USES for this medication?
Ivermectin is also sometimes used to treat certain other roundworm infections, head or pubic lice infestation, and scabies (itchy skin condition caused by infestation with small mites that live under the skin). Talk to your doctor about the risks of using this medication for your condition.
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
What SPECIAL PRECAUTIONS should I follow?
Before taking ivermectin,
What SPECIAL DIETARY instructions should I follow?
Unless your doctor tells you otherwise, continue your normal diet.
What should I do IF I FORGET to take a dose?
Ivermectin is usually taken as a single dose. Tell your doctor if you do not take your medication.
What SIDE EFFECTS can this medicine cause?
Ivermectin may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
If you are taking ivermectin to treat onchocerciasis, you may also experience the following side effects. Tell your doctor if any of these symptoms are severe or do not go away:
Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:
Ivermectin may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.
What should I do in case of OVERDOSE?
In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at http://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.
Symptoms of overdose may include:
What should I know about STORAGE and DISPOSAL of this medication?
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).
Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website http://goo.gl/c4Rm4p for more information.
Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location - one that is up and away and out of their sight and reach. http://www.upandaway.org
What OTHER INFORMATION should I know?
Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your body's response to ivermectin.
Do not let anyone else take your medication. Your prescription is probably not refillable.
Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.
This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.
The American Society of Health-System Pharmacists, Inc. represents that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. makes no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information is not a substitute for medical care.
AHFS® Patient Medication Information™ Copyright, 2025. The American Society of Health-System Pharmacists®, 4500 East-West Highway, Suite 900, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.
Selected Revisions: July 15, 2022.