AUDIENCE: Consumer, Pharmacy, Family Practice
ISSUE: To foster safe use of the over-the counter (OTC) anti-diarrhea drug loperamide, FDA is working with manufacturers to use blister packs or other single dose packaging and to limit the number of doses in a package. FDA continues to receive reports of serious heart problems and deaths with much higher than the recommended doses of loperamide, primarily among people who are intentionally misusing or abusing the product, despite the addition of a warning to the medicine label and a previous communication. Loperamide is a safe drug when used as directed.
Loperamide acts on opioid receptors in the gut to slow the movement in the intestines and decrease the number of bowel movements. It is safe at approved doses, but when much higher than recommended doses are taken, it can lead to serious problems, including severe heart rhythm problems and death.
FDA is continuing to evaluate this safety issue and will update the public when more information is available.
BACKGROUND: Loperamide is FDA-approved to help control symptoms of diarrhea, including Travelers' Diarrhea. The maximum approved daily dose for adults is 8 mg per day for OTC use and 16 mg per day for prescription use. It is sold under the OTC brand name Imodium A-D, as store brands, and as generics.
FDA previously issued a Drug Safety Communication about this safety concern in 2016, and added warnings about serious heart problems to the drug label of prescription loperamide and to the Drug Facts label of OTC loperamide products.
RECOMMENDATION: Patients and consumers should only take the dose of loperamide directed by your health care professionals or according to the OTC Drug Facts label, as taking more than prescribed or listed on the label can cause severe heart rhythm problems or death. If you are using OTC loperamide and your diarrhea lasts more than 2 days, stop taking the medicine and contact your health care professional.
Seek medical attention immediately by calling 911 if you or someone taking loperamide experiences any of the following, and tell health care professionals the person has been taking loperamide:
- Rapid heartbeat or irregular heart rhythm
- Unresponsiveness, meaning that you can't wake the person up or the person doesn't answer or react normally
Health care professionals should be aware that using much higher than recommended doses of loperamide, either intentionally or unintentionally, can result in serious cardiac adverse events, including QT interval prolongation, Torsades de Pointes or other ventricular arrhythmias, syncope, and cardiac arrest. In cases of abuse, individuals often use other drugs together with loperamide in attempts to increase its absorption and penetration across the blood-brain barrier, inhibit loperamide metabolism, and enhance its euphoric effects. Some individuals are taking high doses of loperamide to treat symptoms of opioid withdrawal. If loperamide toxicity is suspected, promptly discontinue the drug and start necessary therapy. For some cases of abnormal heart rhythms in which drug treatment is ineffective, electrical pacing or cardioversion may be required. Also counsel patients to take loperamide only as prescribed or according to the OTC Drug Facts label and advise patients that drug interactions with commonly used medicines may increase the risk of serious cardiac events.
For more information visit the FDA website at: http://www.fda.gov/Safety/MedWatch/SafetyInformation and http://www.fda.gov/Drugs/DrugSafety.
Loperamide may cause serious or life-threatening changes in your heart rhythm, especially in people who have taken more than the recommended amount. Tell your doctor if have or have ever had a prolonged QT interval (a rare heart problem that may cause irregular heartbeat, fainting, or sudden death), a slow or irregular heartbeat, or a low level of potassium in your blood. Also tell your doctor if you are taking or plan to take any of the following medications: amiodarone (Nexterone, Pacerone), chlorpromazine, haloperidol (Haldol), methadone (Dolophine, Methadose), moxifloxacin (Avelox), pentamidine (Nebupent, Pentam), procainamide, quinidine (in Nuedexta), sotalol (Betapace, Betapace AF), thioridazine, and ziprasidone (Geodon). Your doctor will probably tell you not to take loperamide if you are taking any of these medications or if you have any of these conditions. If you experience any of the following symptoms while taking loperamide, call your doctor immediately: fast, irregular, or pounding heartbeat; dizziness; lightheadedness; unresponsiveness; or fainting.
Taking more than the recommended amount of loperamide can cause heart problems that may be serious or cause death. Do not take a larger dose, take it more often, or take it for a longer period of time than prescribed by your doctor or as stated on the package.
Loperamide should not be given to a child younger than 2 years of age because of the risk of serious breathing and heart problems.
Why is this medication prescribed?
Nonprescription (over-the-counter) loperamide is used to control acute diarrhea (loose stools that come on suddenly and usually lasts less than 2 weeks), including travelers' diarrhea. Prescription loperamide is also used to control acute diarrhea and also ongoing diarrhea associated with inflammatory bowel disease (IBD; condition in which the lining of all or part of the intestine is swollen, irritated, or has sores). Prescription loperamide is also used to reduce the amount of fluid in people with ileostomies (surgery to create an opening for waste to leave the body through the abdomen). Loperamide is in a class of medications called antidiarrheal agents. It works by decreasing the flow of fluids and electrolytes into the bowel and by slowing down the movement of the bowel to decrease the number of bowel movements.
How should this medicine be used?
Loperamide comes as a tablet, capsule, and as a suspension or solution (liquid) to take by mouth.Nonprescription (over-the-counter) loperamide usually is taken immediately after each loose bowel movement but not more than the 24-hour maximum amount described on the label. Prescription loperamide is sometimes taken on a schedule (one or more times a day). Follow the directions on the package or on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take loperamide exactly as directed.
If you are giving loperamide to your child, read the package label carefully to make sure that it is the right product for the age of the child. Loperamide should not be given to a child younger than 2 years of age. Check the package label to find out how much medication the child needs. If you know how much your child weighs, give the dose that matches that weight on the chart. If you don't know your child's weight, give the dose that matches your child's age. Ask your child's doctor if you don't know how much medication to give your child.
If you are taking loperamide liquid, do not use a household spoon to measure your dose. Use the measuring cup that came with the medication or use a spoon made especially for measuring liquid medication.
If you are taking loperamide for acute diarrhea and your symptoms get worse or if your diarrhea lasts longer than 48 hours, stop taking this medication and call your doctor.
Other uses for this medicine
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
What special precautions should I follow?
Before taking loperamide,
- tell your doctor and pharmacist if you are allergic to loperamide, any other medications, or any of the ingredients in loperamide products. Check the package label for a list of the ingredients.
- tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: antibiotics such as clarithromycin (Biaxin, in PrevPac) and erythromycin (E.E.S., Ery-Tab, Eryc, others); certain antifungals such as itraconazole (Onmel, Sporanox) and ketoconazole; cimetidine (Tagamet), gemfibrozil (Lopid); quinine (Qualaquin), ranitidine (Zantac), ritonavir (Norvir, in Kaletra), or saquinavir (Invirase). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
- tell your doctor if you have or have ever had ulcerative colitis (condition in which sores develop in the intestines causing pain and diarrhea). or colitis (swelling of the intestine caused by certain bacteria). Also, tell your doctor if you have a fever, blood or mucus in the stool, black stools, or stomach pain without diarrhea. Your doctor will probably tell you not to take loperamide or give it your child if you have one or more of these conditions.
- tell your doctor if you have acquired immunodeficiency syndrome (AIDS) or if you have or have ever had liver disease.
- tell your doctor and pharmacist if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while taking loperamide, call your doctor.
- you should know that this drug may make you drowsy and dizzy. Do not drive a car or operate machinery until you know how this drug affects you.
What special dietary instructions should I follow?
Drink plenty of water or other clear fluids to replace fluids lost while having diarrhea.
What should I do if I forget a dose?
If you are taking scheduled doses of loperamide, take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.
What side effects can this medication cause?
Loperamide may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
If you or someone taking loperamide experience any of the following symptoms, call your/their doctor immediately or get emergency medical treatment:
- red, peeling or blistering skin
- difficulty breathing
- stomach pain or swelling
- bloody stools
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).
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).
Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.
It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org
In case of emergency/overdose
In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://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 the following:
- inability to urinate
- fast, pounding, or irregular heartbeat
- narrowing of the pupils
- slow and shallow breathing
- shortness of breath
What other information should I know?
Ask your pharmacist any questions you have about taking this medicine.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
- Imodium® AD
- K-Pek II®
- Kaopectate 1-D®
- Maalox® Anti-Diarrheal
- Pepto® Diarrhea Control
Brand names of combination products
- Imodium® Multi-Symptom Relief (containing Loperamide, Simethicone)