- Azor®(as a combination product containing Amlodipine, Olmesartan)
- Tribenzor®(as a combination product containing Amlodipine, Hydrochlorothiazide, Olmesartan)
[Posted 07/03/2013]ISSUE: FDA is warning that the blood pressure drug Olmesartan Medoxomil (marketed as Benicar, Benicar HCT, Azor, Tribenzor, and generics) can cause intestinal problems known as sprue-like enteropathy. Symptoms of sprue-like enteropathy include severe, chronic diarrhea with substantial weight loss. FDA has approved changes to the labels of these drugs to include this concern. Sprue-like enteropathy has not been detected with ARB drugs other than olmesartan. FDA will continue to evaluate the safety of olmesartan-containing products and will communicate again if additional information becomes available.
BACKGROUND: Olmesartan medoxomil is an angiotensin II receptor blocker (ARB) approved for the treatment of high blood pressure, alone or with other antihypertensive agents, and is one of eight marketed ARB drugs.
RECOMMENDATION: Health care professionals should tell patients to contact them if they develop severe, chronic diarrhea with substantial weight loss while taking an olmesartan-containing product, even if it takes months to years for symptoms to develop. Patients should contact their health care professional right away if they take an olmesartan-containing product and experience severe diarrhea, diarrhea that does not go away, or significant weight loss. For more information visit the FDA website at: Web Site
and Web Site
Tell your doctor if you are pregnant or plan to become pregnant. Do not take olmesartan if you are pregnant. If you become pregnant while you are taking olmesartan, stop taking olmesartan and call your doctor immediately. Olmesartan may cause death or serious injury to the fetus when taken in the last 6 months of pregnancy.
Olmesartan is used alone or in combination with other medications to treat high blood pressure in adults and children 6 years of age and older. Olmesartan is in a class of medications called angiotensin II receptor antagonists. It works by blocking the action of certain natural substances that tighten the blood vessels, allowing the blood to flow more smoothly and the heart to pump more efficiently.
Olmesartan comes as a tablet to take by mouth. It is usually taken once a day with or without food. To help you remember to take olmesartan, take it at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take olmesartan exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
If your child can not swallow a tablet, talk to your doctor or pharmacist. The pharmacist can prepare a liquid form of this medication for your child.
Your doctor will probably start you on a low dose of olmesartan and may increase your dose after 2 weeks.
Olmesartan controls high blood pressure but does not cure it. Your blood pressure may decrease during the first week of your treatment, but it may take up to 2 weeks before you notice the full benefit of olmesartan. Continue to take olmesartan even if you feel well. Do not stop taking olmesartan without talking to your doctor.
Olmesartan is also sometimes used to treat congestive heart failure (condition in which the heart is unable to pump enough blood to the rest of the body) and diabetic nephropathy (kidney disease in people with diabetes and high blood pressure). Talk to your doctor about the possible risks of using this medication for your condition.
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
Before taking olmesartan,
- tell your doctor and pharmacist if you are allergic to olmesartan,any other medications, or any of the ingredients in olmesartan tablets. Ask your pharmacist for a list of the ingredients.
- tell your doctor if you have diabetes (high blood sugar) and you are taking aliskiren (Tekturna, in Amturnide, Tekamlo, Tekturna HCT). Your doctor will probably tell you not to take olmesartan if you have diabetes and you are also taking aliskiren.
- 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 diuretics ('water pills') and potassium supplements. Your doctor may need to change the doses of your medication or monitor you carefully for side effects.
- tell your doctor if you have or have ever had heart failure, or kidney or liver disease.
- tell your doctor if you are breast-feeding.
- you should know that olmesartan may cause dizziness, lightheadedness, and fainting when you get up too quickly from a lying position. This is more common when you first start taking olmesartan. To help avoid this problem, get out of bed slowly, resting your feet on the floor for a few minutes before standing up.
- you should know that diarrhea, vomiting, not drinking enough fluids, and sweating a lot can cause a drop in blood pressure, which may cause lightheadedness and fainting. Tell your doctor if you have any of these problems or develop them during your treatment.
Do not use salt substitutes containing potassium without talking to your doctor. If your doctor prescribes a low-salt or low-sodium diet, follow these directions carefully.
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.
Olmesartan may cause side effects. Tell your doctor if this symptom is severe or does not go away: Some side effects can be serious. If you experience any of these symptoms or those listed in the SPECIAL PRECAUTIONS section, call your doctor immediately:
- swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
- difficulty breathing or swallowing
Olmesartan may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.
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 [at Web Site] or by phone [1-800-332-1088].
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). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.
In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.
Symptoms of overdose may include
- fast or slow heartbeat
Keep all appointments with your doctor and the laboratory. Your blood pressure should be checked regularly to determine your response to olmesartan.
Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.
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.
AHFS® Consumer Medication Information. © Copyright, The American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.
Selected Revisions: July 15, 2013.