Benicar

Benicar is the brand name of the prescription drug olmesartan, which is used to treat high blood pressure.

The medicine is in a class of drugs known as angiotensin II receptor antagonists, which work by relaxing blood vessels.

Benicar is sometimes also used to treat heart failure and kidney disease.

The drug is manufactured by Daiichi Sankyo, Inc. It was approved by the Food and Drug Administration (FDA) in 2002.

Benicar Warnings

Benicar contains a black-box warning because it can cause death or serious injury to an unborn baby when taken during the last six months of pregnancy.

You shouldn't take this medicine if you're pregnant or plan to become pregnant.

In 2013, the FDA also issued a new warning label about the risk of gastrointestinal side effects associated with Benicar.

Symptoms may include:

• Severe diarrhea
• Significant weight loss
• Stomach pain and discomfort

This medicine may also cause dizziness or fainting when you get up too quickly from a lying position. Tell your doctor if this symptom becomes severe.

Before taking Benicar, tell your health care provider if you have or have ever had:

• Diabetes
• Heart failure
• A heart attack
• A stroke
• An electrolyte issue (such as high potassium levels)
• Gallbladder problems
• Kidney disease
• Liver disease
• Angioedema (swelling of the hands, face, lips, eyes, throat or tongue; difficulty swallowing or breathing; or hoarseness)

Benicar may cause angioedema. Talk to your doctor if you develop any symptoms of this condition.

Also, let your physician know if you have diabetes and are taking the drug aliskiren (Tekturna).

Don't use salt substitutes that contain potassium while taking Benicar without first talking with your doctor.

Tell your doctor if you're taking any supplements that contain potassium.

Let your doctor know if you're dehydrated or get dehydrated easily while taking Benicar.

Dehydration, excessive sweating, vomiting, or severe diarrhea can increase the risk of low blood pressure. Use caution when exercising or when exposed to hot weather.

This medicine may not work well in African-American patients. Talk to your doctor if this is a concern for you.

Benicar shouldn't be used in children younger than age 1, as it could affect kidney development.

Tell your doctor you're taking this medicine before having any type of surgery, including a dental procedure.

Benicar helps control blood pressure, but it doesn't cure the condition. It may take up to two weeks for you to experience the full benefits of this medicine.

Don't stop taking Benicar without first talking to your doctor.

Benicar Lawsuits

Many people who suffered serious gastrointestinal side effects caused by Benicar have filed lawsuits against the drug manufacturer.

They claim the company failed to warn users about the risks and should be held liable.

Pregnancy and Benicar

Benicar can harm an unborn baby. Don't take this medicine if you're pregnant.

If you become pregnant while taking Benicar, call your doctor immediately.

It's not known whether the medicine is found in breast milk. Don't breastfeed while taking this drug without first talking to your doctor.

Tell your doctor about all prescription, non-prescription, illegal, recreational, herbal, nutritional, or dietary drugs you're taking, especially any of the medicines listed in the Warning section, as well as the following:

• An angiotensin-converting enzyme (ACE) inhibitor such as benazepril (Lotensin), captopril (Capoten), enalapril (Vasotec), fosinopril (Monopril), lisinopril (Prinivil, Zestril), moexipril (Univasc), perindopril (Aceon), quinapril (Accupril), ramipril (Altace), or trandolapril (Mavik)
• Angiotensin II receptor antagonists (angiotensin receptor blockers) such as azilsartan (Edarbi), candesartan (Atacand, in Atacand HCT), eprosartan (Teveten, in Teveten HCT), irbesartan (Avapro, in Avalide), losartan (Cozaar, in Hyzaar), telmisartan (Micardis, in Micardis HCT), or valsartan (Diovan, in Diovan HCT, Exforge)
• Colesevelam (Welchol)
• Diuretics (water pills)
• Lithium
• Aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen (Advil, Motrin) and naproxen (Aleve, Naprosyn)

Benicar and Alcohol

Alcohol may worsen certain side effects of Benicar. Talk to your doctor about how much alcohol is safe to consume while taking this medicine.

Benicar and Other Interactions

Benicar may cause fainting, lightheadedness, or dizziness. Don't drive or operate machinery until you know how this medicine will affect you.

Pregnancy category: 1st trimester, C; 2nd and 3rd trimesters, D

Lactation: No human data; use with caution

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

Benicar is a prescription medication used to treat high blood pressure in adults and children over 6 years old. Benicar belongs to a group of drugs called angiotensin II receptor blockers (ARBs), which block a substance in the body that increases blood pressure. Benicar causes blood to flow more smoothly and makes the heart more efficient at pumping blood.

This medication comes in tablet form and is taken once a day, with or without food.

Common side effects of Benicar include low blood pressure and headache. Benicar can cause dizziness.  Do not drive or operate machinery until you know how Benicar affects you.

• Daiichi Sankyo, Inc.

Benicar is part of the drug class:

• ANGIOTENSIN II ANTAGONISTS, PLAIN

• Store Benicar at room temperature.
• Keep this and all medicines out of the reach of children.

WARNING: FETAL TOXICITY

• When pregnancy is detected, discontinue Benicar as soon as possible.
• Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Blood in the urine
• body aches or pain
• chills
• cough or cough producing mucus
• difficulty with breathing
• ear congestion
• fever
• headache
• loss of voice
• nasal congestion
• runny nose
• sneezing
• sore throat
• tightness in the chest
• unusual tiredness or weakness

• Bladder pain
• bloating or swelling of the face, arms, hands, lower legs, or feet
• chest pain
• cloudy urine
• difficult, burning, or painful urination
• fast, pounding, or irregular heartbeat or pulse
• frequent urge to urinate
• joint pain, stiffness, or swelling
• lower back, side, or stomach pain
• swelling of the feet or lower legs

• Confusion
• dark-colored urine
• diarrhea (severe) with weight loss
• dizziness
• hives
• itching
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• muscle cramps or spasms
• muscle pain or stiffness
• nausea or vomiting
• weakness or heaviness of the legs

Get emergency help immediately if any of the following symptoms of overdose occur:

• Blurred vision
• chest pain or discomfort
• dizziness, faintness, or lightheadedness
• sweating

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Back pain
• diarrhea
• dry mouth
• flushed, dry skin
• fruit-like breath odor
• general feeling of discomfort or illness
• increased hunger
• increased thirst
• increased urination
• loss of appetite
• muscle aches
• pain or tenderness around the eyes and cheekbones
• shivering
• tender, swollen glands in the neck
• trouble sleeping
• trouble swallowing
• unexplained weight loss

• Acid or sour stomach
• belching
• difficulty with moving
• feeling of constant movement of self or surroundings
• heartburn
• indigestion
• rapid weight gain
• rash
• sensation of spinning
• tingling of the hands or feet
• unusual weight gain or loss

• Hair loss or thinning of the hair
• lack or loss of strength
• redness of the skin
• welts

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

• If you have an allergy to olmesartan or any other part of this medicine.
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you are taking a drug that has aliskiren in it and you also have high blood sugar (diabetes) or kidney problems. Check with your doctor or pharmacist if you are not sure if a drug you take has aliskiren in it.
• If you are breast-feeding or plan to breast-feed.

This is not a list of all drugs or health problems that interact with Benicar.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Your pharmacist can provide more information about olmesartan.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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Substance Name

Olmesartan

CAS Registry Number

144689-24-7

Drug Class

Antihypertensive Agents

Angiotensin II Type 1 Receptor Blockers