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Irbesartan

Side Effects

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 as soon as possible if any of the following side effects occur:

Rare

  • Dizziness, lightheadedness, or fainting

Frequency not determined

  • Confusion, irregular heartbeat, numbness or tingling in hands, feet, or lips, shortness of breath, difficult breathing , or weakness or heaviness of legs
  • Clay-colored stools, dark urine, itching, loss of appetite, stomach pain, or yellow eyes or skin
  • Large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet or sex organs

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:

Less common

  • Anxiety and/or nervousness
  • Cold-like symptoms
  • Belching, heartburn, and stomach discomfort
  • Cold symptoms
  • Diarrhea
  • Headache
  • Muscle or bone pain
  • Unusual tiredness

Frequency not determined

  • Hives or welts, itching, redness of skin, or skin rash

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.

Precautions

It is important that your doctor check your progress at regular visits to make sure that this medicine is working properly and to check for unwanted effects.

Check with your doctor immediately if you think that you may be pregnant. Irbesartan may cause birth defects or other problems in the baby if taken during pregnancy.

Do not take other medicines unless they have been discussed with your doctor. This especially includes over-the-counter (nonprescription) medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems, since they may tend to increase your blood pressure.

Dizziness or light-headedness may occur, especially if you have been taking a diuretic (water pill). Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you experience these effects.

Check with your doctor right away if you become sick while taking this medicine, especially with severe or continuing nausea and vomiting or diarrhea. These conditions may cause you to lose too much water and lead to low blood pressure.

Dizziness, lightheadedness, or fainting may also occur if you exercise or if the weather is hot. Heavy sweating can cause loss of too much water and result in low blood pressure. Use extra care during exercise or hot weather.

Proper Use

Take this medicine only as directed by your doctor. Do not take more of it and do not take it more often than your doctor ordered. This medicine works best when there is a constant amount in the blood. To help keep the amount constant, do not miss any doses. Also, it is best to take the doses at the same time each day.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor’s orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage form (tablets):
    • For high blood pressure:
      • Adults and adolescents over 13 years of age—150 milligrams (mg) once a day. Your doctor may increase your dose if needed.
      • Children 6 to 12 years of age—75 mg once a day. Your doctor may increase your dose if needed.
      • Children under 6 years of age—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

This medicine has been tested in children over 6 years of age and has not been shown to cause different side effects or problems than it does in adults.

Geriatric

This medicine has been tested in patients 65 years of age or older and has not been shown to cause different side effects or problems in older people than it does in younger adults. However, blood levels of irbesartan may be increased in the elderly and elderly patients may be more sensitive to the effects of irbesartan.

Pregnancy

Pregnancy Category Explanation
1st Trimester C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.
2nd Trimester D Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.
3rd Trimester D Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Bromfenac
  • Celecoxib
  • Diclofenac
  • Diflunisal
  • Etodolac
  • Fenoprofen
  • Flurbiprofen
  • Ibuprofen
  • Indomethacin
  • Ketoprofen
  • Ketorolac
  • Magnesium Salicylate
  • Meclofenamate
  • Mefenamic Acid
  • Meloxicam
  • Nabumetone
  • Naproxen
  • Nepafenac
  • Oxaprozin
  • Piroxicam
  • Salsalate
  • Sulindac
  • Tolmetin

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Congestive heart failure, severe—Lowering of blood pressure by irbesartan may make this condition worse
  • Dehydration—Blood pressure–lowering effects of irbesartan may be increased.
  • Kidney disease—Effects of irbesartan may be increased because of slower removal of medicine from the body.

Description

Irbesartan belongs to the class of medicines called angiotensin II inhibitor antihypertensives. It is used to treat high blood pressure (hypertension).

High blood pressure adds to the workload of the heart and arteries. If it continues for a long time, the heart and arteries may not function properly. This can damage the blood vessels of the brain, heart, and kidneys, resulting in a stroke, heart failure, or kidney failure. High blood pressure also may increase the risk of heart attacks. These problems may be less likely to occur if blood pressure is controlled.

Irbesartan works by blocking the action of a substance in the body that causes blood vessels to tighten. As a result, irbesartan relaxes blood vessels. This lowers blood pressure.

This medicine is available only with your doctor’s prescription.