- Avapro Side Effects
- In Summary
- For the Consumer
- For Healthcare Professionals
- Further information
- More about Avapro (irbesartan)
- How does this medication work? What will it do for me?
- What form(s) does this medication come in?
- How should I use this medication?
- Who should NOT take this medication?
- What side effects are possible with this medication?
- Are there any other precautions or warnings for this medication?
- What other drugs could interact with this medication?
The following important adverse reactions are described elsewhere in the labeling:
- Hypotension in Volume- or Salt-depleted Patients
- Impaired Renal Function
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates.
AVAPRO has been evaluated for safety in more than 4300 patients with hypertension and about 5000 subjects overall. This experience includes 1303 patients treated for over 6 months and 407 patients for 1 year or more.
In placebo-controlled clinical trials, the following adverse reactions were reported in at least 1% of patients treated with AVAPRO (n=1965) and at a higher incidence versus placebo (n=641), excluding those too general to be informative and those not reasonably associated with the use of drug because they were associated with the condition being treated or are very common in the treated population, include: diarrhea (3% vs 2%), dyspepsia/heartburn (2% vs 1%), and fatigue (4% vs 3%).
Irbesartan use was not associated with an increased incidence of dry cough, as is typically associated with ACE inhibitor use. In placebo-controlled studies, the incidence of cough in irbesartan-treated patients was 2.8% versus 2.7% in patients receiving placebo.
Nephropathy In Type 2 Diabetic Patients
Hyperkalemia: In the Irbesartan Diabetic Nephropathy Trial (IDNT) (proteinuria ≥ 900 mg/day, and serum creatinine ranging from 1.0-3.0 mg/dL), the percent of patients with potassium > 6 mEq/L was 18.6% in the AVAPRO group versus 6.0% in the placebo group. Discontinuations due to hyperkalemia in the AVAPRO group were 2.1% versus 0.4% in the placebo group.
In IDNT, the adverse reactions were similar to those seen in patients with hypertension with the exception of an increased incidence of orthostatic symptoms which occurred more frequently in the AVAPRO versus placebo group: dizziness (10.2% vs 6.0%), orthostatic dizziness (5.4% vs 2.7%) and orthostatic hypotension (5.4% vs 3.2%).
The following adverse reactions have been identified during post-approval use of AVAPRO. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate reliably their frequency or to establish a causal relationship to drug exposure.
Urticaria; angioedema (involving swelling of the face, lips, pharynx, and/or tongue); increased liver function tests; jaundice; hepatitis; hyperkalemia; thrombocytopenia; increased CPK; tinnitus.
Read the entire FDA prescribing information for Avapro (Irbesartan)
Avapro Side Effects
Generic Name: irbesartan
Medically reviewed by Drugs.com. Last updated on Nov 26, 2018.
- Side Effects
Note: This document contains side effect information about irbesartan. Some of the dosage forms listed on this page may not apply to the brand name Avapro.
Common side effects of Avapro include: hyperkalemia. See below for a comprehensive list of adverse effects.
For the Consumer
Applies to irbesartan: oral tablet
Oral route (Tablet)
When pregnancy is detected, discontinue irbesartan as soon as possible; drugs that act directly on the renin-angiotensin system can cause serious fetal toxicity.
Along with its needed effects, irbesartan (the active ingredient contained in Avapro) 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 while taking irbesartan:
- cold sweats
- dizziness, faintness, or lightheadedness when getting up from lying or sitting position
- Bladder pain
- bloody or cloudy urine
- chest pain
- difficult, burning, or painful urination
- fast, pounding, or irregular heartbeat or pulse
- frequent urge to urinate
- lower back or side pain
- Chest discomfort
- decreased urine output
- dilated neck veins
- extreme fatigue
- feeling of warmth
- irregular breathing
- irregular heartbeat
- pain or discomfort in the arms, jaw, back, or neck
- redness of the face, neck, arms, and occasionally, upper chest
- shortness of breath
- swelling of the face, fingers, feet, or lower legs
- tightness in the chest
- troubled breathing
- weight gain
Incidence not known
- Abdominal or stomach pain
- black, tarry stools
- bleeding gums
- clay-colored stools
- dark urine
- decreased frequency of urine
- increased thirst
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- loss of appetite
- muscle cramps or spasms
- muscle pain or stiffness
- numbness or tingling in the hands, feet, or lips
- pinpoint red spots on the skin
- unpleasant breath odor
- unusual bleeding or bruising
- unusual tiredness or weakness
- vomiting of blood
- weakness or heaviness of the legs
- weight gain
- yellow eyes or skin
Some side effects of irbesartan 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:
- Acid or sour stomach
- body aches or pain
- bone pain
- dryness or soreness of the throat
- feeling of indigestion
- general feeling of discomfort or illness
- joint pain
- pain in the chest below the breastbone
- runny nose
- stomach discomfort or upset
- stuffy nose
- tender, swollen glands in the neck
- trouble sleeping
- trouble with swallowing
- voice changes
- Blistering, crusting, irritation, itching, or reddening of the skin
- bloated or full feeling
- blurred or loss of vision
- burning, crawling, itching, numbness, prickling, “pins and needles”, or tingling feelings
- change in hearing
- cracked, dry, scaly skin
- decreased interest in sexual intercourse
- difficulty having a bowel movement (stool)
- disturbed color perception
- double vision
- ear drainage
- earache or pain in the ear
- excess air or gas in the stomach or intestines
- halos around lights
- hives or welts
- inability to have or keep an erection
- large, flat, blue or purplish patches in the skin
- loss in sexual ability, desire, drive, or performance
- night blindness
- overbright appearance of lights
- pain, swelling, or redness in the joints
- passing gas
- sleepiness or unusual drowsiness
- tunnel vision
Incidence not known
- Feeling of constant movement of self or surroundings
- sensation of spinning
For Healthcare Professionals
Applies to irbesartan: oral tablet
The most common adverse reactions were hyperkalemia, headache, and dizziness.
Hyperkalemia (5.5 mEq/L or greater) occurred in 29.4% of hypertensive diabetic patients with microalbuminuria and normal renal function and in 46.3% of hypertensive diabetic patients with chronic renal insufficiency and overt proteinuria.
Very common (10% or more): Hyperkalemia (up to 46.3%)
Uncommon (0.1% to 1%): Weight gain
Rare (less than 0.1%): Gout, decreased appetite, increased appetite
Frequency not reported: Hyperkalemia
Very common (10% or more): Headache (up to 12.3%), dizziness (up to 10.2%)
Common (1% to 10%): Orthostatic dizziness
Uncommon (0.1% to 1%): Numbness, somnolence, vertigo, paresthesia
Rare (less than 0.1%): Syncope, tremor, coordination disturbance, taste disturbance
Frequency not reported: Tinnitus, dysgeusia, transient ischemic attack, cerebrovascular accident
Common (1% to 10%): Upper respiratory tract infection, sinus abnormality, cough, pharyngitis, rhinitis
Uncommon (0.1% to 1%): Epistaxis, dyspnea
Frequency not reported: Tracheobronchitis, congestion, pulmonary congestion, wheezing
Common (1% to 10%): Nausea/vomiting, diarrhea, dyspepsia/heartburn, abdominal pain
Uncommon (0.1% to 1%): Constipation, flatulence, dry mouth, abdomen distention
Rare (less than 0.1%): Abnormal stool, oral lesion, dysphagia, esophagitis
Frequency not reported: Gastroenteritis
Common (1% to 10%): Fatigue, chest pain, edema
Uncommon (0.1% to 1%): Weakness, malaise, upper extremity edema, extremity swelling, hearing abnormality
Rare (less than 0.1%): Breast disorder, cold sensation, warmth sensation, pain, head/neck edema, medication bad taste
Frequency not reported: Ear pain, ear abnormality, fever, chills, facial edema
Postmarketing reports: Asthenia
Common (1% to 10%): Musculoskeletal pain, musculoskeletal trauma, plasma creatine kinase increased
Uncommon (0.1% to 1%): Muscle cramp
Rare (less than 0.1%): Arthritis, muscle ache, myalgia, extremity weakness, lower extremity stiffness
Frequency not reported: Arthralgia, musculoskeletal chest pain, joint stiffness, bursitis, muscle weakness
Postmarketing reports: Rhabdomyolysis
Common (1% to 10%): Orthostatic hypotension, tachycardia
Uncommon (0.1% to 1%): Flushing, subjective rhythm disturbance, ECG abnormality, cardiac murmur, cardiac rhythm disturbance, atrial rhythm disturbance, bradycardia, hypotension
Rare (less than 0.1%): Conduction disorder, myocardial infarction, hot flashes
Frequency not reported: Hypertension, angina pectoris, arrhythmic disorder, cardiorespiratory arrest, heart failure, hypertensive crisis
Common (1% to 10%): Anxiety/nervousness
Uncommon (0.1% to 1%): Libido change, sleep disturbance, depression, emotion labile/disturbance
Rare (less than 0.1%): Stress related disorder, disturbing dreams
Common (1% to 10%): Rash
Uncommon (0.1% to 1%): Pruritus, facial erythema, hyperhidrosis
Rare (less than 0.1%): Dermatitis, acne, scalp-hair abnormality
Frequency not reported: Angioedema, urticaria, leukocytoclastic vasculitis, ecchymosis
Common (1% to 10%): Urinary tract infection
Uncommon (0.1% to 1%): Sexual dysfunction, urination abnormality
Frequency not reported: Prostate disorder
Common (1% to 10%): Hemoglobin decreased
Uncommon (0.1% to 1%): Neutropenia
Rare (less than 0.1%): Anemia
Postmarketing reports: Thrombocytopenia
Common (1% to 10%): Influenza
Frequency not reported: Hypersensitivity reactions, ear infection
Postmarketing reports: Anaphylactic reaction, anaphylactic shock
Uncommon (0.1% to 1%): BUN increased, serum creatinine increased
Frequency not reported: Impaired renal function, renal failure
Uncommon (0.1% to 1%): Vision disturbance
Rare (less than 0.1%): Eye disturbance, eyelid abnormality, visual field abnormality
Frequency not reported: Conjunctivitis
Uncommon (0.1% to 1%): Jaundice
Frequency not reported: Hepatitis, abnormal liver function
Postmarketing reports: Elevated liver function tests
1. “Product Information. Avapro (irbesartan).” Bristol-Myers Squibb, Princeton, NJ.
2. Cerner Multum, Inc. “UK Summary of Product Characteristics.” O 0
3. Cerner Multum, Inc. “Australian Product Information.” O 0
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Some side effects may not be reported. You may report them to the FDA.
More about Avapro (irbesartan)
- During Pregnancy or Breastfeeding
- Dosage Information
- Drug Images
- Drug Interactions
- Support Group
- Pricing & Coupons
- En Español
- 37 Reviews
- Generic Availability
- Drug class: angiotensin receptor blockers
- FDA Alerts (5)
- Avapro (Advanced Reading)
- Avapro (AHFS Monograph)
- … +1 more
Related treatment guides
- Diabetic Kidney Disease
- High Blood Pressure
Irbesartan is the generic form of the brand-name drug Avapro, which is used to treat high blood pressure.
It’s also used to treat kidney disease that’s caused by diabetes, as well as heart failure.
The prescription medicine is in a class of drugs known as angiotensin receptor blockers (ARBs), which work by relaxing blood vessels.
Avapro is typically prescribed along with recommendations for healthy lifestyle changes, such as diet and exercise. It’s either taken alone, or sometimes combined with other medicines.
The Food and Drug Administration (FDA) approved irbesartan in 1997. It’s manufactured by Sanofi-Aventis and Bristol-Myers Squibb Company.
Before taking irbesartan, tell you doctor if you have or have ever had:
- Allergies to medications
- Heart failure or blood vessel problems
- Stroke or heart attack
- Kidney disease (or if you’re on dialysis)
- Angioedema (a condition that causes swelling of the hands, face, eyes, lips, throat, or tongue; hoarseness; or swallowing and breathing difficulties)
- Either high blood potassium levels or low blood sodium levels
- Low blood volume
Also let your physician know if you have diabetes and are taking the drug aliskiren (Tekturna, Amturnide, Tekamlo).
This medicine might not work as well in African Americans. Talk to your doctor if this is a concern for you.
Let your doctor know if you’re on a low-salt diet or if you’re dehydrated before taking this medicine.
Tell your physician if you experience diarrhea, vomiting, or excessive sweating while taking irbesartan, because you may be at an increased risk for developing low blood pressure.
Check with your healthcare provider before using a salt substitute or any product that has potassium in it while using irbesartan.
This medicine shouldn’t be given to a child younger than 16. Safety and effectiveness in this age group haven’t been established.
Be sure to let your doctor know you’re taking this medicine before having any type of surgery, including a dental procedure.
This medicine will help control high blood pressure, but it won’t cure the condition.
It might take up to two weeks before you experience the full benefits of the drug. Don’t stop taking irbesartan without first talking to your doctor.
Your physician will probably want to perform frequent lab tests while you take this medicine. Keep all appointments with your doctor and laboratory.
Pregnancy and Irbesartan
Irbesartan contains a black-box warning because it can cause serious injury or death to an unborn baby if it’s taken in the last six months of pregnancy.
Tell your doctor immediately if you’re pregnant or might become pregnant while taking this medicine.
It’s not known whether irbesartan is found in breast milk. Don’t breast-feed a baby while taking this medicine.
How does this medication work? What will it do for me?
Irbesartan belongs to a family of medicines known as angiotensin II receptor blockers. These medicines are used to lower high blood pressure and work by relaxing blood vessels. Irbesartan is used to lower blood pressure and decrease the rate of the progression of kidney damage in patients with type 2 diabetes.
Angiotensin II is a chemical that the body releases to cause the constriction of blood vessels. Irbesartan blocks the action of angiotensin II, resulting in the relaxation of the blood vessels. This relaxation causes the blood pressure to decrease. The full effects of irbesartan are usually seen within about 4 weeks. It can be used alone or in combination with thiazide diuretics (water pills; e.g., hydrochlorothiazide).
This medication does not cure blood pressure, but it does help to control it, when it is taken regularly. Do not stop taking this medication without discussing the risks and benefits with your doctor.
This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.
Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.
Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.
What form(s) does this medication come in?
Each white-to-off-white biconvex, oval tablet, with a heart shape debossed on one side and the digits “2771” on the other, contains irbesartan 75 mg. Nonmedicinal ingredients: croscarmellose sodium, lactose, magnesium stearate, microcrystalline cellulose, poloxamer 188, pregelatinized starch, and silicon dioxide.
Each white-to-off-white biconvex, oval tablet, with a heart shape debossed on one side and the digits “2772” on the other, contains irbesartan 150 mg. Nonmedicinal ingredients: croscarmellose sodium, lactose, magnesium stearate, microcrystalline cellulose, poloxamer 188, pregelatinized starch, and silicon dioxide.
Each white-to-off-white biconvex, oval tablet, with a heart shape debossed on one side and the digits “2773” on the other, contains irbesartan 300 mg. Nonmedicinal ingredients: croscarmellose sodium, lactose, magnesium stearate, microcrystalline cellulose, poloxamer 188, pregelatinized starch, and silicon dioxide.
How should I use this medication?
The usual starting dose of irbesartan is 150 mg daily at approximately the same time each day. If you are taking other medication to reduce your blood pressure, your doctor may start you with a dose of 75 mg daily. The doctor may decide to increase the dose to 300 mg once a day if your blood pressure has not come down enough.
Irbesartan may be taken with or without food but should be taken in the same manner each day.
Make sure you follow your doctor’s instructions about monitoring your blood pressure to ensure that you receive the maximum benefit from the medication.
Many things can affect the dose of a medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.
It is important that this medication be taken exactly as prescribed by your doctor. If you miss a dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.
Store this medication at room temperature, protect it from light and moisture, and keep it out of the reach of children.
Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.
Who should NOT take this medication?
Do not take irbesartan if you:
- are allergic to irbesartan or any ingredients of the medication
- have experienced a serious allergic reaction to another angiotensin II receptor blocker (ARB) (e.g., candesartan, losartan, valsartan)
- have diabetes mellitus or severely reduced kidney function and are taking the medication aliskiren or an angiotensin-converting enzyme (ACE) inhibitor
- are pregnant
- are breast-feeding
- have galactose intolerance or glucose malabsorption (a rare hereditary disease)
What side effects are possible with this medication?
Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent. The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.
The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.
Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.
- swelling of the ankles
- trouble sleeping
- unusual tiredness
Although most of these side effects listed below don’t happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.
Check with your doctor as soon as possible if any of the following side effects occur:
- dark brown urine
- dizziness rising from a sitting or lying position
- muscle pain, tenderness, or weakness
- ringing in the ears
- signs of clotting problems (e.g., unusual nosebleeds, bruising, blood in urine, coughing blood, bleeding gums, cuts that don’t stop bleeding)
- signs of kidney problems (e.g., increased urination at night, decreased urine production, blood in the urine)
- signs of liver problems (e.g., nausea, vomiting, diarrhea, loss of appetite, weight loss, yellowing of the skin or whites of the eyes, dark urine, pale stools)
- signs of too much potassium in the blood (e.g., muscle weakness, irregular heartbeat, general feeling of being unwell)
Stop taking the medication and seek immediate medical attention if any of the following occur:
- signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)
Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.
Are there any other precautions or warnings for this medication?
Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.
HEALTH CANADA ADVISORY
February 4, 2014
Health Canada has issued new restrictions concerning the use of irbesartan. To read the full Health Canada Advisory, visit Health Canada’s web site at www.hc-sc.gc.ca.
Drowsiness/reduced alertness: Irbesartan, like other medications for blood pressure may cause dizziness and lightheadedness, especially if you have been taking a diuretic (water pill). This may affect your ability to drive or operate machinery. Avoid these and other activities until you have determined that this medication does not affect you in this way.
Heart disease: If you have a history of heart problems, such as a recent heart attack or stroke, narrowing of the heart valves (valvular stenosis) or other heart disease, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Kidney function: Irbesartan may affect the function of the kidneys, especially for people who already have kidney problems. If you have reduced kidney function or kidney disease, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Liver function: Liver disease or reduced liver function may cause this medication to build up in the body, causing side effects. If you have liver problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. Your doctor may want to test your liver function regularly with blood tests while you are taking this medication.
If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.
Low blood pressure: Occasionally, a larger-than-expected decrease in blood pressure occurs after taking irbesartan. In some cases, this happens after the first dose. It is more likely to occur if you take diuretics (water pills) or the medication aliskiren, have a reduced salt intake, are on dialysis, or are experiencing diarrhea or vomiting. Blood pressure should be monitored more often in these situations. If you have low blood pressure or are just starting to take this medication, move slowly from a reclining to an upright position to reduce the risk of dizziness.
Potassium levels: This medication may affect potassium levels in the blood, especially when used for heart failure, or when taken with other medications called ACE inhibitors or diuretics such as spironolactone. Your doctor will monitor your potassium levels while you are on this medication. Avoid using salt substitutes that contain potassium while you are taking irbesartan.
Pregnancy: Irbesartan can cause severe harm or death to a developing baby if it is taken by the mother during pregnancy. Therefore, this medication should not be taken by pregnant women. If you become pregnant while taking this medication, contact your doctor immediately.
Breast-feeding: It is not known if irbesartan passes into breast milk. If you are a breast-feeding mother and are taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.
Children: The safety and effectiveness of using this medication have not been established for children.
Seniors: Older adults may be more likely to experience side effects of this medication.
What other drugs could interact with this medication?
There may be an interaction between irbesartan and any of the following:
If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:
- stop taking one of the medications,
- change one of the medications to another,
- change how you are taking one or both of the medications, or
- leave everything as is.
An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.
Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.
All material copyright MediResource Inc. 1996 – 2020. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/drug/getdrug/Avapro