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Does Avapro (irbesartan) cause side effects?
Angiotensin, formed in the blood by the action of angiotensin converting enzyme (ACE), is a powerful chemical that attaches to angiotensin receptors found in many tissues but primarily on smooth muscle cells of blood vessels.
Angiotensin's attachment to the receptors causes the blood vessels to narrow (vasoconstrict), which leads to an increase in blood pressure (hypertension). Avapro blocks the angiotensin receptor. By blocking the action of angiotensin, Avapro dilates blood vessels and reduces blood pressure.
Common side effects of Avapro include
- increased blood potassium (hyperkalemia),
- abdominal pain or heartburn,
- fatigue, and
- reduced blood pressure when rising from a sitting or standing position (orthostatic hypotension).
Serious side effects of Avapro include
- reduced kidney function,
- allergic reactions,
- inflammation and destruction of muscle (rhabdomyolysis), and
- swelling of soft tissues including those of the throat and larynx (angioedema).
Drug interactions of Avapro include potassium-sparing diuretics, potassium supplements, or salt substitutes containing potassium because the combination may lead to elevated potassium in the blood (hyperkalemia) and toxicity from potassium.
- Combining Avapro or other ARBs with nonsteroidal anti-inflammatory drugs (NSAIDs) in patients who are elderly, fluid-depleted (including those on diuretic therapy), or with poor kidney function may result in reduced kidney function, including kidney failure. These effects usually are reversible.
- There have been reports that aspirin and other NSAIDs such as ibuprofen, indomethacin, and naproxen may reduce the effects of ARBs.
All ARBs including Avapro should not be used during pregnancy. When used in the second or third trimester of pregnancy, Avapro and similar drugs may cause injury and even death to the fetus. Avapro should not be used during pregnancy. When pregnancy is detected, Avapro should be stopped as soon as possible.
What are the important side effects of Avapro (irbesartan)?
The most common side effects of irbesartan are:
- abdominal pain or
- fatigue, and
- reduced blood pressure when rising from a sitting or standing position (orthostatic hypotension).
Other important side effects patients may experience include:
- reduced renal function, and
- allergic reactions.
Avapro (irbesartan) side effects list for healthcare professionals
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:
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.
What drugs interact with Avapro (irbesartan)?
Agents Increasing Serum Potassium
- Coadministration of Avapro with other drugs that raise serum potassium levels may result in hyperkalemia, sometimes severe. Monitor serum potassium in such patients.
- Increases in serum lithium concentrations and lithium toxicity have been reported with concomitant use of irbesartan and lithium. Monitor lithium levels in patients receiving irbesartan and lithium.
Non-Steroidal Anti-Inflammatory Drugs (NSAIDs ) Including Selective Cyclooxygenase-2 Inhibitors (COX-2 Inhibitors )
- In patients who are elderly, volume-depleted (including those on diuretic therapy), or with compromised renal function, co-administration of NSAIDs, including selective COX-2 inhibitors, with angiotensin II receptor antagonists (including irbesartan) may result in deterioration of renal function, including possible acute renal failure.
- These effects are usually reversible. Monitor renal function periodically in patients receiving irbesartan and NSAID therapy.
- The antihypertensive effect of angiotensin II receptor antagonists, including irbesartan, may be attenuated by NSAIDs including selective COX-2 inhibitors.
Dual Blockade Of The Renin-Angiotens In System (RAS)
- Dual blockade of the RAS with angiotensin receptor blockers, ACE inhibitors, or aliskiren is associated with increased risks of hypotension, hyperkalemia, and changes in renal function (including acute renal failure) compared to monotherapy.
- Most patients receiving the combination of two RAS inhibitors do not obtain any additional benefit compared to monotherapy. In general, avoid combined use of RAS inhibitors.
- Closely monitor blood pressure, renal function and electrolytes in patients on Avapro and other agents that affect the RAS.
- Do not co-administer aliskiren with Avapro in patients with diabetes. Avoid use of aliskiren with Avapro in patients with renal impairment (GFR < 60 mL/min).
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Related Disease Conditions
High Blood Pressure (Hypertension)
High blood pressure (hypertension) is a disease in which pressure within the arteries of the body is elevated. About 75 million people in the US have hypertension (1 in 3 adults), and only half of them are able to manage it. Many people do not know that they have high blood pressure because it often has no has no warning signs or symptoms. Systolic and diastolic are the two readings in which blood pressure is measured. The American College of Cardiology released new guidelines for high blood pressure in 2017. The guidelines now state that blood normal blood pressure is 120/80 mmHg. If either one of those numbers is higher, you have high blood pressure. The American Academy of Cardiology defines high blood pressure slightly differently. The AAC considers 130/80 mm Hg. or greater (either number) stage 1 hypertension. Stage 2 hypertension is considered 140/90 mm Hg. or greater. If you have high blood pressure you are at risk of developing life threatening diseases like stroke and heart attack.REFERENCE: CDC. High Blood Pressure. Updated: Nov 13, 2017.
What Are the 5 Stages of Chronic Kidney Disease?
The doctor will take your complete medical history along with your family history, such as if anyone in your family has or had diabetes, whether you are on any medications (that can cause kidney damage), and so on. They will perform a thorough physical examination to see if you have any signs or symptoms of CKD.
What Are the Signs That Something Is Wrong With My Kidneys?
Most of the signs of kidney diseases are unnoticed, ignored, or appear very late in the disease. Over 37 million American adults have kidney diseases, and most are not aware of it.
High Blood Pressure Treatment (Natural Home Remedies, Diet, Medications)
High blood pressure (hypertension) means high pressure (tension) in the arteries. Treatment for high blood pressure include lifestyle modifications (alcohol, smoking, coffee, salt, diet, exercise), drugs and medications such as ACE inhibitors, angiotensin receptor blockers, beta blockers, diuretics, calcium channel blockers (CCBs), alpha blockers, clonidine, minoxidil, and Exforge.
Portal hypertension is most commonly caused by cirrhosis, a disease that results from scarring of the liver. Other causes of portal hypertension include blood clots in the portal vein, blockages of the veins that carry the blood from the liver to the heart, and a parasitic infection called schistosomiasis. Symptoms of portal hypertension include varices (enlarged veins), vomiting blood, blood in the stool, black and tarry stool, ascites (abnormal fluid collection within the peritoneum, the sac that contains the intestines within the abdominal cavity), confusion and lethargy, splenomegaly or enlargement of the spleen, and decreased white blood cell counts.
Hypertension-Related Kidney Disease
Second Source WebMD Medical Reference
Pulmonary hypertension is elevated pressure in the pulmonary arteries that carry blood from the lungs to the heart. The most common symptoms are fatigue and difficulty breathing. If the condition goes undiagnosed, more severe symptoms may occur. As pulmonary hypertension worsens, some people with the condition have difficulty performing any activities that require physical exertion. While there is no cure for pulmonary hypertension, it can be managed and treated with medications and supplemental oxygen to increase blood oxygen levels.
Hypertensive Kidney Disease
High blood pressure can damage the kidneys and is one of the leading causes of kidney failure (end-stage renal kidney disease). Kidney damage, like hypertension, can be unnoticeable and detected only through medical tests. If you have kidney disease, you should control your blood pressure. Other treatment options include prescription medications.
Polycystic Kidney Disease (PKD), ARPKD, and ADPKD
Polycystic kidney disease (PKD) is characterized by numerous cysts in the kidneys. Polycystic kidney disease is a genetic disorder. There are two major inherited forms of PKD, autosomal dominant PKD, and autosomal recessive PKD. Symptoms include headaches, urinary tract infections, blood in the urine, liver and pancreatic cysts, abnormal heart valves, high blood pressure, kidney stones, aneurysms, and diverticulosis. Diagnosis of PKD is generally with ultrasound, CT or MRI scan. There is no cure for PKD, so treatment of symptoms is usually the general protocol.
Diabetes and Kidney Disease
In the United States diabetes is the most common cause of kidney failure. High blood pressure and high levels of blood glucose increase the risk that a person with diabetes will eventually progress to kidney failure. Kidney disease in people with diabetes develops over the course of many years. albumin and eGFR are two key markers for kidney disease in people with diabetes. Controlling high blood pressure, blood pressure medications, a moderate protein diet, and compliant management of blood glucose can slow the progression of kidney disease. For those patients who's kidneys eventually fail, dialysis or kidney transplantation is the only option.
Pseudotumor Cerebri (Idiopathic Intracranial Hypertension)
Pseudotumor Cerebri (intracranial hypertension) is a condition where there is an increase in pressure of fluid surrounding the brain and spinal cord (cerebrospinal fluid or CSF) mimicing a brain tumor. The cause is unknown. The most common symptom is headache but also include eye-pain, vision loss and double vision. Pseudotumor cerebri is diagnosed with MRI or CAT scans and treated by discontinuing offending medications (if applicable), weight loss and diuretic medications. The condition can also be helped by repeated drainage of spinal fluid using the lumbar puncture.
Hypertension-Induced Chronic Kidney Disease
Hypertension-induced chronic kidney disease (CKD) is a long-standing kidney condition that develops over time due to persistent or uncontrolled high blood pressure (hypertension).
High Blood Pressure Symptoms
Most people with high blood pressure have no signs or symptoms, even if blood pressure readings reach dangerously high levels. In some patients, symptoms may include fatigue, headaches, dizziness, confusion, sweating, chest pain and vision problems.
Preeclampsia (Pregnancy Induced Hypertension)
Preeclampsia is related to increased blood pressure and protein in the mother's urine. Preeclampsia typically begins after the 20th week of pregnancy. When preeclampsia causes seizures, it is termed "eclampsia" and is the second leading cause of maternal death of in the US. Preeclampsia is the leading cause of fetal complications. Risk factors for preeclampsia include high blood pressure, obesity, multiple births, and women with preexisting medical conditions such as diabetes, kidney disease, rheumatoid arthritis, lupus, or scleroderma. Pregnancy planning and lifestyle changes may reduce the risk of preeclampsia during pregnancy.
What Is High Blood Pressure (Hypertension)?
High blood pressure or hypertension is when the blood pressure readings consistently range from 140 or higher for systolic or 90 or higher for diastolic. Blood pressure readings above 180/120 mmHg are dangerously high and require immediate medical attention.
Treatment & Diagnosis
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Medications & Supplements
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Professional side effects and drug interactions sections courtesy of the U.S. Food and Drug Administration.