Avapro Side Effects

Generic name: irbesartan

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.

Some side effects of Avapro may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to irbesartan: oral tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking irbesartan (the active ingredient contained in Avapro) hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

In rare cases, irbesartan can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. Call your doctor right away if you have unexplained muscle pain, tenderness, or weakness especially if you also have fever, unusual tiredness, and dark colored urine.

Call your doctor at once if you have a serious side effect such as:

• feeling like you might pass out;

• urinating less than usual or not at all;

• drowsiness, confusion, mood changes, increased thirst, loss of appetite, nausea and vomiting; or

• swelling, weight gain, feeling short of breath.

Less serious side effects of irbesartan may include:

• diarrhea;

• heartburn, upset stomach;

• mild dizziness; or

• tired feeling.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to irbesartan: oral tablet

Gastrointestinal

Gastrointestinal side effects have been reported the most frequently. These have included diarrhea (3% vs. 2% with placebo), dyspepsia (2% vs. 1% with placebo), abdominal pain (1% or greater), nausea (1% or greater), and vomiting (1% or greater). Pancreatitis has been reported. Constipation, gastroenteritis, flatulence, and abdominal distension have been reported in less than 1% of patients. Dryness of mouth, pyrosis, and epigastralgia have been reported in less than 1% of patients in postmarketing experience.

Musculoskeletal

Musculoskeletal side effects for irbesartan (the active ingredient contained in Avapro) in relation to placebo have included aches (2% vs. 1%) and pains (2% vs. 1%). Peripheral edema, muscle cramps, arthralgias, musculoskeletal chest pain, joint stiffness, bursitis, and muscle weakness have been reported in less than 1% of patients. Rarely, rhabdomyolysis has been reported in postmarketing experience in patients receiving angiotensin II receptor blockers. Myalgia has been reported in less than 1% of patients in postmarketing experience.

Nervous system

Nervous system side effects have included fatigue (4%) and headache (12%). Dizziness, numbness, somnolence, paresthesias, tremor, transient ischemic attack, and stroke have been reported at a frequency less than or similar to placebo. Lethargy and paresis has been reported in less than 1% of patients in postmarketing experience.

Cardiovascular

Cardiovascular side effects have been reported rarely. These have included orthostatic hypotension (0.4%), chest pain, edema, dizziness, sinus arrhythmia, and tachycardia. Flushing, hypertension, cardiac murmur, myocardial infarction, angina pectoris, arrhythmias, cardiorespiratory arrest, and hypertensive crisis have been reported in less than 1% of patients. Syncope or vertigo have been reported in rates less than or similar to placebo. Bradycardia has been reported in less than 1% of patients in postmarketing experience.

Orthostatic hypotension may be more likely in patients with intravascular volume or salt depletion.

Respiratory

Respiratory side effects for irbesartan (the active ingredient contained in Avapro) in relation to placebo have included upper respiratory tract infections (9% vs. 6%). Pharyngitis, rhinitis, tracheobronchitis, pulmonary congestion, dyspnea, and wheezing have been reported in rates less than or similar to placebo.

Dermatologic

Dermatologic side effects have rarely included rashes. De novo development or exacerbation of psoriasis has been reported. Pruritus, dermatitis, ecchymosis, facial erythema, and urticaria have been reported in less than 1% of patients. Facial edema and sweating have been reported in less than 1% of patients in postmarketing experience. In one case report, a patient developed a polycyclic erythematous rash after two years of treatment with irbesartan (the active ingredient contained in Avapro) Associated symptoms included anorexia, weight loss, fever, rigors, and abnormal liver function tests. Following discontinuation of irbesartan, the patient improved within 24 to 48 hours and made a complete recovery.

Endocrine

Endocrinologic side effects have been reported rarely. Sexual dysfunction, alterations in libido, and attacks of gouty arthritis have been reported in less than 1% of patients.

Genitourinary

Genitourinary side effects including abnormal urination and prostate problems have been reported in less than 1% of patients. Urinary retention and oliguria have been reported in less than 1% of patients in postmarketing experience. At least one case of penile angioedema has also been reported.

Renal

Renal side effects have rarely included new or worsened renal insufficiency.

Hepatic

Hepatic side effects have rarely included cholestatic jaundice. Hepatitis has been reported in postmarketing experience.

Psychiatric

Psychiatric side effects including nightmares and hallucinations have been reported in less than 1% of patients in postmarketing experience. Anxiety, nervousness, depression, emotional problems, and sleep disturbances have been reported at a frequency less than or similar to placebo.

Hypersensitivity

Hypersensitivity reactions including allergic reactions have been reported in less than 1% of patients in postmarketing experience.

General

General side effects including fever, chills, ear pain, and eyelid or ear abnormalities have been reported in less than 1% of patients. General discomfort has been reported in less than 1% of patients in postmarketing experience.

Other

Other side effects reported postmarketing have included thrombocytopenia, impaired renal function, including cases of renal failure. Increased CPK and rhabdomyolysis have been reported in patients receiving angiotensin II receptor blockers.

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