Avapro Side Effects

Generic Name: irbesartan

Please note - some side effects for Avapro may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Avapro - for the Consumer

Avapro

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Avapro:

Diarrhea; dizziness; tiredness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the hands, eyes, mouth, face, lips, or tongue; hoarseness); change in the amount of urine produced; chest pain; dark urine; difficulty swallowing; fast, slow, or irregular heartbeat; muscle pain or cramps; severe or persistent stomach pain (with or without nausea or vomiting); severe or persistent tiredness; symptoms of low blood pressure (eg, fainting, severe dizziness, lightheadedness); vision changes; yellowing of the skin or eyes.

Avapro Side Effects - for the Professional

Avapro

Hypertension

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. Treatment with Avapro was well-tolerated, with an incidence of adverse events similar to placebo. These events generally were mild and transient with no relationship to the dose of Avapro.

In placebo-controlled clinical trials, discontinuation of therapy due to a clinical adverse event was required in 3.3% of patients treated with Avapro, versus 4.5% of patients given placebo.

In placebo-controlled clinical trials, the following adverse event experiences 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%).

The following adverse events occurred at an incidence of 1% or greater in patients treated with irbesartan, but were at least as frequent or more frequent in patients receiving placebo: abdominal pain, anxiety/nervousness, chest pain, dizziness, edema, headache, influenza, musculoskeletal pain, pharyngitis, nausea/vomiting, rash, rhinitis, sinus abnormality, tachycardia and urinary tract infection.

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.

The incidence of hypotension or orthostatic hypotension was low in irbesartan-treated patients (0.4%), unrelated to dosage, and similar to the incidence among placebo-treated patients (0.2%). Dizziness, syncope, and vertigo were reported with equal or less frequency in patients receiving irbesartan compared with placebo.

In addition, the following potentially important events occurred in less than 1% of the 1965 patients and at least 5 patients (0.3%) receiving irbesartan in clinical studies, and those less frequent, clinically significant events (listed by body system). It cannot be determined whether these events were causally related to irbesartan:

Body as a Whole: fever, chills, facial edema, upper extremity edema

Cardiovascular: flushing, hypertension, cardiac murmur, myocardial infarction, angina pectoris, arrhythmic/conduction disorder, cardio-respiratory arrest, heart failure, hypertensive crisis

Dermatologic: pruritus, dermatitis, ecchymosis, erythema face, urticaria

Endocrine/Metabolic/Electrolyte Imbalances: sexual dysfunction, libido change, gout

Gastrointestinal: constipation, oral lesion, gastroenteritis, flatulence, abdominal distention

Musculoskeletal/Connective Tissue: extremity swelling, muscle cramp, arthritis, muscle ache, musculoskeletal chest pain, joint stiffness, bursitis, muscle weakness

Nervous System: sleep disturbance, numbness, somnolence, emotional disturbance, depression, paresthesia, tremor, transient ischemic attack, cerebrovascular accident

Renal/Genitourinary: abnormal urination, prostate disorder

Respiratory: epistaxis, tracheobronchitis, congestion, pulmonary congestion, dyspnea, wheezing

Special Senses: vision disturbance, hearing abnormality, ear infection, ear pain, conjunctivitis, other eye disturbance, eyelid abnormality, ear abnormality

Nephropathy in Type 2 Diabetic Patients

In clinical studies in patients with hypertension and type 2 diabetic renal disease, the adverse drug experiences were similar to those seen in patients with hypertension with the exception of an increased incidence of orthostatic symptoms (dizziness, orthostatic dizziness, and orthostatic hypotension) observed in IDNT (proteinuria ≥900 mg/day, and serum creatinine ranging from 1.0-3.0 mg/dL). In this trial, orthostatic symptoms occurred more frequently in the Avapro group (dizziness 10.2%, orthostatic dizziness 5.4%, orthostatic hypotension 5.4%) than in the placebo group (dizziness 6.0%, orthostatic dizziness 2.7%, orthostatic hypotension 3.2%).

Post-Marketing Experience

The following have been very rarely reported in post-marketing experience: urticaria; angioedema (involving swelling of the face, lips, pharynx, and/or tongue); increased liver function tests; jaundice; and hepatitis. Hyperkalemia has been rarely reported.

Rare cases of rhabdomyolysis have been reported in patients receiving angiotensin II receptor blockers.

Laboratory Test Findings

In controlled clinical trials, clinically important differences in laboratory tests were rarely associated with administration of Avapro.

Creatinine, Blood Urea Nitrogen: Minor increases in blood urea nitrogen (BUN) or serum creatinine were observed in less than 0.7% of patients with essential hypertension treated with Avapro alone versus 0.9% on placebo.

Hematologic: Mean decreases in hemoglobin of 0.2 g/dL were observed in 0.2% of patients receiving Avapro compared to 0.3% of placebo-treated patients. Neutropenia (<1000 cells/mm3) occurred at similar frequencies among patients receiving Avapro (0.3%) and placebo-treated patients (0.5%).

Hyperkalemia: In IDNT (proteinuria ≥900 mg/day, and serum creatinine ranging from 1.0-3.0 mg/dL), the percent of patients with hyperkalemia (>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.

Side Effects by Body System

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 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 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. 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.

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