Irbesartan side effects

List of side effects
Hypertension Nephropathy in type 2 diabetic patients Lab test findings (diabetes) Post-marketing experience
 * Overview
 * Occurrence in ≥ 1% of patients
 * Dry cough
 * Hypotension
 * Occurrence in < 1% of patients
 * Lab test findings (hypertension)

Overview
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. Return to top

Occurrence in ≥ 1% of patients
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. Return to top

Dry cough
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. Return to top

Hypotension
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. Return to top

Occurrence in < 1% of patients
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: Return to top
 * 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

Lab test findings (hypertension)
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%). Return to top

Occurrence in < 3% of patients
The following adverse reactions occurred with an incidence of less than 3.0%. With the exception of leg cramps, the incidence of these side effects was similar to that of placebo alone. Return to top
 * Body as a Whole/Systemic: asthenia, flushing, pain
 * Cardiovascular: palpitations
 * Central Nervous System: insomnia, nervousness, paresthesia, somnolence
 * Dermatologic: pruritus, rash
 * Gastrointestinal: abdominal pain, diarrhea, dry mouth, dyspepsia, flatulence
 * Musculoskeletal: arthralgia, leg cramps
 * Respiratory: chest pain (nonspecific), dyspnea
 * Urogenital: impotence, polyuria

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%). Return to top

Lab test findings (diabetes)
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. Return to top

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. Return to top