Irbesartan Side Effects
Some side effects of irbesartan 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: 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:
heartburn, upset stomach;
mild dizziness; or
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 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 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 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 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 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 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.
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 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 side effects have rarely included new or worsened renal insufficiency.
Hepatic side effects have rarely included cholestatic jaundice. Hepatitis has been reported in postmarketing experience.
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 reactions including allergic reactions have been reported in less than 1% of patients in postmarketing experience.
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 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.
More irbesartan resources
- irbesartan Advanced Consumer (Micromedex) - Includes Dosage Information
- irbesartan MedFacts Consumer Leaflet (Wolters Kluwer)
- Irbesartan Prescribing Information (FDA)
- Irbesartan Professional Patient Advice (Wolters Kluwer)
- Irbesartan Monograph (AHFS DI)
- Avapro Consumer Overview
- Avapro Prescribing Information (FDA)
Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date, and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This information does not endorse drugs, diagnose patients, or recommend therapy. This drug information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug of drug combination is safe, effective, or appropriate for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of information provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse, or pharmacist.