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Irbesartan Side Effects

Medically reviewed by Last updated on Apr 27, 2023.

Applies to irbesartan: oral tablet.


Oral route (Tablet)

When pregnancy is detected, discontinue irbesartan as soon as possible; drugs that act directly on the renin-angiotensin system can cause serious fetal toxicity.

Serious side effects of Irbesartan

Along with its needed effects, irbesartan may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking irbesartan:

More common

Less common


Incidence not known

Other side effects of Irbesartan

Some side effects of irbesartan may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common


Incidence not known

For Healthcare Professionals

Applies to irbesartan: oral tablet.


The most common adverse reactions were hyperkalemia, headache, and dizziness.[Ref]


Very common (10% or more): Hyperkalemia (up to 46.3%)

Uncommon (0.1% to 1%): Weight gain

Rare (less than 0.1%): Gout, decreased appetite, increased appetite

Frequency not reported: Hyperkalemia

Postmarketing reports: Hypoglycemia in diabetic patients[Ref]

Hyperkalemia (5.5 mEq/L or greater) occurred in 29.4% of hypertensive diabetic patients with microalbuminuria and normal renal function and in 46.3% of hypertensive diabetic patients with chronic renal insufficiency and overt proteinuria.[Ref]

Nervous system

Very common (10% or more): Headache (up to 12.3%), dizziness (up to 10.2%)

Common (1% to 10%): Orthostatic dizziness

Uncommon (0.1% to 1%): Numbness, somnolence, vertigo, paresthesia

Rare (less than 0.1%): Syncope, tremor, coordination disturbance, taste disturbance

Frequency not reported: Tinnitus, dysgeusia, transient ischemic attack, cerebrovascular accident[Ref]


Common (1% to 10%): Upper respiratory tract infection, sinus abnormality, cough, pharyngitis, rhinitis

Uncommon (0.1% to 1%): Epistaxis, dyspnea

Frequency not reported: Tracheobronchitis, congestion, pulmonary congestion, wheezing[Ref]


Common (1% to 10%): Nausea/vomiting, diarrhea, dyspepsia/heartburn, abdominal pain

Uncommon (0.1% to 1%): Constipation, flatulence, dry mouth, abdomen distention

Rare (less than 0.1%): Abnormal stool, oral lesion, dysphagia, esophagitis

Frequency not reported: Gastroenteritis[Ref]


Common (1% to 10%): Fatigue, chest pain, edema

Uncommon (0.1% to 1%): Weakness, malaise, upper extremity edema, extremity swelling, hearing abnormality

Rare (less than 0.1%): Breast disorder, cold sensation, warmth sensation, pain, head/neck edema, medication bad taste

Frequency not reported: Ear pain, ear abnormality, fever, chills, facial edema

Postmarketing reports: Asthenia[Ref]


Common (1% to 10%): Musculoskeletal pain, musculoskeletal trauma, plasma creatine kinase increased

Uncommon (0.1% to 1%): Muscle cramp

Rare (less than 0.1%): Arthritis, muscle ache, myalgia, extremity weakness, lower extremity stiffness

Frequency not reported: Arthralgia, musculoskeletal chest pain, joint stiffness, bursitis, muscle weakness

Postmarketing reports: Rhabdomyolysis[Ref]


Common (1% to 10%): Orthostatic hypotension, tachycardia

Uncommon (0.1% to 1%): Flushing, subjective rhythm disturbance, ECG abnormality, cardiac murmur, cardiac rhythm disturbance, atrial rhythm disturbance, bradycardia, hypotension

Rare (less than 0.1%): Conduction disorder, myocardial infarction, hot flashes

Frequency not reported: Hypertension, angina pectoris, arrhythmic disorder, cardiorespiratory arrest, heart failure, hypertensive crisis[Ref]


Common (1% to 10%): Anxiety/nervousness

Uncommon (0.1% to 1%): Libido change, sleep disturbance, depression, emotion labile/disturbance

Rare (less than 0.1%): Stress related disorder, disturbing dreams[Ref]


Common (1% to 10%): Rash

Uncommon (0.1% to 1%): Pruritus, facial erythema, hyperhidrosis

Rare (less than 0.1%): Dermatitis, acne, scalp-hair abnormality

Frequency not reported: Angioedema, urticaria, leukocytoclastic vasculitis, ecchymosis[Ref]


Common (1% to 10%): Urinary tract infection

Uncommon (0.1% to 1%): Sexual dysfunction, urination abnormality

Frequency not reported: Prostate disorder[Ref]


Common (1% to 10%): Hemoglobin decreased

Uncommon (0.1% to 1%): Neutropenia

Postmarketing reports: Thrombocytopenia, anemia[Ref]


Common (1% to 10%): Influenza

Frequency not reported: Hypersensitivity reactions, ear infection

Postmarketing reports: Anaphylactic reaction, anaphylactic shock[Ref]


Uncommon (0.1% to 1%): BUN increased, serum creatinine increased

Frequency not reported: Impaired renal function, renal failure[Ref]


Uncommon (0.1% to 1%): Vision disturbance

Rare (less than 0.1%): Eye disturbance, eyelid abnormality, visual field abnormality

Frequency not reported: Conjunctivitis[Ref]


Uncommon (0.1% to 1%): Jaundice

Frequency not reported: Hepatitis, abnormal liver function

Postmarketing reports: Elevated liver function tests[Ref]


1. Product Information. Avapro (irbesartan). Bristol-Myers Squibb. 2001;PROD.

2. Cerner Multum, Inc. UK Summary of Product Characteristics.

3. Cerner Multum, Inc. Australian Product Information.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.