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Irbesartan Side Effects

Not all side effects for irbesartan may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to irbesartan: oral tablet

In addition to its needed effects, some unwanted effects may be caused by irbesartan. In the event that any of these side effects do occur, they may require medical attention.

You should check with your doctor immediately if any of these side effects occur when taking irbesartan:

More common
  • Chills
  • cold sweats
  • confusion
  • dizziness, faintness, or lightheadedness when getting up from lying or sitting position
Less common
  • Bladder pain
  • bloody or cloudy urine
  • chest pain
  • difficult, burning, or painful urination
  • fast, pounding, or irregular heartbeat or pulse
  • frequent urge to urinate
  • lower back or side pain
  • Chest discomfort
  • decreased urine output
  • dilated neck veins
  • extreme fatigue
  • feeling of warmth
  • fever
  • irregular breathing
  • irregular heartbeat
  • nausea
  • pain or discomfort in the arms, jaw, back, or neck
  • redness of the face, neck, arms, and occasionally, upper chest
  • shortness of breath
  • sweating
  • swelling of the face, fingers, feet, or lower legs
  • tightness in the chest
  • troubled breathing
  • vomiting
  • weight gain
Incidence not known
  • Abdominal or stomach pain
  • black, tarry stools
  • bleeding gums
  • clay-colored stools
  • dark urine
  • decreased frequency of urine
  • headache
  • increased thirst
  • itching
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • loss of appetite
  • muscle cramps or spasms
  • muscle pain or stiffness
  • nervousness
  • numbness or tingling in the hands, feet, or lips
  • pinpoint red spots on the skin
  • rash
  • unpleasant breath odor
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • vomiting of blood
  • weakness or heaviness of the legs
  • weight gain
  • yellow eyes or skin

Some of the side effects that can occur with irbesartan may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

Less common
  • Acid or sour stomach
  • belching
  • body aches or pain
  • bone pain
  • congestion
  • cough
  • diarrhea
  • dryness or soreness of the throat
  • feeling of indigestion
  • general feeling of discomfort or illness
  • heartburn
  • hoarseness
  • joint pain
  • pain in the chest below the breastbone
  • runny nose
  • shivering
  • sneezing
  • stomach discomfort or upset
  • stuffy nose
  • sweating
  • tender, swollen glands in the neck
  • trouble sleeping
  • trouble with swallowing
  • voice changes
  • Blistering, crusting, irritation, itching, or reddening of the skin
  • bloated or full feeling
  • blurred or loss of vision
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • change in hearing
  • cracked, dry, scaly skin
  • decreased interest in sexual intercourse
  • depression
  • difficulty having a bowel movement (stool)
  • disturbed color perception
  • double vision
  • ear drainage
  • earache or pain in the ear
  • excess air or gas in the stomach or intestines
  • halos around lights
  • hives or welts
  • inability to have or keep an erection
  • large, flat, blue or purplish patches in the skin
  • loss in sexual ability, desire, drive, or performance
  • night blindness
  • overbright appearance of lights
  • pain, swelling, or redness in the joints
  • passing gas
  • sleepiness or unusual drowsiness
  • tunnel vision
Incidence not known
  • Feeling of constant movement of self or surroundings
  • sensation of spinning

For Healthcare Professionals

Applies to irbesartan: oral tablet


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

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[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
Rare (less than 0.1%): Anemia
Postmarketing reports: Thrombocytopenia[Ref]


Common (1% to 10%): Influenza
Frequency not reported: Hypersensitivity reactions, ear infection[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, Princeton, NJ.

2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

3. Cerner Multum, Inc. "Australian Product Information." O 0

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