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Irbesartan Side Effects

For the Consumer

Applies to irbesartan: oral tablet

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

  • 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

Rare

  • 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 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

  • 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

Rare

  • 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

General

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

Metabolic

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]

Respiratory

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]

Gastrointestinal

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]

Other

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]

Musculoskeletal

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]

Cardiovascular

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]

Psychiatric

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]

Dermatologic

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]

Genitourinary

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

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

Frequency not reported: Prostate disorder[Ref]

Hematologic

Common (1% to 10%): Hemoglobin decreased

Uncommon (0.1% to 1%): Neutropenia

Rare (less than 0.1%): Anemia

Postmarketing reports: Thrombocytopenia[Ref]

Immunologic

Common (1% to 10%): Influenza

Frequency not reported: Hypersensitivity reactions, ear infection[Ref]

Renal

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

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

Ocular

Uncommon (0.1% to 1%): Vision disturbance

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

Frequency not reported: Conjunctivitis[Ref]

Hepatic

Uncommon (0.1% to 1%): Jaundice

Frequency not reported: Hepatitis, abnormal liver function

Postmarketing reports: Elevated liver function tests[Ref]

References

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

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.

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