Irbesartan Side Effects
Medically reviewed by Drugs.com. Last updated on Jun 9, 2024.
Applies to irbesartan: oral tablet.
Important warnings
This medicine can cause some serious health issues
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
- 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
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
- 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
- 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]
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
- Postmarketing reports: Thrombocytopenia, anemia[Ref]
Immunologic
- Common (1% to 10%): Influenza
- Frequency not reported: Hypersensitivity reactions, ear infection
- Postmarketing reports: Anaphylactic reaction, anaphylactic shock[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. (2001) "Product Information. Avapro (irbesartan)." Bristol-Myers Squibb
2. Cerner Multum, Inc. "UK Summary of Product Characteristics."
3. Cerner Multum, Inc. "Australian Product Information."
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Further information
Irbesartan side effects can vary depending on the individual. 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.