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
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
- cold sweats
- dizziness, faintness, or lightheadedness when getting up from lying or sitting position
- 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
- irregular breathing
- irregular heartbeat
- pain or discomfort in the arms, jaw, back, or neck
- redness of the face, neck, arms, and occasionally, upper chest
- shortness of breath
- swelling of the face, fingers, feet, or lower legs
- tightness in the chest
- troubled breathing
- weight gain
- Abdominal or stomach pain
- black, tarry stools
- bleeding gums
- clay-colored stools
- dark urine
- decreased frequency of urine
- increased thirst
- 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
- numbness or tingling in the hands, feet, or lips
- pinpoint red spots on the skin
- 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
- body aches or pain
- bone pain
- dryness or soreness of the throat
- feeling of indigestion
- general feeling of discomfort or illness
- joint pain
- pain in the chest below the breastbone
- runny nose
- stomach discomfort or upset
- stuffy nose
- 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
- 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
- Feeling of constant movement of self or surroundings
- sensation of spinning
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.
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