Olmesartan Side Effects

It is possible that some side effects of olmesartan may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

For the Consumer

Applies to olmesartan: oral tablet

As well as its needed effects, olmesartan may cause unwanted side effects that require medical attention.

If any of the following side effects occur while taking olmesartan, check with your doctor immediately:

Less common
  • Blood in the urine
  • body aches or pain
  • chills
  • cough or cough producing mucus
  • difficulty with breathing
  • ear congestion
  • fever
  • headache
  • loss of voice
  • nasal congestion
  • runny nose
  • sneezing
  • sore throat
  • tightness in the chest
  • unusual tiredness or weakness
Rare
  • Bladder pain
  • bloating or swelling of the face, arms, hands, lower legs, or feet
  • chest pain
  • cloudy urine
  • difficult, burning, or painful urination
  • fast, pounding, or irregular heartbeat or pulse
  • frequent urge to urinate
  • joint pain, stiffness, or swelling
  • lower back, side, or stomach pain
  • swelling of the feet or lower legs
Incidence not known
  • Confusion
  • dark-colored urine
  • diarrhea (severe) with weight loss
  • dizziness
  • hives
  • itching
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • muscle cramps or spasms
  • muscle pain or stiffness
  • nausea or vomiting
  • weakness or heaviness of the legs

If any of the following symptoms of overdose occur while taking olmesartan, get emergency help immediately:

Symptoms of overdose
  • Blurred vision
  • chest pain or discomfort
  • dizziness, faintness, or lightheadedness
  • sweating

Some olmesartan side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

Less common
  • Back pain
  • diarrhea
  • dry mouth
  • flushed, dry skin
  • fruit-like breath odor
  • general feeling of discomfort or illness
  • increased hunger
  • increased thirst
  • increased urination
  • loss of appetite
  • muscle aches
  • pain or tenderness around the eyes and cheekbones
  • shivering
  • tender, swollen glands in the neck
  • trouble sleeping
  • trouble swallowing
  • unexplained weight loss
Rare
  • Acid or sour stomach
  • belching
  • difficulty with moving
  • feeling of constant movement of self or surroundings
  • heartburn
  • indigestion
  • rapid weight gain
  • rash
  • sensation of spinning
  • tingling of the hands or feet
  • unusual weight gain or loss
Incidence not known
  • Hair loss or thinning of the hair
  • lack or loss of strength
  • redness of the skin
  • welts

For Healthcare Professionals

Applies to olmesartan: oral tablet

Nervous system

Nervous system side effects have included dizziness (3% vs. 1% with placebo), vertigo (0.5% to 1% with placebo), and insomnia (0.5% to 1% with placebo). Asthenia has been reported in postmarketing experience.[Ref]

Respiratory

Respiratory side effects have included cough (0.9% vs. 0.7% with placebo), bronchitis, rhinitis, pharyngitis, sinusitis, and upper respiratory tract infection.[Ref]

Gastrointestinal

Gastrointestinal side effects including abdominal pain, dyspepsia, gastroenteritis, and nausea have been reported in 0.5% to 1% of patients. Vomiting has been reported in postmarketing experience. Diarrhea has been reported in more than 1% of patients but at the same or greater incidence than placebo.[Ref]

Cardiovascular

Cardiovascular side effects including tachycardia, chest pain, and peripheral edema have been reported in 0.5% to 1% of patients. At least 5 cases of facial edema and at least one case of olmesartan-induced angioedema, which resolved over 7 to 10 days after discontinuing olmesartan, have been reported.[Ref]

Metabolic

Metabolic side effects have included hyperglycemia and hypertriglyceridemia. Hyperkalemia has been reported in postmarketing experience.[Ref]

Musculoskeletal

Musculoskeletal side effects including arthralgia, arthritis, myalgia, and skeletal pain have been reported in 0.5% to 1% of patients. Rhabdomyolysis have been reported during postmarketing experience in patients receiving angiotensin II receptor blockers.[Ref]

Dermatologic

Dermatologic side effects have included rash (0.5% to 1%), alopecia, pruritus, and urticaria.[Ref]

Genitourinary

Genitourinary side effects including urinary tract infection have been reported in 0.5% to 1% of patients. Hematuria has been reported in more than 1% of patients but at the same or greater incidence than placebo.[Ref]

Hematologic

Hematologic side effects have included decreased hemoglobin and hematocrit.[Ref]

Hepatic

Hepatic side effects have rarely included liver enzyme and serum bilirubin elevations.[Ref]

Other

Other side effects including back pain, increased creatine phosphokinase, headache, inflicted injury, influenza-like symptoms, and have been reported in more than 1% of patients but at the same or greater incidence than placebo. Fatigue and pain have been reported in 0.5% to 1% of patients.[Ref]

Renal

Renal side effects associated with ACE inhibitors have included increases in serum creatinine or BUN in patients with renal artery stenosis. Acute renal failure and increased serum creatinine levels have been reported in postmarketing experience.[Ref]

Hypersensitivity

Hypersensitivity side effects including rare cases of angioedema and anaphylactic reactions have been reported in patients receiving olmesartan.[Ref]

References

1. Brousil JA, Burke JM "Olmesartan medoxomil: An angiotensin II-receptor blocker." Clin Ther 25 (2003): 1041-55

2. "Product Information. Benicar (olmesartan)." Sankyo Parke Davis, Parsippany, NJ.

3. Nykamp D, Winter EE "Olmesartan medoxomil-induced angioedema." Ann Pharmacother 41 (2007): 518-20

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