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Olmesartan Side Effects

For the Consumer

Applies to olmesartan: oral tablet

Along with its needed effects, olmesartan 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 olmesartan:

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

Get emergency help immediately if any of the following symptoms of overdose occur while taking olmesartan:

Symptoms of Overdose

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

Some side effects of olmesartan 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

  • 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

General

The most common side effect in adults was dizziness.[Ref]

Nervous system

Common (1% to 10%): Dizziness, headache[Ref]

Respiratory

Common (1% to 10%): Bronchitis, pharyngitis, rhinitis, sinusitis, upper respiratory tract infection, coughing, nasopharyngitis, pharyngolaryngeal pain, rhinorrhea[Ref]

Other

Common (1% to 10%): Influenza-like symptoms, chest pain, fatigue, peripheral edema, pain, inflicted injury, fever

Uncommon (0.1% to 1%): Vertigo, asthenia, malaise

Rare (less than 0.1%): Lethargy[Ref]

Gastrointestinal

Common (1% to 10%): Diarrhea, gastroenteritis, nausea, tooth ache, abdominal pain, vomiting, dyspepsia

Uncommon (0.1% to 1%): Dyspepsia

Very rare (less than 0.01%): Sprue-like enteropathy[Ref]

Musculoskeletal

Common (1% to 10%): Back pain, creatine phosphokinase increased, gout, arthralgia, arthritis, skeletal pain

Uncommon (0.1% to 1%): Myalgia

Rare (less than 0.1%): Muscle spasm

Postmarketing reports: Rhabdomyolysis[Ref]

Metabolic

Common (1% to 10%): Hyperglycemia, hypertriglyceridemia, hyperuricemia, pseudohyperkalemia

Uncommon (0.1% to 1%): Hypercholesterolemia, hyperlipemia

Rare (less than 0.1%): Hyperkalemia[Ref]

Hepatic

Common (1% to 10%): GGT increased, AST increased, ALT increased, hepatic enzymes increased

Uncommon (0.1% to 1%): Bilirubinemia

Frequency not reported: Serum bilirubin elevated[Ref]

Genitourinary

Common (1% to 10%): Hematuria, impotence, urinary tract infection[Ref]

Psychiatric

Common (1% to 10%): Anxiety, insomnia[Ref]

Dermatologic

Common (1% to 10%): Hyperhidrosis

Uncommon (0.1% to 1%): Rash, exanthema, allergic dermatitis, urticaria, pruritus, face edema

Postmarketing reports: Alopecia[Ref]

Immunologic

Common (1% to 10%): Influenza

Uncommon (0.1% to 1%): Anaphylactic reaction

Rare (less than 0.1%): Angioedema[Ref]

Renal

Common (1% to 10%): Blood urea increased

Rare (less than 0.1%): Acute renal failure, renal insufficiency, blood creatinine increased[Ref]

Cardiovascular

Uncommon (0.1% to 1%): Tachycardia, angina pectoris

Rare (less than 0.1%): Hypotension[Ref]

Hematologic

Uncommon (0.1% to 1%): Thrombocytopenia

Frequency not reported: Small decreases in hemoglobin and hematocrit[Ref]

References

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