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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

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

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