Applies to olmesartan: oral extemporaneous suspension, oral tablets.
Warning
- May cause fetal and neonatal morbidity and mortality if used during pregnancy.1 31 42 43 44 (See Fetal/Neonatal Morbidity and Mortality under Cautions.)
- If pregnancy is detected, discontinue as soon as possible.1 31 43 44
Side effects include:
Dizziness, back pain, bronchitis, diarrhea, headache, hematuria, hyperglycemia, hypertriglyceridemia, influenza-like symptoms, pharyngitis, rhinitis, sinusitis, upper respiratory tract infection.
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]
