Note: This document contains side effect information about valsartan. Some dosage forms listed on this page may not apply to the brand name Diovan.
Summary
Common side effects of Diovan include: dizziness and increased serum potassium. Other side effects include: hypotension. Continue reading for a comprehensive list of adverse effects.
Applies to valsartan: oral extemporaneous suspension, oral tablets.
Warning
- May cause fetal and neonatal morbidity and mortality if used during pregnancy.1 114 115 116 a (See Fetal/Neonatal Morbidity and Mortality under Cautions.)
- If pregnancy is detected, discontinue as soon as possible.1 115 116 a
Side effects include:
Viral infection, fatigue, abdominal pain; also, dizziness, hypotension, postural dizziness or hypotension, hyperkalemia, arthralgia, diarrhea, and back pain in patients with heart failure.
For Healthcare Professionals
Applies to valsartan: oral capsule, oral liquid, oral tablet.
Nervous system
Very common (10% or more): Headache (up to 14%), dizziness (up to 14%)
Common (1% to 10%): Dizziness
Uncommon (0.1% to 1%): Vertigo[Ref]
Respiratory
Common (1% to 10%): Cough
Uncommon (0.1% to 1%): Dyspnea[Ref]
Hypersensitivity
A 71-year-old woman experienced an acute onset of angioedema and a photosensitive pruritic rash after 3 months of valsartan (the active ingredient contained in Diovan) therapy. Her symptoms dissipated and the rash resolved after treatment with subcutaneous epinephrine, intravenous methylprednisolone, diphenhydramine, and emollient cream.
A unique case of dose-dependent, valsartan-induced angioedema has been reported. Two hours after initiating a dose increase (160 to 320 mg/day) of valsartan, a patient developed angioedema (i.e., swelling of lips and tongue). Symptoms resolved following a reduction in dose to the original dosage of 160 mg/day.[Ref]
Very rare (less than 0.01%): Angioedema[Ref]
Cardiovascular
Common (1% to 10%): Symptomatic hypotension in 5.5% of heart failure patients in clinical trials
Rare (less than 0.1%): Palpitations, chest pain
Frequency not reported: Dizziness related to orthostatic hypotension
Postmarketing reports: Heart failure[Ref]
Metabolic
Common (1% to 10%): Hyperkalemia, hyponatremia[Ref]
Renal
Frequency not reported: Impaired renal function, increases in serum creatinine concentrations, blood urea nitrogen, and potassium
Postmarketing reports: Renal failure[Ref]
Dermatologic
Rare (less than 0.1%): Pruritus, rash, alopecia
Postmarketing reports: Bullous dermatitis[Ref]
Gastrointestinal
Uncommon (0.1% to 1%): Diarrhea, constipation, dry mouth, dyspepsia, anorexia, nausea, vomiting, flatulence
Postmarketing reports: Taste disturbance (i.e., altered sensitivity of basic tastes) has been reported following repeated dosing[Ref]
Musculoskeletal
Common (1% to 10%): Back pain, muscle cramps, myalgias
Very rare (less than 0.01%): Rhabdomyolysis[Ref]
Psychiatric
Frequency not reported: Anxiety, insomnia, paresthesias, somnolence[Ref]
Genitourinary
Very rare (less than 0.01%): Impotence[Ref]
Hematologic
Uncommon (0.1% to 1%): Hematocrit decreased, hemoglobin decreased, neutropenia
Postmarketing reports: Thrombocytopenia, vasculitis[Ref]
Hepatic
Valsartan-associated hepatotoxicity in a patient with hepatitis B surface antigen (HBs-Ag) positivity (without signs and symptoms) has been reported. After 1 month of treatment with valsartan (the active ingredient contained in Diovan) this patient developed pruritic erythematous skin changes, nausea, jaundice, right subcostal abdominal pain, elevated liver enzymes, and mild hepatomegaly. Signs and symptoms of hepatotoxicity resolved within 2 to 3 weeks following discontinuation of valsartan and the patient remained asymptomatic after 6 months of follow-up.[Ref]
Very rare (less than 0.01%): Hepatitis
Frequency not reported: Hepatic enzymes increased[Ref]
