A drug safety evaluation of valsartan

Expert Opin Drug Saf. 2011 Mar;10(2):295-303. doi: 10.1517/14740338.2011.543416. Epub 2010 Dec 11.


Introduction: Angiotensin receptor blockers (ARBs) as a class are generally considered safe and better tolerated than other antihypertensive drugs. The purpose of this report is to review the main data on the safety and tolerability of the second generation ARB valsartan after > 10 years since its initial approval.

Areas covered: We searched Medline for clinical studies published between 1997 and 2010 that involve valsartan and focus on its safety and tolerability profile. The main large-scale studies in hypertension, heart failure, post-myocardial infarction (MI) and chronic kidney disease are reviewed.

Expert opinion: Valsartan demonstrates to be safe and well tolerated both in monotherapy and in combination therapy of hypertension in a broad range of patients, including the elderly, children, diabetics, obese patients and patients at high cardiovascular risk. The most frequently reported adverse events (AEs) are malaise/fatigue, dizziness, headache and nausea/vomiting, whose incidence, however, is similar to that observed with placebo. Cough, a common class effect of ACE inhibitors, occurs less frequently with valsartan. When combined with hydrochlorothiazide, valsartan counteracts the adverse metabolic effects of the diuretic, whereas it reduces ankle edema formation when combined with amlodipine. In diabetic hypertensives, valsartan does not adversely affect glucose and lipid metabolism and even improves it. In post-MI patients, the rate of discontinuation due to AE, mainly hypotension, cough and increased serum creatinine, is lower in valsartan than in ACE inhibitor treated patients. Valsartan is also safe and well tolerated in patients with nephropathy although serum potassium levels need to be monitored more closely.

Publication types

  • Review

MeSH terms

  • Age Factors
  • Aged
  • Angiotensin II Type 1 Receptor Blockers / administration & dosage
  • Angiotensin II Type 1 Receptor Blockers / adverse effects*
  • Angiotensin II Type 1 Receptor Blockers / therapeutic use
  • Antihypertensive Agents / administration & dosage
  • Antihypertensive Agents / adverse effects*
  • Antihypertensive Agents / therapeutic use
  • Child
  • Drug Therapy, Combination
  • Humans
  • Hypertension / drug therapy
  • Risk Factors
  • Tetrazoles / administration & dosage
  • Tetrazoles / adverse effects*
  • Tetrazoles / therapeutic use
  • Valine / administration & dosage
  • Valine / adverse effects
  • Valine / analogs & derivatives*
  • Valine / therapeutic use
  • Valsartan


  • Angiotensin II Type 1 Receptor Blockers
  • Antihypertensive Agents
  • Tetrazoles
  • Valsartan
  • Valine