Skip to Content

Label Changes for:

Diovan (valsartan) 40 mg, 80 mg, 160 mg, and 320 mg Tablets

September 2014

Changes have been made to the PRECAUTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)


Azor (amlodipine/olmesartan medoxomil) 5/20 mg, 10/20 mg, 5/40 mg, and 10/40 mg Tablets
Benicar (olmesartan medoxomil) 5 mg, 20 mg, and 40 mg Tablets
Benicar HCT (olmesartan medoxomil/hydrochlorothiazide) 20/12.5 mg, and 40.12.5 mg, and 40/25 mg Tablets
Diovan (valsartan) 80 mg and 160 mg Capsules
Diovan (valsartan) 40 mg, 80 mg, 160 mg, and 320 mg Tablets
Exforge (amlodipine/valsartan) 5/160 mg, 10/160 mg, 5/320 mg, and 10/320 mg Tablets
Exforge HCT (amlodipine/valsartan/hydrochlorothiazide) 5/160/12.5 mg, 10/160/12.5 mg, 5/160/25 mg, 10/160/25 mg, and 10/320/25 mg Tablets
Tribenzor (olmesartan medoxomil/amlodipine/hydrochlorothiazide) 20/5/12.5 mg, 40/5/25 mg, 40/10/12.5 mg, and 40/10/25 mg Tablets


September 2014


Dual Blockade of the Renin-Angiotensin System

  • Dual blockade of the RAS with angiotensin receptor blockers, ACE inhibitors, or aliskiren is associated with increased risks of hypotension, hyperkalemia, and changes in renal function (including acute renal failure) compared to monotherapy. Most patients receiving the combination of two RAS inhibitors do not obtain any additional benefit compared to monotherapy. In general, avoid combined use of RAS inhibitors. Closely monitor blood pressure, renal function and electrolytes in patients on <drug name> and other agents that affect the RAS.