an and hydrochlorothiazide, USP) has been eva luated for safety in more than 5,700 patients, including over 990 treated for over 6 months, and over 370 for over 1 year. Adverse experiences have generally been mild and transient in nature and have only infrequently required discontinuation of therapy. The overall incidence of adverse reactions with Diovan HCT was comparable to placebo.
The overall frequency of adverse reactions was neither dose-related nor related to gender, age, or race. In controlled clinical trials, discontinuation of therapy due to side effects was required in 2.3% of valsartan-hydrochlorothiazide patients and 3.1% of placebo patients. The most common reasons for discontinuation of therapy with Diovan HCT were headache and dizziness.
The only adverse reaction that occurred in controlled clinical trials in at least 2% of patients treated with Diovan HCT and at a higher incidence in valsartan-hydrochlorothiazide (n=4372) than placebo (n=262) patients was nasopharyngitis (2.4% vs. 1.9%).
Dose-related orthostatic effects were seen in fewer than 1% of patients. In individual trials, a dose-related increase in the incidence of dizziness was observed in patients treated with Diovan HCT.
Other adverse reactions that have been reported with valsartan-hydrochlorothiazide (less than 0.2% of valsartan-hydrochlorothiazide patients in controlled clinical trials) without regard to causality, are listed below:
Cardiovascular : Palpitations and tachycardia
Ear and L abyrinth : Tinnitus and vertigo
Gastrointestinal : Dyspepsia, diarrhea, flatulence, dry mouth, nausea, abdominal pain, abdominal pain upper, and vomiting
General and A dministration S ite C onditions : Asthenia, chest pain, fatigue, peripheral edema and pyrexia
Infections and I nfestations : Bronchitis, bronchitis acute, influenza, gastroenteritis, sinusitis, upper respiratory tract infection and urinary tract infection
Investigations : Blood urea increased
Musculoskeletal : Arthralgia, back pain, muscle cramps, myalgia, and pain in extremity
Nervous S ystem : Dizziness postural, paresthesia, and somnolence
Psychiatric : Anxiety and insomnia
Renal and U rinary : Pollakiuria
Reproductive S ystem : Erectile dysfunction
Respiratory, T horacic and M ediastinal : Dyspnea, cough, nasal congestion, pharyngolaryngeal pain and sinus congestion
Skin and S ubcutaneous T issue : Hyperhidrosis and rash
Vascular : Hypotension
Other reported reactions seen less frequently in clinical trials included abnormal vision, anaphylaxis, bronchospasm, constipation, depression, dehydration, decreased libido, dysuria, epistaxis, flushing, gout, increased appetite, muscle weakness, pharyngitis, pruritus, sunburn, syncope, and viral infection.
Valsartan : In trials in which valsartan was compared to an ACE inhibitor with or without placebo, the incidence of dry cough was significantly greater in the ACE inhibitor group (7.9%) than in the groups who received valsartan (2.6%) or placebo (1.5%). In a 129-patient trial limited to patients who had had dry cough when they had previously received ACE inhibitors, the incidences of cough in patients who received valsartan, hydrochlorothiazide, or lisinopril were 20%, 19%, 69% respectively (p greater than 0.001).
Other reported reactions seen less frequently in clinical trials included chest pain, s
