|
DIOVAN HCT(valsartan and hydrochlorothiazide) tablet, film c(七)
% of patients. In individual trials, a dose-related increase in the incidence of dizziness was observed in patients treated with DiovanHCT.
Other adverse reactions that have been reported with valsartan-hydrochlorothiazide (>0.2% of valsartan-hydrochlorothiazide patients in controlled clinical trials) without regard to causality, are listed below:
Cardiovascular: Palpitations and tachycardia
Ear and Labyrinth: Tinnitus and vertigo
Gastrointestinal: Dyspepsia, diarrhea, flatulence, dry mouth, nausea, abdominal pain, abdominal pain upper, and vomiting
General and Administration Site Conditions: Asthenia, chest pain, fatigue, peripheral edema and pyrexia
Infections and Infestations: 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 System: Dizziness postural, paresthesia, and somnolence
Psychiatric: Anxiety and insomnia
Renal and Urinary: Pollakiuria
Reproductive System: Erectile dysfunction
Respiratory, Thoracic and Mediastinal: Dyspnea, cough, nasal congestion, pharyngolaryngeal pain and sinus congestion
Skin and Subcutaneous Tissue: 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 <0.001).
Other reported reactions seen less frequently in clinical trials included chest pain, syncope, anorexia, vomiting, and angioedema.
Hydrochlorothiazide: Other adverse reactions that have been reported with hydrochlorothiazide, without regard to causality, are listed below:
Body As A Whole: weakness;
Digestive: pancreatitis, jaundice (intrahepatic cholestatic jaundice), sialadenitis, cramping, gastric irritation;
Hematologic: aplastic anemia, agranulocytosis, leukopenia, hemolytic anemia, thrombocytopenia;
Hypersensitivity: purpura, photosensitivity, urticaria, necrotizing angiitis (vasculitis and cutaneous vasculitis), fever, respiratory distress including pneumonitis and pulmonary edema, anaphylactic reactions;
Metabolic: hyperglycemia, glycosuria, hyperuricemia;
Musculoskeletal: muscle spasm;
Nervous System/Psychiatric: restlessness;
Renal: renal failure, renal dysfunction, interstitial nephritis;
Skin: erythema multiforme including Stevens-Johnson syndrome, exfoliative dermatitis including toxic epidermal necrolysis;
Special Senses: transient blurred vision, xanthopsia.
Initial Therapy - Hypertension
In a clinical study in patients with severe hypert |
|
