Diovan (valsartan) has been evaluated for safety in more than 4,000 patients, including over 400 treated for over 6 months, and more than 160 for over 1 year. Adverse reactions have generally been mild and transient in nature and have only infrequently required discontinuation of therapy. The overall incidence of adverse reactions with Diovan was similar to placebo.
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The overall frequency of adverse reactions was neither dose-related nor related to gender, age, race, or regimen. Discontinuation of therapy due to side effects was required in 2.3% of valsartan patients and 2.0% of placebo patients. The most common reasons for discontinuation of therapy with Diovan were headache and dizziness.
The adverse reactions that occurred in placebo-controlled clinical trials in at least 1% of patients treated with Diovan and at a higher incidence in valsartan (n=2,316) than placebo (n=888) patients included viral infection (3% vs. 2%), fatigue (2% vs. 1%), and abdominal pain (2% vs. 1%).
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, HCTZ, or lisinopril were 20%, 19%, and 69% respectively (p < 0.001).
Dose-related orthostatic effects were seen in less than 1% of patients. An increase in the incidence of dizziness was observed in patients treated with Diovan 320 mg (8%) compared to 10 to 160 mg (2% to 4%).
Diovan (valsartan) is an angiotensin II receptor blocker used for the control of hypertension, heart failure, and post heart attack. Diovan is available as a generic.
- Bloody urine
- cold sweats
- decreased frequency or amount of urine
- difficult breathing
- dizziness, faintness, or lightheadedness when getting up from a lying position
- increased thirst
- irregular heartbeat
- loss of appetite
- lower back or side pain
- numbness or tingling in the hands, feet, or lips
- swelling of the face, fingers, or lower legs
- unusual tiredness or weakness
- weakness of heaviness of the legs
- weight gain
- sore throat
- swelling of the mouth, hands, or feet
- trouble with swallowing or breathing (sudden)
Incidence not known
- Black, tarry stools
- bleeding gums
- blood in the urine or stools
- dark urine
- general tiredness and weakness
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- light-colored stools
- pinpoint red spots on the skin
- redness, soreness, or itching skin
- unusual bleeding or bruising
- upper right abdominal or stomach pain
- yellow eyes and skin
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
- Back pain
- blurred vision
- cold or flu-like symptoms
- difficulty with moving
- muscle pain or stiffness
- pain, swelling, or redness in the joints
- stomach pain
Incidence not known
- Hair loss
- thinning of the hair
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
VALSARTAN DISCLAIMER: Do not stop taking a prescribed medication without first consulting with your doctor. Discontinuing a prescribed medication without your doctor’s advice can result in injury or death.