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What is Diovan (valsartan)?
- Diovan is also prescribed after heart attacks since it may reduce deaths in patients who developed congestive heart failure after a heart attack.
- Diovan also may reduce hospitalizations in patients with congestive heart failure.
- Angiotensin, formed in the blood by the action of angiotensin converting enzyme (ACE), is a powerful chemical that attaches to angiotensin receptors found in many tissues but primarily on smooth muscle cells of blood vessels.
- Angiotensin’s attachment to the receptors causes the blood vessels to narrow (vasoconstrict) which leads to an increase in blood pressure (hypertension). Diovan blocks the angiotensin receptor.
- By blocking the action of angiotensin, Diovan dilates blood vessels and reduces blood pressure.
Common side effects of Diovan include:
Serious side effects of Diovan include:
- high blood potassium (hyperkalemia),
- reduced renal function,
- allergic reactions, and rarely,
- rhabdomyolysis (inflammation and destruction of muscle) and angioedema (swelling of soft tissues including those of the throat and larynx).
Drug interactions of Diovan include potassium-sparing diuretics, potassium supplements, or salt substitutes containing potassium which when taken with Diovan may lead to hyperkalemia (elevated potassium in the blood) and in heart failure patients, it increases serum creatinine, a blood test used for monitoring function of the kidneys.
Combining Diovan with nonsteroidal anti-inflammatory drugs (NSAIDs) in patients who are elderly, fluid-depleted, or with poor kidney function may result in reduced kidney function, including kidney failure.
When used in the second or third trimester of pregnancy, Diovan can cause injury and even death to the fetus. Diovan should not be used during pregnancy. When pregnancy is detected, Diovan should be stopped as soon as possible.
What are the important side effects of Diovan (valsartan)?
Valsartan is generally well-tolerated. The most common side effects are:
Other important side effects are:
- reduced renal function, and
- allergic reactions.
Rhabdomyolysis (inflammation and destruction of muscle) and angioedema (swelling of soft tissues including those of the throat and larynx) are rare but serious side effects of valsartan.
Diovan (valsartan) side effects list for healthcare professionals
Clinical Studies Experience
- Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.
- 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.
- 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%).
- Headache, dizziness, upper respiratory infection, cough, diarrhea, rhinitis, sinusitis, nausea, pharyngitis, edema, and arthralgia occurred at a more than 1% rate but at about the same incidence in placebo and valsartan patients.
- 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 has been used concomitantly with hydrochlorothiazide without evidence of clinically important adverse interactions.
- Other adverse reactions that occurred in controlled clinical trials of patients treated with Diovan (>0.2% of valsartan patients) are listed below. It cannot be determined whether these events were causally related to Diovan.
Body as a Whole: Allergic reaction and asthenia
Dermatologic: Pruritus and rash
Special Senses: Vertigo
- Other reported events seen less frequently in clinical trials included chest pain, syncope, anorexia, vomiting, and angioedema.
- Diovan has been evaluated for safety in over 400 pediatric patients aged 6 to 17 years and more than 160 pediatric patients aged 6 months to 5 years.
- No relevant differences were identified between the adverse experience profile for pediatric patients aged 6 to 16 years and that previously reported for adult patients.
- Headache and hyperkalemia were the most common adverse events suspected to be study drug-related in older children (6 to 17 years old) and younger children (6 months to 5 years old), respectively.
- Hyperkalemia was mainly observed in children with underlying renal disease.
- Neurocognitive and developmental assessment of pediatric patients aged 6 to 16 years revealed no overall clinically relevant adverse impact after treatment with Diovan for up to 1 year.
- Diovan is not recommended for pediatric patients under 6 years of age. In a study (n=90) of pediatric patients (1 to 5 years), two deaths and three cases of on-treatment transaminase elevations were seen in the one-year open-label extension phase.
- These 5 events occurred in a study population in which patients frequently had significant co-morbidities.
- A causal relationship to Diovan has not been established. In a second study in which 75 children aged 1 to 6 years were randomized, no deaths and one case of marked liver transaminase elevations occurred during a 1 year open-label extension.
- The adverse experience profile of Diovan in heart failure patients was consistent with the pharmacology of the drug and the health status of the patients.
- In the Valsartan Heart Failure Trial, comparing valsartan in total daily doses up to 320 mg (n=2,506) to placebo (n=2,494), 10% of valsartan patients discontinued for adverse reactions vs. 7% of placebo patients.
- The table shows adverse reactions in double-blind short-term heart failure trials, including the first 4 months of the Valsartan Heart Failure Trial, with an incidence of at least 2% that were more frequent in valsartan-treated patients than in placebo-treated patients.
- All patients received standard drug therapy for heart failure, frequently as multiple medications, which could include diuretics, digitalis, beta-blockers.
- About 93% of patients received concomitant ACE inhibitors.
- Discontinuations occurred in 0.5% of valsartan-treated patients and 0.1% of placebo patients for each of the following:
- elevations in creatinine and
- elevations in potassium.
- Other adverse reactions with an incidence greater than 1% and greater than placebo included
- (NOS = not otherwise specified).
- From the long-term data in the Valsartan Heart Failure Trial, there did not appear to be any significant adverse reactions not previously identified.
- The safety profile of Diovan was consistent with the pharmacology of the drug and the background diseases, cardiovascular risk factors, and clinical course of patients treated in the post-myocardial infarction setting.
- The table shows the percentage of patients discontinued in the valsartan and captopriltreated groups in the Valsartan in Acute Myocardial Infarction Trial (VALIANT) with a rate of at least 0.5% in either of the treatment groups.
- Discontinuations due to renal dysfunction occurred in 1.1% of valsartan-treated patients and 0.8% of captopril-treated patients.
|Discontinuation for adverse|
|Blood creatinine increased||0.6%||0.4%|
The following additional adverse reactions have been reported in postmarketing experience:
Hypersensitivity: There are rare reports of angioedema. Some of these patients previously experienced angioedema with other drugs including ACE inhibitors. Diovan should not be re-administered to patients who have had angioedema.
Renal: Impaired renal function, renal failure
Clinical Laboratory Tests: Hyperkalemia
Blood and Lymphatic: There are very rare reports of thrombocytopenia
Rare cases of rhabdomyolysis have been reported in patients receiving angiotensin II receptor blockers.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
What drugs interact with Diovan (valsartan)?
No clinically significant pharmacokinetic interactions were observed when Diovan (valsartan) was coadministered with
The valsartan-atenolol combination was more antihypertensive than either component, but it did not lower the heart rate more than atenolol alone.
CYP 450 Interactions
In vitro metabolism studies indicate that CYP 450 mediated drug interactions between valsartan and coadministered drugs are unlikely because of the low extent of metabolism.
The results from an in vitro study with human liver tissue indicate that valsartan is a substrate of the hepatic uptake transporter OATP1B1 and the hepatic efflux transporter MRP2. Coadministration of inhibitors of the uptake transporter (rifampin, cyclosporine) or efflux transporter (ritonavir) may increase the systemic exposure to valsartan.
Concomitant use of valsartan with other agents that block the renin-angiotensin system, potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride), potassium supplements, salt substitutes containing potassium or other drugs that may increase potassium levels (e.g., heparin) may lead to increases in serum potassium and in heart failure patients to increases in serum creatinine. If comedication is considered necessary, monitoring of serum potassium is advisable.
Non-Steroidal Anti-Inflammatory Agents including Selective Cyclooxygenase-2 Inhibitors (COX-2 Inhibitors)
In patients who are elderly, volume-depleted (including those on diuretic therapy), or with compromised renal function, coadministration of NSAIDs, including selective COX-2 inhibitors, with angiotensin II receptor antagonists, including valsartan, may result in deterioration of renal function, including possible acute renal failure. These effects are usually reversible. Monitor renal function periodically in patients receiving valsartan and NSAID therapy.
The antihypertensive effect of angiotensin II receptor antagonists, including valsartan, may be attenuated by NSAIDs including selective COX-2 inhibitors.
Dual Blockade of the Renin-Angiotensin System (RAS)
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 Diovan and other agents that affect the RAS.
Do not coadminister aliskiren with Diovan in patients with diabetes. Avoid use of aliskiren with Diovan in patients with renal impairment (GFR <60 mL/min).
Increases in serum lithium concentrations and lithium toxicity have been reported during concomitant administration of lithium with angiotensin II receptor antagonists, including Diovan. Monitor serum lithium levels during concomitant use.
Clinical Laboratory Test Findings
In controlled clinical trials, clinically important changes in standard laboratory parameters were rarely associated with administration of Diovan.
Minor elevations in creatinine occurred in 0.8% of patients taking Diovan and 0.6% given placebo in controlled clinical trials of hypertensive patients. In heart failure trials, greater than 50% increases in creatinine were observed in 3.9% of Diovan-treated patients compared to 0.9% of placebotreated patients. In post-myocardial infarction patients, doubling of serum creatinine was observed in 4.2% of valsartan-treated patients and 3.4% of captopril-treated patients.
Hemoglobin And Hematocrit
Greater than 20% decreases in hemoglobin and hematocrit were observed in 0.4% and 0.8%, respectively, of Diovan patients, compared with 0.1% and 0.1% in placebo-treated patients. One valsartan patient discontinued treatment for microcytic anemia.
Liver Function Tests
Occasional elevations (greater than 150%) of liver chemistries occurred in Diovan-treated patients. Three patients (<0.1%) treated with valsartan discontinued treatment for elevated liver chemistries.
Neutropenia was observed in 1.9% of patients treated with Diovan and 0.8% of patients treated with placebo.
In hypertensive patients, greater than 20% increases in serum potassium were observed in 4.4% of Diovan-treated patients compared to 2.9% of placebo-treated patients. In heart failure patients, greater than 20% increases in serum potassium were observed in 10.0% of Diovantreated patients compared to 5.1% of placebo-treated patients.
Blood Urea Nitrogen (BUN)
In heart failure trials, greater than 50% increases in BUN were observed in 16.6% of Diovan-treated patients compared to 6.3% of placebo-treated patients.
Diovan (valsartan) is an angiotensin receptor blocker (ARB) used to treat high blood pressure and congestive heart failure. Diovan is also prescribed after heart attacks since it may reduce deaths in patients who developed congestive heart failure after a heart attack. Common side effects of Diovan include headache, dizziness, fatigue, abdominal pain, cough, diarrhea and nausea. Diovan should not be used during pregnancy. It is unknown if Diovan is secreted into human milk. Consult your doctor before breastfeeding.
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Second Source WebMD Medical Reference
Second Source WebMD Medical Reference
High Blood Pressure (Hypertension) Signs, Causes, Diet, and Treatment
High blood pressure (hypertension) is a disease in which pressure within the arteries of the body is elevated. About 75 million people in the US have hypertension (1 in 3 adults), and only half of them are able to manage it. Many people do not know that they have high blood pressure because it often has no has no warning signs or symptoms. Systolic and diastolic are the two readings in which blood pressure is measured. The American College of Cardiology released new guidelines for high blood pressure in 2017. The guidelines now state that blood normal blood pressure is 120/80 mmHg. If either one of those numbers is higher, you have high blood pressure. The American Academy of Cardiology defines high blood pressure slightly differently. The AAC considers 130/80 mm Hg. or greater (either number) stage 1 hypertension. Stage 2 hypertension is considered 140/90 mm Hg. or greater. If you have high blood pressure you are at risk of developing life threatening diseases like stroke and heart attack.REFERENCE: CDC. High Blood Pressure. Updated: Nov 13, 2017.
A heart attack happens when a blood clot completely obstructs a coronary artery supplying blood to the heart muscle. A heart attack can cause chest pain, heart failure, and electrical instability of the heart.
Pulmonary hypertension is elevated pressure in the pulmonary arteries that carry blood from the lungs to the heart. The most common symptoms are fatigue and difficulty breathing. If the condition goes undiagnosed, more severe symptoms may occur. As pulmonary hypertension worsens, some people with the condition have difficulty performing any activities that require physical exertion. While there is no cure for pulmonary hypertension, it can be managed and treated with medications and supplemental oxygen to increase blood oxygen levels.
Pseudotumor Cerebri (Idiopathic Intracranial Hypertension)
Pseudotumor Cerebri (intracranial hypertension) is a condition where there is an increase in pressure of fluid surrounding the brain and spinal cord (cerebrospinal fluid or CSF) mimicing a brain tumor. The cause is unknown. The most common symptom is headache but also include eye-pain, vision loss and double vision. Pseudotumor cerebri is diagnosed with MRI or CAT scans and treated by discontinuing offending medications (if applicable), weight loss and diuretic medications. The condition can also be helped by repeated drainage of spinal fluid using the lumbar puncture.
Preeclampsia (Pregnancy Induced Hypertension)
Preeclampsia is related to increased blood pressure and protein in the mother's urine. Preeclampsia typically begins after the 20th week of pregnancy. When preeclampsia causes seizures, it is termed "eclampsia" and is the second leading cause of maternal death of in the US. Preeclampsia is the leading cause of fetal complications. Risk factors for preeclampsia include high blood pressure, obesity, multiple births, and women with preexisting medical conditions such as diabetes, kidney disease, rheumatoid arthritis, lupus, or scleroderma. Pregnancy planning and lifestyle changes may reduce the risk of preeclampsia during pregnancy.
Heart Attack Prevention
Heart disease and heart attacks can be prevented by leading a healthy lifestyle with diet, exercise, and stress management. Symptoms of heart attack in men and women include chest discomfort and pain in the shoulder, neck, jaw, stomach, or back. Women experience the same symptoms as men; however, they also may experience: Extreme fatigue Pain in the upper abdomen Dizziness Fainting Leading a healthy lifestyle with a heart healthy low-fat diet, and exercise can help prevent heart disease and heart attack.
Heart Attack Symptoms and Early Warning Signs
Recognizing heart attack symptoms and signs can help save your life or that of someone you love. Some heart attack symptoms, including left arm pain and chest pain, are well known but other, more nonspecific symptoms may be associated with a heart attack. Nausea, vomiting, malaise, indigestion, sweating, shortness of breath, and fatigue may signal a heart attack. Heart attack symptoms and signs in women may differ from those in men.
Heart Attack Pathology: Photo Essay
A heart attack is a layperson's term for a sudden blockage of a coronary artery. This photo essay includes graphics, pictures, and illustrations of diseased heart tissue and the mechanisms that lead to coronary artery disease, and possible heart attack. A coronary artery occlusion may be fatal, but most patients survive it. Death can occur when the occlusion leads to an abnormal heartbeat (severe arrhythmia) or death of heart muscle (extensive myocardial infarction).
Portal hypertension is most commonly caused by cirrhosis, a disease that results from scarring of the liver. Other causes of portal hypertension include blood clots in the portal vein, blockages of the veins that carry the blood from the liver to the heart, and a parasitic infection called schistosomiasis. Symptoms of portal hypertension include varices (enlarged veins), vomiting blood, blood in the stool, black and tarry stool, ascites (abnormal fluid collection within the peritoneum, the sac that contains the intestines within the abdominal cavity), confusion and lethargy, splenomegaly or enlargement of the spleen, and decreased white blood cell counts.
Hypertensive Kidney Disease
High blood pressure can damage the kidneys and is one of the leading causes of kidney failure (end-stage renal kidney disease). Kidney damage, like hypertension, can be unnoticeable and detected only through medical tests. If you have kidney disease, you should control your blood pressure. Other treatment options include prescription medications.
Vitamins & Exercise: Heart Attack Prevention Series
Vitamins and exercise can lower your risk for heart attack and heart disease. Folic acid, vitamins, and homocysteine levels are interconnected and affect your risk for heart disease or heart attack. For better heart health, avoid the following: fried foods, hard margarine, commercial baked goods, most packaged and processed snack foods, high fat dairy, and processed meats such as bacon, sausage, and deli meats. Antioxidants and exercise also play a key role in heart attack and heart disease prevention. Lower your risk factors for heart disease and heart attack by: lowering cholesterol, lowering blood pressure, diabetes prevention, and smoking cesssation. Here are a few things you can do to prevent heart attacks: Eat whole, natural, fresh foods, eat five to 10 servings of fruits and vegetables daily, eat more omega-3 fatty acids, drink water, tea, non-fat dairy and red wine, eat lean proteins, limit glycemic foods, and exercise daily.
High Blood Pressure Treatment (Natural Home Remedies, Diet, Medications)
High blood pressure (hypertension) means high pressure (tension) in the arteries. Treatment for high blood pressure include lifestyle modifications (alcohol, smoking, coffee, salt, diet, exercise), drugs and medications such as ACE inhibitors, angiotensin receptor blockers, beta blockers, diuretics, calcium channel blockers (CCBs), alpha blockers, clonidine, minoxidil, and Exforge.
Heart Attack Treatment
A heart attack involves damage or death of part of the heart muscle due to a blood clot. The aim of heart attack treatment is to prevent or stop this damage to the heart muscle. Heart attack treatments included medications, procedures, and surgeries to protect the heart muscle against injury.
Heart Attacks in Women
Heart disease, particularly coronary artery disease is the leading cause of heart attacks. Women are more likely to die from a heart attack than men. High cholesterol, high blood pressure, obesity, and high triglycerides are contributors to heart disease. Some of the common symptoms of a heart attack in women include chest pain, shortness of breath, nausea, feeling faint or woozy, and more. Heart disease can be prevented by lifestyle changes and controlling high blood pressure, cholesterol, weight, and diseases such as diabetes.
Heart Attack Prevention Overview
Heart attacks are the major causes of unexpected, sudden death among men and women. A heart attack also is a significant cause of heart failure. The process of developing atherosclerosis (hardening of the arteries) begins early in life. Heart attack prevention should begin in childhood because the atherosclerosis process can not be reversed. The risk of having a heart attack increases if you have diseases or conditions such as high blood pressure, diabetes, and other heart conditions. You can lowering your risk of having a heart attack by: Lifestyle changes, for example: Diet Exercise Quit smoking Control high blood pressure, diabetes, and other diseases that are risk factors) In some cases, medication is the most effective way of preventing a heart attack
Heart Attack vs. Stroke Symptoms, Differences, and Similarities
Heart attack usually is caused by a clot that stops blood flow supplying oxygen to an area of heart muscle, which results in heart muscle death. Stroke or "brain attack" is caused by a loss of blood supply to the brain (usually a blood clot) or by hemorrhagic stroke (bleeding within the brain), which results in brain tissue death. Both heart attack and stroke usually come on suddenly, produce similar symptoms, can be disabling, and can be fatal. The classic symptoms and warning signs of heart attack are different. Classic heart attack warning signs are chest pain or discomfort, shortness of breath, pain that radiates to the shoulders, back, arms, belly, jaw, or teeth, sweating, fainting, and nausea and vomiting. Moreover, woman having a heart attack may have additional symptoms like abdominal pain or discomfort, dizziness, clammy skin, and moderate to severe fatigue. The classic symptoms and warning signs that a person is having a stroke are confusion or loss of consciousness, sudden severe headache, speech problems, problems seeing out of one or both eyes, and numbness or weakness of only one side of the body. Moreover, a woman having a stroke may have additional warning symptom and signs like shortness of breath, disorientation, agitation, behavioral changes, weakness, nausea, vomiting, seizures, and hiccups. Recognition of stroke symptoms is vital for emergency treatment. The acronym "FAST" stands for recognition of Facial drooping, Arm weakness, Speech difficulty, and a Time for action. If you experience the symptoms heart attack or stroke (FAST) or see them develop in another person, then contact 911 immediately.
Heart Attack vs. Heartburn (Differences between Symptoms and Signs)
Heartburn is a symptom of another disease or medical problem and can be described as a feeling of burning in the chest accompanied by symptoms of nausea, vomiting, or a sour taste or food stuck in the back of the throat. Heart attack occurs when an artery in the heart is completely blocked by a blood clot, which causes that portion of heart muscle to die. Heart attack also has symptoms of chest pain, nausea, and vomiting, however, other warning signs and symptoms of a heart attack are unusual weakness or fatigue, and persistent and/or increased severity of symptoms over a few minutes. Heart attack is a life threatening emergency. If you think you or someone you are with is having a heart attack, call 911 immediately for urgent medical treatment. It may save your life.
Treatment & Diagnosis
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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Professional side effects and drug interactions sections courtesy of the U.S. Food and Drug Administration.