Diovan HCT

Diovan HCT is a prescription medication used to treat high blood pressure. It is a single product containing 2 medications: valsartan and hydrochlorothiazide. Valsartan is in a class of medications called angiotensin II receptor antagonists. It works by blocking the action of certain natural substances that tighten the blood vessels, allowing the blood to flow more smoothly and the heart to pump more efficiently. Hydrochlorothiazide is in a class of medications called diuretics ('water pills'). It works by causing the kidneys to get rid of unneeded water and salt from the body into the urine.  

This medication comes in tablet form and is taken once daily, with or without food.

Common side effects of Diovan HCT include nausea, a condition of excess uric acid in the blood (hyperuricemia), and upper respiratory tract infection. Diovan HCT can also cause dizziness. Do not drive or operate heavy machinery until you know how Diovan HCT affects you.

Serious side effects have been reported with Diovan HCT. See the "Diovan HCT Precautions" section.

Common side effects of Diovan HCT include the following:

• nausea
• a condition of excess uric acid in the blood (hyperuricemia)
• dizziness
• an infection that affects the nose, throat, and airways (upper respiratory tract infection)

This is not a complete list of Diovan HCT side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Serious side effects have been reported with Diovan HCT including the following:

• harm to an unborn baby causing injury and even death.
• low blood pressure (hypotension). Low blood pressure is most likely to happen if you:
  • take water pills
  • are on a low salt diet
  • get dialysis treatments
  • have heart problems
  • get sick with vomiting or diarrhea
  • drink alcohol
• allergic reactions. People with and without allergy problems or asthma who take Diovan HCT may get allergic reactions.
• worsening of lupus. Hydrochlorothiazide, one of the medicines in Diovan HCT, may cause lupus to become active or worse.
• fluid and electrolyte (salt) problems. Tell your doctor about any of the following signs and symptoms of fluid and electrolyte problems:
  • dry mouth
  • thirst
  • lack of energy (lethargy)
  • weakness
  • drowsiness
  • restlessness
  • confusion
  • seizures
  • muscle pain or cramps
  • muscle fatigue
  • very low urine output
  • fast heartbeat
  • nausea and vomiting
• kidney problems. Kidney problems may become worse in people that already have kidney disease. Some people will have changes on blood tests for kidney function and may need a lower dose of Diovan HCT. Call your doctor if you get swelling in your feet, ankles, or hands, or unexplained weight gain. If you have heart failure, your doctor should check your kidney function before prescribing Diovan HCT.
• skin rash. Call your doctor right away if you have an unusual skin rash.
• eye problems. One of the medicines in Diovan HCT can cause eye problems that may lead to vision loss. Symptoms of eye problems can happen within hours to weeks of starting Diovan HCT. Tell your doctor right away if you have:
  • decrease in vision
  • eye pain

Do not take Diovan HCT if you:

• are allergic to Diovan HCT or to any of its ingredients, or medicines that contain sulfonamides
• make less urine due to kidney problems
• are a diabetic patient taking aliskiren

Before taking Diovan HCT, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are pregnant or plan to become pregnant
• are breastfeeding
• have liver problems
• have kidney problems
• have or had gallstones
• have lupus
• have high levels of uric acid in the blood
• have ever had a reaction called angioedema to another blood presure medication. Angioedema causes swelling of the face, lips, tongue, throat, and may cause difficulty breathing

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.

Follow all directions on your prescription label. Your doctor may occasionally change your dose. Do not use this medicine in larger or smaller amounts or for longer than recommended.

You may take this medication with or without food.

Your blood pressure will need to be checked often. Your kidney function may also need to be checked.

You may have very low blood pressure while taking this medication. Call your doctor if you are sick with vomiting or diarrhea, or if you are sweating more than usual.

If you need surgery, tell the surgeon ahead of time that you are using hydrochlorothiazide and valsartan.

Keep using this medicine as directed, even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medication for the rest of your life.

Blood pressure medication is only part of a complete treatment program that may also include diet, exercise, regular blood pressure testing, lifestyle changes, and other medications. Follow your doctor's instructions very closely.

Use all medications as directed by your doctor. Read the medication guide or patient instructions provided with each medication. Do not change your doses or stop taking any of your medications without your doctor's advice.

Store at room temperature away from moisture and heat.

• It is used to treat high blood pressure.
• It may be given to you for other reasons. Talk with the doctor.

Use Diovan HCT as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take with or without food.
• Take this medicine at the same time of day.
• To gain the most benefit, do not miss doses.
• Keep taking Diovan HCT as you have been told by your doctor or other health care provider, even if you feel well.
• This medicine may cause you to pass urine more often. To keep from having sleep problems, try to take before 6 pm.
• Drink lots of noncaffeine liquids unless told to drink less liquid by your doctor.

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

• Store at room temperature.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

     General Considerations

The usual starting dose is Diovan HCT 160/12.5 mg once daily. The dosage can be increased after 1 to 2 weeks of therapy to a maximum of one 320/25 tablet once daily as needed to control blood pressure [see Clinical Studies (14.2)]. Maximum antihypertensive effects are attained within 2 to 4 weeks after a change in dose.

     Add-On Therapy

A patient whose blood pressure is not adequately controlled with valsartan (or another ARB) alone or hydrochlorothiazide alone may be switched to combination therapy with Diovan HCT.

A patient who experiences dose-limiting adverse reactions on either component alone may be switched to Diovan HCT containing a lower dose of that component in combination with the other to achieve similar blood pressure reductions. The clinical response to Diovan HCT should be subsequently evaluated and if blood pressure remains uncontrolled after 3 to 4 weeks of therapy, the dose may be titrated up to a maximum of 320/25 mg.

     Replacement Therapy

Diovan HCT may be substituted for the titrated components.

     Initial Therapy

Diovan HCT is not recommended as initial therapy in patients with intravascular volume depletion [see Warnings and Precautions (5.2)].

     Use with Other Antihypertensive Drugs

Diovan HCT may be administered with other antihypertensive agents.

Diovan HCT (valsartan and hydrochlorothiazide, USP) is contraindicated in patients who are hypersensitive to any component of this product.

Because of the hydrochlorothiazide component, this product is contraindicated in patients with anuria or hypersensitivity to other sulfonamide-derived drugs.

Do not coadminister aliskiren with Diovan HCT in patients with diabetes [see Drug Interactions (7)].

Valsartan-Hydrochlorothiazide:

Lithium: Increases in serum lithium concentrations and lithium toxicity have been reported during concomitant administration of lithium with angiotensin II receptor antagonists or thiazides. Monitor lithium levels in patients taking Diovan HCT.

Valsartan: No clinically significant pharmacokinetic interactions were observed when valsartan was coadministered with amlodipine, atenolol, cimetidine, digoxin, furosemide, glyburide, hydrochlorothiazide, or indomethacin. The valsartan-atenolol combination was more antihypertensive than either component, but it did not lower the heart rate more than atenolol alone.

Coadministration of valsartan and warfarin did not change the pharmacokinetics of valsartan or the time-course of the anticoagulant properties of warfarin.

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 [see Clinical Pharmacology (12.3)].

Transporters: 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.

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.

Potassium: 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.

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 HCT and other agents that affect the RAS.

Do not coadminister aliskiren with Diovan HCT in patients with diabetes. Avoid use of aliskiren with Diovan HCT in patients with renal impairment (GFR <60 mL/min).

Hydrochlorothiazide: When administered concurrently, the following drugs may interact with thiazide diuretics:

Antidiabetic Drugs (oral agents and insulin) - Dosage adjustment of the antidiabetic drug may be required.

Nonsteroidal Anti-inflammatory Drugs (NSAIDs and COX-2 selective inhibitors) - When Diovan HCT and nonsteroidal anti-inflammatory agents are used concomitantly, the patient should be observed closely to determine if the desired effect of the diuretic is obtained.

Carbamazepine – May lead to symptomatic hyponatremia.

Ion exchange resins: Staggering the dosage of hydrochlorothiazide and ion exchange resins (e.g., cholestyramine, colestipol) such that hydrochlorothiazide is administered at least 4 hours before or 4 to 6 hours after the administration of resins would potentially minimize the interaction [see Clinical Pharmacology (12.3)].

Cyclosporine: Concomitant treatment with cyclosporine may increase the risk of hyperuricemia and gout-type complications.

Information for Patients

Advise the patient to read the FDA-approved patient labeling (Patient Information).

Pregnancy: Female patients of childbearing age should be told about the consequences of exposure to Diovan HCT during pregnancy. Discuss treatment options with women planning to become pregnant. Patients should be asked to report pregnancies to their physicians as soon as possible.

Symptomatic Hypotension: A patient receiving Diovan HCT should be cautioned that lightheadedness can occur, especially during the first days of therapy, and that it should be reported to the prescribing physician. The patients should be told that if syncope occurs, Diovan HCT should be discontinued until the physician has been consulted.

All patients should be cautioned that inadequate fluid intake, excessive perspiration, diarrhea, or vomiting can lead to an excessive fall in blood pressure, with the same consequences of lightheadedness and possible syncope.

Potassium Supplements: A patient receiving Diovan HCT should be told not to use potassium supplements or salt substitutes containing potassium without consulting the prescribing physician.

T2015-120
July 2015

FDA-Approved Patient Labeling

PATIENT INFORMATION

DIOVAN HCT (DYE’-o-van HCT)

(valsartan and hydrochlorothiazide)

Tablets

Read the Patient Information that comes with DIOVAN HCT before you start taking it and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your doctor about your condition and treatment. If you have any questions about DIOVAN HCT, ask your doctor or pharmacist.

What is DIOVAN HCT?

DIOVAN HCT contains 2 prescription medicines:

1. valsartan, an angiotensin receptor blocker (ARB)
   
2. hydrochlorothiazide (HCTZ), a water pill (diuretic)

DIOVAN HCT may be used to lower high blood pressure (hypertension) in adults-

• when 1 medicine to lower your high blood pressure is not enough.
  
• as the first medicine to lower high blood pressure if your doctor decides you are likely to need more than 1 medicine.

DIOVAN HCT has not been studied in children under 18 years of age.

Who should not take DIOVAN HCT?

Do not take DIOVAN HCT if you:

• are allergic to any of the ingredients in DIOVAN HCT. See the end of this leaflet for a complete list of ingredients in DIOVAN HCT.
  
• make less urine due to kidney problems.
  
• are allergic to medicines that contain sulfonamides.

What should I tell my doctor before taking DIOVAN HCT?

Tell your doctor about all your medical conditions including if you:

• are pregnant or plan to become pregnant. See “What is the most important information I should know about DIOVAN HCT?”
  
• are breastfeeding. DIOVAN HCT passes into breast milk. You should choose either to take DIOVAN HCT or breastfeed, but not both.
  
• have liver problems
  
• have kidney problems
  
• have or had gallstones
  
• have Lupus
  
• have low levels of potassium (with or without symptoms such as muscle weakness, muscle spasms, abnormal heart rhythm) or magnesium in your blood
  
• have high levels of calcium in your blood (with or without symptoms such as nausea, vomiting, constipation, stomach pain, frequent urination, thirst, muscle weakness and twitching).
  
• have high levels of uric acid in the blood.
  
• have ever had a reaction called angioedema, to another blood pressure medication. Angioedema causes swelling of the face, lips, tongue, throat and may cause difficulty breathing.
  

Tell your doctor about all the medicines you take including prescription and nonprescription medicines, vitamins and herbal supplements. Some of your other medicines and Diovan HCT could affect each other, causing serious side effects. Especially, tell your doctor if you take:

• other medicines for high blood pressure or a heart problem
  
• water pills (diuretics)
  
• potassium supplements. Your doctor may check the amount of potassium in your blood periodically.
  
• a salt substitute. Your doctor may check the amount of potassium in your blood periodically.
  
• antidiabetic medicines including insulin
  
• narcotic pain medicines
  
• sleeping pills
  
• lithium, a medicine used in some types of depression (Eskalith®, Lithobid®, Lithium Carbonate, Lithium Citrate)
  
• aspirin or other medicines called non-steroidal anti-inflammatory Drugs
  
• digoxin or other digitalis glycosides (a heart medicine)
  
• muscle relaxants (medicines used during operations)
  
• certain cancer medicines, like cyclophosphamide or methotrexate
• certain antibiotics (rifamycin group), a drug used to protect against transplant rejection (cyclosporine) or an antiretroviral drug used to treat HIV/AIDS infection (ritonavir). These drugs may increase the effect of valsartan.

Ask your doctor if you are not sure if you are taking 1 of these medicines.

Know the medicines you take. Keep a list of your medicines with you to show to your doctor and pharmacist when a new medicine is prescribed. Talk to your doctor or pharmacist before you start taking any new medicine. Your doctor or pharmacist will know what medicines are safe to take together.

How should I take DIOVAN HCT?

• Take DIOVAN HCT exactly as prescribed by your doctor. Your doctor may change your dose if needed.
  
• Take DIOVAN HCT once each day.
  
• DIOVAN HCT can be taken with or without food.
  
• If you miss a dose, take it as soon as you remember. If it is close to your next dose, do not take the missed dose. Just take the next dose at your regular time.
  
• If you take too much DIOVAN HCT, call your doctor or Poison Control Center, or go to the nearest hospital emergency room.

What should I avoid while taking Diovan HCT?

You should not take Diovan HCT during pregnancy. See “What is the most important information I should know about Diovan HCT?”

What are the possible side effects of DIOVAN HCT?

DIOVAN HCT may cause serious side effects including:

• Harm to an unborn baby causing injury and even death. See “What is the most important information I should know about Diovan HCT?”
  
• Low blood pressure (hypotension). Low blood pressure is most likely to happen if you:
  • take water pills
    
  • are on a low salt diet
    
  • get dialysis treatments
    
  • have heart problems
    
  • get sick with vomiting or diarrhea
    
  • drink alcohol

Lie down if you feel faint or dizzy. Call your doctor right away.

• Allergic reactions. People with and without allergy problems or asthma who take Diovan HCT may get allergic reactions.
  
• Worsening of Lupus. Hydrochlorothiazide, 1 of the medicines in Diovan HCT may cause Lupus to become active or worse.
  
• Fluid and electrolyte (salt) problems. Tell your doctor about any of the following signs and symptoms of fluid and electrolyte problems:

• Kidney problems. Kidney problems may become worse in people that already have kidney disease. Some people will have changes on blood tests for kidney function and may need a lower dose of DIOVAN HCT. Call your doctor if you get swelling in your feet, ankles, or hands, or unexplained weight gain. If you have heart failure, your doctor should check your kidney function before prescribing DIOVAN HCT.
  
• Skin rash. Call your doctor right away if you have an unusual skin rash.
• Eye Problems. One of the medicines in Diovan HCT can cause eye problems that may lead to vision loss. Symptoms of eye problems can happen within hours to weeks of starting Diovan HCT. Tell your doctor right away if you have:
  • decrease in vision
    
  • eye pain

Other side effects were generally mild and brief. They generally have not caused patients to stop taking DIOVAN HCT.

Tell your doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of DIOVAN HCT. For a complete list, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How do I store DIOVAN HCT?

• Store DIOVAN HCT tablets at room temperature between 59oF to 86oF (15oC to 30oC).
  
• Keep DIOVAN HCT in a closed container in a dry place.

Keep DIOVAN HCT and all medicines out of the reach of children.

General information about DIOVAN HCT

Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use DIOVAN HCT for a condition for which it was not prescribed. Do not give DIOVAN HCT to other people, even if they have the same symptoms you have. It may harm them.

This leaflet summarizes the most important information about DIOVAN HCT. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about DIOVAN HCT that is written for health professionals. For more information about DIOVAN HCT, go to www.DIOVAN.com or call 1-866-404-6359.

What are the ingredients in DIOVAN HCT?

Active ingredients: Valsartan and hydrochlorothiazide

Inactive ingredients: colloidal silicon dioxide, crospovidone, hydroxypropyl methylcellulose, iron oxides, magnesium stearate, microcrystalline cellulose, polyethylene glycol, talc, and titanium dioxide.

What is high blood pressure (hypertension)? 

Blood pressure is the force in your blood vessels when your heart beats and when your heart rests. You have high blood pressure when the force is too much. DIOVAN HCT can help your blood vessels relax and reduce the amount of water in your body so your blood pressure is lower. Medicines that lower blood pressure lower your risk of having a stroke or heart attack.

High blood pressure makes the heart work harder to pump blood throughout the body and causes damage to the blood vessels. If high blood pressure is not treated, it can lead to stroke, heart attack, heart failure, kidney failure, and vision problems.

Eskalith® and Lithobid® are registered trademarks of Noven Pharmaceuticals, Inc.

Distributed by:

Novartis Pharmaceuticals Corporation

East Hanover, New Jersey 07936

© Novartis

T2015-121
July 2015

PRINCIPAL DISPLAY PANEL

Package Label – 80 mg/12.5 mg

Rx Only             NDC 0078-0314-34

Diovan HCT®

valsartan and hydrochlorothiazide, USP 

80 mg/12.5 mg

90 tablets

PRINCIPAL DISPLAY PANEL

Package Label – 160 mg/12.5 mg

Rx Only             NDC 0078-0315-15

Diovan HCT®

valsartan and hydrochlorothiazide, USP 

160 mg/12.5 mg per tablet

30 tablets

Dosage: See package insert

Store at 25° C (77° F); excursions permitted to 15-30° C (59-86° F).

Protect from moisture.

Please see accompanying full Prescribing Information.

Keep this and all drugs out of the reach of children.

PRINCIPAL DISPLAY PANEL

Package Label – 160 mg/25 mg

Rx Only             NDC 0078-0383-15

Diovan HCT®

valsartan and hydrochlorothiazide, USP 

160 mg/25 mg per tablet

30 tablets

Dosage: See package insert

Store at 25° C (77° F); excursions permitted to 15-30° C (59-86° F).

Protect from moisture.

Please see accompanying full Prescribing Information.

Keep this and all drugs out of the reach of children.

PRINCIPAL DISPLAY PANEL

Package Label – 320 mg/12.5 mg

Rx Only             NDC 0078-0471-15

Diovan HCT®

valsartan and hydrochlorothiazide, USP 

320 mg/12.5 mg per tablet

30 tablets

Dosage: See package insert

Store at 25° C (77° F); excursions permitted to 15-30° C (59-86° F).

Protect from moisture.

Please see accompanying full Prescribing Information.

Keep this and all drugs out of the reach of children.

PRINCIPAL DISPLAY PANEL

Package Label – 320 mg/25 mg

Rx Only             NDC 0078-0472-15

Diovan HCT®

valsartan and hydrochlorothiazide, USP 

320 mg/25 mg per tablet

30 tablets

Dosage: See package insert

Store at 25° C (77° F); excursions permitted to 15-30° C (59-86° F).

Protect from moisture.

Please see accompanying full Prescribing Information.

Keep this and all drugs out of the reach of children.

Applies to hydrochlorothiazide / valsartan: oral tablet

Nervous system

Common (1% to 10%): Headache, fatigue, dizziness
Rare (less than 0.1%): Vertigo, tinnitus[Ref]

Hypersensitivity

Rare cases of interstitial nephritis have been associated with the use of HCTZ. Although HCTZ has been used to treat nephrogenic diabetes insipidus, a case report in which the drug was believed to have caused this condition has been reported.[Ref]

Rare (less than 0.1%): Nausea, diarrhea, rash, acute pulmonary edema, interstitial nephritis or cystitis, anaphylaxis[Ref]

Renal

Rare (less than 0.1%): Renal insufficiency, azotemia[Ref]

In multiple-dose studies in hypertensive patients with stable renal insufficiency and renovascular hypertension, the use of valsartan alone had no clinically significant effects of glomerular filtrate rate, filtration fraction, creatinine clearance, or renal plasma flow. The use of HCTZ has been associated with the development of pre-renal azotemia. Pretreatment volume repletion is recommended prior to initiating therapy.[Ref]

Cardiovascular

Chest pain was reported in more than 2% of patients who were taking this combination drug in controlled trials, but this incidence was not significantly different compared with the incidence of chest pain among placebo patients.[Ref]

Rare (less than 0.1%): Palpitations, chest pain, angioedema
Frequency not reported: Cardiac arrhythmias (including ventricular ectopy and complete AV heart block)[Ref]

Respiratory

Angiotensin II receptor blockade, unlike ACE inhibition, has no impact on the processing of peptides such as bradykinin and substance P, two peptides able to induce cough.

Bronchospasm, dyspnea, and epistaxis have rarely been associated with the use of this drug.[Ref]

Common (1% to 10%): Cough (valsartan component)
Uncommon (0.1% to 1%): Dyspnea, acute pulmonary edema[Ref]

Dermatologic

Frequency not reported: Erythema annular centrifugum, acute eczematous dermatitis, morbilliform, leukocytoclastic vasculitis, phototoxic dermatitis, subacute cutaneous lupus erythematosus-like condition, pruritus, rash[Ref]

Metabolic

Since HCTZ may increase total serum cholesterol by 11%, LDL lipoprotein cholesterol by 12%, and VLDL lipoprotein cholesterol levels by 50%, and may reduce insulin secretion, it should be used with caution in diabetic patients and in those with hypercholesterolemia. True glucose intolerance may develop in approximately 3% of patients. It is typically reversible within six months after discontinuation of therapy.

Hyperuricemia may be an important consideration in patients with a history of gout. Hypophosphatemia and low serum magnesium concentrations may occur, but are usually clinically insignificant except in malnourished patients.[Ref]

Rare (0.01% to 0.1%): Hypokalemia, hyperkalemia, metabolic alkalosis, hyponatremia, hypomagnesemia, hypercalcemia, hyperglycemia, elevated serum uric acid levels, elevated serum cholesterol[Ref]

Gastrointestinal

Thiazide diuretics may increase serum cholesterol and triglycerides, resulting in an increased risk of cholesterol gallstone formation. Reports of bowel strictures associated with thiazide ingestion were reported in the 1960s (although patients in these reports were on a combination HCTZ-potassium product).[Ref]

Uncommon (0.1% to 1%): Diarrhea, constipation, appetite changes, dry mouth, dyspepsia, nausea, vomiting, flatulence, pancreatitis, cholecystitis[Ref]

Immunologic

Rare (0.01% to 0.1%): Allergic vasculitis, hemolytic anemia[Ref]

Endocrine

Frequency not reported: Glucose intolerance, altered lipid profile[Ref]

Use of valsartan alone has not been associated with significant changes in serum lipids or glucose concentrations. However, use of HCTZ may be associated with increases in total serum cholesterol by 11%, LDL lipoprotein cholesterol by 12%, and VLDL lipoprotein cholesterol levels by 50%. In addition, use of HCTZ may be associated with reduced insulin secretion. Therefore, caution is recommended when giving this combination drug to diabetic patients or those with hypercholesterolemia.

Hyperuricemia may be an important consideration in patients with a history of gout. Hypophosphatemia and low serum magnesium concentrations may occur, but are usually clinically insignificant except in malnourished patients.

A prospective study of 34 patients who received oral thiazide diuretics for 14 years without interruption revealed significantly increased average fasting blood glucose levels. Withdrawal of thiazide therapy for 7 months in 10 of the patients resulted in average reductions of 10% in fasting blood glucose and 25% in 2-hour glucose tolerance test values. A control group was not reported.[Ref]

Musculoskeletal

Common (1% to 10%): Back pain, muscle cramps, myalgia[Ref]

Hematologic

Common (1% to 10%): Neutropenia
Uncommon (0.1% to 1%): Hematocrit decreased, hemoglobin decreased
Rare (0.01% to 0.1%): Immune complex hemolytic anemia
Postmarketing reports: Thrombocytopenia[Ref]

Psychiatric

Rare (less than 0.1%): Anxiety, depression, decreased libido, insomnia, paresthesias, somnolence[Ref]

Genitourinary

Rare (less than 0.1%): Impotence, dysuria[Ref]

Hepatic

Uncommon (0.1% to 1%): Increases in hepatic enzymes (usually reversible)[Ref]

Ocular

Rare (less than 0.1%): Abnormal vision, idiosyncratic reactions to hydrochlorothiazide resulting in acute transient myopia and acute angle-closure glaucoma[Ref]

Some side effects of Diovan HCT may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.