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Exforge HCT Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Exforge HCT (amlodipine, valsartan, hydrochlorothiazide) is used to treat high blood pressure (hypertension), and is usually given after other blood pressure medications have been tried without successful treatment of symptoms. Amlodipine is a calcium channel blocker, valsartan is an angiotensin II receptor antagonist, and hydrochlorothiazide is a thiazide diuretic (water pill). Common side effects include dizziness, lightheadedness, or headache as your body adjusts to the medication.
Exforge HCT is taken in a once-daily dosage. The maximum recommended dose is 10/320/25 mg. Exforge HCT may interact with other blood pressure medications, steroids, carbamazepine, lithium, cholestyramine or colestipol, insulin or oral diabetes medications, barbiturates, other diuretics (water pills), aspirin or other NSAIDs (non-steroidal anti-inflammatory drugs), muscle relaxers, or narcotics. Tell your doctor all medications you use. Exforge HCT is not recommended for use during pregnancy due to the risk for harm to a fetus. It is unknown if amlodipine or valsartan pass into breast milk. Hydrochlorothiazide passes into breast milk. Consult your doctor before breast-feeding.
Our Exforge HCT (amlodipine, valsartan, hydrochlorothiazide) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Exforge HCT in Detail - Patient Information: Side Effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have a serious side effect such as:
- eye pain, vision problems;
- feeling like you might pass out;
- swelling, rapid weight gain;
- chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
- slow, fast, or pounding heartbeats;
- urinating less than usual, or not at all;
- easy bruising or bleeding, unusual weakness;
- numbness, tingling, or burning pain;
- jaundice (yellowing of the skin or eyes); or
- dry mouth, increased thirst, drowsiness, restless feeling, confusion, increased urination, fast heart rate, fainting, or seizure (convulsions).
Less serious side effects may include:
- headache, tired feeling;
- nausea, upset stomach;
- muscle spasms, back pain; or
- stuffy nose, sore throat.
Read the entire detailed patient monograph for Exforge HCT (Amlodipine Valsartan Hydrochlorothiazide Tablets)
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Exforge HCT Overview - Patient Information: Side Effects
To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
This product may cause a loss of too much body water (dehydration) and salt/minerals. Tell your doctor right away if you have any symptoms of dehydration or mineral loss, including: extreme thirst, very dry mouth, muscle cramps/weakness, fast/slow/irregular heartbeat, confusion, decreased urination.
Tell your doctor right away if you have any serious side effects, including: fainting, severe tiredness, big toe/joint pain, swelling hands/ankles/feet, symptoms of a high potassium blood level (such as muscle weakness, slow/irregular heartbeat), signs of infection (such as fever, chills, persistent sore throat), unusual change in the amount of urine (not including the normal increase in urine when you first start this drug).
Get medical help right away if you have any very serious side effects, including: decrease in vision, eye pain.
Some people who already have severe heart disease may rarely develop worsening chest pain or a heart attack after starting this medication or increasing the dose. Get medical help right away if you experience: worsening chest pain, symptoms of a heart attack (such as chest/jaw/left arm pain, shortness of breath, unusual sweating).
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Exforge HCT (Amlodipine Valsartan Hydrochlorothiazide Tablets)
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Exforge HCT FDA Prescribing Information: Side Effects
Clinical Trials 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 clinical practice.
In the controlled trial of Exforge HCT, where only the maximum dose (10/320/25 mg) was evaluated, safety data were obtained in 582 patients with hypertension. Adverse reactions have generally been mild and transient in nature and have only infrequently required discontinuation of therapy.
The overall frequency of adverse reactions was similar between men and women, younger ( < 65 years) and older ( > 65 years) patients, and black and white patients. In the active controlled clinical trial, discontinuation because of adverse events occurred in 4.0% of patients treated with Exforge HCT 10/320/25 mg compared to 2.9% of patients treated with valsartan/HCTZ 320/25 mg, 1.6% of patients treated with amlodipine/valsartan 10/320 mg, and 3.4% of patients treated with HCTZ/amlodipine 25/10 mg. The most common reasons for discontinuation of therapy with Exforge HCT were dizziness (1.0%) and hypotension (0.7%).
The most frequent adverse events that occurred in the active controlled clinical trial in at least 2% of patients treated with Exforge HCT are presented in the following table.
|Preferred Term||Aml/Val/HCTZ 10/320/25 mg
|Val/HCTZ 320/25 mg
|Aml/Val 10/320 mg
|HCTZ/Aml 25/10 mg
|Dizziness||48 (8.2)||40 (7.2)||14 (2.5)||23 (4.1)|
|Edema||38 (6.5)||8 (1.4)||65 (11.5)||63 (11.2)|
|Headache||30 (5.2)||31 (5.5)||30 (5.3)||40 (7.1)|
|Dyspepsia||13 (2.2)||5 (0.9)||6 (1.1)||2 (0.4)|
|Fatigue||13 (2.2)||15 (2.7)||12 (2.1)||8 (1.4)|
|Muscle spasms||13 (2.2)||7 (1.3)||7 (1.2)||5 (0.9)|
|Back pain||12 (2.1)||13 (2.3)||5 (0.9)||12 (2.1)|
|Nausea||12 (2.1)||7 (1.3)||10 (1.8)||12 (2.1)|
|Nasopharyngitis||12 (2.1)||13 (2.3)||13 (2.3)||12 (2.1)|
Orthostatic events (orthostatic hypotension and postural dizziness) were seen in 0.5% of patients. Other adverse reactions that occurred in clinical trials with Exforge HCT ( > 0.2%) are listed below. It cannot be determined whether these events were causally related to Exforge HCT.
Cardiac Disorders: tachycardia
Eye Disorders: vision blurred
Infections and Infestations: upper respiratory tract infection, bronchitis, influenza, pharyngitis, tooth abscess, gastroenteritis viral, respiratory tract infection, rhinitis, urinary tract infection
Musculoskeletal and Connective Tissue Disorders: pain in extremity, arthralgia, musculoskeletal pain, muscular weakness, musculoskeletal weakness, musculoskeletal stiffness, joint swelling, neck pain, osteoarthritis, tendonitis
Psychiatric Disorders: anxiety, depression, insomnia
Renal and Urinary Disorders: pollakiuria
Reproductive System and Breast Disorders: erectile dysfunction
Vascular Disorders: hypotension
Amlodipine has been evaluated for safety in more than 11000 patients in US and foreign clinical trials. Other adverse reactions not listed above that have been reported in < 1% but > 0.1% of patients in controlled clinical trials or under conditions of open trials or marketing experience where a causal relationship is uncertain were:
Central and Peripheral Nervous System: neuropathy peripheral, tremor
General: allergic reaction, hot flushes, malaise, rigors, weight gain
Musculoskeletal System: arthrosis, muscle cramps
Psychiatric: sexual dysfunction (male and female), nervousness, abnormal dreams, depersonalization
Autonomic Nervous System: sweating increased
Metabolic and Nutritional: hyperglycemia, thirst
Other adverse reactions reported with amlodipine at a frequency of ≤ 0.1% of patients include: cardiac failure, pulse irregularity, extrasystoles, skin discoloration, urticaria, skin dryness, alopecia, dermatitis, muscle weakness, twitching, ataxia, hypertonia, migraine, cold and clammy skin, apathy, agitation, amnesia, gastritis, increased appetite, loose stools, rhinitis, dysuria, polyuria, parosmia, taste perversion, abnormal visual accommodation, and xerophthalmia. Other reactions occurred sporadically and cannot be distinguished from medications or concurrent disease states such as myocardial infarction and angina.
Adverse reactions reported for amlodipine for indications other than hypertension may be found in its full prescribing information.
Valsartan has been evaluated for safety in more than 4000 hypertensive patients in clinical trials. 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 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).
Other adverse reactions, not listed above, occurring in > 0.2% of patients in controlled clinical trials with valsartan are:
Respiratory: sinusitis, pharyngitis
Adverse reactions reported for valsartan for indications other than hypertension may be found in the prescribing information for Diovan.
Other adverse reactions not listed above that have been reported with hydrochlorothiazide, without regard to causality, are listed below:
Body as a Whole: weakness
Hypersensitivity: photosensitivity, urticaria, necrotizing angiitis (vasculitis and cutaneous vasculitis), fever, respiratory distress including pneumonitis and pulmonary edema, anaphylactic reactions
Metabolic: glycosuria, hyperuricemia
Nervous System/Psychiatric: restlessness
Special Senses: transient blurred vision, xanthopsia.
Clinical Laboratory Test Findings
Clinical laboratory test findings for Exforge HCT were obtained in a controlled trial of Exforge HCT administered at the maximal dose of 10/320/25 mg compared to maximal doses of dual therapies, i.e., valsartan/HCTZ 320/25 mg, amlodipine/valsartan 10/320 mg, and HCTZ/amlodipine 25/10 mg. Findings for the components of Exforge HCT were obtained from other trials.
Creatinine: In hypertensive patients, greater than 50% increases in creatinine occurred in 2.1% of Exforge HCT patients compared to 2.4% of valsartan/HCTZ patients, 0.7% of amlodipine/valsartan patients, and 1.8% of HCTZ/amlodipine patients.
In heart failure patients, greater than 50% increases in creatinine were observed in 3.9% of valsartan-treated patients compared to 0.9% of placebo-treated 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.
Liver Function Tests: Occasional elevations (greater than 150%) of liver chemistries occurred in Exforge HCT-treated patients.
Blood Urea Nitrogen (BUN): In hypertensive patients, greater than 50% increases in BUN were observed in 30% of Exforge HCT-treated patients compared to 29% of valsartan/HCTZ patients, 15.8% of amlodipine/valsartan patients, and 18.5% of HCTZ/amlodipine patients. The majority of BUN values remained within normal limits.
In heart failure patients, greater than 50% increases in BUN were observed in 17% of valsartan-treated patients compared to 6% of placebo-treated patients.
Serum Electrolytes (Potassium): In hypertensive patients, greater than 20% decreases in serum potassium were observed in 6.5% of Exforge HCT-treated patients compared to 3.3% of valsartan/HCTZ patients, 0.4% of amlodipine/valsartan patients, and 19.3% of HCTZ/amlodipine patients. Greater than 20% increases in potassium were observed in 3.5% of Exforge HCT-treated patients compared to 2.4% of valsartan/HCTZ patients, 6.2% of amlodipine/valsartan patients, and 2.2% of HCTZ/amlodipine patients.
In heart failure patients, greater than 20% increases in serum potassium were observed in 10% of valsartantreated patients compared to 5.1% of placebo-treated patients [see WARNINGS AND PRECAUTIONS].
Neutropenia: Neutropenia ( < 1500/L) was observed in 1.9% of patients treated with valsartan and 0.8% of patients treated with placebo.
The following additional adverse reactions have been reported in postmarketing experience. 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.
With amlodipine, gynecomastia has been reported infrequently and a causal relationship is uncertain. Jaundice and hepatic enzyme elevations (mostly consistent with cholestasis or hepatitis), in some cases severe enough to require hospitalization, have been reported in association with use of amlodipine.
The following additional adverse reactions have been reported in postmarketing experience with valsartan or valsartan/hydrochlorothiazide:
Blood and Lymphatic: Decrease in hemoglobin, decrease in hematocrit, neutropenia Hypersensitivity: There are rare reports of angioedema. Some of these patients previously experienced angioedema with other drugs including ACE inhibitors. Exforge HCT should not be re-administered to patients who have had angioedema.
Digestive: Elevated liver enzymes and very rare reports of hepatitis
Renal: Impaired renal function, renal failure
Clinical Laboratory Tests: Hyperkalemia
Dermatologic: Alopecia, bullous dermatitis
Nervous System: Syncope
The following additional adverse reactions have been reported in postmarketing experience with hydrochlorothiazide:
Acute renal failure, renal disorder, aplastic anemia, erythema multiforme, pyrexia, muscle spasm, asthenia, acute angle-closure glaucoma, bone marrow failure, worsening of diabetes control, hypokalemia, blood lipids increased, hyponatremia, hypomagnesemia, hypercalcemia, hypochloremic alkalosis, impotence, visual impairment.
Pathological changes in the parathyroid gland of patients with hypercalcemia and hypophosphatemia have been observed in a few patients on prolonged thiazide therapy. If hypercalcemia occurs, further diagnostic evaluation is necessary.
Read the entire FDA prescribing information for Exforge HCT (Amlodipine Valsartan Hydrochlorothiazide Tablets)
Additional Exforge HCT Information
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