Exforge HCT Side Effects

Generic name: amlodipine / hydrochlorothiazide / valsartan

Note: This document contains side effect information about amlodipine / hydrochlorothiazide / valsartan. Some of the dosage forms listed on this page may not apply to the brand name Exforge HCT.

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

For the Consumer

Applies to amlodipine / hydrochlorothiazide / valsartan: oral tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking amlodipine / hydrochlorothiazide / valsartan: 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 of amlodipine / hydrochlorothiazide / valsartan may include:

• dizziness;

• headache, tired feeling;

• nausea, upset stomach;

• muscle spasms, back pain; or

• stuffy nose, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to amlodipine / hydrochlorothiazide / valsartan: oral tablet

Cardiovascular

Cardiovascular side effects have included orthostatic hypotension and postural dizziness (0.5%). Cardiovascular side effects of the amlodipine component have included arrhythmia (including ventricular tachycardia and atrial fibrillation), bradycardia, chest pain, peripheral ischemia, syncope, postural hypotension, and vasculitis. Cardiovascular side effects associated with the hydrochlorothiazide component have included cardiac arrhythmias, including ventricular ectopy and complete AV heart block associated with hypokalemia and hyponatremia due to hydrochlorothiazide. Hydrochlorothiazide has also been reported to cause pulmonary edema and syncope. Cardiovascular side effects associated with the valsartan component have included dizziness related to orthostatic hypotension and (rarely) palpitations, and chest pain.

Dermatologic

Dermatologic side effects have included pruritus, hyperhidrosis, and rash. Dermatologic side effects associated with the amlodipine component have included angioedema, erythema multiforme, rash erythematosus, and rash maculopapular. Dermatologic side effects associated with the hydrochlorothiazide component have included erythema annular centrifugum, acute eczematous dermatitis, morbilliform and leukocytoclastic vasculitis, phototoxic dermatitis, and a rare subacute lupus erythematosus-like reaction. Dermatologic side effects associated with the valsartan component have rarely been reported and include pruritus, rash and alopecia.

Gastrointestinal

Gastrointestinal side effects have included dyspepsia (2.2%), nausea (2.1%), constipation, diarrhea, abdominal pain, vomiting, toothache, dry mouth, gastritis, increased appetite, anorexia, dehydration, and hemorrhoids. Gastrointestinal side effects associated with the amlodipine component have included anorexia, dysphagia, pancreatitis, and gingival hyperplasia. Gastrointestinal side effects associated with the hydrochlorothiazide component are rare, and include pancreatitis, nausea, and acute cholecystitis. Gastrointestinal side effects associated with the valsartan component have rarely been reported and include diarrhea, constipation, dry mouth, dyspepsia, anorexia, nausea, vomiting, taste disturbance, and flatulence.

General

General side effects have included asthenia, non-cardiac chest pain, chills, and malaise.

Hematologic

Hematologic side effects associated with the amlodipine component have included leucopenia, purpura, and thrombocytopenia. Hematologic side effects associated with the hydrochlorothiazide component have included aplastic anemia, agranulocytosis, and hemolytic anemia. Hematologic side effects associated with the valsartan component have been rare and have included decreases in hematocrit or hemoglobin, neutropenia, and thrombocytopenia.

Hepatic

Hepatic side effects have included blood creatine phosphokinase increased. Hepatic side effects associated with the amlodipine component have included hepatic enzyme elevations and jaundice. Hepatic side effects of the valsartan component have included elevated liver enzymes and very rare reports of hepatitis.

Hypersensitivity

Hypersensitivity side effects associated with the amlodipine component have included at least one case of erythema multiforme. Hypersensitivity side effects associated with the hydrochlorothiazide component have included photosensitivity, urticaria, necrotizing angiitis (vasculitis and cutaneous vasculitis), fever, respiratory distress including pneumonitis and pulmonary edema, and anaphylactic reactions.

Immunologic

Immunologic side effects have included nasopharyngitis (2.1%), respiratory tract infection, bronchitis, influenza, viral infection, tooth abscess, viral gastritis, and rhinitis.

Metabolic

Metabolic side effects have included edema (6.5%), weight loss, blood uric acid increased, blood creatine phosphokinase increased, hypokalemia, diabetes mellitus, hyperlipidemia, hyponatremia, and night sweats. Metabolic side effects associated with the amlodipine component have included hot flushes, malaise, rigors, hyperglycemia, thirst, and weight gain. Metabolic side effects associated with the hydrochlorothiazide component have included glycosuria and hyperuricemia. Metabolic side effects associated with the valsartan component have included hyperkalemia in 4.4% of patients.

Musculoskeletal

Musculoskeletal side effects have included muscle spasms (2.2%), back pain (2.1%), pain in extremity, arthralgia, muscular weakness, musculoskeletal pain and weakness, musculoskeletal stiffness, joint swelling, neck pain, osteoarthritis, and tendonitis. Musculoskeletal side effects associated with the amlodipine component have included arthrosis, and muscle cramps. Musculoskeletal side effects associated with the hydrochlorothiazide component are unusual, and include myalgias and chills. Musculoskeletal side effects associated with the valsartan component have included back pain, muscle cramps, and myalgias. In addition, rare reports of rhabdomyolysis have been reported during postmarketing experience in patients receiving angiotensin II receptor blockers.

Nervous system

Nervous system side effects have included dizziness (8.2%), headache (5.2%), fatigue (2.2%), vertigo, paresthesia, somnolence, syncope, carpal tunnel syndrome, disturbance in attention, dysgeusia, head discomfort, lethargy, sinus headache, and tremor. Nervous system side effects associated with the amlodipine component have included peripheral neuropathy, tremor, and increased sweating. Nervous system side effects associated with the hydrochlorothiazide component have included restlessness. Nervous system side effects associated with the valsartan component have included headaches, orthostatic effects, including dizziness, and vertigo. These side effects appear to be dose dependent and have reportedly been the most common reasons for discontinuation of therapy.

Ocular

Ocular side effects have included blurred vision. Ocular side effects associated with the amlodipine component have included abnormal vision, conjunctivitis, diplopia, and eye pain. Ocular side effects associated with the hydrochlorothiazide component have included transient blurred vision, xanthopsia, and idiosyncratic reactions resulting in acute transient myopia and acute angle-closure glaucoma.

Other

Other side effects have included ear and labyrinth disorders, and tinnitus. Other side effects associated with the amlodipine component have included tinnitus.

Psychiatric

Psychiatric side effects have included anxiety, depression, and insomnia. Psychiatric side effects associated with the valsartan component have included anxiety, insomnia, paresthesia, and somnolence.

Renal

Renal side effects associated with the amlodipine component are rare and have included at least one case of interstitial nephritis. Renal side effects associated with the hydrochlorothiazide component have included an increase in serum creatinine and BUN which may be due to hydrochlorothiazide-induced intravascular volume depletion. Rare cases of interstitial nephritis have also been reported with hydrochlorothiazide use. Renal side effects associated with the valsartan component have included impaired renal function, increases in serum creatinine concentrations, blood urea nitrogen, and potassium.

Respiratory

Respiratory side effects have included dyspnea, nasal congestion, cough, and pharyngolaryngeal pain. Respiratory side effects associated with the amlodipine component have included sexual dysfunction (male and female), nervousness, abnormal dreams, and depersonalization. Respiratory side effects associated with the hydrochlorothiazide component have been rare, and included acute noncardiogenic pulmonary edema. Respiratory side effects associated with the valsartan component have included sinusitis and pharyngitis.

Genitourinary

Genitourinary side effects have included urinary tract infection, erectile dysfunction, dysuria, and pollakiuria. Genitourinary side effects associated with the amlodipine component have included micturition frequency, micturition disorder, and nocturia. Genitourinary side effects associated with the valsartan component have included rare reports of impotence.

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