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

Along with its needed effects, amlodipine / hydrochlorothiazide / valsartan may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking amlodipine / hydrochlorothiazide / valsartan:

More common
  • Dizziness
  • swelling
Rare
  • Bladder pain
  • bloody or cloudy urine
  • blurred vision
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • chest pain
  • chills
  • cold sweats
  • coma
  • confusion
  • convulsions
  • cough
  • decreased urination
  • diarrhea
  • difficult or labored breathing
  • difficult, burning, or painful urination
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • dry mouth
  • fast, pounding, or irregular heartbeat or pulse
  • fever
  • flushed, dry skin
  • frequent urge to urinate
  • fruit-like breath odor
  • head congestion
  • hoarseness or other voice changes
  • increased hunger
  • increased sweating
  • increased thirst
  • lightheadedness
  • loss of appetite
  • loss of consciousness
  • lower back or side pain
  • muscle aches and pains
  • nausea or vomiting
  • numbness or tingling in the hands, feet, or lips
  • shivering
  • sneezing
  • sore throat
  • stuffy or runny nose
  • sweating
  • tightness in the chest
  • trouble sleeping
  • unexplained weight loss
  • unusual tiredness or weakness

Some side effects of amlodipine / hydrochlorothiazide / valsartan 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:

Less common
  • Acid or sour stomach
  • back pain
  • belching
  • heartburn
  • indigestion
  • muscle spasms
  • stomach discomfort, upset, or pain
Rare
  • Bleeding after defecation
  • body aches or pain
  • burning feeling in the chest or stomach
  • change in taste
  • continuing ringing or buzzing or other unexplained noise in the ears
  • decreased interest in sexual intercourse
  • decreased weight
  • depression
  • difficulty having a bowel movement (stool)
  • difficulty moving
  • fear or nervousness
  • feeling of constant movement of self or surroundings
  • hearing loss
  • inability to have or keep an erection
  • increased appetite
  • itching skin
  • lack or loss of strength
  • loss in sexual ability, desire, drive, or performance
  • loss of taste
  • muscle weakness
  • neck pain
  • pain in the arms or legs
  • pain, swelling, or redness in the joints
  • rash
  • sensation of spinning
  • shakiness in the legs, arms, hands, or feet
  • sleeplessness
  • sneezing
  • swelling of the joints
  • tender, swollen glands in the neck
  • tenderness in the stomach area
  • toothache
  • trouble swallowing
  • uncomfortable swelling around the anus
  • unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
  • upper abdominal or stomach pain
  • voice changes
  • weight loss

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.

More about Exforge HCT (amlodipine / hydrochlorothiazide / valsartan)

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