Amlodipine / hydrochlorothiazide / valsartan Side Effects

Not all side effects for amlodipine / hydrochlorothiazide / valsartan may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to amlodipine / hydrochlorothiazide / valsartan: oral tablet

In addition to its needed effects, some unwanted effects may be caused by amlodipine / hydrochlorothiazide / valsartan. In the event that any of these side effects do occur, they may require medical attention.

You should check with your doctor immediately if any of these side effects occur when 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 of the side effects that can occur with amlodipine / hydrochlorothiazide / valsartan may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

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

Rare (less than 0.1%): Palpitations, chest pain, angioedema
Uncommon (0.1% to 1%): Orthostatic hypotension, postural dizziness
Frequency not reported: Cardiac arrhythmias (including ventricular ectopy and complete AV heart block)
-Amlodipine component: Arrhythmia (including ventricular tachycardia and atrial fibrillation), bradycardia, chest pain, peripheral ischemia, syncope, postural hypotension, vasculitis
-Hydrochlorothiazide component: Cardiac arrhythmias (including ventricular ectopy and complete AV heart block associated with hypokalemia and hyponatremia)
-Valsartan component: Dizziness related to orthostatic hypotension, palpitations, chest pain

Dermatologic

Frequency not reported: Erythema annular centrifugum, acute eczematous dermatitis, morbilliform, leukocytoclastic vasculitis, phototoxic dermatitis, subacute cutaneous lupus erythematosus-like condition, pruritus, rash, hyperhidrosis
-Amlodipine component: Angioedema, erythema multiforme, rash erythematosus, rash maculopapular
-Hydrochlorothiazide component: Erythema annular centrifugum, acute eczematous dermatitis, morbilliform, leukocytoclastic vasculitis, phototoxic dermatitis, a rare subacute lupus erythematosus-like reaction

Gastrointestinal

Uncommon (0.1% to 1%): Diarrhea, constipation, appetite changes, dry mouth, dyspepsia, nausea, vomiting, flatulence, pancreatitis, cholecystitis, abdominal pain, toothache, gastritis, anorexia, dehydration, hemorrhoids
-Amlodipine component: Frequency not reported Anorexia, dysphagia, pancreatitis, gingival hyperplasia
-Hydrochlorothiazide component: Rare (less than 0.1%): Pancreatitis, nausea, acute cholecystitis
-Valsartan component: Rare (less than 0.1%): Diarrhea, constipation, dry mouth, dyspepsia, anorexia, nausea, vomiting, taste disturbance, flatulence

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
-Amlodipine component: Frequency not reported: Leucopenia, purpura, thrombocytopenia
-Hydrochlorothiazide component Frequency not reported: Aplastic anemia, agranulocytosis, hemolytic anemia
-Valsartan component: Frequency not reported: Decreases in hematocrit or hemoglobin, neutropenia, thrombocytopenia

Hepatic

Uncommon (0.1% to 1%): Increases in hepatic enzymes (usually reversible)
Frequency not reported: Blood creatine phosphokinase increased
-Amlodipine component: Very rare (less than 0.01%): Hepatitis; Frequency not reported: Hepatic enzyme elevations, jaundice
-Hydrochlorothiazide component: Rare (less than 0.1%): Intrahepatic cholestasis, jaundice.
-Valsartan component: Very rare (less than 0.01%): Hepatitis; Frequency not reported: Elevated liver enzymes

Hypersensitivity

Rare (less than 0.1%): Nausea, diarrhea, rash, acute pulmonary edema, interstitial nephritis or cystitis, anaphylaxis, erythema multiforme, vasculitis, serum sickness
-Hydrochlorothiazide component: Frequency not reported: Photosensitivity, urticaria, necrotizing angiitis (vasculitis and cutaneous vasculitis), fever, respiratory distress including pneumonitis and pulmonary edema, anaphylactic reactions

Immunologic

Common (1% to 10%): nasopharyngitis (2.1%), Respiratory tract infection, bronchitis, influenza, viral infection, tooth abscess, viral gastritis, rhinitis
Rare (0.01% to 0.1%): Allergic vasculitis, hemolytic anemia
-Amlodipine component: Uncommon (0.1% to 1%): Angioedema, erythema multiforme
-Hydrochlorothiazide component: Very rare (less than 0.01%): Necrotizing vasculitis
-Valsartan component: Frequency not reported: Angioedema

Metabolic

Common (1% to 10%): Edema
Rare (0.01% to 0.1%): Hypokalemia, hyperkalemia, metabolic alkalosis, hyponatremia, hypomagnesemia, hypercalcemia, hyperglycemia, elevated serum uric acid levels, elevated serum cholesterol
Frequency not reported: Weight loss, blood uric acid increased, blood creatine phosphokinase increased, hypokalemia, diabetes mellitus, hyperlipidemia, hyponatremia, night sweats
-Amlodipine component: Frequency not reported: Hot flushes, malaise, rigors, hyperglycemia, thirst, weight gain
-Hydrochlorothiazide component: Frequency not reported: Glycosuria, hyperuricemia
-Valsartan component: Common (1% to 10%): Hyperkalemia

Musculoskeletal

Common (1% to 10%): Back pain, muscle cramps
Frequency not reported: Myalgia, asthenia, noncardiac chest pain, pain in extremity, arthralgia, muscular weakness, musculoskeletal pain weakness, musculoskeletal stiffness, joint swelling, neck pain, osteoarthritis, tendonitis
-Amlodipine component: Frequency not reported: Arthrosis, muscle cramps, muscle cramps, muscle weakness, ataxia, hypertonia
-Hydrochlorothiazide component: Frequency not reported: Myalgia, chills
-Valsartan component: Rare (less than 0.1%): Rhabdomyolysis; Frequency not reported: Back pain, muscle cramps

Nervous system

Common (1% to 10%): Headache, fatigue, dizziness, chills, malaise
Rare (less than 0.1%): Vertigo, tinnitus
Frequency not reported: Vertigo, paresthesia, somnolence, syncope, carpal tunnel syndrome, disturbance in attention, dysgeusia, head discomfort, lethargy, sinus headache, tremor
-Amlodipine component: Frequency not reported: Peripheral neuropathy, tremor, increased sweating
-Hydrochlorothiazide component; Frequency not reported: Restlessness
-Valsartan component: Frequency not reported: Headache, orthostatic effects, (including dizziness), vertigo

Ocular

Rare (less than 0.1%): Abnormal vision, blurred vision
-Amlodipine component: Rare (less than 0.1%): Xerophthalmia; Frequency not reported: Abnormal vision, conjunctivitis, diplopia, eye pain
-Hydrochlorothiazide component: Frequency not reported: Transient blurred vision, xanthopsia, idiosyncratic reactions resulting in acute transient myopia and acute angle-closure glaucoma

Psychiatric

Rare (less than 0.1%): Anxiety, depression, decreased libido, insomnia, paresthesias, somnolence
-Amlodipine component: Uncommon (0.1% to 1%): Insomnia, nervousness, depression, abnormal dreams, depersonalization, parosmia, mood changes, apathy, agitation, amnesia;
-Hydrochlorothiazide component: Rare (less than 0.1%): Sleep disturbances, depression
-Valsartan component: Frequency not reported: Insomnia

Renal

Rare (less than 0.1%): Renal insufficiency, azotemia
-Amlodipine component: Rare (less than 0.1%): Interstitial nephritis
-Hydrochlorothiazide component: Rare (less than 0.1%): Interstitial nephritis; Frequency not reported: Increase in serum creatinine and BUN (which may be due to hydrochlorothiazide-induced intravascular volume depletion)
-Valsartan component: Frequency not reported: Impaired renal function, serum creatinine increased, blood urea nitrogen increased, potassium increased

Respiratory

Uncommon (0.1% to 1%): Dyspnea, acute pulmonary edema
-Amlodipine component: Frequency not reported: Pulmonary edema, nasal congestion, cough, pharyngolaryngeal pain
Hydrochlorothiazide component: Rare (less than 0.1%): Acute noncardiogenic pulmonary edema
-Valsartan component: Common (1% to 10%): Cough; Frequency not reported: Sinusitis, pharyngitis

Genitourinary

Rare (less than 0.1%): Dysuria, urinary tract infection, erectile dysfunction, pollakiuria.
-Amlodipine component: Frequency not reported: Micturition frequency, micturition disorder, nocturia, gynecomastia
-Hydrochlorothiazide component: Common (1% to 10%): Dysuria
-Valsartan component: Rare (0.01% to 0.1%): impotence

Endocrine

Frequency not reported: Glucose intolerance, altered lipid profile

Other

Frequency not reported: Ear and labyrinth disorders, tinnitus

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