Amlodipine / Hydrochlorothiazide / Valsartan Side Effects

Medically reviewed by Drugs.com. Last updated on Aug 30, 2024.

Applies to amlodipine / hydrochlorothiazide / valsartan: oral tablet.

Important warnings This medicine can cause some serious health issues

Oral route (tablet)

Drugs with direct action on the renin-angiotensin system can cause injury or death to the developing fetus.

Stop therapy as soon as possible when pregnancy occurs.

Serious side effects

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 or tightness
• chills
• cold sweats
• coma
• confusion
• 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
• persistent non-healing sore
• pink growth
• reddish patch or irritated area
• seizures
• shiny bump
• shivering
• sneezing
• sore throat
• stuffy or runny nose
• sweating
• trouble sleeping
• unexplained weight loss
• unusual tiredness or weakness
• white, yellow or waxy scar-like area

Other side effects

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
• 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
• 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^[Ref]

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^[Ref]

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^[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

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^[Ref]

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^[Ref]

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^[Ref]

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^[Ref]

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^[Ref]

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^[Ref]

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^[Ref]

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^[Ref]

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^[Ref]

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^[Ref]

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^[Ref]

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^[Ref]

Endocrine

• Frequency not reported: Glucose intolerance, altered lipid profile

Other

• Frequency not reported: Ear and labyrinth disorders, tinnitus^[Ref]

Further information

Amlodipine/hydrochlorothiazide/valsartan side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

Medical Disclaimer