Amlodipine / Hydrochlorothiazide / Valsartan Side Effects

Medically reviewed by Drugs.com. Last updated on May 19, 2024.

Applies to amlodipine / hydrochlorothiazide / valsartan: oral tablet.

Precautions

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby, especially in your second or third trimester. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away. You may need to stop using this medicine.

Dizziness, lightheadedness, or fainting may also occur, especially when you get up from a lying or sitting position or if you have been taking a diuretic (water pill). Make sure you know how you react to the medicine before you drive, use machines, or do other things that could be dangerous if you are dizzy or not alert. If you feel dizzy, lie down so you do not faint. Then sit for a few moments before standing to prevent the dizziness from returning. If you faint, call your doctor right away.

Check with your doctor right away if you become sick while taking this medicine, especially with severe or continuing nausea, vomiting, or diarrhea. These conditions may cause you to lose too much water or salt and may lead to low blood pressure. You can also lose water by sweating, so drink plenty of water during exercise or in hot weather.

This medicine may worsen the symptoms of angina (chest pain) or cause a heart attack in certain patients with severe heart or blood vessel disease. Check with your doctor right away if you are having chest pain or discomfort, fast or uneven heartbeat, nausea or vomiting, pain or discomfort in the arms, jaw, back, or neck, trouble breathing, or sweating.

Check with your doctor right away if you have bloody urine, a decrease in frequency or amount of urine, an increase in blood pressure, increased thirst, loss of appetite, lower back or side pain, nausea, swelling of the face, fingers, or lower legs, trouble breathing, unusual tiredness or weakness, vomiting, or weight gain. These could be symptoms of a serious kidney problem.

Check with your doctor immediately if blurred vision, difficulty in reading, eye pain, or any other change in vision occurs during or after treatment. This could be a sign of a serious eye problem. Your doctor may want an eye doctor to check your eyes.

Make sure any doctor or dentist who treats you knows that you are using this medicine. You may need to stop using this medicine several days before having surgery.

Hyperkalemia (high potassium in the blood) may occur in certain people receiving this medicine. Check with your doctor right away if you have stomach pain, confusion, irregular heartbeat, nausea or vomiting, nervousness, numbness or tingling in the hands, feet, or lips, trouble breathing, or weakness or heaviness of the legs. Ask your doctor before you use any medicines, supplements, or salt substitutes that contain potassium without first checking with your doctor.

This medicine may increase your risk of getting skin cancer (eg, non-melanoma skin cancer). Avoid sun exposure. Use a sunscreen when you are outdoors. Avoid sunlamps and tanning beds. Talk to your doctor if you have concerns about this risk.

Do not take other medicines unless they have been discussed with your doctor. This especially includes over-the-counter (nonprescription) medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems, since they may increase your blood pressure.

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:

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:

For healthcare professionals

Applies to amlodipine / hydrochlorothiazide / valsartan: oral tablet.

Cardiovascular adverse events

• 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]

See also:

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.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

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