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Amlodipine / valsartan Side Effects

Medically reviewed by Last updated on Dec 9, 2023.

Applies to amlodipine / valsartan: oral tablet.


Oral route (Tablet)

If pregnancy is confirmed, discontinue amlodipine valsartan immediately. Injury and death to the developing fetus may result from drugs that act directly on the renin-angiotensin system

Serious side effects

Along with its needed effects, amlodipine / 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 / valsartan:

More common

Less common


Get emergency help immediately if any of the following symptoms of overdose occur while taking amlodipine / valsartan:

Symptoms of overdose

Other side effects

Some side effects of amlodipine / 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 / valsartan: oral tablet.


The most common adverse reactions were BUN increased greater than 50%, peripheral edema, nasopharyngitis, upper respiratory tract infection, and dizziness.[Ref]


Very common (10% or more): BUN increased greater than 50% (up to 10.9%)

Common (1% to 10%): Hypokalemia, serum potassium increased greater than 20%

Uncommon (0.1% to 1%): Anorexia, hypercalcemia, hyperlipidemia, hyperuricemia, hyponatremia, gout, non-insulin-dependent diabetes mellitus, hypercholesterolemia


Uncommon (0.1% to 1%): Weight increased, weight decreased

Very rare (less than 0.01%): Hyperglycemia

Common (1% to 10%): BUN increased

Frequency not reported: Serum potassium increased[Ref]


Common (1% to 10%): Asthenia, fatigue, facial edema, edema, peripheral edema, pitting edema

Uncommon (0.1% to 1%): Ear pain, chest pain, pyrexia


Very common (10% or more): Peripheral edema (up to 10.3%)

Common (1% to 10%): Fatigue, edema, ankle swelling

Uncommon (0.1% to 1%): Gynecomastia, asthenia, discomfort, malaise, non-cardiac chest pain, pain


Common (1% to 10%): Peripheral edema

Uncommon (0.1% to 1%): Fatigue[Ref]


Common (1% to 10%): Flushing, hot flush, orthostatic blood pressure decrease

Uncommon (0.1% to 1%): Palpitation, tachycardia, orthostatic hypotension

Rare (less than 0.1%): Hypotension


Common (1% to 10%): Palpitation, flushing

Uncommon (0.1% to 1%): Hypotension

Very rare (less than 0.01%): Arrhythmia, myocardial infarction, vasculitis


Frequency not reported: Vasculitis[Ref]


Common (1% to 10%): Nasopharyngitis, upper respiratory tract infection

Uncommon (0.1% to 1%): Cough, pharyngolaryngeal pain, sinusitis, bronchitis, pharyngitis, pharyngotonsillitis, bronchitis acute, tonsillitis, sinus congestion, dyspnea, epistaxis, productive cough, dysphonia, nasal congestion


Uncommon (0.1% to 1%): Dyspnea, rhinitis

Very rare (less than 0.01%): Cough


Uncommon (0.1% to 1%): Cough[Ref]

Nervous system

Common (1% to 10%): Headache, dizziness

Uncommon (0.1% to 1%): Coordination abnormal, dizziness postural, paresthesia, somnolence, vertigo, sciatica, cervicobrachial syndrome, carpal tunnel syndrome, hypoesthesia, sinus headache

Rare (less than 0.1%): Tinnitus, syncope


Common (1% to 10%): Dizziness, headache, somnolence

Uncommon (0.1% to 1%): Dysgeusia, paresthesia, syncope, tremor, hypoesthesia, tinnitus

Very rare (less than 0.01%): Hypertonia, peripheral neuropathy, neuropathy

Frequency not reported: Extrapyramidal syndrome


Uncommon (0.1% to 1%): Vertigo[Ref]


Common (1% to 10%): Creatine kinase increased greater than 300%

Uncommon (0.1% to 1%): Arthralgia, back pain, joint swelling, epicondylitis, joint sprain, limb injury, muscle spasm, pain in extremity, myalgia, osteoarthritis, musculoskeletal chest pain

Rare (less than 0.1%): Sensation of heaviness


Uncommon (0.1% to 1%): Arthralgia, back pain, muscle spasm, myalgia


Frequency not reported: Myalgia

Postmarketing reports: Rhabdomyolysis[Ref]


Common (1% to 10%): Influenza

Uncommon (0.1% to 1%): Seasonal allergy

Rare (less than 0.1%): Hypersensitivity


Very rare (less than 0.01%): Hypersensitivity


Frequency not reported: Hypersensitivity[Ref]


Common (1% to 10%): Creatinine increased greater than 50%

Uncommon (0.1% to 1%): Nephrolithiasis


Frequency not reported: Serum creatinine increased, renal failure and impairment[Ref]


Common (1% to 10%): ALT increased greater than 150%


Very rare (less than 0.01%): Liver function test abnormal, serum bilirubin increased, hepatitis, intrahepatic cholestasis, jaundice


Frequency not reported: Liver function test abnormal, serum bilirubin increased[Ref]


Uncommon (0.1% to 1%): Abdominal discomfort, abdominal distention, abdominal pain, upper abdominal pain, constipation, diarrhea, dry mouth, nausea, dyspepsia, gastritis, vomiting, colitis, gastroenteritis


Common (1% to 10%): Abdominal discomfort, upper abdominal pain, nausea

Uncommon (0.1% to 1%): Change of bowel habit, diarrhea, dry mouth, dyspepsia, vomiting

Very rare (less than 0.01%): Gastritis, gingival hyperplasia, pancreatitis


Uncommon (0.1% to 1%): Abdominal discomfort, upper abdominal pain[Ref]


Uncommon (0.1% to 1%): Erythema, rash, pruritus, hyperhidrosis, eczema

Rare (less than 0.1%): Exanthema


Uncommon (0.1% to 1%): Alopecia, exanthema, hyperhidrosis, photosensitivity reaction, pruritus, purpura, rash, skin discoloration

Very rare (less than 0.01%): Angioedema, erythema multiforme, urticaria, exfoliative dermatitis, Stevens-Johnson syndrome, Quincke edema


Frequency not reported: Angioedema, dermatitis bullous, pruritus, rash[Ref]


Uncommon (0.1% to 1%): Hematuria, pollakiuria, erectile dysfunction

Rare (less than 0.1%): Polyuria


Uncommon (0.1% to 1%): Micturition disorder, nocturia, pollakiuria, impotence[Ref]


Uncommon (0.1% to 1%): Insomnia, anxiety, depression


Uncommon (0.1% to 1%): Depression, insomnia/sleep disorders, mood swings

Rare (less than 0.1%): Confusion[Ref]


Uncommon (0.1% to 1%): Visual impairment

Rare (less than 0.1%): Visual disturbance


Uncommon (0.1% to 1%): Visual disturbance, visual impairment[Ref]


Uncommon (0.1% to 1%): Lymphadenopathy


Very rare (less than 0.01%): Leukopenia, thrombocytopenia


Frequency not reported: Hemoglobin decreased, hematocrit decreased, neutropenia, thrombocytopenia[Ref]


1. Cerner Multum, Inc. UK Summary of Product Characteristics.

2. Product Information. Exforge (amlodipine-valsartan). Novartis Pharmaceuticals. 2007.

3. Cerner Multum, Inc. Australian Product Information.

Further information

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.