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Amlodipine / valsartan Side Effects

Not all side effects for amlodipine / 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 / valsartan: oral tablet

In addition to its needed effects, some unwanted effects may be caused by amlodipine / 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 / valsartan:

More common
  • Bloating or swelling of the face, arms, hands, lower legs, or feet
  • rapid weight gain
  • tingling of the hands or feet
  • unusual weight gain or loss
Less common
  • Body aches or pain
  • chills
  • cough
  • difficulty with breathing
  • dizziness
  • ear congestion
  • fever
  • headache
  • loss of voice
  • muscle aches
  • sneezing
  • sore throat
  • stuffy or runny nose
  • unusual tiredness or weakness
  • Ankle, knee, or great toe joint pain
  • bloody or cloudy urine
  • blurred or loss of vision
  • burning feeling in the chest or stomach
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • chest pain
  • cold sweats
  • confusion
  • congestion
  • cough producing mucus
  • diarrhea
  • difficult, burning, or painful urination
  • disturbed color perception
  • dizziness, faintness, or lightheadedness when getting up from a lying or sitting position
  • dry mouth
  • fast, irregular, pounding, or racing heartbeat or pulse
  • flushed, dry skin
  • heart murmur
  • hives
  • hoarseness
  • indigestion
  • itching
  • joint pain, stiffness, or swelling
  • loss of appetite
  • nausea
  • pain in the lower back, bottom, or hips
  • pain in the upper leg
  • pain or tenderness around the eyes and cheekbones
  • rash
  • redness of the skin
  • stomach cramps, tenderness, or pain
  • sweating
  • swelling of the eyelids, face, lips, hands, or feet
  • tightness of the chest
  • trouble with swallowing
  • troubled breathing
  • vomiting
  • watery or bloody diarrhea
  • weakness

If any of the following symptoms of overdose occur while taking amlodipine / valsartan, get emergency help immediately:

Symptoms of overdose
  • Chest discomfort
  • cold, clammy skin
  • fast, weak pulse
  • flushing
  • lightheadedness or fainting
  • slow heartbeat

Some of the side effects that can occur with amlodipine / 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:

  • Acid or sour stomach
  • back pain
  • belching
  • bone pain
  • continuing ringing or buzzing or other unexplained noise in the ears
  • difficulty having a bowel movement (stool)
  • difficulty with moving
  • fear or nervousness
  • feeling sad or empty
  • full or bloated feeling
  • hearing loss
  • heartburn
  • inability to have or keep an erection
  • increased sensitivity to sunlight
  • irritability
  • itching, pain, redness, or swelling of the eye or eyelid
  • lack or loss of strength
  • loss in sexual ability, desire, drive, or performance
  • loss of interest or pleasure
  • muscle aching or cramping
  • pain in the arms or legs
  • passing gas
  • pressure in the stomach
  • redness in the joints
  • redness of the skin
  • sensation of spinning
  • skin rash, encrusted, scaly, and oozing
  • sleepiness or unusual drowsiness
  • swelling of the abdominal or stomach area
  • tiredness
  • toothache
  • trouble concentrating
  • unable to sleep
  • unusually warm skin
  • watering of the eyes

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[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." O 0

2. "Product Information. Exforge (amlodipine-valsartan)." Novartis Pharmaceuticals, East Hanover, NJ.

3. Cerner Multum, Inc. "Australian Product Information." O 0

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