Applies to amlodipine / valsartan: oral tablet.

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

• 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

Rare

• 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

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

Symptoms of overdose

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

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:

Rare

• 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.

General

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

Metabolic

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

Amlodipine:

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]

Other

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

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

Amlodipine:

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

Valsartan:

Common (1% to 10%): Peripheral edema

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

Cardiovascular

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

Amlodipine:

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

Uncommon (0.1% to 1%): Hypotension

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

Valsartan:

Frequency not reported: Vasculitis^[Ref]

Respiratory

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

Amlodipine:

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

Very rare (less than 0.01%): Cough

Valsartan:

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

Amlodipine:

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

Valsartan:

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

Musculoskeletal

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

Amlodipine:

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

Valsartan:

Frequency not reported: Myalgia

Postmarketing reports: Rhabdomyolysis^[Ref]

Immunologic

Common (1% to 10%): Influenza

Uncommon (0.1% to 1%): Seasonal allergy

Rare (less than 0.1%): Hypersensitivity

Amlodipine:

Very rare (less than 0.01%): Hypersensitivity

Valsartan:

Frequency not reported: Hypersensitivity^[Ref]

Renal

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

Uncommon (0.1% to 1%): Nephrolithiasis

Valsartan:

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

Hepatic

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

Amlodipine:

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

Valsartan:

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

Gastrointestinal

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

Amlodipine:

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

Valsartan:

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

Dermatologic

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

Rare (less than 0.1%): Exanthema

Amlodipine:

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

Valsartan:

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

Genitourinary

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

Rare (less than 0.1%): Polyuria

Amlodipine:

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

Psychiatric

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

Amlodipine:

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

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

Ocular

Uncommon (0.1% to 1%): Visual impairment

Rare (less than 0.1%): Visual disturbance

Amlodipine:

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

Hematologic

Uncommon (0.1% to 1%): Lymphadenopathy

Amlodipine:

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

Valsartan:

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