Amlodipine / Valsartan Side Effects

Medically reviewed by Drugs.com. Last updated on May 24, 2024.

Applies to amlodipine / valsartan: oral tablet.

Important warnings This medicine can cause some serious health issues

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 side effects

• 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 side effects

• 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 side effects

• 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 side effects

• 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 adverse events

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]

Further information

Amlodipine/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.

Medical Disclaimer