Amlodipine / Valsartan Side Effects

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

Applies to amlodipine / 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. 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.

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 this medicine before you drive, use machines, or do anything else 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.

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 which may cause 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, shortness of breath, or sweating.

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 or medical tests.

Hyperkalemia (high potassium in the blood) may occur in certain people receiving this medicine. Check with your doctor right away if you have the following symptoms: abdominal or stomach pain, confusion, difficulty with breathing, irregular heartbeat, nausea or vomiting, nervousness, numbness or tingling in the hands, feet, or lips, shortness of breath, or weakness or heaviness of the legs. Ask your doctor before you use any medicines, supplements, or salt substitutes that contain potassium.

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 tend to increase your blood pressure.

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:

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:

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]

See also:

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