Amlodipine, Valsartan, and Hydrochlorothiazide (Oral Route)

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Side Effects

Along with its needed effects, a medicine 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:

• Dizziness
• Swelling

• Bladder pain
• Bloody or cloudy urine
• Blurred vision
• Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• Chest pain
• Chills
• Cold sweats
• Coma
• Confusion
• Convulsions
• Cough
• Decreased urination
• Diarrhea
• Difficult or labored breathing
• Difficult, burning, or painful urination
• Dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• Dry mouth
• Fast, pounding, or irregular heartbeat or pulse
• Fever
• Flushed, dry skin
• Frequent urge to urinate
• Fruit-like breath odor
• Head congestion
• Hoarseness or other voice changes
• Increased hunger
• Increased sweating
• Increased thirst
• Lightheadedness
• Loss of appetite
• Loss of consciousness
• Lower back or side pain
• Muscle aches and pains
• Nausea or vomiting
• Numbness or tingling in the hands, feet, or lips
• Shivering
• Sneezing
• Sore throat
• Stuffy or runny nose
• Sweating
• Tightness in the chest
• Trouble sleeping
• Unexplained weight loss
• Unusual tiredness or weakness

Some side effects 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:

• Acid or sour stomach
• Back pain
• Belching
• Heartburn
• Indigestion
• Muscle spasms
• Stomach discomfort, upset, or pain

• Bleeding after defecation
• Body aches or pain
• Burning feeling in the chest or stomach
• Change in taste
• Continuing ringing or buzzing or other unexplained noise in the ears
• Decreased interest in sexual intercourse
• Decreased weight
• Depression
• Difficulty having a bowel movement (stool)
• Difficulty moving
• Fear or nervousness
• Feeling of constant movement of self or surroundings
• Hearing loss
• Inability to have or keep an erection
• Increased appetite
• Itching skin
• Lack or loss of strength
• Loss in sexual ability, desire, drive, or performance
• Loss of taste
• Muscle weakness
• Neck pain
• Pain in the arms or legs
• Pain, swelling, or redness in the joints
• Rash
• Sensation of spinning
• Shakiness in the legs, arms, hands, or feet
• Sleeplessness
• Sneezing
• Swelling of the joints
• Tender, swollen glands in the neck
• Tenderness in the stomach area
• Toothache
• Trouble swallowing
• Uncomfortable swelling around the anus
• Unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
• Upper abdominal or stomach pain
• Voice changes
• Weight loss

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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