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Amlodipine / valsartan Side Effects

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.

Severity: Major

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
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

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

Severity: Minor

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:

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[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]

References

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

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.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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