Exforge Side Effects
Generic name: amlodipine / valsartan
Medically reviewed by Drugs.com. Last updated on May 24, 2024.
Note: This document provides detailed information about Exforge Side Effects associated with amlodipine / valsartan. Some dosage forms listed on this page may not apply specifically to the brand name Exforge.
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
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 of Exforge
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 of Exforge
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]
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References
1. Cerner Multum, Inc. "UK Summary of Product Characteristics."
2. (2007) "Product Information. Exforge (amlodipine-valsartan)." Novartis Pharmaceuticals
3. Cerner Multum, Inc. "Australian Product Information."
More about Exforge (amlodipine / valsartan)
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Further information
Exforge 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.