Amlodipine / valsartan Side Effects
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.
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.
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
- Body aches or pain
- difficulty with breathing
- ear congestion
- loss of voice
- muscle aches
- sore throat
- stuffy or runny nose
- unusual tiredness or weakness
- 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
- cough producing mucus
- 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
- joint pain, stiffness, or swelling
- loss of appetite
- pain in the lower back, bottom, or hips
- pain in the upper leg
- pain or tenderness around the eyes and cheekbones
- redness of the skin
- stomach cramps, tenderness, or pain
- swelling of the eyelids, face, lips, hands, or feet
- tightness of the chest
- trouble with swallowing
- troubled breathing
- watery or bloody diarrhea
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
- lightheadedness or fainting
- slow heartbeat
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
- 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
- inability to have or keep an erection
- increased sensitivity to sunlight
- 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
- trouble concentrating
- unable to sleep
- unusually warm skin
- watering of the eyes
For Healthcare Professionals
Applies to amlodipine / valsartan: oral tablet
Cardiovascular side effects for amlodipine-valsartan in relation to placebo therapy have included peripheral edema (5.4% vs 3.0%). Additional cardiovascular side effects reported include orthostatic events (orthostatic hypotension and postural dizziness) in less than 1% of patients, palpitations, bradycardia, vasculitis, syncope, arrhythmia, heart murmur, and tachycardia.
The incidence of peripheral edema is lower with the combination of amlodipine-valsartan than with amlodipine alone.
Dermatologic side effects including flushing, pruritus, rash, hyperhidrosis, exanthema, eczema, alopecia, and erythema multiforme have been reported.
Endocrine side effects have included diabetes mellitus.
Gastrointestinal side effects have included diarrhea, nausea, constipation, dyspepsia, abdominal pain, anorexia, dysphagia, pancreatitis, gastritis, vomiting, abdominal discomfort and distention, gastroenteritis, dry mouth, flatulence, tonsillitis, and colitis.
Genitourinary side effects have included hematuria, pollakiuria, micturation frequency, nocturia, impotence, erectile dysfunction, and cystitis.
Hematologic side effects have included leucopenia, neutropenia, purpura, and thrombocytopenia.
Hepatic side effects including elevated liver enzymes have been reported in patients treated with amlodipine-valsartan.
Metabolic side effects have included hyperkalemia, gout, hyperglycemia, weight gain, weight loss, and hypercholesterolemia.
Musculoskeletal side effects including arthralgia, back pain, muscle spasms, pain in extremities, myalgia, osteoarthritis, joint swelling, muscle cramps, and musculoskeletal chest pain have been reported.
Nervous system side effects for amlodipine-valsartan in relation to placebo therapy have included dizziness (2.1% vs 0.9%). Other nervous system side effects including headache (4.3%), insomnia, peripheral neuropathy, tremor, sciatica, paresthesia, cerviocobrachial syndrome, carpal tunnel syndrome, hypoesthesia, and somnolence have been reported.
Ocular side effects including abnormal vision, conjunctivitis, diplopia, and eye pain have been reported.
Other side effects have included ear pain, tinnitus, fatigue, asthenia, malaise, lymphadenopathy, fever, edema, and chest pain.
Psychiatric side effects including anxiety, nervousness, abnormal dreams, depersonalization, and depression have been reported.
Renal side effects including nephrolithiasis, and increases in serum creatinine and blood urea nitrogen (BUN) have been reported.
In hypertensive patients, greater than 50% increases in serum creatinine were reported in 0.4% of patients given amlodipine-valsartan compared with 0.6% in those given placebo. In heart failure patients, greater than 50% increases in creatinine were reported in 3.9% of valsartan-treated patients compared with 0.9% of placebo-treated patients. In postmyocardial infarction patients, doubling of serum creatinine were reported in 4.2% of patients given valsartan and in 3.4% of captopril-treated patients.
In hypertensive patients, greater than 50% increases in BUN were reported in 5.5% of amlodipine-valsartan treated patients compared with 4.7% of placebo-treated patients. In heart failure patients, greater than 50% increases in BUN were reported in 16.6% of patients given valsartan compared with 6.3% of patients given placebo.
Respiratory side effects for amlodipine-valsartan in relation to placebo therapy have included nasopharyngitis (4.3% vs 1.8%) and upper respiratory tract infection (2.9% vs 2.1%). Other respiratory side effects have included cough, dyspnea, nasopharyngitis, sinusitis, bronchitis, pharyngitis, pharyngolaryngeal pain, sinus/nasal congestion, dyspnea, epistaxis, pneumonia, and dysphonia.
More about amlodipine/valsartan
- Other brands: Exforge
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