Amlodipine / valsartan Side Effects

Some side effects of amlodipine / valsartan may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to amlodipine / valsartan: oral tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking amlodipine / valsartan: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

In rare cases, amlodipine and valsartan can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. Call your doctor right away if you have unexplained muscle pain, tenderness, or weakness especially if you also have fever, unusual tiredness, and dark colored urine.

Call your doctor at once if you have:

• a light-headed feeling, like you might pass out;

• swelling in your hands or feet, rapid weight gain;

• fast or pounding heartbeats;

• jaundice (yellowing of the skin or eyes); or

• chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling.

Common side effects may include:

• dizziness, spinning sensation; or

• cold symptoms such as stuffy nose, sneezing, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to amlodipine / valsartan: oral tablet

Cardiovascular

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

Dermatologic side effects including flushing, pruritus, rash, hyperhidrosis, exanthema, eczema, alopecia, and erythema multiforme have been reported.

Endocrine

Endocrine side effects have included diabetes mellitus.

Gastrointestinal

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

Genitourinary side effects have included hematuria, pollakiuria, micturation frequency, nocturia, impotence, erectile dysfunction, and cystitis.

Hematologic

Hematologic side effects have included leucopenia, neutropenia, purpura, and thrombocytopenia.

Hepatic

Hepatic side effects including elevated liver enzymes have been reported in patients treated with amlodipine-valsartan.

Metabolic

Metabolic side effects have included hyperkalemia, gout, hyperglycemia, weight gain, weight loss, and hypercholesterolemia.

Musculoskeletal

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

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

Ocular side effects including abnormal vision, conjunctivitis, diplopia, and eye pain have been reported.

Other

Other side effects have included ear pain, tinnitus, fatigue, asthenia, malaise, lymphadenopathy, fever, edema, and chest pain.

Psychiatric

Psychiatric side effects including anxiety, nervousness, abnormal dreams, depersonalization, and depression have been reported.

Renal

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

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.

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