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, cervicobrachial 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 post-myocardial infarction patients, doubling of serum creatinine were reported in 4.2% of patients given Valsartan and in 3.4% of captopril-treated patents.
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, epistaxis, pneumonia, and dysphonia.