Trivan Plus Adverse Reactions

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.