Amloval 80/5/Amloval 160/5/Amloval 160/10 Adverse Reactions

Adverse reactions have been ranked under headings of frequency using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000, including isolated reports). (See table.)

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Additional information on the combination: Peripheral edema, a recognized adverse effect of amlodipine, was generally observed at a lower incidence in patients who received the amlodipine/valsartan combination than in those who received amlodipine alone.
Additional information on the individual components: Valsartan: Not known: Decrease in haemoglobin, decrease in haematocrit, neutropenia, thrombocytopenia, increase of serum potassium, elevation of liver function values including increase of serum bilirubin, renal failure and impairment, elevation of serum creatinine, angioedema, myalgia, vasculitis, hypersensitivity including serum sickness.
Amlodipine: Common: Vomiting.
Uncommon: Alopecia, altered bowel habits, dyspepsia, dyspnoea, rhinitis, gastritis, gingival hyperplasia, gynaecomastia, hyperglycaemia, impotence, increased urinary frequency, leucopenia, malaise, mood changes, myalgia, peripheral neuropathy, pancreatitis, hepatitis, thrombocytopenia, vasculitis, angioedema and erythema multiforme.
Rare: Arrhythmia, myocardial infarction. Rarely, patients, particularly those with severe obstructive coronary artery disease, have developed increased frequency, duration or severity of angina or acute myocardial infarction on starting calcium channel blocker therapy or at the time of dosage increase. Arrhythmia (including ventricular tachycardia and atrial fibrillation) has also been reported. These adverse events may not be distinguishable from the natural history of the underlying disease.
Very rare: Cholestatic jaundice, AST and ALT increase, purpura, rash and pruritus. Exceptional cases of extrapyramidal syndrome have been reported.