whom received valsartan in combination with amlodipine. The following adverse reactions were found to be the most frequently occurring or the most significant or severe: nasopharyngitis, influenza, hypersensitivity, headache, syncope, orthostatic hypotension, oedema, pitting oedema, facial oedema, oedema peripheral, fatigue, flushing, asthenia and hot flush.
Tabulated list of 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 (1/1,000 to <1/100); rare (1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Infections and infestations
Common:
Nasopharyngitis, influenza
Immune system disorders
Rare:
Hypersensitivity
Psychiatric disorders
Rare:
Anxiety
Nervous system disorders
Common:
Headache
Uncommon:
Dizziness, somnolence, dizziness postural, paraesthesia
Eye disorders
Rare:
Visual disturbance
Ear and labyrinth disorders
Uncommon:
Vertigo
Rare:
Tinnitus
Cardiac disorders
Uncommon:
Tachycardia, palpitations
Rare:
Syncope
Vascular disorders
Uncommon:
Orthostatic hypotension
Rare:
Hypotension
Respiratory, thoracic and mediastinal disorders
Uncommon:
Cough, pharyngolaryngeal pain
Gastrointestinal disorders
Uncommon:
Diarrhoea, nausea, abdominal pain, constipation, dry mouth
Skin and subcutaneous tissue disorders
Uncommon:
Rash, erythema
Rare:
Hyperhidrosis, exanthema, pruritus
Musculoskeletal and connective tissue disorders
Uncommon:
Joint swelling, back pain, arthralgia
Rare:
Muscle spasm, sensation of heaviness
Renal and urinary disorders
Rare:
Pollakisuria, polyuria
Reproductive system and breast disorders
Rare:
Erectile dysfunction
General disorders and administration site conditions
Common:
Oedema, pitting oedema, facial oedema, oedema peripheral, fatigue, flushing, asthenia, hot flush
Additional information on the combination
Peripheral oedema, a recognised side 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. In double-blind, controlled clinical trials, the incidence of peripheral oedema by dose was as follows:
% of patients who experienced peripheral oedema
Valsartan (mg)
0
40
80
160
320
Amlodipine (mg)
0
3.0
5.5
2.4
1.6
0.9
2.5
8.0
2.3
5.4
2.4
3.9
5
3.1
4.8
2.3
2.1
2.4
10
10.3
NA
NA
9.0
9.5
The mean incidence of peripheral oedema evenly weighted across all doses was 5.1% with the amlodipine/valsartan combination.
Additional information on the individual components
Adverse reactions previously reported with one of the individual components (amlodipine or valsartan) may be potential adverse reactions with Exforge as well, even if not observed in clinical trials or during the post-marke |
