Co-Diovan Adverse Reactions

Adverse drug reactions reported in clinical trials and laboratory findings occurring more frequently with valsartan plus hydrochlorothiazide versus placebo and individual post-marketing reports are presented as follows according to system organ class. Adverse reactions known to occur with each component given individually but which have not been seen in clinical trials may occur during treatment with valsartan/hydrochlorothiazide.
Adverse drug reactions are ranked by frequency, the most frequent first, 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 ranked in order of decreasing seriousness. (See Table 1.)

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The following events have also been observed during clinical trials in hypertensive patients irrespective of their causal association with the study drug: Abdominal pain, abdominal pain upper, anxiety, arthritis, asthenia, back pain, bronchitis, bronchitis acute, chest pain, dizziness postural, dyspepsia, dyspnea, dry mouth, epistaxis, erectile dysfunction, gastroenteritis, headache, hyperhydrosis, hypoesthesia, influenza, insomnia, ligament sprain, muscle spasms, muscle strain, nasal congestion, nasopharyngitis, nausea, neck pain, oedema, oedema peripheral, otitis media, pain in extremity, palpitations, pharyngolaryngeal pain, pollakiuria, pyrexia, sinusitis, sinus congestion, somnolence, tachycardia, upper respiratory tract infections, urinary tract infections, vertigo, viral infections, vision disturbance.
Additional information on the individual components: Adverse reactions previously reported with one of the individual components may be potential undesirable effects with Co-Diovan as well, even if not observed in clinical trials or during post-marketing period.
Valsartan: (See Table 2.)

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The following events have also been observed during clinical trials in hypertensive patients irrespective of their causal association with the study drug: Arthralgia, asthenia, back pain, diarrhoea, dizziness, headache, insomnia, libido decrease, nausea, oedema, pharyngitis, rhinitis, sinusitis, upper respiratory tract infection, viral infections.
Hydrochlorothiazide: (See Table 3.)

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Description of selected adverse reactions: Non-melanoma skin cancer: Based on available data from epidemiological studies, cumulative dose-dependent association between HCTZ and NMSC has been observed.