Mevalotin Protect Adverse Reactions

The frequencies of adverse events are ranked according to the following: very common (≥ 1/10); common (≥ 1/100, < 1/10); uncommon (≥ 1/1,000, < 1/100); rare (≥ 1/10,000, < 1/1,000); very rare (< 1/10,000).
Clinical trials: Pravastatin Sodium Tablets has been studied at 40 mg in seven randomized double-blind placebo-controlled trials involving over 21,000 patients treated with pravastatin (N = 10764) or placebo (N = 10719), representing over 47,000 patients years of exposure to pravastatin. Over 19,000 patients were followed for a median of 4.8-5.9 years.
The following adverse drug reactions were reported; none of them occurred at a rate in excess of 0.3% in pravastatin group compared to the placebo group. (See Table 1.)

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Events of special clinical interest: Skeletal muscle: Effects on the skeletal muscle, e.g. musculoskeletal pain including arthralgia, muscle cramps, myalgia, muscle weakness and elevated CK levels have been reported in clinical trials. The rate of myalgia (1.4% pravastatin vs 1.4% placebo) and muscle weakness (0.1% pravastatin vs < 0.1% placebo) and the incidence of CK level > 3 x ULN and > 10 x ULN in CARE, WOSCOPS and LIPID was similar to placebo (1.6% pravastatin vs 1.6% placebo and 1.0% pravastatin vs 1.0% placebo, respectively) (see Precautions).
Liver effects: Elevations of serum transaminases have been reported. In the three long-term, placebo-controlled clinical trials CARE, WOSCOPS and LIPID, marked abnormalities of ALT and AST (> 3 x ULN) occurred at similar frequency (≤ 1.2%) in both treatment groups.
Post marketing: In addition to the above, the following adverse events have been reported during post marketing experience of pravastatin. (See Table 2.)

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In addition to the above, the following adverse events have been reported in associations with the use of some statins. (See Table 3.)

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