The frequencies of adverse events are ranked according to the following: very common (≥ 1/10); common (≥ 1/100, < 1/10); uncommon (≥ 1/1000, < 1/100); rare (≥ 1/10,000, < 1/1,000); very rare (< 1/10,000); Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Pravastatin has been studied at 40 mg in seven randomised double-blind placebo-controlled trials involving over 21,000 patients treated with pravastatin (n = 10,764) or placebo (n = 10,719), 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 the pravastatin group compared to the placebo group.
Nervous system disorders:
Uncommon: dizziness, headache, sleep disturbance, insomnia.
Uncommon: vision disturbance (including blurred vision and diplopia).
Uncommon: dyspepsia/heartburn, abdominal pain, nausea/vomiting, constipation, diarrhoea, flatulence.
Skin and subcutaneous tissue disorders
: Uncommon: pruritus, rash, urticaria, scalp/hair abnormality (including alopecia).
Renal and urinary disorders:
Uncommon: abnormal urination (including dysuria, frequency, nocturia).
Reproductive system and breast disorders:
Uncommon: sexual dysfunction.
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).
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.
In addition to the above the following adverse events have been reported during post marketing experience of pravastatin: Nervous system disorders:
Very rare: peripheral polyneuropathy, in particular if used for long period of time, paresthesia.
Immune system disorders:
Very rare: Hypersensitivity reactions: anaphylaxis, angioedema, lupus erythematous - like syndrome.
Very rare: pancreatitis.
Very rare: jaundice, hepatitis, fulminant hepatic necrosis.
Musculoskeletal and connective tissue disorders:
Very rare: rhabdomyolysis, which can be associated with acute renal failure secondary to myoglobinuria, myopathy, myositis, polymyositis.
Isolated cases of tendon disorders, sometimes complicated by rupture.
Nightmares; memory loss; depression.
Exceptional cases of interstitial lung disease, especially with long term therapy.
Diabetes Mellitus: Frequency will depend on the presence or absence of risk factors (fasting blood glucose = 5.6 mmol/L, BMI >30kg/m2
, raised triglycerides, history of hypertension).