Pravastatin Sandoz Adverse Reactions

The frequencies of adverse events are ranked according to the following: 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). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Clinical trials: 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.
Eye disorders: Uncommon: Vision disturbance (including blurred vision and diplopia).
Gastrointestinal disorders: 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.
General disorders: Uncommon: Fatigue.
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 (Cholesterol and Recurrent Events), WOSCOPS (West of Scotland Coronary Prevention study) and LIPID (Long-term Intervention with pravastatin in Ischemic Disease) study 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 previously mentioned, the following adverse events have been reported during post-marketing experience of pravastatin: Immune system disorders: Very rare: Hypersensitivity reactions: anaphylaxis, angioedema, lupus erythematous-like syndrome.
Nervous system disorders: Very rare: Peripheral polyneuropathy, in particular if used for long period of time, paraesthesia.
Gastrointestinal disorders: Very rare: Pancreatitis.
Hepatobiliary disorders: Very rare: Jaundice, hepatitis, fulminant hepatic necrosis.
Not known: Fatal and non fatal hepatic failure.
Skin and subcutaneous tissue disorders: Rare: Photosensitivity reaction.
Very rare: Dermatomyositis.
Not known: Rash including lichenoid rash.
Musculoskeletal and connective tissue disorders: Very rare: Rhabdomyolysis, which can be associated with acute renal failure secondary to myoglobinuria, myopathy (see Precautions); myositis, polymyositis.
Uncommon: Tendon disorders, specifically tendonitis, sometimes complicated by Rupture.
The following adverse events have been reported with some statins: Nightmares; Memory loss; Depression; Exceptional cases of interstitial lung disease, especially with long term therapy (see Precautions); Diabetes mellitus: Frequency will depend on the presence or absence of risk factors (fasting blood glucose at ≥5.6 mmol/l, BMI >30 kg/m², raised triglycerides, history of hypertension).
Musculoskeletal disorders: Not known: Immune-mediated necrotizing myopathy (see Precautions).