Pravastatin Sandoz

Pravastatin Sandoz Adverse Reactions



Lek Pharma


Zuellig Pharma


The information highlighted (if any) are the most recent updates for this brand.
Full Prescribing Info
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 above 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).
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