Corstat

Corstat Adverse Reactions

simvastatin

Manufacturer:

Medreich

Distributor:

The Glory Medicina
/
DKSH
Full Prescribing Info
Adverse Reactions
Corstat is generally well tolerated, for the most part, side effects have been usually mild and transient in nature. Less than 2% on Corstat were discontinued from controlled clinical studies due to side effects attributable to Corstat.
In the premarketing controlled studies, adverse effects occurring with a frequency of ≥1% and considered by the investigator as possibly, probably or definitely drug-related were: Abdominal pain, constipation and flatulence. Other side effects occurring in 0.5-0.9% of patients were asthenia and headache. Myopathy has been reported rarely.
In the Scandinavian Simvastatin Survival Study (4S) involving 4444 patients treated with Corstat 20-40 mg/day (n=2221) or placebo (n=2223), the safety and tolerability profiles were comparable between groups over the median 5.4 years of the study. The following additional side effects were reported either in long-term extension studies or in marketed use: Nausea, diarrhoea, rash, dyspepsia, pruritus, alopecia, dizziness, muscle cramps, myalgia, pancreatitis, paraesthesia, peripheral neuropathy, vomiting and anaemia. Rarely, rhabdomyolysis and hepatitis/jaundice occurred. An apparent hypersensitivity syndrome has been reported rarely which has included some of the following features: Angioedema, lupus-like syndrome, polymyalgia rheumatica, vasculitis, thrombocytopenia, eosinophilia, increased ESR, arthritis, arthralgia, urticaria, photosensitivity, fever, flushing, dyspnoea and malaise.
Laboratory Test Findings: Marked and persistent increases of serum transaminase have been reported infrequently. Elevated alkaline phosphatase and γ-glutamyl transpeptidase have been reported. Liver function test abnormalities have generally been mild and transient. Increases in serum creatine phosphokinase (CPK) levels derived from skeletal muscle have been reported. Side effects-causal relationship unknown: The following side effects have been reported; however, a causal relationship to therapy with Corstat has not been established: Depression, erythema multiforme including Stevens-Johnson syndrome, leucopenia and purpura.
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