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Latest revision as of 18:23, 27 September 2011
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]
List of side effects
Ezetimibe
Post-marketing Experience
Simvastatin
Laboratory Tests
Concomitant Lipid-Lowering Therapy
Ezetimibe
Other adverse experiences reported with ezetimibe in placebo-controlled studies, regardless of causality assessment:
Body as a whole – general disorders: fatigue; Gastrointestinal system disorders: abdominal pain, diarrhea; Infection and infestations: infection viral, pharyngitis, sinusitis; Musculoskeletal system disorders: arthralgia, back pain; Respiratory system disorders: coughing.
Post-marketing Experience
The following adverse reactions have been reported in post-marketing experience, regardless of causality assessment:
Hypersensitivity reactions, including anaphylaxis, angioedema, rash, and urticaria; arthralgia; myalgia; elevations in liver transaminases; hepatitis; thrombocytopenia; pancreatitis; nausea; dizziness; paresthesia; depression; cholelithiasis; cholecystitis; elevated creatine phosphokinase; and, very rarely, myopathy / rhabdomyolysis.
Simvastatin
Other adverse experiences reported with simvastatin in placebo-controlled clinical studies, regardless of causality assessment:
- Body as a whole – general disorders: asthenia;
- Eye disorders: cataract;
- Gastrointestinal system disorders: abdominal pain, constipation, diarrhea, dyspepsia, flatulence, nausea;
- Skin and subcutaneous tissue disorders: eczema, pruritus, rash.
The following effects have been reported with other HMG-CoA reductase inhibitors. Not all the effects listed below have necessarily been associated with simvastatin therapy.
- Musculoskeletal system disorders: muscle cramps, myalgia, myopathy, rhabdomyolysis, arthralgias.
- Nervous system disorders: dysfunction of certain cranial nerves (including alteration of taste, impairment of extra-ocular movement, facial paresis), tremor, dizziness, memory loss, paresthesia, peripheral neuropathy, peripheral nerve palsy, psychic disturbances.
- Ear and labyrinth disorders: vertigo.
- Psychiatric disorders: anxiety, insomnia, depression, loss of libido.
- Hypersensitivity Reactions: An apparent hypersensitivity syndrome has been reported rarely which has included one or more of the following features: anaphylaxis, angioedema, lupus erythematosus-like syndrome]], polymyalgia rheumatica, dermatomyositis, vasculitis, purpura, thrombocytopenia, leukopenia, hemolytic anemia, positive ANA, ESR increase, eosinophilia, arthritis, arthralgia, urticaria, asthenia, photosensitivity, fever, chills, flushing, malaise, dyspnea, toxic epidermal necrolysis, erythema multiforme, including Stevens-Johnson syndrome.
- Gastrointestinal system disorders: pancreatitis, vomiting.
- Hepatobiliary disorders: hepatitis, including chronic active hepatitis, cholestatic jaundice, fatty change in liver, and, rarely, cirrhosis, fulminant hepatic necrosis, hepatic failure, and hepatoma.
- Metabolism and nutrition disorders: anorexia.
- Skin and subcutaneous tissue disorders: alopecia, pruritus. A variety of skin changes (e.g., nodules, discoloration, dryness of skin/mucous membranes, changes to hair/nails) have been reported.
- Reproductive system and breast disorders: gynecomastia, erectile dysfunction.
- Eye disorders: progression of cataracts (lens opacities), ophthalmoplegia.
- Laboratory Abnormalities: elevated transaminases, alkaline phosphatase, γ-glutamyl transpeptidase, and bilirubin; thyroid function abnormalities.
Laboratory Tests
Marked persistent increases of serum transaminases have been noted. About 5% of patients taking simvastatin had elevations of CK levels of 3 or more times the normal value on one or more occasions. This was attributable to the noncardiac fraction of CK. Muscle pain or dysfunction usually was not reported omyolysis).
Concomitant Lipid-Lowering Therapy
In controlled clinical studies in which simvastatin was administered concomitantly with cholestyramine, no adverse reactions peculiar to this concomitant treatment were observed. The adverse reactions that occurred were limited to those reported previously with simvastatin or cholestyramine.
Adolescent Patients (ages 10-17 years)
In a 48-week controlled study in adolescent boys and girls who were at least 1 year post-menarche, 10-17 years of age with heterozygous familial hypercholesterolemia (n=175), the safety and tolerability profile of the group treated with simvastatin (10-40 mg daily) was generally similar to that of the group treated with placebo, with the most common adverse experiences observed in both groups being upper respiratory infection, headache, abdominal pain, and nausea.
Adapted from the FDA Package Insert.