Vytorin

[ezetimibe/simvastatin]

Simvastatin

Other adverse experiences reported with simvastatin in placebo-controlled clinical studies, regardless of causality assessment:

Body as a whole –

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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 hyper sensitivity syndrome has been reported rarely which has
included one or more of the following features:

anaphylaxis, angioedema, lupus erythematous-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, 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.

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