Lescol Side Effects

Generic Name: Fluvastatin

Please note - some side effects for Lescol may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Lescol - for the consumer

Lescol

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Lescol:

Headache; stomach pain or upset.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); change in the amount of urine produced; chest pain; dark urine; fever, chills, or persistent sore throat; flu-like symptoms; joint pain; mental or mood changes; muscle pain, tenderness, or weakness (with or without fever or fatigue); numbness or tingling of the skin, arm, or leg; painful or frequent urination; pale stools; red, swollen, blistered, or peeling skin; severe stomach pain; yellowing of the eyes or skin.

Lescol XL Extended-Release Tablets

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Lescol XL Extended-Release Tablets:

Headache; stomach pain or upset.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); change in the amount of urine produced; chest pain; dark urine; decreased sexual desire or ability; fever, chills, or persistent sore throat; flu-like symptoms; joint pain; mental or mood changes; muscle pain, tenderness, or weakness (with or without fever or fatigue); numbness or tingling of the skin, arm, or leg; painful or frequent urination; pale stools; red, swollen, blistered, or peeling skin; severe stomach pain; yellowing of the eyes or skin.

For the professional

Lescol

In all clinical studies of Lescol® (fluvastatin sodium), 1.0% (32/2969) of fluvastatin-treated patients were discontinued due to adverse experiences attributed to study drug (mean exposure approximately 16 months ranging in duration from 1 to >36 months). This results in an exposure adjusted rate of 0.8% (32/4051) per patient year in fluvastatin patients in controlled studies compared to an incidence of 1.1% (4/355) in placebo patients. Adverse reactions have usually been of mild to moderate severity.

      In controlled clinical studies, 3.9% (36/912) of patients treated with Lescol® XL (fluvastatin sodium) 80 mg discontinued due to adverse events (causality not determined).

      Clinically relevant adverse experiences occurring in the Lescol and Lescol XL controlled studies with a frequency >2%, regardless of causality, include the following:

1 Controlled trials with Lescol Capsules (20 and 40 mg daily and 40 mg twice daily)

2 Controlled trials with Lescol XL 80 mg Tablets

      The following effects have been reported with drugs in this class. Not all the effects listed below have necessarily been associated with fluvastatin sodium therapy.

Skeletal: muscle cramps, myalgia, myopathy, rhabdomyolysis, arthralgias.

Neurological: dysfunction of certain cranial nerves (including alteration of taste, impairment of extra-ocular movement, facial paresis), tremor, dizziness, vertigo, memory loss, paresthesia, peripheral neuropathy, peripheral nerve palsy, psychic disturbances, anxiety, insomnia, depression.

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, 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: pancreatitis, hepatitis, including chronic active hepatitis, cholestatic jaundice, fatty change in liver, and, rarely, cirrhosis, fulminant hepatic necrosis, and hepatoma; anorexia, vomiting.

Skin: alopecia, pruritus. A variety of skin changes (e.g., nodules, discoloration, dryness of skin/mucous membranes, changes to hair/nails) have been reported.

Reproductive: gynecomastia, loss of libido, erectile dysfunction.

Eye: progression of cataracts (lens opacities), ophthalmoplegia.

Laboratory Abnormalities: elevated transaminases, alkaline phosphatase, γ-glutamyl transpeptidase, and bilirubin; thyroid function abnormalities.

Pediatric Patients

In two open-label, uncontrolled studies, 114 patients (66 boys and 48 girls) with heterozygous familial hypercholesterolemia, 9-16 years of age, were treated for 2 years with fluvastatin sodium administered as Lescol capsules 20 mg- 40 mg bid or Lescol XL 80 mg extended-release tablets. The most common adverse events observed were influenza and infections..

Concomitant Therapy

Fluvastatin sodium has been administered concurrently with cholestyramine and nicotinic acid. No adverse reactions unique to the combination or in addition to those previously reported for this class of drugs alone have been reported. Myopathy and rhabdomyolysis (with or without acute renal failure) have been reported when another HMG-CoA reductase inhibitor was used in combination with immunosuppressive drugs, gemfibrozil, erythromycin, or lipid-lowering doses of nicotinic acid. Concomitant therapy with HMG-CoA reductase inhibitors and these agents is generally not recommended.

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