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Lescol

"March 8, 2010 (Miami Beach, Fla.) -- Once again, cholesterol-lowering statin drugs have been shown to be good for more than the heart.

Already linked to a reduced risk of rheumatoid arthritis, diabetes, multiple sclerosis, and cancer, s"...

Lescol

Lescol

Lescol Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Lescol (fluvastatin sodium) reduces low-density lipoprotein (LDL) cholesterol and total cholesterol in the blood, and is used to help prevent heart disease and hardening of the arteries, conditions that can lead to heart attack, stroke, and vascular disease. It is a cholesterol-lowering medication that blocks the production of cholesterol (a type of fat) in the body. Common side effects include stomach upset. Less frequent side effects include muscle pain/tenderness/weakness (especially with fever or unusual tiredness), or change in the amount of urine.

Dose range of Lescol is 20 mg to 80 mg/ day. Lescol may interact with stomach acid reducers, cholestyramine, danazol, diclofenac, glyburide, nefazodone, niacin, phenytoin, rifampin, gemfibrozil or fenofibrate, drugs that weaken your immune system such as cancer medicine or steroids, cyclosporine, tacrolimus, and others; amiodarone, diltiazem, or verapamil, antibiotics, antifungals, blood thinners, or HIV /AIDS medicine. Tell your doctor all medications you area taking. Lescol must not be used during pregnancy. It can cause birth defects. This medication passes into breast milk and may have undesirable effects on a nursing infant. Breast-feeding while using this drug is not recommended.

Our Lescol (fluvastatin sodium) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Lescol in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop taking fluvastatin and call your doctor at once if you have any of these serious side effects:

  • unexplained muscle pain, tenderness, or weakness;
  • fever, unusual tiredness, and dark colored urine;
  • pain or burning when you urinate;
  • swelling, weight gain, urinating less than usual or not at all; or
  • nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

  • headache;
  • mild muscle pain;
  • diarrhea;
  • mild nausea;
  • stomach pain or indigestion;
  • sleep problems (insomnia); or
  • cold symptoms such as stuffy nose, sneezing, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Lescol (Fluvastatin Sodium) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Lescol Overview - Patient Information: Side Effects

SIDE EFFECTS: Stomach upset may occur. If this effect persists or worsens, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

A very small number of people taking fluvastatin may have mild memory problems or confusion. If these rare effects occur, talk to your doctor.

This drug may infrequently cause muscle problems (which can rarely lead to very serious conditions called rhabdomyolysis and autoimmune myopathy). Tell your doctor right away if you develop any of these symptoms during treatment and if these symptoms persist after your doctor stops this drug: muscle pain/tenderness/weakness (especially with fever or unusual tiredness), change in the amount of urine.

This medication may rarely cause liver problems. If you notice any of the following rare but serious side effects, tell your doctor immediately: yellowing eyes/skin, dark urine, severe stomach/abdominal pain, persistent nausea/vomiting.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Lescol (Fluvastatin Sodium)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Lescol FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

The following serious adverse reactions are discussed in greater detail in other sections of the label:

Clinical Studies Experience in Adult Patients

Because clinical studies on LESCOL/LESCOL XL are conducted in varying study populations and study designs, the frequency of adverse reactions observed in the clinical studies of LESCOL/LESCOL XL cannot be directly compared with that in the clinical studies of other statins and may not reflect the frequency of adverse reactions observed in clinical practice.

In the LESCOL placebo-controlled clinical trials database of 2326 patients treated with LESCOL1 (age range 18-75 years, 44% women, 94% Caucasians, 4% Blacks, 2% other ethnicities) with a median treatment duration of 24 weeks, 3.4% of patients on LESCOL and 2.3% patients on placebo discontinued due to adverse reactions regardless of causality. The most common adverse reactions that led to treatment discontinuation and occurred at an incidence greater than placebo were: transaminase increased (0.8%), upper abdominal pain (0.3%), dyspepsia (0.3%), fatigue (0.2%) and diarrhea (0.2%).

In the LESCOL XL database of controlled clinical trials of 912 patients treated with LESCOL XL (age range 21-87 years, 52% women, 91% Caucasians, 4% Blacks, 5% other ethnicities) with a median treatment duration of 24 weeks, 3.9% of patients on LESCOL XL discontinued due to adverse reactions regardless of causality. The most common adverse reactions that led to treatment discontinuation were abdominal pain (0.7%), diarrhea (0.5%), nausea (0.4%), dyspepsia (0.4%) and chest pain (0.3%).

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

Table 1 : Clinical adverse events reported in > 2% in patients treated with LESCOL/LESCOL XL and at an incidence greater than placebo in placebo-controlled trials regardless of causality (% of patients) Pooled Dosages

    LESCOL1
N=2326
(%)
Placebo1
N=960
(%)
LESCOL XL2
N=912
(%)
Musculoskeletal Myalgia 5.0 4.5 3.8
Arthritis 2.1 2.0 1.3
Arthropathy NA NA 3.2
Respiratory Sinusitis 2.6 1.9 3.5
Bronchitis 1.8 1.0 2.6
Gastrointestinal Dyspepsia 7.9 3.2 3.5
Diarrhea 4.9 4.2 3.3
Abdominal pain 4.9 3.8 3.7
Nausea 3.2 2.0 2.5
Flatulence 2.6 2.5 1.4
Tooth disorder 2.1 1.7 1.4
Psychiatric Insomnia 2.7 1.4 0.8
Genitourinary Urinary tract infection 1.6 1.1 2.7
Miscellaneous Headache 8.9 7.8 4.7
Influenza-like symptoms 5.1 5.7 7.1
Accidental Trauma 5.1 4.8 4.2
Fatigue 2.7 2.3 1.6
Allergy 2.3 2.2 1.0
1Controlled trials with LESCOL Capsules (20 and 40 mg daily and 40 mg twice daily) compared to placebo
2Controlled trials with LESCOL XL 80 mg Tablets as compared to LESCOL Capsules

LESCOL Intervention Prevention Study

In the LESCOL Intervention Prevention Study (LIPS), the effect of LESCOL 40 mg, administered twice daily on the risk of recurrent cardiac events was assessed in 1677 patients with CHD who had undergone a percutaneous coronary intervention (PCI) procedure. This was a multicenter, randomized, double-blind, placebo-controlled study, patients were treated with dietary/lifestyle counseling and either LESCOL 40 mg (n=844) or placebo (n=833) given twice daily for a median of 3.9 years [see Clinical Studies].

Table 2 : Clinical adverse events reported in ≥ 2% in patients treated with LESCOL/LESCOL XL and at an incidence greater than placebo in the LIPS Trial regardless of causality (% of patients)

    LESCOL 40 mg b.i.d
N=822
(%)
Placebo
N=818
(%)
Cardiac disorders Atrial fibrillation 2.4 2.0
Gastrointestinal disorders Abdominal pain upper 6.3 4.5
Constipation 3.3 2.1
Dyspepsia 4.5 4.0
Gastric disorder 2.7 2.1
Nausea 2.7 2.3
General disorders Fatigue 4.7 3.8
Edema peripheral 4.4 2.9
Infections and infestations Bronchitis 2.3 2.0
Nasopharyngitis 2.8 2.1
Musculoskeletal and connective tissue disorders Arthralgia 2.1 1.8
Myalgia 2.2 1.6
Pain in extremity 4.1 2.7
Nervous system disorders Dizziness 3.9 3.5
Syncope 2.4 2.2
Respiratory disorders Dyspnea exertional 2.8 2.4
Vascular disorders Hypertension 5.8 4.2
Intermittent claudication 2.3 2.1

Clinical Studies Experience in Pediatric Patients

In patients aged < 18 years, efficacy and safety have not been studied for treatment periods longer than two years.

In two open-label, uncontrolled studies, 66 boys and 48 girls with heterozygous familial hypercholesterolemia ( 9-16 years of age, 80% Caucasian, 19% Other [ mixed ethnicity], 1% Asians) were treated with fluvastatin sodium administered as LESCOL capsules 20 mg -40 mg twice daily, or LESCOL XL 80 mg extended-release tablet [see Clinical Studies and Use In Specific Populations].

Postmarketing Experience

Because adverse reactions from spontaneous reports are reported voluntarily from a population of uncertain size, it is generally not possible to reliably estimate their frequency or establish a causal relationship to drug exposure. 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.

Musculoskeletal: muscle cramps, myalgia, myopathy, rhabdomyolysis, arthralgias, muscle spasms, muscle weakness, myositis.

Neurological: dysfunction of certain cranial nerves (including alteration of taste, impairment of extra-ocular movement, facial paresis), tremor, dizziness, vertigo, paresthesia, hypoesthesia, dysesthesia, peripheral neuropathy, peripheral nerve palsy.

There have been rare postmarketing reports of cognitive impairment (e.g., memory loss, forgetfulness, amnesia, memory impairment, confusion) associated with statin use. These cognitive issues have been reported for all statins. The reports are generally nonserious, and reversible upon statin discontinuation, with variable times to symptom onset (1 day to years) and symptom resolution (median of 3 weeks).

Psychiatric: anxiety, insomnia, depression, psychic disturbances

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 (erythrocyte sedimentation rate) increase, eosinophilia, arthritis, arthralgia, urticaria, asthenia, photosensitivity reaction, 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, cirrhosis, fulminant hepatic necrosis, hepatoma, anorexia, vomiting, fatal and non-fatal hepatic failure.

Skin: rash, dermatitis, including bullous dermatitis, eczema, alopecia, pruritus, a variety of skin changes (e.g. nodules, discoloration, dryness of skin/mucous membranes, changes to hair/nails).

Reproductive: gynecomastia, loss of libido, erectile dysfunction.

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

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

Read the entire FDA prescribing information for Lescol (Fluvastatin Sodium) »

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Lescol - User Reviews

Lescol User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Lescol sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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