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Lescol

Lescol (Fluvastatin Sodium) side effects drug center

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CONSUMER

SIDE EFFECTS

Lescol Side Effects Center

Lescol (fluvastatin sodium) is a cholesterol-lowering medication used to reduce 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. Common side effects of Lescol include:

Tell your doctor if you have rare side effects of Lescol including:

Rarely, statins such as Lescol may cause or worsen diabetes.

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. Breastfeeding 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.

 

Lescol Consumer Information

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

In rare cases, fluvastatin can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. Call your doctor right away if you have unexplained muscle pain, tenderness, or weakness especially if you also have fever, unusual tiredness, or dark colored urine.

Also call your doctor at once if you have:

  • muscle weakness in your hips, shoulders, neck, and back;
  • trouble lifting your arms, trouble climbing or standing;
  • signs of a kidney problem--little or no urinating; painful or difficult urination; swelling in your feet or ankles; feeling tired or short of breath; or
  • liver problems--upper stomach pain, loss of appetite, tiredness, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Common side effects may include:

  • muscle pain;
  • headache; or
  • stomach pain, nausea, or indigestion.

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)

 

Lescol Professional Information

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)

&Copy; Lescol Patient Information is supplied by Cerner Multum, Inc. and Lescol Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.