Note: This document contains side effect information about fluvastatin. Some dosage forms listed on this page may not apply to the brand name Lescol XL.

Summary

More frequent side effects include: dyspepsia, myalgia, and accidental injury. Continue reading for a comprehensive list of adverse effects.

Applies to fluvastatin: oral capsule, oral tablet extended release.

Serious side effects of Lescol XL

Along with its needed effects, fluvastatin (the active ingredient contained in Lescol XL) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking fluvastatin:

More common

• Chills
• diarrhea
• fever
• general feeling of discomfort or illness
• joint pain
• loss of appetite
• muscle aches and pain
• nausea
• runny nose
• shivering
• sore throat
• sweating
• trouble sleeping
• unusual tiredness or weakness
• vomiting

Less common

• Bladder pain
• bloody or cloudy urine
• cough producing mucus
• dark-colored urine
• difficult, burning, or painful urination
• difficulty with breathing
• difficulty with moving
• difficulty with swallowing
• dizziness
• fast heartbeat
• frequent urge to urinate
• hives
• itching
• lower back or side pain
• muscle cramps, spasms, or stiffness
• muscular pain, tenderness, wasting, or weakness
• pain, swelling, or redness in the joints
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• skin rash
• tightness in the chest

Other side effects of Lescol XL

Some side effects of fluvastatin may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Acid or sour stomach
• belching
• headache
• heartburn
• indigestion
• stomach discomfort, upset, or pain

Less common

• Bloated or full feeling
• excess air or gas in the stomach or intestines
• pain or tenderness around the eyes and cheekbones
• passing gas
• unable to sleep

For Healthcare Professionals

Applies to fluvastatin: oral capsule, oral tablet extended release.

General

The most frequently reported side effects were headache, dyspepsia, abdominal pain, nausea, and myalgia.^[Ref]

Musculoskeletal

Common (1% to 10%): Myalgia, arthritis, arthropathy, arthralgia, pain in extremity, back pain

Rare (0.01% to 0.1%): Muscular weakness, myopathy

Very rare (less than 0.01%): Rhabdomyolysis, myositis, lupus erythematosus-like syndrome

Frequency not reported: Immune-mediated necrotizing myopathy

Postmarketing reports: Muscle cramps, muscle spasms^[Ref]

Hepatic

Common (1% to 10%): ALT increased, AST increased

Very rare (less than 0.01%): Hepatitis

Postmarketing reports: Chronic active hepatitis, cholestatic jaundice, fatty change in liver, cirrhosis, fulminant hepatic necrosis, fatal hepatic failure, nonfatal hepatic failure, gamma-glutamyl transpeptidase increased, bilirubin increased^[Ref]

Gastrointestinal

Common (1% to 10%): Dyspepsia, diarrhea, abdominal pain, nausea, flatulence, tooth disorder, upper abdominal pain, constipation, gastric disorder

Very rare (less than 0.01%): Pancreatitis

Postmarketing reports: Vomiting^[Ref]

Dermatologic

Common (1% to 10%): Rash

Rare (0.01% to 0.1%): Urticaria

Very rare (less than 0.01%): Angioedema, face edema, eczema, dermatitis, bullous exanthema

Postmarketing reports: Bullous dermatitis, alopecia, pruritus, skin nodules, skin discoloration, dry skin/mucous membranes, hair/nails changed^[Ref]

Respiratory

Very common (10% or more): Upper respiratory tract infection (16.2%)

Common (1% to 10%): Sinusitis, bronchitis, nasopharyngitis, exertional dyspnea, pharyngitis, rhinitis, cough^[Ref]

Other

Common (1% to 10%): Influenza-like symptoms, accidental trauma, fatigue, peripheral edema, blood transaminases increased, creatine phosphokinase increased

Uncommon (0.1% to 1%): Chest pain

Postmarketing reports: Vertigo, alkaline phosphatase increased^[Ref]

Nervous system

Common (1% to 10%): Headache, dizziness, syncope

Very rare (less than 0.01%): Paresthesia, dysesthesia, hypoesthesia

Postmarketing reports: Tremor, peripheral nerve palsy, peripheral neuropathy, dysfunction of cranial nerve, alteration of taste, extra-ocular movement impaired, facial paresis, cognitive impairment, memory loss, forgetfulness, amnesia, memory impairment^[Ref]

Genitourinary

Common (1% to 10%): Urinary tract infection

Postmarketing reports: Erectile dysfunction, gynecomastia^[Ref]

Cardiovascular

Common (1% to 10%): Atrial fibrillation, hypertension, intermittent claudication

Very rare (less than 0.01%): Vasculitis^[Ref]

Hematologic

Very rare (less than 0.01%): Thrombocytopenia^[Ref]

Renal

Frequency not reported: Myoglobinuria, acute renal failure^[Ref]

Immunologic

Common (1% to 10%): Allergy

Very rare (less than 0.01%): Anaphylactic reaction^[Ref]

Hypersensitivity

An apparent hypersensitivity syndrome was reported rarely and included one or more of the following: anaphylaxis, angioedema, lupus erythematosus-like syndrome, polymyalgia rheumatica, vasculitis, purpura, thrombocytopenia, leukopenia, hemolytic anemia, positive antinuclear antibodies, erythrocyte sedimentation rate increased, eosinophilia, arthritis, arthralgia, urticaria, asthenia, photosensitivity reaction, fever, chills, flushing, malaise, dyspnea, toxic epidermal necrolysis, erythema multiforme, and Stevens-Johnson syndrome.^[Ref]

Rare (less than 0.1%): Hypersensitivity reaction^[Ref]

Oncologic

Postmarketing reports: Hepatoma^[Ref]

Endocrine

Postmarketing reports: Thyroid function abnormal^[Ref]

Psychiatric

Common (1% to 10%): Insomnia

Postmarketing reports: Anxiety, depression, psychic disturbances, loss of libido, confusion^[Ref]

Metabolic

Frequency not reported: HbA1c increased, serum glucose increased

Postmarketing reports: Anorexia^[Ref]

Ocular

Postmarketing reports: Cataracts progressed, lens opacity, ophthalmoplegia^[Ref]