Fluvastatin Side Effects

Some side effects of fluvastatin may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to fluvastatin: oral capsule, oral tablet extended release

Get emergency medical help if you have any of these signs of an allergic reaction while taking fluvastatin: 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;

• confusion, memory problems;

• fever, unusual tiredness, and dark colored urine;

• pain or burning when you urinate;

• swelling, weight gain, urinating less than usual or not at all;

• increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, weight loss); 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 of fluvastatin 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.

For Healthcare Professionals

Applies to fluvastatin: oral capsule, oral tablet extended release

Hepatic

Hepatic side effects of fluvastatin include elevations in liver function tests (1.1%). Other hepatic side effects reported with HMG-CoA reductase inhibitors include hepatitis, cholestatic jaundice, fatty changes in the liver, cirrhosis, hepatoma, and fulminant hepatic necrosis.

Persistent elevations in liver function tests three times normal values were reported in up to 1.1% of patients of fluvastatin in clinical trials. This led to discontinuation of fluvastatin in 0.7% of patients. The majority of these patients were asymptomatic.

Liver function tests should be closely monitored. It is recommended that fluvastatin be discontinued in patients with persistent, significant elevations (three times normal) in liver function parameters.

Carcinogenicity studies in animals have demonstrated that liver tumors can be induced in rodents with long-term HMG-CoA reductase inhibitors. However, a recent carcinogenicity study in animals receiving fluvastatin found no evidence of liver tumors.

The manufacturer reports that the incidence of increased transaminase levels was not increased in patients who took the 80 mg dose of fluvastatin versus lower doses. Of 343 patients treated with the 80 mg dose for an average of 51 weeks, 6 patients (1.7%) discontinued fluvastatin due to AST and/or ALT elevations. The overall incidence of transaminase elevations with the 80 mg dose was 0.9% compared with 1.0% with all fluvastatin dosages in controlled trials. This data was extracted from the Fluvastatin Long-Term Extension Trial (FLUENT), 1994.

Musculoskeletal

Musculoskeletal side effects have included elevations in creatine kinase, myopathy, back pain, and arthropathy. Rhabdomyolysis with renal dysfunction secondary to myoglobinuria has been reported with fluvastatin and other HMG-CoA reductase inhibitors. Musculoskeletal side effects reported with other HMG-CoA reductase inhibitors have included arthralgia, tendon rupture, dermatomyositis, and myalgia.

In addition, some data have suggested that exposure to HMG-CoA reductase inhibitors is associated with a decreased risk of bone fractures in persons older than 50 years of age.

HMG-CoA reductase inhibitors (statins) have been associated with rare cases of severe myopathy and rhabdomyolysis, accompanied by increases in creatine kinase, myoglobinuria, proteinuria, and renal failure. Concomitant use with gemfibrozil (fibric acid derivatives), niacin, cyclosporine, erythromycin (macrolides) or azole antifungals may increase the incidence and severity of musculoskeletal side effects. Other variables associated with an increased risk of statin-induced myopathy include, advanced age, small body stature, female gender, renal and/or hepatic dysfunction, perioperative periods, hypothyroidism, diabetes mellitus, and alcoholism.

Milder forms of myotoxicity (i.e., myalgia) are commonly reported and occur in approximately 5% to 7% of patients taking a statin drug.

Patients should be instructed to report symptoms of muscle pain, weakness, or tenderness. If such symptoms develop, creatine kinase should be measured, and if elevated, fluvastatin should be discontinued. The value of regular monitoring of creatine kinase is not known.

Gastrointestinal

Gastrointestinal side effects have included dyspepsia (8.1%), diarrhea (6.0%), abdominal pain (5.5%), nausea, constipation, and flatulence. Other HMG-CoA reductase inhibitors have been associated with pancreatitis, anorexia, and vomiting.

Hematologic

Hematologic side effects including hemolytic anemia, thrombocytopenia, thrombotic thrombocytopenic purpura (TTP), and leukopenia have occurred with HMG-CoA reductase inhibitors. These effects may be manifestations of a hypersensitivity reaction.

Nervous system

Nervous system side effects have included headache (8.7%), fatigue (3.5%), and dizziness (2.5%). Other nervous system side effects reported with HMG-CoA reductase inhibitors include cranial nerve dysfunction, tremor, vertigo, drowsiness, weight loss, decline in cognitive function, memory loss, paresthesias, peripheral neuropathy, and peripheral nerve palsy.

Dermatologic

Dermatologic effects have included rash (2.7%). Alopecia and pruritus have been reported with other HMG-CoA reductase inhibitors.

Hypersensitivity

Hypersensitivity syndrome has been rarely reported with HMG-CoA reductase inhibitors and is characterized by one or more symptoms, including anaphylaxis, angioedema, lupus erythematosus-like syndrome, polymyalgia rheumatica, vasculitis, purpura, thrombocytopenia, hemolytic anemia, positive ANA, ESR increase, eosinophilia, urticaria, and asthenia.

Genitourinary

Genitourinary side effects of HMG-CoA reductase inhibitors have included erectile dysfunction, impotence, and testicular pain.

Halkin, et al report a case in which use of both lovastatin and pravastatin on different occasions in the same patient lead to reversible impotence. The impotence resolved within 2 weeks after discontinuation of the HMG-CoA reductase inhibitor.

Oncologic

Oncologic side effects including tumor growth in rodents have been associated with many lipid-lowering drugs. Fluvastatin has been specifically associated with thyroid and stomach adenomas in the rat and mouse. Long-term clinical trials are needed to define the risk of cancer in humans.

Endocrine

Endocrine side effects associated with HMG-CoA reductase inhibitors have included hypospermia, gynecomastia and thyroid function abnormalities. In addition, acid maltase deficiency (the genetic disorder also referred to as Pompe's Disease) has been revealed following HMG-CoA therapy in at least one presymptomatic patient.

Psychiatric

Psychiatric side effects associated with HMG-CoA reductase inhibitors have included decreased libido, anxiety, insomnia, depression, suicidal thoughts, delusions, paranoia, agitation, and nightmares.

Renal

Renal side effects including acute renal failure secondary to rhabdomyolysis has been reported with HMG-CoA reductase inhibitors.

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