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Baycol

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Baycol

Discontinued Warning IconPlease Note: This Brand Name drug is no longer available in the US.
(Generic versions may still be available.)

Baycol

Baycol Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Baycol (cerivastatin sodium) blocks the production of cholesterol (a type of fat) in the body and is used to reduce the amounts of LDL (bad) cholesterol and total cholesterol in your blood. It also reduces the amounts of triglycerides (another type of fat) and apolipoprotein B (a protein needed to make cholesterol) in your blood and increases the amount of HDL (good) cholesterol in your blood. The brand name of this medication is discontinued, but generic versions may be available. Common side effects include gas, bloating, nausea, stomach upset, heartburn, abdominal pain, constipation, diarrhea, dizziness, headache, or rash.

The starting-dose of Baycol is 0.4 mg once daily in the evening regardless of previous lipid therapy. Baycol may interact with cyclosporine, gemfibrozil, fenofibrate, niacin, erythromycin, clarithromycin, itraconazole, fluconazole, or ketoconazole. Tell your doctor all medications and supplements you use. Baycol causes birth defects if it is taken during pregnancy. Do not take Baycol if you are pregnant or are planning a pregnancy. This drug passes into breast milk and can harm a nursing infant. Do not take Baycol while breastfeeding.

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

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.

Baycol in Detail - Patient Information: Side Effects

If you experience any of the following serious side effects, stop taking cerivastatin and call your doctor immediately:

  • an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives);
  • muscle aches, pain, or weakness;
  • a fever;
  • "flu-like" symptoms;
  • decreased urine or rust-colored urine;
  • blurred vision; or
  • yellowing of your skin or eyes.

Other, less serious side effects may be more likely to occur. Continue to take cerivastatin and talk to your doctor if you experience

  • gas, bloating, nausea, stomach upset, heartburn, abdominal pain, constipation, or diarrhea;
  • dizziness;
  • headache; or
  • a rash.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

Read the entire detailed patient monograph for Baycol (Cerivastatin (Removed from Market 8/2001)) »

What is Prescribing information?

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

Baycol FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Cerivastatin sodium has been evaluated for adverse events in more than 5,000 patients worldwide. In the U.S. placebo-controlled clinical studies, discontinuations due to adverse events occurred in 3.1% of cerivastatin sodium treated patients and in 2.0% of patients treated with placebo. Adverse reactions have usually been mild and transient.

Clinical Adverse Experiences

Adverse experiences occurring with a frequency ≥ 2% for marketed doses of cerivastatin sodium, regardless of causality assessment, in U.S. placebo-controlled clinical studies, are shown in Table 5 below:

Table 5: Adverse Experiences occurring in ≥ 2% Patients in U.S. Placebo Controlled Clinical Studies

Adverse Event BAYCOL®
(n = 2231)
Placebo
(n = 702)
Any event 63.2% 63.0%
Pharyngitis 9.6% 12.1%
Headache 8.5% 9.5%
Rhinitis 8.3% 10.1%
Sinusitis 4.7% 5.0%
Accidental injury 4.4% 5.6%
Arthralgia 4.3% 3.4%
Dyspepsia 3.8% 4.8%
Flu syndrome 3.7% 6.3%
Back pain 3.4% 5.0%
Asthenia 3.4% 2.1%
Diarrhea 3.3% 3.3%
Rash 3.0% 4.4%
Myalgia 2.5% 2.3%
Abdominal pain 2.5% 3.0%
Nausea 2.4% 3.1%
Leg pain 2.2% 1.4%
Constipation 2.2% 2.0%
Dizziness 2.1% 2.4%
Flatulence 2.1% 2.7%
Chest pain 2.0% 1.8%
Bronchitis 1.3% 2.1%

The following effects have been reported with drugs in this class; not all effects listed below have necessarily been associated with cerivastatin therapy.

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

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

Hypersensitivity Reactions: An apparent hypersensitivity syndrome has been reported that included one or more of the following features: anaphylaxis, angioedema, lupus erythematosus-like syndrome, polymyalgia rheumatica, dermatomyositis, 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, 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, creatine kinase, alkaline phosphatase, γ-glutamyl transpeptidase, and bilirubin; thyroid function abnormalities.

Post-Marketing Adverse Event Reports

The following events have been reported since market introduction. While these events were generally associated with the use of BAYCOL® (cerivastatin (removed from market 8/2001)) , a casual relationship to the use of BAYCOL® (cerivastatin (removed from market 8/2001)) cannot be readily determined due to the spontaneous nature of reporting of medical events, and the lack of controls.

Body as a Whole: Asthenia, fever, headache, anorexia, abdominal pain, epistaxis, edema.

Cardiovascular System: Hypertension, angina pectoris.

Digestive System: Colitis, constipation, diarrhea, duodenal ulcer, dyspepsia, flatulance, gastrointestinal disorder, gastrointestinal hemorrhage, hepatitis, nausea.

Hemolytic and Lymphatic System: Anemia, leukopenia.

Hypersensitivity Reaction: Allergic reaction, anaphylactoid reaction, angioedema, urticaria.

Nervous System: Paralysis, somnolence.

Musculoskeletal System: Myalgia, myasthenia, myopathy, myositis, rhabdomyolysis, hypertonia, hyperkinesia.

Respiratory System: Cough increase.

Urogenital System: Acute renal failure secondary to myoglobinuria.

Special Senses: Cataract specified, visual disturbance, blurred vision.

Laboratory Abnormalities

Amylase increase, elevated transaminases, laboratory tests abnormal, kidney function abnormal, creatine phosphokinase increase.

Concomitant Therapy

In studies where cerivastatin sodium has been administered concomitantly with cholestyramine, no adverse reactions unique to this combination or in addition to those previously reported for this class of drugs were reported. Myopathy and rhabdomyolysis (with or without acute renal failure) have been reported when HMG-CoA reductase inhibitors are used in combination with immunosuppressive drugs, fibric acid derivatives, erythromycin, azole antifungals or lipid-lowering doses of nicotinic acid. Concomitant therapy with HMG-CoA reductase inhibitors and these agents is generally not recommended (see WARNINGS: Skeletal Muscle). Concurrent treatment with gemfibrozil is contraindicated (see CONTRAINDICATIONS and WARNINGS: Skeletal Muscle).

Read the entire FDA prescribing information for Baycol (Cerivastatin (Removed from Market 8/2001)) »

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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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