Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes Bezalip SR (Bezafibrate). If you are concerned about side effects, discuss the risks and benefits of Bezalip SR (Bezafibrate) with your doctor.

The following side effects have been reported by at least 1% of people taking Bezalip SR (Bezafibrate). Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• abdominal pain
• Constipation
• Diarrhea
• headache
• nausea
• rash

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• decreased urine production
• dizziness
• muscle pain, tenderness, or weakness, especially if accompanied by Fever and feeling unwell
• persistent and severe upper abdominal pain
• symptoms of liver problems (e.g., yellow eyes or skin, dark urine, loss of appetite)

Stop taking the medication and seek immediate medical attention if any of the following occur:

• severe skin rash (e.g., blisters, peeling)
• symptoms of a Anaphylaxis (severe allergic reaction) (e.g., Hives; difficulty breathing; swelling of the face, mouth, tongue, or throat)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking Bezalip SR (Bezafibrate).

Each round, white, sustained-release, film-coated tablet printed on one side with "D9" contains 400 mg of Bezalip SR (Bezafibrate). Nonmedicinal ingredients: colloidal silicon dioxide, hydroxypropyl methylcellulose 2208 & 2910, lactose, magnesium stearate, methyl methacrylate, polyethyl acrylate, polyethylene glycol 10,000, polysorbate 80, povidone K25, sodium citrate, sodium lauryl sulfate, talc, and titanium dioxide.

Do not take Bezalip SR (Bezafibrate) if you:

• are allergic to Bezalip SR (Bezafibrate) or any ingredients of Bezalip SR (Bezafibrate)
• are allergic to other "fibrate" medications (e.g., clofibrate, Fenofibrate, Gemfibrozil)
• are breast-feeding
• are pregnant
• are taking a "statin" medication (e.g., Atorvastatin, Lovastatin, Simvastatin, Pravastatin) and have risk factors for muscle problems (e.g., reduced kidney function, severe infection, trauma, surgery, certain hormone or electrolyte imbalances)
• have a disorder known as type 1 hyperlipoproteinemia
• have gallbladder disease
• have had a reaction to any "fibrate" medication that involves a severe skin reaction, such as Sunburn
• have reduced kidney function
• have reduced liver function or primary biliary cirrhosis (damage to the liver cause by inflammation of the bile ducts)

There may be an interaction between Bezalip SR (Bezafibrate) and any of the following:

• Cholestyramine
• Colchicine
• Colestipol
• Cyclosporine
• Ezetimibe
• Linezolid
• monoamine oxidase inhibitors (M.O.S. e.g., Moclobemide, Phenelzine, Rasagiline, Selegiline, Tranylcypromine)
• raltegravir
• Rosiglitazone
• "statins" (e.g., atorvastatin, simvastatin, pravastatin, lovastatin)
• sulfonylureas (e.g., Glyburide, Gliclazide)
• Ursodiol
• Warfarin

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Bezalip SR (Bezafibrate). Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Bezalip SR (Bezafibrate).

Blood counts: Bezalip SR (Bezafibrate) may decrease the amount of hemoglobin (the part of red blood cells that carry oxygen), white blood cells (that help fight infection), and platelets (that help the blood to clot) during the first 12 months of treatment. Your doctor will monitor for these changes with blood tests during your first year of treatment.

Gallstones: Bezalip SR (Bezafibrate) may increase the risk for gallstones. If you experience symptoms of gallstones (e.g., persistent and severe upper abdominal pain, pain in the back between the shoulder blades, pain under the right shoulder, nausea, vomiting), contact your doctor immediately.

Liver function: Bezalip SR (Bezafibrate) may affect your liver function. You will have your liver function monitored regularly with blood tests while you are taking Bezalip SR (Bezafibrate). If you have had liver problems or jaundice (yellowing of the skin or eyes), discuss with your doctor how Bezalip SR (Bezafibrate) may affect the dosing and effectiveness of Bezalip SR (Bezafibrate), and whether any special monitoring is needed.

Muscle problems: Very rarely, Bezalip SR (Bezafibrate) can cause muscle problems such as myositis (inflammation of the muscles) or rhabdomyolysis (breakdown of muscle that can cause kidney damage). If you experience any unexplained muscle pain, tenderness or weakness, especially if you also have a fever and are not feeling well, contact your doctor immediately.

Pregnancy: Bezalip SR (Bezafibrate) should not be taken during pregnancy. Women who could become pregnant while using Bezalip SR (Bezafibrate) should use adequate birth control. If you become pregnant while taking Bezalip SR (Bezafibrate), stop taking it and contact your doctor immediately. If you are planning to become pregnant, you should stop Bezalip SR (Bezafibrate) several months before trying to become pregnant.

Breast-feeding: It is not known if Bezalip SR (Bezafibrate) passes into breast milk. If you are a breast-feeding mother and are taking Bezalip SR (Bezafibrate), it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using Bezalip SR (Bezafibrate) have not been established for children.

Seniors: The use of Bezalip SR (Bezafibrate) by people over the age of 70 is not recommended because of age-related decreases in kidney function.