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This document outlines crucial safety warnings and contraindications associated with the use of niacin ER. Please read them thoroughly and discuss any concerns with your healthcare provider.

• Muscle Breakdown (Rhabdomyolysis): Rarely, using niacin ER in combination with statin medications may lead to a severe condition known as rhabdomyolysis. This involves the breakdown of muscle tissue, releasing proteins into the bloodstream, which can potentially cause serious kidney and heart damage. Be vigilant for symptoms such as unexplained muscle pain, weakness, or tenderness, particularly when you begin taking niacin ER or after increasing the dosage. Individuals at increased risk include those over 65, and those with a history of diabetes, kidney issues, or low thyroid levels.

• Liver Damage: There is a risk of serious and potentially life-threatening liver damage with niacin ER, especially if changing from the immediate-release to the sustained-release form at the same dosage. These forms are not interchangeable, and such a switch could result in an overdose. Heavy alcohol consumption or a history of liver disease also heightens the risk. Avoid niacin ER if you have active liver disease. Regular liver function tests will be conducted by your healthcare provider while on niacin ER. Seek immediate medical attention if you experience severe abdominal pain, nausea, vomiting, or yellowing of the skin or eyes.

Contraindications: Niacin ER should not be used in the following conditions due to the risk of severe health complications:

• Active liver disease
• Active peptic ulcer disease
• Unexplained high liver enzyme levels
• Arterial bleeding

If you have any of these conditions, it is imperative to consult your healthcare provider before starting niacin ER.

Common side effects:

• Flushing
• Diarrhea
• Nausea

Less common but important to monitor:

• Vomiting
• Cough

Serious side effects:

• Signs of liver damage (severe abdominal pain, yellowing of the skin or eyes, severe nausea or vomiting)
• Rhabdomyolysis (unexplained severe muscle pain, tenderness, or weakness)

When taking extended-release niacin (niacin ER), it's important to be aware of potential interactions with other medications and substances:

• Statins: Combining niacin ER with statin medications, such as Atorvastatin or Simvastatin, may increase the risk of muscle problems, including a rare but serious condition called rhabdomyolysis.

• Blood Pressure Medications: Niacin ER can enhance the effects of medications that lower blood pressure, potentially leading to hypotension (abnormally low blood pressure).

• Diabetes Medications: Niacin ER may raise blood sugar levels, which can interfere with the effectiveness of diabetes medications.

• Blood Thinners: Taking niacin ER with anticoagulant or antiplatelet medications can increase the risk of bleeding.

• Alcohol: Consuming alcohol while taking niacin ER can worsen side effects like flushing and itching, and may increase the risk of liver damage.

• Bile Acid Sequestrants: Medications like Cholestyramine or Colestipol can reduce the absorption of niacin ER. To minimize this interaction, it's recommended to take niacin ER at least 4–6 hours before or after these medications.

Always inform your healthcare provider about all medications, supplements, and substances you are using to ensure safe and effective use of niacin ER.