Tricor Medication Summary
No separate FDA Medication Guide was found for this label. This summary is based on FDA/DailyMed prescribing information.
What is this medication?
This medication is described in FDA/DailyMed prescribing information. No separate FDA Medication Guide was found for this label. This summary is based on FDA/DailyMed prescribing information.
What is this medication used for?
TRICOR is a peroxisome proliferator-activated receptor (PPAR) alpha agonist indicated as an adjunct to diet: To reduce elevated LDL-C, Total-C, TG and Apo B, and to increase HDL-C in adult patients with primary hypercholesterolemia or mixed dyslipidemia (1.1). For treatment of adult patients with severe hypertriglyceridemia (1.2). Limitations of Use: Fenofibrate was not shown to reduce coronary heart disease morbidity and mortality in patients with type 2 diabetes mellitus (5.1).
What should I know before taking it?
TRICOR is contraindicated in: patients with severe renal impairment, including those receiving dialysis [see Clinical Pharmacology ( 12.3 ) ]. patients with active liver disease, including those with primary biliary cirrhosis and unexplained persistent liver function abnormalities [see Warnings and Precautions ( 5.2 ) ]. patients with preexisting gallbladder disease [see Warnings and Precautions ( 5.5 ) ]. nursing mothers [see Use in Specific Populations ( 8.2 ) ]. patients with known hypersensitivity to fenofibrate or fenofibric acid [see Warnings and Precautions ( 5.9 ) ].
What important warnings are listed?
Hepatotoxicity: Serious drug-induced liver injury, including liver transplantation and death, has been reported with TRICOR. Monitor patient’s liver function, including serum ALT, AST, and total bilirubin, at baseline and periodically for the duration of therapy. Discontinue if signs or symptoms of liver injury develop or if elevated enzyme levels persist (5.2). Myopathy and rhabdomyolysis : Have been reported in patients taking fenofibrate. Risks are increased during co-administration with a statin (with a significantly higher rate observed for gemfibrozil), particularly in elderly patients and patients with diabetes, renal failure, or hypothyroidism (5.3). Serum creatinine: TRICOR can.
How is this medication usually taken?
48 mg yellow tablets, imprinted with the code identification letters “FI”. 48 mg yellow tablets, imprinted with the “a” logo and code identification letters “FI”. 145 mg white tablets, imprinted with the code identification letters “FO”. 145 mg white tablets, imprinted with the “a” logo and code identification letters “FO”.
What side effects are listed?
The following serious adverse reactions are described below and elsewhere in the labeling: Mortality and coronary heart disease morbidity [see Warnings and Precautions ( 5.1 ) ] Hepatoxicity [see Warnings and Precautions ( 5.2 ) ] Pancreatitis [see Warnings and Precautions ( 5.7 ) ] Hypersensitivity reactions [see Warnings and Precautions ( 5.9 ) ] Venothromboembolic disease [see Warnings and Precautions ( 5.10 ) ]
What interactions are listed?
Coumarin anticoagulants: (7.1). Immunosuppressants: (7.2). Bile acid resins: (7.3).
Where can I find the official prescribing information?
Review the full prescribing information on DailyMed: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=84b2af1b-365e-4723-ac5f-bc826ec47772
⚠️ Disclaimer
This summary is for educational purposes only and is not medical advice. Always consult your doctor, pharmacist, or other licensed healthcare professional before starting, stopping, or changing any medicine. Read full medical disclaimer.