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These highlights do not include all the information needed to use FENOFIBRIC ACID DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for FENOFIBRIC ACID DELAYED-RELEASE CAPSULES. FENOFIBRIC ACID delayed-release capsules, for oral use Initial U.S. Approval: 2008
Medication labelWhy this: Advisory · dailymed-prescription
Fenofibric acid delayed-release capsules is indicated as adjunctive therapy to diet: • to reduce triglyceride (TG) levels in adults with severe hypertriglyceridemia (TG greater than or equal to 500 mg/dL). • to reduce elevated low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia when use of recommended LDL-C lowering therapy is not possible. Limitations of Use • Markedly elevated levels of serum TG (e.g., > 2,000 mg/dL) may increase the risk of developing pancreatitis. The effect of fenofibrate therapy on reducing this risk has not been determined [see Warnings and Precautions (5.7)]. • Fenofibrate did not reduce coronary heart disease morbidity and mortality in two large, randomized controlled trials of patients with type 2 diabetes mellitus [see Warnings and Precautions (5.1) and Clinical Studies (14.4)].
- generic_name
- fenofibric acid
- product_names
- Fenofibric acid
- ndc
- 33342-294, 33342-295, 33342-294-10, 33342-294-12, 33342-295-10, 33342-295-56
- group
- drugs
- license
- us-gov-pd
- attribution
- Courtesy of the National Library of Medicine
- reviewed
- 2026-09-18
- language
- en