Generated automatically from the NAFDAC register, WHO alerts and community data as of today. Not medical advice — always follow your doctor or pharmacist.
From the official U.S. FDA label for fenofibrate, the active ingredient registered with NAFDAC.
Fenofibrate tablet USP 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 ). …
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 )] Adverse reactions > 2% and at least 1% greater than placebo: Abnormal liver tests, increased AST, increased ALT, increased CPK, and rhinitis ( 6 ). To report SUSPECTED ADVERSE REACTIONS, contact Lupin Pharmaceuticals, Inc. …
Severe renal dysfunction, including dialysis patients ( 4 , 8.6 , 12.3 ). Active liver disease ( 4 , 5.3 ). Gallbladder disease ( 4 , 5.5 ). Known hypersensitivity to fenofibrate ( 4 ). Nursing mothers ( 4 , 8.2 ). Fenofibrate is contraindicated in: patients with severe renal impairment, including those receiving dialysis [see CLINICAL PHARMACOLOGY ( 12.3 )] . …
Hepatotoxicity : Serious drug-induced liver injury, including liver transplantation and death, has been reported with fenofibrate. Monitor patient's liver function, including serum ALT, AST, and total bilirubin, atbaseline 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 ). …
8.1 Pregnancy Risk Summary Limited available data with fenofibrate use in pregnant women are insufficient to determine a drug associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. In animal reproduction studies, no evidence of embryo-fetal toxicity was observed with oral administration of fenofibrate in rats and rabbits during organogenesis at doses less than or equivalent to the maximum recommended clinical d …
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Fenolip Tablet contains Fenofibrate (160 mg), as tablet, according to its NAFDAC registration record.
Yes. Fenolip Tablet is listed on the NAFDAC register under registration number B4-1473, and its registration is active as of 6 November 2026.
No WHO falsified or substandard medical product alert currently matches Fenolip Tablet in our automatically synced alert list.
Run a free authenticity scan with the NAFDAC number B4-1473, your pack's expiry date and batch number to get a Trust Score, compare the pack with the NAFDAC record (ingredient, strength, form, manufacturer), and buy only from licensed pharmacies.
Fenofibrate tablet USP 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 t (Summarised from the official U.S. FDA label for fenofibrate. Always follow your doctor or pharmacist.)
Reviews are personal experiences from RxVerify users, not medical advice. Report side effects to your doctor and to NAFDAC.