Fenofibrate

TRICOR

What it isPPAR-alpha agonist that lowers triglycerides; severe hypertriglyceridemia and primary hyperlipidemia.

Why this oneUnlike gemfibrozil, it can be paired more safely with a statin when triglycerides remain severe.

What limits itIt can raise creatinine without true GFR loss; monitor renal function. Gallstones and statin-associated myopathy can end treatment.

FDA-approved for

FDA dosing	Population	Start	Target	Max
Primary hypercholesterolemia / mixed dyslipidemia	adult	160 mg QD	160 mg QD	160 mg QD
Severe hypertriglyceridemia	adult	54–160 mg QD		160 mg QD
Mild–moderate renal impairment	adult	54 mg QD

Titration For severe hypertriglyceridemia, adjust at 4–8 week intervals.

Renal Mild–moderate impairment: initiate 54 mg QD; severe impairment/dialysis: contraindicated (avoid).

Hepatic Contraindicated in active liver disease.

Severe renal impairment, including dialysis
Active liver disease (incl. primary biliary cirrhosis, persistent unexplained LFT abnormalities)
Preexisting gallbladder disease
Nursing mothers

Hepatotoxicity (monitor LFTs)
Myopathy/rhabdomyolysis (increased with statins, elderly, renal failure, hypothyroidism, diabetes)
Reversible increase in serum creatinine
Cholelithiasis
Potentiates coumarin anticoagulants
Acute and delayed hypersensitivity reactions (anaphylaxis, angioedema, severe cutaneous reactions)
Pancreatitis
Venothromboembolic disease

Pregnancy Limited data insufficient; use only if benefit justifies risk.

Lactation Contraindicated in nursing mothers.

NO BOXED WARNINGS

Principal riskMyopathy with a statin; raises creatinine without lowering GFR

Cost, est. cash$5–$150/month

Generic entry2002

Therapeutic safety burden1 / 4

Overdose danger1 / 4

Weight-gain liability0 / 4

Sedation liability0 / 4

QT / Torsades0 / 4

Direct muscarinic antagonism0 / 4

Embryofetal risk2 / 4

Legacy pregnancy categoryC

Defining liabilityMyopathy/rhabdomyolysis and hepatotoxicity; interaction burden varies by agent.

Box: minimal PK interactions