Fenofibric Acid

Fenofibric Acid is a prescription medication used as an adjunct to diet for severe triglyceridemia and primary hypercholesterolemia or mixed dyslipidemia. 

• Fenofibric Acid is available under the following different brand names: Fibricor, Trilipix.

Common side effects of Fenofibric Acid include:

• runny nose,
• sneezing, and
• abnormal laboratory tests

Serious side effects of Fenofibric Acid include:

• sharp stomach pain spreading to the back or shoulder blade,
• loss of appetite,
• stomach pain after just having a meal,
• yellowing of the skin or eyes (jaundice),
• fever,
• chills,
• weakness,
• sore throat,
• mouth sores,
• unusual bruising or bleeding,
• chest pain,
• sudden cough,
• wheezing,
• rapid breathing,
• coughing up blood, and
• swelling, warmth, or redness in an arm or leg

Rare side effects of Fenofibric Acid include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Tablet (Fibricor)

• 35 mg
• 105 mg

Capsule, delayed-release (Trilipix)

• 45 mg
• 135 mg

Hypertriglyceridemia

Adult dosage

• Fibricor: 35-105 mg orally every day
• Trilipix: 45-135 mg orally every day

Primary Hypercholesterolemia or Mixed Lipidemia

Adult dosage

• Fibricor: 105 mg orally every day
• Trilipix: 135 mg orally every day

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Fenofibric Acid has minor interactions with no other drugs.
• Fenofibric Acid has minor interactions with the following drugs:
  • abametapir
  • atorvastatin
  • colchicine
  • fexinidazole
  • fluvastatin
  • idelalisib
  • lovastatin
  • pitavastatin
  • pravastatin
  • rosuvastatin
  • simvastatin
  • tucatinib
  • voxelotor
• Fenofibric Acid has minor interactions with at least 37 other drugs.
• Fenofibric Acid has minor interactions with the following drugs:
  • acetazolamide
  • anastrozole
  • colestipol
  • cyclophosphamide
  • cyclosporine
  • ezetimibe
  • larotrectinib
  • levoketoconazole
  • octacosanol
  • orlistat
  • ribociclib

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• Hypersensitivity
• Severe renal impairment (including dialysis)
• Active liver disease, including primary biliary cirrhosis and unexplained persistent liver function abnormalities
• Pre-existing gallbladder disease
• Breastfeeding women

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Fenofibric Acid?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Fenofibric Acid?”

Cautions

• Effect on coronary heart disease morbidity and mortality not established
• Increases risk of myositis or myopathy, and has been associated with rhabdomyolysis; risk may increase when coadministered with statins
• Higher doses or coadministration with statins associated with increased serum transaminases
• May increase serum creatinine
• May increase cholesterol excretion in bile, potentially leading to cholelithiasis
• Coadministration with warfarin may increase anticoagulant effects resulting in PT/INR prolongation
• Pancreatitis reported; may be a failure of efficacy with severe hypertriglyceridemia, a direct drug effect, or a secondary effect via biliary stone or sludge formation
• May decrease hemoglobin, hematocrit, and leukocytes; thrombocytopenia and agranulocytosis reported; monitoring of blood counts recommended during the first year of therapy
• Anaphylaxis and angioedema reported; if a patient develops signs or symptoms of acute hypersensitivity reaction, advise them to seek immediate medical attention and discontinue therapy
• Acute hypersensitivity reactions (eg, Stevens-Johnson syndrome, toxic necrolysis) reported PE and DVT reported; use caution in patients with risk factors for VTE
• Severe cutaneous adverse drug reactions (SCAR), including Stevens-Johnson syndrome, Toxic Epidermal Necrolysis, and Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), have been reported postmarketing, occurring days to weeks after initiation of fenofibrate; cases of DRESS associated with cutaneous reactions (such as rash exfoliative dermatitis) and a combination of eosinophilia, fever, systemic organ involvement (renal, hepatic, or respiratory); discontinue therapy and treat patients appropriately if SCAR is suspected
• Paradoxical decreases in HDL cholesterol reported; monitor HDL-C within a few months of initiating therapy; discontinue if HDL-C becomes severely depressed; do not restart therapy
• Hepatotoxicity
  • Serious drug-induced liver injury (DILI), including liver transplantation and death, reported; DILI reported within the first few weeks of treatment or after several months of therapy and in some cases has reversed with discontinuation of treatment
  • Patients with DILI have experienced signs and symptoms including dark urine, abnormal stool, jaundice, malaise, abdominal pain, myalgia, weight loss, pruritus, and nausea
  • Many patients had concurrent elevations of total bilirubin, serum alanine transaminase (ALT), and aspartate transaminase (AST)
  • DILI has been characterized as hepatocellular, chronic active, and cholestatic hepatitis, and cirrhosis has occurred in association with chronic active hepatitis
  • In clinical trials, fenofibrate at doses equivalent to 90 mg daily associated with increases in serum AST or ALT; the incidence of increases in transaminases may be dose-related
  • Monitor patient’s liver function, including serum ALT, AST, and total bilirubin, at baseline and periodically for the duration of therapy
  • Discontinue therapy if signs or symptoms of liver injury develop or if elevated enzyme levels persist (ALT or AST more than 3 times the upper limit of normal, or if accompanied by elevation of bilirubin); do not restart therapy in these patients if there is no alternative explanation for the liver injury

Pregnancy and Lactation

• Limited available data on pregnant women are insufficient to determine drug associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes.
• Lactation
  • There is no available information on the presence of the drug in human milk, its effects on breastfed infant, or on milk production; the drug is present in the milk of rats, and is therefore likely to be present in human milk; because of potential for serious adverse reactions in breastfed infants, such as disruption of infant lipid metabolism, women should not breastfeed during treatment and for 5 days after the final dose.\