Triglide Side Effects

Generic Name: fenofibrate

Note: This page contains side effects data for the generic drug fenofibrate. It is possible that some of the dosage forms included below may not apply to the brand name Triglide.

It is possible that some side effects of Triglide may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

For the Consumer

Applies to fenofibrate: oral capsule, oral tablet

As well as its needed effects, fenofibrate (the active ingredient contained in Triglide) may cause unwanted side effects that require medical attention.

If any of the following side effects occur while taking fenofibrate, check with your doctor immediately:

Less common
  • Chills or fever
  • hives or skin rash
  • itching
  • muscle aches and pains
  • nausea or vomiting
Rare
  • Chronic indigestion
  • dark urine
  • muscle cramps, pain, stiffness, swelling, or weakness
  • troubled breathing
  • unusual bleeding or bruising
  • unusual tiredness
  • yellow eyes or skin
Incidence not known
  • Agitation
  • bloating
  • bloody urine
  • decreased frequency or amount of urine
  • lower back or side pain
  • pains in the stomach, side, or abdomen, possibly radiating to the back
  • swelling of the face, fingers, or lower legs
  • swollen joints
  • upper right abdominal or stomach pain

Some fenofibrate side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

More common
  • Runny nose
  • sneezing
  • stuffy nose
Less common
  • Back pain
  • diarrhea
  • eye irritation
  • gas
  • increased sensitivity of the skin to sunlight
Incidence not known
  • Lack or loss of strength

For Healthcare Professionals

Applies to fenofibrate: oral capsule, oral tablet

General

General total body symptoms have included asthenia/fatigue or flu-like symptoms (5%) and infection (18%). During clinical studies, 6% of patients discontinued fenofibrate (the active ingredient contained in Triglide) because of drug-related adverse effects. The most common reason for discontinuation of fenofibrate was skin rash in 2% of patients.

Body as a whole effects probably related to fenofibrate or where causality has not yet been established include weight loss and fever.

Hepatic

In clinical studies, 6% of patients receiving 134 mg to 200 mg fenofibrate (the active ingredient contained in Triglide) daily experienced transaminase levels greater than 3 times the upper limits of normal. No such incidences occurred in patients receiving dosages of 34 mg to 67 mg daily. Hepatotoxicity can occur following weeks or years of therapy and is dose related. Cirrhosis associated with chronic active hepatitis has been reported.

Hepatic side effects have included significant increases in serum transaminase levels.

Musculoskeletal

Patients should be instructed to report symptoms of muscle pain, weakness, or tenderness. If such symptoms develop, creatine kinase should be measured, and, if elevated, fenofibrate (the active ingredient contained in Triglide) should be discontinued.

Gemfibrozil is associated with a higher incidence of myotoxicity (i.e., rhabdomyolysis) than fenofibrate when used in combination with any HMG CoA reductase inhibitor (statin). Fenofibrate is primarily metabolized by glucuronidation, whereas gemfibrozil undergoes extensive oxidative metabolism which results in higher plasma levels of statins. This pharmacokinetic difference may account for the differences in the rates of myotoxicity.

A patient with auto-immune thyroiditis induced hypothyroidism developed acute renal failure secondary to simvastatin/fenofibrate combination therapy induced rhabdomyolysis. Following discontinuation of simvastatin/fenofibrate therapy and thyroid replacement, symptoms (i.e., muscle pain, oliguria) resolved and renal function returned to normal within 14 days.

Musculoskeletal side effects have included arthralgias (3%). In addition, the use of fibrate derivatives, including fenofibrate occasionally has been associated with myositis. Rhabdomyolysis has occurred rarely and generally in association with impaired renal function. Myopathy should be considered in the presence of symptoms of diffuse myalgias, muscle tenderness or weakness, and/or significant increase in serum creatine kinase. Combination therapy with HMG-CoA reductase inhibitors may increase the potential for myositis. Elevations in serum creatinine have also been associated with fenofibrate therapy.

Gastrointestinal

Gastrointestinal side effects included dyspepsia (5%), nausea/vomiting (4%), flatulence, abdominal pain, constipation, or diarrhea (3%), and eructation (1%). In addition, an increased incidence of gallbladder disease/surgeries and pancreatitis occurred during clinical studies. Fibrate derivatives, including fenofibrate (the active ingredient contained in Triglide) may increase cholesterol excretion into bile and result in cholelithiasis.

Gastrointestinal side effects having occurred during fenofibrate therapy where causality has not yet been established have included hematemesis.

Dermatologic

Dermatologic side effects have included pruritus (3%) and rash (6%). During clinical studies, 2% of patients discontinued fenofibrate (the active ingredient contained in Triglide) therapy because of rashes.

Dermatologic side effects possibly related to fenofibrate or where causality has not yet been established have included: photosensitivity, eczema, lupus-like syndrome, ichthyosis, telangiectasis, and alopecia.

Renal

Renal side effects have included acute renal failure. The accumulation of fenofibric acid in the presence of preexisting renal dysfunction causes an increase in levels of fenofibric acid, the main metabolite of fenofibrate (the active ingredient contained in Triglide) Renal side effects of fenofibric acid accumulation include acute renal failure associated with myositis and rhabdomyolysis.

Cardiovascular

Cardiovascular effects which have occurred during fenofibrate (the active ingredient contained in Triglide) therapy where causality has not yet been established include facial and peripheral edema, angina, palpitations, tachycardia, migraine and epistaxis.

Cardiovascular side effects have included arrhythmia (1%) and pulmonary embolus (PE).

Nervous system

Nervous system side effects have included decreased libido (2%) and insomnia (1%).

Nervous system effects probably related to fenofibrate or where causality has not yet been established include dry mouth, vertigo, anxiety, sleep disorders, and confusion.

Respiratory

Respiratory effects probably related to fenofibrate (the active ingredient contained in Triglide) or where causality has not yet been established include allergic pulmonary alveolitis and congestion.

Respiratory side effects have included cough or sinusitis (1%) and rhinitis (4%).

Ocular

Ocular side effects have included eye irritation (2%), eye floaters, blurred vision, or conjunctivitis (1%).

Other

Otic side effects have included earache (1%).

Genitourinary

Genitourinary side effects have included polyuria or vaginitis (1%).

Genitourinary effects occurring during fenofibrate where causality has not yet been established have included decreased male fertility and renal lithiasis.

Hypersensitivity

Hypersensitivity side effects have included severe skin rashes (requiring hospitalization and steroid therapy), urticaria and less severe rashes.

Hematologic

Hematologic side effects have included mild to moderate decreases in hemoglobin and hematocrit and white blood cells, rare incidences of thrombocytopenia and agranulocytosis, and deep vein thrombosis (DVT).

Oncologic

Oncologic effects of tumor growth in rodents have been associated with many lipid-lowering drugs. Fenofibrate (the active ingredient contained in Triglide) has been associated with liver, pancreatic and testicular tumors in rats. Long-term clinical trials are needed to define the risk of cancer in humans.

Endocrine

Endocrine side effects include at least one case of fenofibrate-induced gynecomastia that resolved following discontinuation and recurred upon rechallenge.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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