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

Body as a whole effects probably related to fenofibrate (the active ingredient contained in Triglide) or where causality has not yet been established include weight loss and fever.[Ref]

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

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.[Ref]

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

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.[Ref]

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.[Ref]

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.[Ref]

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

Dermatologic

Dermatologic side effects possibly related to fenofibrate (the active ingredient contained in Triglide) or where causality has not yet been established have included: photosensitivity, eczema, lupus-like syndrome, ichthyosis, telangiectasis, and alopecia.[Ref]

Dermatologic side effects have included pruritus (3%) and rash (6%). During clinical studies, 2% of patients discontinued fenofibrate therapy because of rashes.[Ref]

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.[Ref]

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.[Ref]

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

Nervous system

Nervous system effects probably related to fenofibrate (the active ingredient contained in Triglide) or where causality has not yet been established include dry mouth, vertigo, anxiety, sleep disorders, and confusion.[Ref]

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

Respiratory

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

Respiratory effects probably related to fenofibrate or where causality has not yet been established include allergic pulmonary alveolitis and congestion.[Ref]

Ocular

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

Other

Otic side effects have included earache (1%).[Ref]

Genitourinary

Genitourinary effects occurring during fenofibrate (the active ingredient contained in Triglide) where causality has not yet been established have included decreased male fertility and renal lithiasis.[Ref]

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

Hypersensitivity

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

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).[Ref]

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.[Ref]

Endocrine

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

References

1. Adkins JC, Faulds D "Micronised fenofibrate: a review of its pharmacodynamic properties and clinical efficacy in the management of dyslipidaemia." Drugs 54 (1997): 615-33

2. "Product Information. Tricor (fenofibrate)." Abbott Pharmaceutical, Abbott Park, IL.

3. Kirchgassler KU, Schmitz H, Bach G "Effectiveness and tolerability of 12-week treatment with micronised fenofibrate 200mg in a drug-monitoring programme involving 9884 patients with dyslipidaemia." Clin Drug Invest 15 (1998): 197-204

4. Blane GF "Comparative toxicity and safety profile of fenofibrate and other fibric acid derivatives." Am J Med 83 (1987): 26-36

5. Balfour JA, McTavish D, Heel RC "Fenofibrate. A review of its pharmacodynamic and pharmacokinetic properties and therapeutic use in dyslipidaemia." Drugs 40 (1990): 260-90

6. Brown WV, Dujovne CA, farquhar JW, et al. "Effects of fenofibrate on plasma lipids: double-blind, multicenter study in patients with type IIA or IIB hyperlipidemia." Arteriosclerosis 6 (1986): 670-8

7. Chapman MJ "Pharmacology of fenofibrate." Am J Med 83 (1987): 21-5

8. Alsheikh-Ali AA, Kuvin JT, Karas RH "Risk of adverse events with fibrates." Am J Cardiol 94 (2004): 935-8

9. Barker BJ, Goodenough RR, Falko JM "Fenofibrate monotherapy induced rhabdomyolysis." Diabetes Care 26 (2003): 2482-3

10. Roberts WC "Safety of fenofibrate--US and worldwide experience." Cardiology 76 (1989): 169-79

11. Ritter JL, Nabulsi S "Fenofibrate-induced elevation in serum creatinine." Pharmacotherapy 21 (2001): 1145-9

12. Goldberg AC, Feldman EB, Ginsburg HN, et al. "Fenofibrate for the treatment of type IV and V hyperlipoproteinemias: a double-blind, placebo-controlled multicenter US study." Clin Ther 11 (1989): 69-83

13. Kursat S, Alici T, Colak HB "A case of rhabdomyolysis induced acute renal failure secondary to statin-fibrate-derivative combination and occult hypothyroidism." Clin Nephrol 64 (2005): 391-3

14. Jones PH, Davidson MH "Reporting rate of rhabdomyolysis with fenofibrate + statin versus gemfibrozil + any statin." Am J Cardiol 95 (2005): 120-2

15. Najib J "Fenofibrate in the treatment of dyslipidemia: a review of the data as they relate to the new suprabioavailable tablet formulation." Clin Ther 24 (2002): 2022-50

16. Levin A, Duncan L, Djurdjev O, Shapiro RJ, Frohlich J, Belanger A, Dumas R, Ross S "A randomized placebo-controlled double-blind trial of lipid lowering strategies in patients with renal insufficiency: diet modification with or without fenofibrate." Clin Nephrol 53 (2000): 140-6

17. Guay DR "Micronized fenofibrate: a new fibric acid hypolipidemic agent." Ann Pharmacother 33 (1999): 1083-103

18. Farnier M, Bonnefous F, Debbas N, Irvine A "Comparative efficacy and safety of micronized fenofibrate and simvastatin in patients with primary type IIa or IIb hyperlipidemia." Arch Intern Med 154 (1994): 441-9

19. Brown WV, Dujovne CA, Farquhar JW, Feldman EB, Grundy SM, Knopp RH, Lasser NL, Mellies MJ, Palmer RH, Samuel P, et al "Effects of fenofibrate on plasma lipids. Double-blind, multicenter study in patients with type IIA or IIB hyperlipidemia." Arteriosclerosis 6 (1986): 670-8

20. Leroy D, Dompmartin A, Lorier E, Leport Y, Audebert C "Photosensitivity induced by fenofibrate." Photodermatol Photoimmunol Photomed 7 (1990): 136-7

21. McQuade CR, Griego J, Anderson J, Pai AB "Elevated serum creatinine levels associated with fenofibrate therapy." Am J Health Syst Pharm 65 (2008): 138-41

22. Dierkes J, Westphal S, Luley C "Serum homocysteine increases after therapy with fenofibrate or bezafibrate." Lancet 354 (1999): 219-20

23. Gardette V, Vezzosi D, Maiza JC, Montastruc JL, Olivier P "Gynecomastia associated with fenofibrate." Ann Pharmacother 41 (2007): 508-11

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