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Trilipix

Last reviewed on RxList: 3/7/2017
Trilipix Side Effects Center

Last reviewed on RxList 12/22/2016

Trilipix (fenofibric acid) is a lipid regulating agent used to treat high cholesterol and high triglyceride levels. It is sometimes given together with other cholesterol-lowering medications. Trilipix is available in generic form. Common side effects of Trilipix include:

Trilipix may rarely cause gallstones and liver problems. If you notice any of the following unlikely but serious side effects, tell your doctor:

The dose of Trilipix ranges from 45 to 135 mg once daily, depending on the patient's condition. Dosage is individualized according to patient response. Trilipix may interact with cyclosporine, blood thinners, diuretics (water pills), birth control pills or hormone replacement therapy, or beta-blockers. Tell your doctor all medications and supplements you use. Trilipix is not recommended for use during pregnancy. It may harm a fetus. It is unknown if this medication passes into breast milk. Breastfeeding while using this drug is not recommended.

Our Trilipix (fenofibric acid) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Trilipix Consumer Information

In rare cases, fenofibric acid can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. Stop taking fenofibric acid and call your doctor right away if you have unexplained muscle pain, tenderness, or weakness especially if you also have fever, unusual tiredness, and dark colored urine.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using fenofibric acid and call your doctor at once if you have a serious side effect such as:

  • sharp stomach pain spreading to your back or shoulder blade;
  • stomach pain just after eating a meal;
  • nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • pain, swelling, warmth, or redness in one or both legs; or
  • chest pain, sudden cough, wheezing, rapid breathing, fast heart rate.

Less serious side effects may include:

  • headache, dizziness;
  • back pain;
  • joint pain;
  • diarrhea, upset stomach; or
  • cold symptoms such as stuffy nose, sneezing, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Trilipix (Fenofibric Acid Capsules)

Trilipix Professional Information

SIDE EFFECTS

Clinical Trials Experience

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.

Fenofibric acid is the active metabolite of fenofibrate. Adverse events reported by 2% or more of patients treated with fenofibrate and greater than placebo during double-blind, placebocontrolled trials are listed in Table 1. Adverse events led to discontinuation of treatment in 5.0% of patients treated with fenofibrate and in 3.0% treated with placebo. Increases in liver tests were the most frequent events, causing discontinuation of fenofibrate treatment in 1.6% of patients in double-blind trials.

Table 1: Adverse Events Reported by 2% or More of Patients Treated with Fenofibrate and Greater than Placebo During the Double-Blind, Placebo-Controlled Trials

BODY SYSTEM Adverse Event Fenofibrate*
(N = 439)
Placebo
(N = 365)
BODY AS A WHOLE
  Abdominal Pain 4.6% 4.4%
  Back Pain 3.4% 2.5%
  Headache 3.2% 2.7%
DIGESTIVE
  Nausea 2.3% 1.9%
  Constipation 2.1% 1.4%
INVESTIGATIONS
  Abnormal Liver Tests 7.5% 1.4%
  Increased AST 3.4% 0.5%
  Increased ALT 3.0% 1.6%
  Increased Creatine Phosphokinase 3.0% 1.4%
RESPIRATORY
  Respiratory Disorder 6.2% 5.5%
  Rhinitis 2.3% 1.1%
* Dosage equivalent to 135 mg Trilipix

Clinical trials with Trilipix did not include a placebo-control arm. However, the adverse event profile of Trilipix was generally consistent with that of fenofibrate. The following adverse events not listed above were reported in ≥ 3% of patients taking Trilipix alone:

Gastrointestinal Disorders: Diarrhea, dyspepsia

General Disorders and Administration Site Conditions: Pain

Infections and Infestations: Nasopharyngitis, sinusitis, upper respiratory tract infection

Musculoskeletal and Connective Tissue Disorders: Arthralgia, myalgia, pain in extremity

Nervous System Disorders: Dizzinesss

Postmarketing Experience

The following adverse events have been identified during postapproval use of fenofibrate: rhabdomyolysis, pancreatitis, renal failure, muscle spasms, acute renal failure, hepatitis, cirrhosis, anemia, asthenia, and severely depressed HDL-cholesterol levels.

Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Read the entire FDA prescribing information for Trilipix (Fenofibric Acid Capsules)

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© Trilipix Patient Information is supplied by Cerner Multum, Inc. and Trilipix Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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