Trilipix Side Effects

Generic name: fenofibric acid

Note: This document contains side effect information about fenofibric acid. Some of the dosage forms listed on this page may not apply to the brand name Trilipix.

Some side effects of Trilipix may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to fenofibric acid: oral delayed release capsule, oral tablet

In rare cases, fenofibric acid (the active ingredient contained in Trilipix) 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 while taking fenofibric acid: 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 of fenofibric acid 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.

For Healthcare Professionals

Applies to fenofibric acid: oral delayed release capsule, oral tablet

Gastrointestinal

Gastrointestinal side effects of fenofibric acid (the active ingredient contained in Trilipix) alone or when co-administered with statins have included constipation (2.4% to 3.3%), diarrhea (3.1% to 6.9%), abdominal pain (4.6%), dyspepsia (2.4% to 4.7%), and nausea (3.5% to 5.5%).

Respiratory

Respiratory side effects of fenofibric acid (the active ingredient contained in Trilipix) alone or when co-administered with statins have included respiratory disorder (6.2%), rhinitis (2.3%), nasopharyngitis (3.3% to 4.7%), sinusitis (1.6% to 3.5%), and upper respiratory tract infection (2.9% to 5.3%). Respiratory side effects (greater than or equal to 3%) reported in long-term co-administration studies have included cough, pharyngolaryngeal pain, bronchitis, and influenza.

Musculoskeletal

Musculoskeletal side effects of fenofibric acid (the active ingredient contained in Trilipix) alone or when co-administered with a statin, have included pain (1.4% to 3.5%), arthralgia (3.5% to 4.9%), back pain (3.3% to 6.5%), muscle spasms (1.6% to 4.9%), myalgia (3.1% to 6.1%), and pain in extremity (2.7% to 4.5%). Musculoskeletal side effects (greater than or equal to 3%) reported in long-term co-administration studies have included musculoskeletal pain, increased blood creatine phosphokinase (CPK), and increased aspartate aminotransferase (AST).

Nervous system

Nervous system side effects of fenofibric acid (the active ingredient contained in Trilipix) alone or when co-administered with statins, have included fatigue (2.0% to 3.3%), dizziness (0.8% to 4.1%) and headache (11.9% to 16.7%). Nervous system side effects (greater than or equal to 3%) reported in long-term co-administration studies have included insomnia and hypertension.

Hepatic

Hepatic side effects of fenofibric acid (the active ingredient contained in Trilipix) alone or when co-administered with a statin have included abnormal liver tests (7.5%), increased ALT (0.4% to 3.1%), creatine phosphokinase increased (3%), and increased AST (3.4%). Hepatic side effects (greater than or equal to 3%) reported in long-term co-administration have included increased hepatic enzyme.

Genitourinary

Genitourinary side effects (greater than or equal to 3%) reported in long-term co-administration studies have included urinary tract infection.

Other

Other side effects reported postmarketing have included pancreatitis, acute renal failure, hepatitis, uremia, and cirrhosis.

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