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Trilipix

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Trilipix

Trilipix Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

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

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. Breast-feeding 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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Trilipix in Detail - Patient Information: Side Effects

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) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Trilipix Overview - Patient Information: Side Effects

SIDE EFFECTS: Nausea and headache may occur. If either of these effects persist or worsen, tell your doctor promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

This medication may infrequently cause gallstones and liver problems. If you notice any of the following unlikely but very serious side effects, tell your doctor immediately: persistent nausea/vomiting, severe stomach/abdominal pain, dark urine, yellowing eyes/skin.

This drug may infrequently cause muscle problems (which can rarely lead to a very serious condition called rhabdomyolysis). Tell your doctor immediately if you develop any of these symptoms: muscle pain/tenderness/weakness (especially with fever or unusual tiredness), change in the amount of urine.

Rarely, this medication has caused severe lowering of HDL ("good" cholesterol) levels. This is the opposite of what should happen to your HDL levels (paradoxical reaction). Your HDL cholesterol levels should be checked regularly. Keep all of your laboratory appointments.

Tell your doctor immediately if any of these rare but very serious side effects occur: easy bleeding/bruising, signs of infection (such as fever, persistent sore throat), chest pain, pain/redness/swelling of arms or legs.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Trilipix (Fenofibric Acid Capsules)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Trilipix FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Clinical Trials Experience

Because clinical studies are conducted under widely varying conditions, adverse event rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug.

Trilipix (fenofibric acid)

Monotherapy

Treatment-emergent adverse events reported in 3% or more of patients treated with Trilipix during the randomized controlled trials are listed in Table 1 below.

Co-Administration Therapy with Statins (Double-blind Controlled Trials)

Treatment-emergent adverse events reported in 3% or more of patients treated with Trilipix co-administered with statins during the randomized controlled trials are listed in Table 1 below.

Table 1: Treatment-Emergent Adverse Events Reported in ≥ 3% of Patients Receiving Trilipix or Trilipix Co-Administered with a Statin During Double-Blind Controlled Studies [Number (%)]

Adverse Event Trilipix
(N = 490)
Low-Dose Statin
(N = 493)
Trilipix + Low-Dose Statin
(N = 490)
Moderate-Dose Statin
(N = 491)
Trilipix + Moderate-Dose Statin
(N = 489)
High-Dose Statin
(N = 245)
Gastrointestinal Disorders
  Constipation 16 (3.3) 11 (2.2) 16(3.3) 13 (2.6) 15(3.1) 6(2.4)
  Diarrhea 19(3.9) 16(3.2) 15(3.1) 24 (4.9) 18 (3.7) 17 (6.9)
  Dyspepsia 18(3.7) 13(2.6) 13(2.7) 17 (3.5) 23 (4.7) 6(2.4)
  Nausea 21 (4.3) 18 (3.7) 17(3.5) 22 (4.5) 27 (5.5) 10(4.1)
General Disorders and Administration Site Conditions
  Fatigue  10 (2.0) 13 (2.6) 13(2.7) 13 (2.6) 16(3.3) 5(2.0)
  Pain 17 (3.5) 9(1.8) 16 (3.3) 8(1.6) 7(1-4) 8(3.3)
Infections and Infestations
  Nasopharyngitis 17(3.5) 29 (5.9) 23 (4.7) 16(3.3) 21 (4.3) 9(3.7)
  Sinusitis 16 (3.3) 4 (0.8) 14 (2.9) 8(1.6) 17 (3.5) 4(1.6)
  Upper Respiratory Tract Infection 26 (5.3) 13(2.6) 18(3.7) 23 (4.7) 23 (4.7) 7 (2.9)
Investigations
  ALT Increased 6(1.2) 2 (0.4) 15(3.1) 2(0.4) 12 (2,5) 4(1.6)
Musculoskeletal and Connective Tissue Disorders
  Arthralgia 19(3.9) 22 (4.5) 21 (4.3) 21 (4.3) 17(3.5) 12 (4.9)
  Back Pain 31 (6.3) 31(6.3) 30(6.1) 32(6.5) 20(4,1) 8(3.3)
  Muscle Spasms 8(1.6) 18(3.7) 12 (2.4) 24 (4.9) 15(3.1) 6 (2.4)
  Myalgia 16(3.3) 24 (4.9) 17 (3.5) 23 (4.7) 15 (3.1) 15(6.1)
  Pain in Extremity 22 (4.5) 24(4.9) 14(2.9) 21(4.3) 13 (2.7) 9(3.7)
Nervous System Disorders
  Dizziness 20(4.1) 8(1.6) 19 (3.9) 11 (2.2) 16(3.3) 2 (0.8)
  Headache 62 (12.7) 64(13.0) 64 (13.1) 82 (16.7) 58(11.9) 32(13.1)
Low-dose statin = rosuvastatin 10 mg, simvastatin 20 mg, or atorvastatin 20 mg
Moderate-dose statin = rosuvastatin 20 mg, simvastatin 40 mg, or atorvastatin 40 mg
High-dose statin = rosuvastatin 40 mg, simvastatin 80 mg, or atorvastatin 80 mg

Co-Administration Therapy with Statins (Long-Term Exposure for up to 64 Weeks')

Patients successfully completing any one of the three double-blind, controlled studies were eligible to participate in a 5 2-week long-term extension study where they received Trilipix co-administered with the moderate dose statin. A total of 2201 patients received at least one dose of Trilipix co-administered with a statin in the double-blind controlled study or the long-term extension study for up to a total of 64 weeks of treatment. Additional treatment-emergent adverse events (not listed in Table 1 above) reported in 3% or more of patients receiving Trilipix co-administered with a statin in either the double-blind controlled studies or the long-term extension study are provided below.

Infections and Infestations

Bronchitis, influenza, and urinary tract infection.

Investigations

AST increased, blood CPK increased, and hepatic enzyme increased.

Musculoskeletal and Connective Tissue Disorders

Musculoskeletal pain.

Psychiatric Disorders

Insomnia.

Respiratory, Thoracic, and Mediastinal Disorders

Cough and pharyngolaryngeal pain.

Vascular Disorders

Hypertension.

Fenofibrate

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, placebo-controlled trials are listed in Table 2. 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 2. 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

Postmarketing Experience

The following adverse events have been identified during postapproval use of fenofibrate: myalgia, rhabdomyolysis, pancreatitis, renal failure, muscle spasms, acute renal failure, hepatitis, cirrhosis, anemia, arthralgia, 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 casual relationship to drug exposure.

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

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Trilipix - User Reviews

Trilipix User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Trilipix sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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