Trilipix
- Generic Name: fenofibric acid capsules
- Brand Name: Trilipix
- Drug Class: Fibric Acid Agents
Trilipix (Fenofibric Acid Capsules) side effects drug center
Trilipix Side Effects Center
What Is Trilipix?
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.
What Are Side Effects of Trilipix?
Common side effects of Trilipix include:
- nausea,
- upset stomach,
- headache,
- dizziness,
- back pain,
- joint pain, or
- cold symptoms such as stuffy nose, sneezing, or sore throat.
Trilipix may rarely cause gallstones and liver problems. If you notice any of the following unlikely but serious side effects, tell your doctor:
- persistent nausea or vomiting,
- loss of appetite,
- stomach or abdominal pain,
- yellowing eyes or skin, or
- dark urine.
Dosage for Trilipix
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.
What Drugs, Substances, or Supplements Interact with Trilipix?
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 During Pregnancy and Breastfeeding
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.
Additional Information
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.
Trilipix Consumer Information
Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning in your eyes, skin pain, red or purple skin rash that spreads and causes blistering and peeling).
In rare cases, fenofibric acid can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. Call your doctor right away if you have unexplained muscle pain, tenderness, or weakness especially if you also have fever, unusual tiredness, or dark colored urine.
Also call your doctor at once if you have:
- sharp stomach pain spreading to your back or shoulder blade;
- loss of appetite, stomach pain just after eating a meal;
- jaundice (yellowing of the skin or eyes);
- fever, chills, weakness, sore throat, mouth sores, unusual bruising or bleeding;
- chest pain, sudden cough, wheezing, rapid breathing, coughing up blood; or
- swelling, warmth, or redness in an arm or leg.
Common side effects may include:
- runny nose, sneezing; or
- abnormal laboratory tests.
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, placebo-controlled 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 | ||
Urticaria was seen in 1.1% vs. 0%, and rash in 1.4% vs. 0.8% of fenofibrate and placebo patients respectively in controlled trials.
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: Dizziness
Postmarketing Experience
The following adverse reactions have been identified during postapproval use of fenofibrate. Because these reactions 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: rhabdomyolysis, pancreatitis, renal failure, muscle spasms, acute renal failure, hepatitis, cirrhosis, anemia, asthenia, and severely depressed HDL-cholesterol levels. Photosensitivity reactions to fenofibrate have occurred days to months after initiation; in some of these cases, patients reported a prior photosensitivity reaction to ketoprofen.
Read the entire FDA prescribing information for Trilipix (Fenofibric Acid Capsules)
&Copy; 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.