Trilipix Side Effects
Generic Name: fenofibric acid
Please note - some side effects for Trilipix may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.
Side Effects of Trilipix - for the Consumer
Trilipix Delayed-Release Capsules
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Trilipix Delayed-Release Capsules:
Seek medical attention right away if any of these SEVERE side effects occur when using Trilipix Delayed-Release Capsules:Back pain; diarrhea; dizziness; headache; heartburn or indigestion; nausea; sore throat; stomach upset; upper respiratory tract infection.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); calf or leg pain, swelling, redness, or tenderness; chest pain; coughing up blood; dark urine; decrease in amount of urine produced; fever, chills, or persistent sore throat; loss of appetite; muscle pain, tenderness, or weakness (especially along with fever or unusual tiredness); pale stools; red, swollen, blistered, or peeling skin; severe or persistent headache; severe or persistent nausea, stomach pain, or vomiting; shortness of breath; unusual bruising or bleeding; unusual tiredness or weakness; yellowing of the skin or eyes.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
TopTrilipix Side Effects - for the Professional
Trilipix
Clinical Studies 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.
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.
| 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 52-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.
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.
| 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 | ||
The following adverse events have been identified during postapproval use of fenofibrate: myalgia, rhabdomyolysis, increased creatine phosphokinase, pancreatitis, increased alanine aminotransaminase, increased aspartate aminotransaminase, renal failure, muscle spasms, acute renal failure, hepatitis, cirrhosis, nausea, abdominal pain, anemia, headache, arthralgia, and asthenia. 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.
TopSide Effects by Body System - for Healthcare Professionals
Gastrointestinal
Gastrointestinal side effects of fenofibric acid 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 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 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 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 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.
TopMore Trilipix resources
- Trilipix Prescribing Information (FDA)
- Trilipix Consumer Overview
- Trilipix Advanced Consumer (Micromedex) - Includes Dosage Information
- Trilipix Delayed-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer)
- Fenofibric Acid MedFacts Consumer Leaflet (Wolters Kluwer)
- Fenofibric Acid Prescribing Information (FDA)
- Fibricor Prescribing Information (FDA)
Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date, and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This information does not endorse drugs, diagnose patients, or recommend therapy. This drug information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug of drug combination is safe, effective, or appropriate for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of information provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse, or pharmacist.
