Fenofibric acid Side Effects

Brand Names: Fibricor, Trilipix

Please note - some side effects for Fenofibric acid 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 Fenofibric acid - for the Consumer

Fenofibric Acid

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 Fenofibric Acid:

Back pain; headache; stomach pain.

Seek medical attention right away if any of these SEVERE side effects occur when using Fenofibric Acid:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); calf pain, swelling, or tenderness; chest pain; coughing up blood; dark urine; decrease in the amount of urine produced; fever, chills, or persistent sore throat; muscle pain, tenderness, or weakness (especially along with fever or unusual tiredness); pale stools; red, swollen, blistered, or peeling skin; severe or persistent headache, dizziness, or lightheadedness; severe or persistent nausea, stomach pain, or vomiting; shortness of breath; unusual bruising or bleeding; 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.

Fenofibric Acid 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 Fenofibric Acid Delayed-Release Capsules:

Back pain; diarrhea; dizziness; headache; heartburn or indigestion; nausea; sore throat; stomach upset; upper respiratory tract infection.

Seek medical attention right away if any of these SEVERE side effects occur when using Fenofibric Acid Delayed-Release Capsules:

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.

Top

Fenofibric acid Side Effects - for the Professional

Fenofibric Acid

Clinical Trial Experience

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

Adverse reactions reported by 2% or more of patients treated with fenofibrate (and greater than placebo) during the double-blind, placebo-controlled trials are listed in Table 1. Adverse reactions led to discontinuation of treatment in 5% of patients treated with fenofibrate and in 3% treated with placebo. Increases in liver tests were the most frequent events, causing discontinuation of fenofibrate treatment in 1.6% of patients.

Table 1. Adverse Reactions Reported by 2% or More of Patients Treated with Fenofibrate* During the Double-Blind, Placebo-Controlled Trials

BODY SYSTEM Adverse Reactions	Fenofibrate* (N=439)	Placebo (N=365)
* Fenofibric Acid is the active moiety of fenofibrate; Fenofibrate dosage equivalent to 105 mg Fenofibric Acid.
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%
METABOLIC AND NUTRITIONAL DISORDERS
Abnormal Liver Tests	7.5%	1.4%
Increased ALT	3%	1.6%
Creatine Phosphokinase Increased	3%	1.4%
Increased AST	3.4%	0.5%
RESPIRATORY
Respiratory Disorder	6.2%	5.5%
Rhinitis	2.3%	1.1%

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: myalgia, rhabdomyolysis, increased creatinine phosphokinase, pancreatitis, increased alanine aminotranaminase, increased aspartate aminotranaminase, muscle spasm, acute renal failure, hepatitis, cirrhosis, nausea, abdominal pain, anemia, headache, arthralgia and asthenia.

Top

Side 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.

Top

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.