Lipofen Side Effects

Generic name: fenofibrate

Medically reviewed by Drugs.com. Last updated on Jul 16, 2024.

Note: This document provides detailed information about Lipofen Side Effects associated with fenofibrate. Some dosage forms listed on this page may not apply specifically to the brand name Lipofen.

Applies to fenofibrate: oral capsule, oral tablet.

Precautions

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly to lower your cholesterol and triglyceride (fat) levels and to decide if you should continue to take it. Blood and urine tests may be needed to check for unwanted effects.

Call your doctor right away if you have a headache, stomach pain, vomiting, dark urine, loss of appetite, weight loss, general feeling of tiredness or weakness, light-colored stools, upper right stomach pain, or yellow eyes or skin. These could be symptoms of liver problems.

Check with your doctor right away if you have unexplained muscle pain, tenderness, or weakness, especially if you also have unusual tiredness or fever. These could be symptoms of a serious muscle problem called myopathy.

Check with your doctor right away if you have dark urine, diarrhea, fever, muscle cramps or spasms, muscle pain or stiffness, or feel very tired or weak. These could be symptoms of a serious muscle problem called rhabdomyolysis, which can cause kidney problems.

Pancreatitis may occur while you are using this medicine. Tell your doctor right away if you have bloating, sudden and severe stomach pain, chills, diarrhea, fast heartbeat, fever, indigestion. loss of appetite, nausea, pains in stomach, side, or abdomen, possibly radiating to the back, vomiting.

This medicine may increase your risk of having gallstones. Check with your doctor right away if you have severe stomach pain, especially after eating, with nausea and vomiting.

This medicine may cause serious allergic reactions, including anaphylaxis and angioedema, which can be life-threatening and require immediate medical attention. Tell your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after using this medicine.

Serious skin reactions, including Steven-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS) can occur with this medicine. Check with your doctor right away if you have blistering, peeling, or loosening of the skin, chest pain, chills, cough, diarrhea, itching, joint or muscle pain, painful or difficult urination, rash, red skin lesions, often with a purple center, sore throat, sores, ulcers, or white spots in the mouth or on the lips, or unusual tiredness or weakness.

This medicine may lower the number of some types of blood cells in your body. Because of this, you may bleed or get infections more easily. To help with these problems, avoid being near people who are sick or have infections. Wash your hands often. Stay away from rough sports or other situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be careful when using sharp objects, including razors and fingernail clippers.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Common side effects of Lipofen

Some side effects of fenofibrate may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Serious side effects of Lipofen

Along with its needed effects, fenofibrate (the active ingredient contained in Lipofen) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking fenofibrate:

For healthcare professionals

Applies to fenofibrate: oral capsule, oral tablet.

General adverse events

The most frequently reported side effects have included abnormal liver tests, increased transaminases (ALT and AST), increased creatine phosphokinase (CPK), and rhinitis.^[Ref]

Hepatic

• Common (1% to 10%): Liver function tests abnormal, AST increased, ALT increased
• Uncommon (0.1% to 1%): Cholelithiasis
• Rare (less than 0.1%): Hepatitis
• Postmarketing reports: Cirrhosis, liver fatty deposit, cholecystitis, jaundice, cholangitis, biliary colic, elevated total bilirubin, serious drug-induced liver injury including liver transplantation and death^[Ref]

During clinical trials, transaminase increases to greater than 3 times the upper limit of normal (3 x ULN) occurred in 5.3% of patients taking fenofibrate compared with 1.1% of those on placebo; the incidence of increased transaminases appeared to be dose-related.^[Ref]

Respiratory

• Very common (10% or more): Rhinitis (up to 23.2%), bronchitis (16.4%)
• Common (1% to 10%): Respiratory disorder, pharyngitis, sinusitis
• Uncommon (0.1% to 1%): Pulmonary embolism
• Very rare (less than 0.01%): Interstitial pneumopathy
• Frequency not reported: Cough increased, dyspnea, asthma, pneumonia, laryngitis
• Postmarketing reports: Interstitial lung disease^[Ref]

Musculoskeletal

• Very common (10% or more): Arthralgia (up to 25.1%), back pain (up to 15%)
• Common (1% to 10%): Back pain, myalgia
• Uncommon (0.1% to 1%): Diffuse myalgia, myositis, muscle cramp, muscle weakness
• Very rare (less than 0.01%): Rhabdomyolysis
• Frequency not reported: Arthritis, tenosynovitis, joint disorder, arthrosis, leg cramp, bursitis, myasthenia
• Postmarketing reports: Muscle spasm^[Ref]

Gastrointestinal

• Very common (10% or more): Abdominal pain (up to 15.9%)
• Common (1% to 10%): Nausea, constipation, diarrhea, vomiting, flatulence
• Uncommon (0.1% to 1%): Pancreatitis
• Frequency not reported: Dyspepsia, gastroenteritis, rectal disorder, esophagitis, gastritis, colitis, tooth disorder, gastrointestinal disorder, duodenal ulcer, peptic ulcer, rectal hemorrhage, eructation, gamma glutamyl transpeptidase, dry mouth^[Ref]

Nervous system

• Common (1% to 10%): Headache, dizziness
• Rare (less than 0.1%): Peripheral neuropathy
• Frequency not reported: Migraine, paresthesia, hypertonia, neuralgia, somnolence^[Ref]

Dermatologic

• Common (1% to 10%): Rash, pruritus, urticaria
• Uncommon (0.1% to 1%): Photosensitivity reaction
• Rare (0.01% to 0.1%): Alopecia
• Very rare (less than 0.01%): Cutaneous photosensitivity with erythema, vesiculation, nodulation
• Frequency not reported: Erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, eczema, acne, sweating, fungal dermatitis, skin disorder, contact dermatitis, maculopapular rash, nail disorder, skin ulcer
• Postmarketing reports: Severe cutaneous adverse drug reactions (SCAR), including Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis, and Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), ecchymosis^[Ref]

Photosensitivity reactions have been reported days to months after initiation; in some cases, a prior photosensitivity reaction to ketoprofen had been reported.^[Ref]

Cardiovascular

• Uncommon (0.1% to 1%): Deep vein thrombosis
• Frequency not reported: Angina pectoris, hypertension, vasodilatation, coronary artery disorder, electrocardiogram abnormal, extrasystole, myocardial infarct, peripheral vascular disorder, varicose vein, cardiovascular disorder, hypotension, palpitation, arrhythmia, phlebitis, tachycardia, atrial fibrillation^[Ref]

Ocular

• Common (1% to 10%): Conjunctivitis
• Frequency not reported: Eye disorder, amblyopia, abnormal vision, cataract specified, refraction disorder^[Ref]

Other

• Very common (10% or more): Accidental injury (up to 18.4%), flu syndrome (up to 17.9%), chest pain (up to 10.1%)
• Common (1% to 10%): Creatine phosphokinase increased, malaise, vertigo, fatigue
• Uncommon (0.1% to 1%): Serum creatinine increased, urea increased
• Rare (less than 0.1%): Sexual asthenia
• Frequency not reported: Pain, infection, cyst, hernia, fever, peripheral edema, ear pain, otitis media, herpes zoster, herpes simplex, weight gain, weight loss, edema
• Postmarketing reports: Asthenia^[Ref]

Genitourinary

• Uncommon (0.1% to 1%): Sexual dysfunction
• Frequency not reported: Urinary frequency, prostatic disorder, dysuria, gynecomastia, vaginal moniliasis, cystitis^[Ref]

Hematologic

• Rare (less than 0.1%): Hemoglobin decreased, leukopenia
• Frequency not reported: Eosinophilia, lymphadenopathy, thrombocytopenia, anemia
• Postmarketing reports: Hematocrit decreased^[Ref]

Metabolic

• Frequency not reported: Appetite increased, anorexia, diabetes mellitus, hypoglycemia, gout, hyperuricemia
• Postmarketing reports: High-density lipoprotein cholesterol levels severely depressed^[Ref]

Renal

• Frequency not reported: Kidney function abnormal, urolithiasis
• Postmarketing reports: Renal failure, acute renal failure^[Ref]

Psychiatric

• Common (1% to 10%): Insomnia
• Frequency not reported: Depression, libido decreased, anxiety, nervousness^[Ref]

Endocrine

• Frequency not reported: Diabetes mellitus^[Ref]

Hypersensitivity

• Rare (less than 0.1%): Hypersensitivity reaction
• Frequency not reported: Allergic reaction^[Ref]

See also:

Further information

Lipofen side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer