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Fenofibrate Side Effects

Medically reviewed by Last updated on Aug 28, 2022.


Commonly reported side effects of fenofibrate include: increased serum aspartate aminotransferase and increased serum alanine aminotransferase. Other side effects include: abnormal hepatic function tests, increased creatine phosphokinase in blood specimen, and increased serum transaminases. Continue reading for a comprehensive list of adverse effects.

Applies to fenofibrate: oral capsule, oral tablet.

Serious side effects of Fenofibrate

Along with its needed effects, fenofibrate 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:

Less common


  • Dark urine
  • muscle cramps, spasms, stiffness, swelling, or weakness
  • trouble breathing
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • yellow eyes or skin

Incidence not known

  • Agitation
  • bloating
  • bloody urine
  • constipation
  • cough
  • decreased frequency or amount of urine
  • difficulty in moving
  • fast heartbeat
  • increased blood pressure
  • increased thirst
  • indigestion
  • joint pain or swelling
  • light-colored stools
  • loss of appetite
  • lower back or side pain
  • pains in the stomach, side, or abdomen, possibly radiating to the back
  • pale skin
  • swelling of the face, fingers, or lower legs
  • upper right stomach pain
  • weight gain

Other side effects of Fenofibrate

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:

More common

  • Runny or stuffy nose
  • sneezing

Less common

Incidence not known

  • Lack or loss of strength

For Healthcare Professionals

Applies to fenofibrate: oral capsule, oral tablet.


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


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]


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]


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]


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]


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

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]


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]


Common (1% to 10%): Conjunctivitis

Frequency not reported: Eye disorder, amblyopia, abnormal vision, cataract specified, refraction disorder[Ref]


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]


Uncommon (0.1% to 1%): Sexual dysfunction

Frequency not reported: Urinary frequency, prostatic disorder, dysuria, gynecomastia, vaginal moniliasis, cystitis[Ref]


Rare (less than 0.1%): Hemoglobin decreased, leukopenia

Frequency not reported: Eosinophilia, lymphadenopathy, thrombocytopenia, anemia

Postmarketing reports: Hematocrit decreased[Ref]


Frequency not reported: Appetite increased, anorexia, diabetes mellitus, hypoglycemia, gout, hyperuricemia

Postmarketing reports: High-density lipoprotein cholesterol levels severely depressed[Ref]


Frequency not reported: Kidney function abnormal, urolithiasis

Postmarketing reports: Renal failure, acute renal failure[Ref]


Common (1% to 10%): Insomnia

Frequency not reported: Depression, libido decreased, anxiety, nervousness[Ref]


Frequency not reported: Diabetes mellitus[Ref]


Rare (less than 0.1%): Hypersensitivity reaction

Frequency not reported: Allergic reaction[Ref]


1. "Product Information. Tricor (fenofibrate)." Abbott Pharmaceutical (2001):

2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

3. Cerner Multum, Inc. "Australian Product Information." O 0

4. "Product Information. Antara (fenofibrate)." Lupin Pharmaceuticals Inc (2016):

5. "Product Information. Fenoglide (fenofibrate)." Santarus Inc (2016):

6. "Product Information. Lipofen (fenofibrate)." Kowa Pharmaceuticals America (formerly ProEthic) (2016):

7. "Product Information. Triglide (fenofibrate)." Sciele Pharma Inc (2016):

8. "Product Information. Fenofibrate (fenofibrate)." Mylan Pharmaceuticals Inc (2016):

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.