Fibricor Side Effects

Generic Name: fenofibric acid

Note: This page contains information about the side effects of fenofibric acid. Some of the dosage forms included on this document may not apply to the brand name Fibricor.

Not all side effects for Fibricor may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to fenofibric acid: oral capsule delayed release, oral tablet

In addition to its needed effects, some unwanted effects may be caused by fenofibric acid (the active ingredient contained in Fibricor). In the event that any of these side effects do occur, they may require medical attention.

You should check with your doctor immediately if any of these side effects occur when taking fenofibric acid:

More common
  • Body aches or pain
  • chills
  • cough
  • difficulty with breathing
  • ear congestion
  • fever
  • headache
  • loss of voice
  • nasal congestion
  • runny nose
  • sneezing
  • sore throat
  • unusual tiredness or weakness
Less common
  • Bladder pain
  • bloody or cloudy urine
  • blurred vision
  • cough producing mucus
  • diarrhea
  • difficult, burning, or painful urination
  • difficulty with moving
  • dizziness
  • frequent urge to urinate
  • general feeling of discomfort or illness
  • joint pain
  • loss of appetite
  • lower back or side pain
  • muscle aching or cramping
  • muscle or bone pain
  • muscle pain or stiffness
  • muscle spasms
  • nausea
  • nervousness
  • pain in the arms or legs
  • pounding in the ears
  • shivering
  • shortness of breath
  • slow or fast heartbeat
  • sweating
  • swollen joints
  • tightness in the chest
  • trouble sleeping
  • vomiting
  • wheezing

Some of the side effects that can occur with fenofibric acid may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

Less common
  • Acid or sour stomach
  • belching
  • difficulty having a bowel movement (stool)
  • heartburn
  • indigestion
  • pain or tenderness around the eyes and cheekbones
  • sleeplessness
  • stomach discomfort, upset, or pain
  • unable to sleep

For Healthcare Professionals

Applies to fenofibric acid: oral delayed release capsule, oral tablet

Gastrointestinal

Gastrointestinal side effects of fenofibric acid (the active ingredient contained in Fibricor) 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%).[Ref]

Respiratory

Respiratory side effects of fenofibric acid (the active ingredient contained in Fibricor) 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.[Ref]

Musculoskeletal

Musculoskeletal side effects of fenofibric acid (the active ingredient contained in Fibricor) 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).[Ref]

Nervous system

Nervous system side effects of fenofibric acid (the active ingredient contained in Fibricor) 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.[Ref]

Hepatic

Hepatic side effects of fenofibric acid (the active ingredient contained in Fibricor) 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.[Ref]

Genitourinary

Genitourinary side effects (greater than or equal to 3%) reported in long-term co-administration studies have included urinary tract infection.[Ref]

Other

Other side effects reported postmarketing have included pancreatitis, acute renal failure, hepatitis, uremia, and cirrhosis.[Ref]

References

1. "Product Information. Trilipix (fenofibric acid)." Abbott Pharmaceutical, Abbott Park, IL.

2. "Product Information. Fibricor (fenofibric acid)." AR Scientific Inc, Philadelphia, PA.

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