Fenofibric acid Side Effects
Some side effects of 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.
For the Consumer
Applies to fenofibric acid: oral capsule delayed release, oral tablet
Along with its needed effects, fenofibric acid 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 fenofibric acid:More common
- Body aches or pain
- difficulty with breathing
- ear congestion
- loss of voice
- nasal congestion
- runny nose
- sore throat
- unusual tiredness or weakness
- Bladder pain
- bloody or cloudy urine
- blurred vision
- cough producing mucus
- difficult, burning, or painful urination
- difficulty with moving
- 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
- pain in the arms or legs
- pounding in the ears
- shortness of breath
- slow or fast heartbeat
- swollen joints
- tightness in the chest
- trouble sleeping
Some side effects of fenofibric acid 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:Less common
- Acid or sour stomach
- difficulty having a bowel movement (stool)
- pain or tenderness around the eyes and cheekbones
- stomach discomfort, upset, or pain
- unable to sleep
For Healthcare Professionals
Applies to fenofibric acid: oral delayed release capsule, oral tablet
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 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 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 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 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 side effects (greater than or equal to 3%) reported in long-term co-administration studies have included urinary tract infection.
Other side effects reported postmarketing have included pancreatitis, acute renal failure, hepatitis, uremia, and cirrhosis.
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