Clinical Effects:

  • USES: Fibrates are indicated to reduce elevated levels of LDL-C, Total-C, TG, and Apo B, and to increase HDL-C in patients with primary or mixed dyslipidemia. PHARMACOLOGY: Fibrates activate peroxisome proliferator activated receptor alfa (PPARa), leading to elimination of triglyceride-rich particles, transformation, and increased elimination of small, dense LDL particles and synthesis of apolipoproteins AI, AII, and HDL-C. EPIDEMIOLOGY: Overdose is rare. TOXICITY: The extent of symptoms in human overdose is unknown. ADVERSE EFFECTS: COMMON: Headache, back pain, nasopharyngitis, nausea, myalgia, diarrhea, and upper respiratory tract infection. Increases of serum transaminase levels greater than 3 times the upper limit of normal were reported following fenofibrate therapy. LESS COMMON: Fatigue, increased ALT, and muscle spasms.

Range of Toxicity:

  • TOXICITY: A specific toxic dose has not been established. THERAPEUTIC DOSE: FENOFIBRATE: The recommended dose of fenofibrate is 48 to 145 mg orally once daily; MAX dose 145 mg. FENOFIBRIC ACID: The recommended dose of fenofibric acid is 45 to 135 mg orally once daily; MAX dose 135 mg. CLOFIBRATE: 2 grams daily in divided doses.


  • Support: MANAGEMENT OF MILD TO MODERATE TOXICITY: Treatment is symptomatic and supportive. MANAGEMENT OF SEVERE TOXICITY: Treatment is symptomatic and supportive. Observe clinical status and vital signs in substantial ingestions.
  • Decontamination: PREHOSPITAL: Serious toxicity is not expected after ingestion of roflumilast alone, and prehospital gastrointestinal decontamination is not routinely required. HOSPITAL: Significant toxicity is not expected after overdose; gastrointestinal decontamination is generally not necessary. Activated charcoal should be considered after extremely large ingestions or if more toxic coingestants are involved.
  • Antidote: None.
  • Monitoring of patient: Patients should be observed for CNS depression. Monitor liver enzyme concentrations, urinalysis, and renal function tests in patients with significant overdose. Monitor CK in patients with muscle pain or tenderness.
  • Enhanced elimination procedure: Hemodialysis is UNLIKELY to be of value because of the high degree of protein binding and large volume of distribution.
  • Patient disposition: HOME CRITERIA: Patients with a minor unintentional exposure who are asymptomatic or have mild symptoms can likely be managed at home. OBSERVATION CRITERIA: Patients with an inadvertent overdose who have more than mild symptoms and patients with deliberate self-harm ingestions should be sent to a health care facility for evaluation and treated until symptoms resolve. ADMISSION CRITERIA: Patients who remain symptomatic despite adequate treatment should be admitted. CONSULT CRITERIA: Consult a medical toxicologist or Poison Center for assistance in managing patients with severe toxicity or in whom the diagnosis is unclear.