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Fenofibrate oral

Updated 2 Feb 2023 | Fibrates


Oral formulations of fenofibrate.

Drugs List

  • fenofibrate micronised 160mg tablets
  • fenofibrate micronised 200mg capsules
  • fenofibrate micronised 267mg capsules
  • fenofibrate micronised 67mg capsules
  • LIPANTIL MICRO 200mg capsules
  • LIPANTIL MICRO 267mg capsules
  • LIPANTIL MICRO 67mg capsules
  • SUPRALIP 160mg film coated tablets
  • Therapeutic Indications


    Mixed hyperlipidaemia in patients with CV risk: adjunctive treatment
    Mixed hyperlipidaemia when statin is contraindicated or not tolerated
    Severe hypertriglyceridaemia with or without low HDL cholesterol

    Fenofibrate is indicated as an adjunct to diet and other non-pharmacological treatment (e.g. exercise, weight reduction) for the following:

    Severe hypertriglyceridaemia with or without low HDL cholesterol
    Mixed hyperlipidaemia when a statin is contraindicated or not tolerated
    Mixed hyperlipidaemia in patients at high cardiovascular risk in addition to a statin when triglycerides and HDL cholesterol are not adequately controlled.



    200mg and 267mg capsules
    One 200mg capsule taken once daily, with food.
    In patients with severe dyslipidaemia, an increased dose of 267mg is recommended.

    160mg tablets
    One 160mg tablet daily.
    Patients taking one 200mg capsule can be changed to one 160mg tablet without further dose adjustment.

    67mg capsules
    Initial dose: Three 67mg capsules daily in divided doses, with food.
    Maintenance dose: Two to four 67mg capsules daily.


    Only the 67mg capsules are indicated for use in hypercholesterolaemia in children.

    The manufacturer's recommended dose is one 67mg capsule per day per 20kg bodyweight.

    The following alternative dosing schedule may be suitable:

    Children aged 15 to 18 years
    Three 67mg capsules daily, increased to 4 capsules daily if required.

    Children aged 4 to 15 years
    One 67mg capsule/20kg (maximum 4 capsules) daily.

    Patients with Renal Impairment

    In patients with eGFR between 30 and 59ml/minute/1.73 metre squared, the maximum dose of fenofibrate is 67mg once daily.

    Additional Dosage Information

    The response to therapy should be monitored by determination of serum lipid values (total cholesterol, LDL-C, triglycerides).


    Children under 4 years
    Creatine kinase levels over 5 times upper limit of normal
    Photoallergic or phototoxic reactions to fibrates
    Photosensitivity to ketoprofen
    Biliary cirrhosis
    Gallbladder disease
    Pancreatitis - unless due to severe hypertriglyceridaemia
    Renal impairment - eGFR below 30ml/minute/1.73m sq
    Severe hepatic impairment

    Precautions and Warnings

    Children aged 4 to 18 years
    Family history of hereditary muscular disorders
    High alcohol intake
    Major surgery
    Patients over 70 years
    Severe infection
    Severe trauma
    Glucose-galactose malabsorption syndrome
    Hereditary muscular disorder
    History of muscular toxicity secondary to fibrates
    History of muscular toxicity secondary to HMG-CoA reductase inhibitors
    History of non-traumatic rhabdomyolysis
    History of renal impairment
    Lactose intolerance
    Renal impairment - eGFR 30 to 59 ml/minute/1.73 m squared

    Exclude/correct secondary causes of dyslipidaemia prior to treatment
    Not all available products are licensed for all age groups
    Some formulations contain lactose
    Some products may contain soya or soya derivative
    Evaluate nature of hyperlipidaemia in patients using oestrogens
    Monitor hepatic function
    Monitor patients at risk of muscle toxicity
    Monitor serum creatinine
    Monitor serum transaminases every 3 months during first 12 months of use
    Review if an adequate response not obtained within 3 months
    Discontinue if hepatitis develops
    Discontinue if myopathy is suspected
    Suspend treatment if serum creatinine > 50% upper limit of normal
    Discontinue if ALT level exceeds 3 times the upper limit of normal
    Discontinue if AST level exceeds 3 times the upper limit of normal
    Discontinue if CPK rises to > or equal to 5x upper limit of normal range
    Discontinue if eGFR falls below 30ml/minute/1.73 m squared
    Dietary restrictions should be maintained

    Pancreatitis has been reported in patients taking fenofibrate. This may be as a result of a direct drug effect, obstruction of the common bile duct or a failure of efficacy in patients with severe hypertriglyceridaemia.

    Pregnancy and Lactation


    Fenofibrate is contraindicated during pregnancy.

    Although there is insufficient data in humans, animal studies have not demonstrated any teratogenic effects but have demonstrated embryotoxicity and therefore fenofibrate should not be taken during pregnancy.

    The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( ) or if this is unavailable at the backup site ( ).


    Fenofibrate is contraindicated during breastfeeding.

    There is no data available on the excretion of fenofibrate or its metabolites into breast milk. Lactating mothers should be advised not to breastfeed their child during treatment especially due to the infant's need for cholesterol and the carcinogenicity observed in rats treated with this product. An alternative drug is preferred, especially while nursing a newborn or pre-term infant. The relative low molecular weight (about 319) of the active metabolite suggest that it is excreted into the breast milk (Briggs, 2015). Schaefer (2015) suggests that there is no disadvantage to the mother if treatment is stopped during breastfeeding.

    Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
    Specialist advice is available from the UK Drugs in Lactation Advisory Service at

    Side Effects

    Abdominal pain
    Decrease in haemoglobin
    Deep vein thrombosis (DVT)
    Gastric discomfort
    Gastro-intestinal symptoms
    Hypersensitivity reactions
    Increase in serum transaminases
    Interstitial pneumopathies
    Leukocytes decreased
    Muscle cramps
    Muscle spasm
    Muscle toxicity
    Muscle weakness
    Peripheral neuropathy
    Pulmonary embolism
    Serum creatinine increased
    Serum urea increased
    Sexual asthenia
    Skin nodules
    Stevens-Johnson syndrome
    Toxic epidermal necrolysis
    White blood cell count decreased


    It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

    The following number will direct the caller to the relevant local centre (0844) 892 0111

    Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( ) or if this is unavailable at the backup site ( ).

    Further Information

    Last Full Review Date: January 2018

    Reference Sources

    Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 3nd edition (2015) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

    Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 10th edition (2015) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia.

    Summaries of Product Characteristics: Fenofibrate 67mg capsules. Actavis UK Ltd. Revised January 2017.
    Summaries of Product Characteristics: Fenofibrate 200mg capsules. Actavis UK Ltd. Revised April 2016.

    Summary of Product Characteristics: Fenofibrate 267mg capsules. Zentiva. Revised September 2017.

    Summaries of Product Characteristics: Lipantil Micro 67mg. Mylan Products Ltd. Revised February 2017.
    Summaries of Product Characteristics: Lipantil Micro 200mg. Mylan Products Ltd. Revised February 2017.
    Summaries of Product Characteristics: Lipantil Micro 267mg. Mylan Products Ltd. Revised February 2017.

    Summary of Product Characteristics: Supralip 160mg. Mylan Products Ltd. Revised February 2017.

    NICE - Evidence Services
    Available at:
    Last accessed: 03 January 2018.

    US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
    Available at:
    Fenofibrate. Last revised: 06 December 2013.
    Last accessed: 03 January 2018.

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