Formulary
Fenofibrate: Indications, Dosing, Side Effects and Interactions
Fibrates act by decreasing serum triglycerides; they have variable effect on LDL-cholesterol.
MedNext Academy | 3 min read
Fenofibrate: Indications, Dosing, Side Effects and Interactions
Fibrates act by decreasing serum triglycerides; they have variable effect on LDL-cholesterol.
Drug action
Fibrates act by decreasing serum triglycerides; they have variable effect on LDL-cholesterol.
Indications and dose
**Adjunct to diet and other appropriate measures in mixed hyperlipidaemia if statin contraindicated or not tolerated,Adjunct to diet and other appropriate measures in severe hypertriglyceridaemia,Adjunct to statin in mixed hyperlipidaemia if triglycerides and HDL-cholesterol inadequately controlled in patients at high cardiovascular risk**
- **Adult** (By Mouth Using Capsules): Initially 200 mg daily, then increased if necessary to 267 mg daily, maximum 200 mg daily with concomitant statin, 267 mg capsules not appropriate for initial dose titration.
- **Adult** (By Mouth Using Tablets): 160 mg daily.
**Hyperlipidaemias including familial hypercholesterolaemia (administered on expert advice) for fenofibrate**
- **Child 4-14 years** (By mouth using capsules): One 67 mg (micronised) capsule per 20 kg body-weight daily, maximum four 67 mg capsules daily, or max. three 67 mg capsules daily with concomitant statin.
- **Child 15-17 years** (By mouth using capsules): Initially 3 capsules daily, then increased if necessary to 4 capsules daily, max. 3 capsules daily with concomitant statin, dose relates to 67 mg (micronised) capsules.
Cautions
Correct hypothyroidism before initiating treatment; risk factors for myopathy
Contraindications
Gall bladder disease; pancreatitis (unless due to severe hypertriglyceridaemia); photosensitivity to fibrates; photosensitivity to ketoprofen
Side effects
Common or very common Abdominal pain; diarrhoea; flatulence; nausea; vomiting Uncommon Cholelithiasis; embolism and thrombosis; headache; muscle complaints; muscle weakness; myopathy; pancreatitis; sexual dysfunction; skin reactions Rare or very rare Alopecia; hepatic disorders; photosensitivity reaction Frequency not known Fatigue; interstitial lung disease; rhabdomyolysis (increased risk in renal impairment); severe cutaneous adverse reactions (SCARs)
Interactions
**Severe interactions:**
- Therefore, this combination is not recommended Ciclosporin: Some severe cases of reversible renal function impairment have been reported during concomitant administration of fenofibrate and...
- The renal function of these patients must therefore be closely monitored and the treatment with fenofibrate stopped in the case of severe alteration of laboratory parameters.
- HMG-CoA reductase inhibitors and other fibrates : The risk of serious muscle toxicity I increased if fenofibrate is used concomitantly with HMG-CoA reductase inhibitors or other fibrates.
**Other interactions (4):**
- Oral anticoagulants : Fenofibrate enhances oral anticoagulant effect and may increase risk of bleeding.
- It is recommended that the dose of anticoagulants is reduced by about one third at the start of treatment and then gradually adjusted if necessary according to INR (International Normalised Ratio)...
- Such combination therapy should be used with caution and patients monitored closely for signs of muscle toxicity (see section 4.4) Cytochrome P450 enzymes: In vitro studies using human liver...
- Patients co-administered fenofibrate and CYP2C19, CYP2A6, and especially CYP2C9 metabolised drugs with a narrow therapeutic index should be carefully monitored and, if necessary, dose adjustment of...
Pregnancy
Avoid-embryotoxicity in animal studies.
Breast feeding
Manufacturers advise avoid-no information available.
Hepatic impairment
Manufacturer advises avoid -no information available.
Renal impairment
Use with caution in mild-to-moderate impairment; avoid if eGFR less than 30 mL/minute/1.73 m 2 . M Myotoxicity Special care needed in patients with renal disease, as progressive increases in serum creatinine concentration or failure to follow dosage guidelines may result in myotoxicity (rhabdomyolysis); discontinue if myotoxicity suspected or creatine kinase concentration increases significantly. M Dose adjustments See Prescribing in renal impairment . Max. 67 mg daily if eGFR 30-59 mL/minute/1.73 m 2 . M
Medicinal forms
Tablet,Capsule
Clinical governance
**Author:** MedNext Clinical Team. **Clinical reviewer:** Dr Shameer Deen, MBBS, MS, MRCS. **Sources:** BNF, Indian Pharmacopoeia, CIMS India. **Correction:** Report errors at support@mednext.academy.
Inside MedNext for this topic
- 411 MedNext-authored chapters
- 80,000+ MCQ bank
- 15 study modes
- Growing visual cheat sheets
Study modes
- Notes
- MCQ
- Audio
- Video
- Visual
- 3D Anatomy
- Trace
- Flashcards
- Mnemonics
- Image Bank
- Clinical
- Microscopy
- Audio QBank
- Cadaver
- Book Match
Continue reading
Subject HubPharmacology Hub
All pharmacology resources in one place.
Drug SchedulesIndian Drug Schedules
Schedule H, H1, X and G classifications.
FormularyBrowse all drugs
Search 1,850+ drug profiles.
Study Fenofibrate in the MedNext app
Challenge yourself with targeted pharmacology MCQs on this drug class. Every explanation links back to the chapter that teaches the concept.
Start drug challengeExplore the full formulary

