fenofibrate
Pharmaranks rates Fenofibrate 3.3/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Fenofibrate is a peroxisome proliferator receptor alpha agonist used to treat Coronary Artery Disease, Hypercholesterolemia, Hyperlipoproteinemias, Hypertriglyceridemia.
Peroxisome Proliferator Receptor Alpha Agonist · by Mylan
Generic of Lipofen
Based on 1 source · Recall-safety score from FDA recall history — this product's own recalls and its manufacturer's record. Not an efficacy or quality rating. methodology →
Key facts
- Active ingredient
- Fenofibrate
- Form
- Capsule, Tablet
- Strength
- Fenofibrate 107MG · Fenofibrate 160MG · Fenofibrate 54MG
- Type
- Prescription (Rx)
- Brand or generic
- Generic
- Manufacturer
- Mylan
- Half-life
- about 20 hours — but that is the half-life of fenofibric acid, the active form, not of fenofibrate itself (how long it stays in your system)
- What the pharmacy pays
- ~$3.42 for 30 — not your price
- FDA application
- ANDA076520
- Availability
- Discontinued (per FDA)
How long does Fenofibrate stay in your body?
The elimination half-life of fenofibrate is about 20 hours — but that is the half-life of fenofibric acid, the active form, not of fenofibrate itself — the time it takes the body to clear about half of it. As a rule of thumb, a medicine is mostly gone after roughly 4 to 5 half-lives, though this varies from person to person with age and kidney or liver function. Fenofibrate is a prodrug. The label states it "is a pro-drug of the active chemical moiety fenofibric acid" and that after an oral dose it is "rapidly hydrolyzed by esterases to the active metabolite, fenofibric acid; no unchanged fenofibrate is detected in plasma." So there is no parent half-life to report — the label gives only one figure: "Fenofibric acid is eliminated with a half-life of 20 hours, allowing once daily dosing." That 20 hours is the elimination (terminal) half-life of the active moiety; the label reports no separate distribution phase. Kidney function matters: the label says patients with mild to moderate renal impairment (eGFR 30–59 mL/min/1.73m2) had similar exposure but "an increase in the half-life for fenofibric acid" compared with healthy subjects (it does not say by how much), and severe impairment (eGFR under 30) showed a 2.7-fold increase in exposure with accumulation on chronic dosing — the label says to avoid fenofibrate in severe renal impairment and to reduce the dose in mild-to-moderate. Older adults: in volunteers aged 77–87 the oral clearance of fenofibric acid was 1.2 L/h versus 1.1 L/h in young adults, i.e. essentially unchanged, so no age-related prolongation is described in those with normal renal function. Liver impairment: the label states no pharmacokinetic studies have been conducted in hepatic impairment, so the half-life there is unknown.
This is general information, not medical advice. It doesn’t tell you when a drug test would read negative (tests detect substances for different, often longer, windows) or when it’s safe to take another dose — ask your pharmacist or prescriber. Source: FENOFIBRATE tablet — DailyMed label, §12.3 Pharmacokinetics.
Drug class
May treat (source: NIH RxClass)
See how Fenofibrate ranks — best-rated peroxisome proliferator receptor alpha agonist for:
Dosage forms
Capsule and Tablet
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
Same active ingredient, far cheaper. Is there a generic? →
Request a 90-day supply
Bulk fills usually lower the per-dose price vs monthly refills.
Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
Compare alternatives
A same-class option may cost less. See alternatives →
Frequently asked questions
- What does Fenofibrate treat?
- Fenofibrate (Fenofibrate) may be used to treat coronary artery disease, hypercholesterolemia, hyperlipoproteinemias, hypertriglyceridemia, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How is Fenofibrate rated?
- pharmaranks gives Fenofibrate a composite score of 3.3 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
- How much does Fenofibrate cost?
- Nobody can tell you what you will pay — your price is set by your insurer's formulary, your deductible and the pharmacy's markup, and none of those are published. What IS published is what the pharmacy paid to acquire it: about $3.42 for 30, per the CMS NADAC survey. Treat that as the floor, not the quote — ask the pharmacist for the cash price as well as your copay, because for cheap generics the cash price often wins. Pharmacies pay less for a same-class option, Actos — about $2.77 on the same basis.
- Is there a coupon or discount for Fenofibrate?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Fenofibrate. To pay less, Fenofibrate is already a generic — usually the lowest-cost version — so the main levers are comparing cash prices between pharmacies and using a pharmacy discount-card service. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Fenofibrate?
- Fenofibrate is marketed by Mylan. You can see Mylan's full profile, rating, and other products on pharmaranks.
- Is Fenofibrate a brand-name or generic drug?
- Fenofibrate is a generic medication; its active ingredient is Fenofibrate. Generics contain the same active ingredient as the brand-name original and are usually lower cost.
- Is Fenofibrate available over the counter?
- No. Fenofibrate is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Fenofibrate come in?
- Fenofibrate is currently marketed as capsule and tablet, per the FDA's National Drug Code Directory.
- What class of drug is Fenofibrate?
- Fenofibrate is classified as peroxisome proliferator receptor alpha agonist, per the FDA's Established Pharmacologic Class.
- Is Fenofibrate FDA-registered?
- Fenofibrate is on record with the U.S. FDA under application number ANDA076520. You can verify this on its official FDA label.
- Has Fenofibrate been recalled by the FDA?
- Fenofibrate has no FDA recalls recorded under its own application in the openFDA enforcement database. Its recall-safety score reflects its manufacturer's overall recall record. This is general reference, not medical advice — check the FDA recall database for the latest alerts.
- Is Fenofibrate safe?
- There's no single safe-or-not verdict. pharmaranks gives Fenofibrate a recall-safety score of 66/100, based on its FDA recall history (no recalls under its own FDA application) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.
Information is sourced from public FDA regulatory data. Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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fenofibrate
66/100