
apremilast
Pharmaranks rates Apremilast 3.5/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Apremilast is a phosphodiesterase 4 inhibitor used to treat Psoriatic Arthritis.
Phosphodiesterase 4 Inhibitor · by Macleods Pharms Ltd
Generic of Otezla
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
- Apremilast
- Drug class
- Phosphodiesterase 4 Inhibitor
- Form
- Tablet
- Strength
- Apremilast 10MG · Apremilast 20MG · Apremilast 30MG
- Type
- Prescription (Rx)
- Brand or generic
- Generic
- May treat
- psoriatic arthritis
- Manufacturer
- Macleods Pharms Ltd
- Half-life
- about 6 to 9 hours (terminal elimination half-life) (how long it stays in your system)
- FDA application
- ANDA211788
- Availability
- Discontinued (per FDA)
How long does Apremilast stay in your body?
The elimination half-life of apremilast is about 6 to 9 hours (terminal elimination half-life) — 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. This is the terminal (beta) elimination half-life of the parent drug apremilast in healthy adults; plasma clearance is about 10 L/hr. Apremilast is NOT a prodrug, and its main metabolite, M12 (a glucuronide of O-demethylated apremilast, ~39% of circulating drug), is INACTIVE — so the parent's half-life is the one that matters and there is no longer-lasting active metabolite to report. Population effects the label names: liver — no dose change needed, PK is unaffected by moderate or severe hepatic impairment; kidney — unaffected by mild or moderate renal impairment, but in severe renal impairment a single 30 mg dose gave ~88% higher AUC and ~42% higher Cmax (label calls for dose reduction); older adults (65-85 yrs) — modestly higher exposure (~13% AUC, ~6% Cmax) versus younger adults. This is not a drug-test detection window or dosing guidance.
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: OTEZLA (apremilast) — DailyMed label, Clinical Pharmacology 12.3.
Drug class
May treat (source: NIH RxClass)
See how Apremilast ranks — best-rated phosphodiesterase 4 inhibitor for:
Dosage forms
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 Apremilast treat?
- Apremilast (Apremilast) may be used to treat psoriatic arthritis, 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 Apremilast rated?
- pharmaranks gives Apremilast a composite score of 3.5 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
- Is there a coupon or discount for Apremilast?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Apremilast. To pay less, Apremilast 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 Apremilast?
- Apremilast is marketed by Macleods Pharms Ltd. You can see Macleods Pharms Ltd's full profile, rating, and other products on pharmaranks.
- Is Apremilast a brand-name or generic drug?
- Apremilast is a generic medication; its active ingredient is Apremilast. Generics contain the same active ingredient as the brand-name original and are usually lower cost.
- Is Apremilast available over the counter?
- No. Apremilast 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 Apremilast come in?
- Apremilast is currently marketed as tablet, per the FDA's National Drug Code Directory.
- What class of drug is Apremilast?
- Apremilast is classified as phosphodiesterase 4 inhibitor, per the FDA's Established Pharmacologic Class.
- Is Apremilast FDA-registered?
- Apremilast is on record with the U.S. FDA under application number ANDA211788. You can verify this on its official FDA label.
- Has Apremilast been recalled by the FDA?
- Apremilast 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 Apremilast safe?
- There's no single safe-or-not verdict. pharmaranks gives Apremilast a recall-safety score of 70/100, 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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apremilast
70/100