Apremilast: uses, dosing, side effects & brands
Apremilast is a phosphodiesterase 4 inhibitor sold in the U.S. under 3 brand and generic names, for psoriatic arthritis. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Drug class
- Phosphodiesterase 4 Inhibitor
- Treats (across its forms)
- Psoriatic Arthritis
- Available as
- Tablet · Kit · Tablet, extended release
- Sold as
- 3 products — Otezla, Otezla XR and Apremilast
- Prescription?
- Prescription only
- Generic available?
- Yes
- Half-life
- about 6 to 9 hours (terminal elimination half-life)
How Otezla is dosed
From the FDA label for Otezla (application NDA210745). Other apremilast products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
To reduce the risk of gastrointestinal symptoms, titrate to recommended dosage as follows: Adults with Psoriatic Arthritis, Plaque Psoriasis, or Behçet's Disease See Table 1 for the initial titration schedule. Recommended maintenance dosage is OTEZLA 30 mg twice daily or OTEZLA XR 75 mg once daily ( 2.1 ) Pediatric Patients 6 Years of Age and Older and Weighing at Least 20 kg with Psoriatic Arthritis or Moderate to Severe Plaque Psoriasis See Table 2 for the initial titration schedule ( 2.1 ) For patients weighing 50 kg or more : Recommended maintenance dosage is OTEZLA 30 mg twice daily or OTEZLA XR 75 mg once daily ( 2.1 ) For patients weighing 20 kg to less than 50 kg : Recommended maintenance dosage is OTEZLA 20 mg twice daily ( 2.1 ) Dosage in Patients with Severe Renal Impairment : Adult Patients : For initial dosage titration, titrate using only morning schedule listed in Table 1 and skip afternoon doses. Recommended maintenance dosage is OTEZLA 30 mg once daily ( 2.3 ) Pediatric Patients 6 Years of Age and Older and Weighing at Least 20 kg with Psoriatic Arthritis or Moderate to Severe Plaque Psoriasis : For initial dosage titration, titrate using only morning schedule for appropriate body weight category in Table 2 and skip afternoon doses ( 2.3 ) For patients weighing 50 kg or more: Recommended maintenance dosage is OTEZLA 30 mg once daily ( 2.3 ) For patients…
Everything below is the FDA label for Otezla (tablet, kit). Apremilast is also sold as tablet, extended release, and those are different medicines to take — follow the label for the one you were prescribed.
Otezla side effects
The following adverse reactions are described elsewhere in the labeling: Hypersensitivity [see Warnings and Precautions (5.1) ] Diarrhea, Nausea, and Vomiting [see Warnings and Precautions (5.2) ] Depression [see Warnings and Precautions (5.3) ] Weight Decrease [see Warnings and Precautions (5.4) ] Drug Interactions [see Warnings and Precautions (5.5) ] Psoriatic Arthritis : The most common adverse reactions (≥ 5%) are diarrhea, nausea, and headache ( 6.1 ) Plaque Psoriasis : The most common adverse reactions (≥ 5%) are diarrhea, nausea, upper respiratory tract infection, and headache, including tension headache ( 6.1 ) Behçet's Disease : The most common adverse reactions (≥ 10%) are diarrhea, nausea, headache, and upper respiratory tract infection ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Amgen Inc. at 1-800-77-AMGEN (1-800-772-6436) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. Psoriatic Arthritis Clinical Trials OTEZLA was evaluated in three multicenter, randomized, double-blind, placebo-controlled trials (PsA-1, PsA-2, and PsA-3) of similar design in adult…
Who shouldn’t take Otezla
OTEZLA/OTEZLA XR is contraindicated in patients with a known hypersensitivity to apremilast or to any of the excipients in the formulation [see Warnings and Precautions (5.1) , see Adverse Reactions (6.1) ] . Known hypersensitivity to apremilast or to any of the excipients in the formulation ( 4 )
Otezla drug interactions
7.1 Strong CYP450 Inducers Co-administration with strong CYP450 inducers (such as rifampin) decreases apremilast exposure and may result in loss of efficacy of OTEZLA/OTEZLA XR [see Warnings and Precautions (5.5) and Clinical Pharmacology (12.3) ] .
Every apremilast product we track (3)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Pharmacy pays | |
|---|---|---|---|---|---|---|---|
| 1 | 72/100 | Prescription | Tablet | No data | — | View → | |
| 2 | 72/100 | Prescription | Tablet | No data | — | View → | |
| 3 | 70/100 | Prescription | Tablet | No data | — | View → |
What apremilast pills look like
Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.
Apremilast and breastfeeding
From LactMed, the US National Library of Medicine’s Drugs and Lactation Database — quoted, not rewritten.
Full LactMed record for apremilast: levels in milk, effects in breastfed infants, and the drugs it would consider insteadNo information is available on the clinical use of apremilast during breastfeeding. Although it is not contraindicated, international guidelines and reviews recommend avoiding apremilast during breastfeeding. An alternate drug may be preferred, especially while nursing a newborn or preterm infant.
National Institute of Child Health and Human Development, record revised May 15, 2025. LactMed states its information is not a substitute for professional judgement.
What people report to the FDA about apremilast
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 6,181 reports naming apremilast, and the FDA flagged 79% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:
- psoriatic arthropathy1,519 reports
- synovitis1,427 reports
- headache1,404 reports
- nausea1,396 reports
- fatigue1,388 reports
- rash1,388 reports
- rheumatoid arthritis1,371 reports
- hypertension1,314 reports
Read these as a signal, not a rate. A report does not mean apremilast caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label.
Source: openFDA drug/event (FAERS), retrieved August 25, 2026.
How long apremilast stays in your system
The elimination half-life of apremilast is about 6 to 9 hours (terminal elimination half-life). 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.
OTEZLA (apremilast) — DailyMed label, Clinical Pharmacology 12.3 ↗Half-life is how long the body takes to clear half a dose. It is not the same as how long a drug test can detect it, and it varies with age, kidney and liver function.
Related calculators
Frequently asked questions
What is Otezla?
The active ingredient in OTEZLA/OTEZLA XR tablets is apremilast. Apremilast drug substance is non-hygroscopic. Apremilast drug substance is practically insoluble in water and slightly soluble in alcohol. Apremilast is a phosphodiesterase 4 (PDE4) inhibitor.
What kind of drug is apremilast?
The FDA classifies apremilast as a phosphodiesterase 4 inhibitor. If you are checking whether it is safe to combine with something else, the class is what matters — two drugs from the same class usually should not be stacked.
How long does apremilast stay in your system?
The elimination half-life of apremilast is about 6 to 9 hours (terminal elimination half-life) — that is how long the body takes to clear half of a dose. 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. Half-life is not the same as how long a drug test can detect the drug, and it varies with age, kidney and liver function.
Can you take apremilast with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run apremilast against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What brand names is apremilast sold under?
We track 3 apremilast-containing products in the U.S.: Otezla, Otezla XR and Apremilast. They are the same active ingredient; they differ in form, manufacturer, price and FDA recall record.
What forms does apremilast come in?
Across the brands we track, apremilast is currently marketed as tablet, kit and tablet, extended release, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic apremilast?
Yes. Our catalog lists 1 generic apremilast product alongside the brand versions. A generic has the same active ingredient and must meet the FDA's bioequivalence standard; it usually costs less. Ask your pharmacist which one your plan covers.
Cite this page
- APA
- pharmaranks. (2026, July 24). Apremilast: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/apremilast
- MLA
- “Apremilast: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/apremilast.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Read the full FDA label for apremilast on DailyMed (NIH) ↗.