Apremilast
Apremilast is a once- or twice-daily pill that blocks an enzyme called PDE4 and is used to treat psoriatic arthritis, plaque psoriasis, and oral ulcers linked to Behçet's Disease.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
Apremilast (Otezla) treats psoriatic arthritis, plaque psoriasis and the mouth ulcers of Behçet's disease by blocking an enzyme called PDE4, which raises a signaling chemical (cAMP) and calms inflammation; on the market since about 2014 and available generically, it is a familiar oral option often tried before injectable biologics, though usually milder in effect. Most people tolerate it reasonably well, though diarrhea, nausea and headache are common in the first few weeks and usually settle. Watch for new or worsening depression, other mood changes and unexplained weight loss, and tell your prescriber promptly about any of them, along with severe diarrhea or vomiting.
Clinical pearls
- Swallow the tablets whole, with or without food, and never crush, split or chew them.
- Follow the five-day starting build-up exactly, since jumping straight to the full dose makes nausea and diarrhea more likely.
- Rifampin, phenobarbital, carbamazepine and phenytoin can make apremilast work less well, so tell every prescriber you take it.
- If you also take a water pill or blood pressure medicine, severe diarrhea or vomiting can dehydrate you faster.
Patient information guide A plain-language walkthrough of Apremilast, written from its FDA label.
What Apremilast is used for
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Apremilast is used for these conditions:
- Active psoriatic arthritis in adults, and in children 6 and older (Otezla for at least 20 kg; Otezla XR for at least 50 kg).
- Plaque psoriasis in adults who are candidates for phototherapy or systemic therapy.
- Moderate to severe plaque psoriasis in children 6 and older who are candidates for phototherapy or systemic therapy (Otezla for at least 20 kg; Otezla XR for at least 50 kg).
- Oral ulcers associated with Behçet's Disease in adults.
How Apremilast works
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Apremilast blocks PDE4, an enzyme inside cells. That raises cAMP, a cell signaling chemical. The exact way this improves your condition is not well defined.
Apremilast dosage
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Apremilast is taken by mouth, with or without food. Swallow tablets whole.
- Otezla begins with a 5-day build-up, then continues twice daily.
- Otezla XR is a once-daily maintenance option, and Otezla tablets are used for the build-up.
- Some patients can be switched between Otezla and Otezla XR by their prescriber.
- Dose is based on age, weight and kidney function, so follow your prescriber and label.
Dosing details from the FDA-approved label
From the Apremilast prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.
- Adults with Psoriatic Arthritis, Plaque Psoriasis, or Behçet's Disease
- Titration Day 1 to Day 5 per Table 1 using OTEZLA tablets: Day 1 10 mg AM
- Day 2 10 mg AM, 10 mg PM
- Day 3 10 mg AM, 20 mg PM
- Day 4 20 mg AM, 20 mg PM
- Day 5 20 mg AM, 30 mg PM
- Day 6 and thereafter maintenance dosage is OTEZLA 30 mg twice daily or OTEZLA XR 75 mg once daily taken orally
- Titration is intended to reduce gastrointestinal symptoms; take with or without food; swallow tablets whole, do not crush, split, or chew
- Pediatric patients 6 years of age and older weighing 50 kg or more with Psoriatic Arthritis or Moderate to Severe Plaque Psoriasis
- Initial titration per Table 2 (Day 1 10 mg AM
- Day 2 10 mg AM, 10 mg PM
- Day 3 10 mg AM, 20 mg PM
- Day 4 20 mg AM, 20 mg PM
- Day 5 20 mg AM, 30 mg PM), then maintenance OTEZLA 30 mg twice daily or OTEZLA XR 75 mg once daily taken orally from Day 6
- Dosage based on body weight; OTEZLA tablets used for initial titration
- Pediatric patients 6 years of age and older weighing 20 kg to less than 50 kg with Psoriatic Arthritis or Moderate to Severe Plaque Psoriasis
- Initial titration per Table 2 (Day 1 10 mg AM
- Day 2 10 mg AM, 10 mg PM
- Day 3 10 mg AM, 20 mg PM
- Day 4 20 mg AM, 20 mg PM
- Day 5 20 mg AM, 20 mg PM), then maintenance OTEZLA 20 mg twice daily taken orally from Day 6
- Dosage based on body weight; OTEZLA XR is not listed for this weight group
- Adult patients with severe renal impairment (CLcr less than 30 mL per minute)
- Titrate using only the AM schedule in Table 1 and skip the PM doses
- Maintenance dosage OTEZLA 30 mg once daily
- OTEZLA XR is not recommended; appropriate dosage has not been determined
- Pediatric patients 6 years and older weighing 50 kg or more with severe renal impairment (CLcr less than 30 mL per minute)
- Titrate using only the AM schedule in Table 2 for the appropriate body weight category and skip the PM doses
- Maintenance dosage OTEZLA 30 mg once daily taken orally
- OTEZLA XR is not recommended; appropriate dosage has not been determined
- Pediatric patients 6 years and older weighing 20 kg to less than 50 kg with severe renal impairment (CLcr less than 30 mL per minute)
- Titrate using only the AM schedule in Table 2 for the appropriate body weight category and skip the PM doses
- Maintenance dosage OTEZLA 20 mg once daily taken orally
- OTEZLA XR is not recommended; appropriate dosage has not been determined
- Switching between OTEZLA and OTEZLA XR
- Patients treated with OTEZLA 30 mg twice daily may be switched to OTEZLA XR 75 mg once daily the day following the last dose of OTEZLA 30 mg
- Patients treated with OTEZLA XR 75 mg once daily may be switched to OTEZLA 30 mg twice daily the day following the last dose of OTEZLA XR 75 mg
Read the label’s full dosing text
2 DOSAGE AND ADMINISTRATION 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 weighing 20 kg to less than 50 kg: Recommended maintenance dosage is OTEZLA 20 mg once daily ( 2.3 ) 2.1 Recommended Dosage in Adult and Pediatric Patients with Psoriatic Arthritis, Plaque Psoriasis, and Behçet's Disease Adult Patients with Psoriatic Arthritis, Plaque Psoriasis, or Behçet's Disease The recommended initial dosage titration from Day 1 to Day 5 is shown in Table 1. Following the 5-day titration with OTEZLA, the recommended maintenance dosage is OTEZLA 30 mg twice daily or OTEZLA XR 75 mg once daily taken orally starting on Day 6. This titration is intended to reduce the gastrointestinal symptoms associated with initial therapy. Table 1. Dosage Titration Schedule for Adult Patients with Psoriatic Arthritis, Plaque Psoriasis, or Behçet's Disease OTEZLA Dosage Titration OTEZLA tablets should be used for the initial titration regardless of whether OTEZLA or OTEZLA XR will be used for the maintenance dosage.
Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →
Apremilast side effects
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Most side effects are stomach or head related and often appear in the first weeks.
Common side effects
- Diarrhea
- Nausea
- Headache
- Upper respiratory tract infection (cold-like symptoms)
- Vomiting
- Upper stomach pain
- Decreased appetite
When to get medical help
- Call your doctor right away if you have signs of a serious allergic reaction, such as swelling of the face, lips or throat, or trouble breathing.
- Contact your doctor if you have severe diarrhea, nausea, or vomiting.
- Tell your doctor if you notice new or worsening depression, suicidal thoughts, or other mood changes.
- Tell your doctor about unexplained or significant weight loss.
- Children who are not growing or gaining weight as expected should be checked by their doctor.
Apremilast warnings and precautions
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- Allergic reactions: Angioedema (deep swelling) and anaphylaxis (severe allergic reaction) have been reported. Stop and get help if signs appear.
- Severe diarrhea, nausea, vomiting: Mostly in the first few weeks. Adults 65 and older and people on medicines that cause fluid loss or low blood pressure are at higher risk.
- Depression: Apremilast is linked to more depression. Report mood changes or suicidal thoughts.
- Weight loss: Weight is monitored. Growth is monitored in children.
Apremilast interactions
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One key interaction group matters most.
- Strong enzyme inducers such as rifampin, phenobarbital, carbamazepine and phenytoin lower apremilast levels and may cause it to stop working well.
Interactions listed in the FDA-approved label
From the Apremilast prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
- Strong CYP450 inducers (such as rifampin): Co-administration decreases apremilast exposure and may result in loss of efficacy of OTEZLA/OTEZLA XR.
Read the label’s full interactions text
7 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) ] .
Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.
Before taking Apremilast
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- Do not use if allergic to apremilast or its ingredients.
- Tell your doctor about depression or suicidal thoughts.
- Pregnancy: animal studies suggest a possible risk of fetal loss.
- Breastfeeding: no human data, so discuss benefits and risks with your doctor.
- Severe kidney disease: Otezla dose is lowered; Otezla XR is not recommended.
- Adults 65 and older: higher risk of complications from severe stomach side effects.
What Apremilast does in the body
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In clinical studies, apremilast lowered blood levels of IL-17, IL-22 and TNF-alpha, which are inflammation-related proteins. It also reduced the activity of genes for these proteins in skin. What this means clinically is still unclear.
How your body processes Apremilast
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Otezla is well absorbed by mouth, peaks in about 2.5 hours, and food does not change how much is absorbed. Otezla XR peaks in about 6 hours and can be taken without regard to meals. Apremilast is broken down extensively, mainly by the CYP3A4 enzyme, and is cleared through urine and feces. Its half-life is about 6 to 9 hours.
How to store Apremilast
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Store OTEZLA tablets below 30°C (86°F). Store OTEZLA XR tablets between 20°C and 25°C (68°F and 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) .
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Supplements & herbs that interact with Apremilast
144 supplements and herbal products have documented interactions with Apremilast in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 3
- Moderate · 103
- Minor · 38
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
Apremilast: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Apremilast — the kind of thing our pharmacy team would talk through with you at the counter.
What is apremilast used for?
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How should I take it?
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What side effects should I expect?
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Can it affect my mood or weight?
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Are there medicines I should avoid with it?
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Is it safe in pregnancy?
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Is Apremilast available over the counter?
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When was Apremilast first available?
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Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Apremilast on HelloPharmacist
Apremilast forms and strengths (how it comes)
Apremilast is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Tablet
How this form is used
- Otezla is used for adults with active psoriatic arthritis, plaque psoriasis, and oral ulcers from Behçet's Disease.
- Otezla is used for children 6 and older weighing at least 20 kg with active psoriatic arthritis or moderate to severe plaque psoriasis.
- Otezla is taken by mouth with or without food.
- Otezla tablets are swallowed whole, not crushed, split or chewed.
- Otezla is started with a 5-day gradual dose build-up to lessen stomach symptoms.
- Otezla tablets are used for the initial build-up even if Otezla XR will be used afterward.
Apremilast on the U.S. market: products, makers and brands
How Apremilast appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
1 company lists 8 Apremilast product records with the FDA, mostly as tablet; the earliest marketing or approval year on record is 2014. Brand names on the directory include Otezla; the rest are generics.
Also listed with the FDA, not a patient dose form: Powder (22) · Kit (19) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
How widely Apremilast is used (Medicaid data)
A general measure of how commonly Apremilast is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Apremilast is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Apremilast prescribed? Of the 1,601 medications we measure, Apremilast ranks #568 by Medicaid prescriptions — more than 65% of them.
Utilization by Apremilast product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
apremilast 30 MG Oral Tablet Most dispensed
Summed across the 1 of 5 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1492744
apremilast 20 MG Oral Tablet
Summed across the 1 of 4 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1492740
Other Apremilast products — combination packs and listings not yet matched to a specific clinical product (kept visible so every prescription is accounted for)
Summed across the 1 of 38 listed NDC products with Medicaid activity.
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Apremilast, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 3 of 47 listed Apremilast NDCs with Medicaid activity.
Compare Apremilast products
A representative set of FDA-listed product records for Apremilast — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Tablet | ||||
| 20 mg | Oral | Amgen, Inc | NDA | View NDC → |
| 30 mg | Oral | Amgen, Inc | NDA | View NDC → |
| 75 mg | Oral | Amgen, Inc | NDA | View NDC → |
| 💊Kits | ||||
| — | — | Amgen, Inc × 5 listings | NDA | View NDC → |
Showing 8 of 8 products — FDA National Drug Code Directory. See every product, package size and price: browse all 8 Apremilast NDCs →
Apremilast side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Apremilast — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Apremilast in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
Apremilast FDA approval history
How Apremilast went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
Apremilast recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
The FDA’s enforcement reports list no Apremilast recalls since July 2021.
✅No Apremilast recalls on record since July 2021Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 1492727 2 dose forms · 4 strengths
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Dose form (SCDF) Extended Release Oral Tablet RxCUI 2723447No current FDA listingClinical drug / strength (SCD) 24 HR apremilast 75 MGRxCUI 2723448 -
Dose form (SCDF) Oral Tablet RxCUI 1492731In current FDA listings
Look up RxCUI 1492727 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
Apremilast supply and shortage status
Whether Apremilast is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
💵 What Apremilast costs pharmacies (NADAC benchmark)
The national average invoice price pharmacies pay for the drug itself, from CMS's NADAC survey (data as of Sep 30, 2026). This is a supply-cost benchmark — not a retail price and not what you'd pay at the counter.
| Form | Strength | Pharmacy acquisition benchmark | |
|---|---|---|---|
| Tablet, Film Coated · Oral | 30 mg | $90.57 per tablet | NDC details & price history |
| Tablet, Film Coated · Oral | 20 mg | $89.95 per tablet | NDC details & price history |
| Tablet, Film Coated · Oral | 75 mg | $181.20 per tablet | NDC details & price history |
Source: CMS National Average Drug Acquisition Cost (NADAC), a survey of retail pharmacy invoice prices. Benchmarks shown are the range across package sizes of a representative product for each form and strength — other manufacturers' products may differ.
Apremilast brand names
Apremilast is sold under one brand name in the FDA directory — Otezla. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Apremilast: manufacturers and labelers
One company lists Apremilast products with the FDA. By number of product records, the largest are Amgen, Inc. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
Apremilast drug class (RxNorm)
Apremilast belongs to the Phosphodiesterase 4 Inhibitor class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
Sources for this Apremilast page
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How this page is built
HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Amgen Inc is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →