otezla xr
Pharmaranks rates Otezla XR 3.6/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Otezla XR (Apremilast) is a phosphodiesterase 4 inhibitor used to treat Psoriatic Arthritis.
Apremilast · by Amgen Inc
Available as a generic: Apremilast
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 →
This is one strength of Otezla
The FDA label is the same for every strength in this family, so the full page — with all 2 strengths — lives on Otezla.
- OtezlaApremilast 10MG · Apremilast 20MG · Apremilast 30MG
- Otezla XR (this page)Apremilast 75MG
Key facts
- Active ingredient
- Apremilast
- Drug class
- Phosphodiesterase 4 Inhibitor
- Form
- Tablet, extended release
- Strength
- Apremilast 75MG
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- May treat
- psoriatic arthritis
- Manufacturer
- Amgen Inc
- Half-life
- about 6 to 9 hours (terminal elimination half-life) (how long it stays in your system)
- FDA application
- NDA210745
What is Otezla XR?
From the FDA label: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. Apremilast is known chemically as N-[2-[(1S)-1-(3-ethoxy-4-methoxyphenyl)-2-(methylsulfonyl)ethyl]-2,3-dihydro-1,3-dioxo-1H-isoindol-4-yl]acetamide. Its empirical formula is C 22 H 24 N 2 O 7 S and the molecular weight is 460.5. The chemical structure is: OTEZLA (apremilast) tablets are supplied in 10 mg, 20 mg, and 30 mg strengths for oral administration. Each tablet contains apremilast as the active ingredient and the following inactive ingredients: croscarmellose sodium, iron oxide red, iron oxide yellow (20 and 30 mg only), iron oxide black (30 mg only), lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide. OTEZLA XR (apremilast) extended-release tablets are supplied in a 75 mg strength for oral administration. Each tablet contains apremilast as the active ingredient and the following inactive ingredients: cellulose acetate, colloidal silicon dioxide, ferrosoferric oxide, hydroxypropyl methylcellulose acetate succinate, hypromellose, iron oxide red, magnesium stearate, mannitol, microcrystalline cellulose, polyethylene glycol, polyethylene…
How to use
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…
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…
Warnings
Important safety information
Hypersensitivity : Cases of angioedema and anaphylaxis have been reported during post marketing surveillance. Avoid the use of OTEZLA/OTEZLA XR in patients with known hypersensitivity to apremilast or to any of the excipients in the formulation. If signs or symptoms of serious hypersensitivity reactions develop during treatment, discontinue OTEZLA/OTEZLA XR and institute appropriate therapy ( 5.1 ) Diarrhea, Nausea, and Vomiting : Consider OTEZLA/OTEZLA XR dosage reduction or suspension if patients develop severe diarrhea, nausea, or vomiting ( 5.2 ) Depression : Advise patients, their caregivers, and families to be alert for the emergence or worsening of depression, suicidal thoughts or other mood changes and if such changes occur to contact their healthcare provider. Carefully weigh risks and benefits of treatment with OTEZLA/OTEZLA XR in patients with a history of depression and/or suicidal thoughts or behavior ( 5.3 ) Weight Decrease : Monitor weight regularly. If unexplained or clinically significant weight loss occurs, evaluate weight loss and consider discontinuation of OTEZLA/OTEZLA XR ( 5.4 ) Drug Interactions : Use with strong cytochrome P450 enzyme inducers (e.g., rifampin, phenobarbital, carbamazepine, phenytoin) is not recommended because loss of efficacy may occur ( 5.5 , 7.1 ) 5.1 Hypersensitivity Hypersensitivity reactions, including cases of angioedema and anaphylaxis, have been reported during post marketing surveillance. Avoid the use of OTEZLA/OTEZLA XR in patients with known hypersensitivity to apremilast or to any of the excipients in the formulation. If signs or symptoms of serious hypersensitivity reactions develop during treatment, discontinue OTEZLA/OTEZLA XR and institute appropriate therapy. 5.2 Diarrhea, Nausea, and Vomiting There have been reports of severe diarrhea, nausea, and vomiting associated with the use of OTEZLA. Most events occurred within the first few weeks of treatment. In some cases, patients were hospitalized. Patients 65 years of age or older and patients taking medications that can lead to volume depletion or hypotension may be at a higher risk of complications from severe diarrhea, nausea, or vomiting. Monitor patients who are more susceptible to complications of diarrhea or vomiting. Patients who reduced dosage or discontinued OTEZLA generally improved quickly. Consider OTEZLA/OTEZLA XR dosage reduction or suspension if patients develop severe diarrhea, nausea, or vomiting. 5.3 Depression Treatment with apremilast is associated with an increased incidence of depression. Before using OTEZLA/OTEZLA XR in patients with a history of depression and/or suicidal thoughts or behavior, carefully weigh the risks and benefits of treatment with OTEZLA/OTEZLA XR. Advise patients, their caregivers, and families of the need to be alert for the emergence or worsening of depression, suicidal thoughts or other mood changes, and if such changes occur to contact their healthcare provider. Carefully evaluate the risks and benefits of continuing treatment with OTEZLA/OTEZLA XR if such events occur. Psoriatic Arthritis : During the 16-week placebo-controlled period of the 3 controlled clinical trials, 1.0% (10/998) of subjects treated with OTEZLA reported depression or depressed mood compared to 0.8% (4/495) treated with placebo. During the clinical trials, 0.3% (4/1441) of subjects treated with OTEZLA discontinued treatment due to depression or depressed mood compared with none in placebo treated subjects (0/495). Depression was reported as serious in 0.2% (3/1441) of subjects exposed to OTEZLA, compared to none in placebo-treated subjects (0/495). Instances of suicidal ideation and behavior have been observed in 0.2% (3/1441) of subjects while receiving OTEZLA, compared to none in placebo treated subjects (0/495). In the clinical trials, 2 subjects who received placebo committed suicide compared to none in OTEZLA-treated subjects. Plaque Psoriasis : During the 16-week placebo-controlled period of the 3 controlled clinical trials in adult subjects with moderate to severe plaque psoriasis, 1.3% (12/920) of subjects treated with OTEZLA reported depression compared to 0.4% (2/506) treated with placebo. During the clinical trials, 0.1% (1/1308) of subjects treated with OTEZLA discontinued treatment due to depression compared with none in placebo-treated subjects (0/506). Depression was reported as serious in 0.1% (1/1308) of subjects exposed to OTEZLA, compared to none in placebo-treated subjects (0/506). Instances of suicidal behavior have been observed in 0.1% (1/1308) of subjects while receiving OTEZLA, compared to 0.2% (1/506) in placebo-treated subjects. In the clinical trials, one subject treated with OTEZLA attempted suicide while one who received placebo committed suicide. During the 16-week placebo-controlled period of the clinical trial in adults with mild to moderate plaque psoriasis, the incidence of subjects reporting depression was similar to what was observed in the adult moderate to severe plaque psoriasis trials. Behçet's Disease : During the placebo-controlled period of the phase 3 trial, 1% (1/104) of subjects treated with OTEZLA reported depression/depressed mood compared to 1% (1/103) treated with placebo. None of these reports of depression was serious or led to discontinuation from the trial. No instances of suicidal ideation or behavior were reported during the placebo-controlled period of the phase 3 trial in subjects treated with OTEZLA (0/104) or treated with placebo (0/103). 5.4 Weight Decrease Weight loss may occur in adult or pediatric patients treated with OTEZLA/OTEZLA XR. Regularly monitor the weight of patients treated with OTEZLA/OTEZLA XR. If unexplained or clinically significant weight loss occurs, evaluate weight loss and consider discontinuation of OTEZLA/OTEZLA XR [see Adverse Reactions (6.1) ] . Weight Loss in Adult Patients During the placebo-controlled period of the trials in psoriatic arthritis (PsA), weight decrease between 5%-10% of body weight was reported in 10% (49/497) of subjects treated with OTEZLA 30 mg twice daily compared to 3.3% (16/495) treated with placebo. During the placebo-controlled period of the trials in adults with moderate to severe plaque psoriasis, weight decrease between 5%-10% of body weight occurred in 12% (96/784) of subjects treated with OTEZLA compared to 5% (19/382) treated with placebo. Weight decrease of ≥ 10% of body weight occurred in 2% (16/784) of subjects treated with OTEZLA 30 mg twice daily compared to 1% (3/382) subjects treated with placebo. During the placebo-controlled period of the clinical trial in adults with mild to moderate plaque psoriasis, weight decrease was similar to what was observed in the trials of adults with moderate to severe plaque psoriasis. During the placebo-controlled period of the phase 3 trial in Behçet's Disease, weight decrease > 5% of body weight was reported in 4.9% (5/103) of subjects treated with OTEZLA 30 mg twice daily compared to 3.9% (4/102) subjects treated with placebo. Weight Loss in Pediatric Patients During the placebo-controlled period of the clinical trial in pediatric subjects 6 years of age and older with moderate to severe plaque psoriasis, weight decrease between 5%-10% of body weight occurred in 12% (19/163) of pediatric subjects treated with OTEZLA compared to 2.5% (2/80) of pediatric subjects treated with placebo. Weight decrease of ≥ 10% of body weight occurred in 1% (1/163) of pediatric subjects treated with OTEZLA twice daily compared to 0% (0/80) of pediatric subjects treated with placebo. Closely monitor growth (height and weight) in pediatric patients treated with OTEZLA/OTEZLA XR. Pediatric patients who are not growing or gaining weight as expected may need to have their treatment interrupted. 5.5 Drug Interactions Co-administration of strong cytochrome P450 enzyme inducer, rifampin, resulted in a reduction of systemic exposure of apremilast, which may result in a loss of efficacy of…
Who should not take Otezla XR
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 )
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) ] .
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 Otezla XR ranks — best-rated phosphodiesterase 4 inhibitor for:
Dosage forms
Tablet, extended release
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
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Frequently asked questions
- What does Otezla XR treat?
- Otezla XR (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 Otezla XR rated?
- pharmaranks gives Otezla XR a composite score of 3.6 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 Otezla XR?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Otezla XR. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Otezla XR?
- Otezla XR is marketed by Amgen Inc. You can see Amgen Inc's full profile, rating, and other products on pharmaranks.
- Is Otezla XR a brand-name or generic drug?
- Otezla XR is a brand-name product with the active ingredient Apremilast. Lower-cost generic equivalents containing Apremilast are available — ask your pharmacist.
- Is Otezla XR available over the counter?
- No. Otezla XR 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 Otezla XR come in?
- Otezla XR is currently marketed as tablet, extended release, per the FDA's National Drug Code Directory.
- What class of drug is Otezla XR?
- Otezla XR is classified as phosphodiesterase 4 inhibitor, per the FDA's Established Pharmacologic Class.
- Is Otezla XR FDA-registered?
- Otezla XR is on record with the U.S. FDA under application number NDA210745. You can verify this on its official FDA label.
- Has Otezla XR been recalled by the FDA?
- Otezla XR 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 Otezla XR safe?
- There's no single safe-or-not verdict. pharmaranks gives Otezla XR a recall-safety score of 72/100, 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.
- What are the side effects of Otezla XR?
- Otezla XR's side effects are taken directly from its FDA label. From the label: 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) ]… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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 — the active ingredient in Otezla XR, 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 September 25, 2026.
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otezla xr
72/100