"The U.S. Food and Drug Administration today approved Otezla (apremilast) to treat adults with active psoriatic arthritis (PsA).
PsA is a form of arthritis that affects some people with psoriasis. Most people develop psoriasis first and are "...
Otezla Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Otezla (apremilast) is a phosphodiesterase 4 (PDE4) inhibitor used to treat adult patients with active psoriatic arthritis. Common side effects of Otezla include diarrhea, headache, nausea, upper respiratory tract infection, vomiting, runny or stuffy nose, or abdominal pain.
The recommended maintenance dosage is 30 mg twice daily taken orally starting on Day 6, after 5 days of an initial schedule of titration dosing. Otezla may interact with CYP450 inducers (such as rifampin). Tell your doctor all medications and supplements you use.
During pregnancy, Otezla should be used only if prescribed. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.
Our Otezla (apremilast) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Otezla FDA Prescribing Information: Side Effects
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 3 multicenter, randomized, double-blind, placebo-controlled trials [Studies PsA-1, PsA-2, and PsA-3] of similar design in adult patients with active psoriatic arthritis [see Clinical Studies]. Across the 3 studies, there were 1493 patients randomized equally to placebo, OTEZLA 20 mg twice daily or OTEZLA 30 mg twice daily. Titration was used over the first 5 days [see DOSAGE AND ADMINISTRATION]. Placebo patients whose tender and swollen joint counts had not improved by at least 20% were rerandomized 1:1 in a blinded fashion to either OTEZLA 20 mg twice daily or 30 mg twice daily at week 16 while OTEZLA patients remained on their initial treatment. Patients ranged in age from 18 to 83 years, with an overall median age of 51 years.
The majority of the most common adverse reactions presented in Table 2 occurred within the first 2 weeks of treatment and tended to resolve over time with continued dosing. Diarrhea, headache, and nausea were the most commonly reported adverse reactions. The most common adverse reactions leading to discontinuation for patients taking OTEZLA were nausea (1.8%), diarrhea (1.8%), and headache (1.2%). The proportion of patients with psoriatic arthritis who discontinued treatment due to any adverse reaction was 4.6% for patients taking OTEZLA 30 mg twice daily and 1.2% for placebo-treated patients.
Table 2: Adverse Reactions Reported in ≥ 2% of
Patients on OTEZLA 30 mg Twice Daily and ≥ 1% Than That Observed in
Patients on Placebo for up to Day 112 (Week 16)
|Preferred Term||Placebo||OTEZLA 30 mg BID|
|Day 1 to 5
|Day 6 to Day 112
|Day 1 to 5
|Day 6 to Day 112
|Diarrheaa||6 (1.2)||8 (1.6)||46 (9.3)||38 (7.7)|
|Nauseaa||7 (1.4)||15 (3.1)||37 (7.4)||44 (8.9)|
|Headachea||9 (1.8)||11 (2.2)||24 (4.8)||29 (5.9)|
|Upper respiratory tract infectionb||3 (0.6)||9 (1.8)||3 (0.6)||19 (3.9)|
|Vomitinga||2 (0.4)||2 (0.4)||4 (0.8)||16 (3.2)|
|Nasopharyngitisb||1 (0.2)||8 (1.6)||1 (0.2)||13 (2.6)|
|Abdominal pain upperb||0 (0.0)||1 (0.2)||3 (0.6)||10 (2.0)|
|a Of the reported gastrointestinal adverse
reactions, 1 subject experienced a serious adverse reaction of nausea and
vomiting in OTEZLA 30 mg twice daily; 1 subject treated with OTEZLA 20 mg twice
daily experienced a serious adverse reaction of diarrhea; 1 patient treated
with OTEZLA 30 mg twice daily experienced a serious adverse reaction of
b Of the reported adverse drug reactions none were serious.
c n (%) indicates number of patients and percent.
Other adverse reactions reported in patients on OTEZLA in clinical studies including extension studies:
Immune system disorders: Hypersensitivity
Investigations: Weight decrease
Gastrointestinal Disorders: Frequent bowel movement, gastroesophageal reflux disease, dyspepsia
Metabolism and Nutrition Disorders: Decreased appetite*
Nervous System Disorders: Migraine
Respiratory, Thoracic, and Mediastinal Disorders: Cough
Skin and Subcutaneous Tissue Disorders: Rash
*1 patient treated with OTEZLA 30 mg twice daily experienced a serious adverse reaction.
Psoriasis Clinical Trials
The safety of OTEZLA® was assessed in 1426 subjects in 3 randomized, double-blind, placebo-controlled trials in adult subjects with moderate to severe plaque psoriasis who were candidates for phototherapy or systemic therapy. Subjects were randomized to receive OTEZLA 30 mg twice daily or placebo twice daily. Titration was used over the first 5 days [see DOSAGE AND ADMINISTRATION]. Subjects ranged in age from 18 to 83 years, with an overall median age of 46 years.
Diarrhea, nausea, and upper respiratory tract infection were the most commonly reported adverse reactions. The most common adverse reactions leading to discontinuation for subjects taking OTEZLA were nausea (1.6%), diarrhea (1.0%), and headache (0.8%). The proportion of subjects with psoriasis who discontinued treatment due to any adverse reaction was 6.1% for subjects treated with OTEZLA 30 mg twice daily and 4.1% for placebo-treated subjects.
Table 3: Adverse Reactions Reported in ≥ 1% of
Subjects on OTEZLA and With Greater Frequency Than in Subjects on Placebo; up
to Day 112 (Week 16)
|OTEZLA 30 mg BID
|Preferred Term||n (%)||n (%)|
|Diarrhea||32 (6)||160 (17)|
|Nausea||35 (7)||155 (17)|
|Upper respiratory tract infection||31 (6)||84 (9)|
|Tension headache||21 (4)||75 (8)|
|Headache||19 (4)||55 (6)|
|Abdominal pain*||11 (2)||39 (4)|
|Vomiting||8 (2)||35 (4)|
|Fatigue||9 (2)||29 (3)|
|Dyspepsia||6 (1)||29 (3)|
|Decreased appetite||5 (1)||26 (3)|
|Insomnia||4 (1)||21 (2)|
|Back pain||4 (1)||20 (2)|
|Migraine||5 (1)||19 (2)|
|Frequent bowel movements||1 (0)||17 (2)|
|Depression||2 (0)||12 (1)|
|Bronchitis||2 (0)||12 (1)|
|Tooth abscess||0 (0)||10 (1)|
|Folliculitis||0 (0)||9 (1)|
|Sinus headache||0 (0)||9 (1)|
|*Two subjects treated with OTEZLA experienced serious adverse reaction of abdominal pain.|
Severe worsening of psoriasis (rebound) occurred in 0.3% (4/1184) subjects following discontinuation of treatment with OTEZLA.
Read the entire FDA prescribing information for Otezla (Apremilast Tablets)
Additional Otezla Information
Report Problems to the Food and Drug Administration
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