Safety Information and Side Effects | Otezla® (apremilast) for PsO
Indications
Approved Uses Prescription Otezla®/Otezla XR® (apremilast) is used for the treatment of:

Plaque Psoriasis:

  • OTEZLA/OTEZLA XR: Adult patients with plaque psoriasis who are candidates for phototherapy or systemic therapy. Read more >
Approved Uses Prescription Otezla®/Otezla XR® (apremilast) is used for the treatment of:

Plaque Psoriasis:

  • OTEZLA/OTEZLA XR: Adult patients with plaque psoriasis who are candidates for phototherapy or systemic therapy.
  • OTEZLA: Pediatric patients 6 years of age and older and weighing at least 20 kg (44 lbs) with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.
  • OTEZLA XR: Pediatric patients 6 years of age and older and weighing at least 50 kg (110 lbs) with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.

Active Psoriatic Arthritis:

  • OTEZLA: Adult and pediatric patients 6 years of age and older and weighing at least 20 kg (44 lbs) with active psoriatic arthritis.
  • OTEZLA XR: Adult and pediatric patients 6 years of age and older and weighing at least 50 kg (110 lbs) with active psoriatic arthritis.

Oral Ulcers Associated with Behçet’s Disease:

  • OTEZLA/OTEZLA XR: Adult patients with oral ulcers associated with Behçet’s Disease. Read less >

Otezla has an established safety profile

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Since 2014, doctors have been prescribing Otezla.

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More than 1 million people have been treated with Otezla globally.*

*Estimates of patients treated reflect global data since launch (Apr 2014–Mar 2026; US=56% of data). Calculations based on observed drug utilization parameters and number of units distributed. Utilization patterns change over time to best represent current markets.

Otezla can be taken long-term

And, as with any medication, you may experience side effects

Click below to expand the table that includes the most common side effects of Otezla compared to placebo (sugar pill) seen in clinical studies involving adults with plaque psoriasis:

Mild to Moderate Plaque Psoriasis
My plaques aren’t all over, but still bother me
Most common side effects
(up to week 16) 		Otezla
298 people 		Placebo
296 people
Diarrhea 49 (16.4%) 15 (5.1%)
Headache 39 (13.1%) 15 (5.1%)
Nausea 38 (12.8%) 13 (4.4%)
Nasopharyngitis 22 (7.4%) 8 (2.7%)
Upper respiratory tract infection 17 (5.7%) 15 (5.1%)
  • Moderate to Severe Plaque Psoriasis
    I have visible, uncomfortable plaques
    Most common side effects
    (up to week 16)     		Otezla
    920 people     		Placebo
    506 people
    Diarrhea 160 (17%) 32 (6%)
    Nausea 155 (17%) 35 (7%)
    Upper respiratory tract infection 84 (9%) 31 (6%)
    Tension headache 75 (8%) 21 (4%)
    Headache 55 (6%) 19 (4%)
  • Moderate to Severe Plaque Psoriasis and Moderate to Severe Genital Psoriasis
    I have to deal with plaques “down there”
    Most common side effects
    (up to week 16)     		Otezla
    143 people     		Placebo
    145 people
    Diarrhea 37 (25.9%) 12 (8.3%)
    Headache 33 (23.1%) 16 (11.0%)
    Nausea 32 (22.4%) 11 (7.6%)
    Nasopharyngitis 12 (8.4%) 12 (8.3%)

These are not all the possible side effects of Otezla. Ask your doctor about potential side effects, and be sure to let them know about any side effects that bother you or don’t go away.

Doctor

Don’t be afraid to speak up. Your doctor may be able to offer tips for managing any side effects of Otezla.

Skip the wait.

Unlike some other medications, you can start Otezla right away—no blood tests and no labs required.

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IMPORTANT SAFETY INFORMATION

Do not take Otezla 30 mg tablets or Otezla XR 75 mg extended-release tablets if you are allergic to apremilast or to any of the ingredients in Otezla/Otezla XR.

Otezla/Otezla XR can cause serious side effects, including:

  • Allergic reactions, sometimes severe. Stop using Otezla/Otezla XR and call your healthcare provider or seek emergency help right away if you develop any of the following symptoms of a serious allergic reaction: trouble breathing or swallowing, raised bumps (hives), rash or itching, swelling of the face, lips, tongue, throat or arms.
  • Severe diarrhea, nausea, and vomiting, especially within the first few weeks of treatment. Use in elderly patients and the use of certain medications with Otezla/Otezla XR may increase the risk of complications from having severe diarrhea, nausea, or vomiting. Tell your doctor if any of these conditions occur.
  • Depression. In clinical studies, some patients reported depression or suicidal behavior while taking Otezla. Some patients stopped taking Otezla due to depression. Before starting Otezla/Otezla XR, tell your doctor if you have had feelings of depression, or suicidal thoughts or behavior. Be sure to tell your doctor if any of these symptoms or other mood changes develop or worsen during treatment with Otezla/Otezla XR.
  • Weight loss. Your doctor should monitor your weight regularly. If unexplained or significant weight loss occurs, your doctor will decide if you should continue taking Otezla/Otezla XR. For children 6 years of age or older, their doctor should monitor their growth (height and weight). If they are not growing or gaining weight as expected, their doctor will decide if they should continue taking Otezla/Otezla XR.

Some medicines may make Otezla/Otezla XR less effective and should not be taken with Otezla/Otezla XR. Tell your doctor about all the medicines you take, including prescription and non-prescription medicines.

The most common side effects include diarrhea, nausea, upper respiratory tract infection, tension headache, and headache. These are not all the possible side effects with Otezla/Otezla XR. Ask your doctor about other potential side effects. Tell your doctor about any side effect that bothers you or does not go away.

Tell your doctor if you are pregnant, planning to become pregnant or planning to breastfeed.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-332-1088.

Please click here for the Full Prescribing Information for Otezla/Otezla XR.

APPROVED USES

Prescription Otezla®/Otezla XR® (apremilast) is used for the treatment of:

Active Psoriatic Arthritis:

  • OTEZLA: Adult and pediatric patients 6 years of age and older and weighing at least 20 kg (44 lbs) with active psoriatic arthritis.
  • OTEZLA XR: Adult and pediatric patients 6 years of age and older and weighing at least 50 kg (110 lbs) with active psoriatic arthritis.

Plaque Psoriasis:

  • OTEZLA/OTEZLA XR: Adult patients with plaque psoriasis who are candidates for phototherapy or systemic therapy.
  • OTEZLA: Pediatric patients 6 years of age and older and weighing at least 20 kg (44 lbs) with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.
  • OTEZLA XR: Pediatric patients 6 years of age and older and weighing at least 50 kg (110 lbs) with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.

Oral Ulcers Associated with Behçet’s Disease:

  • OTEZLA/OTEZLA XR: Adult patients with oral ulcers associated with Behçet’s Disease.

IMPORTANT SAFETY INFORMATION

Do not take Otezla 30 mg tablets or Otezla XR 75 mg extended-release tablets if you are allergic to apremilast or to any of the ingredients in Otezla/Otezla XR.

Otezla/Otezla XR can cause serious side effects, including:

  • Allergic reactions, sometimes severe. Stop using Otezla/Otezla XR and call your healthcare provider or seek emergency help right away if you develop any of the following symptoms of a serious allergic reaction: trouble breathing or swallowing, raised bumps (hives), rash or itching, swelling of the face, lips, tongue, throat or arms.