Safety Information | Otezla® (apremilast) for PsA
Indications
APPROVED USES Prescription Otezla®/Otezla XRTM (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. Read more >
Approved Uses Prescription Otezla®/Otezla XRTM (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. Read less >

With a history of established safety, Otezla has numbers you can rely on.

10

years

Since 2014, doctors have been prescribing Otezla.

1 million+

patients

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

14

clinical trials†

Each with safety and side effects data for those taking Otezla.

*Estimates of patients treated reflect global data since launch (Apr 2014-Mar 2024; US=59% of data). Calculations based on observed drug utilization parameters and number of units distributed. Utilization patterns change over time to best represent current markets.

†Across all 4 approved uses including adults with plaque psoriasis, moderate to severe pediatric plaque psoriasis, adults with psoriatic arthritis, and adults with oral ulcers associated with Behçet’s Disease.

You are leaving the Otezla website

Do you wish to leave this site?

YES No
Calendar

We’ve stood the test of time.

Otezla has a safety profile you can rely on, as shown in a study that followed Otezla patients over the course of 5 years on treatment.

No blood tests required for Otezla® (apremilast)

Skip the wait.

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

As with all medications, you may experience side effects while taking Otezla

Learn more
Woman preparing for a doctor's appointment

Prepare for your appointment

Communication is key. Start the conversation.
GET STARTED
Two woman at a brunch gathering

What to expect on Otezla

Find out about managing side effects, seeing results, and more.
GET THE DETAILS
A father with his arm around his daughter, both smiling

Get support

Amgen® SupportPlus can help with financial support and insurance coverage for Otezla.
FIND OUT HOW

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 XRTM (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.