Fact Check_ Otezla Depression Side Effects & Medical Care

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Fact Check: Otezla Depression Side Effects & Medical Care

Verdict: True, but uncommon.

Otezla (apremilast) carries an FDA-approved warning that treatment may be associated with new or worsening depression, suicidal thoughts, or other mood changes. This does not mean everyone taking Otezla will develop depression, but healthcare providers are advised to carefully weigh the benefits and risks, especially in people with a history of depression or suicidal behavior. FDA Access Data+1

What does the evidence show?

Clinical trials found that depression-related adverse events occurred in a small percentage of patients:

  • Psoriatic arthritis: Depression or depressed mood occurred in 1.0% of people taking Otezla versus 0.8% receiving placebo.

  • A small number of patients discontinued treatment because of depression.

  • Rare cases of suicidal ideation and behavior have also been reported during clinical development and post-marketing surveillance. FDA Access Data+1

Although the absolute risk is low, the warning is considered clinically important because mood changes can be serious.

Who may be at higher risk?

Extra caution is recommended for people who have:

  • A personal history of depression

  • Previous suicidal thoughts or attempts

  • Other significant psychiatric conditions

  • Family members or caregivers who notice changes in mood or behavior

Before starting Otezla, clinicians should discuss these risks and determine whether the medication is appropriate. FDA Access Data+1

Symptoms to watch for

Seek medical advice promptly if you notice:

  • Persistent sadness

  • Loss of interest in activities

  • Increased anxiety or irritability

  • Feelings of hopelessness

  • Major personality or mood changes

  • Thoughts of self-harm or suicide

Do not ignore these symptoms or assume they will resolve on their own.

What should patients do?

If mood changes develop while taking Otezla:

  1. Contact your prescribing healthcare professional as soon as possible.

  2. Do not stop the medication without medical guidance unless instructed to do so.

  3. Your clinician may reassess whether continuing Otezla is appropriate or recommend an alternative treatment.

  4. Family members and caregivers should also monitor for behavioral changes, particularly during the first weeks of therapy. FDA Access Data+1

Medical care recommendations

Healthcare providers generally recommend:

  • Reviewing mental health history before prescribing Otezla.

  • Educating patients and caregivers about potential mood-related side effects.

  • Monitoring for depression or suicidal thinking during treatment.

  • Reassessing the balance of benefits and risks if psychiatric symptoms emerge. FDA Access Data+1

Bottom line

The claim that Otezla can cause depression is supported by official prescribing information. However, depression-related side effects are uncommon, affecting only a small proportion of patients in clinical trials. Most people do not experience this complication, but anyone taking Otezla should be aware of possible mood changes and seek prompt medical evaluation if they occur. FDA Access Data+1

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