Apremilast (Otezla) is an oral phosphodiesterase 4 (PDE4) inhibitor widely used in the treatment of psoriatic arthritis, plaque psoriasis, and Behçet's disease-related oral ulcers.

What Are the Side Effects of Apremilast (Otezla)?

Gastrointestinal Reactions

The most common side effects of apremilast are concentrated in the digestive system.

Among patients receiving apremilast treatment, the incidence of diarrhea is as high as 17%, the incidence of nausea is 17%, and the incidence of vomiting is 4%.

These symptoms mainly occur in the early stage of treatment, usually within the first few weeks of medication use.

Especially in elderly patients over 65 years old and patients taking drugs that may cause hypovolemia or hypotension, the risk of complications such as diarrhea, nausea, or vomiting is higher.

Other Common Adverse Reactions

In addition to gastrointestinal symptoms, patients may also experience headache (6%), upper respiratory tract infection (9%), and tension headache (8%).

Some patients have reported symptoms such as upper abdominal pain (4%), fatigue (3%), dyspepsia (3%), and decreased appetite (3%).

Most of these reactions are mild to moderate and often gradually diminish as treatment continues.

Severe Side Effect Warnings for Apremilast (Otezla)

Allergic Reactions

Apremilast may cause severe hypersensitivity reactions, including angioedema and anaphylactic shock.

If patients experience symptoms such as difficulty breathing, or swelling of the face, lips, tongue, or throat during medication use, they should immediately discontinue the drug and seek emergency medical assistance.

Mental Health Effects

Of particular concern is the impact of apremilast on mental health.

In clinical trials for psoriatic arthritis, 1.0% of patients reported depression or low mood.

In clinical trials for psoriasis, 1.3% of patients reported depression.

During treatment, suicidal ideation and behaviors have also been observed. Although the incidence is very low (0.2%), the consequences are serious. Patients, family members, and caregivers need to be alert to the occurrence or worsening of depression, suicidal ideation, or other emotional changes.

Precautions for Taking Apremilast (Otezla)

Medication Use in Special Populations

For patients with severe renal impairment (creatinine clearance less than 30 mL/min), the maintenance dose for adult patients should be reduced to 30 mg once daily.

Pediatric patients have their doses adjusted to 30 mg once daily or 20 mg once daily respectively based on body weight.

Elderly patients need close monitoring due to a higher risk of complications that may be caused by severe diarrhea, nausea, or vomiting.

The use of apremilast in pregnant women may increase the risk of fetal loss, and women of childbearing age should consider family planning during treatment.

Drug Interactions

When apremilast is used in combination with strong cytochrome P450 enzyme inducers (such as rifampicin, phenobarbital, carbamazepine, phenytoin), it may lead to loss of efficacy.

Concurrent use of apremilast with such drugs is not recommended.