Learn about common and serious Apremilast (Otezla) side effects, who's at higher risk, how to manage them, and when to contact your doctor right away.
Starting a new medication always comes with questions — and side effects are usually at the top of the list. If you've been prescribed Apremilast (brand name Otezla) for plaque psoriasis, psoriatic arthritis, or oral ulcers from Behcet's disease, understanding what side effects to expect can help you feel more prepared and know when something needs medical attention.
The good news: most Apremilast side effects are mild and temporary, especially with the built-in dose titration that eases your body into the medication. But some side effects are more serious and worth watching for. Here's what the clinical data and FDA labeling actually say.
Apremilast is a phosphodiesterase 4 (PDE4) inhibitor made by Amgen. It works by reducing inflammation inside your body — specifically by blocking an enzyme called PDE4, which plays a role in the inflammatory process. Unlike biologics that are injected, Apremilast is taken as an oral tablet, making it a popular option for people who want to avoid needles.
For more details on how it works, check out our guide on how Apremilast works. For a complete overview, see What Is Apremilast?
These are the side effects that showed up most frequently in clinical trials. Most are mild to moderate and tend to improve within the first few weeks of treatment:
The 5-day starter pack titration — where you gradually increase your dose from 10 mg to 30 mg twice daily — is specifically designed to minimize these GI side effects. Most people find that symptoms peak in the first week or two and then fade.
While uncommon, some Apremilast side effects are more serious and require prompt medical attention:
This is the side effect that gets the most attention. The FDA labeling includes a warning that Apremilast may cause or worsen depression and, in rare cases, suicidal ideation. During clinical trials, a small number of patients experienced new or worsening depression.
What to do: Tell your doctor right away if you notice changes in mood, feelings of hopelessness, withdrawal from activities you enjoy, or any thoughts of self-harm. Make sure family members and caregivers know to watch for these signs too.
While diarrhea and nausea are common and usually mild, postmarketing reports have documented cases of severe diarrhea, nausea, and vomiting — sometimes requiring hospitalization. This is rare but worth knowing about.
What to do: If you experience persistent or severe diarrhea, vomiting, or dehydration (dry mouth, dark urine, dizziness), contact your doctor.
Some patients taking Apremilast experience significant weight loss. The FDA recommends regular weight monitoring during treatment. In clinical trials, about 10% of patients lost 5-10% of their body weight.
What to do: Weigh yourself regularly. If you notice unexplained weight loss, let your doctor know so they can evaluate whether to continue treatment.
Rarely, Apremilast can cause hypersensitivity reactions including angioedema (swelling of the face, lips, or throat) and anaphylaxis.
What to do: Seek emergency medical care immediately if you experience swelling of the face or throat, difficulty breathing, or hives.
If you have severe renal impairment (creatinine clearance less than 30 mL/min), your doctor should reduce your Apremilast dose to 30 mg once daily instead of twice daily. This is because the medication clears more slowly from your body, increasing the risk of side effects.
There's limited data on Apremilast use during pregnancy. Animal studies showed adverse effects on fetal development. It's also unknown whether Apremilast passes into breast milk. If you're pregnant, planning to become pregnant, or breastfeeding, discuss the risks and benefits with your doctor.
No dose adjustment is required for older adults, but doctors may monitor more closely due to the potential for decreased kidney function and higher sensitivity to GI side effects.
Apremilast is approved for plaque psoriasis in pediatric patients weighing at least 20 kg (44 lbs). Side effects in children are similar to those seen in adults.
Most side effects improve with time, but here are some practical strategies:
Contact your doctor right away if you experience:
Go to the emergency room if you experience signs of a severe allergic reaction or feel you may harm yourself.
Apremilast is generally well-tolerated, and most people get through the initial adjustment period without major issues. The key is knowing what to watch for, following the titration schedule, and keeping your doctor informed about how you're feeling.
If you're weighing whether Apremilast is right for you, talk to your doctor about your specific risk factors. And if cost is a concern, check out our guide on how to save money on Apremilast — because side effects are easier to manage when you're not also stressing about the price tag.
Need help finding Apremilast? Medfinder can help you locate a pharmacy with it in stock.
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