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apremilast vs roflumilast

Side-by-side comparison of apremilast and roflumilast Data from FDA drug databases (Orange Book, NDC Directory, recalls, shortages) covering 20,000+ approved drugs, plus CMS pricing; see our methodology.

Drug Class
apremilast PDE4 Inhibitor
roflumilast PDE4 Inhibitor
Type
apremilast Prescription
roflumilast Prescription
Summary
apremilast

Apremilast (Otezla/Otezla XR) is a medicine that can help adults and children manage psoriatic arthritis and psoriasis. It can also help adults with oral ulcers from Behçet's Disease.

roflumilast

Roflumilast (Daliresp) helps to reduce flare-ups in people with severe COPD. It is for people who also have chronic bronchitis and a history of COPD flare-ups.

What It Treats
apremilast

Apremilast is used to treat active psoriatic arthritis in adults and children 6 years and older. It also treats plaque psoriasis in adults and children 6 years and older who may use light therapy or other medicines that affect the whole body. Apremilast can also treat oral ulcers caused by Behçet's Disease in adults.

roflumilast

Roflumilast is used to lower your chances of COPD flare-ups. It is for adults with severe COPD linked to chronic bronchitis. You should have a history of COPD flare-ups to use this medicine.

How It Works
apremilast

Apremilast is a type of medicine called a phosphodiesterase 4 (PDE4) inhibitor. It works by blocking PDE4 in your body. This helps to reduce inflammation and other symptoms of these conditions.

roflumilast

Roflumilast blocks an enzyme called phosphodiesterase 4 (PDE4). By blocking PDE4, it reduces lung inflammation. This can help prevent COPD flare-ups.

Common Side Effects
apremilast
  • Diarrhea
  • Nausea
  • Headache
  • Upper respiratory tract infection (like a cold)
roflumilast
  • Diarrhea
  • Weight loss
  • Nausea
  • Headache
  • Back pain
FAERS Reports
apremilast
  • Diarrhea 24,315
  • Nausea 21,927
  • Psoriasis 20,247
  • Headache 17,679
  • Medicine not working 15,315
roflumilast
  • Difficulty breathing 1,011
  • Death 729
  • Chronic lung disease 631
  • Diarrhea 567
  • Nausea 465
Serious Warnings
apremilast

Apremilast can cause serious side effects. It can cause allergic reactions like swelling and trouble breathing. It can also cause or worsen depression or suicidal thoughts. Tell your doctor right away if you have any of these side effects.

roflumilast

Roflumilast is not for sudden breathing problems. It may cause mental health problems, including suicidal thoughts. Tell your doctor if you have mood changes or weight loss.

Pregnancy
apremilast

Apremilast may increase the risk of fetal loss during pregnancy. Talk to your doctor if you are pregnant, plan to become pregnant, or are breastfeeding.

roflumilast

It is not known if roflumilast is safe during pregnancy. Do not breastfeed while taking roflumilast.

How to Read This apremilast vs roflumilast Comparison

apremilast is classified in the PDE4 Inhibitor drug class, while roflumilast sits within the PDE4 Inhibitor class. Because both drugs share the same classification, they are often considered interchangeable in theory — but clinical outcomes rarely track that cleanly. Both drugs are prescription-only, so a licensed provider must authorize use.

Adverse event totals above are pulled from the FDA's Adverse Event Reporting System (FAERS). For these top-ranked reactions alone, apremilast has 99,483 submissions while roflumilast has 3,403. Those figures reflect cumulative reporting volume — not per-patient risk — so older, widely dispensed drugs typically look worse on count alone. No direct interaction between these two drugs is listed in our FDA-derived dataset, though co-prescription still warrants pharmacist review. Serious warnings, pregnancy guidance, and contraindications can differ even when indications overlap.

A table cannot substitute for clinical judgment. Effectiveness, tolerability, drug-drug interactions with your other medications, kidney and liver function, pregnancy status, insurance formulary, and price all feed into a decision that only a licensed prescriber can make responsibly. Data here is sourced from FDA Structured Product Labels (SPL) and FAERS, both of which update as manufacturers and clinicians submit new information. This page is for educational purposes only, is not medical advice, and should not be used to self-switch between apremilast and roflumilast — always consult your physician or pharmacist first.

Important: This comparison is for informational purposes only. Drug effects vary between individuals. Always consult your doctor or pharmacist for personalized medical advice.