apremilast
Brand names: Otezla
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.
Drug Pricing (NADAC)
Brand Price
$87.90/unit
Generic Available
No
AMGEN INC
Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →
What it does
Apremilast is used to treat active psoriatic arthritis in adults and children 6 years and older.
Common side effects
Diarrhea, Nausea, Headache
Key warnings
Apremilast can cause serious side effects.
How It Works
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.
How to Take It
Take apremilast as directed by your doctor. To help avoid stomach problems, you'll start with a low dose and increase it over 5 days. Adults usually take 30 mg twice a day or 75 mg once a day. Children's doses depend on their weight.
Pregnancy & Breastfeeding
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.
Missed Dose
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and take your next dose at the regular time.
Storage
Store Otezla tablets below 86°F (30°C). Store Otezla XR tablets between 68°F and 77°F (20°C and 25°C).
Side Effects (from patient reports)
Based on 134,820 FDA adverse event reports.
FDA Adverse Event Report Analysis
Detailed analysis of 143,174 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2012–2025.
Total Reports
143,174
Death-Related Reports
5,453
Hospitalization Reports
10,932
Top Indication
Psoriasis
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 1 | DIARRHOEA | 24,315 |
| 2 | NAUSEA | 21,927 |
| 3 | PSORIASIS | 20,247 |
| 4 | HEADACHE | 17,679 |
| 5 | DRUG INEFFECTIVE | 15,315 |
| 6 | ABDOMINAL DISCOMFORT | 8,065 |
| 7 | PSORIATIC ARTHROPATHY | 7,852 |
| 8 | PAIN | 6,595 |
| 9 | RASH | 6,479 |
| 10 | VOMITING | 6,346 |
| 11 | ARTHRALGIA | 6,226 |
| 12 | FATIGUE | 6,026 |
| 13 | DEPRESSION | 5,414 |
| 14 | OFF LABEL USE | 5,024 |
| 15 | WEIGHT DECREASED | 4,955 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation
Serious Warnings
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.
Known Drug Interactions
7 DRUG INTERACTIONS 7.1 Strong CYP450 Inducers Co-administration with strong CYP450 inducers (such as rifampin) decreases apremilast exposure and may result in loss of efficacy of OTEZLA/OTEZLA XR [see Warnings and Precautions (5.5) and Clinical Pharmacology (12.3) ] .
Mechanism: Rifampin causes your body to break down apremilast much faster than normal, which can make it stop working.
What to do: Taking these together may make apremilast not work as well, so your doctor may need to monitor your treatment closely.
Common Questions
Can I take apremilast if I am allergic to it?
What should I do if I experience severe diarrhea, nausea, or vomiting?
Can apremilast affect my mood?
Will apremilast cause me to lose weight?
Can I take apremilast with other medicines?
What if I have kidney problems?
Can children take apremilast?
How long does it take for apremilast to work?
Can I stop taking apremilast if my symptoms improve?
Will apremilast cure my condition?
What are the common side effects of apremilast?
Does apremilast interact with other medications?
What drug class is apremilast?
Is apremilast safe during pregnancy?
Related Medications in PDE4 Inhibitor
Other drugs grouped near apremilast — same-class peers and common alternatives.
adapalene
Differin
Adapalene and benzoyl peroxide gel is a medicine used on the skin to treat acne.
Compare with apremilast →
azelaic acid
Finacea, Azelex
Azelaic acid gel is a topical medicine that helps treat rosacea.
Compare with apremilast →
benzoyl peroxide
Benzac, PanOxyl
Benzoyl peroxide is a topical medicine that fights germs on your skin.
Compare with apremilast →
betamethasone
Diprosone, Luxiq
Betamethasone dipropionate cream is a strong steroid medicine used on the skin.
Compare with apremilast →
brodalumab
Siliq
Siliq is a medicine used to treat moderate to severe plaque psoriasis.
Compare with apremilast →
Medication Guides
Understanding Drug Interactions
How CYP450 enzymes, inhibitors, and inducers affect your medications
Generic vs Brand Name Drugs
FDA requirements, cost savings, and when the difference matters
Narrow Therapeutic Index Drugs
Why some drugs demand precise dosing and monitoring
Common Drug Interactions
Dangerous medication combinations and how to protect yourself
Related Health & Safety Data
🩺 Find a Doctor
Search prescribers for PDE4 Inhibitor
🏨 Hospital Quality
CMS hospital ratings, safety scores & patient outcomes
💊 Supplement Data
NIH DSLD — check supplement ingredients & label claims
🍽️ Food Safety Alerts
FDA recalls, inspections & outbreak investigations
⚠️ Product Recalls
FDA, CPSC & NHTSA recall search
💉 Procedure Costs
Medicare procedure pricing for 9,297 procedures
Save on apremilast
Compare prices and find discounts at pharmacies near you. Free coupons can save up to 80% on prescriptions.
Disclosure: This link may earn us a commission at no extra cost to you. See our terms.
What the FDA Data Shows for apremilast
The FDA label for apremilast (sold under brand names such as Otezla) classifies it as a prescription-only medication in the PDE4 Inhibitor class. Apremilast is used to treat active psoriatic arthritis in adults and children 6 years and older. Official labeling lists 4 commonly reported side effects, including Diarrhea, Nausea, Headache.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 134,820 voluntary reports. The database also lists 1 documented drug interaction derived from FDA labeling, with the top-flagged interaction rated minor severity. NADAC pricing from CMS.
Report counts do not establish causation — a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history, and patent information further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice — always consult a licensed healthcare provider before starting, stopping, or changing any medication.
Data Sources
Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).
FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. Always consult a healthcare professional before making medication decisions.
Last updated: December 23, 2025
Read our methodology — how this data is sourced, computed, and verified.
All federal data sources used on this page
- FDA Orange Book — approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed — NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) — post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm — standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files — federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database — current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages