Prescription medication · PDE4 Inhibitor
apremilast
Also sold as Otezla. Apremilast is used to treat active psoriatic arthritis in adults and children 6 years and older.
Data updated 2026-05-15
- 143,174
- FDA reportsHeavily reported
- 1
- InteractionFew interactions
- $87.90
- Brand price (NADAC)
What the data shows
apremilast (Otezla) is a prescription PDE4 Inhibitor, more reported than roughly 9 in 10 tracked drugs (143,174 FDA reports), with 1 documented drug interaction.
Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.
apremilast (Otezla) is a prescription PDE4 Inhibitor. Apremilast is used to treat active psoriatic arthritis in adults and children 6 years and older.
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.
Verify with FDA → · CMS NADAC pricing →
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.
The sections below are summarized in plain English from apremilast's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
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.
This is a plain-language summary of apremilast's FDA labeling, not individualized dosing advice. Ask a pharmacist or prescriber before changing how you take this medication.
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.
This is a plain-language summary of apremilast's FDA labeling, not individualized advice. Ask a pharmacist or prescriber about pregnancy or breastfeeding on this medication.
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.
This is a plain-language summary of apremilast's FDA labeling, not individualized advice. Ask a pharmacist or prescriber what to do about your specific missed dose.
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 143,174 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for apremilast, by number of reports
- Diarrhea
Diarrhea
24,315 reports
- Nausea
Nausea
21,927 reports
- Psoriasis
Psoriasis
20,247 reports
- Headache
Headache
17,679 reports
- Stomach discomfort 8,065
Stomach discomfort
8,065 reports
- Psoriatic arthritis 7,852
Psoriatic arthritis
7,852 reports
- Pain 6,595
Pain
6,595 reports
- Rash 6,479
Rash
6,479 reports
- Vomiting 6,346
Vomiting
6,346 reports
- Joint pain 6,226
Joint pain
6,226 reports
What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.
Reports over time
Adverse-event reports filed for apremilast each year to the FDA Adverse Event Reporting System (FAERS).
Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.
Where apremilast sits
apremilast has more FDA adverse-event reports than 91% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.
Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is apremilast; the line is the median (50th percentile).
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
Reports Mentioning Death
5,453
3.8% of reports — not proof of cause
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 |
| 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 |
| 15 | WEIGHT DECREASED | 4,955 |
| 16 | ABDOMINAL PAIN UPPER | 4,760 |
| 18 | PRODUCT DOSE OMISSION | 4,594 |
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.
This is a plain-language summary of interactions documented in FDA labeling, not individualized advice. Ask a pharmacist or prescriber before combining medications.
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?
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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
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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 143,174 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.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled and last refreshed May 2026. See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a correction.
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