Otezla Side Effects

Generic name: apremilast

Medically reviewed by Philip Thornton, DipPharm. Last updated on Sep 27, 2023.

Note: This document provides detailed information about Otezla Side Effects associated with apremilast. Some dosage forms listed on this page may not apply specifically to the brand name Otezla.

Applies to apremilast: oral tablet.

Common side effects of Otezla

Some side effects of apremilast may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common side effects

• body aches or pain
• chills
• diarrhea
• ear congestion
• headache
• loss of voice
• nausea
• sneezing
• sore throat
• stuffy or runny nose

Less common side effects

• back pain
• belching
• burning, itching, pain in the hairy areas, pus at the root of the hair
• decreased appetite
• heartburn
• indigestion
• muscle aches
• stomach discomfort, upset, or pain
• upper abdominal or stomach pain
• vomiting

Serious side effects of Otezla

Along with its needed effects, apremilast (the active ingredient contained in Otezla) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking apremilast:

Rare side effects

• changes in behavior
• discouragement
• feeling sad or empty
• irritability
• lack of appetite
• loss of interest or pleasure
• thoughts of killing oneself
• tiredness
• trouble concentrating
• trouble sleeping

Incidence not known

• cough
• chest tightness
• dizziness
• fast heartbeat
• fever
• hives, itching, or rash
• hoarseness
• irritation
• joint pain, stiffness, or swelling
• large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• redness of the skin
• swelling of the hands or feet
• trouble breathing or swallowing
• unusual tiredness or weakness
• weight loss

For healthcare professionals

Applies to apremilast: oral tablet.

General adverse events

The most common adverse reactions reported in patients (across all treatment indications) included diarrhea, nausea, upper respiratory tract infections, headache, tension headache, upper abdominal pain, vomiting, and back pain.^[Ref]

Dermatologic

• Common (1% to 10%): Folliculitis
• Uncommon (0.1% to 1%): Urticaria, rash, psoriasis
• Frequency not reported: Angioedema

Gastrointestinal

• Very common (10% or more): Diarrhea (up to 41.3%), nausea (up to 19.2%)
• Common (1% to 10%): Abdominal discomfort, upper abdominal pain, vomiting, abdominal pain, dyspepsia, frequent bowel movements, tooth abscess, gastroenteritis, gastroesophageal reflux disease

Gastrointestinal adverse reactions generally occurred within the first 2 weeks of treatment and usually resolved within 4 weeks.

Hypersensitivity

• Uncommon (0.1% to 1%): Hypersensitivity
• Postmarketing reports: Hypersensitivity reactions (including angioedema, anaphylaxis)

Metabolic

• Common (1% to 10%): Decreased appetite

Musculoskeletal

• Common (1% to 10%): Back pain, arthralgia

Nervous system

• Very common (10% or more): Headache (up to 14.4%)
• Common (1% to 10%): Tension headache, sinus headache, migraine

Other

• Very common (10% or more): Decreased weight (up to 14.3%)
• Common (1% to 10%): Fatigue

Psychiatric

• Common (1% to 10%): Insomnia, depression, depressed mood
• Uncommon (0.1% to 1%): Suicidal ideation/behavior
• Postmarketing reports: Completed suicide

Renal

• Common (1% to 10%): Urinary tract infection

Respiratory

• Very common (10% or more): Upper respiratory tract infections (up to 11.5%)
• Common (1% to 10%): Bronchitis, viral upper respiratory tract infections, nasopharyngitis, cough

Frequently asked questions

• Sotyktu vs Otezla: How do they compare?
• Do you need to take Otezla forever?
• How much does Otezla cost?
• Can you drink alcohol while taking Otezla?
• How long does it take for Otezla to work?
• How to stop taking Otezla?
• Who makes Otezla and why is it so expensive?
• How does Otezla work and what's its MOA?
• Does Otezla cause weight gain?

Further information

Otezla side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer