Apremilast Side Effects

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

Applies to apremilast: oral tablet.

Common side effects of apremilast

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

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

Less common

• 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 apremilast

Along with its needed effects, apremilast 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

• 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

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

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Further information

Apremilast 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.

Some side effects may not be reported. You may report them to the FDA.

Medical Disclaimer