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.

Precautions

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly and to decide if you should continue to take it. Blood tests may be needed to check for unwanted effects.

This medicine may cause serious allergic reactions, including anaphylaxis and angioedema, which can be life-threatening and require immediate medical attention. Check with your doctor right away if you have chest tightness, cough, difficulty swallowing, dizziness, fast heartbeat, hives, itching, skin rash, 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, trouble breathing, or unusual tiredness or weakness.

Apremilast may cause severe diarrhea, nausea, or vomiting which is more likely in patients 65 years of age or older, or in patients with low blood pressure (hypotension) or low blood volume (hypovolemia). Talk to your doctor if you have concerns.

This medicine may cause some people to be agitated, irritable, or display other abnormal behaviors. Make sure the doctor knows if you have trouble sleeping, get upset easily, have a big increase in energy, or start to act reckless. Also tell the doctor if you have sudden or strong feelings, such as feeling nervous, angry, restless, violent, or scared. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. If you or your caregiver notice any of these side effects, tell your doctor right away.

This medicine may decrease your weight. Your doctor may need to check your weight regularly during treatment with this medicine. Talk to your doctor about ways to prevent weight loss.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

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:

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:

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

See also:

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