Otezla Side Effects
Generic name: apremilast
Note: This document contains side effect information about apremilast. Some dosage forms listed on this page may not apply to the brand name Otezla.
Applies to apremilast: oral tablet.
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
- 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
Other 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
- 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
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
Frequently asked questions
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More about Otezla (apremilast)
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References
1. Product Information. Otezla (apremilast). Amgen USA. 2023;SUPPL-12.
2. Product Information. Otezla (apremilast). Celgene Pty Ltd. 2023.
3. Product Information. Otezla (apremilast). Amgen Ltd. 2021.
Further information
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.