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Apremilast Side Effects

In Summary

Commonly reported side effects of apremilast include: weight loss. Other side effects include: diarrhea, headache, and nausea. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to apremilast: oral tablet

In addition to its needed effects, some unwanted effects may be caused by apremilast. In the event that any of these side effects do occur, they may require medical attention.

Major Side Effects

You should check with your doctor immediately if any of these side effects occur when 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:
  • Fast heartbeat
  • fever
  • hives, itching, or rash
  • hoarseness
  • irritation
  • joint pain, stiffness, or swelling
  • redness of the skin
  • swelling of the eyelids, face, lips, hands, or feet
  • tightness in the chest
  • troubled breathing or swallowing
  • weight loss

Minor Side Effects

Some of the side effects that can occur with apremilast may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

More common:
  • Body aches or pain
  • chills
  • cough
  • diarrhea
  • ear congestion
  • headache
  • headache, severe and throbbing
  • loss of voice
  • nausea
  • sneezing
  • sore throat
  • stuffy or runny nose
Less common:
  • Acid or sour stomach
  • 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 commonly reported side effects included diarrhea, headache, and nausea.[Ref]

Hypersensitivity

Frequency not reported: Hypersensitivity[Ref]

Gastrointestinal

Common (1% to 10%): Diarrhea, nausea, vomiting, upper abdominal pain
Frequency not reported: Frequent bowel movement, gastroesophageal reflux disease, dyspepsia[Ref]

Respiratory

Common (1% to 10%): Upper respiratory tract infection, nasopharyngitis
Frequency not reported: Cough[Ref]

Dermatologic

Frequency not reported: Rash[Ref]

Metabolic

Frequency not reported: Weight decrease, decreased appetite[Ref]

Nervous system

Common (1% to 10%): Headache
Frequency not reported: Migraine[Ref]

References

1. "Product Information. Otezla (apremilast)." Celgene Corporation, Summit, NJ.

Not all side effects for apremilast may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

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