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Naloxegol Side Effects

For the Consumer

Applies to naloxegol: oral tablet

Along with its needed effects, naloxegol 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 naloxegol:

Less common
  • Abdominal or stomach pain
  • anxiety
  • chills
  • diarrhea
  • increased sweating
  • irritability
  • yawning
Incidence not known
  • Bloody, black or tarry stools
  • heartburn
  • indigestion
  • nausea
  • severe abdominal or stomach pain, cramping, or burning
  • trouble breathing
  • vomiting of material that looks like coffee grounds, severe and continuing

Some side effects of naloxegol 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
  • Bloated
  • excess air or gas in the stomach or bowels
  • full feeling
  • passing gas
Less common
  • Headache
  • vomiting

For Healthcare Professionals

Applies to naloxegol: oral tablet

General

The most common adverse reactions include abdominal pain, nausea, diarrhea, headache, vomiting, and flatulence.[Ref]

Other

Common (1% to 10%): Possible opioid withdrawal (3 or more symptoms on the same day including, but not limited to hyperhidrosis, chills, diarrhea, abdominal pain, anxiety, irritability, and yawning)[Ref]

Possible opioid withdrawal defined as at least 3 adverse reactions potentially related to opioid withdrawal occurring on the same day and not all related to the gastrointestinal system occurred in less than 1% of patients (5 of 441) receiving the 12.5 mg dose and 3% of patients (14 of 446) receiving the 25 mg dose. Symptoms included, but were not limited to hyperhidrosis, chills, diarrhea, abdominal pain, anxiety, irritability, and yawning. For patients receiving methadone, higher frequencies of gastrointestinal adverse reactions were observed compared with other opioids.[Ref]

Gastrointestinal

Very common (10% or more): Abdominal pain (up to 21%)
Common (1% to 10%): Diarrhea, nausea, flatulence, vomiting[Ref]

Reports of severe abdominal pain and/or diarrhea resulting in hospitalization have occurred. Most cases were reported at the higher dose and within a few days of initiating therapy.[Ref]

Dermatologic

Common (1% to 10%): Hyperhidrosis[Ref]

Nervous system

Common (1% to 10%): Headache[Ref]

Respiratory

Common (1% to 10%): Nasopharyngitis[Ref]

References

1. "Product Information. Movantik (naloxegol)." Astra-Zeneca Pharmaceuticals, Wilmington, DE.

2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

3. Cerner Multum, Inc. "Australian Product Information." O 0

Some side effects of naloxegol may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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