Naldemedine Side Effects

Medically reviewed by Drugs.com. Last updated on Dec 8, 2024.

Applies to naldemedine: oral tablet.

Precautions

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly and to decide if you should continue to take it.

This medicine may cause a tear (perforation) in your stomach or bowels. Check with your doctor right away if you have a severe stomach pain that does not go away.

This medicine may cause withdrawal symptoms. Tell your doctor right away if you have increased sweating, chills, increased tearing, redness on the face, neck, arms, and upper chest, feeling cold, abdominal or stomach pain, diarrhea, nausea, and vomiting.

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 (eg, St. John's wort) or vitamin supplements.

Serious side effects of naldemedine

Along with its needed effects, naldemedine 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 naldemedine:

Other side effects of naldemedine

Some side effects of naldemedine 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:

For healthcare professionals

Applies to naldemedine: oral tablet.

General adverse events

The most commonly reported side effects included diarrhea, abdominal pain, nausea, and vomiting.^[Ref]

Gastrointestinal

• Very common (10% or more): Diarrhea (up to 24.5%), abdominal pain (up to 11%)
• Common (1% to 10%): Gastroenteritis, nausea, vomiting
• Frequency not reported: Abdominal discomfort, gastrointestinal pain, gastrointestinal perforation, lower abdominal pain, upper abdominal pain^[Ref]

Serious cases of diarrhea occurred in 2 patients with cancer and opioid-induced constipation.^[Ref]

Other

• Uncommon (0.1% to 1%): Opioid withdrawal syndrome
• Frequency not reported: Chills, feeling cold, pyrexia^[Ref]

Opioid withdrawal syndrome included abdominal pain, agitation, anxiety, arthralgia, chills, diarrhea, feeling cold, flushing, hot flush, hyperhidrosis, increased lacrimation, myalgia, pyrexia, rhinorrhea, sneezing, tachycardia, tremor, vomiting, and/or yarning.^[Ref]

Hypersensitivity

• Rare (0.01% to 0.1%): Hypersensitivity^[Ref]

Respiratory

• Frequency not reported: Rhinorrhea, sneezing, yawning
• Postmarketing reports: Bronchospasm^[Ref]

Cardiovascular

• Frequency not reported: Flushing, hot flush, tachycardia^[Ref]

Psychiatric

• Frequency not reported: Agitation, anxiety^[Ref]

Musculoskeletal

• Frequency not reported: Arthralgia, myalgia^[Ref]

Dermatologic

• Frequency not reported: Hyperhidrosis
• Postmarketing reports: Rash^[Ref]

Nervous system

• Frequency not reported: Tremor^[Ref]

Ocular

• Frequency not reported: Increased lacrimation^[Ref]

See also:

Frequently asked questions

• Which drugs cause opioid-induced constipation?

Further information

Naldemedine 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