Skip to main content

Naldemedine Side Effects

Medically reviewed by Last updated on Sep 20, 2023.

Applies to naldemedine: oral tablet.

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:

More common

Less common

Incidence not known

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:

Incidence not known

For Healthcare Professionals

Applies to naldemedine: oral tablet.


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


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]


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]

Uncommon (0.1% to 1%): Opioid withdrawal syndrome

Frequency not reported: Chills, feeling cold, pyrexia[Ref]


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


Frequency not reported: Rhinorrhea, sneezing, yawning

Postmarketing reports: Bronchospasm[Ref]


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


Frequency not reported: Agitation, anxiety[Ref]


Frequency not reported: Arthralgia, myalgia[Ref]


Frequency not reported: Hyperhidrosis

Postmarketing reports: Rash[Ref]

Nervous system

Frequency not reported: Tremor[Ref]


Frequency not reported: Increased lacrimation[Ref]

Frequently asked questions


1. Cerner Multum, Inc. UK Summary of Product Characteristics.

2. Product Information. Symproic (naldemedine). Shionogi USA Inc. 2017.

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.