Skip to Content

Naldemedine Side Effects

For the Consumer

Applies to naldemedine: oral tablet

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
  • Fast heartbeat
  • fever
  • hives, itching, or rash
  • hoarseness
  • irritation
  • joint pain, stiffness, or swelling
  • loss of appetite
  • redness of the skin
  • swelling of the eyelids, face, lips, hands, or feet
  • tightness in the chest
  • troubled breathing or swallowing
  • vomiting
  • weakness
Incidence not known
  • Bloody, black, or tarry stools
  • chills
  • feeling cold
  • heartburn
  • increased sweating
  • indigestion
  • redness on the face, neck, arms, and upper chest
  • severe abdominal or stomach pain, cramping, or burning
  • vomiting of material that looks like coffee grounds, severe and continuous

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
  • Fast, pounding, or irregular heartbeat or pulse
  • increased tearing

For Healthcare Professionals

Applies to naldemedine: oral tablet

General

The most commonly reported adverse reactions have included abdominal pain, diarrhea, nausea and vomiting.[Ref]

Hypersensitivity

Frequency not reported: Bronchospasm, rash

During clinical trials, 2 patients developed symptoms of hypersensitivity. One had bronchospasm and the other had a rash.

Psychiatric

Adverse reactions consistent with opioid withdrawal have been reported. These reactions may have included hyperhidrosis, hot flush or flushing, chills, tremor, tachycardia, anxiety, agitation, yawning, rhinorrhea, increased lacrimation, sneezing, feeling cold, pyrexia, vomiting, diarrhea, or abdominal pain. The incidence of adverse reactions of opioid withdrawal in 2 pooled studies was similar to placebo (8/542 vs 3/546); in a 52-week study the incidence in drug-treated patients was 3% (20/621) versus 1% (9/619) for placebo.

Common (1% to 10%): Opioid withdrawal

Gastrointestinal

Very common (10% or more): Abdominal pain (up to 11%)
Common (1% to 10%): Diarrhea, nausea, gastroenteritis, vomiting

References

1. "Product Information. Symproic (naldemedine)." Shionogi USA Inc, Florham Park, NJ.

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.

Hide