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Naldemedine Side Effects

Medically reviewed by Drugs.com. Last updated on Aug 8, 2020.

For the Consumer

Applies to naldemedine: oral tablet

Side effects requiring immediate medical attention

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

Side effects not requiring immediate medical attention

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

General

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

Gastrointestinal

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

Other

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]

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]

References

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

2. "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.