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
- Diarrhea
- nausea
- stomach pain
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
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
- Fast, pounding, or irregular heartbeat or pulse
- increased tearing
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]
