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Plecanatide Side Effects

Medically reviewed by Drugs.com. Last updated on March 29, 2020.

In Summary

More frequently reported side effects include: diarrhea. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to plecanatide: oral tablet

Warning

Oral route (Tablet)

Plecanatide is contraindicated in patients less than 6 years of age; in nonclinical studies in young juvenile mice administration of a single oral dose of plecanatide caused deaths due to dehydration. Avoid use of plecanatide in patients 6 years to less than 18 years of age. The safety and effectiveness of plecanatide have not been established in patients less than 18 years of age.

Side effects requiring immediate medical attention

Along with its needed effects, plecanatide 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 plecanatide:

Less common

Side effects not requiring immediate medical attention

Some side effects of plecanatide 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:

Less common

  • Bladder pain
  • bloody or cloudy urine
  • body aches or pain
  • chills
  • cough
  • difficult, burning, or painful urination
  • difficulty with breathing
  • dizziness
  • ear congestion
  • excess air or gas in the stomach or bowels
  • fever
  • full or bloated feeling
  • headache
  • loss of voice
  • lower back or side pain
  • muscle aches
  • nasal congestion
  • nausea
  • pain or tenderness around the eyes and cheekbones
  • passing gas
  • pressure in the stomach
  • sneezing
  • sore throat
  • stuffy or runny nose
  • swelling of the abdominal or stomach area
  • tightness of the chest
  • unusual tiredness or weakness

For Healthcare Professionals

Applies to plecanatide: oral tablet

Gastrointestinal

Common (1% to 10%): Diarrhea

Frequency not reported: Abdominal distention, flatulence, abdominal tenderness[Ref]

Hepatic

In clinical trials, there were 2 patients with ALT greater than 5 to 15 times the upper limit of normal (ULN) and 3 patients with AST greater than 5 x ULN.[Ref]

Frequency not reported: Increased liver biochemical tests[Ref]

Respiratory

Frequency not reported: Sinusitis, upper respiratory tract infection[Ref]

References

1. "Product Information. Trulance (plecanatide)." Synergy Pharmaceuticals Inc., New York, NY.

Frequently asked questions

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.