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Fulyzaq Side Effects

Generic Name: crofelemer

Note: This document contains side effect information about crofelemer. Some of the dosage forms listed on this page may not apply to the brand name Fulyzaq.

In Summary

More frequent side effects include: upper respiratory tract infection. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to crofelemer: oral tablet delayed release

Along with its needed effects, crofelemer (the active ingredient contained in Fulyzaq) 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 crofelemer:

Less common
  • Abdominal or stomach pain
  • bleeding after defecation
  • full or bloated feeling
  • pressure in the stomach
  • swelling of the abdominal or stomach area
  • uncomfortable swelling around the anus

Some side effects of crofelemer 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:

More common Less common
  • Acid or sour stomach
  • back pain
  • belching
  • bladder pain
  • blemishes on the skin
  • blistering, crusting, irritation, itching, or reddening of the skin
  • bloody or cloudy urine
  • cough producing mucus
  • cracked, dry, scaly skin
  • difficult, burning, or painful urination
  • difficulty having a bowel movement (stool)
  • difficulty with moving
  • discouragement
  • dizziness
  • dry mouth
  • excess air or gas in the stomach or intestines
  • fear or nervousness
  • feeling sad or empty
  • frequent urge to urinate
  • heartburn
  • indigestion
  • irritability
  • loss of appetite
  • loss of interest or pleasure
  • lower back or side pain
  • muscle aches
  • muscle or bone pain
  • muscle stiffness
  • nausea and vomiting
  • pain in the arms or legs
  • pain in the groin or genitals
  • pain in the joints
  • pain or tenderness around the eyes and cheekbones
  • painful blisters on the trunk of the body
  • passing gas
  • pimples
  • sharp back pain just below the ribs
  • stomach discomfort or upset
  • tightness in the chest
  • tiredness
  • trouble concentrating
  • trouble sleeping
  • weakness

For Healthcare Professionals

Applies to crofelemer: oral delayed release tablet

Dermatologic

Common (1% to 10%): Acne, dermatitis[Ref]

Gastrointestinal

Common (1% to 10%): Flatulence, nausea, hemorrhoids, abdominal distension, abdominal pain, constipation, dry mouth, dyspepsia, gastroenteritis[Ref]

General

The most common adverse reactions (greater than or equal to 3%) include upper respiratory tract infection, bronchitis, cough, flatulence and increased bilirubin.

Genitourinary

Common (1% to 10%): Urinary tract infection, pollakiuria[Ref]

Hematologic

Common (1% to 10%): Decreased white blood cell count[Ref]

Hepatic

Common (1% to 10%): Increased bilirubin, increased alanine aminotransferase, increased aspartate aminotransferase, increased conjugated bilirubin, increased unconjugated blood bilirubin, nephrolithiasis[Ref]

Musculoskeletal

Common (1% to 10%): Back pain, arthralgia, musculoskeletal pain, pain in extremity[Ref]

Nervous system

Common (1% to 10%): Dizziness[Ref]

Other

Common (1% to 10%): Giardiasis, herpes zoster, procedural pain, seasonal allergy[Ref]

Psychiatric

Common (1% to 10%): Anxiety, depression[Ref]

Respiratory

Common (1% to 10%): Upper respiratory tract infection, bronchitis, cough, nasopharyngitis, sinusitis[Ref]

References

1. "Product Information. Fulyzaq (crofelemer)." Salix Pharmaceuticals, Raleigh, NC.

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.

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