Fulyzaq Side Effects Center

Last updated on RxList: 12/16/2021
Fulyzaq Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Fulyzaq?

Fulyzaq (crofelemer) is an antidiarrheal medication used to treat and relieve symptoms of non-infectious diarrhea in HIV/AIDS patients taking antiretroviral therapy.

What Are Side Effects of Fulyzaq?

Common side effects of Fulyzaq include:

Dosage for Fulyzaq

The recommended dose for Fulyzaq is one 125 mg delayed-release tablet taken orally twice a day, with or without food.

What Drugs, Substances, or Supplements Interact with Fulyzaq?

It was not shown to have significant interactions with drugs used to treat HIV.

Fulyzaq During Pregnancy or Breastfeeding

There are no adequate, well-controlled studies of the effects of Fulyzaq in pregnant women. This drug should be used during pregnancy only if clearly needed. It is not known whether crofelemer is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for adverse reactions in nursing infants from Fulyzaq, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Additional Information

Our Fulyzaq (crofelemer) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

QUESTION

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Fulyzaq Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • dark urine, jaundice (yellowing of the skin or eyes);
  • wheezing, chest tightness, trouble breathing; or
  • worsening diarrhea.

Common side effects may include:

  • abnormal blood tests;
  • gas; or
  • cold symptoms such as stuffy nose, sneezing, cough.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Fulyzaq (Crofelemer Delayed-Release Tablets)

SLIDESHOW

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Fulyzaq Professional Information

SIDE EFFECTS

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. A total of 696 HIV-positive patients in three placebo-controlled trials received FULYZAQ for a mean duration of 78 days. Of the total population across the three trials, 229 patients received a dose of 125 mg twice a day for a mean duration of 141 days, 69 patients received a dose of 250 mg twice a day for a mean duration of 139 days, 102 patients received a dose of 250 mg four times a day for a mean duration of 14 days, 54 patients received a dose of 500 mg twice a day for a mean duration of 146 days, and 242 patients received a dose of 500 mg four times a day for a mean duration of 14 days.

Adverse reactions for FULYZAQ that occurred in at least 2% of patients and at a higher incidence than placebo are provided in Table 1.

Table 1: Adverse Reactions Occurring in at Least 2% of Patients in the 125 mg Twice Daily Group

Adverse Reaction Crofelemer 125 mg BID*
N = 229 n (%)
Placebo
N = 274 n (%)
Upper respiratory tract infection 13 (5.7) 4 (1.5)
Bronchitis 9 (3.9) 0
Cough 8 (3.5) 3 (1.1)
Flatulence 7 (3.1) 3 (1.1)
Increased bilirubin 7 (3.1) 3 (1.1)
Nausea 6 (2.6) 4 (1.5)
Back pain 6 (2.6) 4 (1.5)
Arthralgia 6 (2.6) 0
Urinary tract infection 5 (2.2) 2 (0.7)
Nasopharyngitis 5 (2.2) 2 (0.7)
Musculoskeletal pain 5 (2.2) 1 (0.4)
Hemorrhoids 5 (2.2) 0
Giardiasis 5 (2.2) 0
Anxiety 5 (2.2) 1 (0.4)
Increased alanine aminotransferase 5 (2.2) 3 (1.1)
Abdominal distension 5 (2.2) 1 (0.4)

Adverse reactions that occurred in between 1% and 2% of patients taking a 250 mg daily dose of FULYZAQ were abdominal pain, acne, increased aspartate aminotransferase, increased conjugated bilirubin, increased unconjugated blood bilirubin, constipation, depression, dermatitis, dizziness, dry mouth, dyspepsia, gastroenteritis, herpes zoster, nephrolithiasis, pain in extremity, pollakiuria, procedural pain, seasonal allergy, sinusitis and decreased white blood cell count.

Adverse reactions were similar in patients who received doses greater than 250 mg daily.

Read the entire FDA prescribing information for Fulyzaq (Crofelemer Delayed-Release Tablets)

© Fulyzaq Patient Information is supplied by Cerner Multum, Inc. and Fulyzaq Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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