"The combinations of anti-HIV drugs recommended for pregnant women do not appear in general to increase their children's risk for language delay, according to a study from a National Institutes of Health research network.
Fulyzaq Side Effects Center
Reviewed by Melissa Conrad Stöppler, MD
Fulyzaq (crofelemer) is a prescription antidiarrheal medication that is used to treat and relieve symptoms of non-infectious diarrhea in HIV/AIDS patients taking antiretroviral therapy. The most commonly reported side effects experienced from taking Fulyzaq are upper respiratory tract infections, bronchitis, cough, and flatulence (gas).
The recommended dose for Fulyzaq is one 125 mg delayed-release tablet taken orally twice a day, with or without food. It was not shown to have significant interactions with drugs used to treat HIV.
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.
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.
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Fulyzaq FDA Prescribing 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 = 274
|Upper respiratory tract infection||13 (5.7)||4 (1.5)|
|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)|
|Urinary tract infection||5 (2.2)||2 (0.7)|
|Nasopharyngitis||5 (2.2)||2 (0.7)|
|Musculoskeletal pain||5 (2.2)||1 (0.4)|
|Anxiety||5 (2.2)||1 (0.4)|
|Increased alanine aminotransferase||5 (2.2)||3 (1.1)|
|Abdominal distension||5 (2.2)||1 (0.4)|
|* Twice daily|
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)
Additional Fulyzaq Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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