Mytesi

Last updated on RxList: 11/25/2020
Mytesi Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Mytesi?

Mytesi (crofelemer delayed-release tablets) is an anti-diarrheal indicated for the symptomatic relief of non-infectious diarrhea in adult patients with HIV/AIDS on antiretroviral therapy.

What Are Side Effects of Mytesi?

Common side effects of Mytesi include:

Dosage for Mytesi

The recommended adult dosage of Mytesi is 125 mg taken orally twice a day, with or without food.

What Drugs, Substances, or Supplements Interact with Mytesi?

Mytesi may interact with other drugs. Tell your doctor all medications and supplements you use.

Mytesi During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Mytesi; it is unknown how it would affect a fetus. It is unknown if Mytesi passes into breast milk. Breastfeeding while using Mytesi is not recommended.

Additional Information

Our Mytesi (crofelemer delayed-release tablets) 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.

SLIDESHOW

A Timeline of the HIV/AIDS Pandemic See Slideshow
Mytesi 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 Mytesi (Crofelemer Delayed-release Tablets, for Oral Use)

QUESTION

What is HIV? See Answer
Mytesi 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 MYTESI for a mean duration of 78 days. Of the total population across the three trials, 229 patients received a dosage of 125 mg twice a day for a mean duration of 141 days, and 171 patients received one of four higher than recommended dosages for a mean duration of 139 days (N=69) 14 days (N=102), 146 days (N=54), and 14 days (N=242), respectively.

Adverse reactions in patients treated with MYTESI 125 mg twice daily that occurred in at least 2% of patients and at a higher incidence than placebo are provided in Table 1.

Table 1: Common Adverse Reactions* in HIV-Positive Patients in Three Placebo-Controlled Trials

Adverse ReactionMYTESI
125 mg Twice Daily
N = 229
n (%)
Placebo
N = 274
n (%)
Upper respiratory tract infection13 (6)4 (2)
Bronchitis9 (4)0
Cough8 (4)3 (1)
Flatulence7 (3)3 (1)
Increased bilirubin7 (3)3 (1)
Nausea6 (3)4 (2)
Back pain6 (3)4 (2)
Arthralgia6 (3)0
Urinary tract infection5 (2)2 (1)
Nasopharyngitis5 (2)2 (1)
Musculoskeletal pain5 (2)1 (<1)
Hemorrhoids5 (2)0
Giardiasis5 (2)0
Anxiety5 (2)1 (<1)
Increased alanine aminotransferase5 (2)3 (1)
Abdominal distension5 (2)1 (<1)
* occurring in at least 2% of patients and at a higher incidence than placebo

Less common adverse reactions that occurred in between 1% and 2% of patients taking 125 mg twice daily of MYTESI 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, sinusitis and decreased white blood cell count.

Read the entire FDA prescribing information for Mytesi (Crofelemer Delayed-release Tablets, for Oral Use)

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

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