Prescription medicine
Crofelemer Brand names: Mytesi
Crofelemer (Mytesi) is a prescription medicine with an FDA approval on record since 2012. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the crofelemer FDA label on DailyMed (effective July 31, 2026, Napo Pharmaceuticals, Inc.); the NDA 202292 record on Drugs@FDA; every crofelemer label on DailyMed.
Highlights of the record
FDA label of July 31, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageMYTESI is indicated for symptomatic relief of non-infectious diarrhea in adult patients with HIV/AIDS on anti-retroviral therapy.
Forms and strengths
- 125 mg
Coated tablet.
On the market
- Earliest approval on file
- December 31, 2012 Mytesi, Napo Pharms Inc; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- October 31, 2031 Mytesi tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 233 through July 30, 2026
What is crofelemer used for?
From the label: indications and usageMYTESI is indicated for symptomatic relief of non-infectious diarrhea in adult patients with HIV/AIDS on anti-retroviral therapy. MYTESI is an anti-diarrheal indicated for the symptomatic relief of non-infectious diarrhea in adult patients with HIV/AIDS on anti-retroviral therapy.
Conditions named in the indications of crofelemer's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Antidiarrheal.
Source: FDA drug label (MYTESI), Napo Pharmaceuticals, Inc., effective July 31, 2026 (SPL set 45584fba-8081-4cd1-a21e-3ea8237f62ff), via openFDA; the full label on DailyMed
Is there a generic for crofelemer (Mytesi)?
No generic crofelemer is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 2 patents for Mytesi tablets, the last expiring on October 31, 2031. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2012 earliest approval on file
- 2031 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the crofelemer label say about other medicines?
The crofelemer label names 3 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Lamivudine | drug interactions | DRUG INTERACTIONS 7.1 Nelfinavir, Zidovudine, and Lamivudine MYTESI administration did not have a clinically relevant interaction with nelfinavir, zidovudine, or lamivudine in a drug-drug interaction trial [see Clinical Pharmacology ( 12.3 )]. |
| Nelfinavir | drug interactions | DRUG INTERACTIONS 7.1 Nelfinavir, Zidovudine, and Lamivudine MYTESI administration did not have a clinically relevant interaction with nelfinavir, zidovudine, or lamivudine in a drug-drug interaction trial [see Clinical Pharmacology ( 12.3 )]. |
| Zidovudine | drug interactions | DRUG INTERACTIONS 7.1 Nelfinavir, Zidovudine, and Lamivudine MYTESI administration did not have a clinically relevant interaction with nelfinavir, zidovudine, or lamivudine in a drug-drug interaction trial [see Clinical Pharmacology ( 12.3 )]. |
Source: FDA drug label (MYTESI), Napo Pharmaceuticals, Inc., effective July 31, 2026 (SPL set 45584fba-8081-4cd1-a21e-3ea8237f62ff), via openFDA; the full label on DailyMed
What do FAERS reports show for crofelemer?
The FDA Adverse Event Reporting System holds 233 reports that list crofelemer among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 29 are coded as a death and 29 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as crofelemer?
10 other medicines are given the same way (oral) and in the same FDA class as crofelemer or labeled mainly for the same use (diarrhea), the same class first. Diarrhea lists all 16 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Atropine and diphenoxylate | Diarrhea | 19 labelers | $0.139 per tablet 2.5-0.025 mg tablet | No current entry |
| Atropine and difenoxin | Diarrhea | none listed | $6.91 per tablet 1-0.025 mg tablet | No current entry |
| Bismuth subsalicylate | Diarrhea | none listed | $0.0817 per tablet 262 mg tablet chewable | No current entry |
| Loperamide | Diarrhea | 98 labelers | $0.0549 per capsule 2 mg capsule | No current entry |
| Ciprofloxacin | Diarrhea | 46 labelers | $0.123 per tablet 500 mg tablet | No current entry |
| Dimethicone and loperamide | Diarrhea | 33 labelers | $0.286 per unit Gs anti-diarrheal-antigas cplt | No current entry |
| Nitazoxanide | Diarrhea | 4 labelers | $82.20 per tablet 500 mg tablet | No current entry |
| Rifaximin | Diarrhea | none listed | n/a | No current entry |
Every medicine labeled for the same conditions as crofelemer
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to crofelemer
- 10 medicines for the same use
- Other antidiarrheals
- the pharmacologic class, with prices and generics
- Crofelemer side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other