Prescription medicine
Telotristat Brand names: Xermelo
Telotristat (Xermelo) is a prescription medicine. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the telotristat FDA label on DailyMed (effective August 6, 2026); every telotristat label on DailyMed.
Highlights of the record
FDA label of August 6, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageXermelo is indicated for the treatment of carcinoid syndrome diarrhea in combination with somatostatin analog (SSA) therapy in adults inadequately controlled by SSA therapy.
Forms and strengths
- 250 mg
Tablet.
On the market
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 2 of which 0 under generic applications, 2 under brand applications, repackagers included
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
- 5,728 through July 30, 2026
What is telotristat used for?
From the label: indications and usageXermelo is indicated for the treatment of carcinoid syndrome diarrhea in combination with somatostatin analog (SSA) therapy in adults inadequately controlled by SSA therapy. Xermelo is a tryptophan hydroxylase inhibitor indicated for the treatment of carcinoid syndrome diarrhea in combination with somatostatin analog (SSA) therapy in adults inadequately controlled by SSA therapy.
Conditions named in the indications of telotristat's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Tryptophan Hydroxylase Inhibitor.
Source: FDA drug label (Xermelo), TerSera Therapeutics LLC, effective August 6, 2026 (SPL set a4ac9d62-887c-4c8f-b04d-a5f31cec7c86), via openFDA; the full label on DailyMed
Is there a generic for telotristat (Xermelo)?
No generic telotristat is approved (Drugs@FDA, October 8, 2026).
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the telotristat label say about other medicines?
The telotristat label names 4 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 |
|---|---|---|
| Bupropion | drug interactions | Concomitant use of Xermelo may decrease the efficacy of drugs that are CYP2B6 substrates (e.g., bupropion, efavirenz) by decreasing their systemic exposure. |
| Efavirenz | drug interactions | Concomitant use of Xermelo may decrease the efficacy of drugs that are CYP2B6 substrates (e.g., bupropion, efavirenz) by decreasing their systemic exposure. |
| Midazolam | drug interactions | Concomitant use of Xermelo may decrease the efficacy of drugs that are CYP3A4 substrates (e.g., midazolam) by decreasing their systemic exposure. |
| Octreotide | drug interactions | Concurrent administration of short-acting octreotide with Xermelo significantly decreased the systemic exposure of telotristat ethyl and telotristat, the active metabolite. |
Source: FDA drug label (Xermelo), TerSera Therapeutics LLC, effective August 6, 2026 (SPL set a4ac9d62-887c-4c8f-b04d-a5f31cec7c86), via openFDA; the full label on DailyMed
What do FAERS reports show for telotristat?
The FDA Adverse Event Reporting System holds 5,728 reports that list telotristat among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 402 are coded as a death and 886 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. Reports rose sharply in 2018 (1,722, against a median of 111 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens.
Reports received each year
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 telotristat?
10 other medicines are given the same way (oral) and in the same FDA class as telotristat 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 |
|---|---|---|---|---|
| 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 |
| Atropine and diphenoxylate | Diarrhea | 19 labelers | $0.139 per tablet 2.5-0.025 mg tablet | 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 |
| Atropine and difenoxin | Diarrhea | none listed | $6.91 per tablet 1-0.025 mg tablet | No current entry |
Every medicine labeled for the same conditions as telotristat
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to telotristat
- 10 medicines for the same use
- Telotristat side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other