Telotristat Ethyl
Telotristat ethyl is an oral medicine that reduces excess serotonin production in the gut, used to treat carcinoid syndrome diarrhea in adults whose symptoms are not adequately controlled by somatostatin analog therapy.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 2 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
📖 Telotristat Ethyl: Patient Information Guide
A plain-language walkthrough of Telotristat Ethyl — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.
🎯What it's used for▾
Telotristat ethyl is used in adults for one FDA-approved purpose:
- Xermelo tablets are indicated to treat carcinoid syndrome diarrhea — persistent, hard-to-control diarrhea caused by tumors that overproduce serotonin — when used together with somatostatin analog (SSA) therapy in adults whose diarrhea is not adequately controlled by SSA therapy alone.
⚙️How it works▾
Telotristat ethyl is converted in the body into its active form, telotristat, which blocks an enzyme called tryptophan hydroxylase. This enzyme controls the rate at which the gut makes serotonin. In people with carcinoid syndrome, tumors cause the gut to overproduce serotonin, which drives secretion, gut movement, and inflammation — all contributing to diarrhea. By blocking this enzyme, telotristat lowers peripheral (gut-based) serotonin production and reduces how often diarrhea occurs.
💊How it's taken▾
Xermelo is taken as an oral tablet three times a day. Always take it with food — eating, especially a higher-fat meal, significantly increases how much medicine is absorbed into your body. If you use short-acting octreotide alongside Xermelo, take Xermelo first and wait at least 30 minutes before taking the octreotide injection, because taking them at the same time reduces Xermelo's absorption.
- Take each dose at regular mealtimes to help you remember.
- If you miss a dose, take the next one at its scheduled time — do not double up.
- Stop Xermelo and call your doctor if you develop severe constipation or severe abdominal pain.
🤒Side effects — in detail▾
The most common side effects reported in clinical trials include:
- Nausea
- Headache
- Elevated GGT (a liver enzyme measured on blood tests)
- Depression or depressed mood
- Flatulence (gas)
- Decreased appetite
- Peripheral edema (swelling in the legs or feet)
- Fever (pyrexia)
- Abdominal pain and constipation (reported in a second trial)
More serious but less common reactions include intestinal obstruction, intestinal perforation, and fecaloma (a hardened mass of stool) — stop Xermelo immediately and get medical help if you develop severe or worsening constipation or abdominal pain. Allergic reactions including angioedema (swelling of the face or throat), rash, and itching have also been reported after the drug came to market.
⚠️Warnings & precautions▾
- Constipation risk: Xermelo reduces bowel movement frequency by design, but this can lead to serious complications including intestinal blockage, bowel perforation, and impacted stool (fecaloma). Monitor closely, especially if you are also taking other constipating medicines. Stop Xermelo and contact your doctor immediately if constipation becomes severe or you develop severe or worsening abdominal pain.
- Allergic reactions: Do not use Xermelo if you have ever had a serious allergic reaction to telotristat. Reactions including angioedema, rash, and itching have been reported. Seek emergency care if you experience swelling of the face, lips, or throat.
- Liver impairment: Blood levels of Xermelo are substantially higher in people with liver impairment. Use with caution and under close medical supervision if you have liver problems.
🔀What it interacts with▾
Xermelo can affect how other medicines work in your body. Key interactions to discuss with your care team include:
- CYP3A4 substrates (e.g., midazolam): Xermelo can reduce blood levels of medicines broken down by the CYP3A4 liver enzyme, potentially making them less effective. Your doctor may need to adjust the dose of those medicines.
- CYP2B6 substrates (e.g., bupropion, efavirenz): Similarly, Xermelo can lower levels of medicines processed by CYP2B6, which may reduce their effectiveness. Dose adjustments may be needed.
- Short-acting octreotide: Taking short-acting octreotide at the same time as Xermelo significantly lowers Xermelo's absorption. Always take Xermelo first and wait at least 30 minutes before taking octreotide.
This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.
📋Before taking it▾
- Allergy to telotristat: Do not take Xermelo if you have had a previous allergic reaction to telotristat — this is a contraindication.
- Liver problems: Xermelo reaches higher-than-normal blood levels in people with mild or moderate liver impairment; discuss risks with your doctor. Severe liver impairment data are limited.
- Kidney problems: No dose adjustment is needed for kidney disease as long as you are not on dialysis. Xermelo has not been studied in patients requiring dialysis.
- Pregnancy: There are no human safety data during pregnancy. Animal studies at high doses showed potential harm. Discuss with your doctor if you are pregnant or planning to conceive.
- Breastfeeding: It is not known if telotristat ethyl passes into breast milk. Weigh the benefits of breastfeeding against potential risks; monitor a breastfed infant for constipation.
- Children: Safety and effectiveness in pediatric patients have not been established.
- Older adults: Adults 65 and over responded similarly to younger patients in trials, but individual sensitivity cannot be fully ruled out.
📡Pharmacodynamics — effects in the body▾
Xermelo measurably lowers serotonin levels in the body. In patients with carcinoid syndrome diarrhea, treatment reduced levels of a serotonin breakdown marker in the urine (called 24-hour urinary 5-HIAA) as early as 5 days into treatment, with continued reductions seen at 6 and 12 weeks — while placebo produced no such reduction. At doses well above the recommended level, Xermelo does not cause meaningful changes in heart rhythm (specifically, it does not prolong the QT interval to a clinically relevant extent).
🔬Pharmacokinetics — how your body processes it▾
After you take a Xermelo tablet, it is quickly absorbed and converted in the body to its active form, telotristat, which reaches peak levels in the blood within 1 to 3 hours. Taking it with food — especially a high-fat meal — significantly increases how much of the medicine your body absorbs, which is why food is always recommended. Telotristat is cleared from the body mainly through the feces, with the active metabolite having an apparent half-life (the time for blood levels to fall by half) of about 5 hours. The drug does not significantly build up in the body with regular dosing.
📦How to store it▾
Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) .
📄 Written from Telotristat Ethyl’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →
🩺 Pharmacist Counseling Corner
Quick, plain-English answers to the questions patients ask most about Telotristat Ethyl — the kind of thing our pharmacy team would talk through with you at the counter.
What exactly is Xermelo and why has my doctor added it to my other carcinoid treatment? ▾
Do I need to take Xermelo with food, or can I take it whenever? ▾
What side effects should I expect, and which ones should make me call my doctor right away? ▾
Are there any other medicines I should be careful about while taking Xermelo? ▾
Is it safe to take Xermelo if I'm pregnant or breastfeeding? ▾
What happens if I miss a dose? ▾
Is Telotristat Ethyl available over the counter? ▾
When was Telotristat Ethyl first available? ▾
Who makes Telotristat Ethyl? ▾
💬 Answers drafted from Telotristat Ethyl’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →
🧰 Keep exploring
💊 How Telotristat Ethyl comes
Telotristat Ethyl is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Tablet
How this form is used
- Xermelo tablets are used to treat carcinoid syndrome diarrhea in adults in combination with somatostatin analog (SSA) therapy when SSA therapy alone is not controlling diarrhea adequately.
- Xermelo tablets are taken three times daily by mouth — always take each dose with food to maximize absorption.
- If short-acting octreotide is used alongside Xermelo, take Xermelo first and wait at least 30 minutes before taking the octreotide.
- If you miss a dose of Xermelo, take your next dose at the regular scheduled time — never take two doses at once to catch up.
- Stop taking Xermelo and contact your doctor immediately if severe constipation or severe abdominal pain develops.
📊 Telotristat Ethyl across the U.S. market
How Telotristat Ethyl appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
🔍 Compare Telotristat Ethyl products
A representative set of FDA-listed product records for Telotristat Ethyl — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Tablet | ||||
| 250 mg | — | Catalent Pharma Solutions, LLC | DRUG FOR FURTHER PROCESSING | View NDC → |
| 250 mg | Oral | Lexicon Pharmaceuticals, Inc. × 4 listings | NDA | View NDC → |
| 250 mg | Oral | TerSera Therapeutics LLC × 2 listings | NDA | View NDC → |
Showing 7 of 7 products — FDA National Drug Code Directory. See every product, package size and price: browse all 7 Telotristat Ethyl NDCs →
📈 What people report — real-world data (FDA FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Telotristat Ethyl — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Telotristat Ethyl in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
🏛️ The road to your pharmacy
How Telotristat Ethyl went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
🚨 Recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
Source: openFDA drug enforcement (recall) reports.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 1872441 1 dose form · 1 strength
-
Dose form (SCDF) Oral Tablet RxCUI 1872452In current FDA listingsClinical drug / strength (SCD) 250 MGRxCUI 1872453
Look up RxCUI 1872441 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
📦 Supply & shortage status
Whether Telotristat Ethyl is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
🏷️ Sold under these brand names
🏭 Manufacturers & labelers
🔬 Where this comes from
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How we combine label and product data
HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 2 FDA-filed SPL label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.
For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. TerSera Therapeutics LLC is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.
This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.