Drug · FAERS side-effect profile with label screen
Telotristat Ethyl side effects: what 5,728 FDA adverse event reports show
Drug class
Tryptophan hydroxylase inhibitor
FDA label, Indications wording
Brand names
Xermelo
openFDA label
Who reports
5,728 reports · 35% serious · 402 with death outcome · 56% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Xermelo 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. ( 1 )
FDA label, Indications and Usage
What it is
Xermelo (telotristat ethyl) tablets contain telotristat ethyl as telotristat etiprate, a tryptophan hydroxylase inhibitor. Telotristat etiprate is the hippurate salt of telotristat ethyl [(S)-.
FDA label, Description section
Boxed warning
None in the current label
How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation.
Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)?
That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.
Causality screen of the 40 strongest signals
Labeled adverse reaction 7Labeled (related wording) 2Likely indication confounding 1Reporting / coding artifact 6Lab value / disease marker 6Not in label — unassessed 18
What the badges mean
- Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
- Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
- Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 66 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Hospice care | 87 | 32.6 26.5–40.2ROR 33.1 · χ² 2,612 / p <1e-300 | 32.1 EB05 26.8 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious PRR 75.1 · 72% consumer | no trial data cached |
| Flatulence (gas) | 396 | 25.8 23.4–28.4ROR 27.6 · χ² 9,369 / p <1e-300 | 25.6 EB05 23.5 · IC025 +4.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 21.1 · 93% consumer | no trial data cached |
| Flushing | 351 | 12.6 11.4–14.0ROR 13.4 · χ² 3,750 / p <1e-300 | 12.6 EB05 11.5 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 19.1 · 81% consumer | no trial data cached |
| Frequent bowel movements | 76 | 10.4 8.3–13.0ROR 10.5 · χ² 633 / p 6e-140 | 10.1 EB05 8.3 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 7.2 · 84% consumer | no trial data cached |
| Constipation | 602 | 10.2 9.5–11.0ROR 11.3 · χ² 5,030 / p <1e-300 | 10.2 EB05 9.5 · IC025 +3.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.1 · 84% consumer | no trial data cached |
| Product dose omission | 177 | 9.8 8.5–11.3ROR 10.1 · χ² 1,392 / p <1e-300 | 9.7 EB05 8.5 · IC025 +3.0 3/3 methods agree | Reporting / coding artifact | serious PRR 18.9 · 95% consumer | no trial data cached |
| Abdominal pain | 519 | 8.2 7.5–8.9ROR 8.9 · χ² 3,297 / p <1e-300 | 8.1 EB05 7.6 · IC025 +2.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.1 · 82% consumer | no trial data cached |
| Neoplasm progression | 77 | 8.0 6.4–10.0ROR 8.1 · χ² 468 / p 5e-104 | 7.8 EB05 6.4 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 14.7 · 76% consumer | no trial data cached |
| Blood potassium decreased | 65 | 7.9 6.2–10.1ROR 8.0 · χ² 386 / p 3e-86 | 7.6 EB05 6.1 · IC025 +2.5 3/3 methods agree | Lab value / disease marker | serious PRR 7.4 · 80% consumer | no trial data cached |
| Blood calcium decreased | 24 | 7.8 5.2–11.6ROR 7.8 · χ² 135 / p 1e-31 | 7.0 EB05 4.9 · IC025 +2.1 3/3 methods agree | Lab value / disease marker | serious PRR 6.0 | no trial data cached |
| Blood iron decreased | 23 | 7.2 4.8–10.8ROR 7.2 · χ² 115 / p 3e-27 | 6.4 EB05 4.4 · IC025 +2.0 3/3 methods agree | Lab value / disease marker | serious PRR 9.0 · 86% consumer | no trial data cached |
| Intestinal obstruction | 69 | 6.8 5.3–8.5ROR 6.8 · χ² 332 / p 1e-74 | 6.5 EB05 5.3 · IC025 +2.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 10.7 · 85% consumer | no trial data cached |
| Abdominal distension (bloating) | 176 | 6.2 5.4–7.2ROR 6.4 · χ² 766 / p 7e-169 | 6.1 EB05 5.4 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 4.6 · 85% consumer | no trial data cached |
| Metastases to liver | 29 | 6.1 4.2–8.7ROR 6.1 · χ² 117 / p 1e-27 | 5.6 EB05 4.1 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 9.7 | no trial data cached |
| Hospitalisation | 241 | 5.8 5.1–6.6ROR 6.0 · χ² 957 / p 2e-210 | 5.7 EB05 5.1 · IC025 +2.3 3/3 methods agree | Reporting / coding artifact | serious PRR 9.7 · 85% consumer | no trial data cached |
| Flank pain | 13 | 5.1 3.0–8.8ROR 5.1 · χ² 39 / p 2e-10 | 4.4 EB05 2.7 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 7.6 | no trial data cached |
| Diarrhoea (diarrhea) | 835 | 4.8 4.5–5.1ROR 5.4 · χ² 2,549 / p <1e-300 | 4.7 EB05 4.5 · IC025 +2.1 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 4.4 · 83% consumer | no trial data cached |
| Disease progression | 152 | 4.7 4.0–5.5ROR 4.8 · χ² 444 / p 6e-99 | 4.7 EB05 4.1 · IC025 +2.0 3/3 methods agree | Reporting / coding artifact | serious PRR 8.7 | no trial data cached |
| Feeding disorder | 25 | 4.6 3.1–6.8ROR 4.6 · χ² 67 / p 2e-16 | 4.3 EB05 3.0 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 4.2 · 88% consumer | no trial data cached |
| Blood alkaline phosphatase increased | 31 | 4.6 3.2–6.5ROR 4.6 · χ² 83 / p 5e-20 | 4.3 EB05 3.2 · IC025 +1.5 3/3 methods agree | Lab value / disease marker | serious PRR 5.0 | no trial data cached |
| Neoplasm | 14 | 4.5 2.6–7.5ROR 4.5 · χ² 34 / p 3e-9 | 3.9 EB05 2.5 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 5.1 | no trial data cached |
| Red blood cell count decreased | 34 | 4.4 3.1–6.1ROR 4.4 · χ² 84 / p 2e-20 | 4.1 EB05 3.1 · IC025 +1.5 3/3 methods agree | Lab value / disease marker | serious PRR 3.6 | no trial data cached |
| Haemorrhoids | 22 | 4.1 2.7–6.3ROR 4.1 · χ² 49 / p 1e-12 | 3.8 EB05 2.7 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 3.4 · 77% consumer | no trial data cached |
| Tooth extraction | 14 | 4.1 2.4–7.0ROR 4.1 · χ² 30 / p 2e-8 | 3.7 EB05 2.4 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 2.6 | no trial data cached |
| Haematocrit decreased | 22 | 4.0 2.7–6.1ROR 4.0 · χ² 47 / p 3e-12 | 3.8 EB05 2.6 · IC025 +1.2 3/3 methods agree | Lab value / disease marker | serious PRR 3.0 | no trial data cached |
| Seasonal allergy | 15 | 3.9 2.3–6.5ROR 3.9 · χ² 29 / p 3e-8 | 3.5 EB05 2.3 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious n=5 | no trial data cached |
| Decreased appetite (loss of appetite) | 238 | 3.8 3.3–4.3ROR 3.9 · χ² 485 / p 7e-108 | 3.7 EB05 3.4 · IC025 +1.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.7 · 87% consumer | no trial data cached |
| Treatment noncompliance | 55 | 3.7 2.9–4.8ROR 3.7 · χ² 106 / p 3e-25 | 3.6 EB05 2.9 · IC025 +1.4 3/3 methods agree | Reporting / coding artifact | serious PRR 2.2 · 89% consumer | no trial data cached |
| Gastrointestinal pain | 11 | 3.7 2.0–6.6ROR 3.7 · χ² 19 / p 7e-6 | 3.3 EB05 2.0 · IC025 +0.7 | Labeled adverse reaction exact term | serious PRR 0.8 | no trial data cached |
| Night sweats | 30 | 3.4 2.4–4.9ROR 3.4 · χ² 49 / p 1e-12 | 3.3 EB05 2.4 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 4.8 | no trial data cached |
| Abdominal pain upper | 190 | 3.4 2.9–3.9ROR 3.5 · χ² 320 / p 6e-72 | 3.4 EB05 3.0 · IC025 +1.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.1 · 86% consumer | no trial data cached |
| Dehydration | 120 | 3.3 2.8–3.9ROR 3.3 · χ² 191 / p 1e-43 | 3.3 EB05 2.8 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 4.2 · 82% consumer | no trial data cached |
| Gout | 16 | 3.3 2.0–5.3ROR 3.3 · χ² 23 / p 9e-7 | 3.0 EB05 2.0 · IC025 +0.8 | Not in label — unassessed | serious PRR 5.1 | no trial data cached |
| Adverse drug reaction | 79 | 3.2 2.6–4.0ROR 3.3 · χ² 120 / p 3e-28 | 3.2 EB05 2.6 · IC025 +1.3 3/3 methods agree | Reporting / coding artifact | serious PRR 3.7 · 83% consumer | no trial data cached |
| Ascites | 25 | 3.1 2.1–4.6ROR 3.1 · χ² 34 / p 3e-9 | 3.0 EB05 2.1 · IC025 +0.9 3/3 methods agree | Not in label — unassessed | serious PRR 5.0 | no trial data cached |
| Small intestinal obstruction | 10 | 3.0 1.6–5.5ROR 3.0 · χ² 11 / p 4e-4 | 2.7 EB05 1.6 · IC025 +0.4 | Labeled (related wording) related wording | serious PRR 4.9 | no trial data cached |
| Surgery | 47 | 3.0 2.2–3.9ROR 3.0 · χ² 60 / p 6e-15 | 2.9 EB05 2.3 · IC025 +1.1 3/3 methods agree | Reporting / coding artifact | serious PRR 5.4 · 91% consumer | no trial data cached |
| Taste disorder | 16 | 2.9 1.8–4.8ROR 2.9 · χ² 18 / p 9e-6 | 2.8 EB05 1.8 · IC025 +0.6 | Not in label — unassessed | serious PRR 7.2 | no trial data cached |
| Nausea | 628 | 2.9 2.7–3.1ROR 3.2 · χ² 819 / p 2e-180 | 2.9 EB05 2.7 · IC025 +1.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.8 · 85% consumer | no trial data cached |
| Metastases to bone | 13 | 2.9 1.7–5.0ROR 2.9 · χ² 14 / p 7e-5 | 2.7 EB05 1.7 · IC025 +0.5 | Not in label — unassessed | serious PRR 4.5 | no trial data cached |
Trial evidence (ClinicalTrials.gov)
Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Diarrhoea (diarrhea) | 835 | 4.8 4.5–5.1ROR 5.4 · χ² 2,549 / p <1e-300 | 4.7 EB05 4.5 · IC025 +2.1 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 4.4 · 83% consumer | no trial data cached |
| Nausea | 628 | 2.9 2.7–3.1ROR 3.2 · χ² 819 / p 2e-180 | 2.9 EB05 2.7 · IC025 +1.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.8 · 85% consumer | no trial data cached |
| Constipation | 602 | 10.2 9.5–11.0ROR 11.3 · χ² 5,030 / p <1e-300 | 10.2 EB05 9.5 · IC025 +3.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.1 · 84% consumer | no trial data cached |
| Off label use (used outside approved label) | 519 | 2.2 2.0–2.4ROR 2.3 · χ² 349 / p 4e-78 | 2.2 EB05 2.0 · IC025 +1.0 3/3 methods agree | Reporting / coding artifact | serious PRR 2.1 · 76% consumer | no trial data cached |
| Abdominal pain | 519 | 8.2 7.5–8.9ROR 8.9 · χ² 3,297 / p <1e-300 | 8.1 EB05 7.6 · IC025 +2.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.1 · 82% consumer | no trial data cached |
| Fatigue (tiredness) | 417 | 2.0 1.8–2.2ROR 2.0 · χ² 204 / p 1e-46 | 2.0 EB05 1.8 · IC025 +0.8 | Not in label — unassessed | serious PRR 2.5 · 78% consumer | no trial data cached |
| Flatulence (gas) | 396 | 25.8 23.4–28.4ROR 27.6 · χ² 9,369 / p <1e-300 | 25.6 EB05 23.5 · IC025 +4.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 21.1 · 93% consumer | no trial data cached |
| Flushing | 351 | 12.6 11.4–14.0ROR 13.4 · χ² 3,750 / p <1e-300 | 12.6 EB05 11.5 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 19.1 · 81% consumer | no trial data cached |
| Death | 331 | 1.4 1.3–1.6ROR 1.4 · χ² 40 / p 1e-10 | 1.4 EB05 1.3 · IC025 +0.3 | Outcome field, not a reaction | serious PRR 2.3 | no trial data cached |
| Headache | 327 | 1.9 1.7–2.1ROR 2.0 · χ² 146 / p 8e-34 | 1.9 EB05 1.7 · IC025 +0.8 | Labeled adverse reaction exact term | serious PRR 1.3 · 85% consumer | no trial data cached |
| Malaise (feeling unwell) | 255 | 2.1 1.9–2.4ROR 2.2 · χ² 154 / p 1e-35 | 2.1 EB05 1.9 · IC025 +0.9 | Not in label — unassessed | serious PRR 2.3 · 85% consumer | no trial data cached |
| Hospitalisation | 241 | 5.8 5.1–6.6ROR 6.0 · χ² 957 / p 2e-210 | 5.7 EB05 5.1 · IC025 +2.3 3/3 methods agree | Reporting / coding artifact | serious PRR 9.7 · 85% consumer | no trial data cached |
| Decreased appetite (loss of appetite) | 238 | 3.8 3.3–4.3ROR 3.9 · χ² 485 / p 7e-108 | 3.7 EB05 3.4 · IC025 +1.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.7 · 87% consumer | no trial data cached |
| Abdominal pain upper | 190 | 3.4 2.9–3.9ROR 3.5 · χ² 320 / p 6e-72 | 3.4 EB05 3.0 · IC025 +1.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.1 · 86% consumer | no trial data cached |
| Weight decreased (weight loss) | 182 | 2.4 2.1–2.8ROR 2.4 · χ² 147 / p 3e-34 | 2.4 EB05 2.1 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 2.5 · 80% consumer | no trial data cached |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Hospice care — n=87, PRR 32.6
- Flushing — n=351, PRR 12.6
- Frequent bowel movements — n=76, PRR 10.4
- Neoplasm progression — n=77, PRR 8.0
- Abdominal distension — n=176, PRR 6.2
- Metastases to liver — n=29, PRR 6.1
- Feeding disorder — n=25, PRR 4.6
- Haemorrhoids — n=22, PRR 4.1
- Night sweats — n=30, PRR 3.4
- Dehydration — n=120, PRR 3.3
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Telotristat Ethyl?
In FDA FAERS, the most frequently co-reported reaction terms for Telotristat Ethyl are diarrhoea, nausea, constipation, abdominal pain, fatigue, flatulence. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Telotristat Ethyl have an FDA boxed warning?
No. The FDA label retrieved for Telotristat Ethyl has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Telotristat Ethyl causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID a4ac9d62-887c-4c8f-b04d-a5f31cec7c86, effective 20260806; matched on
openfda.generic_name.exact:"TELOTRISTAT ETHYL") - Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 106 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath
Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.