Teduglutide side effects: what 13,390 FDA adverse event reports show

Teduglutide · Gattex · 1,030 reaction terms · 53,577 drug–reaction co-reports · data 2026-09-14

Drug class

GLP-2 Analog

FDA label (Established Pharmacologic Class)

Brand names

Gattex

openFDA label

Who reports

13,390 reports · 84% serious · 1,151 with death outcome · 62% female

openFDA FAERS counts, all years, deduplication not applied

Used for

GATTEX ® is indicated for the treatment of adults and pediatric patients 1 year of age and older with Short Bowel Syndrome (SBS) who are dependent on parenteral support . GATTEX ® is a glucagon-like peptide-2 (GLP-2) analog indicated for the treatment of adults and pediatric patients 1 year of age and older with Short Bowel Syndrome (SBS) who are dependent on parenteral support. ( 1 )

FDA label, Indications and Usage

What it is

The active ingredient in GATTEX (teduglutide) for injection is teduglutide, which is a 33 amino acid glucagon-like peptide-2 (GLP-2) analog manufactured using a strain of Escherichia coli modified by recombinant DNA technology.

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 2Labeled (related wording) 9Reporting / coding artifact 6Lab value / disease marker 6Not in label — unassessed 17

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.
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. 990 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Gastrointestinal stoma output abnormal	93	2,929.9 2,073.8–4,139.3ROR 2,950.3 · χ² 92,952 / p <1e-300	836.2 EB05 703.0 · IC025 +7.0 3/3 methods agree	Lab value / disease marker	serious n=91	not reported in cached trials
Gastrointestinal stoma output decreased	80	2,058.3 1,473.4–2,875.3ROR 2,070.6 · χ² 69,621 / p <1e-300	727.9 EB05 603.6 · IC025 +6.7 3/3 methods agree	Lab value / disease marker	serious n=76	not reported in cached trials
Stoma site dermatitis	18	1,852.4 933.8–3,674.8ROR 1,854.9 · χ² 14,310 / p <1e-300	443.7 EB05 296.9 · IC025 +4.4 3/3 methods agree	Labeled (related wording) related wording	serious n=17	not reported in cached trials
Gastrointestinal stoma output increased	212	1,335.8 1,112.3–1,604.1ROR 1,357.2 · χ² 150,876 / p <1e-300	672.8 EB05 600.1 · IC025 +7.8 3/3 methods agree	Lab value / disease marker	serious n=198	not reported in cached trials
Stoma prolapse	53	974.0 690.9–1,373.1ROR 977.9 · χ² 30,992 / p <1e-300	491.1 EB05 389.8 · IC025 +6.0 3/3 methods agree	Not in label — unassessed	serious n=51 · ♀ 35% (drug 62%)	not reported in cached trials
Stoma complication	382	943.5 831.7–1,070.4ROR 971.2 · χ² 222,648 / p <1e-300	569.2 EB05 522.8 · IC025 +8.2 3/3 methods agree	Reporting / coding artifact	serious n=318	NCT00930644: 2/51 (3.9%) on Teduglutide (serious AE)
Vascular device infection	1,176	553.3 518.8–590.1ROR 606.5 · χ² 476,963 / p <1e-300	404.9 EB05 385.8 · IC025 +8.3 3/3 methods agree	Labeled (related wording) related wording	serious n=1,176	not reported in cached trials
Stoma site oedema	55	524.1 386.2–711.3ROR 526.2 · χ² 21,048 / p <1e-300	344.5 EB05 274.6 · IC025 +6.0 3/3 methods agree	Labeled (related wording) related wording	serious n=47	not reported in cached trials
Stoma obstruction	46	394.5 285.5–545.1ROR 395.9 · χ² 14,068 / p <1e-300	278.1 EB05 216.9 · IC025 +5.7 3/3 methods agree	Labeled (related wording) related wording	serious n=46	not reported in cached trials
Obstructive defaecation	13	385.9 210.2–708.5ROR 386.3 · χ² 3,691 / p <1e-300	212.8 EB05 132.3 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	serious n=13	not reported in cached trials
Duodenal polyp	39	350.0 247.3–495.3ROR 351.0 · χ² 10,782 / p <1e-300	250.5 EB05 191.2 · IC025 +5.4 3/3 methods agree	Labeled adverse reaction exact term	serious n=24	not reported in cached trials
Small intestine polyp	12	272.4 147.5–503.1ROR 272.7 · χ² 2,532 / p <1e-300	169.7 EB05 103.4 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	–	not reported in cached trials
Vitamin a deficiency	15	269.2 155.6–465.8ROR 269.5 · χ² 3,189 / p <1e-300	177.9 EB05 114.4 · IC025 +3.9 3/3 methods agree	Not in label — unassessed	serious n=15	not reported in cached trials
Device related bacteraemia	43	261.3 189.2–360.9ROR 262.2 · χ² 9,316 / p <1e-300	203.5 EB05 157.4 · IC025 +5.5 3/3 methods agree	Reporting / coding artifact	serious n=43	not reported in cached trials
Overgrowth bacterial	34	223.3 155.9–319.9ROR 223.9 · χ² 6,382 / p <1e-300	176.1 EB05 131.8 · IC025 +5.1 3/3 methods agree	Not in label — unassessed	serious n=31	not reported in cached trials
Device related sepsis	249	218.8 191.8–249.5ROR 222.9 · χ² 47,091 / p <1e-300	189.0 EB05 170.1 · IC025 +6.9 3/3 methods agree	Reporting / coding artifact	serious n=249	not reported in cached trials
Gastrointestinal stoma complication	187	213.2 183.1–248.2ROR 216.2 · χ² 34,518 / p <1e-300	183.9 EB05 162.9 · IC025 +6.7 3/3 methods agree	Reporting / coding artifact	serious n=167	NCT00930644: 2/51 (3.9%) on Teduglutide (serious AE)
Anorectal polyp	11	207.1 110.4–388.5ROR 207.2 · χ² 1,811 / p <1e-300	139.2 EB05 82.9 · IC025 +3.3 3/3 methods agree	Not in label — unassessed	–	not reported in cached trials
Gastrointestinal microorganism overgrowth	34	193.0 135.1–275.5ROR 193.4 · χ² 5,602 / p <1e-300	156.7 EB05 117.3 · IC025 +5.1 3/3 methods agree	Not in label — unassessed	serious n=30	not reported in cached trials
Short-bowel syndrome	60	158.9 121.9–207.1ROR 159.6 · χ² 8,392 / p <1e-300	137.9 EB05 111.0 · IC025 +5.6 3/3 methods agree	Not in label — unassessed	serious n=59	not reported in cached trials
Faecal volume increased	48	157.7 117.2–212.1ROR 158.2 · χ² 6,638 / p <1e-300	135.5 EB05 106.3 · IC025 +5.4 3/3 methods agree	Lab value / disease marker	serious n=47	NCT00930644: 1/51 (2.0%) on Teduglutide (serious AE)
Faecal volume decreased	41	145.2 105.4–199.9ROR 145.6 · χ² 5,235 / p <1e-300	125.2 EB05 96.2 · IC025 +5.2 3/3 methods agree	Lab value / disease marker	serious n=39	NCT00930644: 1/51 (2.0%) on Teduglutide (serious AE)
Stoma site haemorrhage	118	131.6 109.1–158.7ROR 132.8 · χ² 13,975 / p <1e-300	119.1 EB05 102.1 · IC025 +6.0 3/3 methods agree	Labeled (related wording) related wording	serious n=115	not reported in cached trials
Stoma site discomfort	16	121.1 72.8–201.3ROR 121.2 · χ² 1,657 / p <1e-300	99.4 EB05 64.8 · IC025 +3.8 3/3 methods agree	Not in label — unassessed	serious n=12	not reported in cached trials
Dumping syndrome	18	117.2 72.6–189.3ROR 117.4 · χ² 1,822 / p <1e-300	98.0 EB05 65.6 · IC025 +4.0 3/3 methods agree	Not in label — unassessed	serious n=17	not reported in cached trials
Stomal hernia	23	105.7 69.3–161.2ROR 105.8 · χ² 2,135 / p <1e-300	91.6 EB05 64.3 · IC025 +4.3 3/3 methods agree	Not in label — unassessed	serious n=20	not reported in cached trials
Gastrostomy tube site complication	12	103.5 57.7–185.6ROR 103.6 · χ² 1,047 / p 5e-230	84.4 EB05 51.5 · IC025 +3.3 3/3 methods agree	Reporting / coding artifact	serious n=11	not reported in cached trials
Body height increased	30	101.8 70.4–147.2ROR 102.0 · χ² 2,715 / p <1e-300	90.2 EB05 66.2 · IC025 +4.6 3/3 methods agree	Not in label — unassessed	serious n=29 · ♀ 27% (drug 62%) · 100% consumer	not reported in cached trials
Enterocutaneous fistula	51	96.7 72.9–128.3ROR 97.1 · χ² 4,457 / p <1e-300	88.2 EB05 69.7 · IC025 +5.1 3/3 methods agree	Not in label — unassessed	serious n=51	not reported in cached trials
Stoma site pain	83	94.1 75.5–117.4ROR 94.7 · χ² 7,122 / p <1e-300	87.1 EB05 72.4 · IC025 +5.5 3/3 methods agree	Labeled (related wording) related wording	serious n=78	not reported in cached trials
Stoma site inflammation	42	93.7 68.6–127.9ROR 94.0 · χ² 3,544 / p <1e-300	85.1 EB05 65.6 · IC025 +4.9 3/3 methods agree	Labeled (related wording) related wording	serious n=38 · ♀ 82% (drug 62%)	not reported in cached trials
Catheter site thrombosis	14	85.8 50.1–146.9ROR 85.8 · χ² 1,032 / p 9e-227	73.5 EB05 46.5 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious n=14	not reported in cached trials
Obstruction	200	82.4 71.6–94.9ROR 83.7 · χ² 15,200 / p <1e-300	77.8 EB05 69.1 · IC025 +5.8 3/3 methods agree	Labeled adverse reaction exact term	serious n=177	NCT00930644: 1/51 (2.0%) on Teduglutide (serious AE)
Vascular device occlusion	16	78.2 47.3–129.1ROR 78.3 · χ² 1,088 / p 8e-239	68.6 EB05 44.8 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	serious n=16	not reported in cached trials
Gastrointestinal bacterial overgrowth	27	72.6 49.4–106.8ROR 72.8 · χ² 1,753 / p <1e-300	66.3 EB05 47.8 · IC025 +4.3 3/3 methods agree	Not in label — unassessed	serious n=23 · ♀ 30% (drug 62%)	not reported in cached trials
Device related thrombosis	40	66.5 48.5–91.3ROR 66.7 · χ² 2,413 / p <1e-300	62.0 EB05 47.5 · IC025 +4.6 3/3 methods agree	Reporting / coding artifact	serious n=40	not reported in cached trials
Gastrointestinal tract adenoma	14	61.6 36.1–105.0ROR 61.6 · χ² 745 / p 2e-164	55.1 EB05 34.9 · IC025 +3.4 3/3 methods agree	Labeled (related wording) related wording	serious n=8	not reported in cached trials
Colorectal adenoma	12	60.9 34.2–108.5ROR 61.0 · χ² 624 / p 5e-138	53.9 EB05 32.9 · IC025 +3.2 3/3 methods agree	Labeled (related wording) related wording	serious n=8	not reported in cached trials
Blood magnesium abnormal	20	58.8 37.6–91.9ROR 58.9 · χ² 1,040 / p 2e-228	53.9 EB05 36.9 · IC025 +3.8 3/3 methods agree	Lab value / disease marker	serious n=18	not reported in cached trials
Catheter site inflammation	19	55.8 35.3–88.1ROR 55.8 · χ² 934 / p 2e-205	51.2 EB05 34.7 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	serious n=19	not reported in cached trials

Trial evidence (ClinicalTrials.gov)

✓ Trial adverse-event data found on ClinicalTrials.gov

Largest completed trials with posted results that list Teduglutide as a study intervention. The right-hand column of the signal table shows whether each FAERS term was also recorded in these trials, with a real denominator (5 of 40 signal terms matched).

NCT00930644 — Open-Label Study of Teduglutide for Subjects With PN-Dependent Short Bowel Syndrome (SBS) (N=88, PHASE3; 95 AE terms posted; arms: NT,PBO/TED; TED/TED)
NCT00798967 — Study of Teduglutide Effectiveness in Parenteral Nutrition (PN)-Dependent Short Bowel Syndrome (SBS) Subjects (N=86, PHASE3; 42 AE terms posted; arms: Teduglutide; Placebo)

Caveats: trial populations, doses and follow-up differ from the reporting population; AE terms are sponsor-coded and matched here by wording; absence from a trial list means the term was not reported above the sponsor's frequency threshold, not that it cannot occur.

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
Weight decreased (weight loss)	1,266	7.1 6.8–7.5ROR 7.8 · χ² 6,725 / p <1e-300	7.1 EB05 6.8 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious PRR 6.7	NCT00798967: 3/42 (7.1%) on Teduglutide; 3/43 (7.0%) control
Vascular device infection	1,176	553.3 518.8–590.1ROR 606.5 · χ² 476,963 / p <1e-300	404.9 EB05 385.8 · IC025 +8.3 3/3 methods agree	Labeled (related wording) related wording	serious n=1,176	not reported in cached trials
Nausea	1,104	2.2 2.1–2.3ROR 2.3 · χ² 741 / p 1e-163	2.2 EB05 2.1 · IC025 +1.0 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 2.4	NCT00798967: 12/42 (28.6%) on Teduglutide; 8/43 (18.6%) control
Product dose omission issue	1,070	5.9 5.6–6.3ROR 6.3 · χ² 4,394 / p <1e-300	5.9 EB05 5.6 · IC025 +2.5 3/3 methods agree	Reporting / coding artifact	serious PRR 14.3	not reported in cached trials
Abdominal pain	1,066	7.2 6.8–7.6ROR 7.7 · χ² 5,729 / p <1e-300	7.2 EB05 6.8 · IC025 +2.7 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 5.5	NCT00930644: 1/37 (2.7%) on Teduglutide (serious AE)
Diarrhoea (diarrhea)	1,060	2.6 2.4–2.7ROR 2.7 · χ² 1,057 / p 4e-232	2.6 EB05 2.5 · IC025 +1.3 3/3 methods agree	Not in label — unassessed	serious PRR 2.7	NCT00798967: 3/42 (7.1%) on Teduglutide; 5/43 (11.6%) control
Weight increased (weight gain)	881	6.2 5.8–6.6ROR 6.6 · χ² 3,872 / p <1e-300	6.2 EB05 5.8 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious PRR 6.6	NCT00798967: 3/42 (7.1%) on Teduglutide; 3/43 (7.0%) control
Dehydration	876	10.3 9.7–11.0ROR 11.0 · χ² 7,380 / p <1e-300	10.3 EB05 9.7 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious PRR 7.8	NCT00798967: 1/42 (2.4%) on Teduglutide (serious AE)
Vomiting	850	2.8 2.7–3.0ROR 3.0 · χ² 1,034 / p 4e-227	2.8 EB05 2.7 · IC025 +1.4 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 2.5	NCT00798967: 5/42 (11.9%) on Teduglutide; 4/43 (9.3%) control
Death	779	1.4 1.3–1.5ROR 1.4 · χ² 99 / p 1e-23	1.4 EB05 1.3 · IC025 +0.4	Outcome field, not a reaction	serious PRR 1.0	not reported in cached trials
Abdominal distension (bloating)	724	11.0 10.2–11.8ROR 11.5 · χ² 6,537 / p <1e-300	10.9 EB05 10.2 · IC025 +3.3 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 11.1	NCT00798967: 9/42 (21.4%) on Teduglutide; 1/43 (2.3%) control
Pyrexia (fever)	630	2.9 2.6–3.1ROR 2.9 · χ² 767 / p 4e-169	2.8 EB05 2.7 · IC025 +1.4 3/3 methods agree	Not in label — unassessed	serious PRR 2.3	NCT00930644: 4/51 (7.8%) on Teduglutide (serious AE)
Hospitalisation	591	6.1 5.6–6.6ROR 6.3 · χ² 2,518 / p <1e-300	6.0 EB05 5.6 · IC025 +2.5 3/3 methods agree	Reporting / coding artifact	serious PRR 4.3	not reported in cached trials
Inappropriate schedule of product administration	544	4.8 4.4–5.2ROR 5.0 · χ² 1,656 / p <1e-300	4.8 EB05 4.5 · IC025 +2.1 3/3 methods agree	Reporting / coding artifact	serious PRR 7.2	not reported in cached trials
Decreased appetite (loss of appetite)	530	3.6 3.3–3.9ROR 3.7 · χ² 995 / p 9e-219	3.6 EB05 3.3 · IC025 +1.7 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 3.5	not reported in cached trials

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.

Stoma prolapse — n=53, PRR 974.0
Overgrowth bacterial — n=34, PRR 223.3
Gastrointestinal microorganism overgrowth — n=34, PRR 193.0
Short-bowel syndrome — n=60, PRR 158.9
Stomal hernia — n=23, PRR 105.7
Body height increased — n=30, PRR 101.8
Enterocutaneous fistula — n=51, PRR 96.7
Gastrointestinal bacterial overgrowth — n=27, PRR 72.6

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 Teduglutide?

In FDA FAERS, the most frequently co-reported reaction terms for Teduglutide are weight decreased, vascular device infection, nausea, abdominal pain, diarrhoea, weight increased. 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 Teduglutide have an FDA boxed warning?

No. The FDA label retrieved for Teduglutide has no boxed warning; see the label's Warnings and Precautions for the recognised risks.

Do FAERS signals prove that Teduglutide 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 66b69c1e-b25c-44d3-b5ff-1c1de9a516fa, effective 20250905; matched on openfda.generic_name.exact:"TEDUGLUTIDE")
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, field patient.drug.openfda.generic_name.exact, 1,030 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
ClinicalTrials.gov API v2 (query TEDUGLUTIDE, results-bearing studies sorted by enrollment)

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.