What the label lists and what reports show
Teduglutide side effects
Teduglutide's FDA label: “Most common adverse reactions (≥10%) are: abdominal pain, nausea, upper respiratory tract infection, abdominal distension, injection site reaction, vomiting, fluid overload, and hypersensitivity.” FAERS holds 13,396 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is weight decreased (1,266 reports).
- No generic listed
Check it at the source: the teduglutide FDA label on DailyMed (effective September 5, 2025, Takeda Pharmaceuticals America, Inc.); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of GATTEX?GATTEX may cause serious side effects, including: See " What is the most important information I should know about GATTEX? " Fluid overload. Your healthcare provider will check you for too much fluid in your body. Too much fluid in your body may lead to heart failure, especially if you have heart problems. Tell your healthcare provider right away if you get swelling in your feet and ankles, you gain weight very quickly (water weight), or you have trouble breathing. The most common side effects of GATTEX in adults include: stomach area (abdomen) pain or swelling nausea cold or flu symptoms skin reaction where the injection was given (such as redness, pain, swelling, itching, or hives) vomiting swelling of the hands or feet allergic reactions The side effects of GATTEX in pediatric patients are similar to those seen in adults. […]
Source: FDA drug label, Takeda Pharmaceuticals America, Inc., effective September 5, 2025 (SPL set 66b69c1e-b25c-44d3-b5ff-1c1de9a516fa), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions (≥10%) are: abdominal pain, nausea, upper respiratory tract infection, abdominal distension, injection site reaction, vomiting, fluid overload, and hypersensitivity.
Table 1: Common Adverse Reactions Reported at a rate of at least 5% in the GATTEX group, and greater than the placebo group. in Adult Patients with SBS in Placebo-Controlled Studies: Studies 1 and 3
| Adverse Reaction | Placebo (N=59) (%) | GATTEX 0.05 mg/kg Once Daily (N=77) (%) |
|---|---|---|
| Abdominal pain Includes: Abdominal pain, upper abdominal pain, lower abdominal pain | 22 | 30 |
| Nausea | 20 | 23 |
| Upper respiratory tract infection Includes: Upper respiratory tract infection,… | 12 | 21 |
| Abdominal distension | 2 | 20 |
| Injection site reaction Includes: Injection site hematoma, injection site erythema,… | 12 | 13 |
| Vomiting | 10 | 12 |
| Fluid Overload Includes: Fluid overload, peripheral edema, edema, generalized edema,… | 7 | 12 |
| Hypersensitivity Includes: Erythema, rash, dermatitis allergic, pruritus, rash macular,… | 7 | 10 |
| Flatulence | 7 | 9 |
| Decreased appetite | 3 | 7 |
| Influenza Includes: Influenza, influenza-like illness | 2 | 7 |
| Skin hemorrhage Includes: Hematoma, abdominal wall hematoma, post procedural hematoma,… | 2 | 5 |
| Cough | 0 | 5 |
| Sleep disturbances Includes: Insomnia (3 patients) and hypersomnia (1 patient) | 0 | 5 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following serious adverse reactions are described elsewhere in the labeling: Acceleration of Neoplastic Growth [see Warnings and Precautions ( 5.1 )] Intestinal Obstruction [see Warnings and Precautions ( 5.2 )] Biliary and Pancreatic Disease [see Warnings and Precautions ( 5.3 )] Fluid Imbalance and Fluid Overload [see Warnings and Precautions ( 5.4 )] Most common adverse reactions (≥10%) are: abdominal pain, nausea, upper respiratory tract infection, abdominal distension, injection site reaction, vomiting, fluid overload, and hypersensitivity. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Takeda Pharmaceuticals U.S.A., Inc. at 1-877-TAKEDA-7 (1-877-825-3327) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Adults Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed cannot be directly compared to rates in other clinical trials and may not reflect the rates observed in clinical practice. The rates of adverse reactions in 136 adult patients with SBS participating in two randomized, placebo-controlled, 24-week, double-blind clinical studies (Study 1 and Study 3) are summarized in Table 1 . Only those reactions with a rate of at least 5% in the GATTEX group, and greater than placebo group, are summarized in Table 1 .
Source: FDA drug label, Takeda Pharmaceuticals America, Inc., effective September 5, 2025 (SPL set 66b69c1e-b25c-44d3-b5ff-1c1de9a516fa), via openFDA; the full label on DailyMed
What do FAERS reports show?
13,396 reports list teduglutide among the medicines taken, each a report of something that happened, not proof the medicine caused it; 1,151 are coded as a death and 8,022 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. Of the 19 reactions below, 7 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Teduglutide: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions