SIDE EFFECTS OF GATTEX® (teduglutide)?

For people 1 year of age and older with SHORT BOWEL SYNDROME (SBS) who are dependent on parenteral support (PS).

Possible GATTEX Side Effects

GATTEX may cause side effects in adults, adolescents, and children. If you have any questions about side effects, whether before or during treatment, talk to your or your child’s care team.

Common side effects associated with GATTEX

GATTEX may cause serious side effects, including making abnormal cells grow faster, polyps in the colon (large intestine), blockage of the bowel (intestines), swelling (inflammation) or blockage of the gallbladder or pancreas, and fluid overload (too much fluid in your body).

In clinical studies of adults, the most common (≥10%) side effects of GATTEX were:

Common Side Effects* in Adult Patients with SBS in 2 clinical studies

Side Effect GATTEX
(77 people)
(59 people)
Stomach area pain1 30% 22%
Nausea 23% 20%
Upper respiratory tract infection2 21% 12%
Stomach area swelling 20% 2%
Skin reaction where injection was given3 13% 12%
Vomiting 12% 10%
Swelling of the hands or feet4 12% 7%
Allergic reactions5 10% 7%
Passing of gas 9% 7%
Decreased appetite 7% 3%
Influenza6 7% 2%
Bruising7 5% 2%
Cough 5% 0%
Trouble sleeping8 5% 0%

If you experience any side effects, check in with your doctor. Continue taking GATTEX as long as your doctor recommends and work together to understand treatment expectations.

*Reported at a rate of at least 5% in the GATTEX group, and greater than the placebo group.
1Includes: Abdominal pain, upper abdominal pain, lower abdominal pain
2Includes: Upper respiratory tract infection, nasopharyngitis, pharyngitis, sinusitis, laryngitis, rhinitis, viral upper respiratory tract infection
3Includes: Injection site hematoma, injection site erythema, injection site pain, injection site swelling, injection site hemorrhage, injection site discoloration, injection site reaction, injection site rash
4Includes: Fluid overload, peripheral edema, edema, generalized edema, fluid retention and jugular vein distension
5Includes: Erythema, rash, dermatitis allergic, pruritus, rash macular, drug eruption, eyelid edema, flushing
6Includes: Influenza, influenza-like illness
7Includes: Hematoma, abdominal wall hematoma, post procedural hematoma, umbilical hematoma, blood blister
8Includes: Insomnia (3 patients) and hypersomnia (1 patient)

Common side effects in children and adolescents

The safety of GATTEX has been studied in 41 children with short bowel syndrome (SBS) across 2 clinical studies.* The side effects seen in children and adolescents (aged 1 to 17 years) were similar to those seen in adults.

*This includes pediatric patients from a 3-month study that was conducted with GATTEX.

Here’s what to do if side effects occur

Tell your or your child’s doctor right away if you or your child experience any side effects that do not go away. For more information about GATTEX, check out our FAQs.