Gattex Side Effects

Generic name: teduglutide

Note: This document contains side effect information about teduglutide. Some of the dosage forms listed on this page may not apply to the brand name Gattex.

Some side effects of Gattex may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to teduglutide: subcutaneous kit

Get emergency medical help if you have any of these signs of an allergic reaction while taking teduglutide (the active ingredient contained in Gattex) hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using teduglutide and call your doctor at once if you have severe constipation or stomach cramps.

Common side effects may include:

• nausea, vomiting, stomach pain, bloating, gas;

• headache;

• cold symptoms such as stuffy nose, sneezing, sore throat; or

• pain, swelling, redness, or other irritation where the medicine was injected.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to teduglutide: subcutaneous kit

General

The most commonly reported adverse reactions were abdominal pain, injection site reactions (22.4%); nausea (18.2%); headaches (15.9%); abdominal distension (13.8%); upper respiratory tract infection (11.8%).

Cardiovascular

Very common (10% or more): Fluid overload (11.7%)
Frequency not reported: Congestive heart failure

Dermatologic

Common (1% to 10%): Skin hemorrhage (5.2%)

Gastrointestinal

Very common (10% or more): Gastrointestinal stoma complication (in patients with stomas, 41.9%), abdominal pain (37.7%), nausea (24.7%), abdominal distention (19.5%), vomiting (11.7%)
Common (1% to 10%): Flatulence (9.1%), appetite disorders (6.5%), intestinal obstruction/stenosis (3.9%)
Uncommon (0.1% to 1%): Intestinal polyps (0.9%)
Frequency not reported: Acute and chronic pancreatitis, pancreatic pseudocyst

Hepatic

Frequency not reported: Cholecystitis, cholelithiasis, cholestasis (secondary to an obstructed biliary stent)

Hypersensitivity

Common (1% to 10%): Hypersensitivity (7.8%)

Local

Very common (10% or more): Injection site reactions (12%)

Immunologic

Very Common (10% or more): Development of anti-teduglutide (the active ingredient contained in Gattex) antibody (at 24 weeks, 18%)

Nervous system

Very common (10% or more): Headache (15.9%)
Frequency not reported: Coma (with concomitant benzodiazepine use)

Oncologic

Frequency not reported: Lung cancer, metastatic adenocarcinoma

Psychiatric

Common (1% to 10%): Sleep disturbances (5.2%)
Frequency not reported: Deterioration in mental status (with concomitant benzodiazepine use)

Respiratory

Very common (10% or more): Upper respiratory infection (26.0%),
Common (1% to 10%): Cough (5.2%)

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