Gattex Side Effects

Generic Name: teduglutide

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

Not all side effects for Gattex may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to teduglutide: subcutaneous powder for solution

In addition to its needed effects, some unwanted effects may be caused by teduglutide (the active ingredient contained in Gattex). In the event that any of these side effects do occur, they may require medical attention.

You should check with your doctor immediately if any of these side effects occur when taking teduglutide:

More common
  • Abdominal or stomach pain
  • decrease in the amount of urine
  • excess air or gas in the stomach or intestines
  • fast heartbeat
  • fever
  • full or bloated feeling
  • hives
  • hoarseness
  • irritation
  • itching
  • joint pain, stiffness, or swelling
  • noisy, rattling breathing
  • pressure in the stomach
  • rash
  • redness of the skin
  • swelling of the abdominal or stomach area
  • swelling of the eyelids, face, lips, hands, or feet
  • swelling of the fingers, hands, feet, or lower legs
  • tightness in the chest
  • troubled breathing at rest
  • troubled breathing or swallowing
  • weight gain
Less common
  • Indigestion
  • severe nausea or vomiting

Some of the side effects that can occur with teduglutide may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

More common
  • Body aches or pain
  • changes in appetite
  • chills
  • cough
  • ear congestion
  • headache
  • loss of voice
  • nasal congestion
  • nausea
  • runny nose
  • sneezing
  • sore throat
  • trouble sleeping
  • unusual tiredness or weakness
  • vomiting

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%)

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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