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Teduglutide Side Effects

For the Consumer

Applies to teduglutide: subcutaneous powder for solution

Along with its needed effects, teduglutide may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while 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

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

More Common

For Healthcare Professionals

Applies to teduglutide: subcutaneous kit

General

The most commonly reported side effects included anti-teduglutide antibody formation, gastrointestinal stoma complication, abdominal pain, and injection site reactions.[Ref]

Immunologic

Very common (10% or more): Anti-teduglutide antibody formation (up to 48%)

Common (1% to 10%): Influenza, influenza-like illness[Ref]

Gastrointestinal

GI stoma complication (swelling of the stoma and associated complications) is considered a sign of efficacy rather than an adverse event.[Ref]

Very common (10% or more): Abdominal pain and distention (up to 45%), gastrointestinal stoma complication (up to 41.9%), abdominal pain (up to 37.7%), nausea (up to 26%), abdominal distention (up to 19.5%), vomiting (up to 14%)

Common (1% to 10%): Colonic polyp, colonic stenosis, diarrhea, flatulence, intestinal obstruction, intestinal stenosis, pancreatic duct stenosis, pancreatitis, small intestinal stenosis, upper abdominal pain

Uncommon (0.1% to 1%):

Frequency not reported: Acute pancreatitis, chronic pancreatitis, painful defecation, pancreatic pseudocyst[Ref]

Local

Very common (10% or more): Injection site reactions (up to 26%), injection site hematoma (up to 11%)

Common (1% to 10%): injection site erythema

Frequency not reported: Injection site hemorrhage, injection site pain, injection site swelling[Ref]

Respiratory

Very common (10% or more): Respiratory tract infections (up to 28%), upper respiratory tract infection (up to 26%), nasopharyngitis (up to 13%)

Common (1% to 10%): Cough, dyspnea

Frequency not reported: Lower respiratory tract infection[Ref]

Nervous system

Very common (10% or more): Headache (up to 16%)

Uncommon (0.1% to 1%): Syncope

Frequency not reported: Coma, mental status deterioration

Postmarketing reports: Cerebral hemorrhage, dizziness[Ref]

Genitourinary

Very common (10% or more): Urinary tract infection (up to 13%)

Common (1% to 10%): Catheter related infection, catheter sepsis[Ref]

Metabolic

Very common (10% or more): Fluid overload (up to 11.7%)

Common (1% to 10%): Appetite disorders, decreased appetite[Ref]

Psychiatric

Common (1% to 10%): Anxiety, insomnia, sleep disturbances[Ref]

Hepatic

Common (1% to 10%): Cholecystitis, cholecystitis acute

Frequency not reported: Cholelithiasis, cholestasis, gallbladder perforation[Ref]

Cardiovascular

Common (1% to 10%): Cardiac/congestive failure congestive, peripheral edema

Frequency not reported: Cardiac dysfunction

Postmarketing reports: Cardiac arrest, cardiac failure[Ref]

Other

Common (1% to 10%): Fatigue, pyrexia

Frequency not reported: C-reactive protein[Ref]

Oncologic

Common (1% to 10%): Colorectal polyps

Uncommon (0.1% to 1%): Duodenal polyp, hyperplastic sigmoidal polyps, inflammatory stomal polyps

Frequency not reported: Gastric polyp, malignancy, metastatic adenocarcinoma, non-small cell lung cancer, squamous cell lung cancer[Ref]

Dermatologic

Common (1% to 10%): Skin hemorrhage[Ref]

Musculoskeletal

Common (1% to 10%): Arthralgia[Ref]

Hypersensitivity

Common (1% to 10%): Hypersensitivity[Ref]

Endocrine

Frequency not reported: Undiagnosed hypothyroidism[Ref]

References

1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

2. Cerner Multum, Inc. "Australian Product Information." O 0

3. "Product Information. Gattex (teduglutide)." NPS Pharmaceuticals, Bedminster, NJ.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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