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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
  • Indigestion
  • severe nausea or vomiting

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
  • 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 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.

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

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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