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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

Oncologic

Uncommon (0.1% to 1%): Colorectal polyps
Rare (less than 0.1%): Malignancy[Ref]

Cardiovascular

Very common (10% or more): Fluid overload (up to 11.7%)
Common (1% to 10%): Flushing
Uncommon (0.1% to 1%): Syncope
Rare (less than 0.1%): Congestive heart failure
Postmarketing reports: Cardiac arrest, cardiac failure[Ref]

Gastrointestinal

Very common (10% or more): Gastrointestinal stoma complication (up to 41.9%), abdominal pain (up to 37.7%), nausea (up to 27%), abdominal distension (up to 19.5%), vomiting (up to 14%)
Common (1% to 10%): Pancreatic disease, intestinal obstruction/stenosis, flatulence[Ref]

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

Hepatic

Common (1% to 10%): Gallbladder and biliary tract disease (cholecystitis, cholangitis, cholelithiasis, cholestasis), increased c-reactive protein[Ref]

Dermatologic

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

Hypersensitivity

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

Immunologic

Very common (10% or more): Antibody formation (up to 48%)
Common (1% to 10%): Influenza

Nervous system

Very common (10% or more): Headache (up to 17%)
Common (1% to 10%): Paresthesia
Postmarketing reports: Cerebral hemorrhage[Ref]

Psychiatric

Common (1% to 10%): Anxiety, sleep disturbance/disorder
Very rare (less than 0.01%): Mental status deterioration[Ref]

Respiratory

Very common (10% or more): Respiratory tract infection (up to 28%)
Common (1% to 10%): Dyspnea, cough[Ref]

Metabolic

Common (1% to 10%): Appetite disorder

Musculoskeletal

Common (1% to 10%): Arthralgia

Other

Very common (10% or more): Injection site reaction (up to 21.8%), peripheral edema (up to 10%)
Common (1% to 10%): Chest pain, night sweats

Renal

Common (1% to 10%): Renal colic, costovertebral angle tenderness

References

1. "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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