Gattex Side Effects

Generic name: teduglutide

Medically reviewed by Drugs.com. Last updated on Jan 24, 2024.

Note: This document provides detailed information about Gattex.

Applies to teduglutide: subcutaneous powder for solution Side Effects associated with teduglutide. Some dosage forms listed on this page may not apply specifically to the brand name Gattex.

Applies to teduglutide: subcutaneous powder for solution.

Precautions

It is very important that your doctor check your or your child's progress regularly while using this medicine to make sure that this medicine is working properly. Blood and urinary tests, colonoscopy, and gallbladder, biliary tract, and pancreas imaging may be needed to check your progress and for any problems caused by this medicine.

If you have abdominal or stomach pain, severe constipation, nausea, or vomiting, or a severe rash after using this medicine, call your doctor right away.

This medicine may increase your risk for tumors and tumor growth. This is more likely if you have an active cancer in your gut, liver, or pancreas. Talk to your doctor if you have concerns.

If you are rapidly gaining weight, having chest pain or discomfort, extreme tiredness or weakness, irregular breathing, uneven heartbeat, or excessive swelling of the hands, wrist, ankles, or feet, check with your doctor immediately. These may be symptoms of heart problems or your body keeping too much water.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Serious side effects of Gattex

Along with its needed effects, teduglutide (the active ingredient contained in Gattex) 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:

Other side effects of Gattex

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:

For healthcare professionals

Applies to teduglutide: subcutaneous kit.

General adverse events

The most commonly reported side effects included antibody formation, abdominal distention, abdominal pain, and gastrointestinal stoma complications (in patients with a stoma).^[Ref]

Gastrointestinal

• Very common (10% or more): Abdominal distention (up to 45%), abdominal pain (up to 45%), gastrointestinal (GI) stoma complications (up to 42%), nausea (up to 26%), vomiting (up to 14%)
• Common (1% to 10%): Colonic polyp, colonic stenosis, colorectal polyp, diarrhea, flatulence, intestinal obstruction, pancreatic duct stenosis, pancreatitis, small intestinal stenosis, upper abdominal pain
• Uncommon (0.1% to 1%): Duodenal polyp
• Frequency not reported: Abdominal wall hematoma, acute pancreatitis, chronic pancreatitis, gastric polyp, pancreatic disease, pancreatic pseudocyst^[Ref]

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

Respiratory

• Very common (10% or more): Respiratory tract infections (up to 28%), upper respiratory tract reaction (up to 21%), nasopharyngitis (up to 13%)
• Common (1% to 10%): Cough, dyspnea
• Frequency not reported: Laryngitis, lower respiratory tract infection, pharyngitis, rhinitis, sinusitis, viral upper respiratory infection^[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 discoloration, injection site hemorrhage, injection site pain, injection site rash, injection site swelling^[Ref]

Immunologic

• Very common (10% or more): Antibody formation (up to 54%)
• Common (1% to 10%): Catheter related infection, catheter sepsis, influenza, influenza-like illness^[Ref]

Nervous system

• Very common (10% or more): Headache (up to 16%)
• Uncommon (0.1% to 1%): Syncope^[Ref]

Genitourinary

• Very common (10% or more): Urinary tract infection (up to 13%)^[Ref]

Metabolic

• Very common (10% or more): Fluid overload (up to 12%)
• Common (1% to 10%): Decreased appetite
• Frequency not reported: Fluid imbalance, fluid retention^[Ref]

Psychiatric

• Common (1% to 10%): Anxiety, insomnia, sleep disturbance^[Ref]

Cardiovascular

• Common (1% to 10%): Congestive heart failure, peripheral edema
• Frequency not reported: Edema, flushing, generalized edema, hematoma, jugular vein distention, post-procedural hematoma^[Ref]

Hepatic

• Common (1% to 10%): Acute cholecystitis, cholecystitis
• Frequency not reported: Biliary disease, cholelithiasis^[Ref]

Other

• Common (1% to 10%): Fatigue, pyrexia^[Ref]

Dermatologic

• Common (1% to 10%): Skin hemorrhage
• Frequency not reported: Allergic dermatitis, blood blister, drug eruption, erythema, pruritus, macular rash, rash, umbilical hematoma^[Ref]

Musculoskeletal

• Common (1% to 10%): Arthralgia
• Frequency not reported: Hypersomnia^[Ref]

Hypersensitivity

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

Oncologic

• Frequency not reported: Acceleration of neoplastic growth, metastatic adenocarcinoma, lung cancers (squamous and non-small cell)^[Ref]

Ocular

• Frequency not reported: Eyelid edema^[Ref]

Hematologic

• Frequency not reported: Increased c-reactive protein^[Ref]

See also:

Further information

Gattex side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer