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Albiglutide Side Effects

In Summary

Commonly reported side effects of albiglutide include: injection site reaction, diarrhea, and nausea. Other side effects include: vomiting. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to albiglutide: subcutaneous powder for solution

Along with its needed effects, albiglutide 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 albiglutide:

Rare

Incidence Not Known

  • Anxiety, irritability, or mood changes
  • blurred vision
  • cold sweats
  • confusion
  • difficulty with breathing or swallowing
  • dizziness
  • headache
  • increased hunger
  • shakiness
  • skin itching, rash, or redness
  • slurred speech
  • swelling of the face, throat, or tongue
  • unusual tiredness or weakness

Some side effects of albiglutide 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
  • cough
  • diarrhea
  • ear congestion
  • loss of voice
  • muscle pain or stiffness
  • pain in the joints
  • pain or tenderness around the eyes and cheekbones
  • skin reactions, warmth, or redness at the injection site
  • sneezing
  • stuffy or runny nose

For Healthcare Professionals

Applies to albiglutide: subcutaneous powder for injection

General

The most commonly reported adverse reactions have included diarrhea, nausea, and injection site reactions which have included rash, erythema, or itching at the injection site.

Gastrointestinal

The incidence of pancreatitis (adjudicated as likely to be related to therapy) in clinical trials was 0.3% compared with 0% for placebo and 0.1% for comparators (e.g., liraglutide, pioglitazone, glimepiride, sitagliptin, and insulin glargine) with or without background antidiabetic therapy (e.g. metformin)

Gastrointestinal events occurred more frequently with this drug than comparators (38% versus 32%). Diarrhea (13% vs 9%), nausea (12% vs 11%), vomiting (5% vs 4%), and constipation (5% vs 4%) were the most commonly reported, and the majority of events occurred within the first 6 months.[Ref]

Very common (10% or more): Diarrhea (13.1%), nausea (11.1%),

Common (1% to 10%): Vomiting, gastroesophageal reflux disease, dyspepsia, constipation

Uncommon (0.1% to 1%): Appendicitis, acute pancreatitis, intestinal obstruction[Ref]

Hypersensitivity

Frequency not reported: Pruritus, rash, dyspnea

Postmarketing reports: Angioedema[Ref]

Oncologic

Medullary thyroid cancer (MTC) was diagnosed in 1 patient receiving this drug and 1 patient receiving placebo across 8 phase 3 clinical trials; both of these patients had markedly elevated serum calcitonin levels at baseline. MTC has been reported in patients treated with liraglutide, another GLP-1 receptor agonist. The data is insufficient to establish or exclude a causal relationship between MTC and GLP-1 receptor use in humans.[Ref]

Very rare (less than 0.01%): Medullary thyroid cancer[Ref]

Local

Very common (10% or more): Injection site reaction (up to 15%)

Common (1% to 10%): Injection site hematoma, erythema, rash, and/or pruritus

Uncommon (0.1% to 1%): Injection site hypersensitivity and/or hemorrhage[Ref]

Metabolic

Very common (10% or more): Hypoglycemia (when used in combination with insulin or sulfonylurea)

Common (1% to 10%): Hypoglycemia (when used as monotherapy in combination with metformin or pioglitazone)

Frequency not reported: Decreased appetite[Ref]

Renal

Acute renal failure has been reported and may have been the result of dehydration. Postmarketing reports of acute renal failure and worsening chronic renal failure, sometimes requiring hemodialysis, have been reported. Some of these reports have been in patients without known kidney disease. A majority of patients had experienced nausea, vomiting, diarrhea, or dehydration.[Ref]

Frequency not reported: Acute renal failure

Postmarketing reports: Acute renal failure, worsening of chronic renal failure, sometimes requiring hemodialysis[Ref]

Musculoskeletal

Very common (10% or more): Back pain (6.7%), arthralgia (6.6%)[Ref]

Other

Very common (10% or more): Influenza (5.2%)[Ref]

Respiratory

Very common (10% or more): Upper respiratory tract infection (14.2%), cough (6.9%), sinusitis (6.2%)

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

Cardiovascular

Common (1% to 10%): Atrial fibrillation

Uncommon (0.1% to 1%): Atrial flutter

Frequency not reported: Increased heart rate[Ref]

Hepatic

Common (1% to 10%): Increased ALT, gamma glutamyltransferase[Ref]

Immunologic

In a pooled trials, 116 (5.5%) of 2,098 patients exposed to this drug tested positive for anti-albiglutide antibodies at any time during the trials. None of these antibodies were shown to neutralize the activity of albiglutide in an in vitro bioassay.[Ref]

Very common (10% or more): Positive test for anti-albiglutide antibodies[Ref]

References

1. "Product Information. Tanzeum (albiglutide)." GlaxoSmithKline, Research Triangle Park, NC.

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

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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