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Dulaglutide Side Effects

In Summary

Commonly reported side effects of dulaglutide include: diarrhea, frequent bowel movements, nausea, and retching. Other side effects include: abdominal distress, abdominal pain, abdominal tenderness, asthenia, dyspepsia, fatigue, gastrointestinal pain, lower abdominal pain, upper abdominal pain, decreased appetite, and malaise. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to dulaglutide: subcutaneous solution

Along with its needed effects, dulaglutide 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 dulaglutide:

Incidence Not Known

  • Agitation
  • change in urination
  • chills
  • cold sweats
  • confusion
  • cool, pale skin
  • depression
  • difficulty with breathing or swallowing
  • dizziness
  • fast heartbeat
  • fever
  • hives
  • hoarseness
  • hostility
  • increased hunger
  • irritability
  • lethargy
  • loss of appetite
  • lump in the neck
  • muscle twitching
  • pains in the stomach, side, or abdomen, possibly radiating to the back
  • rapid weight gain
  • reddening of the skin, especially around the ears
  • seizures
  • shakiness
  • slurred speech
  • swelling of the eyes or inside of the nose
  • swelling of the face, ankles, or hands
  • trouble breathing
  • unusual tiredness or weakness
  • vomiting
  • yellow eyes or skin

Some side effects of dulaglutide 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

Less Common

  • Acid or sour stomach
  • belching
  • decreased appetite
  • general feeling of discomfort or illness
  • heartburn or indigestion
  • lack or loss of strength
  • stomach discomfort, upset, or pain

Rare

  • Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site

For Healthcare Professionals

Applies to dulaglutide: subcutaneous solution

General

The most common adverse reactions included nausea, diarrhea, vomiting, abdominal pain, and decreased appetite.[Ref]

Gastrointestinal

Very common (10% or more): Nausea (up to 21.1%), diarrhea (up to 13.7%), vomiting (up to 11.5%)

Common (1% to 10%): Abdominal pain, dyspepsia, constipation, flatulence, abdominal distention, gastroesophageal reflux disease, eructation, lipase and/or pancreatic amylase increases from baseline (up to 20%)

Frequency not reported: Pancreatitis[Ref]

During clinical trials, a greater number of pancreatitis related adverse reactions were reported in patients exposed to this drug versus non-incretin comparators (12 cases vs 3 cases). Analyses of adjudicated events revealed 5 cases of confirmed pancreatitis in dulaglutide-exposed patients compared with 1 case in the non-incretin comparator group.

Gastrointestinal events occurred more frequently with the higher dose. Cases were graded as mild, moderate, or severe in 58% and 48%, 35% and 43%, and 7% and 11%, of patients receiving the 0.75 mg dose and the 1.5 mg dose, respectively. The severity of events was graded by clinical trial investigators.[Ref]

Oncologic

One case of Medullary Thyroid Carcinoma (MTC) has been reported in a patient treated with this drug. Prior to receiving treatment, this patient had calcitonin levels approximately 8 times the upper limit of normal.[Ref]

Very rare (less than 0.01%): Medullary Thyroid Carcinoma[Ref]

Metabolic

Very common (10% or more): Hypoglycemia (up to 85% when combined with prandial insulin)

Common (1% to 10%): Decreased appetite[Ref]

Hypoglycemia occurred more frequently when this drug was used in combination with a sulfonylurea or insulin. In combination with prandial insulin, hypoglycemia occurred in 85% and 80% of patients receiving 0.75 mg and 1.5 mg; severe hypoglycemia in 2.4% and 3.4% of patients, respectively. In combination with a sulfonylurea, symptomatic hypoglycemia occurred in 39% and 40%. As add-on therapy to metformin or metformin plus pioglitazone, symptomatic hypoglycemia occurred in up to 5.6% of patients, with no reports of severe hypoglycemia.[Ref]

Cardiovascular

During clinical trials, a mean increase in heart rate of 2 to 4 beats per minute was observed. Sinus tachycardia was reported in 2.8% and 5.6% of patients receiving 0.75 mg and 1.5 mg of dulaglutide compared with 3% in placebo. Persistent sinus tachycardia defined as occurring at more than 2 visits was reported in 0.4%, 1.6%, and 0.2% of patients receiving dulaglutide 0.75 mg, 1.5 mg, or placebo. Episodes of sinus tachycardia associated with an increase of 15 or more beats per minute from baseline occurred in 1.3%, 2.2%, and 0.7% of patients, respectively.[Ref]

Common (1% to 10%): First degree AV block, sinus tachycardia, PR prolongation on ECG

Frequency not reported: Increased heart rate[Ref]

Hypersensitivity

Uncommon (0.1% to 1%): Systemic hypersensitivity including severe urticaria, systemic rash, facial edema, lip swelling[Ref]

Immunologic

In clinical studies 1.6% (n=64) of patients developed anti-drug antibodies (ADAs). Half of the patients had dulaglutide-neutralizing antibodies and half developed antibodies against native GLP-1.[Ref]

Common (1% to 10%): Anti-drug antibodies[Ref]

Local

Common (1% to 10%): Injection site reactions[Ref]

Other

Common (1% to 10%): Fatigue[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. Trulicity (dulaglutide)." Eli Lilly and Company, Indianapolis, IN.

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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