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. Continue reading for a comprehensive list of adverse effects.
Applies to dulaglutide: subcutaneous solution.
Warning
Subcutaneous route (Solution)
In male and female rats, dulaglutide caused a dose-related and treatment-duration-dependent increase in the incidence of thyroid C-cell tumors (adenomas and carcinomas) after lifetime exposure. It is unknown whether dulaglutide causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as human relevance of dulaglutide-induced rodent thyroid C-cell tumors has not been determined. Dulaglutide is contraindicated in patients with a personal or family history of MTC and in patients with multiple endocrine neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the potential risk of MTC with use of dulaglutide and inform them of symptoms of thyroid tumors (eg, mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with dulaglutide.
Serious side effects of Dulaglutide
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:
Less common
- Gaseous stomach pain
- indigestion
- severe nausea or vomiting
- stomach pain or fullness
- yellow eyes or skin
Incidence not known
- Agitation
- change in urination
- chest tightness
- chills
- clay-colored stools
- cold sweats
- confusion
- cool, pale skin
- cough
- decreased urine output
- depression
- diarrhea
- difficulty with breathing or swallowing
- dizziness
- dry mouth
- fainting
- fast heartbeat
- fever
- headache
- hives, itching, skin rash
- hoarseness
- hostility
- increased hunger
- irritability
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, sex organs
- lethargy
- lightheadedness
- 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
- severe constipation
- shakiness
- slurred speech
- sunken eyes
- swelling of the eyes or inside of the nose
- swelling of the face, ankles, or hands
- trouble breathing
- unpleasant breath odor
- unusual tiredness or weakness
- vomiting of blood
- wrinkled skin
Other side effects of Dulaglutide
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:
Less common
- Acid or sour stomach
- belching
- 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
- decreased appetite
- general feeling of discomfort or illness
- heartburn
- lack or loss of strength
- stomach discomfort, upset, or pain
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
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]
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]
Hypersensitivity
Uncommon (0.1% to 1%): Systemic hypersensitivity including severe urticaria, systemic rash, facial edema, lip swelling
Postmarketing reports: Anaphylactic reactions, angioedema[Ref]
Oncologic
Very rare (less than 0.01%): Medullary Thyroid Carcinoma[Ref]
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]
Metabolic
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]
Very common (10% or more): Hypoglycemia (up to 85% when combined with prandial insulin)
Common (1% to 10%): Decreased appetite[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.
During clinical trials, a 2 to 3 millisecond mean increase from baseline in PR interval was observed in dulaglutide-treated patients compared to a mean decrease of 0.9 milliseconds in placebo-treated patients. AV block occurred more frequently compared with placebo (0.9%, 1.7% and 2.3% for placebo, 0.75 mg and 1.5 mg, respectively). On electrocardiograms, a PR interval increase to at least 220 milliseconds was observed in 0.7%, 2.5% and 3.2% of patients treated with placebo, 0.75 mg, 1.5 mg, respectively.[Ref]
Common (1% to 10%): First degree AV block, sinus tachycardia, PR prolongation on ECG
Frequency not reported: Increased heart rate[Ref]
Renal
Postmarketing reports: Increased serum creatinine, acute renal failure or worsening of chronic renal failure (sometimes requiring hemodialysis)
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]
