Key takeaways

Trulicity, an injectable medication used for Type 2 diabetes, can improve blood sugar levels and reduce cardiovascular event risk.
Gastrointestinal issues are the most common side effect of Trulicity, often occurring early in treatment and decreasing over time, with severe cases being rare.
Serious risks include thyroid cancer, pancreatitis, severe allergic reactions, kidney injury, and vision changes, necessitating careful monitoring and immediate medical attention if symptoms arise.
To mitigate side effects, patients are advised to discuss their full medical history with a healthcare provider, use Trulicity as directed, and be prepared to manage symptoms of low blood sugar.

Trulicity, Eli Lilly and Company’s brand name for dulaglutide, is a prescription medicine approved for patients 18 years and older to treat Type 2 diabetes mellitus as an adjunct to diet and exercise. Trulicity is used to improve blood sugar, or glucose, levels, by limiting how much glucose gets into the bloodstream, slowing down food digestion in the stomach, and helping the pancreas release insulin following a meal. Trulicity can also reduce the risk of major cardiovascular events such as heart attack or stroke in people who have heart disease or other risk factors. It is in a class of drugs called glucagon-like peptide-1 (GLP-1) receptor agonists. Trulicity is given once a week by injecting it just under the skin (subcutaneously).

As with any medication, it is important to be aware of side effects and other drug interactions. The following drug information highlights potential Trulicity side effects and how to avoid them.

Common side effects of Trulicity

The most common side effects of Trulicity are gastrointestinal (GI) related and include:

Nausea
Diarrhea
Vomiting
Abdominal pain
Loss of appetite
Indigestion

Most GI adverse events, including nausea, were reported during the first two to three days following the first dose and declined over the first week and after each subsequent dose.

Additional common side effects may include:

Fatigue
Tachycardia (rapid heart rate)
Increased blood levels of pancreatic enzymes amylase and lipase
PR prolongation (a prolonged interval on an electrocardiogram or ECG)

Serious side effects of Trulicity

Severe stomach problems
Risk of thyroid cancer
Pancreatitis (inflamed pancreas)
Hypoglycemia (low blood sugar)
Serious allergic reactions
Acute kidney injury
Changes in vision

Severe stomach problems

GI side effects are the most common adverse events associated with the use of GLP-1 receptor agonists, including Trulicity. Most GI side effects occur when therapy begins, are mild or moderate in severity, and decrease with continued treatment. GI side effects tend to be dose-dependent, i.e., the higher the strength of the starting dose the greater the incidence of GI side effects. In clinical trials, less than 4% of Trulicity patients discontinued the drug due to severe GI side effects.

If you experience nausea, talk to your healthcare professional. The following suggestions may help reduce nausea:

Eat four or more smaller meals instead of three meals a day
Stop eating when you feel full
Eat bland foods and avoid fried or fatty foods

Risk of thyroid cancer

In animal studies, GLP-1 receptor agonists, such as Trulicity, led to the formation of thyroid tumors in mice and rats. Based on these findings in rodents, it was hypothesized that these medications had the potential to cause thyroid cancer in humans as well. This finding led to all GLP-1 receptor agonists having a mandated “boxed warning,” also called a black box warning, from the U.S. Food and Drug Administration (FDA).

In clinical studies, one case of medullary thyroid carcinoma (MTC) was reported in a patient on Trulicity, which is insufficient to either confirm or eliminate the possibility of a connection to the drug. When using Trulicity, you should contact your healthcare professional if you experience a lump or swelling in the neck, trouble swallowing, hoarseness, or shortness of breath. Also, you should not take Trulicity if you or any family member have ever had MTC or if you have multiple endocrine neoplasia syndrome type 2 (MEN 2).

Pancreatitis (inflamed pancreas)

The pancreas is a large gland behind the stomach that produces digestive enzymes and hormones that help regulate sugar, or glucose, levels in the body. Pancreatitis occurs when the digestive enzymes it produces do not leave the pancreas and start to damage its own tissue causing inflammation.

Pancreatitis can occur as acute pancreatitis when it appears suddenly and lasts for only a few days, or it can occur as chronic pancreatitis, which may last many years. Mild cases may resolve without treatment, but severe cases can cause life-threatening complications such as internal bleeding, infection, tissue damage, and harm to other organs such as the heart, lungs, and kidneys.

In an analysis of Trulicity clinical trials, there was no evidence to suggest an increased risk of acute pancreatitis in patients taking the drug. However, you should stop using Trulicity and call your healthcare provider if you have symptoms of pancreatitis such as severe pain in your stomach or abdomen, with or without vomiting, that will not go away.

Hypoglycemia (low blood sugar)

Hypoglycemia is when blood sugar, or glucose, levels have fallen low enough that action is necessary to bring blood sugar levels back to a normal range. Hypoglycemia may last for several hours and severe hypoglycemia may even require medical treatment.

Incidences of severe hypoglycemia with Trulicity in clinical trials were rare and were generally related to additional diabetes therapies used, such as sulfonylureas. The risk of hypoglycemia may be lowered by reducing the dose of the sulfonylurea or other diabetes drug that is being given.

The signs and symptoms of hypoglycemia may include:

Irregular or fast heartbeat
Fatigue
Pale skin
Shakiness
Anxiety
Sweating
Hunger
Irritability
Tingling or numbness of the lips, tongue, or cheek

Worsening hypoglycemia signs and symptoms may include:

Confusion, abnormal behavior, or both, such as the inability to complete routine tasks
Visual disturbances, such as blurred vision
Seizures
Loss of consciousness

Serious allergic reactions

There have been reports of serious hypersensitivity reactions, including anaphylactic reactions, in people using GLP-1 receptor antagonists, including Trulicity. If you experience any of the following symptoms of a serious allergic reaction stop using Trulicity and get medical help right away:

Swelling of the face, lips, tongue, or throat
Problems breathing or swallowing
Severe rash or itching
Fainting or feeling dizzy
Very rapid heartbeat

Acute kidney injury

GLP-1 receptor agonists, including Trulicity, may cause diarrhea, nausea, and vomiting resulting in a loss of fluids, or dehydration, in some patients. There have been reports that if dehydration occurs in people with existing kidney problems it may cause their kidney problems to worsen. Healthcare professionals may need to closely monitor kidney function in these patients if they experience severe GI side effects leading to dehydration.

Changes in vision

People with diabetes may develop an eye condition called diabetic retinopathy, a condition that can cause damage to the tiny blood vessels of the retina (the thin layer of tissue at the back of the eye near the optic nerve). In clinical studies, patients treated with Trulicity with a history of diabetic retinopathy reported increased symptoms including:

Spots in vision
A dark area in central vision
Trouble seeing at night
Colors look faded or washed out
Vision changes from blurry to clear

Rapid improvement in blood glucose levels may actually temporarily worsen diabetic retinopathy. Tell your healthcare provider if you have changes in your vision during treatment with Trulicity.

How long do Trulicity side effects last?

GI side effects, including nausea, were the most frequently reported adverse effects in Trulicity clinical trials. In these studies, 8% to 29% using Trulicity experienced some nausea during the first two to three days after the initial dose. Nausea generally subsided after the first two weeks, but some people experienced nausea with Trulicity beyond their second week of treatment.

Less than 2% of patients in clinical trials had to stop taking Trulicity because of nausea. Some patients didn’t experience nausea until they increased their dose of Trulicity. When adjusting to the higher dose, about 16% of people experienced nausea, and about 1% of people needed to stop taking Trulicity. If you experience nausea, talk to your healthcare professional.

Trulicity contraindications and warnings

Overdose

Overdoses of Trulicity were reported in the clinical trials. Symptoms of overdoses were mostly mild or moderate GI events, such as nausea and vomiting, and mild hypoglycemia.

Should you experience an overdose, contact your healthcare provider. You may need to monitor your blood glucose level to check for hypoglycemia.

Restrictions

You should not use Trulicity if you meet any of the following conditions:

You have Type 1 diabetes
You are younger than 18 years of age
You have severe intestinal or stomach problems
You have a history of pancreatitis
You or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC)
You have multiple endocrine neoplasia syndrome type 2 (MEN 2)
You are allergic to any ingredients in Trulicity

Pregnancy and breastfeeding

While there is limited data regarding the use of Trulicity in pregnant women, there are health considerations regarding the risks of poorly controlled diabetes in pregnancy. Based on animal studies, there may be risks to the fetus from exposure to Trulicity during pregnancy and it should only be used if the potential benefit justifies the potential risk.

Similarly, there is little information on the presence of Trulicity in human breast milk or on the effects on the breastfed infant. Trulicity should only be used if the potential benefit justifies the potential risk.

A woman’s healthcare provider is the best source of information when managing Trulicity and other diabetes treatments while pregnant or breastfeeding.

Trulicity interactions

In clinical studies, there is limited information about drug interactions between Trulicity and other medications. Because Trulicity slows down digestion and the rate that food empties from the stomach, it may affect the rate of absorption of other oral medications. This may be important for drugs where small differences in absorption and blood levels can have an impact on their effectiveness. For that reason, it is important before starting Trulicity to tell your healthcare professional about any other prescription medicines or over-the-counter drugs, vitamins, or herbal supplements you are taking.

If you are taking other antidiabetic medicines, such as sulfonylureas or insulin, your healthcare professional may ask you to reduce their dose when starting Trulicity to avoid the risk of hypoglycemia.

How to avoid Trulicity side effects

1. Talk to a doctor about your health history

Discuss the following with your healthcare provider before beginning Trulicity therapy:

Do you have any other medical conditions, such as problems with your pancreas, kidneys, liver, or stomach, or have a history of diabetic retinopathy (vision problems related to diabetes)?
Do you have GI problems, such as slowed gastric emptying or problems with digesting food?
Do you take any other medicine for diabetes, e.g., insulin or sulfonylureas?
Do you take any other prescription or over-the-counter drugs, vitamins, or herbs?
Are you pregnant or do you plan to become pregnant?
Are you breastfeeding or do you plan to breastfeed?

2. Use Trulicity at the same time and on the same day

Trulicity comes in a disposable, prefilled pen and is injected once weekly under the skin (subcutaneously) in your thigh, upper arm, or stomach. You should administer Trulicity at the same time and on the same day each week. Allow at least three days to pass between injections if you must change from your previously scheduled day. Other Trulicity dosage tips include:

Trulicity may be given without regard to meals or food.
When injecting Trulicity, inject in a different place each time, i.e., don’t use the same injection site twice in a row. Your healthcare provider should provide medical advice on the best places to inject.
If you miss a dose and there are at least three days (72 hours) until the next scheduled dose, you should administer it as soon as possible and then resume your usual once-weekly dosing schedule. If you miss a dose and the next regularly scheduled dose is due in one or two days, do not inject the missed dose and instead resume Trulicity with the next regularly scheduled dose.
Store Trulicity in the refrigerator at (36 to 46 degrees Fahrenheit) and not the freezer; do not use Trulicity if it has been frozen.
If needed, each single-dose pen can be kept at room temperature, not to exceed 86 degrees Fahrenheit for a total of 14 days.
Read and carefully follow the instructions that come with the Trulicity Pen. Ask your healthcare provider if you do not understand the instructions.

3. Be ready to counteract low blood sugar symptoms

If you experience hypoglycemia, or low blood sugar, eat or drink something with a high sugar content such as a non-diet soda, fruit juice, or hard candy. Your healthcare provider may prescribe a glucagon injection kit that may be used for severe hypoglycemia.