Trulicity Side Effects
Generic name: dulaglutide
Note: This document provides detailed information about Trulicity Side Effects associated with dulaglutide. Some dosage forms listed on this page may not apply specifically to the brand name Trulicity.
Applies to dulaglutide: subcutaneous solution.
Important warnings
This medicine can cause some serious health issues
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.
Precautions
It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.
It is very important to carefully follow any instructions from your health care team about:
- Alcohol—Drinking alcohol may cause severe low blood sugar. Discuss this with your health care team.
- Other medicines—Do not take other medicines during the time you are using dulaglutide (the active ingredient contained in Trulicity) unless they have been discussed with your doctor. This especially includes nonprescription medicines, such as aspirin, and medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems.
- Counseling—Other family members need to learn how to prevent side effects or help with side effects if they occur. Also, diabetic patients may need special counseling about diabetes medicine dosing changes that might occur because of lifestyle changes, such as changes in exercise and diet. Furthermore, counseling on contraception and pregnancy may be needed because of the problems that can occur during pregnancy in patients with diabetes.
- Travel—Keep a recent prescription and your medical history with you. Be prepared for an emergency as you would normally. Make allowances for changing time zones and keep your meal times as close as possible to your usual meal times.
- In case of emergency—There may be a time when you need emergency help for a problem caused by your diabetes. You need to be prepared for these emergencies. It is a good idea to wear a medical identification (ID) bracelet or neck chain at all times. Also, carry an ID card in your wallet or purse that says that you have diabetes and a list of all of your medicines.
Check with your doctor right away if you have a mass in the neck, difficulty with swallowing, hoarseness, or trouble breathing. These may be symptoms of a serious thyroid problem.
Pancreatitis (swelling of the pancreas) may occur while you are using this medicine. Tell your doctor right away if you have sudden and severe stomach pain, chills, constipation, nausea, vomiting, fever, or lightheadedness.
This medicine may cause serious allergic reactions, including anaphylaxis and angioedema, which can be life-threatening and require immediate medical attention. Check with your doctor right away if you have chest tightness, cough, difficulty swallowing, dizziness, fast heartbeat, hives, itching, puffiness or swelling of the eyelids or around the eyes, face, lips or tongue, skin rash, trouble breathing, unusual tiredness or weakness, or large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs.
Check with your doctor right away if you have confusion, decreased urination, diarrhea, dizziness, dry mouth, fainting, increase in heart rate, lightheadedness, nausea, vomiting, rapid breathing, sunken eyes, thirst, unusual tiredness or weakness, or wrinkled skin. These may be symptoms of a kidney problem.
This medicine does not cause hypoglycemia (low blood sugar). However, low blood sugar can occur when you use dulaglutide with other medicines that can lower blood sugar, including insulin, metformin, or a sulfonylurea. Low blood sugar also can occur if you delay or miss a meal or snack, exercise more than usual, drink alcohol, or cannot eat because of nausea or vomiting.
- Symptoms of low blood sugar include anxiety, behavior change similar to being drunk, blurred vision, cold sweats, confusion, cool, pale skin, difficulty with thinking, drowsiness, excessive hunger, a fast heartbeat, headache (continuing), nausea, nervousness, nightmares, restless sleep, shakiness, slurred speech, or unusual tiredness or weakness.
- If symptoms of low blood sugar occur, eat glucose tablets or gel, corn syrup, honey, or sugar cubes, or drink fruit juice, non-diet soft drink, or sugar dissolved in water to relieve the symptoms. Also, check your blood for low blood sugar. Glucagon is used in emergency situations when severe symptoms, including seizures (convulsions) or unconsciousness occur. Have a glucagon kit available, along with a syringe and needle, and know how to use it. Members of your family also should know how to use it.
Hyperglycemia (high blood sugar) may occur if you do not take enough or skip a dose of your antidiabetic medicine, overeat or do not follow your meal plan, have a fever or infection, or do not exercise as much as usual.
- Symptoms of high blood sugar include blurred vision, drowsiness, dry mouth, flushed, dry skin, fruit-like breath odor, increased urination (frequency and amount), ketones in the urine, loss of appetite, stomachache, nausea, or vomiting, tiredness, trouble breathing (rapid and deep), unconsciousness, or unusual thirst.
- If symptoms of high blood sugar occur, check your blood sugar level and then call your doctor for instructions.
Check with your doctor right away if you have any changes to your eyes, such as blurred vision or vision changes while you are using this medicine. Your doctor may want you to have your eyes checked by an eye doctor.
Check with your doctor right away if you have gaseous stomach pain, indigestion, recurrent fever, severe nausea or vomiting, stomach fullness, or yellow eyes or skin. These may be symptoms of gallbladder problems (eg, cholelithiasis, cholecystitis).
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 Trulicity
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 side effects
- 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 Trulicity
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 side effects
- 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 adverse events
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]
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
- 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
- Common (1% to 10%): First degree AV block, sinus tachycardia, PR prolongation on ECG
- Frequency not reported: Increased heart rate[Ref]
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]
Renal
- Postmarketing reports: Increased serum creatinine, acute renal failure or worsening of chronic renal failure (sometimes requiring hemodialysis)
Immunologic
- Common (1% to 10%): Anti-drug antibodies[Ref]
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]
Local
- Common (1% to 10%): Injection site reactions[Ref]
Other
- Common (1% to 10%): Fatigue[Ref]
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References
1. Cerner Multum, Inc. "UK Summary of Product Characteristics."
2. Cerner Multum, Inc. "Australian Product Information."
3. (2014) "Product Information. Trulicity (dulaglutide)." Eli Lilly and Company
Frequently asked questions
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Further information
Trulicity 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.