Xultophy Side Effects

Generic name: insulin degludec / liraglutide

Medically reviewed by Drugs.com. Last updated on Jul 23, 2024.

Note: This document provides detailed information about Xultophy Side Effects associated with insulin degludec / liraglutide. Some dosage forms listed on this page may not apply specifically to the brand name Xultophy.

Applies to insulin degludec / liraglutide: subcutaneous solution.

Important warnings This medicine can cause some serious health issues

Subcutaneous route (solution)

Liraglutide, a component of insulin degludec/liraglutide is known to cause dose-dependent and treatment-duration dependent thyroid C-cell tumors in rats and mice.

It is unknown whether this component causes thyroid C-cell tumors in humans.

Use is contraindicated in patients with a personal or family history of medullary thyroid carcinoma (MTC) and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).

Common side effects of Xultophy

Some side effects of insulin degludec / liraglutide 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 side effects

• body aches or pain
• diarrhea
• ear congestion
• loss of voice
• muscle aches
• sneezing
• sore throat
• stuffy or runny nose

Incidence not known

• 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

Serious side effects of Xultophy

Along with its needed effects, insulin degludec / liraglutide 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 insulin degludec / liraglutide:

Incidence not known

• anxiety
• bloating
• bloody urine
• blurred vision
• chest tightness
• chills
• cold, clammy skin
• cold sweats
• confusion
• constipation
• cool, pale skin
• cough
• dark urine
• decreased frequency or amount of urine
• depression
• difficulty swallowing
• dizziness
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• dry mouth
• fast heartbeat
• fast, weak pulse
• fever
• flushed, dry skin
• fruit-like breath odor
• headache
• hives, itching, skin rash
• hoarseness when speaking
• increased hunger
• increased thirst
• increased urination
• indigestion
• irregular heartbeat
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
• lightheadedness
• loss of appetite
• loss of consciousness
• lower back or side pain
• lumps in the neck
• muscle pain or cramps
• nausea
• nightmares
• noisy, rattling breathing
• numbness or tingling in the hands, feet, or lips
• pains in the stomach, side, or abdomen, possibly radiating to the back
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• seizures
• slurred speech
• sweating
• trouble breathing or swallowing
• unexplained weight loss
• unusual tiredness or weakness
• vomiting
• weight gain
• yellow eyes or skin

For healthcare professionals

Applies to insulin degludec / liraglutide: subcutaneous solution.

General adverse events

The most frequently reported adverse reactions included hypoglycemia and gastrointestinal adverse reactions, such as nausea diarrhea, vomiting, constipation, dyspepsia, gastritis, abdominal pain, flatulence, gastroesophageal reflux disease, and abdominal distention.^[Ref]

Gastrointestinal

• Common (1% to 10%): Nausea, diarrhea, vomiting, constipation, dyspepsia, gastritis, abdominal pain, flatulence, gastroesophageal reflux disease, abdominal distension, decreased appetite, increased lipase
• Uncommon (0.1% to 1%): Pancreatitis, including necrotizing pancreatitis

Liraglutide:

• Postmarketing reports: Acute pancreatitis, hemorrhagic and necrotizing pancreatitis (sometimes resulting in death)^[Ref]

Gastrointestinal adverse events occur more frequently at the beginning of therapy and generally diminish within a few days or weeks of continued use. Nausea was transient for most patients.^[Ref]

Metabolic

• Very common (10% or more): Hypoglycemia
• Common (1% to 10%): Decreased appetite
• Uncommon (0.1% to 1%): Dehydration
• Frequency not reported: Weight gain^[Ref]

Weight gain may occur and has been attributed to the anabolic effects of insulin. After 26 weeks of insulin degludec / liraglutide 100/3.6, a mean increase of 2 kg occurred.^[Ref]

Endocrine

Liraglutide:

• Frequency not reported: Increased blood calcitonin, goitre^[Ref]

Hypersensitivity

• Uncommon (0.1% to 1%): Urticaria, rash, pruritus, face swelling
• Rare (less than 0.1%): Hypersensitivity manifested with swelling of tongue and lips, diarrhea, nausea, tiredness, and itching
• Postmarketing reports: Anaphylactic reaction

Liraglutide:

• Postmarketing reports: Angioedema, anaphylactic reactions, rash, pruritus^[Ref]

Hypersensitivity reactions including urticaria, pruritus, and/or swelling of the face have been reported following administration of this drug. Few case of anaphylactic reaction with additional symptoms such as hypotension, palpitations, dyspnea, and edema has been reported postmarketing.^[Ref]

Local

• Common (1% to 10%): Injection site reaction
• Frequency not reported: Lipodystrophy^[Ref]

Injection site reactions included injection site hematoma, pain, hemorrhage, erythema, nodules, swelling, discolorations, pruritus, warmth, and injection site mass. These reactions are generally mild and transient, disappearing with continued treatment. Lipodystrophy may occur at the injection site. Rotation of injection site may help reduce the risk of developing these reactions.^[Ref]

Cardiovascular

• Uncommon (0.1% to 1%): Increased heart rate
• Frequency not reported: Peripheral edema^[Ref]

Mean increase in heart rate of 2 to 3 beats per minute has been observed; long-term clinical effects are unknown.^[Ref]

Dermatologic

• Uncommon (0.1% to 1%): Rash, pruritus, urticaria

Insulin degludec:

Postmarketing period: Localized cutaneous amyloidosis^[Ref]

Immunologic

• Rare (less than 0.1%): Antibody formation^[Ref]

Ocular

Insulin:

• Frequency not reported: Temporary worsening of diabetic retinopathy, transitory reversible ophthalmologic refraction disorder^[Ref]

Temporary worsening of diabetic retinopathy may occur with abrupt improvement in glycemic control; however, long-term improvement may decrease the risk of progression.^[Ref]

Oncologic

Liraglutide:

• Frequency not reported: Thyroid neoplasm, malignant neoplasms

Postmarketing: Medullary thyroid carcinoma^[Ref]

Pooled analysis of liraglutide clinical trials reveals the incidence rate for malignant neoplasms at 10.9, 6.3, and 7.2 per 1000 patient-years for liraglutide, placebo, and active comparator treated patients, respectively. Incidence rates were based on investigator-reported events, medical history, pathology reports, and surgical reports from both blinded and open-label studies. Seven cases of papillary thyroid carcinoma were in liraglutide-treated patients and 1 case in a comparator-treated patient. Most were less than 1 cm in greatest diameter and diagnosed in surgical pathology specimens after thyroidectomy prompted by findings on protocol-specified screening with serum calcitonin or thyroid ultrasound. Seven malignant neoplasm events were reported beyond 1-year exposure to study medication: 4 colon, 1 prostate and 1 nasopharyngeal in liraglutide-treated patients with 1 (colon) reported in a comparator-treated patient.^[Ref]

Renal

• Frequency not reported: Renal impairment, acute renal failure
• Postmarketing reports: Increased serum creatinine, acute renal failure or worsening of chronic renal failure, sometimes requiring hemodialysis^[Ref]

Liraglutide

Hepatic

Liraglutide:

• Common (1% to 10%): Elevated serum bilirubin, cholelithiasis
• Uncommon (0.1% to 1%): Cholecystitis

Postmarketing: Cholestasis, hepatitis, elevated liver enzymes, hyperbilirubinemia^[Ref]

Cholelithiasis and cholecystitis have been reported in liraglutide trials. In doses of up to 3 mg, cholelithiasis and cholecystitis were reported in 1.5% (vs 0.5%) and 0.6% (vs 0.2%), respectively (compared to placebo). The majority of patients with cholelithiasis and cholecystitis required cholecystectomy. In the cardiovascular outcomes trial, liraglutide-treated patients reported an acute event of gallbladder disease such as cholelithiasis or cholecystitis more frequently than those receiving placebo (3.6% vs 1.9%). Most of these events required hospitalization or cholecystectomy.^[Ref]

Nervous system

• Common (1% to 10%): Headache
• Frequency not reported: Acute painful peripheral neuropathy^[Ref]

Acute painful peripheral neuropathy may occur with abrupt improvement in glycemic control; however, long-term improvement may decrease the risk of progression.^[Ref]

Respiratory

• Common (1% to 10%): Nasopharyngitis, upper respiratory infection^[Ref]

Frequently asked questions

• What is the difference between Soliqua and Xultophy?
• What are the active ingredients in Xultophy?
• How and where should I inject insulin?
• What are the different types of insulin?

Further information

Xultophy 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.

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