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Liraglutide Side Effects

Not all side effects for liraglutide may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to liraglutide: subcutaneous solution

In addition to its needed effects, some unwanted effects may be caused by liraglutide. In the event that any of these side effects do occur, they may require medical attention.

You should check with your doctor immediately if any of these side effects occur when taking liraglutide:

More common
  • Bladder pain
  • bloody or cloudy urine
  • cough or hoarseness
  • diarrhea
  • difficult, burning, or painful urination
  • fever or chills
  • frequent urge to urinate
  • general feeling of discomfort or illness
  • headache
  • joint pain
  • loss of appetite
  • lower back or side pain
  • muscle aches and pains
  • nausea
  • runny nose
  • shivering
  • sore throat
  • sweating
  • trouble sleeping
  • unusual tiredness or weakness
  • vomiting
Less common
  • Blurred vision
  • dizziness
  • nervousness
  • pounding in the ears
  • slow or fast heartbeat
Rare
  • Anxiety
  • cold sweats
  • coma
  • confusion
  • cool, pale skin
  • depression
  • hives or welts, itching, or skin rash
  • increased hunger
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • nightmares
  • redness of the skin
  • seizures
  • shakiness
  • slurred speech
Incidence not known
  • Agitation
  • clay-colored stools
  • confusion
  • dark urine
  • decreased urine output
  • depression
  • difficulty with swallowing
  • hostility
  • irritability
  • lethargy
  • muscle twitching
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • rapid weight gain
  • stupor
  • swelling of the face, ankles, or hands
  • tightness in the chest
  • unpleasant breath odor
  • vomiting of blood
  • yellow eyes or skin

Some of the side effects that can occur with liraglutide may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

More common
  • Abdominal or stomach cramps, discomfort, or pain
  • acid or sour stomach
  • back pain
  • belching
  • body aches or pain
  • constipation
  • decreased appetite
  • heartburn
  • indigestion
  • loss of voice
  • pain or tenderness around the eyes and cheekbones
  • sneezing
  • stuffy nose
  • swollen mouth and tongue
  • unpleasant taste
  • urge to have bowel movement
  • weight loss
Less common
  • 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 liraglutide: subcutaneous solution

Gastrointestinal

Chronic Weight Management:
Very common (10% or more): Nausea (39.3%), diarrhea (20.9%), constipation (19.4%), vomiting (15.7%),
Common (1% to 10%): Dyspepsia, abdominal pain, upper abdominal pain, gastroesophageal reflux disease, abdominal distension, eructation, flatulence, dry mouth, gastroenteritis, viral gastroenteritis, increased lipase
Uncommon (0.1% to 1%): Acute pancreatitis, acute gallbladder disease

Type 2 Diabetes Mellitus:
Very common (10% or more): Nausea (up to 28.4%), diarrhea (up to 17.1%), vomiting (up to 10.9%)
Common (1% to 10%): Constipation, dyspepsia, abdominal pain, gastritis, flatulence, abdominal discomfort, toothache
Rare (less than 0.1%): Intestinal obstruction
Postmarketing reports: Acute hemorrhagic or necrotizing pancreatitis, including fatalities[Ref]

Chronic Weight Management:
The percentage of patients reporting nausea declined as treatment continued. Most gastrointestinal events were mild or moderate and did not lead to discontinuation.

Acute pancreatitis occurred in 0.3% (9/3291) of liraglutide-treated patients and 0.1% (1/1843) of placebo patients in clinical trials. Three additional cases occurred in liraglutide-treated patients, 2 in patients who prematurely withdrew from the trial and 1 during an off-treatment follow-up period.

Acute gallbladder disease was reported more frequently in liraglutide-treated patients (1.5% versus 0.5%) during clinical trials. Substantial or rapid weight loss can increase the risk of cholelithiasis, but even after accounting for the degree of weight loss, the incidence of acute gallbladder disease was greater in liraglutide-treated patients.

Type 2 Diabetes Mellitus
There have been postmarketing reports of acute hemorrhagic or necrotizing pancreatitis, including fatalities. During clinical trials, 13 cases of pancreatitis were received among liraglutide treated patients, 9 acute and 4 chronic compared with 1 case in the comparator (glimepiride) group. Some patients had other risk factors for pancreatitis, such as a history of cholelithiasis or alcohol abuse.[Ref]

Metabolic

Chronic Weight Management:
Very common (10% or more): Hypoglycemia in type 2 diabetes (23%)
Common (1% to 10%): Decreased appetite

Type 2 Diabetes Mellitus:
Very common (10% or more): Hypoglycemia (when used in combination with a sulfonylurea)
Common (1% to 10%): Hypoglycemia, anorexia, decreased appetite
Uncommon (0.1% to 1%): Dehydration
Postmarketing reports: Dehydration resulting from nausea, vomiting and diarrhea[Ref]

Chronic Weight Management:
In patients with type 2 diabetes mellitus receiving this drug for chronic weight management, severe hypoglycemia occurred in 0.7% (3/422) of liraglutide-treated patients, each of these patients was also receiving a sulfonylurea. Among all patients receiving this drug in combination with a sulfonylurea, symptomatic hypoglycemia occurred in 43.6% (48/110) of patients. The dose of sulfonylurea had been reduced by 50% at the start of the trial. Among patients not taking a sulfonylurea, symptomatic hypoglycemia occurred in 15.7% (49/312) of patients.

Type 2 Diabetes Mellitus:
Major episodes of hypoglycemia have not been reported in clinical trials in which liraglutide was used as monotherapy, however, when used in combination with a sulfonylurea, hypoglycemia was very commonly reported.[Ref]

Nervous system

Very common (10% or more): Headache (up to 13.6%)
Common (1% to 10%): Dizziness
Frequency not reported: dysgeusia[Ref]

Respiratory

Type 2 Diabetes Mellitus:
Common (1% to 10%): Nasopharyngitis, bronchitis, upper respiratory infection[Ref]

General

The most commonly reported adverse events reported during chronic weight management clinical trials included nausea, hypoglycemia, diarrhea, constipation, vomiting, headache, decreased appetite, dyspepsia, fatigue, dizziness, abdominal pain, and increased lipase.

The most commonly reported adverse events reported during type 2 diabetes mellitus clinical trials included headache, nausea, diarrhea, and anti-liraglutide antibody formation.[Ref]

Cardiovascular

Chronic Weight Management:
Very common (10% or more): Increases in mean resting heart rate
Common (1% to 10%): Hypotension
Uncommon (0.1% to 1%): Cardiac conduction disorder, tachycardia

Type 2 Diabetes Mellitus:
Common (1% to 10%): Increased heart rate[Ref]

Chronic Weight Management:
Cardiac conduction disorders were reported as first degree atrioventricular block, right bundle branch block, or left bundle branch block.

Increases in mean resting heart rate of 2 to 3 beats per minute (bpm) were observed in clinical trials. Increases of 10 and 20 bpm at 2 consecutive visits were 34% and 5% in liraglutide-treated patients versus 19% and 2% in the placebo group, respectively. Resting heart rate exceeding 100 bpm was recorded for 6% of liraglutide-treated patients versus 4% of placebo patients. Tachycardia was reported in 0.6% of liraglutide-treated patients compared with 0.1% of placebo patients. Monitoring heart rate over 24-hours found that liraglutide treatment was associated with a 4 to 9 bpm higher heart rate than placebo. The clinical significance of this is unknown.[Ref]

Genitourinary

Common (1% to 10%): Urinary tract infection[Ref]

Local

Common (1% to 10%): Injection site erythema, injection site reaction[Ref]

The most common injection site reactions were erythema, pruritus, and rash at the injection site.[Ref]

Immunologic

Frequency not reported: Development of anti-liraglutide antibodies[Ref]

Hypersensitivity

Uncommon (0.1% to 1%): Urticaria
Postmarketing reports: Serious hypersensitivity reactions (e.g. anaphylactic reactions and angioedema)[Ref]

Renal

While this drug has not been found to be directly nephrotoxic in animal studies or clinical trials, postmarketing reports of acute renal failure and worsening of chronic renal failure sometimes requiring dialysis have been received. A majority of reports occurred in patients who had experienced nausea, vomiting, diarrhea, or dehydration.[Ref]

Type 2 Diabetes Mellitus:
Uncommon (0.1% to 1%): Renal impairment, acute renal failure
Postmarketing reports: Acute renal failure and worsening of chronic renal failure, sometimes requiring dialysis, increased serum creatinine[Ref]

Dermatologic

Common (1% to 10%): Rash
Uncommon (0.1% to 1%): Urticaria, pruritus[Ref]

Endocrine

Common (1% to 10%): Increased blood calcitonin levels
Uncommon (0.1% to 1%): Goiter[Ref]

Other

Common (1% to 10%): Fatigue
Uncommon (0.1% to 1%): Asthenia, malaise[Ref]

Chronic Weight Management:
Fatigue and asthenia were most commonly reported within the first 12 weeks and were often co-reported with gastrointestinal events.[Ref]

Psychiatric

Chronic Weight Management:
In clinical trials, 0.2% (6/3384) patients receiving liraglutide reported suicidal ideation and 1 attempted suicide. There were no reports in patients receiving placebo.[Ref]

Chronic Weight Management:
Common (1% to 10%): Insomnia, anxiety
Uncommon (0.1% to 1%): Suicidal ideation
Very rare (less than 0.01%): Suicide attempt[Ref]

Hepatic

Chronic Weight Management:
Uncommon (0.1% to 1%): ALT increased
Frequency not reported: AST increased

Type 2 Diabetes Mellitus:
Postmarketing reports: Elevations of liver enzymes, hyperbilirubinemia, cholestasis, hepatitis[Ref]

Oncologic

Chronic Weight Management:
Breast Cancer: During clinical trials, 0.6% (4/2379) of liraglutide-treated patients were diagnosed with breast cancer compared with 0.2% (3/1300) of placebo patients. There were too few cases to determine if these were related to drug treatment and insufficient data to determine whether this drug had an effect on preexisting breast neoplasia.
Papillary Thyroid Cancer: During clinical trials, 0.2% (7/3291) of the liraglutide-treated patients were diagnosed with papillary thyroid carcinoma compared with no cases in 1843 placebo patients.
Colorectal Neoplasms: During clinical trials, 0.5% (17/3291) of the liraglutide-treated patients had benign colorectal neoplasms compared with 0.2% (4/1843) of placebo patients. Malignant colorectal carcinoma was diagnosed in 2 liraglutide-treated patients.

Type 2 Diabetes Mellitus:
In clinical trials, 6 cases of thyroid C-cell hyperplasia were reported among liraglutide-treated patients and 2 cases in the comparator-treated group (1.3 vs 1 case per 1000 patient-years). Medullary thyroid carcinoma was diagnosed in 1 patient in the comparator group who had pretreatment serum calcitonin concentrations greater than 1000 ng/L suggesting preexisting disease. The study required protocol-specified serum calcitonin measurements. All cases of thyroid C-cell hyperplasia were diagnosed after thyroidectomy which was done due to abnormal calcitonin levels. Of the 6 patients with thyroid C-cell hyperplasia, 5 had elevated calcitonin concentrations at baseline and throughout the trial. One patient in both the liraglutide-treated group and the comparator group developed elevated calcitonin concentrations while on treatment.[Ref]

Chronic Weight Management:
Uncommon (0.1% to 1%): Benign colorectal neoplasms, papillary thyroid cancer, breast cancer, malignant colorectal carcinoma

Type 2 Diabetes Mellitus:
Uncommon (0.1% to 1%): Thyroid neoplasms
Frequency not reported: Thyroid C-cell hyperplasia
Postmarketing reports: Medullary Thyroid Cancer[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. Victoza (liraglutide)." Novo Nordisk Pharmaceuticals Inc, Princeton, NJ.

4. "Product Information. Saxenda (liraglutide)." Novo Nordisk Pharmaceuticals Inc, Princeton, NJ.

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