LIRAGLUTIDE

65/100 · Elevated

Manufactured by Novo Nordisk

Liraglutide Adverse Events: Nausea and Pancreatitis Concerns

79,181 FDA adverse event reports analyzed

Last updated: 2026-05-12

About LIRAGLUTIDE

LIRAGLUTIDE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Novo Nordisk. Based on analysis of 79,181 FDA adverse event reports, LIRAGLUTIDE has a safety score of 65 out of 100. This moderate score indicates a notable volume of adverse event reports that patients and providers should be aware of. The most commonly reported adverse reactions for LIRAGLUTIDE include NAUSEA, BLOOD GLUCOSE INCREASED, VOMITING, DIARRHOEA, PANCREATITIS. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for LIRAGLUTIDE.

AI Safety Analysis

Liraglutide has a safety concern score of 65 out of 100, placing it in the elevated concern category based on analysis of FDA adverse event data. The FDA has received approximately 79,181 adverse event reports for this medication, which is primarily manufactured by Novo Nordisk.

The most commonly reported adverse events include Nausea, Blood Glucose Increased, Vomiting. Of classified reports, 47.8% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Nausea and vomiting are the most common gastrointestinal side effects.

Pancreatitis is a significant safety concern, with 2,318 reports. Weight loss is a common effect, with 2,076 reports of weight decreased. Serious adverse events account for 47.8% of all reports.

Patients taking Liraglutide should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Liraglutide can cause gastrointestinal issues and should be used with caution in patients with a history of pancreatitis. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.

Safety Score: 65/100

Liraglutide received a safety concern score of 65/100 (elevated concern). This is based on a 47.8% serious event ratio across 47,844 classified reports. The score accounts for 79,181 total adverse event reports and 100 distinct reaction types. This elevated score indicates a notable proportion of serious adverse events and warrants careful monitoring.

Top Adverse Reactions

NAUSEA7,005 reports
BLOOD GLUCOSE INCREASED3,875 reports
VOMITING3,364 reports
DIARRHOEA3,264 reports
PANCREATITIS2,318 reports
WEIGHT DECREASED2,076 reports
DECREASED APPETITE2,066 reports
HEADACHE1,988 reports
OFF LABEL USE1,728 reports
FATIGUE1,635 reports
DRUG INEFFECTIVE1,539 reports
CONSTIPATION1,491 reports
DIZZINESS1,474 reports
ABDOMINAL PAIN UPPER1,409 reports
MALAISE1,337 reports
ABDOMINAL PAIN1,213 reports
WEIGHT INCREASED1,187 reports
BLOOD GLUCOSE DECREASED1,136 reports
DYSPNOEA1,024 reports
ABDOMINAL DISCOMFORT995 reports
ASTHENIA989 reports
PANCREATIC CARCINOMA944 reports
INJECTION SITE PAIN841 reports
PAIN805 reports
ACUTE KIDNEY INJURY791 reports
DEHYDRATION779 reports
DYSPEPSIA767 reports
ERUCTATION751 reports
PANCREATITIS ACUTE737 reports
GLYCOSYLATED HAEMOGLOBIN INCREASED708 reports
RASH697 reports
BACK PAIN664 reports
ABDOMINAL DISTENSION650 reports
ANXIETY642 reports
FALL610 reports
PRURITUS609 reports
CONDITION AGGRAVATED605 reports
ARTHRALGIA601 reports
PAIN IN EXTREMITY589 reports
INJECTION SITE ERYTHEMA576 reports
FLATULENCE564 reports
GASTROOESOPHAGEAL REFLUX DISEASE556 reports
DEPRESSION522 reports
FEELING ABNORMAL515 reports
DIABETIC KETOACIDOSIS503 reports
INSOMNIA495 reports
RENAL FAILURE485 reports
HYPOGLYCAEMIA480 reports
WEIGHT LOSS POOR451 reports
INJECTION SITE PRURITUS450 reports
DEATH435 reports
DIABETES MELLITUS INADEQUATE CONTROL429 reports
MUSCLE SPASMS428 reports
CHRONIC KIDNEY DISEASE426 reports
HYPERHIDROSIS426 reports
ALOPECIA419 reports
INCORRECT DOSE ADMINISTERED418 reports
DRUG DOSE OMISSION415 reports
SOMNOLENCE414 reports
CHOLELITHIASIS410 reports
INJECTION SITE BRUISING406 reports
URINARY TRACT INFECTION405 reports
VISUAL IMPAIRMENT401 reports
CHEST PAIN393 reports
IMPAIRED GASTRIC EMPTYING387 reports
URTICARIA387 reports
HYPERTENSION384 reports
PRODUCT USE IN UNAPPROVED INDICATION378 reports
PRODUCT USE ISSUE374 reports
INJECTION SITE HAEMATOMA362 reports
INJECTION SITE REACTION360 reports
TREMOR358 reports
INJECTION SITE HAEMORRHAGE357 reports
PNEUMONIA355 reports
COUGH351 reports
DEVICE MALFUNCTION348 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION336 reports
PYREXIA335 reports
VISION BLURRED334 reports
DYSGEUSIA333 reports
HYPERSENSITIVITY331 reports
PALPITATIONS328 reports
HEART RATE INCREASED327 reports
INCREASED APPETITE327 reports
PRODUCT QUALITY ISSUE326 reports
HYPOTENSION324 reports
BLOOD PRESSURE INCREASED322 reports
PRODUCT DOSE OMISSION ISSUE320 reports
ASTHMA319 reports
PERIPHERAL SWELLING318 reports
WRONG TECHNIQUE IN PRODUCT USAGE PROCESS298 reports
DRUG INTERACTION295 reports
MYALGIA290 reports
LOSS OF CONSCIOUSNESS287 reports
CEREBROVASCULAR ACCIDENT286 reports
INJECTION SITE RASH286 reports
NASOPHARYNGITIS286 reports
MYOCARDIAL INFARCTION283 reports
PANCREATIC CARCINOMA METASTATIC283 reports
LIPASE INCREASED281 reports

Key Safety Signals

  • Pancreatitis is a key safety signal, with 2,318 reports.
  • Nausea and vomiting are frequent, with 7,005 and 3,364 reports respectively.
  • Weight changes, both gain and loss, are notable, with 1,187 and 2,076 reports respectively.

Patient Demographics

Adverse event reports by sex: Female: 28,937, Male: 16,114, Unknown: 149. The most frequently reported age groups are age 65 (1,105 reports), age 64 (1,018 reports), age 62 (1,017 reports). These demographics reflect reporting patterns and may not represent the full patient population.

Report Outcomes

Out of 47,844 classified reports for LIRAGLUTIDE:

  • Serious: 22,853 reports (47.8%) — includes hospitalization, disability, life-threatening events, or death
  • Non-Serious: 24,991 reports (52.2%)
Serious 47.8%Non-Serious 52.2%

The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.

Demographics Breakdown

Reports by Sex

Female28,937 (64.0%)
Male16,114 (35.7%)
Unknown149 (0.3%)

Reports by Age

Age 651,105 reports
Age 641,018 reports
Age 621,017 reports
Age 601,013 reports
Age 631,000 reports
Age 58945 reports
Age 66944 reports
Age 59935 reports
Age 61884 reports
Age 67866 reports
Age 56863 reports
Age 68862 reports
Age 55856 reports
Age 69821 reports
Age 57815 reports
Age 70795 reports
Age 54753 reports
Age 71746 reports
Age 52745 reports
Age 53731 reports

Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.

Drug Interactions & Warnings

Liraglutide can cause gastrointestinal issues and should be used with caution in patients with a history of pancreatitis.

What You Should Know

If you are taking Liraglutide, here are important things to know. The most commonly reported side effects include nausea, blood glucose increased, vomiting, diarrhoea, pancreatitis. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Monitor for signs of pancreatitis, such as severe abdominal pain, especially in the upper abdomen. Report any serious adverse events to the FDA's MedWatch program. If you experience a serious adverse reaction, seek emergency medical attention immediately or call 911. You can report side effects to the FDA's MedWatch program at 1-800-FDA-1088.

Regulatory Context

The FDA continues to monitor Liraglutide for safety, particularly for pancreatitis and serious adverse events.

Frequently Asked Questions

How many adverse event reports has the FDA received for Liraglutide?

The FDA has received approximately 79,181 adverse event reports associated with Liraglutide. These reports come from healthcare professionals, consumers, and manufacturers through the FDA Adverse Event Reporting System (FAERS). Note that the number of reports does not directly indicate the frequency of side effects, as adverse events are voluntarily reported and may be underrepresented.

What are the most commonly reported side effects of Liraglutide?

The most frequently reported adverse events for Liraglutide include Nausea, Blood Glucose Increased, Vomiting, Diarrhoea, Pancreatitis. By volume, the top reported reactions are: Nausea (7,005 reports), Blood Glucose Increased (3,875 reports), Vomiting (3,364 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Liraglutide.

What percentage of Liraglutide adverse event reports are serious?

Out of 47,844 classified reports, 22,853 (47.8%) were classified as serious and 24,991 as non-serious. The FDA classifies an event as "serious" if it results in death, hospitalization, disability, or other medically significant outcomes. A higher serious-event ratio warrants closer attention but does not necessarily mean the drug is unsafe.

Who reports adverse events for Liraglutide (by sex)?

Adverse event reports for Liraglutide break down by patient sex as follows: Female: 28,937, Male: 16,114, Unknown: 149. This distribution reflects reporting patterns rather than actual risk differences between groups. Reporting rates can be influenced by prescribing patterns, disease demographics, and reporting behavior.

What age groups report the most side effects for Liraglutide?

The most frequently reported age groups for Liraglutide adverse events are: age 65: 1,105 reports, age 64: 1,018 reports, age 62: 1,017 reports, age 60: 1,013 reports, age 63: 1,000 reports. Age-related reporting patterns can reflect both the demographics of the patient population and potential age-related susceptibility to certain side effects.

Who manufactures Liraglutide?

The primary manufacturer associated with Liraglutide adverse event reports is Novo Nordisk. Multiple manufacturers may produce generic versions of this drug. The manufacturer listed reflects the most frequently reported brand in FDA adverse event data.

What other side effects have been reported for Liraglutide?

Beyond the most common reactions, other reported adverse events for Liraglutide include: Weight Decreased, Decreased Appetite, Headache, Off Label Use, Fatigue. Less common side effects can still be clinically significant. Patients should report any unusual symptoms to their healthcare provider.

How do I report a side effect from Liraglutide?

You can report adverse events from Liraglutide to the FDA through their MedWatch program at www.fda.gov/medwatch, by calling 1-800-FDA-1088, or by completing Form FDA 3500. Healthcare professionals, consumers, and manufacturers can all submit reports. Reporting helps the FDA monitor drug safety after approval.

What is Liraglutide's safety score and what does it mean?

Liraglutide has a safety concern score of 65 out of 100 (elevated concern). This score is calculated from the ratio of serious to non-serious adverse events, the diversity of reported reactions, and the overall volume of reports relative to usage. Nausea and vomiting are the most common gastrointestinal side effects.

What are the key safety signals for Liraglutide?

Key safety signals identified in Liraglutide's adverse event data include: Pancreatitis is a key safety signal, with 2,318 reports.. Nausea and vomiting are frequent, with 7,005 and 3,364 reports respectively.. Weight changes, both gain and loss, are notable, with 1,187 and 2,076 reports respectively.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.

Does Liraglutide interact with other drugs?

Liraglutide can cause gastrointestinal issues and should be used with caution in patients with a history of pancreatitis. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Liraglutide.

What should patients know before taking Liraglutide?

Monitor for signs of pancreatitis, such as severe abdominal pain, especially in the upper abdomen. Report any serious adverse events to the FDA's MedWatch program.

Are Liraglutide side effects well-documented?

Liraglutide has 79,181 adverse event reports on file with the FDA. Pancreatitis is a significant safety concern, with 2,318 reports. The volume of reports for Liraglutide reflects both the drug's usage level and the vigilance of the reporting community.

What is the FDA's position on Liraglutide?

The FDA continues to monitor Liraglutide for safety, particularly for pancreatitis and serious adverse events. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.

Related Drugs

Drugs related to LIRAGLUTIDE based on therapeutic use, drug class, or shared indications:

InsulinMetforminSulfonylureasDPP-4 inhibitorsGLP-1 receptor agonists
Important Disclaimer: This content is generated by AI analysis of FDA adverse event reports and is provided for informational purposes only. It is not medical advice. Adverse event reports submitted to the FDA do not prove that a medication caused the reported side effect. Always consult your healthcare provider before starting, stopping, or changing any medication. If you experience a serious side effect, contact your doctor or call 911 immediately.