Ozempic

N/A

Manufactured by Novo Nordisk

154,936 FDA adverse event reports analyzed

Last updated: 2026-05-19

About Ozempic

Ozempic is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Novo Nordisk. The most commonly reported adverse reactions for Ozempic include NAUSEA, VOMITING, OFF LABEL USE, DIARRHOEA, CONSTIPATION. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for Ozempic.

Top Adverse Reactions

NAUSEA11,220 reports
VOMITING7,403 reports
OFF LABEL USE6,983 reports
DIARRHOEA6,500 reports
CONSTIPATION4,668 reports
DECREASED APPETITE4,594 reports
WEIGHT DECREASED4,038 reports
FATIGUE3,486 reports
HEADACHE3,294 reports
PRODUCT USE IN UNAPPROVED INDICATION3,023 reports
ABDOMINAL PAIN UPPER2,959 reports
IMPAIRED GASTRIC EMPTYING2,950 reports
BLOOD GLUCOSE INCREASED2,836 reports
WRONG TECHNIQUE IN PRODUCT USAGE PROCESS2,830 reports
DIZZINESS2,787 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION2,654 reports
WEIGHT INCREASED2,541 reports
ABDOMINAL PAIN2,496 reports
DEHYDRATION2,114 reports
MALAISE1,984 reports
DRUG INEFFECTIVE1,956 reports
ASTHENIA1,954 reports
PAIN1,827 reports
ILLNESS1,781 reports
DYSPEPSIA1,680 reports
ABDOMINAL DISTENSION1,652 reports
DYSPNOEA1,574 reports
ABDOMINAL DISCOMFORT1,496 reports
ANXIETY1,478 reports
ARTHRALGIA1,435 reports
PANCREATITIS1,348 reports
FALL1,340 reports
DEPRESSION1,335 reports
CONDITION AGGRAVATED1,314 reports
COVID 191,302 reports
INJECTION SITE PAIN1,300 reports
PRODUCT DOSE OMISSION ISSUE1,230 reports
VISUAL IMPAIRMENT1,225 reports
BLOOD GLUCOSE DECREASED1,196 reports
PRURITUS1,194 reports
PRODUCT USE ISSUE1,160 reports
RASH1,109 reports
ERUCTATION1,088 reports
VISION BLURRED1,072 reports
BACK PAIN1,068 reports
FEELING ABNORMAL1,045 reports
INTESTINAL OBSTRUCTION1,037 reports
FLATULENCE1,018 reports
INCREASED APPETITE1,005 reports
GLYCOSYLATED HAEMOGLOBIN INCREASED983 reports
GASTROINTESTINAL DISORDER980 reports
INSOMNIA967 reports
GASTROOESOPHAGEAL REFLUX DISEASE934 reports
COUGH915 reports
PAIN IN EXTREMITY914 reports
PRODUCT COMMUNICATION ISSUE910 reports
HUNGER909 reports
INCORRECT DOSE ADMINISTERED907 reports
ALOPECIA885 reports
WEIGHT LOSS POOR874 reports
MUSCLE SPASMS855 reports
ACUTE KIDNEY INJURY851 reports
URINARY TRACT INFECTION843 reports
HYPERTENSION794 reports
NASOPHARYNGITIS794 reports
ADVERSE DRUG REACTION719 reports
CHOLELITHIASIS689 reports
CHEST PAIN679 reports
BLOOD PRESSURE INCREASED678 reports
PYREXIA675 reports
OPTIC ISCHAEMIC NEUROPATHY661 reports
EMOTIONAL DISTRESS657 reports
DEVICE MALFUNCTION649 reports
SUICIDAL IDEATION611 reports
TREMOR609 reports
MYALGIA605 reports
LOSS OF CONSCIOUSNESS603 reports
PNEUMONIA594 reports
INFLUENZA588 reports
HYPERHIDROSIS584 reports
HYPOTENSION583 reports
PALPITATIONS568 reports
SURGERY568 reports
MEMORY IMPAIRMENT566 reports
ILEUS559 reports
HYPOGLYCAEMIA558 reports
SOMNOLENCE541 reports
PERIPHERAL SWELLING540 reports
HEART RATE INCREASED538 reports
INJECTION SITE HAEMORRHAGE535 reports
INJECTION SITE BRUISING507 reports
DRUG INTERACTION505 reports
CATARACT501 reports
CEREBROVASCULAR ACCIDENT491 reports
ASTHMA488 reports
PARAESTHESIA488 reports
HOSPITALISATION485 reports
MIGRAINE485 reports
STRESS469 reports
CHILLS466 reports

Report Outcomes

Out of 76,469 classified reports for Ozempic:

  • Serious: 41,058 reports (53.7%) — includes hospitalization, disability, life-threatening events, or death
  • Non-Serious: 35,411 reports (46.3%)
Serious 53.7%Non-Serious 46.3%

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

Female46,507 (66.9%)
Male22,982 (33.1%)
Unknown39 (0.1%)

Reports by Age

Age 601,275 reports
Age 651,263 reports
Age 671,231 reports
Age 641,215 reports
Age 621,206 reports
Age 691,200 reports
Age 631,180 reports
Age 661,170 reports
Age 611,168 reports
Age 681,162 reports
Age 701,157 reports
Age 591,115 reports
Age 711,106 reports
Age 551,059 reports
Age 581,056 reports
Age 561,038 reports
Age 731,036 reports
Age 721,034 reports
Age 571,013 reports
Age 54951 reports

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

Frequently Asked Questions

How many FDA adverse event reports are associated with Ozempic?

This profile reflects 154,936 FDA FAERS reports that mention Ozempic. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for Ozempic?

Frequently reported terms in FAERS include NAUSEA, VOMITING, OFF LABEL USE, DIARRHOEA, CONSTIPATION, DECREASED APPETITE. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures Ozempic?

Labeling and FAERS entries often list Novo Nordisk in connection with Ozempic. Always verify the specific product and NDC with your pharmacist.

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Drugs Also Linked to NAUSEA

The following drugs share commonly reported adverse reactions with Ozempic:

0XYGEN (75/100)ABACAVIR SULFATE (85/100)ABALOPARATIDE (35/100)ABEMACICLIB (78/100)Abilify MaintenaABIRATERONE ACETATE (72/100)ACALABRUTINIB (78/100)ACETAMINOPHEN (35/100)ACETAMINOPHEN 325 MG (65/100)ACETAMINOPHEN 325MG (65/100)ACETAMINOPHEN 500 MG (65/100)ACETAMINOPHEN 500MG (85/100)

View all drugs reporting NAUSEA →

Explore More

Safety RankingsSearch All DrugsCompare DrugsNovo Nordisk PortfolioNAUSEA in Other DrugsVOMITING in Other DrugsOFF LABEL USE in Other Drugs
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.