Januvia

N/A

Manufactured by Merck Sharp & Dohme LLC

121,120 FDA adverse event reports analyzed

Last updated: 2026-05-19

About Januvia

Januvia is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Merck Sharp & Dohme LLC. The most commonly reported adverse reactions for Januvia include BLOOD GLUCOSE INCREASED, NAUSEA, DIARRHOEA, DRUG INEFFECTIVE, FATIGUE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for Januvia.

Top Adverse Reactions

BLOOD GLUCOSE INCREASED4,473 reports
NAUSEA3,855 reports
DIARRHOEA3,529 reports
DRUG INEFFECTIVE3,487 reports
FATIGUE2,934 reports
HEADACHE2,538 reports
DIZZINESS2,455 reports
VOMITING2,377 reports
DYSPNOEA2,359 reports
PANCREATITIS2,213 reports
ACUTE KIDNEY INJURY2,193 reports
DEATH2,190 reports
ASTHENIA2,102 reports
MALAISE1,925 reports
WEIGHT DECREASED1,921 reports
PAIN1,897 reports
FALL1,820 reports
PNEUMONIA1,752 reports
ARTHRALGIA1,734 reports
OFF LABEL USE1,686 reports
PANCREATIC CARCINOMA1,669 reports
RASH1,603 reports
PRODUCT DOSE OMISSION ISSUE1,569 reports
HYPOGLYCAEMIA1,560 reports
CONSTIPATION1,475 reports
RENAL FAILURE1,461 reports
ABDOMINAL PAIN1,429 reports
COUGH1,409 reports
ANAEMIA1,390 reports
DECREASED APPETITE1,377 reports
PAIN IN EXTREMITY1,349 reports
PYREXIA1,335 reports
PRURITUS1,330 reports
HYPERTENSION1,293 reports
BACK PAIN1,180 reports
CHRONIC KIDNEY DISEASE1,178 reports
NO ADVERSE EVENT1,170 reports
ABDOMINAL PAIN UPPER1,155 reports
ANXIETY1,129 reports
URINARY TRACT INFECTION1,129 reports
DEHYDRATION1,098 reports
DIABETES MELLITUS INADEQUATE CONTROL1,056 reports
CEREBROVASCULAR ACCIDENT1,043 reports
OEDEMA PERIPHERAL1,029 reports
GLYCOSYLATED HAEMOGLOBIN INCREASED1,019 reports
WEIGHT INCREASED1,001 reports
CONFUSIONAL STATE994 reports
HYPOTENSION966 reports
BLOOD PRESSURE INCREASED949 reports
INSOMNIA902 reports
BLOOD GLUCOSE DECREASED879 reports
MUSCULAR WEAKNESS879 reports
MYOCARDIAL INFARCTION865 reports
NASOPHARYNGITIS862 reports
MYALGIA860 reports
GENERAL PHYSICAL HEALTH DETERIORATION856 reports
DRUG INTERACTION846 reports
ABDOMINAL DISCOMFORT839 reports
CONDITION AGGRAVATED836 reports
DEPRESSION828 reports
CHEST PAIN812 reports
DYSPHAGIA786 reports
DIABETES MELLITUS783 reports
FEELING ABNORMAL780 reports
PERIPHERAL SWELLING780 reports
DRUG DOSE OMISSION760 reports
GAIT DISTURBANCE747 reports
LACTIC ACIDOSIS738 reports
RENAL IMPAIRMENT733 reports
BLADDER CANCER732 reports
GASTROOESOPHAGEAL REFLUX DISEASE730 reports
PRODUCT USE ISSUE714 reports
RHINORRHOEA701 reports
PALPITATIONS682 reports
ATRIAL FIBRILLATION655 reports
BLOOD GLUCOSE ABNORMAL650 reports
PANCREATITIS ACUTE641 reports
MUSCLE SPASMS634 reports
ADVERSE EVENT631 reports
INJECTION SITE PAIN630 reports
SOMNOLENCE627 reports
GASTROINTESTINAL DISORDER624 reports
HYPERGLYCAEMIA615 reports
TREMOR597 reports
HYPERHIDROSIS587 reports
INFLUENZA586 reports
DYSPEPSIA581 reports
BLOOD CREATININE INCREASED579 reports
ARTHRITIS577 reports
ALOPECIA576 reports
HYPERKALAEMIA574 reports
RHEUMATOID ARTHRITIS570 reports
SEPSIS570 reports
DIABETIC KETOACIDOSIS568 reports
DRUG HYPERSENSITIVITY567 reports
CARDIAC FAILURE CONGESTIVE564 reports
VISION BLURRED564 reports
SINUSITIS551 reports
PRODUCT DOSE OMISSION545 reports
CHEST DISCOMFORT542 reports

Report Outcomes

Out of 70,959 classified reports for Januvia:

  • Serious: 45,651 reports (64.3%) — includes hospitalization, disability, life-threatening events, or death
  • Non-Serious: 25,308 reports (35.7%)
Serious 64.3%Non-Serious 35.7%

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

Female33,579 (51.6%)
Male30,761 (47.3%)
Unknown736 (1.1%)

Reports by Age

Age 701,707 reports
Age 651,558 reports
Age 691,385 reports
Age 681,350 reports
Age 721,333 reports
Age 731,322 reports
Age 641,259 reports
Age 711,257 reports
Age 751,255 reports
Age 671,241 reports
Age 741,241 reports
Age 781,216 reports
Age 761,207 reports
Age 631,199 reports
Age 661,193 reports
Age 621,161 reports
Age 771,155 reports
Age 601,150 reports
Age 611,137 reports
Age 801,111 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 Januvia?

This profile reflects 121,120 FDA FAERS reports that mention Januvia. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for Januvia?

Frequently reported terms in FAERS include BLOOD GLUCOSE INCREASED, NAUSEA, DIARRHOEA, DRUG INEFFECTIVE, FATIGUE, HEADACHE. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures Januvia?

Labeling and FAERS entries often list Merck Sharp & Dohme LLC in connection with Januvia. Always verify the specific product and NDC with your pharmacist.

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Drugs Also Linked to BLOOD GLUCOSE INCREASED

The following drugs share commonly reported adverse reactions with Januvia:

ALLANTOIN (76/100)ALPELISIB (78/100)ANTACID TABLETS (65/100)ASENAPINE MALEATE (78/100)CANAGLIFLOZIN (82/100)CARBAMIDE PEROXIDE 6.5% (65/100)DAPAGLIFLOZIN (78/100)DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE (75/100)DULAGLUTIDE (45/100)EMPAGLIFLOZIN (72/100)EXENATIDE (45/100)EZETIMIBE AND SIMVASTATIN (65/100)

View all drugs reporting BLOOD GLUCOSE INCREASED →

Explore More

Safety RankingsSearch All DrugsCompare DrugsMerck Sharp & Dohme LLC PortfolioBLOOD GLUCOSE INCREASED in Other DrugsNAUSEA in Other DrugsDIARRHOEA 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.