Drug side effects
sitagliptin Side Effects
The reactions most often reported to the FDA for sitagliptin (also sold as Januvia), with demographics, serious outcomes, and reporting trends.
Data updated 2026-05-15
- 70,292
- FAERS reports
Data from the FDA Adverse Event Reporting System (FAERS), 2006 to 2025. A FAERS report records a temporal association, not proof of cause. See our methodology for how figures are compiled and de-duplicated.
The most commonly reported side effects of sitagliptin come from 70,292 reports to the FDA, broken down here by frequency, patient demographics, and serious outcomes.
This page analyzes 70,292 reports to the FDA Adverse Event Reporting System (FAERS) for sitagliptin (Januvia): the reactions reported most often, who reported them, serious outcomes such as hospitalization, and year-over-year trends. A FAERS report does not prove the drug caused the effect, and report volume tracks how widely a drug is used, not how likely an effect is for any one person. Educational information, not medical advice.
Total Reports
70,292
Reports Mentioning Death
6,655
9.5% of reports — not proof the medicine caused the death
Hospitalizations
24,338
34.6% of reports
Top Indication
Diabetes Mellitus
Most Reported Adverse Reactions
Who Reports Side Effects
Gender Distribution
Age Distribution
Reporting Trend by Year
Reactions in Death Reports
Top reactions reported in 6,655 reports where death was an outcome. These are voluntarily reported and do not establish causation.
| Reaction | Reports |
|---|---|
| DEATH | 2,153 |
| PANCREATIC CARCINOMA | 960 |
| PANCREATIC CARCINOMA METASTATIC | 442 |
| PNEUMONIA | 393 |
| METASTASES TO LIVER | 381 |
| ACUTE KIDNEY INJURY | 372 |
| HYPERTENSION | 347 |
| RENAL FAILURE | 304 |
| ANAEMIA | 294 |
| DIARRHOEA | 271 |
| DYSPNOEA | 261 |
| MYOCARDIAL INFARCTION | 249 |
| PANCREATITIS | 223 |
| CARDIAC ARREST | 220 |
| CONSTIPATION | 213 |
| CHRONIC KIDNEY DISEASE | 205 |
| ASTHENIA | 203 |
| URINARY TRACT INFECTION | 201 |
| DEHYDRATION | 196 |
| SEPSIS | 196 |
Reactions in Hospitalization Reports
Top reactions in 24,338 reports where hospitalization was an outcome.
| Reaction | Reports |
|---|---|
| NAUSEA | 1,541 |
| ACUTE KIDNEY INJURY | 1,529 |
| PNEUMONIA | 1,387 |
| VOMITING | 1,311 |
| DIARRHOEA | 1,277 |
| FALL | 1,263 |
| DYSPNOEA | 1,260 |
| ASTHENIA | 1,182 |
| PANCREATITIS | 1,182 |
| FATIGUE | 1,165 |
| ANAEMIA | 1,049 |
| PYREXIA | 933 |
| DEHYDRATION | 860 |
| DIZZINESS | 832 |
| BLOOD GLUCOSE INCREASED | 826 |
| MALAISE | 822 |
| HYPOGLYCAEMIA | 818 |
| HYPERTENSION | 775 |
| PAIN | 771 |
| RENAL FAILURE | 763 |
Nearby, Related Medications
What the FAERS Data Reveals About sitagliptin Side Effects
The FDA Adverse Event Reporting System (FAERS) contains 70,292 voluntary reports linked to sitagliptin and its brand equivalents (Januvia), spanning 2006 through 2025. Of those, 6,655 (9.5%) listed death as an outcome and 24,338 (34.6%) involved hospitalization. The most common indication reported alongside adverse events was Diabetes Mellitus.
Demographic breakdowns help contextualize who is being exposed to the drug. Of reports with known sex, 52% were female and 47% male; age distribution skews toward 45-64, with 15,124 reports in that bracket. The single most reported reaction is blood glucose increased with 4,453 submissions, followed by nausea and diarrhoea.
How to read these numbers
FAERS is a signal-detection tool, not a scorecard. Reports are voluntary, and a single case may list multiple suspect drugs, so numbers above should not be read as incidence rates or per-patient risk. Widely prescribed drugs naturally accumulate more reports than niche therapies even when individual risk is low. These aggregates are useful for spotting patterns that merit further pharmacovigilance, not for choosing between medications. This page is for educational reference only and is not medical advice, speak with a licensed clinician about any side-effect concerns.
Drugs With a Similar FAERS Report Volume
Other medications with a total FDA adverse-event report count closest to sitagliptin's 70,292.
Read our methodology - how this data is sourced, computed, and verified.