What the label lists and what reports show
Sitagliptin side effects
Sitagliptin's FDA label lists its adverse reactions in its own words. FAERS holds 74,197 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is blood glucose increased (4,597 reports).
- Generic listed
Check it at the source: the sitagliptin FDA label on DailyMed (effective November 14, 2024, Merck Sharp & Dohme LLC); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of JANUVIA?JANUVIA may cause serious side effects, including: See " What is the most important information I should know about JANUVIA? " . Kidney problems, sometimes requiring dialysis. Low blood sugar (hypoglycemia). If you take JANUVIA with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin, your risk of getting low blood sugar is higher. The dose of your sulfonylurea medicine or insulin may need to be lowered while you use JANUVIA. Signs and symptoms of low blood sugar may include: headache drowsiness irritability hunger dizziness confusion sweating feeling jittery weakness fast heart beat Serious allergic reactions. If you have any symptoms of a serious allergic reaction, stop taking JANUVIA and call your doctor right away or get emergency medical help. See " Who should not take JANUVIA? ". […]
Source: FDA drug label, NDA021995 (Msd), as published by Merck Sharp & Dohme LLC, effective November 14, 2024 (SPL set f85a48d0-0407-4c50-b0fa-7673a160bf01), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe following adverse reactions are also discussed elsewhere in the labeling: Pancreatitis [see Warnings and Precautions (5.1) ] Heart Failure [see Warnings and Precautions (5.2) ] Acute Renal Failure [see Warnings and Precautions (5.3) ] Hypoglycemia with Concomitant Use with Insulin or Insulin Secretagogues [see Warnings and Precautions (5.4) ] Hypersensitivity Reactions [see Warnings and Precautions (5.5) ] Severe and Disabling Arthralgia [see Warnings and Precautions (5.6) ] Bullous Pemphigoid [see Warnings and Precautions (5.7) ] Adverse reactions reported in ≥5% of patients treated with JANUVIA and more commonly than in patients treated with placebo are: upper respiratory tract infection, nasopharyngitis and headache. In the add-on to sulfonylurea and add-on to insulin studies, hypoglycemia was also more commonly reported in patients treated with JANUVIA compared to placebo. …
A table the label prints in its adverse reactions section without a title; its column headings name the groups compared
This table is printed in the BRYNOVIN label published by Azurity Pharmaceuticals, Inc. of January 2, 2025; the label quoted above does not print one.
| Monotherapy (18 or 24 weeks) | Sitagliptin 100 mg N = 443 | Number of Patients (%) Placebo N = 363 |
|---|---|---|
| Nasopharyngitis | 23 (5.2) | 12 (3.3) |
| Upper Respiratory Tract Infection | 11 (6.3) | 6 (3.4) |
| Headache | 9 (5.1) | 7 (3.9) |
| Upper Respiratory Tract Infection | 10 (5.5) | 5 (5.2) |
| Nasopharyngitis | 11 (6.1) | 4 (4.1) |
| Nasopharyngitis | 14 (6.3) | 10 (4.6) |
| Headache | 13 (5.9) | 5 (2.3) |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
Source: FDA drug label, NDA021995 (Msd), as published by Merck Sharp & Dohme LLC, effective November 14, 2024 (SPL set f85a48d0-0407-4c50-b0fa-7673a160bf01), via openFDA; the full label on DailyMed
What do FAERS reports show?
74,197 reports list sitagliptin among the medicines taken, each a report of something that happened, not proof the medicine caused it; 6,991 are coded as a death and 26,159 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 20 reactions below, 9 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Sitagliptin: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions