Prescription medication · DPP-4 Inhibitor
sitagliptin
Also sold as Januvia.
Data updated 2026-05-15
- 70,292
- FDA reportsOften reported
- 8
- InteractionsFew interactions
- $18.33
- Brand price (NADAC)
What the data shows
sitagliptin (Januvia) is a prescription DPP-4 Inhibitor, more reported than most tracked drugs (70,292 FDA reports), with 8 documented drug interactions.
Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.
Verify with FDA → · CMS NADAC pricing →
Drug Pricing (NADAC)
Brand Price
$18.33/unit
Generic Available
No
MERCK SHARP DOHME
Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →
What it does
Information not available.
Common side effects
Diarrhea, Upper respiratory tract infection (like a cold), Headache
Key warnings
No specific warnings noted. Always follow your prescriber's instructions.
Side Effects (from patient reports)
Based on 70,292 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for sitagliptin, by number of reports
- Blood Glucose Increased
Blood Glucose Increased
4,453 reports
- Nausea
Nausea
3,790 reports
- Diarrhoea
Diarrhoea
3,470 reports
- Fatigue
Fatigue
2,885 reports
- Headache
Headache
2,508 reports
- Dizziness
Dizziness
2,435 reports
- Dyspnoea
Dyspnoea
2,340 reports
- Vomiting
Vomiting
2,317 reports
- Pancreatitis
Pancreatitis
2,205 reports
- Death
Death
2,160 reports
What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.
Reports over time
Adverse-event reports filed for sitagliptin each year to the FDA Adverse Event Reporting System (FAERS).
Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.
Where sitagliptin sits
sitagliptin has more FDA adverse-event reports than 80% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.
Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is sitagliptin; the line is the median (50th percentile).
FDA Adverse Event Report Analysis
Detailed analysis of 70,292 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2006–2025.
Total Reports
70,292
Reports Mentioning Death
6,655
9.5% of reports — not proof of cause
Hospitalization Reports
24,338
Top Indication
Diabetes Mellitus
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 1 | BLOOD GLUCOSE INCREASED | 4,453 |
| 2 | NAUSEA | 3,790 |
| 3 | DIARRHOEA | 3,470 |
| 5 | FATIGUE | 2,885 |
| 6 | HEADACHE | 2,508 |
| 7 | DIZZINESS | 2,435 |
| 8 | DYSPNOEA | 2,340 |
| 9 | VOMITING | 2,317 |
| 10 | PANCREATITIS | 2,205 |
| 11 | DEATH | 2,160 |
| 12 | ACUTE KIDNEY INJURY | 2,158 |
| 13 | ASTHENIA | 2,077 |
| 14 | MALAISE | 1,898 |
| 15 | WEIGHT DECREASED | 1,893 |
| 16 | PAIN | 1,867 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation
Known Drug Interactions
Drugs that Reduce Metformin Clearance Clinical Impact: Concomitant use of drugs that interfere with common renal tubular transport systems involved in the renal elimination of metformin (e.g., organic cationic transporter-2 [OCT 2 ] / multidrug and toxin extrusion [MATE] inhibitors) could increase systemic exposure to metformin and may increase the risk for lactic acidosis [see Clinical Pharmacology ( 12.3 )]. Alcohol Clinical Impact: Alcohol is known to potentiate the effect of metformin on lactate metabolism. ( 7 ) Drugs that reduce metformin clearance (such as ranolazine, vandetanib,...
Mechanism: This combination can interfere with how the kidneys remove metformin from the body, which can cause the drug to build up to unsafe levels.
Examples: Topiramate, zonisamide, acetazolamide or dichlorphenamide.
Mechanism: This drug can interfere with how your body manages acid and how your kidneys remove the diabetes medicine. This may lead to a buildup of the medication in your system.
Examples: Ranolazine, vandetanib, dolutegravir, and cimetidine. ( 7 ) Drugs that reduce metformin clearance (such as ranolazine, vandetanib, dolutegravir, and cimetidine) may increase the accumulation of metformin.
Mechanism: Dolutegravir slows down the process of removing the diabetes medicine from your body. This can cause the medicine to build up to higher levels in your blood, which may increase the risk of side effects.
Examples: Ranolazine, vandetanib, dolutegravir, and cimetidine. ( 7 ) Drugs that reduce metformin clearance (such as ranolazine, vandetanib, dolutegravir, and cimetidine) may increase the accumulation of metformin.
Mechanism: Ranolazine reduces how quickly your body gets rid of the diabetes medicine. This can cause the medicine to stay in your body longer and reach higher levels than intended.
Examples: Ranolazine, vandetanib, dolutegravir, and cimetidine. ( 7 ) Drugs that reduce metformin clearance (such as ranolazine, vandetanib, dolutegravir, and cimetidine) may increase the accumulation of metformin.
Mechanism: Cimetidine slows down how quickly your body removes metformin, which can cause the medicine to build up in your blood.
This is a plain-language summary of FDA-label interaction records and does not provide individual medication-combination directions.
Common Questions
What are the common side effects of sitagliptin?
Does sitagliptin interact with other medications?
What drug class is sitagliptin?
Related Medications in DPP-4 Inhibitor
Other drugs grouped near sitagliptin - same-class peers and common alternatives.
acarbose
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Acarbose is a medicine that helps lower blood sugar levels in people with type 2 diabetes.
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alogliptin
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bromocriptine
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canagliflozin
Invokana
Invokana is a medicine used with diet and exercise to lower blood sugar in adults with type 2 diabetes.
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colesevelam
Welchol
Colesevelam is a medicine that helps lower bad cholesterol (LDL-C) and control blood sugar in adults.
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Compare beyond drug class
Nationwide peers by FAERS volume & death-report share
Two PlainMeds-derived comparison paths for sitagliptin: nearest FDA FAERS report volume and nearest death-report share among drugs with at least 1,000 logged reports, excluding same-class neighbors listed above. Counts reflect reporting volume, not proven individual harm.
Similar FAERS report volume
Nearest drugs by total FAERS reports. This record: 70,292.
Similar death-report share
Nearest drugs by FAERS death-report share. This record: 9.47%.
- fosinopril Δ 0.02 pts · 4,213 reports · ACE Inhibitor 9.45%death share
- dutasteride Δ 0.04 pts · 20,677 reports · 5-Alpha Reductase Inhibitor 9.43%death share
- telmisartan Δ 0.05 pts · 33,611 reports · Angiotensin II Receptor Blocker (ARB) 9.42%death share
- alfuzosin Δ 0.07 pts · 2,222 reports · Alpha-1 Blocker (BPH) 9.54%death share
Medication Guides
Understanding Drug Interactions
How CYP450 enzymes, inhibitors, and inducers affect your medications
Generic vs Brand Name Drugs
FDA requirements, cost savings, and when the difference matters
Narrow Therapeutic Index Drugs
FDA bioequivalence and label-record context for narrow therapeutic index medicines
Common Drug Interactions
Dangerous medication combinations and how to protect yourself
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What the FDA Data Shows for sitagliptin
The FDA label for sitagliptin (sold under brand names such as Januvia) classifies it as a prescription-only medication in the DPP-4 Inhibitor class. Regulatory labeling describes its approved uses and the patient populations studied in pre-market trials. Official labeling lists 3 commonly reported side effects, including Diarrhea, Upper respiratory tract infection (like a cold), Headache.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 70,292 voluntary reports. The database also lists 8 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated moderate severity. NADAC pricing from CMS.
Report counts do not establish causation, a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history, and patent information are separate source-record fields. This page is a public FDA/CMS registry and does not provide medical, treatment, substitution, or medication-change directions.
Data Sources
Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).
FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. This registry does not provide medication decisions.
Last updated: June 9, 2025
PlainMeds is rendered directly from FDA openFDA/FAERS extracts, DailyMed labels, and CMS drug-pricing files, no number is typed in by an editor. FAERS counts, recalls, shortages, and price figures on this page are queried live from those federal extracts. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of 2026-05-15. Primary sources: openFDA / FAERS, DailyMed and CMS Part B ASP.
Read our methodology - how this data is sourced, computed, and verified.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled from the source snapshot dated . See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a data issue.
All federal data sources used on this page
- FDA Orange Book - approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed - NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) - post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm - standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files - federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database - current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages