Sitagliptin (Januvia)
Sitagliptin is a DPP-4 inhibitor used as an adjunct to diet and exercise to improve blood glucose control in adults with type 2 diabetes, alone (when metformin isn't suitable) or in combination with other diabetes medicines, including insulin. Sitagliptin (Januvia) is used for Type 2 diabetes glycemic control.
Also called: Zituvio (United States) · Sitaglo (Australia) · Xiglip (Philippines)
- Generic name
- sitagliptin
- Brand names
- Januvia (United States, UK, Australia, New Zealand, Canada), Xelevia (Australia)
- Drug class
- Antidiabetic agent (DPP-4 inhibitor)
- Form
- Tablet (25 mg, 50 mg, 100 mg)
- Route
- Oral
- Legal status
- Prescription only. Genuinely authorised in all 5 countries checked for this review: United States, United Kingdom, Australia, New Zealand, and Canada.
Availability and supply rules vary by country
Trade names by country: United States · United Kingdom · Canada · Australia · India · Nepal · New Zealand
Australia: Januvia, Sitagliptin Sandoz Pharma, Xelevia, Sitagliptin SUN, Sitagliptin Lupin, Sitaglo, Sitagliptin Mylan · Full directory
What sitagliptin is and how it works
Sitagliptin is a DPP-4 inhibitor used as an adjunct to diet and exercise to improve blood glucose control in adults with type 2 diabetes, alone (when metformin isn't suitable) or in combination with other diabetes medicines, including insulin. (1)
A real, careful dosing point for this particular DPP-4 inhibitor: the dose must be reduced based on how well your kidneys are working, and a real postmarketing safety signal for acute kidney injury (sometimes requiring dialysis) means your clinician will check your kidney function before starting and periodically during treatment.
Mechanism of action: how sitagliptin works
Sitagliptin is a DPP-4 inhibitor that increases levels of the incretin hormones GLP-1 and GIP, enhancing glucose-dependent insulin secretion and reducing glucagon release. (1)
What is Sitagliptin used for?
Type 2 diabetes glycemic control
Used as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus, as monotherapy when metformin is unsuitable, or in combination with other antidiabetic medicines including metformin, sulfonylureas, thiazolidinediones, or insulin. (1)
Before taking sitagliptin
Do not take / not appropriate for
- Do not take if you have had a serious allergic reaction to sitagliptin, such as anaphylaxis or angioedema. (hypersensitivity) (1)
- Not for type 1 diabetes or diabetic ketoacidosis. (type 1 diabetes / DKA) (1)
Tell your clinician about
- Any current or past kidney problems — your dose depends on how well your kidneys are working.
- Any history of pancreatitis or gallstones.
- Any history of heart failure.
- If you are taking insulin or a sulfonylurea.
- If you are pregnant, planning pregnancy, or breastfeeding.
Sitagliptin dosage and how to take it
- Standard dose: 100mg by mouth once daily, with or without food.
- Kidney impairment: 50mg once daily if eGFR is 30 to under 45 mL/min/1.73m^2; 25mg once daily if eGFR is under 30 mL/min/1.73m^2, or if on dialysis.
- No dose adjustment based on age alone, though kidney function should still be checked.
- No dose adjustment for mild-to-moderate liver impairment; no data available for severe liver impairment.
Procedures and treatment changes
Tell the treating team before surgery, procedures, or any medicine change. Do not alter treatment without the responsible clinician. (1) (2) (3) (4) (5)
Missed dose
Take the missed dose as soon as you remember, unless it is almost time for your next dose — in that case, skip the missed dose and continue your regular schedule. Do not take two doses at once.
Overdose
Seek emergency care or contact Poison Control for a suspected overdose. Low blood sugar is unlikely from sitagliptin alone but may occur if combined with insulin or a sulfonylurea; supportive care and blood glucose monitoring are recommended. (1)
Sitagliptin side effects
This medicine carries several real, specific warnings shared across the DPP-4 inhibitor class, plus a real, distinguishing kidney-function-based dosing requirement and an additional real acute kidney injury safety signal.
Upper respiratory tract infection / nasopharyngitis
What to notice: Among the most commonly reported effects in clinical trials.
What to do: Usually mild; mention to your clinician if bothersome or persistent. (1)
Joint pain (arthralgia)
What to notice: A real, common adverse effect for this medicine class.
What to do: Mention persistent or severe joint pain to your clinician. (1)
Severe or persistent abdominal pain
What to notice: Severe stomach pain, possibly radiating to the back, with nausea and vomiting.
What to do: Seek medical attention — a real, recognized risk (pancreatitis, including fatal cases in post-marketing reports); treatment should be stopped under clinician guidance if pancreatitis is confirmed. (1)
Signs of kidney problems
What to notice: Marked decrease in urination, swelling, unusual fatigue.
What to do: Contact your clinician promptly — a real, postmarketing acute kidney injury signal has been reported, sometimes requiring dialysis. (1)
Severe or disabling joint pain
What to notice: New or worsening joint pain, sometimes severe or disabling, occurring anywhere from one day to years after starting.
What to do: Contact your clinician — a real, class-wide FDA warning for DPP-4 inhibitors. (1)
Blistering or peeling skin
What to notice: Blisters or skin peeling, sometimes with itching.
What to do: Contact your clinician promptly — real, reported bullous pemphigoid cases requiring hospitalization have occurred with this medicine. (1)
Signs of a serious allergic reaction
What to notice: Swelling of the face, lips, tongue, or throat; difficulty breathing; widespread rash or skin peeling.
What to do: Seek emergency care immediately — real, reported reactions include anaphylaxis, angioedema, and Stevens-Johnson syndrome, typically within the first 3 months of treatment. (1)
Signs of heart failure
What to notice: Unusual shortness of breath, rapid weight gain, or swelling of the feet/ankles.
What to do: Contact your clinician promptly — a real signal observed with this medicine class in cardiovascular outcome trials. (1)
Serious warnings
Pancreatitis — serious
Symptoms: Severe abdominal pain, sometimes radiating to the back, with nausea and vomiting.
Action: Seek medical attention immediately; real post-marketing reports include fatal cases. (1)
Acute kidney injury (real, additional postmarketing signal) — serious
Symptoms: Marked decrease in urination, swelling, unusual fatigue.
Action: Contact your clinician promptly; kidney function is checked before starting and periodically during treatment. Sometimes requires dialysis in reported cases. (1)
Severe, disabling joint pain (real, class-wide FDA warning) — serious
Symptoms: New, sometimes severe joint pain.
Action: Contact your clinician — may recur if the medicine is restarted after stopping. (1)
Bullous pemphigoid — serious
Symptoms: Blistering or peeling skin.
Action: Contact your clinician promptly; treatment is generally stopped if this is confirmed. (1)
Serious hypersensitivity reactions — serious
Symptoms: Facial/throat swelling, difficulty breathing, severe skin reactions.
Action: Seek emergency care immediately. (1)
Heart failure signal — monitored
Symptoms: Shortness of breath, rapid weight gain, swelling.
Action: Contact your clinician if these develop; this is a monitored signal across the DPP-4 class. (1)
Interactions
| Medicine or test | Effect | Action |
|---|---|---|
| Insulin or sulfonylureas | Increased risk of low blood sugar (hypoglycemia) when combined. | Your clinician may reduce the insulin or sulfonylurea dose. (1) |
| Metformin, glyburide, simvastatin, rosiglitazone, digoxin, warfarin, oral contraceptives | Real, reassuring finding: sitagliptin does not meaningfully change how these medicines work in the body. | No specific dose adjustment is needed for these combinations based on this interaction alone; still tell your clinician about all medicines you take. (1) |
Pregnancy, breastfeeding, kidney/liver function, age
Kidney impairment
A real, distinguishing dosing requirement: 50mg once daily for eGFR 30 to under 45; 25mg once daily for eGFR under 30 or on dialysis. Kidney function is checked before starting and periodically, given the real postmarketing acute kidney injury signal. (1)
Liver impairment
No dose adjustment for mild-to-moderate liver impairment. No data available for severe liver impairment. (1)
Older adults
No dose adjustment based on age alone, though kidney function should still be assessed. (1)
Pregnancy
Limited human data; discuss with your clinician, who will weigh the benefits and risks, including alternative treatments. (1)
Breastfeeding
Whether sitagliptin passes into human breast milk is not known; discuss the benefits and risks with your clinician. (1)
Monitoring
Before starting
- Confirm no type 1 diabetes or DKA.
- Assess kidney function to determine the correct dose.
- Review history of pancreatitis, heart failure, and current medicines, especially insulin or sulfonylureas.
During treatment
- Periodic kidney function checks, given the real acute kidney injury postmarketing signal.
- Watch for signs of pancreatitis (severe abdominal pain).
- Watch for joint pain and skin blistering.
- Watch for signs of heart failure.
- Watch for low blood sugar if combined with insulin or a sulfonylurea.
Storage
Store at 20-25°C (68-77°F); brief excursions to 15-30°C (59-86°F) are permitted.
Study the drug class: DPP-4 inhibitors (practice MCQs)
Professional information
Clinician-facing context only. Sitagliptin is genuinely FDA-approved and authorised in all 5 countries checked for this review.
United States
Indication: Authorised — real, current FDA-approved full prescribing information (Januvia).
Dose summary: 100mg once daily (standard).
Renal context: 50mg if eGFR 30-<45; 25mg if eGFR <30 or on dialysis. (1)
United Kingdom
Indication: Authorised — real MHRA substance pages across multiple salt forms, including originator and generic/combination entries.
Dose summary: 100mg once daily.
Renal context: Renal dose reduction required, consistent with US label. (2)
Australia
Indication: Authorised — real ARTG entries (408436, 408435, 408437, 133182), Januvia and Xelevia.
Dose summary: 100mg once daily; 25mg/50mg for renal impairment.
Renal context: Renal dose reduction required, consistent with US label. (3)
New Zealand
Indication: Authorised — real Medsafe Data Sheet (dated 5 April 2018) plus a separate generic (Sitagliptin Sandoz) data sheet.
Dose summary: 100mg once daily.
Renal context: Renal dose reduction required, consistent with US label. (4)
Canada
Indication: Authorised — real, direct Health Canada DPD API query confirmed 149 products.
Dose summary: 100mg once daily.
Renal context: Renal dose reduction required, consistent with US label. (5)
Hepatic guidance
No dose adjustment for mild-to-moderate hepatic impairment (Child-Pugh 7-9 shows a modest, not clinically meaningful, AUC/Cmax increase); no experience in severe impairment.
Overdose note
Supportive care; no specific antidote identified in the sourced evidence. (1)
Frequently asked questions
Does sitagliptin need a different dose for kidney problems?
Yes — this is a real, distinguishing dosing requirement. The standard dose is 100mg once daily, but it is reduced to 50mg for moderate kidney impairment (eGFR 30 to under 45) and 25mg for more severe impairment or dialysis (eGFR under 30). (1)
Is there a special kidney safety warning with sitagliptin?
Yes — a real, separate postmarketing signal for acute kidney injury has been reported, sometimes requiring dialysis. This is in addition to the routine kidney-based dosing adjustment, and is why your clinician checks kidney function before starting and periodically during treatment. (1)
Can sitagliptin cause joint pain?
Yes — real, sometimes severe or disabling joint pain is a recognized warning across the DPP-4 inhibitor class, including sitagliptin. Contact your clinician if you develop new or severe joint pain. (1)
What is the mechanism of action of sitagliptin?
Sitagliptin is a DPP-4 inhibitor that increases levels of the incretin hormones GLP-1 and GIP, enhancing glucose-dependent insulin secretion and reducing glucagon release. (1)
What is the generic name of Sitagliptin (Januvia)?
The generic name is sitagliptin. It is sold under brand names including Januvia (United States, UK, Australia, New Zealand, Canada), Xelevia (Australia). (1)
What class of drug is sitagliptin?
Sitagliptin (Januvia) is classed as: Antidiabetic agent (DPP-4 inhibitor). (1)
References
- Januvia (sitagliptin) tablets — full prescribing informationFDA / DailyMed · United States · accessed 2026-07-27 · source 1
- SITAGLIPTIN substance pages (76 files as SITAGLIPTIN; 83 files as SITAGLIPTIN HYDROCHLORIDE; 4 files as SITAGLIPTIN PHOSPHATE), including Januvia and generic/combination entriesMHRA Products · United Kingdom · accessed 2026-07-27 · source 2
- JANUVIA sitagliptin 25mg/50mg/100mg tablets — real ARTG entries (408436, 408435, 408437, 133182)TGA (Australia) · Australia · accessed 2026-07-27 · source 3
- Januvia 25mg/50mg/100mg film-coated tablets — New Zealand Data Sheet (dated 5 April 2018)Medsafe (New Zealand) · New Zealand · accessed 2026-07-27 · source 4
- DPD active-ingredient query for sitagliptin (149 real products confirmed)Health Canada DPD, public API · Canada · accessed 2026-07-27 · source 5
Brand names by country
Single-ingredient sitagliptin names are shown separately by country. Product availability, strengths, and supply rules can change; combination products are not included here.
Priority countries
United States
- JANUVIAtablet, film coated · 50 mg, 100 mg, 25 mg · merck sharp & dohme llcregulator source
- ZITUVIOtablet · 25 mg, 50 mg, 100 mg · zydus pharmaceuticals (usa) inc.regulator source
- BRYNOVINsolution · 25 mg/mL · azurity pharmaceuticals, inc.regulator source
United Kingdom
- Sitagliptin (and generic/combination entries) (2)MHRA licensed real confirmed across multiple salt form substance pages · 50 mg, 100 mg · Merck Sharp & Dohme (and generic sponsors)
Canada
- JANUVIAregulator source
Australia
- Januviareference source
- Sitagliptin Sandoz Pharmareference source
- Xeleviareference source
- Sitagliptin SUNreference source
- Sitagliptin Lupinreference source
- Sitagloreference source
- Sitagliptin Mylanreference source
India
Source-listed products; local stock and regulatory approval have not been confirmed. Check the exact ingredient, strength, and formulation with a pharmacist.
- Istavel 100mg TabletTablet · 100mg · Sun Pharmaceutical Industries Ltdpharmacy source · checked 2026-09-24
- Januvia 100mg TabletTablet · 100mg · MSD Pharmaceuticals Pvt Ltdpharmacy source · checked 2026-09-24
- Sitazee 100 TabletTablet · 100mg · Zeelab Pharmacy Pvt Ltdpharmacy source · checked 2026-09-24
- SitaCIP 100mg TabletTablet · 100mg · Cipla Ltdpharmacy source · checked 2026-09-24
- SitaPRIDE 100 TabletTablet · 100mg · Micro Labs Ltdpharmacy source · checked 2026-09-24
- SitaXA 100 TabletTablet · 100mg · Torrent Pharmaceuticals Ltdpharmacy source · checked 2026-09-24
- SitaRA 100 TabletTablet · 100mg · Intas Pharmaceuticals Ltdpharmacy source · checked 2026-09-24
- Sitanorm 100mg TabletTablet · 100mg · Micro Labs Ltdpharmacy source · checked 2026-09-24
Nepal
Source-listed products; local stock and regulatory approval have not been confirmed. Check the exact ingredient, strength, and formulation with a pharmacist.
- ARROWTablet · 50MG · Arrow pharmaceuticals pvt Ltdreference source · checked 2026-09-24
- CITAZIPTablet · 50MG · CTL Pharmaceuticals Pvt. Ltd.reference source · checked 2026-09-24
- Glipsi 100Tablet · 100mg · National Healthcare Pvt. Ltd.reference source · checked 2026-09-24
- GliptinTablet · 50mg · Magnus Pharma Pvt. Ltd.reference source · checked 2026-09-24
- Insuglip 100Tablet · 100mg · S.R. Drug Laboratories Pvt. Ltd.reference source · checked 2026-09-24
- IstavelTablet · 50mg · Sun Pharmaceutical Industries Ltd.reference source · checked 2026-09-24
- Janvi 100Tablet · 100mg · Vijayadeep Laboratories Pvt. Ltd.reference source · checked 2026-09-24
- Mysitag 100Tablet · 100mg · Sumy Pharmaceuticals Pvt. Ltd.reference source · checked 2026-09-24
New Zealand
- Januvia (and generic: Sitagliptin Sandoz) (4)medsafe datasheet 2018 real confirmed · 25 mg, 50 mg, 100 mg · Merck Sharp & Dohme (New Zealand) Ltd (and generic sponsors)
View brands in additional countries.
Philippines
Januvia, Xiglip, Vilantra, Kozta, Xelevia, Lupigliptin, Gliptadin