Vildagliptin

Vildagliptin (Galvus) is a diabetes medicine used together with diet and exercise to control blood glucose (sugar) in adults with type 2 diabetes. Vildagliptin is used for Type 2 diabetes mellitus — monotherapy and Type 2 diabetes mellitus — combination therapy.

Also called: Vigliptic (Philippines)

Pronunciation: pronunciation varies by local usage.

Generic name
vildagliptin
Brand names
GALVUS
Drug class
Dipeptidyl peptidase 4 (DPP-4) inhibitor
Form
50 mg tablet
Route
Oral
Legal status
Prescription-only medicine (UK and EU: prescription only; Australia: Schedule 4 Prescription Only Medicine). Vildagliptin is not approved in the United States.

Availability and supply rules vary by country

Trade names by country: United Kingdom · Australia · India · New Zealand

Australia: Galvus · Full directory

What vildagliptin is and how it works

Vildagliptin (Galvus) is a diabetes medicine used together with diet and exercise to control blood glucose (sugar) in adults with type 2 diabetes. It is a dipeptidyl peptidase 4 (DPP-4) inhibitor that works by blocking the breakdown of incretin hormones in the body; these hormones are released after a meal and stimulate the pancreas to produce insulin. By blocking their breakdown, vildagliptin prolongs their action, stimulating the pancreas to produce more insulin when blood glucose levels are high. Vildagliptin does not work when blood glucose is low. It also reduces the amount of glucose made by the liver, by increasing insulin levels and decreasing glucagon levels. (1) (2) (3)

Galvus can only be obtained with a prescription and is available as 50 mg tablets. It is used alone when metformin is not suitable, or together with other diabetes medicines, including insulin, when these do not provide adequate glycaemic control. Because vildagliptin has been associated with liver problems, the doctor should check liver function before treatment and at regular intervals during treatment. Vildagliptin is not approved in the United States.

Mechanism of action: how vildagliptin works

Vildagliptin is a dipeptidyl peptidase 4 (DPP-4) inhibitor. It works by blocking the breakdown of incretin hormones in the body. These hormones are released after a meal and stimulate the pancreas to produce insulin. By blocking the breakdown of incretin hormones in the blood, vildagliptin prolongs their action, stimulating the pancreas to produce more insulin when blood glucose levels are high. Vildagliptin does not work when the blood glucose is low. Vildagliptin also reduces the amount of glucose made by the liver, by increasing insulin levels and decreasing the levels of the hormone glucagon. Together, these processes reduce blood glucose levels and help to control type 2 diabetes. (1) (2)

What is Vildagliptin used for?

Type 2 diabetes mellitus — monotherapy

Indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus as monotherapy in patients in whom metformin is inappropriate due to contraindications or intolerance. (1) (2)

Type 2 diabetes mellitus — combination therapy

Indicated as an adjunct to diet and exercise in combination with other medicinal products for the treatment of diabetes, including insulin, when these do not provide adequate glycaemic control. (1) (2)

Before taking vildagliptin

Do not take / not appropriate for

  • Galvus should not be used in patients with hepatic impairment, including patients with pre-treatment alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 3 times the upper limit of normal (ULN). (all patients) (1)
  • Do not take this medicine if you have hypersensitivity to the active substance or to any of the excipients. (all patients) (1)
  • Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine because it contains lactose. (all patients) (1)
  • Galvus should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis. (all patients) (1)

Tell your clinician about

  • Any liver problems or abnormal liver function tests, including pre-treatment ALT or AST greater than 3 times the upper limit of normal.
  • Kidney problems, including moderate or severe renal impairment or end-stage renal disease (ESRD), and whether you are on haemodialysis.
  • Heart failure, including the NYHA functional class, and any history of congestive heart failure.
  • A history of acute pancreatitis.
  • Whether you take a sulphonylurea or insulin, because of the risk of hypoglycaemia.
  • Whether you take an ACE-inhibitor, because there may be an increased risk of angioedema.
  • Pregnancy, plans for pregnancy, or breastfeeding.
  • Whether you experience dizziness, which may affect your ability to drive or use machines.
(1) (2) (3)

Vildagliptin dosage and how to take it

  • Galvus is for oral use and can be administered with or without a meal.
  • When used as monotherapy, in combination with metformin, in combination with a thiazolidinedione, in combination with metformin and a sulphonylurea, or in combination with insulin (with or without metformin), the recommended daily dose is 100 mg, given as one 50 mg dose in the morning and one 50 mg dose in the evening.
  • When used in dual combination with a sulphonylurea, the recommended dose is 50 mg once daily in the morning. In this patient population, vildagliptin 100 mg daily was no more effective than vildagliptin 50 mg once daily.
  • When used in combination with a sulphonylurea, a lower dose of the sulphonylurea may be considered to reduce the risk of hypoglycaemia.
  • Doses higher than 100 mg are not recommended.
  • Do not change the dose yourself; any dose or treatment decision must be made by your prescriber.
(1) (2)

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)

Missed dose

If a dose of Galvus is missed, it should be taken as soon as the patient remembers. A double dose should not be taken on the same day. Contact your prescriber or pharmacist if you are unsure what to do.

Overdose

Information regarding overdose with vildagliptin is limited. In a rising-dose tolerability study in healthy subjects given Galvus for 10 days, at 400 mg there were three cases of muscle pain, and individual cases of mild and transient paraesthesia, fever, oedema and a transient increase in lipase levels; at 600 mg, one subject experienced oedema of the feet and hands, and increases in creatine phosphokinase (CPK), aspartate aminotransferase (AST), C-reactive protein (CRP) and myoglobin levels, and three other subjects experienced oedema of the feet with paraesthesia in two cases. In the event of an overdose, supportive management is recommended. Vildagliptin cannot be removed by haemodialysis; however, the major hydrolysis metabolite (LAY 151) can be removed by haemodialysis. If you think you may have taken too much, seek urgent medical advice from your doctor or a poison-information service. (1)

Vildagliptin side effects

Safety data were obtained from 5,451 patients exposed to vildagliptin 100 mg daily in randomised double-blind placebo-controlled trials of at least 12 weeks duration. The majority of adverse reactions were mild and transient, not requiring treatment discontinuations. No association was found between adverse reactions and age, ethnicity, duration of exposure or daily dose. Hypoglycaemia has been reported in patients receiving vildagliptin with a sulphonylurea and with insulin. The most common side effect with Galvus (which may affect up to 1 in 10 people) is dizziness.

Nasopharyngitis

What to notice: Very common (may affect more than 1 in 10 people).

What to do: Discuss persistent or troublesome symptoms with the prescribing team. (1)

Headache, dizziness, tremor, constipation, nausea, gastro-oesophageal reflux disease, diarrhoea, abdominal pain (including upper), vomiting, hyperhidrosis, rash, pruritus, dermatitis, arthralgia, myalgia, asthenia, oedema peripheral

What to notice: Common (may affect up to 1 in 10 people).

What to do: Discuss persistent or troublesome symptoms with the prescribing team rather than stopping treatment yourself. (1)

Vision blurred

What to notice: Common (may affect up to 1 in 10 people).

What to do: Discuss persistent or troublesome symptoms with the prescribing team. (1)

Upper respiratory tract infection, flatulence, urticaria, erectile dysfunction, fatigue, chills, abnormal liver function tests, weight increase

What to notice: Uncommon (may affect up to 1 in 100 people).

What to do: Discuss persistent or troublesome symptoms with the prescribing team. (1)

Hypoglycaemia

What to notice: Uncommon in monotherapy. Reported in patients receiving vildagliptin with a sulphonylurea and with insulin.

What to do: Tell your prescriber; a lower dose of the sulphonylurea may be considered to reduce the risk of hypoglycaemia. (1)

Pancreatitis

What to notice: The characteristic symptom of acute pancreatitis. Vildagliptin use has been associated with a risk of developing acute pancreatitis.

What to do: Patients should be informed of the characteristic symptom of acute pancreatitis. If pancreatitis is suspected, vildagliptin should be discontinued; if acute pancreatitis is confirmed, vildagliptin should not be restarted. Seek medical attention promptly and let the clinician advise on treatment. (1)

Hepatic dysfunction (including hepatitis)

What to notice: Rare cases of hepatic dysfunction (including hepatitis) have been reported; these were generally asymptomatic without clinical sequelae and liver function test results returned to normal after discontinuation. Patients who develop jaundice or other signs suggestive of liver dysfunction should discontinue Galvus.

What to do: Seek medical attention promptly; let the clinician you see advise on whether to continue or stop. Following withdrawal and LFT normalisation, treatment with Galvus should not be reinitiated. (1)

Skin disorders

What to notice: Post-marketing reports of bullous and exfoliative skin lesions, including bullous pemphigoid, and cutaneous vasculitis; skin lesions including blistering and ulceration have been reported in extremities of monkeys in non-clinical toxicology studies. Monitoring for skin disorders, such as blistering or ulceration, is recommended.

What to do: Seek medical assessment promptly for blistering, ulceration or other new skin lesions. (1)

Angioedema

What to notice: Rare cases of angioedema have been reported on vildagliptin at a similar rate to controls; a greater proportion of cases were reported when vildagliptin was administered in combination with an ACE-inhibitor. The majority of events were mild in severity and resolved with ongoing vildagliptin treatment.

What to do: Seek medical assessment promptly, especially if you take an ACE-inhibitor. (1)

Serious warnings

Hepatic impairment and liver enzyme monitoring — serious

Symptoms: Increased transaminase levels, jaundice, or other signs suggestive of liver dysfunction. Rare cases of hepatic dysfunction (including hepatitis) have been reported; these were generally asymptomatic without clinical sequelae and liver function test results returned to normal after discontinuation.

Action: Galvus should not be used in patients with hepatic impairment. Liver function tests should be performed before starting treatment and monitored at three-month intervals during the first year and periodically thereafter. Patients who develop increased transaminase levels should be re-tested to confirm, then followed with frequent liver function tests until the abnormality returns to normal. Should an increase in AST or ALT of 3x ULN or greater persist, withdrawal of Galvus therapy is recommended; following withdrawal and LFT normalisation, treatment should not be reinitiated. Let your clinician advise on treatment decisions. (1) (2)

Acute pancreatitis — serious

Symptoms: The characteristic symptom of acute pancreatitis. Use of vildagliptin has been associated with a risk of developing acute pancreatitis.

Action: If pancreatitis is suspected, vildagliptin should be discontinued; if acute pancreatitis is confirmed, vildagliptin should not be restarted. Caution should be exercised in patients with a history of acute pancreatitis. Patients should be informed of the characteristic symptom; seek medical attention promptly and let the clinician advise on treatment. (1)

Hypoglycaemia with sulphonylurea or insulin — serious

Symptoms: Low blood glucose levels. Sulphonylureas are known to cause hypoglycaemia; patients receiving vildagliptin in combination with a sulphonylurea may be at risk. Hypoglycaemia has been reported in patients receiving vildagliptin with a sulphonylurea and with insulin.

Action: A lower dose of the sulphonylurea may be considered to reduce the risk of hypoglycaemia; discuss this with your prescriber. Any dose decision must be made by your clinician. (1)

Cardiac failure — serious

Symptoms: A clinical trial in patients with NYHA functional class I-III showed that treatment with vildagliptin was not associated with a change in left-ventricular function or worsening of pre-existing congestive heart failure (CHF) versus placebo. Clinical experience in patients with NYHA functional class III is still limited and results are inconclusive. There is no experience of vildagliptin use in clinical trials in patients with NYHA functional class IV.

Action: Use is not recommended in patients with NYHA functional class IV. Discuss heart failure with your prescriber. (1)

Not a substitute for insulin; not for type 1 diabetes or diabetic ketoacidosis — serious

Symptoms: Galvus is not a substitute for insulin in insulin-requiring patients and should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis.

Action: Discuss any change in diabetes treatment with your prescriber; do not change treatment yourself. (1)

Renal impairment — serious

Symptoms: There is limited experience in patients with end-stage renal disease (ESRD) on haemodialysis.

Action: Galvus should be used with caution in these patients. Discuss your kidney function with your prescriber. (1)

Interactions

Medicine or testEffectAction
Pioglitazone, metformin and glyburideResults from studies conducted with these oral antidiabetics have shown no clinically relevant pharmacokinetic interactions.Give your prescriber and pharmacist a complete list of your medicines. (1)
Digoxin (Pgp substrate) and warfarin (CYP2C9 substrate)Clinical studies performed with healthy subjects have shown no clinically relevant pharmacokinetic interactions. However, this has not been established in the target population.Give your prescriber and pharmacist a complete list of your medicines. (1)
Amlodipine, ramipril, valsartan or simvastatinDrug-drug interaction studies in healthy subjects were conducted with amlodipine, ramipril, valsartan and simvastatin. In these studies, no clinically relevant pharmacokinetic interactions were observed after co-administration with vildagliptin.Give your prescriber and pharmacist a complete list of your medicines. (1)
ACE-inhibitorsThere may be an increased risk of angioedema in patients concomitantly taking ACE-inhibitors.Tell your prescriber if you take an ACE-inhibitor. (1)
Thiazides, corticosteroids, thyroid products and sympathomimeticsAs with other oral antidiabetic medicinal products, the hypoglycaemic effect of vildagliptin may be reduced by certain active substances, including thiazides, corticosteroids, thyroid products and sympathomimetics.Tell your prescriber about all medicines you take so that your blood glucose control can be assessed. (1)
CYP 450 substrates, inhibitors or inducersVildagliptin is not a cytochrome P (CYP) 450 enzyme substrate and does not inhibit or induce CYP 450 enzymes, so it is not likely to interact with active substances that are substrates, inhibitors or inducers of these enzymes. Vildagliptin has a low potential for interactions with co-administered medicinal products.Give your prescriber and pharmacist a complete list of your medicines. (1)

Pregnancy, breastfeeding, kidney/liver function, age

Elderly (≥ 65 years)

No dose adjustments are necessary in elderly patients. (1)

Renal impairment

No dose adjustment is required in patients with mild renal impairment (creatinine clearance ≥ 50 ml/min). In patients with moderate or severe renal impairment or with end-stage renal disease (ESRD), the recommended dose is 50 mg once daily. There is limited experience in patients with ESRD on haemodialysis, so Galvus should be used with caution in these patients. (1) (2)

Hepatic impairment

Galvus should not be used in patients with hepatic impairment, including patients with pre-treatment ALT or AST greater than 3x the upper limit of normal (ULN). (1)

Children and adolescents (< 18 years)

Galvus is not recommended for use in children and adolescents (under 18 years). The safety and efficacy of Galvus in children and adolescents (under 18 years) have not been established. No data are available. (1)

Pregnancy and breastfeeding

There are no adequate data from the use of vildagliptin in pregnant women. Studies in animals have shown reproductive toxicity at high doses. The potential risk for humans is unknown. Due to lack of human data, Galvus should not be used during pregnancy. It is unknown whether vildagliptin is excreted in human milk; animal studies have shown excretion of vildagliptin in milk, so Galvus should not be used during breast-feeding. Seek advice from your doctor or pharmacist about balancing risks and benefits. (1) (3)

Fertility

No studies on the effect on human fertility have been conducted for Galvus. (1)

Driving and using machines

No studies on the effects on the ability to drive and use machines have been performed. Patients who experience dizziness as an adverse reaction should avoid driving vehicles or using machines. (1)

Monitoring

Before starting

  • Perform liver function tests to know the patient's baseline value before initiating treatment with Galvus.
  • Assess renal function; no dose adjustment is required in mild renal impairment (creatinine clearance ≥ 50 ml/min), but 50 mg once daily is recommended in moderate or severe renal impairment or ESRD.
  • Confirm the exact indication, background treatment, and whether the patient takes a sulphonylurea, insulin, or an ACE-inhibitor.
  • Assess for type 1 diabetes, diabetic ketoacidosis, hepatic impairment, and heart failure (including NYHA functional class).

During treatment

  • Monitor liver function during treatment at three-month intervals during the first year and periodically thereafter.
  • Patients who develop increased transaminase levels should be monitored with a second liver function evaluation to confirm the finding and be followed thereafter with frequent liver function tests until the abnormality(ies) return(s) to normal.
  • Should an increase in AST or ALT of 3x ULN or greater persist, withdrawal of Galvus therapy is recommended; following withdrawal and LFT normalisation, treatment with Galvus should not be reinitiated.
  • Monitor for skin disorders, such as blistering or ulceration, in keeping with routine care of the diabetic patient.
  • Monitor blood glucose, especially in patients receiving vildagliptin with a sulphonylurea or insulin, because of the risk of hypoglycaemia.
  • Reassess glycaemic control and continued eligibility.
(1) (2)

Storage

Store in the original package in order to protect from moisture. Store below 30 degrees Celsius. Protect from moisture. Shelf lifetime is 3 years.

Professional information

Clinician-facing context only. Use the current local indication, dosing table, and background-disease guideline. Vildagliptin is not approved in the United States.

UK / EU

Indication: Type 2 diabetes mellitus — monotherapy, combination with metformin, thiazolidinedione, metformin plus a sulphonylurea, or insulin (with or without metformin)

Dose summary: 100 mg per day, administered as one 50 mg dose in the morning and one 50 mg dose in the evening.

Renal context: No dose adjustment is required in mild renal impairment (creatinine clearance ≥ 50 ml/min). In moderate or severe renal impairment or ESRD, the recommended dose is 50 mg once daily. Limited experience in ESRD on haemodialysis; use with caution. (1) (2)

UK / EU

Indication: Type 2 diabetes mellitus — dual combination with a sulphonylurea

Dose summary: 50 mg once daily administered in the morning. In this patient population, vildagliptin 100 mg daily was no more effective than vildagliptin 50 mg once daily. A lower dose of the sulphonylurea may be considered to reduce the risk of hypoglycaemia.

Renal context: No dose adjustment is required in mild renal impairment (creatinine clearance ≥ 50 ml/min). In moderate or severe renal impairment or ESRD, the recommended dose is 50 mg once daily. Limited experience in ESRD on haemodialysis; use with caution. (1) (2)

All regions

Indication: Any vildagliptin use

Dose summary: Doses higher than 100 mg are not recommended. The safety and efficacy of vildagliptin as triple oral therapy in combination with metformin and a thiazolidinedione have not been established.

Renal context: Renal impairment requires the dose adjustments above; hepatic impairment is a contraindication. Discuss any treatment decision with the prescriber. (1)

Mechanism of action

Hepatic guidance

Galvus should not be used in patients with hepatic impairment, including patients with pre-treatment ALT or AST greater than 3x ULN. Liver function tests should be performed prior to initiation and monitored at three-month intervals during the first year and periodically thereafter.

Overdose note

Information regarding overdose with vildagliptin is limited. In the event of an overdose, supportive management is recommended. Vildagliptin cannot be removed by haemodialysis; however, the major hydrolysis metabolite (LAY 151) can be removed by haemodialysis. (1) (2)

Frequently asked questions

Can Galvus be used instead of metformin?

Galvus is used alone only when metformin is not suitable, because metformin is inappropriate due to contraindications or intolerance. In a study comparing Galvus with metformin, significantly better results were seen with metformin. Discuss with your prescriber which medicine is appropriate for you. (1) (2)

Does Galvus cause low blood glucose (hypoglycaemia)?

Hypoglycaemia was uncommon when vildagliptin was used as monotherapy. It has been reported in patients receiving vildagliptin with a sulphonylurea and with insulin. In combination with a sulphonylurea, a lower dose of the sulphonylurea may be considered to reduce the risk. Discuss any dose decision with your prescriber. (1)

Do I need liver tests while taking Galvus?

Yes. Because vildagliptin has been associated with liver problems, the doctor should carry out tests to check liver function before treatment and at regular intervals during treatment (three-month intervals during the first year and periodically thereafter). (1) (2)

Can Galvus be used in pregnancy or breastfeeding?

Galvus should not be used during pregnancy because there are no adequate data from its use in pregnant women. It is unknown whether vildagliptin is excreted in human milk, so Galvus should not be used during breast-feeding. Seek advice from your doctor or pharmacist about balancing risks and benefits. (1) (3)

Is vildagliptin approved in the United States?

No. Vildagliptin is not approved in the United States. (1)

What is the mechanism of action of vildagliptin?

Vildagliptin is a dipeptidyl peptidase 4 (DPP-4) inhibitor. It works by blocking the breakdown of incretin hormones in the body. These hormones are released after a meal and stimulate the pancreas to produce insulin. By blocking the breakdown of incretin hormones in the blood, vildagliptin prolongs their action, stimulating the pancreas to produce more insulin when blood glucose levels are high. Vildagliptin does not work when the blood glucose is low. Vildagliptin also reduces the amount of glucose made by the liver, by increasing insulin levels and decreasing the levels of the hormone glucagon. Together, these processes reduce blood glucose levels and help to control type 2 diabetes. (1) (2)

What is the generic name of Vildagliptin?

The generic name is vildagliptin. It is sold under brand names including GALVUS. (1) (2) (3)

What class of drug is vildagliptin?

Vildagliptin is classed as: Dipeptidyl peptidase 4 (DPP-4) inhibitor. (1) (2) (3)

References

  1. Galvus 50 mg tablets — Summary of Product Characteristics (Novartis)electronic Medicines Compendium (UK) · United Kingdom · accessed 2026-10-13 · source 1
  2. Galvus (vildagliptin) — EPAR medicine overviewEuropean Medicines Agency · European Union · accessed 2026-10-13 · source 2
  3. Galvus product pagehealthdirect Australia · Australia · accessed 2026-10-13 · source 3

Brand names by country

Single-ingredient vildagliptin names are shown separately by country. Product availability, strengths, and supply rules can change; combination products are not included here.

Priority countries

India

Source-listed products; local stock and regulatory approval have not been confirmed. Check the exact ingredient, strength, and formulation with a pharmacist.

  • Jalra-OD 100mg Tablet SRTablet SR · 100mg · USV Private Limitedpharmacy source recorded · checked 2026-09-24
  • Galvus 50mg TabletTablet · 50mg · Novartis India Ltdpharmacy source recorded · checked 2026-09-24
  • Debiglip 50mg TabletTablet · 50mg · Leeford Healthcare Ltdpharmacy source recorded · checked 2026-09-24
  • Gliptagreat 50 TabletTablet · 50mg · Mankind Pharma Ltdpharmacy source recorded · checked 2026-09-24
  • Torglip 50 TabletTablet · 50mg · Torrent Pharmaceuticals Ltdpharmacy source recorded · checked 2026-09-24
  • Vidadeb 100mg Tablet SRTablet SR · 100mg · Leeford Healthcare Ltdpharmacy source recorded · checked 2026-09-24
  • Vildazem 50 TabletTablet · 50mg · Zeelab Pharmacy Pvt Ltdpharmacy source recorded · checked 2026-09-24
  • Vildamac 50 TabletTablet · 50mg · Macleods Pharmaceuticals Pvt Ltdpharmacy source recorded · checked 2026-09-24
  • Jalra / Jalra ODtablet, OD tablet · 50 mg, 100 mg (OD) · USV Pvt Ltdpharmacy source recorded
  • Vildanoltablet · 50 mg · Knoll Healthcare Pvt Ltdpharmacy source recorded
  • Vilatintablet · 50 mg · Ajanta Pharma Limited · seen on a PharmEasy 50 mg listing page alongside its Vilatin M combinationpharmacy source recorded
View brands in additional countries.

Philippines

Vigliptic, Galvus

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