Galvus (Vildagliptin)
DPP-4 inhibitor for type 2 diabetes mellitus
Quick Facts About Galvus
Key Takeaways About Galvus
- Glucose-dependent action: Galvus primarily works when blood sugar is elevated, which means a lower risk of hypoglycemia compared to some other diabetes medications
- Liver monitoring required: Liver function tests must be performed before starting treatment and regularly during the first year, then periodically
- Flexible combination therapy: Can be used alone or combined with metformin, sulfonylureas, thiazolidinediones, or insulin for better glycemic control
- Not for type 1 diabetes: Galvus is only approved for type 2 diabetes in adults and should not be used for type 1 diabetes or diabetic ketoacidosis
- Kidney dose adjustment: Patients with moderate or severe kidney disease require a reduced dose of 50 mg once daily
What Is Galvus and What Is It Used For?
Galvus (vildagliptin) is an oral antidiabetic medication belonging to the DPP-4 inhibitor class, prescribed for adults with type 2 diabetes mellitus. It helps regulate blood sugar by stimulating insulin release and reducing glucagon production from the pancreas in a glucose-dependent manner.
Galvus is used to treat type 2 diabetes in adults when diet and exercise alone are not sufficient to control blood glucose levels. The active substance, vildagliptin, belongs to a group of medicines called dipeptidyl peptidase-4 (DPP-4) inhibitors, sometimes referred to as gliptins. This medication can be prescribed either on its own (monotherapy) or in combination with other established diabetes treatments that have proven insufficient to achieve adequate glycemic control.
Type 2 diabetes develops when the body either does not produce enough insulin or when the insulin produced does not work effectively (insulin resistance). The condition can also develop when the body produces too much glucagon, a hormone that stimulates glucose production in the liver. Both insulin and glucagon are produced in the pancreas, and an imbalance between these hormones is central to the pathophysiology of type 2 diabetes.
Vildagliptin works by inhibiting the enzyme DPP-4, which normally breaks down incretin hormones (GLP-1 and GIP). By preserving higher levels of these hormones, Galvus stimulates the pancreas to produce more insulin and less glucagon after meals. Importantly, this mechanism is glucose-dependent, meaning vildagliptin primarily acts when blood sugar is elevated, which translates to a lower risk of hypoglycemia compared to some other antidiabetic agents such as sulfonylureas.
Clinical trials have demonstrated that vildagliptin reduces HbA1c (a measure of long-term blood sugar control) by approximately 0.5% to 1.0% when used as monotherapy, with additional reductions when combined with other agents. The European Medicines Agency (EMA) approved Galvus in 2007, and it has since become widely prescribed across Europe and many other countries as part of the diabetes treatment armamentarium.
Even though you are now taking Galvus for your diabetes, it is crucial that you continue to follow the dietary recommendations and exercise program advised by your healthcare provider. Medication works best when combined with a healthy lifestyle, including a balanced diet, regular physical activity, and maintaining a healthy weight.
What Should You Know Before Taking Galvus?
Before starting Galvus, inform your doctor about all medical conditions, especially liver disease, kidney problems, heart failure, and any history of pancreatitis. Galvus should not be used during pregnancy or breastfeeding, and requires regular liver function monitoring.
Contraindications
Galvus must not be taken if you are allergic to vildagliptin or any of the other ingredients in the tablets (including lactose, microcrystalline cellulose, sodium starch glycolate type A, and magnesium stearate). If you suspect you may have an allergy, do not take the medication and speak with your doctor immediately.
Galvus is specifically contraindicated in patients with type 1 diabetes, as the mechanism of action relies on residual beta-cell function that is absent in type 1 diabetes. It should also never be used to treat diabetic ketoacidosis (DKA), a serious condition requiring urgent insulin therapy and medical management.
Warnings and Precautions
Before starting treatment with Galvus, it is essential to discuss your complete medical history with your healthcare provider. There are several important warnings and precautions to consider:
- Liver disease: Galvus may affect liver function. Liver function tests (transaminases) must be performed before initiating treatment, then at three-month intervals during the first year, and periodically thereafter. If you have previously taken vildagliptin and had to discontinue due to liver problems, you should not restart this medication.
- Kidney disease: If you have moderate or severe kidney impairment, or if you are on dialysis, a reduced dose of 50 mg once daily is required. Your doctor will monitor your kidney function regularly.
- Heart failure: Inform your doctor if you have or have had heart failure, as DPP-4 inhibitors require careful use in this population.
- Pancreatitis: If you have a history of pancreatic disease or pancreatitis, discuss this with your doctor. Rare cases of pancreatitis have been reported with DPP-4 inhibitors. Seek immediate medical attention if you experience severe, persistent abdominal pain.
- Sulfonylurea combination: If you are taking a sulfonylurea alongside Galvus, your doctor may need to reduce the sulfonylurea dose to minimize the risk of hypoglycemia (low blood sugar).
Skin complications are common in people with diabetes. Follow the skin and foot care recommendations provided by your healthcare team. Pay particular attention to any new blisters or sores that develop while taking Galvus, and contact your doctor promptly if they occur.
- Severe, persistent abdominal pain (possible pancreatitis)
- Yellowing of the skin or eyes, dark urine, nausea (possible liver problems)
- Swelling of the face, tongue, or throat; difficulty swallowing or breathing (possible angioedema)
Children and Adolescents
Galvus is not recommended for use in children and adolescents under 18 years of age. The safety and efficacy of vildagliptin in this age group have not been established in clinical trials, and there are no data to support its use in pediatric patients.
Pregnancy and Breastfeeding
Galvus should not be used during pregnancy. There are no adequate and well-controlled studies of vildagliptin in pregnant women, and animal studies have indicated potential reproductive toxicity. If you are pregnant, think you may be pregnant, or are planning to become pregnant, consult your doctor before taking this medication. Your healthcare provider will typically switch you to insulin therapy for glycemic control during pregnancy.
It is unknown whether vildagliptin passes into breast milk. Therefore, Galvus should not be used during breastfeeding. Women who are breastfeeding or planning to breastfeed should discuss alternative diabetes treatment options with their doctor.
Driving and Operating Machinery
If you experience dizziness while taking Galvus, do not drive or operate machinery. Dizziness is a known side effect that can impair your ability to safely perform these activities. Be especially cautious when initiating therapy or after dose adjustments.
Important Information About Excipients
Galvus tablets contain lactose (milk sugar). If you have been told by your doctor that you have an intolerance to certain sugars, speak with your doctor before taking this medicine. The tablets also contain sodium, but in quantities less than 1 mmol (23 mg) per tablet, meaning they are essentially sodium-free.
How Does Galvus Interact with Other Drugs?
Galvus can interact with several medications including thiazide diuretics, corticosteroids, thyroid medications, and certain drugs that affect the nervous system. Always inform your doctor about all medications you are taking, as dose adjustments may be necessary.
Drug interactions with vildagliptin are generally less complex than with some other antidiabetic agents, partly because vildagliptin has minimal involvement with the cytochrome P450 enzyme system. However, several interactions are clinically important and require attention from your healthcare provider.
Inform your doctor or pharmacist about all medications you currently take, have recently taken, or may be planning to take. This includes prescription drugs, over-the-counter medications, and herbal supplements. Your doctor may need to adjust the dose of Galvus or your other medications based on potential interactions.
| Interacting Drug | Type | Effect | Action Required |
|---|---|---|---|
| Sulfonylureas (e.g., glimepiride, gliclazide) | Major | Increased risk of hypoglycemia | Sulfonylurea dose reduction may be needed |
| Insulin | Major | Increased risk of hypoglycemia | Insulin dose adjustment may be required |
| Thiazide diuretics (e.g., hydrochlorothiazide) | Moderate | May increase blood glucose levels | Monitor blood glucose more frequently |
| Corticosteroids (e.g., prednisolone) | Moderate | May raise blood glucose significantly | May need dose adjustment; closer monitoring |
| Thyroid medications (e.g., levothyroxine) | Moderate | May affect blood glucose control | Monitor blood glucose during thyroid dose changes |
| ACE inhibitors (e.g., ramipril, enalapril) | Minor | Slightly increased risk of angioedema | Monitor for signs of swelling |
Major Interactions
The most clinically significant interactions occur with other blood glucose-lowering medications, particularly sulfonylureas and insulin. When Galvus is combined with these drugs, the risk of hypoglycemia (low blood sugar) increases substantially. Symptoms of hypoglycemia include trembling, sweating, rapid heartbeat, dizziness, hunger, and confusion. Your doctor will typically reduce the dose of the sulfonylurea or insulin when adding Galvus to your treatment regimen.
Moderate Interactions
Several drug classes can counteract the glucose-lowering effects of Galvus by raising blood sugar levels. Thiazide and other diuretics, corticosteroids (commonly used to treat inflammation), and thyroid medications can all affect blood glucose homeostasis. If you begin or stop taking any of these medications, your doctor will likely need to adjust your diabetes management plan and increase the frequency of blood glucose monitoring during the transition period.
Certain medications that affect the nervous system can also influence blood glucose levels in unpredictable ways. Always discuss any new medication with your prescribing doctor, even if it seems unrelated to diabetes management.
Minor Interactions
ACE inhibitors, frequently prescribed for high blood pressure and heart failure, have been associated with a slightly elevated risk of angioedema when used in combination with DPP-4 inhibitors including vildagliptin. While this interaction is considered minor in frequency, angioedema is a potentially serious adverse event. Your doctor should be aware of this combination and may advise monitoring for early signs of facial or throat swelling.
What Is the Correct Dosage of Galvus?
The standard dose of Galvus is 50 mg once or twice daily depending on how it is used. The maximum daily dose is 100 mg. Always take Galvus exactly as prescribed by your doctor.
Galvus dosage varies between individuals depending on their specific medical condition, kidney function, and combination therapy. Your doctor will determine the exact number of tablets and dosing schedule that is appropriate for you. Never change your dose without medical guidance.
| Patient Group | Dose | Frequency | Notes |
|---|---|---|---|
| Monotherapy (Galvus alone) | 50 mg | Twice daily (morning and evening) | Total 100 mg/day; with or without food |
| With metformin | 50 mg | Twice daily (morning and evening) | Total 100 mg/day; alongside metformin dose |
| With a sulfonylurea | 50 mg | Once daily (morning) | Sulfonylurea dose may need reduction |
| With a glitazone | 50 mg | Twice daily (morning and evening) | Total 100 mg/day |
| With insulin | 50 mg | Twice daily (morning and evening) | Total 100 mg/day; insulin dose may need adjustment |
| Moderate/severe kidney disease or dialysis | 50 mg | Once daily (morning) | Reduced dose required; monitor renal function |
Adults
For most adult patients, the standard dosing of Galvus follows a straightforward approach. When used as monotherapy or in combination with metformin, a thiazolidinedione (glitazone), or insulin, the usual dose is 50 mg taken twice daily — one tablet in the morning and one in the evening. When used in combination with a sulfonylurea, the dose is reduced to 50 mg once daily in the morning. The maximum daily dose of Galvus under any circumstance is 100 mg.
Tablets should be swallowed whole with a glass of water. Galvus can be taken with or without food, though taking it at the same time each day helps maintain consistent blood levels and establishes a routine that supports adherence.
Children
Galvus is not approved for use in children and adolescents under 18 years of age. The safety and efficacy of vildagliptin have not been established in the pediatric population. Children and adolescents with type 2 diabetes should be managed with other approved therapies as determined by their pediatric endocrinologist.
Elderly
No dose adjustment is necessary for elderly patients based on age alone. However, since kidney function naturally declines with age, elderly patients are more likely to require the reduced dose of 50 mg once daily if their renal function falls below certain thresholds. Regular monitoring of kidney function is particularly important in older adults taking Galvus.
Missed Dose
If you forget to take a dose of Galvus, take it as soon as you remember. Then take your next dose at the usual time. However, if it is almost time for your next dose, skip the missed dose and continue with your regular schedule. Do not take a double dose to make up for a forgotten tablet.
Overdose
If you take too many Galvus tablets, or if someone else has taken your medication, contact your doctor or go to the nearest emergency department immediately. Bring the medicine packaging with you so that healthcare professionals can identify the medication and quantity taken. In the event of overdose, supportive care and monitoring of vital signs will be provided as needed.
Do not stop taking Galvus unless your doctor tells you to do so. Discontinuing diabetes medication without medical guidance can lead to uncontrolled blood sugar levels, which over time increases the risk of serious complications including damage to the eyes, kidneys, nerves, and cardiovascular system. If you have questions about how long to continue treatment, speak with your healthcare provider.
What Are the Side Effects of Galvus?
Like all medicines, Galvus can cause side effects, although not everyone experiences them. The most common side effects are upper respiratory symptoms such as sore throat, runny nose, and fever. Rare but serious side effects include pancreatitis, liver damage, and angioedema requiring immediate medical attention.
Side effects associated with vildagliptin have been well characterized through extensive clinical trial programs and post-marketing surveillance. Most side effects are mild to moderate in severity and tend to diminish over time as the body adjusts to the medication. However, certain serious adverse events require immediate medical attention.
- Angioedema (rare): Swelling of the face, tongue, or throat; difficulty swallowing or breathing; sudden rash or hives
- Liver damage (hepatitis) (frequency unknown): Yellow skin or eyes, nausea, loss of appetite, dark-colored urine
- Pancreatitis (rare): Severe, persistent abdominal pain that may radiate to the back, accompanied by nausea and vomiting
Very Common
May affect up to 1 in 10 patients
- Sore throat (nasopharyngitis)
- Runny nose (upper respiratory tract infection)
- Fever
Common
May affect up to 1 in 10 patients
- Headache
- Dizziness
- Tremor
- Nausea and vomiting
- Diarrhea
- Constipation
- Abdominal pain
- Heartburn (gastroesophageal reflux)
- Itchy rash
- Muscle pain (myalgia)
- Joint pain (arthralgia)
- Swollen hands, ankles, or feet (peripheral edema)
- Excessive sweating (hyperhidrosis)
- Blurred vision
Uncommon
May affect up to 1 in 100 patients
- Weight gain
- Chills
- Weakness (asthenia)
- Sexual dysfunction
- Low blood sugar (hypoglycemia)
- Flatulence
Rare
May affect up to 1 in 1,000 patients
- Pancreatitis (inflammation of the pancreas)
- Angioedema (swelling of face, tongue, throat)
Post-Marketing Reports
Frequency cannot be estimated from available data
- Hepatitis (liver inflammation)
- Localized skin peeling or blistering
- Vasculitis (inflammation of blood vessels) resulting in skin rash, pointed flat red spots, or bruising
Hypoglycemia (low blood sugar) is uncommon with Galvus when used alone or with metformin, because the drug's mechanism is glucose-dependent. However, the risk increases significantly when Galvus is combined with a sulfonylurea or insulin. Symptoms of hypoglycemia include shakiness, sweating, rapid heartbeat, hunger, confusion, and difficulty concentrating. If you experience these symptoms, consume a fast-acting sugar source (glucose tablets, fruit juice, or a sugary drink) and inform your doctor.
If you experience any side effects, including those not listed above, report them to your healthcare provider. Reporting suspected adverse reactions is important for ongoing safety monitoring of approved medications. In many countries, patients can also report side effects directly to their national regulatory authority.
How Should You Store Galvus?
Store Galvus in its original packaging at room temperature, away from moisture. Keep out of reach of children and do not use after the expiry date printed on the packaging.
Proper storage of Galvus is important to ensure the medication remains effective throughout its shelf life. Follow these guidelines to maintain the quality and safety of your tablets:
- Keep out of reach and sight of children — Store in a secure location that children cannot access
- Check the expiry date — Do not use Galvus after the expiry date (EXP) printed on the blister pack and carton. The expiry date refers to the last day of that month
- Store in original packaging — The original blister packaging protects the tablets from moisture, which can affect their stability
- Room temperature — No special temperature storage requirements, but avoid extreme heat or humidity
- Do not use damaged packaging — If the packaging is damaged or shows signs of tampering, do not take the medication
- Proper disposal — Do not dispose of unused medicines via wastewater or household waste. Return unused tablets to your pharmacist for safe disposal, which helps protect the environment
What Does Galvus Contain?
Each Galvus tablet contains 50 mg of the active substance vildagliptin. The tablets are round, white to slightly yellowish, and flat, imprinted with "NVR" on one side and "FB" on the other.
Understanding the full composition of your medication is important, particularly if you have known allergies or intolerances to any pharmaceutical excipients.
Active Ingredient
Each Galvus tablet contains 50 mg vildagliptin as the active substance. Vildagliptin is a potent and selective inhibitor of the DPP-4 enzyme, with a molecular formula of C17H25N3O2.
Inactive Ingredients (Excipients)
- Anhydrous lactose — A filler/binder derived from milk sugar
- Microcrystalline cellulose — A common pharmaceutical binder and disintegrant
- Sodium starch glycolate (Type A) — A disintegrant that helps the tablet break down in the gastrointestinal tract
- Magnesium stearate — A lubricant used in tablet manufacturing
Appearance and Pack Sizes
Galvus 50 mg tablets are round, white to light yellowish, and flat. They are imprinted with "NVR" on one side and "FB" on the other side. The tablets are available in pack sizes of 7, 14, 28, 30, 56, 60, 90, 112, 180, or 336 tablets. Multi-packs containing 3 individual packs of 112 tablets each are also available. Not all pack sizes may be marketed in every country.
Galvus is manufactured by Novartis and its authorized manufacturing partners. The marketing authorization is held by Novartis Europharm Limited, Dublin, Ireland.
Frequently Asked Questions About Galvus
Galvus (vildagliptin) is used to treat type 2 diabetes mellitus in adults. It helps regulate blood sugar levels by increasing insulin production and reducing glucagon release from the pancreas. It can be used alone when diet and exercise are insufficient, or in combination with other diabetes medications such as metformin, sulfonylureas, thiazolidinediones, or insulin.
Galvus works by inhibiting the enzyme DPP-4 (dipeptidyl peptidase-4), which normally breaks down incretin hormones (GLP-1 and GIP). By preserving higher levels of these hormones, Galvus stimulates the pancreas to produce more insulin after meals and reduces the liver's production of glucagon. This mechanism is glucose-dependent, meaning it primarily works when blood sugar is elevated, which results in a lower risk of hypoglycemia compared to sulfonylureas.
Yes, Galvus is frequently prescribed in combination with metformin. When used together, the typical dose is 50 mg vildagliptin twice daily (one in the morning and one in the evening) alongside the prescribed metformin dose. A fixed-dose combination tablet containing both vildagliptin and metformin (marketed as Eucreas or Galvumet in some countries) is also available for convenience.
The most common side effects are mild upper respiratory symptoms including sore throat, runny nose, and fever, which affect up to 1 in 10 patients. Common side effects also include headache, dizziness, nausea, constipation, joint pain, and muscle pain. Serious but rare side effects include pancreatitis, liver problems, and angioedema, all of which require immediate medical attention.
Yes. Liver function tests are required before starting Galvus, then at three-month intervals during the first year of treatment, and periodically thereafter. This monitoring is essential to detect any elevation in liver enzymes at an early stage. Your doctor will also monitor HbA1c (long-term blood sugar), kidney function, and other relevant parameters to ensure the medication is working safely and effectively.
No, Galvus should not be used during pregnancy or while breastfeeding. There are no adequate studies in pregnant women, and animal studies have indicated potential reproductive risks. It is also unknown whether vildagliptin passes into breast milk. Women who are pregnant or planning pregnancy should consult their doctor about alternative diabetes treatments, typically insulin therapy.
References
This article is based on international medical guidelines and peer-reviewed research. All medical claims follow evidence level 1A wherever applicable.
- European Medicines Agency (EMA). Galvus (vildagliptin) – Summary of Product Characteristics (SmPC). Last updated December 2025. Available at: EMA – Galvus
- American Diabetes Association (ADA). Standards of Medical Care in Diabetes – 2025. Diabetes Care. 2025;48(Suppl 1). DOI: 10.2337/dc25-SINT
- World Health Organization (WHO). WHO Model List of Essential Medicines, 23rd List. Geneva: WHO; 2023.
- National Institute for Health and Care Excellence (NICE). Type 2 diabetes in adults: management. NICE Guideline NG28. Last updated June 2024.
- Dejager S, Razac S, Foley JE, Schweizer A. Vildagliptin in drug-naive patients with type 2 diabetes: a 24-week, double-blind, randomized, placebo-controlled, multiple-dose study. Horm Metab Res. 2007;39(3):218-223.
- Schweizer A, Dejager S, Foley JE, Couturier A, Ligueros-Saylan M, Kothny W. Assessing the cardio-cerebrovascular safety of vildagliptin: meta-analysis of adjudicated events from a large Phase III type 2 diabetes population. Diabetes Obes Metab. 2010;12(6):485-494.
- Mathieu C, Barnett AH, Brath H, et al. Effectiveness and tolerability of second-line therapy with vildagliptin vs. other oral agents in type 2 diabetes: a real-life worldwide observational study (EDGE). Int J Clin Pract. 2013;67(10):947-956.
- Karagiannis T, Paschos P, Paletas K, Matthews DR, Tsapas A. Dipeptidyl peptidase-4 inhibitors for treatment of type 2 diabetes mellitus in the clinical setting: systematic review and meta-analysis. BMJ. 2012;344:e1369.
Medical Editorial Team
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