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Vildagliptin

AEMPS

Dipeptidyl peptidase-4 (DPP-4) inhibitor

ATC code: A10BH02

Brand names: Galvus, Jalra, Xiliarx, Eucreas (vildagliptin + metformin)

Updated · Methodology

Indications

Marketing claims without evidence base

The drug is promoted for these uses outside international guidelines. Each entry below is analyzed against AEMPS, FDA, EMA, Cochrane and major RCTs.

F

Weight loss

Not recommended

Vildagliptin is a dipeptidyl peptidase-4 (DPP-4) inhibitor antidiabetic. It is prescribed for type 2 diabetes ( 2024, 2024). In people without diabetes, vildagliptin is not indicated for weight loss: the drug has a neutral effect on weight (no significant weight loss) and is not approved for obesity treatment. The drug has specific risks: pancreatitis (rare but dangerous), nasopharyngitis, and hepatotoxicity (requires liver enzyme monitoring). If vildagliptin was prescribed for weight loss without diabetes, consider seeking a second opinion.

Sources

  1. AEMPS: Ficha técnica de Vildagliptina (2024)
  2. Cochrane: Green tea for weight loss and weight maintenance in overweight or obese adults (2012)
How to read tiers A–F
  • AStrong evidence – first or second line in international guidelines
  • BRecommended in selected cases
  • CStudy data contradict each other
  • DBenefit not proven, no documented harm
  • FDocumented harm, or risk without benefit

Mechanism of action

A selective DPP-4 inhibitor (like sitagliptin), raises active incretin GLP-1 and GIP levels, enhancing glucose-dependent insulin secretion and suppressing glucagon. Compared with sitagliptin, shorter 2-hour half-life requiring twice-daily dosing. Not -approved in the US due to hepatotoxicity cases in trials; widely used in Europe.

Safety

Contraindications

  • Vildagliptin hypersensitivity
  • Type 1 diabetes
  • Diabetic ketoacidosis
  • Hepatic impairment or transaminase elevation over 3× upper limit
  • Pregnancy and lactation
  • Age under 18

Serious adverse effects

  • Hepatotoxicity (EMA 2010 warning – mandatory transaminase monitoring)
  • Acute pancreatitis
  • Severe allergic reactions, angioedema
  • Bullous pemphigoid
  • Arthralgia (FDA 2015 warning for DPP-4 class)

Common adverse effects

  • Dizziness
  • Headache
  • Nausea
  • Constipation
  • Nasopharyngitis
  • Hypoglycemia with sulfonylureas

Pregnancy: can you take Vildagliptin?

Limited data. In pregnant T2D patients, insulin is base therapy.

Breastfeeding: can you take Vildagliptin?

Not used during lactation.

Calculate RID

Reference information, not a clinical decision. Discuss feeding pauses or changes with your physician or an IBCLC.

Practical notes

Timing and administration

Take twice daily with or without food. With eGFR under 50 – 50 mg once daily. Not used in hepatic impairment or elevated transaminases – hepatotoxicity risk. Before start and every 3 months in the first year, then as indicated, monitor ALT, AST. With transaminases over 3× upper limit – stop.
Label mentions15 mentions

Verbatim lines from the interaction sections, in the language of the label

From this drug’s label

  • Moderatesulfonilureasclass named in the label
    «Hipoglucemia: Es conocido que las sulfonilureas causan hipoglucemias. Los pacientes que reciben vildagliptina en combinación con una sulfonilurea pueden tener el riesgo de sufrir hipoglucemias. Por…»

    AEMPS, section 4.4 · Open on CIMA

  • Amlodipine
    «Combinación con amlodipino, ramipril, valsartán o simvastatina: Se han realizado ensayos clínicos de interacciones farmacológicas con amlodipino, ramipril, valsartán y simvastatina en sujetos sanos…»

    AEMPS, section 4.5 · Open on CIMA

  • corticosteroidesclass named in the label
    «Como ocurre con otros antidiabéticos orales, el efecto hipoglucemiante de vildagliptina puede verse reducido por determinados principios activos, incluyendo tiazidas, corticosteroides, productos para…»

    AEMPS, section 4.5 · Open on CIMA

  • Digoxin
    «Digoxina (sustrato de la glicoproteína P, gpP), warfarina (sustrato del CYP2C9): Los resultados de ensayos clínicos realizados en voluntarios sanos no han mostrado interacciones farmacocinéticas…»

    AEMPS, section 4.5 · Open on CIMA

  • inhibidores de la ECAclass named in the label
    «Combinación con inhibidores de la ECA: Podría haber un aumento del riesgo de angioedema en pacientes que tomen de forma concomitante inhibidores de la ECA (ver sección 4.8).»

    AEMPS, section 4.5 · Open on CIMA

  • Metformin
    «Combinación con pioglitazona, metformina y gliburida: Los resultados de ensayos clínicos realizados con estos antidiabéticos orales no han mostrado interacciones farmacocinéticas relevantes.»

    AEMPS, section 4.5 · Open on CIMA

  • Pioglitazone
    «Combinación con pioglitazona, metformina y gliburida: Los resultados de ensayos clínicos realizados con estos antidiabéticos orales no han mostrado interacciones farmacocinéticas relevantes.»

    AEMPS, section 4.5 · Open on CIMA

  • Ramipril
    «Combinación con amlodipino, ramipril, valsartán o simvastatina: Se han realizado ensayos clínicos de interacciones farmacológicas con amlodipino, ramipril, valsartán y simvastatina en sujetos sanos…»

    AEMPS, section 4.5 · Open on CIMA

  • simpaticomiméticosclass named in the label
    «Como ocurre con otros antidiabéticos orales, el efecto hipoglucemiante de vildagliptina puede verse reducido por determinados principios activos, incluyendo tiazidas, corticosteroides, productos para…»

    AEMPS, section 4.5 · Open on CIMA

  • Simvastatin
    «Combinación con amlodipino, ramipril, valsartán o simvastatina: Se han realizado ensayos clínicos de interacciones farmacológicas con amlodipino, ramipril, valsartán y simvastatina en sujetos sanos…»

    AEMPS, section 4.5 · Open on CIMA

  • tiazidasclass named in the label
    «Como ocurre con otros antidiabéticos orales, el efecto hipoglucemiante de vildagliptina puede verse reducido por determinados principios activos, incluyendo tiazidas, corticosteroides, productos para…»

    AEMPS, section 4.5 · Open on CIMA

  • Valsartan
    «Combinación con amlodipino, ramipril, valsartán o simvastatina: Se han realizado ensayos clínicos de interacciones farmacológicas con amlodipino, ramipril, valsartán y simvastatina en sujetos sanos…»

    AEMPS, section 4.5 · Open on CIMA

  • Warfarin
    «Digoxina (sustrato de la glicoproteína P, gpP), warfarina (sustrato del CYP2C9): Los resultados de ensayos clínicos realizados en voluntarios sanos no han mostrado interacciones farmacocinéticas…»

    AEMPS, section 4.5 · Open on CIMA

From other drugs’ labels

  • ModerateLisinopril
    «Hipersensibilidad/Angioedema: El uso concomitante de IECA con racecadotrilo, inhibidores de mTOR (por ejemplo, sirólimus, everólimus, temsirólimus) y vildagliptina puede aumentar el riesgo de…»

    AEMPS, section 4.4 · Open on CIMA

  • ModerateRamipril
    «Inhibidores de mTOR o vildagliptina: Es posible que se produzca un aumento del riesgo de angioedema en pacientes que toman medicamentos concomitantes como inhibidores de mTOR (p. ej. temsirolimus…»

    AEMPS, section 4.5 · Open on CIMA

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Frequently asked

What is Vildagliptin used for?

Vildagliptin is evaluated for the following indications with varying evidence strength: Type 2 diabetes mellitus (evidence tier B), Weight loss (evidence tier F). See the full indication matrix with dosing and citations above on this page.

What are the side effects of Vildagliptin?

Common side effects of Vildagliptin (≥ 1 in 100): Dizziness, Headache, Nausea, Constipation, Nasopharyngitis, Hypoglycemia with sulfonylureas. See the Safety section for uncommon and serious reactions.

Is Vildagliptin safe during pregnancy?

Limited data. In pregnant T2D patients, insulin is base therapy.

Is Vildagliptin compatible with breastfeeding?

Not used during lactation.

Who should not take Vildagliptin?

Vildagliptin is contraindicated in: Vildagliptin hypersensitivity; Type 1 diabetes; Diabetic ketoacidosis; Hepatic impairment or transaminase elevation over 3× upper limit; Pregnancy and lactation. Full list in the Safety section.

Official sources

Direct links to regulator labels. Open in a new tab.

Other drugs in this group

Vildagliptin + Metformin, Dapagliflozin, Empagliflozin, Glibenclamide, Insulin degludec, Insulin lispro, Repaglinide, Gliclazide