DPP-4 inhibitor Pregnancy: Should not be used during pregnancy (no adequate human data; animal studies show reproductive toxicity at high doses) or during breast-feeding (excretion in human milk unknown; excreted in animal milk).

Vildagliptin

Brand names: Galvus

Vildagliptin is an oral dipeptidyl peptidase-4 (DPP-4) inhibitor used to improve glycaemic control in type 2 diabetes mellitus, either alone or combined with other antidiabetic agents. It is weight-neutral and carries a low intrinsic risk of hypoglycaemia.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: 100 mg daily, given as 50 mg in the morning and 50 mg in the evening

Route: Oral (with or without a meal)

Frequency: Twice daily (50 mg morning and 50 mg evening)

Max: 100 mg daily — doses higher than 100 mg are not recommended

The 100 mg daily (50 mg twice daily) regimen applies when vildagliptin is used as monotherapy, in combination with metformin, with a thiazolidinedione, with metformin and a sulphonylurea, or with insulin (with or without metformin). DUAL COMBINATION WITH A SULPHONYLUREA IS DIFFERENT: 50 mg once daily in the morning — 100 mg daily was no more effective than 50 mg once daily in this population; consider a lower sulphonylurea dose to reduce hypoglycaemia risk. If a dose is missed it should be taken as soon as the patient remembers, but a double dose should not be taken on the same day. Safety and efficacy as triple oral therapy with metformin and a thiazolidinedione have not been established. Elderly (65 years and over): no dose adjustment necessary. Hepatic impairment: should not be used, including patients with pre-treatment ALT or AST greater than 3x the upper limit of normal. Liver function tests before initiation, then every three months during the first year and periodically thereafter. Paediatric: not recommended in children and adolescents under 18 years — safety and efficacy not established, no data available. Source: eMC SPC for Vildagliptin 50 mg tablets.

Dose adjustments

Renal

No dose adjustment in mild renal impairment (creatinine clearance 50 ml/min or greater). In moderate or severe renal impairment or end-stage renal disease, the recommended dose is 50 mg once daily; use with caution in ESRD on haemodialysis (limited experience).

Dose auto-extracted from UK Summary of Product Characteristics (SPC) via the eMC — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

Hypersensitivity to the active substance or to any of the excipients

Side effects

Nasopharyngitis (very common); upper respiratory tract infection (common)
Dizziness, headache, tremor (common); blurred vision (common)
Gastrointestinal: constipation, nausea, gastro-oesophageal reflux disease, diarrhoea, abdominal pain, vomiting (common); pancreatitis (rare)
Skin: hyperhidrosis, rash, pruritus, dermatitis (common); exfoliative and bullous skin lesions including bullous pemphigoid (frequency not known)
Arthralgia, myalgia, asthenia, peripheral oedema (common); hypoglycaemia and abnormal liver function tests (uncommon); hepatitis (frequency not known)

Clinical monograph

How it works

It inhibits the DPP-4 enzyme, preventing the breakdown of the incretin hormones GLP-1 and GIP, which increases glucose-dependent insulin secretion and suppresses glucagon release.

Prescribing in practice

Rare but serious hepatic dysfunction has been reported, so liver function should be checked before and periodically during treatment, and it should not be started in those with hepatic impairment or raised liver enzymes.
Hypoglycaemia is uncommon on its own but the risk increases when combined with a sulfonylurea or insulin, which may need dose reduction.
Acute pancreatitis has been reported, so it should be stopped if pancreatitis is suspected.

Monitoring

Monitor HbA1c for glycaemic response and liver function before and during treatment, and review for symptoms suggestive of pancreatitis.

Counselling the patient

Take the tablets as directed, with the timing your clinician advises.
Report persistent severe abdominal pain, or yellowing of the skin or eyes.
Low blood sugar is unlikely unless you also take certain other diabetes medicines.

Evidence & guidelines

Its glucose-lowering efficacy was demonstrated in randomised controlled trials in type 2 diabetes supporting its regulatory approval.

Reference: NICE NG28; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Curated clinical cross-links plus same-class fallbacks.

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