Januvia contraindications and warnings


Following is information on contraindications to the use of sitagliptin in general, pregnancy & breastfeeding and children. Please note that the contraindications may vary depending on the dosage form of a drug (eg tablet, syringe, ointment).

When should sitagliptin not be used?

The use of sitagliptin is prohibited at

  • Hypersensitivity to the active substance
  • Type 1 diabetes mellitus
  • a metabolic derailment associated with diabetes (diabetic ketoacidosis)
  • moderate to severe renal impairment due to lack of relevant experience.

Special medical control is required in the treatment with the active substance when sitagliptin is combined with a sulphonylurea. This can lead to sudden hypoglycaemia (hypoglycemia); the doctor may need to reduce the dose of the sulphonylurea.

Following the launch of sitagliptin, some patients have experienced serious hypersensitivity reactions to the active substance. These reactions include shock, vascular swelling and severe skin reactions (including Stevens-Johnson syndrome). These reactions occurred within the first three months after initiation of sitagliptin treatment, reportedly after the first dose. If there is a suspicion of a hypersensitivity reaction, the drug must be discontinued immediately. Diabetes treatment should then be continued with other drugs.

What should you watch out for during pregnancy and lactation?

So far, there have not been enough studies on the use of sitagliptin in pregnant women. In animal experiments, however, there were already indications of malformations at high doses. The potential risk in humans is unknown. Due to the lack of knowledge, the active ingredient should not be taken during pregnancy.

It is not known if sitagliptin is excreted in human breast milk. Animal studies have shown that sitagliptin passes into breast milk. Therefore, the active ingredient should not be taken during breast-feeding.

What should be considered in children?

Because there are no studies on effects and tolerability in children, sitagliptin must not be used in people under the age of 18.

Warnings and Precautions

  • Driving and operating machinery can be affected by dizziness and drowsiness.

Sometimes medications release allergic reactions.
If you notice any signs of allergic reaction, tell your doctor or pharmacist immediately.