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FDA Adds Heart Failure Warnings to Januvia (Sitagliptin)

Heart Failure Warnings to Januvia

Approved by the Food & Drug Administration or FDA for effectively treating Type 2 diabetes, Januvia has shown effective results in managing blood sugar levels in diabetic patients. However, despite these benefits, the FDA has recently updated its safety information for type 2 diabetes drugs, including Januvia. The administration issued cautious warnings regarding the potential risk of heart failure associated with sitagliptin. This announcement has raised concerns regarding the safety of sitagliptin for treating diabetes. So, read on to know why the FDA adds heart failure warnings to Januvia 50 mg tablet and discover its potential side effects. In addition, we will also discuss diabetes drugs other than Januvia that might pose a threat to your health.

New FDA Warnings for Januvia

Januvia (sitagliptin), a DPP-4 inhibitor, is an oral diabetes medication for reducing blood sugar levels. The medicine has received a new warning label from the FDA for increased heart failure risk. While the clinical evidence clearly showed that the medication is not riskier for the heart, the FDA seems to take a safe approach based on other studies of similar medications. According to the outcomes shown in the Trial Evaluating Cardiovascular Outcomes with Sitagliptin (TECOS) study, the drugs used in this medication neither increased nor decreased the cases of hospitalization for heart failure. 

In contrast, Onglyza, another DPP-4 inhibitor, shows a 27% rise in hospitalizations for heart risks in the SAVOR-TIMI study. This clinical study shows that Januvia 100 mg tablet do not fall under the category of heart failure medications for diabetic patients. However, it should be noted that the FDA’s warning label advises against prescribing this medication to individuals at risk for heart failure. For those without such risk, sitagliptin remains a safer treatment option, so they can buy Januvia online. 

Potential Side Effects of Januvia & How to Manage Them

Besides the risks of heart failure, the medication may have a few side effects that might pose a threat to your health. Here are some details on these side effects:


While not so common, Januvia might cause hypoglycemia (low blood sugar) when taken without proper guidance. When this medication is combined with other diabetic drugs, such as insulin or glimepiride, the risk might increase. Hypoglycemia can impair the functioning of cells and organs due to insufficient sugar levels. Serious symptoms of hypoglycemia include:

  • confusion
  • dizziness
  • fast heartbeat
  • headache
  • hunger
  • sweating
  • weakness

Therefore, if you are noticing any of these symptoms, immediately contact your doctor. They will adjust your dosage to manage the amount of sugar in your body. 

Joint Pain

Another potential side effect of this drug is joint pains. However, the researchers are not sure about what exactly causes pain in patients’ joints while taking the medication. So, if you have joint discomfort, inform your doctor. They will prescribe you alternate diabetes medications and will also suggest some treatments related to joint pains. 


Januvia does not usually cause diarrhea. However, as per the clinical trials mentioned on the Merck website, people who took the medicine in combination with other drugs have reported diarrhea as a side effect. Metformin is one of the common medications known to cause diarrhea when taken alongside Januvia. To prevent this risk, it is advisable to drink plenty of water. If the diarrhea lasts for more than three days, seek expert advice.


While very unlikely, this medication can result in cancer as a side effect. According to the National Library of Medicine, a study in Taiwan found that people who took this drug are likely prone to develop thyroid cancer. However, no clinical trials in the United States have any connection between the two. Therefore, if you are taking Januvia 100 mg tablet and have concerns regarding thyroid cancer, it’s advisable to discuss this with your doctor.

Safety Information For Januvia Other Than Heart Failure 

According to the information provided by the FDA, Januvia might have different effects on specific populations other than heart risks. Here is a breakdown:

  • Pregnancy: The data on sitagliptin in pregnant women are limited and insufficient to determine the risk of birth defects and miscarriages. However, there are risks to both the mother and the baby associated with poorly managed diabetes in pregnancy.
  • Lactation: According to the FDA, there is no information available regarding the presence of Januvia in human milk, its effects on breastfed babies, or its impact on milk production. However, sitagliptin has been detected in the milk of lactating rats, which suggests it might also be present in human milk.
  • Renal Impairment: As sitagliptin is excreted by the kidneys, patients with renal impairment (kidney failure) are more exposed to this drug. As a result, lower doses of Januvia are prescribed to people with moderate to severe renal impairment.

What are the Other FDA Warnings for Type 2 Diabetes Drugs?

All over the internet, the FDA safety review has found that type 2 diabetes drugs containing saxagliptin and alogliptin could increase the chances of heart failure, especially among patients with preexisting heart or kidney conditions. As a result, the FDA has issued new warnings to drug labels regarding this safety concern. Additionally, the administration has recommended healthcare professionals consider discontinuing medications containing these two drugs to patients who have high chances of heart failure. 

In case a patient’s blood sugar level is not managed adequately with their current treatment, doctors are advised to prescribe medications that do not include the mentioned drugs. So, if you are a diabetic patient looking to order drugs from Canada that do not contain saxagliptin and alogliptin, like the Januvia 100 mg tablet, reach out to Polar Bear Meds. We deal with a wide range of quality medications that suit every patient’s needs.


The FDA’s recent addition of heart failure warnings to Januvia (sitagliptin) marks an important consideration for the treatment of type 2 diabetes. While Januvia effectively manages blood sugar levels, the updated warnings show a cautious approach to its use, especially in patients at risk for heart failure. Additionally, it’s important for patients to be aware of other side effects and safety information related to sitagliptin when using the drug to avoid potential complications.

Besides, there are other type 2 diabetes drugs, such as saxagliptin and alogliptin, that receive strict warnings from the FDA. These drugs might have more severe side effects than those of Januvia, which has shown neutral results in this area. Therefore, it is important for patients and healthcare providers to be aware of these risks.

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