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Januvia Side Effects

Common Januvia Side Effects

The most commonly reported Januvia side effects (click to view or check a box to report):

Blood Glucose Increased (692)
Pancreatitis (591)
Hypoglycaemia (475)
Headache (432)
Nausea (376)
Diarrhoea (333)
Dizziness (309)
Rash (276)
Pancreatic Carcinoma (236)
Dyspnoea (214)
Weight Decreased (211)
Rhinorrhoea (203)
Oedema Peripheral (202)
Vomiting (193)
Fatigue (189)
Pruritus (187)
Pancreatitis Acute (181)
Abdominal Pain (178)
Renal Failure Acute (176)
Asthenia (170)

➢ More



If you or someone in your family has experienced a serious side effect to a health product, you are encouraged to report the experience to your health care professional (e.g. physician, pharmacist). You could also complete a copy of the side effect reporting form or report your side effect to FDA.

Side effects reports are analyzed to discover potential health product safety signals. Some important reactions may take an extremely long time to develop or occur infrequently. Continued monitoring of adverse reactions is thus essential to maintain a comprehensive safety and effectiveness profile of health products.

Januvia Side Effects Reported to FDA

The following Januvia reports list potential signals of serious risks and new safety information that were identified using the FDA Adverse Event Reporting System (FAERS).
FAERS is a database that contains information on adverse event and medication errors reports submitted to FDA by healthcare professionals (such as physicians, pharmacists, nurses and others), consumers (such as patients, family members, layers and others) and manufacturers.


The appearance of Januvia on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but it does not mean that FDA has found a causal relationship between the drug and the listed risk.
Heart Rate Increased, Tremor, Asthenopia
on Mar 12, 2014 Female from IN , 52 years of age, was diagnosed with and was treated with Januvia. Directly after, patient experienced the unwanted or unexpected Januvia side effects: heart rate increased, tremor, asthenopia. Januvia dosage: 100 Mg, Qd.

Blood Glucose Increased
Patient was taking Januvia. Patient felt the following Januvia side effects: blood glucose increased on Mar 12, 2014 from IN Additional patient health information: Female , 40 years of age, was diagnosed with and. Januvia dosage: 1/day. Patient was hospitalized.

Pancreatitis
Adverse event was reported on Mar 11, 2014 by a Male taking Januvia (Dosage: 100 Mg, Unk) was diagnosed with and. Location: US , 60 years of age, After Januvia was administered, patient encountered several Januvia side effects: pancreatitis.
Multiple concurrent drugs taken:
  • Metformin
Patient was hospitalized.

Pancreatic Carcinoma
on Mar 10, 2014 Male from US , 70 years of age, was diagnosed with and was treated with Januvia. Directly after, patient experienced the unwanted or unexpected Januvia side effects: pancreatic carcinoma. Januvia dosage: N/A.


Alopecia
on Mar 10, 2014 Female from US , 41 years of age, was diagnosed with and was treated with Januvia. Patient felt the following Januvia side effects: alopecia. Januvia dosage: Unk.


Patient was taking Januvia. on Mar 10, 2014 from IN Additional patient health information: Male , 72 years of age, weighting 176.4 lb, . Januvia dosage: 100 Mg, 1 Tab, Qd.

Accident, Limb Operation
Adverse event was reported on Mar 10, 2014 by a Male taking Januvia (Dosage: 1 Df, Qd) . Location: IN , 47 years of age, weighting 154.3 lb, Directly after, patient experienced the unwanted or unexpected Januvia side effects: accident, limb operation.

Tubulointerstitial Nephritis, Renal Failure Acute, Osteoarthritis, Seborrhoeic Keratosis, Diabetic Retinopathy, Urinary Incontinence
on Mar 07, 2014 Male from GB , 81 years of age, weighting 123.5 lb, was diagnosed with and was treated with Januvia. Patient felt the following Januvia side effects: tubulointerstitial nephritis, renal failure acute, osteoarthritis, seborrhoeic keratosis, diabetic retinopathy, urinary incontinence. Januvia dosage: Unk.
Multiple prescriptions taken:
  • Prednisolone (30mg Daily)
  • Simvastatin (1 Tablet Daily, One At Night, 56 Tablet)
  • Amlodipine (10 Mg Daily)
  • Hydroxyzine Hydrochloride (25mg Daily)
  • Omeprazole (20 Mg Daily, One Tablet Daily, 28 Capsule)
  • Doxazosin Mesylate (2 Mg, Bid, Take One Daily, 56 Tablet)
  • Gliclazide (160 Mg, Bid, Two Morning Two Evening, 224 Tablet)
  • Humulin I (2 Pre-filled Disposable Injection)


Macular Oedema, Hepatic Steatosis
on Mar 15, 2014 Male from IN , 53 years of age, was diagnosed with and was treated with Januvia. After Januvia was administered, patient encountered several Januvia side effects: macular oedema, hepatic steatosis. Januvia dosage: 50 Mg, Qd. Patient was hospitalized.

Myocardial Infarction, Cardiac Arrest
Patient was taking Januvia. Directly after, patient experienced the unwanted or unexpected Januvia side effects: myocardial infarction, cardiac arrest on Mar 07, 2014 from PH Additional patient health information: Female , 58 years of age, . Januvia dosage: 50 Mg, One Tablet, Once A Day.

Gastric Disorder, Dyspepsia, Pain, Paraesthesia
Adverse event was reported on Mar 13, 2014 by a Female taking Januvia (Dosage: 1x/day) was diagnosed with and. Location: IN , 51 years of age, Patient felt the following Januvia side effects: gastric disorder, dyspepsia, pain, paraesthesia.

Spondylitis, Hypoaesthesia, Arthropathy
on Mar 17, 2014 Male from IN , 48 years of age, was diagnosed with and was treated with Januvia. After Januvia was administered, patient encountered several Januvia side effects: spondylitis, hypoaesthesia, arthropathy. Januvia dosage: 100 Mg 1x/day.

Blood Glucose Abnormal, Vision Blurred, Body Temperature Decreased, Feeling Cold
on Mar 06, 2014 Male from IN , 62 years of age, weighting 154.3 lb, was treated with Januvia. Directly after, patient experienced the unwanted or unexpected Januvia side effects: blood glucose abnormal, vision blurred, body temperature decreased, feeling cold. Januvia dosage: 1/day.
Associated medications used:
  • Insulin


Nausea, Pancreatic Neuroendocrine Tumour
Patient was taking Januvia. Patient felt the following Januvia side effects: nausea, pancreatic neuroendocrine tumour on Mar 05, 2014 from US Additional patient health information: Male , 54 years of age, weighting 175.0 lb, was diagnosed with and. Januvia dosage: 2 Pills, Twice Daily, Taken By Mouth. Patient was hospitalized and became disabled.

Muscle Rupture
Adverse event was reported on Mar 06, 2014 by a Male taking Januvia (Dosage: 1 Df, Qd) . Location: FR , 63 years of age, After Januvia was administered, patient encountered several Januvia side effects: muscle rupture.
Multiple concurrent drugs taken:
  • Xarelto (20 Mg, Qd)
  • Simvastatin (20 Mg, Qd)
  • Nisisco (1 Df, Qd)
  • Cordarone (200 Mg, Qd)
  • Mediatensyl (120 Mg, Qd)
  • Hemigoxine Nativelle (0.125 Mg, Qd)
  • Stagid (2100 Mg, Qd)


Complication Of Delivery, Exposure During Pregnancy
on Mar 06, 2014 Female from FR , 38 years of age, was diagnosed with and was treated with Januvia. Directly after, patient experienced the unwanted or unexpected Januvia side effects: complication of delivery, exposure during pregnancy. Januvia dosage: Unk.
Associated medications used:
  • Amarel (Unk)
  • Metformin (Unk)


Cleft Lip And Palate, Foetal Exposure During Pregnancy
on Mar 06, 2014 Male from FR , weighting 5.29 lb, was diagnosed with and was treated with Januvia. Patient felt the following Januvia side effects: cleft lip and palate, foetal exposure during pregnancy. Januvia dosage: Unk.
Multiple prescriptions taken:
  • Amarel (Unk)
  • Metformin (Unk)
Patient was hospitalized.

Cerebellar Infarction, Pneumonia
Patient was taking Januvia Tablets 50mg. After Januvia was administered, patient encountered several Januvia side effects: cerebellar infarction, pneumonia on Mar 31, 2014 from JP Additional patient health information: Male , 75 years of age, weighting 125.7 lb, was diagnosed with and. Januvia Tablets 50mg dosage: 50 Mg, Qd. Patient was hospitalized and became disabled.

Loss Of Consciousness, Pneumonia, Hypoglycaemia, Respiratory Disorder, Decreased Appetite
Adverse event was reported on Mar 23, 2014 by a Female taking Januvia Tablets 50mg (Dosage: 50 Mg, Qd) was diagnosed with and. Location: JP , 86 years of age, weighting 61.73 lb, Directly after, patient experienced the unwanted or unexpected Januvia side effects: loss of consciousness, pneumonia, hypoglycaemia, respiratory disorder, decreased appetite.
Associated medications used:
  • Rozerem (8 Mg, Qd)
  • Sennosides (12 Mg, Bid)
  • Memary (20 Mg, Qd)
  • Magnesium Oxide (2 G, Bid)
  • Acecol (2 Mg, Qd)
  • Aricept D (10 Mg, Qd)
  • Takepron (15 Mg, Qd)
  • Opalmon (5 Mg, Bid)
Patient was hospitalized.

Abdominal Pain
on Mar 27, 2014 Male from US , 68 years of age, was diagnosed with and was treated with Januvia. Patient felt the following Januvia side effects: abdominal pain. Januvia dosage: 100 Mg, Qd.
Multiple prescriptions taken:
  • Metformin (1000 Mg, Bid)
Patient was hospitalized.

Pancreatitis Chronic
on Mar 11, 2014 Female from US , 53 years of age, was diagnosed with and was treated with Januvia. After Januvia was administered, patient encountered several Januvia side effects: pancreatitis chronic. Januvia dosage: N/A. Patient was hospitalized.

Hypoglycaemia
Patient was taking Januvia Tablets 100mg. Directly after, patient experienced the unwanted or unexpected Januvia side effects: hypoglycaemia on Mar 03, 2014 from JP Additional patient health information: Male , 84 years of age, was diagnosed with and. Januvia Tablets 100mg dosage: N/A.
Associated medications used:
  • Glimepiride
  • Glimepiride (0.5 Mg, Daily)
  • Voglibose
  • Insulin


Pancreatitis, Rash, Abdominal Pain
Adverse event was reported on Mar 03, 2014 by a Female taking Januvia (Dosage: Unk) was diagnosed with and. Location: US , 74 years of age, Patient felt the following Januvia side effects: pancreatitis, rash, abdominal pain.
Multiple prescriptions taken:
  • Metformin (100 Mg, Bid)
  • Lantus (24 Iu, Hs)
  • Synthroid (Unk)
  • Avapro (Unk)
  • Pravastatin Sodium (Unk)


Pancreatitis
on Mar 03, 2014 Male from US , 46 years of age, was diagnosed with and was treated with Januvia. After Januvia was administered, patient encountered several Januvia side effects: pancreatitis. Januvia dosage: Unk.
Multiple concurrent drugs taken:
  • Lantus (35 Df, Bid)
  • Novolog
  • Glipizide (5 Mg, Bid)
  • Metformin (1000 Mg, Bid)
Patient was hospitalized.

Glomerular Filtration Rate Decreased
on Mar 01, 2014 Female from US , 81 years of age, was diagnosed with and was treated with Januvia. Directly after, patient experienced the unwanted or unexpected Januvia side effects: glomerular filtration rate decreased. Januvia dosage: 100 Mg, Qd.

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Keep Track of Side Effects

Note Your Observations

It is really important to keep of your symptoms, right from the time you start a new medicine. You can do it any way you prefer: in a notebook, in a computer file or using our online tool. You should also note down any other medicines you are taking at the same time, because there could be an interaction between these medicines.

Why Your Notes are Important

Your notes could be helpful in several ways:

  • You can use them to remind you of details that may alert your health care professional(s) to a problem
  • You will have a record to refer to in the future, in case you are ever prescribed the same medicine again

  • Log Form

    You can use the following log form to write down important information, like the date and time you experienced a side effect and your symptoms, how strong the symptoms were, and any other medicines you were using.

    Medicine Name and Dosage:

     

    Side Effects

    Scale

    Date & Time

    Other Medicine(s) or Treatment(s)

     

     

     

     

    Scale: 1 = very mild to 10 = very bad


    Track Online

  • User Sign In
  • Register to track your side effects

  • You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

    Discuss Januvia Side Effects

    Did You Have a Januvia Side Effect?

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    Yes, Moderate
    Yes, Minor
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    How Effective is Januvia for You?

    Exceeded Expectations
    Effective
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    Safety Alerts, Active Ingredients, Usage Information

    Alternative JANUVIA Names:SITAGLIPT

    Active Ingredient: SITAGLIPT

    Januvia Dosage, Warnings, Usage.

    Side Effects reported to FDA: 9243

    Januvia safety alerts: 2009

    Reported deaths: 610

    Reported hospitalizations: 3161

    Sitagliptin (marketed as Januvia and Janumet) - acute pancreatitis

    Audience: Diabetes healthcare professionals, patients

    [Posted 09/25/2009] FDA notified healthcare professionals and patients of revisions to the prescribing information for Januvia (sitagliptin) and Janumet (sitagliptin/metformin) to include information on reported cases of acute pancreatitis in patients using these products. Eighty-eight post-marketing cases of acute pancreatitis, including two cases of hemorrhagic or necrotizing pancreatitis in patients using sitagliptin, were reported to the Agency between October 2006 and February 2009. It is recommended that healthcare professionals monitor patients carefully for the development of pancreatitis after initiation or dose increases of sitagliptin or sitagliptin/metformin. Sitagliptin has not been studied in patients with a history of pancreatitis. Therefore, it is not known whether these patients are at an increased risk for developing pancreatitis and the medication should be used with caution and with appropriate monitoring in patients with a history of pancreatitis. Considerations for healthcare professionals, information for patients, and a Data Summary are provided.

    [09/25/2009 - Information for Healthcare Professionals - FDA]

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