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Joint (42)
Muscle Pain Fever (37)
Itching (29)
Constipation (26)
Joint And Muscle Pain Fever (24)
Hair Loss (19)
Night Sweats (15)
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Januvia Side Effects and Adverse Effects reported to US Food and Drug Administration (FDA)

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Showing 1-25 of 7472 

Colon Cancer, Abdominal Distension (8469772-3)
on Jun 21, 2012 Female from UNITED STATES , 64 years of age, was diagnosed with
  • type 2 diabetes mellitus
and was treated with Januvia. Directly after, patient experienced the unwanted or unexpected Januvia side effects: colon cancer, abdominal distension. Januvia dosage: N/A.
Associated medications used:
  • Metformin


Cardiac Arrest (8468174-3)
Patient was taking Januvia. Patient felt the following Januvia side effects: cardiac arrest on Jun 20, 2012 from PHILIPPINES Additional patient health information: Female , 77 years of age, . Januvia dosage: N/A.

Nausea, Hyperbilirubinaemia, Blood Alkaline Phosphatase Increased, Gallbladder Disorder, Alanine Aminotransferase Increased, Abdominal Pain, Aspartate Aminotransferase Increased (8468172-X)
Adverse event was reported on Jun 22, 2012 by a Male taking Januvia (Dosage: N/A) . Location: UNITED STATES , 65 years of age, After Januvia was administered, patient encountered several Januvia side effects: nausea, hyperbilirubinaemia, blood alkaline phosphatase increased, gallbladder disorder, alanine aminotransferase increased, abdominal pain, aspartate aminotransferase increased.
Multiple concurrent drugs taken:
  • Victoza
  • Glyburide
Patient was hospitalized.

Cerebrovascular Accident (8463445-9)
on Jun 19, 2012 Male from UNITED STATES , 74 years of age, was diagnosed with
  • type 2 diabetes mellitus
and was treated with Januvia. Directly after, patient experienced the unwanted or unexpected Januvia side effects: cerebrovascular accident. Januvia dosage: N/A. Patient was hospitalized.


Pneumonia (8459749-6)
on Jun 20, 2012 Male from JAPAN , 76 years of age, was diagnosed with
  • diabetes mellitus
and was treated with Januvia. Patient felt the following Januvia side effects: pneumonia. Januvia dosage: N/A. Patient was hospitalized.

Constipation (8457729-8)
Patient was taking Januvia. After Januvia was administered, patient encountered several Januvia side effects: constipation on Jun 18, 2012 from UNITED STATES Additional patient health information: Male , 66 years of age, weighting 250.0 lb, was diagnosed with
  • renal impairment
and. Januvia dosage: 50 Daily Po.

Carbohydrate Antigen 19-9 Increased, Amylase Increased, Lipase Increased (8456575-9)
Adverse event was reported on Jun 19, 2012 by a Female taking Januvia (Dosage: N/A) was diagnosed with
  • diabetes mellitus
and. Location: UNITED STATES , 77 years of age, Directly after, patient experienced the unwanted or unexpected Januvia side effects: carbohydrate antigen 19-9 increased, amylase increased, lipase increased.

Malaise, Dyspnoea, Atrioventricular Block Complete (8455329-7)
on Jun 18, 2012 Female from JAPAN , 76 years of age, was treated with Januvia. Patient felt the following Januvia side effects: malaise, dyspnoea, atrioventricular block complete. Januvia dosage: 50 Mg/day.
Multiple prescriptions taken:
  • Valsartan And Hydrochlorothiazide (Unk)
  • Norvasc (5 Mg, Daily)
  • Glimicron (40 Mg/day)
Patient was hospitalized.

Chest Discomfort, Hiatus Hernia (8453628-6)
on Jun 12, 2012 Female from JAPAN , 99 years of age, was treated with Januvia. After Januvia was administered, patient encountered several Januvia side effects: chest discomfort, hiatus hernia. Januvia dosage: N/A. Patient was hospitalized.

Prostate Cancer (8453603-1)
Patient was taking Januvia. Directly after, patient experienced the unwanted or unexpected Januvia side effects: prostate cancer on Jun 09, 2012 from FRANCE Additional patient health information: Male , 55 years of age, weighting 147.7 lb, was diagnosed with
  • type 2 diabetes mellitus
  • dyslipidaemia
and. Januvia dosage: N/A. Patient was hospitalized.

Femoral Neck Fracture, Pyelonephritis, Urinary Tract Infection (8453596-7)
Adverse event was reported on Jun 11, 2012 by a Female taking Januvia (Dosage: N/A) . Location: JAPAN , 78 years of age, Patient felt the following Januvia side effects: femoral neck fracture, pyelonephritis, urinary tract infection. Patient was hospitalized.

Knee Arthroplasty, Movement Disorder (8450699-8)
on Jun 04, 2012 Female from UNITED STATES , 62 years of age, weighting 208.0 lb, was treated with Januvia. After Januvia was administered, patient encountered several Januvia side effects: knee arthroplasty, movement disorder. Januvia dosage: N/A.
Multiple concurrent drugs taken:
  • Celebrex
  • Meloxicam (7.5 Mg (7.5 Mg, Daily), Oral)


White Blood Cell Count Increased, Platelet Count Increased, Off Label Use (8450435-5)
on Jun 12, 2012 Female from JAPAN , 48 years of age, was treated with Januvia. Directly after, patient experienced the unwanted or unexpected Januvia side effects: white blood cell count increased, platelet count increased, off label use. Januvia dosage: N/A.
Associated medications used:
  • Lansoprazole
  • Pandel (Unk)
  • Prograf
  • Alendronate Sodium
  • Prednisolone (20 Mg, Qod)
  • Restamin (40 G, Q2w)


Subdural Haematoma, Pancreatitis (8449477-5)
Patient was taking Januvia. Patient felt the following Januvia side effects: subdural haematoma, pancreatitis on Jun 14, 2012 from UNITED STATES Additional patient health information: Male , 69 years of age, was diagnosed with
  • type 2 diabetes mellitus
and. Januvia dosage: N/A. Patient was hospitalized.

Myocardial Infarction (8449476-3)
Adverse event was reported on Jun 12, 2012 by a Female taking Januvia (Dosage: N/A) was diagnosed with
  • type 2 diabetes mellitus
and. Location: JAPAN , 40 years of age, After Januvia was administered, patient encountered several Januvia side effects: myocardial infarction.
Multiple concurrent drugs taken:
  • Amaryl
  • Metformin Hcl


Prostate Cancer (8448683-3)
on Jun 09, 2012 Male from FRANCE , 55 years of age, weighting 147.7 lb, was diagnosed with
  • type 2 diabetes mellitus
and was treated with Januvia. Directly after, patient experienced the unwanted or unexpected Januvia side effects: prostate cancer. Januvia dosage: N/A.
Associated medications used:
  • Metformin Hydrochloride
Patient was hospitalized.

Cholecystitis Acute (8448673-0)
on Jun 13, 2012 Male from FRANCE , 80 years of age, weighting 158.7 lb, was diagnosed with
  • type 2 diabetes mellitus
and was treated with Januvia. Patient felt the following Januvia side effects: cholecystitis acute. Januvia dosage: N/A.
Multiple prescriptions taken:
  • Insulin Glargine
  • Janumet
  • Metformin
  • Metformin
  • Janumet
Patient was hospitalized.

Prostate Cancer (8448660-2)
Patient was taking Januvia. After Januvia was administered, patient encountered several Januvia side effects: prostate cancer on Jun 09, 2012 from FRANCE Additional patient health information: Male , 59 years of age, weighting 205.0 lb, was diagnosed with
  • type 2 diabetes mellitus
and. Januvia dosage: N/A.
Multiple concurrent drugs taken:
  • Metformin Hydrochloride
Patient was hospitalized.

Pancreatitis, Malaise (8446530-7)
Adverse event was reported on Jun 12, 2012 by a Male taking Januvia (Dosage: N/A) . Location: UNITED STATES , 77 years of age, Directly after, patient experienced the unwanted or unexpected Januvia side effects: pancreatitis, malaise. Patient was hospitalized.

Cataract, Social Avoidant Behaviour, Emotional Distress (8445320-9)
on Jun 08, 2012 Female from UNITED STATES , 60 years of age, weighting 280.0 lb, was diagnosed with
  • diabetes mellitus
and was treated with Januvia. Patient felt the following Januvia side effects: cataract, social avoidant behaviour, emotional distress. Januvia dosage: N/A.
Multiple prescriptions taken:
  • Lasix
  • Effixer
  • Lamictal
  • Seroquel Xr
  • Prinival
  • Nexium
  • Synthroid
  • Lipitor


Laryngeal Cancer (8443141-4)
on Jun 11, 2012 Male from FRANCE , 63 years of age, weighting 224.9 lb, was diagnosed with
  • type 2 diabetes mellitus
and was treated with Januvia. After Januvia was administered, patient encountered several Januvia side effects: laryngeal cancer. Januvia dosage: N/A.
Multiple concurrent drugs taken:
  • Metformin
Patient was hospitalized.

Bradycardia, Cardiac Failure Congestive, Gastroenteritis, Bundle Branch Block Right, Atrioventricular Block, Insomnia (8439612-7)
Patient was taking Januvia. Directly after, patient experienced the unwanted or unexpected Januvia side effects: bradycardia, cardiac failure congestive, gastroenteritis, bundle branch block right, atrioventricular block, insomnia on May 29, 2012 from JAPAN Additional patient health information: Male , 85 years of age, was diagnosed with
  • type 2 diabetes mellitus
and. Januvia dosage: 50 Mg, Daily, Po.
Associated medications used:
  • Kolantyl
  • Femotidine
  • Bio There
  • Glimepiride
  • Lopemin
Patient was hospitalized.

Renal Failure Acute, Diarrhoea (8436751-1)
Adverse event was reported on Jun 04, 2012 by a Female taking Januvia (Dosage: N/A) was diagnosed with
  • diabetes mellitus
and. Location: JAPAN , 66 years of age, weighting 136.7 lb, Patient felt the following Januvia side effects: renal failure acute, diarrhoea.

Musculoskeletal Chest Pain, Gastrooesophageal Reflux Disease (8436717-1)
on Jun 11, 2012 Female from UNITED STATES , weighting 130.0 lb, was diagnosed with
  • diabetes mellitus
and was treated with Januvia. After Januvia was administered, patient encountered several Januvia side effects: musculoskeletal chest pain, gastrooesophageal reflux disease. Januvia dosage: 1 Tab By Mouth Once Daily.

Interstitial Lung Disease (8434364-9)
on Jun 11, 2012 Male from JAPAN , 60 years of age, was diagnosed with
  • diabetes mellitus
and was treated with Januvia. Directly after, patient experienced the unwanted or unexpected Januvia side effects: interstitial lung disease. Januvia dosage: N/A. Patient was hospitalized.

Showing 1-25 of 7472 

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It is very important to keep track of all side effects and discuss them with your doctor. If you think you may have a medical emergency, call your doctor or 911 immediately.

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Most drugs have a large list of nonsevere or mild adverse effects which do not rule out continued usage. These effects depend on individual sensitivity, and can include nausea, dizziness, diarrhea, malaise, vomiting, headache, dermatitis, dry mouth, etc. Check commonly reported side effects . These can be considered a form of pseudo-allergic reaction, as not all users experience these effects; many users experience none at all.

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.

Januvia Information

Alternative JANUVIA Names:SITAGLIPT

Active Ingredient: SITAGLIPT

Januvia Dosage, Warnings, Usage.

Side Effects reported to FDA: 7472. View Januvia Adverse Reports

Januvia safety alerts: 2009

Reported deaths: 301

Reported hospitalizations: 2335

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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