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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
This is a report of a 52-year-old female patient (weight: NA) from IN, suffering from the following symptoms/conditions: diabetes mellitus, who was treated with Januvia (dosage: 100 Mg, Qd, start time: NS), combined with: NA. and developed a serious reaction and side effect(s). The consumer presented with:
  • Heart Rate Increased
  • Tremor
  • Asthenopia
which developed after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Januvia treatment in female patients, resulting in heart rate increased side effect.

Blood Glucose Increased
This report suggests a potential Januvia Blood Glucose Increased side effect(s) that can have serious consequences. A 40-year-old female patient (weight: NA) from IN was diagnosed with the following symptoms/conditions: diabetes mellitus and used Januvia (dosage: 1/day) starting NS. Soon after starting Januvia the patient began experiencing various side effects, including:
  • Blood Glucose Increased
Drugs used concurrently: NA.The patient was hospitalized. Although Januvia demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as blood glucose increased, may still occur.

Pancreatitis
This Pancreatitis problem was reported by a consumer or non-health professional from US. A 60-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: type 2 diabetes mellitus. On NS this consumer started treatment with Januvia (dosage: 100 Mg, Unk). The following drugs were being taken at the same time:
  • Metformin
When commencing Januvia, the patient experienced the following unwanted symptoms/side effects:
  • Pancreatitis
The patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as pancreatitis, may become evident only after a product is in use by the general population.

Pancreatic Carcinoma
This is a report of a 70-year-old male patient (weight: NA) from US. The patient developed the following symptoms/conditions: diabetes mellitus and was treated with Januvia (dosage: NA) starting 2010. Concurrently used drugs: NA.Soon after that, the consumer experienced the following side effects:
  • Pancreatic Carcinoma
This opens a possibility that Januvia treatment could cause the above reactions, including pancreatic carcinoma, and some male subjects may be more susceptible.


Alopecia
A 41-year-old female patient (weight: NA) from US with the following symptoms/conditions: diabetes mellitus started Januvia treatment (dosage: Unk) on NS. Soon after starting Januvia treatment, the subject experienced various side effects, including:
  • Alopecia
Concurrently used drugs: NA. This finding indicates that some female patients could be more vulnerable to Januvia.


A 72-year-old male patient from IN (weight: NA) experienced symptoms, such as: NA and was treated with Januvia(dosage: 100 Mg, 1 Tab, Qd). The treatment was initiated on NS. After that a consumer reported the following side effect(s):
    Concurrently used drugs, which potentially could have contributed to side effect(s) or affected Januvia efficacy: NA.

    Accident, Limb Operation
    In this report, Januvia was administered for the following condition: NA.A 47-year-old male consumer from IN (weight: NA) started Januvia treatment (dosage: 1 Df, Qd) on NS.Sometime after starting the treatment, the patient complained of the following side effect(s):
    • Accident
    • Limb Operation
    A possible interaction with other drugs could have contributed to this reaction: NA.Establishing a causal relationship between a specific drug and consumer's side effects is complex, but it is possible that in this report Januvia treatment could be related to the listed above side effect(s).

    Tubulointerstitial Nephritis, Renal Failure Acute, Osteoarthritis, Seborrhoeic Keratosis, Diabetic Retinopathy, Urinary Incontinence
    This is a report of the following Januvia side effect(s):
    • Tubulointerstitial Nephritis
    • Renal Failure Acute
    • Osteoarthritis
    • Seborrhoeic Keratosis
    • Diabetic Retinopathy
    • Urinary Incontinence
    A 81-year-old male patient from GB (weight: NA) presented with the following condition: type 2 diabetes mellitus and received a treatment with Januvia (dosage: Unk) starting: Mar 05, 2013.The following concurrently used drugs could have generated interactions:
    • 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)
    This report suggests that a Januvia treatment could be associated with the listed above side effect(s).

    Macular Oedema, Hepatic Steatosis
    This Januvia report was submitted by a 53-year-old male consumer from IN (weight: NA). The patient was diagnosed with: diabetes mellitus and Januvia was administered (dosage: 50 Mg, Qd) starting: NS. The consumer developed a set of symptoms:
    • Macular Oedema
    • Hepatic Steatosis
    Other drugs used simultaneously: NA.The patient was hospitalized.Those unexpected symptoms could be linked to a Januvia treatment, however establishing a potential drug-safety problem requires a more detailed clinical analysis.

    Myocardial Infarction, Cardiac Arrest
    This is a report of a possible correlation between Januvia use and the following symptoms/side effect(s):
    • Myocardial Infarction
    • Cardiac Arrest
    which could contribute to an assessment of Januvia risk profile.A 58-year-old female consumer from PH (weight: NA) was suffering from NA and was treated with Januvia (dosage: 50 Mg, One Tablet, Once A Day) starting Aug 04, 2012.Other concurrent medications: NA.

    Gastric Disorder, Dyspepsia, Pain, Paraesthesia
    A 51-year-old female patient from IN (weight: NA) presented with the following symptoms: diabetes mellitus and after a treatment with Januvia (dosage: 1x/day) experienced the following side effect(s):
    • Gastric Disorder
    • Dyspepsia
    • Pain
    • Paraesthesia
    The treatment was started on NS. Januvia was used in combination with the following drugs: NA.This report could alert potential Januvia consumers.

    Spondylitis, Hypoaesthesia, Arthropathy
    In this report, a 48-year-old male patient from IN (weight: NA) was affected by a possible Januvia side effect.The patient was diagnosed with diabetes mellitus. After a treatment with Januvia (dosage: 100 Mg 1x/day, start date: NS), the patient experienced the following side effect(s):
    • Spondylitis
    • Hypoaesthesia
    • Arthropathy
    The following simultaneously used drugs could have led to this reaction: NA.The findings here stress that side effects should be taken into consideration when evaluating a Januvia treatment.

    Blood Glucose Abnormal, Vision Blurred, Body Temperature Decreased, Feeling Cold
    This is a report of a 62-year-old male patient from IN (weight: NA), who used Januvia (dosage: 1/day) for a treatment of NA. After starting a treatment on NS, the patient experienced the following side effect(s):
    • Blood Glucose Abnormal
    • Vision Blurred
    • Body Temperature Decreased
    • Feeling Cold
    The following drugs could possibly have interacted with the Januvia treatment
    • Insulin
    Taken together, these observations suggest that a Januvia treatment could be related to side effect(s), such as Blood Glucose Abnormal, Vision Blurred, Body Temperature Decreased, Feeling Cold.

    Nausea, Pancreatic Neuroendocrine Tumour
    This nausea side effect was reported by a consumer or non-health professional from US. A 54-year-old male patient (weight:NA) experienced the following symptoms/conditions: diabetes mellitus. The patient was prescribed Januvia (dosage: 2 Pills, Twice Daily, Taken By Mouth), which was started on Jan 05, 2009. Concurrently used drugs: NA. When starting to take Januvia the consumer reported the following symptoms:
    • Nausea
    • Pancreatic Neuroendocrine Tumour
    The patient was hospitalized and became disabled. These side effects may potentially be related to Januvia.

    Muscle Rupture
    This is a Januvia side effect report of a 63-year-old male patient (weight:NA) from FR, suffering from the following symptoms/conditions: NA, who was treated with Januvia (dosage:1 Df, Qd, start time: 2010), combined with:
    • 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)
    , and developed a serious reaction and a muscle rupture side effect. The patient presented with:
    • Muscle Rupture
    which developed after the beginning of treatment. This side effect report can indicate a possible existence of increased vulnerability to Januvia treatment in male patients suffering from NA, resulting in muscle rupture.

    Complication Of Delivery, Exposure During Pregnancy
    This report suggests a potential Januvia complication of delivery side effect(s) that can have serious consequences. A 38-year-old female patient from FR (weight:NA) was diagnosed with the following health condition(s): type 2 diabetes mellitus and used Januvia (dosage: Unk) starting NS. Soon after starting Januvia the patient began experiencing various side effects, including:
    • Complication Of Delivery
    • Exposure During Pregnancy
    Drugs used concurrently:
    • Amarel (Unk)
    • Metformin (Unk)
    Although Januvia demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as complication of delivery, may still occur.

    Cleft Lip And Palate, Foetal Exposure During Pregnancy
    This cleft lip and palate problem was reported by a health professional from FR. A male patient (weight: NA) was diagnosed with the following medical condition(s): type 2 diabetes mellitus.On NS a consumer started treatment with Januvia (dosage: Unk). The following drugs/medications were being taken at the same time:
    • Amarel (Unk)
    • Metformin (Unk)
    When commencing Januvia, the patient experienced the following unwanted symptoms /side effects:
    • Cleft Lip And Palate
    • Foetal Exposure During Pregnancy
    The patient was hospitalized. Although all drugs are carefully tested before they are licensed for use, they carry potential side effect risks. Some side effects, such as cleft lip and palate, may become evident only after a product is in use by the general population.

    Cerebellar Infarction, Pneumonia
    This is a Januvia Tablets 50mg side effect report of a 75-year-old male patient (weight: NA) from JP. The patient developed the following symptoms/conditions: type 2 diabetes mellitus and was treated with Januvia Tablets 50mg (dosage: 50 Mg, Qd) starting Nov 02, 2011. Concurrently used drugs: NA. Soon after that, the consumer experienced the following of symptoms:
    • Cerebellar Infarction
    • Pneumonia
    The patient was hospitalized and became disabled. This opens a possibility that Januvia Tablets 50mg could cause cerebellar infarction and that some male patients may be more susceptible.

    Loss Of Consciousness, Pneumonia, Hypoglycaemia, Respiratory Disorder, Decreased Appetite
    A 86-year-old female patient (weight: NA) from JP with the following symptoms: type 2 diabetes mellitus started Januvia Tablets 50mg treatment (dosage: 50 Mg, Qd) on 2013. Soon after starting Januvia Tablets 50mg treatment, the consumer experienced several side effects, including:
    • Loss Of Consciousness
    • Pneumonia
    • Hypoglycaemia
    • Respiratory Disorder
    • Decreased Appetite
    . Concurrently used drugs:
    • 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)
    The patient was hospitalized. This finding indicates that some patients can be more vulnerable to developing Januvia Tablets 50mg side effects, such as loss of consciousness.

    Abdominal Pain
    This abdominal pain side effect was reported by a physician from US. A 68-year-old male patient (weight:NA) experienced the following symptoms/conditions: type 2 diabetes mellitus.The patient was prescribed Januvia (dosage: 100 Mg, Qd), which was started on 201401. Concurrently used drugs:
    • Metformin (1000 Mg, Bid)
    .When starting to take Januvia the consumer reported symptoms, such as:
    • Abdominal Pain
    These side effects may potentially be related to Januvia. The patient was hospitalized.

    Pancreatitis Chronic
    This is a report of a 53-year-old female patient (weight: NA) from US, suffering from the following symptoms/conditions: type 2 diabetes mellitus, who was treated with Januvia (dosage: NA, start time: NS), combined with: NA. and developed a serious reaction and side effect(s). The consumer presented with:
    • Pancreatitis Chronic
    which developed after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Januvia treatment in female patients, resulting in pancreatitis chronic side effect. The patient was hospitalized.

    Hypoglycaemia
    This report suggests a potential Januvia Tablets 100mg Hypoglycaemia side effect(s) that can have serious consequences. A 84-year-old male patient (weight: NA) from JP was diagnosed with the following symptoms/conditions: type 2 diabetes mellitus and used Januvia Tablets 100mg (dosage: NA) starting NS. Soon after starting Januvia Tablets 100mg the patient began experiencing various side effects, including:
    • Hypoglycaemia
    Drugs used concurrently:
    • Glimepiride
    • Glimepiride (0.5 Mg, Daily)
    • Voglibose
    • Insulin
    Although Januvia Tablets 100mg demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as hypoglycaemia, may still occur.

    Pancreatitis, Rash, Abdominal Pain
    This Pancreatitis, Rash, Abdominal Pain problem was reported by a consumer or non-health professional from US. A 74-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: diabetes mellitus. On NS this consumer started treatment with Januvia (dosage: Unk). The following drugs were being taken at the same time:
    • Metformin (100 Mg, Bid)
    • Lantus (24 Iu, Hs)
    • Synthroid (Unk)
    • Avapro (Unk)
    • Pravastatin Sodium (Unk)
    When commencing Januvia, the patient experienced the following unwanted symptoms/side effects:
    • Pancreatitis
    • Rash
    • Abdominal Pain
    Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as pancreatitis, may become evident only after a product is in use by the general population.

    Pancreatitis
    This is a report of a 46-year-old male patient (weight: NA) from US. The patient developed the following symptoms/conditions: type 2 diabetes mellitus and was treated with Januvia (dosage: Unk) starting NS. Concurrently used drugs:
    • Lantus (35 Df, Bid)
    • Novolog
    • Glipizide (5 Mg, Bid)
    • Metformin (1000 Mg, Bid)
    Soon after that, the consumer experienced the following side effects:
    • Pancreatitis
    The patient was hospitalized. This opens a possibility that Januvia treatment could cause the above reactions, including pancreatitis, and some male subjects may be more susceptible.

    Glomerular Filtration Rate Decreased
    A 81-year-old female patient (weight: NA) from US with the following symptoms/conditions: diabetes mellitus started Januvia treatment (dosage: 100 Mg, Qd) on NS. Soon after starting Januvia treatment, the subject experienced various side effects, including:
    • Glomerular Filtration Rate Decreased
    Concurrently used drugs: NA. This finding indicates that some female patients could be more vulnerable to Januvia.

    1 of 370 



    Top 10 Januvia Side Effects for Women

    Women Side EffectsReports
    Blood Glucose Increased 404
    Pancreatitis 300
    Headache 283
    Nausea 265
    Hypoglycaemia 261
    Diarrhoea 197
    Dizziness 176
    Rash 153
    Dyspnoea 145
    Vomiting 130

    Top 10 Januvia Side Effects for Men

    Men Side EffectsReports
    Blood Glucose Increased 286
    Pancreatitis 285
    Hypoglycaemia 212
    Headache 146
    Diarrhoea 134
    Dizziness 132
    Rash 122
    Pancreatic Carcinoma 117
    Nausea 110
    Pancreatitis Acute 103

    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

    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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    How Effective is Januvia for You?

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    Januvia Safety Alerts, Active Ingredients, Usage Information

    NDC0006-0112
    TypeHUMAN PRESCRIPTION DRUG
    Proprietary NameJANUVIA
    Namesitagliptin
    Dosage FormTABLET, FILM COATED
    RouteORAL
    On market since20061016
    LabelerMerck Sharp & Dohme Corp.
    Active Ingredient(s)SITAGLIPTIN PHOSPHATE
    Strength(s)50
    Unit(s)mg/1
    Pharma ClassDipeptidyl Peptidase 4 Inhibitor [EPC],Dipeptidyl Peptidase 4 Inhibitors [MoA]

    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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