"Jan. 29, 2013 -- The American Academy of Pediatrics has issued the first-ever guidelines for the management of type 2 diabetes in children and teens.
Type 2 diabetes is rising rapidly among children and teens because of soaring obesity "...
Janumet Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Janumet (sitagliptin/metformin HCl) is a combination of oral diabetes medicines for people with type 2 diabetes who do not use daily insulin injections. Janumet is not for treating type 1 diabetes. Common side effects of Janumet include nausea, vomiting, stomach upset, diarrhea, constipation, headache, weakness, back pain, joint or muscle pain, a metallic taste in the mouth, or cold symptoms such as runny or stuffy nose, sneezing, and sore throat.
Dosage of Janumet is individualized. Janumet is given twice daily with meals in 50 mg sitagliptin/500 mg metformin hydrochloride or 50 mg sitagliptin/1000 mg metformin hydrochloride doses. Hyperglycemia (high blood sugar) may result if you take Janumet with drugs that raise blood sugar, such as: isoniazid, diuretics (water pills), steroids, phenothiazines, thyroid medicine, birth control pills and other hormones, seizure medicines, and diet pills, or medicines to treat asthma, colds or allergies. Hypoglycemia (low blood sugar) may result if you take Janumet with drugs that lower blood sugar, such as: non-steroidal anti-inflammatory drugs (NSAIDs), aspirin or other salicylates, sulfa drugs, monoamine oxidase inhibitors (MAOIs), beta-blockers, or probenecid. It may also interact with amiloride, triamterene, cimetidine, ranitidine, digoxin, furosemide, morphine, nifedipine, procainamide, quinidine, trimethoprim, or vancomycin. Tell your doctor all medications you use. During pregnancy, Janumet should be used only when prescribed. Your doctor may direct you to use insulin instead of this product during your pregnancy. Metformin can promote ovulation and increase the risk of becoming pregnant. Consult your doctor about use of birth control. Metformin passes into breast milk in small amounts. It is unknown if sitagliptin passes into breast milk. Consult your doctor before breast-feeding.
Our Janumet (sitagliptin/metformin HCl) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Janumet in Detail - Patient Information: Side Effects
This medication may cause lactic acidosis (a build-up of lactic acid in the body, which can be fatal). Lactic acidosis can start slowly and get worse over time. Get emergency medical help if you have even mild symptoms of lactic acidosis, such as: muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, stomach pain, nausea with vomiting, slow or irregular heart rate, dizziness, or feeling very weak or tired.
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have any of these serious side effects:
- pancreatitis - severe pain in your upper stomach spreading to your back, nausea and vomiting, loss of appetite, fast heart rate;
- urinating less than usual or not at all;
- feeling short of breath (even with mild exertion) swelling or rapid weight gain; or
- severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.
Less serious side effects may include:
- diarrhea, constipation, mild nausea, upset stomach;
- headache, weakness, back pain, joint or mucle pain; or
- cold symptoms such as runny or stuffy nose, sneezing, sore throat.
Read the entire detailed patient monograph for Janumet (Sitagliptin Metformin HCL)
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Janumet Overview - Patient Information: Side Effects
Nausea, vomiting, stomach upset, diarrhea, headache, weakness, or a metallic taste in the mouth may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly. If stomach symptoms return later (after taking the same dose for several days or weeks), tell your doctor immediately. Stomach symptoms that occur after the first days of your treatment may be signs of lactic acidosis.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
This medication does not usually cause low blood sugar (hypoglycemia). Low blood sugar may occur if this drug is prescribed with other anti-diabetic medications. Talk with your doctor or pharmacist about whether the dose of your other diabetic medication(s) needs to be lowered.
Symptoms of low blood sugar include sudden sweating, shaking, fast heartbeat, hunger, blurred vision, dizziness, or tingling hands/feet. It is a good habit to carry glucose tablets or gel to treat low blood sugar. If you don't have these reliable forms of glucose, rapidly raise your blood sugar by eating a quick source of sugar such as table sugar, honey, or candy, or drink fruit juice or non-diet soda. Tell your doctor about the reaction immediately. Low blood sugar is more likely if you drink large amounts of alcohol, do unusually heavy exercise, or do not consume enough calories from food. To help prevent low blood sugar, eat meals on a regular schedule, and do not skip meals. Check with your doctor or pharmacist to find out what you should do if you miss a meal.
Symptoms of high blood sugar (hyperglycemia) include thirst, increased urination, confusion, drowsiness, flushing, rapid breathing, and fruity breath odor. If these symptoms occur, tell your doctor immediately. Your doctor may need to adjust your diabetes medication(s).
Tell your doctor right away of any serious side effects, including: change in the amount of urine.
Get medical help right away if you have any very serious side effects, including: signs of pancreatitis (such as persistent nausea/vomiting, loss of appetite, severe stomach/abdominal/back pain), lactic acidosis (see Warning section).
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Janumet (Sitagliptin Metformin HCL)
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Janumet FDA Prescribing Information: Side Effects
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Sitagliptin and Metformin Co-administration in Patients with Type 2 Diabetes Inadequately Controlled on Diet and Exercise
Table 1 summarizes the most common ( ≥ 5% of patients) adverse reactions reported (regardless of investigator assessment of causality) in a 24-week placebo-controlled factorial study in which sitagliptin and metformin were co-administered to patients with type 2 diabetes inadequately controlled on diet and exercise.
Table 1: Sitagliptin and Metformin Co-administered to Patients with
Type 2 Diabetes Inadequately Controlled on Diet and Exercise: Adverse Reactions
Reported (Regardless of Investigator Assessment of Causality) in ≥ 5%
of Patients Receiving Combination Therapy (and Greater than in Patients
|Number of Patients (%)|
N = 176
|Sitagliptin 100 mg QD
N = 179
|Metformin 500 mg/ Metformin 1000 mg bid ††
N = 364††
|Sitagliptin 50 mg bid + Metformin 500 mg/ Metformin 1000 mg bid ††
N = 372††
|Diarrhea||7 (4.0)||5 (2.8)||28 (7.7)||28 (7.5)|
|Upper Respiratory Tract Infection||9 (5.1)||8 (4.5)||19 (5.2)||23 (6.2)|
|Headache||5 (2.8)||2 (1.1)||14 (3.8)||22 (5.9)|
|† Intent-to-treat population.
†† Data pooled for the patients given the lower and higher doses of metformin.
Sitagliptin Add-on Therapy in Patients with Type 2 Diabetes Inadequately Controlled on Metformin Alone
In a 24-week placebo-controlled trial of sitagliptin 100 mg administered once daily added to a twice daily metformin regimen, there were no adverse reactions reported regardless of investigator assessment of causality in ≥ 5% of patients and more commonly than in patients given placebo. Discontinuation of therapy due to clinical adverse reactions was similar to the placebo treatment group (sitagliptin and metformin, 1.9%; placebo and metformin, 2.5%).
Gastrointestinal Adverse Reactions
The incidences of pre-selected gastrointestinal adverse experiences in patients treated with sitagliptin and metformin were similar to those reported for patients treated with metformin alone. See Table 2.
Table 2: Pre-selected Gastrointestinal Adverse Reactions (Regardless
of Investigator Assessment of Causality) Reported in Patients with Type 2
Diabetes Receiving Sitagliptin and Metformin
|Number of Patients (%)|
|Study of Sitagliptin and Metformin in Patients Inadequately Controlled on Diet and Exercise||Study of Sitagliptin Add-on in Patients Inadequately Controlled on Metformin Alone|
N = 176
|Sitagliptin 100 mg QD
N = 179
|Metformin 500 mg/ Metformin 1000 mg bid †
N = 364
|Sitagliptin 50 mg bid + Metformin 500 mg/ Metformin 1000 mg bid †
N = 372
|Placebo and Metformin ≥ 1500 mg daily
N = 237
|Sitagliptin 100 mg QD and Metformin ≥ 1500 mg daily
N = 464
|Diarrhea||7 (4.0)||5 (2.8)||28 (7.7)||28 (7.5)||6 (2.5)||11 (2.4)|
|Nausea||2 (1.1)||2 (1.1)||20 (5.5)||18 (4.8)||2 (0.8)||6 (1.3)|
|Vomiting||1 (0.6)||0 (0.0)||2 (0.5)||8 (2.2)||2 (0.8)||5 (1.1)|
|Abdominal Pain††||4 (2.3)||6 (3.4)||14 (3.8)||11 (3.0)||9 (3.8)||10 (2.2)|
|† Data pooled for the patients given the
lower and higher doses of metformin.
†† Abdominal discomfort was included in the analysis of abdominal pain in the study of initial therapy.
Sitagliptin in Combination with Metformin and Glimepiride
In a 24-week placebo-controlled study of sitagliptin 100 mg as add-on therapy in patients with type 2 diabetes inadequately controlled on metformin and glimepiride (sitagliptin, N=116; placebo, N=113), the adverse reactions reported regardless of investigator assessment of causality in ≥ 5% of patients treated with sitagliptin and more commonly than in patients treated with placebo were: hypoglycemia (Table 3) and headache (6.9%, 2.7%).
Sitagliptin in Combination with Metformin and Rosiglitazone
In a placebo-controlled study of sitagliptin 100 mg as add-on therapy in patients with type 2 diabetes inadequately controlled on metformin and rosiglitazone (sitagliptin, N=181; placebo, N=97), the adverse reactions reported regardless of investigator assessment of causality through Week 18 in ≥ 5% of patients treated with sitagliptin and more commonly than in patients treated with placebo were: upper respiratory tract infection (sitagliptin, 5.5%; placebo, 5.2%) and nasopharyngitis (6.1%, 4.1%). Through Week 54, the adverse reactions reported regardless of investigator assessment of causality in ≥ 5% of patients treated with sitagliptin and more commonly than in patients treated with placebo were: upper respiratory tract infection (sitagliptin, 15.5%; placebo, 6.2%), nasopharyngitis (11.0%, 9.3%), peripheral edema (8.3%, 5.2%), and headache (5.5%, 4.1%).
Sitagliptin in Combination with Metformin and Insulin
In a 24-week placebo-controlled study of sitagliptin 100 mg as add-on therapy in patients with type 2 diabetes inadequately controlled on metformin and insulin (sitagliptin, N=229; placebo, N=233), the only adverse reaction reported regardless of investigator assessment of causality in ≥ 5% of patients treated with sitagliptin and more commonly than in patients treated with placebo was hypoglycemia (Table 3).
In all (N=5) studies, adverse reactions of hypoglycemia were based on all reports of symptomatic hypoglycemia; a concurrent glucose measurement was not required although most (77%) reports of hypoglycemia were accompanied by a blood glucose measurement ≤ 70 mg/dL. When the combination of sitagliptin and metformin was co-administered with a sulfonylurea or with insulin, the percentage of patients reporting at least one adverse reaction of hypoglycemia was higher than that observed with placebo and metformin co-administered with a sulfonylurea or with insulin (Table 3).
Table 3 : Incidence and Rate of Hypoglycemia† (Regardless of
Investigator Assessment of Causality) in Placebo-Controlled Clinical Studies of
Sitagliptin in Combination with Metformin Co-administered with Glimepiride or
|Add-On to Glimepiride + Metformin (24 weeks)||Sitagliptin 100 mg + Metformin + Glimepiride||Placebo + Metformin + Glimepiride|
|N = 116||N = 113|
|Overall (%)||19 (16.4)||1 (0.9)|
|Severe (%)§||0 (0.0)||0 (0.0)|
|Add-On to Insulin + Metformin (24 weeks)||Sitagliptin 100 mg + Metformin + Insulin||Placebo + Metformin + Insulin|
|N = 229||N = 233|
|Overall (%)||35 (15.3)||19 (8.2)|
|Severe (%)§||1 (0.4)||1 (0.4)|
|† Adverse reactions of hypoglycemia were based on all reports of
symptomatic hypoglycemia; a concurrent glucose measurement was not required:
‡ Based on total number of events (i.e., a single patient may have had multiple events).
§ Severe events of hypoglycemia were defined as those events requiring medical assistance or exhibiting depressed level/loss of consciousness or seizure.
The overall incidence of reported adverse reactions of hypoglycemia in patients with type 2 diabetes inadequately controlled on diet and exercise was 0.6% in patients given placebo, 0.6% in patients given sitagliptin alone, 0.8% in patients given metformin alone, and 1.6% in patients given sitagliptin in combination with metformin. In patients with type 2 diabetes inadequately controlled on metformin alone, the overall incidence of adverse reactions of hypoglycemia was 1.3% in patients given add-on sitagliptin and 2.1% in patients given add-on placebo.
In the study of sitagliptin and add-on combination therapy with metformin and rosiglitazone, the overall incidence of hypoglycemia was 2.2% in patients given add-on sitagliptin and 0.0% in patients given add-on placebo through Week 18. Through Week 54, the overall incidence of hypoglycemia was 3.9% in patients given add-on sitagliptin and 1.0% in patients given add-on placebo.
With the combination of sitagliptin and metformin, no clinically meaningful changes in vital signs or in ECG (including in QTc interval) were observed.
In a pooled analysis of 19 double-blind clinical trials that included data from 10,246 patients randomized to receive sitagliptin 100 mg/day (N=5429) or corresponding (active or placebo) control (N=4817), the incidence of acute pancreatitis was 0.1 per 100 patient-years in each group (4 patients with an event in 4708 patient-years for sitagliptin and 4 patients with an event in 3942 patient-years for control) [See WARNINGS AND PRECAUTIONS.]
The most common adverse experience in sitagliptin monotherapy reported regardless of investigator assessment of causality in ≥ 5% of patients and more commonly than in patients given placebo was nasopharyngitis.
The incidence of laboratory adverse reactions was similar in patients treated with sitagliptin and metformin (7.6%) compared to patients treated with placebo and metformin (8.7%). In most but not all studies, a small increase in white blood cell count (approximately 200 cells/microL difference in WBC vs placebo; mean baseline WBC approximately 6600 cells/microL) was observed due to a small increase in neutrophils. This change in laboratory parameters is not considered to be clinically relevant.Metformin hydrochloride
In controlled clinical trials of metformin of 29 weeks duration, a decrease to subnormal levels of previously normal serum Vitamin B12 levels, without clinical manifestations, was observed in approximately 7% of patients. Such decrease, possibly due to interference with B12 absorption from the
B12-intrinsic factor complex, is, however, very rarely associated with anemia and appears to be rapidly reversible with discontinuation of metformin or Vitamin B12 supplementation. [See WARNINGS AND PRECAUTIONS]
Additional adverse reactions have been identified during postapproval use of JANUMET or sitagliptin, one of the components of JANUMET. These reactions have been reported when JANUMET or sitagliptin have been used alone and/or in combination with other antihyperglycemic agents. Because these reactions are reported voluntarily from a population of uncertain size, it is generally not possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Hypersensitivity reactions including anaphylaxis, angioedema, rash, urticaria, cutaneous vasculitis, and exfoliative skin conditions including Stevens-Johnson syndrome [see WARNINGS AND PRECAUTIONS]; upper respiratory tract infection; hepatic enzyme elevations; acute pancreatitis, including fatal and non-fatal hemorrhagic and necrotizing pancreatitis [see INDICATIONS AND USAGE; WARNINGS AND PRECAUTIONS]; worsening renal function, including acute renal failure (sometimes requiring dialysis) [see WARNINGS AND PRECAUTIONS]; constipation; vomiting; headache; arthralgia; myalgia; pain in extremity; back pain.
Read the entire FDA prescribing information for Janumet (Sitagliptin Metformin HCL)
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