Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes Onglyza (Saxagliptin). If you are concerned about side effects, discuss the risks and benefits of Onglyza (Saxagliptin) with your doctor.

The following side effects have been reported by at least 1% of people taking Onglyza (Saxagliptin). Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• headache
• stomach upset

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• blistering, red, or peeling skin
• severe joint pain
• signs of heart failure (e.g., sudden weight gain, difficulty breathing, leg swelling)
• symptoms of a urinary tract infection, e.g.:
• cloudy-looking or foul-smelling urine
• frequent urge to urinate
• pain or burning when urinating
• symptoms of an upper respiratory tract infection, e.g.:
• cough
• Fever
• headache
• runny nose
• sore throat
• symptoms of low blood sugar, e.g.:
• change in mood
• change in vision
• headache
• hunger
• rapid heartbeat
• shaking
• sweating

Stop taking the medication and seek immediate medical attention if any of the following occur:

• signs of pancreatitis (e.g., abdominal pain on the upper left side, back pain, nausea, fever, chills, rapid heartbeat, swollen abdomen)
• symptoms of a serious allergic reaction, e.g.:
• difficulty breathing
• Hives
• skin rash
• swelling of the face, lips, tongue, or throat

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking Onglyza (Saxagliptin).

2.5 mg
Each pale yellow, biconvex, round, film-coated tablet, with "2.5" printed on one side and "4214" printed on the other side in blue ink, contains 2.5 mg of Onglyza (Saxagliptin) as Onglyza (Saxagliptin) hydrochloride. Nonmedicinal ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, and microcrystalline cellulose; film coating: yellow iron oxide, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide; printing ink: FD&C Blue No. 2 and shellac glaze.

5 mg
Each pink, biconvex, round, film-coated tablet with "5" printed on one side and "4215" printed on the other side in blue ink, contains 5 mg of Onglyza (Saxagliptin) as Onglyza (Saxagliptin) hydrochloride. Nonmedicinal ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, and microcrystalline cellulose; film coating: red iron oxide, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide; printing ink: FD&C Blue No. 2 and shellac glaze.

Do not take Onglyza (Saxagliptin) if you:

• are allergic to Onglyza (Saxagliptin) or any ingredients of Onglyza (Saxagliptin)
• have Type 1 Diabetes, diabetic pre-coma or coma, or diabetic ketoacidosis (these conditions should be treated with insulin)

There may be an interaction between Onglyza (Saxagliptin) and any of the following:

• Abiraterone
• acetylsalicylic acid
• Amiodarone
• angiotensin converting enzyme inhibitors (ACEIs; Captopril, Enalapril, Ramipril)
• Apalutamide
• atypical antipsychotics (e.g., Aripiprazole, Clozapine, Olanzapine, Quetiapine, Risperidone)
• "azole" antifungals (e.g., fluconazole, itraconazole, ketoconazole, Voriconazole)
• Bicalutamide
• Carbamazepine
• Carvedilol
• Cobicistat
• conivaptan
• inhaled corticosteroids (e.g., budesonide, ciclesonide, fluticasone)
• oral corticosteroids (e.g., Dexamethasone, Hydrocortisone, Prednisone)
• Cyclosporine
• Danazol
• other diabetes medications (e.g., chlorpropamide, glyburide, insulin, metformin, Rosiglitazone)
• Diltiazem
• Dipyridamole
• Disopyramide
• diuretics (water pills; e.g., Furosemide, Hydrochlorothiazide, triamterene)
• Dronedarone
• Elagolix
• Enzalutamide
• estrogens (e.g., conjugated estrogen, Estradiol, ethinyl estradiol)
• Flibanserin
• Glucagon
• grapefruit juice
• Hepatitis C antivirals (e.g., daclatasvir, grazoprevir, ledipasvir, sofosbuvir)
• HIV non-nucleoside reverse transcriptase inhibitors (NNRTIs; e.g., delavirdine, efavirenz, etravirine, nevirapine)
• HIV protease inhibitors (e.g., atazanavir, indinavir, ritonavir, saquinavir)
• Idelalisib
• Lanreotide
• luteinizing hormone-releasing hormone analogues (e.g., Buserelin, Goserelin, Leuprolide)
• macrolide antibiotics (e.g., clarithromycin, erythromycin)
• Mefloquine
• mifepristone
• Mitotane
• monoamine oxidase inhibitors (M.O.S. e.g., Moclobemide, Phenelzine, Rasagiline, Selegiline, Tranylcypromine)
• Niacin
• Octreotide
• Pasireotide
• Pegvisomant
• Phenobarbital
• Phenytoin
• primidone
• progestins (e.g., Dienogest, Levonorgestrel, medroxyprogesterone, Norethindrone)
• quinidine
• quinine
• quinolone antibiotics (e.g., ciprofloxacin, Norfloxacin, Ofloxacin)
• rifampin
• St. John's wort
• selective serotonin reuptake inhibitors (SSRIs; e.g., Citalopram, Fluoxetine, Paroxetine, Sertraline)
• Sirolimus
• Stiripentol
• sulfonamide antibiotics ("sulfas"; e.g., sulfisoxazole, sulfamethoxazole)
• Tacrolimus
• testosterone
• tyrosine kinase inhibitors (e.g., Bosutinib, Dasatinib, imatinib, Nilotinib)
• Verapamil
• Vorinostat

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Onglyza (Saxagliptin). Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Before you begin taking a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Onglyza (Saxagliptin).

Blood sugar control: If your body experiences stress such as fever, trauma, infection, or surgery, you may lose control of blood glucose. Your doctor may decide to temporarily stop Onglyza (Saxagliptin) and advise you to take insulin. Talk to your doctor if you have fever, infection, or are about to undergo surgery.

Congestive Heart Failure (CHF): Heart failure has been reported in people taking Onglyza (Saxagliptin). If you have CHF or heart disease, discuss with your doctor how Onglyza (Saxagliptin) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Onglyza (Saxagliptin), and whether Onglyza (Saxagliptin) is appropriate for you.

Galactose intolerance/glucose malabsorption: Onglyza (Saxagliptin) is prepared with lactose. If you have lactose or galactose intolerance speak with your doctor about whether Onglyza (Saxagliptin) is appropriate for you.

Hypoglycemia: Onglyza (Saxagliptin) may increase the risk of hypoglycemia (low blood sugar) when taking Onglyza (Saxagliptin) with a sulfonylurea or insulin. If you are taking Onglyza (Saxagliptin) with another medication to reduce blood sugar, your doctor may recommend a lower dose of the other medication.

If you experience low blood sugar (e.g., headache, drowsiness, weakness, dizziness, confusion, irritability, hunger, fast heartbeat, sweating, and feeling jittery) contact your doctor.

Immune system: If you have a weakened immune system (e.g., you have had an organ transplant or have HIV), discuss with your doctor how Onglyza (Saxagliptin) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Onglyza (Saxagliptin), and whether any special monitoring is needed.

Kidney function: Kidney Disease or reduced kidney function may cause Onglyza (Saxagliptin) to build up in the body, causing side effects. If you have reduced kidney function or kidney disease, discuss with your doctor how Onglyza (Saxagliptin) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Onglyza (Saxagliptin), and whether any special monitoring is needed.

Onglyza (Saxagliptin) may also cause reduced kidney function. Your doctor may recommend regular testing to check your kidney function while you are taking Onglyza (Saxagliptin). Onglyza (Saxagliptin) is not recommended for people with end-stage renal disease and those on dialysis.

Liver function: Liver disease or reduced liver function may cause Onglyza (Saxagliptin) to build up in the body, causing side effects. If you have liver problems, discuss with your doctor how Onglyza (Saxagliptin) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Onglyza (Saxagliptin), and whether any special monitoring is needed. Your doctor may want to test your liver function regularly with blood tests while you are taking Onglyza (Saxagliptin).

Onglyza (Saxagliptin) is not recommended for people with moderately or severely reduced liver function.

Pancreatitis: Onglyza (Saxagliptin) can cause the pancreas to become inflamed. If you have a history of pancreatitis, discuss with your doctor how Onglyza (Saxagliptin) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Onglyza (Saxagliptin), and whether any special monitoring is needed.

Report signs of pancreatitis such as abdominal pain on the upper left side, back pain, nausea, fever, chills, rapid heartbeat, or swollen abdomen to your doctor immediately.

Type 1 diabetes and diabetic ketoacidosis: Onglyza (Saxagliptin) should not be used to treat type 1 diabetes, diabetic pre-coma or coma, or diabetic ketoacidosis (increased ketones in the blood or urine).

Pregnancy: Onglyza (Saxagliptin) is not recommended for use during pregnancy. If you become pregnant while taking Onglyza (Saxagliptin), contact your doctor immediately.

Breast-feeding: It is not known if Onglyza (Saxagliptin) passes into breast milk. If you are a breast-feeding mother and are taking Onglyza (Saxagliptin), it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using Onglyza (Saxagliptin) have not been established for children.

Seniors: People over the age of 65 may be more at risk of developing side effects from Onglyza (Saxagliptin).