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 Jentadueto. If you are concerned about side effects, discuss the risks and benefits of Jentadueto with your doctor.

The following side effects have been reported by at least 1% of people taking Jentadueto. 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.

• bloating
• cough
• Diarrhea
• Constipation
• gas
• heartburn
• increased sensitivity to sunlight
• loss of appetite
• metallic taste in mouth
• mouth ulcers
• nausea
• runny nose
• sore throat
• stuffy nose

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

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

• decreased coordination
• decreased Thyroid function (e.g., constipation, dry skin, tiredness, weight gain, sensitive to the cold)
• Hives or rash
• severe joint pain
• signs of Anemia (low red blood cells; e.g., dizziness, pale skin, unusual tiredness or weakness, shortness of breath)
• signs of infection (symptoms may include Fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness)
• skin blisters or erosions
• symptoms of low blood sugar (e.g., shaking, sweating, fast heartbeat, vision changes, hunger, headache, mood swings, slurred speech)
• tingling or numbness in hands or feet

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

• signs of encephalopathy (e.g., muscle weakness in one part of the body, poor decision making, difficulty speaking or swallowing, problems concentrating,  twitching or trembling, seizures)
• signs of lactic acidosis (e.g., nausea, vomiting, increased breathing rate, abdominal pain, unusual muscle pain, unusual tiredness, dizziness, slow or irregular heart rate)
• signs of liver problems (e.g., nausea, vomiting, diarrhea, loss of appetite, weight loss, yellowing of the skin or whites of the eyes, dark urine, pale stools)
• signs of pancreatitis (e.g., abdominal pain on the upper left side, back pain, nausea, fever, chills, rapid heartbeat, swollen abdomen)
• signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)
• signs of a severe skin reaction such as blistering, peeling, a rash covering a large area of the body, a rash that spreads quickly, or a rash combined with fever or discomfort

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 Jentadueto.

2.5 mg / 500 mg
Each light yellow, oval, biconvex, film-coated tablet debossed with "D2/500" on one side and the Boehringer Ingelheim logo on the other side contains 2.5 mg of linagliptin and 500 mg of metformin hydrochloride. Nonmedicinal ingredients: arginine, colloidal silicon dioxide, copovidone, magnesium stearate, and maize starch. Film coating: hypromellose, iron oxide red, iron oxide yellow, propylene glycol, talc, and titanium dioxide.

2.5 mg / 850 mg
Each light orange, oval, biconvex, film-coated tablet debossed with "D2/850" on one side and the Boehringer Ingelheim logo on the other side contains 2.5 mg of linagliptin and 850 mg of metformin hydrochloride. Nonmedicinal ingredients: arginine, colloidal silicon dioxide, copovidone, magnesium stearate, and maize starch. Film coating: hypromellose, iron oxide red, iron oxide yellow, propylene glycol, talc, and titanium dioxide.

2.5 mg / 1000 mg
Each light pink, oval, biconvex, film-coated tablet debossed with "D2/1000" on one side and the Boehringer Ingelheim logo on the other side contains 2.5 mg of linagliptin and 1,000 mg of metformin hydrochloride. Nonmedicinal ingredients: arginine, colloidal silicon dioxide, copovidone, magnesium stearate, and maize starch. Film coating: hypromellose, iron oxide red, iron oxide yellow, propylene glycol, talc, and titanium dioxide.

Do not take linagliptin - metformin if you:

• are allergic to linagliptin, metformin, or any ingredients of the medication
• have Type 1 Diabetes
• are experiencing or recovering from severe infections, trauma, or surgery
• are going to have or have had surgery where you are not eating or drinking normally
• are pregnant or breast-feeding
• are suffering severe dehydration (have lost a lot of water from your body)
• are undergoing radiologic studies involving use of iodinated contrast materials
• drink large amounts of alcohol in the short-term or on a regular basis
• have a history of lactic acidosis or acute/chronic metabolic acidosis (too much acid in the blood), diabetic ketoacidosis with or without coma, or history of ketoacidosis with or without coma
• have diseases associated with lack of oxygen to the tissues such as cardio-respiratory insufficiency
• have reduced kidney function
• have severely reduced liver function
• have very poor blood glucose control (if so, you should not take Jentadueto as the only antidiabetic agent)

There may be an interaction between linagliptin-metformin and any of the following:

• Acetazolamide
• acetylsalicylic acid (Asa)
• alcohol
• androgens (e.g., testosterone)
• angiotensin converting enzyme inhibitors (ACEIs; e.g., Captopril, Lisinopril, Ramipril)
• Apalutamide
• atypical antipsychotics (e.g., Aripiprazole, Clozapine, Olanzapine, Quetiapine, Risperidone)
• Basiliximab
• bictegravir
• Bosentan
• Carbamazepine
• Cephalexin
• chloroquine
• Cimetidine
• inhaled corticosteroids (e.g., budesonide, ciclesonide, fluticasone)
• oral corticosteroids (e.g., Dexamethasone, Hydrocortisone, Prednisone)
• Dabrafenib
• Deferasirox
• diuretics (water pills; e.g., Furosemide, Hydrochlorothiazide, triamterene)
• dolutegravir
• Enzalutamide
• Epinephrine
• estrogens (e.g., conjugated estrogen, Estradiol, ethinyl estradiol)
• Everolimus
• garlic
• ginger
• ginseng (American)
• Glucagon
• glycopyrrolate
• Goserelin
• Hepatitis C antivirals (e.g., elbasvir, grazoprevir, ledipasvir, sofosbuvir, velpatasvir)
• HIV non-nucleoside reverse transcriptase inhibitors (NNRTIs; e.g., efavirenz, etravirine, nevirapine)
• HIV protease inhibitors (e.g., atazanavir, indinavir, ritonavir, saquinavir)
• hydroxychloroquine
• Lamotrigine
• Lanreotide
• Linezolid
• lumacaftor and Ivacaftor
• mifepristone
• Mitotane
• Modafinil
• monoamine oxidase inhibitors (M.O.S. e.g., Moclobemide, Phenelzine, Rasagiline, Selegiline, Tranylcypromine)
• Niacin
• Nilotinib
• non-steroidal anti-inflammatory medications (NSAIDs; e.g., Diclofenac, Ibuprofen, Ketorolac, Naproxen)
• Octreotide
• Ondansetron
• other diabetes medications (e.g., chlorpropamide, glyburide, insulin, metformin, Rosiglitazone)
• Pasireotide
• pentamidine
• Phenobarbital
• Phenytoin
• primidone
• probenecid
• progestins (e.g., Dienogest, Levonorgestrel, medroxyprogesterone, Norethindrone, Progesterone)
• quinidine
• quinine
• quinolone antibiotics (e.g., ciprofloxacin, Norfloxacin, Ofloxacin)
• rifabutin
• rifampin
• St. John's wort
• Sarilumab
• selective serotonin reuptake inhibitors (SSRIs; e.g., Citalopram, Fluoxetine, Paroxetine, Sertraline)
• siltuximab
• Sirolimus
• Somatropin
• sulfonamide antibiotics ("sulfas"; e.g., sulfisoxazole, sulfamethoxazole)
• Sunitinib
• Tacrolimus (systemic)
• Tocilizumab
• Topiramate
• Tramadol
• Trimethoprim
• Venetoclax
• Verapamil
• Vorinostat
• Warfarin

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 Jentadueto. 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 using 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 Jentadueto.

Alcohol intake: Alcohol increases the risk of developing lactic acidosis for people taking metformin. If you are taking Jentadueto, avoid excessive alcohol intake. If you drink alcohol often or heavily, discuss with your doctor how Jentadueto may affect you, how your alcohol intake may affect the dosing and effectiveness of Jentadueto, and whether any special monitoring is needed.

Anemia: Rarely, metformin causes low levels of red blood cells. If you experience symptoms of reduced red blood cell count (anemia) such as shortness of breath, feeling unusually tired or pale skin, contact your doctor as soon as possible.

Your doctor will do blood tests regularly to monitor the number of specific types of blood cells, including red blood cells, in your blood.

Blood sugar monitoring: Monitor your blood sugar regularly at intervals as discussed with your doctor or diabetes educator.

Congestive Heart Failure and heart disease: The safety and effectiveness of linagliptin has not been established for people with congestive heart failure (CHF) or heart disease. For this reason, Jentadueto is not recommended for people with CHF or heart disease.

If you have CHF or heart disease, discuss with your doctor how Jentadueto may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Jentadueto, and whether Jentadueto is appropriate for you.

Dye or contrast agents: If you are going to have an X-ray procedure that uses dye or a contrast agent, you may need to stop taking Jentadueto for a short time. Contact your doctor for instructions.

Hypoglycemia (low blood sugar): Hypoglycemia can occur when linagliptin - metformin is used in combination with a sulfonylurea (e.g., glyburide, Gliclazide) or insulin. Your doctor may suggest a lower dose of your sulfonylurea or insulin when you start Jentadueto.

Hypoglycemia may also occur when you don't eat enough, exercise strenuously without eating enough, or drink alcohol. If you experience low blood sugar (e.g., headache, drowsiness, weakness, dizziness, confusion, irritability, hunger, fast heartbeat, sweating, and feeling jittery) contact your doctor.

During times of stress (e.g., fever, trauma, surgery, infection), your doctor may suggest that you temporarily stop Jentadueto and use insulin to help control your blood sugar levels.

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

Liver function: If you have reduced liver function or liver disease, you may be at an increased risk of developing lactic acidosis. Discuss with your doctor how Jentadueto may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Jentadueto, and whether any special monitoring is needed. Jentadueto is not recommended if you have severely reduced liver function.

Lactic acidosis: Lactic acidosis is a rare but serious problem that occurs due to metformin accumulation (i.e., the body doesn't get rid of it fast enough) during treatment. If you have severe kidney disease, you are at higher risk of developing lactic acidosis. Since alcohol may increase the risk of lactic acidosis, do not drink a lot of alcohol over the short- or long-term while taking Jentadueto. When it does occur (very rarely), it is fatal in 50% of cases. If you experience symptoms of lactic acidosis (e.g., weakness, tiredness, drowsiness, unusual muscle pain, trouble breathing, stomach pain with nausea, vomiting or diarrhea, feeling cold, dizziness, lightheadedness, or slow or irregular heartbeat), stop taking Jentadueto and get immediate medical attention.

Pancreatitis: Jentadueto may cause or worsen pancreatitis (inflammation of the pancreas). If you have a history of pancreatitis, gallstones, Alcoholism, or high triglycerides, you may be more at risk of experiencing this and should be closely monitored by your doctor while taking Jentadueto.

If you experience symptoms of pancreatitis (e.g., upper left abdominal pain, back pain, nausea, fever, chills, rapid heartbeat, swollen abdomen or prolonged and severe abdominal pain with or without vomiting), contact your doctor immediately.

Surgery: Jentadueto should be stopped temporarily for surgery (except for minor surgery where food and fluid intake is not restricted). You will be restarted on Jentadueto once you are eating and drinking, and your kidney function has been tested and is normal. Talk to your doctor for specific instructions.

Thyroid function: For people who have an underactive thyroid, metformin can cause the amount of thyroid hormone in the body to decrease further. If you have an underactive thyroid gland, discuss with your doctor how Jentadueto may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Jentadueto, and whether any special monitoring is needed.

Vitamin B12 levels: Metformin may decrease vitamin B12 levels. Your doctor will monitor your B12 levels with blood tests while you are taking Jentadueto.

Pregnancy: Metformin should not be used during pregnancy. If you become pregnant while taking Jentadueto, contact your doctor immediately. During pregnancy, blood glucose levels should be kept as close to normal as possible using insulin.

Breast-feeding: It is not known if linagliptin passes into breast milk. Metformin does pass into breast milk. If you are breast-feeding, Jentadueto may affect your baby, and so it is recommended that you do not use linagliptin - metformin.

Children: The safety and effectiveness of using Jentadueto have not been established for children less than 18 years old.

Seniors: Seniors are more likely to have reduced liver and kidney function, and may be at increased risk of experiencing side effects to Jentadueto.