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 Forxiga (Dapagliflozin). If you are concerned about side effects, discuss the risks and benefits of Forxiga (Dapagliflozin) with your doctor.

The following side effects have been reported by at least 1% of people taking Forxiga (Dapagliflozin). 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.

• back pain
• Constipation
• Diarrhea
• flu-like illness
• headache
• nausea
• pain in the arms, legs, hands, or feet
• rash
• sore throat

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:

• dizziness or lightheadedness when rising from a sitting or lying position
• pain, tenderness, or swelling in the genital area
• redness or rash of the penis or foreskin (yeast infection)
• signs of dehydration (e.g., decreased urine, dry skin, dry and sticky mouth, sleepiness, dizziness, headache, thirst, confusion)
• signs of kidney problems (e.g., increased urination at night, decreased urine production, blood in the urine, change of urine colour)
• signs of vaginal yeast infection (e.g., vaginal odour, curd-like discharge, itching)
• symptoms of kidney infection (e.g., painful, urgent, or frequent need to urinate; lower back pain; Fever or chills; cloudy or foul smelling urine; blood in urine)
• symptoms of low blood sugar (e.g., cold sweat, cool pale skin, headache, fast heartbeat, weakness, blurred vision)
• symptoms of a urinary tract infection (e.g., pain when urinating, urinating more often than usual, low back or flank pain, strong odour)

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

• severe dehydration (e.g., confusion, sweating stops, heart palpitations)
• severe Hypoglycemia (low blood sugar; disorientation, loss of consciousness, seizure)
• signs of ketoacidosis (e.g., confusion, extreme thirst, loss of appetite, stomach pain, trouble breathing, nausea, vomiting, or unusual tiredness)
• 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)
• symptoms of a serious infection (e.g., fever, chills, rapid breathing or heartbeat)

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 Forxiga (Dapagliflozin).

5 mg
Each yellow, biconvex, round, film-coated tablet, with "5" engraved on one side and "1427" engraved on the other side, contains 5 mg of Forxiga (Dapagliflozin) as Forxiga (Dapagliflozin) propanediol monohydrate. Nonmedicinal ingredients: anhydrous lactose, crospovidone, magnesium stearate, microcrystalline cellulose, and silicon dioxide; film coating: polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, and yellow iron oxide.

10 mg
Each yellow, biconvex, diamond, film-coated tablet with "10" engraved on one side and "1428" engraved on the other side, contains 10 mg of Forxiga (Dapagliflozin) as Forxiga (Dapagliflozin) propanediol monohydrate. Nonmedicinal ingredients: anhydrous lactose, crospovidone, magnesium stearate, microcrystalline cellulose, and silicon dioxide; film coating: polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, and yellow iron oxide.

Do not use Forxiga (Dapagliflozin) if you:

• are allergic to Forxiga (Dapagliflozin) or any ingredients of Forxiga (Dapagliflozin)
• have severely reduced kidney function, end stage Kidney Disease, or are on dialysis
• have Type 1 Diabetes

There may be an interaction between Forxiga (Dapagliflozin) and any of the following:

• alpha lipoic acid
• androgens (e.g., testosterone)
• Aspirin (Asa)
• atypical antipsychotics (e.g., Clozapine, Olanzapine, Quetiapine, Risperidone)
• Buserelin
• Ceritinib
• chloroquine
• Dabrafenib
• Danazol
• other diabetes medications (e.g., chlorpropamide, Glyburide, insulin, Metformin, Rosiglitazone)
• Disopyramide
• diuretics (water pills; e.g., Furosemide, Hydrochlorothiazide, triamterene)
• estrogens (e.g., conjugated estrogen, Estradiol, ethinyl estradiol)
• Everolimus
• Glucagon
• Goserelin
• Hepatitis C antivirals (e.g., daclatasvir, dasabuvir, glecaprevir and pibrentasvir, ledipasvir, paritaprevir, ombitasvir, sofosbuvir, velpatasvir)
• HIV protease inhibitors (e.g., atazanavir, indinavir, ritonavir, saquinavir)
• hydroxychloroquine
• inhaled corticosteroids (e.g., budesonide, ciclesonide, fluticasone)
• Lanreotide
• Leuprolide
• mifepristone
• monoamine oxidase inhibitors (M.O.S. e.g., Moclobemide, Phenelzine, Rasagiline, Selegiline, Tranylcypromine)
• Octreotide
• oral corticosteroids (e.g., Dexamethasone, Hydrocortisone, Prednisone)
• Pasireotide
• Pegvisomant
• pentamidine
• progestins (e.g., Dienogest, Levonorgestrel, medroxyprogesterone, Norethindrone)
• quinine
• quinolone antibiotics (e.g., ciprofloxacin, levofloxacin)
• selective serotonin reuptake inhibitors (SSRIs; e.g., Citalopram, Fluoxetine, Paroxetine, Sertraline)
• Sirolimus
• somatostatin
• somatotropin
• sulfonamide antibiotics ("sulfas"; e.g., sulfisoxazole, sulfamethoxazole)
• Sunitinib
• Tacrolimus
• Temsirolimus
• Tramadol
• Triptorelin
• 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 Forxiga (Dapagliflozin). 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 Forxiga (Dapagliflozin).

Cholesterol: Forxiga (Dapagliflozin) may cause increases in the levels of low-density lipoprotein (LDL) cholesterol in your blood. If you have High Cholesterol, discuss with your doctor how Forxiga (Dapagliflozin) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Forxiga (Dapagliflozin), and whether any special monitoring is needed.

Dizziness: Some people taking Forxiga (Dapagliflozin) may experience decreases in blood pressure. This occurs because the medication causes an increased amount of fluid, along with the glucose, to be removed from the body through the kidneys. These blood pressure drops could lead to dizziness, lightheadedness, and falls. This may occur when you shift your body position, such as rising from a sitting or lying position. If you experience this problem, try getting up more slowly. If it persists or if you faint, contact your doctor. Seniors and other individuals who are at risk of experiencing Low Blood Pressure (e.g., dehydration, taking medications for high blood pressure) should discuss with their doctor how Forxiga (Dapagliflozin) may affect their medical condition, how their medical condition may affect the dosing and effectiveness of Forxiga (Dapagliflozin), and whether any special monitoring is needed.

Driving and using machines: Forxiga (Dapagliflozin) may cause dizziness or lightheadedness, affecting your ability to drive or operate machinery. Avoid driving, operating machinery, or performing other potentially hazardous tasks until you have determined how Forxiga (Dapagliflozin) affects you.

Glucose control: When Forxiga (Dapagliflozin) is taken along with other medications for diabetes, glucose levels may drop too far, causing confusion, cold sweats, cool and pale skin, headache, fast heartbeat, or weakness. Your doctor may suggest decreasing the dose of your other medications when you first start taking Forxiga (Dapagliflozin). If you take other medications for diabetes or medications that can decrease blood glucose levels, discuss with your doctor how Forxiga (Dapagliflozin) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Forxiga (Dapagliflozin), and whether any special monitoring is needed.

Ketoacidosis: There have been reports that diabetic ketoacidosis has been experienced by people taking Forxiga (Dapagliflozin) and other similar medications. Ketoacidosis is a serious condition that occurs when the body does not have enough insulin to use the glucose in the blood. As a result, the body starts to break down fat for energy. This can cause ketones to build up in the blood, making it more acidic. This is a warning sign that your diabetes is out of control.

If you experience high blood glucose levels, thirst, very Dry Mouth or frequent urination, you may be experiencing early signs of ketoacidosis. Contact your doctor as soon as possible for advice on how to manage this condition.

Kidney function: The effectiveness of Forxiga (Dapagliflozin) depends on kidney function because it increases the amount of glucose eliminated through the kidneys. Over time, Forxiga (Dapagliflozin) may cause kidney problems. If you experience signs of kidney problems, such as puffy hands, face, or feet; high blood pressure; unusual muscle cramping; or darkened urine, Forxiga (Dapagliflozin) may be affecting how well your kidneys are working. If you notice any of these symptoms, contact your doctor as soon as possible.

Liver function: If you have liver problems, discuss with your doctor how Forxiga (Dapagliflozin) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Forxiga (Dapagliflozin), and whether any special monitoring is needed. Forxiga (Dapagliflozin) is not recommended for people with severely decreased liver function.

Yeast infections: There is an increased risk of developing genital or vaginal yeast infections when taking Forxiga (Dapagliflozin) as a result of increased glucose in the urine. This is more likely to occur for uncircumcised males and for people who have a history of yeast infections.

Pregnancy: Forxiga (Dapagliflozin) should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking Forxiga (Dapagliflozin), contact your doctor immediately.

Breast-feeding: It is not known if Forxiga (Dapagliflozin) passes into breast milk. If you are a breast-feeding mother and are taking Forxiga (Dapagliflozin), it may affect your baby. Breast-feeding is not recommended when you are taking Forxiga (Dapagliflozin).

Children: The safety and effectiveness of Forxiga (Dapagliflozin) have not been established for children less than 18 years of age.

Seniors: Seniors are more likely to experience side effects with Forxiga (Dapagliflozin) and may require lower doses.