Farxiga Side Effects

Generic name: dapagliflozin

Medically reviewed by Philip Thornton, DipPharm. Last updated on May 30, 2024.

Note: This document provides detailed information about Farxiga Side Effects associated with dapagliflozin. Some dosage forms listed on this page may not apply specifically to the brand name Farxiga.

Applies to dapagliflozin: oral tablet.

Serious side effects of Farxiga

Along with its needed effects, dapagliflozin (the active ingredient contained in Farxiga) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking dapagliflozin:

Other side effects of Farxiga

Some side effects of dapagliflozin may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Precautions

It is very important that your doctor check your progress at regular visits, especially during the first few weeks that you take this medicine. Blood and urine tests may be needed to check for unwanted effects.

Dizziness, lightheadedness, or fainting may occur with this medicine. This is more common if you have kidney disease, low blood pressure, or if you are taking a diuretic (water pill). Taking plenty of fluids each day may help. Drink plenty of water during exercise or in hot weather. Check with your doctor if you have severe nausea, vomiting, or diarrhea that does not stop. This may cause you to lose too much water.

Diabetic ketoacidosis (high ketones and acid in the blood) may occur while you are using this medicine. This can be life-threatening and requires immediate medical attention. Your doctor may give you insulin, fluid, and carbohydrate replacement to treat this condition. Tell your doctor right away if you have nausea, vomiting, trouble breathing, increased thirst or urination, or stomach pain.

Tell your doctor if you have bloody urine, decrease in how much or how often you urinate, painful or difficult urination, lower back or side pain, fever, chills, rapid weight gain, or swelling of the face, finger, or lower legs. These may be symptoms of a serious kidney problem.

This medicine may increase risk of having urinary tract infections, including pyelonephritis or urosepsis. Check with your doctor right away if you have bladder pain, bloody or cloudy urine, difficult, burning, or painful urination, or lower back or side pain.

This medicine may cause vaginal yeast infections in women and yeast infections of the penis in men. This is more common in patients who have a history of genital yeast infections or in men who are not circumcised. Women may have a vaginal discharge, itching, or odor. Men may have redness, itching, swelling, or pain around the penis, or a discharge with a strong odor from the penis. Check with your doctor right away if you have any of these symptoms.

This medicine may cause a rare but serious bacterial infection, called necrotizing fasciitis of the perineum or Fournier's gangrene, which can cause damage to the tissue under the skin in the area between and around the anus and genitals (perineum). Fournier's gangrene may lead to hospitalization, multiple surgeries, or death. Check with your doctor right away if you have fever, unusual tiredness or weakness, or pain, tenderness, redness, or swelling of the area between and around your anus and genitals.

This medicine may cause hypoglycemia (low blood sugar). This is more common when this medicine is taken together with other diabetes medicines (eg, insulin, glipizide, or glyburide). The symptoms of low blood sugar must be treated before they cause you to pass out. People feel different symptoms with low blood sugar. It is important that you learn which symptoms you usually have so you can treat it quickly. Some symptoms of low blood sugar include: behavior changes that are similar to being drunk, blurred vision, cold sweats, confusion, cool, pale skin, difficulty with thinking, drowsiness, excessive hunger, fast heartbeat, headaches that continue, nausea, shakiness, slurred speech, or unusual tiredness or weakness. Talk to your doctor about how to treat low blood sugar.

Hyperglycemia (high blood sugar) may occur if you do not take enough or skip a dose of your diabetes medicine, overeat or do not follow your diet plan, have a fever or infection, or do not exercise as much as usual. Some symptoms of high blood sugar include: blurred vision, drowsiness, dry mouth, flushed and dry skin, a fruit-like breath odor, increased frequency and amount of urination, ketones in the urine, loss of appetite, nausea or vomiting, rapid and deep breathing, tiredness, or unusual thirst. If symptoms of high blood sugar occur, check your blood sugar level and call your doctor for instructions.

Make sure any doctor or dentist who treats you knows that you are using this medicine. This medicine may affect the results of certain medical tests (eg, urine glucose tests may not be accurate). Also, you may need to Stop taking dapagliflozin at least 3 days before you have a surgery or other procedures that require fasting.

Make sure your doctor knows if you are pregnant or planning to become pregnant. If you become pregnant while taking dapagliflozin, your doctor may switch you to another medicine to control your blood sugar. Talk to your doctor about the best way to control your blood sugar if you plan to become pregnant or while you are pregnant.

Do not use this medicine if you are also using or have recently received medicine that weakens your immune system to treat kidney disease.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

For healthcare professionals

Applies to dapagliflozin: oral tablet.

General adverse events

The most common adverse reactions included female genital mycotic infections, nasopharyngitis, and urinary tract infections.^[Ref]

Genitourinary

• Common (1% to 10%): Urinary tract infections increased urination, discomfort with urination, female genital mycotic infections (including vulvovaginal mycotic infection, vaginal infection, vulvovaginal candidiasis, vulvovaginitis, genital infection, genital candidiasis fungal genital infection, vulvitis, genitourinary tract infection, vulval abscess, and vaginitis bacterial), and male mycotic infections (including balanitis, fungal genital infection, balanitis candida, genital candidiasis, genital infection male, penile infection, balanoposthitis, balanoposthitis infective, genital infection, posthitis)
• Postmarketing reports: Urosepsis, pyelonephritis, Fournier's gangrene^[Ref]

In the 5 years (2013 to 2018) since SGLT2 inhibitor approval, 12 cases of Fournier's gangrene have been reported. Reports were almost equal in men and women (men=7; women=5), ages ranged from 38 to 78 years, and the average time to onset after starting an SGLT2 inhibitor was 9.2 months (range 7 days to 25 months). All SGLT2 inhibitor drugs except ertugliflozin were included in the reports. Ertugliflozin being the most recently approved agent, is expected to have the same risk, but insufficient patient use to assess risk. All patients were hospitalized, all required surgery, all required surgical debridement, 5 required more than 1 surgery and 1 required skin grafting. Four cases were complicated by diabetic ketoacidosis, acute kidney injury, and septic shock, leading to prolonged hospitalization, and death in 1 case. In the general population, Fournier's gangrene occurs in about 1.6 out of 100,000 males annually, with the highest incidence in men 50 to 79 years. Since diabetes is a risk factor for Fournier's gangrene, a review of the FAERS database for the last 34 years was done and only 6 cases (all males, median age 57 years) were found with several other classes of antidiabetic drugs. Findings with SGLT2 inhibitors appear to show an association over a shorter time frame and involve both males and females.^[Ref]

Cardiovascular

• Common (1% to 10%): Dyslipidemia
• Uncommon (0.1% to 1%): adverse reactions related to reduced intravascular volume (postural hypotension, orthostatic hypotension, hypotension, dehydration, and syncope)^[Ref]

Metabolic

• Very common (10% or more): Hypoglycemia (up to 43%)
• Common (1% to 10%): Hyperphosphatemia, increases in low-density lipoprotein cholesterol (LDL-C)
• Uncommon (0.1% to 1%): Decreased weight
• Postmarketing reports: Acidosis including diabetic ketoacidosis, ketoacidosis, or ketosis^[Ref]

Hypoglycemia was reported more frequently when this drug was added to sulfonylurea or insulin (up to 43%). Hypoglycemia was not reported in monotherapy trials, and was reported infrequently in add-on trials with metformin, pioglitazone, and dipeptidyl peptidase-4 inhibitors (up to 1.5%,2.1%, and 1.8% respectively). Severe hypoglycemia and diabetic ketoacidosis (DKA) have only been observed in patients with diabetes mellitus.

Ketoacidosis has been reported in patients with type 1 and type 2 diabetes mellitus receiving SGLT2 inhibitors including this drug. Fatalities have been reported. The presentation of ketoacidosis in many cases was atypical with only moderately increased blood glucose values (below 250 mg/dL [14 mmol/L] ). Factors that appear to have predisposed patients to ketoacidosis included insulin deficiency from any cause (including insulin pump failure, insulin dose reduction, history of pancreatitis or pancreatic surgery), reduced caloric intake or increased insulin requirements due to infections, low carbohydrate diet, acute illness, surgery, a previous ketoacidosis, dehydration and alcohol abuse.

In the DECLARE (Dapagliflozin Effect on Cardiovascular Events) study, DKA was reported in 27 and 12 patients in the dapagliflozin (the active ingredient contained in Farxiga) (n=8574) and placebo (n=8569) groups, respectively. Mean changes in LDL cholesterol were 0.4 mg/dL and -2.5 mg/dL in the dapagliflozin and placebo groups, respectively.^[Ref]

Gastrointestinal

• Common (1% to 10%): Nausea, constipation
• Uncommon (0.1% to 1%): Thirst, dry mouth^[Ref]

Hypersensitivity

• Rare (less than 0.1%): Serious anaphylactic reactions, severe cutaneous reactions, and angioedema^[Ref]

Musculoskeletal

• Common (1% to 10%): Back pain, extremity pain
• Frequency not reported: Bone fracture^[Ref]

Bone fractured occurred in 13 patients receiving this drug compared with no placebo patients in a study of patients with an eGFR of 30 to less than 60 mL/min/1.73 m2.^[Ref]

Immunologic

• Common (1% to 10%): Influenza^[Ref]

Oncologic

• Uncommon (0.1% to 1%): Bladder cancer^[Ref]

Newly diagnosed bladder cancer was reported in 10 of 6045 (0.17%) patients receiving this drug in clinical trials compared with 1 of 3512 (0.03%) patients receiving placebo or comparator. Upon excluding patients in whom exposure to study drug was less than 1 year at time of diagnosis, there were no cases associated with placebo and 4 cases with this drug. Due to the low number of cases, further studies are needed.^[Ref]

Renal

• Frequency not reported: Renal failure, serum creatinine increase
• Postmarketing reports: Acute kidney injury, renal impairment^[Ref]

From March 2013 to October 2015, the US FDA received 101 confirmable case reports of acute kidney injury (AKI) with use of canagliflozin (n=73) or dapagliflozin (n=28). Hospitalization was necessary for evaluation and management in 96 cases; admission to the intensive care unit occurred in 22 cases, and death occurred in 4 patients, of which 2 were cardiac-related. Dialysis was necessary in 15 patients, 3 of whom had a history of chronic kidney disease or previous AKI. In 58 cases, time to onset of AKI was within 1 month or less of initiating therapy. In 78 cases in which drug discontinuation was reported, 56 reported subsequent improvement; 3 patients recovered with sequelae, 11 patients did not recover (including the 4 deaths mentioned earlier). Median age was 57 years (range 28 to 78 years; based on 84 cases reporting age). Concomitant ACE inhibitor therapy was reported in 51 cases, diuretic use in 26 cases, and NSAID use in 6 cases. Almost half the patients reported a change in renal function at time of diagnosis (median elevation of serum creatinine from baseline 1.6 mg/dL [based on 32 cases reporting serum creatinine] and median decrease in eGFR 46 mL/min/1.73m2 [based on 13 cases reporting eGFR]).^[Ref]

Endocrine

• Frequency not reported: Small increases in serum parathyroid hormone levels^[Ref]

Nervous system

• Common (1% to 10%): Dizziness, headache^[Ref]

Hepatic

• Very rare (less than 0.01%): Hepatitis^[Ref]

Respiratory

• Common (1% to 10%): Nasopharyngitis^[Ref]

Dermatologic

• Postmarketing reports: Rash^[Ref]

See also:

Frequently asked questions

• Does Farxiga cause weight loss?
• How long does it take for Farxiga to work?
• Can Farxiga cause kidney damage?
• What is Farxiga used for and how does it work?
• Can Farxiga cause constipation?
• Why does Farxiga cause yeast infections?
• What are the ingredient drugs contained in Qternmet XR?

Further information

Farxiga side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer