Farxiga Side Effects

Name of the generic: dapagliflozin

Summary

More common Farxiga side effects are: Pyelonephritis, cystitis in the urinary tract, candidiasis vulvovaginal genital candidiasis syndrome, bacterial vaginosis as well as prostatitis, genitourinary infection and urethritis, vaginal infections such as vulvitis, vulvovaginitis, and. Check out the following list of adverse reactions.

For the Consumer

This is applicable to dapagliflozin tablets for oral use

The Farxiga side effects that occur require immediate medical treatment

In addition to its beneficial impacts, dapagliflozin (the active ingredient that is within Farxiga) could cause unwanted side effects. While some of these side effects could occur, if they occur, they could require medical care.

Talk to your doctor immediately If any of these adverse effects happen while you are taking Farxiga

More common Farxiga side effects

Anxiety
Pain in the bladder
Bloody or cloudy urine
blurred vision
chills
cold sweats
confusion
cool, pale skin
less frequent or a smaller amount of the amount of urine
depression
painful pain, burning, or difficult urinary tract
dizziness
rapid heartbeat
Urinary urges that are frequent
headache
more appetite
Increased thirst
Vagina itching or the genitals
Loss of appetite
loss of consciousness
Lower back or side discomfort
nausea
nightmares
seizures
Shaking
Speech slurred
swelling of the fingers, face, or lower legs
A thick, white vaginal discharge with no or mild scent
Trouble breathing
unusual weakness or fatigue
vomiting
weight gain

Less well-known Farxiga side effects

A foul-smelling discharge from the penis
discomfort in the skin surrounding the penis
Penis rash
redness, itching or constipation of the penis.

Rare Farxiga side effects

Cough
difficulties swallowing
dizziness, faintness or lightheadedness after rising quickly from a sitting or lying or seated
dry mouth
fainting
an increase in heart rate
Large, hive-like swellings on the eyelids, face and lips. It can also be seen on the tongue throat, hands, feet, legs or the genitals
lightheadedness
Swelling or puffiness on the eyelids and around the eyes or lips or the tongue
rapid breathing
skin itchy rash, hives or itching
sunken eyes
sweating
Tightness in the chest
wrinkled skin

Farxiga side effects, the exact cause is not known.

Fever
red, dry skin
Fruit-like breath odor
loss of consciousness
Redness, tenderness, pain or swelling of the region between the anus as well as the genitals
stomach pain
mysterious weight loss

There are no immediate side effects that require medical care

Certain Farxiga side effects can occur, but they usually are not medically relevant care. These adverse effects could be eliminated after treatment, as your body adapts to the medication. Additionally, your healthcare expert may give you suggestions to reduce or eliminate certain adverse consequences.

Consult your physician for any of these adverse reactions persist or cause discomfort or should you have any concerns regarding these Farxiga side effects:

More commonly

Muscle pains
Sore throat
stuffy or nasal congestion

Less popular

The back pain
difficulties in bowel movements
arm or legs

Managing Farxiga side effects (general information)

For Healthcare Professionals

Applies to dapagliflozin: oral tablet

General

The most frequent Farxiga side effects were female mycotic genital nasopharyngitis, genital as well as urinary tract infections.

Genitourinary

The most common Farxiga side effects (1 percent to 10 percent) Urinary tract infections can cause increased urinary frequency, discomfort when urinating female genital mycotic infection (including mycotic vulvovaginal infection vaginal infection, vaginal candidiasis as well as vulvovaginitis, Genital candidiasis, fungal the genital tract, vulvitis an infection of the genitourinary tract and vaginitis, vulval abscess and bacterial) as well as male mycotic diseases (including balanitis fungal genital infection the genital candidiasis, balanitis male genital infections balanoposthitis the balanoposthitis infection, genital infection posthitis)

Reports from postmarketing: Urosepsis, pyelonephritis Fournier’s Gangrene

In the five years (2013 until 2018) between 2013 and 2018 SGLT2 inhibitor approval, 12 cases of Fournier’s gangrene were identified. The reports were nearly equal for males and females (men=7 and women=5) Ages ranged between 38-78 years old, and the median time for onset following the introduction of the SGLT2 inhibitor is 9.2 months (range 7 days to 25 months). All SGLT2 inhibitors except Ertugliflozin are included within the studies.

Ertugliflozin is the latest approved drug is believed to carry the same risk, however, there is not enough patient data to evaluate the risk. All patients required hospitalization for surgery. All required surgery. all needed surgical debridement. five required more than one procedure, and one needed skin transplantation.

Four cases were caused by the condition known as diabetic ketoacidosis acute kidney injury as well as septic shock, which led to prolonged hospitalization and even death in one case. For the majority of people, Fournier’s gangrene is seen in around 1.6 males each year with the highest prevalence among men aged 50-79 years of age.

As diabetes is a risk cause for Fournier’s gangrene an examination of FAERS database over the last 34 years was conducted and only six cases (all males aged 57-59 years, median age) were associated with different classes of anti-diabetic medications. Results with SGLT2 inhibitors are likely to indicate any association with a shorter period of time and include both genders.^¶

Cardiovascular

Common (1% to 10%): Dyslipidemia

Uncommon Farxiga side effects (0.1 percent to 0.1% to) adverse reactions due to decrease the volume of intravascular blood (postural hypotension orthostatic dehydration, hypotension, and syncope), chest pain.

Metabolic

The condition of hypoglycemia has been reported higher often when the drug was added to sulfonylurea and insulin (up to 43 percent). Hypoglycemia was not observed in monotherapy trials and it was not reported often during add-on trials using metformin, pioglitazone and dipeptidyl peptidase-4 inhibitors (up to 1.5%,2.1 percent and 1.8 percentages, in each case). Severe hypoglycemia, as well as diabetes ketoacidosis (DKA), are only found in patients suffering from diabetes mellitus..

Ketoacidosis is a condition that has been identified in patients suffering from type 1 as well as type 2 diabetic mellitus who are taking SGLT2 inhibitors, including this medication. The reports of fatalities are numerous. The ketoacidosis that was seen in a number of instances was unusual, with moderately elevated blood glucose levels (below 250 mg/dL, or 14 mg/Lin in some cases ).

Some factors that could have increased the risk of ketoacidosis in patients include insulin deficiency of any kind (including the failure of insulin pumps or reduction in insulin dose, previous history in Pancreatitis or surgery for the pancreas) and a decrease in caloric intake or an increase in insulin requirement because of infections, an eating a diet low in carbohydrate and acute illness, surgical or prior ketoacidosis dehydration, and alcohol use.

The DECLARE (Dapagliflozin Effect on cardiovascular diseases) Study, DKA has been reported by patients with a total of 27 and 12 in the dapagliflozin (the active ingredient in the Farxiga) (n=8574) or the placebo (n=8569) groups respectively. Changes for LDL cholesterol levels were 0.4 mg/dL, and -2.5 mg/dL for the dapagliflozin group and the placebo group respectively.

Very frequent (10 percent or more) Hypoglycemia (up to 43 (up to 43%))

common (1 10% to 10 percent) Hyperphosphatemia, a rise in cholesterol levels of low-density lipoprotein (LDL-C)

Uncommon (0.1 to 1% to 1 percent) A decrease in weight

Postmarketing reports: Acidosis including diabetic ketoacidosis, ketoacidosis, or ketosis

Gastrointestinal

common (1 percent to 10 percent) The feeling of nausea, constipation

Non-common (0.1 percent to 1.1%) Dry, thirsty mouth

Hypersensitivity

Seldom (less that 0.1 percent) serious anaphylactic reaction and severe cutaneous reactions as well as Angioedema

Musculoskeletal

The most common (1 percent to 10 percent) Back discomfort, pain in the extremities

Frequency not disclosed: Bone fracture

Bone fractures were observed in 13 patients taking this medication compared to placebo subjects in an investigation of patients having an eGFR between 30 and under 60 mL/min/1.73 meters.

Immunologic

Common (1% to 10%): Influenza

Oncologic

The diagnosis of bladder cancer for the first time was discovered in 10 out of 6045 (0.17 percent) patients who received this drug in clinical trials as compared with just 1 out of 3512 (0.03 percent) patients who received placebo or a comparator. After excluding patients whose exposure to the study drug was less than one year at the time of the diagnosis, we found not any cases that were associated with placebo, and 4 cases related to this drug. Because of the small number of cases, additional research is required.

Non-common (0.1 percent to 1.1%) Bladder cancer

Renal

Frequency not disclosed Renal failure and a rise in serum creatinine

Reports on postmarketing Acute kidney injury and renal impairment

From March 2013 until October 2015 between March 2013 and October 2015, from March to October of 2015, US FDA was notified of 101 valid cases from patients suffering acute kidney damage (AKI) that involved canagliflozin (n=73) or dapagliflozin (n=28). Hospitalization was needed to assess and manage the 96 cases. Admission into the intensive care units took place in 22 instances, and deaths occurred in 4 patients, among which two were related to cardiac.

Dialysis was required for 15 patients, 3 of who had a history of renal disease chronic or prior AKI. In 58 of the cases, the time from the onset of AKI was one month or less after initiating treatment. In 78 instances where discontinuation of treatment occurred, 56 experienced improvements following the discontinuation; 3 patients were able to recover with sequelae. 11 patients failed to recover (including those who died as previously mentioned). The median age of patients was 57 (range 28-78 years from 28 to 78 years; based on 84 patients with age reports).

In addition, ACE inhibition therapy has been observed for 51 patients, as was diuretic treatment in 26 instances and NSAID use in six instances. About half of the patients had changes in renal function at the time of diagnosis (median increase in serum creatinine from the baseline 1.6 mg/dL [based upon 32 cases of serum creatinine] as well as a median reduction in eGFR 46 mL/min/1.73m2 Based on 13 cases with eGFR reports in the 13 cases that reported eGFR).

Endocrine

Frequency not disclosed small increases in parathyroid hormone levels

Nervous system

The common (1 10% to 10 percent) headache, dizziness

Hepatic

Very uncommon (less then 0.01 percent): Hepatitis

Respiratory

Common (1% to 10%): Nasopharyngitis

Dermatologic

Postmarketing report Reports on Rash

Additional details

Always consult your physician to confirm that the information provided on this page is applicable to your specific situation.

Some adverse reactions may not be disclosed. Some Farxiga side effects may not be reported. You can be able to report them to the FDA.

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