Farxiga Side Effects

Generic Name: dapagliflozin

Note: This page contains information about the side effects of dapagliflozin. Some of the dosage forms included on this document may not apply to the brand name Farxiga.

Not all side effects for Farxiga may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to dapagliflozin: oral tablet

In addition to its needed effects, some unwanted effects may be caused by dapagliflozin (the active ingredient contained in Farxiga). In the event that any of these side effects do occur, they may require medical attention.

You should check with your doctor immediately if any of these side effects occur when taking dapagliflozin:

More common
  • Anxiety
  • bladder pain
  • bloody or cloudy urine
  • blurred vision
  • chills
  • cold sweats
  • coma
  • confusion
  • cool, pale skin
  • decreased frequency or amount of urine
  • depression
  • difficult, burning, or painful urination
  • dizziness
  • fast heartbeat
  • frequent urge to urinate
  • headache
  • increased hunger
  • increased thirst
  • itching of the vagina or genitals
  • loss of appetite
  • lower back or side pain
  • nausea
  • nightmares
  • seizures
  • shakiness
  • slurred speech
  • swelling of the face, fingers, or lower legs
  • thick, white vaginal discharge with mild or no odor
  • troubled breathing
  • unusual tiredness or weakness
  • vomiting
  • weight gain
Less common
  • Foul smelling discharge from the penis
  • pain in the skin around the penis
  • rash of the penis
  • redness, itching, or swelling of the penis
Rare
  • Cough
  • difficulty with swallowing
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • dry mouth
  • fainting
  • increase in heart rate
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • lightheadedness
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • rapid breathing
  • skin rash, hives, or itching
  • sunken eyes
  • sweating
  • tightness in the chest
  • wrinkled skin

Some of the side effects that can occur with dapagliflozin may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

More common
  • Fever
  • muscle aches
  • sore throat
  • stuffy or runny nose
Less common
  • Back pain
  • difficulty having a bowel movement (stool)
  • pain in the arms or legs

For Healthcare Professionals

Applies to dapagliflozin: oral tablet

General

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

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)

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)

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

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).

Gastrointestinal

Common (1% to 10%): Nausea, constipation
Uncommon (0.1% to 1%): Thirst, dry mouth

Hypersensitivity

Rare (less than 0.1%): Serious anaphylactic reactions, severe cutaneous reactions, and angioedema

Musculoskeletal

Common (1% to 10%): Back pain, extremity pain
Frequency not reported: Bone fracture

Immunologic

Common (1% to 10%): Influenza

Oncologic

Newly diagnosed bladder cancer was reported in 10 of 6045 (0.17%) patients receiving this drug in clinical trials compared with 1 of 3512 (0.3%) 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.

Uncommon (0.1% to 1%): Bladder cancer

Renal

Frequency not reported: Renal failure, serum creatinine increase

Endocrine

Frequency not reported: Small increases in serum parathyroid hormone levels

Nervous system

Common (1% to 10%): Dizziness, headache

Hepatic

Very rare (less than 0.01%): Hepatitis

Respiratory

Common (1% to 10%): Nasopharyngitis

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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