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Safety Profile

POOLED SAFETY ANALYSIS

Adverse reactions from 8 placebo-controlled studies reported in ≥2% of patients1
Dapagliflozin 5 mg + metformin (N=410)
Dapagliflozin 10 mg + metformin (N=983)
Placebo and metformin (N=1185)
Female genital mycotic infectionsa
9.4%
9.3%
1.5%
Nasopharyngitis
6.3%
5.2%
5.9%
Urinary tract infectionsb
6.1%
5.5%
3.6%
Diarrhea
5.9%
4.2%
5.6%
Headache
5.4%
3.3%
2.8%
Male genital mycotic infectionsc
4.3%
3.6%
0%
Influenza
4.1%
2.6%
2.4%
Nausea
3.9%
2.6%
2.0%
Back pain
3.4%
2.5%
3.2%
Dizziness
3.2%
1.8%
2.2%
Cough
3.2%
1.4%
1.9%
Constipation
2.9%
1.9%
1.6%
Dyslipidemia
2.7%
1.5%
1.4%
Pharyngitis
2.7%
1.5%
1.1%
Increased urinationd
2.4%
2.6%
1.4%
Discomfort with urination
2.2%
1.6%
1.1%

aGenital mycotic infections include the following adverse reactions, listed in order of frequency reported for females: vulvovaginal mycotic infection, vaginal infection, genital infection, vulvovaginitis, fungal genital infection, vulvovaginal candidiasis, vulval abscess, genital candidiasis, and vaginitis bacterial. (N for females: Dapagliflozin 10 mg and metformin=430, dapagliflozin 5 mg and metformin=223, placebo and metformin=534.)

bUrinary tract infections include the following adverse reactions, listed in order of frequency reported: urinary tract infection, cystitis, pyelonephritis, urethritis, and prostatitis.

cGenital mycotic infections include the following adverse reactions, listed in order of frequency reported for males: balanitis, fungal genital infection, balanitis candida, genital candidiasis, genital infection, posthitis, balanoposthitis. (N for males: Dapagliflozin 10 mg and metformin=553, dapagliflozin 5 mg and metformin=187, placebo and metformin=651.)

dIncreased urination includes the following adverse reactions, listed in order of frequency reported: pollakiuria, polyuria, and urine output increased.

  • The most commonly reported events leading to discontinuation and reported in at least 3 patients treated with dapagliflozin 10 mg and metformin were renal impairment (0.7%), increased blood creatinine (0.2%), decreased renal creatinine clearance (0.2%), and urinary tract infection (0.2%)1

MOST COMMON ADVERSE REACTIONS FOR EACH COMPONENT OF XIGDUO XR COMBINATION THERAPY1

DAPAGLIFLOZIN
Most common adverse events in
≥5% of patients
% of patients in a pool of 12 placebo-controlled studies for dapagliflozin 5 and 10 mg
Dapagliflozin 5 mg (N=1145)
Dapagliflozin 10 mg (N=1193)
Placebo (N=1393)
Female genital mycotic infectionse
8.4%
6.9%
1.5%
Nasopharyngitis
6.6%
6.3%
6.2%
Urinary tract infectionsf
5.7%
4.3%
3.7%
METFORMIN XR
Most common adverse events in
>5% of patients
% of patients in placebo-controlled metformin XR monotherapy trials
Metformin XR
Placebo
Diarrhea
9.6%
2.6%
Nausea and vomiting
6.5%
1.5%

eGenital mycotic infections include the following adverse reactions, listed in order of frequency reported for females: vulvovaginal mycotic infection, vaginal infection, vulvovaginal candidiasis, vulvovaginitis, genital infection, genital candidiasis, fungal genital infection, vulvitis, genitourinary tract infection, vulval abscess, and vaginitis bacterial. (N for females: Dapagliflozin 10 mg=598, dapagliflozin 5 mg=581, placebo=677.)

fUrinary tract infections include the following adverse reactions, listed in order of frequency reported: urinary tract infection, cystitis, Escherichia urinary tract infection, genitourinary tract infection, pyelonephritis, trigonitis, urethritis, kidney infection, and prostatitis.

  • Diarrhea led to discontinuation of study medication in 0.6% of the patients treated with metformin XR