Glifixy Adverse Reactions

Type 2 diabetes mellitus: In the clinical studies in type 2 diabetes, more than 15,000 patients have been treated with dapagliflozin.
The primary assessment of safety and tolerability was conducted in a pre-specified pooled analysis of 13 short-term (up to 24 weeks) placebo-controlled studies with 2,360 subjects treated with dapagliflozin 10 mg and 2,295 treated with placebo. In the dapagliflozin cardiovascular outcomes study in type 2 diabetes mellitus (DECLARE study), 8,574 patients received dapagliflozin 10 mg and 8,569 received placebo for a median exposure time of 48 months. In total, there were 30,623 patient-years of exposure to dapagliflozin.
The most frequently reported adverse reactions across the clinical studies were genital infections.
Heart failure: In the dapagliflozin cardiovascular outcome study in patients with heart failure with reduced ejection fraction (DAPA-HF study), 2,368 patients were treated with dapagliflozin 10 mg and 2,368 patients with placebo for a median exposure time of 18 months.
The patient population included patients with type 2 diabetes mellitus and without diabetes, and patients with eGFR ≥ 30 mL/min/1.73 m².
The overall safety profile of dapagliflozin in patients with heart failure was consistent with the known safety profile of dapagliflozin.
Chronic kidney disease: In the dapagliflozin renal outcome study in patients with chronic kidney disease (DAPA_CKD), 2,149 patients were treated were dapagliflozin 10 mg and 2,149 patients with placebo for a median exposure time of 27 months. The patient population included patients with type 2 diabetes mellitus and without diabetes, with eGFR ≥ 25 to ≤ 75 mL/min/1.73 m². Treatment was continued if eGFR fell to levels below 25 mL/min/1.73 m². The overall safety profile of dapagliflozin in patients with chronic kidney disease was consistent with the known safety profile of dapagliflozin.
Identified adverse reactions in placebo-controlled clinical studies and postmarketing experience: Infections and infestations: Common: Vulvovaginitis, balanitis and related genital infections, Urinary tract infection.
Uncommon: Fungal infection.
Very rare: Necrotising fasciitis of the perineum (Fournier's gangrene).
Metabolism and nutrition disorders: Very common: Hypoglycaemia (when used with SU or insulin).
Uncommon: Volume depletion, Thirst.
Rare: Diabetic ketoacidosis (when used in type 2 diabetes mellitus).
Nervous system disorder: Common: Dizziness.
Gastrointestinal disorders: Uncommon: Constipation, Dry mouth.
Skin and subcutaneous tissue disorders: Common: Rash.
Very rare: Angioedema.
Musculoskeletal and connective tissue disorders: Common: Back pain.
Renal and urinary disorders: Common: Dysuria, Polyuria.
Uncommon: Nocturia.
Reproductive system and breast disorders: Uncommon: Vulvovaginal pruritus, Pruritus genital.
Investigations: Common: Haematocrit increased, Creatinine renal clearance decreased during initial treatment, Dyslipidaemia.
Uncommon: Blood creatinine increased during initial treatment, Blood urea increased, Weight decreased.