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ATC Codes: None found

Side effects

Options: Hide MedDRA Preferred Terms

MedDRA Preferred Term Side effect Data for drug Placebo Labels
1 2 3
Nasopharyngitis Nasopharyngitis 6.3% - 6.6% 6.2% x
Genital infection fungal Genital infection fungal 2.7% - 8.4% 0.3% - 1.5% x
Back pain Back pain 3.1% - 4.2% 3.2% x x x
Influenza Influenza 2.3% - 2.7% 2.3% x
Urinary tract infection Urinary tract infection 0.3% - 5.7% 3.7% x x x
Dyslipidaemia Dyslipidaemia 2.1% - 2.5% 1.5% x x x
Constipation Constipation 1.9% - 2.2% 1.5% x x
Pain in extremity Pain in extremity 1.7% - 2% 1.4% x
Discomfort Discomfort 1.6% - 2.1% 0.7% x
Nausea Nausea 0.2% - 2.8% 2.4% x x x
Blood creatinine increased Blood creatinine increased 0.4% x x
Serum creatinine increased x x
Dizziness Dizziness 0.2% x x
Dermatitis Rash 0.2% x x
Rash Rash 0.2% x x
Anaphylactic shock Anaphylactic shock x
Angina pectoris Angina unstable x
Angina unstable Angina unstable x
Angioedema Angioedema x
Balanitis Balanitis x x x
Bladder cancer Bladder cancer x
Neoplasm malignant Neoplasm malignant x x
Connective tissue disorder Connective tissue disorder x x
Dehydration Dehydration x x x
Diabetes mellitus Diabetes mellitus x x
Polyuria Diuresis x
Polyuria x x
Dysuria Dysuria x x
Multiple fractures Fracture x x
Fracture Fracture x x
Gastrointestinal disorder Gastrointestinal disorder x
Headache Headache x
Hyperhidrosis Hyperhidrosis x
Hypersensitivity Hypersensitivity x
Hypertension Hypertension x
Hypoglycaemia Hypoglycaemia x x x
Hypoglycemic reaction x
Hypotension Hypotension x x x
Orthostatic hypotension Orthostatic hypotension x x
Fungal infection Fungal infection x
Myocardial infarction Myocardial infarction x
Acute coronary syndrome Myocardial infarction x
Neoplasm Neoplasm x x
Nocturia Nocturia x
Osteopenia Osteopenia x
Urine output increased Polyuria x x
Urine output increased x x
Neoplasm prostate Neoplasm prostate x x
Renal failure Renal failure x
Cerebrovascular accident Cerebrovascular accident x
Thirst Thirst x
Pollakiuria Pollakiuria x x
Urethral disorder Urinary tract disorder x x
Urinary tract disorder Urinary tract disorder x x
Urticaria Urticaria x
Vulvitis Vulvitis x x
Vulvovaginitis Vulvovaginitis x x
Vaginitis bacterial Vaginitis bacterial x x
Vaginal infection Vaginitis bacterial x x
Vaginal infection x x
Hyperphosphataemia Hyperphosphataemia x
Blood urea increased Blood urea increased x
Malnutrition Malnutrition x x
Skin disorder Unspecified disorder of skin and subcutaneous tissue x
Haematocrit increased Haematocrit increased x x
Infection Recurrent infection x
Autoimmune hepatitis Autoimmune hepatitis x
Vulval abscess Vulval abscess x x
Balanitis candida Balanitis candida x x
Genital candidiasis Genital candidiasis x x
Hypovolaemia Hypovolaemia x x x
Genital infection male Genital infection male x x
Penile infection Penile infection x x
Vulvovaginal candidiasis Vulvovaginal candidiasis x x
Infestation Infestation NOS x x
Carcinogenicity Carcinogenicity x x
Vulvovaginal pruritus Vulvovaginal pruritus x
Drug-induced liver injury Drug-induced hepatitis x
Blood pressure fluctuation Change in blood pressure x
Vulvovaginal mycotic infection Vulvovaginal mycotic infection x x


Information about indications was extracted from the indications and usage sections of the labels.


Side effects:29
Source:FDA Structured Product Label

dapagliflozin propanediol monohydrate / FORXIGA

Side effects:45

Color scheme:


    frequent (1% to 100%)
    infrequent (0.1% to 1%)
    rare (<0.1%)
    no frequency information
    not found on label