Drug
Empagliflozin And Metformin Hydrochloride
Important: Reactions below are the flagged terms from this drug’s
FAERS report history (min. 3 co-reports per term) — PRR/ROR indicate
disproportionality in spontaneous reporting, not causation.
Data from FDA FAERS via openFDA. Last recalculated: 2026-09-14.
| Reaction | Co-reports (a) | PRR | ROR | Signal | |
|---|---|---|---|---|---|
| 1 | Diabetic Ketoacidosis | 154 | 47.9 | 50.6 | signal |
| 2 | Impaired Gastric Emptying | 32 | 18.6 | 18.8 | signal |
| 3 | Glycosylated Haemoglobin Increased | 61 | 18.0 | 18.3 | signal |
| 4 | Blood Iron Decreased | 27 | 17.0 | 17.2 | signal |
| 5 | Cyst | 25 | 14.9 | 15.1 | signal |
| 6 | Blood Glucose Abnormal | 35 | 14.0 | 14.2 | signal |
| 7 | Tendonitis | 26 | 12.4 | 12.5 | signal |
| 8 | Glomerular Filtration Rate Decreased | 17 | 10.4 | 10.5 | signal |
| 9 | Synovitis | 25 | 10.3 | 10.4 | signal |
| 10 | Fungal Infection | 44 | 9.8 | 9.9 | signal |
| 11 | Diabetes Mellitus Inadequate Control | 23 | 9.6 | 9.7 | signal |
| 12 | Injection Site Warmth | 26 | 9.4 | 9.4 | signal |
| 13 | Lactic Acidosis | 39 | 9.0 | 9.1 | signal |
| 14 | Eructation | 21 | 8.2 | 8.2 | signal |
| 15 | C-reactive Protein Increased | 38 | 7.7 | 7.8 | signal |
| 16 | Blood Glucose Increased | 189 | 7.4 | 7.9 | signal |
| 17 | Urosepsis | 9 | 7.2 | 7.3 | signal |
| 18 | Metabolic Acidosis | 30 | 7.0 | 7.1 | signal |
| 19 | Blood Glucose Decreased | 45 | 6.9 | 7.0 | signal |
| 20 | Blood Potassium Increased | 14 | 6.4 | 6.4 | signal |
| 21 | Ileus | 10 | 6.0 | 6.0 | signal |
| 22 | Renal Disorder | 35 | 5.6 | 5.6 | signal |
| 23 | Hyperglycaemia | 27 | 5.5 | 5.6 | signal |
| 24 | Nocturia | 9 | 5.5 | 5.5 | signal |
| 25 | Blood Glucose Fluctuation | 8 | 5.4 | 5.4 | signal |
| 26 | Nerve Injury | 8 | 5.3 | 5.3 | signal |
| 27 | Pancreatitis Acute | 15 | 5.0 | 5.0 | signal |
| 28 | Osteoarthritis | 28 | 4.9 | 4.9 | signal |
| 29 | Hypoglycaemia | 31 | 4.7 | 4.8 | signal |
| 30 | Nephrolithiasis | 29 | 4.7 | 4.7 | signal |
| 31 | Thirst | 11 | 4.6 | 4.6 | signal |
| 32 | Pollakiuria | 25 | 4.4 | 4.5 | signal |
| 33 | Renal Pain | 6 | 4.2 | 4.2 | signal |
| 34 | Subdural Haematoma | 8 | 4.1 | 4.1 | signal |
| 35 | Gastroenteritis | 8 | 4.1 | 4.1 | signal |
| 36 | Tachypnoea | 7 | 3.8 | 3.8 | signal |
| 37 | Urinary Retention | 17 | 3.8 | 3.8 | signal |
| 38 | Pancreatitis | 27 | 3.8 | 3.8 | signal |
| 39 | Ligament Sprain | 5 | 3.8 | 3.8 | signal |
| 40 | Prostatic Specific Antigen Increased | 7 | 3.7 | 3.8 | signal |
| 41 | Wrong Technique In Device Usage Process | 23 | 3.7 | 3.7 | signal |
| 42 | Arthropathy | 28 | 3.7 | 3.7 | signal |
| 43 | Osteomyelitis | 9 | 3.7 | 3.7 | signal |
| 44 | Hyperkalaemia | 16 | 3.4 | 3.4 | signal |
| 45 | Extra Dose Administered | 18 | 3.3 | 3.4 | signal |
| 46 | Product Dose Omission In Error | 12 | 3.3 | 3.3 | signal |
| 47 | Limb Injury | 12 | 3.3 | 3.3 | signal |
| 48 | Flatulence | 25 | 3.3 | 3.3 | signal |
| 49 | Laboratory Test Abnormal | 13 | 3.3 | 3.3 | signal |
| 50 | Nerve Compression | 4 | 3.2 | 3.2 | signal |
| 51 | Intestinal Obstruction | 16 | 3.2 | 3.2 | signal |
| 52 | Vaginal Discharge | 4 | 2.9 | 3.0 | no signal |
| 53 | Poor Venous Access | 4 | 2.9 | 2.9 | no signal |
| 54 | Product Odour Abnormal | 4 | 2.9 | 2.9 | no signal |
| 55 | Product Prescribing Error | 9 | 2.8 | 2.8 | signal |
| 56 | Increased Appetite | 7 | 2.8 | 2.8 | signal |
| 57 | Back Disorder | 6 | 2.7 | 2.7 | signal |
| 58 | Product Dispensing Error | 7 | 2.4 | 2.4 | signal |
| 59 | Injection Site Extravasation | 4 | 2.4 | 2.4 | no signal |
| 60 | Deformity | 3 | 2.4 | 2.4 | no signal |
| 61 | Erectile Dysfunction | 8 | 2.3 | 2.3 | signal |
| 62 | Device Defective | 5 | 2.3 | 2.3 | no signal |
| 63 | Inability To Afford Medication | 3 | 2.3 | 2.3 | no signal |
| 64 | Injection Site Mass | 11 | 2.2 | 2.2 | signal |
| 65 | Psoriasis | 39 | 2.2 | 2.2 | signal |
| 66 | Injection Site Discomfort | 3 | 2.2 | 2.2 | no signal |
| 67 | Hereditary Angioedema | 3 | 2.1 | 2.1 | no signal |
| 68 | Injection Site Nodule | 3 | 2.0 | 2.0 | no signal |
| 69 | Incorrect Dose Administered | 59 | 1.9 | 2.0 | no signal |
| 70 | Injection Site Discolouration | 3 | 1.8 | 1.8 | no signal |
| 71 | Pemphigus | 3 | 1.8 | 1.8 | no signal |
| 72 | Incorrect Dose Administered By Device | 6 | 1.7 | 1.8 | no signal |
| 73 | Injection Site Induration | 3 | 1.7 | 1.7 | no signal |
| 74 | Ankylosing Spondylitis | 3 | 1.7 | 1.7 | no signal |
| 75 | Pancreatic Carcinoma | 6 | 1.5 | 1.5 | no signal |
| 76 | Injection Site Urticaria | 5 | 1.5 | 1.5 | no signal |
| 77 | Accidental Underdose | 3 | 1.5 | 1.5 | no signal |
| 78 | Injection Site Pain | 60 | 1.5 | 1.5 | no signal |
| 79 | Device Delivery System Issue | 5 | 1.4 | 1.4 | no signal |
| 80 | Device Issue | 15 | 1.3 | 1.3 | no signal |
| 81 | Device Leakage | 7 | 1.2 | 1.2 | no signal |
| 82 | Injection Site Bruising | 12 | 1.1 | 1.1 | no signal |
| 83 | Injection Site Haemorrhage | 12 | 1.1 | 1.1 | no signal |
| 84 | Intentional Overdose | 9 | 1.0 | 1.0 | no signal |
| 85 | Injection Site Rash | 4 | 1.0 | 1.0 | no signal |
| 86 | Injection Site Pruritus | 8 | 0.9 | 0.9 | no signal |
| 87 | Bladder Cancer | 5 | 0.6 | 0.6 | no signal |
| 88 | Renal Cancer | 3 | 0.5 | 0.5 | no signal |
| 89 | Drug Dose Omission By Device | 3 | 0.3 | 0.3 | no signal |