Drug
Empagliflozin, 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 | 188 | 48.3 | 51.1 | signal |
| 2 | Glycosylated Haemoglobin Increased | 78 | 19.0 | 19.4 | signal |
| 3 | Impaired Gastric Emptying | 37 | 17.8 | 18.0 | signal |
| 4 | Blood Iron Decreased | 27 | 14.0 | 14.1 | signal |
| 5 | Blood Glucose Abnormal | 42 | 13.9 | 14.1 | signal |
| 6 | Cyst | 26 | 12.8 | 12.9 | signal |
| 7 | Fungal Infection | 69 | 12.7 | 12.9 | signal |
| 8 | Tendonitis | 26 | 10.2 | 10.3 | signal |
| 9 | Glomerular Filtration Rate Decreased | 18 | 9.1 | 9.1 | signal |
| 10 | Diabetes Mellitus Inadequate Control | 25 | 8.6 | 8.7 | signal |
| 11 | Synovitis | 25 | 8.5 | 8.5 | signal |
| 12 | Injection Site Warmth | 28 | 8.3 | 8.4 | signal |
| 13 | Lactic Acidosis | 42 | 8.0 | 8.1 | signal |
| 14 | Blood Glucose Increased | 235 | 7.6 | 8.1 | signal |
| 15 | Blood Glucose Decreased | 54 | 6.9 | 6.9 | signal |
| 16 | Eructation | 21 | 6.8 | 6.8 | signal |
| 17 | Urosepsis | 10 | 6.6 | 6.7 | signal |
| 18 | C-reactive Protein Increased | 38 | 6.4 | 6.5 | signal |
| 19 | Metabolic Acidosis | 32 | 6.2 | 6.2 | signal |
| 20 | Nocturia | 11 | 5.6 | 5.6 | signal |
| 21 | Nerve Injury | 10 | 5.5 | 5.5 | signal |
| 22 | Ileus | 11 | 5.5 | 5.5 | signal |
| 23 | Pollakiuria | 36 | 5.3 | 5.3 | signal |
| 24 | Blood Potassium Increased | 14 | 5.3 | 5.3 | signal |
| 25 | Thirst | 15 | 5.1 | 5.2 | signal |
| 26 | Hyperglycaemia | 30 | 5.1 | 5.1 | signal |
| 27 | Blood Glucose Fluctuation | 9 | 5.0 | 5.0 | signal |
| 28 | Pancreatitis Acute | 18 | 4.9 | 5.0 | signal |
| 29 | Renal Disorder | 37 | 4.8 | 4.9 | signal |
| 30 | Osteoarthritis | 30 | 4.3 | 4.3 | signal |
| 31 | Hypoglycaemia | 34 | 4.3 | 4.3 | signal |
| 32 | Nephrolithiasis | 31 | 4.1 | 4.2 | signal |
| 33 | Renal Pain | 7 | 4.1 | 4.1 | signal |
| 34 | Extra Dose Administered | 26 | 4.0 | 4.0 | signal |
| 35 | Nerve Compression | 6 | 4.0 | 4.0 | signal |
| 36 | Weight Decreased | 180 | 3.9 | 4.1 | signal |
| 37 | Pancreatitis | 34 | 3.9 | 4.0 | signal |
| 38 | Hypophagia | 15 | 3.6 | 3.6 | signal |
| 39 | Tachypnoea | 8 | 3.6 | 3.6 | signal |
| 40 | Poor Venous Access | 6 | 3.6 | 3.6 | signal |
| 41 | Urinary Retention | 19 | 3.5 | 3.5 | signal |
| 42 | Arthropathy | 31 | 3.4 | 3.4 | signal |
| 43 | Product Dispensing Error | 12 | 3.4 | 3.4 | signal |
| 44 | Urinary Tract Infection | 92 | 3.3 | 3.4 | signal |
| 45 | Photophobia | 10 | 3.3 | 3.3 | signal |
| 46 | Wrong Technique In Device Usage Process | 24 | 3.2 | 3.2 | signal |
| 47 | Limb Injury | 14 | 3.2 | 3.2 | signal |
| 48 | Laboratory Test Abnormal | 15 | 3.1 | 3.1 | signal |
| 49 | Ligament Sprain | 5 | 3.1 | 3.1 | signal |
| 50 | Prostatic Specific Antigen Increased | 7 | 3.1 | 3.1 | signal |
| 51 | Covid-19 Pneumonia | 6 | 3.1 | 3.1 | signal |
| 52 | Osteomyelitis | 9 | 3.0 | 3.0 | signal |
| 53 | Flatulence | 28 | 3.0 | 3.0 | signal |
| 54 | Hyperkalaemia | 17 | 3.0 | 3.0 | signal |
| 55 | Product Prescribing Error | 11 | 2.8 | 2.8 | signal |
| 56 | Product Dose Omission In Error | 12 | 2.7 | 2.7 | signal |
| 57 | Sinus Congestion | 6 | 2.7 | 2.7 | signal |
| 58 | Intestinal Obstruction | 16 | 2.6 | 2.6 | signal |
| 59 | Diabetes Mellitus | 32 | 2.6 | 2.6 | signal |
| 60 | Subdural Haematoma | 6 | 2.6 | 2.6 | signal |
| 61 | Vaginal Discharge | 4 | 2.4 | 2.4 | no signal |
| 62 | Erectile Dysfunction | 10 | 2.4 | 2.4 | signal |
| 63 | Rotator Cuff Syndrome | 5 | 2.4 | 2.4 | no signal |
| 64 | Product Odour Abnormal | 4 | 2.4 | 2.4 | no signal |
| 65 | Injection Site Mass | 14 | 2.3 | 2.3 | signal |
| 66 | Abscess | 6 | 2.3 | 2.3 | no signal |
| 67 | Increased Appetite | 7 | 2.3 | 2.3 | no signal |
| 68 | Device Defective | 6 | 2.3 | 2.3 | no signal |
| 69 | Back Disorder | 6 | 2.2 | 2.2 | no signal |
| 70 | Choking | 7 | 2.2 | 2.2 | no signal |
| 71 | Psoriasis | 44 | 2.1 | 2.1 | signal |
| 72 | Deformity | 3 | 2.0 | 2.0 | no signal |
| 73 | Incorrect Dose Administered By Device | 8 | 1.9 | 1.9 | no signal |
| 74 | Inability To Afford Medication | 3 | 1.9 | 1.9 | no signal |
| 75 | Incorrect Dose Administered | 68 | 1.8 | 1.9 | no signal |
| 76 | Sars-cov-2 Test Positive | 4 | 1.8 | 1.8 | no signal |
| 77 | Injection Site Discomfort | 3 | 1.8 | 1.8 | no signal |
| 78 | Coronary Artery Occlusion | 4 | 1.8 | 1.8 | no signal |
| 79 | Gastric Disorder | 10 | 1.8 | 1.8 | no signal |
| 80 | Hereditary Angioedema | 3 | 1.7 | 1.7 | no signal |
| 81 | Device Leakage | 12 | 1.7 | 1.7 | no signal |
| 82 | Accidental Underdose | 4 | 1.7 | 1.7 | no signal |
| 83 | Accidental Overdose | 10 | 1.7 | 1.7 | no signal |
| 84 | Injection Site Nodule | 3 | 1.7 | 1.7 | no signal |
| 85 | Injection Site Urticaria | 6 | 1.5 | 1.5 | no signal |
| 86 | Injection Site Discolouration | 3 | 1.5 | 1.5 | no signal |
| 87 | Pemphigus | 3 | 1.5 | 1.5 | no signal |
| 88 | Pancreatic Carcinoma | 7 | 1.5 | 1.5 | no signal |
| 89 | Injection Site Induration | 3 | 1.4 | 1.4 | no signal |
| 90 | Ankylosing Spondylitis | 3 | 1.4 | 1.4 | no signal |
| 91 | Device Delivery System Issue | 6 | 1.4 | 1.4 | no signal |
| 92 | Injection Site Pain | 67 | 1.3 | 1.4 | no signal |
| 93 | Injection Site Haemorrhage | 16 | 1.2 | 1.2 | no signal |
| 94 | Device Issue | 17 | 1.2 | 1.2 | no signal |
| 95 | Psoriatic Arthropathy | 7 | 1.1 | 1.1 | no signal |
| 96 | Injection Site Bruising | 13 | 1.0 | 1.0 | no signal |
| 97 | Intentional Overdose | 10 | 1.0 | 1.0 | no signal |
| 98 | Injection Site Pruritus | 10 | 0.9 | 0.9 | no signal |
| 99 | Exposure Via Skin Contact | 3 | 0.8 | 0.8 | no signal |
| 100 | Injection Site Rash | 4 | 0.8 | 0.8 | no signal |
| 101 | Dermatitis Atopic | 5 | 0.6 | 0.6 | no signal |
| 102 | Bladder Cancer | 5 | 0.5 | 0.5 | no signal |
| 103 | Renal Cancer | 3 | 0.4 | 0.4 | no signal |
| 104 | Device Difficult To Use | 4 | 0.4 | 0.4 | no signal |
| 105 | Drug Dose Omission By Device | 4 | 0.3 | 0.3 | no signal |