Drug
Fosinopril Sodium
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 | Renal Failure Acute | 112 | 25.9 | 27.3 | signal |
| 2 | Hyperkalaemia | 70 | 20.0 | 20.6 | signal |
| 3 | Blood Urea Increased | 25 | 14.8 | 14.9 | signal |
| 4 | Bradycardia | 71 | 13.3 | 13.7 | signal |
| 5 | International Normalised Ratio Increased | 38 | 13.1 | 13.3 | signal |
| 6 | Body Temperature Decreased | 13 | 13.0 | 13.1 | signal |
| 7 | Cardiomegaly | 16 | 12.8 | 12.9 | signal |
| 8 | Supraventricular Tachycardia | 12 | 12.5 | 12.5 | signal |
| 9 | Sinus Bradycardia | 12 | 12.3 | 12.4 | signal |
| 10 | Atelectasis | 12 | 12.3 | 12.4 | signal |
| 11 | Economic Problem | 19 | 12.3 | 12.4 | signal |
| 12 | Orthostatic Hypotension | 21 | 12.0 | 12.1 | signal |
| 13 | Mitral Valve Incompetence | 13 | 11.4 | 11.5 | signal |
| 14 | Coronary Artery Disease | 35 | 11.4 | 11.6 | signal |
| 15 | Faeces Discoloured | 23 | 10.5 | 10.6 | signal |
| 16 | Gastroenteritis | 14 | 9.5 | 9.6 | signal |
| 17 | Arteriosclerosis | 9 | 9.5 | 9.5 | signal |
| 18 | Haematocrit Decreased | 19 | 9.5 | 9.5 | signal |
| 19 | Ulcer | 15 | 9.4 | 9.4 | signal |
| 20 | Hypoglycaemia | 45 | 9.2 | 9.4 | signal |
| 21 | Angioedema | 38 | 8.6 | 8.7 | signal |
| 22 | Sleep Apnoea Syndrome | 16 | 8.3 | 8.4 | signal |
| 23 | Cardiac Failure Congestive | 67 | 8.2 | 8.4 | signal |
| 24 | Swollen Tongue | 25 | 7.9 | 8.0 | signal |
| 25 | Drug Toxicity | 11 | 7.9 | 7.9 | signal |
| 26 | Cyanosis | 12 | 7.6 | 7.6 | signal |
| 27 | Diabetes Mellitus Inadequate Control | 13 | 7.3 | 7.3 | signal |
| 28 | Hypercholesterolaemia | 7 | 7.3 | 7.3 | signal |
| 29 | Hypertensive Crisis | 8 | 7.1 | 7.1 | signal |
| 30 | Coordination Abnormal | 10 | 7.1 | 7.1 | signal |
| 31 | Upper Gastrointestinal Haemorrhage | 12 | 7.1 | 7.1 | signal |
| 32 | Blood Potassium Increased | 11 | 6.7 | 6.8 | signal |
| 33 | Ventricular Tachycardia | 11 | 6.6 | 6.6 | signal |
| 34 | Blood Pressure Systolic Increased | 13 | 6.6 | 6.6 | signal |
| 35 | Iron Deficiency Anaemia | 6 | 6.5 | 6.5 | signal |
| 36 | Ventricular Fibrillation | 7 | 6.2 | 6.3 | signal |
| 37 | Multi-organ Failure | 11 | 6.2 | 6.3 | signal |
| 38 | Blood Creatinine Increased | 41 | 6.2 | 6.3 | signal |
| 39 | Hiatus Hernia | 8 | 6.1 | 6.1 | signal |
| 40 | Myocardial Ischaemia | 7 | 6.1 | 6.1 | signal |
| 41 | Hepatomegaly | 6 | 6.0 | 6.0 | signal |
| 42 | Atrial Fibrillation | 58 | 5.9 | 6.0 | signal |
| 43 | Tooth Abscess | 6 | 5.8 | 5.8 | signal |
| 44 | Myoclonus | 7 | 5.8 | 5.8 | signal |
| 45 | Ventricular Extrasystoles | 6 | 5.7 | 5.7 | signal |
| 46 | Mental Status Changes | 16 | 5.7 | 5.8 | signal |
| 47 | Urinary Incontinence | 17 | 5.7 | 5.7 | signal |
| 48 | Anhedonia | 15 | 5.6 | 5.7 | signal |
| 49 | Oral Herpes | 11 | 5.6 | 5.6 | signal |
| 50 | Transient Ischaemic Attack | 19 | 5.6 | 5.6 | signal |
| 51 | Dental Caries | 6 | 5.4 | 5.4 | signal |
| 52 | Cardiomyopathy | 8 | 5.4 | 5.4 | signal |
| 53 | Grand Mal Convulsion | 5 | 5.3 | 5.3 | signal |
| 54 | Abasia | 13 | 5.2 | 5.2 | signal |
| 55 | Metabolic Acidosis | 16 | 5.0 | 5.1 | signal |
| 56 | Salivary Hypersecretion | 5 | 5.0 | 5.0 | signal |
| 57 | Diabetes Mellitus | 38 | 4.9 | 5.0 | signal |
| 58 | Injury | 35 | 4.9 | 5.0 | signal |
| 59 | Pharmaceutical Product Complaint | 13 | 4.9 | 4.9 | signal |
| 60 | Dialysis | 7 | 4.9 | 4.9 | signal |
| 61 | Coma | 23 | 4.8 | 4.8 | signal |
| 62 | Pulmonary Hypertension | 10 | 4.7 | 4.8 | signal |
| 63 | Myocardial Infarction | 84 | 4.7 | 4.9 | signal |
| 64 | Hypocalcaemia | 9 | 4.7 | 4.8 | signal |
| 65 | Acute Myocardial Infarction | 14 | 4.7 | 4.7 | signal |
| 66 | Face Oedema | 8 | 4.7 | 4.7 | signal |
| 67 | Cardiovascular Disorder | 12 | 4.7 | 4.7 | signal |
| 68 | Circulatory Collapse | 8 | 4.6 | 4.7 | signal |
| 69 | Rash Generalised | 12 | 4.5 | 4.6 | signal |
| 70 | Impaired Healing | 15 | 4.5 | 4.6 | signal |
| 71 | Melaena | 10 | 4.5 | 4.5 | signal |
| 72 | Lymphoma | 7 | 4.5 | 4.5 | signal |
| 73 | Blood Triglycerides Increased | 8 | 4.5 | 4.5 | signal |
| 74 | Frequent Bowel Movements | 12 | 4.4 | 4.4 | signal |
| 75 | Blood Creatine Phosphokinase Increased | 13 | 4.4 | 4.4 | signal |
| 76 | Glycosylated Haemoglobin Increased | 11 | 4.3 | 4.4 | signal |
| 77 | Personality Change | 4 | 4.2 | 4.3 | signal |
| 78 | Drug Level Increased | 7 | 4.2 | 4.2 | signal |
| 79 | Laceration | 4 | 4.2 | 4.2 | signal |
| 80 | Tooth Disorder | 9 | 4.0 | 4.0 | signal |
| 81 | Heart Rate Irregular | 9 | 3.9 | 3.9 | signal |
| 82 | Erectile Dysfunction | 10 | 3.9 | 3.9 | signal |
| 83 | Sudden Death | 4 | 3.7 | 3.7 | signal |
| 84 | Blood Glucose Decreased | 18 | 3.7 | 3.7 | signal |
| 85 | Skin Cancer | 8 | 3.7 | 3.7 | signal |
| 86 | Renal Injury | 11 | 3.6 | 3.7 | signal |
| 87 | Coronary Artery Occlusion | 5 | 3.6 | 3.6 | signal |
| 88 | Nervousness | 19 | 3.6 | 3.6 | signal |
| 89 | Stevens-johnson Syndrome | 8 | 3.6 | 3.6 | signal |
| 90 | Completed Suicide | 29 | 3.4 | 3.5 | signal |
| 91 | Rhabdomyolysis | 14 | 3.3 | 3.4 | signal |
| 92 | Visual Acuity Reduced | 11 | 3.3 | 3.3 | signal |
| 93 | Pharyngeal Oedema | 5 | 3.2 | 3.2 | signal |
| 94 | Extrapyramidal Disorder | 8 | 3.2 | 3.2 | signal |
| 95 | Poisoning | 4 | 3.1 | 3.2 | no signal |
| 96 | Anorexia | 4 | 3.0 | 3.0 | no signal |
| 97 | Ovarian Cyst | 3 | 3.0 | 3.0 | no signal |
| 98 | Prostatic Specific Antigen Increased | 4 | 2.9 | 2.9 | no signal |
| 99 | Metastases To Liver | 5 | 2.8 | 2.8 | signal |
| 100 | Breast Pain | 3 | 2.8 | 2.8 | no signal |
| 101 | Convulsion | 16 | 2.7 | 2.8 | signal |
| 102 | Blood Glucose Increased | 52 | 2.7 | 2.8 | signal |
| 103 | Device Failure | 4 | 2.6 | 2.6 | no signal |
| 104 | Caesarean Section | 3 | 2.5 | 2.5 | no signal |
| 105 | Diabetic Ketoacidosis | 6 | 2.5 | 2.5 | no signal |
| 106 | Injection Site Discolouration | 3 | 2.4 | 2.4 | no signal |
| 107 | Drug Effect Decreased | 13 | 2.4 | 2.4 | signal |
| 108 | Injection Site Irritation | 3 | 2.4 | 2.4 | no signal |
| 109 | Pancreatic Carcinoma | 4 | 1.4 | 1.4 | no signal |
| 110 | Breast Cancer Female | 3 | 1.1 | 1.1 | no signal |
| 111 | Tardive Dyskinesia | 3 | 1.0 | 1.0 | no signal |
| 112 | Incorrect Route Of Drug Administration | 3 | 0.8 | 0.8 | no signal |