Drug
Aliskiren
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 | Ocular Discomfort | 196 | 170.5 | 186.5 | signal |
| 2 | Generalised Oedema | 196 | 150.0 | 164.1 | signal |
| 3 | Affect Lability | 152 | 148.1 | 158.7 | signal |
| 4 | Motor Dysfunction | 150 | 139.6 | 149.4 | signal |
| 5 | Muscle Spasticity | 150 | 113.5 | 121.5 | signal |
| 6 | Head Discomfort | 193 | 102.7 | 112.2 | signal |
| 7 | Coordination Abnormal | 152 | 101.4 | 108.7 | signal |
| 8 | Hemiparesis | 156 | 85.7 | 91.9 | signal |
| 9 | Altered State Of Consciousness | 192 | 83.4 | 91.0 | signal |
| 10 | Photophobia | 158 | 79.1 | 85.0 | signal |
| 11 | Presyncope | 192 | 74.2 | 81.0 | signal |
| 12 | Haematemesis | 201 | 73.9 | 81.0 | signal |
| 13 | Diplopia | 189 | 68.0 | 74.1 | signal |
| 14 | Eating Disorder | 149 | 65.1 | 69.6 | signal |
| 15 | Ascites | 194 | 61.6 | 67.2 | signal |
| 16 | Sinus Congestion | 88 | 60.7 | 63.1 | signal |
| 17 | Skin Haemorrhage | 90 | 58.2 | 60.6 | signal |
| 18 | Abortion Induced | 58 | 57.4 | 58.9 | signal |
| 19 | Haematuria | 197 | 53.6 | 58.6 | signal |
| 20 | Aphasia | 155 | 47.7 | 51.1 | signal |
| 21 | Respiratory Tract Congestion | 80 | 46.9 | 48.6 | signal |
| 22 | Diabetes Mellitus Inadequate Control | 84 | 44.2 | 45.9 | signal |
| 23 | Blindness | 192 | 43.9 | 47.9 | signal |
| 24 | Cardio-respiratory Arrest | 197 | 43.6 | 47.7 | signal |
| 25 | Sinus Disorder | 88 | 41.3 | 43.0 | signal |
| 26 | Dysarthria | 161 | 39.9 | 42.8 | signal |
| 27 | Coma | 194 | 37.9 | 41.4 | signal |
| 28 | Tinnitus | 187 | 37.8 | 41.2 | signal |
| 29 | Sneezing | 89 | 37.1 | 38.5 | signal |
| 30 | Angina Pectoris | 111 | 35.8 | 37.6 | signal |
| 31 | Eye Pain | 197 | 33.2 | 36.3 | signal |
| 32 | Cystitis | 84 | 24.4 | 25.3 | signal |
| 33 | Tachycardia | 213 | 22.3 | 24.5 | signal |
| 34 | Syncope | 233 | 21.6 | 24.0 | signal |
| 35 | Hyperkalaemia | 76 | 20.2 | 20.9 | signal |
| 36 | Blood Pressure Increased | 305 | 18.5 | 21.2 | signal |
| 37 | Sepsis | 205 | 17.1 | 18.7 | signal |
| 38 | Premature Baby | 53 | 16.3 | 16.7 | signal |
| 39 | Chills | 202 | 16.0 | 17.5 | signal |
| 40 | Hypertensive Crisis | 19 | 15.8 | 15.9 | signal |
| 41 | Dysphagia | 148 | 14.5 | 15.5 | signal |
| 42 | Cardiac Failure | 121 | 14.0 | 14.7 | signal |
| 43 | Glomerular Filtration Rate Decreased | 18 | 13.8 | 13.9 | signal |
| 44 | Blood Urea Increased | 25 | 13.8 | 13.9 | signal |
| 45 | Blood Creatinine Increased | 97 | 13.8 | 14.3 | signal |
| 46 | Myocardial Ischaemia | 17 | 13.8 | 13.9 | signal |
| 47 | Ventricular Tachycardia | 24 | 13.4 | 13.6 | signal |
| 48 | Rhinorrhoea | 90 | 13.0 | 13.5 | signal |
| 49 | Foetal Exposure During Pregnancy | 113 | 12.9 | 13.5 | signal |
| 50 | Muscular Weakness | 157 | 12.8 | 13.7 | signal |
| 51 | Cataract | 73 | 11.4 | 11.8 | signal |
| 52 | Cardiomegaly | 15 | 11.2 | 11.3 | signal |
| 53 | Vision Blurred | 164 | 11.1 | 11.9 | signal |
| 54 | Eyelid Oedema | 14 | 11.1 | 11.2 | signal |
| 55 | Myalgia | 200 | 10.9 | 11.9 | signal |
| 56 | Renal Failure Acute | 50 | 10.8 | 11.0 | signal |
| 57 | Cognitive Disorder | 54 | 10.8 | 11.0 | signal |
| 58 | Glycosylated Haemoglobin Increased | 29 | 10.7 | 10.8 | signal |
| 59 | Cerebrovascular Accident | 192 | 10.5 | 11.4 | signal |
| 60 | Fall | 375 | 10.5 | 12.4 | signal |
| 61 | Blood Potassium Increased | 18 | 10.3 | 10.4 | signal |
| 62 | Confusional State | 176 | 10.1 | 10.9 | signal |
| 63 | Skin Exfoliation | 89 | 9.9 | 10.3 | signal |
| 64 | Premature Delivery | 17 | 9.9 | 9.9 | signal |
| 65 | Cough | 294 | 9.8 | 11.1 | signal |
| 66 | Medication Error | 58 | 9.7 | 9.9 | signal |
| 67 | Gastrointestinal Disorder | 91 | 9.6 | 9.9 | signal |
| 68 | Influenza Like Illness | 85 | 9.5 | 9.9 | signal |
| 69 | Depressed Mood | 54 | 9.5 | 9.7 | signal |
| 70 | Somnolence | 205 | 9.5 | 10.3 | signal |
| 71 | Asthenia | 380 | 9.4 | 11.1 | signal |
| 72 | Cardiogenic Shock | 14 | 9.1 | 9.2 | signal |
| 73 | Impaired Work Ability | 21 | 9.1 | 9.2 | signal |
| 74 | Treatment Noncompliance | 53 | 9.1 | 9.2 | signal |
| 75 | Coronary Artery Disease | 29 | 8.8 | 8.9 | signal |
| 76 | Decreased Appetite | 220 | 8.8 | 9.7 | signal |
| 77 | Dizziness Postural | 9 | 8.7 | 8.7 | signal |
| 78 | Sudden Death | 10 | 8.7 | 8.7 | signal |
| 79 | Abdominal Pain Upper | 189 | 8.5 | 9.2 | signal |
| 80 | Haematocrit Decreased | 18 | 8.4 | 8.4 | signal |
| 81 | Drug Interaction | 142 | 8.3 | 8.8 | signal |
| 82 | Oedema Peripheral | 109 | 8.3 | 8.6 | signal |
| 83 | Mitral Valve Incompetence | 10 | 8.2 | 8.2 | signal |
| 84 | Abdominal Pain | 203 | 8.1 | 8.8 | signal |
| 85 | Ventricular Extrasystoles | 9 | 8.0 | 8.1 | signal |
| 86 | Renal Impairment | 72 | 8.0 | 8.2 | signal |
| 87 | Amnesia | 55 | 7.8 | 8.0 | signal |
| 88 | Arthritis | 66 | 7.8 | 8.0 | signal |
| 89 | Chest Discomfort | 84 | 7.6 | 7.9 | signal |
| 90 | Tachypnoea | 11 | 7.5 | 7.6 | signal |
| 91 | Hepatomegaly | 8 | 7.5 | 7.5 | signal |
| 92 | Pyrexia | 279 | 7.5 | 8.4 | signal |
| 93 | Mobility Decreased | 57 | 7.4 | 7.6 | signal |
| 94 | Contusion | 75 | 7.2 | 7.5 | signal |
| 95 | Cerebral Infarction | 19 | 7.2 | 7.3 | signal |
| 96 | Sinusitis | 78 | 7.0 | 7.3 | signal |
| 97 | Influenza | 84 | 7.0 | 7.2 | signal |
| 98 | Orthostatic Hypotension | 13 | 6.9 | 6.9 | signal |
| 99 | Acute Myocardial Infarction | 22 | 6.9 | 7.0 | signal |
| 100 | Ventricular Fibrillation | 8 | 6.7 | 6.7 | signal |
| 101 | Insomnia | 190 | 6.6 | 7.1 | signal |
| 102 | Malaise | 306 | 6.5 | 7.3 | signal |
| 103 | Rheumatoid Arthritis | 78 | 6.4 | 6.6 | signal |
| 104 | Palpitations | 75 | 5.9 | 6.1 | signal |
| 105 | Hypertension | 135 | 5.9 | 6.2 | signal |
| 106 | Arteriosclerosis | 6 | 5.9 | 5.9 | signal |
| 107 | Vomiting | 295 | 5.8 | 6.6 | signal |
| 108 | Psoriasis | 82 | 5.8 | 6.0 | signal |
| 109 | Blood Pressure Systolic Increased | 12 | 5.7 | 5.7 | signal |
| 110 | Proteinuria | 11 | 5.4 | 5.4 | signal |
| 111 | Dyspnoea | 325 | 5.3 | 6.1 | signal |
| 112 | Disease Progression | 67 | 5.3 | 5.4 | signal |
| 113 | Anxiety | 159 | 5.2 | 5.5 | signal |
| 114 | Pruritus | 204 | 5.0 | 5.4 | signal |
| 115 | Atrial Fibrillation | 52 | 4.9 | 5.0 | signal |
| 116 | Face Oedema | 9 | 4.9 | 4.9 | signal |
| 117 | Rebound Effect | 6 | 4.9 | 4.9 | signal |
| 118 | Dizziness | 262 | 4.9 | 5.4 | signal |
| 119 | Headache | 320 | 4.7 | 5.4 | signal |
| 120 | Metabolic Acidosis | 16 | 4.7 | 4.7 | signal |
| 121 | Arthralgia | 208 | 4.7 | 5.0 | signal |
| 122 | Haematoma | 13 | 4.6 | 4.7 | signal |
| 123 | Toxic Skin Eruption | 5 | 4.6 | 4.6 | signal |
| 124 | Pulmonary Oedema | 22 | 4.6 | 4.6 | signal |
| 125 | Nasopharyngitis | 88 | 4.4 | 4.6 | signal |
| 126 | Circulatory Collapse | 8 | 4.3 | 4.4 | signal |
| 127 | Contraindicated Product Administered | 14 | 4.3 | 4.3 | signal |
| 128 | Nephropathy | 4 | 4.0 | 4.0 | signal |
| 129 | Posterior Reversible Encephalopathy Syndrome | 4 | 3.9 | 3.9 | signal |
| 130 | Cardiac Failure Congestive | 34 | 3.9 | 3.9 | signal |
| 131 | Upper Gastrointestinal Haemorrhage | 7 | 3.8 | 3.9 | signal |
| 132 | Sinus Bradycardia | 4 | 3.8 | 3.8 | signal |
| 133 | Melaena | 9 | 3.8 | 3.8 | signal |
| 134 | Colon Cancer | 6 | 3.7 | 3.7 | signal |
| 135 | Product Use Issue | 75 | 3.7 | 3.8 | signal |
| 136 | Ischaemic Stroke | 7 | 3.6 | 3.6 | signal |
| 137 | Electrocardiogram Qt Prolonged | 14 | 3.6 | 3.6 | signal |
| 138 | Hypoglycaemia | 18 | 3.4 | 3.5 | signal |
| 139 | Coronary Artery Occlusion | 5 | 3.4 | 3.4 | signal |
| 140 | Fluid Overload | 5 | 3.1 | 3.1 | signal |
| 141 | Exposure During Pregnancy | 20 | 3.0 | 3.0 | signal |
| 142 | Grand Mal Convulsion | 3 | 3.0 | 3.0 | no signal |
| 143 | Maternal Exposure During Pregnancy | 23 | 2.4 | 2.4 | signal |
| 144 | Gastric Cancer | 5 | 1.8 | 1.8 | no signal |
| 145 | Pancreatic Carcinoma | 3 | 1.0 | 1.0 | no signal |
| 146 | Prostate Cancer | 8 | 0.9 | 0.9 | no signal |
| 147 | Bladder Cancer | 3 | 0.5 | 0.5 | no signal |