Drug
Amlodipine Valsartan And Hydrochlorothiazide
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 | Hypertensive Crisis | 44 | 22.7 | 23.0 | signal |
| 2 | Deafness | 99 | 21.8 | 22.4 | signal |
| 3 | Blood Pressure Abnormal | 59 | 17.2 | 17.4 | signal |
| 4 | Product Prescribing Error | 65 | 15.8 | 16.1 | signal |
| 5 | Blood Pressure Fluctuation | 63 | 15.1 | 15.3 | signal |
| 6 | Cardiomegaly | 32 | 14.9 | 15.0 | signal |
| 7 | Blood Pressure Decreased | 170 | 14.8 | 15.4 | signal |
| 8 | Blood Pressure Increased | 378 | 14.2 | 15.7 | signal |
| 9 | Diabetes Mellitus | 187 | 14.1 | 14.8 | signal |
| 10 | Spinal Disorder | 18 | 10.9 | 11.0 | signal |
| 11 | Accident | 21 | 10.2 | 10.2 | signal |
| 12 | Blood Sodium Decreased | 33 | 10.1 | 10.2 | signal |
| 13 | Arrhythmia | 73 | 8.8 | 9.0 | signal |
| 14 | Drug Prescribing Error | 29 | 8.6 | 8.6 | signal |
| 15 | Blood Triglycerides Increased | 26 | 8.4 | 8.5 | signal |
| 16 | Blood Pressure Systolic Increased | 28 | 8.2 | 8.3 | signal |
| 17 | Wrong Technique In Drug Usage Process | 50 | 7.8 | 7.9 | signal |
| 18 | Hiatus Hernia | 17 | 7.5 | 7.6 | signal |
| 19 | Retinal Detachment | 11 | 6.9 | 6.9 | signal |
| 20 | Arteriosclerosis | 11 | 6.7 | 6.7 | signal |
| 21 | Blindness | 46 | 6.5 | 6.6 | signal |
| 22 | Cataract | 67 | 6.5 | 6.6 | signal |
| 23 | Eye Haemorrhage | 15 | 6.5 | 6.5 | signal |
| 24 | Wrong Technique In Product Usage Process | 226 | 6.4 | 6.8 | signal |
| 25 | Cerebral Infarction | 27 | 6.3 | 6.4 | signal |
| 26 | Hypertension | 230 | 6.2 | 6.6 | signal |
| 27 | Eating Disorder | 23 | 6.2 | 6.2 | signal |
| 28 | Kidney Infection | 21 | 6.2 | 6.2 | signal |
| 29 | Hypoacusis | 44 | 5.9 | 6.0 | signal |
| 30 | Angina Pectoris | 29 | 5.8 | 5.8 | signal |
| 31 | Glaucoma | 19 | 5.7 | 5.7 | signal |
| 32 | Fluid Retention | 49 | 5.5 | 5.6 | signal |
| 33 | Fear | 26 | 5.5 | 5.5 | signal |
| 34 | Gastritis | 25 | 5.5 | 5.5 | signal |
| 35 | Visual Impairment | 114 | 5.3 | 5.5 | signal |
| 36 | Thyroid Disorder | 14 | 5.2 | 5.2 | signal |
| 37 | Ankle Fracture | 14 | 5.2 | 5.2 | signal |
| 38 | Hypokinesia | 13 | 5.1 | 5.2 | signal |
| 39 | Renal Disorder | 41 | 5.0 | 5.1 | signal |
| 40 | Glycosylated Haemoglobin Increased | 22 | 5.0 | 5.0 | signal |
| 41 | Poisoning | 11 | 5.0 | 5.0 | signal |
| 42 | Intervertebral Disc Protrusion | 19 | 5.0 | 5.0 | signal |
| 43 | Blood Thyroid Stimulating Hormone Increased | 8 | 5.0 | 5.0 | signal |
| 44 | Pollakiuria | 36 | 5.0 | 5.0 | signal |
| 45 | Hepatic Steatosis | 16 | 4.9 | 5.0 | signal |
| 46 | Speech Disorder | 45 | 4.9 | 5.0 | signal |
| 47 | Gait Inability | 28 | 4.9 | 4.9 | signal |
| 48 | Platelet Count Increased | 11 | 4.8 | 4.9 | signal |
| 49 | Cholecystitis | 10 | 4.8 | 4.8 | signal |
| 50 | Polyneuropathy | 10 | 4.8 | 4.8 | signal |
| 51 | Blood Cholesterol Increased | 39 | 4.8 | 4.8 | signal |
| 52 | Hypercholesterolaemia | 8 | 4.8 | 4.8 | signal |
| 53 | Peripheral Swelling | 125 | 4.7 | 4.8 | signal |
| 54 | Generalised Oedema | 10 | 4.7 | 4.7 | signal |
| 55 | Abasia | 20 | 4.6 | 4.6 | signal |
| 56 | Blood Potassium Decreased | 24 | 4.6 | 4.6 | signal |
| 57 | Emphysema | 8 | 4.5 | 4.6 | signal |
| 58 | Paralysis | 11 | 4.4 | 4.4 | signal |
| 59 | Eye Disorder | 25 | 4.4 | 4.4 | signal |
| 60 | Joint Dislocation | 8 | 4.4 | 4.4 | signal |
| 61 | Limb Discomfort | 23 | 4.3 | 4.3 | signal |
| 62 | Head Discomfort | 13 | 4.2 | 4.3 | signal |
| 63 | Cerebrovascular Accident | 125 | 4.2 | 4.3 | signal |
| 64 | Local Swelling | 13 | 4.2 | 4.2 | signal |
| 65 | Coronary Artery Occlusion | 10 | 4.2 | 4.2 | signal |
| 66 | Pharyngitis | 9 | 4.2 | 4.2 | signal |
| 67 | Blood Urea Increased | 12 | 4.1 | 4.1 | signal |
| 68 | Basal Cell Carcinoma | 11 | 4.0 | 4.1 | signal |
| 69 | Myocardial Ischaemia | 8 | 4.0 | 4.0 | signal |
| 70 | Obesity | 11 | 4.0 | 4.0 | signal |
| 71 | Foot Fracture | 13 | 3.9 | 3.9 | signal |
| 72 | Movement Disorder | 22 | 3.9 | 3.9 | signal |
| 73 | Sleep Apnoea Syndrome | 13 | 3.9 | 3.9 | signal |
| 74 | Oedema Peripheral | 83 | 3.9 | 4.0 | signal |
| 75 | Acute Myocardial Infarction | 20 | 3.9 | 3.9 | signal |
| 76 | Cardiac Disorder | 61 | 3.7 | 3.8 | signal |
| 77 | Body Height Decreased | 7 | 3.7 | 3.7 | signal |
| 78 | Inflammation | 33 | 3.7 | 3.7 | signal |
| 79 | Hepatic Cirrhosis | 12 | 3.7 | 3.7 | signal |
| 80 | Cholelithiasis | 21 | 3.7 | 3.7 | signal |
| 81 | Haematemesis | 16 | 3.6 | 3.6 | signal |
| 82 | Hernia | 12 | 3.6 | 3.6 | signal |
| 83 | Intraocular Pressure Increased | 8 | 3.6 | 3.6 | signal |
| 84 | Erectile Dysfunction | 16 | 3.6 | 3.6 | signal |
| 85 | Memory Impairment | 85 | 3.6 | 3.6 | signal |
| 86 | Micturition Urgency | 7 | 3.5 | 3.6 | signal |
| 87 | Syncope | 61 | 3.5 | 3.5 | signal |
| 88 | Neoplasm | 7 | 3.5 | 3.5 | signal |
| 89 | Eyelid Oedema | 7 | 3.4 | 3.4 | signal |
| 90 | Spinal Pain | 7 | 3.4 | 3.4 | signal |
| 91 | Aphasia | 18 | 3.4 | 3.4 | signal |
| 92 | Blood Glucose Abnormal | 11 | 3.4 | 3.4 | signal |
| 93 | Drug Intolerance | 57 | 3.4 | 3.4 | signal |
| 94 | Eyelid Ptosis | 6 | 3.4 | 3.4 | signal |
| 95 | Hyponatraemia | 33 | 3.4 | 3.4 | signal |
| 96 | Hemiparesis | 10 | 3.4 | 3.4 | signal |
| 97 | Hypotension | 117 | 3.4 | 3.4 | signal |
| 98 | Stress | 42 | 3.4 | 3.4 | signal |
| 99 | Peripheral Coldness | 8 | 3.3 | 3.3 | signal |
| 100 | Bursitis | 7 | 3.3 | 3.3 | signal |
| 101 | Glomerular Filtration Rate Decreased | 7 | 3.3 | 3.3 | signal |
| 102 | Discomfort | 35 | 3.3 | 3.3 | signal |
| 103 | Lower Limb Fracture | 11 | 3.3 | 3.3 | signal |
| 104 | Feeling Abnormal | 138 | 3.3 | 3.4 | signal |
| 105 | Urinary Retention | 19 | 3.3 | 3.3 | signal |
| 106 | Gait Disturbance | 109 | 3.3 | 3.3 | signal |
| 107 | Blood Potassium Increased | 9 | 3.2 | 3.2 | signal |
| 108 | Upper Limb Fracture | 11 | 3.2 | 3.2 | signal |
| 109 | Dysstasia | 16 | 3.1 | 3.1 | signal |
| 110 | Brain Neoplasm | 5 | 3.1 | 3.1 | signal |
| 111 | Rotator Cuff Syndrome | 7 | 3.1 | 3.1 | signal |
| 112 | Nerve Injury | 6 | 3.1 | 3.1 | signal |
| 113 | Hypothyroidism | 17 | 3.1 | 3.1 | signal |
| 114 | Nervousness | 28 | 3.1 | 3.1 | signal |
| 115 | Circulatory Collapse | 9 | 3.0 | 3.0 | signal |
| 116 | Blood Glucose Increased | 99 | 3.0 | 3.1 | signal |
| 117 | Limb Injury | 14 | 3.0 | 3.0 | signal |
| 118 | Prescribed Overdose | 10 | 3.0 | 3.0 | signal |
| 119 | Joint Injury | 11 | 3.0 | 3.0 | signal |
| 120 | Ligament Sprain | 5 | 2.9 | 2.9 | signal |
| 121 | Ulcer | 8 | 2.9 | 2.9 | signal |
| 122 | Spinal Fracture | 10 | 2.9 | 2.9 | signal |
| 123 | Tinnitus | 23 | 2.9 | 2.9 | signal |
| 124 | Cardiac Failure | 40 | 2.9 | 2.9 | signal |
| 125 | Blindness Unilateral | 7 | 2.9 | 2.9 | signal |
| 126 | Thyroid Cancer | 6 | 2.8 | 2.9 | signal |
| 127 | Dry Throat | 5 | 2.8 | 2.8 | signal |
| 128 | Coronary Artery Disease | 15 | 2.8 | 2.8 | signal |
| 129 | Inappropriate Antidiuretic Hormone Secretion | 5 | 2.8 | 2.8 | signal |
| 130 | Pulmonary Oedema | 22 | 2.8 | 2.8 | signal |
| 131 | Product Availability Issue | 11 | 2.8 | 2.8 | signal |
| 132 | Paraesthesia Oral | 7 | 2.8 | 2.8 | signal |
| 133 | Chromaturia | 11 | 2.8 | 2.8 | signal |
| 134 | Malaise | 207 | 2.7 | 2.8 | signal |
| 135 | Sudden Death | 5 | 2.7 | 2.7 | no signal |
| 136 | Musculoskeletal Discomfort | 8 | 2.7 | 2.7 | signal |
| 137 | Skin Cancer | 10 | 2.7 | 2.7 | signal |
| 138 | Ocular Discomfort | 5 | 2.6 | 2.6 | no signal |
| 139 | Illness | 46 | 2.6 | 2.7 | signal |
| 140 | Pulmonary Thrombosis | 5 | 2.6 | 2.6 | no signal |
| 141 | Bipolar Disorder | 5 | 2.6 | 2.6 | no signal |
| 142 | Blood Glucose Fluctuation | 5 | 2.6 | 2.6 | no signal |
| 143 | Diabetes Mellitus Inadequate Control | 8 | 2.6 | 2.6 | signal |
| 144 | Covid-19 | 77 | 2.5 | 2.5 | signal |
| 145 | Gastric Haemorrhage | 5 | 2.5 | 2.5 | no signal |
| 146 | Respiratory Arrest | 12 | 2.5 | 2.5 | signal |
| 147 | Appendicitis | 4 | 2.5 | 2.5 | no signal |
| 148 | Heart Rate Decreased | 15 | 2.4 | 2.4 | signal |
| 149 | Emotional Disorder | 13 | 2.4 | 2.4 | signal |
| 150 | Depressed Mood | 22 | 2.4 | 2.4 | signal |
| 151 | Vertigo | 25 | 2.4 | 2.4 | signal |
| 152 | Bladder Disorder | 4 | 2.3 | 2.3 | no signal |
| 153 | Inappropriate Schedule Of Drug Administration | 29 | 2.3 | 2.3 | signal |
| 154 | Salivary Hypersecretion | 4 | 2.3 | 2.3 | no signal |
| 155 | Eye Discharge | 4 | 2.3 | 2.3 | no signal |
| 156 | Neoplasm Malignant | 26 | 2.2 | 2.2 | signal |
| 157 | Myocardial Infarction | 68 | 2.2 | 2.2 | signal |
| 158 | Burning Sensation | 27 | 2.2 | 2.2 | signal |
| 159 | Renal Pain | 4 | 2.2 | 2.2 | no signal |
| 160 | Inappropriate Schedule Of Product Administration | 66 | 2.1 | 2.2 | signal |
| 161 | Thrombosis | 30 | 2.1 | 2.1 | signal |
| 162 | Acute Hepatic Failure | 5 | 2.1 | 2.1 | no signal |
| 163 | Cholestasis | 7 | 2.1 | 2.1 | no signal |
| 164 | Prostatic Specific Antigen Increased | 5 | 2.1 | 2.1 | no signal |
| 165 | Choking | 7 | 2.1 | 2.1 | no signal |
| 166 | Aphonia | 5 | 2.1 | 2.1 | no signal |
| 167 | Femur Fracture | 11 | 2.0 | 2.0 | signal |
| 168 | Cardiovascular Disorder | 9 | 2.0 | 2.0 | no signal |
| 169 | Breast Cancer | 33 | 2.0 | 2.0 | signal |
| 170 | Metastases To Lung | 4 | 2.0 | 2.0 | no signal |
| 171 | Rash Generalised | 9 | 2.0 | 2.0 | no signal |
| 172 | Hip Fracture | 11 | 2.0 | 2.0 | no signal |
| 173 | Ischaemic Stroke | 6 | 1.9 | 1.9 | no signal |
| 174 | Macular Degeneration | 4 | 1.9 | 1.9 | no signal |
| 175 | Colon Cancer | 5 | 1.9 | 1.9 | no signal |
| 176 | Wrist Fracture | 4 | 1.9 | 1.9 | no signal |
| 177 | Ill-defined Disorder | 20 | 1.9 | 1.9 | no signal |
| 178 | Extra Dose Administered | 13 | 1.9 | 1.9 | no signal |
| 179 | Anger | 11 | 1.9 | 1.9 | no signal |
| 180 | Tendon Rupture | 4 | 1.9 | 1.9 | no signal |
| 181 | Drug Dispensing Error | 5 | 1.9 | 1.9 | no signal |
| 182 | Incorrect Dose Administered | 71 | 1.8 | 1.8 | no signal |
| 183 | Eructation | 6 | 1.8 | 1.8 | no signal |
| 184 | Posterior Reversible Encephalopathy Syndrome | 3 | 1.8 | 1.8 | no signal |
| 185 | Hallucination, Auditory | 5 | 1.8 | 1.8 | no signal |
| 186 | Decreased Immune Responsiveness | 3 | 1.8 | 1.8 | no signal |
| 187 | Coeliac Disease | 3 | 1.8 | 1.8 | no signal |
| 188 | Prescribed Underdose | 6 | 1.7 | 1.7 | no signal |
| 189 | Death | 256 | 1.7 | 1.8 | no signal |
| 190 | Lung Neoplasm Malignant | 12 | 1.7 | 1.7 | no signal |
| 191 | Metastases To Liver | 5 | 1.6 | 1.6 | no signal |
| 192 | Anosmia | 4 | 1.6 | 1.6 | no signal |
| 193 | Product Packaging Quantity Issue | 3 | 1.6 | 1.6 | no signal |
| 194 | Nephropathy Toxic | 3 | 1.5 | 1.5 | no signal |
| 195 | Cholecystectomy | 3 | 1.5 | 1.5 | no signal |
| 196 | Bone Loss | 4 | 1.5 | 1.5 | no signal |
| 197 | Internal Haemorrhage | 3 | 1.5 | 1.5 | no signal |
| 198 | Lymphoma | 4 | 1.5 | 1.5 | no signal |
| 199 | Diabetic Ketoacidosis | 6 | 1.4 | 1.4 | no signal |
| 200 | Metastases To Bone | 4 | 1.4 | 1.4 | no signal |
| 201 | Libido Decreased | 3 | 1.4 | 1.4 | no signal |
| 202 | Ankylosing Spondylitis | 3 | 1.3 | 1.3 | no signal |
| 203 | Product Dispensing Error | 5 | 1.3 | 1.3 | no signal |
| 204 | Blood Glucose Decreased | 11 | 1.3 | 1.3 | no signal |
| 205 | Suicide Attempt | 13 | 1.2 | 1.2 | no signal |
| 206 | Hepatocellular Injury | 3 | 1.2 | 1.2 | no signal |
| 207 | Hepatic Cancer | 5 | 1.2 | 1.2 | no signal |
| 208 | Multiple Fractures | 3 | 1.0 | 1.0 | no signal |
| 209 | Intentional Overdose | 11 | 1.0 | 1.0 | no signal |
| 210 | Prostate Cancer | 14 | 1.0 | 1.0 | no signal |
| 211 | Pancreatic Carcinoma | 5 | 1.0 | 1.0 | no signal |
| 212 | Renal Cancer | 7 | 0.8 | 0.8 | no signal |
| 213 | Drug Dependence | 21 | 0.7 | 0.7 | no signal |
| 214 | Colorectal Cancer | 4 | 0.5 | 0.5 | no signal |
| 215 | Bladder Cancer | 4 | 0.4 | 0.4 | no signal |