Drug
Silodosin
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 | Urinary Retention | 121 | 19.3 | 19.9 | signal |
| 2 | Inappropriate Antidiuretic Hormone Secretion | 36 | 18.8 | 19.0 | signal |
| 3 | Erectile Dysfunction | 70 | 14.4 | 14.7 | signal |
| 4 | Orthostatic Hypotension | 46 | 14.0 | 14.2 | signal |
| 5 | Sopor | 29 | 11.5 | 11.6 | signal |
| 6 | Prostatic Specific Antigen Increased | 28 | 10.7 | 10.8 | signal |
| 7 | Hypomagnesaemia | 25 | 9.6 | 9.6 | signal |
| 8 | Generalised Oedema | 21 | 9.1 | 9.1 | signal |
| 9 | Pneumonia Aspiration | 42 | 8.9 | 9.0 | signal |
| 10 | Hypocalcaemia | 29 | 8.2 | 8.2 | signal |
| 11 | Interstitial Lung Disease | 74 | 8.1 | 8.3 | signal |
| 12 | Hepatic Encephalopathy | 14 | 8.0 | 8.0 | signal |
| 13 | Dysuria | 55 | 7.9 | 8.0 | signal |
| 14 | Haematuria | 51 | 7.9 | 8.0 | signal |
| 15 | Delusion | 23 | 7.9 | 7.9 | signal |
| 16 | Cytokine Release Syndrome | 27 | 7.5 | 7.6 | signal |
| 17 | Cerebral Infarction | 34 | 7.4 | 7.4 | signal |
| 18 | Nocturia | 16 | 7.0 | 7.0 | signal |
| 19 | Presyncope | 31 | 6.8 | 6.8 | signal |
| 20 | Dizziness Postural | 12 | 6.6 | 6.6 | signal |
| 21 | Micturition Urgency | 14 | 6.6 | 6.6 | signal |
| 22 | Pulmonary Congestion | 16 | 6.4 | 6.4 | signal |
| 23 | Covid-19 Pneumonia | 14 | 6.2 | 6.3 | signal |
| 24 | Hypokalaemia | 54 | 6.2 | 6.3 | signal |
| 25 | Hepatic Cytolysis | 14 | 6.1 | 6.1 | signal |
| 26 | Ileus | 14 | 6.0 | 6.1 | signal |
| 27 | Rash Maculo-papular | 25 | 6.0 | 6.0 | signal |
| 28 | Hyponatraemia | 63 | 5.9 | 6.0 | signal |
| 29 | Hyperbilirubinaemia | 11 | 5.7 | 5.7 | signal |
| 30 | Oral Candidiasis | 13 | 5.3 | 5.3 | signal |
| 31 | Hepatic Function Abnormal | 37 | 5.3 | 5.3 | signal |
| 32 | Arrhythmia | 47 | 5.2 | 5.3 | signal |
| 33 | Hypertensive Crisis | 11 | 5.2 | 5.2 | signal |
| 34 | Bradycardia | 52 | 5.2 | 5.2 | signal |
| 35 | Altered State Of Consciousness | 20 | 4.9 | 4.9 | signal |
| 36 | Lymphopenia | 13 | 4.9 | 4.9 | signal |
| 37 | Acute Kidney Injury | 139 | 4.8 | 5.0 | signal |
| 38 | Subdural Haematoma | 13 | 4.8 | 4.8 | signal |
| 39 | Hyperkalaemia | 31 | 4.7 | 4.7 | signal |
| 40 | Agranulocytosis | 16 | 4.6 | 4.6 | signal |
| 41 | Poisoning Deliberate | 8 | 4.6 | 4.6 | signal |
| 42 | Drug-induced Liver Injury | 26 | 4.5 | 4.5 | signal |
| 43 | Myoclonus | 10 | 4.4 | 4.5 | signal |
| 44 | Aspiration | 9 | 4.4 | 4.4 | signal |
| 45 | Parkinsonism | 8 | 4.4 | 4.4 | signal |
| 46 | Rhabdomyolysis | 34 | 4.3 | 4.4 | signal |
| 47 | Melaena | 18 | 4.3 | 4.3 | signal |
| 48 | Skin Disorder | 27 | 4.3 | 4.3 | signal |
| 49 | Neutrophil Count Decreased | 31 | 4.1 | 4.1 | signal |
| 50 | Hallucination, Visual | 16 | 4.0 | 4.1 | signal |
| 51 | Conjunctivitis | 14 | 4.0 | 4.1 | signal |
| 52 | Cataract | 45 | 4.0 | 4.1 | signal |
| 53 | Drug Interaction | 119 | 4.0 | 4.1 | signal |
| 54 | Syncope | 74 | 3.9 | 4.0 | signal |
| 55 | Toxic Epidermal Necrolysis | 11 | 3.9 | 3.9 | signal |
| 56 | Atrial Fibrillation | 71 | 3.9 | 3.9 | signal |
| 57 | Ischaemic Stroke | 13 | 3.9 | 3.9 | signal |
| 58 | Metabolic Acidosis | 23 | 3.9 | 3.9 | signal |
| 59 | Libido Decreased | 9 | 3.9 | 3.9 | signal |
| 60 | Sinus Bradycardia | 7 | 3.8 | 3.8 | signal |
| 61 | Hypoglycaemia | 35 | 3.8 | 3.8 | signal |
| 62 | Hot Flush | 54 | 3.8 | 3.8 | signal |
| 63 | Body Temperature Decreased | 7 | 3.7 | 3.7 | signal |
| 64 | Pollakiuria | 29 | 3.7 | 3.7 | signal |
| 65 | Electrocardiogram Qt Prolonged | 25 | 3.7 | 3.7 | signal |
| 66 | Haemoptysis | 19 | 3.6 | 3.6 | signal |
| 67 | Blood Pressure Decreased | 45 | 3.6 | 3.6 | signal |
| 68 | Colon Cancer | 10 | 3.6 | 3.6 | signal |
| 69 | Dyspnoea Exertional | 25 | 3.5 | 3.5 | signal |
| 70 | Transfusion | 7 | 3.5 | 3.5 | signal |
| 71 | Drug Level Increased | 11 | 3.5 | 3.5 | signal |
| 72 | Ventricular Tachycardia | 11 | 3.5 | 3.5 | signal |
| 73 | Glomerular Filtration Rate Decreased | 8 | 3.5 | 3.5 | signal |
| 74 | Anaemia | 126 | 3.5 | 3.6 | signal |
| 75 | Erythema Multiforme | 6 | 3.4 | 3.4 | signal |
| 76 | Circulatory Collapse | 11 | 3.4 | 3.4 | signal |
| 77 | Cardiac Failure | 51 | 3.4 | 3.4 | signal |
| 78 | Pneumothorax | 10 | 3.3 | 3.4 | signal |
| 79 | Blood Lactate Dehydrogenase Increased | 10 | 3.3 | 3.3 | signal |
| 80 | Lactic Acidosis | 20 | 3.3 | 3.3 | signal |
| 81 | Hyperthyroidism | 9 | 3.3 | 3.3 | signal |
| 82 | Thrombotic Microangiopathy | 6 | 3.3 | 3.3 | signal |
| 83 | Febrile Neutropenia | 41 | 3.3 | 3.3 | signal |
| 84 | Hypotension | 123 | 3.3 | 3.3 | signal |
| 85 | Pulmonary Mass | 9 | 3.2 | 3.2 | signal |
| 86 | Gastric Haemorrhage | 7 | 3.2 | 3.2 | signal |
| 87 | Rash Macular | 21 | 3.2 | 3.2 | signal |
| 88 | Emphysema | 6 | 3.1 | 3.1 | signal |
| 89 | Pleural Effusion | 36 | 3.1 | 3.2 | signal |
| 90 | Face Oedema | 10 | 3.1 | 3.1 | signal |
| 91 | Anaphylactic Shock | 15 | 3.1 | 3.1 | signal |
| 92 | Proteinuria | 11 | 3.1 | 3.1 | signal |
| 93 | Septic Shock | 25 | 3.1 | 3.1 | signal |
| 94 | Cholestasis | 11 | 3.1 | 3.1 | signal |
| 95 | Shock | 13 | 3.0 | 3.0 | signal |
| 96 | Disseminated Intravascular Coagulation | 8 | 3.0 | 3.0 | signal |
| 97 | Cerebral Haemorrhage | 20 | 3.0 | 3.0 | signal |
| 98 | Pancytopenia | 31 | 2.9 | 3.0 | signal |
| 99 | Product Prescribing Error | 13 | 2.9 | 2.9 | signal |
| 100 | Coma | 26 | 2.9 | 2.9 | signal |
| 101 | Urinary Incontinence | 16 | 2.9 | 2.9 | signal |
| 102 | Cognitive Disorder | 25 | 2.8 | 2.9 | signal |
| 103 | Contraindicated Product Administered | 16 | 2.8 | 2.8 | signal |
| 104 | Gastric Ulcer | 10 | 2.8 | 2.8 | signal |
| 105 | Sars-cov-2 Test Positive | 7 | 2.8 | 2.8 | signal |
| 106 | Tachypnoea | 7 | 2.7 | 2.7 | signal |
| 107 | Eosinophilia | 9 | 2.7 | 2.7 | signal |
| 108 | Disorientation | 20 | 2.7 | 2.7 | signal |
| 109 | Device Occlusion | 7 | 2.7 | 2.7 | signal |
| 110 | Bladder Disorder | 5 | 2.7 | 2.7 | no signal |
| 111 | Pneumocystis Jirovecii Pneumonia | 5 | 2.7 | 2.7 | no signal |
| 112 | Toxic Skin Eruption | 5 | 2.6 | 2.6 | no signal |
| 113 | Pancreatitis Acute | 11 | 2.6 | 2.6 | signal |
| 114 | Subarachnoid Haemorrhage | 5 | 2.6 | 2.6 | no signal |
| 115 | Ear Discomfort | 5 | 2.6 | 2.6 | no signal |
| 116 | Impaired Quality Of Life | 7 | 2.6 | 2.6 | signal |
| 117 | Platelet Count Decreased | 51 | 2.5 | 2.6 | signal |
| 118 | Drug Reaction With Eosinophilia And Systemic Symptoms | 12 | 2.5 | 2.5 | signal |
| 119 | Dyskinesia | 19 | 2.5 | 2.5 | signal |
| 120 | Vertigo | 28 | 2.4 | 2.4 | signal |
| 121 | Acute Myeloid Leukaemia | 7 | 2.4 | 2.4 | signal |
| 122 | Joint Range Of Motion Decreased | 6 | 2.4 | 2.4 | no signal |
| 123 | Stevens-johnson Syndrome | 10 | 2.4 | 2.4 | signal |
| 124 | Thrombocytopenia | 50 | 2.4 | 2.4 | signal |
| 125 | Pneumonitis | 12 | 2.4 | 2.4 | signal |
| 126 | Myocarditis | 5 | 2.3 | 2.3 | no signal |
| 127 | Diverticulitis | 12 | 2.3 | 2.3 | signal |
| 128 | Metastases To Lung | 5 | 2.3 | 2.3 | no signal |
| 129 | Palmar-plantar Erythrodysaesthesia Syndrome | 10 | 2.3 | 2.3 | signal |
| 130 | Epilepsy | 13 | 2.3 | 2.3 | signal |
| 131 | Mania | 7 | 2.3 | 2.3 | no signal |
| 132 | Fracture | 8 | 2.2 | 2.2 | signal |
| 133 | Muscle Rigidity | 5 | 2.2 | 2.2 | no signal |
| 134 | Neutropenia | 56 | 2.2 | 2.2 | signal |
| 135 | Apathy | 6 | 2.2 | 2.2 | no signal |
| 136 | Blood Creatine Phosphokinase Increased | 12 | 2.2 | 2.2 | signal |
| 137 | Hallucination | 30 | 2.1 | 2.1 | signal |
| 138 | Metastases To Liver | 7 | 2.1 | 2.1 | no signal |
| 139 | Drug Level Decreased | 4 | 2.1 | 2.1 | no signal |
| 140 | Visual Acuity Reduced | 13 | 2.1 | 2.1 | signal |
| 141 | Poor Venous Access | 4 | 2.1 | 2.1 | no signal |
| 142 | Scratch | 4 | 2.0 | 2.0 | no signal |
| 143 | Ankylosing Spondylitis | 5 | 2.0 | 2.0 | no signal |
| 144 | Sedation | 10 | 2.0 | 2.0 | signal |
| 145 | Nervous System Disorder | 12 | 2.0 | 2.0 | signal |
| 146 | Acute Hepatic Failure | 5 | 1.9 | 2.0 | no signal |
| 147 | Metastases To Bone | 6 | 1.9 | 1.9 | no signal |
| 148 | Angioedema | 16 | 1.9 | 1.9 | no signal |
| 149 | Cytomegalovirus Infection | 6 | 1.9 | 1.9 | no signal |
| 150 | Nephropathy Toxic | 4 | 1.9 | 1.9 | no signal |
| 151 | Acne | 27 | 1.9 | 1.9 | no signal |
| 152 | Hepatocellular Injury | 5 | 1.9 | 1.9 | no signal |
| 153 | Gastric Cancer | 9 | 1.9 | 1.9 | no signal |
| 154 | Sexual Dysfunction | 4 | 1.8 | 1.8 | no signal |
| 155 | Malignant Neoplasm Progression | 33 | 1.7 | 1.7 | no signal |
| 156 | Myelosuppression | 11 | 1.7 | 1.7 | no signal |
| 157 | Pemphigus | 4 | 1.7 | 1.7 | no signal |
| 158 | Eczema | 16 | 1.7 | 1.7 | no signal |
| 159 | Lung Neoplasm Malignant | 13 | 1.7 | 1.7 | no signal |
| 160 | Hallucination, Auditory | 5 | 1.7 | 1.7 | no signal |
| 161 | Serotonin Syndrome | 6 | 1.7 | 1.7 | no signal |
| 162 | Tuberculosis | 4 | 1.6 | 1.6 | no signal |
| 163 | Euphoric Mood | 3 | 1.5 | 1.5 | no signal |
| 164 | Suicide Attempt | 17 | 1.5 | 1.5 | no signal |
| 165 | Prostate Cancer | 21 | 1.4 | 1.4 | no signal |
| 166 | Intentional Overdose | 16 | 1.3 | 1.3 | no signal |
| 167 | Withdrawal Syndrome | 10 | 1.3 | 1.3 | no signal |
| 168 | Bladder Cancer | 14 | 1.2 | 1.2 | no signal |
| 169 | Drug Abuse | 19 | 1.2 | 1.2 | no signal |
| 170 | Product Taste Abnormal | 3 | 1.2 | 1.2 | no signal |
| 171 | Bone Density Decreased | 7 | 1.2 | 1.2 | no signal |
| 172 | Plasma Cell Myeloma | 8 | 1.1 | 1.1 | no signal |
| 173 | Extrapyramidal Disorder | 5 | 1.1 | 1.1 | no signal |
| 174 | Hepatic Cancer | 4 | 0.9 | 0.9 | no signal |
| 175 | Incorrect Drug Administration Duration | 4 | 0.7 | 0.7 | no signal |
| 176 | Pancreatic Carcinoma | 4 | 0.7 | 0.7 | no signal |
| 177 | Renal Cancer | 3 | 0.3 | 0.3 | no signal |