OpenPV Signal Explorer
FAERS disproportionality dashboard
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Drug

Darolutamide

200 flagged reaction(s) · 8,336 total co-reports · max PRR 64.3
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 Prostatic Specific Antigen Increased 230 64.3 67.1 signal
2 Metastases To Bone 137 32.2 33.0 signal
3 Hot Flush 622 31.7 35.6 signal
4 Brain Fog 45 11.8 11.9 signal
5 Nocturia 32 10.1 10.1 signal
6 Neuropathy Peripheral 189 7.6 7.9 signal
7 Product Dose Omission In Error 52 7.4 7.5 signal
8 Interstitial Lung Disease 85 6.7 6.8 signal
9 Prostate Cancer 131 6.2 6.3 signal
10 Muscle Atrophy 20 6.1 6.1 signal
11 Neutrophil Count Decreased 63 5.9 6.0 signal
12 Pollakiuria 63 5.8 5.8 signal
13 Myelosuppression 50 5.6 5.7 signal
14 Therapy Interrupted 99 5.5 5.6 signal
15 Metastases To Liver 24 5.2 5.2 signal
16 Taste Disorder 27 5.1 5.2 signal
17 Urinary Retention 43 4.9 5.0 signal
18 Blood Sodium Decreased 24 4.9 4.9 signal
19 Liver Function Test Increased 27 4.8 4.8 signal
20 Urosepsis 11 4.6 4.6 signal
21 Blood Calcium Decreased 13 4.4 4.4 signal
22 Night Sweats 37 4.4 4.4 signal
23 Red Blood Cell Count Decreased 32 4.3 4.3 signal
24 Fatigue 829 4.1 4.6 signal
25 Blood Urine Present 20 4.0 4.0 signal
26 Metastases To Lung 12 4.0 4.0 signal
27 Pneumonitis 28 4.0 4.0 signal
28 Bone Pain 58 3.8 3.8 signal
29 Libido Decreased 12 3.7 3.7 signal
30 Gait Inability 32 3.7 3.7 signal
31 Cytokine Release Syndrome 18 3.6 3.6 signal
32 Incontinence 10 3.6 3.6 signal
33 Dizziness Postural 9 3.6 3.6 signal
34 Febrile Neutropenia 62 3.6 3.6 signal
35 Asthenia 352 3.6 3.7 signal
36 Decreased Activity 10 3.6 3.6 signal
37 Blood Iron Decreased 11 3.6 3.6 signal
38 Incorrect Dose Administered 208 3.5 3.6 signal
39 Dysuria 34 3.5 3.5 signal
40 Bladder Disorder 9 3.4 3.5 signal
41 Pneumocystis Jirovecii Pneumonia 9 3.4 3.4 signal
42 Renal Impairment 74 3.4 3.4 signal
43 Ageusia 22 3.4 3.4 signal
44 Erectile Dysfunction 22 3.3 3.3 signal
45 Polyneuropathy 10 3.2 3.2 signal
46 Emotional Disorder 26 3.2 3.2 signal
47 Cytopenia 10 3.2 3.2 signal
48 Dementia 22 3.0 3.0 signal
49 Inappropriate Antidiuretic Hormone Secretion 8 3.0 3.0 signal
50 Blood Test Abnormal 11 3.0 3.0 signal
51 Product Use Complaint 12 3.0 3.0 signal
52 Hepatotoxicity 17 2.9 2.9 signal
53 Apathy 11 2.9 2.9 signal
54 Dysstasia 22 2.9 2.9 signal
55 Constipation 162 2.9 2.9 signal
56 Dyspnoea Exertional 28 2.8 2.9 signal
57 Hepatic Function Abnormal 27 2.8 2.8 signal
58 Blood Alkaline Phosphatase Increased 18 2.8 2.8 signal
59 Product Dose Omission Issue 204 2.7 2.8 signal
60 Alanine Aminotransferase Increased 44 2.7 2.7 signal
61 Hepatic Enzyme Increased 48 2.7 2.7 signal
62 Micturition Urgency 8 2.7 2.7 signal
63 Feeding Disorder 14 2.7 2.7 signal
64 Hypersomnia 20 2.7 2.7 signal
65 Renal Disorder 32 2.6 2.6 signal
66 Blood Potassium Increased 11 2.6 2.6 signal
67 Liver Disorder 30 2.6 2.6 signal
68 Myalgia 115 2.6 2.6 signal
69 Urinary Incontinence 20 2.6 2.6 signal
70 Rhabdomyolysis 28 2.6 2.6 signal
71 Full Blood Count Abnormal 7 2.5 2.5 signal
72 Glomerular Filtration Rate Decreased 8 2.5 2.5 signal
73 Aspartate Aminotransferase Increased 35 2.5 2.5 signal
74 Hepatic Cytolysis 8 2.5 2.5 signal
75 Bone Disorder 12 2.5 2.5 signal
76 Generalised Oedema 8 2.5 2.5 signal
77 Decreased Appetite 150 2.5 2.5 signal
78 Blood Creatinine Increased 42 2.4 2.5 signal
79 Mood Swings 20 2.4 2.4 signal
80 Knee Operation 6 2.4 2.4 no signal
81 Bedridden 8 2.3 2.3 signal
82 Disease Progression 71 2.3 2.3 signal
83 Spinal Pain 7 2.3 2.3 no signal
84 Blood Glucose Abnormal 11 2.3 2.3 signal
85 Sluggishness 6 2.3 2.3 no signal
86 Infusion Related Reaction 39 2.3 2.3 signal
87 Initial Insomnia 6 2.2 2.2 no signal
88 Peripheral Swelling 90 2.2 2.3 signal
89 Muscular Weakness 66 2.2 2.2 signal
90 Coronary Artery Occlusion 8 2.2 2.2 signal
91 Malignant Neoplasm Progression 59 2.2 2.2 signal
92 Spinal Operation 7 2.2 2.2 no signal
93 Mental Impairment 14 2.2 2.2 signal
94 Pain In Extremity 170 2.2 2.2 signal
95 Dysphagia 54 2.2 2.2 signal
96 Renal Pain 6 2.2 2.2 no signal
97 Pneumothorax 9 2.2 2.2 signal
98 Illness 57 2.2 2.2 signal
99 Arthralgia 235 2.2 2.2 signal
100 Eating Disorder 12 2.1 2.1 signal
101 Blood Bilirubin Increased 15 2.1 2.1 signal
102 Pelvic Pain 10 2.1 2.1 signal
103 Pulmonary Arterial Hypertension 8 2.1 2.1 no signal
104 Cardiac Disorder 51 2.1 2.1 signal
105 Nerve Compression 5 2.1 2.1 no signal
106 Product Prescribing Issue 11 2.1 2.1 signal
107 Haematotoxicity 5 2.1 2.1 no signal
108 Nerve Injury 6 2.1 2.1 no signal
109 Middle Insomnia 10 2.0 2.1 signal
110 Personality Change 5 2.0 2.0 no signal
111 Increased Appetite 10 2.0 2.0 signal
112 Arteriosclerosis 5 2.0 2.0 no signal
113 Musculoskeletal Discomfort 9 2.0 2.0 no signal
114 Pharyngeal Swelling 5 2.0 2.0 no signal
115 Lethargy 30 2.0 2.0 no signal
116 Feeling Hot 32 2.0 2.0 no signal
117 Hyperhidrosis 67 2.0 2.0 no signal
118 Therapy Change 5 2.0 2.0 no signal
119 Limb Discomfort 16 2.0 2.0 no signal
120 Limb Injury 14 2.0 2.0 no signal
121 Back Pain 120 2.0 2.0 no signal
122 Atrial Fibrillation 50 2.0 2.0 no signal
123 Death 441 2.0 2.0 no signal
124 Gynaecomastia 16 1.9 2.0 no signal
125 Blood Triglycerides Increased 9 1.9 1.9 no signal
126 Macular Degeneration 6 1.9 1.9 no signal
127 Balance Disorder 43 1.9 1.9 no signal
128 Full Blood Count Decreased 10 1.9 1.9 no signal
129 Weight Increased 110 1.9 1.9 no signal
130 Back Disorder 8 1.9 1.9 no signal
131 Angina Pectoris 14 1.9 1.9 no signal
132 Frequent Bowel Movements 13 1.8 1.8 no signal
133 Glycosylated Haemoglobin Increased 12 1.8 1.8 no signal
134 Transfusion 5 1.8 1.8 no signal
135 Fracture 9 1.8 1.8 no signal
136 Dizziness 236 1.8 1.8 no signal
137 Poor Quality Sleep 10 1.8 1.8 no signal
138 Haemoglobin Decreased 48 1.8 1.8 no signal
139 Feeling Cold 13 1.8 1.8 no signal
140 Faeces Discoloured 10 1.8 1.8 no signal
141 Pulmonary Thrombosis 5 1.7 1.7 no signal
142 Blood Pressure Abnormal 9 1.7 1.7 no signal
143 White Blood Cell Count Decreased 49 1.7 1.7 no signal
144 Gamma-glutamyltransferase Increased 10 1.7 1.7 no signal
145 Ejection Fraction Decreased 7 1.7 1.7 no signal
146 Thirst 8 1.7 1.7 no signal
147 Head Injury 14 1.7 1.7 no signal
148 Mood Altered 12 1.7 1.7 no signal
149 Neutropenia 59 1.7 1.7 no signal
150 Brain Neoplasm 4 1.7 1.7 no signal
151 Hepatic Failure 13 1.6 1.6 no signal
152 Spinal Disorder 4 1.6 1.6 no signal
153 Musculoskeletal Disorder 8 1.6 1.6 no signal
154 Blood Pressure Fluctuation 10 1.6 1.6 no signal
155 Memory Impairment 57 1.6 1.6 no signal
156 Laboratory Test Abnormal 12 1.6 1.6 no signal
157 Tooth Extraction 5 1.5 1.5 no signal
158 Spinal Fracture 8 1.5 1.5 no signal
159 Rash Papular 9 1.5 1.5 no signal
160 Brain Injury 4 1.5 1.5 no signal
161 Cold Sweat 7 1.5 1.5 no signal
162 Hospitalisation 60 1.5 1.5 no signal
163 Metastases To Central Nervous System 5 1.5 1.5 no signal
164 Palmar-plantar Erythrodysaesthesia Syndrome 9 1.5 1.5 no signal
165 Procedural Pain 10 1.4 1.4 no signal
166 Stevens-johnson Syndrome 8 1.4 1.4 no signal
167 Drug Effect Less Than Expected 5 1.4 1.4 no signal
168 Femur Fracture 11 1.4 1.4 no signal
169 Face Oedema 6 1.3 1.4 no signal
170 Cerebrovascular Accident 59 1.3 1.3 no signal
171 Hip Fracture 11 1.3 1.3 no signal
172 Diabetes Mellitus Inadequate Control 6 1.3 1.3 no signal
173 Accident 4 1.3 1.3 no signal
174 Tendon Rupture 4 1.2 1.2 no signal
175 Blood Glucose Increased 61 1.2 1.2 no signal
176 Eye Inflammation 3 1.2 1.2 no signal
177 Neoplasm Malignant 21 1.2 1.2 no signal
178 Surgery 18 1.2 1.2 no signal
179 Malignant Melanoma 4 1.1 1.1 no signal
180 Euphoric Mood 3 1.1 1.1 no signal
181 Dialysis 4 1.1 1.1 no signal
182 Dry Skin 36 1.0 1.0 no signal
183 Cardiovascular Disorder 7 1.0 1.0 no signal
184 Internal Haemorrhage 3 1.0 1.0 no signal
185 Sexual Dysfunction 3 1.0 1.0 no signal
186 Neoplasm Progression 9 1.0 1.0 no signal
187 Abnormal Dreams 7 1.0 1.0 no signal
188 Extra Dose Administered 10 1.0 1.0 no signal
189 Hepatic Cancer 6 0.9 0.9 no signal
190 Intercepted Product Preparation Error 3 0.9 0.9 no signal
191 Neurotoxicity 4 0.9 0.9 no signal
192 Product Availability Issue 5 0.9 0.8 no signal
193 Device Occlusion 3 0.8 0.8 no signal
194 Incorrect Product Administration Duration 4 0.8 0.8 no signal
195 Multiple Fractures 3 0.7 0.7 no signal
196 Pancreatic Carcinoma 4 0.5 0.5 no signal
197 Injection Site Rash 4 0.5 0.5 no signal
198 Gastric Cancer 3 0.4 0.4 no signal
199 Bladder Cancer 5 0.3 0.3 no signal
200 Device Leakage 3 0.3 0.3 no signal