OpenPV Signal Explorer
FAERS disproportionality dashboard
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Drug

Darunavir 800 Mg

252 flagged reaction(s) · 8,693 total co-reports · max PRR 39.0
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 Drug Resistance 289 39.0 40.9 signal
2 Eyelid Ptosis 105 35.7 36.3 signal
3 Foetal Exposure During Pregnancy 501 21.2 23.1 signal
4 Abortion Induced 55 20.1 20.3 signal
5 Premature Baby 173 19.7 20.3 signal
6 Nephropathy Toxic 61 18.9 19.0 signal
7 Premature Delivery 87 18.7 19.0 signal
8 Adrenal Insufficiency 59 17.0 17.1 signal
9 Drug Interaction 697 15.1 16.9 signal
10 Abortion Spontaneous 176 15.0 15.5 signal
11 Diplopia 104 13.8 14.0 signal
12 Exposure During Pregnancy 230 12.7 13.2 signal
13 Treatment Noncompliance 193 12.2 12.6 signal
14 Maternal Exposure During Pregnancy 313 12.2 12.8 signal
15 Drug Level Increased 58 12.0 12.1 signal
16 Drug Level Decreased 31 10.4 10.5 signal
17 Hepatitis C 37 10.4 10.5 signal
18 Pneumocystis Jirovecii Pneumonia 28 9.6 9.7 signal
19 Treatment Failure 224 9.4 9.7 signal
20 Oral Candidiasis 29 7.6 7.7 signal
21 Caesarean Section 26 7.6 7.6 signal
22 Renal Tubular Necrosis 21 7.3 7.3 signal
23 Hyperbilirubinaemia 22 7.3 7.3 signal
24 Brain Injury 21 7.2 7.2 signal
25 Clostridium Difficile Colitis 21 6.8 6.8 signal
26 Acute Myocardial Infarction 58 6.7 6.8 signal
27 Renal Impairment 160 6.6 6.7 signal
28 Osteoporosis 74 6.2 6.2 signal
29 Hypercholesterolaemia 17 6.1 6.1 signal
30 Rash Maculo-papular 39 6.0 6.1 signal
31 Ventricular Fibrillation 19 5.9 5.9 signal
32 Proteinuria 32 5.8 5.8 signal
33 Blood Bilirubin Increased 44 5.6 5.6 signal
34 Hyperlipidaemia 19 5.4 5.5 signal
35 Osteonecrosis 52 5.4 5.4 signal
36 Glomerular Filtration Rate Decreased 19 5.4 5.4 signal
37 End Stage Renal Disease 28 5.2 5.2 signal
38 Serotonin Syndrome 29 5.2 5.2 signal
39 Nephropathy 14 5.1 5.1 signal
40 Hepatic Cytolysis 18 5.1 5.1 signal
41 Osteopenia 22 4.9 5.0 signal
42 Neurotoxicity 25 4.9 4.9 signal
43 Brain Oedema 18 4.9 4.9 signal
44 Hepatic Encephalopathy 13 4.8 4.8 signal
45 Coronary Artery Disease 42 4.7 4.7 signal
46 Cholestasis 26 4.7 4.7 signal
47 Lactic Acidosis 43 4.6 4.6 signal
48 Vitamin D Deficiency 13 4.6 4.6 signal
49 Status Epilepticus 15 4.5 4.6 signal
50 Acute Hepatic Failure 18 4.5 4.5 signal
51 Central Nervous System Lesion 18 4.5 4.5 signal
52 Drug Exposure During Pregnancy 44 4.4 4.4 signal
53 Hepatotoxicity 28 4.3 4.3 signal
54 Cytomegalovirus Infection 21 4.3 4.3 signal
55 Toxic Epidermal Necrolysis 19 4.3 4.3 signal
56 Rhabdomyolysis 52 4.3 4.3 signal
57 Jaundice 33 4.2 4.2 signal
58 Blood Triglycerides Increased 21 4.1 4.1 signal
59 Electrocardiogram Qt Prolonged 42 4.0 4.0 signal
60 Foot Fracture 22 4.0 4.0 signal
61 Ascites 34 4.0 4.0 signal
62 Pancytopenia 63 3.9 3.9 signal
63 Parkinsonism 11 3.9 3.9 signal
64 Acute Kidney Injury 171 3.8 3.9 signal
65 Renal Failure Acute 48 3.8 3.8 signal
66 Economic Problem 17 3.8 3.8 signal
67 Drug Reaction With Eosinophilia And Systemic Symptoms 28 3.8 3.8 signal
68 Transaminases Increased 24 3.7 3.7 signal
69 Drug-induced Liver Injury 33 3.7 3.7 signal
70 Liver Function Test Abnormal 31 3.6 3.6 signal
71 Anhedonia 28 3.6 3.6 signal
72 Pulmonary Hypertension 22 3.6 3.6 signal
73 Eyelid Oedema 12 3.5 3.5 signal
74 Metabolic Acidosis 31 3.4 3.4 signal
75 Poisoning Deliberate 9 3.3 3.3 signal
76 Gastroenteritis 14 3.3 3.3 signal
77 Face Oedema 16 3.2 3.2 signal
78 Post Procedural Haemorrhage 11 3.2 3.2 signal
79 Multiple Organ Dysfunction Syndrome 26 3.2 3.2 signal
80 Nervous System Disorder 29 3.2 3.2 signal
81 Blood Creatine Phosphokinase Increased 27 3.2 3.2 signal
82 Ataxia 11 3.2 3.2 signal
83 Rash Generalised 24 3.1 3.1 signal
84 Alanine Aminotransferase Increased 54 3.0 3.0 signal
85 Lymphadenopathy 31 3.0 3.0 signal
86 Stevens-johnson Syndrome 19 2.9 2.9 signal
87 Haematuria 29 2.9 2.9 signal
88 Covid-19 Pneumonia 10 2.9 2.9 signal
89 C-reactive Protein Increased 30 2.8 2.8 signal
90 Vitreous Floaters 8 2.8 2.8 signal
91 Agranulocytosis 15 2.8 2.8 signal
92 Hepatomegaly 8 2.8 2.8 signal
93 Hepatic Steatosis 15 2.8 2.8 signal
94 Eosinophilia 14 2.7 2.7 signal
95 Toxicity To Various Agents 134 2.7 2.8 signal
96 Shock 18 2.7 2.7 signal
97 Myocardial Ischaemia 9 2.7 2.7 signal
98 Folliculitis 8 2.7 2.7 signal
99 Aspartate Aminotransferase Increased 41 2.6 2.7 signal
100 Splenomegaly 9 2.6 2.6 signal
101 Nephrolithiasis 35 2.6 2.6 signal
102 Blood Creatinine Increased 50 2.6 2.6 signal
103 Gastrointestinal Carcinoma 7 2.6 2.6 signal
104 Renal Pain 8 2.6 2.6 signal
105 Arteriosclerosis 7 2.5 2.5 signal
106 Pancreatitis 39 2.5 2.5 signal
107 Blood Urine Present 14 2.5 2.5 signal
108 Acute Respiratory Distress Syndrome 13 2.5 2.5 signal
109 Dizziness Postural 7 2.5 2.5 signal
110 Hepatic Failure 22 2.5 2.5 signal
111 Blood Alkaline Phosphatase Increased 18 2.5 2.5 signal
112 Diabetes Mellitus 55 2.5 2.5 signal
113 Lymphopenia 10 2.4 2.4 signal
114 Febrile Neutropenia 47 2.4 2.4 signal
115 Sinus Tachycardia 10 2.4 2.4 signal
116 Hepatitis 18 2.4 2.4 signal
117 Liver Injury 17 2.4 2.4 signal
118 Hepatic Cancer 17 2.4 2.4 signal
119 Tuberculosis 9 2.4 2.4 signal
120 Delirium 24 2.4 2.4 signal
121 Thrombocytopenia 77 2.4 2.4 signal
122 Septic Shock 29 2.3 2.3 signal
123 Myoclonus 8 2.3 2.3 signal
124 Anaemia 127 2.3 2.3 signal
125 Mental Disorder 29 2.3 2.3 signal
126 Hyperglycaemia 24 2.3 2.3 signal
127 Candida Infection 11 2.3 2.3 signal
128 Respiratory Failure 48 2.3 2.3 signal
129 Liver Disorder 29 2.2 2.2 signal
130 Incorrect Route Of Product Administration 11 2.2 2.2 signal
131 Encephalopathy 16 2.2 2.2 signal
132 Generalised Oedema 8 2.2 2.2 signal
133 Pregnancy 13 2.2 2.2 signal
134 Hepatic Cirrhosis 12 2.2 2.2 signal
135 Pharyngitis 8 2.2 2.2 signal
136 Tubulointerstitial Nephritis 12 2.2 2.2 signal
137 Nightmare 22 2.2 2.2 signal
138 Nerve Injury 7 2.2 2.2 no signal
139 Mydriasis 8 2.1 2.1 no signal
140 Erectile Dysfunction 16 2.1 2.1 signal
141 Thrombosis 49 2.1 2.1 signal
142 Emphysema 6 2.0 2.0 no signal
143 Angioedema 26 2.0 2.0 signal
144 Chronic Kidney Disease 45 2.0 2.0 signal
145 Pancreatitis Acute 13 2.0 2.0 no signal
146 Nocturia 7 2.0 2.0 no signal
147 Paranoia 10 2.0 2.0 no signal
148 Panic Attack 21 2.0 2.0 no signal
149 Hyperkalaemia 20 2.0 2.0 no signal
150 Bone Density Decreased 18 1.9 1.9 no signal
151 Hallucination, Auditory 9 1.9 1.9 no signal
152 Hepatocellular Injury 8 1.9 1.9 no signal
153 Spinal Fracture 11 1.9 1.9 no signal
154 Generalised Tonic-clonic Seizure 9 1.9 1.9 no signal
155 Cardiac Arrest 45 1.9 1.9 no signal
156 Gamma-glutamyltransferase Increased 12 1.9 1.9 no signal
157 Hepatic Function Abnormal 20 1.8 1.9 no signal
158 Immune System Disorder 7 1.8 1.8 no signal
159 Dysarthria 20 1.8 1.8 no signal
160 Colitis 20 1.8 1.8 no signal
161 Squamous Cell Carcinoma 5 1.8 1.8 no signal
162 Metastases To Lung 6 1.8 1.8 no signal
163 Device Related Infection 8 1.8 1.8 no signal
164 Lymphoma 8 1.8 1.8 no signal
165 Agitation 38 1.8 1.8 no signal
166 Multi-organ Failure 9 1.8 1.8 no signal
167 Decreased Immune Responsiveness 5 1.8 1.8 no signal
168 Blood Iron Decreased 6 1.7 1.7 no signal
169 Psychotic Disorder 15 1.7 1.7 no signal
170 Drug Toxicity 7 1.7 1.7 no signal
171 Rash Pruritic 27 1.7 1.7 no signal
172 Salivary Hypersecretion 5 1.7 1.7 no signal
173 Mass 7 1.7 1.7 no signal
174 Mucosal Inflammation 13 1.7 1.7 no signal
175 Chromaturia 11 1.7 1.7 no signal
176 Hypercalcaemia 6 1.7 1.7 no signal
177 Multiple Fractures 8 1.7 1.7 no signal
178 Neuropathy Peripheral 45 1.6 1.6 no signal
179 Myocardial Infarction 83 1.6 1.6 no signal
180 Hemiparesis 8 1.6 1.6 no signal
181 Sudden Death 5 1.6 1.6 no signal
182 Movement Disorder 15 1.6 1.6 no signal
183 Epilepsy 14 1.6 1.6 no signal
184 Cognitive Disorder 21 1.5 1.5 no signal
185 Type 2 Diabetes Mellitus 15 1.5 1.5 no signal
186 Osteomyelitis 8 1.5 1.5 no signal
187 Myalgia 75 1.5 1.5 no signal
188 Retinal Detachment 4 1.5 1.5 no signal
189 Haematotoxicity 4 1.5 1.5 no signal
190 Product Prescribing Error 10 1.4 1.4 no signal
191 Dialysis 6 1.4 1.4 no signal
192 Neutropenia 57 1.4 1.4 no signal
193 Psychomotor Hyperactivity 7 1.4 1.4 no signal
194 Cerebral Haemorrhage 15 1.4 1.4 no signal
195 Subdural Haematoma 6 1.4 1.4 no signal
196 Swelling Face 27 1.4 1.4 no signal
197 Pulmonary Arterial Hypertension 6 1.4 1.4 no signal
198 No Adverse Event 73 1.4 1.4 no signal
199 Pruritus Generalised 9 1.4 1.4 no signal
200 No Therapeutic Response 5 1.4 1.4 no signal
201 Adverse Event 37 1.4 1.4 no signal
202 Dermatitis Allergic 5 1.4 1.4 no signal
203 Seizure 46 1.4 1.4 no signal
204 Depressed Mood 21 1.4 1.4 no signal
205 Contraindicated Product Administered 12 1.4 1.4 no signal
206 Peritonitis Bacterial 4 1.4 1.4 no signal
207 Local Swelling 7 1.4 1.4 no signal
208 Abnormal Dreams 11 1.4 1.4 no signal
209 Diabetes Mellitus Inadequate Control 7 1.4 1.4 no signal
210 Thirst 7 1.3 1.3 no signal
211 Lip Swelling 13 1.3 1.3 no signal
212 Peritonitis 8 1.3 1.3 no signal
213 Basal Cell Carcinoma 6 1.3 1.3 no signal
214 Bedridden 5 1.3 1.3 no signal
215 Adverse Drug Reaction 34 1.3 1.3 no signal
216 Mental Impairment 9 1.3 1.3 no signal
217 Injection Site Nodule 4 1.2 1.2 no signal
218 Prescribed Overdose 7 1.2 1.2 no signal
219 Cardiovascular Disorder 9 1.2 1.2 no signal
220 Disease Recurrence 16 1.1 1.1 no signal
221 Colon Cancer 5 1.1 1.1 no signal
222 Schizophrenia 4 1.1 1.1 no signal
223 Grand Mal Convulsion 3 1.1 1.1 no signal
224 Anorexia 4 1.0 1.0 no signal
225 Metastases To Bone 5 1.0 1.0 no signal
226 Suicidal Ideation 28 1.0 1.0 no signal
227 Skin Exfoliation 25 1.0 1.0 no signal
228 Sars-cov-2 Test Positive 4 1.0 1.0 no signal
229 Toxic Skin Eruption 3 1.0 1.0 no signal
230 Coronary Artery Occlusion 4 1.0 1.0 no signal
231 Emotional Distress 35 1.0 1.0 no signal
232 Injection Site Reaction 19 0.9 0.9 no signal
233 Death 238 0.9 0.9 no signal
234 Bone Loss 4 0.9 0.9 no signal
235 Prostate Cancer 21 0.9 0.9 no signal
236 Cytopenia 3 0.9 0.9 no signal
237 Intentional Overdose 16 0.9 0.9 no signal
238 Suicide Attempt 15 0.8 0.8 no signal
239 Libido Decreased 3 0.8 0.8 no signal
240 Poisoning 3 0.8 0.8 no signal
241 Completed Suicide 19 0.8 0.8 no signal
242 Uveitis 3 0.8 0.8 no signal
243 Synovitis 4 0.8 0.8 no signal
244 Injection Site Mass 8 0.7 0.7 no signal
245 Intentional Self-injury 4 0.7 0.7 no signal
246 Wrong Technique In Drug Usage Process 7 0.7 0.7 no signal
247 Drug Prescribing Error 3 0.5 0.5 no signal
248 Incorrect Drug Administration Duration 4 0.5 0.5 no signal
249 Drug Abuse 11 0.5 0.4 no signal
250 Myelosuppression 4 0.4 0.4 no signal
251 Pancreatic Carcinoma 3 0.4 0.4 no signal
252 Renal Cancer 3 0.2 0.2 no signal