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Drug

Naloxone

387 flagged reaction(s) · 13,162 total co-reports · max PRR 49.8
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 Respiratory Depression 163 49.8 51.2 signal
2 Unresponsive To Stimuli 168 24.3 25.0 signal
3 Toxicity To Various Agents 773 17.1 19.6 signal
4 Sinus Tachycardia 53 13.9 14.0 signal
5 Depressed Level Of Consciousness 141 13.2 13.6 signal
6 Transfusion 36 12.7 12.8 signal
7 Poisoning 43 12.6 12.7 signal
8 Drug Withdrawal Syndrome Neonatal 50 12.4 12.5 signal
9 Acute Respiratory Failure 58 11.2 11.3 signal
10 Premature Delivery 48 11.1 11.2 signal
11 Pulmonary Oedema 133 11.0 11.2 signal
12 Hypoxia 102 10.8 11.0 signal
13 Electrocardiogram Qt Prolonged 104 10.7 10.9 signal
14 Brain Oedema 35 10.3 10.3 signal
15 Coma 125 9.7 9.9 signal
16 Drug Abuse 216 9.6 9.9 signal
17 Mental Status Changes 70 9.3 9.4 signal
18 Tachypnoea 34 9.3 9.3 signal
19 Caesarean Section 29 9.1 9.2 signal
20 Serotonin Syndrome 47 9.1 9.2 signal
21 Cardiogenic Shock 34 8.8 8.9 signal
22 Oral Candidiasis 30 8.5 8.6 signal
23 Delusion 34 8.1 8.2 signal
24 Pulmonary Congestion 29 8.1 8.2 signal
25 Overdose 461 7.9 8.5 signal
26 Brain Injury 21 7.7 7.8 signal
27 Delirium 72 7.7 7.8 signal
28 Cardiac Arrest 171 7.6 7.8 signal
29 Premature Baby 61 7.5 7.6 signal
30 Respiratory Failure 147 7.5 7.6 signal
31 Sinus Bradycardia 19 7.3 7.3 signal
32 Renal Tubular Necrosis 19 7.2 7.2 signal
33 Encephalopathy 47 7.1 7.2 signal
34 Metabolic Acidosis 60 7.0 7.1 signal
35 Metastases To Bone 31 7.0 7.0 signal
36 Clostridium Difficile Colitis 20 7.0 7.0 signal
37 Drug Toxicity 25 6.7 6.7 signal
38 End Stage Renal Disease 33 6.6 6.7 signal
39 Paranoia 31 6.6 6.7 signal
40 Leukocytosis 32 6.6 6.6 signal
41 Drug Withdrawal Syndrome 156 6.5 6.7 signal
42 Atelectasis 17 6.5 6.5 signal
43 Rhabdomyolysis 71 6.3 6.4 signal
44 Ventricular Tachycardia 28 6.3 6.3 signal
45 Bradycardia 89 6.2 6.3 signal
46 Sedation 43 6.1 6.1 signal
47 Hallucination, Visual 34 6.0 6.0 signal
48 Febrile Neutropenia 104 5.8 5.9 signal
49 Mydriasis 20 5.8 5.8 signal
50 Intentional Overdose 99 5.7 5.8 signal
51 Hepatotoxicity 34 5.7 5.7 signal
52 Cardiomegaly 19 5.7 5.7 signal
53 Acute Kidney Injury 232 5.6 5.8 signal
54 Urosepsis 14 5.6 5.6 signal
55 Disseminated Intravascular Coagulation 21 5.5 5.5 signal
56 Hypothermia 15 5.5 5.5 signal
57 Electrolyte Imbalance 17 5.5 5.5 signal
58 Acute Respiratory Distress Syndrome 26 5.4 5.5 signal
59 Hypercalcaemia 18 5.4 5.4 signal
60 Obesity 23 5.3 5.4 signal
61 Ventricular Fibrillation 16 5.3 5.3 signal
62 Upper Gastrointestinal Haemorrhage 24 5.3 5.3 signal
63 Status Epilepticus 16 5.2 5.2 signal
64 Respiratory Distress 39 5.2 5.3 signal
65 Acute Hepatic Failure 19 5.2 5.2 signal
66 Intervertebral Disc Degeneration 13 5.2 5.2 signal
67 Hypokalaemia 63 5.1 5.1 signal
68 Agitation 101 5.1 5.1 signal
69 Therapy Non-responder 60 5.0 5.0 signal
70 Accidental Overdose 49 5.0 5.0 signal
71 Hospice Care 13 4.9 4.9 signal
72 Sleep Apnoea Syndrome 25 4.8 4.9 signal
73 Hyperkalaemia 45 4.8 4.8 signal
74 Pneumonia Aspiration 32 4.8 4.8 signal
75 Flank Pain 12 4.7 4.8 signal
76 Tubulointerstitial Nephritis 24 4.7 4.8 signal
77 Respiratory Arrest 35 4.7 4.7 signal
78 Dementia 35 4.7 4.7 signal
79 Haematocrit Decreased 25 4.6 4.7 signal
80 Chronic Kidney Disease 95 4.6 4.6 signal
81 Circulatory Collapse 21 4.5 4.6 signal
82 Myocardial Ischaemia 14 4.5 4.5 signal
83 Foetal Exposure During Pregnancy 99 4.5 4.6 signal
84 Myoclonus 14 4.3 4.4 signal
85 Metastases To Central Nervous System 15 4.3 4.3 signal
86 Muscle Twitching 27 4.3 4.3 signal
87 Maternal Exposure During Pregnancy 103 4.3 4.4 signal
88 Arteriosclerosis 11 4.3 4.3 signal
89 Lethargy 67 4.3 4.3 signal
90 Neurotoxicity 20 4.3 4.3 signal
91 Haematemesis 29 4.2 4.2 signal
92 Restlessness 41 4.1 4.2 signal
93 Breast Cancer Metastatic 12 4.1 4.1 signal
94 Hepatomegaly 11 4.1 4.1 signal
95 Aspiration 12 4.1 4.1 signal
96 Suicide Attempt 67 4.1 4.1 signal
97 Shock 25 4.1 4.1 signal
98 Vaginal Discharge 11 4.1 4.1 signal
99 Drug Level Increased 18 4.0 4.0 signal
100 Renal Failure 145 4.0 4.1 signal
101 Hypotension 217 4.0 4.1 signal
102 Drug Interaction 169 3.9 4.0 signal
103 Blood Calcium Decreased 12 3.9 3.9 signal
104 Drug Dependence 172 3.9 4.0 signal
105 Ileus 13 3.9 3.9 signal
106 Posterior Reversible Encephalopathy Syndrome 10 3.9 3.9 signal
107 Transaminases Increased 23 3.8 3.8 signal
108 Cognitive Disorder 48 3.8 3.8 signal
109 Ejection Fraction Decreased 16 3.8 3.8 signal
110 Splenomegaly 12 3.8 3.8 signal
111 Bacteraemia 12 3.8 3.8 signal
112 Cyanosis 16 3.8 3.8 signal
113 Ocular Discomfort 11 3.7 3.8 signal
114 Incorrect Route Of Product Administration 17 3.7 3.8 signal
115 Pulmonary Hypertension 21 3.7 3.7 signal
116 Cytokine Release Syndrome 19 3.7 3.7 signal
117 Septic Shock 43 3.7 3.7 signal
118 Hypertensive Crisis 11 3.6 3.7 signal
119 Somnolence 198 3.6 3.7 signal
120 Tachycardia 87 3.6 3.7 signal
121 General Physical Health Deterioration 112 3.6 3.7 signal
122 Mitral Valve Incompetence 11 3.6 3.6 signal
123 Muscle Spasticity 12 3.6 3.6 signal
124 Hypoglycaemia 46 3.5 3.5 signal
125 Impaired Gastric Emptying 12 3.5 3.5 signal
126 Pelvic Pain 17 3.5 3.5 signal
127 Product Prescribing Issue 19 3.5 3.5 signal
128 Coordination Abnormal 13 3.4 3.4 signal
129 Withdrawal Syndrome 39 3.4 3.4 signal
130 Ankylosing Spondylitis 12 3.4 3.4 signal
131 Muscle Rigidity 11 3.4 3.4 signal
132 Hyperlipidaemia 11 3.4 3.4 signal
133 Hyperglycaemia 33 3.4 3.4 signal
134 Head Discomfort 16 3.4 3.4 signal
135 Joint Range Of Motion Decreased 12 3.3 3.3 signal
136 Small Intestinal Obstruction 11 3.3 3.3 signal
137 Oxygen Saturation Decreased 50 3.3 3.3 signal
138 Generalised Oedema 11 3.3 3.3 signal
139 Sepsis 99 3.3 3.3 signal
140 Sickle Cell Anaemia With Crisis 14 3.3 3.3 signal
141 Rebound Effect 10 3.3 3.3 signal
142 Altered State Of Consciousness 19 3.3 3.3 signal
143 Gastritis 23 3.2 3.2 signal
144 Hyperbilirubinaemia 9 3.2 3.2 signal
145 Hyponatraemia 49 3.2 3.2 signal
146 Sensory Disturbance 14 3.2 3.2 signal
147 Drug Ineffective For Unapproved Indication 48 3.2 3.2 signal
148 Poisoning Deliberate 8 3.2 3.2 signal
149 Grand Mal Convulsion 8 3.2 3.2 signal
150 Ascites 25 3.1 3.2 signal
151 Pancytopenia 47 3.1 3.1 signal
152 Spinal Disorder 8 3.1 3.1 signal
153 Cholecystitis 10 3.1 3.1 signal
154 Skin Laceration 9 3.1 3.1 signal
155 Renal Injury 25 3.1 3.1 signal
156 Multiple Organ Dysfunction Syndrome 23 3.0 3.1 signal
157 Peritonitis 17 3.0 3.0 signal
158 Vitamin D Deficiency 8 3.0 3.0 signal
159 Pneumothorax 13 3.0 3.0 signal
160 Aggression 41 3.0 3.0 signal
161 Tooth Fracture 9 3.0 3.0 signal
162 Dental Caries 9 3.0 3.0 signal
163 Cardio-respiratory Arrest 34 3.0 3.0 signal
164 Blood Alkaline Phosphatase Increased 20 3.0 3.0 signal
165 Generalised Tonic-clonic Seizure 13 2.9 2.9 signal
166 Micturition Urgency 9 2.9 2.9 signal
167 Lymphocyte Count Decreased 14 2.9 2.9 signal
168 Device Occlusion 11 2.9 2.9 signal
169 Feeling Cold 22 2.9 2.9 signal
170 Dysuria 29 2.9 2.9 signal
171 Disorientation 31 2.9 2.9 signal
172 Rib Fracture 16 2.9 2.9 signal
173 Lactic Acidosis 25 2.9 2.9 signal
174 Economic Problem 12 2.9 2.9 signal
175 Euphoric Mood 8 2.9 2.9 signal
176 Osteomyelitis 14 2.9 2.9 signal
177 Dyskinesia 31 2.8 2.8 signal
178 Accident 9 2.8 2.8 signal
179 Haemoptysis 21 2.8 2.8 signal
180 Hypophagia 19 2.8 2.8 signal
181 Urinary Incontinence 22 2.7 2.8 signal
182 Osteopenia 11 2.7 2.7 signal
183 Device Related Infection 11 2.6 2.6 signal
184 Haemoglobin Decreased 73 2.6 2.6 signal
185 Intentional Product Misuse 61 2.6 2.6 signal
186 Hallucination 52 2.6 2.6 signal
187 Urinary Retention 23 2.6 2.6 signal
188 Loss Of Consciousness 87 2.5 2.5 signal
189 Fluid Overload 10 2.5 2.5 signal
190 Atrial Fibrillation 66 2.5 2.5 signal
191 Gamma-glutamyltransferase Increased 15 2.5 2.5 signal
192 Cardiomyopathy 10 2.5 2.5 signal
193 Cellulitis 34 2.5 2.5 signal
194 Pleural Effusion 41 2.5 2.5 signal
195 Covid-19 Pneumonia 8 2.5 2.5 signal
196 Polyneuropathy 8 2.5 2.5 signal
197 Mania 11 2.5 2.5 signal
198 Joint Dislocation 7 2.5 2.5 signal
199 Toxic Epidermal Necrolysis 10 2.5 2.5 signal
200 Liver Injury 16 2.4 2.5 signal
201 Disability 13 2.4 2.4 signal
202 Thrombocytopenia 73 2.4 2.4 signal
203 Iron Deficiency Anaemia 6 2.4 2.4 no signal
204 Mucosal Inflammation 17 2.4 2.4 signal
205 Diverticulitis 18 2.4 2.4 signal
206 Hypomagnesaemia 9 2.4 2.4 signal
207 Seizure 74 2.4 2.4 signal
208 Stomatitis 39 2.4 2.4 signal
209 Photophobia 12 2.4 2.4 signal
210 Hepatic Encephalopathy 6 2.4 2.4 no signal
211 Anaemia 122 2.4 2.4 signal
212 Pulmonary Embolism 61 2.4 2.4 signal
213 Paralysis 9 2.3 2.3 signal
214 Oral Pain 14 2.3 2.3 signal
215 Aspartate Aminotransferase Increased 33 2.3 2.3 signal
216 Rotator Cuff Syndrome 8 2.3 2.3 signal
217 Skin Ulcer 16 2.3 2.3 signal
218 Irritability 37 2.3 2.3 signal
219 Constipation 132 2.3 2.3 signal
220 Ligament Sprain 6 2.2 2.2 no signal
221 Insurance Issue 9 2.2 2.2 signal
222 Anhedonia 16 2.2 2.2 signal
223 Coagulopathy 10 2.2 2.2 signal
224 Hypotonia 6 2.2 2.2 no signal
225 Spinal Pain 7 2.2 2.2 no signal
226 Pneumonitis 16 2.2 2.2 signal
227 Eyelid Ptosis 6 2.2 2.2 no signal
228 Plasma Cell Myeloma 23 2.2 2.2 signal
229 Chills 69 2.2 2.2 signal
230 Ataxia 7 2.2 2.2 no signal
231 Tooth Abscess 6 2.2 2.2 no signal
232 Blood Creatine Phosphokinase Increased 17 2.1 2.2 signal
233 Bursitis 7 2.1 2.1 no signal
234 Glomerular Filtration Rate Decreased 7 2.1 2.1 no signal
235 Tooth Loss 12 2.1 2.1 signal
236 Syringe Issue 10 2.1 2.1 signal
237 Metastases To Liver 10 2.1 2.1 signal
238 Multi-organ Failure 10 2.1 2.1 signal
239 Malignant Neoplasm Progression 58 2.1 2.1 signal
240 Pain In Jaw 16 2.1 2.1 signal
241 Pharyngitis 7 2.1 2.1 no signal
242 Osteonecrosis Of Jaw 14 2.1 2.1 signal
243 Cholelithiasis 18 2.0 2.0 signal
244 Vomiting 256 2.0 2.1 signal
245 Tuberculosis 7 2.0 2.0 no signal
246 Nervous System Disorder 17 2.0 2.0 signal
247 Pancreatitis Acute 12 2.0 2.0 no signal
248 Hyperhidrosis 69 2.0 2.0 no signal
249 Dyspnoea Exertional 20 2.0 2.0 no signal
250 Fistula 6 2.0 2.0 no signal
251 Therapy Partial Responder 8 2.0 2.0 no signal
252 Squamous Cell Carcinoma 5 2.0 2.0 no signal
253 Dermatitis Contact 6 2.0 2.0 no signal
254 Impaired Driving Ability 6 1.9 2.0 no signal
255 Autoimmune Disorder 5 1.9 1.9 no signal
256 International Normalised Ratio Increased 15 1.9 1.9 no signal
257 Epistaxis 39 1.9 1.9 no signal
258 Jaundice 14 1.9 1.9 no signal
259 Joint Injury 11 1.9 1.9 no signal
260 Pallor 14 1.9 1.9 no signal
261 Dysstasia 15 1.9 1.9 no signal
262 Salivary Hypersecretion 5 1.9 1.9 no signal
263 Haematoma 13 1.8 1.8 no signal
264 Contraindicated Product Administered 15 1.8 1.8 no signal
265 Neuropathy Peripheral 47 1.8 1.8 no signal
266 Ovarian Cyst 5 1.8 1.8 no signal
267 Migraine 47 1.8 1.8 no signal
268 Mental Impairment 12 1.8 1.8 no signal
269 Restless Legs Syndrome 9 1.8 1.8 no signal
270 Dialysis 7 1.8 1.8 no signal
271 Inappropriate Antidiuretic Hormone Secretion 5 1.8 1.8 no signal
272 Neutrophil Count Increased 5 1.8 1.8 no signal
273 Libido Decreased 6 1.8 1.8 no signal
274 Hypokinesia 7 1.8 1.8 no signal
275 Mental Disorder 21 1.8 1.8 no signal
276 Cytomegalovirus Infection 8 1.8 1.8 no signal
277 Disturbance In Attention 26 1.8 1.8 no signal
278 Skin Lesion 13 1.8 1.8 no signal
279 Psychotic Disorder 14 1.8 1.8 no signal
280 Foot Fracture 9 1.8 1.8 no signal
281 Renal Pain 5 1.7 1.8 no signal
282 Abdominal Pain Lower 12 1.7 1.8 no signal
283 Acute Myocardial Infarction 14 1.7 1.8 no signal
284 Clostridium Difficile Infection 10 1.7 1.7 no signal
285 Gastrointestinal Pain 5 1.7 1.7 no signal
286 Haematochezia 25 1.7 1.7 no signal
287 Fibromyalgia 11 1.7 1.7 no signal
288 Medication Error 25 1.7 1.7 no signal
289 Exposure During Pregnancy 28 1.7 1.7 no signal
290 Intentional Self-injury 9 1.6 1.7 no signal
291 Toothache 8 1.6 1.6 no signal
292 Anger 15 1.6 1.6 no signal
293 Renal Failure Acute 19 1.6 1.6 no signal
294 Chronic Obstructive Pulmonary Disease 23 1.6 1.6 no signal
295 Abscess 7 1.6 1.6 no signal
296 Blood Lactate Dehydrogenase Increased 7 1.6 1.6 no signal
297 Gingival Bleeding 6 1.6 1.6 no signal
298 Drug Ineffective 568 1.6 1.7 no signal
299 Oral Discomfort 6 1.6 1.6 no signal
300 Personality Change 4 1.6 1.6 no signal
301 Carpal Tunnel Syndrome 6 1.6 1.6 no signal
302 Tremor 71 1.6 1.6 no signal
303 Osteonecrosis 14 1.6 1.6 no signal
304 Product Prescribing Error 10 1.6 1.6 no signal
305 Leukopenia 21 1.6 1.6 no signal
306 Neuroleptic Malignant Syndrome 5 1.6 1.6 no signal
307 Impaired Quality Of Life 6 1.5 1.5 no signal
308 Menstruation Irregular 11 1.5 1.5 no signal
309 Localised Infection 10 1.5 1.5 no signal
310 Hepatic Cytolysis 5 1.5 1.5 no signal
311 Product Administration Error 8 1.5 1.5 no signal
312 Intestinal Obstruction 15 1.5 1.5 no signal
313 Diabetes Mellitus Inadequate Control 7 1.5 1.5 no signal
314 Lymphoma 6 1.4 1.4 no signal
315 Swollen Tongue 12 1.4 1.4 no signal
316 Hallucination, Auditory 6 1.4 1.4 no signal
317 Mood Swings 12 1.4 1.4 no signal
318 Sudden Death 4 1.4 1.4 no signal
319 Interstitial Lung Disease 18 1.4 1.4 no signal
320 Neutrophil Count Decreased 15 1.4 1.4 no signal
321 Completed Suicide 31 1.4 1.4 no signal
322 Cerebral Infarction 9 1.4 1.4 no signal
323 Cholestasis 7 1.4 1.4 no signal
324 Bipolar Disorder 4 1.4 1.4 no signal
325 Disease Progression 43 1.3 1.4 no signal
326 Central Nervous System Lesion 5 1.3 1.3 no signal
327 Drug Prescribing Error 7 1.3 1.3 no signal
328 Nephropathy Toxic 4 1.3 1.3 no signal
329 Full Blood Count Decreased 7 1.3 1.3 no signal
330 Gastric Haemorrhage 4 1.3 1.3 no signal
331 Rash Generalised 9 1.3 1.3 no signal
332 Bone Marrow Failure 7 1.3 1.3 no signal
333 Suicidal Ideation 31 1.3 1.3 no signal
334 Cytopenia 4 1.2 1.2 no signal
335 Intentional Drug Misuse 7 1.2 1.2 no signal
336 Device Failure 5 1.2 1.2 no signal
337 Emotional Distress 40 1.2 1.2 no signal
338 Brain Neoplasm 3 1.2 1.2 no signal
339 Abnormal Behaviour 13 1.2 1.2 no signal
340 Deformity 3 1.2 1.2 no signal
341 Extrapyramidal Disorder 8 1.2 1.2 no signal
342 Neoplasm Progression 11 1.2 1.2 no signal
343 Thrombotic Microangiopathy 3 1.1 1.1 no signal
344 Coeliac Disease 3 1.1 1.1 no signal
345 Inability To Afford Medication 3 1.1 1.1 no signal
346 Pneumocystis Jirovecii Pneumonia 3 1.1 1.1 no signal
347 Neoplasm Malignant 20 1.1 1.1 no signal
348 Product Dose Omission In Error 8 1.1 1.1 no signal
349 Angioedema 13 1.1 1.1 no signal
350 Drug Level Decreased 3 1.1 1.1 no signal
351 Convulsion 17 1.1 1.1 no signal
352 Akathisia 4 1.1 1.1 no signal
353 Death 251 1.1 1.1 no signal
354 Femur Fracture 9 1.1 1.1 no signal
355 Procedural Pain 8 1.1 1.1 no signal
356 Myelodysplastic Syndrome 4 1.0 1.0 no signal
357 Therapy Interrupted 19 1.0 1.0 no signal
358 Gastric Cancer 7 1.0 1.0 no signal
359 Vaginal Haemorrhage 11 1.0 1.0 no signal
360 Acute Myeloid Leukaemia 4 0.9 0.9 no signal
361 Bone Density Decreased 8 0.9 0.9 no signal
362 Diabetic Ketoacidosis 6 0.9 0.9 no signal
363 Device Defective 4 0.9 0.9 no signal
364 Hepatitis C 3 0.9 0.9 no signal
365 Intraocular Pressure Increased 3 0.9 0.9 no signal
366 Drug Administration Error 7 0.8 0.8 no signal
367 Sopor 3 0.8 0.8 no signal
368 Pancreatic Carcinoma 6 0.8 0.8 no signal
369 Bone Loss 3 0.7 0.7 no signal
370 Product Preparation Error 4 0.7 0.7 no signal
371 Device Delivery System Issue 5 0.7 0.7 no signal
372 Drug Effect Incomplete 7 0.7 0.7 no signal
373 Multiple Sclerosis Relapse 13 0.7 0.7 no signal
374 Needle Issue 5 0.6 0.6 no signal
375 Psoriatic Arthropathy 7 0.6 0.6 no signal
376 Abortion Spontaneous 7 0.6 0.6 no signal
377 Drug Effective For Unapproved Indication 5 0.6 0.6 no signal
378 Palmar-plantar Erythrodysaesthesia Syndrome 4 0.6 0.6 no signal
379 Dependence 9 0.6 0.6 no signal
380 Multiple Sclerosis 7 0.5 0.5 no signal
381 Device Dislocation 5 0.4 0.4 no signal
382 Breast Cancer Female 3 0.4 0.4 no signal
383 Device Issue 9 0.4 0.4 no signal
384 Dermatitis Atopic 5 0.4 0.4 no signal
385 Accidental Exposure To Product 9 0.3 0.3 no signal
386 Device Breakage 3 0.3 0.3 no signal
387 Drug Dose Omission By Device 4 0.2 0.2 no signal