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Drug

Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hbr

408 flagged reaction(s) · 18,616 total co-reports · max PRR 79.5
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 Helicobacter Infection 123 79.5 82.6 signal
2 Folliculitis 124 79.1 82.2 signal
3 Pemphigus 123 65.0 67.6 signal
4 Hand Deformity 125 62.8 65.3 signal
5 Pericarditis 137 53.9 56.3 signal
6 Hypercholesterolaemia 71 48.6 49.7 signal
7 Synovitis 128 46.5 48.4 signal
8 Joint Range Of Motion Decreased 87 42.6 43.8 signal
9 Bursitis 72 39.1 39.9 signal
10 Glossodynia 125 36.6 38.0 signal
11 Wound Infection 60 36.1 36.8 signal
12 Irritable Bowel Syndrome 112 34.3 35.5 signal
13 Autoimmune Disorder 47 32.1 32.6 signal
14 Wound 135 31.7 33.1 signal
15 Systemic Lupus Erythematosus 164 30.3 31.9 signal
16 Fibromyalgia 102 27.4 28.3 signal
17 Impaired Healing 133 26.5 27.6 signal
18 Liver Injury 97 26.2 27.0 signal
19 Obesity 62 25.4 25.9 signal
20 Sciatica 58 23.9 24.3 signal
21 Red Blood Cell Sedimentation Rate Increased 39 23.0 23.2 signal
22 Affect Lability 34 23.0 23.2 signal
23 Type 2 Diabetes Mellitus 115 22.2 23.0 signal
24 Lower Respiratory Tract Infection 149 21.5 22.5 signal
25 Liver Function Test Increased 69 21.1 21.6 signal
26 Lower Limb Fracture 56 19.1 19.5 signal
27 Psoriatic Arthropathy 117 19.0 19.7 signal
28 Coeliac Disease 27 17.9 18.1 signal
29 Delirium 93 17.5 18.0 signal
30 Prescribed Overdose 50 16.9 17.1 signal
31 Gait Inability 85 16.8 17.2 signal
32 Pulmonary Fibrosis 49 16.7 17.0 signal
33 Apathy 37 16.6 16.8 signal
34 C-reactive Protein Increased 89 16.0 16.4 signal
35 Infusion Related Reaction 157 15.5 16.2 signal
36 Joint Dislocation 25 15.5 15.6 signal
37 Back Injury 25 15.1 15.2 signal
38 Blood Cholesterol Increased 105 14.7 15.1 signal
39 Contraindicated Product Administered 67 14.5 14.8 signal
40 Osteoarthritis 91 14.0 14.3 signal
41 Arthropathy 118 13.8 14.3 signal
42 Night Sweats 68 13.8 14.0 signal
43 Blister 118 13.7 14.2 signal
44 Hepatic Enzyme Increased 142 13.6 14.2 signal
45 Foot Deformity 23 13.5 13.6 signal
46 Mobility Decreased 145 13.2 13.8 signal
47 Schizophrenia 24 12.9 13.0 signal
48 Discomfort 119 12.8 13.3 signal
49 Head Discomfort 34 12.6 12.7 signal
50 Immunodeficiency 27 11.9 12.0 signal
51 Ill-defined Disorder 111 11.9 12.3 signal
52 Nightmare 62 11.6 11.8 signal
53 Stomatitis 105 11.3 11.6 signal
54 Injury 121 11.2 11.6 signal
55 General Physical Health Deterioration 196 11.1 11.8 signal
56 Wheezing 100 11.0 11.3 signal
57 Liver Disorder 74 10.9 11.1 signal
58 Inflammation 85 10.8 11.1 signal
59 Swelling 154 10.7 11.2 signal
60 Blood Iron Decreased 19 10.5 10.6 signal
61 Hepatic Cirrhosis 30 10.5 10.5 signal
62 Squamous Cell Carcinoma 15 10.4 10.4 signal
63 Sleep Disorder 111 10.3 10.7 signal
64 Pregnancy 32 10.3 10.4 signal
65 Motor Dysfunction 16 10.3 10.4 signal
66 Laryngitis 17 10.2 10.3 signal
67 Frequent Bowel Movements 42 10.2 10.3 signal
68 Taste Disorder 31 10.1 10.2 signal
69 Confusional State 250 10.1 10.8 signal
70 Impaired Quality Of Life 22 10.0 10.0 signal
71 Musculoskeletal Pain 80 9.9 10.1 signal
72 Lung Disorder 74 9.8 10.1 signal
73 Urinary Retention 49 9.6 9.7 signal
74 Prescribed Underdose 29 9.5 9.6 signal
75 Oedema 78 9.4 9.6 signal
76 Musculoskeletal Stiffness 126 9.4 9.7 signal
77 Sedation 37 9.2 9.3 signal
78 Contusion 136 9.2 9.6 signal
79 Gastrointestinal Disorder 125 9.2 9.5 signal
80 Urosepsis 13 9.2 9.2 signal
81 Road Traffic Accident 59 9.2 9.3 signal
82 Rheumatoid Arthritis 157 9.0 9.5 signal
83 Loss Of Personal Independence In Daily Activities 66 9.0 9.2 signal
84 Bedridden 18 8.9 9.0 signal
85 Muscle Spasticity 17 8.9 9.0 signal
86 Joint Swelling 160 8.7 9.1 signal
87 Poor Quality Sleep 28 8.5 8.6 signal
88 Dry Mouth 101 8.1 8.4 signal
89 Drug-induced Liver Injury 38 8.0 8.1 signal
90 Liver Function Test Abnormal 36 8.0 8.1 signal
91 Tubulointerstitial Nephritis 23 8.0 8.1 signal
92 Medication Error 68 8.0 8.1 signal
93 Adverse Reaction 16 7.9 7.9 signal
94 Pneumonitis 32 7.7 7.8 signal
95 Hepatitis 30 7.6 7.7 signal
96 Therapeutic Product Effect Decreased 51 7.5 7.6 signal
97 Intentional Product Use Issue 99 7.3 7.5 signal
98 Maternal Exposure During Pregnancy 99 7.3 7.5 signal
99 Hip Arthroplasty 17 7.3 7.3 signal
100 Rectal Haemorrhage 48 7.3 7.3 signal
101 Exposure During Pregnancy 69 7.2 7.4 signal
102 Knee Arthroplasty 23 7.2 7.2 signal
103 Encephalopathy 27 7.2 7.2 signal
104 Vertigo 67 7.2 7.3 signal
105 Sinusitis 110 7.0 7.2 signal
106 Neutrophil Count Increased 11 7.0 7.0 signal
107 Hypertension 225 6.9 7.4 signal
108 Myocarditis 12 6.9 6.9 signal
109 Throat Tightness 28 6.8 6.8 signal
110 Splenomegaly 12 6.7 6.7 signal
111 Lymphocyte Count Decreased 18 6.6 6.7 signal
112 Hyponatraemia 57 6.6 6.7 signal
113 Bladder Disorder 10 6.5 6.6 signal
114 Fracture 19 6.5 6.6 signal
115 Migraine 95 6.5 6.7 signal
116 Epilepsy 30 6.4 6.5 signal
117 Hypoaesthesia 147 6.4 6.6 signal
118 Iron Deficiency Anaemia 9 6.4 6.4 signal
119 Ear Infection 26 6.4 6.4 signal
120 Skin Haemorrhage 14 6.3 6.3 signal
121 Abdominal Discomfort 160 6.2 6.5 signal
122 Infection 138 6.2 6.5 signal
123 Restlessness 35 6.2 6.3 signal
124 Pallor 26 6.2 6.2 signal
125 Cytokine Release Syndrome 18 6.2 6.2 signal
126 Hypersensitivity 175 6.1 6.4 signal
127 Colitis Ulcerative 42 6.1 6.2 signal
128 Hemiparesis 16 6.1 6.1 signal
129 Neck Pain 52 6.1 6.1 signal
130 Back Disorder 15 6.0 6.0 signal
131 Pyrexia 315 5.9 6.5 signal
132 Emphysema 9 5.8 5.8 signal
133 Sinus Congestion 12 5.8 5.8 signal
134 Respiratory Tract Congestion 14 5.7 5.8 signal
135 Oxygen Saturation Decreased 49 5.7 5.8 signal
136 Sleep Disorder Due To A General Medical Condition 14 5.6 5.7 signal
137 Swollen Tongue 27 5.6 5.7 signal
138 Drug Intolerance 83 5.6 5.7 signal
139 Febrile Neutropenia 57 5.6 5.7 signal
140 Cognitive Disorder 40 5.6 5.7 signal
141 Haemoglobin Decreased 88 5.6 5.7 signal
142 Hypokalaemia 39 5.5 5.6 signal
143 Platelet Count Increased 11 5.5 5.5 signal
144 Breast Cancer Metastatic 9 5.5 5.5 signal
145 Joint Stiffness 22 5.5 5.5 signal
146 Peripheral Swelling 128 5.4 5.6 signal
147 Incorrect Route Of Product Administration 14 5.4 5.4 signal
148 Oral Herpes 16 5.4 5.4 signal
149 Gamma-glutamyltransferase Increased 18 5.3 5.3 signal
150 Nasopharyngitis 148 5.2 5.4 signal
151 Angina Pectoris 23 5.2 5.2 signal
152 Amnesia 52 5.2 5.3 signal
153 Oedema Peripheral 97 5.2 5.3 signal
154 Treatment Failure 64 5.1 5.2 signal
155 Dyspepsia 76 5.0 5.1 signal
156 Musculoskeletal Chest Pain 12 5.0 5.1 signal
157 Arthritis 61 5.0 5.1 signal
158 Ear Pain 15 5.0 5.0 signal
159 Oral Candidiasis 10 5.0 5.0 signal
160 Red Blood Cell Count Decreased 22 5.0 5.0 signal
161 Accidental Overdose 28 5.0 5.0 signal
162 Paraesthesia Oral 11 5.0 5.0 signal
163 Therapy Non-responder 34 5.0 5.0 signal
164 Hyperthyroidism 11 5.0 5.0 signal
165 Incontinence 8 4.9 4.9 signal
166 Blood Creatine Phosphokinase Increased 22 4.9 4.9 signal
167 Haematocrit Decreased 15 4.9 4.9 signal
168 Impaired Work Ability 16 4.9 4.9 signal
169 Malignant Melanoma 10 4.9 4.9 signal
170 Urticaria 124 4.9 5.0 signal
171 Glomerular Filtration Rate Decreased 9 4.8 4.8 signal
172 Lethargy 42 4.8 4.8 signal
173 Osteoporosis 30 4.7 4.8 signal
174 Hernia 14 4.7 4.8 signal
175 Decreased Appetite 168 4.7 4.9 signal
176 Decreased Immune Responsiveness 7 4.7 4.7 signal
177 Coordination Abnormal 10 4.6 4.6 signal
178 Disability 14 4.6 4.6 signal
179 Muscular Weakness 80 4.6 4.7 signal
180 Alopecia 137 4.5 4.7 signal
181 Asthma 78 4.5 4.6 signal
182 Haematochezia 38 4.5 4.5 signal
183 Diverticulitis 19 4.5 4.5 signal
184 Body Temperature Increased 14 4.5 4.5 signal
185 Pain In Extremity 200 4.4 4.6 signal
186 Atrial Fibrillation 66 4.4 4.5 signal
187 Urinary Incontinence 20 4.4 4.4 signal
188 Metastases To Bone 11 4.4 4.4 signal
189 Respiratory Disorder 20 4.3 4.4 signal
190 Mouth Ulceration 14 4.3 4.3 signal
191 Haemorrhoids 13 4.3 4.3 signal
192 Gastrooesophageal Reflux Disease 53 4.3 4.4 signal
193 Neuralgia 16 4.3 4.3 signal
194 Chest Pain 122 4.3 4.4 signal
195 Eating Disorder 14 4.3 4.3 signal
196 Upper Gastrointestinal Haemorrhage 11 4.2 4.3 signal
197 Weight Increased 144 4.2 4.4 signal
198 Appendicitis 6 4.2 4.2 signal
199 Intervertebral Disc Degeneration 6 4.2 4.2 signal
200 Pharyngitis 8 4.2 4.2 signal
201 Rib Fracture 13 4.1 4.1 signal
202 Hepatic Failure 19 4.1 4.1 signal
203 Hyperhidrosis 81 4.1 4.2 signal
204 Aphasia 19 4.1 4.1 signal
205 Blood Lactate Dehydrogenase Increased 10 4.1 4.1 signal
206 Condition Aggravated 187 4.0 4.2 signal
207 Haematoma 16 4.0 4.0 signal
208 Limb Discomfort 19 4.0 4.0 signal
209 Dysarthria 23 4.0 4.0 signal
210 Colitis 23 4.0 4.0 signal
211 Sinus Disorder 12 3.9 4.0 signal
212 Stress 43 3.9 3.9 signal
213 Suicide Attempt 36 3.9 3.9 signal
214 Hepatic Steatosis 11 3.8 3.9 signal
215 Photophobia 11 3.8 3.8 signal
216 Temperature Intolerance 6 3.8 3.8 signal
217 Tinnitus 27 3.8 3.8 signal
218 Haematuria 20 3.8 3.8 signal
219 Hypocalcaemia 11 3.8 3.8 signal
220 Ventricular Extrasystoles 6 3.8 3.8 signal
221 Acute Myocardial Infarction 17 3.7 3.8 signal
222 Respiratory Depression 7 3.7 3.7 signal
223 Paraesthesia 90 3.7 3.8 signal
224 Lymphopenia 8 3.7 3.7 signal
225 Nephrolithiasis 26 3.7 3.7 signal
226 Hypercalcaemia 7 3.7 3.7 signal
227 Choking 11 3.7 3.7 signal
228 Abdominal Pain Upper 116 3.7 3.8 signal
229 Mood Swings 18 3.7 3.7 signal
230 Bone Pain 33 3.7 3.7 signal
231 Sensory Disturbance 9 3.6 3.6 signal
232 Pulmonary Oedema 25 3.6 3.7 signal
233 Spinal Fracture 11 3.6 3.6 signal
234 Fall 182 3.6 3.7 signal
235 Drug Hypersensitivity 106 3.6 3.6 signal
236 Blood Glucose Fluctuation 6 3.6 3.6 signal
237 Ascites 16 3.5 3.6 signal
238 Nervous System Disorder 17 3.5 3.5 signal
239 Nerve Compression 5 3.5 3.5 signal
240 Blood Thyroid Stimulating Hormone Increased 5 3.5 3.5 signal
241 Cardiomyopathy 8 3.5 3.5 signal
242 Ovarian Cancer 5 3.5 3.5 signal
243 Dehydration 72 3.5 3.6 signal
244 Diplopia 14 3.5 3.5 signal
245 Palpitations 63 3.5 3.6 signal
246 Eczema 27 3.5 3.5 signal
247 Sneezing 12 3.5 3.5 signal
248 Anxiety 153 3.5 3.6 signal
249 Product Use In Unapproved Indication 131 3.5 3.6 signal
250 Hypoacusis 23 3.5 3.5 signal
251 Rash 232 3.5 3.7 signal
252 Muscle Spasms 98 3.5 3.6 signal
253 Blood Calcium Decreased 6 3.5 3.5 signal
254 Chromaturia 12 3.5 3.5 signal
255 Arthralgia 220 3.5 3.6 signal
256 Chills 62 3.4 3.5 signal
257 Pulmonary Embolism 50 3.4 3.4 signal
258 Memory Impairment 72 3.4 3.5 signal
259 Pharyngeal Swelling 5 3.4 3.4 signal
260 Feeling Hot 32 3.4 3.4 signal
261 Malaise 229 3.4 3.6 signal
262 Thrombocytopenia 58 3.4 3.4 signal
263 Retching 11 3.4 3.4 signal
264 Depression 118 3.4 3.5 signal
265 Sinus Bradycardia 5 3.4 3.4 signal
266 Cellulitis 26 3.4 3.4 signal
267 Femur Fracture 16 3.4 3.4 signal
268 Basal Cell Carcinoma 8 3.3 3.3 signal
269 Gait Disturbance 98 3.3 3.4 signal
270 Pancreatitis 27 3.3 3.3 signal
271 Chest Discomfort 52 3.3 3.4 signal
272 Lung Infection 8 3.3 3.3 signal
273 Deep Vein Thrombosis 33 3.3 3.3 signal
274 Pain 310 3.3 3.5 signal
275 Cytopenia 6 3.3 3.3 signal
276 Intentional Overdose 32 3.3 3.3 signal
277 Feeling Cold 14 3.3 3.3 signal
278 Intervertebral Disc Protrusion 11 3.3 3.3 signal
279 Gout 9 3.3 3.3 signal
280 Dyspnoea 283 3.3 3.5 signal
281 Blood Test Abnormal 7 3.2 3.3 signal
282 Vaginal Discharge 5 3.2 3.2 signal
283 Toothache 9 3.2 3.2 signal
284 Injection Site Reaction 34 3.2 3.2 signal
285 Mental Impairment 12 3.2 3.2 signal
286 Myelodysplastic Syndrome 7 3.1 3.2 signal
287 Insomnia 129 3.1 3.2 signal
288 Headache 301 3.1 3.3 signal
289 Tooth Loss 10 3.1 3.1 signal
290 Hereditary Angioedema 5 3.1 3.1 signal
291 Renal Pain 5 3.1 3.1 signal
292 Gastric Ulcer 9 3.1 3.1 signal
293 Blood Urine Present 9 3.1 3.1 signal
294 Intentional Product Misuse 41 3.1 3.1 signal
295 Syncope 47 3.1 3.1 signal
296 Cystitis 15 3.1 3.1 signal
297 Arrhythmia 22 3.0 3.0 signal
298 Hypersomnia 13 3.0 3.0 signal
299 Fluid Retention 23 2.9 3.0 signal
300 Feeding Disorder 9 2.9 2.9 signal
301 Acute Myeloid Leukaemia 7 2.9 2.9 signal
302 Sars-cov-2 Test Positive 6 2.9 2.9 signal
303 Abortion Spontaneous 18 2.9 2.9 signal
304 Dysgeusia 33 2.9 2.9 signal
305 Pelvic Pain 8 2.9 2.9 signal
306 Rhinorrhoea 28 2.8 2.8 signal
307 Neoplasm 5 2.8 2.8 signal
308 Device Occlusion 6 2.8 2.8 signal
309 Dementia 12 2.8 2.8 signal
310 Rash Macular 15 2.8 2.8 signal
311 Spinal Pain 5 2.8 2.8 signal
312 Photosensitivity Reaction 7 2.8 2.8 signal
313 Adverse Drug Reaction 38 2.8 2.8 signal
314 Product Use Issue 79 2.8 2.8 signal
315 Spinal Disorder 4 2.7 2.7 no signal
316 Posterior Reversible Encephalopathy Syndrome 4 2.7 2.7 no signal
317 Bronchospasm 6 2.7 2.7 signal
318 Skin Discolouration 19 2.7 2.7 signal
319 Parkinsonism 4 2.7 2.7 no signal
320 Circulatory Collapse 7 2.7 2.7 signal
321 Cerebral Infarction 10 2.7 2.7 signal
322 Melaena 9 2.7 2.7 signal
323 Fluid Overload 6 2.6 2.6 signal
324 Secretion Discharge 5 2.6 2.6 no signal
325 Movement Disorder 13 2.6 2.6 signal
326 Rash Papular 9 2.6 2.6 signal
327 Cold Sweat 7 2.6 2.6 signal
328 Delusion 6 2.5 2.5 signal
329 Ejection Fraction Decreased 6 2.5 2.5 signal
330 Neutropenia 52 2.5 2.5 signal
331 Unintended Pregnancy 4 2.5 2.5 no signal
332 Deafness 10 2.5 2.5 signal
333 Transfusion 4 2.5 2.5 no signal
334 Product Prescribing Error 9 2.5 2.5 signal
335 Immune System Disorder 5 2.5 2.5 no signal
336 Hallucination 28 2.4 2.4 signal
337 Dyskinesia 15 2.4 2.4 signal
338 Cerebrovascular Accident 62 2.4 2.4 signal
339 Anaphylactic Reaction 20 2.4 2.4 signal
340 Aggression 18 2.3 2.3 signal
341 Nerve Injury 4 2.3 2.3 no signal
342 Hypertensive Crisis 4 2.3 2.3 no signal
343 Abdominal Pain Lower 9 2.3 2.3 signal
344 Transient Ischaemic Attack 12 2.3 2.3 signal
345 Influenza Like Illness 29 2.3 2.3 signal
346 Metastases To Lung 4 2.3 2.3 no signal
347 Laboratory Test Abnormal 10 2.2 2.2 signal
348 Blood Triglycerides Increased 6 2.2 2.2 no signal
349 Psoriasis 44 2.2 2.2 signal
350 Neuroleptic Malignant Syndrome 4 2.2 2.2 no signal
351 Macular Degeneration 4 2.2 2.2 no signal
352 Wrist Fracture 4 2.2 2.2 no signal
353 Increased Tendency To Bruise 3 2.1 2.1 no signal
354 Skin Cancer 7 2.1 2.1 no signal
355 Tendon Rupture 4 2.1 2.1 no signal
356 Drug Dispensing Error 5 2.1 2.1 no signal
357 Erythema Multiforme 3 2.1 2.1 no signal
358 Tendonitis 5 2.1 2.1 no signal
359 Pharyngeal Oedema 5 2.1 2.1 no signal
360 Deformity 3 2.1 2.1 no signal
361 Hair Colour Changes 4 2.1 2.1 no signal
362 Product Availability Issue 7 2.0 2.0 no signal
363 Hip Fracture 10 2.0 2.0 signal
364 Ankylosing Spondylitis 4 2.0 2.0 no signal
365 Abnormal Behaviour 12 2.0 2.0 no signal
366 Ovarian Cyst 3 1.9 1.9 no signal
367 Hunger 4 1.9 1.9 no signal
368 Uveitis 4 1.9 1.9 no signal
369 Angioedema 13 1.9 1.9 no signal
370 Multiple Sclerosis 14 1.9 1.9 no signal
371 Metastases To Liver 5 1.9 1.9 no signal
372 Overdose 58 1.7 1.8 no signal
373 Haemorrhage Intracranial 4 1.7 1.7 no signal
374 Malignant Neoplasm Progression 27 1.7 1.7 no signal
375 Drug Abuse 22 1.7 1.7 no signal
376 Madarosis 3 1.7 1.7 no signal
377 Menorrhagia 5 1.6 1.6 no signal
378 Thyroid Cancer 3 1.6 1.6 no signal
379 Incorrect Product Administration Duration 5 1.6 1.6 no signal
380 Multiple Sclerosis Relapse 17 1.6 1.6 no signal
381 Injection Site Discolouration 3 1.6 1.6 no signal
382 Cytomegalovirus Infection 4 1.6 1.6 no signal
383 Poisoning 3 1.5 1.5 no signal
384 Metastases To Central Nervous System 3 1.5 1.5 no signal
385 Complication Associated With Device 3 1.5 1.5 no signal
386 Product Quality Issue 30 1.4 1.5 no signal
387 Hair Texture Abnormal 3 1.4 1.4 no signal
388 Blood Glucose Abnormal 4 1.4 1.4 no signal
389 Tardive Dyskinesia 6 1.4 1.4 no signal
390 Osteonecrosis Of Jaw 5 1.3 1.3 no signal
391 Product Adhesion Issue 7 1.3 1.3 no signal
392 Acne 14 1.2 1.2 no signal
393 Multiple Fractures 3 1.2 1.2 no signal
394 Drug Exposure During Pregnancy 6 1.1 1.1 no signal
395 Vaginal Haemorrhage 7 1.1 1.1 no signal
396 Gynaecomastia 5 1.0 1.0 no signal
397 Drug Prescribing Error 3 1.0 1.0 no signal
398 Wrong Technique In Drug Usage Process 5 0.9 0.9 no signal
399 Product Complaint 3 0.8 0.8 no signal
400 Myelosuppression 4 0.8 0.8 no signal
401 Breast Cancer 11 0.8 0.8 no signal
402 Device Dislocation 5 0.7 0.7 no signal
403 Incorrect Route Of Drug Administration 4 0.7 0.7 no signal
404 Incorrect Drug Administration Duration 3 0.7 0.7 no signal
405 Device Breakage 4 0.7 0.7 no signal
406 Drug Withdrawal Syndrome 7 0.5 0.5 no signal
407 Prostate Cancer 6 0.5 0.5 no signal
408 Device Leakage 3 0.5 0.5 no signal