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Drug

Acetaminophen, Aspirin (nsaid), And Caffeine

363 flagged reaction(s) · 11,317 total co-reports · max PRR 13.4
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 Effective For Unapproved Indication 133 13.4 13.7 signal
2 Ulcer 52 9.6 9.7 signal
3 Migraine 264 8.2 8.5 signal
4 Gastric Disorder 77 6.5 6.6 signal
5 Gastric Ulcer 42 6.5 6.5 signal
6 Gastric Haemorrhage 25 6.3 6.4 signal
7 Feeling Jittery 41 6.3 6.3 signal
8 Therapeutic Response Unexpected 89 5.8 5.9 signal
9 End Stage Renal Disease 31 4.9 5.0 signal
10 Contraindicated Product Administered 47 4.6 4.6 signal
11 Drug Ineffective 2,009 4.5 5.8 signal
12 Drug Effect Incomplete 55 4.4 4.4 signal
13 Chronic Kidney Disease 111 4.3 4.3 signal
14 Drug Administration Error 45 4.2 4.3 signal
15 Vitamin D Deficiency 14 4.2 4.2 signal
16 Drug Ineffective For Unapproved Indication 80 4.2 4.3 signal
17 Product Physical Issue 28 4.1 4.1 signal
18 Drug Effect Less Than Expected 18 3.8 3.8 signal
19 Poor Quality Sleep 27 3.7 3.7 signal
20 Tooth Fracture 13 3.5 3.5 signal
21 Product Quality Issue 148 3.2 3.3 signal
22 Dental Caries 12 3.2 3.2 signal
23 Initial Insomnia 11 3.2 3.2 signal
24 Product Use In Unapproved Indication 262 3.2 3.2 signal
25 Tubulointerstitial Nephritis 20 3.1 3.1 signal
26 Impaired Driving Ability 12 3.1 3.1 signal
27 Incorrect Drug Administration Duration 30 3.1 3.1 signal
28 Abdominal Discomfort 170 3.0 3.0 signal
29 Sinus Disorder 20 3.0 3.0 signal
30 Bladder Disorder 10 3.0 3.0 signal
31 Seasonal Allergy 14 2.9 2.9 signal
32 Brain Neoplasm 9 2.9 2.9 signal
33 Micturition Urgency 11 2.8 2.9 signal
34 Dysmenorrhoea 12 2.7 2.7 signal
35 Gastrointestinal Pain 10 2.7 2.7 signal
36 Ovarian Cyst 9 2.6 2.6 signal
37 Abdominal Pain Upper 183 2.6 2.7 signal
38 Euphoric Mood 9 2.6 2.6 signal
39 Increased Tendency To Bruise 8 2.5 2.6 signal
40 Headache 543 2.5 2.7 signal
41 Hypoaesthesia Oral 13 2.5 2.5 signal
42 Transfusion 9 2.5 2.5 signal
43 Laceration 8 2.5 2.5 signal
44 Paraesthesia Oral 12 2.5 2.5 signal
45 Pain In Jaw 23 2.4 2.4 signal
46 Muscle Tightness 13 2.4 2.4 signal
47 Extra Dose Administered 32 2.4 2.4 signal
48 Intentional Product Misuse 69 2.3 2.3 signal
49 Liver Disorder 35 2.3 2.3 signal
50 Tinnitus 36 2.3 2.3 signal
51 Therapeutic Product Effect Incomplete 55 2.3 2.3 signal
52 Limb Injury 21 2.3 2.3 signal
53 Product Use Complaint 12 2.3 2.3 signal
54 Toothache 14 2.3 2.3 signal
55 Insomnia 204 2.2 2.3 signal
56 Drug Dependence 122 2.2 2.2 signal
57 Photophobia 14 2.2 2.2 signal
58 Quality Of Life Decreased 10 2.2 2.2 signal
59 Spinal Operation 9 2.2 2.2 signal
60 Dyspepsia 72 2.2 2.2 signal
61 Hypersomnia 21 2.2 2.2 signal
62 Renal Injury 22 2.2 2.2 signal
63 Product Complaint 18 2.1 2.1 signal
64 Infusion Site Pain 9 2.1 2.1 no signal
65 Product Substitution Issue 40 2.0 2.0 signal
66 Hiatus Hernia 9 2.0 2.0 no signal
67 Sciatica 11 2.0 2.0 signal
68 Incorrect Product Administration Duration 14 2.0 2.0 signal
69 Intervertebral Disc Protrusion 15 2.0 2.0 signal
70 Product Odour Abnormal 7 2.0 2.0 no signal
71 Macular Degeneration 8 2.0 2.0 no signal
72 Tooth Disorder 15 2.0 2.0 no signal
73 Ear Pain 13 2.0 2.0 no signal
74 Inappropriate Schedule Of Drug Administration 48 2.0 2.0 no signal
75 Incontinence 7 1.9 1.9 no signal
76 Restless Legs Syndrome 12 1.9 1.9 no signal
77 Palpitations 77 1.9 1.9 no signal
78 Ill-defined Disorder 40 1.9 1.9 no signal
79 Renal Failure 87 1.9 1.9 no signal
80 Gastrooesophageal Reflux Disease 52 1.9 1.9 no signal
81 Nephropathy 6 1.9 1.9 no signal
82 Gait Inability 21 1.9 1.9 no signal
83 Spinal Disorder 6 1.9 1.9 no signal
84 Foot Fracture 12 1.9 1.9 no signal
85 Cystitis 20 1.8 1.8 no signal
86 Neck Pain 35 1.8 1.8 no signal
87 Liver Injury 15 1.8 1.8 no signal
88 Rebound Effect 7 1.8 1.8 no signal
89 Dermatitis Contact 7 1.8 1.8 no signal
90 Back Disorder 10 1.8 1.8 no signal
91 Gout 11 1.8 1.8 no signal
92 Kidney Infection 12 1.8 1.8 no signal
93 Abnormal Dreams 17 1.8 1.8 no signal
94 Liver Function Test Increased 13 1.8 1.8 no signal
95 Gastritis 16 1.8 1.8 no signal
96 Impaired Work Ability 13 1.8 1.8 no signal
97 Insurance Issue 9 1.8 1.8 no signal
98 Panic Attack 22 1.8 1.8 no signal
99 Expired Product Administered 20 1.8 1.8 no signal
100 Multiple Sclerosis Relapse 41 1.7 1.7 no signal
101 Temperature Intolerance 6 1.7 1.7 no signal
102 Hot Flush 44 1.7 1.7 no signal
103 Peripheral Coldness 8 1.7 1.7 no signal
104 Central Nervous System Lesion 8 1.7 1.7 no signal
105 Feeling Abnormal 139 1.7 1.7 no signal
106 Fibromyalgia 14 1.7 1.7 no signal
107 Tooth Loss 12 1.7 1.7 no signal
108 Tenderness 6 1.7 1.7 no signal
109 Contusion 55 1.7 1.7 no signal
110 Hereditary Angioedema 6 1.7 1.7 no signal
111 Nervousness 30 1.7 1.7 no signal
112 Renal Pain 6 1.7 1.7 no signal
113 Choking 11 1.7 1.7 no signal
114 Breast Pain 6 1.7 1.7 no signal
115 Drug Effect Decreased 30 1.6 1.6 no signal
116 Anxiety 156 1.6 1.6 no signal
117 Wrong Technique In Product Usage Process 110 1.6 1.6 no signal
118 Rotator Cuff Syndrome 7 1.6 1.6 no signal
119 Nerve Compression 5 1.6 1.6 no signal
120 Vertigo 33 1.6 1.6 no signal
121 Medication Error 30 1.6 1.6 no signal
122 Memory Impairment 74 1.6 1.6 no signal
123 Product Use Issue 100 1.6 1.6 no signal
124 Thinking Abnormal 10 1.6 1.6 no signal
125 Joint Stiffness 14 1.6 1.6 no signal
126 Tooth Infection 7 1.6 1.6 no signal
127 Drug Hypersensitivity 103 1.6 1.6 no signal
128 Hypoaesthesia 79 1.5 1.6 no signal
129 Sinusitis 54 1.5 1.5 no signal
130 Heart Rate Increased 52 1.5 1.5 no signal
131 Musculoskeletal Discomfort 9 1.5 1.5 no signal
132 Autoimmune Disorder 5 1.5 1.5 no signal
133 Balance Disorder 45 1.5 1.5 no signal
134 Therapy Change 5 1.5 1.5 no signal
135 Retching 11 1.5 1.5 no signal
136 Limb Discomfort 16 1.5 1.5 no signal
137 Pharyngeal Oedema 8 1.5 1.5 no signal
138 Dysstasia 15 1.5 1.5 no signal
139 Bone Pain 30 1.5 1.5 no signal
140 Head Discomfort 9 1.5 1.5 no signal
141 Blood Iron Decreased 6 1.5 1.5 no signal
142 Lymphocyte Count Decreased 9 1.5 1.5 no signal
143 Nausea 400 1.5 1.5 no signal
144 Tremor 84 1.5 1.5 no signal
145 Oral Discomfort 7 1.5 1.5 no signal
146 Product Administration Error 10 1.5 1.5 no signal
147 Wrist Fracture 6 1.5 1.5 no signal
148 Back Pain 116 1.5 1.5 no signal
149 Coordination Abnormal 7 1.5 1.5 no signal
150 Oropharyngeal Pain 46 1.5 1.5 no signal
151 Speech Disorder 26 1.5 1.5 no signal
152 Flatulence 28 1.5 1.5 no signal
153 Motor Dysfunction 5 1.5 1.5 no signal
154 Eyelid Ptosis 5 1.4 1.4 no signal
155 Ear Infection 13 1.4 1.4 no signal
156 Incorrect Dose Administered 110 1.4 1.4 no signal
157 Small Intestinal Obstruction 6 1.4 1.4 no signal
158 Menstruation Delayed 5 1.4 1.4 no signal
159 Musculoskeletal Stiffness 42 1.4 1.4 no signal
160 Illness 48 1.4 1.4 no signal
161 Paraesthesia 75 1.4 1.4 no signal
162 Brain Oedema 6 1.4 1.4 no signal
163 Joint Dislocation 5 1.4 1.4 no signal
164 Urinary Incontinence 14 1.4 1.4 no signal
165 Renal Disorder 22 1.4 1.4 no signal
166 Injection Site Bruising 37 1.4 1.4 no signal
167 Product Dose Omission 31 1.4 1.4 no signal
168 Decreased Activity 5 1.4 1.4 no signal
169 Scar 8 1.4 1.4 no signal
170 Crying 17 1.4 1.4 no signal
171 Depression 106 1.4 1.4 no signal
172 Back Injury 5 1.4 1.4 no signal
173 Swelling Face 30 1.4 1.4 no signal
174 Faeces Discoloured 10 1.4 1.4 no signal
175 Ocular Discomfort 5 1.4 1.4 no signal
176 Stress 33 1.3 1.3 no signal
177 Bedridden 6 1.3 1.3 no signal
178 Bipolar Disorder 5 1.3 1.3 no signal
179 Adverse Event 42 1.3 1.3 no signal
180 Pruritus Generalised 10 1.3 1.3 no signal
181 Eye Haemorrhage 6 1.3 1.3 no signal
182 Activities Of Daily Living Impaired 9 1.3 1.3 no signal
183 Influenza Like Illness 37 1.3 1.3 no signal
184 Psoriatic Arthropathy 18 1.3 1.3 no signal
185 Malignant Melanoma 6 1.3 1.3 no signal
186 Product Dose Omission In Error 12 1.3 1.3 no signal
187 Product Taste Abnormal 6 1.3 1.3 no signal
188 Arthritis 35 1.3 1.3 no signal
189 Amnesia 29 1.3 1.3 no signal
190 Disturbance In Attention 24 1.3 1.3 no signal
191 Head Injury 14 1.3 1.3 no signal
192 Chromaturia 10 1.3 1.3 no signal
193 Anger 15 1.3 1.3 no signal
194 Acute Hepatic Failure 6 1.3 1.3 no signal
195 Mood Swings 14 1.3 1.3 no signal
196 Depressed Mood 23 1.3 1.3 no signal
197 Multiple Sclerosis 21 1.3 1.3 no signal
198 Exposure During Pregnancy 27 1.3 1.3 no signal
199 Sleep Disorder Due To A General Medical Condition 7 1.3 1.3 no signal
200 Haematemesis 11 1.3 1.3 no signal
201 Therapy Cessation 22 1.3 1.3 no signal
202 Muscle Spasms 79 1.3 1.3 no signal
203 Feeling Cold 12 1.3 1.3 no signal
204 Aphonia 6 1.3 1.3 no signal
205 Hepatic Encephalopathy 4 1.3 1.3 no signal
206 Impaired Healing 14 1.3 1.3 no signal
207 Withdrawal Syndrome 18 1.3 1.3 no signal
208 Adverse Drug Reaction 38 1.2 1.2 no signal
209 Irritable Bowel Syndrome 9 1.2 1.2 no signal
210 Cerebral Haemorrhage 15 1.2 1.2 no signal
211 Application Site Erythema 11 1.2 1.2 no signal
212 Pharyngeal Swelling 4 1.2 1.2 no signal
213 Hernia 8 1.2 1.2 no signal
214 Glaucoma 8 1.2 1.2 no signal
215 Upper Gastrointestinal Haemorrhage 7 1.2 1.2 no signal
216 Burning Sensation 29 1.2 1.2 no signal
217 Apathy 6 1.2 1.2 no signal
218 Dysphonia 24 1.2 1.2 no signal
219 Hemiparesis 7 1.2 1.2 no signal
220 Hepatitis C 5 1.2 1.2 no signal
221 Coeliac Disease 4 1.2 1.2 no signal
222 Inability To Afford Medication 4 1.2 1.2 no signal
223 Eye Swelling 15 1.2 1.2 no signal
224 Mood Altered 11 1.2 1.2 no signal
225 No Therapeutic Response 5 1.2 1.2 no signal
226 Cyst 5 1.2 1.2 no signal
227 Rash Macular 14 1.2 1.2 no signal
228 Menorrhagia 8 1.2 1.2 no signal
229 Tooth Extraction 5 1.2 1.2 no signal
230 Upper Limb Fracture 8 1.2 1.2 no signal
231 Brain Injury 4 1.2 1.2 no signal
232 Muscle Atrophy 5 1.2 1.2 no signal
233 Underdose 29 1.2 1.2 no signal
234 Overdose 85 1.2 1.2 no signal
235 Seizure 45 1.2 1.2 no signal
236 Eye Discharge 4 1.1 1.1 no signal
237 Ear Discomfort 4 1.1 1.1 no signal
238 Thyroid Disorder 6 1.1 1.1 no signal
239 Emotional Disorder 12 1.1 1.1 no signal
240 Basal Cell Carcinoma 6 1.1 1.1 no signal
241 Platelet Count Increased 5 1.1 1.1 no signal
242 Road Traffic Accident 16 1.1 1.1 no signal
243 Bone Disorder 7 1.1 1.1 no signal
244 Throat Irritation 17 1.1 1.1 no signal
245 Complication Associated With Device 5 1.1 1.1 no signal
246 Adverse Reaction 5 1.1 1.1 no signal
247 Middle Insomnia 7 1.1 1.1 no signal
248 Abscess 6 1.1 1.1 no signal
249 Nightmare 13 1.1 1.1 no signal
250 Drug Administered At Inappropriate Site 4 1.1 1.1 no signal
251 Sensory Disturbance 6 1.1 1.1 no signal
252 Hair Texture Abnormal 5 1.1 1.1 no signal
253 Body Height Decreased 4 1.1 1.1 no signal
254 Eructation 7 1.1 1.1 no signal
255 Pulmonary Thrombosis 4 1.1 1.1 no signal
256 Gingival Bleeding 5 1.1 1.1 no signal
257 Eye Pruritus 12 1.1 1.1 no signal
258 Blood Glucose Fluctuation 4 1.1 1.1 no signal
259 Flushing 37 1.1 1.1 no signal
260 Dysgeusia 27 1.1 1.1 no signal
261 Lip Swelling 12 1.1 1.1 no signal
262 Injection Site Pruritus 24 1.1 1.1 no signal
263 Drug Prescribing Error 7 1.1 1.1 no signal
264 Nerve Injury 4 1.1 1.1 no signal
265 Visual Acuity Reduced 12 1.1 1.1 no signal
266 Gastrointestinal Haemorrhage 30 1.0 1.0 no signal
267 Vaginal Haemorrhage 15 1.0 1.0 no signal
268 Injection Site Erythema 43 1.0 1.0 no signal
269 Skin Haemorrhage 5 1.0 1.0 no signal
270 Therapeutic Response Shortened 11 1.0 1.0 no signal
271 Caesarean Section 4 1.0 1.0 no signal
272 Laboratory Test Abnormal 10 1.0 1.0 no signal
273 Hallucination, Visual 7 1.0 1.0 no signal
274 Throat Tightness 9 1.0 1.0 no signal
275 Fear 9 1.0 1.0 no signal
276 Therapy Partial Responder 5 1.0 1.0 no signal
277 Pelvic Pain 6 1.0 1.0 no signal
278 Drug Dose Omission 55 1.0 1.0 no signal
279 Circumstance Or Information Capable Of Leading To Medication Error 11 1.0 1.0 no signal
280 Haemorrhage 34 1.0 1.0 no signal
281 Blood Count Abnormal 5 1.0 1.0 no signal
282 Blood Thyroid Stimulating Hormone Increased 3 1.0 1.0 no signal
283 Skin Cancer 7 1.0 1.0 no signal
284 Personality Change 3 0.9 0.9 no signal
285 Increased Appetite 6 0.9 0.9 no signal
286 Hair Colour Changes 4 0.9 0.9 no signal
287 Glossodynia 7 0.9 0.9 no signal
288 Product Adhesion Issue 11 0.9 0.9 no signal
289 Affect Lability 3 0.9 0.9 no signal
290 Metastases To Bone 5 0.9 0.9 no signal
291 Generalised Tonic-clonic Seizure 5 0.9 0.9 no signal
292 Psychotic Disorder 9 0.9 0.9 no signal
293 Disability 6 0.9 0.9 no signal
294 Acne 23 0.9 0.9 no signal
295 Accidental Overdose 11 0.9 0.9 no signal
296 Salivary Hypersecretion 3 0.9 0.9 no signal
297 Amenorrhoea 5 0.9 0.9 no signal
298 Vaginal Discharge 3 0.9 0.9 no signal
299 Full Blood Count Decreased 6 0.9 0.9 no signal
300 Hunger 4 0.9 0.9 no signal
301 Sluggishness 3 0.9 0.9 no signal
302 Suicidal Ideation 27 0.9 0.9 no signal
303 Drug Level Decreased 3 0.9 0.9 no signal
304 Psoriasis 38 0.9 0.9 no signal
305 Poor Venous Access 3 0.9 0.9 no signal
306 Application Site Rash 4 0.9 0.9 no signal
307 Procedural Pain 8 0.8 0.8 no signal
308 Local Swelling 5 0.8 0.8 no signal
309 Irritability 17 0.8 0.8 no signal
310 Product Administered At Inappropriate Site 5 0.8 0.8 no signal
311 Device Malfunction 18 0.8 0.8 no signal
312 Colon Cancer 4 0.8 0.8 no signal
313 Pharmaceutical Product Complaint 7 0.8 0.8 no signal
314 Cholecystectomy 3 0.8 0.8 no signal
315 Menstruation Irregular 7 0.8 0.8 no signal
316 Bone Loss 4 0.8 0.8 no signal
317 Internal Haemorrhage 3 0.8 0.8 no signal
318 Device Difficult To Use 17 0.8 0.8 no signal
319 Madarosis 3 0.8 0.8 no signal
320 Device Dislocation 11 0.7 0.7 no signal
321 Skin Burning Sensation 18 0.7 0.7 no signal
322 Injection Site Urticaria 6 0.7 0.7 no signal
323 Pregnancy 5 0.7 0.7 no signal
324 Injection Site Pain 75 0.7 0.7 no signal
325 Injection Site Warmth 5 0.7 0.7 no signal
326 Multiple Fractures 4 0.7 0.7 no signal
327 Abasia 6 0.7 0.7 no signal
328 Rheumatoid Arthritis 27 0.7 0.7 no signal
329 Injection Site Swelling 18 0.7 0.7 no signal
330 Metrorrhagia 4 0.7 0.7 no signal
331 Ankylosing Spondylitis 3 0.7 0.7 no signal
332 Application Site Pain 5 0.7 0.7 no signal
333 Application Site Pruritus 5 0.6 0.6 no signal
334 Intentional Overdose 14 0.6 0.6 no signal
335 Injection Site Reaction 15 0.6 0.6 no signal
336 Injection Site Mass 8 0.6 0.6 no signal
337 Prostatic Specific Antigen Increased 3 0.6 0.6 no signal
338 Device Occlusion 3 0.6 0.6 no signal
339 Palmar-plantar Erythrodysaesthesia Syndrome 5 0.6 0.6 no signal
340 Product Storage Error 18 0.6 0.6 no signal
341 Drug Withdrawal Syndrome 18 0.6 0.6 no signal
342 Injection Site Haemorrhage 16 0.6 0.6 no signal
343 Intentional Self-injury 4 0.6 0.6 no signal
344 Injection Site Rash 6 0.6 0.6 no signal
345 Drug Dose Omission By Device 15 0.6 0.6 no signal
346 Intentional Drug Misuse 4 0.6 0.6 no signal
347 Tardive Dyskinesia 5 0.5 0.5 no signal
348 Device Use Issue 3 0.5 0.5 no signal
349 Foetal Exposure During Pregnancy 14 0.5 0.5 no signal
350 Accidental Exposure To Product 16 0.5 0.5 no signal
351 Dystonia 3 0.5 0.5 no signal
352 Abortion Spontaneous 6 0.4 0.4 no signal
353 Incorrect Route Of Drug Administration 5 0.4 0.4 no signal
354 Wrong Technique In Drug Usage Process 5 0.4 0.4 no signal
355 Skin Irritation 6 0.4 0.4 no signal
356 Incorrect Dose Administered By Device 3 0.3 0.3 no signal
357 Device Leakage 5 0.3 0.3 no signal
358 Gastric Cancer 3 0.3 0.3 no signal
359 Wrong Technique In Device Usage Process 5 0.3 0.3 no signal
360 Dependence 6 0.3 0.3 no signal
361 Needle Issue 3 0.3 0.3 no signal
362 Device Issue 8 0.3 0.3 no signal
363 Device Expulsion 4 0.2 0.2 no signal