OpenPV Signal Explorer
FAERS disproportionality dashboard
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Drug

Bayer Aspirin Extra Strength

222 flagged reaction(s) · 4,397 total co-reports · max PRR 19.9
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 Upper Gastrointestinal Haemorrhage 63 19.9 20.2 signal
2 Gastric Haemorrhage 34 15.6 15.8 signal
3 Internal Haemorrhage 33 15.3 15.5 signal
4 Gastrointestinal Haemorrhage 226 14.3 15.1 signal
5 Incorrect Drug Administration Duration 67 12.5 12.7 signal
6 Rectal Haemorrhage 68 8.4 8.5 signal
7 Gastric Ulcer 30 8.4 8.4 signal
8 Product Prescribing Issue 26 6.8 6.8 signal
9 Expired Product Administered 40 6.4 6.5 signal
10 Increased Tendency To Bruise 11 6.3 6.4 signal
11 Product Use Complaint 18 6.2 6.2 signal
12 End Stage Renal Disease 21 6.1 6.1 signal
13 Hair Colour Changes 14 5.9 5.9 signal
14 Product Use Issue 208 5.9 6.2 signal
15 Hiatus Hernia 14 5.7 5.8 signal
16 Epistaxis 79 5.6 5.7 signal
17 Drug Administration Error 32 5.5 5.5 signal
18 Post Procedural Haemorrhage 12 5.5 5.5 signal
19 Haematuria 35 5.4 5.5 signal
20 Body Height Decreased 11 5.4 5.4 signal
21 Ulcer 16 5.3 5.4 signal
22 Haemorrhage Intracranial 15 5.3 5.3 signal
23 Drug Hypersensitivity 194 5.3 5.5 signal
24 Madarosis 11 5.0 5.0 signal
25 Incorrect Product Administration Duration 19 5.0 5.0 signal
26 Therapeutic Response Unexpected 42 5.0 5.0 signal
27 Choking 18 4.9 4.9 signal
28 Chronic Kidney Disease 70 4.9 4.9 signal
29 Subdural Haematoma 13 4.8 4.8 signal
30 Hair Texture Abnormal 12 4.7 4.7 signal
31 Product Use In Unapproved Indication 214 4.7 4.9 signal
32 Blood Urine Present 16 4.5 4.5 signal
33 Macular Degeneration 10 4.5 4.5 signal
34 Hyperlipidaemia 10 4.4 4.4 signal
35 Eye Haemorrhage 11 4.4 4.4 signal
36 Drug Prescribing Error 16 4.4 4.4 signal
37 Nerve Injury 9 4.3 4.3 signal
38 Sneezing 18 4.3 4.3 signal
39 Haemorrhage 83 4.2 4.3 signal
40 Haemoptysis 22 4.2 4.2 signal
41 Faeces Discoloured 17 4.2 4.2 signal
42 Melaena 17 4.1 4.1 signal
43 Pulmonary Congestion 10 4.0 4.0 signal
44 Nephropathy 7 4.0 4.0 signal
45 Malignant Melanoma 10 4.0 4.0 signal
46 Squamous Cell Carcinoma 7 3.9 4.0 signal
47 Intentional Product Misuse 63 3.9 3.9 signal
48 Coagulopathy 12 3.8 3.8 signal
49 Haematemesis 18 3.8 3.8 signal
50 Acute Kidney Injury 107 3.7 3.8 signal
51 Cerebral Haemorrhage 25 3.7 3.7 signal
52 Emphysema 7 3.7 3.7 signal
53 Circumstance Or Information Capable Of Leading To Medication Error 23 3.6 3.7 signal
54 Product Taste Abnormal 9 3.6 3.6 signal
55 Renal Pain 7 3.5 3.5 signal
56 Nocturia 8 3.5 3.5 signal
57 Prescribed Underdose 13 3.5 3.5 signal
58 Nerve Compression 6 3.5 3.5 signal
59 Back Injury 7 3.4 3.4 signal
60 Drug Dispensing Error 10 3.4 3.4 signal
61 Intervertebral Disc Degeneration 6 3.4 3.4 signal
62 Spinal Disorder 6 3.4 3.4 signal
63 Skin Haemorrhage 9 3.3 3.3 signal
64 Type 2 Diabetes Mellitus 21 3.3 3.3 signal
65 Hypokinesia 9 3.3 3.3 signal
66 Throat Irritation 27 3.2 3.2 signal
67 Haematochezia 33 3.2 3.2 signal
68 Blood Potassium Decreased 18 3.2 3.2 signal
69 Drug Effect Incomplete 22 3.2 3.2 signal
70 Subarachnoid Haemorrhage 6 3.1 3.1 signal
71 Poor Quality Product Administered 6 3.1 3.1 signal
72 Inappropriate Schedule Of Drug Administration 42 3.1 3.1 signal
73 Contusion 55 3.0 3.1 signal
74 Myocardial Infarction 100 3.0 3.1 signal
75 Contraindicated Product Administered 17 3.0 3.0 signal
76 Muscle Tightness 9 3.0 3.0 signal
77 Back Disorder 9 2.9 2.9 signal
78 Pulmonary Thrombosis 6 2.9 2.9 signal
79 Limb Discomfort 17 2.9 2.9 signal
80 Impaired Gastric Emptying 7 2.9 2.9 signal
81 Product Packaging Issue 5 2.9 2.9 signal
82 Knee Arthroplasty 11 2.8 2.8 signal
83 Musculoskeletal Disorder 10 2.8 2.8 signal
84 Gastric Disorder 18 2.7 2.8 signal
85 Knee Operation 5 2.7 2.7 no signal
86 Gingival Bleeding 7 2.7 2.7 signal
87 Coronary Artery Occlusion 7 2.7 2.7 signal
88 Blood Triglycerides Increased 9 2.7 2.7 signal
89 Sinus Disorder 10 2.7 2.7 signal
90 Ischaemic Stroke 9 2.7 2.7 signal
91 Bladder Disorder 5 2.7 2.7 no signal
92 Aphonia 7 2.7 2.7 signal
93 Transient Ischaemic Attack 17 2.7 2.7 signal
94 Tinnitus 23 2.7 2.7 signal
95 Haematoma 13 2.7 2.7 signal
96 Chronic Obstructive Pulmonary Disease 26 2.6 2.7 signal
97 Carpal Tunnel Syndrome 7 2.6 2.7 signal
98 Full Blood Count Decreased 10 2.6 2.6 signal
99 Nervousness 26 2.6 2.6 signal
100 Dry Throat 5 2.6 2.6 no signal
101 Lip Swelling 16 2.6 2.6 signal
102 Rhinorrhoea 31 2.6 2.6 signal
103 Musculoskeletal Pain 25 2.5 2.5 signal
104 Cataract 28 2.5 2.5 signal
105 Glaucoma 9 2.5 2.5 signal
106 Cerebrovascular Accident 79 2.5 2.5 signal
107 Flatulence 26 2.4 2.4 signal
108 Kidney Infection 9 2.4 2.4 signal
109 Pain In Jaw 13 2.4 2.4 signal
110 Intervertebral Disc Protrusion 10 2.4 2.4 signal
111 Delusion 7 2.4 2.4 signal
112 Underdose 33 2.4 2.4 signal
113 Product Physical Issue 9 2.4 2.4 signal
114 Ankle Fracture 7 2.4 2.4 signal
115 Pharyngeal Oedema 7 2.4 2.4 signal
116 Drug Effective For Unapproved Indication 13 2.4 2.4 signal
117 Limb Injury 12 2.4 2.4 signal
118 Restless Legs Syndrome 8 2.3 2.3 signal
119 Respiratory Arrest 12 2.3 2.3 signal
120 Irritable Bowel Syndrome 9 2.2 2.2 signal
121 Anaphylactic Reaction 23 2.2 2.2 signal
122 Skin Cancer 9 2.2 2.2 signal
123 Angina Pectoris 12 2.2 2.2 signal
124 Swollen Tongue 13 2.2 2.2 signal
125 Hernia 8 2.2 2.2 signal
126 Hemiparesis 7 2.2 2.2 no signal
127 Application Site Pain 9 2.2 2.2 signal
128 Tendon Rupture 5 2.1 2.1 no signal
129 Colon Cancer 6 2.1 2.1 no signal
130 Brain Injury 4 2.1 2.1 no signal
131 Chromaturia 9 2.1 2.1 signal
132 Fluid Retention 20 2.1 2.1 signal
133 Initial Insomnia 4 2.1 2.1 no signal
134 Eye Discharge 4 2.1 2.1 no signal
135 Rotator Cuff Syndrome 5 2.1 2.1 no signal
136 Toothache 7 2.1 2.1 no signal
137 Incorrect Dose Administered 87 2.1 2.1 signal
138 Scratch 4 2.1 2.1 no signal
139 Wrong Technique In Product Usage Process 78 2.1 2.1 signal
140 Immune System Disorder 5 2.0 2.0 no signal
141 Blood Glucose Abnormal 7 2.0 2.0 no signal
142 Incorrect Product Storage 5 2.0 2.0 no signal
143 Localised Infection 9 2.0 2.0 no signal
144 Throat Tightness 10 2.0 2.0 no signal
145 Feeling Jittery 7 1.9 1.9 no signal
146 Renal Injury 11 1.9 1.9 no signal
147 Bipolar Disorder 4 1.9 1.9 no signal
148 Prescribed Overdose 7 1.9 1.9 no signal
149 Prostatic Specific Antigen Increased 5 1.9 1.9 no signal
150 Oral Discomfort 5 1.9 1.9 no signal
151 Anaphylactic Shock 9 1.9 1.9 no signal
152 Hip Fracture 11 1.8 1.8 no signal
153 Product Quality Issue 46 1.8 1.8 no signal
154 Fluid Overload 5 1.8 1.8 no signal
155 Cardiac Failure Congestive 27 1.8 1.8 no signal
156 Blood Glucose Decreased 16 1.8 1.8 no signal
157 Spinal Operation 4 1.8 1.8 no signal
158 Thyroid Cancer 4 1.8 1.8 no signal
159 Cardiac Disorder 31 1.8 1.8 no signal
160 Impaired Work Ability 7 1.7 1.7 no signal
161 Extra Dose Administered 13 1.7 1.7 no signal
162 Thyroid Disorder 5 1.7 1.7 no signal
163 Drug Dose Omission 54 1.7 1.7 no signal
164 Thinking Abnormal 6 1.7 1.7 no signal
165 Basal Cell Carcinoma 5 1.7 1.7 no signal
166 Deformity 3 1.7 1.7 no signal
167 Pruritus Generalised 7 1.7 1.7 no signal
168 Laceration 3 1.7 1.7 no signal
169 Cardiovascular Disorder 8 1.7 1.7 no signal
170 Drug Effect Decreased 17 1.7 1.7 no signal
171 Sleep Disorder Due To A General Medical Condition 5 1.6 1.6 no signal
172 Application Site Erythema 8 1.6 1.6 no signal
173 Product Odour Abnormal 3 1.5 1.5 no signal
174 Local Swelling 5 1.5 1.5 no signal
175 Vaginal Haemorrhage 12 1.5 1.5 no signal
176 Drug Administered At Inappropriate Site 3 1.5 1.5 no signal
177 Abasia 7 1.5 1.5 no signal
178 Pulmonary Arterial Hypertension 4 1.5 1.5 no signal
179 Injection Site Nodule 3 1.5 1.5 no signal
180 Application Site Pruritus 6 1.4 1.4 no signal
181 Blood Count Abnormal 4 1.4 1.4 no signal
182 Procedural Pain 7 1.3 1.3 no signal
183 Intentional Overdose 16 1.3 1.3 no signal
184 Activities Of Daily Living Impaired 5 1.3 1.3 no signal
185 Product Dose Omission 16 1.3 1.3 no signal
186 Glycosylated Haemoglobin Increased 6 1.3 1.3 no signal
187 Intentional Drug Misuse 5 1.3 1.3 no signal
188 Injection Site Induration 3 1.2 1.2 no signal
189 Multiple Sclerosis 11 1.2 1.2 no signal
190 Device Malfunction 15 1.2 1.2 no signal
191 Application Site Rash 3 1.2 1.2 no signal
192 Abnormal Dreams 6 1.1 1.1 no signal
193 Blood Glucose Increased 39 1.1 1.1 no signal
194 Injection Site Haemorrhage 16 1.1 1.1 no signal
195 Menorrhagia 4 1.1 1.1 no signal
196 Psoriatic Arthropathy 8 1.1 1.1 no signal
197 Lung Neoplasm Malignant 8 1.0 1.0 no signal
198 Injection Site Bruising 15 1.0 1.0 no signal
199 Wrong Technique In Drug Usage Process 7 1.0 1.0 no signal
200 Product Dispensing Error 4 1.0 1.0 no signal
201 Plasma Cell Myeloma 7 1.0 1.0 no signal
202 Psoriasis 23 0.9 0.9 no signal
203 Injection Site Swelling 13 0.9 0.9 no signal
204 Injection Site Urticaria 4 0.9 0.9 no signal
205 Injection Site Pain 50 0.9 0.9 no signal
206 Product Complaint 4 0.9 0.9 no signal
207 Incorrect Dose Administered By Device 4 0.8 0.8 no signal
208 Drug Dependence 24 0.8 0.8 no signal
209 Product Preparation Error 3 0.8 0.8 no signal
210 Multiple Sclerosis Relapse 10 0.8 0.8 no signal
211 Device Leakage 6 0.8 0.8 no signal
212 Pancreatic Carcinoma 4 0.7 0.7 no signal
213 Injection Site Mass 5 0.7 0.7 no signal
214 Wrong Technique In Device Usage Process 6 0.7 0.7 no signal
215 Hepatic Cancer 3 0.7 0.7 no signal
216 Injection Site Pruritus 7 0.6 0.6 no signal
217 Accidental Exposure To Product 10 0.5 0.5 no signal
218 Breast Cancer 9 0.5 0.5 no signal
219 Device Issue 8 0.5 0.5 no signal
220 Product Adhesion Issue 3 0.4 0.4 no signal
221 Renal Cancer 4 0.4 0.4 no signal
222 Device Difficult To Use 4 0.3 0.3 no signal