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Drug

Stool Softener

296 flagged reaction(s) · 5,904 total co-reports · max PRR 10.3
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 Spinal Disorder 16 10.3 10.3 signal
2 Body Height Decreased 17 9.6 9.6 signal
3 Atelectasis 14 8.8 8.8 signal
4 Musculoskeletal Chest Pain 22 8.6 8.7 signal
5 Nocturia 17 8.5 8.6 signal
6 Flank Pain 13 8.5 8.5 signal
7 Constipation 282 7.9 8.5 signal
8 Activities Of Daily Living Impaired 26 7.9 7.9 signal
9 Haemorrhoids 25 7.8 7.8 signal
10 Oral Pain 28 7.6 7.6 signal
11 Intervertebral Disc Degeneration 11 7.2 7.2 signal
12 Abasia 29 7.0 7.1 signal
13 Laceration 11 7.0 7.0 signal
14 Hiatus Hernia 14 6.6 6.6 signal
15 Rib Fracture 22 6.5 6.6 signal
16 Hypercholesterolaemia 10 6.4 6.4 signal
17 Bone Disorder 19 6.3 6.3 signal
18 Local Swelling 18 6.2 6.2 signal
19 Ankle Fracture 15 5.9 5.9 signal
20 Anorexia 12 5.6 5.6 signal
21 Hyperlipidaemia 11 5.6 5.6 signal
22 Bursitis 11 5.5 5.6 signal
23 Spinal Fracture 18 5.5 5.5 signal
24 Scab 10 5.4 5.4 signal
25 Iron Deficiency Anaemia 8 5.3 5.3 signal
26 Nerve Compression 8 5.3 5.3 signal
27 Tenderness 9 5.2 5.3 signal
28 Osteopenia 13 5.2 5.2 signal
29 Blood Urine Present 16 5.1 5.1 signal
30 Gout 15 5.1 5.1 signal
31 Wrist Fracture 10 5.1 5.1 signal
32 Lung Infection 13 5.0 5.0 signal
33 Musculoskeletal Discomfort 14 4.9 5.0 signal
34 Hypercalcaemia 10 4.9 4.9 signal
35 Ligament Sprain 8 4.9 4.9 signal
36 Sinus Disorder 16 4.9 4.9 signal
37 Upper Limb Fracture 16 4.9 4.9 signal
38 Emphysema 8 4.8 4.8 signal
39 Rectal Haemorrhage 34 4.8 4.8 signal
40 Initial Insomnia 8 4.8 4.8 signal
41 Intervertebral Disc Protrusion 17 4.7 4.7 signal
42 Injection Site Haematoma 11 4.6 4.6 signal
43 Joint Range Of Motion Decreased 10 4.5 4.6 signal
44 Blood Sodium Decreased 14 4.5 4.5 signal
45 Osteoarthritis 31 4.4 4.5 signal
46 Dental Caries 8 4.4 4.4 signal
47 Diverticulitis 20 4.4 4.4 signal
48 Toothache 13 4.4 4.4 signal
49 Dry Mouth 58 4.4 4.4 signal
50 Balance Disorder 62 4.4 4.4 signal
51 Tooth Disorder 16 4.4 4.4 signal
52 Thyroid Disorder 11 4.3 4.3 signal
53 Oedema Peripheral 87 4.3 4.4 signal
54 Urinary Incontinence 21 4.3 4.3 signal
55 Mitral Valve Incompetence 8 4.3 4.3 signal
56 Flatulence 40 4.3 4.3 signal
57 Flushing 72 4.3 4.4 signal
58 Cholecystectomy 8 4.3 4.3 signal
59 Impaired Driving Ability 8 4.3 4.3 signal
60 Rotator Cuff Syndrome 9 4.2 4.3 signal
61 Blood Potassium Decreased 21 4.2 4.3 signal
62 Respiratory Tract Congestion 11 4.2 4.2 signal
63 Plasma Cell Myeloma 27 4.2 4.2 signal
64 Contusion 66 4.2 4.2 signal
65 Pruritus Generalised 15 4.2 4.2 signal
66 Osteonecrosis Of Jaw 17 4.1 4.2 signal
67 Metastases To Bone 11 4.1 4.1 signal
68 Glossodynia 15 4.1 4.1 signal
69 Gallbladder Disorder 12 4.1 4.1 signal
70 Pain In Jaw 19 4.1 4.1 signal
71 Therapeutic Response Unexpected 30 4.1 4.1 signal
72 Joint Dislocation 7 4.0 4.0 signal
73 Musculoskeletal Pain 35 4.0 4.1 signal
74 Coagulopathy 11 4.0 4.0 signal
75 Heart Rate Irregular 15 4.0 4.0 signal
76 Retching 14 4.0 4.0 signal
77 Joint Injury 14 4.0 4.0 signal
78 Hip Fracture 21 4.0 4.0 signal
79 Increased Tendency To Bruise 6 4.0 4.0 signal
80 Dysphonia 38 4.0 4.0 signal
81 Mental Status Changes 18 3.9 4.0 signal
82 Nervousness 34 3.9 4.0 signal
83 Dehydration 86 3.9 4.0 signal
84 Scar 11 3.9 3.9 signal
85 Carpal Tunnel Syndrome 9 3.9 3.9 signal
86 Impaired Healing 21 3.9 3.9 signal
87 Chronic Obstructive Pulmonary Disease 33 3.8 3.9 signal
88 Incorrect Drug Administration Duration 18 3.8 3.9 signal
89 Feeling Jittery 12 3.8 3.8 signal
90 Back Pain 146 3.8 3.9 signal
91 Wrong Technique In Drug Usage Process 23 3.8 3.8 signal
92 Blood Calcium Decreased 7 3.8 3.8 signal
93 Bronchitis 46 3.8 3.8 signal
94 Micturition Urgency 7 3.8 3.8 signal
95 Dyspepsia 60 3.7 3.8 signal
96 Fluid Retention 31 3.7 3.7 signal
97 Osteomyelitis 11 3.7 3.7 signal
98 Dysgeusia 45 3.7 3.7 signal
99 Head Injury 19 3.7 3.7 signal
100 Blood Iron Decreased 7 3.6 3.6 signal
101 Temperature Intolerance 6 3.6 3.6 signal
102 Macular Degeneration 7 3.6 3.6 signal
103 Thinking Abnormal 11 3.6 3.6 signal
104 Tooth Abscess 6 3.6 3.6 signal
105 Gingival Bleeding 8 3.6 3.6 signal
106 Limb Discomfort 18 3.5 3.5 signal
107 Eructation 11 3.5 3.5 signal
108 Gastritis 15 3.5 3.5 signal
109 Small Intestinal Obstruction 7 3.5 3.5 signal
110 Muscle Spasticity 7 3.4 3.4 signal
111 Stomatitis 34 3.4 3.4 signal
112 Back Injury 6 3.4 3.4 signal
113 Pollakiuria 23 3.4 3.4 signal
114 Gastroenteritis Viral 10 3.4 3.4 signal
115 Hypokinesia 8 3.3 3.4 signal
116 Muscle Spasms 101 3.3 3.4 signal
117 Bipolar Disorder 6 3.3 3.3 signal
118 Fall 181 3.3 3.4 signal
119 Blood Pressure Decreased 36 3.3 3.3 signal
120 Laboratory Test Abnormal 16 3.3 3.3 signal
121 Cardiac Failure Congestive 44 3.3 3.3 signal
122 Fluid Overload 8 3.3 3.3 signal
123 Burning Sensation 38 3.3 3.3 signal
124 Blood Thyroid Stimulating Hormone Increased 5 3.3 3.3 signal
125 Cardiomyopathy 8 3.3 3.3 signal
126 Convulsion 31 3.2 3.3 signal
127 Cystitis 17 3.2 3.2 signal
128 Chromaturia 12 3.2 3.2 signal
129 Hypoaesthesia Oral 8 3.2 3.2 signal
130 Incorrect Product Storage 7 3.2 3.2 signal
131 Red Blood Cell Count Decreased 15 3.2 3.2 signal
132 Cataract 31 3.2 3.2 signal
133 Neck Pain 29 3.2 3.2 signal
134 Drug Dispensing Error 8 3.1 3.1 signal
135 Choking 10 3.1 3.1 signal
136 Knee Operation 5 3.1 3.1 signal
137 Eating Disorder 11 3.1 3.1 signal
138 Impaired Work Ability 11 3.1 3.1 signal
139 Dysstasia 15 3.1 3.1 signal
140 Bone Pain 30 3.1 3.1 signal
141 Drug Dose Omission 85 3.1 3.1 signal
142 Prostatic Specific Antigen Increased 7 3.1 3.1 signal
143 Amnesia 33 3.1 3.1 signal
144 Lacrimation Increased 15 3.1 3.1 signal
145 Gait Disturbance 96 3.0 3.1 signal
146 Mass 7 3.0 3.0 signal
147 Neuropathy Peripheral 47 3.0 3.1 signal
148 Restless Legs Syndrome 9 3.0 3.0 signal
149 Back Disorder 8 3.0 3.0 signal
150 Rash Papular 11 3.0 3.0 signal
151 No Therapeutic Response 6 2.9 3.0 signal
152 Middle Insomnia 9 2.9 2.9 signal
153 Myelodysplastic Syndrome 7 2.9 2.9 signal
154 Paraesthesia 76 2.9 3.0 signal
155 Intestinal Obstruction 18 2.9 2.9 signal
156 Epistaxis 36 2.9 2.9 signal
157 Increased Appetite 9 2.9 2.9 signal
158 Visual Acuity Reduced 16 2.9 2.9 signal
159 Pain In Extremity 141 2.9 3.0 signal
160 Skeletal Injury 5 2.9 2.9 signal
161 Mouth Ulceration 10 2.9 2.9 signal
162 Intentional Drug Misuse 10 2.9 2.9 signal
163 Dyskinesia 19 2.8 2.9 signal
164 Metastases To Central Nervous System 6 2.8 2.9 signal
165 Irritable Bowel Syndrome 10 2.8 2.9 signal
166 Drug Administered At Inappropriate Site 5 2.8 2.8 signal
167 Glaucoma 9 2.8 2.8 signal
168 Hip Arthroplasty 7 2.8 2.8 signal
169 Nodule 6 2.8 2.8 signal
170 Gastric Disorder 16 2.8 2.8 signal
171 Pulmonary Thrombosis 5 2.8 2.8 signal
172 Eye Disorder 15 2.8 2.8 signal
173 Rash Generalised 12 2.8 2.8 signal
174 Immune System Disorder 6 2.8 2.8 signal
175 Tooth Infection 6 2.8 2.8 signal
176 Road Traffic Accident 19 2.8 2.8 signal
177 Haematochezia 25 2.8 2.8 signal
178 Cold Sweat 8 2.8 2.8 signal
179 Chest Discomfort 46 2.7 2.8 signal
180 Red Blood Cell Sedimentation Rate Increased 5 2.7 2.7 no signal
181 Foot Deformity 5 2.7 2.7 no signal
182 Rhinorrhoea 29 2.7 2.8 signal
183 Eye Haemorrhage 6 2.7 2.7 signal
184 Full Blood Count Decreased 9 2.7 2.7 signal
185 Liver Function Test Abnormal 13 2.7 2.7 signal
186 Deep Vein Thrombosis 29 2.7 2.7 signal
187 Sinus Congestion 6 2.7 2.7 signal
188 Hyperhidrosis 57 2.7 2.7 signal
189 Renal Failure Acute 19 2.7 2.7 signal
190 Application Site Pruritus 10 2.7 2.7 signal
191 Blood Glucose Decreased 21 2.6 2.7 signal
192 Coronary Artery Occlusion 6 2.6 2.6 signal
193 Movement Disorder 14 2.6 2.6 signal
194 Thrombosis 35 2.6 2.7 signal
195 White Blood Cell Count Decreased 47 2.6 2.7 signal
196 Oral Discomfort 6 2.6 2.6 signal
197 Aphonia 6 2.6 2.6 signal
198 Eyelid Oedema 5 2.6 2.6 no signal
199 Blindness Unilateral 6 2.6 2.6 signal
200 Squamous Cell Carcinoma 4 2.6 2.6 no signal
201 Leukaemia 4 2.6 2.6 no signal
202 Skin Fissures 8 2.6 2.6 signal
203 Feeling Hot 26 2.6 2.6 signal
204 Psychomotor Hyperactivity 7 2.6 2.6 signal
205 Speech Disorder 22 2.6 2.6 signal
206 Hypoacusis 18 2.5 2.6 signal
207 Drug Administration Error 13 2.5 2.5 signal
208 Transient Ischaemic Attack 14 2.5 2.5 signal
209 Oral Herpes 8 2.5 2.5 signal
210 Hot Flush 31 2.5 2.5 signal
211 Therapy Cessation 21 2.5 2.5 signal
212 Restlessness 15 2.5 2.5 signal
213 Gastrointestinal Haemorrhage 34 2.5 2.5 signal
214 Injection Site Discolouration 5 2.5 2.5 no signal
215 Colon Cancer 6 2.4 2.4 no signal
216 Influenza Like Illness 33 2.4 2.4 signal
217 Joint Swelling 48 2.4 2.4 signal
218 Injury 28 2.4 2.4 signal
219 Abnormal Dreams 11 2.4 2.4 signal
220 Coronary Artery Disease 12 2.4 2.4 signal
221 Blood Count Abnormal 6 2.4 2.4 no signal
222 Feeling Abnormal 93 2.4 2.4 signal
223 Palmar-plantar Erythrodysaesthesia Syndrome 9 2.3 2.3 signal
224 Drug Effect Decreased 21 2.3 2.3 signal
225 Basal Cell Carcinoma 6 2.3 2.3 no signal
226 Panic Attack 14 2.3 2.3 signal
227 Ankylosing Spondylitis 5 2.3 2.3 no signal
228 Application Site Erythema 10 2.3 2.3 signal
229 Breast Pain 4 2.3 2.3 no signal
230 Skin Exfoliation 31 2.3 2.3 signal
231 Hunger 5 2.3 2.3 no signal
232 Mental Impairment 9 2.3 2.3 signal
233 Unevaluable Event 28 2.2 2.3 signal
234 Musculoskeletal Disorder 7 2.2 2.2 no signal
235 Blood Glucose Fluctuation 4 2.2 2.2 no signal
236 Hernia 7 2.2 2.2 no signal
237 Multiple Fractures 6 2.2 2.2 no signal
238 Drug Withdrawal Syndrome 32 2.2 2.2 signal
239 Inappropriate Schedule Of Drug Administration 26 2.2 2.2 signal
240 Ageusia 9 2.2 2.2 signal
241 Dementia 10 2.2 2.2 signal
242 Sneezing 8 2.2 2.2 no signal
243 Lymphopenia 5 2.2 2.2 no signal
244 Fistula 4 2.2 2.2 no signal
245 Cardiovascular Disorder 9 2.1 2.1 signal
246 Nightmare 12 2.1 2.1 signal
247 Mood Swings 11 2.1 2.1 signal
248 Injection Site Bruising 27 2.1 2.1 signal
249 Metastases To Liver 6 2.1 2.1 no signal
250 Product Quality Issue 46 2.1 2.1 signal
251 Cardiac Disorder 32 2.1 2.1 signal
252 Brain Neoplasm 3 2.0 2.0 no signal
253 Skin Cancer 7 2.0 2.0 no signal
254 Malignant Neoplasm Progression 33 2.0 2.0 no signal
255 Deformity 3 1.9 1.9 no signal
256 Eye Inflammation 3 1.9 1.9 no signal
257 Hair Colour Changes 4 1.9 1.9 no signal
258 Blood Glucose Increased 60 1.9 1.9 no signal
259 Injection Site Haemorrhage 25 1.9 1.9 no signal
260 Multiple Sclerosis 15 1.9 1.9 no signal
261 Injection Site Induration 4 1.9 1.9 no signal
262 Mania 5 1.8 1.9 no signal
263 Dry Skin 40 1.8 1.9 no signal
264 Crying 11 1.8 1.8 no signal
265 Malignant Melanoma 4 1.8 1.8 no signal
266 Euphoric Mood 3 1.8 1.8 no signal
267 Application Site Rash 4 1.8 1.8 no signal
268 Knee Arthroplasty 6 1.7 1.8 no signal
269 Withdrawal Syndrome 12 1.7 1.7 no signal
270 Tardive Dyskinesia 8 1.7 1.7 no signal
271 Abnormal Behaviour 11 1.7 1.7 no signal
272 Injection Site Nodule 3 1.7 1.7 no signal
273 Drug Effect Incomplete 10 1.6 1.7 no signal
274 Injection Site Erythema 33 1.6 1.6 no signal
275 Device Failure 4 1.6 1.6 no signal
276 Product Adhesion Issue 9 1.5 1.5 no signal
277 Multiple Sclerosis Relapse 17 1.5 1.5 no signal
278 Application Site Irritation 3 1.5 1.5 no signal
279 Injection Site Extravasation 3 1.5 1.5 no signal
280 Injection Site Pain 70 1.4 1.4 no signal
281 Pharmaceutical Product Complaint 6 1.4 1.4 no signal
282 Osteonecrosis 7 1.3 1.3 no signal
283 Drug Prescribing Error 4 1.2 1.2 no signal
284 Vaginal Haemorrhage 8 1.1 1.1 no signal
285 Skin Burning Sensation 13 1.1 1.1 no signal
286 Drug Exposure During Pregnancy 6 1.1 1.1 no signal
287 Synovitis 3 1.0 1.0 no signal
288 Injection Site Warmth 3 0.9 0.9 no signal
289 Injection Site Swelling 10 0.8 0.8 no signal
290 Extrapyramidal Disorder 3 0.7 0.7 no signal
291 Incorrect Dose Administered By Device 3 0.7 0.7 no signal
292 Bladder Cancer 7 0.7 0.7 no signal
293 Device Dislocation 5 0.7 0.7 no signal
294 Breast Cancer 10 0.6 0.6 no signal
295 Device Breakage 4 0.6 0.6 no signal
296 Renal Cancer 4 0.5 0.5 no signal