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Drug

Atropine Sulfate Monohydrate

164 flagged reaction(s) · 3,258 total co-reports · max PRR 141.7
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 Macular Degeneration 197 141.7 153.8 signal
2 Vaginal Discharge 65 54.9 56.3 signal
3 Paraesthesia Oral 89 52.5 54.4 signal
4 Oral Candidiasis 66 43.0 44.1 signal
5 Mydriasis 39 25.7 26.1 signal
6 Procedural Pain 84 25.7 26.5 signal
7 Frequent Bowel Movements 70 22.0 22.6 signal
8 Colitis 73 16.4 16.8 signal
9 Rectal Haemorrhage 81 15.9 16.4 signal
10 Ventricular Tachycardia 30 15.3 15.5 signal
11 Supraventricular Tachycardia 16 14.1 14.2 signal
12 Colitis Ulcerative 67 12.7 13.0 signal
13 Disseminated Intravascular Coagulation 21 12.6 12.6 signal
14 Foot Deformity 16 12.2 12.2 signal
15 Ventricular Fibrillation 16 12.1 12.2 signal
16 Retinal Detachment 13 11.9 12.0 signal
17 Toxic Epidermal Necrolysis 21 11.8 11.8 signal
18 Haematochezia 76 11.6 12.0 signal
19 Infusion Related Reaction 89 11.4 11.8 signal
20 Therapeutic Product Effect Incomplete 94 11.2 11.6 signal
21 Body Temperature Decreased 13 11.0 11.1 signal
22 Cardiogenic Shock 18 10.6 10.7 signal
23 Anaphylactic Shock 32 10.5 10.7 signal
24 Ileus 15 10.3 10.3 signal
25 Bradycardia 63 10.0 10.2 signal
26 Ankle Fracture 18 9.8 9.9 signal
27 Metabolic Acidosis 35 9.3 9.4 signal
28 Neuroleptic Malignant Syndrome 13 9.2 9.3 signal
29 Muscle Rigidity 13 9.2 9.2 signal
30 Atelectasis 10 8.7 8.7 signal
31 Photophobia 19 8.6 8.6 signal
32 Eye Pain 56 8.6 8.7 signal
33 Dyspepsia 96 8.3 8.5 signal
34 Delusion 15 8.2 8.2 signal
35 Sinus Bradycardia 9 7.8 7.9 signal
36 Rhabdomyolysis 38 7.7 7.8 signal
37 Respiratory Depression 11 7.6 7.6 signal
38 Foot Fracture 17 7.5 7.6 signal
39 Blood Calcium Decreased 10 7.5 7.5 signal
40 Cardiomyopathy 13 7.4 7.4 signal
41 Post Procedural Complication 16 7.0 7.1 signal
42 Synovitis 15 7.0 7.0 signal
43 Delirium 28 6.8 6.9 signal
44 Myocardial Ischaemia 9 6.6 6.6 signal
45 Sinus Tachycardia 11 6.5 6.6 signal
46 Ventricular Extrasystoles 8 6.5 6.5 signal
47 Bronchospasm 11 6.5 6.5 signal
48 Cardiac Arrest 62 6.3 6.4 signal
49 Eye Inflammation 7 6.3 6.3 signal
50 Cardio-respiratory Arrest 31 6.2 6.3 signal
51 Blood Pressure Systolic Increased 14 6.0 6.1 signal
52 Product Administration Error 14 5.9 5.9 signal
53 Blood Lactate Dehydrogenase Increased 11 5.8 5.8 signal
54 Eye Discharge 7 5.8 5.8 signal
55 Multi-organ Failure 12 5.8 5.8 signal
56 Thirst 12 5.7 5.7 signal
57 Blood Pressure Decreased 44 5.6 5.7 signal
58 Shock 15 5.5 5.6 signal
59 Haematocrit Decreased 13 5.5 5.5 signal
60 Cardiomegaly 8 5.4 5.5 signal
61 Circulatory Collapse 11 5.4 5.4 signal
62 Abortion Induced 6 5.4 5.4 signal
63 Muscle Atrophy 8 5.4 5.4 signal
64 Brain Oedema 8 5.3 5.4 signal
65 Impaired Gastric Emptying 8 5.3 5.3 signal
66 Paralysis 9 5.3 5.3 signal
67 Pulmonary Oedema 28 5.3 5.3 signal
68 Affect Lability 6 5.2 5.2 signal
69 Hallucination, Visual 13 5.2 5.2 signal
70 Coagulopathy 10 5.1 5.1 signal
71 Salivary Hypersecretion 6 5.1 5.1 signal
72 Euphoric Mood 6 4.9 4.9 signal
73 Skin Ulcer 15 4.9 4.9 signal
74 Urinary Retention 19 4.8 4.8 signal
75 Skin Laceration 6 4.7 4.7 signal
76 Ocular Discomfort 6 4.7 4.7 signal
77 Blood Creatine Phosphokinase Increased 16 4.6 4.6 signal
78 Transaminases Increased 12 4.6 4.6 signal
79 Obstructive Airways Disorder 6 4.5 4.5 signal
80 Poisoning Deliberate 5 4.5 4.5 signal
81 Depressed Level Of Consciousness 21 4.5 4.5 signal
82 Dysarthria 20 4.5 4.5 signal
83 Erythema 108 4.4 4.6 signal
84 Tachypnoea 7 4.4 4.4 signal
85 Psychotic Disorder 15 4.3 4.3 signal
86 Cyanosis 8 4.3 4.3 signal
87 Ataxia 6 4.2 4.3 signal
88 Hypotonia 5 4.2 4.2 signal
89 Schizophrenia 6 4.2 4.2 signal
90 Agitation 36 4.1 4.2 signal
91 Extrapyramidal Disorder 12 4.0 4.0 signal
92 Visual Acuity Reduced 16 4.0 4.0 signal
93 Incorrect Route Of Product Administration 8 4.0 4.0 signal
94 Feeling Jittery 9 4.0 4.0 signal
95 Cholestasis 9 4.0 4.0 signal
96 Intraocular Pressure Increased 6 3.9 3.9 signal
97 Product Dispensing Error 10 3.9 3.9 signal
98 Syringe Issue 8 3.8 3.9 signal
99 Metastases To Liver 8 3.8 3.9 signal
100 Cerebral Infarction 11 3.8 3.8 signal
101 Hypertensive Crisis 5 3.8 3.8 signal
102 Eye Infection 5 3.8 3.8 signal
103 Neoplasm 5 3.7 3.7 signal
104 Hepatic Function Abnormal 16 3.6 3.7 signal
105 Respiratory Arrest 12 3.6 3.7 signal
106 Toxicity To Various Agents 72 3.6 3.7 signal
107 Ocular Hyperaemia 20 3.6 3.6 signal
108 Eyelid Oedema 5 3.6 3.6 signal
109 Blindness Unilateral 6 3.6 3.6 signal
110 Heart Rate Decreased 15 3.6 3.6 signal
111 Drug Hypersensitivity 82 3.6 3.6 signal
112 Blood Urine Present 8 3.5 3.5 signal
113 Swollen Tongue 13 3.5 3.5 signal
114 Glaucoma 8 3.5 3.5 signal
115 Paranoia 7 3.4 3.4 signal
116 Psoriatic Arthropathy 16 3.4 3.4 signal
117 Medication Error 22 3.3 3.4 signal
118 Pharyngeal Oedema 6 3.2 3.2 signal
119 Needle Issue 11 3.2 3.3 signal
120 Haematoma 10 3.2 3.2 signal
121 Lung Infection 6 3.2 3.2 signal
122 Blindness 15 3.1 3.1 signal
123 Eructation 7 3.1 3.1 signal
124 Generalised Tonic-clonic Seizure 6 3.1 3.1 signal
125 Hallucination 27 3.0 3.1 signal
126 Myocarditis 4 3.0 3.0 no signal
127 Eye Swelling 13 3.0 3.0 signal
128 Sedation 9 2.9 2.9 signal
129 Myoclonus 4 2.8 2.8 no signal
130 Therapy Partial Responder 5 2.8 2.8 signal
131 Diarrhoea Haemorrhagic 3 2.7 2.7 no signal
132 Laceration 3 2.7 2.7 no signal
133 Mania 5 2.6 2.6 no signal
134 Pneumocystis Jirovecii Pneumonia 3 2.5 2.5 no signal
135 Peritonitis 6 2.4 2.4 no signal
136 Device Occlusion 4 2.4 2.4 no signal
137 Eye Irritation 16 2.4 2.4 signal
138 Lactic Acidosis 9 2.4 2.4 signal
139 Apathy 4 2.3 2.3 no signal
140 Drug Reaction With Eosinophilia And Systemic Symptoms 7 2.3 2.3 no signal
141 Accidental Overdose 10 2.3 2.3 signal
142 Eye Pruritus 9 2.3 2.3 signal
143 Colon Cancer 4 2.3 2.3 no signal
144 Drug Dispensing Error 4 2.2 2.2 no signal
145 Incorrect Route Of Drug Administration 9 2.1 2.1 signal
146 Metastases To Bone 4 2.1 2.1 no signal
147 Poisoning 3 2.0 2.0 no signal
148 Complication Associated With Device 3 1.9 1.9 no signal
149 Uveitis 3 1.9 1.9 no signal
150 Lung Neoplasm Malignant 9 1.8 1.8 no signal
151 Device Breakage 8 1.7 1.7 no signal
152 Device Failure 3 1.7 1.7 no signal
153 Pharmaceutical Product Complaint 5 1.6 1.6 no signal
154 Device Defective 3 1.6 1.6 no signal
155 Device Use Issue 3 1.5 1.5 no signal
156 Intentional Overdose 10 1.3 1.3 no signal
157 Dystonia 3 1.3 1.3 no signal
158 Circumstance Or Information Capable Of Leading To Medication Error 5 1.3 1.3 no signal
159 Drug Abuse 12 1.2 1.2 no signal
160 Completed Suicide 11 1.1 1.1 no signal
161 Device Issue 10 1.0 1.0 no signal
162 Myelosuppression 3 0.7 0.7 no signal
163 Drug Exposure During Pregnancy 3 0.7 0.7 no signal
164 Colorectal Cancer 3 0.5 0.5 no signal