Drug
Atropine Sulfate Monohydrate
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 |