Drug
Oxytocin
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 | Premature Delivery | 160 | 71.0 | 75.0 | signal |
| 2 | Caesarean Section | 105 | 63.3 | 65.6 | signal |
| 3 | Premature Baby | 206 | 48.3 | 51.8 | signal |
| 4 | Exposure During Pregnancy | 361 | 41.1 | 46.6 | signal |
| 5 | Foetal Exposure During Pregnancy | 443 | 38.5 | 45.1 | signal |
| 6 | Maternal Exposure During Pregnancy | 432 | 34.6 | 40.3 | signal |
| 7 | Drug Exposure During Pregnancy | 143 | 29.3 | 30.7 | signal |
| 8 | Hypothermia | 24 | 16.7 | 16.8 | signal |
| 9 | Disseminated Intravascular Coagulation | 32 | 16.0 | 16.1 | signal |
| 10 | Hypotonia | 16 | 11.2 | 11.3 | signal |
| 11 | Hypoxia | 54 | 10.8 | 11.0 | signal |
| 12 | Anaphylactic Reaction | 66 | 8.5 | 8.6 | signal |
| 13 | Cyanosis | 18 | 8.0 | 8.1 | signal |
| 14 | Pregnancy | 22 | 7.7 | 7.7 | signal |
| 15 | Pulmonary Oedema | 47 | 7.4 | 7.5 | signal |
| 16 | Status Epilepticus | 11 | 6.8 | 6.9 | signal |
| 17 | Hypotension | 191 | 6.7 | 7.1 | signal |
| 18 | Myoclonus | 11 | 6.5 | 6.5 | signal |
| 19 | Sinus Tachycardia | 13 | 6.5 | 6.5 | signal |
| 20 | Bronchospasm | 13 | 6.4 | 6.4 | signal |
| 21 | Respiratory Distress | 25 | 6.4 | 6.4 | signal |
| 22 | Metabolic Acidosis | 28 | 6.2 | 6.3 | signal |
| 23 | Tachycardia | 77 | 6.1 | 6.2 | signal |
| 24 | Pulmonary Hypertension | 18 | 6.1 | 6.1 | signal |
| 25 | Paraesthesia Oral | 12 | 5.9 | 5.9 | signal |
| 26 | Aspiration | 9 | 5.8 | 5.9 | signal |
| 27 | Sinus Bradycardia | 8 | 5.8 | 5.8 | signal |
| 28 | Anaphylactic Shock | 21 | 5.8 | 5.8 | signal |
| 29 | Respiratory Depression | 10 | 5.7 | 5.8 | signal |
| 30 | Generalised Tonic-clonic Seizure | 13 | 5.6 | 5.6 | signal |
| 31 | Ejection Fraction Decreased | 12 | 5.4 | 5.4 | signal |
| 32 | Circulatory Collapse | 13 | 5.3 | 5.4 | signal |
| 33 | Vaginal Haemorrhage | 32 | 5.3 | 5.3 | signal |
| 34 | Tachypnoea | 10 | 5.2 | 5.2 | signal |
| 35 | Posterior Reversible Encephalopathy Syndrome | 7 | 5.2 | 5.2 | signal |
| 36 | Contraindicated Product Administered | 22 | 5.1 | 5.2 | signal |
| 37 | Mitral Valve Incompetence | 8 | 5.0 | 5.0 | signal |
| 38 | Myocardial Ischaemia | 8 | 4.9 | 4.9 | signal |
| 39 | Subarachnoid Haemorrhage | 7 | 4.8 | 4.8 | signal |
| 40 | Tooth Infection | 9 | 4.8 | 4.8 | signal |
| 41 | Oxygen Saturation Decreased | 37 | 4.7 | 4.7 | signal |
| 42 | No Therapeutic Response | 8 | 4.5 | 4.6 | signal |
| 43 | Proteinuria | 12 | 4.5 | 4.5 | signal |
| 44 | Ventricular Fibrillation | 7 | 4.4 | 4.4 | signal |
| 45 | Supraventricular Tachycardia | 6 | 4.4 | 4.4 | signal |
| 46 | Hyponatraemia | 35 | 4.4 | 4.4 | signal |
| 47 | Cardiomyopathy | 9 | 4.3 | 4.3 | signal |
| 48 | Motor Dysfunction | 6 | 4.2 | 4.2 | signal |
| 49 | Acute Respiratory Distress Syndrome | 10 | 4.0 | 4.0 | signal |
| 50 | Bradycardia | 30 | 4.0 | 4.0 | signal |
| 51 | Aphasia | 17 | 3.9 | 4.0 | signal |
| 52 | Haemoglobin Decreased | 56 | 3.8 | 3.9 | signal |
| 53 | Drug Withdrawal Syndrome Neonatal | 8 | 3.8 | 3.8 | signal |
| 54 | Depressed Level Of Consciousness | 21 | 3.7 | 3.8 | signal |
| 55 | Shock | 12 | 3.7 | 3.7 | signal |
| 56 | Post Procedural Complication | 10 | 3.7 | 3.7 | signal |
| 57 | Cardiac Arrest | 43 | 3.7 | 3.7 | signal |
| 58 | Body Temperature Decreased | 5 | 3.5 | 3.5 | signal |
| 59 | Cardiogenic Shock | 7 | 3.5 | 3.5 | signal |
| 60 | Dermatitis Allergic | 6 | 3.4 | 3.4 | signal |
| 61 | Cardio-respiratory Arrest | 20 | 3.3 | 3.4 | signal |
| 62 | Face Oedema | 8 | 3.3 | 3.3 | signal |
| 63 | Drug Resistance | 12 | 3.3 | 3.3 | signal |
| 64 | Unresponsive To Stimuli | 12 | 3.3 | 3.3 | signal |
| 65 | Multi-organ Failure | 8 | 3.2 | 3.2 | signal |
| 66 | Dyskinesia | 18 | 3.1 | 3.1 | signal |
| 67 | Haemorrhage | 45 | 3.0 | 3.1 | signal |
| 68 | Grand Mal Convulsion | 4 | 3.0 | 3.0 | no signal |
| 69 | Abortion Induced | 4 | 3.0 | 3.0 | no signal |
| 70 | Vaginal Discharge | 4 | 2.8 | 2.8 | no signal |
| 71 | Injury | 28 | 2.8 | 2.8 | signal |
| 72 | Anhedonia | 10 | 2.7 | 2.7 | signal |
| 73 | Abortion Spontaneous | 15 | 2.6 | 2.6 | signal |
| 74 | Pruritus Generalised | 8 | 2.6 | 2.6 | signal |
| 75 | Muscle Rigidity | 4 | 2.4 | 2.4 | no signal |
| 76 | Procedural Pain | 8 | 2.0 | 2.0 | no signal |
| 77 | Pelvic Pain | 5 | 1.9 | 1.9 | no signal |
| 78 | Blood Count Abnormal | 4 | 1.8 | 1.8 | no signal |
| 79 | Ankylosing Spondylitis | 3 | 1.6 | 1.6 | no signal |
| 80 | Prostatic Specific Antigen Increased | 3 | 1.5 | 1.5 | no signal |
| 81 | Dystonia | 4 | 1.4 | 1.4 | no signal |
| 82 | Drug Dispensing Error | 3 | 1.4 | 1.4 | no signal |
| 83 | Incorrect Route Of Drug Administration | 7 | 1.4 | 1.4 | no signal |
| 84 | Pharmaceutical Product Complaint | 5 | 1.3 | 1.3 | no signal |
| 85 | Drug Effect Incomplete | 6 | 1.1 | 1.1 | no signal |
| 86 | Circumstance Or Information Capable Of Leading To Medication Error | 5 | 1.0 | 1.0 | no signal |
| 87 | Product Preparation Error | 3 | 1.0 | 1.0 | no signal |
| 88 | Dependence | 8 | 1.0 | 1.0 | no signal |
| 89 | Drug Withdrawal Syndrome | 11 | 0.9 | 0.9 | no signal |
| 90 | Incorrect Dose Administered By Device | 3 | 0.8 | 0.8 | no signal |
| 91 | Device Dislocation | 5 | 0.8 | 0.8 | no signal |
| 92 | Drug Dependence | 17 | 0.7 | 0.7 | no signal |
| 93 | Device Malfunction | 7 | 0.7 | 0.7 | no signal |
| 94 | Device Issue | 9 | 0.7 | 0.7 | no signal |
| 95 | Device Difficult To Use | 4 | 0.4 | 0.4 | no signal |