Drug
Alprostadil
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 | Neutrophil Count Increased | 54 | 30.9 | 31.3 | signal |
| 2 | Lymphocyte Count Decreased | 79 | 26.2 | 26.8 | signal |
| 3 | Erectile Dysfunction | 93 | 21.2 | 21.7 | signal |
| 4 | Blood Urea Increased | 59 | 20.5 | 20.9 | signal |
| 5 | Haematotoxicity | 20 | 12.6 | 12.7 | signal |
| 6 | Device Failure | 27 | 10.4 | 10.5 | signal |
| 7 | Needle Issue | 49 | 10.0 | 10.2 | signal |
| 8 | Disseminated Intravascular Coagulation | 21 | 8.7 | 8.7 | signal |
| 9 | Arteriosclerosis | 14 | 8.7 | 8.7 | signal |
| 10 | Generalised Oedema | 18 | 8.6 | 8.6 | signal |
| 11 | Drug Reaction With Eosinophilia And Systemic Symptoms | 36 | 8.2 | 8.3 | signal |
| 12 | Lung Infection | 22 | 8.2 | 8.2 | signal |
| 13 | Drug Effect Decreased | 73 | 7.8 | 8.0 | signal |
| 14 | White Blood Cell Count Increased | 51 | 7.7 | 7.8 | signal |
| 15 | Syringe Issue | 23 | 7.7 | 7.7 | signal |
| 16 | Caesarean Section | 15 | 7.5 | 7.5 | signal |
| 17 | Hyperlipidaemia | 15 | 7.3 | 7.3 | signal |
| 18 | Sexual Dysfunction | 14 | 7.0 | 7.0 | signal |
| 19 | Toxic Epidermal Necrolysis | 18 | 7.0 | 7.0 | signal |
| 20 | Myocardial Ischaemia | 13 | 6.6 | 6.6 | signal |
| 21 | Injury Associated With Device | 22 | 6.4 | 6.4 | signal |
| 22 | Procedural Pain | 29 | 6.1 | 6.2 | signal |
| 23 | Blood Triglycerides Increased | 17 | 5.6 | 5.6 | signal |
| 24 | Thrombotic Microangiopathy | 9 | 5.4 | 5.4 | signal |
| 25 | Cardiac Failure | 73 | 5.3 | 5.4 | signal |
| 26 | C-reactive Protein Increased | 33 | 5.3 | 5.3 | signal |
| 27 | Blood Alkaline Phosphatase Increased | 21 | 4.9 | 5.0 | signal |
| 28 | Supraventricular Tachycardia | 8 | 4.9 | 4.9 | signal |
| 29 | Device Malfunction | 55 | 4.8 | 4.8 | signal |
| 30 | Wrong Technique In Drug Usage Process | 30 | 4.8 | 4.8 | signal |
| 31 | Haemoglobin Decreased | 83 | 4.7 | 4.8 | signal |
| 32 | Motor Dysfunction | 8 | 4.6 | 4.6 | signal |
| 33 | Drug Effect Incomplete | 29 | 4.6 | 4.6 | signal |
| 34 | Device Mechanical Issue | 10 | 4.5 | 4.5 | signal |
| 35 | Product Prescribing Error | 18 | 4.4 | 4.5 | signal |
| 36 | Hepatic Function Abnormal | 28 | 4.4 | 4.4 | signal |
| 37 | Pulmonary Congestion | 10 | 4.4 | 4.4 | signal |
| 38 | Multiple Organ Dysfunction Syndrome | 21 | 4.4 | 4.4 | signal |
| 39 | Hypokalaemia | 34 | 4.3 | 4.4 | signal |
| 40 | Ischaemic Stroke | 13 | 4.3 | 4.3 | signal |
| 41 | Coagulopathy | 12 | 4.2 | 4.2 | signal |
| 42 | Prostatic Specific Antigen Increased | 10 | 4.2 | 4.2 | signal |
| 43 | Drug Effect Less Than Expected | 10 | 4.1 | 4.2 | signal |
| 44 | Shock | 16 | 4.1 | 4.1 | signal |
| 45 | Product Quality Issue | 92 | 4.0 | 4.1 | signal |
| 46 | Injection Site Haematoma | 10 | 4.0 | 4.0 | signal |
| 47 | Injection Site Discomfort | 7 | 4.0 | 4.0 | signal |
| 48 | Post Procedural Complication | 13 | 4.0 | 4.0 | signal |
| 49 | Ventricular Extrasystoles | 7 | 3.9 | 3.9 | signal |
| 50 | Ataxia | 8 | 3.9 | 3.9 | signal |
| 51 | Malignant Melanoma | 9 | 3.9 | 3.9 | signal |
| 52 | Drug Ineffective | 883 | 3.9 | 4.9 | signal |
| 53 | Cytomegalovirus Infection | 11 | 3.9 | 3.9 | signal |
| 54 | Pharmaceutical Product Complaint | 17 | 3.8 | 3.8 | signal |
| 55 | Pregnancy | 13 | 3.8 | 3.8 | signal |
| 56 | Alanine Aminotransferase Increased | 39 | 3.7 | 3.7 | signal |
| 57 | Dialysis | 9 | 3.7 | 3.7 | signal |
| 58 | Ventricular Fibrillation | 7 | 3.7 | 3.7 | signal |
| 59 | Blood Creatinine Increased | 41 | 3.7 | 3.7 | signal |
| 60 | Dizziness Postural | 6 | 3.7 | 3.7 | signal |
| 61 | Pulmonary Oedema | 28 | 3.7 | 3.7 | signal |
| 62 | Drug-induced Liver Injury | 19 | 3.6 | 3.6 | signal |
| 63 | Ascites | 18 | 3.6 | 3.6 | signal |
| 64 | Blood Cholesterol Increased | 28 | 3.5 | 3.5 | signal |
| 65 | Incorrect Product Storage | 8 | 3.5 | 3.5 | signal |
| 66 | End Stage Renal Disease | 11 | 3.5 | 3.5 | signal |
| 67 | Skin Ulcer | 15 | 3.4 | 3.4 | signal |
| 68 | Drug Dispensing Error | 9 | 3.4 | 3.4 | signal |
| 69 | Drug Administration Error | 18 | 3.4 | 3.4 | signal |
| 70 | Blood Urine Present | 11 | 3.4 | 3.4 | signal |
| 71 | Cyanosis | 9 | 3.3 | 3.3 | signal |
| 72 | No Therapeutic Response | 7 | 3.3 | 3.3 | signal |
| 73 | Premature Baby | 17 | 3.3 | 3.3 | signal |
| 74 | Device Defective | 9 | 3.3 | 3.3 | signal |
| 75 | Blood Potassium Increased | 9 | 3.2 | 3.2 | signal |
| 76 | Haematuria | 19 | 3.2 | 3.3 | signal |
| 77 | Blood Bilirubin Increased | 15 | 3.2 | 3.2 | signal |
| 78 | Product Dispensing Error | 12 | 3.2 | 3.2 | signal |
| 79 | Product Packaging Issue | 5 | 3.2 | 3.2 | signal |
| 80 | Therapeutic Product Effect Decreased | 23 | 3.0 | 3.0 | signal |
| 81 | Drug Prescribing Error | 10 | 3.0 | 3.0 | signal |
| 82 | Multi-organ Failure | 9 | 3.0 | 3.0 | signal |
| 83 | Diabetes Mellitus | 39 | 3.0 | 3.0 | signal |
| 84 | Haemoptysis | 14 | 2.9 | 2.9 | signal |
| 85 | Therapeutic Product Effect Incomplete | 35 | 2.9 | 2.9 | signal |
| 86 | Toxic Skin Eruption | 5 | 2.9 | 2.9 | signal |
| 87 | Cerebral Infarction | 12 | 2.9 | 2.9 | signal |
| 88 | Subarachnoid Haemorrhage | 5 | 2.9 | 2.9 | signal |
| 89 | Poor Quality Product Administered | 5 | 2.9 | 2.9 | signal |
| 90 | Injection Site Discolouration | 6 | 2.8 | 2.8 | signal |
| 91 | Device Breakage | 19 | 2.8 | 2.8 | signal |
| 92 | Ventricular Tachycardia | 8 | 2.8 | 2.8 | signal |
| 93 | Expired Product Administered | 16 | 2.8 | 2.8 | signal |
| 94 | Intentional Drug Misuse | 10 | 2.8 | 2.8 | signal |
| 95 | Drug Administered At Inappropriate Site | 5 | 2.7 | 2.7 | no signal |
| 96 | Haemorrhage Intracranial | 7 | 2.7 | 2.7 | signal |
| 97 | Wound Infection | 5 | 2.7 | 2.7 | no signal |
| 98 | Product Use Complaint | 7 | 2.6 | 2.6 | signal |
| 99 | Product Administration Error | 9 | 2.6 | 2.6 | signal |
| 100 | Prostate Cancer | 36 | 2.6 | 2.6 | signal |
| 101 | Injection Site Haemorrhage | 35 | 2.6 | 2.6 | signal |
| 102 | Abscess | 7 | 2.6 | 2.6 | signal |
| 103 | Incorrect Dose Administered By Device | 11 | 2.5 | 2.5 | signal |
| 104 | Coronary Artery Disease | 13 | 2.5 | 2.5 | signal |
| 105 | Angina Pectoris | 12 | 2.4 | 2.4 | signal |
| 106 | Device Use Issue | 7 | 2.4 | 2.4 | signal |
| 107 | Stevens-johnson Syndrome | 9 | 2.4 | 2.4 | signal |
| 108 | Body Temperature Decreased | 4 | 2.4 | 2.4 | no signal |
| 109 | Interstitial Lung Disease | 19 | 2.3 | 2.3 | signal |
| 110 | Hyperbilirubinaemia | 4 | 2.3 | 2.3 | no signal |
| 111 | Product Preparation Error | 8 | 2.3 | 2.3 | signal |
| 112 | Device Leakage | 16 | 2.2 | 2.2 | signal |
| 113 | Device Occlusion | 5 | 2.1 | 2.1 | no signal |
| 114 | Obstructive Airways Disorder | 4 | 2.1 | 2.1 | no signal |
| 115 | Drug Exposure During Pregnancy | 12 | 2.0 | 2.0 | signal |
| 116 | Gastric Haemorrhage | 4 | 2.0 | 2.0 | no signal |
| 117 | Blood Glucose Increased | 65 | 2.0 | 2.0 | signal |
| 118 | Medication Error | 19 | 2.0 | 2.0 | signal |
| 119 | Peritonitis | 7 | 2.0 | 2.0 | no signal |
| 120 | Blood Thyroid Stimulating Hormone Increased | 3 | 1.9 | 1.9 | no signal |
| 121 | Lymphoma | 5 | 1.9 | 1.9 | no signal |
| 122 | Anaphylactic Shock | 8 | 1.8 | 1.8 | no signal |
| 123 | Anorexia | 4 | 1.8 | 1.8 | no signal |
| 124 | Injection Site Pain | 92 | 1.8 | 1.8 | no signal |
| 125 | Inappropriate Antidiuretic Hormone Secretion | 3 | 1.7 | 1.7 | no signal |
| 126 | Neurotoxicity | 5 | 1.7 | 1.7 | no signal |
| 127 | Wrong Technique In Device Usage Process | 13 | 1.7 | 1.7 | no signal |
| 128 | Cardiovascular Disorder | 7 | 1.6 | 1.6 | no signal |
| 129 | Blood Glucose Fluctuation | 3 | 1.6 | 1.6 | no signal |
| 130 | Drug Resistance | 7 | 1.6 | 1.6 | no signal |
| 131 | Myocarditis | 3 | 1.5 | 1.5 | no signal |
| 132 | Bone Marrow Failure | 5 | 1.4 | 1.4 | no signal |
| 133 | Libido Decreased | 3 | 1.4 | 1.4 | no signal |
| 134 | Injection Site Induration | 3 | 1.4 | 1.4 | no signal |
| 135 | Incorrect Dose Administered | 50 | 1.3 | 1.3 | no signal |
| 136 | Wrong Technique In Product Usage Process | 44 | 1.3 | 1.3 | no signal |
| 137 | Diabetic Ketoacidosis | 5 | 1.2 | 1.2 | no signal |
| 138 | Pulmonary Arterial Hypertension | 3 | 1.2 | 1.2 | no signal |
| 139 | Myelosuppression | 7 | 1.2 | 1.2 | no signal |
| 140 | Dystonia | 4 | 1.2 | 1.2 | no signal |
| 141 | Drug Effective For Unapproved Indication | 6 | 1.2 | 1.2 | no signal |
| 142 | Device Delivery System Issue | 5 | 1.1 | 1.1 | no signal |
| 143 | Application Site Pain | 4 | 1.1 | 1.1 | no signal |
| 144 | Circumstance Or Information Capable Of Leading To Medication Error | 6 | 1.0 | 1.0 | no signal |
| 145 | Tardive Dyskinesia | 5 | 1.0 | 1.0 | no signal |
| 146 | Product Storage Error | 15 | 1.0 | 1.0 | no signal |
| 147 | Device Issue | 15 | 1.0 | 1.0 | no signal |
| 148 | Injection Site Mass | 6 | 1.0 | 1.0 | no signal |
| 149 | Product Complaint | 4 | 0.9 | 0.9 | no signal |
| 150 | Bladder Cancer | 9 | 0.9 | 0.9 | no signal |
| 151 | Exposure Via Skin Contact | 3 | 0.8 | 0.8 | no signal |
| 152 | Gynaecomastia | 4 | 0.7 | 0.7 | no signal |
| 153 | Device Use Error | 4 | 0.7 | 0.7 | no signal |
| 154 | Device Difficult To Use | 7 | 0.6 | 0.6 | no signal |
| 155 | Drug Dependence | 13 | 0.5 | 0.5 | no signal |
| 156 | Drug Dose Omission By Device | 5 | 0.4 | 0.4 | no signal |
| 157 | Dependence | 3 | 0.3 | 0.3 | no signal |