Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Alprostadil
Drug ID BADD_D00086
Description Alprostadil is produced endogenously and causes vasodilation by means of a direct effect on vascular and ductus arteriosus (DA) smooth muscle, preventing or reversing the functional closure of the DA that occurs shortly after birth. This results in increased pulmonary or systemic blood flow in infants. In infants, it is used for palliative, not definitive, therapy to temporarily maintain the patency of the ductus arteriosus until corrective or palliative surgery can be performed in neonates who have congenital heart defects and who depend upon the patent ductus for survival. In adults, it is used for the treatment of erectile dysfunction due to neurogenic, vasculogenic, psychogenic, or mixed etiology.
Indications and Usage For palliative, not definitive, therapy to temporarily maintain the patency of the ductus arteriosus until corrective or palliative surgery can be performed in neonates who have congenital heart defects and who depend upon the patent ductus for survival. Also for the treatment of erectile dysfunction due to neurogenic, vasculogenic, psychogenic, or mixed etiology.
Marketing Status approved; investigational
ATC Code C01EA01; G04BE01
DrugBank ID DB00770
KEGG ID D00180
MeSH ID D000527
PubChem ID 5280723
TTD Drug ID D0I4DQ
NDC Product Code 0037-8120; 0037-8130; 0037-8140; 68245-0007; 73212-075; 45542-1152; 49452-0073; 40016-010; 0009-3701; 0009-5182; 52244-020; 82231-101; 0009-3169; 0009-5181; 63539-221; 0009-0042; 51552-0498; 51927-2196; 71052-146; 63539-121; 63902-100; 0009-0215; 52244-010; 52244-040; 38779-0944; 65035-101; 0009-7686
UNII F5TD010360
Synonyms Alprostadil | PGE1alpha | Prostaglandin E1alpha | PGE1 | Lipo-PGE1 | Lipo PGE1 | Prostaglandin E1 | Caverject | Edex | Prostavasin | Muse | Viridal | Vasaprostan | Minprog | Sugiran | Prostin VR | Prostine VR
Chemical Information
Molecular Formula C20H34O5
CAS Registry Number 745-65-3
SMILES CCCCCC(C=CC1C(CC(=O)C1CCCCCCC(=O)O)O)O
Chemical Structure
ADRs Induced by Drug
*The priority for ADR severity classification is based on FAERS assessment, followed by the most severe level in CTCAE rating. If neither is available, it will be displayed as 'Not available'.
**The 'Not Available' level is hidden by default and can be restored by clicking on the legend twice.
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Injection site pain08.02.03.010; 12.07.03.0110.015384%-
Injection site pruritus08.02.03.013; 12.07.03.014; 23.03.12.007---
Injection site reaction08.02.03.014; 12.07.03.015--
Injury12.01.08.004---
Instillation site pain08.02.01.008; 12.07.01.008---
Iron deficiency anaemia01.03.01.002; 14.13.02.0010.001148%-
Irritability08.01.03.011; 19.04.02.0130.001148%
Joint dislocation12.04.02.007; 15.01.07.002---
Lethargy08.01.01.008; 17.02.04.003; 19.04.04.004--
Local reaction08.01.03.012---
Loss of consciousness17.02.04.004---
Memory impairment17.03.02.003; 19.20.01.0030.003903%
Microcephaly03.11.02.002; 15.11.02.002---
Micturition urgency20.02.02.006--
Multiple fractures12.04.02.009; 15.08.02.005---
Muscle spasms15.05.03.004--
Mydriasis06.05.03.004; 17.02.11.003---
Myocardial infarction02.02.02.007; 24.04.04.0090.002296%
Nasal congestion22.04.04.001--
Nausea07.01.07.001--
Neoplasm skin16.03.02.003; 23.08.02.003---
Nervousness19.06.02.003---
Oedema08.01.07.006; 14.05.06.010---
Pain08.01.08.004--
Pain in extremity15.03.04.010--
Pelvic pain07.01.06.012; 20.02.03.007; 21.10.01.001--
Penile haemorrhage21.12.01.011; 24.07.03.0180.001148%-
Penile pain21.12.01.0080.010677%
Penile swelling21.12.01.0060.003903%-
Penis disorder21.12.01.001---
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ADReCS-Target
Drug Name ADR Term Target
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