Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Miltefosine
Drug ID BADD_D01469
Description Miltefosine is a broad spectrum antimicrobial, anti-leishmanial, phospholipid drug that was originally developed in the 1980s as an anti-cancer agent. It is currently the only recognized oral agent used to treat visceral, cutaneous, and mucosal forms of leishmaniasis, a neglected tropical disease. It can be administered topically or orally and is only indicated in patients aged 12 years or older. The CDC has also recommended it as a first line treatment for free-living amebae (FLA) infections such as primary amebic meningoencephalitis and granulomatous amebic encephalitis.
Indications and Usage For the treatment of mucosal (caused by Leishmania braziliensis), cutaneous (caused by L. braziliensis, L. guyanensis, and L. panamensis), and visceral leishmaniasis (caused by L. donovani). In comparing Leishmania drug susceptibility, it has been found that L. donovani is the most susceptible to miltefosine while L. major is the least susceptible. Off-label use includes treatment of free-living amebae (FLA) infections (unlabeled use; CDC, 2013).
Marketing Status approved; investigational
ATC Code P01CX04
DrugBank ID DB09031
KEGG ID D02494
MeSH ID C039128
PubChem ID 3599
TTD Drug ID D00FGR
NDC Product Code 69051-300; 71052-509
UNII 53EY29W7EC
Synonyms miltefosine | n-hexadecylphosphorylcholine | HDPC | hexadecylphosphocholine | Miltex | Impavido | D 18506 | D18506 | D-18506
Chemical Information
Molecular Formula C21H46NO4P
CAS Registry Number 58066-85-6
SMILES CCCCCCCCCCCCCCCCOP(=O)([O-])OCC[N+](C)(C)C
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)
Abdominal pain07.01.05.002--
Agranulocytosis01.02.03.001---
Asthenia08.01.01.001---
Diarrhoea07.02.01.001--
Dizziness02.11.04.006; 17.02.05.003; 24.06.02.007--
Ejaculation failure21.03.01.003---
Epistaxis22.04.03.001; 24.07.01.005--
Generalised oedema08.01.07.004; 14.05.06.007--
Headache17.14.01.001--
Jaundice01.06.04.004; 09.01.01.004; 23.03.03.030---
Lymphangitis01.09.01.005; 11.01.15.001; 24.09.02.001---
Malaise08.01.01.003--
Melaena07.12.02.004; 24.07.02.013---
Motion sickness04.04.01.001; 17.02.12.001---
Nausea07.01.07.001--
Oedema peripheral02.05.04.007; 08.01.07.007; 14.05.06.011--
Pruritus23.03.12.001--
Pyrexia08.05.02.003--
Scrotal pain21.12.02.004--
Seizure17.12.03.001--
Somnolence17.02.04.006; 19.02.05.003--
Thrombocytopenia01.08.01.002---
Vomiting07.01.07.003--
Decreased appetite08.01.09.028; 14.03.01.005--
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