Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Milnacipran hydrochloride
Drug ID BADD_D01466
Description Milnacipran is a selective serotonin and norepinephrine reuptake inhibitor (SNRI) and like many agents in this category was originally developed for and continues to be approved and indicated for the treatment of depression [F3928, F3934, A175786, A175951]. Furthermore, in 2009 the US FDA approved milnacipran for the additional indication of treating fibromyalgia [F3925], although other regional regulatory authorities like the EMA, among others, have not yet approved the agent for such treatment, citing lack of robust evidence of efficacy, insufficient demonstration of maintenance of effect, and other concerns [F3928, F3934]. Nevertheless, milnacipran demonstrates a somewhat unique characteristic among SNRIs to elicit a relatively balanced reuptake inhibition of both serotonin and noradrenaline, with a somewhat increased preference for noradrenaline reuptake inhibition - which is potentially a point of interest given the plausible proposal that noradrenaline plays an important role in the mitigation of pain signals in the descending inhibitory pain pathways in the brain and spinal cord [A175759, A175843, A175846]. Moreover, recent research has shown that the levorotatory enantiomer of milnacipran, levomilnacipran, may have the capacity to inhibit the activity of beta-site amyloid precursor protein cleaving enzyme-1 (BACE-1), which has investigationally been associated with β-amyloid plaque formation - making the agent a possible course of treatment for Alzheimer's disease [A175957].
Indications and Usage Milnacipran is used to treat moderate to severe clinical depression but this indication is not yet FDA-approved in the USA. Milnacipran is labelled for the treatment of fibromyalgia pain.
Marketing Status Prescription; Discontinued
ATC Code N06AX17
DrugBank ID DB04896
KEGG ID D01107
MeSH ID D000078764
PubChem ID 163701
TTD Drug ID D09VGC
NDC Product Code 55111-936; 0456-1551; 65015-814; 0456-1525; 0456-1511; 55154-4626; 59349-0021; 50370-0025; 0456-1513; 0456-1526; 68554-0066; 0456-1550; 0456-1500; 0456-1510; 0456-1512; 66039-875
Synonyms Milnacipran | Midalcipran | Milnacipran Hydrochloride | 1-Phenyl-1-diethylaminocarbonyl-2-aminomethylcyclopropane HCl | 1 Phenyl 1 diethylaminocarbonyl 2 aminomethylcyclopropane HCl | Ixel | F 2207 | F-2207 | F2207 | Savella
Chemical Information
Molecular Formula C15H23ClN2O
CAS Registry Number 101152-94-7
SMILES CCN(CC)C(=O)C1(CC1CN)C2=CC=CC=C2.Cl
Chemical Structure
ADR Related Proteins Induced by Drug
ADR Term Protein Name UniProt AC TTD Target ID PMID
Not AvailableNot AvailableNot AvailableNot AvailableNot Available
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Abdominal distension07.01.04.001--
Abdominal pain07.01.05.002--
Accommodation disorder06.02.04.001--Not Available
Aggression19.05.01.001--Not Available
Anger19.04.02.001--Not Available
Anxiety19.06.02.002--
Asthenia08.01.01.001--Not Available
Bladder pain20.02.02.001--Not Available
Blood pressure increased13.14.03.005--Not Available
Body temperature increased13.15.01.001--Not Available
Chest discomfort22.02.08.001; 08.01.08.019; 02.02.02.009--Not Available
Chest pain22.02.08.003; 08.01.08.002; 02.02.02.011--Not Available
Chills08.01.09.001; 15.05.03.016--
Constipation07.02.02.001--
Cystitis20.03.02.002; 11.01.14.001--
Delirium19.13.02.001--
Depression19.15.01.001--
Dermatitis23.03.04.002--Not Available
Diarrhoea07.02.01.001--
Dizziness24.06.02.007; 17.02.05.003; 02.01.02.004--
Dry mouth07.06.01.002--
Dysgeusia17.02.07.003; 07.14.03.001--
Dyspepsia07.01.02.001--
Dyspnoea22.02.01.004; 02.01.03.002--
Dysuria20.02.02.002--
Ejaculation disorder21.03.01.002--
Ejaculation failure21.03.01.003--Not Available
Endocrine disorder05.09.01.001--Not Available
Erythema multiforme23.03.01.003; 10.01.03.015--
Eye disorder06.08.03.001--Not Available
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