Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Milnacipran
Drug ID BADD_D02449
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 a selective serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the management of fibromyalgia in patients that are 18 years old or above [F3925]. At the same time, levomilnacipran is indicated for the treatment of major depressive disorder (MDD) in patients that are 18 years old or above [F3922], although some regional prescribing information notes that use of the medication is specifically for the short-term symptomatic relief of MDD [F3919]. Nevertheless, it is important to note that the regulatory approval of and/or indications listed here for milnacipran may or may not exist and/or vary greatly between regions and nations [F3928, F3934].
Marketing Status Not Available
ATC Code N06AX17
DrugBank ID DB04896
KEGG ID D08222
MeSH ID D000078764
PubChem ID 65833
TTD Drug ID D09VGC
NDC Product Code Not Available
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 C15H22N2O
CAS Registry Number 96847-55-1
SMILES CCN(CC)C(=O)C1(CC1CN)C2=CC=CC=C2
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 pain07.01.05.0020.003226%
Aggression19.05.01.0010.002151%Not Available
Agitation17.02.05.012; 19.06.02.0010.002151%
Anxiety19.06.02.0020.007527%
Asthenia08.01.01.001--Not Available
Blood pressure increased13.14.03.0050.006452%Not Available
Confusional state19.13.01.001; 17.02.03.0050.004301%
Crying19.04.02.002; 17.02.05.013; 12.02.11.001; 08.01.03.0050.003226%Not Available
Death08.04.01.001--
Dehydration14.05.05.0010.004301%
Depression19.15.01.0010.008602%
Diarrhoea07.02.01.001--
Dizziness24.06.02.007; 17.02.05.003; 02.01.02.0040.008602%
Drug hypersensitivity10.01.01.0010.022581%Not Available
Dyspnoea22.02.01.004; 02.01.03.002--
Emotional disorder19.04.02.0050.002151%Not Available
Fatigue08.01.01.002--
Feeling abnormal08.01.09.0140.004301%Not Available
Food allergy10.01.01.0120.002151%Not Available
Headache17.14.01.0010.015054%
Heart rate increased13.14.04.0020.005376%Not Available
Hyperhidrosis08.01.03.028; 23.02.03.0040.007527%
Hypersensitivity10.01.03.0030.013979%
Hypertension24.08.02.0010.005376%
Hypertensive crisis24.08.01.0010.003226%Not Available
Hypomania19.16.02.0010.003226%Not Available
Hypotension24.06.03.0020.002151%
Insomnia19.02.01.002; 17.15.03.0020.005376%
Malaise08.01.01.0030.003226%
Migraine24.03.05.003; 17.14.02.0010.002151%Not Available
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