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 a selective serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the management of fibromyalgia in patients that are 18 years old or above [F3925]. While milnacipran may be used for the treatment of major depressive disorder (MDD), it is only recommended in adult patients who are 18 years old or above [F3922] due to an increased risk for suicidal ideation, thinking, and behavior in children, adolescents, and young adults taking antidepressants for major depressive disorder (MDD) and other psychiatric disorders. Some regional prescribing information notes that the 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 approved; investigational
ATC Code N06AX17
DrugBank ID DB04896
KEGG ID D01107
MeSH ID D000078764
PubChem ID 163701
TTD Drug ID D09VGC
NDC Product Code 65015-814; 0456-1513; 0456-1550; 0456-1526; 55154-4626; 0456-1510; 66039-875; 0456-1512; 0456-1525; 50370-0025; 55111-936; 68554-0066; 59349-0021; 0456-1500; 0456-1551; 0456-1511
UNII RNZ43O5WW5
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
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)
Fall12.01.08.002--
Fatigue08.01.01.002--
Flatulence07.01.04.002--
Flushing08.01.03.025; 24.03.01.002; 23.06.05.003--
Galactorrhoea21.05.02.002; 05.03.04.002--Not Available
Gastrooesophageal reflux disease07.02.02.003--
Gastrointestinal disorder07.11.01.001--Not Available
Gastrointestinal pain07.01.05.005--
Generalised tonic-clonic seizure17.12.01.002--Not Available
Hallucination19.10.04.003--
Headache17.14.01.001--
Heart rate increased13.14.04.002--Not Available
Hepatitis09.01.07.004--Not Available
Hypercholesterolaemia14.08.01.001--Not Available
Hyperhidrosis23.02.03.004; 08.01.03.028--
Hyperprolactinaemia05.03.01.002--Not Available
Hypertension24.08.02.001--
Hypertensive crisis24.08.01.001--Not Available
Hypoaesthesia17.02.06.023; 23.03.03.081--Not Available
Hyponatraemia14.05.04.002--
Infection11.01.08.002--Not Available
Insomnia17.15.03.002; 19.02.01.002--
Irritability19.04.02.013; 08.01.03.011--
Leukopenia01.02.02.001--Not Available
Libido decreased19.08.03.001; 21.03.02.005--
Loss of consciousness17.02.04.004--Not Available
Menopausal symptoms21.02.02.002--Not Available
Migraine24.03.05.003; 17.14.02.001--Not Available
Nausea07.01.07.001--
Nervous system disorder17.02.10.001--Not Available
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