All FDA-approved EMA-approved PMDA-approved
Target Card Uniprot Example: P23975

levomilnacipran 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
	4864	96847-54-0

Description:

Molecule

Description

Molfile Inchi Smiles Synonyms: levomilnacipran levomilnacipran hydrochloride fetzima levomilnacipran HCl

a selective serotonin and norepinephrine reuptake inhibitor (SNRI), mechanism of the antidepressant action of levomilnacipran is unknown, but is thought to be related to the potentiation of serotonin and norepinephrine in the central nervous system Molecular weight: 246.35 Formula: C15H22N2O CLOGP: 1.91 LIPINSKI: 0 HAC: 3 HDO: 1 TPSA: 46.33 ALOGS: -2.30 ROTB: 5 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Drug dosage:

Dose	Unit	Route
40	mg	O

ADMET properties:

Property	Value	Reference
fu (Fraction unbound in plasma)	0.68 %	Kawashima H, Watanabe R, Esaki T, Kuroda M, Nagao C, Natsume-Kitatani Y, Ohashi R, Komura H, Mizuguchi K
BA (Bioavailability)	0.88 %	Kawashima H, Watanabe R, Esaki T, Kuroda M, Nagao C, Natsume-Kitatani Y, Ohashi R, Komura H, Mizuguchi K

Approvals:

Date	Agency	Company	Orphan
July 25, 2013	FDA	FOREST LABS INC

FDA Adverse Event Reporting System (Female)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Blepharospasm	333.13	36.97	68	1946	5928	63481080
Taste disorder	277.36	36.97	68	1946	13594	63473414
Epilepsy	235.70	36.97	69	1945	26996	63460012
Memory impairment	173.24	36.97	78	1936	104180	63382828
Migraine	154.90	36.97	72	1942	103274	63383734
Gastrooesophageal reflux disease	153.87	36.97	70	1944	95569	63391439
Paraesthesia	131.89	36.97	74	1940	156892	63330116
Hypoaesthesia	124.38	36.97	73	1941	168320	63318688
Abdominal pain upper	113.13	36.97	74	1940	206370	63280638
Persistent genital arousal disorder	96.22	36.97	15	1999	271	63486737
Drug intolerance	74.43	36.97	68	1946	308593	63178415
Vomiting	62.28	36.97	82	1932	559535	62927473
Suicidal ideation	59.25	36.97	32	1982	62389	63424619
Pain	42.33	36.97	80	1934	740548	62746460
Off label use	39.92	36.97	74	1940	674388	62812620
Serotonin syndrome	39.73	36.97	19	1995	28663	63458345

FDA Adverse Event Reporting System (Male)

None

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Blepharospasm	243.66	40.01	48	1482	5803	79737055
Taste disorder	196.09	40.01	48	1482	15775	79727083
Epilepsy	151.02	40.01	48	1482	40812	79702046
Memory impairment	133.13	40.01	57	1473	111677	79631181
Migraine	122.15	40.01	50	1480	87443	79655415
Gastrooesophageal reflux disease	113.70	40.01	50	1480	104196	79638662
Paraesthesia	99.82	40.01	54	1476	176269	79566589
Hypoaesthesia	98.96	40.01	54	1476	179298	79563560
Persistent genital arousal disorder	96.14	40.01	14	1516	267	79742591
Abdominal pain upper	85.27	40.01	53	1477	223766	79519092
Drug intolerance	63.33	40.01	47	1483	264072	79478786
Vomiting	41.67	40.01	57	1473	665771	79077087

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	N06AX28	NERVOUS SYSTEM PSYCHOANALEPTICS ANTIDEPRESSANTS Other antidepressants
FDA MoA	N0000000102	Norepinephrine Uptake Inhibitors
FDA MoA	N0000000109	Serotonin Uptake Inhibitors
MeSH PA	D000928	Antidepressive Agents
MeSH PA	D002491	Central Nervous System Agents
MeSH PA	D049990	Membrane Transport Modulators
MeSH PA	D018377	Neurotransmitter Agents
MeSH PA	D014179	Neurotransmitter Uptake Inhibitors
MeSH PA	D011619	Psychotropic Drugs
MeSH PA	D000068760	Serotonin and Noradrenaline Reuptake Inhibitors
FDA EPC	N0000175749	Serotonin and Norepinephrine Reuptake Inhibitor

Drug Use | Suggest Off label Use Form| |View source of the data|

Disease	Relation	SNOMED_ID	DOID
Major depressive disorder	indication	370143000
Angle-closure glaucoma	contraindication	392291006	DOID:13550

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	10.64	Basic

Orange Book patent data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Patent number	Patent expiration date	Patent use
EQ 120MG BASE	FETZIMA	ABBVIE	N204168	July 25, 2013	RX	CAPSULE, EXTENDED RELEASE	ORAL	RE43879	Jan. 11, 2026	TREATMENT OF MAJOR DEPRESSIVE DISORDER (MDD)
EQ 20MG BASE	FETZIMA	ABBVIE	N204168	July 25, 2013	RX	CAPSULE, EXTENDED RELEASE	ORAL	RE43879	Jan. 11, 2026	TREATMENT OF MAJOR DEPRESSIVE DISORDER (MDD)
EQ 40MG BASE	FETZIMA	ABBVIE	N204168	July 25, 2013	RX	CAPSULE, EXTENDED RELEASE	ORAL	RE43879	Jan. 11, 2026	TREATMENT OF MAJOR DEPRESSIVE DISORDER (MDD)
EQ 80MG BASE	FETZIMA	ABBVIE	N204168	July 25, 2013	RX	CAPSULE, EXTENDED RELEASE	ORAL	RE43879	Jan. 11, 2026	TREATMENT OF MAJOR DEPRESSIVE DISORDER (MDD)
EQ 120MG BASE	FETZIMA	ABBVIE	N204168	July 25, 2013	RX	CAPSULE, EXTENDED RELEASE	ORAL	8481598	March 2, 2031	TREATMENT OF MAJOR DEPRESSIVE DISORDER (MDD)
EQ 20MG BASE	FETZIMA	ABBVIE	N204168	July 25, 2013	RX	CAPSULE, EXTENDED RELEASE	ORAL	8481598	March 2, 2031	TREATMENT OF MAJOR DEPRESSIVE DISORDER (MDD)
EQ 40MG BASE	FETZIMA	ABBVIE	N204168	July 25, 2013	RX	CAPSULE, EXTENDED RELEASE	ORAL	8481598	March 2, 2031	TREATMENT OF MAJOR DEPRESSIVE DISORDER (MDD)
EQ 80MG BASE	FETZIMA	ABBVIE	N204168	July 25, 2013	RX	CAPSULE, EXTENDED RELEASE	ORAL	8481598	March 2, 2031	TREATMENT OF MAJOR DEPRESSIVE DISORDER (MDD)

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
Sodium-dependent serotonin transporter	Transporter	P31645	SC6A4_HUMAN	INHIBITOR	Ki	7.95		SCIENTIFIC LITERATURE	SCIENTIFIC LITERATURE
Sodium-dependent noradrenaline transporter	Transporter	P23975	SC6A2_HUMAN	INHIBITOR	Ki	7.04		SCIENTIFIC LITERATURE	SCIENTIFIC LITERATURE
Sodium-dependent dopamine transporter	Transporter	Q01959	SC6A3_HUMAN		IC50	5.49		CHEMBL
Sodium-dependent serotonin transporter	Transporter		SC6A4_RAT		Ki	8.07		CHEMBL
Glutamate NMDA receptor	Ion channel		NMDZ1_RAT NMDE1_RAT NMDE2_RAT NMDE3_RAT NMDE4_RAT NMD3B_RAT NMD3A_RAT		IC50	5.20		CHEMBL

External reference:

ID	Source
D10072	KEGG_DRUG
4032886	VUID
N0000189503	NUI
4032886	VANDF
CHEBI:136040	CHEBI
CHEMBL99946	ChEMBL_ID
7435	IUPHAR_LIGAND_ID
175131-60-9	SECONDARY_CAS_RN
DB08918	DRUGBANK_ID
1433211	RXNORM
204684	MMSL
29577	MMSL
31358	MMSL
d08114	MMSL
015223	NDDF
015224	NDDF
C3541367	UMLSCUI
D000078862	MESH_DESCRIPTOR_UI
CHEMBL2105732	ChEMBL_ID
8740	INN_ID
6917779	PUBCHEM_CID
UGM0326TXX	UNII

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Fetzima	HUMAN PRESCRIPTION DRUG LABEL	1	0456-2212	CAPSULE, EXTENDED RELEASE	120 mg	ORAL	NDA	35 sections
Fetzima	HUMAN PRESCRIPTION DRUG LABEL	1	0456-2212	CAPSULE, EXTENDED RELEASE	120 mg	ORAL	NDA	35 sections
Fetzima	HUMAN PRESCRIPTION DRUG LABEL	1	0456-2212	CAPSULE, EXTENDED RELEASE	120 mg	ORAL	NDA	35 sections
Fetzima	HUMAN PRESCRIPTION DRUG LABEL	1	0456-2220	CAPSULE, EXTENDED RELEASE	20 mg	ORAL	NDA	35 sections
Fetzima	HUMAN PRESCRIPTION DRUG LABEL	1	0456-2220	CAPSULE, EXTENDED RELEASE	20 mg	ORAL	NDA	35 sections
Fetzima	HUMAN PRESCRIPTION DRUG LABEL	1	0456-2220	CAPSULE, EXTENDED RELEASE	20 mg	ORAL	NDA	35 sections
Fetzima	HUMAN PRESCRIPTION DRUG LABEL	1	0456-2240	CAPSULE, EXTENDED RELEASE	40 mg	ORAL	NDA	35 sections
Fetzima	HUMAN PRESCRIPTION DRUG LABEL	1	0456-2240	CAPSULE, EXTENDED RELEASE	40 mg	ORAL	NDA	35 sections
Fetzima	HUMAN PRESCRIPTION DRUG LABEL	1	0456-2240	CAPSULE, EXTENDED RELEASE	40 mg	ORAL	NDA	35 sections
Fetzima	HUMAN PRESCRIPTION DRUG LABEL	1	0456-2280	CAPSULE, EXTENDED RELEASE	80 mg	ORAL	NDA	35 sections
Fetzima	HUMAN PRESCRIPTION DRUG LABEL	1	0456-2280	CAPSULE, EXTENDED RELEASE	80 mg	ORAL	NDA	35 sections
Fetzima	HUMAN PRESCRIPTION DRUG LABEL	1	0456-2280	CAPSULE, EXTENDED RELEASE	80 mg	ORAL	NDA	35 sections
Levomilnacipran	HUMAN PRESCRIPTION DRUG LABEL	1	65162-411	CAPSULE, EXTENDED RELEASE	20 mg	ORAL	ANDA	29 sections
Levomilnacipran	HUMAN PRESCRIPTION DRUG LABEL	1	65162-411	CAPSULE, EXTENDED RELEASE	20 mg	ORAL	ANDA	29 sections
Levomilnacipran	HUMAN PRESCRIPTION DRUG LABEL	1	65162-411	CAPSULE, EXTENDED RELEASE	20 mg	ORAL	ANDA	29 sections
Levomilnacipran	HUMAN PRESCRIPTION DRUG LABEL	1	65162-437	CAPSULE, EXTENDED RELEASE	80 mg	ORAL	ANDA	29 sections
Levomilnacipran	HUMAN PRESCRIPTION DRUG LABEL	1	65162-437	CAPSULE, EXTENDED RELEASE	80 mg	ORAL	ANDA	29 sections
Levomilnacipran	HUMAN PRESCRIPTION DRUG LABEL	1	65162-437	CAPSULE, EXTENDED RELEASE	80 mg	ORAL	ANDA	29 sections
Levomilnacipran	HUMAN PRESCRIPTION DRUG LABEL	1	65162-455	CAPSULE, EXTENDED RELEASE	120 mg	ORAL	ANDA	29 sections
Levomilnacipran	HUMAN PRESCRIPTION DRUG LABEL	1	65162-455	CAPSULE, EXTENDED RELEASE	120 mg	ORAL	ANDA	29 sections
Levomilnacipran	HUMAN PRESCRIPTION DRUG LABEL	1	65162-455	CAPSULE, EXTENDED RELEASE	120 mg	ORAL	ANDA	29 sections
Levomilnacipran	HUMAN PRESCRIPTION DRUG LABEL	1	65162-960	CAPSULE, EXTENDED RELEASE	40 mg	ORAL	ANDA	29 sections
Levomilnacipran	HUMAN PRESCRIPTION DRUG LABEL	1	65162-960	CAPSULE, EXTENDED RELEASE	40 mg	ORAL	ANDA	29 sections
Levomilnacipran	HUMAN PRESCRIPTION DRUG LABEL	1	65162-960	CAPSULE, EXTENDED RELEASE	40 mg	ORAL	ANDA	29 sections