Venlafaxine - PharmaKB

Venlafaxine

Effexor, Venlafaxine (venlafaxine) is a small molecule pharmaceutical. Venlafaxine was first approved as Effexor on 1993-12-28. It is used to treat attention deficit disorder with hyperactivity, autistic disorder, chronic fatigue syndrome, depressive disorder, and obsessive-compulsive disorder amongst others in the USA. The pharmaceutical is active against sodium-dependent serotonin transporter and sodium-dependent noradrenaline transporter.

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Therapeutic Areas

Therapeutic Area	MeSH
musculoskeletal diseases	D009140
nervous system diseases	D009422
signs and symptoms pathological conditions	D013568
psychological phenomena	D011579
mental disorders	D001523
musculoskeletal and neural physiological phenomena	D055687

Trade Name

FDA

EMA

Effexor, Venlafaxine, Venlafaxine besylate (discontinued: Effexor, Venlafaxine)

Drug Products

FDA

EMA

New Drug Application (NDA)

Abbreviated New Drug Application (ANDA)

Venlafaxine hydrochloride

Tradename	Company	Number	Date	Products
VENLAFAXINE HYDROCHLORIDE	RVL Pharmaceuticals	N-022104 RX	2008-05-20	4 products, RLD
EFFEXOR XR	Upjohn	N-020699 RX	1997-10-20	3 products, RLD, RS

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Venlafaxine besylate

Tradename	Company	Number	Date	Products
VENLAFAXINE BESYLATE	Almatica Pharma	N-215429 RX	2022-06-29	1 products, RLD, RS

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FDA

EMA

Brand Name	Status	Last Update
	New Drug Application	2009-10-27
effexor	New Drug Application	2023-08-15
effexor xr		2008-12-03
venlafaxine	ANDA	2025-12-02
venlafaxine hcl	ANDA	2024-12-31
venlafaxine hcl er	ANDA	2025-01-22
venlafaxine hydrochloride	ANDA	2025-12-11
venlafaxine hydrochloride, extended release	ANDA	2024-01-04

Indications

FDA

EMA

Indication	Ontology	MeSH	ICD-10
pain	EFO_0003843	D010146	R52
chronic fatigue syndrome	EFO_0004540	D015673	G93.31
attention deficit disorder with hyperactivity	EFO_0003888	D001289	F90
obsessive-compulsive disorder	EFO_0004242	D009771	F42
depressive disorder	EFO_1002014	D003866	F32.A
autistic disorder	EFO_0003758	D001321	F84.0

Agency Specific

FDA

EMA

No data

Patent Expiration

Patent	Expires	Flag	FDA Information
Venlafaxine Besylate, Venlafaxine Besylate, Almatica
7776358	2028-05-16	DP
6717015	2023-03-27	DS, DP	U-451

ATC Codes

N: Nervous system drugs

— N06: Psychoanaleptics

— N06A: Antidepressants

— N06AX: Other antidepressants in atc

— N06AX16: Venlafaxine

HCPCS

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Clinical

Clinical Trials

266 clinical trials

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Indications Phases 4

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Depression	D003863	—	F33.9	3	22	31	53	30	133
Depressive disorder	D003866	EFO_1002014	F32.A	4	19	29	39	19	105
Major depressive disorder	D003865	EFO_0003761	F22	4	16	26	30	18	90
Anxiety disorders	D001008	EFO_0006788	F41.1	—	5	7	5	6	21
Healthy volunteers/patients	—	—	—	14	—	1	1	1	17
Treatment-resistant depressive disorder	D061218	—	—	1	—	7	3	2	13
Bipolar disorder	D001714	EFO_0000289	F30.9	—	1	2	5	1	9
Post-traumatic stress disorders	D013313	EFO_0001358	F43.1	—	—	—	4	3	7
Mood disorders	D019964	EFO_0004247	F30-F39	—	1	1	2	2	6
Pain	D010146	EFO_0003843	R52	—	—	—	2	4	6

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Indications Phases 3

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Hot flashes	D019584	—	—	—	2	3	—	5	10
Breast neoplasms	D001943	EFO_0003869	C50	—	1	2	—	2	5
Fibromyalgia	D005356	EFO_0005687	M79.1	1	2	1	—	2	4
Obsessive-compulsive disorder	D009771	EFO_0004242	F42	—	1	1	—	2	4
Compulsive personality disorder	D003193	—	F60.5	—	1	1	—	1	3
Sleep initiation and maintenance disorders	D007319	—	F51.01	—	—	2	—	1	3
Mental disorders	D001523	EFO_0000677	F91.9	—	—	1	—	1	2
Schizophrenia	D012559	EFO_0000692	F20	—	—	2	—	—	2
Cancer pain	D000072716	—	G89.3	—	1	1	—	1	2
Low back pain	D017116	—	M54.5	—	1	1	—	1	2

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Indications Phases 2

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Generalized anxiety disorder	D000098647	—	—	—	2	—	—	2	4
Suicidal ideation	D059020	EFO_0004320	R45.851	—	1	—	—	1	2
Myofascial pain syndromes	D009209	EFO_1001054	—	1	1	—	—	—	1
Type 2 diabetes mellitus	D003924	EFO_0001360	E11	—	1	—	—	—	1
Prediabetic state	D011236	EFO_1001121	R73.03	—	1	—	—	—	1
Diabetes mellitus	D003920	EFO_0000400	E08-E13	—	1	—	—	—	1
Insulin resistance	D007333	EFO_0002614	E88.819	—	1	—	—	—	1
Glucose intolerance	D018149	HP_0000833	R73.03	—	1	—	—	—	1
Post-head injury coma	D020207	—	—	—	1	—	—	—	1
Neck pain	D019547	—	M54.2	—	1	—	—	—	1

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Indications Phases 1

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Malnutrition	D044342	EFO_0008572	E40-E46	4	—	—	—	—	4
Drug interactions	D004347	—	—	1	—	—	—	1	2
Bariatric surgery	D050110	—	—	1	—	—	—	—	1

Indications Without Phase

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Drug-related side effects and adverse reactions	D064420	—	T88.7	—	—	—	—	5	5
Neoplasms	D009369	—	C80	—	—	—	—	2	2
Intractable pain	D010148	—	—	—	—	—	—	1	1
Pharmacokinetics	D010599	—	—	—	—	—	—	1	1
Pregnancy	D011247	EFO_0002950	Z33.1	—	—	—	—	1	1
Inflammation	D007249	MP_0001845	—	—	—	—	—	1	1
Substance-related disorders	D019966	EFO_0003890	F13	—	—	—	—	1	1
Chronic disease	D002908	—	—	—	—	—	—	1	1
Renal insufficiency	D051437	—	N19	—	—	—	—	1	1
Acute kidney injury	D058186	—	N17	—	—	—	—	1	1

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Epidemiology

Epidemiological information for investigational and approved indications

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Drug

General

Drug common name	Venlafaxine
INN	venlafaxine
Description	Venlafaxine is a tertiary amino compound that is N,N-dimethylethanamine substituted at position 1 by a 1-hydroxycyclohexyl and 4-methoxyphenyl group. It has a role as an antidepressant, a serotonin uptake inhibitor, an adrenergic uptake inhibitor, a dopamine uptake inhibitor, an analgesic, an environmental contaminant and a xenobiotic. It is a member of cyclohexanols, a tertiary alcohol, a tertiary amino compound and a monomethoxybenzene.
Classification	Small molecule
Drug class	antianxiety, antidepressant inhibitor of norepinephrine and dopamine re-uptake
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)	COc1ccc(C(CN(C)C)C2(O)CCCCC2)cc1

Identifiers

PDB	—
CAS-ID	93413-69-5
RxCUI	—
ChEMBL ID	CHEMBL637
ChEBI ID	9943
PubChem CID	5656
DrugBank	DB00285
UNII ID	GRZ5RCB1QG (ChemIDplus, GSRS)

Target

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Variants

No data

Financial

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Effexor – Viatris

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Effexor – Pfizer

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Estimated US medical usage

Venlafaxine

Total medical expenditures per year (USD, in millions)

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Trends

PubMed Central

Top Terms for Disease or Syndrome:

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Additional graphs summarizing 19,737 documents

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Safety

Black-box Warning

Black-box warning for: Effexor, Effexor xr, Venlafaxine, Venlafaxine hcl, Venlafaxine hcl er, Venlafaxine hydrochloride, Venlafaxine hydrochloride, extended release

Adverse Events

Top Adverse Reactions

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85,997 adverse events reported

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