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Drug ReportsSertraline
Sertraline
Sertraline, Zoloft (sertraline) is a small molecule pharmaceutical. Sertraline was first approved as Zoloft on 1991-12-30. It is used to treat depressive disorder, feeding and eating disorders, obsessive-compulsive disorder, panic disorder, and post-traumatic stress disorders in the USA. The pharmaceutical is active against sodium-dependent serotonin transporter.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
mental disordersD001523
Trade Name
FDA
EMA
Sertraline, Zoloft (discontinued: Sertraline, Zoloft)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Sertraline hydrochloride
Tradename
Company
Number
Date
Products
SERTRALINE HYDROCHLORIDEAlmatica PharmaN-215133 RX2021-10-04
2 products, RLD
ZOLOFTViatrisN-019839 RX1991-12-30
3 products, RLD, RS
ZOLOFTViatrisN-020990 RX1999-12-07
1 products, RLD, RS
Show 1 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
finjozyANDA2026-11-03
sertralineANDA2026-09-22
sertraline hclANDA2026-10-30
sertraline hydrochlorideANDA2026-10-29
sertraline hydrochloride tabletsANDA2009-08-20
zoloftNew Drug Application2023-08-15
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
panic disorderEFO_0004262D016584F41.0
post-traumatic stress disordersEFO_0001358D013313F43.1
obsessive-compulsive disorderEFO_0004242D009771F42
depressive disorderEFO_1002014D003866F32.A
feeding and eating disorders—D001068F50
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
N: Nervous system drugs
— N06: Psychoanaleptics
— N06A: Antidepressants
— N06AB: Selective serotonin reuptake inhibitors
— N06AB06: Sertraline
HCPCS
No data
Clinical
Clinical Trials
438 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
DepressionD003863—F33.9939376176212
Depressive disorderD003866EFO_1002014F32.A932374352165
Major depressive disorderD003865EFO_0003761F22824253238124
Post-traumatic stress disordersD013313EFO_0001358F43.145813937
Anxiety disordersD001008EFO_0006788F41.118591334
Traumatic stress disordersD040921——3479425
Obsessive-compulsive disorderD009771EFO_0004242F42—238921
Healthy volunteers/patients———14——2319
Compulsive personality disorderD003193—F60.5—237516
Treatment-resistant depressive disorderD061218——1174114
Show 53 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
SchizophreniaD012559EFO_0000692F20——2—35
Cognitive dysfunctionD060825—G31.84——1—45
Wounds and injuriesD014947—T14.8111—35
Heart failureD006333EFO_0003144I50—11—34
Sleep initiation and maintenance disordersD007319—F51.01—13—14
Separation anxietyD001010EFO_1001916——11—24
Cardiovascular diseasesD002318EFO_0000319I98—11—24
Autistic disorderD001321EFO_0003758F84.0—31——4
Heart diseasesD006331EFO_0003777I51.9112——4
Brain injuriesD001930—S06.9—11—23
Show 26 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Substance-related disordersD019966EFO_0003890F13—2——24
Autism spectrum disorderD000067877—F84.0—3———3
Chronic painD059350———1——12
Low back painD017116—M54.5—1——12
Parkinson diseaseD010300EFO_0002508G2011——12
Hepatitis cD006526—B19.211———2
Fragile x syndromeD005600—Q99.2—2———2
Cocaine-related disordersD019970—F14—2———2
PruritusD011537—L29—2———2
GlioblastomaD005909EFO_0000515—11———1
Show 26 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
OverweightD050177—E66.31———23
Huntington diseaseD006816Orphanet_399G101————1
LeukemiaD007938—C951————1
Myeloid leukemia acuteD015470—C92.01————1
Myeloid leukemiaD007951—C921————1
Myelodysplastic syndromesD009190—D461————1
PreleukemiaD011289——1————1
Migraine disordersD008881EFO_0003821G431————1
VertigoD014717—H81.391————1
DizzinessD004244—R421————1
Show 3 more
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
InflammationD007249MP_0001845—————33
Taste disordersD013651——————33
Psychological distressD000079225——————33
Suicidal ideationD059020EFO_0004320R45.851————22
HypoglycemiaD007003—E16.2————22
MalnutritionD044342EFO_0008572E40-E46————22
Breast neoplasmsD001943EFO_0003869C50————22
Hot flashesD019584——————22
Combat disordersD003130——————22
HemorrhageD006470MP_0001914R58————11
Show 64 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameSertraline
INNsertraline
Description
Sertraline is a member of the class of tetralins that is tetralin which is substituted at positions 1 and 4 by a methylamino and a 3,4-dichlorophenyl group, respectively (the S,S diastereoisomer). A selective serotonin-reuptake inhibitor (SSRI), it is administered orally as the hydrochloride salt as an antidepressant for the treatment of depression, obsessive-compulsive disorder, panic disorder and post-traumatic stress disorder. It has a role as an antidepressant and a serotonin uptake inhibitor. It is a member of tetralins, a secondary amino compound and a dichlorobenzene. It is a conjugate base of a sertraline(1+). It derives from a hydride of a tetralin.
Classification
Small molecule
Drug classselective serotonin reuptake inhibitors (SSRI)
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
CN[C@H]1CC[C@@H](c2ccc(Cl)c(Cl)c2)c2ccccc21
Identifiers
PDB—
CAS-ID79617-96-2
RxCUI—
ChEMBL IDCHEMBL809
ChEBI ID9123
PubChem CID68617
DrugBankDB01104
UNII IDQUC7NX6WMB (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
$
€
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Zoloft – Viatris
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Zoloft – Pfizer
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Estimated US medical usage
Sertraline
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Trends
PubMed Central
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Additional graphs summarizing 9,999 documents
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Safety
Black-box Warning
Black-box warning for: Finjozy, Sertraline, Sertraline hcl, Sertraline hydrochloride, Sertraline hydrochloride tablets, Zoloft
Adverse Events
Top Adverse Reactions
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76,763 adverse events reported
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