ADReCS

Pharmaceutical Information

Drug Name	Fluoxetine
Drug ID	BADD_D00932
Description	Fluoxetine is a 2nd generation antidepressant categorized as a selective serotonin reuptake inhibitor (SSRI).[A181673] It gained FDA approval in 1987 and although it was initially intended for the treatment of depression, today it is commonly prescribed to manage depression in addition to various other pathologies.[L7721]
Indications and Usage	Fluoxetine is indicated for both acute and maintenance treatment of major depressive disorder, obsessive compulsive disorder, and bulimia nervosa; however, it is only indicated for acute treatment of panic disorder independent of whether agoraphobia is present.[L7664] Fluoxetine may also be used in combination with olanzapine to treat depression related to Bipolar I Disorder, and treatment resistant depression.[L7664]
Marketing Status	approved; vet_approved
ATC Code	N06AB03
DrugBank ID	DB00472
KEGG ID	D00326
MeSH ID	D005473
PubChem ID	3386
TTD Drug ID	D0TR5X
NDC Product Code	0093-0807; 43063-839; 53002-2305; 61919-869; 62332-243; 71335-0924; 0615-8093; 0093-7198; 50090-3180; 50111-647; 50228-421; 59651-308; 68645-130; 0615-7625; 72241-009; 0904-5785; 0904-7195; 49884-468; 55111-150; 59651-324; 62332-242; 65862-306; 71209-041; 61919-885; 63304-632; 72241-008; 80426-044; 63187-233; 63629-8179; 70518-3752; 71335-0565; 80425-0313; 59651-309; 13668-443; 46708-273; 68645-131; 80426-045; 23155-028; 23155-030; 42291-398; 42571-388; 62332-024; 63187-089; 71335-1048; 0904-5784; 23155-029; 42291-396; 42571-389; 62332-022; 72162-1506; 72241-007; 16714-112; 16714-113; 42291-397; 42571-387; 43598-566; 46708-272; 50228-420; 58118-0645; 70518-1619; 71209-042; 13668-473; 50111-648; 55154-1341; 61919-100; 62332-023; 63629-2201; 71205-178; 71205-188; 71209-040; 42708-025; 46708-271; 53002-5016
UNII	01K63SUP8D
Synonyms	Fluoxetine \| Fluoxetin \| N-Methyl-gamma-(4-(trifluoromethyl)phenoxy)benzenepropanamine \| Lilly-110140 \| Lilly 110140 \| Lilly110140 \| Sarafem \| Fluoxetine Hydrochloride \| Prozac

Chemical Information

Molecular Formula	C17H18F3NO
CAS Registry Number	54910-89-3
SMILES	CNCCC(C1=CC=CC=C1)OC2=CC=C(C=C2)C(F)(F)F
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)
Bradycardia neonatal	18.04.07.004; 02.03.02.019	0.000049%		Not Available
Meconium stain	18.05.01.008	0.000030%		Not Available
Aortic dilatation	24.03.04.007	0.000020%		Not Available
Subacute cutaneous lupus erythematosus	23.03.02.020; 15.06.02.012; 10.04.03.012	0.000049%		Not Available
Right ventricular dysfunction	02.04.02.033	0.000039%
Negative thoughts	19.15.02.012	0.000049%		Not Available
Sopor	19.02.04.002; 17.02.04.021	0.000207%		Not Available
Psychogenic seizure	19.24.01.007; 17.12.03.042	0.000112%		Not Available
Neonatal aspiration	22.11.01.008; 18.04.09.007	0.000020%		Not Available
Arterial stenosis	24.04.02.012	0.000039%		Not Available
Disturbance in social behaviour	19.05.01.018	0.000020%		Not Available
Foot deformity	15.10.03.005	0.000059%		Not Available
Head deformity	15.10.05.005	0.000049%		Not Available
Neck deformity	15.10.04.009	0.000049%		Not Available
Gastric cancer stage IV	16.13.03.003; 07.21.02.003	0.000039%		Not Available
Accidental death	12.01.08.040; 08.04.01.013	0.000039%		Not Available
Periodic limb movement disorder	17.15.04.006; 15.05.03.034; 19.02.05.009	0.000020%		Not Available
Tachyphrenia	19.10.03.010; 17.03.03.007	0.000087%		Not Available
Oral cavity fistula	07.11.05.014	0.000020%
Central nervous system necrosis	17.02.10.020; 24.04.06.032	0.000020%
Stress cardiomyopathy	24.04.04.026; 02.04.01.012	0.000059%		Not Available
Tethered cord syndrome	20.03.03.007; 17.10.01.023	0.000030%		Not Available
Velopharyngeal incompetence	22.04.05.020; 07.05.01.020	0.000030%		Not Available
Right atrial dilatation	02.04.02.032	0.000020%		Not Available
Sleep-related eating disorder	19.02.03.012; 17.15.02.009; 14.03.01.012	0.000030%		Not Available
Heart valve incompetence	02.07.02.003	0.000030%		Not Available
Foetal hypokinesia	18.03.02.015	0.000069%		Not Available
Gross motor delay	19.22.01.004; 17.01.02.021	0.000020%		Not Available
Motor developmental delay	19.22.01.005; 17.01.02.023	0.000079%		Not Available
Limb asymmetry	15.10.03.009	0.000020%

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