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)
Toxic epidermal necrolysis	23.03.01.008; 12.03.01.015; 11.07.01.006; 10.01.01.006	-	-
Transient ischaemic attack	24.04.06.005; 17.08.04.001	-	-
Tremor	17.01.06.002	0.000937%
Trichorrhexis	23.02.06.007	0.000049%		Not Available
Tricuspid valve incompetence	02.07.05.001	0.000207%		Not Available
Trismus	17.01.03.004; 15.05.04.004	0.000059%
Tympanic membrane perforation	12.01.14.001; 04.05.04.001	0.000020%		Not Available
Unintended pregnancy	18.08.01.001	-	-	Not Available
Unresponsive to stimuli	17.02.05.031	0.000118%		Not Available
Upper respiratory tract infection	22.07.03.011; 11.01.13.009	-	-
Urethral pain	20.02.02.014	-	-	Not Available
Urethritis	20.07.02.001; 11.01.14.008	-	-
Urinary incontinence	20.02.02.010; 17.05.01.008	0.000106%
Urinary retention	20.02.02.011	0.000423%
Urinary tract infection	11.01.14.004; 20.08.02.001	-	-
Urticaria	23.04.02.001; 10.01.06.001	-	-
Uterine haemorrhage	24.07.03.004; 21.07.01.005	-	-
Uterine leiomyoma	16.04.02.001; 21.07.02.004	-	-	Not Available
Uterine spasm	21.07.03.002	-	-	Not Available
Vaginal discharge	21.08.02.002	-	-
Vaginal haemorrhage	24.07.03.005; 21.08.01.001	0.000138%
Vaginal infection	21.14.02.002; 11.01.10.002	-	-
Vascular headache	17.14.01.005; 24.03.05.007	-	-	Not Available
Vascular purpura	24.07.06.011; 23.06.01.008; 01.01.04.007	-	-	Not Available
Vasculitis	24.12.04.027; 10.02.02.006	-	-
Vasodilatation	24.03.02.003; 23.06.05.006	-	-	Not Available
Vasospasm	24.04.02.002	-	-	Not Available
Vein disorder	24.03.02.015	0.000030%		Not Available
Ventricular arrhythmia	02.03.04.006	-	-
Ventricular extrasystoles	02.03.04.007	0.000098%		Not Available

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