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)
Bradyphrenia	19.10.03.002; 17.03.03.004	0.000049%		Not Available
Abulia	19.01.02.009; 17.02.05.040	0.000020%		Not Available
Sudden onset of sleep	17.15.04.003	0.000020%		Not Available
Cervix haemorrhage uterine	21.06.01.005; 24.07.03.011	-	-	Not Available
Urogenital haemorrhage	24.07.01.044; 21.10.05.008; 20.08.01.006	-	-	Not Available
Neonatal hypoxia	22.11.02.002; 18.04.15.002	0.000059%		Not Available
Morbid thoughts	19.10.03.004	0.000020%		Not Available
Ventricular hypokinesia	02.04.02.013	0.000020%		Not Available
Lupus-like syndrome	23.03.02.004; 15.06.02.004; 10.04.03.003	0.000020%		Not Available
Cardiopulmonary failure	22.02.06.004; 02.05.01.004	0.000030%		Not Available
Self-injurious ideation	19.12.01.007	0.000201%		Not Available
Madarosis	23.02.02.004; 06.06.04.010	0.000039%		Not Available
Facial paresis	17.04.03.002	0.000069%
Acute coronary syndrome	24.04.04.011; 02.02.02.015	-	-	Not Available
Necrotising colitis	07.08.01.013	0.000020%		Not Available
Metabolic syndrome	14.06.02.007; 05.06.02.007; 24.08.02.014	0.000020%		Not Available
Large intestinal haemorrhage	07.12.03.003; 24.07.02.026	-	-
Drug tolerance	08.06.01.003	-	-	Not Available
Eosinophilic pneumonia acute	22.01.01.008; 01.02.04.004	0.000039%		Not Available
Musculoskeletal stiffness	15.03.05.027	0.000181%		Not Available
Musculoskeletal discomfort	15.03.04.001	-	-	Not Available
Inappropriate antidiuretic hormone secretion	05.03.03.001; 14.05.07.001	0.000148%		Not Available
Clonic convulsion	17.12.03.008	-	-	Not Available
Secretion discharge	08.01.03.019	0.000083%		Not Available
Growth retardation	15.03.05.016; 14.03.02.031; 05.03.02.007	0.000020%
Cerebral haematoma	24.07.04.006; 17.08.01.014	0.000020%		Not Available
Depressive symptom	19.15.02.003	0.000020%		Not Available
Affect lability	19.04.01.001	0.000112%		Not Available
Cerebral disorder	17.02.10.017	0.000049%		Not Available
Phonophobia	19.06.03.003; 04.03.01.008	0.000020%		Not Available

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