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)
Brain injury	19.07.03.007; 17.11.01.003	0.000059%		Not Available
Intellectual disability	19.21.06.001; 17.03.07.001	0.000059%		Not Available
Toe walking	15.03.05.032; 19.01.02.011; 17.02.05.048	-	-	Not Available
Langerhans' cell histiocytosis	01.13.04.003; 09.01.08.018; 22.01.01.016; 16.21.04.003; 15.09.03.008	-	-	Not Available
Hypoxic-ischaemic encephalopathy	17.13.02.006; 24.04.06.021; 22.02.02.011	0.000039%		Not Available
Foetal growth restriction	18.03.01.002	0.000118%
Gestational hypertension	24.08.07.004; 18.02.03.004	0.000193%		Not Available
Microsomia	08.01.03.056	0.000030%		Not Available
Slow speech	19.19.02.004; 17.02.08.016	0.000049%		Not Available
Resting tremor	17.01.06.008	0.000030%		Not Available
Drug-induced liver injury	12.03.01.044; 09.01.07.023	0.000285%		Not Available
Reversible cerebral vasoconstriction syndrome	24.04.06.026; 18.06.01.004; 17.08.02.014	0.000295%		Not Available
Platelet dysfunction	01.08.03.003	0.000059%		Not Available
Autoimmune haemolytic anaemia	10.04.01.005; 01.06.01.004	-	-	Not Available
Candida infection	11.03.03.021	-	-
Foetal heart rate deceleration abnormality	18.03.02.012; 02.03.02.022	0.000059%		Not Available
Language disorder	19.19.01.006; 17.02.08.015	0.000020%		Not Available
Irregular breathing	22.02.01.026	0.000020%		Not Available
Intrusive thoughts	19.10.03.008	0.000049%		Not Available
Anal incontinence	17.05.01.021; 07.01.06.029	0.000020%
Depersonalisation/derealisation disorder	19.14.01.004	0.000030%		Not Available
Gambling disorder	19.07.06.015	0.000039%		Not Available
Somatic symptom disorder	19.24.01.006	0.000020%		Not Available
Abnormal loss of weight	14.03.02.019	0.000020%		Not Available
Abortion threatened	18.01.04.003	0.000020%		Not Available
Agitated depression	19.15.01.007; 17.02.05.050	0.000053%		Not Available
Alcohol interaction	08.06.03.003	0.000118%		Not Available
Anorexia nervosa	19.09.01.007; 14.03.03.002	0.000030%		Not Available
Arrested labour	18.07.03.003	0.000069%		Not Available
Arrhythmia neonatal	18.04.07.005; 02.03.02.024	0.000030%		Not Available

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