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)
Seizure like phenomena	17.12.03.030	-	-	Not Available
Hyporesponsive to stimuli	17.02.05.057	0.000030%		Not Available
Eye colour change	06.06.06.008	0.000030%		Not Available
Neonatal behavioural syndrome	22.11.02.007; 18.04.04.010; 17.02.05.058; 15.05.04.020	0.000128%		Not Available
Genital paraesthesia	21.10.05.016; 17.02.06.032	0.000030%		Not Available
Junctional ectopic tachycardia	18.04.07.007; 12.02.01.026; 02.03.03.019	0.000030%		Not Available
Rapid eye movement sleep behaviour disorder	19.02.03.010; 17.15.04.008	0.000039%		Not Available
Infantile apnoea	22.11.02.004; 18.04.15.003	0.000079%		Not Available
Obsessive-compulsive symptom	19.06.05.010	0.000020%		Not Available
Selective eating disorder	19.09.01.012; 14.03.02.024	0.000049%		Not Available
Attention deficit hyperactivity disorder	19.21.04.004	0.000368%		Not Available
Autophobia	19.06.03.013	0.000030%		Not Available
Behaviour disorder	19.01.01.005	0.000030%		Not Available
Breast complication associated with device	08.07.06.001; 21.05.04.015	0.000020%		Not Available
Dilated cardiomyopathy	02.04.01.017	0.000030%		Not Available
Drug use disorder	19.07.06.012	0.000020%		Not Available
Electric shock sensation	17.02.07.024; 08.06.02.023	-	-	Not Available
Face presentation	18.03.04.003	0.000020%		Not Available
Fear of weight gain	19.06.03.018	0.000020%		Not Available
Foetal arrhythmia	02.03.02.034; 18.03.02.021	0.000020%		Not Available
Genital anaesthesia	21.10.05.021; 17.02.06.042	0.000049%		Not Available
Haemophagocytic lymphohistiocytosis	16.32.03.038; 10.02.01.077; 01.05.01.026	0.000020%		Not Available
Heavy menstrual bleeding	21.01.03.005	-	-	Not Available
Hepatic cytolysis	09.01.07.036	0.000039%		Not Available
Hypersensitivity pneumonitis	22.01.01.027; 10.01.03.056	-	-	Not Available
Immune thrombocytopenia	01.08.01.013; 10.02.01.083	0.000020%		Not Available
Inhibitory drug interaction	08.06.03.014	0.000079%		Not Available
Intermenstrual bleeding	21.01.01.015	-	-	Not Available
Mast cell activation syndrome	10.02.01.090; 01.05.01.030	0.000118%		Not Available
Near death experience	19.10.05.007; 17.02.04.023	0.000020%		Not Available

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