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)
Influenza	22.07.02.001; 11.05.03.001	-	-	Not Available
Influenza like illness	08.01.03.010	0.000146%
Inguinal hernia	07.16.02.001	0.000020%		Not Available
Initial insomnia	19.02.01.005; 17.15.03.005	0.000063%		Not Available
Injection site erythema	23.03.06.015; 12.07.03.001; 08.02.03.001	0.000173%		Not Available
Injection site induration	08.02.03.007; 12.07.03.007	0.000110%		Not Available
Injection site mass	12.07.03.010; 08.02.03.009	0.000187%		Not Available
Injection site pain	12.07.03.011; 08.02.03.010	0.000331%		Not Available
Injection site pruritus	12.07.03.014; 23.03.12.007; 08.02.03.013	0.000087%		Not Available
Injection site reaction	12.07.03.015; 08.02.03.014	0.000278%
Injection site warmth	12.07.03.036; 08.02.03.036	0.000134%		Not Available
Injury	12.01.08.004	-	-	Not Available
Insomnia	19.02.01.002; 17.15.03.002	0.000951%
Insulin resistance	14.06.02.003; 05.06.02.003	0.000020%		Not Available
Intentional self-injury	19.12.01.002; 12.01.08.036	0.001092%		Not Available
Interstitial lung disease	22.01.02.003; 10.02.01.033	-	-	Not Available
Intestinal ischaemia	24.04.08.001; 07.15.02.001	0.000030%		Not Available
Intestinal obstruction	07.13.01.002	-	-	Not Available
Intestinal perforation	07.04.06.002	0.000020%		Not Available
Intracranial pressure increased	17.07.02.002	0.000059%		Not Available
Iritis	10.02.01.022; 06.04.03.002	0.000020%		Not Available
Iron deficiency anaemia	14.13.02.001; 01.03.01.002	0.000020%		Not Available
Irritability	08.01.03.011; 19.04.02.013	0.000510%
Jaundice	23.03.03.030; 09.01.01.004; 01.06.04.004	0.000138%		Not Available
Jaundice cholestatic	09.01.01.005	-	-	Not Available
Jaundice neonatal	09.01.01.008; 01.06.04.006; 18.04.08.001	0.000069%		Not Available
Kawasaki's disease	24.12.02.004; 11.07.01.007; 10.02.02.009	0.000020%		Not Available
Lacrimation increased	06.08.02.004	0.000039%
Lactose intolerance	14.02.02.001; 07.17.01.003	-	-	Not Available
Laryngeal oedema	23.04.01.005; 22.04.02.001; 10.01.05.003	-	-

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