Adverse Drug Reaction Classification System

         

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 phenomena17.12.03.030---
Hyporesponsive to stimuli17.02.05.0570.000030%-
Eye colour change06.06.06.0080.000030%-
Neonatal behavioural syndrome15.05.04.020; 17.02.05.058; 18.04.04.010; 22.11.02.0070.000128%-
Genital paraesthesia17.02.06.032; 21.10.05.0160.000030%-
Junctional ectopic tachycardia02.03.03.019; 12.02.01.026; 18.04.07.0070.000030%-
Rapid eye movement sleep behaviour disorder17.15.04.008; 19.02.03.0100.000039%-
Infantile apnoea18.04.15.003; 22.11.02.0040.000079%-
Obsessive-compulsive symptom19.06.05.0100.000020%-
Selective eating disorder14.03.02.024; 19.09.01.0120.000049%-
Attention deficit hyperactivity disorder19.21.04.0040.000368%-
Autophobia19.06.03.0130.000030%-
Behaviour disorder19.01.01.0050.000030%-
Breast complication associated with device08.07.06.001; 21.05.04.0150.000020%-
Dilated cardiomyopathy02.04.01.0170.000030%-
Drug use disorder19.07.06.0120.000020%-
Electric shock sensation08.06.02.023; 17.02.07.024---
Face presentation18.03.04.0030.000020%-
Fear of weight gain19.06.03.0180.000020%-
Foetal arrhythmia02.03.02.034; 18.03.02.0210.000020%-
Genital anaesthesia17.02.06.042; 21.10.05.0210.000049%-
Haemophagocytic lymphohistiocytosis01.05.01.026; 10.02.01.077; 16.32.03.0380.000020%-
Heavy menstrual bleeding21.01.03.005---
Hepatic cytolysis09.01.07.0360.000039%-
Hypersensitivity pneumonitis10.01.03.056; 22.01.01.027---
Immune thrombocytopenia01.08.01.013; 10.02.01.0830.000020%-
Inhibitory drug interaction08.06.03.0140.000079%-
Intermenstrual bleeding21.01.01.015---
Mast cell activation syndrome01.05.01.030; 10.02.01.0900.000118%-
Near death experience17.02.04.023; 19.10.05.0070.000020%-
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ADReCS-Target
Drug Name ADR Term Target
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