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)
Urine output increased13.13.03.002---
Gastric pH decreased13.05.04.001---
Hot flush08.01.03.027; 21.02.02.001; 24.03.01.005--
Brain neoplasm16.30.01.003; 17.20.01.0030.000030%-
Breast disorder21.05.04.004---
Cranial nerve disorder17.04.01.0010.000030%-
Eye movement disorder06.05.02.008; 17.02.05.0250.000128%-
Genital haemorrhage21.10.05.002; 24.07.03.007---
Impulse-control disorder19.18.01.0020.000093%-
Libido disorder19.08.03.004; 21.03.02.0060.000020%-
Ischaemic stroke17.08.01.018; 24.04.06.0100.000118%-
Jaw disorder15.02.04.0090.000089%-
Lactation disorder18.06.02.003; 21.05.02.0040.000043%
Learning disorder19.21.05.0010.000039%-
Malnutrition14.03.02.004---
Mental disorder19.07.01.0020.000122%-
Motor dysfunction15.05.06.006; 17.01.02.0310.000020%-
Partial seizures17.12.03.0100.000020%-
Therapeutic reaction time decreased08.06.01.015---
Cardiac valve disease02.07.02.0010.000069%-
Abnormal behaviour19.01.01.0010.000415%-
Decreased appetite08.01.09.028; 14.03.01.005--
Central nervous system stimulation25.04.01.001---
Feeling of body temperature change08.01.09.0120.000030%-
Erectile dysfunction19.08.04.001; 21.03.01.0070.000098%
Psychiatric symptom19.01.02.0010.000020%-
Pulmonary vascular disorder22.06.03.002; 24.03.08.0030.000020%-
Respiratory disorder neonatal18.04.09.002; 22.11.01.0020.000167%-
Ill-defined disorder08.01.03.049---
Mitral valve disease02.07.01.0030.000020%
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ADReCS-Target
Drug Name ADR Term Target
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