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)
Pulmonary artery stenosis24.04.09.011; 22.06.03.0060.000059%Not Available
Pulmonary haemosiderosis22.01.02.024; 14.13.03.0060.000049%Not Available
Pulmonary sarcoidosis22.01.01.023; 10.02.06.0030.000039%Not Available
Pulmonary valve stenosis02.07.04.0050.000246%Not Available
Reading disorder19.21.05.0030.000020%Not Available
Shoulder dystocia18.03.04.0020.000020%Not Available
Small for dates baby18.04.02.0020.000285%Not Available
Social anxiety disorder19.06.03.0100.000020%Not Available
Speech disorder developmental19.19.01.003; 17.02.08.0110.000039%Not Available
Transient tachypnoea of the newborn22.11.01.010; 18.04.09.0100.000020%Not Available
Umbilical cord around neck18.04.14.0040.000049%Not Available
Vesicoureteric reflux20.03.05.0020.000020%Not Available
Violence-related symptom19.05.01.022--Not Available
Umbilical cord abnormality18.04.14.0030.000030%Not Available
Hypertonia neonatal18.04.01.016; 17.05.02.017; 15.05.04.0190.000079%Not Available
Subdural hygroma17.11.01.0180.000020%Not Available
Self-induced vomiting19.09.02.0010.000020%Not Available
Cerebral ventricle dilatation17.11.01.0130.000059%Not Available
Weight loss poor14.03.02.0270.000030%Not Available
Live birth18.08.02.0070.000059%Not Available
Poor weight gain neonatal18.04.02.0050.000049%Not Available
Self esteem decreased19.05.02.0040.000063%Not Available
Right ventricular hypertrophy02.04.02.0340.000079%Not Available
Pulmonary oedema neonatal22.01.03.011; 18.04.09.009; 02.05.02.0070.000039%Not Available
Tongue biting12.01.17.023; 17.02.05.064; 07.14.01.0130.000020%Not Available
Meconium in amniotic fluid18.05.01.0070.000069%Not Available
Retroplacental haematoma24.07.03.029; 18.02.01.0060.000030%Not Available
Breast cancer metastatic21.05.01.016; 16.10.01.0080.000039%Not Available
Tracheomalacia08.07.02.002; 22.04.07.0110.000079%Not Available
Oppositional defiant disorder19.21.04.0030.000020%Not Available
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ADReCS-Target
Drug Name ADR Term Target
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