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)
Atelectasis neonatal22.11.01.004; 18.04.09.0040.000059%Not Available
Blood hyposmosis14.05.01.0080.000049%Not Available
Breast cancer recurrent21.05.01.017; 16.10.01.0090.000039%Not Available
Carcinoid syndrome05.08.02.005; 16.32.02.0040.000108%Not Available
Cephalo-pelvic disproportion18.07.02.0090.000030%Not Available
Coeliac disease07.17.01.008; 14.02.01.007; 10.04.04.0120.000039%Not Available
Concomitant disease aggravated08.01.03.0630.000030%Not Available
Confabulation19.10.03.0090.000020%Not Available
Cyanosis neonatal22.11.02.003; 18.04.09.0060.000039%Not Available
Dissociative identity disorder19.14.01.0060.000059%Not Available
Drowning08.04.01.014; 12.01.18.0030.000020%Not Available
Excessive masturbation19.08.03.0070.000020%Not Available
Exhibitionism19.08.06.0010.000043%Not Available
Grandiosity19.05.01.0190.000020%Not Available
Impulsive behaviour19.18.01.0010.000118%Not Available
Large for dates baby18.04.02.0040.000089%Not Available
Macrosomia08.01.03.0730.000039%Not Available
Mitral valve prolapse02.07.01.0080.000059%Not Available
Mitral valve stenosis02.07.01.0090.000020%Not Available
Neonatal anoxia22.11.02.005; 18.04.15.0040.000020%Not Available
Neonatal asphyxia22.11.02.006; 18.04.15.0050.000039%Not Available
Neonatal respiratory acidosis22.11.01.009; 18.04.09.008; 14.01.04.0060.000039%Not Available
Neonatal respiratory arrest22.11.02.008; 18.04.17.0010.000020%Not Available
Neonatal respiratory depression22.11.02.009; 18.04.17.0020.000079%Not Available
Neonatal respiratory distress syndrome18.04.10.003; 22.11.02.0100.000207%Not Available
Normal newborn18.08.06.0010.000067%Not Available
Persecutory delusion19.10.01.0070.000059%Not Available
Placenta praevia18.05.02.0040.000030%Not Available
Placenta praevia haemorrhage24.07.03.026; 18.02.01.0050.000020%Not Available
Placental insufficiency18.05.02.006; 24.04.12.0020.000020%Not Available
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ADReCS-Target
Drug Name ADR Term Target
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