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)
Pituitary tumour benign16.37.02.001; 05.03.05.0030.000020%Not Available
Sensation of foreign body08.01.09.0020.000053%Not Available
Ulcer haemorrhage24.07.01.040; 08.03.06.003--Not Available
Blood disorder01.05.01.004--Not Available
Adjustment disorder19.23.01.0010.000020%Not Available
Disease recurrence08.01.03.0500.000236%Not Available
Neoplasm recurrence16.16.02.0040.000030%Not Available
Obstructive airways disorder22.03.01.0110.000030%Not Available
Psychotic disorder19.03.01.0020.000201%
Genital infection female21.14.04.003; 11.01.10.011--Not Available
Hyperlipidaemia14.08.03.001--
Renal impairment20.01.03.010--Not Available
Urethritis noninfective20.07.02.002--Not Available
Facial spasm17.04.03.010--Not Available
Cystitis noninfective20.03.02.001--
Chorioretinopathy06.09.01.0060.000020%Not Available
Autism spectrum disorder17.03.05.003; 19.22.02.0020.001027%Not Available
Lipoedema14.08.04.0210.000020%Not Available
Gastrointestinal inflammation07.08.03.0070.000030%Not Available
Oral mucosal exfoliation07.05.05.0110.000030%Not Available
Spontaneous haematoma24.07.01.054; 01.01.03.0060.000020%Not Available
Bone marrow failure01.03.03.0050.000128%
Suicidal behaviour19.12.01.0060.000167%Not Available
Bronchial hyperreactivity22.03.01.0160.000020%Not Available
Substance abuse19.07.06.0180.000039%Not Available
Hypersexuality19.08.03.0050.000030%Not Available
Liver injury12.01.17.012; 09.01.07.0220.000049%Not Available
Regurgitation07.01.07.0040.000049%Not Available
Low birth weight baby18.04.02.0030.000157%Not Available
Compulsive shopping19.06.05.0040.000059%Not Available
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ADReCS-Target
Drug Name ADR Term Target
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