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)
Feeling of despair19.15.02.0060.000106%Not Available
Fibrocystic breast disease21.05.04.018; 16.14.01.003--Not Available
Flat affect19.04.01.0040.000053%Not Available
Flatulence07.01.04.002--
Fluid retention20.01.02.003; 14.05.06.002--Not Available
Foetal alcohol syndrome17.19.03.003; 03.02.02.002; 12.03.03.002; 18.03.03.002--Not Available
Foetal distress syndrome18.03.02.0030.000069%Not Available
Food interaction08.06.03.0020.000132%Not Available
Fungal skin infection23.11.03.006; 11.03.05.002--Not Available
Furuncle23.11.02.009; 11.02.05.008--Not Available
Gait disturbance15.03.05.013; 17.02.05.016; 08.01.02.002--
Galactorrhoea21.05.02.002; 05.03.04.0020.000079%Not Available
Gastric ulcer07.04.03.002--
Gastric ulcer haemorrhage24.07.02.003; 07.04.03.005--Not Available
Gastritis07.08.02.0010.000039%
Gastrooesophageal reflux disease07.02.02.0030.000392%
Gastroenteritis11.01.07.004; 07.19.03.001--Not Available
Gastrointestinal disorder07.11.01.001--Not Available
Gastrointestinal haemorrhage07.12.02.001; 24.07.02.009--Not Available
Gastrointestinal pain07.01.05.0050.000020%
Generalised anxiety disorder19.06.01.0040.000020%Not Available
Generalised oedema14.05.06.007; 08.01.07.004--
Generalised tonic-clonic seizure17.12.01.0020.000374%Not Available
Gestational diabetes18.02.04.001; 14.06.01.008; 05.06.01.0080.000303%Not Available
Gingival bleeding24.07.02.010; 07.09.07.001--Not Available
Gingivitis11.01.04.013; 07.09.10.002--
Glaucoma06.03.01.002--
Glossitis07.14.01.001--Not Available
Glycosuria20.02.01.005--
Goitre14.11.01.008; 05.02.01.001--Not Available
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ADReCS-Target
Drug Name ADR Term Target
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