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)
Necrotising enterocolitis neonatal18.04.11.002; 07.08.03.0110.000049%Not Available
Haemorrhagic transformation stroke24.07.04.018; 17.08.01.0360.000039%Not Available
Foetal death18.01.02.003; 08.04.01.0110.000089%
Haemorrhage24.07.01.002--Not Available
Postmenopausal haemorrhage24.07.03.002; 21.02.01.0020.000020%Not Available
Body height decreased13.15.01.029--Not Available
Gynaecological examination abnormal13.15.01.021--Not Available
Colitis microscopic07.08.01.0110.000039%Not Available
Temperature intolerance08.01.09.0220.000020%Not Available
Paraesthesia oral17.02.06.008; 07.05.05.0350.000043%Not Available
Testis cancer21.13.02.001; 16.25.03.0010.000138%Not Available
Anxiety disorder19.06.01.0020.000030%Not Available
Bipolar disorder19.16.01.0030.000039%Not Available
Cognitive disorder19.21.02.001; 17.03.03.0030.000157%
Female sexual dysfunction21.03.02.004; 19.08.05.001--Not Available
Major depression19.15.01.0030.000102%Not Available
Reflux gastritis07.08.02.0040.000053%Not Available
Pulseless electrical activity02.03.04.0200.000049%Not Available
Hypogonadism21.03.02.010; 05.05.04.0020.000030%Not Available
Orchitis noninfective21.09.02.003--Not Available
Nuchal rigidity17.05.02.006; 15.05.04.005--Not Available
Restless legs syndrome17.02.07.008; 15.05.03.0120.000108%Not Available
Disturbance in sexual arousal19.08.04.003--Not Available
Bone metabolism disorder15.02.03.009; 14.04.04.0090.000030%Not Available
Venous occlusion24.04.02.0090.000020%Not Available
Ventricular dysfunction02.04.02.0050.000020%Not Available
Cerebral vasoconstriction24.04.06.025; 17.08.02.0120.000148%Not Available
Angiopathy24.03.02.0070.000020%Not Available
Epidermal necrosis23.03.03.035--Not Available
Blood alkaline phosphatase increased13.04.02.004--
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ADReCS-Target
Drug Name ADR Term Target
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