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 Labeled indication include: major depressive disorder (MDD), moderate to severe bulimia nervosa, obsessive-compulsive disorder (OCD), premenstrual dysphoric disorder (PMDD), panic disorder with or without agoraphobia, and combination treatment with olanzapine for treatment-resistant or bipolar I depression. Unlabeled indications include: selective mutism, mild dementia-associated agitation in nonpsychotic patients, post-traumatic stress disorder (PTSD), social anxiety disorder, chronic neuropathic pain, fibromyalgia, and Raynaud's phenomenon.
Marketing Status Prescription; Discontinued
ATC Code N06AB03
DrugBank ID DB00472
KEGG ID D00326
MeSH ID D005473
PubChem ID 3386
TTD Drug ID D0TR5X
NDC Product Code 0093-7188; 50090-3332; 50228-420; 67296-1198; 63304-632; 70934-712; 63187-233; 50111-647; 61919-253; 0904-5785; 50228-421; 59651-324; 61919-885; 58118-0645; 59651-308; 53002-2305; 42708-025; 16714-112; 68071-4033; 42291-397; 16714-113; 23155-030; 71209-041; 42291-398; 0093-7198; 63629-2201; 59651-309; 61919-745; 46708-272; 53002-5016; 16714-353; 23155-029; 68001-129; 0093-0807; 62332-242; 46708-273; 71335-0924; 61919-869; 62332-022; 65862-306; 68071-4606; 46708-271; 72241-007; 43063-839; 55111-150; 50090-2776; 0615-8093; 49884-468; 16714-351; 23155-028; 71610-464; 0093-5262; 0904-5784; 68645-130; 43598-566; 60760-259; 55154-1341; 16714-352; 13668-473; 71205-178; 13668-443; 61919-100; 55700-089; 0615-7625; 50090-0744; 42291-396; 62332-243; 63187-089; 72241-008; 71335-1048; 50111-648; 71209-040; 72241-009; 71205-188; 61919-490; 71335-0565; 62332-024; 68645-131; 63629-8179; 62332-023; 71209-042
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
ADR Related Proteins Induced by Drug
ADR Term Protein Name UniProt AC TTD Target ID PMID
Poisoning and toxicityCytochrome P450 2D6P10635T57392Not Available
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Death neonatal18.04.01.002; 08.04.01.0020.000024%
Decreased activity19.11.01.002; 08.01.01.0060.000136%Not Available
Decreased interest19.15.02.0040.000091%Not Available
Decubitus ulcer23.03.11.0060.000091%Not Available
Dehydration14.05.05.001--
Delirium19.13.02.0010.000726%
Delusion19.10.01.0010.000363%
Dementia Alzheimer's type19.20.03.001; 17.03.06.0010.000091%Not Available
Dental caries07.09.01.0010.000091%
Dependence19.07.02.003--Not Available
Depressed level of consciousness17.02.04.0020.000998%
Depressed mood19.15.02.0010.001543%Not Available
Depression19.15.01.0010.005128%
Depression suicidal19.15.01.0040.000091%Not Available
Dermatitis23.03.04.0020.000136%Not Available
Dermatitis bullous23.03.01.0020.000182%
Dermatitis contact23.03.04.004; 12.03.01.040; 10.01.01.003--Not Available
Dermatitis exfoliative23.03.07.001; 10.01.01.004--
Dermoid cyst16.02.02.006; 03.05.01.0050.000091%Not Available
Developmental delay08.01.03.0370.000635%Not Available
Diabetes insipidus14.05.07.003; 05.03.03.0040.000227%Not Available
Diabetes mellitus14.06.01.001; 05.06.01.001--Not Available
Diabetic ketoacidosis14.07.03.001; 05.07.03.001--Not Available
Diaphragmatic paralysis22.09.02.002; 17.01.04.0140.000091%Not Available
Diarrhoea07.02.01.001--
Diarrhoea haemorrhagic07.02.01.002; 24.07.02.004--Not Available
Dilatation atrial02.04.02.0190.000091%Not Available
Dilatation ventricular02.04.02.0260.000771%Not Available
Diplopia06.02.06.002; 17.17.01.0050.000363%Not Available
Discomfort08.01.08.003--Not Available
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