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)
Oppositional defiant disorder19.21.04.0030.000091%Not Available
Bradycardia neonatal18.04.07.004; 02.03.02.0190.000227%Not Available
Meconium stain18.05.01.0080.000136%Not Available
Aortic dilatation24.03.04.0070.000091%Not Available
Subacute cutaneous lupus erythematosus10.04.03.012; 23.03.02.020; 15.06.02.0120.000227%Not Available
Right ventricular dysfunction02.04.02.0330.000136%
Negative thoughts19.15.02.0120.000227%Not Available
Sopor19.02.04.002; 17.02.04.0210.000545%Not Available
Psychogenic seizure19.24.01.0070.000363%Not Available
Neonatal aspiration18.04.09.007; 22.11.01.0080.000091%Not Available
Wound infection staphylococcal12.02.05.051; 11.02.05.0140.000091%Not Available
Tongue injury12.01.09.020; 07.14.01.0160.000091%Not Available
Base excess increased13.02.01.0220.000136%Not Available
Laryngomalacia22.04.02.007; 03.16.02.0040.000091%Not Available
Analgesic drug level increased13.17.01.0140.000136%Not Available
Arterial stenosis24.04.02.0120.000136%Not Available
Communication disorder19.19.01.0080.000091%Not Available
Congenital aortic anomaly24.03.03.021; 03.07.08.0030.000182%Not Available
Congenital cardiovascular anomaly24.03.03.011; 03.07.10.001; 02.08.02.0040.001815%Not Available
Congenital pulmonary artery anomaly03.07.09.004; 24.03.03.0240.000036%Not Available
Foot deformity15.10.03.0050.000272%Not Available
Head deformity15.10.05.0050.000227%Not Available
Neck deformity15.10.04.0090.000227%Not Available
Antidepressant drug level increased13.17.01.0260.000182%Not Available
Gastric cancer stage IV16.13.03.003; 07.21.02.0030.000047%Not Available
Congenital nose malformation22.10.02.003; 03.16.04.0010.000227%Not Available
Antipsychotic drug level increased13.17.01.0300.000227%Not Available
Atrioventricular septal defect03.07.02.005; 02.04.02.0290.000272%Not Available
Congenital heart valve disorder03.07.05.001; 02.07.02.0020.000318%Not Available
Amniotic band syndrome18.05.01.006; 15.11.07.017; 03.11.07.0170.000036%Not Available
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